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Drugmakers’ sway growing over studies

So much so that objectivity is in jeopardy, observers say

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.

“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 statement.

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 Dr. Steven 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.

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.

Maybe the most widely reported research controversy arose over the arthritis drug Vioxx, which had been featured positively in a NEJM article. The article reported the results of a trial that was funded by Merck and was co-written by two company researchers.

Five years later, journal editors reported discovering that the authors had omitted key incidences of heart troubles, creating “misleading” conclusions about the drug’s safety. Before the drug was pulled from the market, according to a review by an FDA investigator, it caused an extra 27,000 heart attacks and cardiac-related deaths.

Other industry-funded papers published in NEJM have led to conclusions that were later contradicted. Research published in NEJM regarding bestsellers such as the anemia drug Epogen and heart drug Natrecor has been challenged later by studies performed by other researchers.

“Unfortunately, the entire evidence base has been perverted,” said Joseph Ross, a professor at Yale Medical School who has studied the issue.

Just because industry-funded researchers arrived at conclusions that were later discarded does not mean that money biased their findings. Researchers get things wrong for lots of reasons – errors are a part of science.

But Ross notes that corporate bias can be particularly strong. The odds of coming to a conclusion favorable to the industry are 3.6 times greater in research sponsored by the industry than in research sponsored by government and nonprofit groups, according to a published analysis by Justin Bekelman, a professor at the University of Pennsylvania.

Moreover, at the same time that companies have been funding a larger share of research, they have shifted the job of conducting trials away from nonprofit academic hospitals to for-profit “contract research organizations.” Critics say that with this change, bias is less likely to be challenged.

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