Free
Editor's Message  |   November 2005
Law Enforcement Campaign: Barrier to Optimal Pain Management
Author Notes
• Dr Goldstein, a member of the JAOA's Editorial Advisory Board, is a professor of clinical pharmacology and coordinator of pharmacology in the Department of Neuroscience, Physiology and Pharmacology at the Philadelphia College of Osteopathic Medicine in Pennsylvania. Dr Goldstein has served as consultant to the Philadelphia Field Office of the Drug Enforcement Administration, the Eastern District of the US Attorney's Office, and the Pennsylvania Board of Probation and Parole, among other agencies.
• E-mail: FREDG@pcom.edu
Article Information
Pain Management/Palliative Care
Editor's Message   |   November 2005
##### Law Enforcement Campaign: Barrier to Optimal Pain Management
The Journal of the American Osteopathic Association, November 2005, Vol. 105, S2-S3. doi:
The Journal of the American Osteopathic Association, November 2005, Vol. 105, S2-S3. doi:
After receiving a request from her oncologist for assistance in pain management, I went to see Joan (not her real name) in her hospital room. She was a 21-year-old patient who had just been readmitted to Walter Reed Army Medical Center (Walter Reed); she had had cancer since the age of 13 years. It was 1983, and I was a medical scientist on sabbatical leave to Walter Reed, conducting a clinical investigation designed to enhance opioid analgesia in patients with cancer.
When I entered Joan's room, she took off her oxygen mask, which had a dull metal flange on it, and—right in front of me—tried to slit her wrist with the flange because she was in excruciating pain. Unfortunately, she was terminally ill, and two decades ago pharmacologic options were limited for outpatient treatment of constant severe pain. Therefore, Joan's oncologist had to admit Joan to the hospital in order to manage her pain as effectively as possible.
To provide adequate analgesia, morphine would have to be given intravenously and also increased to a level at which Joan would probably be sedated. Our team (oncologist, nurse, social worker, chaplain, and medical scientist) decided to make this adjustment. During the next few days after being admitted, Joan was more comfortable. On Friday of that week, the team felt that Joan's mother could tell her that it was “OK to go.” During the weekend, she did—and Joan died in her mother's arms.
This sad event, forever implanted in my memory, is the inner driving force for my strongly advocating pain management. It is this memory that helps me educate health professionals—from medical students to physicians attending continuing medical education programs—that patients in pain must be treated continuously and aggressively. At Walter Reed, such treatment was offered. But 22 years ago, it required hospitalization.
Although only a few additional opioids have been synthesized during the past 20 years, the pharmaceutical industry has worked diligently, professionally, ethically and, of course, legally to develop many new extended-action formulations of standard opioid medications (eg, morphine and oxycodone). Such products are now available and have become part of routine treatment provided by healthcare professionals involved in management of chronic pain, regardless of whether the cause is a cancerous or noncancerous condition. These new long-acting formulations allow us to keep patients comfortable at a steady level—without major swings from severe pain to sedation and back to severe pain again—over 24 hours for as many days, months, or years as necessary.
During the past few years, abuse of approved sustained-release formulations of opioids (initially high-dose products, but more recently those of lower doses) has become a problem. A substantial degree of negativity has been directed at one particular proprietary brand of oxycodone hydrochloride—OxyContin. Every healthcare professional knows that certain drugs have always been abused in the United States, including not only opioids, but also benzodiazepines, stimulants (eg, amphetamines, methylphenidate), and, of course, alcohol. Also during this period, law enforcement (eg, the Drug Enforcement Administration [DEA]) has been increasingly targeting physicians, especially those who specialize in pain management.
It was of extreme interest to read a report titled Treating Doctors as Drug Dealers. The DEA's War on Prescription Painkillers, written by Ronald T. Libby, PhD, professor of political science and public administration at the University of North Florida. The publication is the Cato Institute Policy Analysis No. 545, June 16, 2005. In this 27-page report with more than 100 references, Dr Libby presents many details from published articles to support his contention that the DEA is unfairly and inappropriately targeting physicians.
Among his major points are:
• “The problem [against OxyContin] was exacerbated when the media began reporting that OxyContin was finding its way to the black market for illicit drugs, resulting in an outbreak of related crime, overdoses, and deaths. Though many of those reports proved to be exaggerated or unfounded, critics in Congress and the Department of Justice scolded the U.S. Drug Enforcement Administration for the alleged pervasiveness of OxyContin abuse.” [Italics added for emphasis.—F.J.G.]
• “The DEA responded with an aggressive plan to eradicate illegal use or diversion' of OxyContin. The plan uses familiar law enforcement methods from the War on Drugs, such as aggressive undercover investigation, asset forfeiture, and informers.”
Prof Libby states that the DEA's painkiller campaign:

