Gastroenterology News

University Of Kentucky Gill Heart Researchers Study Abdominal Aortic Aneurysms

2012-02-11T12:06:00.000-08:00

As the baby boomer generation races toward Medicare eligibility, a new screening procedure could mean that many men in the United States may soon learn that they have a killer condition they can do little or nothing about.

Anticipating a surge in diagnosed cases of abdominal aortic aneurysm, a condition for which Medicare just approved a one-time free screening for men, University of Kentucky researchers are working with $8.5 million in NIH funding to understand the condition and how it can be treated.

"In collaborative studies with Lisa Cassis, professor and director of the UK Graduate Center for Nutritional Sciences, we serendipitously developed an animal model of abdominal aneurysms that is not used in many laboratories, This model has provided us with way of defining the mechanisms that initiate and propagate this devastating disease," said Alan Daugherty, Director, UK Cardiovascular Research Center.
the United States there are currently 78.8 million baby boomers - people born between 1946 and 1964. More than half of baby boomers will be age 50 or older by next May, and this January will mark the 60th birthdays of the oldest boomers, according to an analysis of U.S. Census data by American Demographics.

Abdominal aneurysm currently ranks as the 10th leading killer in the United States; although scientists suspect that the incidence may be even higher as the disease is only detected upon autopsy, and autopsies are not always performed in the deaths of older people. The condition primarily affects men over age 55, so the Medicare-covered screening will only be for men. Currently, if a screening detects an abdominal aneurysm, patients face an expensive and unsure course of surgical of treatment. The aneurysm must be monitored, and physicians must use their best judgment to decide when and if surgery is warranted. Open surgery is a long term fix for this disease, but is associated with risks and long recovery times. More recently, endovascular approaches have been developed in which patients recover quickly. However, this intervention is not without significant risk, and is expensive. There is a dire need for development of a drug that will favorably impact this disease. At present, there is no non-surgical therapy for abdominal aortic aneurysm that has proven of benefit.

The expected hit to the Medicare system from the influx of aging baby boomers means that surgical treatment for every case of abdominal aneurysm expected to be diagnosed in coming years would be prohibitive.

Aside from costs, the number of surgeons, support staff and facilities equipped to deal with the surgery will be outstripped by the need to treat the huge numbers of men who may learn they have an aneurysm threatening their lives.

The research team at UK HealthCare's Jack and Linda Gill Heart Institute, led by Daugherty, will spend the next five years working with an animal model of abdominal aneurysm. The goal is to form a sufficient understanding of the condition to move into clinical trials, and eventually into the implementation of a pharmacological treatment for abdominal aneurysm.

Cassis and Nancy R. Webb, associate professor of internal medicine, along with Daugherty will direct their research toward understanding three separate facets of abdominal aneurysm. Cassis will lead a group focusing on gender effects, asking why the condition is much more prevalent in men. Webb's team will look at the role inflammation processes play in the disease, while Daugherty will investigate why abdominal aneurysm is always located in a specific location of the abdominal aorta.

A pharmacological solution to abdominal aneurysm treatment would mean that instead of waiting and wondering about a diagnosed aneurysm, patients and their doctors could aggressively treat the problem through drug therapies.

Pharmacological treatment is projected to be less expensive and less risky for most patients. Given the amount of time it takes to research a drug and bring it to market, it is possible that today's crop of 50-something baby boomer men may have an answer to abdominal aneurysm treatment by the time they qualify for the Medicare-approved screening at age 65.

UK was chosen as the site for this research after a peer review process at the National Institutes of Health enthusiastically endorsed the proposed research program that has been developed by the team of UK investigators, Daugherty, Cassis, and Webb. The Cardiovascular Research Center currently has more than $20 million dollars in NIH and other funding, and is a leader in cutting-edge clinical and translational research.

In striving to become a Top 20 public research institution, the University of Kentucky is a catalyst for a new Commonwealth - a Kentucky that is healthier, better educated, and positioned to compete in a global and changing economy. For more information about UK's efforts to become a Top 20 university, please go to uky.edu/OPBPA/Top20.html

Contact: Allison Elliott

University of Kentucky

New Technique Reveals Pancreatic Stem Cells

2012-02-04T12:04:00.000-08:00

Wanted: stems cells. Just like those absconders chased by police all over the world, everybody can tell about their good deeds but none really knows how to recognize them. Yet, thanks to a study published in the Proceedings of the National Accademy of Sciences (PNAS) and authored by Nobel Laureate for Medicine in 2007 Mario Capecchi and by the researcher from the Catholic University of Rome Eugenio Sangiorgi, we now know how to reveal the stem cells camouflaged in the pancreas.

A stem cell is a cell capable of generating all the other cells constituting the same tissue (sometimes also called "adult stem cell").

"Reading the newspapers sometimes one would doubt it," says Sangiorgi, "but we don't know many things about stem cells. It might look odd, but for instance we don't have a method to distinguish a priori between a stem cell and any other cell in the same tissue. We can only infer that a cell really is a stem cell by observing its behaviour."

In other words, when a researcher encounters a tissue, it's not immediately possible to identify with certainty and thus isolate a stem cell. In some case, like in the meadows, we now know where they are located and how to single them out - and hence we have been capable of successful life saving transplants for many years. But in the case of the pancreas, as in that of many other tissues, until some years ago we doubted that these special cells were even present there.

"Together with Professor Capecchi, we had already designed in the past a novel way to mark the stem cells in a tissue: a sort of little flag, capable of helping us to effectively label the cells we were looking for", explains Sangiorgi. In order to achieve this, Capecchi and Sangiorgi used a molecular switch, that is a piece of DNA, which activates itself once the mouse under scrutiny takes a special drug. When the switch is "on", a special fluorescent protein is produced (and, as a matter of fact, the study about this type of proteins won the Nobel Prize in Chemistry last October). The luminous cells are indeed the long-sought stem cells.

"In order to understand that these are really stem cells, we need only to wait", comments Sangiorgi. "A normal cell is sooner or later destined to die. A stem cell, instead, retains its capacity to renew itself and replicate. Thus, if we can still observe, many months later, that a cell is still alive, that means it is indeed a stem cell - or a cell derived directly from the division of a stem cell".

In the newly published article, Sangiorgi and Capecchi have shown with their technique that a particular subset of the pancreatic cells, the so-called acinar cells, are indeed stem cells. The truly interesting aspect of their results is that these cells also produce important digestive enzymes.

"So far, a stem cell was really looked upon as a sort of General, in charge of all the other cells, but really doing nothing: an undifferentiated cell, but with no specific task other than generating new tissue. Acinar cells, on the other hand, despite being proved stem cells, have a well defined task in the pancreas. They are like soldiers doing their job, but also capable - when necessary - of taking over the reins of the government", tells Sangiorgi with a metaphor.

The work of Capecchi and Sangiorgi paves the way to an extension of the definition of the stem cell, which will lead to a more detailed study on the proliferation mechanisms at the root of the success of these cells - and of their potential danger.

"Thanks to their extraordinary reproductive power - Sangiorgi, in fact, explains - these cells might even turn out to be carcinogenic. But if we are capable of constructing an effective instrument like ours in order to isolate and study them even in other organs, we can study their properties and give many answers about the way they work. One of the things we would like to understand is if also in vivo these types of cells - somehow eternal - are more tumour-sensitive - for instance because they tend to accumulate all the potential environmental risk factors throughout their very long life".

Eugenio Sangiorgi has been collaborating with Mario Capecchi for many years: "I already admired him a great deal before he won the Nobel Prize", he says. "The nicest thing about him is that - even at 72 - he keeps working in active research and continues being as enthusiastic as a child, always full of new ideas".

Source:
Eugenio Sangiorgi

Catholic University of Rome

Motion Sickness A Reality In The Virtual World, Too

2012-01-28T12:02:00.000-08:00

Clemson University psychologist Eric Muth sees motion sickness as potential fallout from high-end technology that once was limited to the commercial marketplace moving to consumer use in gaming devices.

Microsoft's Kinect is the latest example of technology with the potential to use a helmet-mounted display to immerse the gamer in a 3D virtual world. It uses sensors and software to detect body movement and positioning to control responses in a game environment, although he said the risk of motion sickness from Kinect itself likely is low.

"What was once limited to the military and high-tech research, where users were screened and monitored for negative reactions, is available now to the public," said Muth, who is director of Clemson's Human Factors Institute. "You're not talking about carefully selected users like pilots and astronauts. Anybody with a few hundred dollars to spend can use it and the access will spread. The downside could be that people sensitive to visual disorders and susceptible to motion sickness suffer symptoms ranging from nausea to seizures. There needs to be a lot more research into the side effects."

Muth's research focuses on helmet-mounted displays that are used in virtual-environments technology. Before coming to Clemson 11 years ago, Muth spent three years in the Navy as an aerospace experimental psychologist working on wearable monitors and tracking systems to improve military training and to monitor soldiers, sailors and marines during combat. Now he uses helmet-mounted displays to study motion sickness, nausea and other upper gastrointestinal discomforts - the area of his graduate studies at the Pennsylvania State University under Robert Stern, a pioneer in biofeedback.

"Basically, when people are exposed to stimuli from a helmet-mounted display in the lab, it involves linking a subject's head movements to the changing view in the virtual environment," he said. "The response is complicated. It's not just a perceptual adjustment.

"Years ago research showed that the brain can re-set an upside-down view of world to be right side up. Constantly changing images pose a bigger challenge for the brain, which has to deal with 'lag': the time it takes the computer system to update and display changing visual images corresponding to the users head movements. This may be a variable linked to motion sickness and other symptoms related to helmet-mounted devices."

Muth and the other researchers at the Human Factors Institute seek to improve the way people interact with technology and devices.

"Helmet-mounted devices are going to be found everywhere as video gamers and the public get caught up in virtual reality," said Muth. "We have already seen the popularity of 3D movies, and 3D television is making its way into our living rooms. We need to know more about the side effects and how to deal with them. I would not allow my kids to use this technology before checking their susceptibility to the downsides, and even then I would limit and monitor their access to the virtual world."

Source:

Eric Muth

Clemson University

Hospital Stress Turns Friendly Gut Bacteria Nasty, Killing 40% Of Patients

2012-01-21T12:00:00.000-08:00

Researchers have discovered that our friendly gut bacteria, vital partners in fermenting and processing our everyday food, turn on us in times of stress such as major surgery, cancer chemotherapy or bowel disease and seize the opportunity to create havoc and kill our other probiotic bacteria.

Swimmer's Ear, infections from wearing contact lenses, and puncture wounds in children's feet which turn septic are all caused by the common bacteria Pseudomonas aeruginosa, which is widely found in soil, water and sewage. While only 3% of people normally harbour this organism in their intestines, during hospitalization for critical illness, more than 50% of patients end up with this bacteria. Most of the time Pseudomonas aeruginosa lives within our guts in peaceful co-existence when we have plenty of food and good health. But in times of stress such as during hospital stays they rapidly turn on us and become concerned only for their own survival. Patients infected with Pseudomonas aeruginosa have a high fatality rate approaching 40%.

"Since most hospital acquired infections develop from bacteria we already have in our guts, working out how to shield them from the stress molecules we produce may be a more effective treatment than trying to use antibiotics to kill them", says medical researcher Professor Olga Zaborina from the University of Chicago, USA.

The scientists have discovered for the first time that these bacteria have a highly sophisticated sensing apparatus which recognises and intercepts chemical compounds we produce during stress such as endorphin hormones, immune system molecules such as interferon, and signals produced by damaged and oxygen starved tissues like adenosine.

"This means that the bacteria have evolved a way of taking advantage of any opportunity through their highly refined 'sense and respond circuits' which can identify the very molecules we humans use to respond to stress or illness", says Professor Zaborina. "This virulence circuitry is so clever that P. aeruginosa can recognise our weakness, communicate this information to other bacteria, and simultaneously release compounds which kill our normal probiotic gut bacteria", giving them home field advantage right off the bat.

Currently over-using antibiotics in hospitals is causing major problems with the spread of antibiotic resistance amongst bacteria. Even ordinary environmental bacteria have evolved a highly sophisticated mechanism to become resistant to antibiotics, enabling them to kill badly stressed and weak patients. Intestinal bacteria such as P. aeruginosa are a particular problem because they form a protective slime, called a biofilm, which stops antibiotics from killing them. Even within the slime they can still sense and respond to a host's stress chemicals, causing infections.

The only treatments available until now have been a 'take no prisoners' approach using antibiotics which kill several types of bacteria including the normal, protective, probiotic bacteria in our guts, further weakening the patient.

"If we do not find a strategy to contain intestinal bacteria rather than eliminating them, which helps spread resistance, we will soon run out of effective antibiotics", says Professor Zaborina. "We know of many diseases caused or complicated by intestinal bacteria such as Inflammatory Bowel Disease, infectious diarrhoea, or cancer treatments such as chemotherapy and bone marrow transplants".

"Yet in all these cases specific bacterial strains responsible for the problem cannot always be identified, because the species are difficult to culture", says Professor Zaborina. In addition it is not just the mere presence of the strains in the intestine that may be threatening, but rather the state of their virulence, which is not routinely examined clinically. "Exposing the Dr Jekyll and Mr Hyde nature of intestinal bacteria is a key to understanding how they behave. We cannot afford to ignore their will to survive during stress".

The scientists suggest that in future paying better attention to the needs of our gut bacteria, especially when someone is sick, dehydrated, starved or stressed, could help to reduce the need for antibiotics and lead to a lower hospital acquired infection rate.

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What The Public Needs To Know About Restaurant Inspections

2012-01-14T11:58:00.000-08:00

Foodborne diseases cause an estimated 76 million illnesses in the U.S. each year with about half associated with restaurant meals. More than 70 billion meals per year are purchased in restaurants in the U.S., accounting for 47% of total food expenditure. Therefore, preventing restaurant-associated foodborne disease is an important task of public health departments. According to an article published in the June 2008 issue of the American Journal of Preventive Medicine, the public is generally unaware of the frequency of restaurant inspections and the consequences of poor inspection results.

According to Timothy F. Jones, MD, Tennessee Department of Health and Vanderbilt University School of Medicine, "That consumers have a number of misconceptions and unrealistically high expectations of the restaurant-inspection system was a major finding of this large survey. Inspections are one mechanism through which regulatory agencies educate operators and encourage ongoing compliance. However, the industry must ultimately take responsibility for consistently and effectively maintaining food safety. Public health and regulatory agencies should work closely with the industry to improve consumers' understanding of inspection scores and the limitations of regulatory inspections, as well as the role of regulatory inspections in disease prevention."

Using data from telephone surveys of 2000 adults in Tennessee in 2006, researchers found that while almost all respondents (97%) were aware that restaurants were inspected regularly, over 50% believed that inspections occurred from 5 to more than 12 times per year. Only 33% correctly answered that the inspection frequency is twice per year. When asked how often restaurants should be inspected, even fewer people (9%) responded that restaurants should be inspected two times per year; 53% believed that inspections should occur about 12 times per year. When asked about the relative importance of inspections to protect consumers from illnesses, 70% said "very important" and 28% said it was "the most important" safety measure.

Tennessee restaurant inspectors use a 44-item checklist with a total possible score of 100 for best performance. Respondents were asked what score would be the lowest acceptable for a restaurant at which they would eat. Seventy-seven percent said a score of 80 or greater, of whom, 45% said more than 90. This contrasts to a mean score of 82 from another study of 168,000 inspections in Tennessee and where only one third of all restaurants scored higher than 90.

When asked what should happen if a restaurant did not get an acceptable score, 657 (37%) said the restaurant should be closed immediately and allowed to reopen when the situation was corrected. In Tennessee, as in many jurisdictions, it is unusual for sanctions to be imposed on an establishment based on a single inspection. Regulators work with operators to promptly mitigate risks, but closure generally follows recurrent problems that have gone uncorrected after substantial training and consultation.

The article is "Public Knowledge and Attitudes Regarding Public Health Inspections of Restaurants" by Timothy F. Jones, MD, and Karen Grimm, MA. It appears in the American Journal of Preventive Medicine, Volume 34, Issue 6 (June 2008) published by Elsevier.

Source: AJPM Editorial Office

Elsevier Health Sciences

European Regulators Reaffirm Pfizer's COX-2 Portfolio

2012-01-07T11:56:00.000-08:00

Pfizer Inc said today that European regulators have completed their safety assessment of the COX-2 specific inhibitor class and have reaffirmed the use of Pfizer's COX-2 specific inhibitor medicines Celebrex, Bextra and Dynastat in a broad range of patients.

The review, which began in July 2002, was conducted by the Committee for Proprietary Medicinal Products and has been ratified by the European Commission. As part of the ratification, Pfizer will revise the labels of its COX-2 specific inhibitors to clarify for physicians how best to use these medicines in patients with cardiovascular disease as well as patients at high risk of gastrointestinal events and patients who take low-dose aspirin.

'We are pleased that the Commission has affirmed the use of these important medicines for patients across Europe," said Dr. Jack Watters, Vice President of Medical and Regulatory Affairs for Pfizer Europe/Canada.

"Pfizer 's COX-2 specific inhibitor medicines have been studied in tens of thousands of patients worldwide and have been shown to be not only effective in reducing pain and inflammation, but do so with less risk of the gastrointestinal side effects often associated with older, non-steroidal anti-inflammatory drugs (NSAIDs)."

One of the many studies that demonstrate the superior gastrointestinal safety profile of Celebrex involved more than 1.4 million elderly patients in Ontario, Canada of which over 15,000 were treated with Celebrex. This study showed that patients who took older NSAIDs were four times more likely to be hospitalized due to a gastrointestinal hemorrhage than patients who received Celebrex.

European regulators affirmed that Celebrex can be appropriately used in patients with cardiovascular disease based on the large body of data submitted by Pfizer. One of these studies, which included more than 22,000 patients, confirmed that those who received Celebrex were not at an increased risk of serious coronary heart disease compared to patients who received placebo or other pain medicines (rofecoxib, naproxen and ibuprofen).

Pfizer's COX-2 specific inhibitor portfolio consists of Celebrex and Bextra, both oral medicines indicated for the treatment of rheumatoid and osteoarthritis, as well as Dynastat, an injectable COX-2 specific inhibitor used to manage post-surgical pain.

Celebrex is the most widely prescribed COX-2 specific inhibitor in the world with over 42 million patients treated since its introduction in 1999.

View drug information on Bextra.

Gastroenterologist Offers Tips For Choosing A Probiotic

2011-12-31T11:54:00.000-08:00

Probiotics are a new health "buzzword" that has people asking questions like "Should I be taking probiotics? If so, which ones?" "Are probiotic foods sufficient, or do I need a supplement?" "How do you know which brands are best or safest?"

When it comes to using probiotics effectively, some self-education is required, says Patricia Raymond, MD, board-certified gastroenterologist, author and assistant professor at Eastern Virginia Medical School.

"In the United States, probiotics are either food additives, or 'dietary supplements,'" says Dr. Raymond. "Because they are considered supplements and not drugs, they are not heavily regulated by the FDA, so you need to do some research to determine which ones will work for you."

Dr. Raymond offers her tips for choosing a probiotic:

- Assess your health needs: There is a very large variety of strains of probiotics available
and some are better suited to assist with certain problems than others. "If you're someone who simply suffers from occasional constipation, then a probiotic yogurt may do the trick," advises Dr. Raymond. "However, if you suffer from chronic, serious conditions, a supplement may be more appropriate, as more serious conditions require a probiotic dosage of at least 1 billion live micro-organisms in order to have an effect." Foods cannot sustain a number of micro-organisms that high.

- Look for scientific research. As more U.S. physicians are starting to accept probiotics as a legitimate therapy, more studies are being done with them. "For example, Saccharomyces boulardii, a yeast-based probiotic strain commonly sold under the brand name Florastor, has been shown in studies to provide significant benefits in managing even severe illnesses such as C. diff-associated disease, Crohn's disease and Ulcerative Colitis," says Dr. Raymond. Talk to your doctor to find out about the available science that supports the use of probiotics.

- Consider your lifestyle. The form in which a probiotics is packaged may be integral in how successfully you take it. "If you are a frequent traveler looking to combat issues like traveler's diarrhea, a probiotic that needs refrigeration may not be appropriate for you," suggests Dr. Raymond. "Instead, look for a freeze-dried product that can be stored and transported at room temperature."

- Read the labels: Do not take a probiotic that does not list the strain and number of live micro-organisms on the package. Also avoid products that do not have an expiration date.

florastories/

Abbott Launches Humira (Adalimumab) For Crohn's Disease

2011-12-24T11:52:00.000-08:00

Abbott launches HUMIRA® (adalimumab) as a treatment for severe, active Crohn's disease. Adalimumab is the first fully-human tumour necrosis factor antagonist (anti-TNF) to receive a licence for Crohn's disease, a chronic inflammatory disease of the gastrointestinal tract that impairs the lives of up to 60,000 people in the UK1 and causes 70-80% of patients to require major surgery within their lifetime.2

"Currently, there is no cure for Crohn's disease, which reinforces the need for effective treatment options that will help maintain control of the disease. Adalimumab represents an important advance in managing this serious and debilitating condition," said Professor Ghosh, Gastroenterologist from Hammersmith Hospital, London.

Clinical trials of adalimumab showed that:

-- Adalimumab demonstrated response from as early as week one3

-- Three times as many patients who continued on adalimumab maintained clinical remission*at one year compared with placebo4

-- 29% of patients on adalimumab in clinical remission at one year were able to discontinue use of corticosteroids compared with only 6% on placebo.4

Adalimumab is the second anti-TNF licenced for Crohn's disease but the first to offer adult patients the convenience of self-injection at home.

"The unpredictability of Crohn's disease makes it difficult to lead a normal life as the disease can flare-up at any time. We welcome the approval of adalimumab as a new treatment option which will assist patient independence and improve quality of life for Crohn's disease patients" said Richard Driscoll, Director of the National Association for Colitis and Crohn's Disease (NACC).

How adalimumab works

Adalimumab is a fully human monoclonal antibody that works by specifically blocking the activity of TNF, which is a key component of the inflammatory process associated with Crohn's disease. Fully human monoclonal antibodies are essentially indistinguishable from antibodies found in the body and represent the latest advance in the evolution of monoclonal antibodies.

Clinical trials

The EMEA's decision is based on the results of three-randomised, double-blind, placebo-controlled, multi-centre trials of adalimumab. In each trial, clinical remission was measured by a Crohn's Disease Activity Index (CDAI) score of less than 150. CDAI is a weighted composite score of eight clinical factors that evaluate patient wellness, including daily number of liquid or very soft stools, severity of abdominal pain, levels of general wellness and other measures.

CLASSIC I (Clinical assessment of Adalimumab Safety and efficacy Studied as an Induction therapy in Crohn's disease)3 was a study of 299 patients with moderate to severe Crohn's disease who were new to anti-TNF therapy. Results showed that adalimumab demonstrated response from week 1 and resulted in a greater percentage of patients achieving clinical remission at four weeks compared to placebo.

CHARM (Crohn???s trial of the fully Human antibody Adalimumab for Remission Maintenance) 4 was a 56-week trial that enrolled 854 patients with moderate to severely active Crohn's disease. The 499 patients who demonstrated clinical response (CDAI decrease of greater than or equal to 70 points from baseline) to adalimumab during a four-week, open-label induction phase were randomized to receive either adalimumab or placebo. Three times as many patients who continued on adalimumab maintained clinical remission at one year compared to placebo.

GAIN (Gauging Adalimumab effectiveness in Infliximab Non-Responders)5 evaluated the efficacy of adalimumab in 325 patients with moderate to severely active Crohn's disease who had previously lost response or were unable to tolerate infliximab. Adalimumab induced significantly higher rates of clinical remission compared to placebo.

More about Crohn's disease

Typically diagnosed before the age of 40, 6 Crohn's disease can have a devastating impact on the day-to-day life of patients, many of whom are young and active. Five years after developing Crohn's, 15-20% of people are disabled to some degree by their disease.7 Common symptoms include diarrhoea, abdominal pain, weight loss, fever, and in some cases, rectal bleeding. Many patients develop complications such as intestinal obstruction, fistulas (ulcers that form tunnels to surrounding tissues), and malnutrition.

Adalimumab licensed indications8

Crohn's disease

Adalimumab is indicated for treatment of severe, active Crohn's disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.

For induction treatment, adalimumab should be given in combination with cortiocosteroids. Adalimumab can be given as monotherapy in case of intolerance to corticosteroids or when continued treatment with corticosteroids is inappropriate.

The recommended adalimumab induction dose regimen for adult patients with severe Crohn's disease is usually 80 mg at week 0 followed by 40 mg at week 2.

In case there is a need for a more rapid response to therapy, the regimen 160 mg at week 0 (dose can be administered as four injections in one day or as two injections per day for two consecutive days), 80 mg at week 2, can be used with the awareness that the risk for adverse events is higher during induction. After induction treatment, the recommended dose is 40 mg every other week via subcutaneous injection.

Rheumatoid arthritis

Adalimumab in combination with methotrexate, is indicated for:

-- the treatment of moderate to severe, active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.

-- the treatment of severe, active and progressive RA in adults not previously treated with methotrexate.

Psoriatic arthritis

Article Type Normal Article Headline Article Article Type 2 Normal What Is? Insert for Today 14 June 1Adalimumab is indicated for the treatment of active and progressive psoriatic arthritis (PsA) in adults when the response to previous disease-modifying anti?rheumatic drug therapy has been inadequate.

Ankylosing spondylitis

Adalimumab is indicated for the treatment of adults with severe active ankylosing spondylitis (AS) who have had an inadequate response to conventional therapy.

For RA, PsA and AS, adalimumab is usually administered as 40mg every other week as a single dose via subcutaneous injection.

Please refer to the Summary of Product Characteristics for full information on adalimumab including contraindications, special warnings and precautions and side effect information.8

To date, adalimumab has been approved across indications in 67 countries, and more than 180,000 people worldwide are currently being treated with adalimumab. Clinical trials are currently under way evaluating the potential of adalimumab in other immune-mediated diseases.

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, device and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries.

abbott

References

1 The National Association for Colitis and Crohn's Disease (UK) IBD Basics Accessed 04 April 2007 nacc/content/ibd.asp

2 Carter M et al. Guidelines for the management of inflammatory bowel disease in
adults. Gut. 2004; 53: 1-16

3 Hanauer SB, et al. Human anti-tumour necrosis factor monoclonal antibody (adalimumab) in Crohn's disease: the CLASSIC 1 trial. Gastroenterology 2006; 130:323-333

4 Colombel JF, et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial. Gastroenterology 2007;132:52-65

5 Sandborn, Rutgeerts et al. Adalimumab Induction Therapy for Crohn Disease Previously Treated with Infliximab: A Randomized Trial. nnals of internal Medicine 2007;146 (12)

6 Crohn's disease NHS Direct Online Health Encyclopedia Accessed 22 May 2006
nhsdirect.nhs

7 Binder V, et al. Prognosis in Crohn's disease--based on results from a regional patient group from the county of Copenhagen. Gut 1985 Feb;26(2):146-50

8 Electronics Medicines Compendium Humira (adalimumab) Summary of Product characteristics emc.medicinesbr>

View drug information on Humira.

Peppermint Earns Respect In Mainstream Medicine

2011-12-17T11:50:00.000-08:00

University of Adelaide researchers have shown for the first time how peppermint helps to relieve Irritable Bowel Syndrome, which affects up to 20% of the population.

In a paper published this week in the international journal Pain, researchers from the University's Nerve-Gut Research Laboratory explain how peppermint activates an "anti-pain" channel in the colon, soothing inflammatory pain in the gastrointestinal tract.

Dr Stuart Brierley says while peppermint has been commonly prescribed by naturopaths for many years, there has been no clinical evidence until now to demonstrate why it is so effective in relieving pain.

"Our research shows that peppermint acts through a specific anti-pain channel called TRPM8 to reduce pain sensing fibres, particularly those activated by mustard and chilli. This is potentially the first step in determining a new type of mainstream clinical treatment for Irritable Bowel Syndrome (IBS)," he says.

IBS is a gastrointestinal disorder, causing abdominal pain, bloating, diarrhoea and/or constipation. It affects about 20% of Australians and costs millions of dollars each year in lost productivity, work absenteeism and health care.

"This is a debilitating condition and affects many people on a daily basis, particularly women who are twice as likely to experience Irritable Bowel Syndrome," Dr Brierley says.

"Some people find their symptoms appear after consuming fatty and spicy foods, coffee and alcohol, but it is more complex than that. There appears to be a definite link between IBS and a former bout of gastroenteritis, which leaves nerve pain fibres in a heightened state, altering mechanisms in the gut wall and resulting in ongoing pain."

Dr Brierley says the recent floods in Queensland and Victoria could result in a spike of gastroenteritis cases in Australia due to the contamination of some water supplies in affected regions.

He said case studies in Europe and Canada showed that many people who contracted gastroenteritis from contaminated water supplies went on to experience IBS symptoms that persisted for at least eight years.

There is no cure for IBS and it often comes and goes over a person's lifetime.

Apart from gastroenteritis and food intolerance, IBS can be brought on by food poisoning, stress, a reaction to antibiotics, and in some cases is genetic.

Dr Brierley is one of 25 researchers who work at the University of Adelaide's Nerve-Gut Research Laboratory, hoping to find cures and treatments for a range of intestinal diseases.

Source:
University of Adelaide

National Heritage Insurance Company Revises PillCam(R) SB Guidelines For California Medicare Patients

2011-12-10T11:48:00.000-08:00

Given Imaging Ltd. (NASDAQ: GIVN) today announced that the National Heritage Insurance Company (NHIC), California's Medicare Part B carrier, has revised its existing coverage policy for small bowel capsule endoscopy so that patients will no longer be required to undergo an upper endoscopy (EGD) prior to PillCam SB. NHIC serves approximately 3 million Medicare beneficiaries in California.

NIHC's revised policy states that PillCam SB is now considered an appropriate diagnostic following a negative colonoscopy to evaluate patients with suspected, but undiagnosed Crohn's disease. Further policy revisions include the use of PillCam SB in the diagnosis of iron deficiency anemia (IDA). These amendments now coincide with policy changes made in 2006 by NHIC of New England which services an additional 1 million Medicare beneficiaries in Massachusetts, Maine, New Hampshire and Vermont.

"Medicare administrators around the country continue to recognize the ability to effectively detect and diagnose diseases of the small intestine using capsule endoscopy," said Dr. C. Gregory Albers, medical director of gastrointestinal diagnostic services the H.H. Chao Comprehensive Digestive Disease Center at the University of California, Irvine Medical Center. "We expect that this procedure will benefit more patients by eliminating the need for a prior upper endoscopy."

The updated guidelines are effective immediately. Physicians reporting claims for reimbursement of capsule endoscopy of the small bowel should use CPT code 91110. For more information visit www.medicarenhic

About Given Imaging Ltd.

Given Imaging is redefining gastrointestinal diagnosis by developing, producing and marketing innovative, patient-friendly products for detecting gastrointestinal disorders. The company's technology platform is the PillCam® Platform, featuring the PillCam video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient, a sensor array, data recorder and RAPID® software. Given Imaging has three commercially available capsules: the PillCam SB video capsule to visualize the entire small intestine which is currently marketed in the United States and in more than 60 other countries; the PillCam ESO video capsule to visualize the esophagus; and the Agile™ patency capsule to determine the free passage of the PillCam capsule in the GI tract. The PillCam COLON video capsule to visualize the colon has been cleared for marketing in the European Union, and multi-center clinical trials are underway in Europe and the U.S. A capsule to visualize the stomach is under development. More than 500,000 patients worldwide have benefited from the PillCam capsule endoscopy procedure. Given Imaging's headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel; it has direct sales and marketing operations in the United States, Germany and France, and local offices in Japan, Spain and Australia. For more information, visit www.givenimaging.

This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, projections about our business and our future revenues, expenses and profitability. Forward-looking statements may be, but are not necessarily, identified by the use of forward-looking terminology such as "may," "anticipates," "estimates," "expects," "intends," "plans," "believes," and words and terms of similar substance. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual events, results, performance, circumstances or achievements of the Company to be materially different from any future events, results, performance, circumstances or achievements expressed or implied by such forward-looking statements. Factors that could cause actual events, results, performance, circumstances or achievements to differ from such forward-looking statements include, but are not limited to, the following: (1) satisfactory results of clinical trials with PillCam Colon (2) our ability to receive regulatory clearance or approval to market our products or changes in regulatory environment, (3) our success in implementing our sales, marketing and manufacturing plans, (4) protection and validity of patents and other intellectual property rights, (5) the impact of currency exchange rates, (6) the effect of competition by other companies, (7) the outcome of future litigation, including patent litigation with Olympus Corporation, (8) the reimbursement policies for our product from healthcare payors, (9) quarterly variations in operating results, (10) the possibility of armed conflict or civil or military unrest in Israel, and (11) other risks and factors disclosed in our filings with the U.S. Securities and Exchange Commission, including, but not limited to, risks and factors identified under such headings as "Risk Factors," "Cautionary Language Regarding Forward-Looking Statements" and "Operating Results and Financial Review and Prospects" in the Company's Annual Report on Form 20-F for the year ended December 31, 2005. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Except for the Company's ongoing obligations to disclose material information under the applicable securities laws, it undertakes no obligation to release publicly any revisions to any forward-looking statements, to report events or to report the occurrence of unanticipated events.

Researchers Wake Up Viruses Inside Tumors To Image And Then Destroy Cancers

2011-12-03T11:46:00.000-08:00

Researchers have found a way to activate Epstein-Barr viruses inside tumors as a way to identify patients whose infection can then be manipulated to destroy their tumors. They say this strategy could offer a novel way of treating many cancers associated with Epstein-Barr, including at least four different types of lymphoma and nasopharyngeal and gastric cancers.

In the March 1 issue of Clinical Cancer Research, a team of radiologists and oncologists from Johns Hopkins Medical Institutions describe how they used two agents already on the market - one of which is the multiple myeloma drug Velcade - to light up tumor viruses on a gamma camera. The technique is the first in the new field of in vivo molecular-genetic imaging that doesn't require transfecting tumors with a "reporter" gene, the scientists say.

"The beauty of this is that you don't have to introduce any reporter genes into the tumor because they are already there," says radiologist Martin G. Pomper, M.D., Ph.D. "This is the only example we know of where it is possible to image activated endogenous gene expression without having to transfect cells."

