Senate Report 106-299 - THE PAIN RELIEF PROMOTION ACT

[Senate Report 106-299]
[From the U.S. Government Publishing Office]

Calendar No. 566
106th Congress Report
SENATE
2d Session 106-299

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THE PAIN RELIEF PROMOTION ACT

_______

May 23, 2000.--Ordered to be printed

_______

Mr. Hatch, from the Committee on the Judiciary, submitted the following

R E P O R T

together with

MINORITY VIEWS

[To accompany H.R. 2260]

The Committee on the Judiciary, to which was referred the
bill (H.R. 2260) amending the Controlled Substances Act to
promote pain management and palliative care without permitting
assisted suicide and euthanasia, and for other purposes, having
considered the same, reports favorably thereon, with an
amendment in the nature of a substitute, and recommends that
the bill, as amended, do pass.

CONTENTS

Page

I. Text of H.R. 2260................................................1
.................................................................
II. Purpose and summary..............................................5
.................................................................
III. Background and need for the legislation..........................6
.................................................................
IV. Section-by-section analysis.....................................15
.................................................................
V. Legislative history and vote of the Committee...................19
.................................................................
VI. Explanation of the legislation and Committee views..............22
.................................................................
VII. Cost estimate...................................................46
.................................................................
VIII.Regulatory impact statement.....................................49

.................................................................
IX. Minority views of Senators Leahy, Kennedy, Kohl, and Feinstein..50
.................................................................
X. Changes in existing law.........................................83

I. Text of H.R. 2260
The amendment is as follows:
Strike all after the enacting clause and insert the
following:

SECTION 1. SHORT TITLE.

This Act may be cited as the ``Pain Relief Promotion Act of 2000''.

SEC. 2. FINDINGS.

Congress finds that--
(1) in the first decade of the new millennium there should be
a new emphasis on pain management and palliative care;
(2) the use of certain narcotics and other drugs or
substances with a potential for abuse is strictly regulated
under the Controlled Substances Act;
(3) the dispensing and distribution of certain controlled
substances by properly registered practitioners for legitimate
medical purposes are permitted under the Controlled Substances
Act and implementing regulations;
(4) the dispensing or distribution of certain controlled
substances for the purpose of relieving pain and discomfort
even if it increases the risk of death is a legitimate medical
purpose and is permissible under the Controlled Substances Act;
(5) inadequate treatment of pain, especially for chronic
diseases and conditions, irreversible diseases such as cancer,
and end-of-life care, is a serious public health problem
affecting hundreds of thousands of patients every year;
physicians should not hesitate to dispense or distribute
controlled substances when medically indicated for these
conditions; and
(6) for the reasons set forth in section 101 of the
Controlled Substances Act (21 U.S.C. 801), the dispensing and
distribution of controlled substances for any purpose affect
interstate commerce.

TITLE I--PROMOTING PAIN MANAGEMENT AND PALLIATIVE CARE

SEC. 101. ACTIVITIES OF AGENCY FOR HEALTHCARE RESEARCH AND QUALITY.

Part A of title IX of the Public Health Service Act (42 U.S.C. 299 et
seq.) is amended by adding at the end the following:

``SEC. 903. PROGRAM FOR PAIN MANAGEMENT AND PALLIATIVE CARE RESEARCH
AND QUALITY.

``(a) In General.--Subject to subsections (e) and (f) of section 902,
the Director shall carry out a program to accomplish the following:
``(1) Promote and advance scientific understanding of pain
management and palliative care.
``(2) Collect and disseminate protocols and evidence-based
practices regarding pain management and palliative care, with
priority given to pain management for terminally ill patients,
and make such information available to public and private
health care programs and providers, health professions schools,
and hospices, and to the general public.
``(b) Definition.--In this section, the term `pain management and
palliative care' means--
``(1) the active, total care of patients whose disease or
medical condition is not responsive to curative treatment or
whose prognosis is limited due to progressive, far-advanced
disease; and
``(2) the evaluation, diagnosis, treatment, and management of
primary and secondary pain, whether acute, chronic, persistent,
intractable, or associated with the end of life;
the purpose of which is to diagnose and alleviate pain and other
distressing signs and symptoms and to enhance the quality of life, not
to hasten or postpone death.''.

SEC. 102. ACTIVITIES OF HEALTH RESOURCES AND SERVICES ADMINISTRATION.

(a) In General.--Part D of title VII of the Public Health Service Act
(42 U.S.C. 294 et seq.) is amended--
(1) by redesignating sections 754 through 757 as sections 755
through 758, respectively; and
(2) by inserting after section 753 the following:

``SEC. 754. PROGRAM FOR EDUCATION AND TRAINING IN PAIN MANAGEMENT AND
PALLIATIVE CARE.

``(a) In General.--The Secretary, in consultation with the Director
of the Agency for Healthcare Research and Quality, may award grants,
cooperative agreements, and contracts to health professions schools,
hospices, and other public and private entities for the development and
implementation of programs to provide education and training to health
care professionals in pain management and palliative care.
``(b) Priority.--In making awards under subsection (a), the Secretary
shall give priority to awards for the implementation of programs under
such subsection.
``(c) Certain Topics.--An award may be made under subsection (a) only
if the applicant for the award agrees that the program to be carried
out with the award will include information and education on--
``(1) means for diagnosing and alleviating pain and other
distressing signs and symptoms of patients, especially
terminally ill patients, including the medically appropriate
use of controlled substances;
``(2) applicable laws on controlled substances, including
laws permitting health care professionals to dispense or
administer controlled substances as needed to relieve pain even
in cases where such efforts may unintentionally increase the
risk of death; and
``(3) recent findings, developments, and improvements in the
provision of pain management and palliative care.
``(d) Program Sites.--Education and training under subsection (a) may
be provided at or through health professions schools, residency
training programs and other graduate programs in the health
professions, entities that provide continuing medical education,
hospices, and such other programs or sites as the Secretary determines
to be appropriate.
``(e) Evaluation of Programs.--The Secretary shall (directly or
through grants or contracts) provide for the evaluation of programs
implemented under subsection (a) in order to determine the effect of
such programs on knowledge and practice regarding pain management and
palliative care.
``(f) Peer Review Groups.--In carrying out section 799(f) with
respect to this section, the Secretary shall ensure that the membership
of each peer review group involved includes individuals with expertise
and experience in pain management and palliative care for the
population of patients whose needs are to be served by the program.
``(g) Definition.--In this section, the term `pain management and
palliative care' means--
``(1) the active, total care of patients whose disease or
medical condition is not responsive to curative treatment or
whose prognosis is limited due to progressive, far-advanced
disease; and
``(2) the evaluation, diagnosis, treatment, and management of
primary and secondary pain, whether acute, chronic, persistent,
intractable, or associated with the end of life;
the purpose of which is to diagnose and alleviate pain and other
distressing signs and symptoms and to enhance the quality of life, not
to hasten or postpone death.''.
(b) Authorization of Appropriations; Allocation.--
(1) In general.--Section 758 of the Public Health Service Act
(as redesignated by subsection (a)(1) of this section) is
amended, in subsection (b)(1)(C), by striking ``sections 753,
754, and 755'' and inserting ``sections 753, 754, 755, and
756''.
(2) Amount.--With respect to section 758 of the Public Health
Service Act (as redesignated by subsection (a)(1) of this
section), the dollar amount specified in subsection (b)(1)(C)
of such section is deemed to be increased by $5,000,000.

SEC. 103. DECADE OF PAIN CONTROL AND RESEARCH.

The calendar decade beginning January 1, 2001, is designated as the
``Decade of Pain Control and Research''.

SEC. 104. EFFECTIVE DATE.

The amendments made by this title shall take effect on the date of
enactment of this Act.

TITLE II--USE OF CONTROLLED SUBSTANCES CONSISTENT WITH THE CONTROLLED
SUBSTANCES ACT

SEC. 201. REINFORCING EXISTING STANDARD FOR LEGITIMATE USE OF
CONTROLLED SUBSTANCES.

(a) In General.--Section 303 of the Controlled Substances Act (21
U.S.C. 823) is amended by adding at the end the following:
``(i)(1) 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.
``(2)(A) Notwithstanding any other provision of this Act, in
determining whether a registration is consistent with the public
interest under this Act, the Attorney General shall give no force and
effect to State law authorizing or permitting assisted suicide or
euthanasia.
``(B) Paragraph (2) applies only to conduct occurring after the date
of enactment of this subsection.
``(3) Nothing in this subsection shall be construed to alter the
roles of the Federal and State governments in regulating the practice
of medicine. Regardless of whether the Attorney General determines
pursuant to this section that the registration of a practitioner is
inconsistent with the public interest, it remains solely within the
discretion of State authorities to determine whether action should be
taken with respect to the State professional license of the
practitioner or State prescribing privileges.
``(4) Nothing in the Pain Relief Promotion Act of 2000 (including the
amendments made by such Act) shall be construed--
``(A) to modify the Federal requirements that a controlled
substance be dispensed only for a legitimate medical purpose
pursuant to paragraph (1); or
``(B) to provide the Attorney General with the authority to
issue national standards for pain management and palliative
care clinical practice, research, or quality;
except that the Attorney General may take such other actions as may be
necessary to enforce this Act.''.
(b) Pain Relief.--Section 304(c) of the Controlled Substances Act (21
U.S.C. 824(c)) is amended--
(1) by striking ``(c) Before'' and inserting the following:
``(c) Procedures.--
``(1) Order to show cause.--Before''; and
(2) by adding at the end the following:
``(2) Burden of proof.--At any proceeding under paragraph
(1), where the order to show cause is based on the alleged
intentions of the applicant or registrant to cause or assist in
causing death, and the practitioner claims a defense under
paragraph (1) of section 303(i), the Attorney General shall
have the burden of proving, by clear and convincing evidence,
that the practitioner's intent was to dispense, distribute, or
administer a controlled substance for the purpose of causing
death or assisting another person in causing death. In meeting
such burden, it shall not be sufficient to prove that the
applicant or registrant knew that the use of controlled
substance may increase the risk of death.''.

SEC. 202. EDUCATION AND TRAINING PROGRAMS.

Section 502(a) of the Controlled Substances Act (21 U.S.C. 872(a)) is
amended--
(1) by striking ``and'' at the end of paragraph (5);
(2) by striking the period at the end of paragraph (6) and
inserting ``; and''; and
(3) by adding at the end the following:
``(7) educational and training programs for Federal, State,
and local personnel, incorporating recommendations, subject to
the provisions of subsections (e) and (f) of section 902 of the
Public Health Service Act, by the Secretary of Health and Human
Services, on the means by which investigation and enforcement
actions by law enforcement personnel may better accommodate the
necessary and legitimate use of controlled substances in pain
management and palliative care.
Nothing in this subsection shall be construed to alter the roles of the
Federal and State governments in regulating the practice of
medicine.''.

SEC. 203. FUNDING AUTHORITY.

Notwithstanding any other provision of law, the operation of the
diversion control fee account program of the Drug Enforcement
Administration shall be construed to include carrying out section
303(i) of the Controlled Substances Act (21 U.S.C. 823(i)), as added by
this Act, and subsections (a)(4) and (c)(2) of section 304 of the
Controlled Substances Act (21 U.S.C. 824), as amended by this Act.

SEC. 204. EFFECTIVE DATE.

The amendments made by this title shall take effect on the date of
enactment of this Act.

II. Purpose and Summary
The purpose of the Pain Relief Promotion Act is to promote
pain research and management and palliative care and to make
clear that medications subject to the Controlled Substances Act
(``CSA'') may not be lawfully used to assist in suicide or to
perform euthanasia. In the 105th Congress, the Judiciary
Committee favorably reported the Lethal Drug Abuse Prevention
Act, S. 2151 (Report 105-372); this legislation and similar
goals to the substitute language to H.R. 2260 that the
Committee now adopts.
In enacting the Controlled Substances Act of 1970, the
Congress firmly established the principle that certain types of
drug substances were subject to national regulation. The
statute recognizes that ``[m]any of the drugs included within
this title have a useful and legitimate medical purpose and are
necessary to maintain the health and general welfare of the
American public.'' \1\ However, the law also was mindful of the
fact that illicit traffic use of controlled substances has ``*
* * a substantial and detrimental effect on the health and
general welfare of the American people.''\2\ Further, the CSA
finds that ``[f]ederal control of the interstate incidents in
traffic in controlled substances is essential to the effective
control of the interstate incidents in the United States.''\3\
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\1\ 21 U.S.C. 801(1).
\2\ 21 U.S.C. 801(2).
\3\ 21 U.S.C. 801(6).
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H.R. 2260, as adopted by the Judiciary Committee, advances
the two historical goals of the CSA of promoting the public
health by making necessary medications available to patients
and protecting the public safety by curbing illicit diversion
of these substances. H.R. 2260 explicitly adopts a safe harbor
that makes clear that physicians and other health care
professionals acting to alleviate pain or discomfort in the
usual course of medical practice are protected under the CSA,
even if such use of a controlled substance may increase the
risk of death. The legislation also makes clear that the
diversion of controlled substances for the purpose of causing
death or assisting another person in causing death is not
permitted under the CSA.
Inadequate treatment of pain is a serious public health
problem affecting hundreds of thousands of patients a year.
Perhaps ``the biggest obstacle'' to adequate treatment of pain,
however, is ``ignorance'': Few medical schools or residency
programs require training in pain management, and many rank-
and-file physicals are unaware of modern advances in palliative
care.\4\
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\4\ S. Brownlee and J. Schrof, ``The Quality of Mercy,'' U.S. News
and World Report, vol. 122, No. 10 (Mar. 17, 1997): p. 56.
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Highlighting the need for improved care, and posing its own
obstacle to such improvement, is the drive by some for
acceptance of assisted suicide as a ``quick fix'' supplanting
the more difficult but more responsible task of caring for
terminally ill patients' real needs. As the National Hospice
Organization has warned, ``the acceptance of assisted suicide
as a way to deal with terminal illness would undercut further
efforts to increase the public's awareness of hospice as a
life-affirming option.''\5\
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\5\ Brief for Amicus National Hospice Organization at 18, Vacco v.
Quill, 521 U.S. 793 (1997) and Washington v. Glucksberg, 521 U.S. 702
(1997).
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H.R. 2260 addresses this problem in several ways. In
addition to definitively establishing that the use of
controlled substances to alleviate pain or discomfort in the
usual course of professional practice is authorized and
encouraged under Federal law, in order to promote better pain
management, H.R. 2260 authorizes a $5,000,000 program under
which the Secretary of Health and Human Services may award
grants to health professions schools, hospices and other sites
to develop and implement palliative care education and
training. Third, it authorizes the Agency for Health-care
Research and Quality in the Department of Health and Human
Services to collect and disseminate protocols for palliative
care, while making clear that neither the Department nor the
Attorney General are authorized to mandate national standards
of clinical practice in this area.
The legislation reinforces the widely held view that under
existing law the purpose of causing death or assisting another
person in causing death is not a legitimate use of controlled
substances and is not consistent with public health and safety.
In order to encourage medical practitioners to prescribe,
dispense, distribute and administer controlled substances as
medically appropriate in order to relieve pain and discomfort,
the bill makes it more difficult to revoke doctors'
registrations to prescribe controlled substances by raising the
required standard of proof from the current preponderance of
the evidence standard to the more difficult to satisfy clear
and convincing evidence standard.
It is also important to note that the bill would designate
this decade as the ``Decade of Pain Control and Research.''
This will result in focusing greater attention among scientists
and practitioners into pain management and research. Further,
the law charges the Attorney General to carry out educational
training programs for law enforcement personnel in how better
to accommodate health professionals' legitimate use of
controlled substances for pain management.
In summary, this legislation is premised on the principle
that the Controlled Substances Act contemplates use of
controlled substances to alleviate pain and suffering and that
this purpose cannot be turned on its head--and turned against a
central teaching of the Hippocratic Oath--First, do no harm--by
allowing controlled substances to be intentionally used as
agents of death.
Under the Pain Relief Promotion Act, as amended, Congress
finds that Federal law regarding controlled substances allows
dispensing and distributing controlled substances only by
properly registered practitioners for legitimate medical
purposes. The bill finds that the dispensing and distribution
of controlled substances, acts which affect interstate
commerce, are not legitimate medical purposes when used to
assist in a suicide or euthanasia. At the same time, the
measure recognizes the key role that controlled substances can
play in the legitimate medical use of relieving pain and
discomfort.

III. Background and Need for the Legislation
A number of recent events have sparked a national debate
over the interwined legal and ethical issues surrounding end-
of-life care, especially the provision of adequate pain relief
and palliative care and physician-assisted suicide. These
include: the involvement of Jack Kevorkian in a lengthy series
of assisted suicides before being finally convicted of homicide
after giving a lethal injection to a man with severe
disabilities in a videotape aired on national television; two,
recent Supreme Court cases on assisted suicide, Vacco v. Quill
\6\ and Washington v. Glucksberg;\7\ enactment of Oregon's
Measure 16 (the ``Death with Dignity Act'');\8\ Presidential
signature of the Assisted Suicide Funding Restriction Act of
1997 (Public Law 105-12) \9\; and the Senate Judiciary
Committee's favorable action on S. 2151 in the 10th Congress.
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\6\ 521 U.S. 793 (1997).
\7\ 521 U.S. 702 (1997).
\8\ Or. Rev. Stat Sec. 127.800-127.995
\9\ The Assisted Suicide Funding Restriction Act of 1997, 111 Stat.
23, Apr. 30, 1997.
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On November 8, 1994, Oregon became the only jurisdiction in
the United States authorizing physician-assisted suicide as a
matter of State law when the State's voters approved Ballot
Measure 16 by a slight margin of 51 percent to 49 percent.\10\
On November 27, 1994, however, a lawsuit was filed against the
measure alleging its unconstitutionality on equal protection
and due process grounds that prevented it from going into
immediate effect.\11\ On August 3, 1995, a Federal district
court held the law unconstitutional as a violation of the 14th
amendment's equal protection clause.\12\ The State of Oregon
appealed the decision, and on February 27, 1997, the ninth
circuit overturned the lower court's decision without reaching
the merits, instead ruling that the plaintiffs lacked
standing.\13\ On October 27, 1997, the ninth circuit
accordingly lifted the injunction against the act, which thus
officially went for the repeal of the act by a margin of 60
percent to 40 percent. However, on November 5, 1997, the
Federal Drug Enforcement Administration issued a ruling that
regardless of the change in Oregon's State law, under the
Federal Controlled Substances Act federally controlled drugs
could not legally be prescribed or administered to assist
suicide, either in Oregon or any other State. (After the ruling
was later reversed by Attorney General Reno, as described in
detail below, all of the drugs officially reported as having
been used to assist in the death of patients under Oregon's
Death with Dignity Act were federally controlled
substances.\14\) Meanwhile, on June 26, 1997, the U.S. Supreme
Court reversed two circuit courts of appeal rulings that had
struck down the laws of New York and Washington preventing
assisting suicide; the Nations highest court concluded that the
laws prohibiting assisting suicide do not violate the U.S.
Constitution. The Solicitor General of the United States filed
briefs as amicus curiae opposing the overturning of the State
laws in each case. In his brief in the Glucksberg case, the
Solicitor General emphasized that there is a clear ethical and
legal distinction between pain control that unintentionally
hastens death and the prescribing of lethal drugs with the
intent to cause death:
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\10\ See Spencer Heinz, ``Assisted Suicide: Advocates Weigh In,''
Oregonian, Dec. 9, 1994, at A1. The Death With Dignity Act authorizes
terminally ill Oregon residents, those who are determined to have fewer
than 6 months to live, to obtain a lethal prescription. In other
circumstances, Or. Rev. Stat. Sec. 163.125 continues to apply:
``Criminal homicide constitutes manslaughter in the second degree when
* * * [a] person intentionally causes or aids another person to commit
suicide.'' (Emphasis added.)
\11\ Federal District Court Judge Michael Hogan agreed with the
opponents and issued a temporary restraining order against
implementation of the act on the day before it was to go into effect,
pending a full hearing of their claims. On December 27, 1994, Judge
Hogan placed his temporary restraining with a preliminary injunction,
further delaying implementation of the act. Lee v. Lee Oegon, 891 F.
Supp. 1429, 1431 (D. Or. 1995).
\12\ Lee v. Oregon, 891 F. Supp. 1429, 1431 (D. Or. 1995).
\13\ 107 F. 3rd 1382 (9th Cir. 1997). On May 16, 1997, a petition
for writ of certiorari was filed with the U.S. Supreme Court, and the
Court denied the petition on October 14, 1997. 522 U.S. 927 (1997).
\14\ A Sullivan et al., ``Legalized Physician-Assisted Suicide in
Oregon--The Second Year,'' New England Journal of Medicine, vol. 342,
no. 8 (Feb. 24, 2000); p. 598, 599; A. Chin et al., ``Legalized
Physician-Assisted Suicide in Oregon--The First Year's Experience,''
New England Journal of Medicine, vol. 340, no. 7 (Feb. 18, 1999), p.
577, 578 (of 21 lethal prescriptions, 20 were for 9g of secobarbitol or
pentobarbitol; one was for (26 of the 27 patients were given 9g or more
of secobarbitol; one received 6 g of phenobarbitol).

[T]he ethical standards of the medical community have
long permitted physicians to prescribe medication in
sufficient doses to relieve pain, even when the
necessary dose will hasten death. * * * So long as the
physician's intent is to relieve pain, and not to cause
death, such treatment does not violate the ethical
standards of the medical community.\15\
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\15\ Brief for the United States as Amicus Curiae Supporting
Petitioners at 17-18, Washington v. Glucksberg, 521 U.S. 702 (1997).

The Supreme Court concurred with this distinction, noting,
``Just as a State may prohibit assisting suicide while
permitting patients to refuse unwanted lifesaving treatment, it
may permit palliative care related to that refusal, which may
have the foreseen but unintended `double effect' of hastening
the patient's death. See New York task force. When Death is
Sought, supra, n. 6, at 163 (`It is widely recognized that the
provision of pain medication is ethically and professionally
acceptable even when the treatment may hasten the patient's
death, if the medication is intended to alleviate pain and
severe discomfort, not to cause death').'' \16\
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\16\ Vacco v. Quill, 521 U.S. 793, 808 n. 11 (1997).
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The Solicitor General also noted that ``no Federal law * *
* either authorizes or accommodates physician assisted
suicide.'' \17\
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\17\ Solicitor General's Amicus Brief at 2, Glucksberg. Relevant
portions of the Glucksberg brief are as follows: Health facilities
controlled by the Federal Government ``do not permit physicians to
assist patients in committing suicide by providing lethal dosages of
medication.'' Id. at 1; ``Overriding State interests justify the
State's decision to ban physicians from prescribing lethal
medication.'' Id. at 9; ``There is an important and common-sense
distinction between withdrawing artificial supports so that a disease
will progress to its inevitable end, and providing chemicals to be used
to kill someone.'' Id.; ``Once a State decides to create an exception
to its prohibition against assisted suicide, there is no obvious
stopping point.'' Id. at 10; ``One special source of concern is that
terminally ill persons who contemplate suicide often suffer from
undiagnosed depression and inadequately treated pain * * *. In most
cases, once appropriate treatment is provided, the desire for suicide
abates.'' Id. at 19; ``Any exception to the ban on assisted suicide
therefore runs a very significant risk that persons with treatable
depression and pain will be allowed to commit suicide. A State has an
overriding interest in avoiding that risk and in protecting persons who
would want to remain alive if provided with the appropriate
treatment.'' Id. at 20; ``Another area of concern is that terminally
ill patients are often extremely vulnerable and susceptible to
influence by physicians, family members, and others on whom they depend
for support * * *. The point is not that physicians or family members
will attempt to coerce persons into committing suicide, although there
may be some cases of that. The real dangers are much more subtle and
extremely difficult to monitor and address.'' Id.; ``Another difficulty
with permitting doctors to prescribe lethal drugs for terminally ill
patients is that illnesses can be misdiagnosed as terminal * * *. If
the State were to create an exception to its ban on assisted suicide
for terminally ill adults, such a misdiagnosis could have tragic
consequences * * *. The State has an ovewhelmingly strong interest in
preventing such tragedies from occurring.'' Id. at 22; In the
Netherlands, which allowed assisted suicide with safeguards, ``a recent
study shows that those procedural safeguards have not worked.'' Id. at
23; ``[T]here is a very significant distinction between removing
artificial supports--and thereby allowing the underlying disease to
progress to its inevitable end--and providing chemicals to kill
someone. In one case, the cause of death can reasonably be viewed as
the underlying disease; in the other, the cause of death can only be
viewed as the lethal medication.'' Id. at 24; Similarly, after
reviewing various Federal policies that forbid physician-assisted
suicide in Veteran's Administration hospitals, military hospitals, the
National Institutes of Health, and the Indian Health Service, the
Solicitor General's amicus brief in Vacco v. Quill stated: ``No Federal
law authorizes or encourages physician assisted suicide.'' Brief for
the United States as Amicus Curiae Supporting Petitioners at 2, Vacco.
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In upholding laws preventing assisting suicide, the Supreme
Court described the legitimacy of the governmental interests at
stake:

Those who attempt suicide--terminally ill or not--
often suffer from depression or other mental disorders.
See New York Task Force 13-22, 126-128 (more than 95
percent of those who commit suicide had a major
psychiatric illness at the time of death; among the
terminally ill, uncontrolled pain is a ``risk factor''
because it contributes to depression): * * * Research
indicates * * * that many people who request physician-
assisted suicide withdraw that request if their
depression and pain are treated. H. Hendin, ``Seduced
by Death: Doctors, Patients and the Dutch Cure'', 24-25
(1997) (suicidal, terminally ill patients ``usually
respond well to treatment for depressive illness and
pain medication and are then grateful to be alive'') *
* *

* * * * * * *

[T]he State has an interest in protecting vulnerable
groups--including the poor, the elderly, and disabled
persons--from abuse, neglect, and mistakes. * * * [T]he
New York Task Force warned that ``[l]egalizing
physician-assisted suicide would pose profound risks to
many individuals who are ill and vulnerable. * * * The
risk of harm is greatest for the many individuals in
our society whose autonomy and well-being are already
compromised by poverty, lack of access to good medical
care, advanced age, or membership in a stigmatized
social group.'' New York Task Force 120, see
``Compassion in Dying,'' 49 F.3d, at 593 (``[A]n
insidious bias against the handicapped--again coupled
with a cost-saving mentality--makes them especially in
need of Washington's statutory protection''). If
physician-assisted suicide were permitted, many might
resort to it to spare their families the substantial
financial burden of end-of-life health-care costs.
The State's interest here goes beyond protecting the
vulnerable from coercion; it extends to protecting
disabled and terminally ill people from prejudice,
negative and inaccurate stereotypes, and ``societal
indifference.'' 49 F.3d, at 592. The State's assisted-
suicide ban reflects and reinforces its policy that the
lives of terminally ill, disabled, and elderly people
must be no less valued than the lives of the young and
healthy, and that a seriously disabled person's
suicidal impulses should be interpreted and treated the
same way as anyone else's.\18\
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\18\ Glucksberg, 521 U.S. at 730, 731-32.