• “cast a chill over physician-patient candor needed for successful treatment”;
• “resulted in pursuit and prosecution of well-meaning physicians”;
• “scared many physicians away from the field of pain management”;
• “probably persuaded other physicians not to enter this specialty, thus worsening the already widespread problem of patients being undertreated or untreated for chronic pain.”
He also found that conclusions drawn by the DEA from these data were “significantly flawed.” Among his other major points are:
• “The DEA's criteria for OxyContin-related deaths' are problematic.” Fifty-eight analgesic drugs contain oxycodone. Because “there is no chemical test to distinguish OxyContin from other oxycodone drugs, it is difficult to see how the DEA” could positively claim “that a death attributable to oxycodone is due to OxyContin and not other short-acting oxycodone drugs.” However, “the DEA counts as an OxyContin-related death'” any fatality “in which oxycodone was detected without the presence of aspirin or [acetaminophen].”
• “If an OxyContin tablet is found in the gastrointestinal tract of a deceased person, the DEA labels it an OxyContin-verified death,' regardless of other circumstances. Even more problematic, if investigators find OxyContin pills or prescriptions at a crime scene, or a family member or witness merely mentions the presence of OxyContin, the death is also confirmed as OxyContin-verified.'”
• Victims of overdose often had multiple drugs in their systems. Autopsy reports of OxyContin-related deaths showed:

• In approximately 40%, diazepam-like drugs were present;
• In another 40%, a second opiate (eg, hydrocodone bitartrate and acetaminophen combination) plus oxycodone was found;
• 30% showed an antidepressant such as fluoxetine hydrochloride;
• 14% had over-the-counter antihistamines or cold medications present;
• “Deaths like those could be the result of any of the drugs present, drugs working in combination, or one or more drugs plus effects of other conditions, such as illness or disease.”
Dr Libby reported that the March 2003 issue of the Journal of Analytical Toxicology found “919 deaths related to oxycodone in 23 states over a three-year period,” but that “only 12 showed confirmed evidence of the presence of oxycodone alone in the system of the deceased.” [Italics added for emphasis—F.J.G.]. About 70 percent of these deaths resulted from “multiple drug poisoning” of other drugs containing oxycodone in combination with diazepam-type tranquilizers, alcohol, cocaine, marijuana, and/or other narcotics and antidepressants. As Dr Libby points out, “That is strong evidence that many of the deaths attributed to OxyContin by government officials are not the result of unknowing pain patients who grew addicted and overdosed, but of habitual drug users who may have used the drug with any number of other substances, any one of which could have contributed to overdose and death.” [Italics added for emphasis—F.J.G.]
He states, “In the absence of opioids like OxyContin, habitual users will, in all likelihood, merely switch to more available drugs. However, pain patients who rely on the drug for relief don't have that option. They're far more likely to suffer from the scarcity caused by the DEA's crackdown than are common drug abusers the agency claims it is targeting.” [Italics added for emphasis—F.J.G.]
Dr Libby found another problem with the DEA claims of an “OxyContin epidemic”: “the agency's inflated estimate of risk of death. In 2000, physicians wrote 7.1 million prescriptions for oxycodone products without aspirin or [acetaminophen], 5.8 million of them for OxyContin. According to the DEA's own autopsy data, there were 146 OxyContin-verified deaths' that year, and 318 OxyContin-likely deaths,' for a total of 464 OxyContin-related deaths.' That amounts to a risk of just 0.00008 percent, or eight deaths per 100,000 OxyContin prescriptions—2.5 verified,' and 5.5 likely-related.'” [Italics added for emphasis—F.J.G.]
As Dr Libby states, even the preceding numbers are “calculated only after taking the DEA's troubling conclusions about causation at face value. By contrast, approximately 16,500 people die each year from gastrointestinal bleeding associated with nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin or ibuprofen.” NSAIDs are not as effective as opioids at treating patients with severe chronic pain. “Both classes of painkillers have beneficial medical uses.” Opioids are found on the black market and “may lead to occasional deaths by overdose.” NSAIDs are not used recreationally, but they cause “35 times more deaths per year.” [Italics added for emphasis—F.J.G.]
Dr Libby writes, “Given these numbers, all of the time, energy, tax dollars, and worry expended on eradicating the OxyContin `threat'—not to mention the menace to civil liberties—seems unfounded.”
Conclusion
We recognize many barriers that prevent optimal management of chronic pain using opioids, including an unfounded fear of becoming an addict (opiophobia) expressed by some physicians and many patients. However, it is extremely clear that extended-release formulations have improved the lives of those who suffer from chronic pain responsive to opioid therapy, whether the cause of pain is a malignancy or a noncancerous disorder. The improper law enforcement campaign against physicians who correctly use opioids to treat their patients reduces the chance that adequate analgesia will be provided throughout the United States.
Dr Goldstein discloses that he affirms that Purdue Pharma LP did not request and had absolutely no input regarding his decision to write this editorial. He has received an honorarium for serving as coordinating editor for the 2005 JAOA supplement series on pain management and could have completed his assignment without writing this opinion. However, based on the current national bias that is having an impact on pain management, Dr Goldstein felt compelled to write this editor's message.

This continuing medical education publication is supported by an unrestricted educational grant from Purdue Pharma LP.

Editor's Note

The JAOA has documents on file from both the Cato Institute and Purdue Pharma LP averring that Purdue Pharma LP did not fund or influence the publication of the Cato Institute Policy Analysis No. 545, June 16, 2005, the full text of which is available at: http://www.cato.org/pubs/pas/pa545.pdf.