As drug industry’s influence over research grows, so does the potential for bias

(Dustin Franz/ FOR THE WASHINGTON POST ) - Steven Nissen, a heart specialist at The Cleveland Clinic, has linked pharmaceutical drugs such as Vioxx and Avandia with high cardiovascular risks in patients.

(Dustin Franz/ FOR THE WASHINGTON POST ) - Steven Nissen, a heart specialist at The Cleveland Clinic, has linked pharmaceutical drugs such as Vioxx and Avandia with high cardiovascular risks in patients.

For drugmaker GlaxoSmithKline, the 17-page article in the New England Journal of Medicine represented a coup.

The 2006 report described a trial that compared three diabetes drugs and concluded that Avandia, the company’s new drug, performed best.

Graphic

Conflicted influences
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Conflicted influences

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The connections between article authors and pharmaceutical companies.
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The connections between article authors and pharmaceutical companies.

“We now have clear evidence from a large international study that the initial use of [Avandia] is more effective than standard therapies,” a senior vice president of GlaxoSmithKline, Lawson Macartney, said in a news release.

What only careful readers of the article would have gleaned is the extent of the financial connections between the drugmaker and the research. The trial had been funded by GlaxoSmithKline, and each of the 11 authors had received money from the company. Four were employees and held company stock. The other seven were academic experts who had received grants or consultant fees from the firm.

Whether these ties altered the report on Avandia may be impossible for readers to know. But while sorting through the data from more than 4,000 patients, the investigators missed hints of a danger that, when fully realized four years later, would lead to Avandia’s virtual disappearance from the United States:

The drug raised the risk of heart attacks.

“If you looked closely at the data that was out there, you could see warning signs,” said Steven E. Nissen, a Cleveland Clinic cardiologist who issued one of the earliest warnings about the drug. “But they were overlooked.”

A Food and Drug Administration scientist later estimated that the drug had been associated with 83,000 heart attacks and deaths.

Arguably the most prestigious medical journal in the world, the New England Journal of Medicine regularly features articles over which pharmaceutical companies and their employees can exert significant influence.

Over a year-long period ending in August, NEJM published 73 articles on original studies of new drugs, encompassing drugs approved by the FDA since 2000 and experimental drugs, according to a review by The Washington Post.

Of those articles, 60 were funded by a pharmaceutical company, 50 were co-written by drug company employees and 37 had a lead author, typically an academic, who had previously accepted outside compensation from the sponsoring drug company in the form of consultant pay, grants or speaker fees.

The New England Journal of Medicine is not alone in featuring research sponsored in large part by drug companies — it has become a common practice that reflects the growing role of industry money in research.

Years ago, the government funded a larger share of such experiments. But since about the mid-1980s, research funding by pharmaceutical firms has exceeded what the National Institutes of Health spends. Last year, the industry spent $39 billion on research in the United States while NIH spent $31 billion.

The billions that the drug companies invest in such experiments help fund the world’s quest for cures. But their aim is not just public health. That money is also part of a high-risk quest for profits, and over the past decade corporate interference has repeatedly muddled the nation’s drug science, sometimes with potentially lethal consequences.

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