No news can be news, too!
Before we are allowed to take drugs for aches, pains and diseases they have to be vetted through a process of clinical trials involving human subjects. Efforts are underway in the USA to make sure inconclusive trial results, or negative ones, are fully reported alongside successful treatments, according to The Economist.
In its 11 September issue, the renowned current affairs magazine The Economist hit on a sore point in the medical and pharmaceutical sectors, that negative clinical-trial results are underreported. But in its piece, ‘Clinical trials: the sounds of silence’, it stresses that this may soon change as researchers and drug makers feel the pressure from the US Congress, courts and from major scientific journals to change their ways.
|Keeping a close eye on clinical trial reporting|
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The pharmaceutical industry has been singled out because, according to 2002 statistics produced by the American Medical Association (AMA), it funds 70% of such trials in the States. Why is this so important? Incomplete reporting – leaving out the null findings – is troublesome, The Economist notes, because it skews the ‘meta-analyses’ process which involves compiling data from previous related studies of a treatment. If the negative or null findings are left out by omission, or even deliberately, this analysis is thinned down which can undermine its effectiveness.
“The medical profession has been aware of this problem for some time,” the article says, but the drug companies have a “vested interest in keeping negative results quiet, so change has been slow in coming,” it adds. Because drugs are meant for human consumption, the public has the right to the clinical trial information. What’s more, the article continues, “The widespread government funding of basic research also gives the public a moral claim on the results.”
Change on the way
The first force of change, according to the report, has come from a legal settlement in August between a major British pharmaceutical company and the State of New York concerning allegations that the drug maker “deliberately suppressed negative results” from clinical trials carried out on an anti-depressant. The settlement included a commitment by the company to post on-line summaries of the missing information up to a certain date.
Last week the International Committee of Medical Journal Editors (ICMJE) – a group of editors from major journals such as the Lancet, the Journal of the AMA, the New England Journal of Medicine, and 11 other major medical publications – announced that, by mid-2005, all research they publish will have to be registered in advance in an independent and publicly available database. None was specified but the ClinicalTrials.gov site, run by the American National Institute of Health, appears a natural candidate, notes The Economist.
The third wind of change comes from the Congress which, the article says, is expected to table new legislation to “increase compliance with existing requirements to post trial data to ClinicalTrials.gov”, and it is likely to adopt an AMA proposal on the subject. The industry defends its “very good history of compliance” and claims that pressure to report more fully might be a disincentive for new drug development.
One of the ICMJE editors says the monetary incentives are so big this claim is dubious, but he concedes the coming legislation and his own group’s actions may lower the number of ‘seeding trials’ – trials on drugs already approved for one use and tested for other treatments. This American-led initiative for greater reporting transparency marks the beginning of a potentially more widespread trend which the global research and medical fraternities will no doubt be keenly observing.
Research Contacts page
ClinicalTrials: sounds of silence (The Economist, 11 September 2004)ClinicalTrials.govICMJE (see point III.A.)