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Testimony to FDA June 26, 2000

On June 26, 2000, 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 (NDA) 21-200, Zelnorm/Zelmac (tegaserod), produced by Novartis Pharmaceuticals Corporation:

Before I begin, I would just like to say that I am here on behalf of patients and that my expenses have not been supported by any particular pharmaceutical company.

Members of the Committee, thank you for the opportunity to appear before you today. I am the founder and president of the International Foundation for Functional Gastrointestinal Disorders and establish current chairman of the Digestive Disease National Coalition.

The IFFGD addresses the needs of individuals with functional gastrointestinal disorders, irritable bowel syndrome being the most predominant one.

As the founder of IFFGD, I began the organization in 1991 when there was no specific medical treatment offered to patients living with irritable bowel syndrome. It wasn’t until the mid-1990’s that we saw a stronger interest in the functional GI disorders and IBS in particular.

As you heard today, irritable bowel syndrome is a chronic complex of symptoms, affecting as much as 20 percent of the population. Symptoms include abdominal pain, bloating, constipation, diarrhea and fecal soiling. These common dysfunctions strike people from all walks of life and result in a significant toll of human suffering and disability.

Irritable bowel syndrome represents one of the most common conditions encountered by gastroenterologists and general internists. It accounts for 20 to 50 percent of all referrals to gastroenterology clinics. Approximately 70 percent of individuals with IBS in the community are female, with the incidence being reported as high as 90 percent in medical centers.

In the U.S. Householder Survey of Functional Gastrointestinal Disorders, Prevalence, Sociodemography and Health Impact, Drossman reported individuals with IBS will miss 13.4 days of work annually as opposed to the 4.9 national average. IBS alone has recently been called a multi-billion dollar problem by the gastroenterology community.

Survey data by Talley reflect that patients with IBS incurred an annual health care bill of $742 (1992 dollars) compared to $429 for those without the condition.

Data also reveals that there is an increased risk of unnecessary abdominal surgery correlated by IBS patients. Hysterectomy or ovarian surgery has been reported in female patients with IBS as high as 47 to 55 percent and has been performed more often than in comparison groups.

One of our goals has been to move the research field forward to provide a better understanding of the pathophysiology of IBS and the underlying mechanisms with the hope that one day better medical management and treatments will be available to treat patients with IBS.

We are making progress. We are seeing the development and approval of drugs designed specifically for the treatment of IBS. I think it is important to recognize that the spectrum of symptoms that an IBS patient faces can range from severe constipation to severe diarrhea, or perhaps alternating between the two, all the while dealing with the pain that accompanies irritable bowel syndrome. It is difficult to imagine the impact of IBS without personally experiencing this chronic disorder.

If these drugs are found to be safe and effective, I would urge you to make them available to the patients who so desperately need them.

The toll of IBS is on the individual’s quality of life and discomfort, affecting almost every aspect of their life. Each day presents itself with uncertainty, not knowing if their day will be plagued by bowel symptoms or not.

The World Health Organization has defined Quality of Life as being “not only the absence of disease and infirmity but also the presence of physical, mental, and social well being.” Quality of life may also be defined as an individual’s overall satisfaction with life and one’s general sense of person well being. It also includes their functional capacity and their own perception of disease.

Health Related Quality of Life includes: physical function, somatic sensation, psychologic state, and social interactions that are affected by one’s health status. Health related quality of life indicators are subjective. Their validation lies primarily with the patient.

Eisen, Locke, and Provenzale report gastroenterologists spend 50 percent of their time caring for patients with functional bowel disorders. These disorders do not have mortality or physiological endpoints, thus, the evaluation of health related quality of life becomes critically important.

Patrick, Drossman and colleagues developed the IBS Quality of Life Measures that distinguishes symptoms, functional states, perceived quality of life and social disability components. Their results confirmed that IBS has a broad and significant impact on a person’s quality of life in addition to the disease activity and symptom impact.

At IFFGD, we talk to tens of thousands of individuals who live with IBS and there is a constant theme that we hear from women and men. They consistently confirm the isolation that many IBS sufferers experience.

