The capacity to treat pain has never been greater; but, as you will read in the articles that follow, the problem of undertreated and neglected pain in the United States persists. Deep-seated perceptions and practices undergird this strong and well-documented pattern of neglect. Among the reasons frequently noted for the inadequacy of treatment for pain, however, is that the legal system actually penalizes effective interventions to relieve pain while it leaves neglect of pain unthreatened. It is the mission of the American Society of Law, Medicine & Ethics (ASLME) to explore areas, such as this one, where developments in medicine directly encounter the law and, in turn, create ethical issues for clinicians, regulators, patients, and lawyers.

This special issue of the Journal of Law, Medicine & Ethics is part of a multi-year project in which ASLME, with the wonderful support of the Mayday Fund, has worked to address legal and regulatory barriers to effective pain relief.

The problem of inadequate pain management for both terminally ill patients and patients with chronic pain has recently been documented by a number of authors and studies. A 1997 report by the Institute of Medicine (IOM), for example, states that “a significant proportion of dying patients and patients with advanced disease experience serious pain, despite the availability of effective pharmacological and other options for relieving most pain.” There are particularly impressive data that pain associated with cancer is not adequately treated.

The problem has been attributed to (1) inadequate education of physicians on approaches to pain management and an often misguided belief that prolonged therapy with certain pain medication will lead to addiction; (2) legal obstacles, such as physicians’ fear of criminal prosecution and other disciplinary actions by state licensing boards for overprescribing narcotics; and (3) inadequate insurance coverage as a result of narrow eligibility criteria for hospice care for Medicare beneficiaries, and inadequate reimbursement more generally for pain management and palliative care.

The United States, unlike all other industrialized nations, does not have a comprehensive public system for financing health care. Nevertheless, the magnitude of America's public health care financing effort is remarkable. Of the one trillion dollars the United States spent on health care in 1996, almost half, $483.1 billion, was spent by public programs. In 1995, Medicare—our social insurance program for persons over sixty-five and the long-term disabled—overed 37.5 million Americans; Medicaid—our program for indigent elderly and disabled persons and indigent children and their families—covered 36.3 million. In 1996, Medicare and Medicaid spent $203.1 and $147.7 billion, respectively. The payment policies of these massive public health care programs have a profound effect on the provision of health care.

Many of the recipients of Medicare and Medicaid suffer pain. In 1994, 376,200 Americans over age sixty-five died of cancer. Virtually all of these would have been Medicare recipients, and as many as 70 percent of them died in unrelieved pain. Nearly four million Americans over sixty-five endured the pain of inpatient surgery in 1995, again nearly all of whom were Medicare recipients.

Two significant, apparently unrelated, trends have emerged in American society and medicine. First, American medicine is reexamining its approach to dying. The Institute of Medicine, the American Medical Association and private funding organizations have recognized that too many dying people suffer from pain and other distress that clinicians can prevent or relieve. Second, this past decade has marked a sharp increase in the number of physicians prosecuted for criminal negligence based on arguably negligent patient care. The case often cited as a watershed is People u. Einaugfer, which involved a New York nursing home patient whose physician was convicted in 1993 of two criminal misdemeanors after he ordered an elderly dialysis patient to be tube fed through a peritoneal dialysis Catheter.

How is the growing awareness of dying patients’ pain and the increasing willingness of prosecutors to charge physicians with crimes connected? Pain at the end of life is frequently treated with narcotics, prescription drugs that are closely regulated by state and federal law. That complex web of laws—and a growing fear of legal sanctions—has deterred physicians from prescribing controlled substances. As those legal sanctions move from disciplinary actions to criminal charges, physicians’ fears may expand.

A decade ago, conventional wisdom in the medical establishment was that physicians treating chronic pain with opioid analgesics were at a substantial risk of being sanctioned for overprescribing by state medical regulatory boards. Dozens of articles written since have alluded to this risk as an obstacle to effective pain re1ief. In the early 1990s, a number of high profile cases in which physicians were disciplined by regulatory boards for overprescribing to patients with chronic pain were reported in the press. Although the board actions in many of these cases were eventually overturned by state judiciaries, the publicity heightened practitioners’. sensitivity to the regulatory risks associated with prescribing opioids.

A review of the available data on state medical board actions nationwide for the period from 1990 to 1996 reveals that the perception of regulatory risk far exceeds the reality. Indeed, relatively few (less than 5 percent) of the disciplinary actions taken for overprescribing by state medical boards in any given year directly concern the treatment of chronic pain—malignant or nonmalignant—in patients.

Recently, due to a number of converging factors, there have been significant shifts in public policy regarding the legitimacy of treating chronic pain with opioids. Traditional tenets handed down in medical, dental, nursing, and pharmacy education created a distinct reluctance on the part of practitioners to prescribe opioids on a continual basis. Much has been written about the reasons for these attitudes. One of the barriers that is very consistently reported by prescribers is the fear of regulatory and legal repercussions to ongoing prescription of this class of medications. It is in this arena that sentinel changes have occurred, the most recent of which is the promulgation of a document prepared by the Federation of State Medical Boards (FSMB), which suggests a set of guidelines meant to be endorsed or adopted by individual medical licensing boards on how to approach this particular aspect of practice. These guidelines, representing a broad consensus from a wide constituency, were developed in a relatively open forum and detail a balanced approach to the prescription of opioids for chronic pain.