The Reboxetine Scandal — How Should We Make Medical Trial Data Available?

Connotea Imports 2012-07-31

Summary:

"In the US and Europe, trial registries have sprung up in an attempt to blunt some suspect practices, namely suppressing studies that don’t pan out. Journals help enforce the registries by refusing to accept studies not registered before they commenced. But enforcement is spotty, and one result has been that industry is increasingly conducting trials in countries without registry requirements (e.g., eastern Europe, some Asian countries)....Recently, a meta-analysis published in the BMJ showed once again that upstream filtering by commercial entities can have severely deleterious effects on patients. In conducting a meta-analysis, a group of researchers found that 74% of the data from clinical trials had been suppressed leading up to the approval of reboxetine for the acute treatment of severe depression. When these missing patient data were added back in, the beneficial effects reported for reboxetine vanished while a host of risks emerged. Essentially, industry pulled a fast one. The authors hit on the main lesson from this in one succinct sentence, a point that apparently all the editorialists missed: "Our findings underline the urgent need for mandatory publication of trial data." ...Medical publishers have not successfully made a...zone [like arXiv] for medical research findings, despite the clear need....A database capturing all clinical trial data from industry and elsewhere would be a big step in the right direction, and it is entirely feasible. Improving journals in response to this problem won’t be adequate. We need to improve data reporting. It’s time for medical journal editors to recognize that journals and databases are entirely different things, and that the path to the database should no longer pass through the journal. In fact, the path to the journal should pass through the database."

Link:

http://scholarlykitchen.sspnet.org/2010/11/16/the-reboxetine-scandal-how-should-we-make-medical-trial-data-available/

From feeds:

Open Access Tracking Project (OATP) » Connotea Imports

Tags:

oa.medicine oa.new oa.data oa.comment oa.negative oa.pharma oa.mandates.data

Authors:

petersuber

Date tagged:

07/31/2012, 15:31

Date published:

11/18/2010, 13:54