Online Research Study: Irritable Bowel Syndrome (IBS), Diet and Lifestyle

October 27, 2012

The following short online study is posted with the permission of Brittany Craig, a graduate student in nutrition at New York University, who is conducting this research under supervision as part of her degree requirements. This anonymous survey is open to anyone with IBS in any country who is at least 18 years old. The questions focus on severity of symptoms, stress levels, physical activity, and diet.  The link below will remain active for approximately one month after this post.  Any questions or concerns regarding this study should be directed to Brittany Craig, her instructor, or NYU at the contact emails on the first screen of this survey.

Previous posts on open clinical trials for IBS can be found by clicking the clinical trials category in the blog archives on the upper right sidebar of this blog. We also have a page for IBS studies on the main IBS Impact site, which was last updated in October 2012. The research and links pages and the July 26, 2011  post provide additional general resources.

We welcome researchers affiliated with academic, medical or pharmaceutical entities, or reputable organizations representing IBS or commonly overlapping conditions, to contact us directly with additional studies they wish to be considered for posting. Contact links for the founder/listowner and the webmaster can be found on the home page of the main IBS Impact website.

IBS Impact makes these study announcements available for general information,  and encourages its members and site visitors to make their own individual, informed choices about their potential participation in any study.  IBS Impact, as an entity, is not directly affiliated with any research sponsor and receives no funding from any source for studies or links we feature on this blog, the main site or social media.

ACTION ALERT: Food and Drug Administration Needs Comments From People With IBS By November 1, 2012

October 20, 2012

UPDATE: 05/01/2013 : In April 2013, the FDA selected IBS as one of 3 functional gastrointestinal disorders and one of 16 varied disorders in total for the first 3 years of this program. See more information in the May 1, 2013 post.

The International Foundation for Functional Gastrointestinal Disorders and its grassroots arm, the Digestive Health Alliance, has issued a new advocacy alert yesterday.  According to information provided by IFFGD/DHA, the U.S Food and Drug Administration, which is responsible for the review, approval and regulation of medications sold in the U.S, has identified irritable bowel syndrome (IBS) as one of 39 health conditions to be considered for a new “patient-focused initiative.”  The FDA will ultimately choose 20 of these 39 for this program, which will involve public meetings  over the next 5 years with people affected by the conditions to discuss their experiences. It is hoped that these meetings will positively influence FDA decision-making in regard to these disorders. To quote IFFGD/DHA’s alert, the FDA’s criteria for inclusion in this initiative are:

  • Disease areas that are chronic, symptomatic, or affect functioning and activities of daily living;
  • Disease areas that reflect a range of severity;
  • Disease areas for which aspects of the disease are not formally captured in clinical trials;
  • Disease areas that have a severe impact on identifiable subpopulations; 
  • Disease areas that represent a broad range in terms of size of the affected population; or disease areas for which there are currently no therapies or very few therapies, or the available therapies do not directly affect how a patient feels, functions, or survives

As many people with IBS and our supporters are aware, many of these criteria fit IBS very well. The FDA is having a public comment period that ends on November 1, 2012. IFFGD/DHA is asking the IBS community to send our comments to the FDA in order to advocate for IBS to be selected for the final list of disorders in this initiative. While at this time, irritable bowel syndrome is the only functional gastrointestinal and motility disorder specifically identified as a candidate for the initiative, IFFGD/DHA indicates that the FDA welcomes and IFFGD/DHA encourages those affected by other FGIMDs to comment as well on the impact of their specific conditions for the FDA’s general awareness of such disorders. The FDA comment form also accommodates comments from international sources, so if any readers of this blog outside the U.S. would like to share their views and experiences, IBS Impact encourages you to do so. Anyone who chooses to submit a comment, please clearly state the disorder about which you are commenting, and use the FDA criteria quoted above to guide the details of your experiences that you discuss.

The Digestive Health Alliance page explaining this action alert includes a link to the correct FDA page here. DHA FDA Alert, October 2012

If you prefer to go directly to the FDA comment page for this specific issue, please click here.  FDA Patient-Focused Drug Development Comment Form. Please note that although the heading  states “Prescription Drug User Fee Act” and  does not mention IBS specifically, as many conditions are under consideration, this is the correct link.

IFFGD/DHA and IBS Impact urge people with IBS and those who support us to take this opportunity to explain our lived experiences with IBS and the impact on our lives. Our advocacy to ensure that IBS is ultimately included in this initiative will create other opportunities for public comment that have the potential to influence the FDA regarding IBS in a manner that can pave the way for long-term, systemic changes to benefit our community.

Representatives Cummings of Maryland and Davis of California Co-Sponsor HR 2239 for Functional Gastrointestinal and Motility Disorders

October 10, 2012

UPDATE: HR 2239 did not pass in the 112th Congress. In February 2013, the Act was reintroduced in the 113th Congress as HR 842. Please see the March 2, 2013 post or click on the HR 842 category on the blog sidebar for updated information.

Representatives Elijah Cummings (D-MD-7) and Susan Davis (D-CA-53)  have recently become co-sponsors to the Functional Gastrointestinal and Motility Disorders Research Enhancement Act of 2011.

Representative Cummings represents Maryland’s 7th District, which includes parts of the city of Baltimore, Baltimore County and Howard County. According to Representative Cummings’ official website, he has a past record of supporting other legislation concerning health care for veterans. Persian Gulf era service members and veterans are disproportionately affected by functional gastrointestinal disorders, including IBS,  as discussed by this blog on August  12, 2011  and August 25, 2011.