A variety of blood and solid cancers are more likely to occur in people who have been infected with the Epstein-Barr virus (EBV), but not everyone with these cancers has such infections. For those who do, researchers, such as Hopkins oncologist and co-author Richard F. Ambinder, M.D., Ph.D., have been working on ways to activate the reproductive, or "lytic" cycle, within the virus to make it replicate within the tumor cell. When enough viral particles are produced, the tumor will burst, releasing the virus. In animal experiments, this experimental therapy, called lytic induction therapy, results in tumor death.

As the first step in this study, researchers screened a wide variety of drugs to see if any of them could reawaken the virus. They were fortunate in that one of the genes that is expressed upon viral lytic induction is EBV's thymidine kinase (EBV-TK), an enzyme that helps the virus begin to reproduce. This kinase is of interest because researchers know its "sister" kinase, the one produced by the herpes simplex virus, can be imaged by an injected radiolabeled chemical (FIAU), which can then be imaged using a gamma camera.

"To perform molecular-genetic imaging, we have always had to infect cells with active herpes simplex virus so that they can replicate, express TK, and only then could we use the FIAU tracer to make the cells light up," Pomper says. "So we were hoping to find a way to turn latent Epstein-Barr virus on in these cancers, and use the thymidine kinase it then produces to enable us to see the virus-associated tumors with radiolabeled FIAU."

The researchers screened 2,700 agents until they hit upon Velcade, a targeted chemotherapy drug already approved for use in multiple myeloma. "We were both surprised and lucky," he says. "Velcade is a proteasome inhibitor, but it also induces the lytic cycle thereby activating the TK in the Epstein-Barr virus. Once the TK is activated, we can image the tumors."

To test their findings, the researchers used mice carrying human Burkitt's lymphoma, a cancer often associated with Epstein-Barr viral infection. Tumors glowed in mice given Velcade followed by an injection of FIAU, but not in mice that weren't given Velcade. Mice whose Burkitt's lymphoma did not contain Epstein-Barr virus also did not respond to either Velcade or FIAU, according to researchers.

"Velcade woke up the virus in the tumors, which increased viral load by 12-fold, all the while cranking out TK," Pomper says. "An injection of FIAU made it easy to image the tumors with virus in them."

The method is highly sensitive, he says: as few as five percent of the cells within the tumor mass needed to be induced into the lytic cycle in order to be detected.

Not only can FIAU light up the tumors, it can also potentially kill them, Pomper says. For imaging purposes, FIAU can carry a radionuclide that emits a low energy gamma photon, but it can also be engineered to carry therapeutic radionuclides, which are lethal to cells in which TK is activated.

Results of this study suggests that this strategy could be applied to other viruses associated with tumors, and that other drugs may potentially be used to activate these viruses, Pomper says. "Velcade is only one of an array of new, as well as older agents, that can induce lytic infection, and a particular agent could be tailored for use in a specific patient through imaging," he says.

The study was funded by the National Cancer Institute.

The mission of the American Association for Cancer Research is to prevent and cure cancer. Founded in 1907, AACR is the world's oldest and largest professional organization dedicated to advancing cancer research. The membership includes more than 24,000 basic, translational, and clinical researchers; health care professionals; and cancer survivors and advocates in the United States and more than 70 other countries. AACR marshals the full spectrum of expertise from the cancer community to accelerate progress in the prevention, diagnosis and treatment of cancer through high-quality scientific and educational programs. It funds innovative, meritorious research grants. The AACR Annual Meeting attracts more than 17,000 participants who share the latest discoveries and developments in the field. Special Conferences throughout the year present novel data across a wide variety of topics in cancer research, treatment, and patient care. AACR publishes five major peer-reviewed journals: Cancer Research; Clinical Cancer Research; Molecular Cancer Therapeutics; Molecular Cancer Research; and Cancer Epidemiology, Biomarkers & Prevention. Its most recent publication, CR, is a magazine for cancer survivors, patient advocates, their families, physicians, and scientists. It provides a forum for sharing essential, evidence-based information and perspectives on progress in cancer research, survivorship, and advocacy.

aacr

View drug information on Velcade.

A Step Closer To Drugs Against Winter Vomiting Disease

2011-11-26T11:44:00.000-08:00

The virus that causes winter vomiting disease invades cells by attaching to particular sugar molecules on the surface of the cells. This is the conclusion of a thesis presented at the Sahlgrenska Academy, University of Gothenburg, Sweden. This result may be an important step in the development of a drug against the regular hospital-based epidemics caused by the virus.

Winter vomiting disease is an infectious inflammation of the gastro-intestinal tract, which occurs principally during the winter months. There is presently no vaccine, and no drugs to combat the infection. The disease causes diarrhoea and vomiting, and its consequences may be very serious for people who are already seriously ill or weak.

"We are aiming to develop a drug that can be given to vulnerable persons and to children in day-care when it has become clear that another epidemic is starting to break out. More research will, however, be required. Our results are important steps along the way, but it will probably be several years before a drug is commercially available", says Gustaf Rydell who successfully defended his PhD thesis on June 8, 2009.

The thesis describes how the virus for winter vomiting disease can attach to cells by binding to special sugar chains. One of these chains is characterised in that it has a monosaccharide known as sialic acid at its end. The thesis also shows that the virus binds to such sugar chains even when they are not part of the cell surface. This means that it may be possible for the sugar chains to prevent the virus infecting the cells by blocking its binding structures.

"Our results suggest that the sugar chains that have sialic acid are important for infection by the virus, but this must be confirmed. If it is true, it would be possible to develop a drug that blocks the access of the virus to the sugar molecule. One thing that we must investigate first, however, is whether there are other target molecules that the virus can use to enter the cell. These may be the starting point for even more effective drugs", says Gustaf Rydell.

NOROVIRUSES

Noroviruses are considered to be the micro-organism that causes the greatest incidence of vomiting and diarrhoea in the world. The viruses are responsible for approximately 200,000 child deaths in developing countries each year. Development of pharmaceuticals is made difficult by the fact that new virus strains arise continuously. One fifth of the population of Europe are "secretor negative" individuals, and these people have an inherited resistance to noroviruses.

Source:
Elin Lindstr?¶m Claessen

University of Gothenburg

Study Of Esophageal Cancer Patients Found That Marital Status Affected Quality Of Life

2011-11-19T11:42:00.000-08:00

In a surprising finding, American scientists have discovered that when battling oesophageal cancer, married patients don't fare as well as their single counterparts in certain aspects of their quality of life.

In the study, presented at the European Cancer Conference (ECCO 14) in Barcelona, 212 oesophageal cancer patients and 489 patients with Barrett's oesophagus, a non-cancerous condition linked to acid reflux, filled out two quality of life questionnaires a year apart. Changes in the scores between the two assessments were analysed according to marital status.

No differences in quality of life changes over time were seen between marital states in the patients with Barrett's oesophagus. That finding was expected because the condition is not a potentially fatal one requiring stressful major treatment.

"In general, there were not major differences in quality of life between single and married oesophageal cancer patients, but there were slight differences in some aspects," said the study's lead researcher, Dr. Robert Miller, an assistant professor of oncology at the Mayo Clinic in Rochester, Minnesota.

For the single patients, quality of life scores relating to pain frequency, overall physical wellbeing and legal worries improved between the first and second questionnaire. However, married patients reported less improvement in their legal worries than the single patients did, and worsening physical wellbeing and increasing pain frequency over time.

"In the second questionnaire, single people rated their overall physical quality of life at a score 0.7 points higher on a scale of one to 10 than they did on the first questionnaire. However, for married people, the score dropped 0.4 points," Miller said.

The results for pain frequency were similar, with the singles improving by 0.6 points and the married patients reporting a 0.9-point deterioration.

When it came to perceptions of legal worries, all patients reported improvement, but the singles moved 1.1 points up the scale, while the married patients gained only 0.2 points.

"These findings were surprising, as we thought we'd be demonstrating improved outcomes in married patients," Miller said.

Most previous studies comparing the quality of life of married and single cancer patients, chiefly in breast but also in brain cancer, indicate that married people do better than single people, noted Miller. He said one reason why the current study came out differently could be that oesophageal cancer has a worse prognosis in comparison to some of the other types of cancers previously studied.

Also, there were approximately nine men to every woman in the oesophageal cancer group. This gender ratio may account for the difference between the latest results and those seen in studies of breast cancer patients.

"It's hard to interpret why married patients didn't do as well as single patients, but one explanation could be that having a family to support and care for when you have a serious and potentially life-threatening disease may increase a person's worries, leading to a decrease in quality of life," said Miller. "Being single may be associated with less negative changes in quality of life over time because the disease is more disruptive if you have others relying on one's participation in family social and economic activities."

Married patients diagnosed with oesophageal cancer may require extra diligence when evaluating pain and other somatic complaints, and there may be issues outside the standard concerns of medicine, Miller said.

Catalogue no: 1107

Source: Emma Ross

ECCO-the European CanCer Conference

Gene Linked To Vertebral Defects In Patient Populations Identified By Stowers Institute Researchers

2011-11-12T11:40:00.000-08:00

Stowers Institute researchers Karen Staehling-Hampton, Ph.D., Managing Director of Molecular Biology, and Olivier Pourqui?©, Ph.D., Investigator, collaborated with colleagues from around the world to show that genes known to cause spinal mutations in chick and mouse model systems also play an important role in human patients with congenital vertebral abnormalities.

The discovery was published on the Web site of the American Journal of Human Genetics.

Working with samples from 31 patients at Boston Children's Hospital with various congenital vertebral defects, the team sequenced five genes thought to be involved in the malformations. In a patient of Puerto Rican descent, the team discovered a mutation in the MESP2 gene - a mutation that completely disrupted the function of the gene.

The affected patient had Spondylothoracic Dysostosis, also known as Jarcho-Levin Syndrome. Spondylothoracic Dysostosis is a rare genetic disorder characterized by distinctive malformations of the vertebrae and ribs, respiratory problems, and other abnormalities. Infants born with Spondylothoracic Dysostosis have short necks, limited neck motion, and are short in stature. Spondylothoracic Dysostosis is prevalent in the Puerto Rican population.

Sequencing of samples from additional Spondylothoracic Dysostosis patients of Puerto Rican descent demonstrated the same mutation in the MESP2 gene.

"Spondylothoracic Dysostosis was first characterized in the Puerto Rican population 70 years ago," said Dr. Staehling-Hampton, co-equal first author on the paper, "but the gene mutation causing the condition was not isolated until now. The MESP2 mutation can be detected by a simple assay, so identification of this mutation will allow people who have a family history of Spondylothoracic Dysostosis to determine if they carry the mutation and whether they are at risk of passing the disorder on to future generations."

"After working for many years to study spinal formation in chicks and mice, it is rewarding to expand our investigation to clinical applications," said Dr. Pourqui?©, senior author on the publication. "We will continue to work with colleagues to collect more samples from patients with congenital vertebral abnormalities and sequence more genes to look for causative mutations. Additionally, we will sequence MESP2 in a larger collection of DNA samples from Puerto Rico to determine the carrier frequency of this MESP2 mutation in the general Puerto Rican population."

Kym Delventhal, a Laboratory Manager in the Stowers Institute's Molecular Biology Facility, also contributed to this publication.

Additional contributing authors include Alberto Cornier, Department of Molecular Medicine, La Concepci??n Hospital, San German, Puerto Rico and Department of Biochemistry, Ponce School of Medicine, Ponce, Puerto Rico; Yumiko Saga, Division of Mammalian Development, National Institute of Genetics, Mishima, Japan; Jean-Francois Caubet, Department of Orthopaedic Surgery, Children's Hospital Boston; Nobuo Sasaki, Division of Mammalian Development, National Institute of Genetics, Mishima, Japan; Sian Ellard, Department of Molecular Genetics, Royal Devon and Exeter Hospital, Exeter, United Kingdom; Elizabeth Young, Department of Molecular Genetics, Royal Devon and Exeter Hospital, Exeter, United Kingdom; Norman Ramirez, Department of Orthopaedics, La Concepci??n Hospital, San German, Puerto Rico; Simon Carlo, Department of Molecular Medicine, La Concepci??n Hospital, San German, Puerto Rico and Department of Genetics, San Juan Bautista School of Medicine, Caguas, Puerto Rico; Jose Torres, Department of Biochemistry, Ponce School of Medicine, Ponce, Puerto Rico; John Emans, Department of Orthopaedic Surgery, Children's Hospital Boston; and Peter Turnpenny, Clinical Genetics Department, Royal Devon and Exeter Hospital, Exeter, United Kingdom.

The Stowers Institute Molecular Biology Facility supports investigators in their research endeavors by providing high-quality services, participation in collaborative projects, and access to state-of-the-art technology. Learn more about their work at www.stowers-institute/Public/CoreFacilities.asp#mobio.

Dr. Pourqui?© also is an investigator with the Howard Hughes Medical Institute and a Professor in the Department of Anatomy & Cell Biology at the University of Kansas School of Medicine. Learn more about his work at stowers-institute/labs/PourquieLab.asp.

About the Stowers Institute

Housed in a 600,000 square-foot state-of-the-art facility on a 10-acre campus in the heart of Kansas City, Missouri, the Stowers Institute for Medical Research conducts basic research on fundamental processes of cellular life. Through its commitment to collaborative research and the use of cutting-edge technology, the Institute seeks more effective means of preventing, treating, and curing disease. The Institute was founded by Jim and Virginia Stowers, two cancer survivors who have created combined endowments of $2 billion in support of basic research of the highest quality.

Source: Marie Jennings

Stowers Institute for Medical Research

Injectable Bulking Agent Improves Symptoms Of Faecal Incontinence

2011-11-05T12:38:00.000-07:00

Injection of a bulking agent into the anal canal improves symptoms of faecal incontinence more than does a sham (placebo) treatment. The authors say this is the first time such a randomised trial comparing active and sham treatments has proven efficacy, and that the treatment is safe. The authors of the Article are Dr Wilhelm Graf, Department of
Surgery, Akademiska sjukhuset, Uppsala, Sweden, and colleagues.

The prevalence of faecal incontinence is the same in men and women and ranges from around 3% in individuals aged 20-30 years to around 15% in those older than 70 years. The cause of faecal incontinence is multifactorial and not completely understood. Two recognised types of clinical incontinence exist: passive incontinence and urge incontinence. Passive incontinence (ie, leakage without notice) is related to low anal resting pressure and internal sphincter deficiency. Urge incontinence (ie, inability to withstand an urge to defecate) is often attributed to an insufficiency in external sphincter tone and activity.

While injection of a bulking agent in the anal canal is increasingly used to treat for faecal incontinence, efficacy has not been shown in a controlled trial. In this study the authors aimed to assess the efficacy of injection of dextranomer in stabilised hyaluronic acid (NASHA Dx) for treatment of faecal incontinence.

206 patients aged 18 to 75 years from the USA and Europe were randomly assigned to receive 4 injections of 1 ml of NASHA Dx in the anal canal (136 patients) or sham treatment (the same injections but no substance injected). The researchers found that, after six months, just over half (52%) patients who received NASHA Dx had a 50% or more reduction in the number of incontinence episodes, compared with less than a third (31%) who received sham treatment. There were 128 treatment-related adverse events reported in the treatment group, and 29 in the sham group. These included transient injection-site bleeding (7 in treatment group, 12 in sham) and pain (6 in treatment group, 1 in sham) Two adverse events in the treatment group were serious (1 rectal abscess and 1 prostatic abscess).

The authors conclude: "The treatment might also be used as a treatment before more invasive techniques or as an additional or adjuvant treatment if other treatments do not give adequate symptomatic relief. This treatment is easy to apply and safe. A refinement of selection criteria for patients, optimum injected dose, ideal site of injection, and long-term results might further increase the acceptance of this minimally invasive treatment."

In a linked Comment, Dr Christine Norton, Bucks New University and Imperial College Healthcare NHS Trust, St Mary's Hospital, London, UK, says that more detailed information is needed before the study could be replicated. She points to several important data not included, such as of the type of incontinence suffered (urge, passive or both), anal pressures, ultrasound appearance, or sensation, which might give clues about the mechanism of action.

Asking whether or not the study should change clinical practice, she concludes: "Maybe, but until we ask patients what they think, we cannot be sure whether a statistically significant result will actually change people's lives."

Link to Article and Comment

Source
The Lancet

New Generation Oral Vaccine Uses Dairy Probiotics To Protect Against Disease

2011-10-29T12:36:00.000-07:00

Instead of a dreaded injection with a needle, someday getting vaccinated against disease may be as pleasant as drinking a yogurt smoothie.

A researcher from the Northwestern University Feinberg School of Medicine has developed a new oral vaccine using probiotics, the healthy bacteria that are found in dairy products like yogurt and cheese. He has successfully used the approach in a preclinical study to create immunity to anthrax exposure. He also is using the method to develop a breast cancer vaccine and vaccines for various infectious diseases.

This new generation vaccine has big benefits beyond eliminating the "Ouch!" factor. Delivering the vaccine to the gut -- rather than injecting it into a muscle -- harnesses the full power of the body's primary immune force, which is located in the small intestine.

"This is potentially a great advance in the way we give vaccines to people," said Mansour Mohamadzadeh, the lead author and an associate professor of medicine in gastroenterology at the Feinberg School.

"You swallow the vaccine, and the bacteria colonize your intestine and start to produce the vaccine in your gut," Mohamadzadeh said. "Then it's quickly dispatched throughout your body. If you can activate the immune system in your gut, you get a much more powerful immune response than by injecting it. The pathogenic bacteria will be eliminated faster."

Most vaccines consist of protein and won't maintain their effectiveness after being digested by the stomach. However, the lactobacillus protects the vacThe Northwestern study was reported in a recent issue of the Proceedings of the National Academy of Science.

There are other advantages to the new oral vaccine. Probiotics, which are natural immune stimulators, eliminate the need for a chemical in traditional vaccines that inflames the immune system and triggers a local immune response. The chemical, called an adjuant, may cause side effects such as dizziness, arm swelling and vomiting. Probiotic vaccines also are inexpensive to produce.

The specially engineered vaccine gives more immune bang for the buck than an injected one because it induces a local and a systemic immune response. The vaccine targets the first line of gut immune cells called dendritic cells -- the commanders-in-chiefs of the immune system. They engulf the vaccine then instruct the immune system's foot soldiers -- killer T-cells and B-cells -- to seek out and destroy any cells in the body infected with a particular bacterium or virus.

In the study, Mohamadzadeh fed mice the new oral anthrax vaccine, and then exposed them to anthrax bacteria. Eighty percent of the mice survived, which is comparable to the results when mice were injected with anthrax vaccine, he said.

"Their immune response was higher and more robust than with the injected vaccine," Mohamadzadeh said. The mice generated a much higher T and B immunity against the pathogenic bacteria.

Mohamadzadeh's vaccine technology can be applied to many other diseases. He is developing an oral vaccine for breast cancer using probiotics. The vaccine would use the Her2/neu breast cancer antigen, a protein highly produced by breast tumor cells, and train the immune system to destroy any cells producing Her2/neu, he said.

In addition, Mohamadzadeh has developed a "multi-tasking" cancer vaccine against breast, colon and pancreatic cancer that soon will be tested in mouse models.

The technology also can be used to develop a probiotic vaccine for HIV, hepatitis C and the flu, he said.

Terrence Barrrett, M.D., chief and professor of gastroenterology at the Feinberg School, said delivering a vaccine to the gut is the most logical route.

"Nature isn't used to seeing antigens injected into a muscle," said Barrett, who also is a physician at Northwestern Memorial Hospital. "The place where your immune system is designed to encounter and mount a defense against antigens is your gut."

Notes:

The study was funded by the National Institutes of Health and the North Carolina Dairy Foundation.cine until it is in the small intestine.

Source:
Marla Paul

Northwestern University

Scientists Locate First Common Bowel Cancer Gene, UK

2011-10-22T12:34:00.000-07:00

Cancer Research UK funded scientists have for the first time identified a common genetic variant that can increase a person's risk of developing bowel cancer. Their findings appear in two papers published online in Nature Genetics 1,2 last Sunday.

Several genes are already known to contribute to bowel cancer risk. However, these are extremely rare among the population - only around one person in every 2,500 carries any of the known bowel cancer genes and they account for less than five per cent of bowel cancer cases arising annually. Around 35,000 new cases of bowel cancer are diagnosed in the UK each year and it is estimated that genetic risk contributes to around a third of cases of the disease.

Reporting their findings in two separate papers, research teams based in Edinburgh and London studied the genetic make-up in a total of over 30,000 people in a hunt for the genes that make up the rest of this risk. Around half of the participants were bowel cancer patients and half were healthy people.

Each team carried out a 'whole genome search' and pinpointed a gene that is faulty more often amongst bowel cancer patients than in people without the disease. They narrowed down the gene's location within the genome to a region called 8q24. Scientists recently found that men who have the same genetic variant are at an increased risk of developing prostate cancer.

Around half of the general population carry the genetic variant, which results in a 20 per cent increased risk of developing bowel cancer. Lifetime risk of the disease rises from around one in 20 for people who do not carry a faulty copy of the gene to one in 16 for people who do. The evidence in these papers indicates that around one in 10 bowel cancers diagnosed in the UK are linked to this genetic fault - equating to around 3,500 cases each year.

Because the increased risk incurred by this genetic fault is relatively small, it would not be suitable for genetic testing at this stage. But it may be possible to design a test for a combination of genes as more 'low risk' variants are found. Identifying people who have an increased risk of developing bowel cancer will improve prevention, diagnosis and treatment of the disease in the future.

In the first study, Professor Malcolm Dunlop, from the University of Edinburgh and the Medical Research Council's Human Genetics Unit, and an international team of researchers compared the DNA of around 8,000 bowel cancer patients from North America, France and Scotland, to that of around 8,000 healthy people.

Professor Dunlop said: "Scanning the entire genome of large numbers of people has enabled us to identify the first common genetic variant that increases bowel cancer risk. We are now using an even more refined "genome-wide scan" to discover yet more genes linked to bowel cancer risk.

"Understanding all the genes involved is a bit like putting together a jigsaw puzzle in the dark. First we have to feel around for the genes involved and only then will we be able to find out how they all fit together to contribute to increased risk. By identifying these genetic variants, we will be in a better position to understand how such changes can lead to cancer."

The second study was jointly led by Professor Ian Tomlinson from Cancer Research UK's London Research Institute and Professor Richard Houlston from The Institute of Cancer Research. They examined the DNA of a similar number of patients and healthy people from England.

Professor Tomlinson said: "This is an important first step but we still have a long way to go before we have a complete picture of all the genes that are involved in inherited bowel cancer risk. Eventually it may be possible for scientists to design treatments to prevent people at increased risk of the disease from developing bowel cancer altogether."

Both teams used a multi-stepped approach to find the region of the genome that was linked to bowel cancer risk. They studied thousands of 'tags' - distinct blocks of DNA that act as signposts for genes - in hundreds of people. The tags which were more common among the bowel cancer patients than the healthy people were then reassessed in new, larger groups of patients and healthy people.

After repeating this process many times the researchers whittled down the tags to just one - 8q24. This painstaking work led researchers to a still to be identified gene within this part of the genome that is responsible for the increased risk of bowel cancer among the patients they studied.

Cancer Research UK is launching similar genome wide studies for lung and ovarian cancer and scientists hope to find out more about the genes linked to these cancers as a result.

Harpal Kumar, chief executive of Cancer Research UK, which has instigated this series of genome-wide studies for common cancers, said: "This is an extremely important discovery which will significantly improve our understanding of the biology of bowel cancer and what causes it. In the future we hope studies like this across a range of cancers will help people at increased risk of the developing the disease through the development of tailored screening and treatment programmes."

1. "A colorectal cancer susceptibility locus on chromosome 8q24 identified by a genome wide association scan." Brent W. Zanke, et al. (2007) Nature Genetics. Working with Canadian collaborators on a "whole genome scan" to identify genes that might contribute to bowel cancer risk, the research group in Edinburgh narrowed the search down and pinpointed one genetic region on the long arm of chromosome 8 (8q24) where a common variation is associated with bowel cancer risk. This study was supported by Cancer Research UK, the Medical Research Council, the Scottish Executive Chief Scientist's Office and CORE.

2. "A genome-wide association scan of tag SNPs identifies a novel susceptibility variant for colorectal cancer at 8q24.21." Ian Tomlinson et al. (2007) Nature Genetics. The London team and collaborators also undertook a genome scan of their own. Among several potential locations of new bowel cancer genes, the strongest evidence independently pointed to 8q24. This study was supported by Cancer Research UK, the Bobby Moore Fund for Cancer Research UK, CORE, the European Union, the Thomas Falknor Fund and Leukaemia Research.

The technology used in these studies was provided by Illumina.

Bowel cancer

Every year in the UK, around 35,000 people are diagnosed with bowel cancer. It is the third most common cancer after breast and lung and the disease causes almost 16,100 deaths in the UK every year. Around two-thirds of cases are in the large bowel (colon) and the remaining third are in the back passage (rectum). The occurrence of bowel cancer is strongly related to age, with over 80 per cent of cases arising in people who are 60 years of older.

Inherited risk

One factor that can increase risk of developing bowel cancer is an inherited faulty gene (genetic mutation). An inherited genetic mutation may mean that several people on the same side of a family develop bowel cancer. This is called a 'strong family history'. There are a number of known genetic conditions linked to bowel cancer, including familial adenomatous polyposis (FAP) and hereditary non-polyposis colorectal cancer (HNPCC).

A strong family history usually means several relatives have been diagnosed with bowel cancer on the same side of the family. It can also mean there are one or more relatives diagnosed at a particularly young age. People who are concerned they may have a strong family risk should talk to their GP. The doctor may refer them to a genetics clinic for specialist advice about their risk, screening and the availability of genetic testing.

Bowel cancer screening

Screening means looking for early signs of a particular disease in 'healthy' people who don't have symptoms. Results from large scale Government pilot studies published in 2003 suggested that a national bowel screening of the normal population would help save lives. The Government is now phasing in a national screening programme across the country.

Men and women aged between 60-69 years old are being offered a test every two years. The screening method used is called faecal occult blood testing (FOB). Faecal occult blood testing means looking for hidden (occult) blood in your stool (faeces). People can do the test themselves at home.

For more information about bowel cancer or screening visit our patient information website CancerHelp UK.

Cancer Research UK

-- Together with its partners and supporters, Cancer Research UK's vision is to beat cancer.

-- Cancer Research UK carries out world-class research to improve understanding of the disease and find out how to prevent, diagnose and treat different kinds of cancer.

-- Cancer Research UK ensures that its findings are used to improve the lives of all cancer patients.

-- Cancer Research UK helps people to understand cancer, the progress that is being made and the choices each person can make.

-- Cancer Research UK works in partnership with others to achieve the greatest impact in the global fight against cancer.

For further information about Cancer Research UK's work or to find out how to support the charity, visit cancerresearchuk/.

Keeping Food Safe From Farm To Table

2011-10-15T12:32:00.000-07:00

Food safety problems can arise at any of multiple stages of food production, and illnesses that result from them are frequently not detected or reported, according to a new report from the American Academy of Microbiology.

The report, "Global Food Safety: Keeping Food Safe from Farm to Table," is based on a colloquium convened by the Academy in 2009. Colloquium participants with expertise in microbiology, public health, food science, and economics reviewed the current state of affairs in microbiological food safety around the world.

The path from food production to consumption is increasingly complicated. Each plate of food may contain ingredients from many countries - each of which may have passed through different processing facilities, and may have been handled by wholesalers, retailers, and multiple transportation companies before finally reaching the consumer's shelf or refrigerator. No single agency regulates all of the steps in this process.

Each link in the food safety chain would benefit from further research and new technologies - specific examples of which are detailed in this report. Regulations that promote good agricultural and manufacturing practices would not only help decrease lapses in food safety, but would make it easier to trace problems back to their inception.

Consumer education is also an important component of food safety. Consumers are often unaware of safe food handling practices, especially as new food products are introduced. Because consumer-caused foodborne illnesses are often not recognized as such, much less systematically reported, an important barrier to reducing their incidence is inadequate knowledge of which foods, agents, and practices pose the greatest risk.

It is very difficult to know how many people are made sick by food, which foods are at fault, which pathogens are most widespread or dangerous, and where those pathogens entered the food production system. In such a situation, where should research, prevention and education efforts be directed? In this report, each step in our complicated food production and supply system is described, highlighting key points of vulnerability and making it clear that providing safe food is a shared responsibility.

Food safety is complex, and a perfectly safe food supply is an unrealistic goal. However, as this report explains, there are opportunities for improving food safety at each step of the production and consumption process and many areas where further research could help identify and quantify risks and generate solutions. The report also identifies food safety vulnerabilities that might be addressed through investments in new technologies or more effective education.

Source:

Jim Sliwa

American Society for Microbiology

First Detailed View Of Molecular Structure May Usher In New Class Of Cancer Drugs

2011-10-08T12:30:00.000-07:00

High resolution views of a receptor molecule that is implicated in cancer offer a clear target for the development of a new class of cancer drugs, Yale School of Medicine researchers report July 27 in Cell.

It is also anticipated that the new family of drugs may be applied for the treatment of gastrointestinal stromal tumor (GIST) cancers that are resistant to Gleevec and Sutent. Although these drugs would target the same receptors as Gleevec and Sutent, they would do so by a different mechanism and may therefore be useful for patients who are resistant to these drugs.

"I was surprised to see what the molecules did when they were activated," said Joseph Schlessinger, professor and chair of pharmacology and senior author of the study. "The arrangement is much simpler and more elegant than I thought."

The paper, accompanying images, and animation-which looks like a beautiful dance-provide the first detailed, atomic level view of the receptor tyrosine kinase (RTK) Kit before and after it is activated. There are 59 RTK proteins in humans and they play critical roles in the control of a great variety of normal cellular processes as well as in several cancers.

Schlessinger said the newly-revealed mechanism for RTK activation is utilized by many RTKs. "Moreover, these structures offer unexpected new opportunities for drug discovery for the treatment of cancers and other diseases driven by activated RTKs," he said.

The finding is the result of many years of work involving protein expression, biochemical and biophysical studies and X-ray crystallography, a method used for viewing molecules at a resolution high enough to see atomic detail.

The receptor tyrosine kinase Kit and its natural ligand stem cell factor play an important role in normal blood cell production, gut function, pigmentation, and reproduction. Humans in whom this function is suppressed, or the function is lost, have what is known as a piebald trait-a wing-like discoloration on the chest and abdomen, a white forelock of hair, deafness, and constipation. Mice with the same mutation also have depigmentation and are often anemic and sterile. However, mutations in which the Kit function is activated are found in a variety of human cancers, among them gastro-intestinal stromal tumors (GIST) and several forms of leukemia.

The structural analysis clearly shows a conformational change as stem cell factor brings two Kit molecules together, resulting in a large rearrangement of and association between parts of the molecule. Schlessinger said the next step is to identify drugs that can form a wedge in the Kit molecule, making it impossible for them to join together and be activated.

Co-authors include Satoru Yuzawa, Yarden Opatowsky, Zhontang Zhang, Valsan Mandiyan, and Irit Lax.

Cell: (July 27, 2007)

yale.edu

View drug information on Gleevec; Sutent.

Gender And Family Size Influences IBS Symptoms In Children

2011-10-01T12:28:00.000-07:00

Research presented at the 71st Annual Scientific Meeting of the American College of Gastroenterology suggests that illness behavior, specifically complaints of recurrent abdominal pain, in girls with mothers who have Irritable Bowel Syndrome (IBS) may be intensified in smaller families, where children have more one-on-one contact with their mothers.

Researcher Shelby Langer, PhD and colleagues from the University of Washington looked at survey data from 631 children of 450 mothers, 46 percent of whom had a diagnosis of IBS. Mothers completed the Children's Somatization Inventory, which measures nonspecific somatic symptoms including headaches, back pain, sore muscles, and abdominal pain. Mothers rated the severity of their children's abdominal pain for two weeks using a five-point scale ranging from "no pain" to "a whole lot of pain."

In general, mothers with IBS reported greater abdominal pain severity for their children than did control mothers. Mothers with IBS reported greater pain severity for girls versus boys when the child had either no siblings or one sibling, but not two or more siblings. This pattern was reversed for non-IBS mothers, who reported greater pain severity for girls versus boys when the child had two or more siblings.

"Our findings are in line with well-established gender differences in pain reported in the medical literature, and are consistent with work published by Dr. Rona Levy and colleagues on the psychosocial effects of maternal IBS status," said Dr. Langer.

In the study, Dr. Langer looked at the interactive effects of maternal IBS status, child gender and family size, and her results paint a more complex picture. Her findings suggest that

Onset of IBS Symptoms in Children with IBS Mothers

mothers who do not have IBS rate girls as having greater pain than boys in large but not small families. Dr. Langer's research suggests that perhaps girls in large families use symptom complaints as a means of getting attention.

In comparison, mothers who do have IBS rate girls as having greater pain than boys in small but not large families. Dr. Langer explains, "The acquisition of illness behavior by daughters of women with IBS may be intensified in smaller families, where presumably these children have more one-on-one time to learn either through observation or other mechanisms. Future research is needed to explore the mechanisms by which family size, child gender and maternal IBS cases interact."

About the American College of Gastroenterology

The ACG was formed in 1932 to advance the scientific study and medical treatment of disorders of the gastrointestinal (GI) tract. The College promotes the highest standards in medical education and is guided by its commitment to meeting the needs of clinical gastroenterology practitioners. Consumers can get more information on GI diseases through the following ACG-sponsored programs:

ibsrelief

acg.gi

Nearly 300 Olive Garden Restaurant Customers Sick In Indiana

2011-09-24T12:26:00.000-07:00

According to the Marion County Health Department, Indiana, Indianapolis, nearly 300 people who ate at the Olive Garden restaurant, Castleton area, got sick. Some people became so ill they had to be hospitalized. According to sources in the area, new reports of sickness continue to come in.

It is still not known what caused the sickness of so many people, but a food borne illness would be the logical choice, as the one thing everyone had in common was that they ate in the same place. The restaurant was open earlier on today, but is now closed.

John Althardt, who works at the Marlon Health Department, said that by closing the restaurant, authorities will be able to investigate the matter better and hopefully break the cycle of infection. It won't be until Monday when the Health Department decide whether to allow the Olive Garden to open again.

The restaurant was given a thorough inspection on Tuesday - nothing was detected that might shed some light on this spate of illnesses; they gave the restaurant a clean bill of health.

Not everyone who got ill ate there at the same time. Some had dined there last Saturday, others on Sunday, and Monday. Sick customers have experienced stomachache, vomiting, nausea, diarrhea and fever.

