Dear PCC member:
I am forwarding the following excellent analysis of the Pain Relief Promotion Act. The source is a non-profit organization--Americans for Integrity in Palliative Care--which dedicates its effort to enhancing care at the end-of-life. Because of a one week delay in "mark-up" of the bill, it is not too late to write or contact the senators (as outlined at the end of this message). Please consider doing this NOW!
Thank you,
William L. Toffler MD, National Director, PCC

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Americans for Integrity in Palliative Care Update on Pain Relief Bill

Some state medical societies continue to criticize the proposed federal Pain Relief Promotion Act, based, we believe, on a misunderstanding of its meaning and effect. They have expressed a fear that it will expand federal authority over pain control, intrude into medical practice, overturn state guidelines on pain management, and any number of other horrors.

Americans for Integrity in Palliative Care supports the legislation because, having studied it, we have concluded like the AMA's own Reference Committee on Legislation did in December, that the charges are without merit. In fact, the bill does just the opposite * but to understand why, one must be clear on the meaning of key terms in the federal law.

The Pain Relief Promotion Act writes the following two sentences into the federal Controlled Substances Act:

"For purposes of this Act and any regulations to implement this Act, alleviating pain or discomfort in the usual course of professional practice is a legitimate medical purpose for the dispensing, distributing, or administering of a controlled substance that is consistent with public health and safety, even if the use of such a substance may increase the risk of death. Nothing in this section authorizes intentionally dispensing, distributing, or administering a controlled substance for the purpose of causing death or assisting another person in causing death."

The problem arises from misunderstandings of the key phrases "usual course of professional practice" and "legitimate medical purpose." Both are terms of art with definite legal meanings.

By saying that a physician must be practicing within "the usual course of professional practice," the Act is automatically deferring to professional societies and state licensing authorities as to how one defines the scope of medical practice. As one legal expert has written, "when a physician prescribes a controlled substance in the course of professional practice, he or she is outside the DEA's [Drug Enforcement Administration's] enforcement authority. The responsibility for policing prescriptions of these drugs in the course of professional practice rests with state regulatory authorities, such as state medical boards" (Charles Wilson, "Establishing a Right to Palliative Care at the End of Life" (www.bazelon.org/pall8art.html ).

By saying that a physician who so practices shall be seen by the federal government as serving a "legitimate medical purpose," the Act is not creating new federal authority or establishing a new federal definition of medicine. On the contrary: It is establishing that the entire practice of pain control (as defined by professional societies and states), up to and including pain control that may increase the risk of death, is to be left alone by the DEA. That is, the DEA has no authority to regulate medicine as such * it only has authority to prevent "diversion" to "non-medical" purposes which endanger health and safety.

So a translation into ordinary English of the proposed Act would go like this: "If you're practicing pain control in accord with the medical standards set by your profession and/or your state licensing authorities, the DEA now has orders from Congress to leave you alone to do your job. In particular, the DEA must recognize that the side-effect of increasing the risk of death, when this is demanded by the needs of aggressive pain control, is ethically accepted throughout the profession and should not be confused with illicit activity." This new protection, of course, does not extend to cases where a doctor intentionally gives out drugs for the purpose of causing people's deaths * but then, that's a felony in almost every state already anyway and has never been part of ethical medical practice.

This does not mean that states have absolute and unreviewable authority to ignore federal law * that has never been true under the Supremacy Clause of the Constitution. But federal law will prevail over state law (and even then, only for purposes of implementing the federal law) in cases of direct conflict. And the only time a state law could conflict with this federal law is when (a) it tries to authorize deliberate killing of patients or (b) it tries to condemn doctors who do pain control that may unintentionally hasten death. The first case is of interest only to Oregon; the second has been more than a theoretical threat in some states, and doctors should welcome another authority to cite in their defense. Some state prosecutors have actually tried to indict doctors for homicide when their hospice patients die with large doses of morphine in their bodies. Now doctors in these situations will be able to point to the acceptance of the principle of double effect in federal law. Even the existence of this clear federal standard does not force the states to change their state laws: for example, a state may still allow doctors who assist suicides to keep their state medical licenses. But the fact that federal law explicitly accepts the principle of double effect can certainly be used in state proceedings to show how broadly the principle is accepted.

