Studies: Merck misled on Vioxx

The company has been named in 26,500 lawsuits by people saying they were harmed by Vioxx.

Washington Post

WASHINGTON — Two teams of researchers with access to thousands of documents gathered in lawsuits over the painkiller Vioxx allege that Merck Co. waged a campaign of deception to promote its drug, moving slowly to warn of possible hazards while at the same time dressing up in-house research as the work of independent academic researchers.

The reports in Wednesday’s Journal of the American Medical Association in effect charge one of the world’s biggest pharmaceutical makers with various forms of scientific fraud.

One study alleges Merck gave an incomplete accounting to the Food and Drug Administration of deaths in a clinical trial of Vioxx in people with mild dementia.

Federal regulators eventually got the data, which added to the growing evidence that Vioxx increased the risk of heart attack or stroke.

Simultaneously, Merck was using what the JAMA authors term “guest authorship and ghostwriting” to make it appear that research done by its own employees or contractors was the work of scientists in medical schools and universities.

That presumably gave the findings more credibility when they were published in medical journals, boosting Vioxx’s profile in the crowded painkiller market.

Vioxx, whose generic name is rofecoxib, went on the market in 1999. It became a “blockbuster” with $2.3 billion in sales in 2003 but was voluntarily withdrawn in September 2004 after several studies showed that it increased the risk of heart attacks and strokes.

Since then, Merck has been named in 26,500 lawsuits by people saying they were harmed by the drug.

Last fall, the company created a $4.85 billion fund to settle the claims while not admitting that Vioxx caused heart attacks, strokes or deaths.

The two JAMA papers — based on access to company documents made public through the lawsuits — claim to provide a look at practices widespread in the pharmaceutical industry.

This view was endorsed in an editorial signed by the journal’s editor, Catherine DeAngelis, who wrote, “But make no mistake — the manipulation of study results, authors, editors, and reviewers is not the sole purview of one company.”

Although the two studies question the integrity of dozens of physicians and scientists, the JAMA authors did not seek responses from them.

Several of those people called the conclusions incorrect, incomplete or unfair.

A spokesman for Merck’s legal team dismissed the JAMA authors as “people in the pay of trial lawyers.”