FDA Testimony

Transcripts of testimony presented to the U.S. Food and Drug Administration (FDA) by IFFGD.

IFFGD Testimony To FDA
April 23, 2002
Transcript of public testimony by Nancy J. Norton
(Nancy J. Norton testified on behalf of IFFGD members.)

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:

1. It may or may not represent miscoding.
2. There may be under-reporting of deaths related to medical interventions that were never correctly attributed to the diagnosis of IBS.
3. 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.

Letter From IFFGD to the FDA
November 9, 2000

IFFGD presented the following views 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.

IFFGD Testimony to FDA
June 27th, 2000
Transcript of public testimony by Nancy J. Norton
(Nancy Norton testified on behalf of IFFGD members)

DEPARTMENT OF HEALTH AND HUMAN SERVICES, FOOD AND DRUG ADMINISTRATION, CENTER FOR DRUG EVALUATION AND RESEARCH
GASTROINTESTINAL DRUGS ADVISORY COMMITTEE
NDA 21-107, LOTRONEX (ALOSETRON)
Glaxo Wellcome
Tuesday, June 27, 2000 8:30 a.m.
Marriott Washington Center
9751 Washington Boulevard
Gaithersburg, Maryland

MS. NORTON: 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.

Thank you.

IFFGD Testimony to FDA
June 26, 2000
Transcript of public testimony by Nancy J. Norton
(Nancy J. Norton testified on behalf of IFFGD members)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
GASTROINTESTINAL DRUGS ADVISORY COMMITTEE
NDA 21-200, Zelnorm/Zelmac (tegaserod)
Novartis Pharmaceuticals Corporation

Marriott Washington Center
9751 Washington Boulevard
Gathersburg, Maryland

MS. NORTON: 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.