U.S. Food and Drug Administration Seeks Public Comment on Prucalopride for Chronic Idiopathic Constipation (CIC) and Tegaserod for Irritable Bowel Syndrome with Constipation (IBS-C) by October 16, 2018

UPDATE:  10/19/2018: The Gastrointestinal Drugs Advisory Committee voted to recommend approval of both of the medications under consideration below. This does not mean that the medications have the full approval of the FDA and can be made available yet. However, it is a positive step forward in the process toward full approval.

 

On Wednesday, October 17, 2018, from 8:00 a.m. to 5:00 p.m at the Bethesda Marriott in Bethesda, Maryland, the U.S. Food and Drug Administration (FDA) he Food and Drug will hold a public meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to consider the safety and effectiveness of two medications, prucalopride, intended for treatment of Chronic Idiopathic Constipation (CIC), and tegaserod, intended for treatment of irritable bowel syndrome with constipation (IBS-C). Manufacturers are seeking FDA approval to make both available in the United States.

Prucalopride, a selective serotonin type 4 receptor agonist, has been in use for several years in Canada under the brand name Restoran and in various European countries as Resolor. Tegaserod (brand name Zelnorm), a selective serotonin type 4 receptor partial agonist was available  in the United States and Canada from 2002-2007, when the FDA and  Health Canada, each asked for its withdrawal due to many reports of serious side effects, including unstable angina and strokes. Since then, the FDA has only made Zelnorm available on a rare emergency basis after a physician application for specific individual patients. The current FDA application, if successful, would return Zelnorm to market in the U.S. only for women without risk factors for cardiovascular complications.

The Committee is seeking comments from the gastrointestinal disorders community before midnight Eastern time on October 16. 2018. Electronic comments may be submitted here for tegaserod (Zelnorm), with the understanding that all identifying and health information included in comments will be publicly accessible on the Internet. Those wishing to comment confidentially are asked to submit two identical copies paper documents with a cover sheet stating, “This document contains confidential information.” by mail, courier or hand delivery to : Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. The FDA will add all information not specifically indicated as confidential to the public docket.  All comments for Zelnorm must be marked with the following docket: Docket No. FDA-2018-N-3223 for “Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.”

The instructions for comments on prucalopride are similar with a different electronic link here and a different identifying docket number that must be placed on comments, Docket No. FDA-2018-N-0055 for “Gastrointestinal Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.”

IBS Impact encourages U.S. readers to familiarize themselves with the above medications so that they can make informed comments. This is an opportunity to communicate the needs of the gastrointestinal disorders community directly to a committee of the FDA that can make recommendations before or against approval.  There are only a few days remaining before the deadline, so act now.

 

Updates to IBS Impact.com Main Website, September 2018

IBS Impact has recently completed the latest round of updates to many pages of our main website,  IBS Impact.com,

The home page, advocacy page, research page, IBS studies page, and links page, plus the news updates in the blue and white footers of every page all have additions or updates of content or links, or deletions of outdated links in the last few months.

Readers interested in the most recent news, events, clinical trial and advocacy opportunities, and articles between main site updates, may follow this blog or our Facebook or Twitter feeds (links found on the lower right sidebar of this blog and in the light blue footer sections below each page of the main site).  Each has slightly different information on an ongoing basis. Regardless of one’s interest in IBS, whether personal or professional, most users should find useful and interesting material and links. The current site reflects resources in six English-speaking countries which are among the top sources of hits to the site and this blog: the United States, Canada, the United Kingdom, Ireland, Australia and New Zealand. Several additional countries are occasionally represented on various pages.

Because of the redesign and transfer of the site to new hosting twice in 2015 and 2016, some links embedded in older posts on this blog or search engine results relating to IBS Impact.com may result in error messages, but you should still reach the site itself. If so, please use the navigation links at the top of the site to reach the desired subpage.  No information that is still currently useful has been removed from the site, although in some cases, the location has changed. Only outdated details and occasional defunct links for which there is no replacement available at this time have been deleted. The date of last update is indicated at the bottom of subpages that change periodically.

Please feel free to check out the site here. Our goals with the website, blog and social media are to provide a varied range of current, scientifically accurate, reputable information and resources to people with IBS and their families and friends, and to encourage informed choices, proactive self-advocacy and worldwide public awareness of IBS, and the unmet medical or social needs many of us face as a result of IBS.

