Billie Taylor, a former Oxycontin user who has remained off the drug since… (Joel Prince/For The Washington…)
Over much of the past decade, the official word on OxyContin was that it rarely posed problems of addiction for patients.
The label on the drug, which was approved by the FDA, said the risks of addiction were “reported to be small.”
The New England Journal of Medicine, the nation’s premier medical publication, informed readers that studies indicated that such painkillers pose “a minimal risk of addiction.”
Another important journal study, which the manufacturer of OxyContin reprinted 10,000 times, indicated that in a trial of arthritis patients, only a handful showed withdrawal symptoms.
Those reassuring claims, which became part of a scientific consensus, have been quietly dropped or called into question in recent years, as many in the medical profession rediscovered the destructive power of opiates. But the damage arising from those misconceptions may have been vast.
The nation is confronting an ongoing epidemic of addiction to prescription painkillers — more widespread than cocaine or heroin — that has left nearly 2 million in its grip, according to federal statistics.
“It turns out that the doctors didn’t know what they were talking about,” said Barbara Howard, whose daughter Leslie, a home-care nurse, died of an overdose in 2009 in this small Appalachian town devastated by the epidemic. She had developed a habit after knee surgery. She left behind a 9-year-old son.
“Leslie trusted the doctors. We thought the doctors knew what was best. But they didn’t. We — and lots of the other victims — had no warning.”
Conflicts of interest
A closer look at the opioid painkiller binge — retail prescriptions have roughly tripled in the past 20 years — shows that the rising sales and addictions were catalyzed by a massive effort by pharmaceutical companies to shape medical opinion and practice.
Opioids are a class of powerful drugs, often used for pain, that includes morphine, heroin and brand names such as OxyContin, Vicodin and Percocet.
For years, doctors had been cautious about prescribing opioids to anyone except patients with cancer or in acute pain.
But drug manufacturers and some pain specialists helped create a body of scientific research assuaging the long-standing worries about opioids and pushed to expand the use of the drugs in people with chronic pain — bad backs, arthritis, sore knees.
Their studies reported minimal risks of addiction and dependence. These, in turn, were accepted by the FDA and the nation’s medical journals. State medical boards made their rules for prescribing opioids more liberal. Academic and industry articles dismissed the old fears as “opiophobia.”
These reports reached doctors through marketing efforts and told them that there were few risks in using opioids to treat chronic pain.
But according to a Washington Post examination of key scientific papers, a court document and FDA records, many of those claims were developed in studies supported by Purdue Pharma, the maker of OxyContin, or other drug manufacturers. In addition, the conclusions they reached were sometimes unsupported by the data, and when the FDA was struggling to come up with an opioid policy, it turned to a panel populated by doctors who had financial relationships with Purdue and other drugmakers.
●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.
●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.