The charge that it is inappropriate for government to judge "intent to kill" in such cases are simply thirty years late. The federal Controlled Substances Act has always authorized the DEA to revoke the federal registrations of doctors who use those registrations to violate state laws. The vast majority of state laws already make it a crime to "intentionally" assist a suicide; and the DEA has the authority already to make its own determination as to whether each element of the crime was proved. The new bill doesn't change any of this: its only new legal effect is to provide new protection for pain control that may unintentionally hasten death. If the government thereby finds it more difficult to go after doctors because it has to prove "intent," that is a difficulty that protects the physician, giving him or her every benefit of doubt.

State medical societies are understandably concerned that the law should give as much deference as possible to local professional standards and to individual physicians practicing aggressive pain control. It is tragic that when a law finally comes along that does just that, it is opposed because certain terms and words are being misunderstood.

More details on the relationship between federal law and state guidelines on pain control are set forth in the following fact sheet by AIPC. I hope this information is helpful in understanding this important legislation, which deserves all physicians' support.

Thank you.

Gene Tarne

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The Pain Relief Promotion Act and State Guidelines on Palliative Care: Compatibility, Not Conflict

A question has been raised whether the Pain Relief Promotion Act (PRPA) of 1999 will somehow override or preempt helpful regulations on palliative care that have been enacted by the states. Americans for Integrity in Palliative Care believes any concern on this point is misplaced, for the following reasons:

* While states sometimes have reason to be wary of federal intrusions into their practices, such misgivings do not apply to the Pain Relief Promotion Act. This is clear from the language of the bill itself and from the bill's intent, as made explicit by one of its sponsors, Tom Coburn, a practicing physician and Representative from Oklahoma:

"Is it the intent of this bill to undermine States' ability to help patients access appropriate palliative care? No, it is not the intent whatsoever. Is it the intent of this bill to create a fear on the part of physicians so they will not do the proper thing when it comes to caring for end-of-life, pain-enduring patients? No, that is not the intent. And that is not the consequence... What we actually do is define better so that we do not put physicians at risk and give them a safe harbor."

"Are we trying to go around guidelines for end-of-life issues in the State? No, we are not trying to do that at all. What we are trying to say is have whatever guidelines they want, but as far as the use of narcotics, we do not think that those narcotics ought to be used to intentionally take a life."

* Rep. Tom Coburn, Congressional Record, 10/27/99, page H10880

* No state law on palliative care will be superseded by the Pain Relief Promotion Act. The legislation merely clarifies that it is no violation of the federal Controlled Substances Act (CSA) to dispense, distribute or administer a controlled substance to alleviate pain or discomfort. This provision has the effect of bringing federal law into conformity with similar provisions already enacted by the states. When state guidelines allow a pain management practice * up to and including one that may involve unintentionally hastening death * health professionals will now have explicit assurances that they need not fear federal liability for following such guidance.

* States will remain free, as they always have been, to enact their own legislation on palliative care. Any additional standards that the states may set to ensure that pain management is practiced in the most responsible and effective manner remain completely within their authority. Section 201 of H.R. 2260 actually instructs the Department of Health and Human Services to "collect and disseminate" such existing protocols and make them more widely available so physicians in other states can learn about available resources in this field. Obviously this provision would make no sense if the legislation were designed to preempt such protocols. American Medical Association President Thomas Reardon, M.D. correctly notes that the PRPA "does not pre-empt state initiatives that encourage pain management."

* Strictly speaking, even the Oregon law is not preempted or overturned by the federal bill. Only when state and federal laws directly conflict with each other, as when one law requires what another forbids, does federal preemption arise in this field of law [Cf. Aspen Health Law Center, Pharmacy Law Answer Book (Aspen Publications: Gaithersburg, MD 1996), p. 9; R Abood and D. Brushwood, Pharmacy Practice and the Law (Aspen Publications: Gaithersburg, MD 1997), p.23]. Oregon state law allows assisted suicide in certain cases, while the federal law adds that if such assisted suicides are done there are certain federally controlled drugs that cannot be used for the purpose. Both laws continue to stand, since the Oregon law does not require that suicides be assisted using federally regulated drugs. In the other 49 states, there is no conflict at all between the federal law and state laws providing for the use of controlled substances to manage pain.

In Oregon, doctors will simply have to use drugs that do not implicate the federal government in actively facilitating and supporting assisted suicide. As AIPC founding member Dr. Walter Hunter notes: "Under this law, Oregon physicians and patients will remain free to pursue assisted suicide. They just cannot use the medications covered by the Controlled Substances Act (CSA). And that should not create undue hardship since, to my knowledge, no double blinded controlled clinical studies have been conducted anywhere to determine the precise lethal dose of these medications. In other words, Oregon physicians can use any medication not covered by the CSA to cause death. And they can use it as they have been doing with controlled substances: guessing at the dose necessary to cause death 100% of the time for those patients they wish to see dead."

