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Policy Perspectives
January 12, 2000

The Pain Relief Promotion Act of 1999: A Serious Threat to Palliative Care

Author Affiliations

Author Affiliations: Center for Law and Health, Indiana University School of Law-Indianapolis (Dr Orentlicher); and Center for Bioethics, University of Pennsylvania Health System, Philadelphia (Dr Caplan).

 

Policy Perspectives Section Editors: Robert J. Blendon, ScD, Harvard School of Public Health, Boston, Mass; Drummond Rennie, MD, Deputy Editor, JAMA.

JAMA. 2000;283(2):255-258. doi:10.1001/jama.283.2.255
Abstract

Recent educational efforts in the US medical community have begun to address the critical issue of palliative care for terminally ill patients. However, a newly introduced bill in Congress, the Pain Relief Promotion Act of 1999 (PRPA), could dramatically hinder these efforts if enacted. The act criminally punishes the use of controlled substances to cause—or assist in causing—a patient's death. The primary purposes of PRPA are to override the physician-assisted suicide law currently in effect in Oregon and prohibit other states from enacting similar laws. The act also includes valuable provisions for better research and education in palliative care, but the benefits of those provisions are outweighed by the punitive sections of the act. Under PRPA, the quality of palliative care in the United States could be compromised when physicians, fearing criminal prosecution, err on the side of caution rather than risk their patients' deaths by using highly aggressive pain treatments. Furthermore, PRPA would put Drug Enforcement Administration officials, who have no medical expertise, in the position of regulating medical decisions. The act also would interfere with individual states' long-standing authority over medical practice. Finally, PRPA would discourage physicians from engaging in experimentation and innovation in palliative care, again out of concern for crossing the line between relief of suffering and physician-assisted suicide. Other bills have been introduced that go much further than PRPA to encourage palliative care, without its problematic provisions. Regardless of the controversy surrounding physician-assisted suicide in the United States, the need for quality end-of-life care will be far better served if Congress enacts one of these bills rather than PRPA.

During the past few years, aggressive educational efforts have started to correct a major failing in medical care—the inadequate treatment of pain and other physical suffering in dying patients.1 SUPPORT (Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments), a multisite study on end-of-life care, found that many terminally ill patients were undertreated for pain,2 and fear of intolerable suffering is a major reason for public support of assisted suicide.3 In response, the American Medical Association, American College of Physicians, Department of Veterans Affairs, and other health care entities have mounted intensive campaigns to ensure that physicians are sufficiently sensitive to their patients' needs for aggressive palliative care.4

However, progress in this area may be dealt a severe setback should Congress decide to enact the Pain Relief Promotion Act of 1999 (PRPA). The act, which was introduced by Rep Henry Hyde (R, Ill) and Sen Don Nickles (R, Okla), is designed to override Oregon's physician-assisted suicide law.5 Under PRPA, physicians would violate the federal Controlled Substances Act if they administer opioids or other drugs to hasten a patient's death. The primary goal of PRPA is to prevent physicians in Oregon from continuing to implement the Death with Dignity Act.6 However, the most likely effect of PRPA would be to discourage physicians nationwide from adequately treating the suffering of their dying patients.

The proposed act also includes provisions designed to promote better palliative care, and these provisions could be valuable. However, Sen John D. Rockefeller (D, WVa) and Sen Ron Wyden (D, Ore) have authored other bills that go much further than PRPA in encouraging palliative care, and they do so without PRPA's problematic clauses.7,8 Patients, physicians, and the general public would be better served if one of these bills is passed instead of PRPA.

Although we (the authors) do not agree on the need for legalized assisted suicide, we are united in our fear that PRPA could turn back the clock on the emerging practice of palliative care and needlessly exacerbate physicians' fears that they will be subject to prosecution for their legitimate efforts to ease the suffering of terminally ill patients. One need not support assisted suicide to oppose PRPA. The potential harm to palliative care will likely outweigh any benefit from preventing patients' suicides.

Provisions in prpa

The act contains 2 major parts (or "titles" in legislative language). In Title I, the act amends the Controlled Substances Act to nullify Oregon's physician-assisted suicide law. According to Section 101 of PRPA, opiate drugs and other controlled substances may not intentionally be used "for the purpose of causing death or assisting another person in causing death." Moreover, in deciding what uses of controlled substances are consistent with the public interest, the US attorney general "shall give no force and effect to state law authorizing or permitting assisted suicide or euthanasia."9 If physicians in Oregon were convicted for performing assisted suicide in violation of the PRPA-amended Controlled Substances Act, they would face the same criminal penalties faced by anyone who unlawfully distributes a controlled substance. In addition to reversing Oregon's assisted-suicide legislation, Title I of PRPA would effectively prevent any other state from legalizing physician-assisted suicide.

