IBS Self Help and Support Group - You Don't Have to Cope Alone

IBS Support Group Newsletter

April - May - June 2002

IN THIS ISSUE

SPOTLIGHT
  • Presentation at FDA Advisory Committee meeting for Lotronex on April 23, 2002 and subsequent approval on June 7, 2002
  • Poll Results: Restrictions IBS patients are willing to accept for access to IBS Medications
  • Research Survey for Canadian IBS Sufferers starting on July 9, 2002

NEWS LINKS

  • Medscape: Irritable Bowel Syndrome: Physiology and Management
  • Medscape: Inflammation, Infection, and Irritable Bowel Syndrome: An Update
  • New Survey Shows That Less Than Two Percent Of People Are Aware That Irritable Bowel Syndrome Is More Widespread Than Asthma, Depression And Diabetes
  • FDA Approves Restricted Marketing Of Lotronex
  • Lotronex Action Group and IBS Group comment about FDA's Approval to allow Access to Lotronex
  • Articles Surrounding Lotronex FDA Advisory Committee Meeting and Re-introduction

INDUSTRY NEWS

  • Novartis: Zelnorm approved for marketing in Canada and Brazil
  • GlaxoSmithKline: Lotronex® tablets to be re-introduced for women with severe IBS-D
  • Solvay Pharmaceutical is studying Cilansetron for IBS-D
  • Forest Laboratories is studying Dexloxiglumide for IBS-C

ONGOING

  • Poll: What kind of fund raising would you as a member, support?
  • Attention Young Adult IBSers in the NYC Area about a get together

SPONSORED LINK

  • Safe and Effective Probiotic Supplement for Irritable Bowel Syndrome Treatment.    IBS information and resources available.  Visit http://www.probiohealth.com/?10008 and try KE-99 LACTO today.

Presentation at FDA Advisory Committee meeting for Lotronex on April 23, 2002 and subsequent approval on June 7, 2002

On November 28, 2000, Glaxo Wellcome announced that, at the request of the US Food and Drug Administration (FDA), it would voluntarily withdraw Lotronex (alosetron), its treatment for diarrhea-predominant irritable bowel syndrome (IBS) sufferers, from the US market with immediate effect. In December 2000, members of the IBS Self Help Group help to establish the Lotronex Action Group (LAG) which was seeking continued access to the medicine.

On April 23, 2002, the Food and Drug Administration scheduled a joint meeting of an advisory committee on gastrointestinal drugs and a newly formed panel on drug safety to discuss ``risk management'' of Lotronex.  Several members from the Lotronex Action Group and myself, representing the IBS Self Help Group, delivered testimonies to the advisory committee.  Many of us delivered very passionate personal messages.  The advisory committee clearly heard our words and by the end of the day voted overwhelmingly to recommend to the FDA that Lotronex be re-approved for marketing.  On June 7, 2002 the **FDA and GlaxoSmithKline announced that Lotronex would be re-approved for restricted access for diarrhea-predominant women suffering from Irritable Bowel Syndrome.  As a team, the Lotronex Action Group and IBS Self Help Group, made unprecedented history in returning a drug to the market that had been previously withdrawn.  We also received an unprecedented amount of media attention.  This for a grassroots organization without any assistance from a large financial or influential supporter.

I am very proud of our achievements to date.  With your member support, I know that we will continue to raise awareness for this illness and the symptoms and quality of life issues that many of us face each and every day.

Jeffrey D. Roberts, B.Sc.
President & Founder
IBS Self Help and Support Group
ibs@ibsgroup.org
http://www.ibsgroup.org
 
** The FDA's information about Lotronex including Patient and Physician agreement forms is located here: http://www.fda.gov/cder/drug/infopage/lotronex/lotronex.htm

Poll Results: Restrictions IBS patients are willing to accept for access to IBS Medications

A poll was taken on the IBS Self Help Group Bulletin Board which aimed to gather data based on what type of restrictions, if any, that IBS patients would be willing to accept for access to IBS medications.

The poll consisted of 7 questions.  The results were included in the IBS Self Help Group's testimony to the FDA at the FDA Advisory Committee meeting for Lotronex (alosetron) on April 23, 2002.