IBS Impact as an entity, is not directly affiliated with any other organization, site, or research sponsor and receives no funding for the information we post on the main website, this blog or our Twitter and Facebook pages. We do welcome constructive collaboration and value the many individuals, websites, organizations,  and clinical and research entities who continue to support, encourage and amplify our efforts in various ways to benefit the cause of IBS awareness and advocacy worldwide.

Comments, suggestions, corrections of outdated links, article submissions, and clinical trials or surveys by researchers affiliated with academic, medical, or pharmaceutical entities or reputable evidence-based organizations representing IBS or commonly overlapping conditions in any country are all welcome and will be thoughtfully considered. A contact form  can be found on the main site, or comments can be left on this blog.  Thank you to all of our readers and social media followers for your interest and participation.

IFFGD Virtual Advocacy Day, September 26, 2018, Needs U.S Citizens to Advocate for Functional GI Research

The International Foundation for Functional Gastrointestinal Disorders (IFFGD) has announced that Virtual Advocacy Day 2018 is coming soon on September 26, 2018. Virtual Advocacy Day is IFFGD’s annual day on which it encourages U.S. citizens to contact their members of the federal House of Representatives in support of the Functional Gastrointestinal and Motility Disorders Research Enhancement Act. (HR 1187)

For this year, IFFGD is trying an additional strategy and asking for adults and children with functional gastrointestinal and motility disorders, families, friends, and other supporters to write letters and draw pictures about the experiences of living with FGIMDs and the need to support FGIMD research through the Act. Please send them by Friday, September 21, 2018 to IFFGD’s Washington, DC liaison, Peter Herzog at herzog@hmcw.org or mail them to 507 Capitol Court NE, Suite 200, Washington DC 20002. Each letter or picture will be hand-delivered to the senders’ individual Member of the House of Representatives to ask for co-sponsorship of HR 1187 in time for Virtual Advocacy Day on September 26. Self-advocates and family members and friends are also encouraged to follow up with a phone call to the Representative on that day. See IFFGD’s Virtual Advocacy Day 2018 page for more information and sample letters and phone calls. If your Representative already supports HR 1187– see a list later in this post– then please consider writing and/or calling to say thank you.

According to IFFGD and the official Congressional legislative database Congress.gov, Representative Brian Fitzpatrick (R-PA-8) is the latest representative to sign on in early September 2018 as a co-sponsor of the Functional Gastrointestinal and Motility Disorders Research Enhancement Act of 2017.

Representative Fitzpatrick is serving his first term as a member of the House of Representatives. He represents Pennsylvania’s 8th district which encompasses Bucks County and parts of Montgomery Country. According to Representative Fitzpatrick’s official House website, he currently is a member of several caucuses for other health conditions and disabilities.IBS Impact thanks Representative Fitzpatrick for adding his support for FGIMDs.

In officially supporting HR 1187, Representative Fitzpatrick joins Representative F. James Sensenbrenner, Jr. (R-WI-5), who is the initial sponsor, and co-sponsors, Representative Mark Pocan (D-WI-2), Representative Eliot Engel (D-NY-16), Representative Dave Loebsack (D-IA-2),  Representative Alcee Hastings (D-FL-20), Representative Tom Suozzi (D-NY-3), Representative Ron Kind (D-WI-3),  Representative Gwen Moore (D-WI-4),  Representative Andre Carson (D-IN-7), Representative Donald Payne, Jr. (D-NJ-10), Representative Zoe Lofgren (D-CA-19), Representative John Faso (R-NY-19), and Representative David Price (D-NC-4), Representative Gerald (Gerry) Connolly (D-VA-11), and Representative Ed Perlmutter (D-CO-7) If you are a constituent of any of these legislators, please take a few minutes in connection with Virtual Advocacy Day to call, write, or contact him or her on social media to thank him or her for his support of the functional gastrointestinal and motility disorders community.

U. S. citizens, if your Member of Congress is not yet a co-sponsor of HR 1187, please see the previous post from March 21, 2017 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. Keep in mind that your Representative may be different from before because of the 2016 elections, district boundaries that may have been re-drawn, or if you have moved.

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 1187 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 1187.

