06/24/99 Committee on the Judiciary - Orentlicher Statement

HEARING ON H.R. 2260

"The Pain Relief Promotion Act of 1999"

June 24, 1999

SUBCOMMITTEE ON THE CONSTITUTION

Committee on the Judiciary

U.S. House of Representatives

Testimony of

DAVID ORENTLICHER, MD, JD

Professor of Law and Co-Director, Center for Law and Health

Indiana University School of Law-Indianapolis

735 W. New York Street

Indianapolis, IN 46202-5194

(317) 274-4993

Thank you very much, Chairman Hyde, for inviting me to appear and testify at this hearing.

My name is David Orentlicher. I am a professor of law and co-director of the Center for Law and Health at the Indiana University School of Law-Indianapolis and was formerly the director of the Division of Medical Ethics at the American Medical Association. I have degrees in both medicine and law from Harvard.

"The Pain Relief Promotion Act of 1999" is admirable in its effort to promote better palliative care of dying patients. However, the Act should not be passed for two important reasons: (1) it would end up compromising the quality of palliative care, doing far more harm than good, and (2) Congress has other bills before it that will properly serve the goal of promoting the highest quality palliative care.

In my testimony, I will elaborate on these two points by discussing them and three related points at greater length:

1. The Act will compromise the quality of palliative care in this country. Physicians are very sensitive to the possibility of criminal prosecution, and this Act's emphasis on enforcement actions by federal, state and local law enforcement personnel will discourage the aggressive and appropriate treatment of pain at the end of life.

There are no clear lines between the different kinds of end-of-life care. What might be too much pain medication for one person would not even begin to treat the pain of another person with the very same symptoms. No two of us our exactly alike, and our biological make-up dictates different treatments, doses and tolerance levels to medication.

The absence of clear lines is well illustrated by this Act. As the prohibition in Section 101 and the narrow definition of palliative care in Section 906 of the Act indicate, the line between acceptable palliative care and unacceptable assisted suicide rests solely on the physician's intent. When intent is the critical issue, physicians must--and will--worry that law enforcement officers will see a criminal intent even when none existed. Moreover, with this Act, physicians are at risk not merely for revocation of their license to prescribe controlled substances--as called for in last year's Lethal Drug Abuse Prevention Act--they are also subject to jail time.

Palliative care is a new and emerging field in medicine, with rapid changes in knowledge and understanding. To freeze the science at this time, as this bill would do by providing a far too narrow definition of palliative care, would be a mistake. As someone with both legal and medical training, I understand the desire of policymakers to use the law to establish clear, black-and-white rules, but I also understand the absolute necessity for medicine to work in fuzzy shades of gray. That gray area makes legislation, regulation and enforcement of medicine at the end of life very difficult and threatens the ability of doctors to improve the quality of palliative care.

As several major studies indicate, the reality is that legal concerns already make physicians overly cautious about prescribing the medications necessary to relieve the pain of their patients. Given the seriously disruptive and traumatic nature of criminal prosecutions, this Act will make physicians err even more on the side of caution. Often extra caution is good, but in this case it means that tens of thousands of patients will continue to die without adequate treatment of their pain. 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.

2. The Act subjects medical care to the oversight of officials with no expertise in medical care. By empowering officials of the Drug Enforcement Administration and other federal, state and local law enforcement personnel to prosecute physicians to determine their intent, this Act subjects physicians who care for dying patients to the oversight of police with no expertise in the provision of medical care. The Act does say that it will provide training to law enforcement personnel to help them discern appropriate use of palliative care medications, but health care professionals with years and years of training do not agree on such guidelines. They recognize that the practice of medicine, especially among end-stage terminally ill patients, is best when done on a case-by-case basis, using the patient's best interest as the most appropriate barometer. A weekend seminar in medicine for police officers will not replace years of working with and understanding the practice of medicine for terminally ill patients.

Instead of being regulated by people sensitive to the nuances of medical treatment and the need for compassionate administration of narcotic drugs to dying patients, physicians will be regulated by people trained in criminal enforcement and instructed to curtail the use of controlled substances. The Controlled Substances Act was not designed to address difficult medical and social policies, and the DEA was not constituted to regulate medical practitioners.

Doctors must now worry about federal, state and local law enforcement personnel roaming the halls of hospitals and nursing homes and looking over their shoulders when they try to meet the needs of their dying patients. Second guessing of treatments by nurses, hospice workers or pharmacists could create just enough suspicion to start a police investigation. This will inevitably distract physicians from their primary goal--the treatment of their patients by the most effective means available to them.

3. The Act interferes with the ability of states to engage in experimentation and innovation in the care of dying patients. Congress and the courts have long recognized the importance of the laboratory of state experimentation on complicated matters of social policy. Because the optimal approach is often not clear, our federal system encourages states to try different approaches. With local variations, the country can discover the best course of action.

This Act most obviously frustrates state experimentation and innovation by overriding Oregon's Death with Dignity Act. When the U.S. 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." Similarly, observed Justice Rehnquist in his opinion for the Court, "public concern and democratic action are . . . sharply focused on how best to protect dignity and independence at the end of life, with the result that there have been many significant changes in state laws and in the attitudes those laws reflect."

Mindful of its difficultly navigating other areas of complex social policy, the Court indicated its desire to see issues relating to end-of-life care resolved through the local and democratic processes of state legislatures. In a bold departure from the Supreme Court's guidance, this Act would bring an abrupt end of state experimentation and the accompanying efforts to protect dignity and independence at the end of life.

Equally important, this Act also frustrates state experimentation and innovation in palliative care. 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 assisted suicide. Doctors who care for patients at the end of life need to be free and encouraged to try different approaches in their efforts to relieve suffering. The threat of prosecution under this Act will discourage physicians from pursuing promising treatments that are closest to the border between lawful palliative care and unlawful assisted suicide. And, this chilling effect will occur in all 50 states.

4. The Act usurps the states' rightful authority over medical practice. By imposing a federal mandate, this Act contravenes the principle of federalism, a basic tenet of American law and democracy. Traditionally, the regulation of medical practice should be 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." Similarly, the Controlled Substances Act, which this Act 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." Rather than defer to state law in the regulation of medical practice, this Act specifically directs that state law be ignored. Section 101 directs 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. This departure from the structure of the Controlled Substances Act represents a serious invasion of states' rights.

5. The Act's good intentions can be better served through other, pending legislation. Whatever one's views on the role of assisted suicide in end-of-life care, we can all agree on the need for better palliative care. This Act is admirable for its efforts to enhance the quality of palliative care in this country. Nevertheless, those efforts are seriously compromised by the Act itself, in its provisions that will chill the provision of aggressive pain relief. Fortunately, there are other bills before Congress that incorporate the good parts of this Act without combining them with the counterproductive parts. Patients and physicians will be better served if Congress enacts one of these other bills, for example, "The Conquering Pain Act" or "The Compassionate Care Act."

Note: In response to the Committee's instructions to witnesses, I have not received any federal grant, contract or subcontract in the current or preceding two fiscal years. I am not representing any other party at this hearing.