Healthy Skepticism Library item: 13529

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Publication type: news

Boseley S.
Drug firm accused of death rate data failures
The Guardian 2008 Apr 16
http://www.guardian.co.uk/society/2008/apr/16/health.usa/print

Full text:

multinational drug company that made a painkiller that had to be withdrawn from sale because it was found to cause heart attacks may have hidden the death rate from the authorities for several years, it was claimed yesterday. Internal company documents released during litigation in the US suggest that Merck, makers of Vioxx, gave the US Food and Drug Administration only selected data on deaths in its clinical trials, and failed to include people who had a fatal heart attack soon after coming off the drug.

The documents also show that papers published in journals on the results of Vioxx trials were ghostwritten by employees or contracted medical writers, and that leading doctors were later invited to be named as authors. Financial links were sometimes but not always declared.

The editors of the Journal of the American Medical Association called for reforms to prevent the manipulation of data from clinical trials by drug companies as it published the Vioxx revelations in two separate papers. The authors of the papers are paid consultants for the families of patients who are suing Merck, but the journal has required them to publish all the company documents analysed on the web, so that their charges can be dissected by others. They allege that internal company reports of three trials which Merck funded to find out whether Vioxx – usually taken by arthritis sufferers – could stave off Alzheimer’s disease show a death rate on the drug higher than that published.

Bruce Psaty and Richard Kronmal, from the University of Washington in Seattle, say that internal company records from 2001 give 34 deaths among the 1,069 Vioxx patients from two of the Alzheimer’s trials and 12 among the 1,078 on placebo – a threefold increase among those on the drug. But the published data of the first study in 2004 stated there were 11 deaths which were “non drug-related” among 346 Vioxx patients, and two among those on placebo. In the second study published in 2005 there were said to be 24 deaths among 725 Vioxx patients and 15 among the 732 on placebo, with 17 and two more respectively within 14 days of the last dose. But, say the researchers, neither study analysed the mortality data.

In July 2001, Merck had reported mortality data to the FDA. Psaty and Kronmal wrote that “deaths that had occurred more than 14 days after discontinuation of the trial drug apparently were not included”. When the FDA questioned the figures, in December 2001, it emerged that there was no independent data. The second journal paper reveals that manuscripts for scientific journals were written by Merck employees. Doctors attached to leading universities would then be invited to take authorship. Some, but not all, declared financial support from industry.