ScienceDaily (May 10, 2011) — Medicines regulators are protecting drug company profits rather than the lives and welfare of patients by withholding unpublished trial data, argue researchers on the British Medical Journal website.
They call for full access to full trial reports (published and unpublished) to allow the true benefits and harms of treatments to be independently assessed by the scientific community.
Despite the existence of hundreds of thousands of clinical trials, doctors are unable to choose the best treatments for their patients because research results are being reported selectively, write Professor Peter Gøtzsche and Dr Anders Jørgensen from the Nordic Cochrane Centre in Denmark.
Selective reporting can have disastrous consequences. For example, Rofecoxib (Vioxx) has probably caused about 100,000 unnecessary heart attacks in the USA alone, while anti-arrhythmic drugs have probably caused the premature death of about 50,000 Americans each year in the 1980s…..
P. C. Gotzsche, A. W. Jorgensen. Opening up data at the European Medicines Agency. BMJ, 2011; 342 (may10 1): d2686 DOI: 10.1136/bmj.d2686 [Links to the free full text of the article]
- Are overseas trials generating suspect data on new drugs? (fiercebiotech.com)
Call for clinical trial raw data to be freely available to all (& a related call from the scientific community)
A recent BMJ editorial (Goodbye PubMed, hello raw data) ****calls for clinical raw data to be freely available to everyone.
The author cites the example of the influenza drug oseltamivir manufactured by Roche.
Reviewers for Cochrane Reviews asked Roche to release clinical trial data so they could systematically and comprehensively review antivirals as flu treatments. Roche refused, leaving the reviewers with inadequate incomplete information to complete their analysis.
The editor ends his article with these paragraphs…
From now on, they say, reviewers must have access to all unpublished data, not only from unpublished trials—the usual focus of concern about publication bias—but also from those that have been published in peer reviewed journals. Reviewers must assess entire trial programmes, and so new tools and methods are needed. If the trial reports are incomplete, reviewers should turn to reports from the drug regulators. As Tom Jefferson, the lead author for the Cochrane review, told me, “it’s goodbye PubMed, goodbye Embase.”
The reviewers have posted their new style protocol for this review on the Cochrane site and, recognising the enormity of the task, they are recording how much work is involved. But it must be clear to everyone that such a heroic approach is unsustainable across the whole of healthcare, given the resource constraints on academics and regulators. Which brings us back to what seems to be the only real solution—that the raw data from trials must be made freely available. Journals clearly have a role to play in making this happen, as An-Wen Chan agrees in his editorial (doi:10.1136/bmj.d80). The International Committee of Medical Journal Editors meets in a few months’ time. This will be on the agenda.
Scientists also see the need for access to research data.
The entire 2011 January/February issue of D-Lib Magazine is devoted to this topic.
**Cochrane Reviews are part of the Cochrane Collaboration, which
strives to provide the best evidence for health care. Cochrane reviews involve specific interventions in a specific clinical context, as antivirals for flu prevention in healthy adults. Individual reviews involve extensive literature research performed by independent teams of professionals.
Most reviews are only available through a paid subscription to the Cochrane Collaboration. However, many medical and academic libraries subscribe to the Cochrane Collaboration. Contact an academic reference librarian to see if they subscribe and if they provide access to the public.
****Via a MedLib posting by medical librarian Susan Fowler