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 1187 will not require a debate or vote on the floor of the House of Representatives, and will pass as soon as it reaches 218 sponsor/cosponsors, or a simple majority of the House. In order for this milestone to be accomplished during the current Congress, the 115th, the necessary number of sponsor/cosponsors must be reached by December 2018. Every two years, the Congressional membership will be different as a result of elections. Thus, if HR 1187 has not passed by that time,  a similar bill will have to be reintroduced and the FGIMD community will have to start the process of gathering co-sponsors anew. This is what occurred with HR 2239 in 2012, HR 842 in 2014 and HR 2311 in 2016. 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.

As irritable bowel syndrome (IBS), is the most common functional gastrointestinal and motility disorder, IBS Impact strongly encourages readers to join with self-advocates with other FGIMDs for Virtual Advocacy Day. Amplifying our voices as FGIMD-affected people, along with others in similar situations, can increase awareness of HR 1187 and our needs to the public and to Congressional members with the power to help our community.

Online Study: “Understanding IBS Patient Self-Management Strategies and their Relation to Outcomes”, Icahn-Mount Sinai, September 2018

The following study is currently seeking adults 18-65 years old who are fluent in English and have a diagnosis of IBS. The primary investigator is Laurie Keefer, PhD of Icahn Mount Sinai Medical School in New York, in cooperation with the Center for Psychosocial Research in GI at Northwestern University in Chicago. IBS Impact received this link from another CPRGI affiliated researcher of gastrointestinal health psychology with a request to share.

The study is expected to take 30-45 minutes online. The questions include general demographics such as age, gender, race/ethnicity, level of education and household income, some medical questions, as well as questions about IBS related symptoms, emotions and opinions of using a GI health psychologist. No actual identifying information is requested.

The study has received institutional ethical approval. All information available to IBS Impact is in this post and on the study page. We encourage potential volunteers to read the informed consent page at the link below, and if you agree, to proceed with the pages of the study that follow.

https://survey.co1.qualtrics.com/jfe/form/SV_250qRkJwHKVMWQB?Q_CH

Please address any further questions or concerns directly to Dr. Keefer at the phone number or email address given in the linked description.

IBS Impact welcomes researchers affiliated with academic, medical or pharmaceutical entities, or reputable organizations representing IBS or related or commonly overlapping conditions, to contact us directly with additional studies or surveys they wish to be considered for posting. A contact form is available on the main IBS Impact website.

IBS Impact makes these announcements available for general information, and encourages its members and site visitors to make their own individual, informed choices about their potential participation. Additional studies can be found by clicking on the Research– Clinical Trials sub-category in the right sidebar of this blog on our main website IBS studies page. Please be sure to check the date at the top or bottom of a given post, as many posts from this blog remain visible in search engines for several years, and studies stop accepting volunteers or conclude the trials after a period of time. IBS Impact, as an entity, is not directly affiliated with any research sponsor or organization and receives no funding from any source for studies, surveys or links we feature on this blog, the main site or social media.

American Neurogastroenterology and Motility Society Twitter Chat, “Hypnosis and GI Disorders”, August 20, 2018, 3:00-4:00 PM ET

The American Neurogastroenterology and Motility Society (ANMS) has announced that it will be holding a Twitter chat from 3:00-4:00 PM Eastern time, Monday, August 20, 2018 on the subject of “Hypnosis and GI Disorders.” The chat moderator will be Tiffany Taft, PhD,  Assistant Professor in the gastroenterology division of Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA and founding partner in the health psychology practice Oak Park Behavioral Medicine in suburban Oak Park and Evanston, Illinois. Dr, Taft’s research studies have occasionally appeared on this blog, and she wrote a guest post for us on IBS and stigma, a major focus of her research, for IBS Awareness Month 2013.

ANMS’s Twitter handle is @ANMSociety and the chat can be found using the hashtag #ANMSChat

IBS Impact encourages people with irritable bowel syndrome and/or their family members to make time to attend and participate in this open, public chat, which allows one to interact directly with a GI health psychologist who is associated with a leading medical school known for gastrointestinal health psychology research and clinical care. Participants will have the opportunity to ask questions and/or give feedback about general needs and concerns regarding IBS and gut-directed hypnotherapy.

A reminder to all interested parties: All information shared on Twitter in connection with this chat will remain online, potentially accessible to the public indefinitely and is designed to address issues of general interest within the scheduled hour. It is not an appropriate venue to seek diagnosis or treatment of an individual medical situation from Dr. Taft or other professionals who may be participating in the discussion. However, it is a quality, evidence-based and unique opportunity to further one’s self-education on the IBS and gut-directed hypnotherapy. IBS Impact thanks Dr, Taft and ANMS for making this chat available, with best wishes for a successful chat.