Marion County Health Department

Economic Impact Of Gastroesophageal Reflux Disease Revealed

2011-09-17T12:24:00.000-07:00

Gastroesophageal reflux disease (GERD) has a substantial economic impact on society due to its effect on productivity while at work, according to the results of a new systematic review published today in Alimentary Pharmacology & Therapeutics.[1]

The review, which analysed data reported by patients from eight studies involving more than 7,000 people across seven countries, suggests that the average loss in productivity while at work in a general working population with reflux disease could be as great as 10 per cent.1

Reduced productivity at work increased with reflux symptom severity, and sleep disturbance due to reflux symptoms caused work productivity losses as high as 40 per cent.1

As an example, using these findings for the US, this translates into a total cost to US employers of up to $75 billion per year.1 In comparison, the direct yearly costs for treating reflux disease in the US via healthcare services and medication are estimated at $9.3 billion.1

Dr Alan Barkun, Director of the Division of Gastroenterology at McGill University and McGill University Health Center, Montreal, Canada, said that these results have important implications for the way in which reflux disease treatment should be viewed.
"The strong association between reduced work productivity and total symptom burden suggests that by relieving reflux symptoms patients may be able to perform better at work."

In addition the data also highlights that by initiating effective therapy, the costs may be offset by improvements in work productivity following treatment1.

The patient-reported results in this review are supported by data from a case-control study using objective assessments of work productivity that was recently presented at the annual Digestive Disease Week conference, Los Angeles, USA.[2] The study involved more than 27,000 employees with or without reflux disease, and results confirm that there truly is a link between reflux disease and reduced productivity at work - also when measuring productivity in terms of number of units processed per hour and per year.

The reduction in work productivity as a result of reflux disease is similar to that of people with other chronic and troublesome diseases, such as arthritis and back pain.1

Reflux disease - also known as gastroesophageal reflux disease (GERD) - is a chronic disease that causes significant impairment to sufferer's health related quality of life.[3] In addition to its impact on work productivity, people with GERD experience physical, social and emotional problems as a result of the pain, worry and sleep disturbance caused by their condition.3,[4]

References:

[1]. Wahlqvist P et al. Aliment Pharmacol Ther 2006; 25

[2]. Wahlqvist P et al. Abstract S1124. DDW 2006 (Los Angeles, USA. 20-25 May)

[3]. Wiklund, I. Dig Dis 2004; 22: 108-14

[4]. Liker et al. J Am Board Fam Pract 2005; 18: 393-400

astrazeneca

Antioxidants Offer Pain Relief In Patients With Chronic Pancreatitis

2011-09-10T12:22:00.000-07:00

Antioxidant supplementation was found to be effective in relieving pain and reducing levels of oxidative stress in patients with chronic pancreatitis (CP), reports a new study in Gastroenterology. CP is a progressive inflammatory disease of the pancreas in which patients experience abdominal pain (in early stage) and diabetes and maldigestion (in late stage). Pain is the major problem in 90 percent of patients with CP and currently, there is no effective medical therapy for pain relief. Gastroenterology is the official journal of the American Gastroenterological Association (AGA) Institute.

In this placebo-controlled, double blind trial, 127 patients, ages 30.5+/-10.5, were assigned to placebo or antioxidant groups. After six months, the reduction in the number of painful days/month was significantly higher in the antioxidant group, compared with the placebo group (7.4?±6.8 versus 3.2?±4, respectively). The reduction in the number of analgesic tablets/month was also higher in the antioxidant group (10.5?±11.8 versus 4.4?±5.8, respectively). Furthermore, 32 percent and 13 percent of patients became pain free in the antioxidant and placebo groups, respectively; the beneficial effect of antioxidants on pain relief was noted early at three months.

"Abdominal pain, the predominant symptom in patients with CP, is difficult to treat. The main reason for a largely ineffective medical treatment is that the mechanism of pain in CP is not well understood," said Pramod Kumar Garg, MD, DM, of the All India Institute of Medical Sciences, New Delhi and lead author of the study. "We are encouraged by our findings, as significant improvement was noted with antioxidants in respect to all the parameters of pain in this study. In addition, reduction in pain resulted in fewer man-days lost, thus providing functional employment gain to the patients. The findings should spur further research in this exciting area."

There are two important implications of this study - the fact that measures of oxidative stress were increased initially and decreased subsequently after supplementation with antioxidants suggests that there is a state of heightened free radical mediated injury in CP, and that injury is reversible. Second, with regard to pain management, this trial showed that antioxidant therapy is effective for pain relief in patients with CP. This assumes significance since no effective medical therapy exists for pain relief for such patients.

Pancreatitis is inflammation of the pancreas that usually begins as a sudden attack and is often caused by gallstones, alcohol abuse or genetic mutations. Symptoms of pancreatitis start with a gradual or sudden severe pain in the center part of the upper abdomen going through to the back. Treatment often focuses on the nutritional and metabolic needs of the patient and on relieving pain. Most people with chronic pancreatitis have a good prognosis if they follow their treatment regimen. "Aside from medication, abstaining from alcohol and smoking are most important and key to halt the progression of CP," added Dr. Garg.

Visit gastro/patient for more patient information about pancreatitis.

About the AGA Institute

The American Gastroenterological Association (AGA) is dedicated to the mission of advancing the science and practice of gastroenterology. Founded in 1897, the AGA is one of the oldest medical-specialty societies in the U.S. Comprised of two non-profit organizations - the AGA and the AGA Institute - our more than 16,000 members include physicians and scientists who research, diagnose and treat disorders of the gastrointestinal tract and liver. The AGA, a 501(c6) organization, administers all membership and public policy activities, while the AGA Institute, a 501(c3) organization, runs the organization's practice, research and educational programs. On a monthly basis, the AGA Institute publishes two highly respected journals, Gastroenterology and Clinical Gastroenterology and Hepatology. The organization's annual meeting is Digestive Disease Week®, which is held each May and is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. For more information, please visit gastro.

About Gastroenterology

Gastroenterology, the official journal of the AGA Institute, is the most prominent scientific journal in the specialty and is in the top 1 percent of indexed medical journals internationally. The journal publishes clinical and basic science studies of all aspects of the digestive system, including the liver and pancreas, as well as nutrition. The journal is abstracted and indexed in Biological Abstracts, CABS, Chemical Abstracts, Current Contents, Excerpta Medica, Index Medicus, Nutrition Abstracts and Science Citation Index. For more information, visit gastrojournal.

Source: Alissa J. Cruz

American Gastroenterological Association

Cardia Resection For Perforated Gastroesophageal Cancer

2011-09-03T12:20:00.000-07:00

Iatrogenic perforation of cancer of the esophagus or the gastroesophageal (GE) junction is a severe complication. Its incidence has increased most likely because of more aggressive palliative endoscopic therapy and the current widespread use of endoscopic ultrasound (EUS) for accurate preoperative staging. Therapy, i.e. conservative versus surgical treatment remains controversial.

Professor J?¶rg Kleeff from the Munich (Germany) report a case of 82-year-old man with iatrogenic perforation of adenocarcinoma of the GE junction. This article was published in the World Journal of Gastroenterology.

Given serious complications brought by initial endoscopic intervention, they decided to choose immediate explorative laparotomy. Intraoperatively, the tumor was localized and removed completely by resection of the cardia and part of the distal esophagus. For reconstruction, a partial proximal gastric tube was constructed using linear staplers. After treatment, the patient recovered quickly and discharged from hospital within 2 wk. On a further follow-up after 4 wk, the patient held no complaint of reflux or dysphagic symptoms.

The study revealed that the management of esophageal perforation in the context of an underlying malignancy demands an individual approach that depends upon the site and etiology of the perforation. Irrespective of the therapeutic approach, the prognosis after tumor perforation is dismal.

Reference: Gillen S, Friess H, Kleeff J. Palliative cardia resection with gastroesophageal reconstruction for perforated carcinoma of the gastroesophageal junction. World J Gastroenterol 2009; 15(24): 3065-3067;

Source:
Lai-Fu Li

World Journal of Gastroenterology

Clinical Trial Launched To Test New Treatment Technique For Bowel Cancer

2011-08-27T12:18:00.000-07:00

Cancer Research UK this week launches a new trial for patients with bowel cancer that has spread to the liver to see whether a new radiotherapy treatment technique is more effective than standard chemotherapy.

Researchers at trial centres across the UK and coordinated at Oxford University will test a new treatment called Radio-embolisation, a form of internal radiotherapy that uses the tumour's blood supply to target multiple sites of disease within the liver. They will combine this new treatment with standard chemotherapy in patients recently diagnosed with bowel cancer that has spread to the liver.

The first patient will start the treatment this week at the Royal Surrey County Hospital in Guildford.

Despite major advances in treating advanced bowel cancer, the number of patients who survive beyond five years remains disappointingly low - less than 10 per cent.

The trial - called FOXFIRE and funded by Cancer Research UK and by Sirtex Medical Ltd.- aims to recruit almost 500 patients in the UK with advanced bowel cancer. The results are being combined with an international study called SIRFLOX, meaning that over 800 patients will be studied worldwide.

The patients will be divided into two groups at random. One group will receive chemotherapy plus Radio-embolisation and the other will receive chemotherapy alone.

Dr Ricky Sharma, the chief investigator from the Cancer Research UK and Medical Research Council Gray Institute for Radiation Oncology and Biology at the University of Oxford, said: "Although we now have several new ways of treating bowel cancer which has spread to the liver, we are keen to develop other novel techniques to improve treatment.

"What is exciting about this new technique is that we know that radiotherapy works well in treating bowel cancer and this new way of administering high-dose radiation therapy directly into the blood supply of the cancer appears to be effective when we combine it with chemotherapy.

"We are hoping that this national trial will tell us whether this new form of radiotherapy, when combined with standard chemotherapy, improves the outcome for individual patients."

More than 37,500 cases of bowel cancer are diagnosed each year making it the third most common cancer in the UK.

Kate Law, Cancer Research UK's director of clinical trials, said: "Without clinical trials like FOXFIRE, we wouldn't be able to improve techniques for cancers that are hard to treat. It's a promising trial and we look forward to following its progress and seeing the results."

Reference

- The FOXFIRE trial on Current Controlled Trials

Notes

1. Trial centres are located across the UK and are now recruiting patients - for more information visit the The Oncology Clinical Trials Office website.

2. Radio-embolisation (also known as Selective Internal Radiation Therapy, or SIRT) takes advantage of the leaky and immature blood vessels in cancers to deliver a high dose of radiotherapy to primary liver cancer or other cancers that have spread to the liver. The radioactive particles (called SIR-spheres microspheres) are tiny polymer beads that are delivered directly into and around each tumour via a catheter tube inserted into the patient's groin and then passed up, under X-ray guidance, into the blood supply of the liver.

The radiotherapy delivered is a very high dose which travels only about 2-3 mm within liver tissues. No other types of radiation are emitted by the microspheres, so there is minimal risk to other organs of the patient's body. Since radiotherapy works very differently from chemotherapy, this treatment often works even when cancers have become resistant to chemotherapy.

The FOXFIRE clinical trial aims to see if giving chemotherapy and radio-embolisation together when cancer is first detected in the liver is better than the current standard therapy, i.e. using chemotherapy alone.

3. Supported by the Bobby Moore Fund for Cancer Research UK.

4. More information about bowel cancer on our patient information website, CancerHelp UK

Source
Cancer Research UK

A Promising Endoscopic Technique For Rectal Carcinoids

2011-08-20T12:16:00.000-07:00

Conventional snare polypectomy or endoscopic mucosal resection often presents an unsatisfactory result in complete resection of rectal carcinoids. It was perfomed EMR-L with 3D-EUS for rectal carcinoids and compared between EMR-L with 3D-EUS and EMR-L alone. The rate of complete resection and the vertical resection margin has been reported.

A research article was published in the World Journal of Gastroenterology. This reseach team was led by Prof. Maetani from Division of Gastroenterology, Toho University Ohashi medical center. Conventional snare polypectomy or endoscopic mucosal resection often presents an unsatisfactory result in complete resection of rectal carcinoids. Various endoscopic treatments were demonstrated.reported. Authors perfomed EMR-L with 3D-EUS for rectal carcinoids and compared between EMR-L with 3D-EUS and EMR-L alone.

The rate of complete resection for EMR-L with 3D-EUS and EMR-L alone was 100% and 71%. The vertical resection margin of EMR-L with 3D-EUS was longer than that of EMR-L alone.

EMR-L is effective as an endoscopic treatment for rectal carcinoids. In combination with 3D-EUS, a safe and complete resection is further assured.

Successful outcomes of EMR-L with 3D-EUS in this study demonstrate a new view of good endoscopic technique for rectal carcinoids.

Reference: Abe T, Kakemura T, Fujinuma S, Maetani I. Successful outcomes of EMR-L with 3D-EUS for rectal carcinoids in comparison with our historical controls. World J Gastroenterol 2008;14(25): 4054-4058wjgnet/1007-9327/14/4054.asp

Correspondence to: Tsuyoshi Abe, MD, Division of Gastroenterology, Department of Internal Medicine, Toho University Ohashi Medical Center, 2-17-6 Ohashi Meguro-ku, Tokyo 153-8515, Japan.

About World Journal of Gastroenterology

World Journal of Gastroenterology (WJG), a leading international journal in gastroenterology and hepatology, has established a reputation for publishing first class research on esophageal cancer, gastric cancer, liver cancer, viral hepatitis, colorectal cancer, and H pylori infection. It provides a forum for both clinicians and scientists. WJG has been indexed and abstracted in Current Contents/Clinical Medicine, Science Citation Index Expanded (also known as SciSearch) and Journal Citation Reports/Science Edition, Index Medicus, MEDLINE and PubMed, Chemical Abstracts, EMBASE/Excerpta Medica, Abstracts Journals, Nature Clinical Practice Gastroenterology and Hepatology, CAB Abstracts and Global Health. ISI JCR 2003-2000 IF: 3.318, 2.532, 1.445 and 0.993. WJG is a weekly journal published by WJG Press. The publication dates are the 7th, 14th, 21st, and 28th of every month. The WJG is supported by The National Natural Science Foundation of China, No. 30224801 and No. 30424812, and was founded with the title China National Journal of New Gastroenterology on October 1, 1995, and renamed WJG on January 25, 1998.

About The WJG Press

The WJG Press mainly publishes World Journal of Gastroenterology.

Source: Lai-Fu Li

World Journal of Gastroenterology

Noise Is Distressing For People With Colostomies

2011-08-13T12:14:00.000-07:00

Results from a new survey show that those with colostomy pouches face a noise issue which can affect their quality of life.

A colostomy may be needed as a result of abdominal surgery for conditions such as Crohn's disease, colitis or more commonly cancer - and can even result from complications of childbirth. It means that instead of going to the loo 'normally' those affected have a `stoma' or opening created in their abdomen and use a pouch to collect bodily waste which is emptied and changed regularly.

Although many people responding to the survey report that they do not notice pouch noise, a large proportion - almost 70 per cent - state they are conscious of the noise their pouch makes including almost 16 per cent who said they notice it 'a lot.'

As many as 40 per cent are embarrassed by the noise of their pouch and 15 per cent avoid going out in public in case people hear the noise. Almost half said 'life would be easier' if the pouch was quieter.

A fifth say pouch noise affects their sex life and 18 per cent say it affects their relationships. More than 80 per cent of responders were either married or in a relationship. Three-quarters were aged 70 or under, including 18 per cent under 50.

Despite this, three-quarters of responders who are embarrassed by their pouch noise have not mentioned this problem to their specialist nurse. Other issues include mood with a third saying that pouch noise affects how they feel and 26 per cent report that it impacts on their social life.

The taboo does appear to be reducing, as the survey shows 64 per cent are happy to discuss their situation with friends and 43 per cent with colleagues.

But almost a fifth are still not comfortable discussing it with a partner. More than half of partners say they, too, notice the noise; 14 per cent are embarrassed by it in public and say it restricts what they do. Almost a third say life would be easier for them without the noise.

The survey, sponsored by the healthcare company Hollister, assessed quality of life factors such as social life, relationships, holidays and work and was completed by 76 users of pouches and their partners, via the Colostomy Association's website and by face-to-face interviews. Overall, responders had been living with a pouch from between six months to 30 years with the majority needing a colostomy as a result of cancer.

The charity believes there are 110,000 people in the UK who have a stoma and use bags to collect bodily waste as a result of cancer or other conditions and more than 6,400 permanent colostomy operations are performed each year.

In the survey, the responders describe the noise as a 'ruffling' commenting that it made them feel uncomfortable in close proximity with others - even leading to relationship breakdowns and issues at work in some cases.

It is not just older people who need a colostomy. Yvonne Cole, 21, from Somerset, has been using a colostomy bag for over a year as a result of Crohn's disease and ulcerative colitis. "Noise has been an issue for me in the past", explains Yvonne. "It always sounded as though I was wearing a carrier bag when I moved around and people would stop and stare at me. I was also very conscious of the bulkiness of the pouches as I am quite small. I am now using new noise reducing pouches which are much more discreet and have helped me a lot, and I am incredibly lucky that I have such a supportive family and fianc?©."

Explains Rebecca Davenport, a specialist stoma nurse, "Many of the patients I meet have faced life threatening conditions which have resulted in the need for a colostomy. So not only do they have to come to terms with a serious illness and the impact this has on their life and the lives of their partners and families, but many also have psychological issues associated with their colostomy pouch, one of which is noise. I think many people feel that noise will be viewed as insignificant in the scale of things and are reluctant to discuss it with their nurse, but there are solutions we can offer them. Pouch noise is an issue and people should not be afraid to ask for help."

Source:

Colostomy Association

Studies Find Screening Colonoscopies May Be Done More Frequently Than Recommended, And May Not Be Beneficial To Some Older Adults

2011-08-06T12:12:00.000-07:00

Among Medicare beneficiaries, a large portion of colonoscopies for screening purposes are performed more frequently than recommended intervals. But among older patients treated at Veterans Affairs facilities, warranted follow-up colonoscopies for patients with positive fecal blood tests often do not occur, or cause burden when they do. These findings are from two reports posted online today that will appear in the August 8 print issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

Colonoscopy, a screening test used for the detection of colorectal cancer, may be overused as a screening tool, the authors suggest as part of the Less Is More series in the journal, with potential negative consequences including adverse effects without sufficient benefit, unnecessary expense, and use of limited medical resources. At first screening, most patients have no signs of cancer and clinical guidelines recommend that the next screening colonoscopy not take place for another ten years. "Identifying and decreasing overuse of screening colonoscopy should free up resources to increase appropriate colonoscopy in inadequately screened populations," write the authors.

James S. Goodwin, M.D., and colleagues from the University of Texas Medical Branch, Galveston, analyzed a national sample of 5 percent of persons enrolled in Medicare from 2000 through 2008. They identified patients at average risk for colon cancer who received an initial screening colonoscopy between 2001 and 2003. The researchers determined that 24,071 patients in the sample had a negative screening examination result and calculated the time before the procedure was repeated.

Of the group of 24,071, nearly one-fourth (23.5 percent) received a follow-up colonoscopy within seven years with no clear indication for the early repeated examination. Repeat screening rates were relatively high among older patients (45.6 percent in ages 75 to 79 years, and 32.9 percent in patients ages 80 years and older). Researchers also found that men, patients with more health conditions, those screened in high-volume colonoscopy settings, and those in certain geographic areas were more likely to be tested.

The authors recommend that closer attention be paid to colonoscopy screening rates so that this procedure is reserved for those who can really benefit from it. "Early repeated colonoscopies without clear indication compose a substantial proportion of the present endoscopist workload and also represents substantial Medicare expenditures," they state. "Given the increasing public interest in and ownership of cancer screening, public information campaigns that emphasize both the necessity for colorectal cancer screening as well as the dangers of overuse may prove beneficial in reducing overuse."

In another article, Christine E. Kistler, M.D., M.A.Sc. from the University of North Carolina at Chapel Hill, and colleagues, found that some patients who should receive colonoscopies did not receive the procedure, and some who did experienced a burden from screening. The authors studied 212 patients receiving care through Veterans Affairs facilities, and who were age 70 or older and had a positive result on a fecal occult blood test (FOBT). The study participants were followed-up for seven years to determine what other interventions occurred and what the outcomes for patients were.

More than half of the patients (118 of 212, or 56 percent) received a follow-up colonoscopy, which found 34 significant adenomas and six cases of cancer. Among this group, ten percent developed complications from the procedure or from cancer therapy. Of those (94 of 212, or 44 percent) who did not have a follow-up colonoscopy, three died of colorectal cancer within a five-year period and 43 died from other causes. The authors also estimated the relative benefits and burdens of the procedure against patients' life expectancies.

The findings point to the need to better determine which patients are good candidates for FOBT in the first place. "As with all screening tests, FOBT does not benefit most patients because most do not have cancer or significant adenomas," write the authors. Still, the proportion of those who had cancer or significant adenomas detected by the test and successfully treated (15.6 percent) "suggests that a significant minority received net benefit from current practices." Noting that those with the best life expectancies were the most likely to benefit from the test, the authors conclude, "Our study supports guidelines that recommend using life expectancy to guide colorectal cancer screening decisions in older adults and argues against one-size-fits-all interventions that simply aim to increase overall screening and follow-up rates."

Arch Intern Med.
2011;doi:10.1001/archinternmed/2011.212; doi:10.1001/archinternmed.2011.206.

What Is Constipation? What Causes Constipation?

2011-07-30T12:10:00.000-07:00

The word constipation comes from the Latin constipare meaning "to press, crowd together", and from 1400 A.D. Latin Constipationem. According to Medilexicon's medical dictionary, constipation is "A condition in which bowel movements are infrequent or incomplete". Constipation is also known as costiveness, and irregularity.

Constipation is a condition of the digestive system. The sufferer has hard feces that are difficult to expel. In most cases, this occurs because the colon has absorbed too much of the water from the food that is in the colon. The slower the food moves through your digestive tract, the more water the colon will absorb from food. Consequently, the feces become dry and hard. Defecation (emptying the bowels) can become very painful, and in some serious cases there may be symptoms of bowel obstruction. When the constipation is very severe; when the constipation prevents the passage of feces and gas, it is called obstipation.
What causes constipation?
Constipation happens when the colon absorbs too much water, or if the muscles in the colon are contracting slowly or poorly so that the stool moves too slowly and loses more water.

Interesting articles

What are laxatives? Do laxatives work?

What is fiber? What is dietary fiber? Fiber rich foods.

What is a balanced fluid intake?

All about opioids and opioid induced constipation

What is irritable bowel syndrome (IBS)? What are the symptoms of IBS?

What is Crohn's disease? What causes Crohn's disease?

Here are the most common causes of constipation:

The sufferer's diet is lacking in adequate quantities of fiber

It is well known that people whose diets include a good quantity of fiber are significantly less likely to suffer from constipation. Foods low in fiber are high fat foods, such as cheese, meats, and eggs. If you consume them, make sure you are also eating enough fruits, vegetables, and whole grains - which are rich in fiber.

There are two main types of fiber, soluble and insoluble. Soluble dissolves in water, while insoluble doesn't. Fiber cannot be digested. However, soluble fiber is transformed as it passes through the digestive tract, where it is fermented by bacteria. Soluble fiber absorbs water, and becomes gelatinous as it does so. Insoluble fiber passes through the gut without changing its form.

Quite simply, fiber promotes bowel movements and prevents constipation. Studies have indicated, however, that fiber is not that useful in dealing with constipation, it is better at preventing it.

The sufferer is too physically inactive. This is especially the case if the person is elderly

We know that if somebody has had to lie down in bed for a long time, perhaps for several days or weeks, his/her risk of having constipation is significantly increased. Experts are not sure why. Some say that physical activity keeps our metabolism high, making most things in our bodies happen more rapidly. Elderly people tend to have a more sedentary life, compared to younger, people, and are therefore at higher risk of constipation. Physically active people are much less likely to become constipated than inactive people.

Some drugs

It is common for people to forget that there are a lot of medications that can cause constipation. The most common ones are:

-- Narcotic (opioid) pain drugs, such as codeine (Tylenol#3), oxycodone (Percocet), and hydromorphone (Dilaudid)

-- Antidepressants, such as amitriptyline (Elavil) and imipramine (Tofranil)

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-- Anticonvulsants such as phenytoin (Dilantin) and carbamazepine (Tegretol)
Iron supplements

-- Calcium channel blocking drugs such as diltiazem (Cardizem) and nifedipine (Procardia)

-- Aluminum-containing antacids such as Amphojel and Basaljel

-- Diuretics such as chlorothiazide (Diuril)

Milk

Some people become constipated when they consume mild and dairy products.

IBS (irritable bowel syndrome)

People who suffer from IBS get constipation much more frequently, compared to the rest of the population.

Pregnancy

Pregnancy brings about hormonal changes which can make a woman more susceptible to constipation. Also, the uterus may compress the intestine, slowing down the passage of the food.

Aging

As we get older our metabolism slows down, resulting in less intestinal activity. The muscles in the digestive tract do not work as well as they used to.

A change in routine, such as when travelling

When we travel our normal routine changes. This can have an effect on our digestive system, which sometimes results in constipation. Meals are eaten at different times, we might go to bed, get up, and go to the toilet at different times. All these changes may raise the risk of constipation.

Overuse of laxatives

We all think we should go to the toilet at least once a day - this is a myth. To make sure that happens many people self-medicate with laxatives products they buy at the pharmacy. Laxatives are effective; they do help bowel movements. The problem is that if we keep taking them we gradually have to up the dose for the same effect. Laxatives can be habit-forming. When we become dependent on them there is a significant risk of constipation when we stop taking them.

Not going to the toilet when you feel the urge to

There can be many reasons for this. Perhaps we are not at home and would prefer to wait till we get back. It is surprising how many people never open their bowels in the toilets at work or at school. Others may be too busy to go, while some people don't because of emotional stress. Children often stop going if they are being toilet trained and find the whole training program nerve-racking. Sometimes children are too busy playing and put off going to the toilet. However, if you ignore the urge to have a bowel movement, that urge can gradually go away until you no longer feel the need to go. The longer you delay it, the drier and harder the stool will become.

Not drinking enough water (dehydration)

Experts say that if you already have constipation, drinking more liquids might not relieve it. However, if you regularly drink plenty of water you are less likely to become constipated. If you tend to suffer regularly from constipation you should seriously consider increasing your consumption of water. Many sodas and drinks containing caffeine may cause dehydration and worsen your constipation. Alcohol also dehydrates the body and should be avoided if you are constipated, or very susceptible to constipation.

Problems with the colon, or rectum

Tumors can compress or restrict the passages and cause constipation. Also scar tissue (adhesions), diverticulosis, and abnormal narrowing of the colon or rectum (colorectal stricture). People with Hirschsprung disease are susceptible to constipation (a birth defect in which some nerve cells are absent in the large intestine. The intestine does move stool through, consequently the intestine becomes blocked, causing the abdomen to enlarge).

Some diseases and conditions

Diseases that tend to slow down the movement of the feces through the colon, rectum, or anus are more likely to cause constipation. They include the following:

Neurological disorders

MS (Multiple Sclerosis), Parkinson's Disease, Stroke, Spinal Cord Injuries, Chronic Idiopathic Intestinal Pseudo-Obstruction

Endocrine and metabolic conditions

Uremia, Diabetes, Hypercalcemia, Poor Glycemic Control, Hypothyroidism

Systemic diseases (Diseases that affect a number of organs and tissues, or affects the body as a whole)

Lupus, scleroderma, and amyloidosis

Cancer

Mainly due to the medications for pain, and chemotherapy. Also if a tumor blocks or squeezes the digestive system.

What is the treatment for constipation?
It is important to remember that the necessity to defecate at least once a day is a myth. Constipation happens when you want to go but are unable to evacuate the feces. In the majority of cases, constipation resolves itself without any treatment or risk to health.

The treatment of recurring constipation can include lifestyle changes. Doing more exercise, eating more fiber, and drinking more water. Some studies contradict the high fiber advice; a study published in the American Journal of Gastroenterology found that the role of dietary fiber to treat chronic constipation is exaggerated. A low fiber diet has been proven not to be the cause of constipation and the success of fiber intake as treatment is modest.

Usually, laxatives will successfully treat most cases of constipation - but should be used with care and only when really necessary. In more difficult cases the person may need a prescription medication. Some people have responded well to biofeedback.

It is important to try to find out what has caused the constipation is in the first place - there could be an underlying illness or condition. Some people with recurring constipation use a daily diary where they record their bowel movements, stool characteristics, and other factors which may help both the doctor and patient devise the best treatment.

Some gastroenterologists comment that there are people who do not allocate enough time for their defecation. Set aside enough time to allow your toilet visit to be unstressed and uninterrupted, and do not ignore an urge to have a bowel movement.

Over-the-Counter laxatives

Only use these laxatives as a last resort. They can be habit forming, as was mentioned above:

Stimulants - they make the muscles in your intestines contract rhythmically. These include Correctol, Dulcolax and Senokot.

Lubricants - they help the stool move down the colon more easily. These include mineral oil and Fleet.

Stool softeners - they rehydrate (moisten) the stool. These include Colace and Surfak.

Fiber supplements - these are perhaps the safest laxatives. They are also called bulk laxatives. These include FiberCon, Metamucil, Konsyl, Serutan and Citrucel. Make sure you have plenty of water when you take them.

Osmotics - they facilitate the movement of fluids through the colon. These include Cephulac, Sorbitol, and Miralax.

Saline laxatives - they draw water into the colon. These include milk of magnesia.

Choride channel activators - these require a prescription. These include lubiprostone (Amitiza).

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5-HT-4 agonists - they increase the secretion of fluid in the intestines, and also speed up the rate at which food passes through the colon. These include Prucalopride.

Relistor was approved by the FDA in April, 2008 for the treatment of opioid-induced constipation. Opioids are commonly prescribed on a continuous basis for patients with late-stage, advanced illness to help alleviate pain.

If your doctor identifies an underlying disorder that may be causing your constipation he/she will treat that disorder.

If you have pelvic floor dysfunction, you may be treated with biofeedback. It is a retraining technique that helps you learn how to coordinate the muscles appropriately so that you have a successful bowel movement.

If the constipation does not respond to any treatment, as a last resort it might be recommendable to remove part of the colon. When this happens the troublesome segment(s) of the anal sphincter or rectum are removed.
How common is constipation?

Among children

According to research carried out at Nationwide Children's Hospital, Columbus, Ohio, the burden of illness in children suffering from constipation, and the costs associated with this condition, are roughly of the same magnitude as those for asthma and attention deficit-hyperactivity disorder (ADHD). According to researchers at the University of Iowa, constipation is the most common cause of children's abdominal pain.

Adults and people in general

According to a presentation by Boehringer Ingelheim, data show that 12% of people worldwide suffer from self-defined constipation. The figure varies depending on the region; people in the Americas and Asia Pacific suffer twice as much as their European counterparts, where the incidence of constipation is lowest (Americas and Asia Pacific mean 17.3% -v- European mean 8.75%).

According to a study carried out by the University of Iowa, chronic constipation affects 15% to 20% of the U.S. population.

Further reading

ACR's Guidelines For CT Colonography Interpretation Examined In Study At Digestive Disease Week

2011-07-23T12:08:00.000-07:00

A study presented at Digestive Disease Week® 2008 examined the American College of Radiology's (ACR) CT colonography guidelines recommending that polyps up to 5mm in size not be reported on CT colonography by applying them to an endoscopic database that collected information about polyps that had been removed and processed. The guidelines also recommend that patients with one or two polyps 6 to 9 mm in size and no larger polyps can have repeat CT colonography in three years rather than prompt polypectomy. The database included information for 10,780 polyps removed from 5,079 patients (among 10,034 colonoscopies) over a five-year interval. Overall, the study determined that if CT colonography rather than colonoscopy had been used in this population, and assuming 100 percent sensitivity of CT colonography for polyps ?‰? 6 mm and ACR interpretation recommendations, then 29 percent of all patients and 30 percent of patients over age 50 with high risk adenoma findings would have been interpreted as normal. High risk adenoma findings were defined according to current post-polypectomy surveillance guidelines as any adenoma 1 cm or larger in size, any adenoma with high grade dysplasia or villous elements, or patients with three or more adenomas of any size. An additional 18 percent of both groups could have had polypectomy delayed for at least three years.

The study, "American College of Radiology (ACR) Recommendations for CT Colonography (CTC) Interpretation: Implications for Resection of High Risk Adenoma Findings," was presented by Douglas K. Rex, MD, FASGE, chancellors professor of medicine, Indiana University School of Medicine and director of endoscopy at Indiana University Hospital, who also presented other research during DDW® on large sessile adenomas and their association with a high prevalence of synchronous neoplasia.

Large Sessile Adenomas Are Associated with a High Prevalence of Synchronous Neoplasia

In this study, patients with large (?‰? 2cm) sessile adenomas who undergo piecemeal endoscopic resection are recommended to have a follow up examination in three to six months to examine the polypectomy site for residual disease. The study was a retrospective single academic center review of synchronous neoplastic findings in 190 consecutive patients with intact colons and single large sessile adenomas resected endoscopically. All included patients had at least one full colonoscopy. Synchronous polyps were those removed at the same colonoscopy that discovered the large sessile adenoma, or at any follow up endoscopic examination within 12 months of discovery of the large sessile adenoma.

Researchers found that 75 percent of patients had at least one synchronous adenoma, and the 190 patients had an average of four synchronous adenomas. Thirty percent of patients had at least one synchronous advanced adenoma (adenoma ?‰?1 cm in size, or with high grade dysplasia or villous element), and three percent had synchronous lesions with high-grade dysplasia. Synchronous disease was distributed throughout the colon and was likely to be in a distant colonic segment as in the same or an adjacent colonic segment. Researchers concluded that patients with large sessile adenomas resected endoscopically warrant follow up not only to ensure complete resection, but also to ensure clearing of the entire colon.

Preoperative Detection of Familial Pancreatic Neoplasms by Endoscopic Ultrasonography (EUS), Multidetector Computed Tomography (CT) and/or Magnetic Resonance Cholangiopancreatography (MRCP)

Research by Marcia I. Canto, MD, FASGE, associate professor of medicine and oncology, Johns Hopkins University, Baltimore, MD, was presented on the preoperative detection of familial pancreatic neoplasms. Lives can be saved if high grade dysplasia and early familial ductal adenocarcinoma can be detected in high risk individuals before these lesions progress to advanced disease. Researchers looked to characterize pancreatic neoplastic lesions detected by imaging tests in high risk individuals; to compare the diagnostic yield and incremental benefit of EUS over CT/MRCP; and to determine the incremental benefit of fine needle aspiration (FNA) over EUS alone.

