IFFGD Founder and President Nancy Norton presented the following testimony on behalf of IFFGD members at a June 27, 2000 Center for Drug Evaluation and Research, Gastrointestinal Drugs Advisory Committee meeting on NDA 21-107, LOTRONEX (alosetron):
Thank you, Members of the Committee. I hope you are not going to be tired of hearing from me once again today but I am here today to speak about the serious nature of IBS and the disconnect that still exists between the perceptions of the disease and the actual experience, and the profound impact this disease can have on the lives of those who suffer from it.
Perhaps because there is a general association of IBS with life stress and the assumption that it doesn’t kill you, the disorder has historically been marginalized, symptoms trivialized, and patients dismissed as more in need of psychological treatment than medical care. Forty million Americans are thankful that IBS is not a killer disease, but that is not to say that IBS is not a serious disease. IBS doesn’t kill. Rather, it robs people of their life.
As the founder of IFFGD, I began the organization with the intent of raising awareness. I can assure you that in 1991, when we began the organization, little information was available to patients. Unfortunately, there still persists an attitude by many in the medical community that IBS is something that need not be taken seriously.
It has only been recently that investigators and practitioners have begun to appreciate that a functional GI disorder such as IBS is a chronic medical condition with central and peripheral pathophysiology, involving a complex interaction of multiple mechanisms, a dysregulation of brain-gut systems. We now have more diagnostic tools to look at dysfunction. In addition to traditional motility tests, we have the Rome criteria that facilitate a symptom-based diagnosis. We have barostats that measure intestinal tone, and we even have brain imaging that allows us to see how patterns of neural function differ in patients with IBS.
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. Yet, in the recent survey, IBS in American Women, when physicians were asked about their familiarity with the Rome criteria only 1 percent of primary care physicians were very familiar with it, and 14 percent were somewhat familiar with it. In the GI community 18 percent of gastroenterologists were familiar with it, and 41 percent were somewhat familiar with the Rome criteria.
Thus, there is a failure within the medical community to make available to patients a safe, consistent and supportive means of diagnosing IBS in treating the disease. An affirmative diagnosis of IBS facilitates a positive patient and physician relationship in which a treatment approach can be formulated which often includes a combination of treatment modalities that is best suited to the individual patient. Those patients who do not receive an affirmative diagnosis may be asked to endure an array of progressively invasive tests, only to receive in the end a diagnosis that begins with the words, “there is nothing wrong with you,” and perhaps further, “let’s try to treat the single symptom,” knowing full-well that IBS is characterized by multiple symptoms, leaving the patient to still contend with either the pain, the diarrhea, the constipation, the bloating, the gas, the urgency and perhaps the fecal soiling.
At IFFGD we are contacted every single day of the year by people who come to us, seeking help like refugees from this type of negative clinical experience. It is important to understand that IBS is a complex disease entity with potentially serious and even devastating consequences for the millions who suffer from it. Does the benchmark for burden of illness need to be equated to cancer before we consider a disease to be serious enough to provide medical management and potential drug therapy? I certainly hope not, for IBS is a disease that we need to take seriously and ease the toll of human suffering.
We have data that shows us the effect on quality of life, and we also have data that demonstrates the economic impact of IBS increased absenteeism, increases in annual healthcare bills and perhaps unnecessary surgery. All of this, again, confirms a pattern of human suffering. The data is there in concrete terms for those who need to see it to believe it.
For the IBS patient who lives it, it is quite a different matter. The person who lives with IBS is continually making adjustments in their life to accommodate the symptoms they experience. Little by little we begin to shut ourselves off from society and family because of our symptoms. IBS can be a very isolating condition. It is difficult to express the loss that those of us feel for months and years of living with IBS. Symptoms may range from mild to severe, from inconvenient to devastating. For some people, they may question whether to eat that hot spicy food they crave; for others it is the question of do they eat at all. There is a common expression among us, “nothing in; nothing out.”
Depending on what commitments a person has for the day or the week, they try to juggle this complicated guessing game of what to eat, what to drink, what medications to take, their sleep patterns, their stress management techniques, and all of this often to no avail.
We have recognized IBS as a chronic disease. We are making progress but a recent article in the British Medical Journal made the observation that classically only half of patients with chronic disease are identified. Only half of those identified receive treatment, and only half of those treated are treated adequately, meaning that only 12 percent are being optimally managed. I would ask that we move forward in offering patients the best possible care. The responsibility is a shared on, beginning in medical school and carried through to the practicing physicians. The pharmaceutical companies also share in the responsibility of educating the medical community and the general public about the risks and the benefits of any medication.
Last but not least, we, the patients, share in the responsibility of educating ourselves about any medical condition and medications we are taking. Our goals have been to raise awareness and provide educational information and support to those who suffer from functional GI disorders. At IFFGD, we have been fortunate to be part of a community of scientists and clinicians who share our concerns and believe in the needs of these patients. I hope that we will all continue this effect to improve the lives of IBS patients.