Drug industry clinical trials and the resulting reports criticized

A bottle of Avandia, which has been recalled.

A Washington Post story the other day explained the conflict that some might think is inherent in pharmaceutical companies testing their own drugs before applying to the FDA for approval in advance of distribution to patients - and the difficulty in trying to detect the financially-induced bias of authors of papers that spin out of such clinical trials.

» A link to the story is here.
»  A link to howling protest from the Pharmaceutical Research and Manufacturers of America is here.

The story used the clinical trials by GlaxoSmithKline in the run-up to the release of the very problematic diabetes drug Avandia. As a Glaxo spokesperson says in the story, the current leadership of the company has changed since then.

Beyond the issue of the data and what it shows, there is the recurring problem of doctors and researchers paid by companies writing reports that eventually show up in publications, including the prestigious New England Journal of Medicine.

“I used to think that if studies were subject to rigorous peer review it would then be enough to simply disclose authors’ commercial ties,” Marcia Angell, who retired as editor in chief of NEJM in 2000 after more than 20 years at the publication, told the Post. “But I no longer believe that’s enough. It’s too hard for anyone — editors, peer reviewers, readers — to tell whether that bias has affected the work.”

Angell said in the story that a key change is that drug companies keep more testing in house, or control access to the information when they hire contract research organizations. Previously, more of the clinical testing was handled by academic institutions and others theoretically less beholden to profit-making companies.

“It used to be that drug companies would hand their new drug over to an academic center to have it tested, and then they sat back and waited,” Angell said, according to the Post. “Now they’re intimately involved in every step along the way, and they treat academic researchers more like hired hands.”

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