Data prospectively collected from 1998-2007 from two screening studies and the center's clinical screening program were analyzed. High risk individuals with Peutz-Jeghers syndrome or first degree relatives from familial ductal adenocarcinoma kindreds with at least two affected, had either multi-detector CT and or MRI/MRCP, and EUS. Radiologic and EUS features of each preoperatively detected lesion were compared with the pathologic findings. The diagnostic yield of each imaging modality was calculated on a per lesion basis.

Of 165 patients who had EUS and CT/MRCP, 19 asymptomatic high risk individuals underwent partial resection (15), partial followed by completion pancreatectomy (3), or total pancreatectomy (1) for 44 pancreatic lesions (size range 2.6-21 mm) detected by EUS, CT or MRCP. Researchers concluded that most pancreatic neoplasms detected by screening tests are small and low grade, but six percent of intraductal papillary mucinous neoplasms < 3 cm may contain high grade dysplasia. EUS detects almost twice as many neoplastic lesions as CT/MRCP, regardless of size, and FNA adds little to EUS.

Peroral Cholangioscopy Guided Stone Therapy - Report of an International Multicenter Registry

A study by Mansour A. Parsi, MD, department of gastroenterology at the Cleveland Clinic Foundation, examined peroral cholangioscopy used for the management of biliary stones that cannot be removed by conventional methods. The need for two expert operators and technical limitations of cholangioscopes has hampered its widespread adoption for the management of difficult to remove biliary stones. Researchers examined the SpyGlass Direct Visualization (SGDVS) system single operator peroral cholangioscope with four-way tip deflection that recently became commercially available. The aim of the study was to evaluate the efficacy and safety of the SGDVS for treatment of difficult to remove biliary stones and assess the utility of the device for detection of missed stones by endoscopic retrograde cholangiography (ERC).

Ninety-eight patients had cholangioscopy guided stone therapy using SGDVS. These patients reflect 33 percent of the cases in a multicenter open-label cholangioscopy registry involving 15 tertiary care centers in the US and Europe in which each patient undergoes ERC immediately followed by cholangioscopy. Procedural indications were bile duct stones not amenable to removal by conventional methods or missed by ERC. Procedural success was defined as the ability to adequately visualize and initiate stone therapy.

Stone location was 56 percent for the common bile duct (CBD), 22 percent for the common hepatic duct (CHD), seven percent for the intrahepatic ducts (IHD), ten percent for the cystic duct, gallbladder was one percent, and the left and right hepatic ducts (LHD and RHD) was four percent. In 59 percent of the cases, stones were impacted, and in 29 percent, stones were reported as missed during the ERC immediately preceding the cholangioscopy. Procedural success was 92 percent in the group as a whole.

DDW® is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW took place May 17-22, 2008, at the San Diego Convention Center, San Diego, Calif. The meeting showcased approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit www.ddwddw/
About the American Society for Gastrointestinal Endoscopy

Founded in 1941, the mission of the American Society for Gastrointestinal Endoscopy is to be the leader in advancing patient care and digestive health by promoting excellence in gastrointestinal endoscopy. ASGE, with more than 10,000 physician members worldwide, promotes the highest standards for endoscopic training and practice, fosters endoscopic research, recognizes distinguished contributions to endoscopy, and is the foremost resource for endoscopic education. Visit www.asgeasge/ and screen4coloncancer/ for more information.

About Endoscopy

Endoscopy is performed by specially-trained physicians called endoscopists using the most current technology to diagnose and treat diseases of the gastrointestinal tract. Using flexible, thin tubes called endoscopes, endoscopists are able to access the human digestive tract without incisions via natural orifices. Endoscopes are designed with high-intensity lighting and fitted with precision devices that allow viewing and treatment of the gastrointestinal system. In many cases, screening or treatment of conditions can be delivered via the endoscope without the need for further sedation, treatment or hospital stay.

Source: Anne Brownsey

American Society for Gastrointestinal Endoscopy

CEA-Leti And 7 Partners To Study Ways To Improve Treatment Of Inflammatory Bowel Disease

2011-07-16T12:06:00.000-07:00

CEA-Leti today announced a new project designed to develop a novel nanocarrier-based approach to improve the treatment of inflammatory bowel disease, and increasingly common condition in Europe.

The Delivering Nano-pharmaceuticals through Biological Barriers project, known as BIBA, involves eight partners in France, Germany, Spain and Switzerland. BIBA is coordinated by CEA-Leti as part of its research program on organic nanocarriers and delivery systems for clinical applications like molecular imaging and drug delivery.

The three-year study is designed to develop an anti-inflammatory corticoid and/or an immunosuppressant encapsulated within a biodegradable nanocarrier for improved treatment of IBD and reduced side effects. Industry supervision of the preclinical proof of concept will enhance quality control to guaranty a faster regulatory application after the project.

Inflammatory bowel disease (IBD) includes Crohn's disease (CD) and ulcerative colitis (UC). Medical treatment of IBD is mostly based on the use of corticosteroid to induce remission and of an immunosuppressant to prevent relapses. But these approaches are inefficient in more than 70 percent of patients with CD, and 20 percent of the patients with UC who ultimately require surgery for control of the disease. Corticosteroids like prednisolone can induce remission in a high proportion (60-80 percent) of patients.

However, the required doses of steroids cannot be administered long-time due to adverse events. BIBA will investigate local delivery of encapsulated corticosteroids and immunosuppressants using two types of organic biodegradable nanocarriers to prevent side effects. Passive targeting of nano-delivery systems in inflamed tissues exploiting the so-called enhanced permeability and retention (EPR) effect is expected to increase the local concentration of cortico??ds in inflamed areas.

One model of corticoid, budesonide, and one model of immunosuppressant, cyclosporine, will be separately encapsulated in three dosage forms - oral, colonic, and intravenous - to maximise the delivery of anti-inflammatory drugs through the gastrointestinal tract, with two nanocarriers: lipid "baby bubbles" (Lipidots®) and poly(lactic-co-glycolic acid) (PLGA) particles. In vitro experiments will be performed on a lab model of healthy and pathological epithelium to screen the most relevant nano-pharmaceuticals.

Formulations will then be evaluated in vivo in appropriate rodent colitis models. Animal models allow both the examination of inflammatory processes (both early and late events) as well as the evaluation of new therapeutic modalities. Non-invasive magnetic resonance imaging (MRI) and optical fluorescence in combination with histological analysis will be used to monitor the effect of the therapy on the inflamed mucosa.

The BIBA study is funded by the European programme ERANET EuroNanoMed. Leti's partners in the project include:

- Helmholtz-Institute for Pharmaceutical Research Saarland, Saarbrucken, Germany; and PHAST Gesellschaft f??r Pharmazeutische Qualit?¤tstandards mbH, Homburg, Germany

- Institut Albert Bonniot, INSERM-UJF U823, Grenoble, France

- Two Spanish hospitals: Instituto de Investigaci??n Sanitaria La Paz, Madrid; and Institut Investigacions Biom??diques August Pi i Sunyer, Barcelona; and the

- Institute of Anatomy of the University of Zurich

Source:

CEA-Leti

New Evidence Supports Non-invasive Routine Screening And Earlier Diagnosis Of Colon Cancer

2011-07-09T12:04:00.000-07:00

New results of a pivotal study recently presented at a meeting of the American College of Radiology Imaging Network (ACRIN), showed that Computed Tomography (CT) colonography is at least as sensitive as conventional colonoscopy in detecting adenomas of 1 cm diameter or larger. Adenomas are precursors to colorectal cancer, the second most common cause of death from cancer in the EU with more than 138,000 deaths in 20001. The results of the study are expected to lead to wider adoption of CT colonography (also known as virtual colonoscopy) as routine screening for colorectal cancer. The study, funded by the US National Institutes of Health (NIH), was initiated in 2005 and has involved more than 2,500 asymptomatic patients aged 50 or over at 15 centres across the USA.

The trial compared the detection of polyps and early-stage cancer of the colon using either conventional optical colonoscopy or CT colonography, in which X-ray slice images are reconstructed by computer to provide a virtual image of the colon. Patients were investigated using both procedures and the resulting CT images were read by a panel of radiologists.

Dr Stuart Taylor of University College Hospital, London, a consultant radiologist, commented: "This very well designed study is the largest to date which has specifically investigated the use of CT colonography to screen for colorectal neoplasia in asymptomatic individuals, and has produced very positive results. The 90% sensitivity for identifying patients harbouring a 1 cm adenoma essentially validates the previously reported excellent performance of screening CT colonography by Dr Perry Pickhardt in 2003. I think we can now conclude that, when performed by appropriately trained readers, CT colonography is a viable and robust screening tool for colorectal cancer."

Colonoscopy is widely considered to be the gold-standard method of examining the colon and rectum, but it is expensive, the patient must undergo sedation, and there is a small risk of perforation of the colon, making it unsuitable for large scale population screening2.

David Sumner, Chief Executive of Medicsight, one of the industry leaders in the development of computer-aided detection (CAD) and image analysis software, said: "We welcome the results of this landmark study, confirming our belief that CT colonography is a genuine and robust option in the armamentarium that physicians have at their disposal when screening for colorectal cancer. This is likely to lead to a material increase in the use of CT colonography for screening populations who are most at risk of developing this devastating condition. Medicsight's ColonCAD™ software, which can be used with multi-detector CT imaging equipment, helps radiologists to interpret the CT scans and identify early-stage lesions."

The occurrence of colorectal cancer is strongly related to age, with 83% of cases arising in people who are 60 years or older3. Among individuals diagnosed with colorectal cancer, survival is highly dependent on how advanced the disease is at diagnosis. Five-year survival is 90% if the disease is diagnosed while it affects only the large intestine but only 65% once it has spread to the lymph nodes and 9% if it has spread throughout the body4. Most colorectal cancers arise from precursor lesions in the large intestine called 'adenomatous polyps'. Screening is important because it means that adenomatous polyps can be removed before they become cancerous. Screening also means that colorectal cancer can be diagnosed at an earlier stage4.

There are several methods currently used for colorectal cancer screening and there are advantages and disadvantages associated with all of them. CT colonography is a newer, less invasive method of examining the colon and rectum in which computed tomography is used to generate two- and three-dimensional images of the colon and rectum. Virtual colonoscopy has been found to be as effective at detecting adenomatous polyps as colonoscopy in an earlier study5.

References

1. GLOBOCAN 2000. Cancer Incidence, Mortality and Prevalence Worldwide (2000 estimates).

2. Scholefield JH. ABC of colorectal cancer: screening. BMJ 2000;321(7267):1004-6

3. Cancer Research UK. UK Bowel Cancer incidence statistics. Available here. Accessed on 12 September 2007

4. Smith RA, Mettlin CJ, Eyre H. 31. Cancer Screening and Early Detection. In: D. W. Kufe et al., eds. Cancer Medicine. 6 ed. Hamilton, London: BC Decker Inc, 2003

5. Pickhardt PJ, Choi JR, Hwang I, et al. Computed tomographic virtual colonoscopy to screen for colorectal neoplasia in asymptomatic adults. N Engl J Med 2003;349(23):2191-200

Medicsight PLC is a UK-based, research driven, leading developer of computer-aided detection (CAD) and image analysis software for the medical imaging market. The CAD software automatically highlights suspicious areas on computerised tomography (CT) scans of the colon and lung, helping radiologists to identify, measure and analyse potential disease and early indicators of disease. Medicsight's computer-aided detection (CAD) software has been validated using one of the world's largest and most population diverse databases of verified patient CT scan data. Medicsight's ColonCAD™ and LungCAD™ software products are seamlessly integrated with the advanced 3D visualisation workstations of several industry-leading imaging equipment partners.

About Computer-Aided Detection

With increasingly sophisticated radiological imaging hardware such as Multi-Detector CT scanners, radiologists are facing a growing challenge in the amount of detailed patient image data that they must review for each patient examination. Some CT scan examinations generate as many as 1000 images per patient. Review of this data by the radiologist is not only time-consuming but also prone to error due to reader fatigue. CAD software can help the reviewing radiologist by analysing the image data and automatically highlighting suspicious regions of interest for closer inspection. Without CAD software some potential abnormalities or areas of disease may be overlooked. This is critical for diagnosis and the management of patient outcomes as early detection of disease greatly increases the probability of successful treatment and a positive therapeutic outcome.

About Medicsight's CAD software

Medicsight's ColonCAD™ and LungCAD™ software use an advanced CAD algorithm to analyse CT scans of the colon and lung and automatically highlight suspicious areas that may be indicators of disease. CAD may highlight areas easily overlooked by the reviewing radiologist, such as small lesions or regions that are hidden from view behind folds in the colon or normal structures and surrounding tissue in the lung.

Both CAD products seamlessly integrate with the advanced 3D visualisation platforms of industry-leading imaging equipment partners. The integrated systems provide sophisticated image viewing capabilities, including 3D reconstructed image data, with the added advantage of demonstrating automatic CAD findings to assist clinical end users in the detection and analysis of disease. This allows clinical end users to perform either a 'second read', where CAD findings are displayed to the user after completion of an initial review of the CT scan data, or a 'concurrent read' where CAD findings are displayed during the user's initial review of the original CT scan images.

Since inception, Medicsight has developed close and lasting relationships with some of the world's foremost clinicians in product related areas. This provides the Company with a wealth of clinical expertise and dedicated clinical research to support ongoing product development. Medicsight also collaborates with a number of leading academic institutions and clinical research programmes worldwide to develop the Company's comprehensive database of population diverse verified patient CT scan data, thus allowing Medicsight's products to be validated to the highest possible standards.

About ACRIN

The American College of Radiology Imaging Network (ACRIN) is a national cancer research organization sponsored and funded by the US National Cancer Institute.

About adenomas

An adenoma (sometimes known as a polyp) is a slow-growing benign tumour. This is the most common type of early-stage tumour found in the colon and typically projects into the colon from the wall. Adenomas are routinely removed on identification because of their tendency to become malignant.

acrin/

Discovery Could Improve Understanding Of Ulcerative Colitis, Lead To New Therapies

2011-07-02T12:02:00.000-07:00

An international team led by University of Pittsburgh School of Medicine researchers has identified genetic markers associated with risk for ulcerative colitis. The findings, which appear as an advance online publication of the journal Nature Genetics, bring researchers closer to understanding the biological pathways involved in the disease and may lead to the development of new treatments that specifically target them.

Ulcerative colitis is a chronic, relapsing disorder that causes inflammation and ulceration in the inner lining of the rectum and large intestine. The most common symptoms are diarrhea (oftentimes bloody) and abdominal pain. Ulcerative colitis and Crohn's disease, another chronic gastrointestinal inflammatory disorder, are the two major forms of inflammatory bowel disease (IBD).

"Ulcerative colitis and Crohn's disease are chronic conditions that impact the day-to-day lives of patients," said senior author of the study Richard H. Duerr, M.D., associate professor of medicine and human genetics at the University of Pittsburgh School of Medicine and Graduate School of Public Health. "IBD is most often diagnosed in the teenage years or early adulthood. While patients usually don't die from IBD, affected individuals live with its debilitating symptoms during the most productive years of their lives."

Because IBD tends to run in families, researchers have long thought that genetic factors play a role. Technology developed in recent years has enabled systematic, genome-wide searches for gene markers associated with common human diseases, and the discovery of more than 30 genetic risk factors for Crohn's disease has been one of the major success stories in this new era of research. While some genetic factors associated with Crohn's disease also predispose individuals to ulcerative colitis, markers specific for ulcerative colitis had yet to be found. To do so, researchers performed a genome-wide association study of hundreds of thousands of genetic markers using DNA samples from 1,052 individuals with ulcerative colitis and pre-exisiting data from 2,571 controls, all of European ancestry and residing in North America. Several genetic markers on chromosomes 1p36 and 12q15 showed highly significant associations with ulcerative colitis, and the association evidence was replicated in independent European ancestry samples from North America and southern Italy. Nearby genes implicated as possibly playing a role in ulcerative colitis include the ring finger protein 186 (RNF186), OTU domain containing 3 (OTUD3), and phospholipase A2, group IIE (PLA2G2E) - genes on chromosome 1p36, and the interferon, gamma (IFNG), interleukin 26 (IL26), and interleukin 22 (IL22) genes on chromosome 12q15. RNF186 and OTUD3 are members of gene families involved in protein turnover and diverse cellular processes. PLA2G2E, IFNG, IL26 and IL22 are known to play a role in inflammation and the immune response. The study also found highly suggestive associations between ulcerative colitis and genetic markers on chromosome 7q31 within or near the laminin, beta 1 (LAMB1) gene, which is a member of a gene family known to play a role in intestinal health and disease, and confirmed previously identified associations between ulcerative colitis and genetic variants in the interleukin 23 receptor (IL23R) gene on chromosome 1p31 and the major histocompatibility complex on chromosome 6p21.

"My laboratory is focused on studying the genetic basis for IBD," said Dr. Duerr. "Through genetic mapping, we and our collaborators are successfully identifying regions of the genome that contain IBD genes. The next steps are to understand the functional significance of IBD-associated genetic variants, and then to develop new treatments that specifically target biological pathways implicated by the genetic discoveries. The overall goal of this work is to improve the lives of the millions of patients worldwide that suffer from IBD."

The study's authors represent the IBD Genetics Consortium, which is funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH). In addition to the University of Pittsburgh, the NIDDK IBD Genetics Consortium's member institutions include Cedars-Sinai Medical Center in Los Angeles, the University of Chicago, Johns Hopkins University, Universit?© de Montr?©al and the Montreal Heart Institute, Mount Sinai Hospital in Toronto, and Yale University. Other study authors who collaborated with the NIDDK IBD Genetics Consortium to enable the study include researchers from Carnegie Mellon University, the Cleveland Clinic Foundation, The Feinstein Institute for Medical Research, and the Massachusetts General Hospital; CHUM - H??pital Saint-Luc in Montreal, The Hospital for Sick Children and Princess Margaret Hospital in Toronto, and CHAUQ - H??pital du St-Sacrement in Quebec; and the IRCCS -CSS Hospital in S. Giovanni Rotondo, Italy.

The University of Pittsburgh School of Medicine is one of the nation's leading medical schools, renowned for its curriculum that emphasizes both the science and humanity of medicine and its remarkable growth in NIH grant support, which has more than doubled since 1998. For fiscal year 2006, the University ranked sixth out of more than 3,000 entities receiving NIH support with respect to the research grants awarded to its faculty. As one of the university's six Schools of the Health Sciences, the School of Medicine is the academic partner to the University of Pittsburgh Medical Center (UPMC). Their combined mission is to train tomorrow's health care specialists and biomedical scientists, engage in groundbreaking research that will advance understanding of the causes and treatments of disease and participate in the delivery of outstanding patient care.

Source: Courtney McCrimmon

University of Pittsburgh Schools of the Health Sciences

Laparoscopic Management Of Advanced Renal Cell Carcinoma With Level I Renal Vein Thrombus

2011-06-25T12:00:00.000-07:00

UroToday- Traditionally, venous involvement, bulky retroperitoneal adenopathy, and large tumors with extracapsular extension have served as relative contraindications to radical nephrectomy performed through a laparoscopic approach. Increased experience and skill with this approach over time has resulted in expanding the indications of laparoscopic surgical techniques to deal with more and more complex surgical issues. Here Kapoor and colleagues report on their experience with laparoscopic management of level I tumor thrombi during laparoscopic radical nephrectomy.

The authors report on 12 patients with level I tumor thrombi that were diagnosed preoperatively. This report differs from previous studies in the literature in that all patients were known to have tumor thrombi preoperatively. Of these 12, 6 were done with a hand assisted laparoscopic technique, primarily because of large tumors with hilar adenopathy precluded a pure laparoscopic approach. Intraoperative laparoscopic ultrasound was used in 4 to delineate the extent of the thrombus to facilitate surgical management of the renal vein. Two cases were electively converted to open surgery due to more extensive venous involvement than perceived preoperatively. Seven of the 12 patients had metastatic disease at the time of surgery and two of these died of progressive disease after surgery, prior to the administration of systemic therapy. Mean blood loss was 200 ml and mean OR time was 220 minutes. The median length of stay was 4 days. There were no intraoperative complications and no positive margins or local recurrences in the series. The authors noted that the hand assisted approach was particularly useful in "milking back" the thrombus prior to application of the vascular stapler.

Increasing use of laparoscopic approaches in the management of renal cell carcinoma has resulted in the development of surgical skills that allow approaches to more complex surgical problems. As a consequence, selected patients with even locally advanced disease can enjoy the decreased morbidity associated with laparoscopic surgery.

Kapoor A, Nguan C, Al-Shaiji TF, Hussain A, Fazio L, Al Omar M, Luke PPW

Urology 68(3): 514-517, 2006.

Reviewed by UroToday Contributing Editor Christopher G. Wood, MD, FACS

UroToday - the only urology website with original content global urology key opinion leaders actively engaged in clinical practice.

To access the latest urology news releases from UroToday, go to:
www.urotoday

Copyright © 2006 - UroToday

Lubiprostone May Improve Symptom Relief Rates In Adults With IBS-C

2011-06-22T23:07:00.001-07:00

A new study demonstrated that the active ingredient in AMITIZA® (lubiprostone), given 8 mcg twice a day, may improve symptom relief rates in adults with irritable bowel syndrome with constipation (IBS-C). These results were presented as a late-breaker at Digestive Disease Week 2007, the largest annual international meeting of digestive disease specialists.

"In this study, patients receiving lubiprostone were nearly twice as likely to achieve an overall response from symptoms of IBS-C compared to those receiving placebo," said Douglas A. Drossman, M.D., primary investigator, UNC Center for Functional GI and Motility Disorders, University of North Carolina, and the Chair of the Rome Committee. "As a result, lubiprostone may represent an important treatment for IBS-C sufferers."

IBS is a condition that affects approximately 58 million Americans and accounts for 25-50 percent of referrals to gastroenterologists. IBS-C symptoms include abdominal pain or discomfort associated with defecation or a change in bowel habits with features of disordered defecation.

Lubiprostone is a novel selective chloride channel activator that has been shown to be effective and well-tolerated in a number of well-controlled clinical trials in patients with chronic idiopathic constipation. Lubiprostone is marketed in the U.S. as AMITIZA, a 24-mcg gelcap that was approved for use for chronic idiopathic constipation in adults on January 31, 2006.

Sucampo Pharmaceuticals expects to submit a supplemental New Drug Application for IBS-C to the U.S. Food and Drug Administration by July 2007.

About the Study for IBS-C (lubiprostone 8 mcg)

In two phase III, multi-center, double-blind, randomized, placebo-controlled trials, 1,171 adults diagnosed with IBS-C (Rome II Criteria) were enrolled and received lubiprostone 8 mcg taken twice daily (783 adults) or placebo (388 adults) over a 12-week period.

Primary efficacy was determined by a unique question: "How would you rate your relief of IBS symptoms (abdominal discomfort/pain, bowel habits and other IBS symptoms) over the past week compared to how you felt before you entered the study"" A 7-point balanced scale with a strict evaluation using the two highest scale points to qualify as a responder was used. Patients were considered monthly responders if they reported at least moderate relief four out of four weeks or significant relief two out of four weeks. To qualify as an overall responder (the measure used in the primary endpoint), patients had to be a monthly responder for at least two out of three months. During the evaluation period, patients discontinuing for any reason or reporting an increase in rescue medication use, lack of efficacy or moderately or significantly worse relief were deemed non-responders. These responder rates may not be comparable to those in other studies since the new scale was more restrictive than those used in previous reports.

The findings demonstrated that patients receiving lubiprostone 8 mcg twice daily were nearly twice as likely to achieve overall response compared to those receiving placebo (lubiprostone 17.9 percent vs. placebo 10.1 percent, P=0.001). There was a similar incidence of serious adverse events (1 percent in each group) and related adverse events (lubiprostone 22 percent vs. placebo 21 percent) compared to placebo. The most common treatment-related adverse events (>5% of patients) were nausea (8 percent vs. 4 percent, respectively), diarrhea (6 percent vs. 4 percent, respectively) and abdominal pain (4 percent vs. 5 percent, respectively).

About Irritable Bowel Syndrome with Constipation (IBS-C)

Irritable bowel syndrome (IBS) is a chronic disorder characterized by abdominal discomfort and pain, and bowel habit changes including symptoms of constipation and/or diarrhea. The condition can significantly interfere with daily activities and reduce patients' quality of life, resulting in absences from school, missed work and reduced productivity.

Three main types include IBS with constipation (IBS-C), with diarrhea (IBS-D) and with mixed symptoms of constipation and diarrhea (IBS-M). In IBS-C, symptoms are present for at least 3 days per month over a 3-month period. Although people with IBS-C report suffering from many of the same symptoms associated with constipation, the presence of abdominal discomfort and pain is what differentiates IBS-C from chronic constipation. Additionally, the hypersensitivity of the gastrointestinal system of individuals with IBS makes them more prone to experience the effects of even mild symptoms of constipation or diarrhea. The condition is approximately 2 to 2.5 times more prevalent in women than men, and women are more likely to report a history of constipation.

About AMITIZA® (lubiprostone) 24 mcg BID for Chronic Idiopathic Constipation

AMITIZA is indicated for the treatment of Chronic Idiopathic Constipation in the adult population. AMITIZA should not be used in patients with a known hypersensitivity to any components of the formulation and in patients with a history of mechanical gastrointestinal obstruction. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be evaluated prior to initiating AMITIZA treatment.

The safety of AMITIZA in pregnancy has not been evaluated in humans. In guinea pigs, lubiprostone has been shown to have the potential to cause fetal loss. AMITIZA should be used during pregnancy only if the benefit justifies the potential risk to the fetus. Women who could become pregnant should have a negative pregnancy test prior to beginning therapy with AMITIZA and should be capable of complying with effective contraceptive measures.

AMITIZA should not be administered to patients that have severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment. If the diarrhea becomes severe, patients should consult their health professional.

In clinical trials for Chronic Idiopathic Constipation (24 mcg BID), the most common adverse event was nausea (31%). Other adverse events (=5% of patients) included diarrhea (13%), headache (13%), abdominal distention (7%), abdominal pain (7%), flatulence (6%), sinusitis (5%) and vomiting (5%).

For full prescribing information, visit amitiza/.

AMITIZA® is a registered trademark of Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc., is an emerging pharmaceutical company based in Bethesda, Md. Sucampo Pharmaceuticals was founded in 1996 by Sachiko Kuno, Ph.D., the company's President and Chair of the Board of Directors, and Ryuji Ueno, M.D., Ph.D., Ph.D., the company's Chief Executive Officer and Chief Scientific Officer. Sucampo Pharmaceuticals focuses on the development and commercialization of drugs based on prostones, a class of compounds derived from functional fatty acids that occur naturally in the human body. The therapeutic potential of prostones was first identified by Dr. Ueno. In January 2006, Sucampo Pharmaceuticals received marketing approval from the FDA for its first product, AMITIZA, for the treatment of Chronic Idiopathic Constipation in adults. In October 2004, Sucampo Pharmaceuticals entered into an agreement with Takeda Pharmaceutical Company Limited (Osaka, Japan) to co-promote and market AMITIZA in the United States and Canada. Sucampo Pharmaceuticals' specialized sales force complements the efforts of Takeda by focusing on institutional and long-term care facilities. To learn more about the company and its products, visit sucampo/.

Takeda Pharmaceuticals North America, Inc.

Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. In the United States, Takeda currently markets products for diabetes, insomnia, wakefulness and gastroenterology. The company has a robust pipeline with compounds in development for diabetes, cardiovascular disease and other conditions. Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. To learn more about the company and its products, visit tpna/.

About Digestive Disease Week

Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 19-24, 2007, at the Washington Convention Center, Washington, DC. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit ddw/.

New study demonstrates that Lubiprostone may improve symptom relief rates in adults with IBS-C

Food Poisoning Bacterium Become Resistant To Antibiotics, Thanks To This Protein

2011-06-22T12:00:00.048-07:00

A new protein has been identified that promotes the development of
antibiotic resistance in Campylobacter bacteria,
the most commonly recognized source of food poisoning, according to a
study released on June 5, 2008 in the open access journal PLoS
Pathogens.

Campylobacter jejuni is the most common foodbourne
bacterial pathogen in humans, and it is present even in developed
countries. Standard treatment for infection with this bacterium is the
broad-spectrum antimicrobial fluoroquinolone, but the organism has been
found in many strains around the world that are resistant to this
antidote. Previous studies have shown that Campylobacter
is actually highly susceptible to mutation towards antibiotic
resistance, but the reasons behind this trait have been unclear.

To investigate this, researchers from Iowa State University's College
of Veterinary Medicine, led by Dr. Qijing Zhang, employed various
molecular biology techniques to observe the response of Campylobacter
to changes in Mfd, a protein involved in DNA transcription and repair,
in the presence of fluoroquinolone. They found that elimination of this
protein from the bacterium precipitated a 100-fold reduction in the
rate of creation of new strains that were resistant. This indicates
that this protein likely plays an important role in this type of
mutation.

Thusfar, Mfd had not been recognized with the function of promoting
antibiotic resistance. It is possible that other factors influence the
mutation frequency of these and similar organisms, so further study is
necessary to elucidate other influential aspects of this mechanism.

About PLoS Pathogens

PLoS
Pathogens (www.plospathogens)
publishes outstanding original
articles that significantly advance the understanding of pathogens and
how they interact with their host organisms. All works published in
PLoS Pathogens are open access. Everything is immediately available
subject only to the condition that the original authorship and source
are properly attributed. Copyright is retained by the authors. The
Public Library of Science uses the Creative Commons Attribution License.

About the Public Library of Science

The
Public Library of Science (PLoS) is a non-profit organization of
scientists and physicians committed to making the world's scientific
and medical literature a freely available public resource. For more
information, visit plos.

Key Role of Mfd in the Development of Fluoroquinolone
Resistance in Campylobacter jejuni.

Han J, Sahin O, Barton Y-W, Zhang Q

PLoS Pathog 4(6): e1000083.

doi:10.1371/journal.ppat.1000083

Click
Here For Full Length Article

Anna Sophia McKenney

Pfizer Affirms Celebrex Safety in response to withdrawal of Merck's Vioxx

2011-06-22T12:00:00.047-07:00

In response to Merck & Co.'s announcement today of the worldwide withdrawal of its COX-2 medicine Vioxx, Pfizer Inc issued the following statement:

Over 27 million patients in the United States have been prescribed Celebrex (celecoxib), which was approved by the U.S. Food and Drug Administration in 1998.

"Pfizer is confident in the long-term cardiovascular safety of Celebrex," said Dr. Joe Feczko, Pfizer's president of worldwide development.

In a recent FDA-sponsored study of 1.4 million patients, those who received Celebrex demonstrated no increased risk of cardiac events.

"Patients taking COX-2 inhibitors may be confused and should speak with their doctors," Dr. Feczko said. "Because of its outstanding long-term safety profile and broad indication base including osteoarthritis, rheumatoid arthritis and acute pain, Celebrex is an appropriate treatment alternative."

Celebrex was the first COX-2 inhibitor, a class of medicine designed to relieve pain without the serious gastrointestinal side effects associated with older non-steroidal anti-inflammatory medicines. In 2001, Pfizer introduced Bextra (valdecoxib), its second COX-2 inhibitor, for use in osteoarthritis and rheumatoid arthritis. Bextra's cardiovascular safety profile is also well established in long-term studies.

Data show that since the introduction of COX-2 inhibitors, the rate of hospitalizations for gastrointestinal events associated with long-term arthritis treatment has declined significantly.

celebrex

View drug information on Bextra; Vioxx.

Iowa Department Of Public Health Informa That E.coli Cases Increase

2011-06-22T12:00:00.046-07:00

Since late September, 29 cases of Eli O157:H7 and related strains have been reported to IDPH. This compares to an average of 18.4 cases during the same time period over the last five years. Of the 29 cases, 22 involve children ages 12 years and younger. Several of these children have been admitted to the hospital and a few have experienced significant kidney damage as a result of their Eli infection.

All E. coli cases are investigated to determine if there are contaminated food items on the market, or if particular risks exist in a community, such as poorly-chlorinated kiddies' pools. Action is taken by public health officials if there is even a suspicion of increased risk.

The recent Eli cases investigated by IDPH include a small cluster of cases in eastern Iowa. Several things associated with the cases increased the risk of E. coli exposure, such as drinking unpasteurized apple cider, eating fresh, unwashed apples, and eating ground beef. "With the exception of the eastern Iowa cluster, all the other cases have been reported across the state and have no common exposures," said IDPH medical director, Dr. Patricia Quinlisk. "Thus it is important for everyone to be aware of how Eli exposure can occur, and what each person can do to reduce their risk of becoming ill."

Potential sources of Eli contamination include drinking raw, unpasteurized juice or milk; contact with farm animals either in a farm setting or petting zoo; consumption of under-cooked ground meats or of foods contaminated by raw meat juices; and consumption of raw, unwashed produce. Eli can also be transmitted from an ill person to a healthy person, which is why hand washing is very important.

Eli O157:H7 and related strains are bacteria. The main symptom of Eli O157:H7 and similar infections is diarrhea, which may be bloody. Stomach cramps and chills may also occur. Fever is rarely reported. Anyone with symptoms of Eli O157:H7 should consult with his or her health care provider immediately. Approximately 8 percent of cases will develop complications involving the kidneys, especially young children. The infection may also cause a person's blood clotting systems to malfunction.

Eli infections can be prevented:

- Make sure fresh juice or milk has been pasteurized. Even small samples can make a person sick.

- People with diarrhea should not prepare or touch food meant for others.

- Wash hands with soap and water after using the restroom. If soap and water are not available, use an alcohol based hand gel to clean hands.

- When caring for someone with diarrhea, wash your hands after giving any care, and ensure that the ill person's hands are frequently washed, too.

- Cook all ground meats like hamburger thoroughly - to a temperature of 155 F for at least 15-16 seconds, or until juices run clear and no pink is visible.

- Always wash fresh vegetables or fruits thoroughly before eating.

IDPH recommends parents and caregivers become aware of the possible exposures for Eli, and take actions to reduce their own and their children's risk of exposure.

