Last week, in response to mounting problems with the painkiller OxyContin, filed legislation in Congress to withdraw its Food and Drug Administration approval and remove it from the market. While the bill received a robust response from both supporters and opponents, there remains considerable misunderstanding as to the nature of the OxyContin threat.
This product is one of the most addictive substances to be sold legally in the United States. It is more addictive than cocaine and second only to heroin in addictiveness among narcotics. The premise of my legislation is that the drug is so inherently addictive that it is unsafe for the general population to whom it is being marketed and prescribed.
As originally approved, OxyContin was supposed to be for end-stage cancer patients and others with severe and escalating pain – those people for whom the drug’s addictive propensity was balanced by the extreme circumstances of the patient. Because of its overpowering addiction rate, the U.S. Drug Enforcement Agency described OxyContin as a painkiller of last resort.
However, as the Government Accountability Office has reported, Purdue Pharma has aggressively expanded the market for OxyContin to include patients who suffer from mild to moderate and intermittent pain related to broken bones, dental discomfort and lower back pain. In stunning testimony, a former district manager for Purdue Pharma in West Virginia disclosed that the company instructed sales reps to tell doctors “it is `virtually’ non-addicting.”
As a result of Purdue Pharma’s reckless marketing of OxyContin, the number of prescriptions exploded, and by 2003 nearly half of all OxyContin prescriptions were being written by primary care doctors, not pain management specialists.
The FDA issued three warning letters to Purdue Pharma about its unlawful marketing representations in May 2000, August 2001 and January 2003. In the last letter, Thomas Abrams, director of the FDA Division of Drug Marketing, Advertising and Communications, stated: “Your journal advertisements are misleading because they make prominent claims of effectiveness for pain relief, but omit from the body of advertisements crucial facts related to the serious, potentially fatal safety risks associated with the risks of OxyContin to be abused, and the limitations on its appropriate indicated use.”
Meanwhile, it appears the incidence of OxyContin addiction is going off the charts. Fifty-six percent of all OxyContin addictions have occurred in patients who were legally prescribed the drug.
My legislation would be unnecessary if manufacturer Purdue Pharma, which derives 80 percent of its profit from this one drug, took mitigating steps without congressional pressure.
It could, for instance, redesign the drug with a lower addiction rate and build in precautions to prevent OxyContin’s time-release feature from being overridden and abused. The manufacturer could provide consistent label warnings as to OxyContin’s addictive characteristics, and cease and desist its aggressive marketing of the drug by salespeople and “detailers” to primary care physicians. By restricting the distribution chain to specialists at pain clinics and hospitals, and by limiting the conditions for which OxyContin may be prescribed, the dangers could be greatly diminished.
Finally, Purdue Pharma should become more engaged in research and rehabilitation efforts aimed at treating those with OxyContin addictions. But until we see meaningful steps to make OxyContin safer, I have no other option than to seek its removal.