Members of the Court also expressed concern that legal
acceptance of assisted suicide could erode society's
willingness to expand pain management and other aspects of
palliative care for dying patients. As Justice Breyer noted
during oral argument, the Netherlands, which permits assisted
suicide, had been found by a select committee of the British
House of Lords to contain only three palliative care centers,
compared with 185 in Great Britain where assisted suicide is
forbidden.\19\
---------------------------------------------------------------------------
\19\ Oral Arguments in Vacco v. Quill, reprinted in 12 issues in
``Law & Medicine,'' 417, 437 (spring 1997).
---------------------------------------------------------------------------
While litigation was still pending challenging Oregon's law
authorizing assisted suicide, on the one hand, and the laws of
Washington and New York prohibiting it, on the other hand,
Congress debated the issue of whether the Federal Government
would facilitate euthanasia and assisting suicide should it
become legal. On April 30, 1997, after the bill had passed the
House by a vote of 398-16 and the Senate by a vote of 99-0,
President William J. Clinton signed the Assisted Suicide
Funding Restriction Act of 1997.\20\ The law prohibits the use
of Federal funds to cause a patient's death. It also
effectively prohibits the practice of assisted suicide in
Federal health facilities, removes it from the scope of
``rights'' under State laws of which patients must be informed
under the Federal Patient Self-Determination Act, and forbids
Federal subsidies to health programs or benefit packages which
include assisted suicide.
---------------------------------------------------------------------------
\20\ Public Law 105-12, April 30, 1997, 111 Stat. 23, largely
codified at 42 U.S.C. 14401 to 14408.
---------------------------------------------------------------------------
Of central importance to the law was the intent-based
distinction it made between the provision of services for the
purpose of alleviating pain even then they may increase the
risk of death and their provision for the purpose of causing
death. 42 U.S.C. 14402(b)(4) provided that nothing in the Act

shall be construed to apply to or to affect any
limitation relating to * * * the use of an item, good,
benefit, or service furnished for the purpose of
alleviating pain or discomfort, even if such use may
increase the risk of death, so long as such item, good,
benefit, or service is not also furnished for the
purpose of causing, or the purpose of assisting in
causing, death, for any reason.\21\
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\21\ In its letter endorsing the Assisted Suicide Funding
Restriction Act of 1997, the American Medical Association emphasized
the positive role of this provision:

The AMA is particularly pleased to note that your bill
acknowledges--in its ``Rules of Construction'' section--the
appropriate role for physicians and other caregivers in
end-of-life patient care.* * * Most important * * * is the
Rule of Construction which recognizes the medical principle
of ``secondary effect,'' that is, the provision of adequate
palliative treatment, even though the palliative agent may
also forseeably hasten death. This provision assures
patients and physicians alike that legislation opposing
assisted suicide will not chill appropriate palliative and
---------------------------------------------------------------------------
end-of-life care.

Letter from P. John Seward, M.D., executive vice president, American
Medical Association, to Senator John Ashcroft 1 (Feb. 12, 1997).

It is noteworthy that this intent-based distinction in
existing law governs not only Federal funding, but also the
provision of medical treatment

(1) by or in a health care facility owned or operated
by the Federal Government, or
(2) by any physician or other individual employed by
the Federal Government to provide health care services
within the scope of the physician's or individual's
employment * * *.\22\
---------------------------------------------------------------------------
\22\ 42 U.S.C. 14402(c).

President Clinton lauded the bill, saying it ``will allow
the Federal Government to speak with a clear voice in opposing
these practices,'' and warning that ``to endorse assisted
suicide would set us on a disturbing and perhaps dangerous
path.'' \23\
---------------------------------------------------------------------------
\23\ Statement by President William Jefferson Clinton upon signing
H.R. 1003, 33 weekly comp. Pres. Doc. 617 (May 5, 1997).
---------------------------------------------------------------------------
In this act Congress also recognized the need to promote
pain management and palliative care in part as a bulwark
against desperate resort to assisted suicide. The act urged
priority attention to this field in grant programs managed by
the Department of Health and Human Services, and commissioned
the Government Accounting Office to conduct a study of medical
school training in palliative care. The disappointing findings
of that study have highlighted the need for a more focused
commitment to professional training in palliative care, like
that found in the present legislation.

``The availability of continuing medical education
courses that focus on palliative care issues for
terminally or chronically ill people appears limited,''
the GAO found.\24\ The American Medical Association's
database of over 2,000 accredited continuing medical
education activities found that few specifically
addressed palliative care. A recent MedPAC report on
end of life care stated: ``Much knowledge of effective
palliative care exists, but it has been infrequently
taught to health care professionals and infrequently
put into practice.'' \25\
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\24\ U.S. General Accounting Office, ``Suicide Prevention: Efforts
to Increase Research and Education in Palliative Care'' (Washington,
DC: GPO, 1998), GAO/HEHS-98-128, p. 11.
\25\ Medicare Payment Advisory Commission, ``Report to the
Congress: Selected Medicare Issues'' (Washington, DC: GPO, 1998), p.
120.

This lack of medical education and public focus comes at
great detriment to patients. As stated in the GAO report:
``People suffering from terminal or chronic illnesses or from
disabilities are considered especially vulnerable to suicide
because their need or desire for palliative- or comfort-care
may not be adequately met in a health system that focuses on
curative care.'' \26\
---------------------------------------------------------------------------
\26\ GAO, ``Suicide Prevention,'' p. 1.
---------------------------------------------------------------------------
Shortly after the effective date of the Assisted Suicide
Funding Restriction Act, on July 25, 1997, the Chairmen of the
Senate and House Judiciary Committees, Senator Orrin Hatch and
Representative Henry Hyde, wrote a joint letter to Drug
Enforcement Administrator Thomas Constantine inquiring whether
delivering, distributing, dispensing, prescribing, filling a
prescription, or administering a controlled substance in the
deliberate assistance of a suicide would violate the Controlled
Substances Act, regardless of whether assisting suicide were to
become legal as a matter of State law.
As noted in the July, 1997, letter to Mr. Constantine,
under existing regulations (21 CFR 1306.04), a controlled
substance must be used ``for a legitimate medical purpose by an
individual practitioner acting in the usual course of his
professional practice.''
A panoply of national and State medical associations have
condemned the practice of assisting suicide, both in testimony
to the Congress and in briefs accompanying the Vacco and
Washington cases. Even before enactment of the Assisted Suicide
Funding Restriction Act of 1997, the Health Care Financing
Administration had determined that physician-assisted suicide
is not ``reasonable and necessary'' to the diagnosis or
treatment of disease and injury, and therefore is not
reimbursable under Medicare.\27\
---------------------------------------------------------------------------
\27\ Letter of May 1, 1996, from Debbie I. Chang, Director of the
Office of Legislative and Intergovernmental Affairs, Health Care
Financing Administration.
---------------------------------------------------------------------------
In response to the letter of Chairman Hatch and Hyde, the
Drug Enforcement Administration undertook a serious review of
professional organizations' views, case law, legal briefs, law
review articles, and State laws related to assisted suicide.
Based on that study, in a November 5, 1997, response, DEA
Administrator Constantine advised the Members of Congress that
``we are persuaded that delivering, dispensing or prescribing a
controlled substance with the intent of assisting a suicide
would not be under any current definition a `legitimate medical
purpose' '' ``As a result,'' Administrator Constantine found,
``the activities you described in your letter to us would be,
in our opinion, a violation of the CSA.''
Several months later, the two Chairmen received a letter
from Attorney General Janet Reno dated June 5, 1998. This
letter had the effect of upholding the DEA position with
respect to the use of controlled substances for assisting
suicide or euthanasia in any State which has not authorized the
practice as a matter of State law, and even within Oregon to
the extent assisting suicide remains illegal (for example, for
a person who is not predicted to die within 6 months). She
wrote, ``Adverse action under the CSA may well be warranted * *
* where a physician assists in a suicide in a state that has
not authorized the practice under any conditions, or where a
physician fails to comply with state procedures in doing so.''
\28\
---------------------------------------------------------------------------
\28\ More recently, a letter from the DEA has confirmed this
position. ``H.R. 2260 does not alter the long-standing federal
requirement that controlled substances be dispensed only for a
legitimate medical purpose by a practitioner acting in the usual course
of professional practice. The bill simply makes clear that, in
determining whether a registration is consistent with the public
interest, the Attorney General (and DEA, by designation), `shall give
no force and effect to State law authorizing assisted suicide or
euthanasia.' Since Oregon is the only State with a law permitting
assisted suicide, DEA's authority to take administrative action in
every other state would not be changed by H.R. 2260.'' Letter from
Donnie R. Marshall, Acting Administrator, Drug Enforcement
Administration (Apr. 5, 2000), p. 2 (emphasis added).
---------------------------------------------------------------------------
However, the Attorney General's letter overruled the DEA's
determination that federally controlled substances could not be
used to assist suicides when such assistance is permitted as a
matter of Oregon State law. ``[A]dverse action against a
physician who has assisted in a suicide in full compliance with
the Oregon act would not be authorized by the CSA,'' she wrote.
The Attorney General's opinion and the need for legislation
to reverse it can best be evaluated in the context of the
history and structure of the Controlled Substance Act.
The Controlled Substances Act of 1970 (CSA) provides a
uniform national standard for the control of potentially
dangerous drugs, and a system of enforcement and penalties that
is, in important respects, independent of State law. The CSA
prohibits any distribution of controlled substances unless the
distribution is authorized pursuant to a statutory
exception.\29\
---------------------------------------------------------------------------
\29\ According to 21 U.S.C. 841, it is ``unlawful for any person
[to] knowingly or intentionally * * * distribute, or dispense * * * a
controlled substance'' * * * ``[e]xcept as authorized by this
subchapter [Control and Enforcement, 801 904].''
---------------------------------------------------------------------------
One such exception is distribution pursuant to registration
by the Attorney General under 21 U.S.C. 823. Physician and
pharmacists may apply to The Drug Enforcement Administration
(DEA) for a Federal license to prescribe and administer
controlled substances, called a DEA registration. The primary
role of DEA with respect to pharmaceutical controlled
substances is to prevent, detect, and investigate their
diversion from legitimate uses while ensuring their
availability for legitimate medical use.\30\
---------------------------------------------------------------------------
\30\ All DEA policies, procedures, and investigative programs with
respect to this issue are guided by the underlying principle stated in
the Code of Federal Regulations which links the validity of any
prescription for a controlled substance to the requirement that it be
``issued for a legitimate medical purpose by an individual practitioner
acting in the usual course of his professional practice.'' 21 CFR
1306.04.
---------------------------------------------------------------------------
While physicians receive their licenses to practice
medicine from State medical boards, they receive this separate
registration to prescribe controlled substances directly from
the DEA.\31\ Prescriptions for these potentially dangerous
drugs must be written using DEA registration numbers.
---------------------------------------------------------------------------
\31\ As Congress declared in 1984 when it last revised this part of
the CSA. Registration of a physician under the Controlled Substances
Act is a matter entirely separate from a physician's State license to
practice medicine. Therefore, revocation of registration only precludes
a physician from dispensing substances controlled under the Controlled
Substances Act and does not preclude his dispensing other prescription
drugs or his continued practice of medicine. S. Rep. No. 98-225, at 267
(1983), reprinted in 1984 U.S.C.C.A.N. 3182, 3449 n. 40.
---------------------------------------------------------------------------
The CSA was amended in 1984 to strengthen the DEA's ability
to prevent diversion of federally regulated prescriptions drugs
for illicit purposes.\32\ The chief concern cited as
justification for the 1984 amendments was the potential of
controlled substances to cause physical harm and death when
used for something other than a legitimate medical purpose.
According to Representative Hughes, the chief House sponsor of
the measure, ``The bill gives to DEA greater latitude to
suspend or revoke the registration of a practitioner who
dispenses drugs in a manner that threatens the public health
and safety.'' \33\
---------------------------------------------------------------------------
\32\ The amendments were approved by the U.S. Senate 91 to 1 on
February 2, 1984, as part of a Comprehensive Crime Control Act (S.
1762). Almost identical language was approved by the House 392 to 1 on
September 18, 1984. The House and Senate versions were reconciled and
ultimately approved as part of H.J. Res. 648, a continuing resolution
which became law on October 12, 1984 (Public Law No. 98-473, Stat.
1987).
\33\ 130 Cong. Rec. 25849 (1984). Representatives Hughes also cited
a Government study indicating that ``prescription drugs are responsible
for close to 70 percent of the deaths and injuries due to drug abuse.''
Id. at 25849.
---------------------------------------------------------------------------
The 1984 amendments were designed to give the DEA more
independent authority to revoke a physician's registration in
cases where a State was unable or unwilling to intervene.\34\
---------------------------------------------------------------------------
\34\ Representative Hamilton Fish, another sponsor of the
amendments, said giving such flexibility to the Federal Government was
necessary because States often did not respond adequately to these
abuses: ``State policing of these activities, as well as peer review
within the profession, have not been adequate control measures. State
laws regarding the dispensing of controlled substances are also
inadequate.'' Id. at 25849.
At a hearing before the House Commerce Subcommittee on Health and
the Environment, the DEA called the expanded Federal authority to
revoke practitioner registration ``one of the most important sections
of the bill,'' not only because States were often ill-equipped to
enforce their own drug laws but also because ``many controlled drug
violations involving prescription drugs are not felonies under State
law and therefore cannot be used in a DEA revocation action'' under
then-existing law. Dangerous Drug Diversion Control Act of 1984:
Hearing on H.R. 5656 before the Subcommittee on Health and the
Environment of the House Committee on Energy and Commerce, 98th Cong.
404 (1984) (statement of Gene R. Haislip, Deputy Assistant
Administrator, Drug Enforcement Administration).
---------------------------------------------------------------------------
21 M.S.C. 823 of the GSA sets forth requirements for
controlled substances registrations and section 824 sets forth
grounds for revocation. Physicians who abuse their
registrations and prescribe controlled substances for
nonmedical purposes are subject to license revocation under
section 824 and to potential criminal prosecution under section
841.\35\
---------------------------------------------------------------------------
\35\ In practice, a criminal proceeding is almost never initiated.
Instead, an administrative penalty is applied (simply revoking or
suspending the physician's special Federal privilege to handle
controlled substances), and this effectively prevents further illicit
use. Typically, the DEA does not initiate action at all until after the
State has acted against a registrant.
---------------------------------------------------------------------------
Section 823 provides that the Attorney General may deny an
application for registration ``if such registration would be
inconsistent with the public interest'' \36\ as determined by
consideration of several factors.\37\
---------------------------------------------------------------------------
\36\ As Representative Charles Rangel said in support of the
amendments:

Under current law, the DEA must register physicians,
pharmacies, or other practitioners if they are authorized
to dispense drugs by the law of the State in which they
practice. * * * The public interest standard added by H.R.
5656 will provide greater flexibility to deny or revoke
---------------------------------------------------------------------------
registrations in the most egregious cases.

130 Cong. Rec. 25,852 (1984).
---------------------------------------------------------------------------
\37\ 21 U.S.C. 824(a)(4) provides that one of the grounds for
revocation is the commission of ``such acts as would render his
registration under section 823 of this title inconsistent with the
public interest as determined under such section.''
---------------------------------------------------------------------------
Two of the factors listed under 823 that are relevant to
assisted suicide are: compliance with State law relating to
controlled substances (21 U.S.C. 823(f)(4)), and the public
health and safety (21 U.S.C. 823(f)(5)). Most States
specifically prohibit assisted suicide; no State has authorized
assisted suicide except Oregon.\38\
---------------------------------------------------------------------------
\38\ Currently, 44 States prohibit assisted suicide, either through
statutes or common law. Thirty-eight States prohibit assisted suicide
through statutes: Alaska: (Ak. Stat. Sec. 11.41.120 [1998]; Arizona:
(Az. Rev. Stat. Ann., Sec. 13-1103(A)(3) [West Supp. 1998-1999]);
Arkansas: (Ark. Code Ann., Sec. 5-10-104(a)(2) [Michie 1993], Sec. 5-
10-106 [Supp. 1999]); California: (CA Penal Code, Sec. 401 [West
1999]); Colorado: (CO Rev. Stat. Ann., Sec. 18-3-104(1)(b) [West
1999]); Connecticut: (CT Gen. Stat. Ann., Sec. 53a-56(a)(2) [West
1994]); Delaware: (DE Code Ann., title 11 Sec. 645 [Michie 1995]);
Florida: (FL Stat. Ann., Sec. 782.08 [West 1992]); Georgia: (GA Code
Ann., Sec. 16-5-5(b) [Michie 1998]), Hawaii: (HI Rev. Stat., Sec. 707-
702(1)(b) [Michie 1999]); Illinois: (IL Comp. Stat., ch. 720, Sec. 5/
12-31(a)(2) [Smith-Hurd Supp. 1999]); Indiana: (IN Stat. Ann., Sec. 35-
42-1-2.5 [Burns 1998]); Iowa: (IA Code Ann. Sec. 707A.2 [West Supp.
1999]); Kansas: (KS Stat. Ann., Sec. 21-3406 [Supp. 1999]); Kentucky:
(Ken. Stat. Ann., Sec. 216.302 [Michie 1998]); Louisiana: (La. Rev.
Stat. Ann. Sec. 14: 32.12 [West 1997]); Maine: (Me. Rev. Stat. Ann.,
tit. 17-A Sec. 204 [West 1983]); Maryland (Assisted Suicide--
Prohibition Act, ch. 700, 1999 Laws of Maryland); Michigan: (Mich.
Comp. Laws Ann., Sec. 750.329a [Supp. 1999]); Minnesota: (Minn. Stat.
Ann., Sec. 609.215 [Supp. 1999]); Mississippi: (Miss. Code Ann.,
Sec. 97-3-49 [1994]); Missouri: (Mo. Ann. Stat., 565.023(1)(2) [1999]);
Montana: (Mont. Code Ann., Sec. 45-5-105 [1999]); Nebraska: (Neb. Rev.
Stat. Ann., Sec. 28-307 [Michie 1995]); New Hampshire: (N.H. Rev. Stat.
Ann. Sec. 630:4 [1996]): New Jersey: (N.J. Stat. Ann. Sec. 2C: 11-6
[West 1995]); New Mexico: (N.M. Stat. Ann., Sec. 30-2-4 [Michie 1994]);
New York: (N.Y. Penal Law, Sec. Sec. 120.30, 125.15(3) [West 1998]);
North Dakota: (N.D. Cent. Code, Sec. 12.1-16-04 [Michie 1997]);
Oklahoma: (Okla. Stat. Ann., Sec. Sec. 813, 814, 815 [West 1983],
Sec. Sec. 3141.1 to 3141.8 [West Supp. 1999]); Pennsylvania: (Penn.
Cons. Stat. Ann., tit. 18 Sec. 2505(b) [West 1998]); Rhode Island:
(R.I. Gen. Laws, Sec. Sec. 11-60-1 through 11-60-5 [West Supp. 1998]);
South Carolina: (S.C. Code of Laws Sec. 16-3-1090 [West Supp. 1998]);
South Dakota: (S.D. Codified Laws Sec. 22-16-37 [Michie 1998]);
Tennessee: (Tenn. Code Ann., Sec. 39-13-216 [Michie 1997]); Texas:
(Tex. Penal Code Ann., Sec. 22.08 [West 1994]); Virginia: (Va. Code
Ann., Sec. 8.01-622.1 [Michie Supp. 1999]); Washington: (Wash. Rev.
Code Ann., Sec. 9A.36.060 [West 1988]); Wisconsin: (Wis. Stat. Ann.,
Sec. 940.12 [West 1996]); Six States prevent assisting suicide through
application of the common law of crimes: Alabama, Idaho, Massachusetts,
Nevada, Vermont, and West Virginia. Issue Brief, Health Policy Tracking
Service, National Conference of State Legislature, (Sept. 17, 1999)
(Maria Rothoner and Elizabeth Kaiser). It is also arguable that Ohio
prohibits assisting suicide under the common law. Blackburn v. State,
23 Ohio St. 146 (1872). It is also noteworthy that in circumstances
other than those covered by the Oregon Death with Dignity Act, Oregon
prohibits assisting suicide by statute. Or. Rev. Stat. Sec. 163.125
provides, ``Criminal Homicide constitutes manslaughter in the second
degree when * * * [a] person intentionally causes or aids another
person to commit suicide.''
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Public health and safety has been invoked as a separate
ground for revoking the registrations of physicians who
prescribe drugs used in lethal overdoses.\39\ In some cases,
the physicians were found to have been negligently involved in
suicides or attempted suicides.\40\
---------------------------------------------------------------------------
\39\ See, e.g., ``Denial of Registration of Dr. Samuel Fertig,'' 49
Fed. Reg. 6577 (Feb. 22, 1984) (denied a registration for prescribing
massive quantities of controlled substances to several young people who
used them in lethal overdoses, despite fact that State license had been
restored, on grounds that he ``was responsible, directly or indirectly,
for the deaths of several young people''); ``Revocation of Registration
of Dr. Murray Walker,'' 55 Fed. Reg. 5306 (Feb. 14, 1990) (registration
revoked for prescribing Percodan for nonmedical purposes to several
people, one of whom died of an overdose, the DEA stating, ``Substances
are controlled because they are potentially dangerous and therefore
should be handled with extreme care. Respondent has failed to exercise
such care and, as a result, has ignored his duties as a health care
professional to protect the public health and safety from the illicit
use of these drugs.''). See 21 U.S.C. 824(c) for the procedure for such
a suspension or revocation, and 21 U.S.C. 824(d) for the authority to
``suspend any registration simultaneously with the institution of
proceedings under this section, in cases where [the Attorney General]
finds that there is an imminent danger to the public health or
safety.''
\40\ See, e.g., ``Denial of registration of Dr. Pompeyo Q. Braga
Bonado,'' 55 Fed. Reg. 37579 (Sept . 12 1990). Here, the DNA found that
granting a registration to this physician would be ``clearly contrary
to the public interest.'' id. at 37580. The physician had prescribed
controlled substances to several individuals ``for no legitimate
medical purpose,'' including to one man addicted to Percocet who was
hospitalized after a suicide attempt. ``As a health care professional
and DEA registrant,'' the DEA stated, ``Respondent bears a heavy
responsibility to ensure that the controlled substances he prescribes
are not abused.'' id. at 37580.
---------------------------------------------------------------------------
Each of these cases was theoretically a candidate for
criminal prosecution under section 841, but, apparently, no
Federal criminal prosecution followed. Even where physicians
were previously convicted of manslaughter under State law for
negligent and reckless involvement in a suicide or other lethal
overdose, the separate Federal standard of ``public health and
safety'' was the basis upon which the registration was revoked
and, in one case, reinstatement repeatedly denied.\41\
---------------------------------------------------------------------------
\41\ In the case of ``Revocation of Registration of Hugh Schade,
M.D.,'' 60 Fed. Reg. 56354 (Nov. 8, 1995), Dr. Schade gave potentially
lethal amounts of Darvocet to a depressed patient who used them to
commit suicide. Giving these drugs to a patient in this mental state,
said one expert witness, was ``like handing him a loaded gun.'' While
Dr. Schade was also convicted of negligent homicide under State law
because of this case, his DEA application was denied not on the basis
that he had violated a State law, but on the separate basis that his
conduct objectively threatened ``public health and safety''.
In the case of ``Revocation Registration of David W. Bradway,
M.D.,'' 48 Fed. Reg. 49937 (Oct. 28, 1983), the physician's
registration was revoked after conviction under State law on various
counts, most notably ``one count of manslaughter by unlawfully
distributing controlled substances in such a grossly negligent [and]
reckless manner as to cause the death of an individual'' Id. at 49937.
Years later, after allegedly rehabilitating and resuming medical
practice, the physician applied for a new DEA registration; citing the
fact that ``a death was directly attributable to Respondent's misuse of
his DEA Certificate of Registration,'' the DEA denied the application,
stating:

It is the position of the DEA that a Certificate of
Registration to handle controlled substances is a
privilege, not a right, and it should only be granted to
doctors who have demonstrated high standards of ethical
conduct and who are completely trustworthy in handling
dangerous controlled substances which, as can be seen in
this case, can have a devastating impact on individuals who
---------------------------------------------------------------------------
abuse them.

54 Fed. Reg. at 53384. In 1992 he again applied for a DEA registration,
but due to ``the egregious nature of Respondent's past conduct,'' the
DNA ruled in 1994 (15 years after the patient's death) that ``the
registration of the Respondent is still not in the public interest''.
Id. at 6299.

This background indicates that H.R. 2260 does not expand
Federal authority to act against misuse of controlled
substances in 49 States, and that its application in Oregon is
fully consistent with current understanding of the relationship
between State and Federal authority under the CSA.

IV. Section-by-Section Analysis
Following is a section-by-section analysis of the
Chairman's substitute as ordered reported by the Committee on
April 27, 2000:
Section 1. Short title
Entitles the act the ``Pain Relief Promotion Act of 2000.''
Section 2. Findings
Makes a series of findings about the importance of
emphasizing pain management and palliative care in the first
decade of the new millennium, the regulation of drugs with a
potential for abuse under the Controlled Substances Act, the
use of such drugs by practitioners for legitimate medical
purposes, especially the purpose of relieving pain and
discomfort even if it increases the risk of death, the need for
improved treatment of pain, and the fact that dispensing and
distributing such drugs affects interstate commerce.

