Friday, October 11, 2013

Editorial: FDA seems too cozy with manufacturers of pain pills


Oct. 11, 2013 @ 12:00 AM

Pain pill abuse is arguably today's most devastating drug abuse trend.

Illicit marijuana use is more prevalent, with an estimated 31 million saying they have used pot or hash in the past year, according to the 2012 National Survey on Drug Use and Health.

But the number of people abusing pain pills has risen to about 12.5 million -- about three times the level of cocaine or hallucinogens, according to the survey -- and the impact on families and crime is much more severe. The link between prescription drug addiction and rising rates of heroin use only makes it worse.

Even more disturbing is that these are legal drugs, sanctioned by the government and generating billions in profits for drug manufacturers and distributors. Unfortunately, both the regulators and the industry could have done more to avoid the explosion of abuse, and the sometimes cozy relationship between the two could be a big part of the problem.

This week, the Washington Post put the spotlight on that issue with a report that private companies paid as much as $25,000 to participate in the Food and Drug Administration's advisory panel discussions on federal regulations for prescription painkillers.

The panel was organized by two medical professors, Robert Dworkin of the University of Rochester and Dennis Turk of the University of Washington, to give FDA advice on how to evaluate evidence from clinical trials, the newspaper reported. The money went to the researchers and not the FDA, but it raises many red flags.

"Instead of protecting the public health, the FDA has been allowing the drug companies to pay for a seat at a small table where all the rules were written," said Craig Mayton, a Columbus, Ohio, attorney who helped reveal the practice.

U.S. Sen. Joe Manchin (D-W.Va.), who has advocated for tighter restrictions on the marketing of pain pills, has called for an FDA investigation of the "pay to play" allegations.

"If these allegations are true, they explain why it has taken the FDA almost a year to reach a decision to reschedule hydrocodone even after their own expert advisory panel recommended it," Manchin said in a press release. "It is a shame that some of these companies were able to influence the FDA's decision with a $25,000 contribution, while West Virginian families are destroyed by the addiction these pills cause."

The public certainly deserves some answers on this panel process.

But more importantly, closer scrutiny of the industry's role in the expansion of the market for these drugs is long overdue. What portion of that production is being diverted to abuse and what is being done to stop it? It is time to hold drug manufacturers more accountable.

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