Alleged drug industry ties add twist to saga of oxycontin regulations

Oxy_DEA_250.jpgWith the rapid rise in deaths attributed to narcotic painkillers, the US Food and Drug Administration (FDA) plans to further restrict their use in the clinic in the next few months when it introduces new regulations, which might include the establishment of patient registries and training doctors on their use.

Now, an article in Saturday’s Milwaukee Journal Sentinel alleges that two prominent critics of such restrictions, David Joranson and Aaron Gilson from the University of Wisconsin School of Medicine and Public Health, may have been influenced by funding they received from drug manufacturers, including oxycontin producer Purdue Pharma. Joransen co-authored a consensus statement from the American Pain Society and the American Academy of Pain Medicine emphasizing the safety of these medications.

The alleged industry influence is only the latest twist in the topsy-turvy saga of opioid regulations. In February 2009, the FDA issued notices to 16 manufacturers of narcotic painkillers to develop so-called Risk Evaluation and Mitigation Strategies (REMSs) to reduce the number of accidental overdoses. But the following year, the FDA’s advisory committee struck down the plan due to concerns that the proposed regulations were insufficient to prevent the misuse, abuse and deaths due to these medications.

While the FDA mulls over the new rules, doctors remain concerned that these regulations will make it harder to treat patients struggling with chronic pain. Just last week, at the annual meeting of the American Academy of Pain Medicine, physicians urged the FDA to consider instead state-run drug monitoring programs.

So whatever form the FDA rules take, they will not necessarily win over everyone.

Image: DEA

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