There is general agreement that the “principle of balance” should guide controlled substance policy and regulation in the United States. Although the diversion of controlled substances from medical to nonmedical purposes is a significant public health problem, overly aggressive controlled substance regulation has been shown to have an unintended deterrent effect on appropriate controlled substance use, including pain management with opioid analgesics. The promotion of effective pain management and the reduction of substance abuse are equally important regulatory objectives. Neither regulatory (...) objective need be sacrificed to achieve the other. Rather, the two objectives must be balanced with each other to assure that necessary pain management is encouraged while drug abuse is curtailed.Approximately 75 million people in the United States suffer from severe pain. Fifty million of these suffer chronic pain, and 25 million suffer acute pain from trauma or surgery. Pain is not merely an uncomfortable symptom. (shrink)

This paper is a response to Christopher Boorse's recent defense of hisBiostatistical Theory (BST) of health and disease. Boorse maintains that hisconcept of theoretical health and disease reflects the ``consideredusage of pathologists.'' I argue that pathologists do not use ``disease'' inthe purely theoretical way that is required by the BST. Pathology does notdraw a sharp distinction between theoretical and practical aspects ofmedicine. Pathology does not even need a theoretical concept of disease. Itsfocus is not theoretical, but practical; pathology's goal is (...) to contribute tothe healing of patients. Pathology, even experimental pathology, is notvalue-free. Not only ``disease'' but also such terms as ``nerve'' and ``organ''are laden with conceptual values. (shrink)

Pharmacists, physicians, and other health care personnel practice within an integrated system of laws and regulations that influence many treatment modalities. Capitation, managed care, and other controls strain these relationships by mandating greater oversight of how health care is delivered. From a pharmacists’s perspective, any use of medication requites knowledge of three omnipresent factors: regulatory control, formularies, and economic decision making. My objective is to raise awareness of these issues as they relate to the prescription of pain medication and to (...) pain management generally.All practice-oriented drug law and regulation is based on the federal Controlled Substances Act of 1970. The Act, also known as Title II, is part of a much larger piece of legislation, the Comprehensive Drug Abuse Prevention and Control Act of 1970. CSA was enacted to regulate the manufacturing, distribution, dispensing, and delivery of drugs or substances that are subject to, or have the potential for, abuse or physical or psychological dependence. (shrink)

We can think about the use of controlled substances in the treatment of anxiety disorders in two simple but diametrically opposed ways. First, we can say that anxiety disorders are trivial and require only acts of willpower, or, if anxiety disorders do require treatment, they are better treated without the use of benzodiazepines. When BZs are used to treat anxiety, they pose grave risks of addiction to the patients to whom these medicines are prescribed; they relieve patients’ symptoms, but are (...) the equivalent of a pharmacological “roach motel,” a haven into which many unsuspecting patients enter, but from which few emerge without becoming addicted. Patients must then face terrible struggles to free themselves of dependence on BZs, and this compounds the problem for which they sought treatment. Furthermore, the large number of prescriptions for BZs are a threat to the public health because these drugs are widely abused by alcoholics and drug addicts. (shrink)

Uncertainty regarding potential disciplinary action may give physicians pause when considering whether to accept a chronic pain patient or how to treat a patient who may require long-term or high doses of opioids. Surveys have shown that physicians fear potential disciplinary acrion for prescribing controlled substances and that physicians will, in some cases, inadequately prescribe opioids due to fear of regulatory scrutiny. Prescribing opioids for long-term pain management, particularly noncancer pain management, has been controversial; and boards have investigated and, in (...) some cases, disciplined physicians for such prescribing. While in virtually all of these cases the disciplinary actions were successfully appealed, news of the success was not often as well-publicized as news of the disciplinary actions, leaving some physicians confused about their potential liability when prescribing opioids for pain. The confusion has perhaps increased as a result of two relatively recent cases, one where a physician was successfully disciplined by a state medical board for undertreatment of his patients’ pain, and another where the physician was successfully sued for inadequate pain treatment. (shrink)

The regulation of narcotic medications used in narcotic addiction treatment is unique in medical therapeutics. Physicians who want to use narcotics for this indication must obtain a separate annual registration from the Drug Enforcement Administration. Annual registration is contingent on compliance with both the DEA's security regulations as well as treatment regulations jointly promulgated by the Food and Drug Administration and the National Institute on Drug Abuse.During the last decade, a number of events have occurred that persuaded NIDA that it (...) is time to reevaluate the current method by which the Department of Health and Human Services regulates methadone treatment. As a result of research during the past twenty years, we have learned about the effective components of methadone treatment. In comparison to other available treatment modalities for opioid addiction, methadone treatment is uniquely effective when administered by well-trained medical staffs. (shrink)