While it rejects assisted suicide, Title I of PRPA tries to make a strong statement in favor of palliative care. According to the act, it is part of legitimate medical practice to use a controlled substance with the intent to alleviate patients' pain "even if the use of such a substance may increase the risk of death."9 The act calls for educational and training programs for local, state, and federal law enforcement personnel on the "legitimate use of controlled substances in pain management and palliative care."10

Title II of PRPA is designed to promote palliative care research and education. In Section 906, the Agency for Healthcare Research and Quality (formerly AHCPR) is called on to develop a program to "advance scientific understanding of palliative care."11 The act also instructs the Agency for Healthcare Research and Quality to collect and disseminate protocols for palliative care to health care providers, educational institutions, and the general public. This act backs congressional support for palliative care by authorizing $5 million a year in grants to public and private entities for "programs to provide education and training to health care professionals in palliative care."12

Although we laud PRPA's efforts to promote palliative care, the act's punitive provisions seriously undermine that goal.

Concerns about prpa

PRPA Would Likely Compromise the Quality of Palliative Care

Specialists in palliative care recognize that very aggressive treatments are often necessary to relieve a terminally ill patient's pain, feelings of suffocation, or other physical suffering. What might be too much medication for one person would not even begin to alleviate the suffering of other patients with the same diagnosis and symptoms. Although the risk of fatal consequences is lower than commonly believed,13 sometimes the amount of medication needed to allay pain will cause the patient's death.14,15 Yet, under Section 101 of PRPA, the line between acceptable palliative care and unacceptable assisted suicide is defined solely by the physician's intent: Was the physician intending to cause the patient's death, or was the patient's death a known, but undesired, risk of the treatment?

When intent is the critical issue, physicians must worry that law enforcement officers will see a criminal intent where none existed. Had a patient ever asked for help in dying prior to the aggressive treatment of pain? How would that request and the patient's subsequent death be viewed by the police? Moreover, experts in bioethics and health care law disagree about the line between permissible and impermissible treatment at the end of life. A federal prosecutor can easily find articles in leading academic journals critical of treatments that are generally viewed as appropriate palliative care.16 The risk of prosecution is further exacerbated by the fact that when high doses of medication are being administered and a terminally ill patient dies of natural causes, the death may nevertheless be ascribed to the medication. Even specialists in end-of-life care make this misidentification of the cause of death.13

Under PRPA, physicians would be at risk not merely for revocation of their license to prescribe controlled substances, they also would be subject to prison sentences usually reserved for major dealers of illicit drugs. If a physician uses aggressive doses of opiate drugs to provide palliative care, and the physician were charged under PRPA, a conviction would result in draconian consequences. A physician convicted under PRPA for using a Schedule II drug and causing a patient's death would face a minimum sentence of 20 years in prison and a maximum sentence of lifelong incarceration.17 With that heavy a threat, physicians would likely be restrained when treating the pain of dying patients.

The unfortunate reality is that even now legal concerns make physicians overly cautious about prescribing the medications necessary to relieve the pain and other suffering of their patients. Prosecutions are rarely brought against physicians for assisting a patient's suicide or for misusing controlled substances to treat pain, and many prosecutors would not bring charges even when they learned of an assisted suicide.18 However, in the past decade, physicians have become more likely to face not only civil lawsuits but also criminal prosecutions when charged with substandard medical care, including overly aggressive pain management.4 Given the seriously disruptive and traumatic nature of criminal prosecutions, physicians report that the threat of legal liability causes them to undertreat pain.19 Physicians already err too strongly on the side of caution, and PRPA would likely exacerbate that tendency. As a result, many patients may continue to die without adequate treatment of their suffering.

To be sure, even without PRPA, the Drug Enforcement Administration (DEA) could invoke the Controlled Substances Act to investigate physicians providing aggressive palliative care. When Congress passed the Controlled Substances Act to address trafficking in illicit drugs, it employed language that incidentally covers physicians who use controlled substances to assist a patient's suicide or perform euthanasia. However, prosecutors do not (and indeed cannot) enforce every law on the books; they focus on crimes that raise particular concern. Without PRPA, the DEA has not been given a mandate from Congress to focus its limited prosecutorial resources on end-of-life care. With PRPA, the DEA would have such a mandate, and the DEA ultimately takes its instructions from Congress. If, on the other hand, PRPA is defeated, Congress would send a clear signal to the DEA to not focus on end-of-life care.

Here too, physicians' perceptions are critical. Even before the DEA would step up its surveillance of end-of-life care, physicians would have good reason because of PRPA to worry about the possibility of increased investigatory activity. Assurances from the Clinton Administration might help, but only until the president leaves office.