Representative Perlmutter of Colorado Co-Sponsors HR 1187 for Functional Gastrointestinal and Motility Disorders

According to IFFGD and the official Congressional legislative database Congress.gov, Representative Ed Perlmutter (D-CO-7) signed on in early July 2018 as a co-sponsor of the Functional Gastrointestinal and Motility Disorders Research Enhancement Act of 2017.

Representative Perlmutter is serving his sixth term as a member of the House of Representatives. He represents Colorado’s 7th district which encompasses the northern and western suburbs of Denver in Adams and Jefferson Counties. He was also a co-sponsor of two previous versions of the Functional Gastrointestinal and Motility Disorders Research Enhancement Act,  HR 2239, in the 112th Congress during 2011-2012 and HR 842 in 2013-2014. Representative Perlmutter’s official House website is linked here.

IBS Impact commends Representative Perlmutter for renewing his support. If you are a constituent of Representative Perlmutter, please take a few minutes to write or call him or contact him on social media with your thanks.

In officially supporting HR 1187, Representative Perlmutter joins Representative F. James Sensenbrenner, Jr. (R-WI-5), who is the initial sponsor, and co-sponsors, Representative Mark Pocan (D-WI-2), Representative Eliot Engel (D-NY-16), Representative Dave Loebsack (D-IA-2),  Representative Alcee Hastings (D-FL-20), Representative Tom Suozzi (D-NY-3), Representative Ron Kind (D-WI-3),  Representative Gwen Moore (D-WI-4),  Representative Andre Carson (D-IN-7), Representative Donald Payne, Jr. (D-NJ-10), Representative Zoe Lofgren (D-CA-19), Representative John Faso (R-NY-19), and Representative David Price (D-NC-4), and Representative Gerald (Gerry) Connolly (D-VA-11). If you are a constituent of any of these legislators, please take a few minutes to call, write, or contact him or her on social media to thank him or her for his support of the functional gastrointestinal and motility disorders community.

U. S. citizens, if your Member of Congress is not yet a co-sponsor of HR 1187, please see the previous post from March 21, 2017 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. Keep in mind that your Representative may be different from before because of the 2016 elections, district boundaries that may have been re-drawn, or if you have moved.

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 1187 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 1187.

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 1187 will not require a debate or vote on the floor of the House of Representatives, and will pass as soon as it reaches 218 sponsor/cosponsors, or a simple majority of the House. In order for this milestone to be accomplished during the current Congress, the 115th, the necessary number of sponsor/cosponsors must be reached by December 2018. Every two years, the Congressional membership will be different as a result of elections. Thus, if HR 1187 has not passed by that time,  a similar bill will have to be reintroduced and the FGIMD community will have to start the process of gathering co-sponsors anew. This is what occurred with HR 2239 in 2012, HR 842 in 2014 and HR 2311 in 2016. 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 Facebook page or Twitter feed for further updates on HR 1187 as they occur. Links to the social media sites can be found on the right sidebar of the blog.

Representative Connolly of Virginia Co-Sponsors HR 1187 for Functional Gastrointestinal and Motility Disorders

According to IFFGD and the official Congressional legislative database Congress.gov,  Representative Gerald (Gerry) Connolly (D-VA-11) signed on in early June 2018 as a co-sponsor of the Functional Gastrointestinal and Motility Disorders Research Enhancement Act of 2017.

Representative Connolly is serving his fifth term as a member of the House of Representatives. He represents Virginia’s 11th district, which encompasses the city of Fairfax and the majority of Fairfax and Prince William Counties. According to Representative Connolly’s official House website,  he has a record of supporting much legislation health, medical research, and veterans’ issues.  As previously discussed on this blog on August 12, 2011 and August 25, 2011, military service members and veterans are at disproportionately high risk for functional gastrointestinal disorders like IBS, which are already very common in the general population.

Representative Connolly was also a co-sponsor of HR 842, a previous version of this Act in 2013, which was not passed by the House of Representatives at that time. IBS Impact commends Representative Connolly for renewing his support.