title i
Section 101. Activities of Agency for healthcare research and quality
This section amends the Public Health Services Act by
authorizing a program responsibility for the Agency for
Healthcare Research and Quality in the Department of Health and
Human Services to promote and advance scientific understanding
of palliative care. The Agency is directed to collect and
disseminate protocols and evidence-based practices for pain
management and palliative care with priority for terminally ill
patients.
The section is specifically made subject to subsections (e)
and (f) of section 902 of the Public Health Service Act [42
U.S.C. 299a(e) and (f)],\42\ added by the Healthcare Research
and Quality Act of 1999, Public Law 106-129, which prevent the
mandating of national standards of clinical practice.
---------------------------------------------------------------------------
\42\ The provisions of subsections (e) and (f) of Section 902 of
the Public Health Service act state:
---------------------------------------------------------------------------
(e) Disclaimer.--The Agency shall not mandate national
standards of clinical practice or quality health care
standards. Recommendations resulting from projects funded
and published by the Agency shall include a corresponding
disclaimer.
(f) Rule of Construction.--Nothing in this section shall
be construed to imply that the Agency's role is to mandate
a national standard or specific approach to quality
measurement and reporting. In research and quality
improvement activities, the Agency shall consider a wide
range of choices, providers, health care delivery systems,
and individual preferences.
This section has a definition of pain management and
palliative care which is a modified version of the World Health
Organization's definition of palliative care.
Section 102. Activities of Health Resources and Services Administration
This section amends the Public Health Services Act by
authorizing a program for education and training in pain
management and palliative care in the Health Resources and
Services Administration of the Department of Health and Human
Services. This section allows the Secretary, in consultation
with the Director of the Agency for Healthcare Research and
Quality to award grants, cooperative agreements and contracts
to health professions schools, hospices, and other public and
private entities to develop and implement pain management and
palliative care education and training programs for health care
professions.
This section requires the applicant for the award to
include three educational informational components in the
program: (1) the program must have a component that addresses a
means for diagnosing and alleviating pain and other distressing
signs and symptoms of patients, especially in terminally ill
patients, including the use of controlled substances; (2) the
program must provide information and education on the
applicable laws on controlled substances, including those
permitting dispensing or administering them to relieve pain
even in cases where such efforts may unintentionally increase
the risk of death, and (3) the information and education must
provide recent findings and developments in the improvement of
pain management and palliative care. Health professions
schools, residency training programs, continuing education,
graduate programs in the health professions, hospices, and
other sites as determined by the Secretary will be used as
program sites.
This section also requires the Secretary to evaluate the
programs directly or through grants or contracts and mandates
that the Secretary include individuals with expertise and
experience in pain management and palliative care for the
population of patients whose needs are to be served in each
peer review group involved in the selection of the grantees.
Five million dollars annually are authorized to carry out
these program.
Section 103. Decade of pain control and research
This section designates the decade beginning January 1,
2001, as the ``Decade of Pain Control and Research.''
Section 104. Effective date
This section makes title I effective on the date of
enactment.
Section 201: Reinforcing existing standard for legitimate use
controlled substances
This section amends the Controlled Substances Act to
establish that physicians and other licensed health care
professionals holding DEA registrations are authorized to
dispense, distribute, or administer controlled substances for
the legitimate medical purpose of alleviating a patient's pain
or discomfort in the usual course of professional practice even
if the use of these drugs may increase the risk of death.\43\
Essentially, this provision makes clear that these exists a
``safe harbor'' for those who dispense controlled substances
for pain relief and palliative care, even if such treatment
increases a patient's risk of death. The Department of Justice
(DOJ) has taken the position that the Pain Relief Act ``would
eliminate any ambiguity about the legality of using controlled
substances to alleviate the pain and suffering of the
terminally ill by reducing any perceived threat of
administrative and criminal sanctions in this context.'' \44\
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\43\ Because the language of H.R. 2260 applies only to dispensing,
distributing, or administering controlled substances, it can only apply
to schedule II, III, IV, or V drugs. Schedule I drugs, such as
marihuana (21 CFR 1308.11(d)(19)), may not be dispensed for any reason
but may be used only for approved research. 21 U.S.C. 823(f) provides,
``The Attorney General shall register practitioners (including
pharmacies, as distinguished from pharmacists) to dispense, or conduct
research with, controlled substances in schedule II, III, IV, or V, if
the applicant is authorized to dispense, or conduct research with
respect to, controlled substances under the laws of the State in which
he practices. The Attorney General may deny an application for such
registration if he determines that the issuance of such registration
would be inconsistent with the public interest. In determining the
public interest, the following factors shall be considered: * * * (5)
such other factors as may be relevant to and consistent with the public
health and safety.'' By contrast, the only provision authorizing
registration of practitioners with respect to schedule I controlled
substances is for research: ``Registration applications by
practitioners wishing to conduct research with controlled substances in
schedule I shall be referred to the Secretary, who shall determine
qualifications and competency of each practitioner requesting
registration.'' Id. Thus, a physician's or pharmacist's registration to
dispense controlled substances under 21 U.S.C. 823 does not apply to or
authorize dispensing marihuana since it is a schedule I controlled
substance.
\44\ Letter from Robert Raben, Assistant Attorney General,
Department of Justice, to Hon. Henry Hyde, Oct. 19, 1999.
---------------------------------------------------------------------------
Without creating any new Federal standard, this section
also ensures that the new safe harbor is not construed to
change the proper interpretation of current law that the
administration, dispensing, or distribution of a controlled
substance for the purpose of assisting a suicide \45\ is not
authorized by the Controlled Substances Act. Individuals
covered by the CSA would not be subject to any new liability
under the statute--with the exception of those who would
attempt in the future to rely on the Oregon Act as a defense to
alleged violations of the CSA.
---------------------------------------------------------------------------
\45\ ``Webster's Third New International Dictionary Unabridged''
(Merriam-Webster, 1986) defines ``suicide'' in relevant part as ``the
act or an instance of taking one's own life voluntarily and
intentionally; self-destruction,'' It defines ``euthanasia'' in
relevant part as ``the act or practice of painlessly putting to death
persons suffering from incurable conditions or diseases.'' By
``assisted suicide,'' the bill describes provision of means to another
person with the intent of enabling or assisting that person to kill
himself or herself (as by ingesting a lethal overdose). By
``euthanasia'' the bill more generally describes the use of active
means by one person to cause the death of another person (as by lethal
injection) because, as a result of illness, injury, or disability,
either the person is deemed to be dying or suffering or the person is
considered to be a ``burden'' on family, community or society. It
should be emphasized that euthanasia can occur whether or not the
person who is killed consents to be killed. Cf. H.R. Rep. No. 46 Pt. I,
105th Cong., 1st sess. 11 (1997) (Assisted Suicide Funding Restriction
Act of 1997).
---------------------------------------------------------------------------
This section further provides that the Attorney General in
implementing the Controlled Substances Act shall not give force
or effect to any State law permitting assisted suicide or
euthanasia. This effectively overturns the June 5, 1998, ruling
of the Attorney General insofar as that ruling concluded ``the
CSA does not authorize DEA to prosecute, or to revoke the DEA
registration of, a physician who has assisted in a suicide in
compliance with Oregon law [or the law of any other state that
might authorize assisting suicide or euthanasia].'' \46\
---------------------------------------------------------------------------
\46\ Letter from Attorney General Janet Reno to Hon. Henry Hyde
(June 5, 1998) p. 3.
---------------------------------------------------------------------------
This section provides that the provisions of the bill are
effective only upon enactment with no retroactive effect. This
means that the Oregon statute will serve as a defense for any
actions taken in compliance under the Oregon law prior to the
enactment of H.R. 2260, if enacted.
This section further provides that nothing in it shall be
construed to alter the roles of the Federal and State
governments in regulating the practice of medicine, affirming
that regardless of whether a practitioner's DEA registration is
deemed inconsistent with the public interest, the status of the
practitioner's State professional license and State prescribing
privileges remain solely within the discretion of State
authorities.
This section also provides that nothing in the act is to be
construed to modify Federal requirements that a controlled
substance may be dispensed only for a legitimate medical
purpose nor to authorize the Attorney General to issue national
standards for pain management and palliative care clinical
practice, research, or quality, except that the Attorney
General may take such other actions as may be necessary to
enforce the act.
This section provides that in any proceeding to revoke or
suspend a DEA registration based on alleged intent to cause or
assist in causing death in which the practitioner claims to
have been dispensing, distributing, or administering controlled
substances to alleviate pain or discomfort in the usual course
of professional practice, the burden rests with the Attorney
General to prove by clear and convincing evidence that the
practitioner's intent was to cause or assist in causing the
death.
Section 202: Education and training programs
This section directs educational and research training
programs for law enforcement to include means by which they may
better accommodate the necessary and legitimate use of
controlled substances in pain management and palliative care.
This section clarifies that, because the activities under
this legislation are consistent with the Drug Enforcement
Administration's registration activities under current law,
agency activities pursuant to this bill are to be reimbursed
under the diversion control fee account.
Section 204. Effective date
This section establishes that the effective date of the act
is that of its enactment.

V. Legislative History and Vote of the Committee
H.R. 2260, the ``Pain Relief Promotion Act of 1999'' was
received in the Senate on October 28, 1999, after being passed
in the House. On November 19, 1999, it was read twice and
referred to the Committee on the Judiciary. A companion
measure, S. 1272, had been introduced by Senators Nickles and
Lieberman on June 23, 1999, and was referred to the Committee
on Health, Education, Labor, and Pensions, which held hearings
on October 13, 1999. It currently has 43 sponsors and
cosponsors.\47\ No further action has been taken on S. 1272.
---------------------------------------------------------------------------
\47\ S. 1272 is currently sponsored by Senators Nickles, Lieberman,
Abraham, Allard, Bayh, Bennett, Bond, Breaux, Brownback, Bunning,
Burns, Cochran, Coverdell, Craig, Crapo, DeWine, Dodd, Domenici, Enzi,
Fitzgerald, Frist, Grams, Grassley, Gregg, Hagel, Helms, Hutchinson,
Inhofe, Kyl, Landrieu, Lott, Lugar, Mack, McConnell, Moynihan,
Murkowski, Santorum, Sessions, Shelby, R. Smith, Thomas, Thurmond, and
Voinovich.
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In the House of Representatives, H.R. 2260 had been
introduced on June 17, 1999, by Judiciary Committee Chairman
Henry Hyde and Representative Bart Stupak. The Judiciary
Committee's Subcommittee on the Constitution approved the bill,
without amendment, by a voice vote on July 20, 1999. The full
Committee ordered it reported on September 14, 1999. On October
13, 1999, the Commerce Committee proceeded to the immediate
consideration of H.R. 2260 and ordered it reported to the
House, amended, by a voice vote. The House of Representatives
voted to pass H.R. 2260 on October 27, 1999, by a vote of 271
to 156.
On April 25, 2000, the Judiciary Committee held a hearing
to examine issues associated with the legislation, including
its effect on the provision of palliative care to terminally
ill patients and its interrelationship with State law. The
Committee heard testimony from two panels of witnesses,
including Members of Congress and public advocates expert in
end-of-life care issues.
In the first panel, Senator Don Nickles of Oklahoma
testified that the purposes of the bill are two-fold: To
promote aggressive pain management and to clarify Federal law
on the use of controlled substances. To advance pain
management, the bill establishes that the relief of pain and
discomfort is a ``legitimate medical purpose,'' even if the
large doses used in treating pain may increase the risk of
death. It also provides Federal support for training and
research in the areas of pain management and palliative care.
To clarify the use of federally controlled drugs, H.R. 2260
states that their use to deliberately cause death or assist in
causing death is not a legitimate medical purpose. Therefore,
for purposes of the Controlled Substances Act of 1970, the
Attorney General ``shall give no force and effect to State law
authorizing or permitting assisted suicide or euthanasia.''
Also on panel one, Senator Ron Wyden of Oregon testified
against H.R. 2260. He said that he opposes assisted suicide,
but does not believe that he has the authority to apply his
personal convictions as a substitute for the judgment made by
Oregon voters. Senator Wyden strongly expressed the view that
the Oregon law, twice the subject of favorable statewide
popular votes, ought not to be thwarted by the application of
H.R. 2260. Senator Wyden expressed other concerns with the
bill, including his belief that it would tie the hands of
doctors who treat patients in severe pain, including the
terminally ill. He argued that the bill could cause doctors to
underprescribe medication and leave patients in intractable
pain.
As the final witness in the first panel, Senator Gordon
Smith of Oregon explained that he believes assisted suicide is
an issue of conscience. He outlined his own experience with the
law as an Oregon State Senator and a member of the State
senate's Health Care and bioethics Committee, as well as his
experiences as a lay bishop visiting the sick, the elderly and
the dying. He expressed his concern that acceptance of
assisting suicide will lead to pressures on vulnerable people
to feel they have a duty to die if they are an economic burden
to their families and society. He stated that while a majority
of Oregon voters supports the State's law on assisted suicide,
he would follow his own conscience and his best judgment on
sound public policy and vote for the legislation.
The second panel of witnesses consisted of experts who deal
with end-of-life issues and physician-assisted suicide. The
first witness in this panel, Dr. Eric Chevlen, is the director
of palliative care at St. Elizabeth hospital in Ohio and
medical director of two hospices. Dr. Chevlen expressed his
support of H.R. 2260. He believes it will improve the ability
of doctors to relieve suffering, which is a legitimate medical
purpose, while he believes that assisted suicide is not. Dr.
Chevlen maintained that H.R. 2260 restores the uniform
application of the Controlled Substances Act to all 50 states
and does not usurp the rights of the States.
Dr. Arthur Caplan, a nationally recognized expert in the
field of bioethics; Dr. Caplan directs the Center for Bioethics
at the University of Pennsylvania; he is Trustee Professor at
the University of Pennsylvania. Dr. Caplan voiced opposition to
the legislation because of his concern that it could hinder
doctors in aggressively treating pain. Dr. Chaplan believes
that decisions about pain control and treatment of the dying
should be kept, as much as possible, in the hands of health
care professionals, not legal authorities.
The third witness was Rabbi J. David Bleich, professor of
law at the Benjamin Cardozo School of Law, professor of Talmud
and director of the graduate program in jurisprudence and
family law at the Rabbi Isaac Elchanan Theological Seminary, as
well as Herbert and Florence Tenzer Professor of Jewish Law and
Ethics at Yeshiva University. He spoke at the request of the
Union of Orthodox Jewish Congregations of America. Rabbi Bleich
testified that the effect of H.R. 2260 is solely to remove the
Federal imprimatur for assisted suicide, a practice he
described as morally repugnant to the majority of our populace
and offensive to the traditions of our country. He also stated
his belief that H.R. 2260 encourages palliative care above and
beyond current law, while paying full deference to the
physician's judgment in managing pain.
The fourth witness, Dr. Kathleen Foley, is a Professor of
neurology, neuroscience and clinical pharmacology at the
Cornell University Medical College, as well as the attending
neurologist in the Pain and Palliative Care Service at Memorial
Sloan-Kettering Cancer Center. She opposed H.R. 2260 because
she believes it expands the authority of the Controlled
Substances Act, does not provide sufficient funding to have any
real impact on pain management, and may lead doctors to
undertreat patients with pain because of concern for regulatory
oversight.
The fifth and final witness, Dr. Walter Hunter, associate
national medical director of VistaCare Hospice, testified in
support of the legislation, stating that this bill will not
interfere with his ability, as a hospice physician, to deliver
palliative care. In fact, argued Dr. Hunter, the Chairman's
substitute for H.R. 2260 recognizes legitimate palliative care
and protects physicians who practice it, while prohibiting the
deliberate killing of a patient. He said the legislation would
make an important first step in committing the Federal
Government to optimum palliative care for all patients who need
it.
The bill was considered by the full committee in an
executive session on April 27, 2000. Chairman Hatch offered a
substitute amendment which was agreed to by a recorded roll
call vote 10 yeas to 8 nays, as follows:
YEAS NAYS
Thurmond Leahy
Grassley Kennedy
Kyl Kohl
DeWine Feinstein
Ashcroft Feingold
Abraham Torricelli
Sessions Schumer
Smith Specter
Biden
Hatch

VI. Explanation of Legislation and Committee Views

a. promoting better pain management and palliative care
In written testimony submitted to the Committee, the Pain
Care Coalition (representing the American Academy of Pain
Medicine, the American Headache Society, and the American Pain
Society) summarized current problems in assuring that pain is
adequately treated:

Pain is a major public health problem in this
country. It effects people of all ages and at every
stage of life. It is generally recognized that
throughout the nation, and regardless of age, setting,
or health status, severe pain is often under-treated or
mistreated, if not overlooked entirely. Nine out of ten
Americans experience some sort of pain on a regular
basis--monthly or more often. Fifty million Americans
are partially or totally disabled by pain, and 45
percent of all Americans seek care for persistent pain
at some point in their lives. Pain imposes a tremendous
burden on these individuals and their families.

* * * * * * *

* * * Recent studies of end-of-life care in
hospitals, of the elderly in nursing homes, and of the
general public in Michigan all reach the same
conclusion: many, many people endure unnecessary
suffering due to inadequate pain care.

As one palliative care expert has written:

In a society at the brink of accepting physician-
assisted suicide, medical schools still do not
adequately teach pain management and care for the
dying. * * * [T]he University of Wisconsin Medical
School published a study of U.S. cancer centers which
documented that 42 percent of cancer patients in pain
were not prescribed appropriate pain medication. In
another study, 86 percent of the surveyed American
oncologists believe that most patients with cancer pain
are undermedicated. Even today, many doctors--and too
many dying patients--needlessly fear addiction.
Similarly, patients may fear side effects of
medications more than pain. Moreover, it is documented
that patients tend to underreport pain to avoid
becoming ``a complainer'' or to prevent distracting the
doctor from ``more important matters.'' The net
consequence of these factors is needless suffering, but
each one of these obstacles to assuring comfort among
the nation's dying is surmountable.
* * * Comfort at the end of life is medically
possible. Once comfort is assured, the experience of
dying can become a rich, meaningful time of life for
the dying person and his or her family, a time marked
by a sense of rightness and peace. This is true even
for those who once considered suicide because of
``intractable'' pain or other uncontrolled symptoms. We
must insist, immediately, that medical schools and
training programs--including NCI's designated cancer
centers--teach care for the dying. This single change
could improve current and future care immediately.\48\

\48\ Ira Byock, M.D. (Hospice Medical Director of Partners in Home
Care, Missoula, Montana), ``Caring for the Dying: We Must Confront the
Issues,'' ``Choices,'' vol. 4, no. 2 (summer 1995): p. 5.

The problem is not that modern medicine is incapable of
controlling pain, but that too many clinicians are inadequately
trained in the most up-to-date techniques. In a survey of 1,177
physicians who had treated a total of more than 70,000 patients
with cancer in the previous six months, 76 percent cited lack
of knowledge as a barrier to their ability to control pain.\49\
---------------------------------------------------------------------------
\49\ U. von Roenn et al., ``Physician attitudes and practice in
cancer pain management,'' ``Ann. Intern. Med.,'' vol. 119 (1993): pp.
121-26.
---------------------------------------------------------------------------
In title I, the bill amends the Public Health Service Act
to authorize programs within the Department of Health and Human
Services to develop and advance the scientific understanding of
palliative care and for education and training in palliative
care. These programs take two principal forms.
First, subject to provisions ensuring that it does not
mandate national clinical standards, the Agency for Healthcare
Research and Quality is to collect and disseminate protocols
and evidence-based practices regarding pain management and
palliative care. The objective of this program is not for the
Agency itself to draft or develop such protocols and practice
guidelines, but rather to foster widespread knowledge of those
already developed or to be developed by other sources, such as
medical specialty organizations. Based on a survey of senior
medical directors from Blue Cross Blue Shield insurance plans
across the country, a study by Diane Hoffman recently concluded
that ``insurers have a hard time identifying good pain-relief
providers. Before we can make improvements in this area, we
need more evidence-based treatment guidelines, preferably from
randomized clinical trials, better use of the guidelines we do
have, and the development of more meaningful standards.'' \50\
Hoffman concluded that widespread dissemination and acceptance
of such guidelines is needed to obtain adequate and appropriate
coverage of pain relief treatments by private insurers.
``[U]ntil then, it is rough on insurers to take the lead in
providing coverage.''
---------------------------------------------------------------------------
\50\ Charles Marwick, ``New Advocates of Adequate Treatment Say
Have No Fear of Pain or of Prosecution.'' ``Journal of the American
Medical Association,'' vol. 281, no. 5 (Feb. 3, 1999): p. 406.
---------------------------------------------------------------------------
Second, title I provides for the awarding of grants,
cooperative agreements, and contracts by the HHS Health
Resources and Services Administration to health professions
schools, hospices, and other public and private entities to
develop and implement palliative care education and training
programs for health care professionals in palliative care. The
decision to award these programs will be made by peer review
groups, each of which must include one or more individuals with
expertise and experience in palliative care for the population
to be served by the program.
As Dr. Hunter testified,

As a physician, I am ashamed to admit that the vast
majority of our nation's medical schools and residency
programs have simply failed to make medical ethics,
pain and symptom management priorities in their
curricula. This information, however, is absolutely
essential for physicians to properly provide excellent
care for patients. * * * This legislation provides for
much needed education in the professional community. We
at VistaCare applaud this bill for its commitment of
monies for the advancement of understanding of
palliative care and for the education of health care
professionals in the principles and practice of
palliative care. This commitment of time and money to
these educational efforts will send a very clear
message that the United States Congress has taken up
the cause of providing competent, compassionate, and
comprehensive palliative care for our citizens who face
life-threatening illness.

b. assisting suicide and euthanasia
By a margin of 64 percent to 31 percent, Americans say that
Federal law should not allow the use of federally controlled
drugs for the purpose of assisted suicide and euthanasia.\51\
The dangers posed by federal facilitation of legalized assisted
suicide were dramatically stated by Oregon Senator Gordon Smith
in his moving testimony to the committee: \52\
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\51\ Wirthlin Worldwide national telephone poll June 10, 1999. 3.1
percent margin of error at the 95 percent confidence level. The
question wording was as follows:

As you may or may not know, the use of narcotics and other
dangerous drugs is generally prohibited by federal law
except when a doctor prescribes them for a ``legitimate
medical purpose.'' Should the federal law allow use of
these federally controlled drugs for the purpose of
assisted suicide and euthanasia?
31 percent Yes.
64 percent No.
5 percent Don't Know/Refused.

\52\ It is noteworthy that neither Senator Wyden in his testimony
before the Committee nor any member of the Committee has attempted to
argue for or defend the legalization of assisting suicide as a matter
of public policy, nor (apart from raising federalism issues dealt with
below) to argue that the Federal Government should facilitate assisting
suicide or euthanasia as a positive public policy.

To [allow federally controlled substances to be used in
physician assisted suicide] * * * would have
consequences over time unimaginable now-consequences
outlined by Derek Humphry, an Oregonian and one of the
most vocal and visible advocates of assisted suicide,
in his 1998 book Freedom to Die.
The final chapter of Mr. Humphrey's book is entitled
``The Unspoken Argument.'' Why it is unspoken? Because
it is so awful. Let me quote from page 313 of Mr.
Humphry's book, where he reveals the true reason why he
believes assisted suicide's time has come:
``* * * one must look at the realities of the
increasing cost of health care in an aging society,
because in the final analysis, economics, not the quest
for broadened individual liberties or increased
autonomy, will drive assisted suicide to the plateau of
acceptable practice.''
Then he asks this chilling question:
``Is there, in fact, a duty to die--a responsibility
within the family unit--that should remain voluntary
but expected nevertheless?''
Mr. Humphry answers yes, but I believe we must answer
his vision of Orwellian ugliness with a resounding no.
I will not be party to building such a society or
justifying such a culture of death. In such a culture,
we should never wonder why children do not value life
when adults write laws that do not value it either.
The right to kill oneself is a private one. It is a
right that can be exercised in nearly anyone's medicine
cabinet. But it is dangerous to make doctors and the
state complicit in killing, even though consensual. In
an age of medical rationing and for profit HMO's, there
is a terrible ethical and financial conflict of
interest. And the federal government should see it and
stay away from it. Where Mr. Humphry sees a duty to
die, I see a duty to resolve the shortcomings of our
medical budgets rationally and honestly without
sacrificing the most vulnerable in our society-the
elderly and the disabled.

