DEA Enters New Territory, Health Law & Policy Institute

DEA Enters New Territory -- Supports Pain Treatment and
Investigates Deaths Caused by a Brand Name Drug

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 undertreatment of pain is a serious problem, especially for critically ill patients or those near death;

opioid analgesics, used as recommended, are often the most effective treatment for pain;

opioids have a huge potential for abuse justifying careful regulation by the DEA and the states;

abusers use fraud, theft, forged prescriptions, and unscrupulous health professionals to divert opioids from legitimate channels;

drug abuse must be taken seriously, but it should not infringe upon the legitimate use of a drug when medically indicated; and

education of health care professionals, law enforcement personnel, and the general public will enable everyone to make proper decisions concerning the treatment of pain.

This statement represents the DEA's first attempt to lift the fear that clouds many physicians' prescriptions for pain. At the same time, however, the maker of OxyContin®, a popular pain medication, has some explaining to do.

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:

OxyContin® was introduced by Purdue Pharma in 1995. It is a controlled release formulation of the Schedule II narcotic, oxycodone, used in treating chronic moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. The controlled release formulation has an important role in the management of pain where dose administration should be limited to twice, rather than four to six times, per day. DEA Congressional Testimony, available at http://www.dea.gov/pubs/cngrtest/ct082801.htm. Mr. Woodworth testified that from 1996 to 2000, prescriptions of OxyContin® had increased by 18 times to 5.8 million prescriptions. Other similar medications had seen decreases or steady prescriptions in the 100,000 to 400,000 range annually during the same period. Mr. Woodworth further testified that in the last couple of years, the DEA has seen increasing abuse of this drug. OxyContin® has been popular among abusers because by merely crushing the tablets, they can circumvent the time release effect and obtain a high off the strong concentration of oxycodone, the drug's active ingredient. (In his testimony, Mr. Woodworth made it clear that the DEA does not intend to restrict the legitimate prescription of OxyContin® for patients with legitimate medical needs. http://www.dea.gov/pubs/cngrtest/ct082801.htm.)

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.

11/09/01