Representative Davis represents California’s 53rd District, which includes much of San Diego County, including about half of the city of San Diego and south to the U.S-Mexico border, Lemon Grove, Imperial Beach and Coronado. According to Representative Davis’ official website, she is the ranking member of the House Subcommittee on Military Personnel, and has a past history of supporting much legislation on behalf of veterans, as well as health care, including medical research budgets for the National Institutes of Health, and women’s issues. In most countries, women comprise approximately two-thirds of adults with IBS.

If you are a constituent of Representative Cummings or Representative Davis, please take a few minutes to write or call with your thanks for the support of HR 2239.

In officially supporting HR 2239, Representative Cummings and Representative Davis  join the lead sponsor, Representative F. James Sensenbrenner, Jr. (R-WI-5) and co-sponsors, Representative James Moran (D-VA-8), Representative Peter Welch (D-VT), Representative Elton Gallegly (R-CA-24),  Representative Jesse Jackson, Jr. (D-IL-2), Representative Tammy Baldwin (D-WI-2),  Representative Maurice Hinchey (D-NY-22),  Representative Nan Hayworth (R-NY-19), Representative Gwen Moore (D-WI-4), Representative Ed Perlmutter (D-CO-7), Representative David Price (D-NC-4), Representative Mazie Hirono (D-HI-2), Representative Ron Kind (D-WI-3), Representative Dan Boren, (D-OK-2), and Representative Bill Posey  (R-FL 15)   U.S. citizens residing in the districts of Representative Cummings’ and Representative Davis’  colleagues listed here, please thank them as well.

According to the information on THOMAS, the Library of Congress legislative database, it appears that the bill is currently under consideration in the Subcommittee on Health. If you would like to see a list of the members of that Subcommittee, click here and scroll down to the fourth subcommittee listing.

U. S. citizens, if your Member of Congress is not yet a co-sponsor of HR 2239 and you have not contacted him or her recently to ask for his or her support,  please see these previous posts from July 6, 2011 and March 6, 2012 for links to the bill and more details on how to do so.  Often, it takes multiple attempts to elicit any interest from legislators, so if you do not receive a reply, do not hesitate to try again or to switch contact methods until you attract attention.

Your personal experiences as a person with IBS and/or other functional GI/motility disorders, or as a concerned family member, friend or colleague, are most effective in communicating to legislators and their staff that there are real human beings behind the statistics. However, even general expressions of support are helpful.

HR 2239 is bipartisan legislation (supported by members of both parties) and according to IFFGD discussions with IBS Impact,  is “revenue-neutral,” meaning that there will be no additional taxes or spending added to the current federal deficit if it is enacted. Discretionary funds are available at the National Institutes of Health to be allocated if Congress directs NIH, through this Act, that functional gastrointestinal and motility disorders are a priority. Congress will only do so if we, as a community, are able to show them the importance of the research, education and FDA coordination provided for in HR 2239.

NIH grants funding to researchers throughout the world, not just in the U.S., so in the long run, enactment of this Act may also benefit readers with IBS in other countries. Medical research also sometimes involves multinational teams of scientists, and in any case, study results are usually published globally, adding to the cumulative knowledge worldwide.

It is IBS Impact’s understanding that HR 2239 will most likely not require a debate or vote on the floor of the House of Representatives, and will pass as soon as it reaches 219 sponsor/cosponsors, or a simple majority of the House. In order for this milestone to be accomplished during the current Congress, the 112th,  the necessary number of sponsor/cosponsors must be reached by December 2012. Beginning in January 2013, the Congressional membership will be different as a result of the upcoming 2012 elections. Thus, a similar bill will have to be reintroduced and the FGIMD community will have to start the process of gathering cosponsors anew. As of October 2012, IFFGD/DHA has advised IBS Impact that reintroduction is expected sometime in 2013. While it is quite common for legislation of various sorts to take several Congresses to pass, our continuing advocacy now can increase awareness, build momentum and perhaps accelerate passage. It is in our hands.

Check back on this blog or join IBS Impact’s Yahoo discussion group for further updates on HR 2239 as they occur.

U.S. Federal Budget Extension Temporarily Delays Potential National Institutes of Health Cuts

October 5, 2012

About two and a half weeks ago, this blog posted an alert regarding the U.S federal budget, which affects research funding to the National Institutes of Health. IFFGD/the Digestive Health Alliance reports that a temporary budget extension is now in effect. Below are excerpts of the IFFGD/DHA update on this issue.

On Friday, September 28, 2012, the President signed into law a six month budget extension. This continuing resolution was passed by the House of Representatives on September 13 and the Senate on September 22.

Though Congress aims for an appropriations bill to fund an entire fiscal year, continuing resolutions are a common occurrence […]

The continuing resolution agreed upon by the 112th Congress is based on funding levels agreed to in last year’s bipartisan Budget Control Act and will fund federal programs through March 27, 2013 at near current levels.

This temporarily alleviates the threat to NIH funding, but an automatic 7.8% cut is still possible. This cut, equal to billions of dollars for the NIH, will go into effect next year unless Congress passes an alternative plan to meet deficit reduction targets. This is part of what the 113th Congress and sitting President will consider once budget considerations resume next year.
The Capwiz alert for this budget issue that was linked in IBS Impact’s previous post, and allowed individuals to contact their legislators, has been deactivated on the IFFGD Legislative Action Center page for the time being. IFFGD/DHA plans to renew its advocacy efforts in this direction early next year. IBS Impact will follow developments as they occur and encourage readers to get involved at the appropriate time.