A Healthy Dose of Skepticism Is Well Justified

On Sept. 22, 2012, the New England Journal of Medicine (NEJM) published a noteworthy study assessing how disclosures about funding sources for clinical trials evaluating new drugs affect physicians’ confidence in the results of those trials and their willingness to prescribe the drug being evaluated.

The study asked board-certified internists to review abstracts describing clinical trials for three hypothetical new drugs. Each abstract disclosed one of three sources of funding: a drug company, the National Institutes of Health (NIH) or none. The internists then answered standardized questions about their perceptions of the trials.

Not surprisingly — and indeed, reassuringly — the researchers found that the 269 physicians who participated in the study had the least confidence on average in the results of hypothetical studies funded by drug companies and were least willing to prescribe the drugs evaluated in the drug-company-sponsored trials. In contrast, physicians’ confidence in results and willingness to prescribe the studied drug were highest for those hypothetical trials funded by the NIH.

However, in a disappointing and troubling editorial entitled “Believe the Data” that accompanied the NEJM study results, the NEJM editor-in-chief, Dr. Jeffrey Drazen, essentially encouraged physicians to disregard the funding source of clinical trials testing new drugs when weighing the reliability of the evidence from such trials and deciding whether to begin prescribing these drugs.

Despite decades of well-documented bad behavior by the pharmaceutical industry, Dr. Drazen shamelessly sought to defend the interests of this leading source of advertising revenue for the NEJM.

History is filled with examples of drug companies only publishing data from clinical trials demonstrating the positive effects of a new drug, while the results of similarly designed trials showing no benefit are go unpublished. In studies that are published, drug companies routinely seek to present the data in the most positive light and, in some cases, withhold critically important data showing that the drug tested is not as safe or effective as portrayed.

As readers of Worst Pills, Best Pills News are well aware, a healthy dose of skepticism about data from industry-sponsored clinical trials presented in medical journals, even those as prestigious as the NEJM, is well-justified.