Partly, this is because IBS is very difficult for most people to discuss. Many patients believe it would help if they could talk about their condition and share their experiences. But the reality for them is that even mild symptoms can be very embarrassing to discuss.

More severe symptoms like unpredictable pain, urgency and bowel incontinence are close to unmentionable for many sufferers. Interviews with IBS patients consistently reveal that few talk about their symptoms with anyone else. Indeed, many patients go to great lengths to hide from others their condition and their own distress.

What does distress feel like if you have IBS?

If you are a person with constipation-predominant IBS, chances are your distress and pain will increase with each day that passes that you do not have a bowel movement. The feeling of fullness and bloating, the pressure that begins in your rib cage, the distention in your stomach, the ache through your midsection, the cramping in your intestines causes you to double over in pain.

Each day that passes that you are not able to evacuate, you find yourself straining to have a bowel movement. We all know that continual straining to have a bowel movement may eventually cause more severe problems in the future, like rectal prolapse, which may result in fecal incontinence and ultimately surgical intervention.

For the IBS patient, the pain and discomfort is now, and they need to relieve that pain.

We see so many messages about constipation and diarrhea through the media that I think that people often lose sight of just how severe these conditions can be when you are faced with them as a chronic condition.

Who stops to think about the fact that IBS patients with constipation are afraid to leave their home or be in a social situation because of continual gas and bloating that they experience with their constipation?

There is little compassion when it comes to understanding bowel disorders and the impact that they have on people’s lives.

IBS affects not only one’s professional life, but also their personal life as well. It is difficult to plan trips, to eat in a restaurant, or even go shopping. Friendships, intimate relationships, and one’s sex life are affected by it. There is no spontaneity in life for the person who lives with IBS.

There is a quiet anxiety, an anticipatory response to perhaps what will be next. One may be depressed at times feeling that their life is out of control or at the very least that their life is controlled by their bowel.

We live life from the edge of the room never willing to truly participate to the fullest for fear of having to find the quickest way out. There is a loss. There is lost potential.

IBS is invisible to others, but it affects every aspect of our life. Who would know our pain and oftentimes the shame that we feel except those who are closest to us. There are times when we feel very isolated because of our IBS.

There is a loss of spontaneity when symptoms may intrude at any time. Plans made often need to be changed. IBS is unpredictable. One can wake up in the morning feeling fine and within a short time encounter abdominal cramping to the point that you are doubled over in pain and unable to function.

The unpredictable bowel symptoms may make it next to impossible to leave home. For those of us who are attempting to manage our symptoms in the workplace and in social settings, we may find ourselves stranded in public restrooms until we feel some sense of security around our bowel. Public restrooms become a nightmare for us.

IBS patients are to be credited for the personal strength that they find each day to even just walk outside the door and into life while attempting to manage their bowel.

Few of you here today had to think about your bowel management program. You most likely came today with little thought, if any, as to are the public restrooms close at hand, how long would the taxi ride be from the hotel, where was your seat on the airplane, is it an aisle seat or a window seat.

These are just the little things that most of us don’t give a second thought to. The person with IBS is thinking all the time about logistically how do they get through the day. For many people with IBS, the risk of leaving familiar surroundings is just too great. Their life is truly diminished little by little.

If there is any question in your mind as to the need to provide medical treatment to millions of individuals who suffer from IBS, please, let me share one more experience with you. On January 27th, Camille Grammer, who suffers from IBS, appeared with her husband Kelsey Grammer on the Today show with Katie Couric, on behalf of IFFGD. The foundation received over 12,000 phone calls from people looking for help. The 12,000 people who called are just the tip of the iceberg of those who need help. Today, you are in a position to provide it.

Many of those people expressed how alone they felt. They were looking for someone to tell them that there is a reason to be hopeful for their future and that medical science is working to find answers for them.

You are here to make recommendations on a potential new drug treatment for IBS that may provide relief for a significant proportion of the IBS population.

If Zelmac is shown to be safe and effective, it will represent a significant step forward in providing treatment for sufferers of IBS.

Thank you.

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