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Comments to FDA November 9, 2000

IFFGD sent the following written comments to the FDA in connection with a November 9, 2000 meeting of the Food and Drug Administration (FDA) Gastrointestinal Drugs Advisory Committee to discuss Lotronex:

Recent attention has focused on the new drug, Lotronex, for the treatment of Irritable Bowel Syndrome (IBS) symptoms in women who suffer from IBS-associated abdominal pain and discomfort, and for whom diarrhea is their main symptom. IBS is a disturbance in the regulation of bowel function. This dysregulation of brain-gut function can result in symptoms that include pain and altered bowel function including diarrhea and/or constipation. About 30% of people affected by IBS will experience mainly diarrhea and about 20% will experience mainly constipation. The remainder of people will experience symptoms that alternate between constipation and diarrhea.

At the International Foundation for Functional Gastrointestinal Disorders (IFFGD) we talk to thousands of people who suffer from Irritable Bowel Syndrome. Everyday, IBS takes a toll on the lives of millions of people. Similar to other common chronic conditions, it is a disorder that needs to be taken very seriously. We have been working for the past ten years to encourage better access to clinical care, better diagnostic and treatment options for IBS patients, and better understanding of what it is like for people to live with IBS symptoms. The following presents some of our views about the impact IBS-associated pain and diarrhea can have on a person, some of the problems and issues surrounding the disorder, and implications for treatment.

Irritable Bowel Syndrome is a chronic disorder characterized by pain, which can be severe, and a combination of chronic or recurrent gastrointestinal symptoms. Chronic illness may involve repeated episodes of deterioration in which the patient confronts and adjusts to the losses imposed. Hope often shifts from the desire for a cure to finding ways to cope with the disease.

Symptoms range from inconvenient to disabling for those with IBS. The impact of IBS symptoms is comparable to other chronic diseases. For the millions of people with moderate to severe IBS who suffer the multiple symptoms of this disease there has been little that actually provides sustained relief; from pain, from a constant sense of urgency to have a bowel movement, from diarrhea – relief that enables one to attempt to live a normal life. IBS robs people of daily life. For some this occurs in small ways that one hardly notices until they realize they have given much of their life to coping with the disorder.

For others it is very dramatic, day after day causing one to be afraid to leave home for fear of experiencing fecal incontinence—at work or school, in a social setting, or even in the privacy of their own home—their body overwhelmed by painful intestinal cramping and diarrhea.

It is difficult for those who do not experience IBS to this severity to imagine what it is like living day after day like this. Imagine if everyday, or even several times a week, you woke up with symptoms like a GI flu. You feel severe abdominal cramping to the point of being doubled over in pain, nausea, and diarrhea. You may be in your bathroom for an hour or more before, exhausted, you feel you can leave your home. You plan your day around the availability of restrooms. You are hesitant to eat because symptoms might start all over again. You sometimes miss work, or cancel appointments because of IBS. It affects not only your professional or educational life, but your personal life as well. It is difficult to plan trips, eat in restaurants, go to a movie, take public transportation, or even go for a walk–you need quick or immediate access to a bathroom. Your fear of not making it to a bathroom, of having an “accident,” can be disabling. Your friendships and your most intimate relationships are affected. Your disease is invisible as you strive to hide it from others but it affects every aspect of your life.

Irritable Bowel Syndrome presents some unique challenges. The disorder does not fit the traditional Biomedical Model. To patients, the symptoms are often unmentionable and embarrassing, and to physicians, in the absence of structural abnormalities, symptoms may be relegated to being “psychiatric,” or not truly existing as clinical entities. However, our understanding of IBS pathophysiology and treatment has changed dramatically over the past decade. The common perception of “illegitimacy” is unfounded and not consistent with these new scientific findings.

We are concerned about the patient with IBS. It is not a disorder that is easily talked about, even with one’s own physician. The word “bowel” seems to be taboo in our society. In fact, in 1999, when IFFGD produced our first public service announcement (PSA) about Irritable Bowel Syndrome, 50% of the top television markets we surveyed prior to production said they would not air the PSA if we mentioned the word “bowel!” Thus, to ensure the broadest distribution we could not even name the disease in a public health message (we used the acronym, IBS). We believe it is essential that people understand the true nature and symptoms of IBS so that they are most likely to seek the appropriate care.