Among the most comprehensive and careful modern
examinations of this issue was one undertaken in 1994 by the
New York State Task Force on Life and the Law, appointed by New
York's Governor Mario Cuomo.\53\ Its 23 members, drawn from the
fields of medicine, law, and ethics, differed on whether
assisting suicide could in theory be ethically appropriate, but
the task force was unanimous in concluding ``that legalizing it
would pose serious and insurmountable risks of mistake and
abuse that would greatly outweigh any benefit that might be
achieved. These risks center on the likelihood that many
individuals would request suicide assistance because of
improper medical care, unrecognized lack of decisionmaking
capacity, or coercion, not because of a voluntary, settled
commitment to die.'' \54\
---------------------------------------------------------------------------
\53\ The New York State Task Force on Life and the Law, ``When
Death is Sought: Assisted Suicide and Euthanasia in the Medical
Context'' New York: The New York State Task Force on Life and the Law,
1994).
\54\ The New York State Task Force on Life and the Law, ``When
Death is Sought: Assisted Suicide and Euthanasia in the Medical Context
Supplement to Report April 1997'' (New York: The New York State Task
Force on Life and the Law, 1997), p. 4. http://www.health.state.ny.us/
nysdoh/taskfce/sought.pdf
---------------------------------------------------------------------------
In 1997, the task force issued a supplement to its report
that briefly summarized in 10 points ``the primary risks
associated with legalization'' \55\:
---------------------------------------------------------------------------
\55\ Id. at 4-5.
---------------------------------------------------------------------------
Undiagnosed or untreated mental illness. Many
individuals who contemplate suicide--including those who are
terminally ill--suffer from treatable mental disorders, most
commonly clinical depression. Yet, physicians routinely fail to
diagnose and treat these disorders, particularly among patients
at the end of life. As such, if assisted suicide is legalized,
many requests based on mental illness are likely to be granted,
even though they do not reflect a competent, settled decision
to die.
Improperly managed physical symptoms. Requests for
assisted suicide are also highly correlated with unrelieved
pain and other discomfort associated with physical illness.
Despite significant advances in palliative care, the pain and
discomfort that accompanies many physical illnesses are often
grossly undertreated in current clinical practice. If assisted
suicide is legalized, physicians are likely to grant requests
for assisted suicide from patients in pain before all available
options to relieve the patient's pain have thoroughly been
explored.
Insufficient attention to the suffering and fears
of dying patients. For some individuals with terminal or
incurable diseases, suicide may appear to be the only solution
to profound existential suffering, feelings of abandonment, or
fears about the process of dying. While the provision of
psychological, spiritual, and social supports--particularly,
comprehensive hospice services--can often address these
concerns, many individuals do not receive these interventions.
If physician-assisted suicide is legalized, many individuals
are likely to seek the option because their suffering and fears
have not adequately been addressed.
Vulnerability of socially marginalized groups. No
matter how carefully any guidelines for physician-assisted
suicide are framed, the practice will be implemented through
the prism of social inequality and bias that characterizes the
delivery of services in all segments of our society, including
health care. The practices will pose the greatest risks to
those who are poor, elderly, isolated, members of a minority
group, or who lack access to good medical care.
Devaluation of the lives of the disabled. A
physician's reaction to a patient's request for suicide
assistance is likely to depend heavily on the physician's
perception of the patient's quality of life. Physicians, like
the rest of society, may often devalue the quality of life
individuals with disabilities, and may therefore be
particularly inclined to grant requests for suicide assistance
from disabled patients.
Sense of obligation. The legalization of assisted
suicide would itself send a message that suicide is a socially
acceptable response to terminal or incurable disease. Some
patients are likely to feel pressured to take this option,
particularly those who feel obligated to relieve their loved
ones of the burden of care. Those patients who do not want to
commit suicide may feel obligated to justify their decision to
continue living.
Patient deference to physician recommendations.
Physicians typically make recommendations about treatment
options, and patients generally do what physicians recommend.
Once a physician states or implies that assisted suicide would
be ``medically appropriate,'' some patients will feel that they
have few, if any, alternatives but to accept the
recommendation.
Increasing financial incentives to limit care.
Physician-assisted suicide is far less expensive than
palliative and supportive care at the end of life. As medical
care shifts to a system of capitation, financial incentives to
limit treatment may influence the way that the option of
physician-assisted suicide is presented to patients, as well as
the range of alternatives patients are able to obtain.
Arbitrariness of proposed limits. Once society
authorizes physician-assisted suicide for competent, terminally
ill patients experiencing unbelievable suffering, it will be
difficult, if not impossible, to contain the option to such a
limited group. Individuals who are not competent, who are not
terminally ill, or who cannot self-administer lethal drugs will
also seek the option of physician-assisted death, and no
principled basis will exist to deny them this right.
Impossibility of developing effective regulation.
The clinical safeguards that have been proposed to prevent
abuse and errors are unlikely to be realized in everyday
medical practice. Moreover, the private nature of these
decisions would undermine efforts to monitor physicians'
behavior to prevent mistake and abuse.
The data so far publicly available about the operation of
Oregon's assisted suicide law does not inspire confidence that
the dangers detailed by the New York Task Force on Life and the
Law are being avoided in that State.
On February 17, 1999, the Oregon Health Division released a
report detailing the first full year under Oregon's physician-
assisted suicide law. A report on the second year was released
on February 23, 2000.\56\ Forty-three physician-assisted
suicides were reported for the 2 years, all of them involving
the use of federally controlled substances. According to family
members surveyed for the second report, in 47 percent of the
cases patients were influenced to undergo assisted suicide by
``concern about being a burden on others.'' \57\
---------------------------------------------------------------------------
\56\ Amy Sullivan et al., ``Legalized Physician-Assisted Suicide in
Oregon--The Second Year,'' ``New England Journal of Medicine,'' vol.
342, no. 8 (Feb. 24, 2000): p. 598. http://www.ohd.hr.state.or.us/chs/
pas/ar-index.htm
\57\ Id. at 601.
---------------------------------------------------------------------------
The report also revealed that a predominant motivation was
fear of future disability. The two reasons most frequently
cited were ``concern about loss of control of bodily
functions'' (68 percent) and ``loss of autonomy'' (63 percent)
\58\ This is consistent with the first year's report, which
noted that those whose suicides were assisted at the time of
death were less disabled than a control group of patients who
did not commit suicide. Disability rights activists frequently
point out that nondisabled people can have a distorted and
negative view of the quality of life with a disability, and
that newly disabled people go through an adjustment period
before realizing this.\59\ Tragically, those whose fear of
disability led to their deaths in Oregon will never have that
opportunity.\60\
---------------------------------------------------------------------------
\58\ Id.
\59\ In one study, the duration of disability was positively
related with acceptance of disability in persons with spinal cord
injury-related paralysis. Severity of disability was of no importance
in accepting life with a disability. F. Woodrich J.B. Patterson,
``Variables Related to Acceptance of Disability in Persons With Spinal
Cord Injuries,'' ``Journal of Rehabilitation,'' vol. 49, no. 3 (June,
July, Aug. 1983) pp. 26-30. 86 percent of spinal cord injured high-
level quadriplegics rated their quality of life as average or better
than average, while only 17 percent of their emergency room doctors,
nurses, and technicians thought that if they acquired quadriplegia they
would have a quality of life average or better than average. K.A.
Gerhart et al. ``Quality of Life Following Spinal Cord Injury:
Knowledge and Attitudes of Emergency Care Providers,'' ``Annals of
Emergency Medicine,'' vol. 23, no. 4 (Apr. 1994): pp. 807-812.
\60\ Disability rights groups that have taken a position opposing
the legalization of assisting suicide include American Disabled for
Attendant Programs, Disability Rights Education and Defense Fund,
Justice for All, National Council on Disability, National Council on
Independent Living, National Spinal Cord Injury Association, Not Dead
Yet, TASH, World Association of Persons with Disabilities, and World
Institute on Disability. In the words of Not Dead Yet, ``[A]ssisted
suicide cannot be legalized so long as people with disabilities face
prejudice, discrimination, and pressure to `get out of the way.' '' Not
Dead Yet, ``The Pain Relief Promotion Act of 1999,'' Nov. 12, 1999.
---------------------------------------------------------------------------
The reports are lacking in several respects. They do not
provide independent objectively verified information about the
extent to which physicians have complied with the law, but
instead, rely heavily on physician self-reporting. This
deficiency in objective reporting is exacerbated by the fact
that the law itself is governed by a ``good faith'' standard
that protects physicians from civil, professional, and criminal
liability so long as they believe ``in good faith'' that they
have complied with the guidelines.\61\
---------------------------------------------------------------------------
\61\ Or. Rev. Stat. Sec. 127.885 (1997). An Oregon physician
generally acknowledged to have performed active euthanasia without his
patient's consent (still a homicide under Oregon law) was declared
``unprosecutable'' by State officials because of the climate created by
the Oregon law permitting assisted suicide. See Doctor won't be
prosecuted, The Bulletin (Bend, OR), Dec. 11, 1997, at 7.
---------------------------------------------------------------------------
The reports make no serious effort to uncover the extent of
covert assisted suicide,\62\ and the law's confidentiality
requirements \63\ and its provision barring notification of
family members without a patient's express consent \64\ make it
very unlikely that abuses will be discovered.\65\
Significantly, the reports fail to provide thorough information
on the mental state of the patients. Under the Oregon law,
physicians are to assist suicides only in cases where a patient
is expected to die in 6 months,\66\ yet physicians generally
concede, and the professional literature confirms, that such
predictions of life expectancy are unreliable.\67\
---------------------------------------------------------------------------
\62\ Upon releasing the first report, the Oregon Health Division
distributed a memorandum to State employees stating that any employee
who reveals that a physician-assisted death has occurred in his or her
county ``will immediately be terminated.'' Death with Dignity
Memorandum from Sharon Rice, Manager Registration Unit, Center for
Health Statistics of the Oregon Health Division, to County Vital
Records Registrars and Deputies (Dec. 12, 1997), reprinted in
``Confidentiality of Death Certificates,'' 14, ``Issues in Law & Med.''
333, 334 (1998).
\63\ Or. Rev. Stat. Sec. 127.865 (1997).
\64\ Or. Rev. Stat. Sec. 127.835 (1997).
\65\ Another factor worthy of note is that, during the first year
of the assisted suicide law's operation, the Oregon Health Plan placed
barriers to the funding of antidepressants (Jeanette Hamby, ``The Enemy
Within: State Bureaucratic Rules Threaten the Spirit of Oregon Health
Plan's Founding Principles,'' ``Oregonian,'' Jan. 21, 1998), restricted
the availability of mental health services (Joe Rojas-Burke, ``Survey
Gives Oregon Health Plan High Marks,'' ``Oregonian,'' Feb. 3, 1999, at
B15), and restricted pain medication for poor and disabled patients
(Diane Gianelli, ``Suicide Opponents Rip Oregon Medicaid Pain Control
Policy,'' ``American Medical News,'' Sept. 28, 1998). By contrast,
Oregon fully funds assisted suicide. See Pain Relief Promotion Act of
1999, hearing on H.R. 2260 before the Subcommittee on the Constitution
of the House Committee on the Judiciary, 106th Cong. (June 24, 1999)
(statement of N. Gregory Hamilton, M.D., president of Physicians for
Compassionate Care) <>
[hereinafter cited as Hamilton testimony]. Some private Health
Maintenance Organizations have placed caps on in-home palliative care
while fully funding assisted suicide. Id.
\66\ Or. Rev. Stat. Sec. Sec. 127.800, 127.805 (1997).
\67\ Joanne Lynn et al., ``Defining the `Terminally Ill'; Insights
from SUPPORT,'' 35, ``Duquesne Law Review,'' 311 (1996); Eric Chevlen,
``The Limits of Prognostication,'' 35, ``Duquesne Law Review,'' 337
(1996); Robert A. Pearlman, ``Inaccurate Predictions of Life
expectancy,'' ``Archives of Internal Medicine,'' vol. 148, no. 12 (Dec.
1988): pp. 2537-38.
---------------------------------------------------------------------------
In addition, physicians are to assist suicides only in
cases where a patient is not suffering from ``a psychiatric or
psychological disorder, or depression causing impaired
judgment.'' \68\ Most physicians are ill-equipped to detect
depression in their patients at all, much less to determine
what level of clinical depression is sufficient to cause
``impaired judgment.'' \69\
---------------------------------------------------------------------------
\68\ Or. Rev. Stat. 127.825 (1997).
\69\ Lethal Drug Abuse Prevention Act: Hearing on H.R. 4006 before
the Subcommittee on the Constitution of the House Committee on the
Judiciary, 105th Cong., 2d sess. (July 14, 1998) (oral statement of Dr.
Herbert Hendin). See also, The New York State Task Force on Life and
the Law, When Death is Sought: Assisted Suicide and Euthanasia in the
Medical Context'' (New York: The New York State Task Force on Life and
the Law, 1994): p. 1268. http://www.health.state.ny.us/nysdoh/provider/
death.htm. The chief author of the Oregon law has written somewhat
chillingly that ``depression in itself does not rule out the
physician's assistance'' under the act. See Cheryl K. Smith,
``Safeguards for Physician-assisted Suicide: The Oregon Death with
Dignity Act,'' in ``Death, Dying and the Law,'' ed. Sheila McLean
(Brookfield, Vt.: Dartmouth, 1996): p. 75.
---------------------------------------------------------------------------
Certain omissions call into question the comprehensiveness
of the Oregon reports. For example, they fail to mention that
it appears that the first publicly reported case of assisted
suicide in the State involved an out-of-State woman who was
found to be depressed by one doctor she consulted. Within 3
weeks of contacting Compassion in Dying and moving to Oregon,
she was dead by lethal overdose. Significantly, while two
doctors had rendered opinions against the assisted suicide,
including a physician who believed the woman was suffering from
clinical depression, these opinions were not included in the
report.\70\ Two opposing conclusions, at opposite extremes,
have been articulated about the Pain Relief Promotion Act: that
if enacted it will override State law so as to prohibit all
instances of assisting suicide, and that it will have no effect
on their number. The Committee believes that neither extreme is
correct.
---------------------------------------------------------------------------
\70\ See Herbert Hendin et al., ``Physician-Assisted Suicide:
Reflections on Oregon's First Case,'' 14 issues in ``Law & Med.'' 243
(1998).
---------------------------------------------------------------------------
The Pain Relief Promotion Act does not nullify or pre-empt
Oregon's statute legalizing certain cases of assisting suicide.
It simply prevents the Federal Government's facilitation of
assisting suicide by refusing to authorize the use of federally
controlled substances to assist suicide, regardless of whether
such assistance is legal or illegal as a matter of State law.
The same would be true with respect to any statute that a state
might in the future enact permitting assisting suicide or
euthanasia as a matter of State law. Killing of patients by
means other than the use of federally controlled substances is
not prohibited by the Pain Relief Promotion Act.
At the same time, the Committee believes that just as
Federal facilitation of assisting suicide is likely to increase
its incidence, refusal of the Federal Government to facilitate
it is likely to decrease that incidence. In particular, refusal
to authorize the use of federally controlled drugs to put
patients to death is likely to help prevent the
institutionalization of induced death as a standard part of
medical practice. A study published in the April 23, 1998,
``New England Journal of Medicine,'' showed that while 36
percent of doctors would be willing to write lethal
prescriptions if assisting suicide were legal, only 11 percent
are willing to do so while it is against the law.\71\
Currently, while 18.3 percent of doctors have been asked to
assist suicide with a lethal prescription, only 3.3 percent
have done so. This suggests that legal limits are effectively
deterring over two-thirds of doctors who otherwise might assist
suicide.
---------------------------------------------------------------------------
\71\ Diane Meier et al., ``A National Survey of Physician-Assisted
Suicide and Euthanasia in the United States,'' ``New England Journal of
Medicine,'' vol. 338, no. 17 (Apr. 23, 1998): p. 1193.
---------------------------------------------------------------------------

c. federalism
Both Senator Wyden in his testimony before the Committee
and members of the Committee who oppose the bill have argued
that it usurps the power of States to enact legislation, a
power which is reserved under the 10th amendment to the
Constitution.
The Controlled Substances Act (CSA) was enacted almost 30
years ago as a measure to ensure strict, national regulation of
drugs which have a serious potential for abuse. Given the
devastating national problem of illicit drug use, the
Controlled Substances Act itself found that, ``The illegal
importation, manufacture, distribution, and possession for
improper use of controlled substances have a substantial and
detrimental effect on the health and general welfare of the
American people.'' It is almost inconceivable that it could
seriously be contended that the Controlled Substances Act is
beyond the constitutional authority of Congress,\72\ nor does
the Committee believe that many Members of Congress would favor
its repeal so as to eliminate any national regulation of
narcotics and other dangerous drugs. Given the national and
indeed the international nature of the drug problem, it is
difficult to see how a 50-State, crazy quilt approach to the
regulation of controlled substances could adequately protect
the health of the American public.
---------------------------------------------------------------------------
\72\ Congress has made the following findings with respect to the
effect of traffic in controlled substances on interstate commerce in 21
U.S.C. Sec. 801 (3)-(6):

(3) A major portion of the traffic in controlled
substances flows through interstate and foreign commerce.
Incidents of the traffic which are not an integral part of
the interstate or foreign flow, such as manufacture, local
distribution, and possession, nonetheless have substantial
and direct effect upon interstate commerce because--
(A) after manufacture, many controlled substances are
transported in interstate commerce immediately before their
distribution, and
(B) controlled substances distributed locally usually
have been transported in interstate commerce immediately
before their distribution, and
(C) controlled substances possessed commonly flow through
interstate commerce immediately prior to such possession.
(4) Local distribution and possession of controlled
substances contribute to swelling the interstate traffic in
such substances.
(5) Controlled substances manufactured and distributed
intrastate cannot be differentiated from controlled
substances manufactured and distributed interstate. Thus,
it is not feasible to distinguish, in terms of controls,
between controlled substances manufactured and distributed
interstate and controlled substances manufactured and
distributed intrastate.
(6) Federal control of the intrastate incidents of the
traffic in controlled substances is essential to the
effective control of the interstate incidents of such
traffic.

Section 2(6) of the Pain Relief Promotion Act finds that ``for the
reasons set forth in section 101 of the Controlled Substances Act (21
U.S.C. 801), the dispensing and distribution of controlled substances
for any purpose affect interstate commerce.''
---------------------------------------------------------------------------
Every Federal circuit court of appeal that has considered the
issue--and almost all have--has upheld the constitutionality of the
Controlled Substances Act as a valid exercise of Congressional power to
regulate interstate commerce. United States v. Edwards, 98 F.3rd 1364,
1369 (D.C. Cir. 1996); United States v. Lerebours, 87 F.3rd 582, 584-85
(1st Cir. 1996); Proyect v. United States, 101 F.3rd 11, 13-14 (2d Cir.
1996); United States v. Leshuk, 65 F.3d 1105, 1112 (4th Cir. 1995);
United States v. Clark, 67 F.3rd 1154 (5th Cir. 1995), cert. denied,
116 S. Ct. 1432 (1996); United States v. Tucker, 90 F.3rd 1135, 1139-41
(6th Cir. 1996); United States v. Rogers, 89 F.3rd 1326, 1338 (7th Cir.
1996); United States v. Bell, 90 F.3rd 318, 321 (8th Cir. 1996); United
States v. Bramble, 103 F.3rd 1475, 1479-80 (9th Cir. 1996); United
States v. Wacker, 72 F.3rd 1453, 1475 (10th Cir. 1995), cert. denied,
117 S. Ct. 136 (1996); United States v. Jackson, 111 F.3rd 101, 102
(11th Cir. 1997).
---------------------------------------------------------------------------
As Senator Nickles testified before the Committee:

Under present Federal law, the Controlled Substances
Act, these federally-controlled substances can only be
prescribed for a ``legitimate medical purpose'' in the
usual course of professional practice, to promote
public health and safety. A lethal overdose, otherwise
known as assisted suicide, has never been considered a
legitimate medical purpose and certainly does not
promote public health and safety.
* * * When Oregon passed a state law to allow
physician assisted suicide, it had that right. But it
did not have the right to change or amend an existing
federal law. If Oregon were to legalize the use of
heroin for any purposes that wouldn't change the
federal law prohibiting its use. The Controlled
Substances Act is a federal law governing all 50
states, not 49.

Given the structure of the Controlled Substances Act and
its implementing regulations, the Federal Government must
either treat assisting suicide and euthanasia as forms of
legitimate medical practice, or as an unauthorized misuse of
controlled substances. It would hardly be consistent to concede
that Congress has the constitutional authority to enact a
Controlled Substances Act to prevent potent drugs from being
used for other than legitimate medical purposes, yet to
maintain that Congress may not constitutionally set boundaries
for what may count as a legitimate medical purpose.\73\
---------------------------------------------------------------------------
\73\ That setting such boundaries is integral to the Controlled
Substances Act is implicit in the provisions of 21 U.S.C. 801a. In that
section Congress finds and declares that the Comprehensive Drug Abuse
Prevention and Control Act of 1970 (which amended the Controlled
Substances Act) is the means employed by the United States to fulfill
its treaty obligations under the Convention on Psychotropic Substances
signed at Vienna, Austria, on February 21, 1971. In subsection (3),
Congress finds that this ensures that nothing in the Convention ``will
interfere with ethical medical practice in this country as determined
by the Secretary of Health and Human Services on the basis of a
consensus of the views of the American medical and scientific
community.'' It is noteworthy that the measure of what constitutes
ethical medical practice is not left by this subsection solely to the
varying interpretations of the several States, but rather is deemed to
arise from the consensus of the American medical and scientific
community. It was an analysis of precisely that consensus that lead
Drug Enforcement Administrator Constantine to make the original
determination that assisting suicide and euthanasia are not legitimate
medical purposes in the course of professional practice for the
purposes of the Controlled Substances Act, a determination the
Committee considers to be documentably accurate.
---------------------------------------------------------------------------
The Committee is convinced that it is both constitutional
and good public policy for Congress to ensure that federally
controlled substances are not used to effectuate the ultimate
harm of deliberately inflicting death.\74\
---------------------------------------------------------------------------
\74\ In Washington v. Glucksberg, 521 U.S. 702, 735 (1997), the
Court wrote, ``Throughout the nation, Americans are engaged in an
earnest and profound debate about the morality, legality and
practicality of physician-assisted suicide. Our holding permits this
debate to continue, as it should in a democratic society.'' This
passage is sometimes cited for the position that States may
constitutionally choose, if they wish, to legalize physician-assisted
suicide.
Clearly, however, this was not the Court's own view. Neither in the
quoted passage nor elsewhere in its opinion did the Court assign this
issue to state as opposed to Federal jurisdiction. In reviewing the
Nation's longstanding tradition against assisting suicide, it cited
Federal enactments such as the Assisted Suicide Funding Restriction Act
of 1997 alongside State laws. Illustrating the Government's interest in
protecting terminally ill patients, the Court favorably cited an
earlier decision upholding the Federal Food and Drug Administration's
authority ``to protect the terminally ill, no less than other
patients,'' from life-endangering drugs. Id. at 729, quoting United
States v. Rutherford, 442 U.S. 544, 558 (1979).
Indeed, the Court explicitly left open the question of whether
State laws like Oregon's authorizing assisting suicide in certain
circumstances might themselves be unconstitutional. Oregon's law
selectively permitting assisted suicide for certain patients had been
found by one Federal district court to violate equal protection; that
ruling was not before the Supreme Court. See Lee v. Oregon, 891 F.Supp.
1429 (D. Or. 1995), vacated on other grounds, 107 F.3d 1382 (9th Cir.
1997), cert. denied, 118 S. Ct. 328 (1997). As Chief Justice Rehnquist
said in his majority opinion in Glucksberg: ``Lee, of course, is not
before us * * * and we offer no opinion as to the validity of the Lee
court's reasoning.'' Glucksberg, 521 U.S. at 709-710 n. 7. To this day
no appellate court in the country has ruled on the constitutionality of
a law like Oregon's.
---------------------------------------------------------------------------

d. intent as a basis for distinguishing between the use of controlled
substances to alleviate pain and to assist suicide
Following the substantial changes to address medical
concerns incorporated in the Chairman's substitute adopted by
the Committee, remaining charges that the Pain Relief Promotion
Act could adversely impact pain control center on objections to
the intent standard.\75\ As articulated by Oregon Senator Ron
Wyden in his testimony before the Committee, the criticism is
this:
---------------------------------------------------------------------------
\75\ The intent distinction is found in Section 201(a)(i)(1):

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.

Your bill would authorize local, state, and Federal law
enforcement officials, with no expertise and scant
training in health care, to dissect a physician's
intent with respect to prescribing pain relief
medications. * * * [T]he effect would be * * *
physicians' fear of being investigated by law
enforcement and losing their ability to practice
medicine will result in less aggressive pain management
for countless patients.

Yet the intent distinction whose negative effects on pain
relief are thus predicted is in fact now part of Federal law,
the Assisted Suicide Funding Restriction Act, which was enacted
in 1997, after having passed the Senate without a dissenting
vote.\76\ Moreover, an intent standard is currently
incorporated in the law of Senator Wyden's State of Oregon, as
it is in most States, including many States represented by
members of the Judiciary Committee.\77\
---------------------------------------------------------------------------
\76\ See supra nn. 11 and accompanying text. As pointed out there,
the intend standard in the Assisted Suicide Funding Restriction Act
(ASFRA) governs not only Federal funding, but also the provision of
medical treatment in Federal health care facilities and by physicians
and other health care professionals employed by the Federal Government.
The Committee is unaware of any evidence that the provision of pain
relief in Federal facilities or by federally employed physicians has
been chilled by ASFRA. Indeed, Veterans Administration hospitals
implemented widely praised improvements in palliative care after
passage of the act. S. Beckwith, ``VA Makes Better End-of-Life Care a
Top Priority,'' ``Last Acts Newsletter,'' Summer 1998 at 6.
\77\ In circumstances other than those of terminally ill
individuals, Or. Rev. Stat. Sec. 163.125 continues to apply: ``Criminal
homicide constitutes manslaughter in the second degree when * * * [a]
person intentionally causes or aids another person to commit suicide.''
(Emphasis added.)
Similarly, California Penal Code section 401 (West 1998) punishes
any doctor (or other person) who ``deliberately aids, or advises, or
encourages another to commit suicide.'' (Emphasis added.) New Jersey
Statutes Annotated sec. 2C: 11-6 (West 1999) punishes anyone who
``purposely causes or aids another person to commit suicide.''
(Emphasis added.) New York Penal Law sec. 125.15 (McKinney 1999)
punishes anyone who ``intentionally causes or aids another person to
commit suicide.'' (Emphasis added.) Wisconsin Statutes Annotated sec.
940.12 (1997-98) punishes anyone who ``with intent that another take
his or her own life assists such person to commit suicide.'' (Emphasis
added.)
---------------------------------------------------------------------------
As Dr. Eric Chevlen, director of Palliative Care at the
Cancer Care Center of St. Elizabeth Medical Center in
Youngstown, Ohio, testified, there is empirical evidence of the
effect of an intent-based standard, similar to that in the Pain
Relief Promotion Act, on the willingness of physicians to
prescribe pain-killing drugs.\78\ During the 1990's, the six
States of Iowa, Kansas, Louisiana, Rhode Island, Virginia, and
Tennessee all adopted statutes strikingly similar in wording to
the promotion of the Pain Relief Promotion Act protecting
doctors who provide pain relief even at the risk of death while
preventing intentionally causing death.\79\ The following
charts, derived from DEA data, demonstrate that per capita
morphine use went up, not down, after enactment of all of these
laws:
---------------------------------------------------------------------------
\78\ As explained in more detail in the following two subsections
of this report, since the DEA automatically has the authority now to
investigate cases where controlled substances have been used to violate
State law, it has authority now to investigate whether these drugs were
used ``intentionally'' to assist a suicide. The only new legal effect
of the Pain Relief Promotion Act in almost every State is to provide
clearer protection against a broader application of the law when
practitioners are seeking to control pain.
\79\ The relevant provisions are as follows: Iowa Code
Sec. 707A.3.1. (Adopted 1996.) (``A licensed health care professional
who administers, prescribes, or dispenses medications or who performs
or prescribes procedures to relieve another person's pain or
discomfort, even if the medication or procedure may hasten or increase
the risk of death, does not violate section 707A.2 unless the
medications or procedures are intentionally or knowingly administered,
prescribed, or dispensed with the primary intention of causing
death.''); Kan. Stat. Ann. Sec. 60-4403(a) (Adopted 1998.) (``A
licensed health care professional who administers, prescribes or
dispenses medications or procedures to relieve another person's pain or
discomfort, even if the medication or procedure may hasten or increase
the risk of death, does not violate K.S.A. 21-3406 and amendments
thereto unless the medications or procedures are knowingly
administered, prescribed or dispensed with the intent to cause death.);
La. Rev. Stat. Ann. Sec. 14:32.12 (Adopted 1995). (``The provisions of
this Section shall not apply to any licensed physician or other
authorized licensed health care professional who * * * [p]rescribes,
dispenses, or administers any medication, treatment, or procedure if
the intent is to relieve the patient's pain or suffering and not to
cause death.''); R.I. Gen. Laws Sec. 11-60-4(A) (``A licensed health
care professional who administers, prescribes, or dispenses medications
or procedures to relieve another person's pain or discomfort, even if
the medication or procedure may hasten or increase the risk of death,
does not violate the provision of this chapter unless the medications
or procedures are knowingly administered, prescribed, or dispensed to
cause death.''); Va. Code Ann. Sec. 8.01-622.1 (E). (``This section
shall not apply to a licensed health care provider who (i) administers,
prescribes or dispenses medications or procedures to relieve another
person's pain or discomfort and without intent to cause death, even if
the medication or procedure may hasten or increase the risk of death. *
* * This section shall not apply to any person who properly administers
a legally prescribed medication without intent to cause death, even if
the medication may hasten or increase the risk of death.''); and Tenn.
Code Ann. Sec. 39-13-216(b)(2) (Adopted 1993.) (``It is not an offense
under this section to: * * * [p]rescribe, dispense, or administer
medications or perform medical procedures calculated or intended to
relieve another person's pain or discomfort (but not calculated or
intended to cause death), even if the medications or medical procedures
may hasten or increase the risk of death * * *'').
---------------------------------------------------------------------------

While she testified in opposition to the Pain Relief
Promotion Act, Dr. Kathleen M. Foley, attending neurologist in
the Pain & Palliative Care Service at Memorial Sloan-Kettering
Cancer Center and Professor of neurology, neuroscience and
clinical pharmacology at the Cornell University Medical
College, summarized significant evidence that in modern
medicine providing effective pain relief does not entail an
increased risk of death:

Pain and palliative care experts have defined clear
distinctions between pain management and palliative
care, and physician assisted suicide. Yet, it has been
the advocates for physician assisted suicide who have
used the argument that opioids, such as morphine, kill
and to try to relate these practices. Yet, there is a
preponderance of evidence that demonstrates that the
proper use of opioids in patients with chronic pain, as
well as in patients at the end of life, does not hasten
their death. There is accumulating data to suggest that
the proper use of opioids may in fact prolong their
lives.
Studies by Dr. Brescia at Calvary Hospital in New
York City show that there is no correlation between the
dose of opioids a patient receives in the last weeks of
life and the timing of their death. Studies of dying
patients who were being withdrawn from respiratory
support demonstrate that those patients who received
morphine lived longer than those who did not receive
morphine. Studies recently published from a series of
British hospices show no difference in the time to
death between those patients who were sedated to
control their symptoms as compared to those patients
who were not sedated. Finally, the doses of opioids
that are often used to treat patients at the end of
life are highly variable. The great majority of dying
patients are receiving doses in a range equivalent to
what you or I might receive as part of postoperative
pain management and these doses are safe and effective.

The New York State Task Force on Life and the Law has made
a similar point:

While high doses of morphine can depress respiration
when administered to patients who have not developed
tolerance to the drug, physicians who treat patients
with morphine for the relief of pain increase the dose
gradually, so that tolerance can develop. * * * The
claim that the use of morphine at properly titrated
levels ``hastens'' patients' deaths, based on the
effects of high doses of morphine on patients who have
not developed tolerance, is entirely unfounded. It
represents one of the many myths about the consequences
of using narcotics in the clinical setting. * * * \80\
---------------------------------------------------------------------------
\80\ The New York State Task Force on Life and the Law, ``When
Death is Sought: Assisted Suicide and Euthanasia in the Medical Context
Supplement to Report April 1997'' (New York: The New York State Task
Force on Life and the Law, 1997), p. 17. http://www.health.state.ny.us/
nysdoh/taskfce/sought.pdf

If physicians do not need to increase the risk of death in
order to provide the most effective pain relief available, even
the theoretical possibility that preventing the use of
controlled substances with intent to cause death will ``chill''
the provision of effective pain relief of course vanishes.
However, although rare, there are circumstances in which
providing effective pain relief may indeed increase the risk of
death.\81\
---------------------------------------------------------------------------
\81\ Dr. Walter R. Hunter, associate national medical director,
VistaCare Hospice, Indianapolis, IN, testified concerning such an
instance from his own experience:

As an example of the work I am called to do daily, let me
describe a case of a young AIDS patient I cared for a few
years ago. On a Monday morning the hospice for whom I
worked received a phone call from his family that he was
having difficulty breathing. His nurse and I made a house
call. When we entered the room we could hear his laborious
and most respirations across the room. His respiratory rate
was 44 and he was unconscious. We immediately set to work.
I gave him 40 mg of Lasix (furosemide) intravenously. There
was no effect. I then gave him 10 mg of morphine
intravenously. There was no effect after several minutes. I
repeated the dose of 10 mg of morphine and waited several
minutes. Again, there was no effect. I gave 5 mg of
morphine. There was still no effect. I then gave 5 mg of
Valium (diazepam) in an attempt to sedate him and ease the
work of breathing. There was no effect. I repeated the
Valium dose and there was still no effect. I gave 5 mg of
morphine, waited, saw no effect and gave another, 10 mg of
marphine. After a few minutes, his respirations decreased
to about 20. This was a reasonable goal. However, instead
of stabilizing at 20, they continued to diminish and he
stopped breathing several minutes later.
* * * * * * *
I knew that there was a slight risk of lethal side
effects to the medications. But I knew that I might have to
risk them, tolerate them in part or in totality if I were
to attempt to ease his breathing easier. Had I intended the
side effect of cessation of breathing. I did not intend for
him to die, but I did intend to make his breathing, I would
not have given incremental doses of medicine over time and
observed his clinical response with each dose. I would have
given a very large dose all at once to stop the breathing.
* * * * * * *
* * * In short, the Principle of Double Effect guided me
through the decision making process and the actions I
performed in this case. Chairman's Substitute for H.R. 2260
recognizes what I did in this case as legitimate palliative
care, does not view my actions as assisting a suicide or
committing euthanasia, and therefore protects me from
prosecution for committing those acts.
Therefore, the Pain Relief Promotion Act introduces into
the Controlled Substances Act a ``safe harbor'' for physicians
to protect them in any eventuality in which such an increased
risk of death may be associated with the use of controlled
substances to alleviate pain or discomfort. While existing DEA
guidelines recognize and encourage the use of federally
controlled substances for the treatment of pain, \82\ they do
not mention or specifically protect the provision of a
controlled substance to alleviate pain or discomfort ``even if
the use of such a substance may increase the risk of death.''
This new protection, in the words of the American Medical
Association, ``is a vital element in creating a legal
environment in which physicians may administer appropriate pain
core for patients.'' \83\
---------------------------------------------------------------------------
\82\ In March 1990 the DEA published guidelines which stated
``Controlled substances have legitimate clinical usefulness and the
prescriber should not hesitate to consider prescribing them when they
are indicated for the comfort and well-being of patients.''
``Guidelines for Prescribers of Control Substances: A Joint Statement
of the Drug Enforcement Administration and the DEA/Practitioners
Working Committee'' Physician's Manual, Drug Enforcement
Administration,'' rev. Mar. 1990, p. 24. The DEA has also stated:

Controlled substances and, in particular narcotic
analgesics, may be used in the treatment of pain
experienced by a patient with a terminal illness or chronic
discorder. These drugs have a legitimate clinical use and
the physician should not hestitate to prescribe, dispense,
or administer them when they are indicated for a legitimate
medical purpose. It is the position of the Drug Enforcement
Administration that these controlled substances should be
prescriged, dispensed, or administered when there is a
---------------------------------------------------------------------------
legitimate medical need.