In officially supporting HR 1187, Representative Connolly joins Representative F. James Sensenbrenner, Jr. (R-WI-5), who is the initial sponsor, and co-sponsors, Representatives Mark Pocan (D-WI-2), Eliot Engel (D-NY-16), Dave Loebsack (D-IA-2), Alcee Hastings (D-FL-20) Tom Suozzi (D-NY-3), Ron Kind (D-WI-3), Gwen Moore (D-WI-4),  Representative Andre Carson (D-IN-7), Representative Donald Payne, Jr. (D-NJ-10), Representative Zoe Lofgren (D-CA-19), Representative John Faso (R-NY-19), and Representative David Price (D-NC-4) If you are a constituent of any of these legislators, please take a few minutes to call, write, or contact him or her on social media to thank him or her for his  support of the functional gastrointestinal and motility disorders community.

U. S. citizens, if your Member of Congress is not yet a co-sponsor of HR 1187, please see the previous post from March 21, 2017 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. Keep in mind that your Representative may be different from before because of the 2016 elections, district boundaries that may have been re-drawn, or if you have moved.

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 1187 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 1187.

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 1187 will not require a debate or vote on the floor of the House of Representatives, and will pass as soon as it reaches 218 sponsor/cosponsors, or a simple majority of the House. In order for this milestone to be accomplished during the current Congress, the 115th,  the necessary number of sponsor/cosponsors must be reached by December 2018. Every two years, the Congressional membership will be different as a result of elections. Thus, if HR 1187 has not passed by that time,  a similar bill will have to be reintroduced and the FGIMD community will have to start the process of gathering co-sponsors anew. This is what occurred with HR 2239 in 2012, HR 842 in 2014 and HR 2311 in 2016. 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 Facebook page or Twitter feed for further updates on HR 1187 as they occur. Links to the social media sites can be found on the right sidebar of the blog.

International Foundation for Functional Gastrointestinal Disorders (IFFGD) Seeks Volunteers for New Patient Panel, June 2018

The International Foundation for Functional Gastrointestinal Disorders (IFFGD) is an established, reputable U.S. based 501c3 not-for-profit organization/charity focused on irritable bowel syndrome (IBS) and related functional gastrointestinal disorders, also known as disorders of gut-brain interaction. IFFGD was founded in 1991 by an FGID-affected family and continues to have people with FGIDs or family members/supporters among its staff. IFFGD is a science-based organization with leading FGID clinicians and researchers from 11 countries on its advisory board.

Now IFFGD is reaching out to people affected by FGIDs, including IBS, as well as concerned family members and friends, to join a new Patient Panel. This involves occasional opportunities to give IFFGD feedback on the needs and experiences of our community, IFFGD’s programs and services, and to participate in IFFGD’s awareness and advocacy efforts. IFFGD is not asking for a specific time commitment or obligating panel members to respond to every opportunity, simply identifying those who are interested in being contacted and willing to participate in some of the potential requests. If you wish to volunteer, you may indicate this to IFFGD staff at the following link.

http://www.surveygizmo.com/s3/4361777/IFFGD-Patient-Panel

IBS Impact encourages affected people and family members who wish to make a real difference in services to the IBS/functional gastrointestinal and motility disorders community to consider this important opportunity.

Online Study: Cognitive Mediators of Bowel Discomfort Validation Study, Swinburne University, Australia, June 2018

The following study currently seeking men and women at least 18 years old in any country with chronic gastrointestinal conditions is a followup to an online study posted here on August 12, 2017.  The 2017 study is now closed to new volunteers.

The current study has received institutional ethical approval. All information available to IBS Impact is below and at the study link. Please address any further questions or concerns directly to the research team at the phone number or email address given below. This description is adapted from excerpts of the one on the study page.

In 2017 we conducted a study which developed a new scale (Cognitive Mediators of Bowel Discomfort Scale) to assess cognitive processes associated with bowel discomfort. We are now conducting a new study and looking for both male and female participants who are at least 18 years of age. The current project is exploring how responses to the Cognitive Mediators of Bowel Discomfort Scale relate to other similar scales. …

…Your responses will help us better understand how thinking patterns impact upon gastrointestinal discomfort. Further, your participation will also help us to evaluate our new scale against other similar scales. We hope that the validation of our new scale will lead to better ways to measure and assess common cognitive factors associated with bowel discomfort.

