On Date: Sat, 18 Mar 2006 04:42:15 -0500 Allen Esterson wrote: > On 17 March Mike Palij wrote in relation to the drug trial that went > wrong: > > >Well, I doubt that the companies involved will be > >releasing any background about the participants, much > >in the way that the drug manufacturer has "embargoed" > >info about earler studies involving TGN1412. What > >has been released in the press and media about the > >background of the subjects should raise some concerns. > > Why would this depend on the companies involved?
In the last few years it has become increasingly apparent that pharmceutical companies are very selective about what they reveal about the clinical trials that they sponsor. For example, the following comes from a recent news article in the jounral Nature: (Jim Giles, Drug trials: Stacking the deck Nature 440, 270-272 (16 March 2006) | doi:10.1038/440270a http://www.nature.com/nature/journal/v440/n7082/full/440270a.html ) |One of the biggest problems with clinical-trial reporting, the |suppression of negative results, shows the importance of such |debates. Because clinical researchers are not obliged to publish |their findings, ambiguous or negative results can languish in |filing cabinets, resulting in what Christine Laine, an editor at |the Annals of Internal Medicine in Philadelphia, Pennsylvania, |calls "phantom papers". If that happens, the journal record will |give an over-optimistic impression of the treatments studied, |with consequences for peer reviewers, government regulators |and patients. | |One alleged example hit the headlines in 2004. At that time, |the antidepressant Paxil (paroxetine), made by London-based |drug giant GlaxoSmithKline, was a popular treatment for |adolescents in the United States. But doctors have now been |warned off prescribing Paxil to youngsters, after evidence |emerged that it increases the risk of suicidal behaviour. It was |claimed in a court case brought in the United States that |GlaxoSmithKline had suppressed data showing this since |1998. Rick Koenig, a spokesman for GlaxoSmithKline, says |the company thought the charges unfounded, but agreed to |pay $2.5 million to avoid the costs and time of litigation. | |[jump to a later part of the article] |Last year, for example, a French team showed that only |40% of trials registered with its country's ethics committees |in 1984 had been published by 2002, despite more than twice |as many having been completed1. Crucially, papers with |inconclusive results not only took longer to publish (see graph), |they were less likely to see the light of day at all. Researchers |in any field can sit on negative or inconclusive results. But |critics say that clinical researchers carry a greater ethical |burden, as their findings inform decisions about the licensing |of drugs. Although the above is concerned with more serious issues like the "embargoing" (suppresion?) of null/ambigouous results or serious side effects, it is likely that other details about the conduct of the research, such as who participated, details that may seem innocuous to us but may be viewed as "trade secrets" by corporate suits, would also be "embargoed. As I see it, the problem is that the company owns the research, lock stock, and barrel, and the person(s) who decide what to release about a clinical trial are not the scientists who conducted the trial but businesspeople who are probably more concerned with the profit margin of their company than with scientific or ethical issues. > In the coming days and weeks there's nothing to stop > relatives, or the victims themselves if and when they > recover, from talking to the press. Upon reflection, I realized that this would probably be only way to get info about who participated and what happened to them. From what I've read, it appears that the company has not required the study participants to maintain confidentiality about their experiences in the study, a situation that I think future trials will "remedy" (i.e., companies may require participant to sign non-disclosure statements about their experience in a clinical trial). > No doubt at present the > relatives don't want press intrusion, but there has been a smattering of > information about the participants. For instance the Daily Mail reports > the words of one of the participants who was given a placebo, Nick > Whybrow, described as a bar manager. And one of the victims is reported by > his girlfriend to be Ryan Wilson, a student. Indeed, I've seen similar reports. But I wonder about the background characteristics of all of the subjects who have been recruited so far and possibly even enrolled into the study -- the drug company appears to want the study done quickly, as implied by the administering the drug-placebo treatments to a relatively "large" group of participants initially instead of testing a couple of subjects first (a methodological point raised in one of the articles I cited previously). I don't think that we'll be hearing about these other subjects anytime soon. > Incidentally, re the original report on the participants in the Daily Mail > (not recorded in any other paper I have seen over the last few days), one > of the two Australians among the participants has now metamorphosed into a > New Zealander. Well, more or less the right part of the world. -:) Which is why one should always be cautious about what one reads in the papers and the media. ;-) > Allen Esterson -Mike Palij [EMAIL PROTECTED] New York University --- You are currently subscribed to tips as: [email protected] To unsubscribe send a blank email to [EMAIL PROTECTED]
