The Promotion and Marketing of OxyContin: Commercial Triumph, Public Health Tragedy
▻https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2622774
Un article scientifique de 2009 sur le marketing d’Oxycontin.
OxyContin’s commercial success did not depend on the merits of the drug compared with other available opioid preparations. The Medical Letter on Drugs and Therapeutics concluded in 2001 that oxycodone offered no advantage over appropriate doses of other potent opioids.3 Randomized double-blind studies comparing OxyContin given every 12 hours with immediate-release oxycodone given 4 times daily showed comparable efficacy and safety for use with chronic back pain4 and cancer-related pain.5,6 Randomized double-blind studies that compared OxyContin with controlled-release morphine for cancer-related pain also found comparable efficacy and safety.7–9 The FDA’s medical review officer, in evaluating the efficacy of OxyContin in Purdue’s 1995 new drug
application, concluded that OxyContin had not been shown to have a significant advantage over conventional, immediate-release oxycodone taken 4 times daily other than a reduction in frequency of dosing.10 In a review of the medical literature, Chou et al. made similar conclusions.11
The promotion and marketing of OxyContin occurred during a recent trend in the liberalization of the use of opioids in the treatment of pain, particularly for chronic non–cancer-related pain. Purdue pursued an “aggressive” campaign to promote the use of opioids in general and OxyContin in particular.1,12–17 In 2001 alone, the company spent $200 million18 in an array of approaches to market and promote OxyContin.❞
From 1996 to 2001, Purdue conducted more than 40 national pain-management and speaker-training conferences at resorts in Florida, Arizona, and California. More than 5000 physicians, pharmacists, and nurses attended these all-expenses-paid symposia, where they were recruited and trained for Purdue’s national speaker bureau.19(p22)
In much of its promotional campaign—in literature and audiotapes for physicians, brochures and videotapes for patients, and its “Partners Against Pain” Web site—Purdue claimed that the risk of addiction from OxyContin was extremely small.43–49
Purdue trained its sales representatives to carry the message that the risk of addiction was “less than one percent.”50(p99)
In 1998, Purdue distributed 15 000 copies of an OxyContin video to physicians without submitting it to the FDA for review, an oversight later acknowledged by Purdue. In 2001, Purdue submitted to the FDA a second version of the video, which the FDA did not review until October 2002—after the General Accounting Office inquired about its content. After its review, the FDA concluded that the video minimized the risks from OxyContin and made unsubstantiated claims regarding its benefits to patients.19
When OxyContin entered the market in 1996, the FDA approved its original label, which stated that iatrogenic addiction was “very rare” if opioids were legitimately used in the management of pain. In July 2001, to reflect the available scientific evidence, the label was modified to state that data were not available for establishing the true incidence of addiction in chronic-pain patients. The 2001 labeling also deleted the original statement that the delayed absorption of OxyContin was believed to reduce the abuse liability of the drug.19 A more thorough review of the available scientific evidence prior to the original labeling might have prevented some of the need for the 2001 label revision.