IBS: A Call to Action

Participate in IFFGD's IBS: A Call to Action

On behalf of individuals affected by IBS, we need your help. As many of you are painfully aware, until 2002 no single medication available on the U.S. market had been demonstrated in well-designed and well-controlled clinical trials to be superior to placebo for the treatment of IBS. Yet, of the 30 million or more people in the U.S. afflicted with IBS, an estimated 10 million or more suffer from "moderate" or "severe" symptoms that often do not respond to dietary or lifestyle changes alone. These symptoms challenge or impair physical, emotional, economic, educational, and social well-being of those affected.

• We continue to be concerned that members of Congress and regulators within the Food and Drug Administration (FDA) are not fully aware of the burden of illness endured by the IBS patient.
• We are concerned that the FDA, as they continue to assess the safety and efficacy of medical treatments for IBS, appreciates the magnitude of pain and suffering endured by many IBS patients.
• We believe that the FDA should apply a standard for the assessment of burden of illness in IBS that is consistent with all chronic and debilitating (non-fatal) conditions.

Please help us to explain the burden of illness associated with IBS by sharing your personal story with your Congressional leaders. Explain the impact that IBS symptoms have on your life. Ask your representatives to request clarification from the FDA regarding the standards they use for the assessment of burden of illness in all chronic or debilitating (non-fatal) conditions, and to demand consistent application of this standard when evaluating the risk/benefit ratio of new treatments for IBS.

Background Information

General Considerations

New drug treatments for IBS are being developed. Consistent standards for assessment of new medications are crucial so that the removal of alosetron* (Lotronex™) in 2001, and the initial "not-approvable" status of tegaserod** (Zelnorm™), which subsequently received FDA approval on July 24, 2002, does not have negative implications on future treatment options for IBS. (*On June 7, 2002 a supplemental New Drug Application was approved that allows restricted marketing of alosetron. **On April 2, 2008, Novartis terminated the restricted access program, launched June 7, 2008, which allowed some U.S. patients to continue to receive the drug. On March 30, 2007 U.S. and Canadian marketing and sales of Zelnorm had been voluntarily discontinued by the manufacturer at the request of regulators due to safety concerns.)

There are no known drugs that are completely free of side effects. Risk is measured relative to perceived benefit, and benefit is relative to the burden of illness. Common medications such as non-steroidal anti-inflammatory drugs (NSAIDs) like aspirin, ibuprofen, naproxen, and others are known to have serious, and even fatal, adverse effects. Nonetheless, these drugs are available over-the-counter, as well as by prescription, for symptomatic relief of chronic or debilitating (non-fatal) disorders (e.g., inflammation, arthritis).[1]

What About IBS

Risk of adverse effect is reduced with accurate diagnosis and appropriate prescribing. Dramatic changes have occurred over the past decade in the understanding and diagnosis of IBS. The introduction of the Rome criteria in 1994, and subsequent Rome II, facilitates uncomplicated and reliable diagnosis of IBS. Current understanding of the disease means that a positive diagnosis can now be made as opposed to the outdated, vague "diagnosis of exclusion."[2, 3]

How serious is IBS

Well-designed studies on health status in IBS patients show profound effects on work absenteeism, loss of daily function, and health costs. [3, 4, 5, 6, 7, 8] And while IBS itself does not lead to surgery, data shows that in women with IBS there is an increased risk of unnecessary surgery (e.g., gall-bladder surgery, hysterectomy, or ovarian surgery). [3, 9] Yet until recently, no single medication available in the U.S. had been demonstrated in well-designed and well-controlled clinical trials to be superior to placebo for the treatment of IBS.[10, 11] Clearly there is a need for the FDA to ensure that standards consistent with those applied to other chronic or debilitating (non-fatal) disorders are applied to treatments for IBS.