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Testimony to FDA April 23, 2002

On April 23, 2002, IFFGD Founder and President, Nancy J. Norton presented the following testimony on behalf of IFFGD members to the Center for Drug Evaluation and Research, Gastrointestinal Drugs Advisory Committee regarding risk management for (NDA)21-107, LOTRONEX (alosetron), produced by GlaxoSmithKline:

Mister Chairman, I would like to thank the Advisory Committee for the opportunity to appear before you today.

I ask you to consider two issues that are key components of determining benefit and risk in IBS: What are the consequences of alternative therapies or no treatment for chronic, multiple symptoms of IBS; and what is the level of disability, morbidity, and mortality associated with IBS.

Data reveals that for many people, there are severe consequences, and a distressing level of disability, morbidity, and mortality that results from the search for effective treatment for unrelieved chronic symptoms of IBS.

The newly signed Veteran Education and Benefits Expansion Act of 2001 – H. R. 1291 (Public Law 107-103) recognizes IBS as a chronic disability with an associated burden of illness that warrants compensation and disability under covered benefits for Gulf War Veterans.

The Expansion Act prompted us to look into possible IBS mortality in the U.S. Vital Statistics data from the CDC (Centers for Disease Control). Remarkably, we found that between 1979 and 1999, 1,031 deaths were attributed to IBS. Where did the presumptions come from; “IBS does not lead to surgery, does not shorten the life span and does not cause death.” The data says otherwise.

We asked several epidemiologists what they thought about the mortality coding associated with IBS. Among their responses were:

It may or may not represent miscoding.
There may be under-reporting of deaths related to medical interventions that were never correctly attributed to the diagnosis of IBS.
And finally, we don’t know what it means.
I think it’s time we find out. Let me elaborate on some things we do know.

People die from procedure related complications, including from diagnostic tests and surgical interventions that are unnecessary – and people with unrelieved chronic symptoms of IBS are at risk for these procedures.

In January 2002 I was a panel member at the NIH State of the Science Conference on Endoscopic Retrograde Cholangiopancreatography (ERCP) for Diagnosis and Therapy.

The differential diagnosis of abdominal pain of possible pancreatic or biliary origin includes, in part, clinically apparent entities such as IBS.

Diagnostic ERCP has NO ROLE in the assessment of these patients. Yet, among those at highest risk for diagnostic ERCP, and ERCP-induced pancreatitis and even death, are young, otherwise healthy, females reporting recurrent abdominal pain.

There is a risk of Cholecystectomy associated with unrelieved symptoms of IBS. A recent article in the British Journal of Surgery reported that Cholecystectomy was common in patients with IBS, most often in women. Symptoms of IBS may cause diagnostic confusion and lead to inappropriate surgery.

Longstreth cites that the incorrect attribution of IBS symptoms to gynecological pathology can lead to unnecessary surgery. As many as 47% of women with IBS have undergone hysterectomy and 55% ovarian surgery.

Both radical and simple hysterectomy has shown to give rise to changes in urinary function, including incontinence and to disturbances of bowel function associated with surgical trauma.

There is mortality data in relationship to incontinence. Nakanishi and colleagues reported that incontinence in elderly people living at home has appreciable effects on mortality.

Consider that IBS patients run the risk of incontinence not only due to surgical intervention, but also as a result of the inability of the anal sphincter muscle to compensate for repeated bouts of loose stool or diarrhea. And many constipated patients experience fecal incontinence due to seepage around impacted stool. In a recent IFFGD survey, 25% of individuals with IBS reported loss of bowel control — a disability that has enormous impact on a person’s life and well-being.

I will conclude with results from the IFFGD survey, IBS in the Real World, a quantitative research study conducted from February to March 2002 among adults drawn from the IFFGD database. While this information may not generalize all with IBS, it clearly represents those we at IFFGD talk to daily.

In the telephone survey, 350 respondents were interviewed who reported having a diagnosis of IBS. Almost half were diagnosed ten or more years ago. Symptoms were reported as severe by 43%, moderate by 40%, and mild by 17%.

Nearly half reported daily episodes of IBS symptoms and 70% more than weekly episodes.

Duration of IBS episodes was reported as ongoing or continuous, occurring every day of the year, by nearly one-quarter of respondents.

39% rated the pain of their IBS symptoms as extreme or very severe.

Symptoms – in terms of interfering with daily life – were described as extremely or very bothersome by two-thirds of sufferers. 5% of respondents reported being on disability due to their IBS.

More than two-thirds reported visiting a physician or health care provider during the past six months for their IBS, with 15% of the total sample reporting six or more visits.

These IBS sufferers, seeking to control their symptoms, reported using 143 prescription drugs, 71 over-the-counter medications, plus 67 herbal remedies — a total of 281 different treatments.

Yet overall, fewer than one-third of these IBS sufferers reported satisfaction with the drugs and remedies they use to treat IBS symptoms.

Prescription drugs were more often considered to be effective by those with milder cases of IBS, less frequent episodes, or symptoms that do not interfere with daily activity.

Over the counter medications were rated as either not effective or only somewhat effective by nearly three-quarters of those currently using them.

Significantly, 62% report side effects from the prescription drugs being taken. Almost half reported the side effects as severe or moderate.

12% had to visit an ER
7% were hospitalized
24% had to visit their health care provider
22% had to stop driving
And 18% reported missing work or school
In summary, these IBS sufferers face the challenge of living with their disease day in and day out for years. Most suffer severe and painful symptoms that seriously impact their daily life. They frequently utilize health care providers due to IBS symptoms. They take a plethora of drugs finding little or no relief. They are dissatisfied with existing medications prescribed for IBS symptoms from which they suffer frequent, and sometimes severe, side effects.

Mister Chairman and members of the committee, IBS is a serious disease. For the significant number of people whose symptoms are frequent and often debilitating, treatments are needed to provide symptom relief. Unrelieved symptoms of IBS can lead to disability, morbidity, and even mortality. In this context, a safe and effective drug to relieve the multiple symptoms of IBS would be a significant step forward for patients.

Thank you.

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