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FOR IMMEDIATE RELEASE

Purdue Pharma Disputes DEA Analysis of Medical Examiner Reports

Stamford, CT - April 16, 2002 - Physicians from the U.S. Food & Drug Administration (FDA) and Purdue Pharma attended a meeting at the U.S. Drug Enforcement Administration (DEA) on April 12 to review for the first time the DEA’s interpretation of Medical Examiner reports on overdose deaths in which the analgesic oxycodone was present post mortem.  At the meeting, DEA presented an overview of past Medical Examiner reports received by the agency and suggested there had been an increase in the number of overdose deaths “attributed” to OxyContin^® (oxycodone HCl controlled-release) Tablets.  The DEA has acknowledged, however, that these terms do not mean that OxyContin^® was the cause of death.

Of the 949 complete Medical Examiner reports received by DEA covering a two-year period, 146 deaths were categorized by the DEA as “OxyContin verified” and 318 deaths were categorized as “OxyContin likely.”.  DEA acknowledged that the term “OxyContin verified” means only that the agency has concluded to its satisfaction that OxyContin was a source of the oxycodone present in the bloodstream — not necessarily the cause of death.  The term “OxyContin likely” is similarly used by the DEA to speculate on the source of the oxycodone found in the blood, but not on the cause of death.  The majority of post-mortem toxicology reports showed that multiple drugs were present. Purdue physicians strongly disagreed with the DEA's interpretation of these reports, which suffer from serious interpretive and methodological flaws that undermine the conclusions drawn.

Despite numerous requests by the company over the past year, the DEA has refused to share these Medical Examiner reports with Purdue, and declined on Friday to share the reports with the FDA — making it impossible to subject these reports to a proper scientific review by qualified experts. Purdue has already shared with the FDA the information the company has collected from a similar compilation of Medical Examiner reports and has repeatedly offered this information to the DEA.  The majority of the Medical Examiner reports received by Purdue as part of its regular drug safety monitoring concluded that polydrug toxicity, not any one drug alone, was the cause of death.

“While abuse of prescription medications, including OxyContin, poses serious health risks, including death, it is impossible to conclude and inappropriate to imply that OxyContin was the cause of death in the majority of cases characterized as ‘OxyContin likely’ or ‘OxyContin verified,’” said Paul Goldenheim, MD, senior physician and Executive Vice President of Worldwide Research and Development.  “And while there is no question that there have been deaths by overdose from the abuse of OxyContin, autopsy reports received by the company have confirmed that, in most cases, the deaths were due to polydrug toxicity.  Unfortunately, these reports reflect a pattern of drug abuse in the United States that results in thousands of such deaths every year.”

“While any death is tragic, Purdue believes that almost none of these reports involves overdoses by patients with legitimate medical needs using the medicine as prescribed under the treatment of a healthcare professional,” added Dr. Goldenheim.  “Testimony from medical experts and government officials at Congressional hearings and a recent FDA advisory committee meeting concluded that the benefits of OxyContin when used as directed clearly outweigh the risk associated with its intentional abuse.” 

The labeling for OxyContin contains the following warning:

Full prescribing information for OxyContin is available at http://www.purduepharma.com/PRESSROOM/PI/OXYCONTIN_PI.PDF

This and other recent announcements are available on the Purdue Pharma website at www.purduepharma.com.