FOUNDING MEMBERS, AMERICANS FOR INTEGRITY IN PALLIATIVE CARE

C. Everett Koop, M.D
Former Surgeon General of the United States; Senior Scholar, the Koop Institute at Dartmouth Medical Center.

Herbert Hendin, MD
Professor of Psychiatry, New York Medical College; Executive Director, American Foundation for Suicide Prevention; Author of Seduced by Death: Doctors, Patients and Assisted Suicide (W.W. Norton 1998).

Eric Chevlen, MD
Director of Palliative Care, St. Elizabeth Health Center, Youngstown, Ohio; Diplomate of the American Boards of Internal Medicine, Medical Oncology, Hematology, Pain Medicine, and Hospice and Palliative Medicine.

Walter R. Hunter, MD
Associate National Medical Director, VistaCare Hospice; member, ethics committees, National Hospice Organization and the American Academy of Hospice and Palliative Medicine.

Wesley J. Smith, Esq.
Attorney and consumer advocate; author of Forced Exit: The Slippery Slope from Assisted Suicide to Legalized Murder (Random House 1997).

Edmund Pellegrino, MD
Member and past Director of the Center for Clinical Bioethics and John Carroll Professor of Medicine and Medical Ethics, Georgetown University Medical Center.

Ralph Miech, MD, Ph.D.
Associate Professor of Pharmacology, Brown University School of Medicine.

Carlos F. Gomez, MD, Ph.D.
Assistant Professor of Medicine and Medical Director of the Palliative Care Program, University of Virginia Health System; author of Regulating Death: Euthanasia and the Case of the Netherlands (Free Press, 1991).

William Toffler, MD
Professor and Director of Education Section, Department of Family Medicine, Oregon Health Sciences University; co-founder and National Director, Physicians for Compassionate Care.

N. Gregory Hamilton, MD
Psychiatrist in Portland, Oregon; author of The Self and the Ego in Psychotherapy (Jason Aronson 1996); cofounder and President, Physicians for Compassionate Care.

James Towey, Esq.
Founder and President, Aging with Dignity and author of Five Wishes, the advance directive now legally valid in 33 states.

(Institutional affiliations are for identification purposes only).

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To ALL AIPC founding Members:
As you may know by now, the Senate is on the verge of taking up the Pain Relief Promotion Act. A markup for the bill was scheduled for last Thursday in the Senate Judiciary Committee, but this has been postponed until sometime later this week (probably Thursday, 4/6/00).

I would ask and urge all of you, if you have not already done so, to write to the Senate in support of this legislation. I believe all of you had already written to Hyde and/or Nickles when the bill was up in the House last fall. You can just take this letter and update it with the Senate Bill number -- S.1272. Most important is to send a letter to Senator Hatch, the Chair of the committee, and if possible, to Senator Leahy also, who is the ranking Democratic member. Faxes numbers for them, and for all the Judiciary Committee members are given below. PLEASE, also, cc a copy of your letter to Debbie Price in Senator Nickles office (Sen. Nickles is the chief sponsor of the bill) She is at Fax: 202-228-0034. Finally, if you could please fax a copy to me at 703 684-5813.

Thank you for your urgent attention to this matter and for all the work you are doing and have done to get this legislation passed.

Gene
PS Please feel free to share this message with any colleagues you think will help in this effort!

Orrin Hatch, chairman - Utah 224-6331

Strom Thurmond - South Carolina 224-1300; also 228-0463

Charles Grassley - Iowa 224-6020

Arlen Specter - Pennsylvania 228-1229

Jon Kyl - Arizona 224-2207

Mike DeWine - Ohio 224-6519

John Ashcroft - Missouri 228-0998

Spencer Abraham - Michigan 224-8834;228-1244

Jeff Sessions - Alabama 224-3149

Robert Smith - New Hampshire 224-1353

Democrats

Patrick Leahy, ranking member - Vermont 224-3479

Edward Kennedy - Massachusetts 224-2417

Joseph Biden - Delaware 224-0139

Herbert Kohl - Wisconsin 224-9787;228-0463

Dianne Feinstein - California 228-3954

Russ Feingold - Wisconsin 224-2725

Robert Torricelli - New Jersey 224-8567

Charles Schumer - New York 228-3027; 224-6542