Ciunterfeiters are exploiting  intense demand for prescription drugs that can give a “high” comparable to cocaine, heroin or methamphetamines.

In the geographic area of Scandinavia (Scandinavia is a historical and geographical region centered on the Scandinavian Peninsula in Northern Europe and includes the three kingdoms of Denmark, Norway and Sweden. The other Nordic countries, Finland, Iceland and the Faroe Islands, are also sometimes included because of their close historic and cultural relations to Norway, Sweden, and Denmark) ,  demand for flunitrazepam  ( a sedative commonly branded with the trademark name of Rohypnol)  increasingly is being met by unauthorized production ; and in North America ( Canada , the U.S.A and Mexico)  where widespread use of prescription drugs , including the narcotic analgesic fentanyl – 80 times as potent as heroin – has been blamed for a spike in  drug related overdose deaths.  Indeed the makers of Oxycontin ( Purdue Pharma)  disputed the F.D.A. concern over deaths from the medication insisting that the deaths were circumstantial and not related to the painkiller medication.  The deaths were coincidental to the medication found in the deceased bodies and stomachs.

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Jim Heins

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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: