Background: Opioid Pseudoaddiction
Controlled Substances Act
The war on pain has become a casualty of the war on drugs. A small population of drug abusers now dictates the policy for a much larger population of pain sufferers. Ushering in the war on drugs under President Nixon, the Controlled Substances Act (CSA), passed in 1970, classifies drugs according to addiction potential into schedules I-V. Schedules I-V describe the addiction potential of controlled substances as well as their medical usefulness.
Drugs in schedules I-V have a decreasing potential for abuse - schedule I drugs have the highest potential for abuse and no current medical use, and schedule V drugs have the lowest potential for abuse of the controlled substances. Physicians regularly use schedule II drugs, such as opioids, to treat pain. The CSA requires extensive record keeping and tracking of physician prescribing habits, and pharmacy dispensing of controlled substances. The CSA also requires prescribers to register with the Attorney General and obtain a controlled substances license.
The DEA, a part of the Federal Bureau of Investigation, enforces and administers the CSA. Under the CSA, a physician is criminally liable if he or she prescribes opioid medications for a purpose other than a legitimate medical purpose and outside of the usual course of his professional practice. Prosecutors and federal regulators define legitimate medical purpose, which usurps the physician's prerogative and creates a cavernous schism between the DEA and medical professionals (who value making independent medical assessments and decisions free from government threats of punishment). Importantly, this cavernous schism prevents necessary cooperation between the DEA and physicians to win both the war on drugs and the war on pain.
The CSA also hinders optimal pain management in several other ways. The CSA leads to prosecution of opioid prescribers. Since 2001, the DEA has targeted the prescription and abuse of OxyContin, an opioid analgesic, because of a spate of deaths related to its use. The OxyContin campaign raised scrutiny of opioid medications to the level of illegal, non-prescription street drugs such as cocaine and heroin. Along with the increased scrutiny, physician prosecutions under drug trafficking laws are increasing.
The DEA espouses a policy of balancing pain relief promotion with prevention of pain medication abuse and takes as its responsibility to ensure drugs are not diverted for illicit purposes. Despite the DEA's statement of commitment to the promotion of pain relief, the DEA's enforcement of the CSA unfortunately has a chilling effect on opioid prescribing. Under-treatment of pain is now the norm because of physicians' fears of prosecution. Attorney General Janet Reno initiated a federal campaign which intensified under Attorney General John Ashcroft and has been likened to state-sponsored terrorism to prosecute opioid-prescribing physicians. The government's continued threat under U.S. Attorney General Eric Holder to investigate narcotic prescription practices deters physicians from medically appropriate prescribing because physician practices are dependent upon maintaining a reputation of unimpeachable integrity. A governmental investigation into a physician's practice may serve to destroy a physician's career. Intense media coverage often accompanies physician investigation and prosecution. Because of physician prosecutions, not even the most honest and competent doctors can practice pain medicine with any assurance for safety for themselves or continuity of care for their patients. The DEA and courts treat well-intentioned doctors as drug dealers in the United States.
Almost two-dozen law enforcement agents raided Dr. Frank Fisher's general practice in 1999 and arrested him on drug and homicide charges stemming from opioid prescribing. After not being able to post his $15 million bail, Dr. Fisher, a Harvard Medical School graduate, languished in jail for 5 months before being exonerated of all drug and homicide charges. The State's reckless aggressiveness in implicating Dr. Fisher was inexcusable. One of Dr. Fisher's alleged homicide victims was Rebecca Mae Williams for whom Dr. Fisher prescribed a moderate dose of 160 mg. OxyContin daily for chronic pain. While her boyfriend was driving, Rebecca died in a motor vehicle accident of a hangman's fracture of the neck, open skull fracture, and severe internal injuries. Because she had opioid drugs in her system, the County Medical Examiner determined that she died of an opioid overdose instead of the obvious overwhelming lethal injuries sustained in the motor vehicle accident.
State and federal prosecutors have referred to arrested doctors as being no different than drug kingpins or crack dealers' and they call the doctors' patients drug addicts. Assistant U.S. Attorney Gene Rossi told the Washington Post in 2002 that the Attorney General's Office will root out pain physicians like the Taliban. The Office of National Drug Control Policy plans to propose stricter supervision of pain clinics within the next year. The Obama White House also plans to lobby Congress to require physicians to complete training in opioid prescribing prior to being granted a controlled substances license. What the government fails to recognize is that rather than addressing the actual problem, the regulations punish doctors instead.
On the other hand, patients and patient advocates laud these same doctors as heroes, and these doctors refer to their pain patients as vulnerable and suffering human beings. Current stringent over-enforcement of opioid prescribing laws is causing the already small number of physicians willing to treat chronic pain patients to dwindle. Under-treated pain costs society in terms of absenteeism, depression, alcoholism, family disruption, domestic violence, decreased productivity, and suicide. The economic costs in the United States alone may reach $100 billion annually.
Doctors who prescribe opioids are also shunned by other physicians who will not care for the opioid-prescribing doctor's patients, for fear of getting pulled into any possible future DEA investigations. An opioid-prescribing physician may then have difficulty finding coverage for days off or obtaining consultations from other physicians. Pharmacies, likewise, may refuse to fill opioid prescriptions from physicians who frequently prescribe opioid medications, because of a fear of DEA investigation of their pharmacy. The fear may arise from seeing a large volume of opioid prescriptions coming from a single pain medicine provider, or from actual DEA investigative calls to their pharmacy.
The DEA is charged with enforcement of the CSA, and may jail physicians for overprescribing narcotics. The DEA determines legitimate medical purpose and what constitutes in the usual course of [a physician's] professional practice, which may be interpreted subjectively or objectively. If interpreted subjectively, then the physician's belief that his practice of prescribing opioid medications appropriately provides pain relief, then the belief exonerates him. If interpreted objectively, however, the usual course of his professional practice indicates adherence to accepted medical standards as determined by the medical community. The objective approach to interpretation in this instance penalizes doctors at the cutting-edge of their field because they are beyond the realm of accepted practice.
Physicians and the DEA have clashed over the interpretation of legitimate medical purpose and whether long term high dose opioid prescriptions, often required for adequate chronic pain management, can come within the realm of a legitimate medical purpose. The DEA, however, is not part of the medical community. Decisions of legitimate medical purpose and the usual course of professional practice should be left up to physicians on state medical boards and pain societies - not federal agencies.
