Saturday, May 7, 2016

OxyContin's 12-hour problem: An investigation with local ties

The drugmaker Purdue Pharma launched OxyContin two decades ago with a bold marketing claim: One dose relieves pain for 12 hours, more than twice as long as generic medications.

Patients would no longer have to wake up in the middle of the night to take their pills, Purdue told doctors. One OxyContin tablet in the morning and one before bed would provide "smooth and sustained pain control all day and all night."

On the strength of that promise, OxyContin became America's bestselling painkiller, and Purdue reaped $31 billion in revenue.

But OxyContin's stunning success masked a fundamental problem: The drug wears off hours early in many people, a Los Angeles Times investigation found. OxyContin is a chemical cousin of heroin, and when it doesn't last, patients can experience excruciating symptoms of withdrawal, including an intense craving for the drug.

The problem offers new insight into why so many people have become addicted to OxyContin, one of the most abused pharmaceuticals in U.S. history.

'Death was looking real good to me'

As a varsity athlete at the University of Central Florida and later a public school teacher, Burgess MacNamara was used to following rules.

That changed in 1999 when he had knee surgery and his doctor put him on OxyContin. MacNamara, then a 27­-year-old gym teacher at an elementary school near Orlando, was familiar with painkillers. He'd been given Percocet and Vicodin for sports injuries, but he said OxyContin was unlike anything he'd ever experienced.

"The first six hours, it is awesome," he said. Then the effect began to "teeter off" and he became preoccupied with his next dose: "That's all you think about. Your whole day revolves around that."

MacNamara said he soon began taking pills early.

"I can't even tell you the times I actually waited 12 hours," he said. "There weren't many of them."

Within a month, he was crushing and snorting the pills. Within a year, he was forging prescriptions. He eventually tried heroin, which was cheaper, and other drugs. MacNamara was arrested for forging prescriptions, possession of controlled substances, stealing pills from a school clinic and other drug-fueled crimes. He lost his teaching career and spent 19 months behind bars.

"Death was looking real good to me," recalled MacNamara, who said he has been sober for the last two and a half years.

The Times investigation, based on thousands of pages of confidential Purdue documents and other records, found that:

  • Purdue has known about the problem for decades. Even before OxyContin went on the market, clinical trials showed many patients weren't getting 12 hours of relief. Since the drug's debut in 1996, the company has been confronted with additional evidence, including complaints from doctors, reports from its own sales reps and independent research.
  • The company has held fast to the claim of 12-hour relief, in part to protect its revenue. OxyContin's market dominance and its high price — up to hundreds of dollars per bottle — hinge on its 12-hour duration. Without that, it offers little advantage over less expensive painkillers.
  • When many doctors began prescribing OxyContin at shorter intervals in the late 1990s, Purdue executives mobilized hundreds of sales reps to "refocus" physicians on 12-hour dosing. Anything shorter "needs to be nipped in the bud. NOW!!" one manager wrote to her staff.
  • Purdue tells doctors to prescribe stronger doses, not more frequent ones, when patients complain that OxyContin doesn't last 12 hours. That approach creates risks of its own. Research shows that the more potent the dose of an opioid such as OxyContin, the greater the possibility of overdose and death.
  • More than half of long-term OxyContin users are on doses that public health officials consider dangerously high, according to an analysis of nationwide prescription data conducted for The Times.
  • 'The higher you go, the more likely you are to die'

    OxyContin is still hugely popular. Doctors wrote 5.4 million prescriptions for the painkiller in 2014, and according to a Purdue spokesman, 80% were for 12-hour dosing.

    After years of the company telling doctors to answer complaints about duration with greater strengths of OxyContin, many patients are taking the drug at doses that public health officials now consider dangerously high.

    At The Times' request, scientists at the University of Arkansas for Medical Sciences analyzed OxyContin prescriptions in a database of insurance claims covering about 7 million patients across the country.

    In 2014, the analysis found, more than 52% of patients taking OxyContin longer than three months were prescribed doses greater than 60 milligrams a day. The Centers for Disease Control and Prevention issued guidelines in March urging physicians to "avoid" or "carefully justify" prescriptions of that strength.

    Told of the Arkansas analysis, Dr. Debra Houry, director of the CDC's National Center for Injury Prevention and Control and a leader of the agency's response to the opioid epidemic, called it "really concerning."

    "The higher you go, the more likely you are to die," she said.

    To this day, physicians frequently contact Purdue with questions about dosing. Only 12-hour dosing has been proved safe, the company tells them.

    Editor's Note: This story is an abbreviated version of a Los Angeles Times investigation. To see the full project, click here.


    Source: OxyContin's 12-hour problem: An investigation with local ties

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