Id., p. 21.
---------------------------------------------------------------------------
\83\ Letter from Dr. E. Ratcliffe Anderson, executive vice
president, American Medical Association, to Chairman Orrin Hatch (Apr.
6, 2000), p. 1.
---------------------------------------------------------------------------

e. the effect of title ii on states other than oregon
At present, under the same June 5, 1998, ruling by Attorney
General Janet Reno that allowed the use of federally controlled
drugs to assist suicides which comply with Oregon State law,
the Drug Enforcement Administration (DEA) may nevertheless
revoke the registration of any doctor or other registrant who
uses federally controlled substances to assist suicide ``in a
state that has not authorized the practice under any
conditions.'' \84\ Thus, in 49 States the bill does not
increase the DEA's existing authority at all. Therefore, in all
States other than Oregon, the bill will in no way increase DEA
authority to investigate or revoke the registrations of health
care personnel.
---------------------------------------------------------------------------
\84\ See supra n. 14 and accompanying text.
---------------------------------------------------------------------------
It will, in fact, limit such DEA authority in two
significant ways.
First, as noted in the preceding subsection, it will
introduce an explicit ``safe harbor'' for physicians and other
registrants when federally controlled substances are used to
alleviate pain or discomfort even when this may increase the
risk of death.
Second, it will increase the burden of proof the DEA must
meet when seeking to suspend or revoke a registration based on
an intent to cause or assist in causing death whenever the
registrant claims that she or he was acting to alleviate pain
or discomfort in the usual course of professional practice.
That burden will be raised from the current preponderance of
the evidence standard common to such administrative proceedings
to ``clear and convincing evidence,'' the highest standard to
the civil law (the standard required, for example, for
involuntary commitment to a mental health facility).
In the words of Chairman Hatch at the Committee's hearing
on this bill,

[T]o address the concerns of health care providers, the
substitute bill that I will offer during the
Committee's mark-up of H.R. 2260 contains a provision
that is neither in the House bill nor the Senate
companion bill. The new provision, modeled on the
legislation reported out of this Committee during the
105th Congress, establishes the higher clear and
convincing evidentiary standard for DEA administrative
hearing involving allegations of assisted suicide or
euthanasia. I know DOJ and DEA oppose this higher
standard. However, when we completed our mark-up in
1998, I pledged to the members of this Committee--to
Senators Leahy and Feinstein--that I would continue to
work to see whether we could develop a broader a
broader consensus on this bill. I believe it is proper
for Congress to make a strong statement about the need
for state-of-the-art pain management and palliative
care and to restore the original intent of our drugs
laws relative to assisted suicide.

Therefore, in all these States the only effect of the bill
will be to reduce, and not increase, any conceivable ``chilling
effect'' on pain medication prescription that may exist under
the current Controlled Substances Act.\85\
---------------------------------------------------------------------------
\85\ The DEA has stated:

Even if H.R. 2260 were enacted, it is not feasible that DEA
would devote its limited resources to investigate an
allegation that a practitioner assisted suicide unless
either (i) the practitioner made a clear admission that s/
he dispensed controlled substances with the specific intent
to assist suicide or (ii) competent state or local
authorities concluded--based on sufficient evidence
provided to DEA--that the practitioner dispensed controlled
---------------------------------------------------------------------------
substances with the specific intent to assist suicide.

Memorandum from Ken Ronald, DEA Congressional Affairs, Mar. 28, 2000.

f. the effect of title ii in oregon
Oregon is the only State that has enacted legislation
authorizing physicians to assist suicides, and therefore is the
only State in which the DEA, under the June 1998 ruling of the
Attorney General, currently cannot revoke or suspend
registrations in such instances. Hence, it is the only State in
which this legislation can even arguably be said to expand DEA
authority over current practice under the Attorney General's
highly debateable view of the current statutory situation.
However, this expanded authority should not and will not lead
to any increased DEA scrutiny of Oregon physicians' pain relief
prescribing practices. Instead, reports and records required by
the Oregon Death with Dignity Act will unmistakeably
demonstrate whether federally controlled substances have been
intentionally dispensed to assist suicide as authorized by
Oregon State law.
Under section 127.865(b) of the Oregon Revised Statutes,
``The [Oregon Health] Division shall require any health care
provider upon dispensing medication pursuant to ORS 127.800 to
127.897 to file a copy of the dispensing record with the
division.'' Thus, in order to comply with the Oregon Death with
Dignity Act and escape criminal liability that would otherwise
exist under Oregon law for assisting a suicide,\86\ a physician
must file a form listing the precise drugs used to assist a
suicide with State authorities.
---------------------------------------------------------------------------
\86\ Whenever anyone assists suicide in a manner that does not
comply with the Oregon Death with Dignity Act, Or. Rev. Stat.
Sec. 163.125 continues to apply: ``Criminals homicide constitutes
manslaughter in the second degree when * * * [a] person intentionally
causes or aids another person to commit suicide.'' Under Attorney
General Reno's ruling, such unauthorized assisted suicides can prompt
adverse action by the DEA as well.
---------------------------------------------------------------------------
The Drug Enforcement Administration has authority to
subpoena these dispensing records from the State authorities.
Under section 876 of the CSA, ``[i]n any investigation * * *
with respect to controlled substances, the Attorney General may
* * * require the production of any records (including books,
papers, documents, and other tangible things which constitute
or contain evidence) which the Attorney General finds relevant
or material to the investigation.''
The DEA therefore has the authority to obtain copies of any
relevant reports filed with the Oregon authorities.\87\ These
provide identification of each physician who has provided
lethal drugs to a patient for the purpose of assisting suicide
as permitted by Oregon law, and will identify the substances
used.
---------------------------------------------------------------------------
\87\ Oregon authorities have been quoted as indicating they would
refuse to furnish the DEA with such reports. ``Oregon says data on
suicide protected,'' ``The Oregonian,'' Nov. 27, 1999. The Committee
notes that under the supremacy clause of article VI, cl. 2 of the U.S.
Constitution, they would not legally have this option. It provides,
``This Constitution, and the Laws of the United States which shall be
made in Pursuance thereof * * * shall be the supreme Law of the Land;
any Thing in the Constitution or Laws of any State to the Contrary
notwithstanding.''
---------------------------------------------------------------------------
This information will indicate unequivocally whether a
federally controlled substance had been prescribed to assist
suicide in violation of Federal law.\88\ If so, this would be
sufficient in itself--without need for further investigation--
to provide adequate evidence for the suspension or revocation
of the physician's registration to distribute controlled
substances in accordance with 21 U.S.C. 824(a)(4).\89\
---------------------------------------------------------------------------
\88\ It is the intent of the Committee that the DEA maintain
confidentiality of the information so obtained to the full extent
compatible with enforcement of the Controlled Substances Act.
\89\ The situation would then fall within one of the limited
circumstances in which the DEA states it would in practice be in a
position to act against a practitioner's registration for assisting
suicide, namely when ``the practitioner made a clear admission that s/
he dispensed controlled substances with the specific intent to assist a
suicide.'' See supra n. 68.
See 21 U.S.C. 824(c) for the procedure for such a suspension or
revocation, and 21 U.S.C. 824(d) for the authority to ``suspend any
registration simultaneously with the institution of proceedings under
this section, in cases where [the Attorney General] finds that there is
an imminent danger to the public health or safety.''
---------------------------------------------------------------------------
The DEA would have the same authority to obtain such
documents in any other State in which assistance of suicide
should become legal and in which reports of such assistance
must be made, as a matter of State law, to State authorities.
Therefore, the DEA may identify all cases in which
federally controlled substances have been used to assist
suicide in Oregon in compliance with Oregon law \90\ simply by
obtaining reports from the Oregon Health Division without ever
having to review patient medical records or otherwise
investigate physicians. Thus, physicians in Oregon who
prescribe controlled substances for pain relief will have no
reason to fear investigation of their use of controlled
substances for pain, and should not, therefore, be deterred in
any way from prescribing pain relief.
---------------------------------------------------------------------------
\90\ Anyone who assists a suicide in Oregon but fails to provide
Oregon authorities the required report is in violation of Oregon law.
Under the Attorney General's June 1998 ruling, of course, registration
under the CSA is currently subject to revocation ``where a physician
fails to comply with state procedures in [assisting suicide].'' Thus, a
physician who assists suicide without making the reports required by
Oregon law is equally subject to registration revocation under current
law and under the Pain Relief Promotion Act.
---------------------------------------------------------------------------

g. preventing federally imposed clinical standards and protecting the
authority of states to regulate medicine

The substitute proposed by Chairman Hatch and adopted by
the Committee substantially rewrites the House-passed
legislation to ensure that it provides the Federal Government
no authority to mandate standards of clinical practice and that
it protects the authority of the States to regulate medical
practice.\91\
The substitute now includes a provision stating: ``Nothing
in the Pain Relief Promotion Act of 2000 (including the
amendments made by such Act) shall be construed * * * to
provide the Attorney General with the authority to issue
national standards for pain management an palliative care
clinical practice, research, or quality * * .'' Section
201(a)(4)(B).
In order to ensure that the Department of Health and Human
Services does not use the bill as the basis to promulgate
mandatory national clinical standards for pain management or
palliative care, the provision in the bill providing for the
collection and dissemination of protocols and evidence-based
practices for pain management and palliative care (section
903[a] being added to the Public Health Service Act by section
101 of the bill) has been made specifically subject to
provisions in the recently passed Healthcare Resarch and
Quality At of 1999, Public Law 106-129, that provide that the
relevant ``Agency shall not mandate national standards of
clinical practice or quality health care standards.
Recommendations resulting from projects funded and published by
the Agency shall include a corresponding disclaimer'' and state
``Nothing in this section shall be construed to imply that the
Agency's role is to mandate a national standard or specific
approach to quality measurement and reporting. In research and
quality improvement activities, the Agency shall consider a
wide range of choices, providers, health care delivery systems,
and individual preferences.'' \92\
---------------------------------------------------------------------------
\91\ After opposing the Lethal Drug Abuse Prevention Act in 1998,
the American Medical Association, the National Hospice Organization,
and other medical groups endorsed its substantially reworked successor,
the Pain Relief Promotion Act, in 1999. In December 1999 the AMA House
of Delegates adopted a resolution calling for changes in the bill to
deal with a perceived concern that under it the Federal Government
might be authorized to ``establish federal protocols and/or regulations
for pain management and palliative care''. After detailed negotiations
by Chairman Hatch and sponsor Senator Don Nickles with representatives
for the AMA, the Pain Care Coalition, and other medical groups, a
substitute was crafted to address this concern. This substitute, unlike
the House-passed legislation, has now been endorsed by the Pain Care
Coalition, which is comprised of the American Academy of Pain Medicine,
the American Headache Society, and the American Pain Society. The AMA
wrote to Chairman Hatch that ``The language of the Substitute * * *
fully satisfies the concerns expressed by our House of Delegates.''
Letter from Dr. E. Ratcliffe Anderson, executive vice president,
American Medical Association, to Chairman Orrin Hatch (Apr. 6, 2000),
p. 2.
\92\ Public Health Service Act, Sec. 902(e) and (f) [42 U.S.C.
299a(e) and (f)].
---------------------------------------------------------------------------
The bill's provision for training DEA and other law
enforcement personnel has been substantially reworked. The
training is now to be focused on how ``investigation and
enforcement actions by law enforcement personnel may better
accommodate the necessary and legitimate use of controlled
substances in pain management and palliative care.'' This
replaces language in the original bill which had been seen as
suggesting that law enforcement personnel might themselves be
``trained'' in how to make determinations about what is or is
not appropriate pain management and palliative care.
In addition, to clarify that the bill does not generally
pre-empt State laws or standards relating to the practice of
medicine, a provision has been added as section 201(a)(i)(3)
stating, ``Nothing in this subsection shall be construed to
alter the roles of the Federal and State governments in
regulating the practice of medicine. Regardless of whether the
Attorney General determines pursuant to this section that a
practitioner's registration is inconsistent with the public
interest, it remains solely within the discretion of State
authorities to determine whether action should be taken with
respect to the State professional license of the practitioner
or State prescribing privileges.''

VII. Cost Estimate

U.S. Congress,
Congressional Budget Office,
Washington, DC, May 9, 2000.
Hon. Orrin G. Hatch,
Chairman, Committee on the Judiciary, U.S. Senate, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for H.R. 2260, the Pain
Relief Promotion Act of 2000.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contacts are Mark
Grabowicz (for effects on spending by the Department of
Justice), who can be reached at 226-2860; Cynthia S. Dudzinski
(for costs to the Health Resources and Services
Administration), who can be reached at 226-9010; Christopher J.
Topoleski (for costs to the Agency for Health Care Research and
Quality), who can be reached at 226-9010; Shelley Finlayson
(for the state and local impact), who can be reached at 225-
3220; and John Harris (for the private-sector impact), who can
be reached at 226-2618.
Sincerely,
Barry B. Anderson
(For Dan L. Crippen, Director).
Enclosure.

Congressional Budget Office Cost Estimate

H.R. 2260--Pain Relief Promotion Act of 2000

Summary: H.R. 2260 would increase an existing authorization
of appropriations to the Health Resources and Services
Administration (HRSA) for the purpose of making grants to
public and private entities to educate and train health care
professionals in palliative care. The act also would direct the
Agency for Health Care Research and Quality (AHRQ) to develop a
program to improve palliative care, and would prohibit the use
of controlled substances for assisted suicide or euthanasia,
regardless of any state law authorizing such activity.
Assuming appropriation of the necessary amounts, CBO
estimates that implementing H.R. 2260 would result in
additional discretionary spending of about $25 million over the
2000-2005 period. Enacting this legislation could affect direct
spending and receipts, so pay-as-you-go procedures would apply;
however, CBO estimates that the amounts involved would be less
than $500,000 a year.
H.R. 2260 contains both an intergovernmental and a private-
sector mandate as defined in the Unfunded Mandates Reform Act
(UMRA). CBO estimates that the act would result in no costs to
state, local, or tribal governments, so the threshold
established in UMRA ($55 million in 2000, adjusted annually for
inflation) would not be exceeded. CBO also estimates that the
costs of the private-sector mandate would fall below the
threshold established in UMRA ($109 million in 2000, adjusted
annually for inflation).
Estimated cost to the Federal Government: The estimated
budgetary impact of H.R. 2260 is shown in the following table.
The costs of this legislation fall within budget function 550
(health).

CHANGES IN SPENDING SUBJECT TO APPROPRIATION \1\
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
-----------------------------------------------------
2000 2001 2002 2003 2004 2005
----------------------------------------------------------------------------------------------------------------
Estimated Authorization Level............................. 7 7 7 2 2 2
Estimated Outlays......................................... 2 6 7 5 3 2
----------------------------------------------------------------------------------------------------------------
\1\ The bill could also affect direct spending and receipts, but CBO estimates any additional costs and receipts
would be less than $500,000 annually.

Basis of estimate: For the purposes of this estimate, CBO
assumes that the legislation will be enacted during fiscal year
2000, that the necessary amounts will be provided each year,
and that outlays will follow historical spending rates for
these activities.

Spending subject to appropriation

The estimated change in spending subject to appropriation
has two components: (1) an increase in the existing
authorization of HRSA grants for education and training of
health care professionals, and (2) a new AHRQ research program
aimed at improving the quality of care for terminally ill
patients.
The existing HRSA grant program received an appropriation
of $23 million for fiscal year 2000. This program is part of a
larger HRSA activity which has a current authorization of such
sums as necessary through fiscal year 2002. H.R. 2260 would
increase the existing target level of $23 million a year
(within that ``such sums'' authorization) by $5 million. The
agency would use the additional funds to award grants to public
and private entities to develop, implement, and evaluate
education and training programs in palliative care.
H.R. 2260 would direct AHRQ to develop a research program
to improve palliative care, mainly through the collection and
dissemination of guidelines for providing such care. CBO
estimates that implementing this provision would cost about $1
million in fiscal year 2000 and $2 million annually thereafter,
assuming the appropriation of the necessary amounts. (The
agency received an appropriation of $111.4 million for 2000.)

Direct spending and revenues

Violations of the act's provisions regarding the use of
controlled substances to assist in suicide could face
revocation of their license to prescribe controlled substances.
Upon revocation of an individual's license, the Drug
Enforcement Administration could seize any such substances in
their possession. Thus, enacting H.R. 2260 could lead to the
seizure of more assets and their forfeiture to the United
States, but we estimate that any such increase would be less
than $500,000 annually in value. Proceeds from the sale of any
such assets would be deposited as revenues into the Assets
Forfeiture Fund of the Department of Justice and spent from
that fund, generally in the same year. Thus, the changes in
direct spending from the Assets Forfeiture Fund would match any
increase in revenues to that fund.
Violators of the act's provisions also could be subject to
criminal fines, so the federal government might collect
additional fines if H.R. 2260 is enacted. Collections of such
fines are recorded in the budget as governmental receipts
(revenues), which are deposited in the Crime Victims Fund and
spent in subsequent years. CBO expects that any additional
receipts and direct spending would be negligible.
Pay-as-you-go considerations: The Balanced Budget and
Emergency Deficit Control Act sets up pay-as-you-go procedures
for legislation affecting direct spending or receipts. Enacting
H.R. 2260 could affect both direct spending and receipts, but
CBO estimates that any such effects would be less than $500,000
a year.
Estimated impact on state, local, and tribal governments:
H.R. 2260 contains an intergovernmental mandate as defined in
UMRA, but CBO estimates that complying with the mandate would
impose no costs on state, local, or tribal governments, and
thus would not exceed the threshold established in that act
($55 million in 2000, adjusted annually for inflation).
In October 1997, an Oregon law that legalized doctor-
assisted suicide for terminally ill patients went into effect.
Since that time, the interaction of the Controlled Substances
Act with that state law has been controversial. As it currently
stands, under both Oregon and federal law, it is acceptable for
doctors in Oregon to use federally controlled substances for
the purposes set forth in state law. H.R. 2260 would direct the
Attorney General to give no force and effect to such a state
law when determining whether the federal registration of a
doctor under the Controlled Substances Act is consistent with
the public interest. This would be a preemption of the Oregon
``Death with Dignity Act'' because it would limit the options
available to doctors acting under that state law. Because the
state would not be required to take any action, the preemption
would have not no cost. The act also would authorize $5 million
for education and training in palliative care for health care
professionals, many of whom are employed by state and local
facilities.
Estimated impact on the private sector: H.R. 2260 would
create a new private-sector mandate for physicians registered
to prescribe or administer federally controlled substances by
prohibiting the use of such substances in physician-assisted
suicides. Under current law, medical practitioners who are
licensed by the state must also register with the U.S. Attorney
General through the Drug Enforcement Administration if they
intend to dispense or prescribe controlled substances. The act
would amend the Controlled Substances Act to require the Drug
Enforcement Administration to treat the use of controlled
substances for physician-assisted suicide as a violation of the
act without regard for state law permitting the practice.
Doctors who violate the prohibition would have to give up their
stocks of controlled substances and would no longer be
permitted to use controlled substances in their medical
practice. The prohibition would affect doctors in Oregon, which
is the only state that permits physician-assisted suicide. CBO
estimates that the direct costs associated with the mandate
would fall below the threshold in UMRA ($109 million in 2000,
adjusted annually for inflation).
Previous CBO estimate: On September 24, 1999, CBO
transmitted a cost estimate for H.R. 2260, as ordered reported
by the House Committee on the Judiciary on September 14, 1999.
On October 18, 1999, CBO transmitted a cost estimate for H.R.
2260, as ordered reported by the House Committee on Commerce on
October 13, 1999. The three versions of the legislation are
similar and the cost estimates are nearly identical.
Estimate prepared by: Federal Costs: DOJ--Mark Grabowicz;
HRSA--Cynthia S. Dudzinski; AHRQ--Christopher J. Topoleski.
Impact on State, Local, and Tribal Governments; Shellby
Finlayson. Impact on the Private Sector: John Harris.
Estimate approved by: Peter H. Fontaine, Deputy Assistant
Director for Budget Analysis.

VIII. Regulatory Impact Statement

In compliance with paragraph 11(b)(1), rule XXVI of the
Standing Rules of the Senate, the Committee, after due
consideration, concludes that H.R. 2260 will not have
significant regulatory impact.

IX. MINORITY VIEWS OF SENATORS LEAHY, KENNEDY, KOHL, AND FEINSTEIN

contents

I. Introduction
II. Background
A. PRPA would override the Department of Justice's
well-reasoned position on the role of Federal drug
enforcement
B. The many modifications made to PRPA have only made
it worse
III. PRPA seriously violates basic principles of federalism
A. PRPA contradicts the views of all nine Supreme Court
justices
B. PRPA would eviscerate the States' well-established
power to regulate medical practices
C. PRPA would undermine and effectively nullify many
innovative State laws and programs that have nothing to
do with physician-assisted suicide
IV. Many in the medical community agree that PRPA would be
harmful
A. PRPA would discourage effective pain management and
palliative care
B. PRPA would not address the needs of terminally ill
Americans or those suffering from chronic pain
C. PRPA would replace State medical boards with Federal
drug enforcement agents as governors of pain management
practices
D. PRPA would interfere with the goals of hospice and
comfort care
V. The majority's other arguments are also incorrect
A. PRPA would do nothing to lessen the demand for
physician-assisted suicide
B. PRPA would further expand the DEA's authority over
the practice of medicine
C. PRPA is not necessary to ensure the uniform
application of the Controlled Substances Act
D. PRPA would have a chilling effect on the use of
morphine and other legal drugs to manage pain
VI. Conclusion

I. Introduction

We strongly oppose the Hatch substitute to H.R. 2260, the
Pain Relief Promotion Act of 2000 (PRPA).\1\ Although we--like
the majority--are troubled by physician-assisted suicide, we
see this legislation as unprecedented, unnecessary, and
harmful.
---------------------------------------------------------------------------
\1\ For convenience, we will refer to the Hatch substitute as PRPA.
---------------------------------------------------------------------------
It is unprecedented because it would effectively establish
the first preemptive Federal standard of care for the medical
profession in the United States--seriously undermining well-
established principles of federalism.
It is unnecessary because it would needlessly encroach on
State medical boards' traditional regulatory role in policing
doctors' actions, a role they have been performing well for
more than a century.
And it is harmful because it would have a chilling effect
on medical care givers, indirectly causing further suffering in
thousands of terminally ill patients and leading to an increase
in the number of suicides.
Over thirty established National and State-based medical
organizations share our concerns.\2\
---------------------------------------------------------------------------
\2\ These include:
American Academy of Family Physicians
American Academy of Hospice and Palliative Medicine
American Academy of Pharmaceutical Physicians
American Geriatrics Society
American Nurses Association
American Pain Foundation
American Pharmaceutical Association
American Society for Action on Pain
American Society of Health-System Pharmacists
American Society of Pain Management Nurses
College on Problems of Drug Dependence
Hospice and Palliative Nurses Association
National Foundation for the Treatment of Pain
Oncology Nursing Society
Society of General Internal Medicine
Triumph over Pain Foundation
California Medical Association
Massachusetts Medical Society
North Carolina Medical Society
Oregon Medical Association
Rhode Island Medical Association
San Francisco Medical Society
Indiana State Hospice and Palliative Care Association
Hospice Federation of Massachusetts
Kansas Association of Hospices
Maine Hospice Council
Maine Consortium of Palliative Care and Hospice
Missouri Hospice and Palliative Care Association
New Hampshire State Hospice Organization
New Jersey Hospice and Palliative Care Organization
New York State Hospice Organization
Oregon Hospice Association
Other organizations with concerns about PRPA include the Hospice of
the Carolinas, Americans for Better Care of the Dying, and the North
Carolina Board of Pharmacy.
---------------------------------------------------------------------------

II. Background

Most States have debated physician-assisted suicide and
decided to prohibit its practice. Thus far, one state--Oregon--
has passed a law permitting the practice. The issue continues
to arise and voters in at least one other State will go to the
polls in the upcoming elections to decide whether to legalize
physician-assisted suicide.
Following its long-standing tradition of public referenda,
Oregon has held two public referenda votes on the issue of
physician-assisted suicide. Oregon voters first passed the
Oregon Death With Dignity Act by public referendum on November
8, 1994, with 51 percent of the vote. The State legislature
then decided to return the law for an additional public
referendum in which voters were asked if they wanted to
maintain the law. On November 4, 1997, Oregon's voters voted to
keep the law by 60 percent of the vote.
The Death With Dignity Act provides for a comprehensive and
detailed procedure by which a mentally competent terminally ill
patient may request assistance to end his or her life ``in a
humane and dignified manner.'' \3\ Under the Oregon law, the
physician is required to provide extensive documentation,
including that the patient has made three separate requests for
assistance in ending his or her life. One of these requests
must be in writing and witnessed by two individuals who are not
family members. The process must also include documentation
that this is a voluntary request. A second opinion must confirm
that the patient is a capable adult with a terminal illness and
that the patient has less than six months to live. The patient
and physician must also enter into a discussion about
alternatives to physician-assisted suicide. Should the patient
decide that he wants to engage in physician-assisted suicide,
he must administer the lethal dose himself.
---------------------------------------------------------------------------
\3\ Or. Rev. Stat. 127.800 et seq.
---------------------------------------------------------------------------
In the first 2 years of its existence, 42 terminally ill
Oregonians took their lives under the State statute. Thirty of
the 42 had terminal cancer. During this period, a total of
about 60,000 Oregonians have died, about 14,000 from cancer.
Patients taking lethal drugs under the Oregon law account for
only a minute percentage of these deaths. Last year, patients
taking lethal medications under the law accounted for \9/100\
of one percent of deaths in Oregon and \39/100\ of one percent
of cancer deaths in Oregon; the previous year, it was \6/100\
of one percent of deaths and \20/100\ of one percent of cancer
deaths.\4\ A recent survey of Oregon physicians shows that many
patients who request physician-assisted suicide choose--after
appropriate medical, social, or spiritual intervention--not to
take their lives.\5\
---------------------------------------------------------------------------
\4\ A. D. Sullivan, et al., Legalized Physician-Assisted Suicide in
Oregon--The Second Year, New England Journal of Medicine, vol. 342, no.
8, at 598-604 (2000).
\5\ L. Ganzini, et al., Physicians' Experiences with the Oregon
Death With Dignity Act, New England Journal of Medicine, vol. 342, no.
8, at 557-563 (2000).
---------------------------------------------------------------------------

