OxyContin Controversy—The 12 Hour Pain Relief Lie That May Have Caused An Epidemic

By Paul Gaita 05/09/16

Purdue Pharma reportedly knew OxyContin did not provide 12-hour relief for decades, but maintained its efficacy to remain relevant in the pain med industry.  

Oxycontin Controversy—The 12 Hour Pain Relief Lie That May Have Caused An Epidemic
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The painkiller OxyContin is at the root of the prescription opioid epidemic that has plagued the United States since the late 1990s, and has claimed more than 190,000 lives. Now, an LA Times investigation has revealed that Purdue Pharma, the makers of OxyContin, aggressively marketed the drug as a 12-hour pain relief medication to doctors and patients, despite knowing for years that its efficacy wore off after just eight hours.

The Times reviewed three decades’ worth of internal documents from court cases and government investigations—many of which were sealed by the courts—including company emails and memos, Food and Drug Administration (FDA) records and medical journal files. From these thousands of pages, the investigation learned that: 

Purdue was aware that OxyContin did not provide 12 hours of relief for decades. A 1989 clinical study conducted by Purdue scientists at two hospitals in Puerto Rico found that in a study group of 90 women who were given the drug while recuperating from abdominal and gynecological surgery, more than a third complained about pain after eight hours and about half required more medication before reaching 12 hours. A subsequent study involving 164 cancer patients found that one third of the group found OxyContin “ineffective.” Despite these and many other similar tests, Purdue continued to develop the drug as 12-hour pain relief, and received FDA approval in 1995 based on the Puerto Rico study. 

Purdue maintained OxyContin’s 12-hour efficacy in part to maintain a foothold in the pain medication industry. The company had made its name and fortune on MS Contin, a morphine pill for cancer treatment, but in 1990 predicted a massive decline in revenue driven by generic competition as MS Contin's patent ran out. It found a solution in oxycodone, a pain relief medication also marketed as Percocet, and applied its delayed-release technique to extend the efficacy beyond the six hours of relief offered by most generics.

The resulting drug, OxyContin, was then marketed to family doctors and general practitioners as an effective cure for nearly all types of pain, taken just twice a day. Purdue spent $207 million in promotion—a 1996 ad featured in medical journals showed two dosage cups with the tag line, “Remember, effective relief just takes two.” Within five years, OxyContin was generating more than $1 billion in yearly sales for Purdue. By 2010, the drug accounted for a third of all sales revenues for painkillers that year.

Doctors who jumped on the OxyContin bandwagon discovered that the company’s claims did not match patients’ reports about the drug’s ability to relieve pain. Reports from Purdue sales representatives detailed statements from medical professionals who said that physicians were prescribing the drug for three or even four doses a day, which set off alarms within the company (“These numbers are very scary,” one sales manager notes). Purdue responded by telling sales reps to “refocus” clinicians back to a 12-hour schedule, and recommended increasing the strength of the dose instead of the frequency. Supervisors dangled financial bonuses and trips to Hawaii as an incentive to drive home this policy.

As a result, many patients began taking the drug at doses that were far higher than levels considered safe by public health offices like the Centers for Disease Control and Prevention (CDC). The Times asked scientists at the University of Arkansas for Medical Sciences to analyze OxyContin prescriptions in a database of insurance claims for 7 million patients. The results, published in 2014, found that 52% of patients taking OxyContin for more than three months were prescribed doses of 60 milligrams a day—strengths which the CDC urged doctors to avoid in guidelines published in March of this year. Research studies have also found that patients on higher doses of opioids were more likely to overdose; a study from Sunnybrook Health Sciences Centre in Ontario, Canada found that "a man taking high-dose opioids is more likely to die from his medication than almost anything else."

Patients began filing lawsuits against Purdue in the early 2000s, but the company has been effective in either neutralizing many of these claims or settling them on confidential terms. It did suffer a serious blow at the hands of the U.S. Department of Justice, which launched a criminal investigation in 2007 into marketing claims that OxyContin was less addictive than other painkillers. Three top executives pleaded guilty to fraud charges, and Purdue was ordered to pay $635 million. Despite this, the investigation did not address the claims of 12-hour efficacy; a 2013 investigation by the FDA was to feature testimony from Brown University professor Dr. David Egilman, an expert on warning labels, who claimed that Purdue had willfully ignored the science that proved OxyContin was ineffective as a 12-hour dose and had created an “addiction producing machine.” Purdue lawyers barred him from revealing confidential information and sealed testimony from company executives, which all but gutted his claims. 

In response to the Times’ article, Purdue submitted a one-page response that echoed the FDA assessment of OxyContin as a 12-hour drug. “Scientific evidence amassed over more than 20 years, including more than a dozen controlled clinical studies, supports FDA’s approval of 12-hour dosing for OxyContin,” wrote Dr. Gail Cawkwell, Purdue’s chief medical officer. Company officials added in the same statement that “Purdue [has] dedicated [itself] to helping address our nation’s opioid epidemic.”

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Paul Gaita lives in Los Angeles. He has contributed to the Los Angeles Times, Variety, LA Weekly, Amazon.com and The Los Angeles Beat, among many other publications and websites.