Drug Companies Failing To Provide Details on Clinical Trials, NEJM Editor Says

Main Category: Pharma Industry / Biotech Industry
Article Date: 25 May 2005 - 11:00 PDT

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Jeffrey Drazen, editor in chief of the New England Journal of Medicine, said on Monday that three of the largest pharmaceutical companies... -- GlaxoSmithKline, Merck and Pfizer -- are "making a mockery" of efforts to offer more transparency in clinical trials by failing to provide accurate information about their studies, the AP/Hartford Courant reports. In September 2004, the members of the International Committee of Medical Journal Editors announced that they will cease publishing studies that are not registered in an NIH database -- ClinicalTrials.gov -- at the time of their launches. The Pharmaceutical Research and Manufacturers of America and three other major pharmaceutical associations earlier this year recommended to their members that they submit clinical trial information to the public registry beginning in July. Pharmaceutical companies are legally required to register trials for products treating serious or life-threatening diseases, but in recent months they have begun registering other types of studies on the site, as well as listing them on their own Web sites. Following a review of the information posted by 10 pharmaceutical companies on the registry, Drazen said that GSK, Merck and Pfizer are failing to provide useful data on clinical trials they register on the site. Drazen said the three companies provided inadequate information on the number of patients in trials and also failed to clearly outline primary and secondary goals of the trials. Drazen said the three companies are "giving nonsense details," adding, "They are written in a way that they are trying to hide what they are doing." Drazen said that a number of other companies have complied with the requirements -- including Eli Lilly and Abbott Laboratories, which are "90% in compliance" -- but that some companies recently have begun to follow the lead of GSK, Merck and Pfizer in their disclosures (Agovino, AP/Hartford Courant, 5/24).

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