Iowa Department of Public Health

Data From Clinical Trial Examining Lubiprostone For The Treatment Of Opioid-induced Bowel Dysfunction Presented At Digestive Disease Week Conference

2011-06-22T12:00:00.045-07:00

Sucampo Pharmaceuticals, Inc. today announced the presentation of results from a phase 3 clinical trial investigating the use of lubiprostone in non-cancer pain patients with Opioid-induced Bowel Dysfunction (OBD). These results were the subject of an oral presentation at the Digestive Disease Week (DDW) 2010 conference in New Orleans, Louisiana, on May 5, 2010.

Byron Cryer, M.D., the John C. Vanatta III Professor of Medicine at the University of Texas, Southwestern, in Dallas, Texas, who was an investigator in the trial and presented the data at DDW, said, "Opioid-induced Bowel Dysfunction in patients with chronic non-cancer pain is a serious problem. In the Phase 3 results of this study presented here, some patients received relief from constipation without a reduction in their pain medication."

Gayle R. Dolecek, P.D., M.P.H., Senior Vice President, Research & Development, Sucampo Pharmaceuticals, Inc., said, "We were pleased to see these data from the Phase 3 results of lubiprostone in this trial as we believe lubiprostone may represent a future treatment strategy for OBD patients if approved in this patient population."

The results reported are from a randomized, double-blind, placebo-controlled phase 3 clinical trial (known as OBD0631) that assessed the safety and efficacy of lubiprostone (24 mcg twice daily) for the treatment of OBD in patients taking opioids for non-cancer pain. In this trial, patients with OBD were randomized to receive either lubiprostone 24 mcg gel capsules or matching placebo capsules twice a day every day for 12 weeks.

A total of 875 OBD patients with non-cancer pain were randomized into two identically designed phase 3 trials. The data reported at DDW are from one of these trials, in which statistical significance was achieved for the primary endpoint in one study (OBD0631), but not in the other study (OBD632). Statistically significant improvements were seen for eight of the 12 secondary endpoints in study OBD0631. In study OBD0632, statistically significant improvements were noted for two of 12 secondary endpoints.

Among the key results of the OBD0631 trial were:

- The primary efficacy endpoint, the change from baseline in spontaneous bowel movement (SBM) frequency at Week 8 in patients without reduction in dose of study medication, achieved statistical significance (p=0.0226) for patients taking lubiprostone (n=167) compared to placebo (n=169).

- Patients taking lubiprostone achieved a significantly (p=0.02) greater increase in the mean number of SBMs per week in eight of the 12 weeks of the trial, as compared to placebo patients.

- The percentage of patients who achieved a SBM within 24 hours and 48 hours was significantly higher with lubiprostone as compared to placebo (p=0.0126 at 24 hours, and p=0.0360 at 48 hours).

- Statistical significance was achieved for the overall change from baseline in constipation-associated symptom endpoints including: constipation severity (p=0.0006); stool consistency (p

- The most commonly reported adverse events in this trial were nausea, diarrhea, and abdominal distension. Overall 4.6% of patients (3.2% placebo vs. 5.9% lubiprostone) discontinued due to an adverse event.

About the Trial Design

A total of 443 OBD patients enrolled at multiple sites in the U.S. and Canada were randomized into this double-blind, placebo-controlled phase 3 clinical trial and received one 24-mcg gel capsule of lubiprostone or placebo twice a day for 12 weeks. Patients in the trial were administered different opioid pain medications including fentanyl, methadone, morphine, and oxycontin.

AMITIZA® (lubiprostone) for Chronic Idiopathic Constipation in Adults and Irritable Bowel Syndrome with Constipation in Adult Women

AMITIZA® (lubiprostone) is indicated for the treatment of Chronic Idiopathic Constipation (24 mcg twice daily) in adults and for Irritable Bowel Syndrome with Constipation (8 mcg twice daily) in women ?‰? 18 years old.

Important Safety Information

AMITIZA is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be thoroughly evaluated by the treating healthcare provider to confirm the absence of such an obstruction prior to initiating AMITIZA treatment.

The safety of AMITIZA in pregnancy has not been evaluated in humans. AMITIZA should be used during pregnancy only if the benefit justifies the potential risk to the fetus. Women who could become pregnant should have a negative pregnancy test prior to beginning therapy with AMITIZA and should be capable of complying with effective contraceptive measures.

Patients taking AMITIZA may experience nausea. If this occurs, concomitant administration of food with AMITIZA may reduce symptoms of nausea. Patients who experience severe nausea should inform their healthcare provider.

AMITIZA should not be prescribed to patients that have severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment and inform their healthcare provider if the diarrhea becomes severe.

Patients taking AMITIZA may experience dyspnea within an hour of first dose. This symptom generally resolves within three hours, but may recur with repeat dosing. Patients who experience dyspnea should inform their healthcare provider. Some patients have discontinued therapy because of dyspnea.

In clinical trials of AMITIZA (24 mcg twice daily vs. placebo; N=1113 vs. N=316) in patients with Chronic Idiopathic Constipation, the most common adverse reactions (incidence > 4%) were nausea (29% vs. 3%), diarrhea (12% vs. 4%) were nausea (8% vs. 4%), diarrhea (7% vs. 4%), and abdominal pain (5% vs. 5%).

About Digestive Disease Week (DDW)

DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 1 - 5, 2010, in New Orleans. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit ddw.

Source
Sucampo Pharmaceuticals, Inc.

View drug information on Amitiza; OxyContin.

Spinach E. coli Linked To California Spinach Processor

2011-06-22T12:00:00.044-07:00

US government investigators have linked the latest E. coli poisoning outbreak to a spinach processor in San Juan Bautista, California, called Earthbound Farm, owned by Natural Selection Foods LLC. Infected patients have reported consuming other brands made by Natural Selection Foods.

Investigations are still ongoing to check for other sources, according to Dr. David Acheson, Chief Medical Officer, FDA Center for Food Safety and Applied Nutrition.

Natural Selection Foods is recalling all its spinach-containing products. The following products belong to Natural Selection Foods:

-- Bellissima, Dole

-- Cheney Brothers

-- Coastline

-- Cross Valley

-- D'Arrigo Brothers

-- Earthbound Farm

-- Emeril, Sysco

-- Fresh Point

-- Green Harvest

-- Jansal Valley

-- Mann

-- Mills Family Farm

-- Natural Selection Foods

-- Nature's Basket

-- O Organic

-- Premium Fresh

-- President's Choice

-- Pride of San Juan

-- Pro-Mark, Compliments

-- ProAct

-- Rave Spinach

-- Ready Pac

-- River Ranch, Superior

-- Riverside Farms

-- Snoboy

-- Tanimura & Antle

-- The Farmer's Market

-- Trader Joe's

(These products contain spinach)

Shoppers wanting a refund or replacement coupons can call 800-690-3200.
The latest E. coli outbreak was first reported on August 25th. The Food and Drugs Administration (FDA) has issued a nationwide warning, telling people not to buy or consume the said raw spinach products. Even washing will not eliminate the bacteria (boiling will).

So far, the following states have reported human cases of E. coli poisoning (O157:H7 strain):

-- California

-- Connecticut

-- Idaho

-- Indiana

-- Kentucky

-- Maine

-- Michigan

-- Minnesota

-- New Mexico

-- Nevada

-- New York

-- Ohio

-- Oregon

-- Pennsylvania

-- Utah

-- Virginia

-- Washington

-- Wyoming

(Source: CDC - at least 94 cases so far)

The O157:H7 strain of E. coli causes diarrhea (commonly with bloody stools). Some patients can experience fever. Abdominal pain is also common. Most healthy adults make a full recovery within seven days. However, some people, such as young children and the elderly, may develop Hemolytic Uremic Syndrome (a form of kidney failure).

-- Click here for news on this outbreak from the FDA

News From Journal Of Clinical Investigation Online Early: April 6, 2009

2011-06-22T12:00:00.043-07:00

ONCOLOGY: Harnessing immune cells to target skin cancer

One subset of immune cells known to contribute to the immune response that targets tumors is the NK cell subset. Although this suggests that NK cell-based therapeutics have anticancer potential, more information is needed about the interactions between NK cells and human tumor cells if this promise is to be realized. A team of researchers, at The Babraham Institute, United Kingdom, and the University of Catanzaro "Magna Graecia", Italy, has now provided insight into this issue by studying both human metastatic melanomas (aggressive forms of skin cancer that have spread to other sites) and spontaneous mouse melanomas.

The team, led by Francesco Colucci and Ennio Carbone, found that human melanoma cell lines derived from lymph node metastases expressed proteins that interacted with the NK cell protein DNAM-1 and with a group of NK cell proteins known as NCRs. These cell lines were particularly susceptible to being killed by NK cells both in vitro and after being transplanted into mice. Consistent with these data from human cell lines, mouse spontaneous melanomas and melanoma cell lines both expressed proteins that bound DNAM-1 and NCRs. Further, interfering with the interaction of DNAM-1 and NCRs with proteins on melanoma cells reduced NK cell-mediated killing of human and mouse melanoma cells lines in vitro and in vivo. The authors therefore conclude that DNAM-1 and NCRs are critical for NK cell-mediated killing of melanoma cells and suggest that NK cells could be harnessed to prevent melanoma metastasis.

TITLE: NCRs and DNAM-1 mediate NK cell recognition and lysis of human and mouse melanoma cell lines in vitro and in vivo

AUTHOR CONTACT:

Francesco Colucci

The Babraham Institute, Cambridge, United Kingdom.

Ennio Carbone

University of Catanzaro "Magna Graecia", Catanzaro, Italy.

View the PDF of this article at: https://www.the-jci/article.php?id=36022

GASTROENTEROLOGY: The protein Cd1d controls intestinal colonization with bacteria

The intestines of all mammals, including humans, are home to a large number of species of bacteria. The identity of these bacteria affects both the normal functioning of the intestines and the occurrence of immune-mediated intestinal diseases, such as inflammatory bowel disease. Despite the importance of these bacteria, little is known about the host factors that control their colonization of the intestines. However, Edward Nieuwenhuis and colleagues, at Erasmus Medical Center, The Netherlands, have now identified a role for the protein Cd1d in regulating intestinal colonization by bacteria in mice.

In the study, when analyzed under specific pathogen-free or germ-free conditions and compared with Cd1d-sufficient mice, Cd1d-deficient mice exhibited increased colonization of the small intestine following administration of a number of species of bacteria (Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus, or Lactobacillus gasseri) into their stomachs. By contrast, activation of immune cells that bind Cd1d prevented intestinal colonization of specific pathogen-free Cd1d-sufficient mice with P. aeruginosa and E. coli. Further analysis revealed a role for Paneth cells, which are found only in the small intestine, in the process. The authors therefore conclude that Cd1d controls colonization of the intestines with bacteria via a mechanism that involves Paneth cells and suggest that manipulating Cd1d might provide a way to modulate the identity of the bacteria in the intestines.

TITLE: Cd1d-dependent regulation of bacterial colonization in the intestine of mice

AUTHOR CONTACT:

Edward E.S. Nieuwenhuis

Erasmus Medical Center, Rotterdam, The Netherlands.

View the PDF of this article at: https://www.the-jci/article.php?id=36509

PHYSIOLOGY: A link between low oxygen levels and intestinal iron absorption

The only way for iron, which is an essential nutrient, to be taken up by the body is for it to be absorbed by the intestine. Low iron levels can lead to anemia, which is characterized by weakness and fatigue and, in severe cases, heart failure. In a new study, Carole Peyssonnaux and her colleagues at Universit?© Paris Descartes, France, have identified a link between one of the HIF proteins that help cells adapt to low oxygen levels (hypoxia) and iron absorption in the small intestine, which they found was hypoxic. Using transgenic mice, they showed that HIF-2-alpha (but not HIF-1-alpha) helped maintain iron levels in the intestine by regulating expression of the primary iron transporter gene. Furthermore, mice lacking HIF-2-alpha displayed low levels of iron in the blood and liver. The authors therefore conclude that strategies targeting HIF-2-alpha may be useful in treating patients with iron disorders.

TITLE: HIF-2-alpha, but not HIF-1-alpha, promotes iron absorption in mice

AUTHOR CONTACT:

Carole Peyssonnaux

Universit?© Paris Descartes, CNRS (UMR 8104), Paris, France.

View the PDF of this article at: https://www.the-jci/article.php?id=38499

NEPHROLOGY: Fragmenting mitochondria underlie acute kidney failure

Damage to kidney cells known as renal tubular cells is a major cause of acute kidney failure, which is increasing in prevalence. In particular, damage to the energy generating compartments of the cell, which are known as mitochondria, is central to renal tubular cell death. Zheng Dong and colleagues, at the Medical College of Georgia, Augusta, have now provided new insight into the mitochondrial changes that occur in acute rodent kidney injury, information that they hope might provide new avenues of research for those developing drugs to combat this condition.

In the study, analysis of rat renal tubular cells in vitro following exposure to conditions that induce acute kidney injury in vivo, revealed that mitochondria fragmented before the cells died. Furthermore, both knocking down expression of the protein Drp1, which is known to be involved in mitochondrial fission, and blocking its function substantially reduced mitochondrial fragmentation and apoptotic cell death. Consistent with these data, mitochondrial fragmentation was observed in two mouse models of acute kidney injury and treatment with a newly identified pharmacological inhibitor of Drp1 reduced renal tubular cell apoptosis and acute kidney injury.

TITLE: Regulation of mitochondrial dynamics in acute kidney injury in cell culture and rodent models

AUTHOR CONTACT:

Zheng Dong

Medical College of Georgia, Augusta, Georgia, USA.

View the PDF of this article at: https://www.the-jci/article.php?id=37829

Source:
Karen Honey

Journal of Clinical Investigation

A Spoonful Of Sugar Makes The Medicine Go To Work

2011-06-22T12:00:00.042-07:00

There will soon be no more bitter pills to swallow, thanks to new research by Leeds scientists: a spoonful of sugar will be all we need for our bodies to make their own medicine.

Professor Simon Carding of Leeds' Faculty of Biological Sciences has adapted bacteria in our own bodies to produce a treatment for Inflammatory Bowel Disease (IBD). Bacteria and viruses have been used before to deliver drugs in this way, but Professor Carding has solved the major problem with this kind of treatment: he uses a sugar to 'switch' the bacteria on and off. By eating the sugar, a patient will set the medicine to work and then can end the treatment simply by stopping consumption of the sugar.

"Current bacteria and virus delivery systems produce their drugs non-stop, but for many treatments there is a narrow concentration range at which drugs are beneficial," said Professor Carding. "Outside of this, the treatment can be counterproductive and make the condition worse. It's vitally important to be able to control when and how much of the drug is administered and we believe our discovery will provide that control."

Professor Carding has modified one of the trillions of bacteria in the human gut so that it will produce human growth factors which help repair the layer of cells lining the colon, so reducing inflammation caused by IBD. But he's also adapted the bacteria so it only activates in the presence of a plant sugar called xylan that is found in tree bark. Xylan is naturally present in food in low concentrations, so by taking it in higher quantities, a patient will be able to produce their own medicine as and when they need it.

"The human gut has a huge number of bacteria, and this treatment simply adapts what's there naturally to treat the disease," said Professor Carding. "We're already looking at using the same technique for colorectal cancer, as we believe we could modify the bacteria to produce factors that will reduce tumour growth. Treatment of diseases elsewhere in the body might also be possible as most things present in the gut can get taken into the blood stream."

The discovery has been patented and is being developed further with support from the University's technology transfer partner, Techtran Group Ltd part of the IP Group plc and the Medical Research Council. The technique has been shown to work in vitro, but the researchers will be testing the treatment over the next twelve months in preparation for clinical trials.

LEEDS UNIVERSITY

Leeds

LS2 9JT

leeds.ac

Bowel Cancer Indicator Should Lead To Better Treatment

2011-06-22T12:00:00.041-07:00

STEM cell scientists have developed a more accurate way of identifying aggressive forms of bowel cancer, which should eventually lead to better treatment and survival rates.

The UK-led team, headed by scientists from Durham University and the North East England Stem Cell Institute, (NESCI*), studied tissue samples from 700 colorectal cancer patients and tracked their progress.

They found that patients who had a stem cell marker protein called Lamin A present in their tissue were more likely to have an aggressive form of the disease.

The team concluded that if the marker is detected in the early forms of colorectal cancer, these patients should be given chemotherapy in addition to the surgery normally offered to ensure a better survival predicament.

The team now aims to develop a robust prognostic tool for use in the health service.

The study, funded by the Association for International Cancer Research and NHS Research and Development funds, is published in the open-access scientific journal PLoS ONE.

The Durham University/NESCI scientists worked with colleagues from The James Cook University Hospital, Middlesbrough, and the Departments of Pathology and Epidemiology at the University of Maastricht in the Netherlands.

Bowel cancer is the third most common cancer in the UK, where each year more than 36,000 people are diagnosed with the disease. Worldwide over a million new cases of bowel cancer were diagnosed in 2002.

Almost three-quarters of bowel cancer cases occur in people aged 65 and over. The development of disease is linked with diet, lifestyle and environmental factors. (Source of statistics: Cancer Research UK fact sheet).

In colorectal cancer, there are four key stages of the disease. The stage of a patient's cancer is determined by a series of hospital tests, the results of which inform the treatment they are given.

In the two earlier stages, before the cancer involves the lymph nodes, patients normally have an operation to remove the cancer from the bowel. They are rarely given chemotherapy in addition to the surgery. This is because for many patients, who are often elderly and frail, chemotherapy may cause more harm than benefit. It's therefore critical to know when and in whom it should be used.

However, the new study suggests that around one third of these patients will express the Lamin A stem cell marker, which indicates a more serious form of the cancer. These patients, argue the scientists, should be given chemotherapy to target these stem cells, which should ultimately improve their recovery and survival rates.

Professor Chris Hutchison, of Durham University and NESCI, said: "Currently the hospitals use a standard test to work out how far the cancer has progressed and then they use this to determine the treatment the patient should receive. However, we are potentially able to more accurately predict who would benefit from chemotherapy."

Dr Stefan Przyborski, of Durham University and NESCI, said: "We now aim to carry out more work in this area to develop a prognostic tool which we hope will eventually be for widespread use by the health services in the treatment of bowel cancer."

Professor Robert Wilson, a consultant surgeon and bowel cancer specialist at The James Cook University Hospital, Middlesbrough, said: "We have a very high number of patients with bowel cancer in the north east of England in particular. We know the best treatment for very early and very late disease but there are still a lot of unknowns in-between these two extremes.

"Chemotherapy can be very useful but can have a number of side effects, so we only want to use it where we think there's a good chance it will help. This test will help us determine that."

* 'The North-east England Stem Cell Institute (NESCI) draws together Durham and Newcastle Universities, the Newcastle-upon-Tyne Hospitals NHS Foundation Trust and other partners in a unique interdisciplinary collaboration to convert stem cell research and technologies into cost-effective, ethically-robust 21st century health solutions to ameliorate degenerative diseases, the effects of ageing and serious injury. The Institute has received substantial funding and other support from the Regional Development Agency, One NorthEast and is partly based at the International Centre for Life in Newcastle.' nesci.ac

Lamin A/C Is a Risk Biomarker in Colorectal Cancer.
Willis ND, Cox TR, Rahman-Casa?±s SF, Smits K, Przyborski SA, et al. (2008)

PLoS ONE 3(8): e2988. doi:10.1371/journal.pone.0002988

Please click here to view article online

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Suffering From The Symptoms Of Irritable Bowel Syndrome? Medical Experts Say Get Tested For Celiac Disease, Now Easier To Diagnose

2011-06-22T12:00:00.040-07:00

Estimates indicate that up to 20 percent of North Americans, possibly as high as 30 per cent in some countries, cope with the painful and debilitating symptoms of irritable bowel syndrome (IBS). According to the American College of Gastroenterology, all patients with symptoms of IBS should be tested for celiac disease, a lifelong hereditary disorder which has some of the same symptoms.

Celiac disease can make IBS symptoms worse. In some cases, it might even be the cause.

There is no cure for IBS. Instead the focus is on a wide variety of treatments to relieve the symptoms, and one of the treatments is a high fibre diet, which includes whole grains and certain cereals. But the only treatment for celiac disease is a gluten free diet for life. Gluten is a protein found in wheat, rye and barley. Because of its sticky characteristics, it can also be found in certain other food products and even in some medications.

At-home Test Kit Now Available

Now there's a simple, accurate way to find out if you're susceptible to celiac disease. For the first time in Canada, Health Canada has approved the Biocard™ Celiac Test Kit, an at-home test that measures gluten antibodies from a fingertip blood sample. The test gives you a high degree of certainty that you are either developing the disease or already have it, but you still need to see your doctor for a confirmation.

What is celiac disease?

Celiac disease occurs when gluten triggers an abnormal response that damages the lining of the small intestine, interfering with your absorption of nutrients. The disease is hereditary and lifelong, and affects people differently. But many of the symptoms of celiac disease are the same for IBS such as diarrhea, bloating and abdominal pain.

Left untreated, celiac disease increases the risk of malnutrition, osteoporosis (because of poor absorption of calcium and vitamin D), infertility, certain digestive cancers and other conditions such as Type 1 diabetes and thyroid disease. Research indicates that in North America, one person out of every 100 has celiac disease, and almost 97 per cent of those affected remain undiagnosed.

Celiac disease affects people differently and not all symptoms are obvious.

Classic celiac symptoms include diarrhea, stomach pain, weight loss and, in children, delayed growth. For others, the symptoms are subtler, such as such as bloating, or excess gas. Fatigue, weakness, joint pain and migraines -- symptoms typically not associated with the gut -- are also reported. Not surprisingly, the diagnosis is often irritable bowel syndrome, anemia, stress or chronic fatigue syndrome.

Average time for correct diagnosis of celiac disease - 12 years: According to a 2007 survey of the Canadian Celiac Association's more than 5000 members, the average time it took to be diagnosed was 12 years. Many reported consulting with three or more doctors before their diagnosis was confirmed.

The Process for Diagnosing Celiac Disease

With the Biocard™ Celiac Test Kit, a person can find out within 10 minutes if they have the antibodies associated with celiac disease. While the test even indicates if the disease is in its early stages, confirming the diagnosis requires a small bowel biopsy in which an endoscope is passed through the mouth into the stomach's upper intestine so that the lining can be examined and a biopsy taken.

The day your diagnosis is confirmed and you start your gluten-free diet, is the day you're on the road to recovery. It could also mark the beginning of your relief from the painful and distressing symptoms common to IBS. Celiac patients on the gluten-free diet with persisting bowel symptoms should seek medical help for other gut-related disorders such as colitis and Crohn's disease.

Information on celiac disease, the Biocard™ Celiac Test Kit, and links to key informational sites can be found at celiachometest. The kit can be purchased online, or at London Drugs, Rexall Pharma Plus, Price Smart, Save on Foods and other major Canadian retail chains.

About 2G Pharma Inc.

Founded by Karina Nelimarkka and Janet Monk, 2G Pharma markets the unique, patient-friendly celiac disease test kit first developed by AniBiotech in Finland. This kit has been redesigned for the Canadian market and is currently the only Health Canada approved point-of-care celiac disease test kit available. Information on celiac disease, the Biocard™ Celiac Test and links to key informational sites can be found at celiachometest.

2G Pharma Inc.

Will Chemotherapy Work? Einstein Researchers Develop Test That May Offer Answer For Colorectal Patients

2011-06-22T12:00:00.039-07:00

By measuring the activity of four genes in cancer cells, scientists at the
Albert Einstein College of Medicine of Yeshiva University accurately predicted whether colorectal tumors
are sensitive or resistant to 5-Fluorouracil (5-FU), an important chemotherapy drug. The diagnostic
advance, described in the July 1 issue of Cancer Research, could help doctors make the crucial decision as
to whether a colorectal cancer patient should receive 5-FU or instead be treated surgically or with other
chemotherapy agents.

Several years ago, Dr. Robert Singer and colleagues at Einstein developed a novel microscopy
technique known as fluorescence in situ hybridization (FISH) that allows researchers to see whether a gene
of interest in a single cell is activated (transcribed). In this study, Dr. Singer wanted to see whether FISH
could help in treating patients with colorectal cancer, the second-leading cause of cancer death among men
and women in the U.S.

"Since genes play such a significant role in causing cancer, you'd assume that you might find a
different transcriptional profile in cancers that are sensitive to chemotherapy from those that are resistant,"
says Dr. Singer, professor and co-chair of anatomy and structural biology at Einstein. "The drug 5-
Fluorouracil is a mainstay of chemotherapy for colorectal cancer, but only 30 percent of patients respond to
it-and there's no way to know in advance which patients will benefit and which won't. We showed in this study that applying our FISH technique to colorectal tumors could accurately predict the patients' responses to 5-FU chemotherapy."

The researchers started with 12 "candidate genes" that earlier were found to correlate with response
to 5-FU. They then tested each gene in four different colorectal cancer cell lines (two extremely sensitive to
5-FU and two extremely resistant), using the FISH technique to look for active transcription sites in
individual cells. Various combinations of these genes were then examined in search of a gene expression
pattern that was associated with either resistance or sensitivity to 5-FU. The researchers found a pattern of
four genes that correctly classified each of the four cell lines as either sensitive or resistant to 5-FU.

To see whether their four-gene "signature" would work under clinical conditions, the researchers
obtained biopsy specimens from seven patients who had undergone treatment for colorectal cancer at the
Kimmel Cancer Center in Philadelphia. Then, to predict 5-FU sensitivity or resistance, they measured the
activity of the four genes in several hundred cells from each specimen. (The treatment results for all patients
were known, but the Einstein researchers were "blinded" to the outcomes until later.) For all seven patients,
the gene-expression pattern correctly predicted whether their tumors were sensitive or resistant to 5-FU
chemotherapy.

"Taking a chemotherapy drug that won't help you means not only risking serious side effects but
losing valuable time that would better be spent on a different and more effective treatment option," says Dr.
Singer. "We hope that this four-gene test may ultimately help steer colorectal cancer patients to a treatment
strategy with the best chance for a successful outcome." The next step, he says, is a clinical trial in which
the four-gene pattern will be tested on a larger number of patients.

Other Einstein researchers involved in the study were lead author Rossanna C. Pezo, Saumil J.
Gandhi and Leonard H. Augenlicht. Collaborators also included L. Andrew Shirley and Richard G. Pestell
of Thomas Jefferson University in Philadelphia.

Albert Eisntein College of Medicine

Dr. Delbert L. Chumley Elected President Of The American College Of Gastroenterology

2011-06-22T12:00:00.038-07:00

Delbert L. Chumley, M.D., FACG, was elected by the membership as the 2010-2011 president of the American College of Gastroenterology (ACG), a national specialty association representing more than 12,000 clinical gastroenterologists and other specialists in digestive diseases. Dr. Chumley officially took his position as president during the College's 75th Annual Scientific Meeting, held this week in San Antonio, which coincidentally is Dr. Chumley's hometown. In this position, Dr. Chumley will direct ACG's programs which include continuing medical education in the clinical, scientific and patient-related skills of gastroenterology, policies involving national and state medical affairs, managed care issues and clinical investigation.

Dr. Chumley is a private practice gastroenterologist who says, "My approach and philosophy to clinical practice is simple: always serve the patient's needs first - and everything else will fall in place." For Dr. Chumley, the art of medicine means that physicians have a primary responsibility to listen to their patients and gain their trust. He considers it a privilege to perform a physical examination on the patient and recommend appropriate diagnostic or treatment options.

"As I witness the effect of computerization, diminishing reimbursement, increasing hassle factors, and implementation of physician extenders, I am deeply concerned that the patient could merely become an 'icon' and that the profession of medicine risks being slowly dismantled," Dr. Chumley said. "Regardless of the pressures of private practice, I try every day to ensure that my patients receive my undivided attention and that they leave my office satisfied and feeling that I listened to and addressed their needs."

Currently, Dr. Chumley is in private gastroenterology practice with Gastroenterology Consultants of San Antonio. Dr. Chumley has served Clinical Professor of Medicine, University of Texas Health Science Center at San Antonio since 1996. Dr. Chumley received his medical degree from the University of Texas Medical Branch in Galveston where he also served his residency and chief residency in internal medicine, followed by a fellowship in gastroenterology. He is board certified in internal medicine and gastroenterology.

Dr. Chumley has served the College with loyalty and distinction for many years: first as Governor from South Texas (1992-1996); then as Trustee (1997-2003, and (2004-2006). He has moved through ACG's leadership ranks, first as Secretary (2006-2007), Treasurer (2007-2008), Vice President (2008-2009), and President-Elect (2009-2010). His active serviceto ACG committees includes: Educational Affairs (1992-1996); Credentials (1994-2001); and Membership (1994-2001, Chair 1999-2001). On behalf of ACG, Dr. Chumley was Co-Chair of the National GI Carrier Advisory Committee (2001-2004). This group oversees and has input into federal Medicare payment issues.

Dr. Chumley is also active in Texas medical organizations, including the Texas Medical Association. He as served as Treasurer of the Texas Society for Gastroenterology and Endoscopy (TSGE) from 1987 to 2004, and President from 2007 to 2009. TSGE is one of the largest and most active state medical societies in gastroenterology. Dr. Chumley directed TSGE postgraduate courses in conjunction with the ACG in 1993, 1994 and 1995. From 2007 to 2008 he served as President of Bexar County Medical Society, the seventh largest county medical association in the nation.

"In light of our changing economic and political environment, among the College's top priorities must be to carefully monitor new health care regulations as they are enacted and to communicate their potential impact to private practitioners. A personal goal in assuming the role of ACG President is to continue to oversee and evaluate the College's investment and revenue policies in order to ensure ACG's financial stability and future growth," Dr. Chumley commented.

Dr. Chumley and his wife, Louise, reside in San Antonio and have three children.

Source:

American College of Gastroenterology (ACG)

Potential New Treatment For Ulcerative Colitis Following Discovery

2011-06-22T12:00:00.037-07:00

McMaster University researchers have identified a specific chemical that may trigger remission in patients with the debilitating disease of ulcerative colitis.

The team from the Farncombe Family Digestive Health Research Institute has found that people in long-term remission of ulcerative colitis have elevated levels of the same chemical, prostaglandin D2, which they previously found to be important in promoting healing and maintaining remission of the condition in laboratory rats.

"The levels of prostaglandin D2 were only elevated in those patients in long-term remission, and that suggests it is a key factor in preventing new episodes of ulcerative colitis," said John Wallace, director of the Institute and a professor of medicine for the Michael G. DeGroote School of Medicine.

Ulcerative colitis impacts 100,000 Canadians and millions worldwide, but has an unknown cause and limited treatment options. Most people are never cured, and often require surgical removal of the colon.

The discovery may lead to a new treatment for inflammatory bowel disease which would promote production of prostaglandin D2, Wallace said. "It is entirely possible our findings could extend to Crohn's disease as well."

The study by Wallace and post doctoral student Linda Vong with colleagues from the University of Calgary is being published in the prestigious journal Proceedings of the National Academy of Sciences (PNAS) on June 14. Funding for the research was provided by the Canadian Institutes for Health Research and the Crohn's and Colitis Foundation of Canada.

Source:

Veronica McGuire

McMaster University

Plant Offers Scientists New Insights Into Intestinal Cancer

2011-06-22T12:00:00.036-07:00

Dutch scientists have gained important new insights into intestinal cancer from studying a plant. The disease is called Peutz-Jeghers Syndrome, a hereditary disorder where people develop intestinal polyps that turn into malignant tumors. "With experiments on these plants we now have a better understanding of how cancer cells react in the human body," says the principle investigator, Maikel Peppelenbosch.

Peppelenbosch, as professor of Cell Biology at the Erasmus MC in Rotterdam, carried out this research for Top Institute Pharma. "A natural process such as cell division occurs in both plants and humans," Prof. Peppelenbosch explains. "Cancer cells that sense they are getting too much food will rapidly multiply. By imitating this process in plants and studying what happens to the plant cells we have learned a great deal about the development of Peutz-Jeghers Syndrome."

Among other things, the investigators found a protein in the plants that could be a target for a medicine. They expect the same protein (p21Rac) may also be disordered in patients with intestinal cancer. "These insights come from a very unexpected angle," says Peppelenbosch.

According to the professor in Cell Biology, these new insights could also be used for another disease, called Tuberous Sclerosis Complex (TSC). It is a serious, rare disease that causes tumors in children. "By imitating the disease in plants, we hope to design a specific therapy eventually," continues Prof. Peppelenbosch.

Universities in Rotterdam, Leiden, Utrecht and Twente, and the biotech company Pepscan are partners in this Top Institute Pharma project.

Source: Top Institute Pharma

Physician First In Virginia To Deliver New Cancer Fighting Technique

2011-06-22T12:00:00.035-07:00

The world's smallest flexible microscope is diagnosing some big diseases and allowing physicians to treat patients on the spot. Dr. Michel Kahaleh, associate professor of medicine in the Division of Gastroenterology and Hepatology at the University of Virginia Health System, is the only physician in Virginia currently using probe-based confocal laser endomicroscopy (pCLE). pCLE is a technique that lets him view live tissue in real time at the cellular level. This allows the identification of cancer with pinpoint precision and permits precise removal of the diseased tissue.

"Until now, if we found suspicious tissue during one of these diagnostic procedures, we often had to randomly sample it and send it to the laboratory for analysis, which can take up to a week," says Kahaleh. "With pCLE, we can pinpoint the dangerous tissue during the initial diagnostic procedure and remove or treat it the same day."

Kahaleh and his team are using pCLE to more accurately differentiate cancerous and pre-cancerous tissue during colonoscopies, upper endoscopies, and the standard pancreatic and bile duct cancer detection procedure. They also use pCLE to catch and treat gastrointestinal cancers and other GI diseases, including those of the colon, bile duct, pancreas, and esophagus.

"This new imaging tool gives us the opportunity to immediately see changes up to the cell level and potentially gain insights of what may be wrong, thus optimizing patient treatment," Dr. Kahaleh explains.

Kahaleh also believes that this technique represents the future of medicine a future in which doctors and researchers deliver ways to diagnose and treat diseases all at once. He thinks this will save time and reduce trauma for patients while improving efficiency.

Cellvizio is the technology platform that enables the pCLE technique. It is cleared by the Food & Drug Administration for use in the gastrointestinal tract and lungs, and over 5,000 Cellvizio procedures have been completed worldwide to date.

The University of Virginia Health System is among the nation's leading academic research health systems in the country. It combines high-technology, tertiary care for patients from all over the Commonwealth and beyond. UVA Health System has medical programs ranked by U.S. News and World Report as top 50 programs.

