REVEALED: The Explosive 2002 DEA PowerPoint about OxyContin Abuse

Late in my research for PHARMA, I received “a sealed brown manila envelope without a return address.” Two of those arrived several months apart, one with copies of documents that purported to be internal DEA and FDA documents from the early 2000s about the Drug agency’s investigation of abuse and diversion of OxyContin. The other included a thumb-drive that had a PowerPoint presentation. I subsequently confirmed the authenticity of those files although the sender has remained a mystery.

The PowerPoint I received was played at what I describe in PHARMA as “an extraordinary summit meeting with representatives from Purdue and the FDA at Drug Enforcement’s Washington headquarters.” That April 12, 2002 meeting had been called by Laura Nagel, from the DEA’s Office of Diversion Control. She was joined by drug agency colleagues, Frank Sapienza, chief of the Drug & Chemical Evaluation Section, Christine Sannerud, senior scientific advisor in the Diversion Control Division, and David Gauvin, a pharmacologist who was a senior drug science officer.

THE FDA was represented by Deborah Leiderman, director for controlled substances in the Center for Drug Evaluation and Research.

Purdue Pharma sent COO Michael Friedman, Chief Counsel Howard Udell, and its medical director, Paul Goldenheim.

The DEA team believed that OxyContin, on the market for only six years, had emerged a leading narcotic prescription favored by addicts and responsible for a growing number of overdose fatalities. DEA met resistance when trying to convince the FDA that the drug should be subject to stricter prescription refill regulations since it was abused and diverted widely in the black market. In order to convince the FDA of the size of the emerging OxyContin problem, the DEA had requested that the National Association of Medical Examiners collect and send two years of autopsies in which there had been “oxycodone positive toxicologies.”

The result of the DEA science team’s analysis of those autopsies is what is included in this 59-slide PowerPoint (warning: some of the slides are graphic). The Purdue representatives dismissed the results and did their best to raise doubts about the DEA’s methodology and accuracy. The DEA had expected that from Purdue. What shocked the DEA reps, however, is when the FDA sided with Purdue. As I write in PHARMA, “Nagel and Gauvin looked at each other in disbelief.” They later discussed whether the FDA “might have sabotaged their investigation.” Ultimately they concluded the FDA had backed Purdue to exercise its power in a bureaucratic turf war with the drug agency.

Whatever the reason for the FDA’s recalcitrance, its failure to back the DEA in the spring of 2002, gave Purdue an unrestricted free pass to continue its overzealous marketing and promotion of OxyContin.

For the first time in the public record, this is the PowerPoint that the FDA ignored 18 years ago.