Estimated time commitment is 30 minutes. All information provided is anonymous. At the completion of the study, participants may opt in to providing an email address for a random drawing to receive one of four AUS $100 Amazon gift cards and/or being contacted about future studies, but this is not required.

https://swinuw.au1.qualtrics.com/jfe/form/SV_3kHEHoJXWwlcORn

For more information, please contact the research team: Principal Investigator: Dr Simon Knowles, (Senior Lecturer and Clinical Psychologist ) 61 (03) 9214 8206, email: sknowles@swin.edu.au 

Other investigators involved: Dr Pragalathan Apputhurai (Lecturer in Statistics), Dr Rebecca Burgell (Consultant Gastroenterologist, The Alfred Hospital), Mr. Stephan Moller (Research Assistant) & Professor Laurie Keefer (Health Psychologist, Susan and Leonard Feinstein IBD Clinical Center, New York).

IBS Impact welcomes researchers affiliated with academic, medical or pharmaceutical entities, or reputable organizations representing IBS or related or commonly overlapping conditions, to contact us directly with additional studies or surveys they wish to be considered for posting. A contact form is available on the main IBS Impact website.

IBS Impact makes these announcements available for general information, and encourages its members and site visitors to make their own individual, informed choices about their potential participation. Additional studies can be found by clicking on the Research– Clinical Trials sub-category in the right sidebar of this blog on our main website IBS studies page. Please be sure to check the date at the top or bottom of a given post, as many posts from this blog remain visible in search engines for several years, and studies stop accepting volunteers or conclude the trials after a period of time. IBS Impact, as an entity, is not directly affiliated with any research sponsor or organization and receives no funding from any source for studies, surveys or links we feature on this blog, the main site or social media.

Representative Price of North Carolina Co-Sponsors HR 1187 for Functional Gastrointestinal and Motility Disorders

According to IFFGD and the official Congressional legislative database Congress.gov,  Representative David Price (D-NC-4) signed on in late May 2018 as a co-sponsor of the Functional Gastrointestinal and Motility Disorders Research Enhancement Act of 2017.

Representative Price is currently serving his sixteenth non-consecutive term in Congress representing the 4th District of North Carolina, which currently encompasses much of the Triangle region in the central part of the state, including parts of Durham, Orange and Wake Counties and parts of According to his official House website, Representative Price is currently a member of the Committee on Appropriations, where he supported increases in funding to the National Institutes of Health. He also is a member of the Subcommittee on Homeland Security, which has jurisdiction over many pieces of legislation concerning the military. As previously discussed on this blog on August 12, 2011 and August 25, 2011, military service members and veterans are at disproportionately high risk of functional gastrointestinal disorders like IBS, which are already very common in the general population. In the 112th and 113th Congresses in 2011-2012, and 2013-2014 Representative Price was also a co-sponsor of HR 2239 and HR 842, previous versions of this Act, which were not passed by the House of Representatives at those times. IBS Impact commends Representative Price for renewing his support.

In officially supporting HR 1187, Representative Price joins Representative F. James Sensenbrenner, Jr. (R-WI-5), who is the initial sponsor, and co-sponsors, Representatives Mark Pocan (D-WI-2), Eliot Engel (D-NY-16), Dave Loebsack (D-IA-2), Alcee Hastings (D-FL-20) Tom Suozzi (D-NY-3), Ron Kind (D-WI-3), Gwen Moore (D-WI-4),  Representative Andre Carson (D-IN-7), Representative Donald Payne, Jr. (D-NJ-10), Representative Zoe Lofgren (D-CA-19) and Representative John Faso (R-NY-19). If you are a constituent of any of these legislators, please take a few minutes to call, write, or contact him or her on social media to thank him or her for his  support of the functional gastrointestinal and motility disorders community.

U. S. citizens, if your Member of Congress is not yet a co-sponsor of HR 1187, please see the previous post from March 21, 2017 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. Keep in mind that your Representative may be different from before because of the 2016 elections, district boundaries that may have been re-drawn, or if you have moved.

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 1187 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 1187.

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 1187 will not require a debate or vote on the floor of the House of Representatives, and will pass as soon as it reaches 218 sponsor/cosponsors, or a simple majority of the House. In order for this milestone to be accomplished during the current Congress, the 115th,  the necessary number of sponsor/cosponsors must be reached by December 2018. Every two years, the Congressional membership will be different as a result of elections. Thus, if HR 1187 has not passed by that time,  a similar bill will have to be reintroduced and the FGIMD community will have to start the process of gathering co-sponsors anew. This is what occurred with HR 2239 in 2012, HR 842 in 2014 and HR 2311 in 2016. 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 Facebook page or Twitter feed for further updates on HR 1187 as they occur. Links to the social media sites can be found on the right sidebar of the blog.