The DEA's OxyContin
Action Plan:

An Unproven Drug Epidemic

by
Ronald T. Libby
University of North Florida
[email protected] and [email protected]
Tel (904) 808-4612 and
(904) 806-4404

The Politics of Pain Management
Public Policy & Patient Access to Effective Pain Treatment
House Office Building December 16, 2003

The Drug Abuse Prevention and Control Act of 1970 initiated the government's �war on drugs.� The DEA's mission was to �bring to the criminal and civil justice system substances destined for illicit traffic in the U.S.� (www.dea.gov/agency/mission.htm). Title II of the Act, the Controlled Substances Act (CSA), also gave the DEA power to regulate pharmaceutical drugs. Until the 1990s, the government focused upon eradicating illegal black market drugs such as heroin, cocaine, �crack� cocaine, Ecstasy and marijuana in urban areas and the violence associated with drug trafficking.

• In 1999, the Government Accounting Office (GAO) issued a report that was highly critical of the DEA. They said that the DEA had no measurable proof that it had reduced the illegal drug supply in the country (Drug Control, DEA's Strategies and Operations in the 1990s (GAO/GGD-99-108, July 1999).

  The Department of Justice (DOJ) also gave the DEA a negative evaluation and concluded that its goals were not consistent with the federal National Drug Control Strategy (Department of Justice, Status of Achieving Key Outcomes and Addressing Major Management Challenges (GAO-01-729, June 2001). Glen A. Fine, the Inspector General of DOJ, questioned why the DEA was not doing more to combat prescription drug abuse when it was a problem equal to cocaine. Fine claimed that 4.1 million Americans used cocaine in 2001 while 6.4 million illegally used narcotic painkillers. He said that misused painkillers accounted for 30 percent of emergency room deaths and injuries.

• In 2001, the DEA responded to this criticism by announcing a major new anti-drug campaign called the OxyContin Action Plan (U.S. Department of Justice, DEA-Industry Communicator, �OxyContin Special�, Vol. 01, p. 3.) Asa Hutchinson, the DEA Administrator explained that OxyContin was a deadly drug epidemic spreading throughout rural America (DEA Congressional Testimony, April 11, 2002, p. 1). Hutchinson said that the DEA would reallocate their resources to balance the growing drug threat in rural as well as urban areas.

  The campaign was against �a dangerous new drug abuse trend��the non-medical use of OxyContin, a best selling long-lasting pain relief drug. The DEA reported that four million Americans were misusing prescription drugs leading to addiction, injury and death. They estimated that the misuse of this drug was costing the health care system more than $100 billion a year.

• In order to justify the DEA's national campaign against OxyContin, the DEA surveyed 775 medical examiners from the National Association of Medical Examiners and instructed them to report �OxyContin-related deaths� in 2000 and 2001. Based upon the (www.deadiversion.usdoj.gov/drugs_concern/oxycodone/oxycontin7.htm) autopsy reports, the DEA claimed that there were 464 OxyContin-related deaths in those years. This figure is highly questionable, however.

  In the first place there is no test to distinguish OxyContin from any of the other 58 Oxycodone containing products. OxyContin is the Purdue Pharma brand name for a single entity oxycodone product that is a long-acting, higher dosage pain medication. Most of the other Oxycodone products such as Vicodin, Lortabs and Lorcet are a lower dosage and contain other pain relievers such as aspirin and Tylenol.

  The second problem with the claim of an OxyContin epidemic is the criteria applied to the DEA's definition of an �OxyContin-related death.� The Oxycodone detected by a medical examiner in an autopsy without the presence of aspirin or Tylenol was classified as an �OxyContin-likely death.� The DEA counted as �OxyContin-verified death� the presence of OxyContin tablet content in the gastrointestinal tract, tablets or prescription at the crime scene, on the body or reported by any family member or witness present at the death.

  The problem with this definition is that most of the decedents had multiple drugs in their bodies. More than 40 percent of the autopsy reports contained Valium-like drugs, about 40 percent contained an opiate in addition to Oxycodone and 30 percent contained an anti-depressant, 15 percent contained cocaine and 14 percent contained over the counter anti-histamines or cold medications. Therefore, death could have been attributed to any number of drugs or combination of drugs or diseases. Indeed, a March 2003 issue of the Journal of Analytical Toxicology found that of the 919 deaths related to oxycodone in 23 states over three year, in only 12 cases was OxyContin alone found. The other deaths were an overdose of other oxycodone-containing drugs such as Percocet or a combination of drugs. Almost all had at least three other drugs in their systems, mostly alcohol, Valium-type tranquilizers, cocaine or other narcotics.

