Revolving door from FDA to biopharma industry raises concerns about cronyism

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That darn pharma industry and our nation’s “for sale” faux regulatory agencies. There they go cajoling again.

In a letter published online just moments ago in the always eye-opening British Medical Journal, doctors Vinay Prasad and Jeffrey Bien of Oregon Health and Science University reveal a not-so-shocking truth: A large number of scientists, when they leave the U.S. Food and Drug Administration, go to work for the pharmaceutical industry they once were hired to scrutinize.

“Medical reviewers at the U.S. Food and Drug Administration are vital to effective regulation, interpreting whether a drug’s harm-benefit balance is favourable,” they wrote. “The transition from regulator to advising companies seems logical, but it raises concern as to whether regulators indefatigably act in the public interest.”

Indeed, it allows them to show pharma how to navigate loopholes, cut corners, and, heaven forbid, even work connections with their former employer for the gain of their client. This exact sort of thing is like, oh, I don’t know, former health care executives from hospitals with market dominance being appointed to boards that can effectively keep competition out (i.e., Strategic Behavioral Health’s proposal for a Bettendorf psychiatric hospital).

Monnnney-monnnney-monnnney-monnnney….MONNNNNEY!

The doctors searched the FDA database (drugs@FDA.gov) for medical reviews from 2001 to 2010, focusing on hematology-oncology (life-saving cancer drugs) approvals. The cost of these drugs, known as biologicals, are among the most astronomically priced on the market. But indeed, they save lives.

They identified 55 individual FDA reviewers who assessed the pharma applications for new medicines. Of those 55 during that time period, nearly half (27) continued to work for the FDA exclusively.

But among those who left the FDA, 15 (57.7 percent) landed in the biologics industry or served as consultants for it.

What’s even more concerning is that last month, according to a BMJ news release, “the FDA said it may loosen conflict of interest rules because a shortage of independent experts means that its current rule (no more than 13 percent of advisers with industry ties) is delaying new drug approvals.”

To reporters who have sat through decades of city council meetings in cities across the country like myself, this will ring familiar: City officials who depart the public rolls and then go to work for developers, for example. Nobody knows how to rip through red tape than the guys (and gals) who used to roll it out.

“We are concerned by these findings,” the authors wrote. “If anything, we underestimate the extent of this phenomenon, as not all reviewers’ future careers could be identified.”

Is it any wonder government and healthcare lack both efficiency and adequate oversight? Cronyism is costing this nation more than just billions of dollars, my friends.

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