Evidence

Merck Ghostwriters Behind Favorable Vioxx Articles

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Documents unearthed in lawsuits against the painkiller Vioxx show the drug’s maker, Merck, wrote article drafts about the drug’s performance but found outside physicians to be listed as authors.

Two studies published today in the Journal of the American Medical Association show the company apparently manipulated dozens of publications to promote the drug, according to an accompanying editorial. It charges that ghostwriting is not confined to Merck.

The studies provide “a rare, detailed look in the industry practice of ghostwriting medical research studies that are then published in academic journals,” according to the New York Times. The Washington Post goes further, saying the studies “in effect accuse one of the world’s biggest pharmaceutical makers of various forms of scientific fraud.”

The ghostwriting article (PDF posted by the New York Times) tells of one draft Merck paper that had the byline listed as “External author?” Later, two researchers’ names were filled in as the primary authors.

A second article said Merck failed to completely account for deaths in a trial of Vioxx in people with mild dementia, although the company eventually gave all of its data to the Food and Drug Administration. The early report to the FDA included the number of people who died while taking the drug or soon after they stopped, but did not include deaths of those who stopped taking the drug months earlier.

Vioxx has since been withdrawn from the market because of concerns it causes heart problems. The company has agreed to a $4.85 billion settlement with Vioxx plaintiffs.

A Merck spokesman told the Post that the authors of the JAMA studies are “people in the pay of trial lawyers.” Authors of supposedly ghostwritten Vioxx articles contacted by the Post and New York Times said they had done substantial work on the studies and had contributed to the articles.

The Wall Street Journal reports that five of the JAMA articles’ six authors were paid consultants to Vioxx lawyers.

Merck research chief Peter Kim told the Wall Street Journal, “We are disappointed that such false and misleading statements about Merck from trial lawyers have made their way into a medical journal.”

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