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Testimony to FDA December 2, 2010

On December 2, 2010, Dane Christiansen provided the following testimony on behalf of IFFGD members to the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee regarding the consideration of the Ocean Theapeutics’ product Solesta for the treatment of incontinence:

Good afternoon. My name is Dane Christiansen and I am here today representing the International Foundation for Functional Gastrointestinal Disorders or IFFGD, a registered nonprofit education and research organization. Our mission is to inform, assist, and support people affected by gastrointestinal (GI) disorders and bowel incontinence. I am here today to speak out on behalf of patients about the burden of incontinence and the need for better treatments. My expenses have not been paid by any particular company. At IFFGD we do invite companies with a demonstrated interest in the disorders we address to work with us toward advancing our mission through our “Industry Council”. While I have no personal financial relationship with Oceana Therapeutics or Q-Med, Oceana is a paid member of the IFFGD’s Industry Council.

Let me start by thanking the Panel for holding this important meeting and expressing my appreciation for the opportunity to provide comments.

IFFGD was founded in 1991 by patient advocates Nancy Norton and William Norton. Now, 20 years later, IFFGD has grown into an organization that reaches millions of individuals affected by GI disorders and fecal incontinence. Through the support programs we offer we are routinely contacted by patients who share their stories of how they became incontinent, entered a healthcare setting that was ill equipped to address their needs, and ultimately adjusted their lifestyles by gradually withdrawing from work and social settings until they lead a solitary existence with little hope for change. Any anecdotal evidence I present today will reference the experiences of the patients who have contacted the IFFGD over the years, and any empirical evidence I cite will be from the National Institutes of Health’s 2007 State-of-the-Science Conference on the Prevention of Fecal and Urinary Incontinence, which the IFFGD helped organize.

Fecal incontinence affects individuals of all ages and backgrounds. While this patient population is diverse, the personal approach to dealing with this health issue is universal. There is pain, discomfort, and embarrassment coupled with social stigma and a perceived loss of self-worth. Few affected individuals are comfortable discussing the issue with anyone, including families, friends, and even doctors. Many persons suffering incontinence go through a process of adaptation to accommodate and deal with their fecal incontinence rather than work with a healthcare provider to address it. It is said that uncertainty is the worst illness, and so this adaptation often means rarely leaving home, rarely engaging in social activities, always being very close to a toilet, and always being prepared for an episode of incontinence. This is a lot of adjustment for one person to take on without typically even mentioning their health issues to a healthcare provider or a trusted friend.

Roughly 70% of affected individual do not tell their primary care provider about issues or events which could be identified as incontinence. A variety of factors influence this overall reluctance to speak with a physician about fecal incontinence. For example, there is a popular misperception that these issues do not constitute a medical problem and there is nothing a doctor can do in terms of a medical intervention. There is also a popular view that the only medical intervention is serious surgery. Some patients who have not responded to drugs or dietary changes feel as if they are making a choice between adaptation and an ostomy or having a portion of their colon or rectum removed.

Many patients do not tell their healthcare providers about incontinence for a simple reason, they aren’t asked. Only 25% or less of patients are asked by primary care physicians about incontinence. Of those who are asked, 75% do discuss the condition with their doctors. However, the majority of doctors do not ask these questions and as a result, fecal incontinence is under-reported. The reluctance of patients to volunteer information combined with the lack of pro-activity on behalf of physicians leads to a don’t-tell-don’t-ask scenario where care suffers.

Reasonable, practical treatment options are needed for fecal incontinence to help improve the doctor-patient dialogue in this regard. Knowing that there are accessible medical interventions will encourage patients to discuss incontinence-related health issues with their healthcare providers. Concurrently, the availability of approachable medical devices, procedures, and products will lead to more physicians initiating this important dialogue when they detect warning signs from their patients.

Beyond the burden of incontinence, the direct costs to individuals, the healthcare system, and federal programs are immense. Like other chronic conditions, prolonged management leads to a high price tag. These costs are exacerbated when you take into consideration other factors, such as incontinence being a primary reason for nursing home admissions. While incontinence is not a normal part of aging, the prevalence rises markedly as people age. At a time when our overall population is aging we can expect to see incontinence-related expenses increase as well. Effective, accessible, and relatively-inexpensive treatment options are quickly needed to lower the direct and indirect costs of fecal incontinence.

Above all else, additional treatment options are needed because there remains a serious unmet need in the patient community. Many of us in this room can only sympathize with the experience of living with fecal incontinence. This lack of personal attachment makes it all too easy to inadvertently trivialize the impact of fecal incontinence. It is for this reason that I would like to read 2 stories, written in the patients’ own words which have been chosen at random from the IFFGD’s archive of Courageous Stories.

Quote, “The most distressing thing for me is incontinence and the ensuing depression which this evokes. I have given up well paid jobs because of it and have suffered a severe loss of social life.

“It seems that my whole life is dominated by my bowel to the extent that some days I am afraid to leave the house. I have encountered severe incontinence where my bowel has evacuated itself in the street, in my car and once in a store. I get none or very little warning. There is absolutely no control over it. I can only try to reach a toilet, which isn’t always successful.

“The other type of incontinence is where my bowel releases smaller amounts of stool frequently throughout the day without my realizing it is happening. This again results in me being afraid to leave the house and I get very down at constantly having to clean myself, wash my underwear and shower only for it to happen again a short time later. I am becoming more and more desperate and am at my wits end with it all.”

And this story, “I am 30 years old and dealing with fecal incontinence. This time it happened in my car 15 minutes from home. If I would have had more than a second to realize what was about to happen I would have pulled over and ran for the ditch, but there was no time. My problems were caused by childbirth; I ended up with a fourth degree tear that now haunts me. Two years later I started having smears and problems with defecation. I was traumatized by visions of having an accident during sexual intercourse, so I lost interest and pushed my boyfriend away. Then I decided to have an anal sphincter repair. I was so excited and hopeful. My stitches came apart in three days and it took me almost six months to heal.

“I am very depressed. I try to keep positive, but now my career is in jeopardy. I feel gross, I have put on weight and all I want to do is cry when I have days like these. I have supportive family and friends, but I still feel alone.”

The reason these stories could be chosen at random is because the experience they are trying to communicate is all too common for patients with fecal incontinence. Innovative safe and effective treatment options for fecal incontinence patients are badly needed. If Solesta is shown to be a safe and effective therapy, it will be a significant step forward.

I would like to once again thank the Panel for convening this meeting and continuing to work to address this issue.

Thank you for your time and thank you for the opportunity to comment.

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