Source: University of Virginia Health System

New Information Guides Available For Patients Diagnosed With Inflammatory Bowel Disease

2011-06-22T12:00:00.034-07:00

To help those with inflammatory bowel disease (IBD) be better informed and involved in managing their disease, the European Foundation of Crohn's & Ulcerative Colitis Associations (EFCCA) has launched a new series of guides titled "Life and IBD". For over one million people across Europe who have it, IBD can be an overwhelming experience with new physicians, medications and terminology.

The guides in the "Life and IBD" series are designed to be personalised so patients can access information appropriate to their life stage and disease severity. The first guide contains useful information about preparing for visits to the doctor, questions to ask one's gastroenterologist and a self-assessment to determine the severity of IBD symptoms. The second guide in the series provides a roadmap for developing an IBD management plan, which gives patients a clear strategy for keeping their IBD symptoms under control. The third guide in the series is intended to help patients understand their illness, what causes it, how it might affect them and their role in managing the illness.

"Often, patients are not sure how to speak openly and honestly about how their IBD is affecting them because of fear of embarrassment," said Marco Greco, Chairman of the EFCCA. "The 'Life and IBD' guides provide tools to help people with IBD keep the lines of communication open with their physician, making them a trusted partner in care."

According to a recent survey conducted by EFCCA, nearly half of physicians in Europe do not ask patients about their quality of life and nearly half of patients do not initiate a conversation about quality of life-related concerns with their physicians. Discussing these concerns can provide important information about effectiveness of treatment, and materials such as the "Life and IBD" guides can help close the communication gap between physicians and patients and provide patients with a feeling of empowerment.

"Crohn's disease and ulcerative colitis are complicated diseases, with a number of varied symptoms, potential complications and treatment options," said Professor Subrata Ghosh, Division on Medicine, Imperial College, London, United Kingdom. "Because no two people with IBD are the same, it's important for patients to work closely with their physicians to ensure their treatment plans are meeting their needs."

For patients, open conversation with their physicians can help ensure their disease does not derail their lives. "I'm often forced to miss work because of my disease," said Alexandra Gliati of Greece, who has Crohn's disease. "It's very important that I stay vigilant in treating my IBD to avoid a flare, and the information found in these guides has helped me talk to my doctor and better manage my disease."

The "Life and IBD" guides can be viewed, downloaded and printed from the EFCCA website, located at LifeAndIBD. "Life and IBD" is supported by Abbott, a global broad-based healthcare company.

About the European Foundation of Crohn's & Ulcerative Colitis Associations

Established in 1993, the EFCCA's mission is to improve the well being of patients with IBD and their partners and families through: working with and for the EFCCA Member National Associations and others throughout all of Europe; facilitating the exchange of information and the promotion of cross-frontier activities; effecting regular contact with the European authorities, doctors, health professionals and organizations and with others worldwide; and the encouragement of scientific research into IBD causes and treatment. EFCCA membership now includes 23 European national Crohn's and colitis patient associations. www.efcca

Medicare Reimbursement Rates Increase For Advanced Biologically-Based Fistula Treatment

2011-06-22T12:00:00.033-07:00

Hospitals nationwide will receive six percent higher reimbursement payments for outpatient repair of anal fistulas using Cook Medical's Biodesign® Fistula Plug, a device designed specifically to treat this painful and embarrassing disorder of the lower GI tract. According to new Medicare payment schedules effective January 1st, hospital outpatient surgery departments will receive approximately $2,200 per procedure, while freestanding ambulatory surgery centers will be paid about $1,300 on average1. The new fee levels come at an opportune time, as fistulas continue to affect tens of thousands of patients each year in North America alone.

The Centers for Medicare and Medicaid Services (CMS) regularly review charge data from health care providers to determine future facility reimbursement rates. New Medicare fee schedules, published annually, reflect CMS' goal of establishing appropriate payment rates without creating disincentives that could deprive patients of effective treatment. The actual amount of facility reimbursement depends on a number of factors, including the provider and/or site of service (whether a physician, hospital, or ambulatory service, whether inpatient or outpatient) and the facilities' geographic location. Unlike Medicare, commercial insurance plans do not have a consistent national payment methodology, and fee arrangements between these insurers and health care providers vary considerably.

Since Cook introduced the Biodesign Fistula Plug in 2005, health care providers have increasingly recognized the strong performance of biologic grafts for fistula repair. A fistula is an abnormal channel that develops between body organs or an organ and the skin, often in the intestinal tract. Anal fistulas can develop because of mechanical stress caused by Crohn's disease, colitis, diverticulitis and other inflammatory bowel diseases.2 They leak fluid, interfere with bowel movements and cause discomfort during sitting and moving. Many can be repaired with a simple procedure called a fistulotomy, but approximately 30 percent of anal fistulas are considered complex and require alternative treatments less likely to prevent anal incontinence.

The Biodesign Fistula Plug is the first device designed and FDA cleared specifically for closing anal fistulas. Unlike other forms of treatment, the Biodesign Fistula Plug does not have a risk of sphincter muscle damage, a potential complication of fistulotomy that can cause incontinence. To further optimize procedural outcomes, Cook recently introduced the Biodesign Fistula Plug Set, a collection of accessory tools designed to help physicians achieve best outcomes in use of the Biodesign Fistula Plug. Available now, the Biodesign Fistula Plug Set includes the Biodesign Fistula Plug itself, brush, irrigation catheters, syringe and sutures.

Biodesign communicates with the body, signaling surrounding tissue to grow throughout the biologic scaffold to close the fistula, allowing the body to restore itself. It combines the best attributes of biologic grafts-resistance to infection and complete remodeling-with the added benefits of moderate price, ease of use and widespread availability.

"In thousands of fistula repair procedures around the world, the Biodesign Fistula Plug has achieved significant success rates in treating the most painful and complex fistulas," said Andy Cron, vice president and global business unit leader of Cook Medical's Surgery strategic business unit. "We hope these new reimbursement rates will advance awareness of this important procedure so that more patients suffering from debilitating fistulas can return to an improved quality of life."

About Biodesign

Biodesign is an evolution of soft tissue repair, addressing physicians' needs for an advanced biologic graft. Once implanted, Biodesign communicates with the body, signaling surrounding tissue to grow across the scaffold, allowing the body to restore itself. Biodesign completely remodels into fully vascularized tissue that becomes stronger over time, providing a permanent repair without a permanent material. Biodesign combines the best attributes of biologic grafts-resistance to infection and complete remodeling-with the added benefits of moderate price, ease of use and widespread availability. Introduced by Cook in 1995 and manufactured in the Cook Biotech facility in West Lafayette, Ind., the grafts have been used in more than one million procedures and 97 countries to treat hernias, fistulas, stress urinary incontinence, pelvic organ prolapse and Peyronie's disease, as well as in staple line reinforcement for bariatric surgery, plastic and reconstructive surgery, and wound care. To date, more than 800 peer-reviewed articles have been published on the technology behind Biodesign.

1. This statement reflects the approximate average for Medicare payments and will vary across states depending on local coverage policies.

2. Legall I. Anal fistulas and fissures.

Source:

Cook Medical

Can Polypectomy Be Performed Without Interruption Of Anticoagulation?

2011-06-22T12:00:00.032-07:00

Currently, patients taking anticoagulants to prevent stroke and blood clots are often recommended to stop these medications in order to perform colonoscopy with removal of polyps.

However, interruption of these medications can place patients at risk of stroke and blood clots. A group led by Shai Friedland at the VA Palo Alto hospital in California reported their experience removing small colon polyps without interrupting anticoagulation. Their study was published in the World Journal of Gastroenterology.

Two hundred and twenty five polypectomies were performed in 123 patients. Patients followed a standardized protocol that included stopping warfarin for 36 h to avoid supratherapeutic anticoagulation from the bowel preparation. Patients with lesions larger than 1 cm were generally rescheduled for polypectomy off warfarin. Endoscopic clips were routinely applied prophylactically.

They reported that one patient (0.8%, 95% CI: 0.1%-4.5%) developed major post-polypectomy bleeding that required transfusion. Two others (1.6%, 95% CI: 0.5%-5.7%) had self-limited hematochezia at home and did not seek medical attention. The average polyp size was 5.1 ?± 2.2 mm. They announced that polypectomy can be performed in therapeutically anticoagulated patients with lesions up to 1 cm in size with an acceptable bleeding rate.

Reference: Friedland S, Sedehi D, Soetikno R. Colonoscopic polypectomy in anticoagulated patients. World Journal of Gastroenterology 2009; 15(16): 1973-1976
wjgnet/1007-9327/15/1973.asp

Source:
Lai-Fu Li

World Journal of Gastroenterology

View drug information on Warfarin Sodium tablets.

What Is Chronic Pancreatitis? What Causes Chronic Pancreatitis?

2011-06-22T12:00:00.031-07:00

Chronic pancreatitis is long-term progressive inflammatory disease of the pancreas that leads to permanent deterioration of the structure and function of the pancreas. It is estimated that in Western Europe and North American chronic pancreatitis is diagnosed in 3 to 9 people in every 100,000 each year.

The most common cause is long-term alcohol abuse - it is thought to account for approximately 70% of all cases. The gradual rise in the incidence of chronic pancreatitis in several countries around the globe has been attributed to increasing alcohol consumption and earlier diagnosis.

Chronic pancreatitis results in over 122,000 outpatient visits and 56,000 hospitalizations annually in the USA. Significantly more men than women are affected.

Chronic pancreatitis usually begins in adults aged 40 to 50.
What is the pancreas?
The pancreas is a gland organ that is located in the abdomen, behind the stomach and below the ribcage. It is part of the digestive system and produces important enzymes and hormones that help break down foods. It has an endocrine function because it releases juices directly into the bloodstream, and it has an exocrine function because it releases juices into ducts.

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Enzymes, or digestive juices, produced by the pancreas are secreted into the small intestine to further break down food after it has left the stomach. The gland also produces the hormone insulin and secretes it into the bloodstream in order to regulate the body's glucose or sugar level.
What are the symptoms of chronic pancreatitis?

Pain - the patient may feel pain in the upper abdomen. The pain may sometimes be severe and can travel along the back. It is usually more intense after eating. Some pain relief may be gained by leaning forward or curling into a ball.

Nausea and vomiting - more commonly experienced during episodes of pain.

Constant pain - As the disease progresses the episodes of pain become more frequent and severe. Some patients eventually suffer constant abdominal pain.

As chronic pancreatitis progresses, and the pancreas' ability to produce digestive juices deteriorates, the following symptoms will appear:

Smelly and greasy feces (stools)
Bloating
Abdominal cramps
Flatulence (breaking wind, farting)

Eventually the pancreas may not be able to produce insulin, leading to diabetes type 1, with the following symptoms:

Thirst
Frequent urination
Intense hunger
Weight loss
Tiredness (fatigue)
Blurred vision

What are the causes of chronic pancreatitis?
Chronic pancreatitis is usually the follow-on of repeated episodes of acute pancreatitis which lead to permanent damage of the pancreas.

Acute pancreatitis is caused when trypsin becomes activated within the pancreas. Trypsin is an enzyme produced in the pancreas and released into the intestines where it breaks down proteins as part of the digestive system. Trypsin is inactive until it has reached the intestines. If trypsin becomes activated inside the pancreas it will start to digest the pancreas itself, leading to irritation and inflammation of the pancreas - acute pancreatitis. Alcohol can cause a process which triggers the activation of trypsin inside the pancreas, as can gallstones.

Alcohol misuse causes 70% of chronic pancreatitis cases

People who misuse alcohol and develop acute pancreatitis tend to have repeated episodes, and eventually develop chronic pancreatitis (long-term) - that is why 70% of all chronic pancreatitis cases are caused by alcohol misuse. The repeated bouts of acute pancreatitis eventually take their toll on the pancreas, causing permanent damage, which then becomes chronic pancreatitis - also known as alcoholic chronic pancreatitis.

According to the National Health Service, UK, long-term alcoholic misuse that typically causes chronic pancreatitis consists of about 10 to 15 years of 10 units of alcohol per day or more. A typical 750ml bottle of 12% wine contains 9 units of alcohol. Approximately 5% to 10% of people with long-term alcohol misuse develop chronic pancreatitis.

Experts believe that patients with alcoholic chronic pancreatitis have specific genetic mutations which make them more susceptible to the effects of alcohol.

Idiopathic chronic pancreatitis makes up the bulk of the remaining 30% of cases

When a disease is idiopathic it means there is no known cause or reason to explain why or how it developed. Idiopathic chronic pancreatitis accounts for most of the remaining cases. Most cases of idiopathic chronic pancreatitis start to develop in people aged 10 to 20 years, and those over 50.

Nobody is certain why other age groups are rarely affected. The SPINK-1 and The CFTR genes, types of mutated genes, exist in about 50% of patients with idiopathic chronic pancreatitis. Experts believe these genetic mutations may undermine the functions of the pancreas.

Other much rarer causes include autoimmune chronic pancreatitis in which the person's own immune system attacks the pancreas, heredity pancreatitis where patients have a genetic condition and are born with a faulty pancreas, and cystic fibrosis, another genetic condition which damages certain organs.

How is chronic pancreatitis diagnosed?
There are no reliable tests to diagnose chronic pancreatitis. A doctor will suspect the disease because of the patient's symptoms, history of repeated acute pancreatitis flare-ups, or alcohol abuse.

Blood tests may be useful in checking the blood glucose levels, which may be elevated.

Blood tests for elevated levels of amylase and lipase are not reliable at this stage. Amylase and lipase blood levels rise during the first couple of days of pancreatitis, and then settle back to normal after five to seven days. A patient with chronic pancreatitis would have had the disease for much longer.

Doctors need to have a good look at the pancreas in order to diagnose the disease properly. This will most likely involve:

An ultrasound scan - high frequency sound waves create an image on a monitor of the pancreas and its surroundings.

A CT (computed tomography) scan - X-rays are used to take many pictures of the same area from several angles, which are then placed together to produce a 3-D image. The scan will reveal changes of chronic pancreatitis.

MRCP (magnetic resonance cholangiopancreatography) scan - this scan will show the bile and pancreatic ducts more clearly than a CT scan.

An ERCP (endoscopic retrograde cholangio-pancreatography) scan - an endoscope (thin, flexible tube with a camera at the end) is inserted into the digestive system. The doctor uses ultrasound to guide the endoscope through.

Patients with chronic pancreatitis have an elevated risk of developing pancreatic cancer. If symptoms worsen, especially the narrowing of the pancreatic duct, doctors may suspect cancer. If so, they will order a CT scan, MRI scan, or endoscopic study.
What are the treatment options for chronic pancreatitis?
Lifestyle changes

Patients with chronic pancreatitis will need to undergo some lifestyle changes. These will include:

Stop drinking - giving up drinking will help prevent further damage to the pancreas. It will also contribute significantly towards relieving the pain. Some people may need professional help to quit alcohol.

Stop smoking - smoking is not a cause of pancreatitis, but it can accelerate the progression of the disease.

Diet - the pancreas is involved in digestion; pancreatitis damages the functions of the pancreas. This means that patients with the disease will have difficulty digesting many foods. Rather than three large meals a day, patients will be advised to change to six small meals. It is also better to avoid fatty meals, i.e. to follow a low-fat diet.

A diet plan will either be drawn up by the doctor, or the patient may be referred to a qualified dietitian.

Depending on the extent of pancreatic damage, patients may also have to take artificial versions of some enzymes to aid digestion. These will ease bloating, make the feces less greasy and foul-smelling, and help the abdominal cramps.

Pain - treatment should not only focus on helping ease the pain symptoms, but also depression which is a common consequence of long-term pain. Doctors will usually use a step-by-step approach, in which mild painkillers are prescribed, gradually becoming stronger until the patient responds.

Insulin - the pancreas may stop producing insulin if the damage is extensive. The patient will have developed diabetes type 1. Regular insulin treatment will become part of the treatment for the rest of the patient's life. Diabetes type 1 caused by chronic pancreatitis involves injections, not tablets because most likely the digestive system will not be able to break them down.

Surgery

Severe chronic pain sometimes does not respond to painkilling medications. The ducts in the pancreas may have become blocked, causing an accumulation of digestive juices which puts pressure on them, causing intense pain. Another cause of chronic and intense pain could be inflammation of the head (top section) of the pancreas. The inflammation aggravates the nerve endings.

Endoscopic surgery - a narrow, hollow, flexible tube (endoscope) goes into the digestive system guided by ultrasound. A devise with a tiny deflated balloon at the end is threaded through the endoscope. When it reaches the duct the balloon is inflated, thus widening the duct. A stent is placed to stop the duct from narrowing back.

Pancreas resection - the head of the pancreas is surgically removed. This not only relieves the pain caused by inflammation which was irritating the nerve endings, but it also reduces pressure on the ducts. Three main techniques are used for pancreas resection:

The Beger procedure - this involves resection of the inflamed pancreatic head with careful sparing of the duodenum, the rest of the pancreas is reconnected to the intestines.

The Frey procedure - this is used when the doctor believes pain is being caused by both inflammation of the head of the pancreas as well as the blocked ducts. The Frey procedure adds a longitudinal duct decompression to the pancreatic head resection - the head of the pancreas is surgically removed, and the ducts are decompressed by connecting them directly to the intestines.

Pylorus-sparing pancreaticoduodenectomy (PPPD) - the gall bladder, ducts, and the head of the pancreas are all surgically removed. This is only done in very severe cases of intense chronic pain where the head of the pancreas is inflamed and the ducts are blocked as well. This is the most effective procedure for reducing pain and conserving pancreas function. However, it has the highest risk infection and internal bleeding.

Total pancreatectomy - this involves the surgical removal of the whole pancreas. It is very effective in dealing with the pain. However, the patient will be totally dependent on treatment for some of the vital functions of the pancreas, such as the release of insulin.

Autologous pancreatic islet cell transplantation (APICT) - during the total pancreatectomy procedure a suspension of isolated islet cells is created from the surgically removed pancreas and injected into the portal vein of the liver. The islets cells will function as a free graft in the liver - they will exist in the liver where they produce insulin.
What are the complications of chronic pancreatitis?
Stress, anxiety, depression

The disease may have an effect on the patient's psychological and emotional well being. Constant or recurring pain, which is often severe, may cause distress, anxiety, irritability, stress and depression. It is important for patients to tell their doctors if they are emotionally or psychologically affected. If there is a support group in your area, being able to talk to people who share the same condition may help you feel less isolated and more able to cope.

Pseudocyst

This is a collection of tissue, fluid, debris, pancreatic enzymes, and blood in the abdomen, caused by leakage of digestive fluids escaping from a faulty pancreatic duct. Pseudocysts don't usually cause any problems. However, sometimes they can become infected, cause blockage to part of the intestine, or rupture and cause internal bleeding. If this happens the cyst will have to be surgically drained.

Pancreatic cancer

Even though pancreatic cancer is more common among patients with chronic pancreatitis, the risk is only 1 in 500.
Prevention of chronic pancreatitis
Patients with acute pancreatitis significantly reduce their risk of developing chronic pancreatitis if they give up drinking alcohol. This is especially the case for patients who drink heavily and regularly.

Virulence Factor That Induces Fatal Fungal Infection Identified By Singapore Scientists

2011-06-22T12:00:00.030-07:00

Scientists here have found that certain substances from bacteria living in the human intestine cause the normally harmless Candida albicans fungus to become highly infectious.

This discovery by researchers at Singapore's Agency for Science, Technology and Research (A*STAR)'s Institute of Molecular and Cell Biology (IMCB) could possibly lead to the development of novel treatments for immunocompromised patients infected by the fungus.

The team of scientists, led by Associate Professor Wang Yue, a principal investigator at the IMCB, identified peptidoglycan (PGN) - a carbohydrate from bacteria - as a factor responsible for causing the conversion of the otherwise harmless C. albicans to its infectious form.

The research findings were recently published in the current journal Cell Host & Microbe.

Once in the infectious form, the fungus is able to invade surrounding tissues and escape destruction by the body's own immune cells. Since immunocompromised patients such as those with AIDS or those undergoing chemotherapy or radiation treatment are extremely susceptible to fungal-induced systemic infections, this finding offers an important clue to the basis of C. albicans infections.

After confirming the presence of PGN-derived molecules in human blood, the researchers discovered that the fungus is able to "sense" the presence of the same molecules, which are produced in abundance by bacteria residing in the gastrointestinal track. Earlier studies suggested that PGNs can enter the blood stream through the intestinal wall. When direct binding of the PGN-derived molecules to a specific protein in C. albicans takes place, it triggers interactions and "sensing" processes that induce the fungus to start growing long, threadlike tubes called hyphae, hence signifying its conversion to the virulent, life-threatening form.

This is the first time that the identities of the "inducer" and that of its "sensor" in C. albicans have been clearly established.

Said Wang, who has been working on C. albicans for more than eight years, "It has been more than 50 years since human blood was first found to contain molecules that can strongly induce C. albicans infection. In spite of efforts by many laboratories worldwide, the identity of the 'inducer' remained elusive. Thus, we are very excited about being able to help solve this long-held mystery. Finding the PGN sensor in C. albicans is also of great importance, because we can now develop anti-Candida therapies by blocking the sensory mechanism."

According to UNAIDS statistics, the AIDS pandemic claimed an estimated 2.1 million lives in 2007 alone. The latest findings by the Singapore researchers may provide insight for the development of potential anti-Candida therapy in patients suffering from fungal-induced systemic infections.

Previous research breakthroughs by the IMCB team included the discovery of the gene involved in triggering the infectious form of C. albicans, as well as the way in which the gene and its by-products facilitated the transformation process of the fungus.

The research findings described in the press release can be found in the July 17, 2008 print issue of Cell Host & Microbe. The paper is titled, "Bacterial Peptidoglycan triggers Candida albicans hyphal growth by directly activating the adenylyl cyclase Cyr1p."

IMCB:

The Institute of Molecular and Cell Biology (IMCB) is a member of Singapore's Agency for Science, Technology and Research (A*STAR) and is funded through A*STAR's Biomedical Research Council (BMRC). It is a world-class research institute that focuses its activities on six major fields: Cell Biology, Developmental Biology, Structural Biology, Infectious Diseases, Cancer Biology and Translational Research,with core strengths in cell cycling, cell signalling, cell death, cell motility and protein trafficking. Its recent achievements include leading an international consortium that successfully sequenced the entire pufferfish (Fugu) genome. The IMCB was awarded the Nikkei Prize 2000 for Technological Innovation in recognition of its growth into a leading international research centre and its collaboration with industry and research institutes worldwide. Established in 1987, the Institute currently has 35 independent research groups with more than 400 staff members. imcb.a-star.edu.sg

A*STAR:

The Agency for Science, Technology and Research, or A*STAR, is Singapore's lead agency for fostering world-class scientific research and talent for a vibrant knowledge-based Singapore. A*STAR actively nurtures public sector research and development in Biomedical Sciences, Physical Sciences and Engineering, with a particular focus on fields essential to Singapore's manufacturing industry and new growth industries. It oversees 14 research institutes and supports extramural research with the universities, hospital research centres and other local and international partners. At the heart of this knowledge-intensive work is human capital. Top local and international scientific talent drive knowledge creation at A*STAR research institutes. The Agency also sends scholars for undergraduate, graduate and post-doctoral training in the best universities, a reflection of the high priority A*STAR places on nurturing the next generation of scientific talent. a-star.edu.sg

ASGE announces grant recipients in annual research awards program

2011-06-22T12:00:00.029-07:00

The American Society for Gastrointestinal Endoscopy (ASGE) and the ASGE Foundation announced this year's institutional
winners of medical research grants, as part of the ASGE's annual Research & Outcomes & Effectiveness Awards Program.

The ASGE Research Committee received 31 applications for research project funding last fall and granted a total of $234,700
to the 11 institutions that were chosen to receive grants, including nine from the United States and two from Canada.

"Each grant application undergoes a vigorous peer review process," stated James Scheiman, MD, chair of the ASGE Awards
Committee and a member of the Gastroenterology Division of the University of Michigan.

"With the help of generous donations through the ASGE Foundation, the ASGE provides the opportunity for gastrointestinal
endoscopic investigators to answer key questions regarding the clinical application of new endoscopic technology," Dr.
Scheiman said. He also indicated that a goal of the ASGE Research Committee is to help launch medical research careers for
members of the recipient research teams.

The ASGE Awards Program was initiated in 1985 and has awarded more than $3 million in research dollars. Its objective is to
foster research in gastrointestinal endoscopy both within and outside of academic centers.

The institutions receiving ASGE grants in this 20th year of the program include:

Case Western Reserve University, Cleveland, OH;

The Cleveland Clinic Foundation, Cleveland;

Emory University School of Medicine, Atlanta;

Indiana University School of Medicine, Roudebush VA Medical Center, Indianapolis;

Legacy Health System, Portland;

Massachusetts General Hospital, Boston;

Research Institute of the McGill University Health Center, Montreal;

Sunnybrook & Women's College HSC, Toronto;

University of California, Davis Medical Center, Sacramento;

University of Utah Medical Center, Salt Lake City; and

VA Medical Center, Kansas City;

For information on the ASGE Awards Program, please visit the ASGE website at asge or e-mail to asgegrantsasge/.

Source: American Society for Gastrointestinal Endoscopy, Oak Brook, IL

Robert J. Buzogany - asgenewsmsn

American Society for Gastrointestinal Endoscopy

Herbal Medicines For Treatment Of Gastrointestinal Disease

2011-06-22T12:00:00.028-07:00

Herbal medicines could benefit patients suffering from gastrointestinal (GI) motility disorders that cannot be treated using conventional drug therapy. In a study published in Neurogastroenterology and Motility, researchers reviewed data on Japanese herbal medicines and found them to be effective in reducing the symptoms of GI disorders such as functional dyspepsia, constipation, and postoperative ileus.

"Japanese herbal medicines have been used in East Asia for thousands of years," says lead researcher Hidekazu Suzuki, Associate Professor at the Keio University School of Medicine. "Our review of the world medical literature reveals that herbal medicines serve a valuable role in the management of patients with functional gastrointestinal disorders."

Many of the drugs used to treat GI motility disorders are ineffective or cause unwanted side effects and, in some cases, this has led to drugs being withdrawn from the market. Herbal medicine is an attractive alternative.

The researchers reviewed data from studies looking at the effect of several different Japanese herbal medicines including the use of Rikkunshi-to, Dai-Kenchu-to, and other herbal medicines. Rikkunshi-to, which is prepared from eight crude herbs, was effective in reducing discomfort caused by functional dyspepsia. Dai-Kenchu-to, a mixture of ginseng, ginger, and zanthoxylum fruit, was beneficial for constipation in children and patients suffering from post-operative ileus - disruption of normal bowel movements following an operation. Another herbal medicine, hangeshashin-to, reduced the severity and frequency of diarrhoea caused by anti-cancer drugs.

In Japan, herbal medicine is manufactured in standardised form with regards to quality and quantity of ingredients. The researchers say the health benefits of standardised formulations of herbal medicines require more rigorous examination, particularly in the Western world.
"There is a mandate to provide accurate data regarding the effectiveness of non-traditional therapy, not only to our patients but also to healthcare providers who face the dilemma of recommending or opposing management strategies that incorporate herbal medicine," says Suzuki.

Full citation: Suzuki, H., Inadomi, J.M. and Hibi, T.; Japanese Herbal Medicine in Functional Gastrointestinal Disorders; Neurogastroenterology and Motility (2009); DOI: 10.1111/j.1365-2982.2009.01290.x

Neurogastroenterology & Motility is the official Journal of the European Society of Neurogastroenterology and Motility, the American Neurogastroenterology & Motility Society and the Functional Brain-Gut Research Group. Edited by Jan Tack, Keith Sharkey and Joseph Szurszewski, it has an ISI Journal Citation Reports® Ranking: 2007 of 14/50 (Gastroenterology & Hepatology) and 68/211 (Neurosciences), and an Impact Factor of 3.364. The field of gastrointestinal motility has undergone phenomenal growth and change in the past three decades since it emerged as a distinct speciality. Neurogastroenterology & Motility provides a forum where current issues and advances relating to the motor function of the GI tract can be presented and discussed. It is of interest to both clinicians and researchers. For further information please visit www3.interscience.wiley/journal/118498177/home

Wiley-Blackwell was formed in February 2007 as a result of the acquisition of Blackwell Publishing Ltd. by John Wiley & Sons, Inc., and its merger with Wiley's Scientific, Technical, and Medical business. Together, the companies have created a global publishing business with deep strength in every major academic and professional field. Wiley-Blackwell publishes approximately 1,400 scholarly peer-reviewed journals and an extensive collection of books with global appeal.

Source
Wiley-Blackwell

The Best Strategy For Treating Helicobacter Pylori

2011-06-22T12:00:00.027-07:00

The most popular treatment for H pylori is triple therapy but resistance to Clarithromycin is reducing its effectiveness. Courses using four drugs have been known to be more successful but are used less popular because of their side-effects. While, what is the best way for treating H pylori-related diseases.

A research article to be published on 28 June 2008, in the World Journal of Gastroenterology addresses this question. The research team led by Prof. Mr Siok Ching from United Kingdom compared a lansoprazole-based triple versus quadruple therapy for H pylori eradication with emphasis on side effect profile, patient compliance and eradication rate at a rural district general hospital in Wales, United Kingdom.

Overall the treatment of H Pylori using both three drugs and four drugs are still highly effective in rural North Wales (92%), however, almost all (97%) of the patients who managed to complete the course of four tablets got rid of the infection.

Authors feel that treatments with four drugs remain the best option for white Caucasians in rural UK. Patients need educating about the side effects of the drugs and the reasons for treatment so that they can reap the full benefits.

They concluded that one-week triple and quadruple therapies have similar intention-to-treat eradication rates. Certain side effects are more common with quadruple therapy, which can compromise patient compliance. Patient education or modifications to the regimen are alternative options to improve compliance of the quadruple regimen.

The side effects may be reduced by replacing metronidazole with amoxycillin but patients should be better educated about the side effects in order to improve compliance and cure rates.

Reference: Ching SS, Sabanathan S, Jenkinson LR. Treatment of H pylori in surgical practice: A randomised trial of triple versus quadruple therapy in a rural district general hospital. World J Gastroenterol 2008; 14(24): 3855-3860
wjgnet/1007-9327/14/3855.asp

Correspondence to: Lloyd R. Jenkinson, Department of Surgery, Ysbyty Gwynedd, Penrhosgarnedd, Bangor, Gwynedd LL57 2PW, Wales, United Kingdom

About World Journal of Gastroenterology

World Journal of Gastroenterology (WJG), a leading international journal in gastroenterology and hepatology, has established a reputation for publishing first class research on esophageal cancer, gastric cancer, liver cancer, viral hepatitis, colorectal cancer, and H pylori infection. It provides a forum for both clinicians and scientists. WJG has been indexed and abstracted in Current Contents/Clinical Medicine, Science Citation Index Expanded (also known as SciSearch) and Journal Citation Reports/Science Edition, Index Medicus, MEDLINE and PubMed, Chemical Abstracts, EMBASE/Excerpta Medica, Abstracts Journals, Nature Clinical Practice Gastroenterology and Hepatology, CAB Abstracts and Global Health. ISI JCR 2003-2000 IF: 3.318, 2.532, 1.445 and 0.993. WJG is a weekly journal published by WJG Press. The publication dates are the 7th, 14th, 21st, and 28th of every month. The WJG is supported by The National Natural Science Foundation of China, No. 30224801 and No. 30424812, and was founded with the title China National Journal of New Gastroenterology on October 1, 1995, and renamed WJG on January 25, 1998.

Source: Lai-Fu Li

World Journal of Gastroenterology

View drug information on Clarithromycin.

Wyeth And Progenics Announce Preliminary Clinical Trial Results For RELISTOR Oral And Intravenous Formulations

2011-06-22T12:00:00.026-07:00

Wyeth
Pharmaceuticals, a division of Wyeth (NYSE: WYE), and Progenics
Pharmaceuticals, Inc. (Nasdaq: PGNX), announced preliminary results
from two clinical trials conducted with investigational oral and
intravenous formulations of RELISTOR(TM) (methylnaltrexone bromide).

The first of these studies, a phase 2 trial, evaluated the effects of
an oral formulation of RELISTOR for the treatment of opioid-induced
constipation (OIC), in patients with chronic, non-malignant pain. This
study showed positive activity.

The second study, a phase 3 trial, examined the use of an intravenous
formulation of RELISTOR for post-operative ileus (POI). In this study, the
drug did not meet its primary or secondary end points.

RELISTOR Oral Formulation

The study of the RELISTOR oral formulation was a double-blind,
randomized, placebo-controlled phase 2 trial. In this four-week trial of
122 patients with chronic, non-malignant pain (such as back pain,
neuropathic pain or osteoarthritis) who were receiving opioids for pain
management, the once daily oral formulation of RELISTOR showed
statistically significant activity as assessed by the occurrence of
spontaneous bowel movements and other efficacy measures. This oral
formulation was also shown to be generally well tolerated.

"We are pleased by the preliminary findings of this oral formulation"
says Paul J. Maddon, M.D., Ph.D., Founder, Chief Executive Officer and
Chief Science Officer of Progenics Pharmaceuticals, Inc. "We await results
within the coming months from a second, ongoing phase 2 study involving the
oral formulation of RELISTOR that was announced last July to have positive
activity in a phase 1 trial."

RELISTOR Intravenous Formulation

The Progenics-conducted phase 3 study of an intravenous formulation of
RELISTOR for patients with post-operative ileus (POI) did not meet the
primary or secondary end points, confirming the earlier findings of the
Wyeth phase 3 intravenous POI study announced on March 12, 2008. Progenics
and Wyeth will now study the results of both phase 3 intravenous POI
studies to determine whether and how to continue development of this
formulation of RELISTOR and this indication.

RELISTOR Franchise

"We are committed to continuing to develop the RELISTOR franchise to
help address the unmet medical needs of patients suffering from the
gastrointestinal side effects of opioids. Following the results from a
second phase 2 clinical trial of another oral formulation, Wyeth and
Progenics will further define the continued development plan for oral
RELISTOR," says Gary L. Stiles, M.D., Executive Vice President, Chief
Medical Officer, Wyeth Pharmaceuticals.

About RELISTOR and Opioids

RELISTOR is a peripherally acting mu-opioid receptor antagonist that
counteracts the constipating effects of opioid pain medications in the
gastrointestinal tract without affecting their ability to relieve pain.

