Rising painkiller addiction shows damage from drugmakers’ role in shaping medical opinion

●A review of 16 key clinical trials on the subject shows that five were funded by Purdue and an OxyContin distributor, two were co-authored by Purdue employees, and two were sponsored by other drug companies making different opioids. None of the 16studies showed clear warnings about the addiction dangers or the physical dependence generated by the drugs. The low rate of addiction reported in these studies is at odds with more recent findings indicating that diagnoses of addiction are common in opioid patients.

●Internal company documents indicate that one of the key published studies sponsored by Purdue — the one reprinted 10,000 times — omitted suspected cases of withdrawal symptoms. The published paper offered assurance that only two of more than 100 OxyContin patients had withdrawal symptoms; the internal documents showed that at least 11 exhibited possible signs of withdrawal, and some experts say it is likely that at the doses given, most of the patients would have experienced withdrawal.

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Prescriptions for opioid painkillers are rising.

●To refine its policy on opioids, the FDA convened a key meeting in 2002 and invited 10 outside experts for advice. Five of them reported having served as speakers or investigators for Purdue. Three others reported working as speakers for or as advisers and consultants to other pharmaceutical companies.

One of those FDA advisers, Russell Portenoy, who was then the chair of the Department of Pain Medicine and Palliative Care at the Beth Israel Medical Center in New York, has since expressed regret for his evangelism on behalf of opioids.

He was “trying to create a narrative so that the primary care audience would . . . feel more comfortable about opioids,” Portenoy said in a 2010 interview with Andrew Kolodny, the chief of a group seeking to rein in drug use, Physicians for Responsible Opioid Prescribing. “Because the primary goal was to destigmatize [opioids], we often left evidence behind. . . .

“To the extent that some of the adverse outcomes now are as bad as they have become in terms of endemic occurrences of addiction and unintentional overdose deaths, it’s quite scary to think about how the growth in that prescribing driven by people like me led in part to that occurring.”

Through a spokesman, Portenoy declined to comment for this report, but he has said that he continues to believe that many patients with chronic pain can benefit from opioids, though the estimates of how many patients may become addicted are larger than previously thought.

At the time of the 2002 FDA meeting, Portenoy reported being a speaker for Purdue Pharma. He also reported involvements on contracts and grants with Parke-Davis, Boehringer Ingelheim, Elan, Ortho Biotech, Endo, Ametek, Medtronic, Purdue Pharma, Pfizer, Janssen, Abbott, Curatech, Ortho-McNeil and Searle.

James Heins, a spokesman for Purdue, said that “it is implausible that our marketing caused an upsurge in overall prescriptions of opioids or in the incidence of abuse” because the company commands only a small portion of the painkiller market.