PRPA Would Subject Medical Care to the Oversight of Officials With No Such Expertise

This act would empower DEA officials to investigate physicians for evidence of criminal misconduct. Yet these officials are trained to arrest drug dealers, not to make the fine distinctions between aggressive palliative care and assisted suicide. As the Department of Justice observed last year during its testimony on a bill similar to PRPA that was also written to amend the Controlled Substances Act, the Controlled Substances Act was not designed to address difficult medical and ethical issues at the end of life, and the DEA was not constituted to regulate medical practitioners when they treat the suffering of terminally ill patients.20

The Controlled Substances Act is an anti–drug abuse law enforcement statute, administered by the attorney general.21 Using it to regulate medical decisions would undermine the long-standing congressional allocation of jurisdiction among different branches of the federal government.22 In 1970, when it enacted the Controlled Substances Act, Congress established the principle of "balance" in deciding how to distribute governmental authority for regulating controlled substances.21 The Food and Drug Administration (FDA) retained sole authority to determine when opioids and other drugs are sufficiently safe and effective to be prescribed by physicians. The Department of Health and Human Services was given responsibility to make other decisions of a medical or scientific nature involving controlled substances. The Department of Justice was given the authority to prevent and prosecute illicit drug use, a power that has been exercised in large part by the DEA.21

The Pain Relief Promotion Act would disrupt this careful balance, one that has served the United States well for nearly 30 years, by injecting the DEA's investigatory apparatus into the debate over the role of assisted suicide in end-of-life care. Instead of looking to medical experts and the FDA for guidance on the appropriate use of opioids, barbiturates, and other palliative drugs in end-of-life care, physicians also would have to consider the views of the DEA's agents. Together with the Controlled Substances Act, PRPA would grant the DEA authority to issue regulations regarding the use of controlled substances in end-of-life care.9 It is difficult to see how the DEA could promulgate such regulations without deciding important medical and scientific questions that should be resolved by other agencies and persons.

PRPA Would Interfere With the States' Long-standing Authority Over Medical Practice

By using a federal statute to override an Oregon health care law, PRPA would contravene the principle of federalism, a basic tenet of American law and democracy. Traditionally, the regulation of medical practice has been left to the states and their medical boards, not to the federal government and its law enforcement agencies. Indeed, the preamble to the Medicare law expressly prohibits any federal "supervision or control over the practice of medicine or the manner in which medical services are provided."23 Similarly, the Controlled Substances Act, which PRPA would amend, generally requires the attorney general to grant physicians the authority to prescribe controlled substances "if the applicant is authorized to dispense . . . controlled substances under the laws of the State in which he practices."24 Rather than defer to state law in the regulation of medical practice, PRPA specifically directs that state law be ignored. Section 101 of PRPA instructs the attorney general to "give no force and effect to state law authorizing or permitting assisted suicide" in deciding whether to permit physicians to prescribe controlled substances.9 At times, the federal government should exercise its authority to regulate medical practice, but only when there is a good justification to do so. For example, the need for safe drugs provides strong support for the role of the FDA in approving new pharmaceuticals. Similarly strong justification is missing from PRPA. The alternative bills before Congress7,8 would not violate principles of federalism because, through financial support and other assistance, they would foster state efforts to improve palliative care.

PRPA Would Interfere With Experimentation and Innovation in the Care of Dying Patients

The nature of palliative care is very much in evolution, as physicians try to determine the best way to relieve their patients' suffering. What has become clear is that some patients need unusually aggressive palliative treatment, and the most aggressive of those treatments can look very much like euthanasia. This is especially true of practices such as terminal sedation, which the Supreme Court has recognized as a valid modality for alleviating the suffering of dying patients.16,25 Physicians who care for patients at the end of life need to be able to try different approaches in their efforts to relieve suffering. The threat of prosecution under PRPA could discourage physicians from pursuing promising treatments that are closest to the border between lawful palliative care and the unlawful hastening of death. This chilling effect would occur not only in Oregon but nationwide.

The proposed act would most directly frustrate state experimentation and innovation by overriding Oregon's Death with Dignity Act. When the US Supreme Court declined to recognize a constitutional right to physician-assisted suicide in 1997, it acknowledged the uncertainty regarding the value of assisted suicide, and it invited states to explore different responses to requests for assisted suicide. As Justice Souter wrote, state experimentation is "highly desirable" on "an emerging issue like assisted suicide." State legislatures, he wrote, have "the power to experiment, moving forward and pulling back as facts emerge within their own jurisdiction."26 Mindful of its difficulty navigating other areas of complex social policy, the Supreme Court indicated its desire to see the physician-assisted suicide debate resolved through the local and democratic processes of state legislatures. However, PRPA would abruptly end state experimentation, negating Oregon's assisted suicide law and precluding any other state from following Oregon's example.

Better ways to further palliative care

Whatever one's views on the role of assisted suicide in end-of-life care, physicians generally agree on the need for better palliative care. The Pain Relief Promotion Act does promote efforts to enhance the quality of palliative care in this country; it would encourage more research and education in care for dying patients and provide funding for those activities. Nevertheless, these positive aspects of PRPA are seriously compromised by provisions that would hinder the delivery of aggressive treatment to relieve pain and other suffering. Other bills before Congress go much further than PRPA in promoting palliative care, and they do so without including any counterproductive provisions. Patients, physicians, and all Americans will be better served if Congress enacts one of these other bills.7,8

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