A. prpa would override the department of justice's well-reasoned
position on the role of federal drug enforcement

In July 1997, and again in October 1997, Senator Hatch and
Representative Hyde, writing on behalf of the Senate and House
Judiciary Committees respectively, asked then Drug Enforcement
Administration (DEA) Administrator Thomas Constantine whether
prescribing or dispensing a controlled substance with the
``deliberate intent of assisting a suicide'' would violate the
Controlled Substances Act (CSA).
In a letter dated November 5, 1997, Mr. Constantine
responded that ``delivering, dispensing or prescribing a
controlled substance with the intent of assisting a suicide
would not fall under any current definition of a `legitimate
medical purpose' '' and such activity would violate the CSA.
Thus, 1 day after the second successful Oregon assisted suicide
referendum, the DEA declared it had authority to prosecute
physicians in Oregon who prescribed drugs at the request of a
terminally ill patient in compliance with State law.
On June 5, 1998, Attorney General Reno issued a letter on
the Oregon referendum. In this letter, after a thorough review
of relevant authority, General Reno rejected the DEA's
position, concluding that a healthcare provider who assisted
with a suicide in full compliance with the Oregon referendum
did not violate the CSA. First, she determined that the CSA
``was intended to keep legally available controlled substances
within lawful channels of distribution and use'' by seeking
``to prevent both the trafficking in these substances for
unauthorized purposes and drug abuse.'' Then she found that
Congress did not intend the CSA to ``displace the States as the
primary regulators of the medical profession, or to override a
State's determination as to what constitutes legitimate medical
practice in the absence of a Federal law prohibiting that
practice. Indeed, the CSA is essentially silent with regard to
regulating the practice of medicine that involves legally
available drugs. * * *''
General Reno also noted that giving the DEA the mission of
determining whether a doctor who assists a suicide in
compliance with State law has gone beyond the legitimate
practice of medicine or acted against the public interest would
go far beyond the scope of the CSA because it would put the
agency in the position of resolving fundamental questions of
morality and public policy. Finally, she reiterated that the
President continues to oppose assisted suicide and Federal
support for it. Numerous National and State medical
organizations, including the American Medical Association,
concurred with the Attorney General's letter.\6\
---------------------------------------------------------------------------
\6\ See, e.g., ``Statement of the American Medical Association to
the Committee'' on Health, Education, Labor, and Pensions Committee,
U.S. Senate, Oct. 13, 1999 (``The AMA concurred with the Attorney
General's June 5, 1998 opinion that provided that neither the language
of the CSA nor its legislative history supported the Act's application
to physicians in compliance with state law.'').
---------------------------------------------------------------------------
If enacted, PRPA would override the Department of Justice's
position regarding the purpose of the CSA and the role of the
DEA. For the first time, a federal statute will empower an
agency--one established to go after drug abusers and
traffickers--to regulate and investigate doctors, pharmacists,
and other healthcare providers regarding their use of
controlled substances for the purposes of pain relief.

b. the many modifications made to prpa have only made it worse

PRPA has been through numerous incarnations. Each time,
supporters have restructured PRPA and added boilerplate
language about pain relief, palliative care, or federalism to
try to placate the bill's many critics. However, these frequent
alterations have not changed the substance of the bill and done
little but raise the suspicion that supporters want to conceal
their true intention: to overrule Oregon's physician-assisted
suicide law. Revealingly, for example, the majority views
dismiss pain relief promotion in 2\1/2\ pages and then spend
more than 26 pages arguing about assisted suicide.
Most recently, Senator Hatch has offered a substitute
amendment to PRPA. Unfortunately, changes offered by that
substitute are mostly symbolic. For example, the substitute
adds nonbinding findings about the importance of pain
management and palliative care, declares a Decade of Pain
Control and Research, and puts the provisions supposedly
promoting palliative care before--rather than after--the
provisions overruling Oregon law.
These modifications do nothing to improve the bill. Worse,
if they have any effect at all, it would be to hurt the 50
million Americans in chronic pain and the millions of
terminally ill Americans who all too often face excruciating
agony before they die. Former Harvard Law School Dean James
Vorenberg and other experts crisply summarize the majority's
changes as follows: ``Senator Hatch's substitute bill doubles
the size of the original H.R. 2260 by adding to it some hastily
put together jurisdictional and procedural provisions that
exacerbate the bill's potential for frightening physicians into
undertreating pain.'' \7\ These experts also note, ``[W]e have
concluded that the substitut[e] represents, if anything, a
greater threat than the original to the effort to improve
delivery of palliative care to patients who presently suffer
unrelieved pain.'' \8\
---------------------------------------------------------------------------
\7\ Letter from Harvard Law School Professor James Vorenberg,
Boston College Law School Professor Charles H. Baron, and former
Assistant Attorney General of the Massachusetts Board of Registration
in Medicine Garrick F. Cole to Senator Edward Kennedy, dated Apr. 10,
2000, at 1.
\8\ Id.
---------------------------------------------------------------------------
The first change offered by the Hatch substitute is some
superfluous language intended to camouflage the legislation's
attack on our system of federalism: ``Nothing in this
subsection shall be construed to alter the roles of the Federal
and State governments in regulating the practice of medicine.''
\9\
---------------------------------------------------------------------------
\9\ Sec. 201(a).
---------------------------------------------------------------------------
To suggest that this provision has any meaning is
laughable. The whole point of the subsection--and indeed of the
bill itself--is to overrule the people of Oregon's decision to
allow a limited form of physician-assisted suicide. Currently,
State governments may permit or forbid physician-assisted
suicide as they see fit; under the bill, the Federal Government
would usurp this decision from the States and effectively ban
almost all physician-assisted suicide. Hence, the bill is
intended to and would alter the roles of Federal and State
governments in regulating the practice of medicine.
In addition, the added language is merely a rule of
construction. Rules of construction exist so that, if any
ambiguity inheres in a statute, a court knows how to interpret
that ambiguity. But PRPA's effect on Oregon law is not
ambiguous. The Hatch substitute would clearly nullify Oregon's
physician-assisted suicide law and greatly interfere with
statutes passed by other States concerning pain management and
palliative care. Moreover, if this bill had been enacted
several years ago, when it was first proposed, every single
doctor or pharmacist in Oregon who subsequently assisted a
suicide would have faced the loss of his or her DEA
registration, a mandatory minimum 20-year jail term, and a
possible $1,000,000 plus fine.\10\ In fact, healthcare
providers who participated in several assisted suicides in
concert with other persons, could have even faced the death
penalty.\11\ The purpose of the Hatch substitute, of course, is
to give Oregon doctors the Hobson's choice of practicing
medicine in compliance with State law or facing draconian
federal sanctions. Hence, PRPA would not preserve the roles of
the Federal and State governments with regard to regulating the
practice of medicine; it would reverse them.
---------------------------------------------------------------------------
\10\ 21 U.S.C. 841.
\11\ 21 U.S.C. 848.
---------------------------------------------------------------------------
It makes a mockery of the legislative process to pass a
bill that clearly preempts State law and then contains a
sentence suggesting that, if a court finds any ambiguity, the
statute should be construed as not preempting State law. It is
equally misleading to add a clause--as PRPA also does--
providing that the bill's physician-assisted suicide ban
``applies only to conduct occurring after the date of enactment
of this subsection'' and then claim that this provision would
protect healthcare providers who have participated lawfully
under Oregon's law. First, the Constitution's Ex Post Facto
Clause would already shield these healthcare providers from
criminal punishment.\12\ Second, regardless of PRPA,
investigators can easily examine documents in Oregon naming
physicians, family members, and others who may have provided
advice for a physician-assisted suicide and use the information
they glean to target those individuals for future scrutiny.
---------------------------------------------------------------------------
\12\ See, e.g., Collins v. Youngblood, 487 U.S. 37, 41-43 (1990).
---------------------------------------------------------------------------
Other language added by the Hatch substitute is similarly
meaningless. For example, the Hatch substitute adds the
following:

Regardless of whether the Attorney General determines
pursuant to this section that the registration of a
practitioner is inconsistent with the public interest,
it remains solely within the discretion of State
authorities to determine whether action should be taken
with respect to State professional license of the
practitioner or State prescribing privileges.\13\
---------------------------------------------------------------------------
\13\ Sec. 201(a).

This language is irrelevant because if the DEA revokes a
doctor's registration, the doctor's career is effectively over,
regardless of what the State may or may not do (and of course,
given PRPA, State authorities are likely to follow the
DEA).\14\ Moreover, even if the DEA decides not to revoke the
doctor's registration, the agency's investigation might
irreparably damage his or her career. And, regardless of what
the DEA does, the state medical board could still sanction him
or her, since under PRPA ``it remains solely within the
discretion of State authorities'' to regulate the state's
doctors.\15\
---------------------------------------------------------------------------
\14\ In every State, a doctor must hold a ``current DEA
registration'' to be able to prescribe controlled substances. If the
Federal Government finds a doctor in violation of PRPA, the doctor will
almost certainly lose his or her DEA registration, which will in turn
eliminate his or her right under State law to prescribe a controlled
substance. Loss of DEA registration makes it difficult--if not
impossible--for a doctor to practice medicine, regardless of whether
the State revokes the doctor's license to practice or takes other
action against the doctor. See, e.g., Sokoloff v. Saxbe, 501 F.2d 571
(2d Cir. 1974) (finding that revoking doctor's DEA registration
seriously affects doctor's capacity to practice medicine).
\15\ Sec. 201(a). Under the quoted PRPA language, a physician or
pharmacist could go to jail for violating the CSA but still not lose
his or her State medical or pharmacy license.
---------------------------------------------------------------------------
The Hatch substitute also adds that nothing in PRPA shall
be construed ``to provide the Attorney General with the
authority to issue national standards for pain management and
palliative care clinical practice, research, or quality.'' \16\
However, PRPA itself imposes such a national standard--or
rather substandard--so this second rule of construction is also
irrelevant. In short, the bill would give the DEA a statutory
license to second-guess every doctor's administration of pain
medication or palliative care to determine if the doctor is
acting with a ``legitimate medical purpose.''
---------------------------------------------------------------------------
\16\ Sec. 201(a).
---------------------------------------------------------------------------
Moreover, what PRPA appears to take away from the Attorney
General it returns with the following clause: ``except that the
Attorney General may take such other actions as may be
necessary to enforce this Act.'' \17\ This open-ended language
not only contradicts the second rule of construction but also
appears to confer broad authority on the Attorney General to
regulate the practice of medicine within a State's borders.
Finally, the standard of medical care developed through law
enforcement training programs the Hatch substitute also
authorizes would become the de facto standard.\18\ Law
enforcement--not doctors, pharmacists, or nurses--would
determine what is proper medical care.
---------------------------------------------------------------------------
\17\ Id.
\18\ Sec. 202.
---------------------------------------------------------------------------
The Hatch substitute then states:

For the purposes of 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.\19\
---------------------------------------------------------------------------
\19\ Sec. 201(a).

This ``double effect'' \20\ language adds nothing to the
bill; alleviating pain or discomfort in this way is ``a
prerogative doctors have always had.'' \21\ Not only does it
confer no enforceable rights on doctors but it already exists
as an ``administrative guideline.'' \22\ As Dr. Eric Chevlen,
one the supporters of PRPA, conceded, ``[E]very day of my
practice since I left medical school, I have been practicing
under that law because that has been the law since the CSA was
established. * * *'' \23\
---------------------------------------------------------------------------
\20\ Rooted in 13th century Catholic theological teachings, the
doctrine of ``double effect'' holds that an effect that would be
morally wrong if it were caused intentionally is permissible if it was
unintended--even if it was foreseeable. This principle has guided
physicians for centuries: doctors are free to prescribe powerful drugs
to relieve pain, even if these drugs run the risk of hastening the
patient's death.
\21\ Care for the Dying Congressional Mischief, New England Journal
of Medicine, vol. 341, no. 25, at 1923-24.
\22\ Testimony of Eric Chevlen before the Senate Committee on the
Judiciary, July 31, 1998, at 79, line 6-17.
\23\ Id. at 79, lines 14-16.
---------------------------------------------------------------------------
Finally, supporters of the Hatch substitute trumpet the
fact that they now require the Attorney General to prove by
``clear and convincing'' evidence that a doctor intended to
assist a suicide rather than by a mere ``preponderance'' of
evidence.\24\ They suggest that this would reduce the chilling
effect PRPA would have on healthcare providers. However, the
Supreme Court has suggested that the difference between
``preponderance'' and ``clear and convincing'' is unclear and
that how these two standards of proof affect decisionmaking may
well be ``unknowable.'' \25\ Moreover, Dean Vorenberg and other
experts point out that:
---------------------------------------------------------------------------
\24\ 24 Sect. 201(b).
\25\ Addington v. Texas, 441 U.S. 418, 424-25 (1979).

Whatever difference the higher level of proof might
make in other circumstances, it is likely to make very
little difference in this context. When we are speaking
of physicians' intentions, we are dealing with an
internal mental event that will not, in the ordinary
case, be amenable to any sort of objective proof.
Although, in the end, the Attorney General may have no
easier time proving what went on in a physician's mind
than a physician would have disproving it, the fact
that H.R. 2260 makes every physician vulnerable to
investigation and prosecution whenever he prescribes
controlled substances to a dying patient will
undoubtedly have a chilling effect on his willingness
to effectively treat pain.\26\
---------------------------------------------------------------------------
\26\ Letter from Harvard Law School Prof. James Vorenberg, Boston
College Law School Prof. Charles H. Baron, and former Assistant
Attorney General of the Massachusetts Board of Registration in Medicine
Garrick F. Cole to Senator Edward Kennedy, dated Apr. 10, 2000, at 2.

This chilling effect would possibly result in tens of thousands
of patients dying without adequate pain or palliative care, and
even subject doctors to civil liability for undertreating
patients.

III. PRPA Seriously Violates Basic Principles of Federalism

PRPA seriously violates the basic tenets of federalism.
Medical practice has always been regulated by the States under
their traditional police powers. This bill attempts to upset
the time-tested and constitutionally enshrined division of
power between the Federal Government and the States in order to
target a single law in a single State.
Currently, physician-assisted suicide is illegal in 45
States (36 by statute; nine under common law).\27\ In one
State, Oregon, the citizens have twice approved by referendum
physician-assisted suicide under very limited and highly
regulated circumstances.\28\ Moreover, at least 20 States have
established commissions or task forces to examine end-of-life
care issues, including physician-assisted suicide.\29\ And
voters in at least one State will be voting soon on whether to
legalize physician-assisted suicide. Clearly, the States have
made--and are continuing to make--a concerted effort to address
the issue of physician-assisted suicide intelligently and
thoroughly. PRPA would not enhance the regulation of physician-
assisted suicide. On the contrary, it is extremely harmful to
the States' ongoing efforts in this area.
---------------------------------------------------------------------------
\27\ D. Merrit, et al. of the National Conference of State
Legislatures, and J. Lynn, et al. of the Center to Improve the Care of
the Dying, The George Washington University, State Initiatives in End-
of-Life Care: Policy Guide for State Legislators, National Conference
of State Legislatures, at 40 (1998) (the ``End-of Life Care: Policy
Guide''). The four States which do not have a criminal statute or
common law banning physician-assisted suicide are North Carolina, Ohio,
Utah and Wyoming.
\28\ Or. Rev. Stat. Sec. Sec. 127.800-127.995.
\29\ End-of-Life Care: Policy Guide, at 3.
---------------------------------------------------------------------------
In fact, PRPA's attempt to usurp the rights of Oregon's
citizens to deal with the issue of physician-assisted suicide
is entirely indefensible. When asked about PRPA, one Oregon
resident--who twice voted against legalizing physician-assisted
suicide--said:

Why are they doing this? The people in Oregon had a
vote. I may not agree with it, but is Congress really
saying that our vote doesn't count, it doesn't matter?
That's just wrong.\30\
---------------------------------------------------------------------------
\30\ Sam Howe Verhovek, ``Oregon Chafes at Measure to Stop Assisted
Suicide,'' The New York Times, Oct. 29, 1999, at A1.

Moreover, it is certainly ironic that the Republican
Senators in the majority, who often promote themselves as
members of the party of States' rights, would choose to
overrule a law just because they are uncomfortable with it.
Indeed, President Reagan's Solicitor General, Charles Fried,
has pointed out that ``[i]f principles of federalism--to which
I'd bet many of those voting for this bill fervently swear
allegiance--mean anything, this issue is none of Congress'
business.'' \31\
---------------------------------------------------------------------------
\31\ Charles Fried, ``Leave the Personal to the States,'' The New
York Times, Oct. 29, 1999, at A35.
---------------------------------------------------------------------------
Although the majority argues that PRPA is designed to mend
a ``50-state, crazy quilt approach to the regulation of
controlled substances,'' \32\ it is readily apparent that PRPA
was drafted and is being moved forward not in an effort to deal
with controlled substances, but rather in a direct attempt to
limit starkly the scope of the Oregon referendum and physician-
assisted suicide in that State. The ``problem'' that this bill
aims to solve is simply that the voters of Oregon have decided
to permit physician-assisted suicide in their State. Indeed,
Thomas Marzen, general counsel for the National Legal Center
for the Medically Dependent and Disabled and an originator of
PRPA, has admitted that ``paralyzing Oregon's law has always
been the goal.'' \33\ Marzen also stated that the strategy
behind PRPA works--because doctors are very reluctant to go up
against the DEA and the Controlled Substances Act''--that is,
PRPA is effective because it intimidates doctors and chills
their discretion in treating patients.\34\
---------------------------------------------------------------------------
\32\ Majority Views at ____.
\33\ The Oregonian, Sept. 8, 1999, at A8.
\34\ Id.
---------------------------------------------------------------------------

a. prpa contradicts the views of all nine supreme court justices

The majority cites two 1997 Supreme Court cases on assisted
suicide--Washington v. Glucksberg \35\ and Vacco v. Quill
\36\--as support.\37\ Unfortunately for the majority though,
the justices unanimously ruled in these cases that the States,
not the Federal Government, should determine how best to
address the issue of physician-assisted suicide.\38\
---------------------------------------------------------------------------
\35\ 521 U.S. 702 (1997).
\36\ 521 U.S. 793 (1997).
\37\ The majority also points to the enactment of the ``Assisted
Suicide Prevention Act,'' P.L. 105-12, which outlawed the use of
Federal funds for the practice of physician-assisted suicide. But the
existence of a Federal statute forbidding Federal money to be used for
physician-assisted suicide says nothing about whether the Federal
Government can or should forbid States from permitting (let alone
funding) this practice.
\38\ The Supreme Court's denial of certiorari in a case that
challenged the Oregon referendum--Lee v. Oregon, 107 F.3d 1382 (9th
Cir.), cert. denied, 522 U.S. 927 (1997)--further demonstrates the
Court's belief that the issue of assisted suicide is best left to the
States.
---------------------------------------------------------------------------
In Glucksberg, for example, the Supreme Court refused to
strike down a State assisted-suicide ban under Federal
constitutional due process principles, concluding that ``the
States are currently engaged in serious, thoughtful
examinations of physician-assisted suicide and other similar
issues. * * * Throughout the Nation, Americans are engaged in
an earnest and profound debate about the morality, legality,
and practicality of physician-assisted suicide. Our holding
permits this debate to continue as it should in a democratic
society.\39\
---------------------------------------------------------------------------
\39\ Glucksberg, 521 U.S. at 719, 735.
---------------------------------------------------------------------------
Other justices concurred in this point. Justice Souter
noted that ``facts necessary to resolve the controversy * * *
are more readily subject to discovery through legislative
factfinding and experimentation. It is assumed in this case,
and must be, that a * * * State [may] bar aid to any but a
knowing and responsible person intending suicide. How, and how
far, a State should act in that interest are judgments for the
State.* * * \40\ He further stated that there is good reason to
suppose that there will be additional ``experimentation'' by
the States in this area and such experimentation is ``highly
desirable.'' \41\ Justices O'Connor, Ginsburg, and Breyer
stated, ``As the Court recognizes, States are presently
undertaking extensive and serious evaluation of physician-
assisted suicide and other related issues. In such
circumstances, the challenging task of crafting appropriate
procedures for safeguarding * * * liberty interests is
entrusted to the laboratory of the States.''\42\ Justice
Stevens noted that ``[t]he Court ends its opinion with the
important observation that our holding today is fully
consistent with a continuation of the vigorous debate about the
morality, legality, and practicality of physician-assisted
suicide.''\43\
---------------------------------------------------------------------------
\40\ Id. at 787.
\41\ Id. at 788-89.
\42\ Id. at 737 (citations and internal quotation marks omitted).
\43\ Id.
---------------------------------------------------------------------------
Indeed, this was exactly the result called for in an amici
curiae brief filed by a large number of States. This brief,
written by then Alabama Attorney General Jeff Sessions and
other attorneys general, argued that

[s]tatutes in a majority of States * * * recognize
an individual's right to refuse unwanted medical
treatment and, at the same time, reject any affirmative
act to end life. Whether that balance should be
abandoned and the line redrawn to permit an individual
to commit suicide without state interference, and then
redrawn yet again to permit assisted suicide, is a
matter appropriately left for the people to decide,
through their duly elected representatives or by
initiative ballot. The principles of federalism
embodied in our Constitution require no less.\44\
---------------------------------------------------------------------------
\44\ Brief Amici Curiae of the States of California, et al.,
Washington v. Glucksberg, Nov. 8, 1996.

PRPA would stop in its tracks the very experimentation the
Supreme Court found so important. Not only would referenda and
state legislatures be shut down on this issue but State courts
as well. For example, in the absence of a Federal law to the
contrary, State supreme courts would normally be free to
disregard Glucksberg and recognize a State constitutional right
to assisted suicide. Indeed, several State supreme courts had
found in their State constitutions a right to die without
unwanted medical intervention more than a decade before the
U.S. Supreme Court followed suit with regard to the Federal
Constitution.\45\ However, if PRPA passes, no State supreme
court in the country could meaningfully recognize such a right.
Under PRPA, the DEA--not to mention Federal, State, and local
prosecutors--would be free to ignore such a State
constitutional interpretation.
---------------------------------------------------------------------------
\45\ See, e.g., Cruzan v. Director, MDH, 497 U.S. 261 (1990); In re
Quinlan, 348 A.2d 801 (N.J 1975); Superintendent of Belchertown State
School v. Saikewicz, 370 N.E.2d 417 (Mass. 1977).
---------------------------------------------------------------------------
PRPA would not only choke off States' ``serious, thoughtful
examinations'' about physician-assisted suicide,\46\ it would
also discourage the administration of strong medicine to
terminally ill patients. Thus, ironically enough, PRPA would
perhaps invite the Supreme Court to find a constitutional right
to physician-assisted suicide. Indeed, a number of justices
left open the possibility of finding a right to assisted
suicide under such circumstances. Justice Breyer noted, for
instance, that if there were a law preventing the
administration of drugs as needed to avoid pain at the end of
life, then--as Justice O'Connor suggests, the Court might have
to revisit its conclusions in these cases.'' \47\ And Justice
Souter stated that ``While I do not decide for all time that
respondents' claim should not be recognized, I acknowledge the
legislative institutional competence as the better one to deal
with that claim at this time.'' \48\ PRPA could lead to its
sponsors' worst nightmare: a right to physician-assisted
suicide that they could topple only by amending the
Constitution.
---------------------------------------------------------------------------
\46\ Glucksberg, 521 U.S. at 719.
\47\ Id. at 792.
\48\ Id. at 789.
---------------------------------------------------------------------------
In addition, the Supreme Court's assisted suicide opinions
have made clear that barriers to the availability of proper
palliative care must be eliminated.\49\ In fact, the Court has,
---------------------------------------------------------------------------
\49\ R. A. Burt, ``The Supreme Court Speaks--Not Assisted Suicide
but a Constitutional Right to Palliative Care'', New England Journal of
Medicine, vol. 337, at 1234-1236 (1997).

conclude[d] that the double-effect doctrine provides a
rational and constitutional basis for States to allow
narcotics given in high dosages for pain relief in
terminally ill patients, while prohibiting assisted
suicide. Thus the majority opinion delineates an
acceptable justification for aggressive palliative care
* * * The concurring justices go further suggesting
that the State is obligated to permit physicians to
provide adequate pain relief at the end of life, even
if such care leads to unconsciousness or hastens
death.\50\
---------------------------------------------------------------------------
\50\ A. Lapers and B. Lo, ``The Supreme Court Addresses Physician-
Assisted Suicide: Can its Rulings Improve Palliative Care?'', Archives
of Family Medicine, vol. 8, at 200-205 (1999).

The Supreme Court has also given its imprimatur to the use
of sedatives and analgesics when life-sustaining treatment is
being withheld or withdrawn as well as to the practice of
terminal sedation.\51\
---------------------------------------------------------------------------
\51\ Thus, it is troubling that the majority loosely throws around
the word ``euthanasia'' defined in a way that includes these approved
end-of-life medical practices. See Majority Views, at n. 45. This is
certainly not the Supreme Court's definition of the term nor ours.
The majority also makes the timeworn argument that supporters of
Oregon's physician-assisted suicide law really want to legalize
euthanasia, and quote some of Derek Humphry's 1998 book ``Freedom to
Die'' as ``proof.'' However, Humphry advocates a kind of assisted
suicide illegal in Oregon, not physician-assisted suicide as practiced
in the State. See D. Humphry and M. Clement, ``Freedom to Die,'' at
313-34 (1998). Moreover, there is no evidence that Oregon voters share
Humphry's support of euthanasia.
---------------------------------------------------------------------------
Therefore, for all the above reasons, PRPA contradicts the
Supreme Court's rulings in this area and flies in the face of
settled jurisprudence.

b. prpa would eviscerate the states' well-established power to regulate
medical practices

The majority claims that PRPA would not usurp the police
power of the States to regulate medical practices, and that it
is not designed to negate Oregon's Death With Dignity Act. It
is clear, however, that these are precisely the two things the
bill would accomplish. In fact, this poorly written, poorly
thought-out statute would wreak havoc on States' traditional
police authority to regulate their own doctors--an authority
they have enjoyed for more than 200 years. And for what? To
tell the voters of Oregon that they cannot pass a law that has
resulted in a couple of dozen assisted suicides each year by
terminally ill patients.
First, although the DEA has the authority to regulate how
doctors and pharmacists use and dispense controlled substances,
this regulatory power does not appear to include the ability to
directly investigate doctors and pharmacists who have allegedly
engaged in physician-assisted suicide. In the Attorney
General's June 5, 1998 letter, the Department of Justice
clearly limited its views to the situation in Oregon. By
indicating that the DEA could not investigate doctors in
Oregon, where physician-assisted suicide is permissible under
certain limited circumstances, we do not believe the Department
meant to imply that the DEA could investigate in other States.
In our opinion, this letter did not resolve this issue. The
States have traditionally regulated medical practice and all 50
States have their own medical review boards, which are the
proper forum to investigate such matters.
This bill would add an unnecessary new layer of review of
medical and pharmacy practice regarding pain management by
providing the DEA with the power to investigate doctors and
pharmacists independent from any criminal or medical board
proceedings. In our view, the DEA is not qualified to handle
investigations into allegation of the misuse of pain management
drugs. When asked during a Committee hearing whether the DEA
can discern between an appropriate dosage of drugs and one
intended to kill, then DEA Administrator Constantine testified
that:

[T]hose types of evidentiary bases that you would have
to use would have to come from somebody in the medical
community. * * * So you really would need an expert
medical opinion to be able to say that the
administration of that level and amount of drugs to
that individual caused the death.\52\
---------------------------------------------------------------------------
\52\ Testimony of Thomas Constantine before the Senate Committee on
the Judiciary, July 31, 1998, at 55, lines 5-13.

And DEA Acting Administrator Donnie Marshall recently
reiterated that the agency lacks the ``expertise'' to determine
whether physicians are appropriately prescribing pain
medications.\53\ As then Principal Deputy Associate Attorney
General Joseph N. Onek testified, PRPA ``will embroil the DEA
in decisions about the use of pain medication for terminally
ill patients which it is poorly equipped to make.'' \54\
---------------------------------------------------------------------------
\53\ Letter from Donnie R. Marshall to Senator Orrin G. Hatch,
dated Apr. 5, 2000.
\54\ Testimony of Joseph Onek before the Senate Committee on the
Judiciary, July 31, 1998 at 28, lines 14-19.

