Drugmakers would appear to have learned their lesson about hiding unwelcome data in the past as the number of trials posted on the USA’s National Institutes of Health website with incomplete information has dropped dramatically.
According to an editorial in the New England Journal of Medicine, of the near-3,000 studies posted at clinicaltrials.gov, the NIH's voluntary registration site, the number with incomplete information has dropped from 26% before 2006 to 8% in the first 11 months of last year.
The editorial’s authors, NEJM editor-in-chief Jeffrey Drazen and Deborah Zarin, said that “although more can be done, this improvement in registration quality is to be praised.” They believe this new-found efficiency is the pharmaceutical industry’s response to the stance taken by the International Committee of Medical Journal Editors, which represents such publications as The Lancet, the Journal of the American Medical Association and the NEJM who, in 2005, started to reject articles about trial results unless the studies were included on a public database.
The issue of disclosing clinical trial data was thrust into the spotlight in the summer of 2004 after Attorney General, (and now Governor) of New York, Eliot Spitzer, filed a lawsuit against GlaxoSmithKline, alleging that the UK behemoth had suppressed negative results showing its antidepressant Paxil (paroxetine) was linked to an increased risk of suicidal thoughts and acts in children and adolescents. GSK paid out $2.5 million to settle that particular case.
Nowadays many firms have launched their own clinical trial registry but this step, and the improved performance on the NIH site, is not convincing opponents of voluntary schemes. Democrat Congressman Edward Markey is in favour of a federal law mandating that clinical trials be registered and told The Boston Globe that "a voluntary registry is like allowing a student to pick which grades he wants to include on his report card and which ones he wants to leave out."
Many in the pharmaceutical industry are not keen on a mandatory approach amid fears that the public’s hopes could be raised falsely over drugs that do not make it to market. Such a move would also increase a company's exposure to its competitors in terms of what trials it is conducting on which drugs