Drug-Research Scandal: Patients Lose Again

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Isn't anyone looking out for patients' welfare these days?

Last week we read about how the U.S. Food and Drug Administration was hampered from investigating problems at the compounding pharmacy accused of supplying tainted drugs linked to the recent meningitis outbreak that sickened nearly 500 and killed 34.

Then on Sunday a Washington Post investigation charged that the drug industry's growing influence over research on new medications has resulted in studies being manipulated to obscure dangerous side effects so the drugs will be approved by the FDA.

Over the past decade, reporter Peter Whoriskey wrote, controversies over highly profitable, blockbuster drugs such as Vioxx, Avandia and Celebrex have raised questions about whether pharmaceutical-company-funded research is often deliberately misleading in order to hide a drug's risks.

Among other things, a large number of studies published in prestigious medical journals have been carried out by scientists with financial connections to drugmakers - either the scientists were employees who owned company stock, or academic experts who had received generous grants and consulting fees from a company - raising serious questions about bias.

"Company executives seeking to promote their drugs can design research that makes their products look better. They can select like-minded academics" - whom they pay - "to perform the work. And they can run the statistics in ways that make their own drugs look better than they are. If troubling signs about a drug arise, they can steer clear of further exploration," Whoriskey wrote.

In the case of Avandia, for example, which became the subject of a Senate investigation, the heart dangers of the drug were masked by a number of tactics, Whoriskey reported, including publishing incomplete trial data or not publishing overly negative trials. The drug was subsequently approved and, by one FDA estimate, was later associated with 83,000 heart attacks and deaths before being pulled from pharmacy shelves.

It took a cardiologist, Steven E. Nissen, M.D., of the Cleveland Clinic, and a colleague, Kathy Wolski, to do the right thing - comb through the data of every trial of Avandia, including a large number that had been unpublished - to confirm that the medication raised the risk of heart attack by elevating cholesterol.

"If you looked closely at the data that was out there, you could see warning signs," Nissen told the Washington Post. "But they were overlooked." Avandia's maker, GlaxoSmithKline, said it acted properly throughout.

Nissen and Wolski submitted their findings to the New England Journal of Medicine in 2007, but it wasn't until 2010 that the FDA announced major restrictions on the use of Avandia, and 2011 when the agency announced the drug would no longer be sold.

The question is, why should it be left to an individual hero - a determined doctor or a persevering journalist - to do what the government approval process should be doing?

Unfortunately, part of the problem is that the government is now funding a smaller share of drug research than the pharmaceutical industry is.

As the editor in chief of the New England Journal of Medicine, Jeffrey M. Drazen, M.D., told the Post he has "no illusions about what the demand for profits can do to pure motives," but he noted that the "stakes are highest for patients."

There is now a push for more transparency and to compel drug companies to release all of the data from trials. But has the damage already been done? Increasingly, patients are left wondering if anyone is looking out for their welfare and not just the bottom line.

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