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Correspondence

Attorney General's Intrusion into Clinical Practice

N Engl J Med 2002; 346:1918-1919June 13, 2002

Article

To the Editor:

Attorney General John Ashcroft's challenge to the Death with Dignity Act in Oregon is unusual in that one person with a personal ideology that is based on religious beliefs feels justified in forcing all other citizens to comply with his philosophy. This fanaticism is particularly disturbing given that those on whom he is forcing his beliefs suffer from terminal illnesses without hope of improvement.

The article by Lowenstein and Wanzer (Feb. 7 issue)1 appropriately discusses examples of medications that are used for purposes other than assisted suicide and whose use may be challenged if Ashcroft's directive is permitted to stand. To the best of my knowledge, however, no legal scholars have challenged the basis for this directive, which is an incorrect definition in a “Memorandum for the Attorney General” stating that:

. . . physician-assisted suicide typically involves the use of a lethal dose of a combination of drugs, including controlled substances. First, the patient is sedated using either a barbiturate (e.g., sodium pentothal), or an opiate (e.g., morphine). Then, one or more drugs are used to paralyze the muscles and/or to stop the heart. The sedatives involved in these procedures are controlled substances under the CSA [Controlled Substances Act].2

The above description defines active euthanasia, used most frequently, in the United States, for prison inmates in Texas who have been sentenced to death; in these cases, a doctor injects the medications. In physician-assisted suicide, the terminally ill patient must consume oral medication. It appears that, in Ashcroft's opinion, only the most dangerous criminals should be permitted a speedy, sure, and peaceful method of dying, whereas hopelessly ill patients should be sentenced to “life” with no remaining quality.

Richard MacDonald, M.D.
Hemlock Society USA, Denver, CO 80250-1810

2 References
  1. 1

    Lowenstein E, Wanzer SH. The U.S. attorney general's intrusion into medical practice. N Engl J Med 2002;346:447-448
    Full Text | Web of Science | Medline

  2. 2

    Memorandum for the Attorney General: whether physician-assisted suicide serves a “legitimate medical purpose” under the Drug Enforcement Administration's regulations implementing the Controlled Substances Act. Washington, D.C.: Department of Justice Office of Legal Counsel, June 27, 2001.

To the Editor:

Lowenstein and Wanzer persuasively criticize Attorney General Ashcroft's attempt to interfere with Oregon's Death with Dignity Act. Two comments are in order. First, contrary to their assertion, this sort of interference has happened before: during the Reagan administration, when it “down-scheduled” a form of tetrahydrocannabinol, the Drug Enforcement Administration (DEA) made a policy announcement in which they threatened to withdraw the certificates of registration of any physician who engaged in the off-label use of this drug, which is marketed as dronabinol (Marinol) and was originally approved by the Food and Drug Administration (FDA) only as an antiemetic agent for patients receiving chemotherapy.1 Second, early in the Reagan administration, a group of death-row inmates from Texas had petitioned the FDA to restrict the off-label use of drugs for lethal injection, a request that the agency denied in deference to the choices made by state penal officials; the Supreme Court affirmed that decision, indicating that this was a matter appropriately left to the enforcement discretion of the FDA.2 Does Ashcroft's initiative signal a willingness by the current administration to revisit that curious dispute? I'm quite certain that concern about federalism would quickly resurface to justify inaction on that front.

Lars Noah, J.D.
University of Florida, Gainesville, FL 32611

2 References
  1. 1

    Drug Enforcement Administration. Schedules of controlled substances: rescheduling of synthetic dronabinol in sesame oil and encapsulated in soft gelatin capsules from schedule I to schedule II: statement of policy. Fed Regist 1986;51:17476-17477

  2. 2

    Heckler v. Chaney, 470 U.S. 821 (1985).

Author/Editor Response

The authors reply:

To the Editor: MacDonald states that no one has challenged Attorney General Ashcroft on his confusion of the definition of physician-assisted suicide (the subject of the Oregon Death with Dignity Act) with that of euthanasia (an act that is illegal in all jurisdictions in the United States).1 We agree. This imprecision by Ashcroft, whereby he describes a method for euthanasia in objecting to legislation on physician-assisted suicide, provides another compelling argument as to why the Department of Justice should not intrude into the practice of medicine. The Department of Justice cannot even successfully define what it condemns.

We disagree with MacDonald's equation of euthanasia with executing prisoners with the use of drugs. When a prisoner is put to death by drugs, the act does not constitute euthanasia by any accepted definition.

Noah correctly notes that there was an attempt by the DEA in 1986 to confine the medical use of a Schedule II drug to a single indication — that is, relief of nausea associated with cancer treatment. The agency attempted to implement this restriction on use by incorporating a “Statement of Policy” into the Final Rule and threatening to revoke the DEA registration of any physician who prescribed drugs for off-label indications.2 This action was controversial at the time and of dubious legality; since it was never challenged in court, the question of its legality remains open. That the attempt was not successful is evidenced by the fact that in 1999, the DEA further downscheduled that drug (dronabinol) to Schedule III.3 The DEA did so because it recognized another indication — anorexia and wasting related to the acquired immunodeficiency syndrome — and acknowledged that the hazards presented by this medication did not justify Schedule II restrictions. The affirmation by the Supreme Court of the FDA's refusal to interfere with the off-label use of Schedule II drugs for the purpose of lethal injection, also brought to our attention by Noah, strengthens the case against Ashcroft's directive.4

Edward Lowenstein, M.D.
Harvard Medical School, Boston, MA 02115

Sidney H. Wanzer, M.D.
333 Thoreau St., Concord, MA 01742

4 References
  1. 1

    Ashcroft J. Memorandum for Asa Hutchinson. Washington, D.C.: Office of the Attorney General, November 6, 2001.

  2. 2

    Drug Enforcement Administration. Schedules of controlled substances: rescheduling of synthetic dronabinol in sesame oil and encapsulated in soft gelatin capsules from schedule I to schedule II: statement of policy. Fed Regist 1986;51:17476-17477

  3. 3

    Schedules of controlled substances: rescheduling of the Food and Drug Administration approved product containing synthetic dronabinol [(-)-deHa]<9>-(trans)-tetrahydrocannabinol] in sesame oil and encapsulated in soft gelatin capsules from schedule II to schedule III. Fed Regist 1999;64:35928-35928
    Medline

  4. 4

    Heckler v. Chaney, 470 U.S. 821 (1985).

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