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Prof. pushes for release of Vioxx documents

David Egilman wins legal right to request access to previously confidential papers

New documents may be released concerning Vioxx, a prescription drug that has come under fire in the past few years for its correlation with negative health effects, after litigation efforts by David Egilman, clinical professor of family medicine. 

A Kentucky court ruling last week granted Egilman the right to ask Merck — the pharmaceutical company that produced the drug — to release several documents previously marked confidential. But Merck could still deny Egilman’s request.

Vioxx, which was widely prescribed as a painkiller, left the market in 2004 after evidence surfaced that chronic use of the drug is linked to heart attacks and strokes. Egilman co-authored a study published in 2010 that found patients taking Vioxx were at higher cardiovascular risk than other patients on a placebo, and he has served as an expert witness for many lawsuits against the company.

Some legal and medical experts have doubted Merck’s timeliness in pulling Vioxx from the market, Egilman said. The company may have had sufficient evidence showing the health risks associated with the drug months or years before it left shelves. Gaining access to the new Merck documents could provide an additional sign of Merck’s questionable research methods and the negative effects Vioxx has had on its users, he added.

“They’re hiding memos and data about how they misled people that could be important for public health purposes,” he said.

In 2008, Egilman assisted in finding that the company used ghostwriters in its publications, allowing guest scientists unaffiliated with the company to sign off on them without having actually written the documents, The Herald reported at the time.

“Merck is confident we have acted responsibly, from researching Vioxx prior to approval, to monitoring it while it was on the market, and to voluntarily withdrawing it when we did,” wrote Lainie Keller, Merck’s director of global communications, in an email to The Herald.

If Egilman gains access to the documents, he plans to release them to the U.S. Food and Drug Administration and the Yale Open Data Access Project, he said.

The YODA Project is “an effort to try to facilitate the distribution of data and promote open science,” said Harlan Krumholz, professor of cardiology at Yale and the project’s principal investigator. The initiative evaluates clinical trial data to ensure physicians are prescribing pharmaceuticals and administering medical devices correctly.

While the Vioxx debate is an ongoing issue, when a company releases its documents, it shows its commitment to scientific integrity, Krumholz said.

“Science has historically sequestered data,” he said, adding that when people consent to participate in experiments, the data should be a public good.

The Vioxx discussion demonstrates the need for more accountability of drug companies, Egilman said. In many cases, they face only small repercussions after thousands of people have been harmed, he added.

Egilman previously grappled with the pharmaceutical company producing the drug Zyprexa — an antipsychotic prescribed for schizophrenia and bipolar disorder — by pushing for the drug’s documents to become public. He admitted to previously violating a protective order for leaking Zyprexa’s documents and paid a $100,000 fine, the New York Times reported in 2007.


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