In addition, PRPA changes the fundamental balance that was
struck in the Controlled Substances Act to create separate
Federal and State domains with regard to controlled substances.
The CSA is a law enforcement statute aimed at preventing drug
abuse, diversion, and trafficking; that is why it is
administered by the Attorney General--the Nation's chief law
enforcement officer. However, as David Joranson, director of
the University of Wisconsin Pain and Policy Studies Group and
leading expert on the CSA, has testified, Congress certainly
did not draft CSA with the intention of giving the Attorney
General plenary authority over every aspect of Federal drug law
enforcement. Specifically, Congress recognized that the
Attorney General would have no real role in three areas: ``(1)
the medical and scientific decisions necessary to administer
the CSA, (2) * * * the medical uses of drugs, and (3) * *
* the role of State laws, especially those regulating medical
practice.'' \55\ Yet PRPA licenses the Attorney General to
invade all three of these areas, all domains that the CSA
carefully reserved to the States.
---------------------------------------------------------------------------
\55\ Testimony of David E. Joranson before Senate Committee on
Health, Education, Labor, and Pensions, October 13, 1999, at 2-3.
---------------------------------------------------------------------------
PRPA is unquestionably at war with the clear legislative
intent behind the CSA. For example, in discussing the
requirement of registration for doctors, pharmacies, and
hospitals, the House Committee that crafted the CSA reported
that those ``engaged in the distribution chain would be
required to be registered, but registration would be as a
matter of right where the individual or firm is engaged in
activities involving these drugs that are permitted by State
law.'' \56\ And, in spite of the majority's suggestion
otherwise, the 1984 amendment by which Congress added a
requirement that the Attorney General determine that
registration was ``in the public interest'' is not to the
contrary.\57\ This change was made simply to prevent ``improper
diversion'' of controlled substances to people for whom they
were not prescribed--such diversion risked fueling ``drug
abuse.'' \58\
---------------------------------------------------------------------------
\56\ H.R. 91-1444 (Sept. 10, 1970) (emphasis added).
\57\ See 21 U.S.C. 823, 824.
\58\ H.R. 98-0030, at 266-67 (Sept. 17, 1984); Humphreys v. DEA, 96
F.3d 658, 661 (3d Cir. 1996).
---------------------------------------------------------------------------
The American public overwhelmingly agrees that the States
should regulate assisted suicide. The results of a national
opinion survey released in July 1998 show that:
72 percent of the respondents oppose Federal
legislation prohibiting doctors from prescribing medication
that a terminally ill patient could take to end his or her own
life.\59\
---------------------------------------------------------------------------
\59\ Id.
---------------------------------------------------------------------------
76 percent of the respondents agree that ``[i]t
is not appropriate for Congress to get involved in regulating
legal drugs prescribed by doctors to their patients.'' \60\
---------------------------------------------------------------------------
\60\ GLS Research, National Voter Research Findings, ``Attitudes
Regarding the Terminally Ill'' (July 1998).
---------------------------------------------------------------------------
Despite the majority's statements to the contrary, PRPA was
obviously drafted to override Oregon's Death With Dignity Act.
It is hardly a coincidence that until Oregon decided to permit
physician-assisted suicide, Congress never considered any
action to ``clarify'' the CSA's stance on the use of controlled
substances for assisted suicide, even though physician-assisted
suicides were occurring illegally around the country. Worse,
PRPA nullifies the States' long-established authority to
regulate medical practices within their own borders.

c. prpa would undermine and effectively nullify many innovative state
laws and programs that have nothing to do with physician-assisted
suicide

What is particularly unfortunate about PRPA is that it not
only usurps the States' traditional role in managing medical
practices, but that it would undermine and even nullify
innovative State efforts to deal with medical issues such as
physician-assisted suicide and pain management. PRPA would run
roughshod over countless licensure acts, pain statutes, and
other medical and pharmacy laws and regulations, muting and
distorting their effect.
A number of States, for example, have passed laws directing
doctors to alleviate their patients' pain. In 1988, Virginia
passed the first state law addressing the need to treat pain in
terminally ill cancer patients. Several States--starting with
Texas in 1989, California in 1990, and Florida in 1994--have
passed intractable pain treatment acts. Other States, starting
again with California in 1997, have passed pain patients' bills
of rights. PRPA would undercut these laws by threatening every
healthcare provider aggressively treating pain with draconian
penalties, including loss of DEA registration and/or a minimum
20 years in jail. This would lead to more patient pain and
suffering.
PRPA would preempt other kinds of State laws as well. A
number of States have passed innovative, sometimes unique laws
to deal with the crisis of poor palliative care and pain
management.\61\ PRPA would render these laws irrelevant.
---------------------------------------------------------------------------
\61\ Just in the past few years, for example, California has
enacted a host of creative statutes intended to improve the lives of
the sick and dying. These include laws that:
Add pain management and end-of-life care to the continuing
education curricula of doctors, surgeons, and nurses;
Eliminate the need for a triplicate prescription for
Schedule II drugs for terminal patients;
Institute an electronic monitoring system pilot program at
the Board of Pharmacy;
Establish an expedited system for HMO approval for pain
medication for terminally ill patients;
Revise California Medical Board disciplinary processes for
doctors who treat their patients' pain;
Require that all health care facilities assess pain as a
fifth vital sign and require that the information be charted; and
Mandate that medical school curricula include coursework
in end-of-life care and pain management.
---------------------------------------------------------------------------
Congress should pass legislation to reinforce and enhance
State efforts to deal with the public health crisis of poor
management, not bills undercutting and nullifying such efforts.

IV. Many in the Medical Community Agree That PRPA Would Be Harmful

This bill will result in a step backwards in the treatment
of pain; physicians will be hesitant to prescribe and
pharmacists will be hesitant to dispense sufficient doses of
controlled substances due to a fear of unwarranted
investigations, possible revocations of their Federal
registrations, aggressive criminal prosecutions, and even long
jail terms. As the New England Journal of Medicine--probably
the world's preeminent medical publication--has stated in an
editorial against PRPA:

The bill's effect would be felt more by terminally ill
patients who do not wish physician-assisted suicide
than by those who do, since there are so many more of
them. Many terminally ill patients require extremely
high doses of controlled substances for adequate relief
of symptoms. Doctors, faced with the possibility of
long prison sentences if their intentions are misread,
may be reluctant to prescribe or administer such doses.
Treatment of pain in the terminally ill is already
notoriously inadequate, largely because our society's
preoccupation with drug abuse seeps into the medical
arena. Many doctors are concerned about the scrutiny
they invite when they prescribe or administer
controlled substances, and they are hypersensitive to
`drug-seeking behavior' in patients. Patients, as well
as doctors, often have exaggerated fears of addiction
and the side effects of narcotics. Congress would make
this bad situation worse.\62\
---------------------------------------------------------------------------
\62\ ``Care for the Dying--Congressional Mischief,'' New England
Journal of Medicine, vol. 341, no. 25, at 1923-24.

In short, PRPA would make physicians and pharmacists far less
likely to prescribe and dispense the most effective pain
management drugs, thus needlessly causing patients to suffer
from otherwise treatable pain and encouraging them to consider
suicide as a way to end their torment.

A. PRPA would discourage effective pain management and palliative care

Unrelieved pain is a public health crisis in the United
States. Fifty percent of patients experience moderate to severe
pain at least half the time in their last days of life.\63\
Opioids are the major class of analgesics used in the
management of moderate to severe pain because of their
effectiveness, the ease of establishing an appropriate dose,
and favorable risk to benefit ratio.\64\ Opioids, however, are
also classified as a controlled substance under the CSA.
---------------------------------------------------------------------------
\63\ ``The Study to Understand Prognoses and Preferences for
Outcomes and Risks of Treatment,'' The Journal of the American Medical
Association, Vol. 274, at 1591-98 (1995).
\64\ The Cancer Pain Management Panel. Clinical Management of
Cancer Pain. Practice Guideline No. 9 Agency for Health Care Policy and
Research, U.S. Department of Health and Human Services, at 49-60
(1994).
---------------------------------------------------------------------------
The DEA, therefore, would be newly empowered to interfere
in the physician-patient and/or pharmacist-patient relationship
to determine why the physician or pharmacist is prescribing or
dispensing (or perhaps overprescribing or overdispensing) this
medication. And prosecutors would be newly authorized to follow
up on these investigations and bring charges against any
healthcare provider who prescribes or dispenses a controlled
substance to a patient who later dies. In fact, if PRPA passes,
prosecutors could pursue charges against healthcare providers
in Oregon and other States even if those providers only attempt
to assist a patient's suicide.\65\ This could easily happen
where, for instance, a doctor prescribes a lethal medication
and the terminally ill person subsequently opts not to commit
assisted suicide.
---------------------------------------------------------------------------
\65\ See, e.g., 21 U.S.C. 846.
---------------------------------------------------------------------------
Worse, because the Controlled Substances Act was written as
a law to prevent drug abuse, diversion, and trafficking, it
contains broad language regarding those who might be considered
a conspirator or aider and a better of a drug-related
crime.\66\ By lumping health care providers who aggressively
treat pain together with drug abusers and drug traffickers,
PRPA throws a wide regulatory net over the medical community.
Federal law enforcement officers could not only investigate and
charge physicians and pharmacists but also nurses, orderlies,
hospital directors, medical board members, and others. Only a
test case would really be able to define the scope of this
extraordinarily broad statute.
---------------------------------------------------------------------------
\66\ Id.
---------------------------------------------------------------------------
Therefore, PRPA would inevitably lead to physicians and
pharmacists not prescribing or dispensing or perhaps
underprescribing opioids in an effort to escape unnecessary
bureaucracy and potentially harmful investigations.\67\
---------------------------------------------------------------------------
\67\ Experts have pointed out that the CSA itself contains
impediments to effective pain management. A New York State Commission
of Health report, for example, details a number of these obstacles and
makes numerous recommendations about how to remove them. These
recommendations include definitional changes, the partial filing of
Schedule II prescriptions, and broadening the existing law under which
controlled substances may lawfully be prescribed and dispensed to
habitual users but still be used to treat nonmalignant acute and
chronic pain.
If the majority had truly wanted to improve pain management, it
could have implemented some of these recommendations. However, other
than putting into statute what DEA regulations already provide
concerning the use of controlled substances for pain, this legislation
does nothing to address any concerns raised about the CSA's effect on
pain treatment.
---------------------------------------------------------------------------
Some of the most distinguished doctors, pharmacists,
ethicists, and scientists in the country have testified before
Congress about this problem, including Kathleen M. Foley,
Attending Neurologist in the Pain and Palliative Care Service
at Memorial Sloan-Kettering Cancer Center and Professor of
Neurology at Cornell University; Arthur L. Caplan, Ph.D.,
Director of the Center for Bioethics and Trustee Professor at
the University of Pennsylvania; Scott Fishman, M.D., Chief of
the Division of Pain Medicine at the University of California
at Davis and author of ``The War on Pain;'' Joseph J. Fins,
M.D., F.A.C.P., Associate Professor of Medicine at Cornell
University; David Orentlicher, M.D., J.D., Professor of Law and
Co-Director of the Center for Law and Health at the Indiana
University School of Law-Indianapolis; David E. Joranson,
Senior Scientist and Director of the Pain and Policy Studies
Group at the University of Wisconsin Comprehensive Cancer
Center at Madison; and Calvin H. Knowlton, R.Ph., M.Div.,
Ph.D., Past President of the American Pharmaceutical
Association. Numerous others wrote in to express similar views.
As Dr. Fins put it, for example, PRPA would ``have the dire
de facto effect of criminalizing the use of opioids at the end
of life. This would be a tragedy for dying patients and their
families who would have to watch them suffer. As a physician,
it seems inappropriate to me that medical practice should be
dictated by the fear of a regulatory agency and not by
professional and scientific norms.'' \68\ Dr. Caplan testified
similarly:
---------------------------------------------------------------------------
\68\ Testimony of Joseph J. Fins, M.D., F.A.C.P. before the Senate
Committee on Health, Education, Labor, and Pensions, Oct. 13, 1999.

It is well known from many previous studies that
physicians cite legal concerns as one of the main
reasons for their unwillingness to use narcotics and
other agents to control pain aggressively. * * * I
believe that this legislation will scare many doctors
and nurses and administrators into inaction in the face
of pain. * * * Studies consistently indicate that
physicians are unduly influenced by regulatory
considerations in their use of opioids and other drugs.
* * * If the goal of the PRPA is to encourage pain
control it is hard to see how the introduction of more
liability and greater prosecutorial authority will
achieve this end.\69\
---------------------------------------------------------------------------
\69\ Testimony of Arthur L. Caplan, Ph.D., before the Senate
Committee on Judiciary, Apr. 25, 2000, at 3-5.

---------------------------------------------------------------------------
Dr. Fishman echoed these views:

The possibility of having one's actions misinterpreted
with extremely harsh consequences will almost certainly
make most physicians think twice before ordering a
strong narcotic pain reliever, and many will
unfortunately opt to ignore the patients' pain. * * *
It is ironic that the ``Hatch substitute,'' which seeks
to prevent physician-assisted suicide, will ultimately
impair one of the truly effective counters to
physician-assisted suicide, which is swift and
effective pain medicine. Thus, the ``Hatch substitute''
will neither bring about what it seeks to accomplish,
nor prevent what it seeks to block.\70\
---------------------------------------------------------------------------
\70\ Written Testimony of Scott Fishman, M.D., before the Senate
Committee on Judiciary, Apr. 20, 2000, at 1-2.

Patients weighed in, too. Kimberly A. Kynsi, for example,
wrote to make sure that Congress knew how much she would suffer
---------------------------------------------------------------------------
if PRPA passes. As she explained:

I am a chronic pain sufferer. I have lived with this
pain my whole life, (I am 45 years old), and it will be
with me until I die. I finally received help in dealing
with this pain 4\1/2\ years ago. I now have an almost
normal life. I can enjoy my family and get out of the
house to enjoy the world. Before I got help with
opiates I was ready to give up on life. I was screaming
and crying nearly 24 hours a day.
My concern with H.R. 2260 is that someone other than
my doctor will dictate how much opiates I can receive.
As it is, I now take more than twice what is
``standard'' for my body weight. It took me 40 years to
find out what it felt like not to be in pain. This bill
will frighten doctors away from prescribing the
necessary medications for people like me, chronic pain
sufferers. I have a difficult enough time getting
refills when my doctor is on vacation. This bill will
make it impossible.\71\
---------------------------------------------------------------------------
\71\ Letter from Kimberly A. Kynsi to Senator Dianne Feinstein,
dated Apr. 6, 2000.

Besides this evidence, there are numerous reports and
studies concluding that overly bureaucratic regulation of pain
management drugs discourages effective palliative care. The
Institute of Medicine (IOM), for example, recently published an
exhaustive report pointing out that ``[n]umerous studies
indicate that dying patients and patients with advanced
illnesses experience considerable amounts of pain and other
physical and psychological symptoms.''\72\ Many studies also
demonstrate that one of the primary barriers to treating that
pain adequately has been government regulation. For example:
---------------------------------------------------------------------------
\72\ M. J. Field, and C. K. Cassel, eds., with the Institute of
Medicine, ``Approaching Death: Approving Care at the End of Life'' 128
(1997).
---------------------------------------------------------------------------
In a survey of controlled substance laws in 38
countries, the World Health Organization found that ``[t]he
proliferation of national laws and/or administrative measures
regulating the prescription and distribution of opioid drugs
necessary for cancer pain relief has hindered access by
patients to these drugs.'' \73\
---------------------------------------------------------------------------
\73\ World Health Organization, ``Cancer Pain Relief,'' at 28
(1986).
---------------------------------------------------------------------------
A nationwide study of cancer physicians
demonstrated a ``reluctance to prescribe'' opioids due to
concern about ``excessive regulations.'' These excessive
regulations were viewed as barriers to effective cancer pain
management. Doctors'' concerns were greatest in States with
triplicate prescription programs.\74\
---------------------------------------------------------------------------
\74\ J. Von Roenn, et. al., ``Results of Physicians' Attitudes
toward Cancer Pain Management Survey,'' Proceedings of the American
Society of Clinical Oncology, Vol. 109, p. 326 (1991).
---------------------------------------------------------------------------
In California, 69 percent of physicians surveyed
stated that the risk of disciplinary action made them more
reluctant to use opioids in pain management with \1/3\
reporting that their patients may be suffering from neglected,
treatable pain.\75\
---------------------------------------------------------------------------
\75\ F. J. Skelly, ``Fear of Sanctions Limits Prescribing of Pain
Drugs,'' American Medical News, at 19 (Aug. 15, 1994).
---------------------------------------------------------------------------
A survey completed by the New York Ad Hoc
Committee on Pain Management for the New York State Health
Commissioner found that physicians Amay be concerned that
aggressive pain management using controlled substances could be
misconstrued as inappropriate and/or excessive prescribing and
could lead to a professional misconduct or other administrative
proceedings.'' \76\
---------------------------------------------------------------------------
\76\ New York State Public Health Council, Report to the
Commissioner of Health, ``Breaking Down the Barriers to Effective Pain
Management: Recommendations to Improve the Assessment and Treatment of
Pain in New York State'' at 10 (1998).
---------------------------------------------------------------------------
Seventy-one percent of physicians surveyed in New
York State reported that they do not prescribe effective
medication for cancer pain, if such prescriptions require them
to use a special State-monitored prescription form for
controlled substances even when the medication is legal and
medically indicated for the patient.\77\
---------------------------------------------------------------------------
\77\ Id. at 11, App. F.
---------------------------------------------------------------------------
A study of 13,625 elderly cancer patients living
in Medicare/Medicaid certified nursing homes found 26 percent
of residents with daily pain received no medication for pain.
Daily pain is prevalent among nursing home residents with
cancer; that pain is often left untreated, especially in
African-American and older patients; \78\ and
---------------------------------------------------------------------------
\78\ R. Bernabei, et al., ``Pain Management in Elderly Patients
with Cancer,'' Journal of the American Medical Association, vol. 279,
at 1877-1882 (1998).
---------------------------------------------------------------------------
An article states that one-quarter of medical
licensing and disciplinary board members surveyed were unaware
that prescribing opioids for an extended period for cancer
patients was both legal and acceptable medical practice.\79\
---------------------------------------------------------------------------
\79\ D.E. Joranson, ``Federal and State Regulation of Opioids,''
Journal of Pain and Symptom Management, vol. 5, at S12-23 (1990).

These studies point to the need for less regulation, and
demonstrate that current restrictions already result in massive
undertreatment of pain and neglect of suffering. Here are some
real-life examples of that undertreatment and its consequences,
examples which are sure to multiply if PRPA becomes the law of
the land:
E.B., a 54-year-old man, underwent successful
surgery for bladder cancer. After the surgery, he complained of
severe pelvic pain. E.B. was given limited amount of Percodan,
but this only partially relieved his pain. His family physician
was afraid to increase the dose. E.B. went to pain clinics in
Dallas and ended up in Lubbock, TX. He was given hypogastric
nerve blocks without relief. According to his daughter, E.B.
asked for pain medication to enable him to drive back to
Kansas, but the pain clinic refused. Upon arriving home, E.B.
took Tylenol, but without any relief. He then wrote a brief
note, saying that he could no longer live with his pain, went
to the garage, shut the door, and started the car. E.B. died of
carbon monoxide poisoning. Even more tragically, the exhaust
fumes seeped into an upstairs bedroom, killing E.B.'s 18-year-
old daughter.\80\
---------------------------------------------------------------------------
\80\ Letter from Harvey L. Rose, M.D. to Senator Dianne Feinstein,
dated Apr. 3, 2000.
---------------------------------------------------------------------------
A 78-year-old man (E.H.) was denied adequate pain
relief medicine on consecutive visits to the emergency room for
severe pain resulting from an acute medical condition. In
desperation, E.H. shot himself through the head, and his wife--
who would have had to return to a nursing home upon his death--
followed suit and shot herself in the heart.\81\
---------------------------------------------------------------------------
\81\ Id.
---------------------------------------------------------------------------
An 80-year-old woman was diagnosed with spinal
stenosis. After being denied pain medication for the extreme
discomfort that she was experiencing relating to this disorder,
the elderly woman jumped from a window in her senior citizen
center, plummeting 20 stories to her death.\82\
---------------------------------------------------------------------------
\82\ Id.
---------------------------------------------------------------------------
A 29-year-old athlete (T.T.) committed suicide due
to agonizing pain that she was experiencing due to a particular
medical disorder. T.T.'s physician, a specialist in the field
of this disorder, had been reluctantly prescribing medication
that adequately controlled her pain. However, the physician
became so uncomfortable prescribing the medicine that one day
he refused to grant her an early refill. In several emotional
suicide notes, T.T. related her adamant disgust with the
already disgraceful and difficult procedure associated with
procuring adequate pain medication from doctors. Because she
could not cope with the excruciating pain that she was
suffering from without the relief of pain medicine, T.T. killed
herself.\83\
---------------------------------------------------------------------------
\83\ Id.
---------------------------------------------------------------------------
A patient was suffering from severe chronic daily
headaches and was put on pain medication for relief. The doctor
then decided that he could no longer continue to prescribe the
medication to her. As a result, the patient had a severe
migraine and experienced nausea and vomiting for several days.
In an attempt to control the pain that she was experiencing,
she overdosed on aspirin and acetaminophen, and died in the
hospital soon after.\84\
---------------------------------------------------------------------------
\84\ Id.
---------------------------------------------------------------------------
A 78-year-old woman (S.N.) was suffering serious
pain in her neck and shoulders due to previous disc surgeries.
S.N.'s doctors had been unwilling to give her enough pain
medication and repeatedly called her a drug addict because of
her requests for additional pain relief medicine. S.N.
attempted suicide four times through various means including
wrist slashing, medication overdoses, and electrocution in her
bathtub. She was then sent to a psychiatric hospital and a
clinic for drug addicts before she became the patient of
another doctor. That doctor was willing to prescribe adequate
pain medication, and as a result S.N. continued to live
(without the desire to attempt suicide) in a senior center
until her death 2 years later from natural causes.\85\
---------------------------------------------------------------------------
\85\ Id.
---------------------------------------------------------------------------
A patient was suffering from early prostate cancer
with mild pain, but was very concerned with how his pain would
be managed by doctors as his condition became steadily worse.
Several weeks after his first consultation with another doctor,
the patient killed himself out of fear that he would not be
given adequate pain medication.\86\
---------------------------------------------------------------------------
\86\ E-mail from Scott Fishman, M.D., chief of the Division of Pain
Medicine, University of California at Davis, to Senator Dianne
Feinstein, dated Apr. 4, 2000.
---------------------------------------------------------------------------
A cardiologist was caring for a patient with heart
disease and colon cancer. The cardiologist was so wary of
prescribing any pain medication for the patient's significant
abdominal pain, that he asked another doctor to write the
prescription for him. If that doctor had not been willing to
step in for the cardiologist and prescribe the medication, and
had not actively encouraged the cardiologist to continue
administering the medication, the patient would have died an
agonizingly painful death. Additionally, that second doctor
reports that he has witnessed patients suffer for weeks, or
even months with pain from advanced stages of cancer when
doctors have been unwilling to prescribe pain relief
medication.\87\
---------------------------------------------------------------------------
\87\ Letter from Robert V. Brody, M.D., San Francisco General
Hospital, to Senator Dianne Feinstein.
---------------------------------------------------------------------------
A Dateline NBC segment has described the ordeal of
William Bergman. Mr. Bergman was suffering from terminal lung
cancer. Doctors refused to prescribe adequate pain control and
as a result he died in agony. The California Medical Board
ruled that the doctors had undertreated Mr. Bergman's pain, but
refused to take action against the doctors.\88\
---------------------------------------------------------------------------
\88\ See Sheryl Gay Stolberg, ``Doctors Walk Fine Line in Giving
Painkillers to Dying Patients'', San Diego Union-Tribune, Oct. 21,
1998, at E5.
---------------------------------------------------------------------------
A patient (J.D.) with ``unremitting, sharp,
burning, throbbing'' pain from cancer was not given adequate
pain relief medication. As a result, J.D. had unnecessarily
agonizing difficulty sleeping, breathing, and even sitting in a
chair. Despite the fact that J.D.'s wife was a physician who
strongly advocated for pain relief to relieve his condition, he
was still unable to receive adequate medication due to the
reluctance of doctors to prescribe pain relief medicine.\89\
---------------------------------------------------------------------------
\89\ Letter from Karen C. Douglas, M.D. to Senator Dianne
Feinstein, dated Apr. 5, 2000.

The majority claims that PRPA would help solve the problems
demonstrated by these cases. But that is simply false. In fact,
PRPA would cause additional suffering in tens of thousands of
terminally ill patients or patients with chronic pain, and it
would drive many of these individuals to suicide. PRPA not only
fails to address the underlying need that may cause some
patients to seek physician-assisted suicide, it exacerbates
that need. Thus, the bill would have the perverse effect of
increasing the demand for assisted suicide.
As PRPA reduces the number of physicians who are willing to
prescribe the most effective pain relieving medications
(controlled substances such as narcotics and opioid
analgesics), the number of suffering patients and the amount of
each's pain will steadily grow. Many of these patients--unable
to handle the severity of their pain--will desperately turn to
the ``final exit'' of assisted suicide, an outcome we wish to
avoid at all costs.
Moreover, PRPA would not even do what it really intends:
stop physician-assisted suicide in Oregon. A physician in
Oregon (or any other State) could still assist a suicide by
prescribing a noncontrolled substance, an over-the-counter
drug, or common chemicals such as carbon monoxide or potassium
(which Jack Kevorkian used)--though, of course, this is not the
intent of the Oregon law.

b. prpa would not address the needs of terminally ill americans or
those suffering from chronic pain

Despite the claim made by the bill's title that it would
promote pain relief, this legislation does virtually nothing to
address the needs of the 50 million Americans who are in
chronic pain or the needs of the 2.4 million Americans who die
each year.
As discussed above, the Institute of Medicine recently
completed one of the most wide-ranging and detailed studies
ever done on end-of-life care. To undertake the study, the IOM
appointed a 12-member committee of experts in medical and
nursing care for chronically and severely ill patients, ethics,
quality of care, health policy, health services research, law,
economics, social services, and related fields. This committee
met with numerous groups, researchers, and others and surveyed
the relevant literature. The committee settled on seven
recommendations for ``the achievement of a compassionate care
system that dying people and those close to them can rely on
for respectful and effective care.'' \90\ However, in spite of
this work, as Dr. Kathleen Foley of Memorial Sloan-Kettering
Cancer Center testified, PRPA does not even begin to address a
single one of these recommendations.\91\ Worse, the legislation
actually defies the recommendations. Rather than work to reform
``burdensome regulations * * * that impede effective use of
opioids to relieve pain and suffering'' (recommendation 3), for
example, PRPA imposes just such a regulation, one of
breathtaking preemptive sweep.
---------------------------------------------------------------------------
\90\ The seven IOM recommendations are:
(1) People with advanced, potentially fatal illnesses and those
close to them should be able to expect and receive reliable, skillful,
and supportive care.
(2) Physicians, nurses, social workers, and other health
professionals must commit themselves to improving care for dying
patients and to using existing knowledge effectively to prevent and
relieve pain and other symptoms.
(3) Because many problems in care stem from system problems,
policymakers, consumer groups, and purchasers of health care should
work with health care practitioners, organizations, and researchers to:

Strengthen methods for measuring the quality of
life and other outcomes of care for dying patients and
those close to them;
Develop better tools and strategies for
improving the quality of care and holding healthcare
organizations accountable for care at the end of life;
Revise mechanisms for financing care so that
they encourage rather than impede good end-of-life care and
sustain rather than frustrate coordinated systems of
excellent care; and
Reform drug prescription laws, burdensome
regulation, and State medical board policies and practices
that impede effective use of opioids to relieve pain and
suffering.

