By Melanie R. Margolis
The Drug Enforcement Agency (DEA) takes its job very seriously. In its quest to stop abuse of controlled substances, the DEA has instilled fear in the hearts of physicians who prescribe them. Physicians who fear disciplinary action or prosecution for over-prescribing controlled substances may fail to relieve preventable pain in patients. The undertreatment of pain in America is well-documented. See, e.g., S. Van McCrary, Discipline of Oregon Physician for Undertreating Pain is an Appropriate Response to a Serious Problem at Bioethics/990921Discipline.html and R. Scott, Physician Disciplined for Undertreating Pain at Bioethics/990913Physician.html.
The Controlled Substances Act of 1970 (CSA) is the source of the DEA's authority to regulate controlled substances. The CSA requires that controlled substances be prescribed only for a "legitimate medical purpose." While relieving legitimate pain is such a purpose, uncertainty has interfered with the prescribing of adequate medication for pain relief.
In an unprecedented move, the DEA made it clear that it does not intend to restrict legitimate pain prescriptions. The DEA, along with twenty-one health organizations, issued its first-ever consensus statement on pain relief. The statement, entitled "Promoting Pain Relief and Preventing Abuse of Pain Medications: A Critical Balancing Act," is available at http://www.lastacts.org/briefingoct01/Consensus.pdf. Announced on October 23, 2001, the statement demonstrates the consensus of the DEA and these health organizations as to the following:
The DEA recently launched a study of OxyContin®, marking the first time the DEA has looked into the link between a brand name drug and deaths caused by overdose. See, e.g., B. Meier, Overdoses of Painkiller Are Linked to 282 Deaths, New York Times, section 1A, page 20 (Oct. 28, 2001). The DEA has investigated the links between certain active ingredients (used in many drugs) and overdose deaths, but never before has the DEA looked at the connection between a specific brand name drug and overdose deaths -- and never before has the DEA encountered a drug quite like OxyContin®.
OxyContin®, a controlled substance for controlling pain, is available only by prescription; however, OxyContin® has not only become popular among patients legitimately in need of pain medication, but it has become incredibly popular among drug abusers. Terrance W. Woodworth, a deputy director at the DEA, testified before the House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations on August 18, 2001 concerning OxyContin®. He said:
The DEA estimates that OxyContin® is responsible for 282 overdose deaths in the last 19 months. At issue in the study is the marketing of the drug by maker Purdue Pharma. Purdue Pharma promoted the drug by distributing free 7-day supplies of OxyContin® to physicians. The physicians distributed the free OxyContin® to patients to whom the physicians were prescribing OxyContin®. The DEA questions the practice of handing out free prescriptions when the maker was aware of reports of abuse of the drug. Purdue Pharma counters that the freebies were only given to patients with a prescription for, and in legitimate need of, the drug, and were therefore, not contributing to the misuse of the drug.