Opioids provide pain relief by specifically interacting with mu-opioid
receptors within the central nervous system (CNS) -- the brain and spinal
cord. However, opioids also interact with mu-opioid receptors found outside
the CNS, such as those within the gastrointestinal tract, resulting in
constipation that can be debilitating. RELISTOR selectively displaces
opioids from the mu-opioid receptors outside the CNS, including those
located in the gastrointestinal tract, thereby decreasing their
constipating effects. Because of its chemical structure, RELISTOR does not
affect the opioid-mediated analgesic effects on the CNS.

About Subcutaneous RELISTOR

On April 24, 2008, the United States Food and Drug Administration
approved RELISTOR subcutaneous injection for the treatment of OIC in
patients with advanced illness who are receiving palliative care, when
response to laxative therapy has not been sufficient. The use of RELISTOR
beyond four months has not been studied. Wyeth expects to make subcutaneous
RELISTOR available in the United States in early June. Subcutaneous
RELISTOR has also been approved in Canada and is awaiting Australian
approval and European approval, having received a positive opinion from the
Committee for Medicinal Products for Human Use (CHMP), the EMEA scientific
committee, in April.

Important Safety Information for Subcutaneous RELISTOR

-- RELISTOR is contraindicated in patients with known or suspected
mechanical gastrointestinal obstruction.

-- If severe or persistent diarrhea occurs during treatment, advise
patients to discontinue therapy with RELISTOR and consult their
physician.

-- Use of RELISTOR has not been studied in patients with peritoneal
catheters.

-- The most common adverse reactions with RELISTOR in clinical trials were
abdominal pain, flatulence, and nausea.

RELISTOR Prescribing Information is available at relistor.

About the Collaboration

In December 2005, Wyeth and Progenics Pharmaceuticals entered into an
exclusive, worldwide agreement for the joint development and
commercialization of methylnaltrexone for the treatment of opioid-induced
side effects.

About the Companies

Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the
areas of women's health care, infectious disease, gastrointestinal health,
central nervous system, inflammation, transplantation, hemophilia,
oncology, vaccines and nutritional products. Wyeth is one of the world's
largest research-driven pharmaceutical and health care products companies.
It is a leader in the discovery, development, manufacturing and marketing
of pharmaceuticals, vaccines, biotechnology products, nutritionals and
non-prescription medicines that improve the quality of life for people
worldwide. The Company's major divisions include Wyeth Pharmaceuticals,
Wyeth Consumer Healthcare and Fort Dodge Animal Health.

WYETH DISCLOSURE NOTICE: The statements in this press release that are
not historical facts are forward-looking statements that are subject to
risks and uncertainties that could cause actual results to differ
materially from those expressed or implied by such statements. In
particular, there can be no assurance that the subcutaneous form of
RELISTOR will be commercially successful in the United States and Canada or
that RELISTOR will be successfully developed and commercialized in other
formulations or indications and/or in other countries. Other risks and
uncertainties that could cause actual results to differ materially from
those expressed or implied by forward-looking statements include, without
limitation, the inherent uncertainty of the timing and success of, and
expense associated with, research, development, regulatory approval and
commercialization of our products and pipeline products; government
cost-containment initiatives; restrictions on third-party payments for our
products; substantial competition in our industry, including from branded
and generic products; emerging data on our products and pipeline products;
the importance of strong performance from our principal products and our
anticipated new product introductions; the highly regulated nature of our
business; product liability, intellectual property and other litigation
risks and environmental liabilities; uncertainty regarding our intellectual
property rights and those of others; difficulties associated with, and
regulatory compliance with respect to, manufacturing of our products; risks
associated with our strategic relationships; economic conditions including
interest and currency exchange rate fluctuations; changes in generally
accepted accounting principles; trade buying patterns; the impact of
legislation and regulatory compliance; risks and uncertainties associated
with global operations and sales; and other risks and uncertainties,
including those detailed from time to time in our periodic reports filed
with the Securities and Exchange Commission, including our current reports
on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K,
particularly the discussion under the caption "Item 1A, RISK FACTORS" in
our Annual Report on Form 10-K for the year ended December 31, 2007, which
was filed with the Securities and Exchange Commission on February 29, 2008.
The forward-looking statements in this press release are qualified by these
risk factors. We assume no obligation to publicly update any
forward-looking statements, whether as a result of new information, future
developments or otherwise.

Progenics Pharmaceuticals, Inc., of Tarrytown, NY, is a
biopharmaceutical company focusing on the development and commercialization
of innovative therapeutic products to treat the unmet medical needs of
patients with debilitating conditions and life-threatening diseases.
Principal programs are directed toward gastroenterology, virology --
including human immunodeficiency virus (HIV) and hepatitis C virus (HCV)
infections -- and oncology. Progenics, in collaboration with Wyeth, is
developing RELISTOR(TM) (methylnaltrexone bromide) for the treatment of
opioid-induced side effects, including constipation (subcutaneous and oral
formulations) and post-operative ileus (intravenous formulation). In the
U.S., RELISTOR (methylnaltrexone bromide) subcutaneous injection is
indicated for the treatment of opioid-induced constipation (OIC) in
patients with advanced illness who are receiving palliative care, when
response to laxative therapy has not been sufficient. In Canada, RELISTOR
(methylnaltrexone bromide injection) for subcutaneous use is indicated for
the treatment of OIC in patients with advanced illness receiving palliative
care. Applications are pending related to the potential marketing of
RELISTOR in Europe, where a Positive Opinion has been rendered by the
Committee for Medicinal Products for Human Use, the scientific committee of
the European Medicines Agency, as well as in Australia and other countries.
In the area of virology, Progenics is developing the HIV entry inhibitor
PRO 140, a humanized monoclonal antibody targeting the entry co-receptor
CCR5, which has completed phase 1b clinical studies with positive results.
PRO 140 is currently in phase 2 clinical testing. Pre-clinical programs for
the development of novel HCV entry inhibitors are also underway. In the
area of oncology, the Company is developing a human monoclonal
antibody-drug conjugate (ADC) for the treatment of prostate cancer -- a
selectively targeted cytotoxic antibody directed against prostate-specific
membrane antigen (PSMA). PSMA is a protein found on the surface of prostate
cancer cells as well as in blood vessels supplying other solid tumors.
Progenics is also developing vaccines designed to treat prostate cancer by
stimulating an immune response to PSMA.

DISCLOSURE NOTICE: The information contained in this document is
current as of May 9, 2008. This press release contains forward-looking
statements. Any statements contained herein that are not statements of
historical fact may be forward-looking statements. When the Company uses
the words 'anticipates,' 'plans,' 'expects' and similar expressions, it is
identifying forward-looking statements. Such forward-looking statements
involve risks and uncertainties which may cause the Company's actual
results, performance or achievements to be materially different from those
expressed or implied by forward-looking statements. Such factors include,
among others, the uncertainties associated with product development, the
risk that clinical trials will not commence or proceed as planned, the
risks and uncertainties associated with dependence upon the actions of our
corporate, academic and other collaborators and of government regulatory
agencies, the risk that the Company's licenses to intellectual property may
be terminated because of its failure to have satisfied performance
milestones, the risk that products that appear promising in early clinical
trials do not demonstrate efficacy in larger-scale clinical trials, the
risk that the Company may not be able to manufacture commercial quantities
of its products, the uncertainty of future profitability and other factors
set forth more fully in the Company's Annual Report on Form 10-K for the
fiscal year ended December 31, 2007 and other reports filed with the
Securities and Exchange Commission, to which investors are referred for
further information. In particular, the Company cannot assure you that any
of its programs will result in a commercial product.

Progenics does not have a policy of updating or revising
forward-looking statements and assumes no obligation to update any
forward-looking statements contained in this document as a result of new
information or future events or developments. Thus, it should not be
assumed that the Company's silence over time means that actual events are
bearing out as expressed or implied in such forward-looking statements.

Wyeth Pharmaceuticals

wyeth

Swine Flu: As H1N1 Looms, Study Shows Students Aren't Protecting Themselves

2011-06-22T12:00:00.025-07:00

As public health experts warn of potential widespread outbreaks of H1N1 flu this school year, a new study from North Carolina State University shows that students do not comply with basic preventative measures as much as they think they do. In other words, the kids aren't washing their hands.

"Hand washing is a significant preventative measure for many communicable diseases, from respiratory diseases like H1N1 to foodborne illness agents, such as norovirus," says Dr. Ben Chapman, assistant professor of family and consumer sciences and food safety extension specialist at NC State. The new study, which examined student compliance with hand hygiene recommendations during an outbreak of norovirus at a university in Ontario, finds that only 17 percent of students followed posted hand hygiene recommendations - but that 83 percent of students reported that they had been in compliance. Norovirus causes gastrointestinal problems, including vomiting and diarrhea. Every year there are 30 to 40 outbreaks of norovirus on university campuses, affecting thousands of students.

Chapman, who co-authored the research, says this is the first study to observe student hygiene behavior in the midst of an outbreak. Previous studies examined self-reporting data after an outbreak - and the new research shows that the self-reporting data may be inaccurate.

"Typically, health officials put up posters and signs and rely on self-reporting to determine whether these methods are effective," Chapman says. "And people say they are washing their hands more. But, as it turns out, that's not true.

"The study shows that while health authorities may give people the tools we think they need to limit the spread of an outbreak, the information we're giving them is not compelling enough to change their behavior. Basically, it doesn't work. But we do it again with every outbreak, and we're doing it now with H1N1."

Chapman says the study shows that health officials need to target specific audiences, such as students in a particular dorm or who eat at a particular cafeteria, and tailor their information to those audiences. For example, telling them where the nearest washrooms are, or pointing out where hand sanitizer units are located. "The more specific the information is for an audience, the better off you are," Chapman says.

Chapman adds that health authorities also need to use language appropriate to their target audience. "For example, don't refer to something as a 'gastrointestinal illness,'" he says, "instead, tell them 'this could make you puke' or 'dude, wash your hands.' The idea is to craft compelling messages that create discussion in that audience. Make them talk about it."

Chapman also says that health officials should take advantage of social media, such as text messaging and Facebook, to raise awareness. "If your audience consists of students," he explains, "you should use media that students use.

"Campuses need to expect outbreaks will happen and plan accordingly. Have the response tools in hand."

The study, "University Students' Hand Hygiene Practice During a Gastrointestinal Outbreak in Residence: What They Say They Do and What They Actually Do," was co-authored by Chapman, Dr. Douglas Powell of Kansas State University and Brae Surgeoner, a former graduate student at the University of Guelph. The study was published in the September issue of the Journal of Environmental Health.

Study Abstract

"University Students' Hand Hygiene Practice During a Gastrointestinal Outbreak in Residence: What They Say They Do and What They Actually Do"

Authors: Brae V. Surgeoner, University of Guelph; Benjamin J. Chapman, North Carolina State University; Douglas A. Powell, Kansas State University

Published: September 2009, Journal of Environmental Health

Published research on outbreaks of gastrointestinal illness has focused primarily on the results of epidemiological and clinical data collected postoutbreak; little research has been done on actual preventative practices during an outbreak. In this study, the authors observed student compliance with hand hygiene recommendations at the height of a suspected norovirus outbreak in a university residence in Ontario, Canada. Data on observed practices was compared to postoutbreak self-report surveys administered to students to examine their beliefs and perceptions about hand hygiene. Observed compliance with prescribed hand hygiene recommendations occurred 17.4% of the time. Despite knowledge of hand hygiene protocols and low compliance, 83.0% of students indicated that they practiced correct hand hygiene during the outbreak. To proactively prepare for future outbreaks, a current and thorough crisis communications and management strategy, targeted at a university student audience and supplemented with proper hand washing tools, should be enacted by residence administration.

Source:
Matt Shipman

North Carolina State University

Over 30 New Studies Of Oral Xeloda(R) Featured At The 2008 Gastrointestinal Cancers Symposium

2011-06-22T12:00:00.024-07:00

Roche announced that a
total of 33 abstracts involving its oral chemotherapy Xeloda(R) have been
accepted for presentation at the 2008 Gastrointestinal Cancers Symposium in
Orlando, Fla., from Jan. 25 to 27.

Five poster presentations based on U.S. data offer additional knowledge
about Xeloda. Two of these U.S. abstracts compare the safety profile and
usage patterns of therapy with oral Xeloda to that of intravenous
fluorouracil (5-FU) therapy in gastroesophageal cancer. A second pair of
U.S. abstracts evaluates the usage patterns and cost of Xeloda-based
regimens against those of 5-FU-based regimens in colon and rectal cancer.
The fifth U.S. abstract highlights preclinical efficacy and tolerability
results of a novel Xeloda regimen (7/7, or 7 days on, 7 days off) using
higher daily doses for the treatment of colorectal cancer.

-- Jan. 25, noon to 1 p.m., [Poster No. 72], A claims database analysis of
capecitabine treatment patterns in patients with gastroesophageal
cancer (GEC) (Presenter: Wasif Saif)

-- Jan. 25, noon to 1 p.m., [Poster No. 71], Capecitabine in patients with
gastroesophageal cancer (GEC): A claims database analysis of adverse
events (AEs) (Presenter: Wasif Saif)

-- Jan. 26, 5:30 to 6:30 p.m., [Poster No. 364], A claims database cost-
comparison analysis of capecitabine in the treatment of patients with
colon or rectal cancer (CRC) (Presenter: Edward Chu)

-- Jan. 27, 7 to 8 a.m., [Poster No. 465], Capecitabine use in patients
with colon and rectal cancer (CRC): A claims database analysis of
treatment (Presenter: Edward Chu)

-- Jan. 27, 7 to 8 a.m., [Poster No. A29], In vivo activity of traditional
vs. novel regimens of capecitabine (C) alone and in combination in a
colorectal cancer xenograft model (Presenter: Kenneth Kolinsky)

Collectively, the findings of these studies highlight the efficacy and
safety of oral Xeloda as a potential alternative to 5-FU in
gastroesophageal and colorectal cancers and support further clinical
testing to examine the efficacy and safety benefits of the 7/7 Xeloda
dosing regimen. Global data presentations, including a meta-analysis that
compares the overall survival benefit between Xeloda and 5-FU in adjuvant
and metastatic settings, provide similar insights.

About Xeloda

Xeloda is the only FDA-approved oral chemotherapy for both metastatic
breast cancer and adjuvant and metastatic colorectal cancer. Inactive in
pill form, Xeloda is enzymatically activated within the body; when it comes
into contact with a naturally occurring protein called thymidine
phosphorylase, or TP, Xeloda is transformed into 5-FU, a cytotoxic
(cell-killing) drug. Because many cancers have higher levels of TP than
does normal tissue, more 5-FU is delivered to the tumor than to other
tissue.

A clinically important drug interaction between Xeloda and warfarin has
been demonstrated; altered coagulation parameters and/or bleeding and death
have been reported. Clinically significant increases in prothrombin time
(PT) and INR have been observed within days to months after starting
Xeloda, and infrequently within one month of stopping Xeloda. For patients
receiving both drugs concomitantly, frequent monitoring of INR or PT is
recommended. Age greater than 60 and a diagnosis of cancer independently
predispose patients to an increased risk of coagulopathy.

Xeloda is contraindicated in patients who have a known hypersensitivity
to 5-fluorouracil, and in patients with known dihydropyrimidine
dehydrogenase (DPD) deficiency. Xeloda is contraindicated in patients with
severe renal impairment. For patients with moderate renal impairment, dose
reduction is required.

The most common adverse events (greater than or equal to 20%) of Xeloda
monotherapy were diarrhea, nausea, stomatitis and hand-foot syndrome. As
with any cancer therapy, there is a risk of side effects, and these are
usually manageable and reversible with dose modification or interruption.

About Roche

Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S.
pharmaceuticals headquarters of the Roche Group, one of the world's leading
research-oriented healthcare groups with core businesses in pharmaceuticals
and diagnostics. For more than 100 years in the U.S., Roche has been
committed to developing innovative products and services that address
prevention, diagnosis and treatment of diseases, thus enhancing people's
health and quality of life. An employer of choice, in 2007 Roche was named
Top Company of the Year by Med Ad News, one of the Top 20 Employers
(Science) and ranked the No. 1 Company to Sell For (Selling Power). In
previous years, Roche has been named as a Top Company for Older Workers
(AARP) and one of the Best Companies to Work For in America (Fortune). For
additional information about the U.S. pharmaceuticals business, visit our
websites: rocheusa or roche.us.

All trademarks used or mentioned in this release are protected by law.

Roche

rocheusa

View drug information on Warfarin Sodium tablets; Xeloda.

A New Explanation Of 'Asian Paradox'

2011-06-22T12:00:00.023-07:00

Although Helicobacter pylori (H. pylori) has been classified as a class I (or definite) carcinogen by World Health Organization (WHO), the controversy as to why only a minority of infected patients develop gastric cancer still remains. Moreover, in Asian countries such as Indonesia, Japan, China, and Thailand, where the H. pylori infection rates are similar, there is a significant difference regarding the outcome of gastric cancer. That fact has been termed the "Asian paradox".

A research article published in the World Journal of Gastroenterology addresses this question. Research, led by Murdani Abdullah, MD from Division of Gastroenterology, Department of Internal Medicine, University of Indonesia, was based on the old concept of a cascade of mucosal changes that develops from acute/chronic gastritis to gastric cancer as proposed by P. Correa. The difference in the pattern of H. pylori-associated gastritis may explain the difference in the incidence of gastric cancer between Indonesia and Japan. Previous studies have never evaluated the cascade of gastric mucosal changes prior to gastric cancer. In this research, the transformation of gastric mucosa that is induced by H. pylori infection prior to gastric cancer was investigated. The transformation was then compared between Indonesian and Japanese patients, the two countries that represent the "Asian paradox".

From 1998 to 1999, 42 Japanese patients at Yamanashi Medical University Hospital, Koufu and 125 Indonesian patients at Metropolitan Medical Centre Hospital, Jakarta were consecutively enrolled. From this research, it was seen that there was a significant difference in the grade and activity of gastric mucosal changes between Indonesian and Japanese H. pylori-positive patients. This finding suggests that there may be a different host response between Indonesian and Japanese people regarding H. pylori infection. The authors believe that lifestyle and genetic factors are considered to play a major role, in the meantime, their research may act as the initial step in explaining the "Asian paradox".

Reference: Abdullah M, Ohtsuka H, Rani AA, Sato T, Syam AF, Fujino MA. Helicobacter pylori infection and gastropathy: A comparison between Indonesian and Japanese patients. World J Gastroenterol 2009; 15(39): 4928-4931 wjgnet/1007-9327/15/4928.asp

Source: Jin-Lei Wang

World Journal of Gastroenterology

Study Demonstrated AMITIZA (Lubiprostone) Showed Efficacy

2011-06-22T12:00:00.022-07:00

Results of a secondary analysis of two pivotal studies were presented today at the 71st Annual Meeting of the American College of Gastroenterology (ACG), and showed that 60 percent of patients treated with AMITIZA™ (lubiprostone) experienced a spontaneous bowel movement (SBM) within 24 hours of treatment, and 80 percent experienced a SBM within 48 hours of treatment. Additionally, AMITIZA, the first selective chloride channel activator approved by the FDA for the treatment of chronic idiopathic constipation in adults, showed improvement in long-term symptom relief of this disorder with significant improvements in constipation severity, abdominal bloating and discomfort for up to 12 months.

"These results are encouraging for physicians who treat patients with constipation because there are few treatments approved for chronic constipation that can be used long term," said Satish Rao, M.D., professor of medicine and director, Neurogastroenterology and GI Motility at University of Iowa. "These data indicate that lubiprostone may provide rapid and long-term relief of symptoms."

Constipation, one of the most common digestive complaints, accounts for more than 2.5 million doctor visits in the U.S. each year according to the ACG. It is a condition that often requires rapid and predictable relief of symptoms with limited long-term treatment options. In clinical studies, relief was defined as three or more SBMs per week.

AMITIZA has a novel mechanism of action that works by activating chloride channels to increase fluid secretion in the intestine, thereby increasing the passage of stool and improving signs and symptoms associated with chronic idiopathic constipation. AMITIZA is the only prescription medication for chronic idiopathic constipation that has been approved by the FDA for use in adults, including those 65 years and over and that has demonstrated effectiveness for use beyond 12 weeks.

Study Design: Spontaneous Bowel Movements within 24 Hours and 48 Hours

To determine the onset of action of AMITIZA within 24 and 48 hours, individual and pooled results from two well-controlled Phase III trials were examined: 239 participants received AMITIZA 24 mcg twice daily and 240 participants received placebo. Data on time to first SBM and percentage of patients experiencing a SBM within 24 and 48 hours following initial study-drug administration were compared by study and pooled between treatment groups (placebo vs. AMITIZA). For each study, the time to first SBM was significantly shorter for patients taking AMITIZA compared with those taking placebo (P is less than or equal to 0.006).

* In the individual studies, 57 to 63 percent of patients treated with AMITIZA and 32 to 37 percent of placebo patients had a SBM within 24 hours (P is less than or equal to 0.0024).

* At the 48-hour timepoint in the individual studies, a SBM occurred in 79 to 80 percent of patients treated with AMITIZA vs. 61 to 66 percent of placebo patients (P is less than or equal to 0.0258).

* In the pooled analysis, 60 percent of patients treated with AMITIZA had a SBM within 24 hours and 80 percent had a SBM within 48 hours, compared with 35 and 63 percent of placebo patients, respectively (P is less than 0.0001).

Study Design: Long-Term Use of AMITIZA

To evaluate the long-term safety of AMITIZA, a 48-week, open-label trial of patients who had not received AMITIZA before was conducted. In total, 324 participants with chronic idiopathic constipation received AMITIZA 24 mcg taken twice daily.

The findings revealed that AMITIZA was generally well tolerated throughout the study's duration. Sixty-seven percent of patients experienced at least one treatment-related adverse event (AE). The most common treatment-related AEs included nausea (30.2%) and diarrhea (19.4%). Improvements in assessments of constipation severity, abdominal bloating and abdominal discomfort were statistically significant at all visits compared to baseline (P is less than or equal to 0.001).

Further, patients were asked to assess constipation severity and abdominal symptoms of bloating and discomfort using a 5-point scale where 0=absent, 1=mild, 2=moderate, 3=severe and 4=very severe, at each study visit (approximately every 6 weeks). Specifically:

* Constipation severity was improved by an average of 1.11 points at Week 1 (N=320), 1.17 points at Week 24 (N=183), 1.28 points at Week 48 (N=152) and 0.99 points for the last on-drug measurement (N=320) from a mean baseline value of 2.69 (N=320).

* Abdominal bloating was improved by an average of 0.70 points at Week 1 (N=320), 0.80 points at Week 24 (N=183), 0.88 points at Week 48 (N=152) and 0.68 points for the last on-drug measurement (N=320) from a mean baseline value of 1.88 (N=320).

* Abdominal discomfort was improved by an average of 0.65 points at Week 1 (N=320), 0.66 points at week 25 (N=183), 0.78 points at Week 48 (N=152) and 0.60 points for the last on-drug measurement (N=320) from a mean baseline value of 1.60 (N=320).

AMITIZA, approved by the U.S. Food and Drug Administration (FDA) in January 2006 for the treatment of chronic idiopathic constipation in adults, was developed by Sucampo Pharmaceuticals, Inc., and is jointly marketed in the United States by Sucampo and Takeda Pharmaceuticals North America, Inc.

About Chronic Idiopathic Constipation

Constipation is one of the most common digestive complaints, affecting more than 42 million adults in the United States. It is the cause of 2.5 million visits to physicians and 92,000 hospitalizations annually. Chronic idiopathic constipation is defined by the infrequent or difficult passage of the stool for a period of at least three months. "Idiopathic" means the cause of the constipation is unknown and not due to an underlying illness or medication. The signs and symptoms associated with chronic idiopathic constipation include abdominal discomfort, bloating, straining, and hard or lumpy stools.

About AMITIZA

AMITIZA is indicated for the treatment of chronic idiopathic constipation in the adult population. AMITIZA should not be used in patients with a known hypersensitivity to any components of the formulation and in patients with a history of mechanical gastrointestinal obstruction. Patients with symptoms suggestive of mechanical gastrointestinal obstruction should be evaluated prior to initiating AMITIZA treatment.

The safety of AMITIZA in pregnancy has not been evaluated in humans. In guinea pigs, lubiprostone has been shown to have the potential to cause fetal loss. AMITIZA should be used during pregnancy only if the benefit justifies the potential risk to the fetus. Women who could become pregnant should have a negative pregnancy test prior to beginning therapy with AMITIZA and should be capable of complying with effective contraceptive measures.

AMITIZA should not be administered to patients that have severe diarrhea. Patients should be aware of the possible occurrence of diarrhea during treatment. If the diarrhea becomes severe, patients should consult their health professional.

In clinical trials, the most common adverse event was nausea (31%). Other adverse events (greater than or equal to 5% of patients) included diarrhea (13%), headache (13%), abdominal distention (7%), abdominal pain (7%), flatulence (6%), sinusitis (5%) and vomiting (5%).

For full prescribing information, visit amitiza/.

AMITIZA™ is a trademark of Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc.

Sucampo Pharmaceuticals, Inc., is an emerging pharmaceutical company based in Bethesda, Md. Sucampo was founded in 1996 by Sachiko Kuno, Ph.D., the company's President and Chair of the Board of Directors, and Ryuji Ueno, M.D., Ph.D., Ph.D., the company's Chief Executive Officer and Chief Scientific Officer. Sucampo focuses on the development and commercialization of drugs based on prostones, a class of compounds derived from functional fatty acids that occur naturally in the human body. The therapeutic potential of prostones was first identified by Dr. Ueno. In January 2006, Sucampo received marketing approval from the FDA for its first product, AMITIZA, for the treatment of chronic idiopathic constipation in adults.

In October 2004, Sucampo entered into an agreement with Takeda Pharmaceutical Company Limited (Osaka, Japan) to co-promote and market AMITIZA in the United States and Canada. Sucampo's specialized sales force complements the efforts of Takeda by focusing on institutional and long-term care facilities. Currently, two pivotal Phase 3 clinical trials of AMITIZA for the treatment of irritable bowel syndrome with constipation (IBS-C) are ongoing, and Phase 2/3 pivotal clinical trials for the treatment of opioid bowel dysfunction (OBD) are expected to commence in early 2007.

To learn more about the company and its products, visit sucampo/.

Takeda Pharmaceuticals North America, Inc.

Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. In the United States, Takeda currently markets oral diabetes, insomnia, cholesterol-lowering and gastroenterology treatments, and has a robust pipeline with compounds in development for diabetes, cardiovascular disease and other conditions. Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. To learn more about the company and its products, visit tpna/.

Contact: Dave Buckalew

Ketchum

View drug information on Amitiza.

Dental Infection Linked To Diabetes During Pregnancy

2011-06-22T12:00:00.021-07:00

Nearly one out of two women with gestational diabetes also have periodontal disease, according to research released this month by Tulane University researchers. In contrast, just over one in ten pregnant women without gestational diabetes have periodontal disease. The study, available in the October issue of the American Journal of Obstetrics and Gynecology, is the first to demonstrate a link between poor oral health and diabetes during pregnancy.

Periodontal disease is a chronic infection of the gums and mouth. Gestational diabetes is an inability to process dietary sugars normally during pregnancy. Gestational diabetes puts women and their babies at increased risk of injury and illness.

The team of researchers analyzed health data from 256 pregnant women who participated in the National Health and Nutrition Examination Study III. Based on their analysis, the researchers recommend that dental care during pregnancy should be considered as a way to help prevent gestational diabetes.

Study authors are Tulane obstetrician Gabriella Pridjian; Tulane epidemiologists Xiong Xu and Pierre Buekens; and Louisiana State University dental health researcher Sotirios Vastardis.

Tulane University

215 Gibson Hall

New Orleans, LA 70118-5698

United States

Tulane University

Sequential And Combination Chemotherapy Equally Effective In Treating Advanced Colorectal Cancer

2011-06-22T12:00:00.020-07:00

Many patients with incurable advanced colorectal cancer could be offered a more gentle treatment strategy starting with a single chemotherapy drug, as an alternative to current standard initial combination chemotherapy, without compromising their survival. These are the conclusions of authors of two separate Articles published in this week's edition of The Lancet.

They believe their results challenge conventional clinical practice in this area; however, an accompanying Comment says that evidence supports the continuing use of initial combination chemotherapy.

Colorectal cancer causes over half a million deaths every year worldwide. This death toll could fall with advances in prevention, screening and treatment - but there are many patients in which controlling the cancer sufficiently to delay death and reduce symptoms is the only realistic therapeutic goal.

In the first Article, Professor Matt Seymour, University of Leeds and the Gastrointestinal Research Unit, Cookridge Hospital, Leeds, UK and colleagues at the UK National Cancer Research Institute discuss the results of the Medical Research Council FOCUS Trial. This trial is the largest randomised clinical trial ever conducted in the treatment of advanced colorectal cancer, and involved 2135 patients divided into three groups. The first group received single-drug treatment with fluorouracil for as long as it controlled their disease, followed by single-drug treatment irinotecan. The second group received fluorouracil followed by combination treatment (fluorouracil plus irinotecan or oxaliplatin), while the third group received combination chemotherapy from the outset.

The researchers found that patients in the first group had the shortest survival, but the second and third groups had similar overall survival. Toxic effects were lowest during the single-treatment fluorouracil, and quality of life scores were similar throughout all the treatment regimens.

The authors conclude: "This large randomised trial has produced a surprising result which challenges accepted standard treatment approaches in advanced colorectal cancer therapy." For the larger number of patients with more extensive metastases who will not be cured, they add: "FOCUS offers an important choice, informed by the knowledge that a decision to opt for staged treatment approach, starting with less toxic therapy and keeping active agents in reserve, entails minimal, if any, compromise in survival."

In the second Article, Professor Cornelis Punt, Department of Medical Oncology, Radboud University Nijmegen Medical Centre, The Netherlands, and colleagues report the results of the CAIRO trial. In this study, 820 patients were randomly assigned to receive either sequential treatment with capecitabine, irinotecan and oxaliplatin; or combination treatment of capecitabine plus irinotecan followed by capecitabine plus oxaliplatin. They found that median overall survival rates were similar in the two groups. Previous studies have shown at least similar efficacy and a favourable toxicity profile for capecitabine when compared with fluorouracil.

The authors conclude: "Our results show that, for patients with advanced colorectal cancer, combination treatment with all effective cytotoxic drugs was no better than their sequential use. Progression-free survival over all subsequent treatment lines was not significantly different between the study groups. Additionally, sequential treatment was associated with less toxicity during first-line treatment than was combination therapy."

"Chemotherapy remains the backbone of systemic treatment in this disease, and our results indicate that sequential treatment remains a valid treatment option for these patients."

In the accompanying Comment, Dr Hans-Joachim Schmoll, Martin-Luther University, Halle, and Dr Daniel Sergeant, Mayo Clinic, Rochester, Minnesota, USA, say: "Clinically validated prognostic and predictive factors, such as genomic tests, are needed to define in which patients more intensive therapy is worthwhile, and ideally, which specific treatment should be used.

"Until then, to maximise potential benefit for each patient, an approach based on prognosis and disease presentation with initial combination chemotherapy for most patients, reserving single-agent fluorouracil for a subgroup with less aggressive or never-resectable disease, should be the standard of care for first-line treatment of metastatic colorectal cancer.

"FOCUS and CAIRO support the use of first-line single agent fluorouracil for the latter subgroup of patients and therefore provide an ethical basis for investigating novel drugs in combination with single-agent fluoropyrimidines in future trials, to further develop the treatment armamentarium for patients with colorectal cancer."

lancet

New Therapeutic Treatment Approach Improves Survival In Esophageal Cancer Patients

2011-06-22T12:00:00.019-07:00

A study released at the 73rd Annual Scientific Meeting of the American College of Gastroenterology in Orlando found that a new therapeutic treatment, when delivered endoscopically and used in combination with chemotherapy and radiation therapy, improved survival rates in patients with locally advanced esophageal cancer. Cancer of the esophagus often has a poor survival rate.

Dr. Kenneth Chang of University of California Irvine Medical Center and his colleagues conducted a Phase 2 multi-center study on the safety and long-term efficacy of a new biologic therapy (TNFeradeTM), an injection of an anti-tumor agent, in 24 patients with locally advanced esophageal cancer.

Patients received standard care chemotherapy and radiation. In addition, the patients received TNFeradeTM through a standard endoscope or endoscopic ultrasound that guided the injection directly into the esophageal tumor. TNFeradeTM contains a non-replicating virus, which has been engineered to deliver the gene for a cancer fighting protein, TNF-alpha and works synergistically with chemoradiation representing a "triple threat" to cancer cells.

TNFeradeTM was administered once a week for a total of 5 treatments. Surgery was performed 5-11 weeks after completion of therapy. Researchers monitored the effects of this combined therapy by observing the side effects, tumor response, and overall survival.

Researchers found most tumors were of the "adenocarcinoma" type. These tumors were locally advanced (had gone through the deeper layers of the esophagus and/or had spread to lymph nodes) but still potential candidates for surgery.

TNFeradeTM in combination with chemoradiation in this group of patients, resulted in a median survival of 48.4 months, in contrast to previously published trials showing a median survival of 9.7 to 34 months. At one particular dose all four of the patients were alive without any recurrence at 48 months. Three of these patients had tumor resections, which showed no residual cancer cells in the surgical specimens.

According to lead investigator Dr. Chang, "This new treatment, in combination with chemoradiation in this group of patients, represents an encouraging increase in survival relative to historical controls and therefore warrants additional evaluation. TNFeradeTM is a promising treatment that represents a new paradigm in esophageal cancer treatment, with the gastroenterologist administering the local anti-tumor agent through a scope."

About the American College of Gastroenterology

Founded in 1932, the American College of Gastroenterology (ACG) is an organization with an international membership of more than 10,000 individuals from 80 countries. The College is committed to serving the clinically oriented digestive disease specialist through its emphasis on scholarly practice, teaching and research. The mission of the College is to serve the evolving needs of physicians in the delivery of high quality, scientifically sound, humanistic, ethical, and cost-effective health care to gastroenterology patients.

The ACG is committed to providing accurate, unbiased and up-to-date health information. Visit the ACG Web site acg.gi/ to access educational resources for patients and their families spanning the broad range of digestive diseases and conditions - both common and not-so-common. Organized by disease, state and organ system, these educational materials, developed by ACG physician experts, are offered for the information and benefit of patients and the public.

