False marketing of overtly addictive drugs is performed daily without consequence. Purdue Pharma, L.P., makers of the highly addictive OxyContin (oxycodone HCl controlled-release), has made this clear.

According to the Food and Drug Administration (FDA), Purdue Pharma L.P. circulated false Direct-to-Consumer (DTC) advertising through their endorsements of OxyContin in the world�s most prestigious medical journal, the Journal of the American Medical Association (JAMA). The division of Drug Marketing, Advertising and Communications of the FDA sent a letter to Purdue Pharma stating that they were in clear violation of FDA regulations. Their violation: making unsubstantiated claims of effectiveness and grossly overstating the safety profile of OxyContin while promoting it for obtaining a �Life with Relief.� Despite Purdue Pharma�s non-compliance with the law, the FDA did not press charges. As a result, their false marketing continues.

Putting wealth before health, Purdue Pharma L.P. distributed 15,000 copies of an OxyContin video to physicians without submitting it to the FDA for review. Entitled �I Got My Life Back: Patients in Pain Tell Their Story,� the video presented pain relief experiences of various patients and the pain medications, including OxyContin, they had been prescribed. FDA regulations require pharmaceutical manufacturers to submit all promotional materials for approved prescription drug products to the FDA at the time of their initial use. Purdue Pharma L.P. did not comply with this regulation. Thus, the FDA did not have an opportunity to review the video to ensure that the information it contained was truthful, balanced, and accurately communicated. Purdue and the FDA acknowledged the oversight of not submitting the video to FDA for approval. No action was taken.

Releasing a second version of the video, Purdue Pharma L.P. followed legal procedure by submitting it to the FDA for review. Though, in its report to Congress, the U.S. General Accounting Office (GAO) stated that the FDA failed to review the video. Later, it was discovered that it, like the first video, made unsubstantiated claims and minimized the risks associated with taking OxyContin. Most astounding, Purdue Pharma L.P. claimed that OxyContin had been shown to cause addiction in less than 1 percent of patients - a damned lie.

Pushing for approval by the FDA in 1995, Purdue Pharma L.P. insisted that OxyContin be used only for cancer pain. Purdue Pharma sold $1 billion worth of OxyContin in less than five years from the time of its approval thanks to false DTC advertising. In addition to profits, false marketing has led to devastating effects on those people who were prescribed Oxycontin under the wrong conditions. Consider that the number of people who used OxyContin for illicit purposes at least once increased from 399,000 to 957,000 in a single year.[1]

Recognizing the dangers of OxyContin, the Drug Enforcement Agency (DEA) has listed OxyContin as a Schedule II controlled substance in the USA. According to the DEA, since its release on the market, the annual number of prescriptions for the �synthetic morphine� has risen from around 300,000 to nearly 6 million. During that same period, the number of oxycodone-related deaths has skyrocketed by 400%. Currently, OxyContin is the number one prescribed Schedule II narcotic in the United States.

Exactly how OxyContin works in the body is not understood. But its dangers are well documented. OxyContin is an opiod agonist (narcotic), which possesses powerful addictive properties. These addictive properties are akin to heroin and morphine and know no boundaries of destruction. Its addictive nature can smother even the strongest of wills. OxyContin produces respiratory depression. Additionally, Oxycodone causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum. As a result, digestion of food in the small intestine is delayed or nonexistent, and propulsive contractions are decreased, culminating in constipation and the back up of fecal matter.

False advertising is the number one tool used by drug companies to turn perfectly healthy people into patients. While the FDA has acknowledged Purdue Pharma�s indiscretions by acting as a paper tiger, it has done nothing to ameliorate it. They have failed as the self-proclaimed custodians of national health.

Footnotes:

1 Health and Human Services press release. September 5, 2002.