We are concerned that Irritable Bowel Syndrome has long been trivialized by the misinformed and patients marginalized by many who could help. It is time for a change – among clinicians, investigators, health agencies, educators, and public information providers. It is time to recognize this is a real disorder that can have serious consequences for those who have it.

We are concerned that among women, data reveals an increased risk of unnecessary surgery, for extra-abdominal and abdominal surgery correlated with IBS patients. Hysterectomy or ovarian surgery has been performed more often in women with IBS than in comparison groups. This misdiagnosed and misguided treatment may be due to a lack of knowledge and education that could prove dangerous for patients.

We are concerned that too little attention is paid to advances made on behalf of IBS patients. We have entered an era where we can make a “positive” diagnosis of IBS based on the Rome Criteria, along with limited tests to rule out other disease factors, rather than a “negative” diagnosis based solely on exclusion of other possible inflammatory, infectious or structural abnormalities – often accompanied by invasive and unnecessary tests.

We are concerned that too often the only treatment offered is to suppress the predominant symptom presented by a patient with IBS, rather than attempting to better understand and treat the underlying disorder in each individual. The disorder is characterized by multiple symptoms, even in a person with so-called “diarrhea predominant” IBS. It often requires an integrated approach to treatment of the pain, and either the diarrhea, the bloating, the gas, the urgency, and perhaps the fecal soiling that one may experience.

All of this has implications for the treatment of IBS. At IFFGD our hope has been that the medical community will increasingly look for answers for those with this disease and that, in addition to current strategies to help manage, we will have safe and effective medications that can help treat IBS. Current strategies include dietary or lifestyle changes, stress management or relaxation techniques, cognitive approaches, over-the-counter antidiarrheals for temporary relief, and anticholinergics for pain. For severe pain, low-dose antidepressants may be prescribed. The most common medications used for IBS are the anticholinergics. They have been used for decades, yet they have limited impact, troublesome CNS side effects, and a tendency for patients to develop apparent tolerance over time after an initial period of symptom relief.

Over the past several years we have seen a rapid growth in scientific understanding of IBS. Neurotransmitter research, brain imaging studies, consistent diagnostic criteria, and quality of life studies are all contributing to the legitimization of the disorder as a diagnostic entity. We want to see continued growth of support for education and research, and clinical application of new understandings.

As an organization we urge patients to become educated about their medical condition, about treatment or management options, and about any medications they are taking. We encourage people to work with their physician, one who is well versed in helping them manage their health care needs. We are interested in working with other interested parties to help assure access to safe and effective treatment of IBS.

Industry, physicians, and patients all have a role in drug treatment. The pharmaceutical industry needs to provide the data necessary for accurate analysis of the risks and benefits of the medication they develop; they need to work closely with physicians, pharmacists, and patients to help ensure clear and useful prescribing information. Physicians need to be certain of the diagnosis before prescribing appropriate medication for IBS. Patients need to understand the risks and benefits associated with any medication. Without the responsible participation of all three parties, treatments will not be effective and the risk of side effects will increase. Finally, regulatory agencies, like the FDA, have an obligation to ensure that safe and effective medications are made available.

We urge the FDA to consider the impact IBS has on patients when looking at the risks and benefits of any medication approved to treat IBS. As adverse events are reported, we urge that mechanisms be in place to ensure that any possible causal relationship between the drug and the event is clearly supported. We urge consideration of how side effects can be managed before they get to a crisis point for patients.

Questions have been raised about the safety and efficacy of Lotronex. We believe that a critical review by independent clinicians and investigators experienced in this area of medicine would be essential to rationally sort out questions about safety and efficacy in the context of the risk/benefit ratio for the IBS disease model.

We are concerned about patient safety, and we are also concerned that IBS patients have access to the best available, effective, and appropriate treatment. Therefore, we urge that decisions be made for or against the use of any drug in the face of adequate documentation, and hopefully after careful scientific and epidemiological investigation that involves experienced consultants. We hope that the FDA can activate the proper resources to answer questions of safety and efficacy accurately and expeditiously so that the IBS patient can best be served.

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