Congress and the Pain Relief Promotion Act

Will physicians be too scared to prescribe sufficient opioids to patients in pain?

Chilling repercussions are likely to result from the Pain Relief Promotion Act of 1999, a bill (HR2260) passed by the House of Representatives and now being considered by the Senate (S1272; available at: http://thomas.loc.gov). In essence, it is a simple piece of legislation with two major provisions. The first essentially nullifies patients' rights to physician-assisted suicide under the Oregon Death With Dignity Act.¹ It does this by declaring that assisted suicide and euthanasia are not legitimate medical uses of federally controlled drugs and that practitioners who prescribe for these uses are subject to the criminal penalties of the 1970 Controlled Substance Act. The second recognizes the concept of “double effect”—that is, allowing actions with unintended adverse outcomes, if that action is the only way to bring about a more desirable outcome. The application here is the unintended (but acceptable) hastening of death through the use of pain medication, if that is the only way to relieve the suffering of a dying patient.

Ironically, the drafters of this legislation have themselves used double-effect reasoning in this measure. To stifle the actions of a single state, they risk denying pain relief to patients throughout the nation. When physicians realize that this law means that the US Drug Enforcement Agency and federal prosecutors will be judging their “intent” in prescribing, they are likely to back away from aggressive pain relief with opioid analgesics. Supporters of the legislation say that this will not happen, but knowledgeable witnesses speaking before congressional committees have testified otherwise.

This is not the first time that the US Congress has tried to stop Oregon's law. After a second referendum approved physician-assisted suicide by an even larger margin (60%-40%) than the first (51%-49%),² the Lethal Drug Abuse Prevention Act of 1998 (HR4006 in the House and S2151 in the Senate) was introduced in the 105th Congress. This proposed legislation would have permitted the revocation of Drug Enforcement Agency registration of physicians or pharmacists who had intentionally dispensed or distributed a controlled substance for the purpose of physician-assisted suicide. Because of opposition, this approach was abandoned and replaced in 1999 with the current bills.

The language of these bills, recognizing double effect and affirming the goals of palliative care (including modest program funding), has improved the prospect of their passage over last year's bill. The Pain Relief Promotion Act of 1999 has garnered the support of the American Medical Association and the National Hospice Organization. Some advocates of humane palliative care believe that such legislation would further these goals.

Many others, however, are frightened by the prospect of the federal government second guessing physicians' intent when prescribing controlled substances. This proposed act provides for a criminal penalty against physicians: a maximum of 20 years in jail and license revocation. David Orentlicher, formerly director of the American Medical Association's Division of Medical Ethics, told the House Judiciary Committee: “Given the seriously disruptive and traumatic nature of criminal prosecutions, this act will make physicians err even more on the side of caution.”³ He concluded, “No matter how many words you attempt to write into this act to define and encourage good pain management and palliative care, the reality of the practice of medicine all over the country is that doctors would rather avoid risk, interrogation, and investigation at all costs.”

In describing the effect of legal sanctions on physician behavior, Sandra H. Johnson, past president of the American Society of Law, Medicine, and Ethics, wrote,⁴

Doctors' fears of disciplinary action and criminal prosecution are justified. There is no evidence that large numbers of physicians are sanctioned for their treatment of patients in pain, but the impact of the process on those physicians who are only investigated, or only charged but not disciplined, or only warned or cautioned but not penalized is severe.

Many physicians will think that a large dose of opioid will imply intent to bring about death. Indeed, many physicians are already uncomfortable with the large opioid doses recommended by experts in palliative medicine. One textbook on palliative medicine says, “While doses can become extremely large during this process, the absolute dose is immaterial”⁵ as long as the balance between analgesia and side effects remains favorable. A retrospective review of 100 patients at Memorial Sloan-Kettering Cancer Center, New York, in 1990 documented the dosage of opioids in the last days of life. In the 24 hours before death, 23% of the patients required more than 300 mg of intramuscular morphine sulfate (equivalent to 900 mg of oral morphine), and 7% needed more than 2,000 mg of intramuscular morphine (6,000 mg of oral morphine).⁶ With the threat of criminal prosecutions looming, how many physicians, fearing such large doses would suggest the intent to kill, would actually follow such recommendations?

If Congress were serious about pain, it would pass Senate bill S941 (House bill HR2188), the Conquering Pain Act, introduced by Senator Ron Wyden of Oregon. This thoughtful and comprehensive bill addresses many of the barriers to adequate pain management and quality care of dying patients, including reimbursement barriers. The bill would establish regional networks to help disseminate information about best practices in pain management. It also calls for surgeon general and Institute of Medicine reports on pain that would include identifying state and federal regulations that pose barriers to care. Unfortunately, the goal of pain relief for millions of Americans is apparently being sacrificed to the desire of this Congress to negate the mandate of the citizens of the state of Oregon.