Download Statement of Ron Libby, Ph.D. - Word file

The DEA’s OxyCotin 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 antidrug 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 OxyCotin, a best selling long-lasting pain relief drug. The DEA
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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
“OxyCotin-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 antidepressant, 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
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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, Valiumtype tranquilizers, cocaine or other narcotics.
The third problem with the DEA’s claim for an OxyCotin 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
OxyCotin. The DEA’s autopsy data reported 146 OxyCotin-verified deaths and
318 “OxyCotin-likely deaths” for a total of 464 deaths. That works out to 0.00008
percent or 8 deaths for every 100,000 OxyCotin 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 OxyCotin
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
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pain patients are addicted and represents no threat to public safety and morality.
The DEA takes the position that narcotics such as OxyCotin 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 (SunSentinel, “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 OxyCotin 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 OxyCotin and other opioids. The DEA’s OxyCotin Action
Plan resulted in high profile prosecutions of doctors. With each trial
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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 naïve” (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.
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