OxyContin Marketing Tactics Under Attack

Even though FDA officials and company executives maintain that Purdue Pharma hasn't violated any rules governing pharma advertising, critics who want to ban the sale of the painkiller OxyContin complain about the company's promotional excesses. At a hearing before the Senate Health, Education, Labor and Pensions (HELP) Committee in February, patient advocates blamed soaring abuse of the medication on company sales and advertising activities.

John Jenkins, director of the Office of New Drugs at FDA's Center for Drug Evaluation and Research, pointed out that Purdue has directed all its marketing for OxyContin to health professionals and not to consumers. There was one letter from FDA's Division of Drug Marketing, Advertising, and Communications in May 2000 complaining about false and misleading claims in an Oxy journal ad, but Purdue halted the promotion.

Paul Goldenheim, Purdue's vice-president of research, said the company trains its sales force to promote responsible prescribing of OxyContin and established a telephone hotline last July for physicians to report "inappropriate" actions by reps. Purdue also put a cap on commissions linked to any single high-prescribing doctor.

Jenkins and several health experts testified to the value of OxyContin in helping patients control chronic pain and to the importance of having a range of pain-control therapies to meet various medical needs. Richard Payne of Memorial Sloan-Kettering Cancer Center in New York pointed out that OxyContin's controlled-release formulation is an effective option for patients who cannot tolerate oral morphine. FDA has worked with Purdue to strengthen label warnings and to educate physicians and patients about ways to curb misuse and abuse of the therapy. The agency believes that the benefits of OxyContin outweigh the risks, Jenkins concluded.

The long-term solution to OxyContin abuse may be to reformulate the product, adding an opioid antagonist that blocks the "high" abusers get by crushing the sustained release tablet before consuming it. Purdue has launched clinical studies to see if adding another active ingredient compromises the product's effectiveness or exposes patients to additional adverse events. Even if the new product is safe and effective, the blocking action of the test formulation works only when taken by injection or snorting-not orally. Reformulation may help curb abuse, commented Wesley Clark of the Substance Abuse Mental Health Services Administration, but he expects that abusers will figure out how to defeat the blocker.