Restrictions IBS patients are will to accept for access to IBS medications  (202 votes.)
Medicines specific to IBS are accessible to a sufferer diagnosed
only by a gastroenterologist and not by a family physician 41% (83)
 
by a family physician (or gastroenterologist) 59% (119)
 
A follow up appointment is
mandatory with a gastroenterologist prior to a prescription refill 22% (44)
 
mandatory with a family physician (or gastroenterologist) prior to a prescription refill 38% (76)
 
unnecessary, but must receive a prescription refill from a gastroenterologist 15% (30)
 
unnecessary, but may receive a prescription refill from a family physician (or gastroenterologist) 26% (52)
 
Medication may be supplied
one month at a time 26% (52)
 
three months at a time 54% (110)
 
six months at a time 14% (28)
 
unlimited 6% (12)
 
Physicians use of an IBS medication
should not be used as a diagnostic tool for determining if a patient suffers from IBS 76% (154)
 
may be used as a diagnostic tool for determining if a patient suffers from IBS 24% (48)
 
Prior to receiving an IBS medication
patient must sign a waiver limiting liability to pharmceutical or FDA agency 46% (93)
 
patient does not have to sign a waiver limiting liability to pharmceutical or FDA agency 54% (109)
 
Prior to receiving an IBS medication
patient must agree to participate in a survey about use and side-effects sponsored by pharmaceutical and/or FDA agency 64% (130)
 
patient does not have agree to participate in a survey about use and side-effects sponsored by pharmaceutical and/or FDA agency 36% (72)
 
 

Restrictions: Informed Consent  (62 votes.)
Yes 95% (59)
 
No 5% (3)
 

Research Survey for Canadian IBS Sufferers starting on July 9, 2002

On July 8, 2002 a research survey will be conducted for Canadian IBS sufferers.  The research survey will ask questions about your illness, namely symptoms, treatment, side effects, and the overall impact on your quality of life.  Your involvement in this research survey is very important and appreciated.  If you live in Canada please plan to complete this research survey on July 8, 2002.

The survey will be conducted by phone interviews and on the Internet at this URL:

http://www.panel.angusreid.com/survey/3737a01.cfm

Poll: What kind of fund raising would you as a member, support?

A new poll on the IBS Self Help Group website asks "Which type of fund raising would you support?"

Annual membership dues?
Subscription based newsletter?
Fee for access to Bulletin Board?
No dues - more advertising on-line?
Direct mail advertising?
Events ie: symposium, conference?

Member's may complete the poll on the IBS Self Help Group's bulletin board here:

http://www.ibsgroup.org/ubb/ultimatebb.php?ubb=get_topic;f=31;t=000003

Attention Young Adult IBSers in the NYC Area

"methical" and "Aeeda", that's Jay and Aeeda, from the IBS BB Young Adult's Issues forum are trying to get together as many young adults with IBS in the NYC area as they can for a weekend get-together. Aeeda, who started this idea, lives close to a beach in Brooklyn and has invited everyone to hang out there, kindly offering her home's bathroom accommodations in addition to the beach's, so you shouldn't feel too hesitant due to IBS symptoms-related worries. The date is open to whatever works best for everyone.

Jay writes, "Are you guys interested? I think it could be a really good experience, especially for people of our age. Not too many of us have many friends with IBS with whom we could relate. I think a lot of us would benefit from meeting and knowing other young people with the same problems and experiences. Plus, we'd have fun too."

For more information please review this posting on the IBS Self Help Group's bulletin board:

http://www.ibsgroup.org/ubb/ultimatebb.php?ubb=get_topic;f=1;t=028185

Or contact Jay and/or Aeeda by email here: jayzey76@hotmail.com, aeeda_80@hotmail.com

NEWS LINKS

INDUSTRY NEWS

 

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MEMBER DONATION INFORMATION

Consider making a donation to the IBS Self Help Group to support our efforts. Donations to the IBS Self Help Group help offset the internet fees for the website, administration expenses, the cost of mailings to individuals, and the cost to attend industry events. A suggested annual donation of $25 would help cover costs but a donation in any amount would be appreciated, although not required for membership.

Visit http://www.ibsgroup.org/main/donate.html to make a donation.

NEWSLETTERS

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