(4) Educators and other healthcare professionals should initiate
changes in undergraduate, graduate, and continuing education to ensure
that practitioners have relevant attitudes, knowledge, and skills to
care well for dying patients.
(5) Palliative care should become, if not a medical speciality, at
least a defined area of expertise, education, and research.
(6) The Nation's research establishment should define and implement
priorities for strengthening the knowledge base for end-of-life care.
(7) A continuing public discussion is essential to develop a better
understanding of the modern experience of dying, the options available
to patients and families, and the obligations of communities to those
approaching death.
See M.J. Field, and C.K. Cassel, eds., with the Institute of
Medicine, Approaching Death: Approving Care at the End of Life 7-13
(1997).
\91\ Testimony of Kathleen Foley, M.D., before the Senate Committee
on the Judiciary, July 31, 1998 at 28, lines 15-17.
---------------------------------------------------------------------------
True, PRPA does authorize $5 million in grants for
education and training. But there is less here than meets the
eye. The money is for less than 2 years and the Health
Resources Services Administration (HRSA) already has the
authority to fund this kind of training. In addition, as the
Congressional Budget Office recently noted, the existing HRSA
grant program has already received an appropriation of $23
million for fiscal year 2000.\92\
---------------------------------------------------------------------------
\92\ Congressional Budget Office Cost Estimate, H.R. 2260, at 2
(May 9, 2000).
---------------------------------------------------------------------------
The $5 million in additional money is rather paltry
compared to the billions this Nation spends each year on end-
of-life care and less than what some private foundations
disburse in a single year on medical education and training
grants. In fact, the Robert Wood Johnson Foundation alone spent
over $80 million in the past 5 years on training for palliative
care and pain management. Moreover, a General Accounting Office
review of how HRSA used funds set aside for suicide prevention
projects--as required under the 1997 Federal ban against
funding of assisted suicide--found HRSA had not placed a high
priority on spending this money and had not even spent all the
money available. Nothing in PRPA would address this problem. As
Dr. Foley testified, ``[T]he Bill provides insufficient funding
to have any ``real'' impact on pain and palliative care
education and training.'' \93\
---------------------------------------------------------------------------
\93\ Testimony of Kathleen Foley, M.D., before the Senate Committee
on the Judiciary, Apr. 25, 2000, at 1.
---------------------------------------------------------------------------
At bottom, this meager authorization seems far more related
to public relations than public health. It is simply not a
serious commitment of resources to this huge problem.

c. prpa would replace state medical boards with federal drug
enforcement agents as governors of pain management practices

Since they were established more than a century ago, State
medical boards have evolved into sophisticated regulatory
agencies dedicated to protecting the public from unacceptable
practitioners. All States have medical licensing boards that
oversee the practice of medicine, including physicians'
prescribing patterns. The current system of medical licensure
has worked well in protecting the public health. This system is
also the most appropriate and most effective forum for
regulating pain management practices.
PRPA would establish a new and burdensome oversight
mechanism whereby the DEA would have prospective authority to
deny DEA registration based on the DEA's interpretation of the
healthcare provider's intent. Any DEA investigation on the
issue of a provider's intent--which is always an issue when a
controlled substance is given to a patient--would be quite
intrusive because the DEA would have the virtually impossible
task of discerning ``why'' a physician prescribed the drug he
or she did and ``why'' the particular amount of that drug was
prescribed. As many healthcare providers have pointed out and
as was discussed in the Department of Justice's testimony
before the Committee, most terminally ill patients already have
an ample supply of controlled substances on hand to use in any
suicide effort. The DEA, therefore, would not be able to make
an objective determination based upon the drug and dosage the
patient had on hand. Rather, the DEA would be forced to
determine the intent behind every prescription or combination
of prescriptions. This cannot be done without an intrusive
investigation that pries both into the practice of the
physician and pharmacist involved, and the lives of the family
and friends of the deceased. PRPA would make the question of a
physician's intent in treating a patient crucial and, as the
Department of Justice stated,

the issue of intent would not necessarily be resolved
simply by asking physicians about their intent. To
establish intent, the DEA might also need to
investigate the details of the physician's prescribing
practices and of the physician's relationship with the
patient and the patient's family.\94\
---------------------------------------------------------------------------
\94\ Letter of L. Anthony Sutin, Acting Assistant Attorney General,
to Senator Orrin G. Hatch, dated Sept. 16, 1998.

In addition, the issue of a physician's intent is not
always clear. Research and experience indicate that when
physicians and nurses take action that may hasten death, they
invariably have many intentions.\95\ For example, one study
revealed that when doctors ordered controlled substances to be
administered to patients who were dying and who were to have
life-sustaining treatment withheld or withdrawn, those
physicians typically had more than three different intentions
behind their orders and 36 percent of the physicians had as one
of their intentions hastening death. Similarly, nurses who
administered the medications had on average almost three
intentions, and 39 percent of them said that one of their
intentions was to hasten death.\96\
---------------------------------------------------------------------------
\95\ T.E. Quill, The Ambiguity of Clinical Intentions, New England
Journal of Medicine, vol. 329, at 1039-1040 (1993).
\96\ W. Wilson, et al., ``Ordering and Administration of Sedatives
and Analgesics During the Withholding and Withdrawal of Life Support
from Critically Ill Patients,'' Journal of the American Medical
Association, vol. 267, at 949-953 (1992).
---------------------------------------------------------------------------
As these figures indicate, the issue of ``intent'' is
especially complicated in the case of treating terminally ill
patients. Many doctors subscribe to the principle of ``double
effect,'' under which it is perfectly ethical for a doctor to
administer medicine to a patient even if it is foreseeable that
that medicine will hasten the patient's death. Indeed, ``there
is evidence that a significant number of physicians support the
practice of hastening death in particular situations.''
Glucksberg, 521 U.S. at 749 n.12 (Stevens, J., concurring)
(citing relevant literature).
Moreover, this enhanced role for the DEA conflicts with the
mission of medical licensure boards, which, unlike the DEA,
have long held the role of assuring appropriate delivery of
medical care. If enacted, this legislation would replace the
well-established system of peer review and regulation at the
State level with an untested, superfluous, and intrusive
Federal enforcement mechanism. According to the Federation of
State Medical Boards (FSMB), in cases where the inappropriate
prescribing of controlled substances is determined, State
medical boards already require a physician to surrender his or
her DEA certificate as part of the disciplinary action taken
and to notify the DEA of such action. In fact, surrendering a
DEA certificate may be only one of the conditions a medical
board imposes on a physician. If the physician fails to comply
with all the terms of the disciplinary action, the board may
then revoke his or her medical license.
Under the current system, all licensed physicians are
subject to peer review. Hospitals, other healthcare
organizations and insurance companies are asked to provide
licensing boards with any information about adverse actions
they have taken against individual physicians. These reports
are reviewed by the State boards and, if necessary,
disciplinary action is taken. In addition, a majority of State
boards require all licensees to continue their medical
education in order to maintain licensure. These processes are
designed to help identify those individuals who should no
longer be engaged in the practice of medicine and to ensure
that physicians maintain their level of medical knowledge and
clinical abilities.
In some States, licensure boards are taking steps to
educate physicians on the proper use of pain medication for
patients nearing the end of life. Recently, the FSMB published
``Proposed Model Guidelines for the Use of Controlled
Substances'' in the treatment of pain. The federation is
recommending all States adopt these model guidelines as a way
to educate and reassure physicians that they can safely use
controlled substances to treat pain.
Clearly, the boards have taken a comprehensive approach to
the governing and advising of physicians and pharmacists on the
practice of pain management. There is no reason to strip them
of their responsibility or to pile on layers of unnecessary
Federal bureaucracy.

d. prpa would interfere with the goals of hospice and comfort care

In 1997, 3200 hospices cared for nearly 500,000 terminally
ill patients in the United States. Hospices provide
comprehensive and compassionate care by addressing the
physical, psychological, social and spiritual needs of dying
patients and their families. One of the main goals of hospice
care is to treat patients' pain aggressively through a variety
of means, including the use of controlled substances. These
include the use of morphine and other opioids so patients can
maintain the highest quality of life during their remaining
days.
Hospice care use has increased significantly in Oregon as a
result of the physician-assisted suicide debate and the legal
requirement that physicians and their patients discuss options
other than physician-assisted suicide. This increase
demonstrates the public's need for information concerning
alternatives to physician-assisted suicide and the overall need
for improvements in end-of-life care. Oregon is also the only
State to have disciplined a physician for the under-use of pain
medication and has consistently been in the top ten States for
per capita morphine use.
PRPA neither addresses the public's need for information
concerning alternatives to physician-assisted suicide nor
promotes improvements in end-of-life care that might make a
terminally ill individual seek other options. Palliative care
and pain management are both evolving fields that should be
left to medical professionals, not law enforcement, to provide
care for the dying without excessive government intrusion. PRPA
does not address these serious concerns, and in the opinion of
numerous physicians, pharmacists, hospice providers, nurses,
and pain patients, it will only exacerbate the problems of pain
management and hinder the ongoing evolution of the fields of
palliative care and pain management.

V. The Majority's Other Arguments are Also Incorrect

a. prpa would do nothing to lessen the demand for physician-assisted
suicide

The majority contends that PRPA would discourage physician-
assisted suicide. Nothing could be further from the truth.
Forty-seven bioethicists with differing views about
physician-assisted suicide wrote members of the Judiciary
Committee that:

H.R. 2260 will not eliminate physician-assisted
suicide. Every study that has been conducted in this
country reveals its occurrence, in every part of the
country where such research has been undertaken,
underground and in completely uncontrolled conditions.
This bill will simply drive the practice further
underground into more disguised and more unprotected
conditions.\97\
---------------------------------------------------------------------------
\97\ Letter from Alan Meisel, J.D., Director of the Center for
Bioethics and Health Law, University of Pittsburgh, and 46 other
bioethicists to Senator Arlen Specter, dated Apr. 24, 2000, at 2-3
(footnote listing research studies omitted).

And supporters of PRPA agree. Rabbi Bleich--who has written two
law review articles on the subject--not only testified that
PRPA ``will not have the effect of reducing the incidence of
physician-assisted suicide,'' \98\ but even noted that ``I
doubt very much * * * that the passage of the bill will prevent
as much as a single suicide.'' \99\ Supporters of PRPA have
focused so intently on Oregon--the one State that, so far, has
dissented from the majority view on physician-assisted
suicide--that they have blinded themselves to the fact that
physician-assisted suicide is a national problem and a tragic
symptom of a healthcare system that is failing some of our most
vulnerable citizens.
---------------------------------------------------------------------------
\98\ Testimony of Rabbi J. David Bleich before the Senate Committee
on the Judiciary, Apr. 25, 2000, at 51, lines 8-12.
\99\ Id., at 77, lines 12-17.
---------------------------------------------------------------------------
If we truly want to end the practice of physician-assisted
suicide everywhere, we need a far more complete and complex
response than this bill provides.
For starters, we need to do much more to educate people on
end-of-life care. For example, a study published in the Journal
of the American Medical Association found that of the 50 best
selling general and specialty medical textbooks, less than \1/
4\ contained helpful of end-of-life information.\100\ Moreover,
recent polls reveal that nine out of ten Americans would want
the kind of care that hospice provides but that many who
respond do not know what services hospices offer.\101\ Last, a
recent study published reviewing the Oregon experience found
that when physicians did find an intervention appropriate for
the patient, including pain management, the request for
physician-assisted suicide receded.\102\
---------------------------------------------------------------------------
\100\ M. Rabow, et al., ``End-of Life Care Content in 50 Textbooks
from Multiple Specialties,'' Journal of the American Medical
Association, vol. 283, at 771-78.
\101\ See, e.g., Judy Talbert, ``Expansion of Hospice Benefits
Needed,'' Pittsburgh Post-Gazette, June 1, 1999, at F10.
\102\ L. Ganzini, et al., ``Physicians' Experiences with the Oregon
Death With Dignity Act,'' New England Journal of Medicine, vol. 342,
no. 8, at 557-563 (2000).
---------------------------------------------------------------------------

b. prpa would further expand the dea's authority over the practice of
medicine

The majority repeatedly states that PRPA would only expand
the DEA's authority over the practice of medicine in one State:
Oregon. That is incorrect.
The DEA's current mission is to determine the ``appropriate
use'' of drugs only as part of an effort to prevent diversion
and illegal drug trafficking. Yet, the majority wants the DEA
to now get involved in defining the medical uses of drugs.
The CSA was passed to prevent and control drug abuse--to
interrupt the flow of illicit drugs to the street. It was never
intended to empower the DEA to make a medical determination of
what is a reasonable and necessary use of drugs for patient
care, at least beyond the narrow band of cases involving
illegal drug diversion or trafficking.

c. prpa is not necessary to ensure the uniform application of the
controlled substances act

The majority claims that this legislation is necessary to
avoid the creation of 50 different State policies regarding the
Controlled Substances Act. The CSA classifies drugs as to their
dependence and medical use and is directed to prevent diversion
and illegal drug trafficking. No evidence has been brought
forward to show that States are revising the schedules included
in the CSA.
If the proponents really want uniform usage of drugs in the
practice of medicine, then the Federal Government would have to
preempt State medical and pharmacy laws. Such an effort would
run counter to the long established way in which States, not
the Federal Government, have regulated medicine and pharmacy
practices.

d. prpa would have a chilling effect on the use of morphine and other
legal drugs to manage pain

Proponents of this legislation point to States in which
morphine use increased after similar legislation passed and try
to argue that this shows that passage of PRPA would not have a
chilling effect on pain management. However, as shown in the
discussion in part IV and as demonstrated in the letters and
other documents filed by the many State medical societies
opposing PRPA, the legislation would have a chilling effect on
the use of morphine and other legal drugs to manage pain.
Moreover, the proponents' argument is simply wrong on its face.
First, proponents ignore the fact that some of the top-
ranked States for pre capita morphine use have no comparable
statutes to PRPA--including Nevada (fourth ranked) and Vermont
(fifth ranked). See Figures 1 and 2. And Oregon itself, PRPA's
sponsors' target, ranked second in per capita morphine use.
Second, proponents fail to recognize that the national
average for morphine use increased during the periods they
cite. The fact is that morphine use increased in most States
during this period, not just in a few States with PRPA-type
laws.
Third, proponents carefully omit reference to States where
passage of PRPA-type legislation was followed by a decrease in
the use of morphine or an increase less than the national
average. For example, Oklahoma passed a law similar to PRPA in
1998, a year when Oklahoma was ranked 30th in the country for
the use of morphine. A year later, Oklahoma had dropped to 34th
in the Nation--even though morphine use increased nationally
during this period. See Figure 3. Similarly, while there has
been an increase in morphine use in Iowa since that State
passed a PRPA-type law in 1996, this increase has been less
than the national average. See Figure 4. And the same can be
said for Louisiana, which passed a law similar to Iowa's in
1995. See Figure 5.
Fourth, the morphine-use statistics proponents cite do not
specify who is receiving the drug. We do not know if the
numbers reflect morphine receipt by post-operative pain
patients, chronic pain patients, and/or dying patients. To know
whether a State PRPA-type law really had a chilling effect on
prescription of morphine, we would need to know if such severe
regulation caused doctors to be more unwilling to prescribe
morphine to patients facing imminent death.
And the answer to that question is an unqualified yes. As
discussed above, numerous surveys of doctors have shown that
they are often unwilling to give morphine to dying patients
because of regulatory fears.
DEA regulations published in 1974 already make clear the
policy that controlled substances should be used for pain.
Simply changing the statute will not solve the well-documented
health crisis patients in pain face today.

VI. Conclusion

Physician assisted-suicide is a disturbing practice that we
all seek to eliminate. We would prefer that no person ever be
put in the situation where he or she is suffering so much pain,
that he or she chooses self-inflicted death over the agony
being endured. The reality, however, is that physician-assisted
suicide does exist and PRPA does not address the reasons why
individuals ask their physicians for help in dying.
Indeed, the majority, under the guise of amending the CSA,
has attempted to substitute its judgment for those of the
States, especially that of Oregon. The result of this misguided
effort is a bill that would discourage appropriate, palliative
care and may actually increase the demand for physician-
assisted suicide.
If the majority really wishes to reduce physician-assisted
suicide, it should address the root causes of the practice.
Patients do not commit assisted suicide because their
physicians have the power to prescribe controlled substances
for pain relief. On the contrary, for the most part, patients
commit suicide because they are suffering from chronic pain
and/or depression, because they fear being a burden on their
loved ones, or because they do not have access to palliative or
hospice care. This bill does nothing to address these far
reaching and complex problems. In fact, PRPA just makes them
worse.
Ironically, proponents of PRPA invoke the Hippocratic maxim
``first, do no harm'' as a justification for the bill. Instead,
it is Congress that should invoke that principle here with
regard to itself--and reject this unprecedented, unnecessary,
and harmful legislation.
Patrick Leahy.
Ted Kennedy.
Herb Kohl.
Dianne Feinstein.

X. Changes in Existing Law

In compliance with paragraph 12 of rule XXVI of the
Standing Rules of the Senate, changes in existing law made by
S. 625, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in brackets, new matter is
printed in italic, and existing law in which no change is
proposed is shown in roman):

CONTROLLED SUBSTANCES ACT

TITLE II--CONTROL AND ENFORCEMENT

* * * * * * *

PART C--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF
CONTROLLED SUBSTANCES; PIPERIDINE REPORTING

* * * * * * *

registration requirements

Sec. 303. [823] (a) The Attorney General * * *

* * * * * * *

(h) The Attorney General shall register an applicant to
distribute a list I chemical unless the Attorney General
determines that registration of the applicant is inconsistent
with the public interest. Registration under this subsection
shall not be required for the distribution of a drug product
that is exempted under section 102(39)(A)(iv). In determining
the public interest for the purposes of this subsection, the
Attorney General shall consider--
(1) maintenance by the applicant of effective controls
against diversion of listed chemicals into other than
legitimate channels;

* * * * * * *

(5) such other factors as are relevant to and
consistent with the public health and safety.
(i)(1) 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.
(2)(A) Notwithstanding any other provision of this Act, in
determining whether a registration is consistent with the
public interest under this Act, the Attorney General shall give
no force and effect to State law authorizing or permitting
assisted suicide or euthanasia.
(B) Paragraph (2) applies only to conduct occurring after
the date of enactment of this subsection.
(3) Nothing in this subsection shall be construed to alter
the roles of the Federal and State governments in regulating
the practice of medicine. Regardless of whether the Attorney
General determines pursuant to this section that the
registration of a practitioner is inconsistent with the public
interest, it remains solely within the discretion of State
authorities to determine whether action should be taken with
respect to the State professional license of the practitioner
or State prescribing privileges.
(4) Nothing in the Pain Relief Promotion Act of 2000
(including the amendments made by such Act) shall be
construed--
(A) to modify the Federal requirements that a
controlled substance be dispensed only for a legitimate
medical purpose pursuant to paragraph (1); or
(B) to provide the Attorney General with the
authority to issue national standards for pain
management and palliative care clinical practice,
research, or quality;
except that the Attorney General may take such other actions as
may be necessary to enforce this Act.

denial, revocation, or suspension of registration

Sec. 304. [824] (a) A registration pursuant to section 303
to manufacture, distribute, or dispense a controlled substance
or a list I chemical may be suspended or revoked by the
Attorney General upon a finding that the registrant--

* * * * * * *

[(c) Before] (c) Procedures.--
(1) Order to show cause._Before taking action
pursuant to this section, or pursuant to a denial of
registration under section 303, the Attorney General
shall serve upon the applicant or registrant an order
to show cause why registration should not be denied,
revoked, or suspended. The order to show cause shall
contain a statement of the basis thereof and shall call
upon the applicant or registrant to appear before the
Attorney General at a time and place stated in the
order, but in no event less than thirty days after the
date of receipt of the order. Proceedings to deny,
revoke, or suspend shall be conducted pursuant to this
section in accordance with subchapter II of chapter 5
of title 5 of the United States Code. Such proceedings
shall be independent of, and not in lieu of, criminal
prosecution or other proceedings under this title or
any other law of the United States.
(2) Burden of proof.--At any proceeding under
paragraph (1), where the order to show cause is based
on the alleged intentions of the applicant or
registrant to cause or assist in causing death, and the
practitioner claims a defense under paragraph (1) of
section 303(i), the Attorney General shall have the
burden of proving, by clear and convincing evidence,
that the practitioner's intent was to dispense,
distribute, or administer a controlled substance for
the purpose of causing death or assisting another
person in causing death. In meeting such burden, it
shall not be sufficient to prove that the applicant or
registrant knew that the use of controlled substance
may increase the risk of death.

* * * * * * *

PART E--ADMINISTRATIVE AND ENFORCEMENT PROVISIONS

* * * * * * *

education and research programs of the attorney general

Sec. 502. [872] (a) The Attorney General is authorized to
carry out educational and research programs directly related to
enforcement of the laws under his jurisdiction concerning drugs
or other substances which are or may be subject to control
under this title. Such programs may include--
(1) educational and training programs on drug abuse
and controlled substances law enforcement for local,
State, and Federal personnel;

* * * * * * *

(5) studies or special projects to develop more
effective methods to prevent diversion of controlled
substances into the illegal channels; [and]
(6) studies or special projects to develop
information necessary to carry out his functions under
section 201 of this title[.]; and
(7) educational and training programs for Federal,
State, and local personnel, incorporating
recommendations, subject to the provisions of
subsections (e) and (f) of section 902 of the Public
Health Service Act, by the Secretary of Health and
Human Services, on the means by which investigation and
enforcement actions by law enforcement personnel may
better accommodate the necessary and legitimate by of
controlled substances in pain management and palliative
care.
Nothing in this subsection shall be construed to alter the
roles of the Federal and State governments in regulating the
practice of medicine.

* * * * * * *

PUBLIC HEALTH SERVICE ACT

* * * * * * *

TITLE VII--HEALTH PROFESSIONS EDUCATION

* * * * * * *

PART D--INTERDISCIPLINARY, COMMUNITY-BASED LINKAGES

* * * * * * *

SEC. 753. [294C] EDUCATION AND TRAINING RELATING TO GERIATRICS.

(a) Geriatric Education Centers.--
(1) In general.--The Secretary shall award grants or
contracts under this section to entities described in
paragraphs (1), (3), or (4) of section 799B, and
section 853(2), for the establishment or operation of
geriatric education centers.

* * * * * * *

(c) Geriatric Facility Fellowships.--
(1) Establishment of program.--The Secretary shall
establish a program to provide Geriatric Academic
Career Awards to eligible individuals to promote the
career development of such individuals as academic
geriatricians.

* * * * * * *

(5) Service requirement.--An individual who receives
an Award under this subsection shall provide training
in clinical geriatrics, including the training of
interdisciplinary teams of health care professionals.
The provision of such training shall constitute at
least 75 percent of the obligations of such individual
under the Award.

SEC. 754. PROGRAM FOR EDUCATION AND TRAINING IN PAIN MANAGEMENT AND
PALLIATIVE CARE.

(a) In General.--The Secretary, in consultation with the
Director of the Agency for Healthcare Research and Quality, may
award grants cooperative agreements, and contracts to health
professions schools, hospices, and other public and private
entities for the development and implementation of programs to
provide education and training to health care professionals in
pain management and palliative care.
(b) Priority.--In making awards under subsection (a), the
Secretary shall give priority to awards for the implementation
of programs under such subsection.
(c) Certain Topics.--An award may be made under subsection
(a) only if the applicant for the award agrees that the program
to be carried out with the award will include information and
education on--
(1) means for diagnosing and alleviating pain and
other distressing signs and symptoms of patients,
especially terminally ill patients, including the
medically appropriate use of controlled substances;
(2) applicable laws on controlled substances,
including laws permitting health care professionals to
dispense or administer controlled substances as needed
to relieve pain even in cases where such efforts may
unintentionally increase the risk of death; and
(3) recent findings, developments, and improvements
in the provision of pain management and palliative
care.
(d) Program Sites.--Education and training under subsection
(a) may be provided at or through health professions schools,
residency training programs and other graduate programs in the
health professions, entities that provide continuing medical
education, hospices, and such other programs or sites as the
Secretary determines to be appropriate.
(e) Evaluation of Programs.--The Secretary shall (directly
or through grants or contracts) provide for the evaluation of
programs implemented under subsection (a) in order to determine
the effect of such programs on knowledge and practice regarding
pain management and palliative care.
(f) Peer Review Groups.--In carrying out section 799(f)
with respect to this section, the Secretary shall ensure that
the membership of each peer review group involved includes
individuals with expertise and experience in pain management
and palliative care for the population of patients whose needs
are to be served by the program.
(g) Definition.--In this section, the term ``pain
management and palliative care'' means--
(1) the active, total care of patients whose disease
or medical condition is not responsive to curative
treatment or whose prognosis is limited due to
progressive, far-advanced disease; and
(2) the evaluation, diagnosis, treatment, and
management of primary and secondary pain, whether
acute, chronic, persistent, intractable, or associated
with the end of life;
the purpose of which is to diagnose and alleviate pain and
other distressing signs and symptoms and to enhance the quality
of life, not to hasten or postpone death.

SEC. [754] 755. [294D] QUENTIN N. BURDICK PROGRAM FOR RURAL
INTERDISCIPLINARY TRAINING.

(a) Grants.--The Secretary may make grants or contracts
under this section to help entities fund authorized activities
under an application approved under subsection (c).

* * * * * * *

SEC. [755] 756. [294E] ALLIED HEALTH AND OTHER DISCIPLINES.

(a) In General.--The Secretary may make grants or contracts
under this section to help entities fund activities of the type
described in subsection (b).

* * * * * * *

SEC. [756] 757. [294F] ADVISORY COMMITTEE ON INTERDISCIPLINARY,
COMMUNITY-BASED LINKAGES.

(a) Establishment.--The Secretary shall establish an
advisory committee to be known as the Advisory Committee on
Interdisciplinary, Community-Based Linkages (in this section
referred to as the ``Advisory Committee'').

* * * * * * *

SEC. [757] 758. [294G] AUTHORIZATION OF APPROPRIATIONS.

(a) In General.--There are authorized to be appropriated to
carry out this part, $55,600,000 for fiscal year 1998, and such
sums as may be necessary for each of the fiscal years 1999
through 2002.
(b) Allocation.--
(1) In general.--Of the amounts appropriated under
subsection (a) for a fiscal year, the Secretary shall
make available--
(A) not less than $28,587,000 for awards of
grants and contracts under section 751;

* * * * * * *

(C) not less than $22,631,000 for awards of
grants and contracts under [sections 753, 754,
and 755] sections 753, 754, 755, and 756.

* * * * * * *

HEALTHCARE RESEARCH AND QUALITY ACT OF 1999

* * * * * * *

TITLE IX--AGENCY FOR HEALTHCARE RESEARCH AND QUALITY

PART A--ESTABLISHMENT AND GENERAL DUTIES

SEC. 901. MISSION AND DUTIES.

(a) In General.--There is established within the Public
Health Service an agency to be known as the Agency for
Healthcare Research and Quality, which shall be headed by a
director appointed by the Secretary. The Secretary shall carry
out this title acting through the Director.

* * * * * * *

SEC. 902. GENERAL AUTHORITIES.

(a) In General.--In carrying out section 901(b), the
Director shall conduct and support research, evaluations, and
training, support demonstration projects, research networks,
and multidisciplinary centers, provide technical assistance,
and disseminate information on health care and on systems for
the delivery of such care, including activities with respect
to--

* * * * * * *

(g) Annual Report.--Beginning with fiscal year 2003, the
Director shall annually submit to the Congress a report
regarding prevailing disparities in health care delivery is it
relates to racial factors and socioeconomic factors in priority
populations.

SEC. 903. PROGRAM FOR PAIN MANAGEMENT AND PALLIATIVE CARE RESEARCH AND
QUALITY.

(a) In General.--Subject to subsections (e) and (f) of
section 902, the Director shall carry out a program to
accomplish the following:
(1) Promote and advance scientific understanding of
pain management and palliative care.
(2) Collect and disseminate protocols and evidence-
based practices regarding pain management and
palliative care, with priority given to pain management
for terminally ill patients, and make such information
available to public and private health care programs
and providers, health professions schools, and
hospices, and to the general public.
(b) Definition.--In this section, the term ``pain
management and palliative care'' means--
(1) the active, total care of patients whose disease
or medical condition is not responsive to curative
treatment or whose prognosis is limited due to
progressive, far-advanced disease; and
(2) the evaluation, diagnosis, treatment, and
management of primary and secondary pain, whether
acute, chronic, persistent, intractable, or associated
with the end of life;
the purpose of which is to diagnose and alleviate pain and
other distressing signs and symptoms and to enhance the quality
of life, not to hasten or postpone death.

* * * * * * *