Monday, November 19, 2012

Physicians' Healthy Skepticism About Pharma-Funded Research

"Is Big Pharma getting too much flak from doctors?" That's the title of a recent Reuters article (find it here) that reviews a Harvard study published in the New England Journal of Medicine (NEJM). The study found that physicians were half as willing to prescribe drugs studied in industry-funded trials as they were to prescribe drugs studied in NIH-funded trials of equal scientific rigor.

In an editorial response, editor-in-chief Dr. Jeffrey Drazen listed the steps the journal has to improve the reporting of clinical trials such as publishing study protocols and posting the financial associations of study authors. Drazen also noted that "NIH-sponsored studies also have substantial incentives, including academic promotion and recognition, to try to ensure that their studies change practice."

Pardon me if I don't believe the career incentives of NIH scientists are on par with the huge financial incentives of pharma companies, some of which have been found guilty of "spinning" unfavorable data (e.g., the Merck VIOXX scandal; see here and here) and hiding important safety information (e.g., GSK and Avandia; see here).

"A trial's validity should ride on the study design, the quality of data-accrual and analytic processes, and the fairness of results reporting," said Drazen. "Ideally, these factors — not the funding source — should be the criteria for deciding the clinical utility."

The study authors, however, had this to say about that: "Financial disclosure is important, but more fundamental strategies, such as avoiding selective reporting of results in reports of industry-sponsored trials, ensuring protocol and data transparency, and providing an independent review of end points, will be needed to more effectively promote the translation of high-quality clinical trials — whatever their funding source — into practice."

The steps taken by the NEJM and other medical journals may address some of these concerns, but nothing they do can unearth situations where drug companies and their paid researchers criminally hide safety data or selectively report positive results. How is a journal going to discover that? And since there is past incidents where this has happened, IMHO physicians SHOULD be skeptical of trial results sponsored by pharma companies and perhaps not prescribe new drugs to their patients until there is independent confirmation that the results are valid.

The drug industry, however, also plays a big role in this "validation" process AFTER trial results are published. "Key Opinion Leaders," paid by pharma companies, are often deployed to spread the word and influence other physicians to prescribe the product*. But at least physicians can get other, less biased, opinions from their colleagues. This may be where "gated" online physician forums can be helpful (see here).

*Speaking of physicians deployed by pharma to spread the word, A recent Journal Sentinel/MedPage Today investigation found the growth in Advair sales followed new asthma treatment recommendations that were written largely by doctors who received money from GlaxoSmithKline and other companies that market the drugs. The picture of how a potentially dangerous drug became commonly prescribed comes from a Journal Sentinel/MedPage Today review of transcripts of FDA hearings, financial disclosures, medical journal articles and a U.S. Department of Justice complaint against GlaxoSmithKline. Read more here...

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