  The third problem with the DEA's claim for an OxyContin epidemic is the DEA's estimate of death risk. In 2000 there were 7.1 million prescriptions of Oxycodone products without aspirin or Tylenol of which 5.8 million were OxyContin. The DEA's autopsy data reported 146 OxyContin-verified deaths and 318 �OxyContin-likely deaths� for a total of 464 deaths. That works out to 0.00008 percent or 8 deaths for every 100,000 OxyContin prescriptions, 2.5 verified deaths for 100,000 prescriptions and 5.5 likely-related deaths per 100,000 prescriptions. It is a stretch to claim that these low numbers constitute a deadly drug prescription epidemic sweeping rural America.

• The DEA has targeted doctors, pharmacists and dentists as the major source of illegal prescription diversion. (Special OxyContin Issue Vol. 01, p. 3). From October 1999 through March 2002, for example, the DEA investigated 247 OxyContin diversion cases including 159 cases in 2001 alone. These investigations have led to a total of 328 arrests. (www.deadiversion.usdoj.gov/fed_r) In 2001, there were 3,097 diversion investigations and 861 investigations of doctors (DEA Update, National Association of State Controlled Substance Authorities, Myrtle Beach, South Carolina, October 2002).

• Diversion investigations focus on doctors who prescribe high levels of OxyContin and other narcotics to alleged �addicts.� The DEA defines �addicts� as individuals who habitually use any narcotic drug that endangers the public morals, health, safety, or welfare [21 USC Sec. 802 (1)]. This has led to the mistaken belief that chronic non-cancerous pain patients who are prescribed large amounts of narcotics are addicts and that physicians who treat them are conspirators in the illegal drug trade. This ignores the medical fact that less than one percent of chronic pain patients are addicted and represents no threat to public safety and morality. The DEA takes the position that narcotics such as OxyContin should be the drug of �last resort for chronic pain� (DEA-Industry Communicator, �OxyContin Special� Volume 01, 2001, p. 16). Determining whether a pain patient is also an �addict� and whether OxyContin is �medically necessary� in treating chronic pain is clearly beyond the expertise and mission of the DEA.

  The DEA claims that the OxyContin Action Plan has not created a �chilling effect� upon doctors' treatment of chronic pain patients. They argue that the number (www.usdoj.gov/dea/pubs/pressrel/pr103003p.html) of doctors registered by the DEA to prescribe narcotics in 2003 was 963,385. They investigated 557 doctors, imposed penalties against 441 physicians, and arrested 34 doctors. That represents only 0.05 percent of all doctors who are registered.

This seriously understates the magnitude of the impact that DEA investigations and prosecutions have had upon physicians who treat chronic pain patients. Dr. J. David Haddox who works for Purdue Pharma, the manufacturer of OxyContin estimated that there are fewer than 4,000 doctors specialized in pain management in the entire country (Dow Jones Newswires, �FDA Panel: OxyContin's Approval Shouldn't Be Limited�, September 9, 2003). Theoretically, any licensed doctor can prescribe narcotics. However, in reality only a small percent of physicians risk prescribing these drugs.

Only 16 doctors in Florida ordered more than $1 million in opiates during 2003 and out of 56,926 only 574 prescribed $100,000 in pharmacy billings (Sun-Sentinel, �Deaths Mount as Doctors, Pharmacists and patients abuse the Medicaid System, November 30, 2003). One percent of the physicians in Florida were responsible for prescribing large doses of OxyContin and other narcotics. If Florida is representative of the country, that means that only one percent of the 963,385 physicians are responsible for treating between 30 and 80 million chronic and cancer patients in the country. The DEA monitors and investigates doctors who prescribe high doses of OxyContin and other opioids. The DEA's OxyContin Action Plan resulted in high profile prosecutions of doctors. With each trial the number of physicians who are still willing to treat patients with narcotics dwindles leaving pain sufferers desperately seeking treatment.

Terminology

Addiction - Addicts take drugs to get high, �mellow out� and largely avoid life. They are lost to themselves, to their families and society. They cannot work and are typically engaged in criminal activity. They are at high risk of a variety of infectious diseases, including hepatitis and AIDS. Addiction is a chronic, relapsing condition and it is a major hurdle to go off the drug.

Tolerance - Pain patients on an opioid can interact with their families, get out of hospitals, go back to work and seek to maintain their health. Getting off drugs is a relatively uncomplicated process. Pain patients who become dependent on opioids during medical therapy rarely become addicted to drugs. There is no theoretical upper limit to the amount of opioids that can be prescribed to control pain. A patient who has been receiving opioids for pain over time can tolerate levels that would kill a person who is �opioid na�ve� (has no tolerance).

Narcotics - A group of drugs that relieves pain by preventing transmission of pain messages to the brain also referred to as opioids.

OxyContin - It was approved by the FDA in 1995. The drug has a time-release feature that controls pain over an extended period of time. It is used to control moderate to severe chronic pain related to cancer, AIDS and other debilitating conditions. When misused, the drug is crushed thereby providing an immediate full dose of oxycodone and producing a heroin-like high. From 1995 to 2000, OxyContin prescriptions increased by 1,800 percent to 5.8 million per year.