News

US drug maker resisted changes to its opioid dosing recommendations to protect revenue, newspaper alleges

BMJ 2016; 353 doi: https://doi.org/10.1136/bmj.i2683 (Published 11 May 2016) Cite this as: BMJ 2016;353:i2683
  1. Michael McCarthy
  1. Seattle

The drug manufacturer Purdue Pharmaceuticals resisted efforts to change the dosing recommendations for its long acting opioid OxyContin to protect its revenues, the Los Angeles Times has alleged in an investigative report published on 5 May.1

The company, however, has strongly rejected the paper’s claims. “In an attempt to resurrect a long-discredited theory, the paper ignores the clinical and regulatory data that directly contradicts their story,” Purdue said in a statement.

The report stated that Purdue had continued to promote its claim that the drug gave 12 hour pain relief despite evidence from clinical trials and reports from doctors in practice that, for many patients, it was much shorter acting. This caused patients to experience a cycle of relief and withdrawal that increased their risk of addiction, the newspaper reported.

The report said, “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.”

Rather than instructing doctors to prescribe the drug more frequently Purdue had recommended prescribing higher doses, increasing the odds of overdose and death, the newspaper alleged. It added, “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.”

The company, however, said that the US Food and Drug Administration’s support for 12 hour dosing of OxyContin was based on more than a dozen controlled clinical studies. “The OxyContin label has been updated more than 30 times and at no point did FDA request a change to the dosing frequency,” said Purdue. “In fact, the FDA-approved label clearly states, ‘There are no well-controlled clinical studies evaluating the safety and efficacy with dosing more frequently than every 12 hours.’”

Given the FDA’s approved indications for OxyContin, Purdue could not have recommended more frequent dosing, the manufacturer argued, adding, “The FDA prohibits pharmaceutical companies from promoting their products for uses, including dosing, not approved by the agency. Given FDA has not approved OxyContin for eight hour use, we do not recommend that dosing to prescribers.”

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