Source: Rosanne Riesenman

American College of Gastroenterology

Diagnosis Of Depressed-Type Early Gastric Cancer Facilitated By Optimal Band Imaging With Endoscopy

2011-06-22T12:00:00.018-07:00

A study from the Jichi Medical University in Japan shows that optimal band imaging used with an endoscope provided images that clearly identified depressed-type early gastric cancer without magnification in 96 percent of study participants. The study appears in the February issue of Gastrointestinal Endoscopy, the monthly peer-reviewed scientific journal of the American Society for Gastrointestinal Endoscopy.

Gastric cancer is one of the most prevalent types of cancer in the world. If gastric cancer is found early, the five-year survival rate increases nearly 90 percent. In contrast, most patients with advanced gastric cancer have a poor prognosis. Gastric cancer is classified as elevated, flat and depressed types. Despite improvements in endoscopic technologies, depressed-type early gastric cancer is challenging to diagnose because it manifests as subtle changes in color and shape. Variations in color, however, can also mean inflammation, so it is difficult to determine what is benign and what is malignant. Therefore, biopsies must then be taken.

"In our comparative study, the optimal band imaging system with endoscopy showed contrasting images that could delineate the depressed-type early gastric cancers more easily than conventional endoscopy," said the study's lead author Hiroyuki Osawa, MD, Jichi Medical University. "A distinct demarcation was observed endoscopically between the reddish images of the cancerous lesion and the yellowish images of the surrounding noncancerous area. This is the first report of optimal band images for early gastric cancer."

Optimal band imaging (OBI) was developed with the aim of enhancing the capillary pattern and pit patterns of lesions in endoscopic images. In contrast to narrow band imaging, in which the bandwidth of spectral transmittance is narrowed by optical filters, the OBI system is based on a new spectral estimation technique that replaces the need for optical filters. OBI takes an ordinary endoscopic image from the video processor and arithmetically processes the reflected photons to reconstitute virtual images for a choice of different wavelengths.

Patients and Methods

An OBI system with electronic endoscope for the upper-gastrointestinal tract was used in this prospective study. Twenty-seven patients between May and December 2006 who were diagnosed with conventional endoscopy as having depressed-type early gastric cancer participated in the study. The mean age of the patients was 65.3 years with 23 men and four women. Twenty-four patients were diagnosed with differentiated adenocarcinoma and three patients with undifferentiated adenocarcinoma by the histopathologic evaluation of biopsy specimens. Researchers used the OBI system without magnification to observe the entire stomach because of the ample light intensity.

Results

With the OBI system, depressed type-early gastric cancer in 26 of 27 cases were easily identified because it clearly showed contrasting demarcation lines between the reddish images of the cancerous lesions and the yellowish images of the surrounding noncancerous area. A 40-fold magnification was then applied to observe the pit pattern, the disappearance of pit pattern or an irregular microvascular pattern of the cancerous lesions. This further enhanced the demarcation of the cancer and the noncancerous areas.

Researchers concluded that OBI images were better than conventional endoscopy images in identifying depressed-type early gastric cancer, but said that further study is warranted. They noted that even medical students, who had not had considerable amounts of clinical endoscopic experience, were able to easily identify the demarcation line between cancer and noncancerous areas in optimal band images versus conventional endoscopic images. OBI is available even without magnification during routine endoscopy because the system provides the same light intensity as conventional endoscopy. The researchers stated that such nonmagnified optimal band images may be ideal for screening, whereas magnified optimal band images are more suitable for detailed examination of early gastric cancer.

About the American Society for Gastrointestinal Endoscopy

Founded in 1941, the mission of the American Society for Gastrointestinal Endoscopy is to be the leader in advancing patient care and digestive health by promoting excellence in gastrointestinal endoscopy. ASGE, with more than 10,000 physician members worldwide, promotes the highest standards for endoscopic training and practice, fosters endoscopic research, recognizes distinguished contributions to endoscopy, and is the foremost resource for endoscopic education. Visit asge/ and screen4coloncancer/ for more information.

About Endoscopy

Endoscopy is performed by specially-trained physicians called endoscopists using the most current technology to diagnose and treat diseases of the gastrointestinal tract. Using flexible, thin tubes called endoscopes, endoscopists are able to access the human digestive tract without incisions via natural orifices. Endoscopes are designed with high-intensity lighting and fitted with precision devices that allow viewing and treatment of the gastrointestinal system. In many cases, screening or treatment of conditions can be delivered via the endoscope without the need for further sedation, treatment or hospital stay.

Source: Anne Brownsey

American Society for Gastrointestinal Endoscopy

Asacol® 800mg Mr Tablets Approved For Ulcerative Colitis (UC), Maintenance Of Remission Of UC And Crohn's Ileo-Colitis

2011-06-22T12:00:00.017-07:00

Procter & Gamble Pharmaceuticals (NYSE: P&G)
announced today that Asacol® (mesalazine) 800mg Modified Release (MR) tablets have been
approved for the treatment of mild to moderate ulcerative colitis (UC) and maintenance of
remission of UC and Crohn's ileo-colitis in the United Kingdom by the Medicines and
Healthcare products Regulatory Agency (MHRA).

Asacol 800mg MR tablets have been approved for moderately active UC patients at the new
high 4.8 grams per day dose based on the ASCEND (Assessing the Safety and Clinical Efficacy of a New Dose of 5-ASA) I and II clinical trials that demonstrated Asacol 800mg MR
tablets given at 4.8g per day resulted in faster symptom relief compared to 2.4g per day in
moderately active UC patients.1 Median time to symptom resolution was 9 days for rectal
bleeding and 12 days for resolution of abnormal stool frequency for moderately active UC
patients receiving Asacol 800mg MR tablets given at 4.8g per day compared to 16 days and
15 days respectively, with those who received mesalazine 400mg tablets dosed at 2.4g per
day.1 Importantly, there were no significant differences in the overall serious side effect profile
with Asacol 800mg MR tablets dosed at 4.8g per day compared to mesalazine 400mg dosed
at 2.4g per day.2

"This is a clinically useful advance for patients with ulcerative colitis," said Simon Travis,
DPhil, FRCP, Consultant Physician and Gastroenterologist at the John Radcliffe Hospital in
Oxford. "Symptoms of rectal bleeding and diarrhoea resolve faster on higher dose Asacol,
without increasing side effects for acute, moderately active UC patients."

"Procter & Gamble is delighted to bring this new option to ulcerative colitis patients," said
Hans van Zoonen, Vice President Pharmaceuticals and Personal Healthcare, Europe. "We
firmly believe that Asacol 800mg MR tablets will bring faster symptom relief to moderately
active UC patients. The development of the 800mg tablet is part of our commitment to provide
patients with more dosing choice and convenient options. Asacol is a key pillar to our growing
GI franchise, one of three strategic focus areas within P&G Pharmaceuticals," he added.

Asacol 800mg MR tablets are indicated for the treatment of mild and moderate acute
exacerbations of ulcerative colitis, to be administered at 2.4g/day and 4.8g/day, respectively,
in divided doses. Asacol 800mg MR tablets, administered up to 2.4g/day, are also indicated
for the maintenance of remission of ulcerative colitis and Crohn's ileo-colitis.

Procter & Gamble will advise healthcare professionals as soon as the new product is
available for prescription to patients.

References

1. Marion JF et al., Gut 2006; 55(Suppl II): Abstract 140

2. Hanauer SB et al., Can J Gastroenterol2005; 19(Supp C): Abstract R.0471

About Procter & Gamble Pharmaceuticals

Procter & Gamble has a rich heritage in health care that extends back more than 150 years.
Then and now, P&G is driven by our mission to improve the lives of people around the world
every day. P&G's health care products include prescription medicines, over-the-counter
medications and oral care products. P&G began developing and marketing prescription
products in the late 1960s.

Three billion times a day, P&G brands touch the lives of people around the world. The
company has one of the strongest portfolios of trusted, quality, leadership brands, including
Actonel®, Asacol®, Crest®, Fibresure®, Intrinsa®, Metamucil®, Oral-B®, Pepto-bismol®,
Thermacare®, Vicks®, Pampers®, Ariel®, Always®, Pantene®, Herbal Essences®, Mach3®,
Fairy®, Ace®, Lenor®, M. Propre®, Tampax®, Tempo®, Dash®, Pringles®, Iams®,
Eukanuba®, Duracell®, Olay®, Head & Shoulders®, Wella, Gillette®, and Braun. The P&G
community consists of 138,000 employees working in over 80 countries worldwide. Please
visit pg for the latest news and in-depth information about P&G and its
brands. For more information about P&G Pharmaceuticals, please visit pgpharma

About Asacol and Asacol 800mg MR Clinical Trials

Data analysis is from the combined results of two double-blind, randomised, multi-site, 6-
week, controlled clinical trials designed to assess the safety and efficacy of 4.8 g/day
modified-release mesalazine with an 800mg tablet compared to 2.4 g/day modified-release
mesalazine with a 400mg tablet for the treatment of moderately active ulcerative colitis.

The two ASCEND (Assessing the Safety and Clinical Efficacy of a New Dose of 5-ASA)
studies demonstrated that for patients with moderately active ulcerative colitis, beginning
treatment with twice the standard dose of mesalazine, 4.8 grams per day with a new 800mg
tablet rather than 2.4 grams per day using a 400mg mesalazine tablet for six weeks, resulted
in faster symptom relief for moderately active UC patients with no increase in side effects.

Treatment success was defined as improvement from baseline at week six with either
complete response (remission) or partial response (improvement) to treatment.

Asacol 800mg MR tablets, at 4.8 g/day, demonstrated an overall incidence of adverse events
comparable to mesalazine 400mg tablets dosed at 2.4 g/day. Reported adverse events were generally mild and transient, and seldom resulted in discontinuation of treatment. Most
commonly reported adverse events for Asacol 800mg MR tablets were nausea (6.1%),
headache (5.4%), vomiting (4.1%) and flatulence (4.1%), while those for mesalazine 400mg
tablets were headache (5.8%), abdominal pain (4.5%) and ulcerative colitis (3.9%). Patients
should be made aware that ulcerative colitis rarely remits completely. Abrupt discontinuation
of mesalazine therapy is not recommended and may result in relapse. Asacol 800mg MR
tablets are contraindicated in patients with a history of sensitivity to salicylates or renal
sensitivity to sulphasalazine, confirmed severe renal impairment (GFR less than 20 ml/min),
hypersensitivity to any of the ingredients, severe hepatic impairment, gastric or duodenal
ulcer and haemorrhagic tendency. Asacol 800mg MR tablets should be used with extreme
caution in patients with confirmed mild to moderate renal impairment. It is recommended that
all patients have an evaluation of renal function prior to initiation of Asacol 800mg MR tablets
and periodically while on Asacol 800mg MR tablet therapy. Please refer to the Asacol 800mg
MR tablet Summary of Product Characteristics for a complete list of adverse events.

Asacol 800mg MR tablets are indicated for the treatment of mild acute exacerbations of
ulcerative colitis, and for the treatment of moderate acute ulcerative colitis to be administered
at 2.4g/day and 4.8g/day, respectively, in divided doses. Asacol 800mg MR tablets,
administered at 2.4g/day, are also indicated for the maintenance of remission of ulcerative
colitis and Crohn's ileo-colitis in divided doses.

Interchangeability between Asacol 800mg MR tablets and Asacol 400mg MR tablets has not
been established.

pgpharma

View drug information on Actonel; Asacol.

Data Available From ERBITUX(R) Phase III Study In First-Line Treatment Of Advanced Pancreatic Cancer

2011-06-22T12:00:00.016-07:00

ImClone Systems
Incorporated (Nasdaq: IMCL) and Bristol-Myers Squibb Company (NYSE: BMY)
today announced that a Phase III study of ERBITUX(R) (Cetuximab) plus
gemcitabine (a chemotherapy) in patients with locally advanced unresectable
or metastatic pancreatic cancer did not meet its primary endpoint of
improving overall survival.

Conducted by the Southwest Oncology Group (SWOG), a cancer center
network sponsored by the National Cancer Institute, the open-label,
randomized study compared ERBITUX plus gemcitabine to gemcitabine alone in
more than 700 patients with pancreatic cancer in the first-line treatment
setting. The study was conducted in centers throughout the United States
and Canada. It was completed in a significantly shorter time than
projected, providing a timely answer to an important research question.
SWOG has informed ImClone and Bristol-Myers Squibb that the primary study
endpoint of statistically improving overall survival was not met. The three
parties -- SWOG, ImClone, and Bristol-Myers Squibb -- will engage in joint
efforts to fully interpret these results.

"This study was designed to examine the Phase II results we previously
observed for ERBITUX in patients with pancreatic cancer," stated Eric K.
Rowinsky, M.D., Chief Medical Officer and Senior Vice President of ImClone
Systems. "We still consider pancreatic cancer to be of the utmost priority
and we intend to pursue additional evaluations with ERBITUX including a
pilot study of ERBITUX and bevacizumab with or without gemcitabine, as well
as our pipeline agents, to improve the outcome for patients with pancreatic
cancer."

"Pancreatic cancer is a devastating disease with few effective
treatment options, and it is unfortunate that the use of ERBITUX in this
trial has not demonstrated the benefit it has shown in other tumors," said
Martin Birkhofer, M.D., Vice President, Oncology Global Medical Affairs,
Bristol-Myers Squibb. "We are anxious to understand these data in greater
detail and are committed to exploring the potential benefits that ERBITUX
may provide to cancer patients."

About Pancreatic Cancer

This year in the U.S., approximately 33,700 people will be diagnosed
with cancer of the pancreas. Pancreatic cancer accounts for about six
percent (6%) of all cancer deaths, or about 32,000 deaths per year. The
current 5-year survival rate is about five percent (5%). The number of
deaths from this disease highlights the importance of seeking better
therapies for pancreatic cancer through clinical trials testing novel
drugs. During the past 30 years, the numbers of new cases of pancreatic
cancer (incidence) and deaths (mortality) have changed little.

About ERBITUX(R) (Cetuximab)

ERBITUX is a monoclonal antibody (IgG1 Mab) designed to inhibit the
function of a molecular structure expressed on the surface of normal and
tumor cells called the epidermal growth factor receptor (EGFR, HER1,
c-ErbB-1). In vitro assays and in vivo animal studies have shown that
binding of ERBITUX to the EGFR blocks phosphorylation and activation of
receptor-associated kinases, resulting in inhibition of cell growth,
induction of apoptosis, and decreased matrix metalloproteinase and vascular
endothelial growth factor production. In vitro, ERBITUX can mediate
antibody-dependent cellular cytotoxicity (ADCC) against certain human tumor
types. While the mechanism of ERBITUX' anti-tumor effect(s) in vivo is
unknown, all of these processes may contribute to the overall therapeutic
effect of ERBITUX. EGFR is part of a signaling pathway that is linked to
the growth and development of many human cancers, including those of the
head and neck, colon and rectum.

ERBITUX (Cetuximab), in combination with radiation therapy, is
indicated for the treatment of locally or regionally advanced squamous cell
carcinoma of the head and neck. ERBITUX as a single agent is indicated for
the treatment of patients with recurrent or metastatic squamous cell
carcinoma of the head and neck for whom prior platinum-based therapy has
failed.

ERBITUX is indicated for the treatment of EGFR-expressing, metastatic
colorectal carcinoma (mCRC) in combination with irinotecan for patients who
are refractory to irinotecan-based chemotherapy, and as a single agent for
patients who are intolerant to irinotecan-based therapy. The effectiveness
of ERBITUX for the treatment of EGFR-expressing mCRC cancer is based on
objective response rates. Currently, no data are available that demonstrate
an improvement in disease-related symptoms or increased survival with
ERBITUX for the treatment of EGFR-expressing mCRC.

For full prescribing information, including boxed WARNINGS regarding
infusion reactions and cardiopulmonary arrest, visit
ERBITUX.

Important Safety Information

Grade 3/4 infusion reactions, rarely with fatal outcome (

As Population Ages And Need For Palliative Care Grows, Experts Tackle New Challenge For The First Time At European Meeting

2011-06-22T12:00:00.015-07:00

Experts from across Europe are gathering at a scientific symposium held at the fifth European Association for Palliative Care (EAPC) congress in Trondheim, Norway, on the 29th May, to discuss the challenges of managing an overlooked and distressing symptom that affects large numbers of patients receiving opioids as part of palliative care management for advanced illness: opioid-induced constipation (OIC). It is a condition that is often under-diagnosed in patients in the palliative care setting.

As Europe's population ages, so the number of patients living with advanced illness is likely to increase.1 Pain relief is often a key part of palliative care and opioids are routinely used to relieve the pain.2 However, the effective pain relief provided by opioids is often accompanied with a less welcome side-effect and OIC is a near universal occurrence in patients receiving opioid analgesics in the palliative care setting.3,4 OIC can be so severe, that it may result in patients choosing to sacrifice their pain medication, to mitigate the problem.

"OIC usually goes under-diagnosed", says Professor Kaasa, St Olave's University Hospital, Norway. "Clinicians don't ask about it and patients don't talk about it, which means it is often poorly managed. The discomfort and distress of OIC can affect the quality of life of patients receiving palliative care for advanced illness."

"OIC is a significant cause of distress", concurs Dr Philip Larkin, Senior Lecturer in Nursing, National University of Ireland. "A recent survey showed that a third of patients in Europe with moderate to severe symptoms receive no treatment.5 We need to put in place a European-wide consensus on how to diagnose and manage this problem now, as the demand for palliative care is growing and is predicted to continue to grow as the population of Europe ages."

"For too long OIC has been a burden for our patients despite our current treatments", notes Dr Jay Thomas, Center for Palliative Studies at San Diego Hospice and The Institute for Palliative Medicine, United States. "As clinicians, we have to be vigilant to diagnose it and aggressively treat it. Having new tools that enable OIC to be treated without interfering with pain management is a welcome addition that can help relieve suffering and give patients back some control and quality of life."

Each year, more than 1.5 million Americans receive palliative care due to an advanced illness, such as incurable cancer, end-stage heart and lung disease, or AIDS.6,7 Similar figures are not available for Europe, which may be considered indicative of the fact that this is an overlooked condition and an area of unmet medical need. However, despite this problem and the limitations of laxative therapies experts concluded that with the introduction of novel targeted therapies, the outlook for patients suffering from the distressing condition looks more positive.

The clinical impact of OIC was discussed at a scientific symposium sponsored by Wyeth, which convened a wide range of experts in palliative care including geriatricians, oncologists, nurses, researchers, palliative care physicians and general physicians. The experts will discuss the challenges in diagnosing and managing the condition in patients in the palliative care setting. They will also be discussing the limitations of laxative therapies and insights into the future with novel targeted therapies which convey a bright outlook for the distressing condition.

About Wyeth Pharmaceuticals

Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products. Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products, nutritionals and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.

Additional information on Wyeth is available at wyeth.eu

The EAPC Research Forum addresses researchers and clinicians from all disciplines specialised in palliative care.

Wyeth is developing methylnaltrexone bromide, a peripherally acting mu-opioid receptor antagonists (PAMORA) that reverses the constipating effects of opioid pain medications in the gastrointestinal tract without affecting their ability to relieve pain. In April 2008 it was approved for use in the US by the FDA and received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in Europe.

References

1. Davies E, Higginson I. Better Palliative Care for Older People. WHO, 2004. See here.

2. Gutstein HB, Akil H. Opioid Analgesics. In: Brunton LL, Lazo JS, Parker KL, eds. Goodman & Gilman's The Pharmacological Basis of Therapeutics. 11th Ed. New York, NY: McGraw-Hill; 2006: 547-590

3. Fallon MT. Constipation in cancer patients: prevalence, pathogenesis, and cost-related issues. Eur J Pain. 1999;3(suppl A):3-7

4. Emanuel EJ, Emanuel LL. Palliative and end-of-life care. In: Kasper DL, Braunwald E, Fauci AS, et al, eds. Harrison's Principles of Internal Medicine. 16th ed. New York, NY: McGraw-Hill; 2005:53-66

5. Laugsand EA, EAPC et al. Unpublished findings

6. Mini?±o AM, Heron M, Murphy SL, et al. Deaths: final data for 2004. Health E-Stats. Released November 24, 2006. Available here. Accessed March 9, 2007

7. National Hospice and Palliative Care Organization. NHPCO's Facts and Figures -
2005 Findings. Available here. Accessed May 30, 2007

Wyeth Pharmaceuticals

E. Coli Linked To Kidney Problems, Heart Disease And High Blood Pressure

2011-06-22T12:00:00.014-07:00

People who become infected with E. Coli have a higher risk of later on developing hypertension, heart disease and kidney problems, Canadian researchers wrote in an article published in the BMJ (British Medical Journal). The authors say their study underscores how important it is to have clean water and food, as well as monitoring infected people carefully. E. coli is the same as Escherichia coli.

Health authorities in America believe that approximately 120,000 people each year develop gastro-enteric illnesses from E. coli 0157:H7 infections. About 2,000 are admitted to hospital 60 sixty die each year.

However, very little is known about the long-term outlook for people with E. coli infection, the researchers explained.

William F. Clark, MD, professor of nephrology at Victoria Hospital, London, Ontario, Canada, and team set out to assess the risk of cardiovascular disease, kidney problems and hypertension within eight years of becoming infected with E. coli as a result of consuming contaminated water.

They gathered data from the Walkerton Health Study, which evaluated the long-term health of 1,977 individuals who had developed gastroenteritis from a tainted municipal water system in May 2000. The water had been infected with Campylobacter and E. Coli 0157:H7 bacteria. 1,067 of them became ill with acute gastroenteritis, and 378 went to see a doctor about it.

The researchers discovered that those who had developed gastroenteritis symptoms had a 1.3 higher risk of developing hypertension (high blood pressure) compared to those who had not become infected. Renal impairment (kidney problem) risk was 3.4 times higher, and the chances of having a cardiovascular event, such as stroke or heart attack was 2.1 times higher.

The authors concluded:
"Our findings underline the need for following up individual cases of food or water poisoning by E coli O157:H7 to prevent or reduce silent progressive vascular injury.

These long term consequences emphasise the importance of ensuring safe food and water supply as a cornerstone of public health."
"Long term risk for hypertension, renal impairment, and cardiovascular disease after gastroenteritis from drinking water contaminated with Escherichia coli O157:H7: a prospective cohort study"

William F Clark, Jessica M Sontrop, Jennifer J Macnab, Marina Salvadori, Louise Moist, Rita SuriAmit X Garg

BMJ 2010; 341:c6020

FDA 510(k) Clinical Trial Progress For AppyScore, World's First Blood-Based Diagnostic Test For Human Appendicitis

2011-06-22T12:00:00.013-07:00

AspenBio Pharma,
Inc. (NASDAQ: APPY), an emerging bio-pharmaceutical company dedicated
to the development of novel drugs and diagnostics for humans and
animals, reported the enrollment level in the ongoing FDA 510(k)
clinical trial for AppyScore(TM), the world's first blood-based
diagnostic test for human appendicitis exceeds 700 patients.

As of November 17, 2008, there were 701 patients enrolled in the
ongoing clinical trial in which 800 patient enrollments will complete
the study. Based upon current ongoing weekly enrollment rates, the
company anticipates achieving the goal of 800 patient enrollments
within weeks.

The study enrollment is focused on patients arriving at hospital
emergency rooms with a primary complaint of abdominal pain. Qualified
patients are further narrowed with criteria related to medical
history and duration and location of abdominal pain.

Patient test results from the independent multicenter study are
completely blind. Therefore, until the trial is completed and data is
unlocked, information concerning trial results will remain unknown to
all parties, including AspenBio, its independent Contract Research
Organization ("CRO") and the participating hospitals.

Based upon the current progress, the company expects to complete the
trial later in 2008, to be followed by reporting the data and then
anticipates submitting its FDA 510(k) application early in 2009.

Following achievement of the final study enrollment target of 800,
the company estimates an additional four to six weeks will be required
for its independent medical data contractor to review and QC (quality
control) all final patient and study data, un-blind the study patient
codes, and provide final data metrics for statistical analysis. This
data will be forwarded to an independent medical statistician who
will conduct statistical analysis and study results, which will then
be reported to the company for inclusion in its FDA submission.

The company anticipates completing its FDA 510(k) application in
early 2009. Although the company has confidence in its product,
results of any blind trial can be unpredictable and inconsistent.
Unforeseen events can occur, and there are many factors which are
beyond the control of the company. Therefore, there can be no
assurance AspenBio will be able to achieve its anticipated timelines
or meet expectations.

Upon completion of 800 patient enrollments in this clinical trial,
the company plans to provide an update to shareholders that enrollment
targets have been achieved. Approximately four to six weeks following
achievement of full enrollment, the company plans to issue an
additional summary update to shareholders on the final key study
results as it prepares and completes its submission of the FDA 510(k)
application.

As discussed in our press release on October 22, 2008, advancing
AppyScore and the current FDA application for our 45 minute ELISA lab
test is the company's number one priority. In addition, the company
continues to make progress on two additional formats of the
appendicitis test in its product pipeline. The two additional
versions of the test, now in formal GMP development, are designed to
be approximately three times faster, providing results in
approximately 15 minutes and are less labor intensive.

AspenBio Pharma president and CEO, Richard Donnelly, stated,
"Completing this 800 patient trial and achieving FDA 510(k) clearance
of our AppyScore appendicitis blood test is the primary focus in the
company. While the actual date of completion of the trial is too
close to call, at current rates, we are now down to just a few more
weeks of enrollment, which is exciting."

As reported earlier, results of recent unpublished pilot data
suggests that the assay performs with consistently high sensitivity
and has shown a trend of improved specificity. Further analysis of
this pilot data suggests that AppyScore in combination with other
existing standard of care tests, including white blood count ("WBC")
and computed tomography ("CT"), may provide a significant improvement
in the quality of diagnostic information available to the physician.
While results in any large blind trial cannot be assured, the company
believes the current 800 patient trial will demonstrate this improved
clinical utility.

About AspenBio Pharma, Inc.

AspenBio Pharma is an emerging bio-pharmaceutical company dedicated
to the discovery; development, manufacture, and marketing of novel
proprietary products, including those that enhance the reproductive
efficiency of animals and that have large worldwide market potential.
The company was originally formed to produce purified proteins for
diagnostic applications and has successfully leveraged this
foundational science and technology expertise to rapidly develop an
enviable late-stage pipeline of several novel reproduction hormone
analogs for wide-ranging therapeutic use initially in bovine and
equine species. AspenBio Pharma continues to advance the development
and testing of its three first-generation blood-based human
diagnostic tests designed as an aid in the diagnosis of human
appendicitis.

Forward-Looking Statements

This news release includes "forward-looking statements" of AspenBio
Pharma, Inc. ("APPY") as defined by the Securities and Exchange
Commission (the "SEC"). All statements, other than statements of
historical fact, included in the press release that address
activities, events or developments that APPY believes or anticipates
will or may occur in the future are forward-looking statements. These
statements are based on certain assumptions made based on experience,
expected future developments and other factors APPY believes are
appropriate in the circumstances. Such statements are subject to a
number of assumptions, risks and uncertainties, many of which are
beyond the control of APPY. Investors are cautioned that any such
statements are not guarantees of future performance. Actual results
or developments may differ materially from those projected in the
forward-looking statements as a result of many factors, including
statements regarding the ability to successfully complete the
clinical trials and pivotal studies required for FDA submission,
obtain FDA approval for, cost effectively manufacture and generate
revenues from the appendicitis test as well as the animal products
under this agreement and other new products, execute agreements
required to successfully advance the company's objectives, retain the
scientific management team to advance the products, overcome adverse
changes in market conditions and the regulatory environment,
fluctuations in sales volumes, obtain and enforce intellectual
property rights, and realization of intangible assets. Furthermore,
APPY does not intend (and is not obligated) to update publicly any
forward-looking statements. The contents of this news release should
be considered in conjunction with the warnings and cautionary
statements contained in APPY's recent filings with the SEC.

AspenBio Pharma, Inc.

Reps. Thompson And Ramstad's Bill Helps More Seniors Prevent Cancer, USA

2011-06-22T12:00:00.012-07:00

Recently, Reps. Mike Thompson (D-CA) and Jim Ramstad (R-MN) introduced legislation to improve beneficiary access to Medicare's cancer screening services.

The Medicare Early Detection of Cancer Promotion Act will waive co-pays for colonoscopy and mammography services and extend the eligibility period for the "Welcome to Medicare" visit from the current time frame of six months to one year.

"The vast majority of cancer diagnoses and deaths happen to older Americans, so we should be making it as easy as possible for seniors to get regular cancer screenings," said Thompson. Sixty percent of new cancer diagnoses and 70 percent of cancer deaths occur in people over 65. "Co-pays for these services create a barrier to care," added Thompson. "If we eliminate the co-pays, more seniors will get screened, saving lives and money."

"Nearly 100,000 Americans will die this year from colorectal and breast cancer, yet many of these deaths could have been prevented" said Ramstad. "By passing the Medicare Early Detection of Cancer Promotion Act, we can expand access to life-saving colonoscopy and mammography services, services that are truly the first line of defense in preventing cancer deaths."

Currently, beneficiaries pay no coinsurance for most cancer screening services covered by Medicare, but they must pay a 20 percent co-pay for colonoscopy and mammography services. This legislation will eliminate co-pays for mammograms and colonoscopies, prompting more seniors to utilize these live-saving services.

In addition to saving lives, promoting cancer prevention also saves Medicare - and the American taxpayer - money. Preventive services cost considerably less than caring for people with cancer. For example, Medicare pays between $200 and $400 for a colonoscopy - but if colon cancer metastasizes, total costs of care can exceed $58,000 per patient.

The efficacy of cancer prevention screening is clear. When caught in the first stages, the five year survival rate for breast cancer is 98 percent and the five year survival rate for colorectal cancer is 90 percent. However, if these cancers move into more advanced stages, the survival rates are only 26 percent for breast cancer and 10 percent for colorectal cancer.

This legislation will also increase the number of seniors who seek cancer prevention services by extending the "Welcome to Medicare" period. During these physicals, Medicare beneficiaries can take advantage of certain screening and preventive health services and learn about others. Currently, fewer than 5 percent of new beneficiaries are seeking appointments for the "Welcome to Medicare" visit, and extending the eligibility period means that more people will be able to benefit from it.

Thompson and Ramstad are both members of the Ways & Means Health Subcommittee.

mikethompson.house

house/ramstad

New Study Reconfirms Long-Term Strength Of Surgisis(R) Biodesign™ Hernia Graft

2011-06-22T12:00:00.011-07:00

A five-year study confirms the long-term strength and durability of the Biodesign Hernia Graft, Cook Medical, a world leader in advanced tissue repair, announced today. The study, the largest published series with the longest follow-up time for a biologic mesh used in hernia repair, demonstrated that the Biodesign Hernia Graft possesses the clinically important strength of non-absorbable mesh, while providing the benefit of decreased infection complications of absorbable mesh.

"Biodesign's long-term strength and ability to communicate with the body by signaling surrounding tissue to remodel are very important benefits for patients," said Mark Bleyer, president of Cook Biotech. "The body uses the Biodesign graft as a lattice to guide tissue regeneration and heal itself with a repair that endures, as shown in the study."

Morris E. Franklin, Jr., MD, et. al, of the Texas Endosurgery Institute, San Antonio, Texas, performed the study investigating the placement of biologic grafts to repair infected or potentially contaminated abdominal wall defects. Placement of the Biodesign Hernia Graft for incisional, umbilical, inguinal, femoral and parastomal hernias in potentially or grossly contaminated fields was thoroughly examined.

"The use of the Biodesign Hernia Graft in contaminated or potentially contaminated fields is a safe and feasible alternative to hernia repair with a minimal recurrence rate and satisfactory results in long-term follow-up," said Franklin.

From May 2000 to October 2006, 133 procedures were performed on 116 patients. The study results were published in Surgical Endoscopy, Volume 22, No. 9, September 2008.

Manufactured in the Cook Biotech facility in West Lafayette, Ind., Biodesign is a breakthrough technology that provides signals and support for the body to restore itself. It incorporates the best attributes of a biologic graft-complete remodeling and resistance to infection-yet it's easy to use, widely available and moderately priced.

About Cook Medical

Cook Medical was one of the first companies to help popularize interventional medicine, pioneering many of the devices now commonly used worldwide to perform minimally invasive medical procedures. Today, the company integrates device design, biopharma, gene and cell therapy and biotech to enhance patient safety and improve clinical outcomes in the fields of aortic intervention; interventional cardiology; critical care medicine; gastroenterology; radiology, peripheral vascular, bone access and oncology; surgery and soft tissue repair; urology; and assisted reproductive technology, gynecology and high-risk obstetrics. Cook is a past winner of the prestigious Medical Device Manufacturer of the Year Award from Medical Device & Diagnostic Industry magazine.

Source
Cook Medical

Lack Of Adverse Interaction Between Clopidogrel And Stomach Medicine Shown By Cogent Trial

2011-06-22T12:00:00.010-07:00

Results from a late breaking clinical trial called COGENT demonstrate that the combination of giving patients clopidogrel, a blood thinner commonly prescribed to patients with cardiovascular disease, and stomach medicines such as omeprazole, known as proton pump inhibitors (PPIs), did not lead to adverse events, as some prior studies had suggested. The results were presented at the 21st annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation (CRF).

COGENT is the first randomized assessment of administering clopidogrel and PPIs, which reduce the production of gastric acid, on clinical events. The trial involved 3,627 patients at 393 sites. Follow up was limited due to early termination of the trial.

Internal bleeding is a common adverse effect of antiplatelet or blood thinner therapies, such as clopidogrel. The gastrointestinal tract is the most common location for this type of bleeding, which often occurs in the form of peptic ulcer disease. The purpose of the trial was to determine whether the administration of clopidogrel and omeprazole is safe and effective in reducing the incidence of gastrointestinal bleeding and symptomatic ulcer disease in the setting of concomitant aspirin therapy.

The primary endpoint of the trial was a composite of upper gastrointestinal clinical events, including gastroduodenal bleeding, symptomatic gastroduodenal ulcer, and persistent pain with multiple gastric erosions, obstruction or perforation.

There was a significant reduction in gastrointestinal events with PPI use. This had not been previously demonstrated in patients receiving aspirin and clopidogrel.

"Further research is needed to define the optimal strategy to reduce GI events in patients on antithrombotic therapy, though prophylactic PPI use seems promising," said lead investigator, Deepak L. Bhatt, MD, MPH, Chief of Cardiology at VA Boston Healthcare System and Director, Integrated Interventional Cardiovascular Program at Brigham and Women's Hospital and the VA Boston Healthcare System.

Source:
Judy Romero

Cardiovascular Research Foundation