They Laughed When We Sat Down
They laughed when we sat down and started exchanging messages with our keyboards. But it is now six months later and the FDA and GlaxoSmithKline are still meeting and these meetings concern the possibility of the return of lotronex to people who benefitted from its use. If this occurs it will make history. The FDA has never allowed the return of a drug to market after it was withdrawn because of potential dangers.
Why this strange twist of fate? The story begins with scientific advances in the understanding of irritable bowel syndrome which have led to development of medications targeted toward serotonin receptors in the colon. Lotronex (alosetron - a 5-HT3 antagonist) was the first of this class of drugs to be released. This release itself was controversial and some felt it was premature and there have been undocumented allegations that pharmaceutical companies have enlisted and paid for efforts on the part of consumers for early or priority release of some medications, including lotronex
Following reports of lotronex-associated deaths, the Health Research Group of Public Citizen petitioned the FDA to pull the drug from the market. In November its manufacturer, Glaxo (which became GlaxoSmithKline in December), withdrew the medication rather than agree to conditions for continued marketing called for by the FDA. Law firms began researching and advertising for clients in the media and on the internet (a websearch conducted on June 7, 2001 turned up several references to ‘lotronex’ and the first 30 were to websites set up by law firms for people who might want to claim they had been harmed by lotronex use). The drug was finished according to the media, market-watchers, and everybody in the know, including patients and their physicians (including prominent gastrointestinal specialists).
Because of the dismay and despair evident in the messages people were sending to a self-help support group bulletin board its owner, Jeffrey Roberts, set up a separate discussion forum for support and information sharing about what might be done to survive without the medication. There were some willing to pay any amount to obtain the drug. There was a suggestion that lotronex could be produced in Mongolia and packaged and sold in Tijuana. And some wanted to descend en masse on Washington It soon became clear that there were a lot of people whose lives had been ravaged by irritable bowel syndrome and that these people came from all walks of life.
These people were sitting at their computers and they wanted to be heard. A mailing list was set up for mutual support. Coordinators came forward to help channel the obvious energy in constructive directions. People began writing and calling and sending emails to anyone and everyone. These people sitting at their computers began obtaining and exchanging information about what had happened to them and where they could send their letters and their stories.
People at the FDA (Janet Woodcock is one identifiable party) and Glaxo began paying attention to what they were hearing in these stories and letters. The two parties began meeting (these meetings themselves are closed to outsiders) to work out a way of resolving their differences so people who had benefited from a medication would be able to obtain it. These meetings are continuing six months afterwards and it is likely that a future meeting will allow for public input and that a scientific advisory panel will be appointed to evaluate the issues. At this point in time (June, 2001), economic, medical and ethical , and political forces may well impact the timing and character of this meeting and panel and affect the ultimate outcome and fate of this and similar medications.
The “Lotronex Wars” continue but in a very important way the Lotronex Action Group did acheive a real victory when some members appeared on national television and people could see not only those who were allegedly harmed but also those who benefited from lotronex. We are still sitting. I’m still sitting at my keyboard, but now I have confidence that scientific issues will be discussed in a scientific forum, that people with medical conditions can be heard, and that all viewpoints will have some representation here in the media, financial, and political arenas.
I still sit, but not as hopelessly as before.
”FDA is not ignoring people with IBS. If GSK were to abandon their efforts on Lotronex, we would let people know. I understand why you are frustrated, but the advisory committee issue is not a signal that there is a problem” Text of email message dated 6/6/2001 from Janet Woodcock to a member of the lotronex action group.
CBS News Washington Correspondent Sharyl Attkisson, 6/5/2001. http://www.gastro.org/adhf/ibs-guide.html A brief current overview for physicians.
tegasrod, another medication which acts on a different receptor in a different fashion, has received final approval and is currenly scheduled for release this month [June, 2001] by it’s manufacturer under the name of zelnorm (changed from zelmac).
David Willman’s story “FDA Minimized Issue of Lotronex's Safety” in the Los Angeles Times, 11/2/2001 (http://www.latimes.com/news/nation/updates2/lat_lotronex001102.htm) summarizes this history along with information on ischemic colitis and constipation the effects which some but not all experts feel were the results of lotronex.
[this is asserted by Willman and also in the editorial in Lancet but this is also a side-track and complicated twist that leads away from the main issue as I see it]
HRG petiton of August 31, 2000 to Jane Henney, M.D., then Commissioner of the FDA http://www.citizen.org:8765/query.html?rq=0&col=pcindex&ht=0&qp=&qt=lotronex&q;s=&qc=&pw=100%25&ws=0&la=&qm=0&st=1&nh=10&lk=1&rf=0&oq=&rq=0&si=1
[this can be documented through posts to the self-help group bulletin board, email responses I received from patients, emails I received from physicians, but perhaps the best citation would be Dr. Drossman’s update http://www.med.unc.edu/wrkunits/2depts/medicine/fgidc/ibsupdate.htm which is also in print in their Participate Newsletter of May, 2001 and posted on the LAG site
http://www.ibsgroup.org/
Because of problems with changing diagnostic criteria, under-reporting (for example, most men appear reluctant to discuss the problem with physicians), and the relative recency of the recognition of irritable bowel syndrome as a clinical entity, accurate statistics are difficult to determine. A psychologist, Edward B. Blanchard, looks at some of these issues in his recent Irritable Bowel Syndrome: Psychosocial Assessment and Treatment (Washington, American Psychological Association, 2001). Most estimates have indicated that between 10 and 25% of the population are affected with numbers for females being higher than for males and that of those affected, 5 to 10% experience serious and disabling symptoms. The American Gastroenterological Association’s recently released The Burden of Gastrointestinal Diseases (Bethesda, MD, AGA, 2001) contains references to current sources of data on these issues.
see Willman’s story of May 30, “FDA Moving to Revive Deadly Drug,” in the Los Angeles Times ( http://www.latimes.com/health/news/20010530/t000045183.html) contains current information onthese issues.
Richard Horton’s commentary in the May 19 issue of The Lancet (357, Number 9268), “Lotronex and the FDA: a Fatal Erosion of Integrity” gices an overview of these issues.
Public Citizen is associated in most people’s minds with Ralph Nader and taxes federal agency appointments are current concerns.
http://ibscrohns.about.com/health/ibscrohns/library/weekly/aa052401a.htm
“The IBS Self Help Group is a separate organization dedicated to educating those who suffer from irritable bowel syndrome and to increase awareness about this and other functional gastrointestinal disorders. The Lotronex Action Group (LAG) was started by a number of former Lotronex users who are also members of the IBS Self Help Group” Statement by Jeffrey Roberts posted to the LAG (Lotronex Action Group) mailing list 6/11/2001.