[Congressional Record Volume 146, Number 65 (Tuesday, May 23, 2000)]
[Senate]
[Pages S4311-S4313]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. WYDEN:
  S. 2607. A bill to promote pain management and palliative care 
without permitting assisted suicide euthanasia, and for other purposes; 
to the Committee on Health, Education, Labor, and Pensions.


                       Pain Relief Promotion Act

 Mr. WYDEN. Mr. President, today I am introducing legislation 
which was actually authored by Senators Nickles and Hatch, and which 
they have entitled the ``Pain Relief Promotion Act.'' Their bill which 
I am now introducing is identical to H.R. 2260 as reported out of the 
Judiciary Committee on April 27, 2000, as amended. Today, it has been 
referred by the Senate Parliamentarian to the Committee on Health, 
Education, Labor, and Pensions (HELP).
  While I remain steadfastly opposed to the ``Pain Relief Promotion Act 
of 2000,'' I am introducing this bill for one reason: to call the 
Senate's attention to the fact that a far-reaching health policy bill--
which many experts believe has the potential to sentence millions of 
sick and dying patients across the nation to needless pain and 
suffering--was mistakenly referred to a committee with insufficient 
health policy resources and no health policy jurisdiction. It is that 
bill which the Judiciary Committee reported and which, without 
consideration by the committee with health expertise, the Republican 
leadership wants to bring to the floor. The unintended consequence of 
this could be the tragic decline of the quality of pain care across our 
nation.
  Some historical context might help my colleagues and their staff 
better understand how the Senate finds itself in this unfortunate 
situation, and the important issues that are at stake. On two separate 
occasions, the State of Oregon passed a ballot measure that would allow 
terminally ill persons, with less than six months left to live, to 
obtain a physician-assisted suicide if they met a variety of safeguard 
requirements. As a private citizen, I voted twice with the minority of 
my state in opposition to that measure.
  In response to Oregon's vote, several of our congressional 
colleagues, including Senator Nickles, Senator Lieberman, and 
Congressman Henry Hyde, promptly undertook legislative and other 
efforts to overturn Oregon's law. I do not, for the purposes of today, 
debate the merits of the Oregon law, or the merits of physician-
assisted suicide, generally.
  The original ``Pain Relief Promotion Act,'' S. 1272, was introduced 
in the Senate by Senator Nickles, and referred to the Committee on 
Health, Education, Labor and Pensions (HELP) on June 23, 1999. That 
committee held one inconclusive hearing on October 13, 1999, at which 
time it was reported that Senators on both sides of the aisle wished to 
investigate the matter more thoroughly before acting on the 
legislation.
  Then, on November 19, 1999, Bob Dove, the Senate Parliamentarian, 
made what he termed ``a mistake'' when he referred H.R. 2260-- the 
virtually identical House-passed version of the ``Pain Relief Promotion 
Act''--to the Senate Judiciary Committee. Over the course of my service 
in the Senate, I have come to know Mr. Dove to be a man of integrity 
and fairness, and one of the most dedicated and enduring public 
servants in Washington, D.C. When he discovered his mistake, to his 
great credit, Mr. Dove did something all-too-rare in this town; he 
simply acknowledged his error. According to an article by the 
Associated Press on December 7, 1999, Mr. Dove stated plainly that he 
had mistakenly referred the bill to the Judiciary Committee, instead of 
the HELP Committee.
  Lord knows I've made a few mistakes in my day, so I want to make 
clear that I harbor nothing but respect for Mr. Dove, and that I do not 
for one second question Mr. Dove's motives. But the mistake made on 
November 19, 1999, if left uncorrected, threatens unspeakably negative 
and long-lasting consequences for the future of health care in this 
nation.
  The jurisdiction of the HELP Committee over the ``Pain Relief 
Promotion Act'' is clear. The Senate Manual describes the jurisdiction 
of this committee as including ``measures relating to education, labor, 
health, and public welfare''. The Senate Manual also describes the HELP 
Committee as having jurisdiction over aging, biomedical research and 
development, handicapped individuals, occupational safety and health, 
and public health.
  According to the Senate Manual, the jurisdiction of the Judiciary 
Committee includes bankruptcy, mutiny, espionage, counterfeiting, civil 
liberties, constitutional amendments, federal courts and judges, 
government information, holidays and celebrations, immigration and 
naturalization, interstate compacts generally, judicial proceedings, 
local courts in territories and possessions, measures relating to 
claims against the United States, national penitentiaries, patent 
office, patents, copyrights trademarks, protection of trade and 
commerce against unlawful restraints and monopolies, revision and 
codification of the statutes of the United States, and state and 
territorial boundary lines.
  The committee jurisdiction is not a close call, in this case. As the 
Senate's leading expert on jurisdiction has now demonstrated, this bill 
is fundamentally an issue of medical practice, which clearly is within 
the jurisdiction of the HELP Committee.
  Congress has heard conflicting messages from respected medical 
experts on both sides of this debate about whether the ``Pain Relief 
Promotion Act'' may, in fact, have a chilling effect on physicians' 
pain management, thus actually increasing suffering at the end of life. 
Under the legislation, federal, state, and local law enforcement could 
receive training to begin scrutinizing physicians' end-of-life care. 
Many believe that the legislation sends the wrong signal to physicians 
and others caring for those who are dying, noting the disparity between 
the $5 million allotted for training in palliative care and the $80 
million potentially available for law enforcement activities.
  In addition, there is considerable concern that this legislation puts 
into statute perceptions about pain medication that the scientific 
world has been trying to change. Physicians often believe that the 
aggressive use of certain pain medications, such as morphine, will 
hasten death. Recent scientific studies show this is not the case. Dr. 
Kathleen M. Foley, Attending Neurologist in the Pain and Palliative 
Care Service at Memorial Sloan-Kettering Cancer Center and Professor of 
Neurology, Neuroscience and Clinical Pharmacology at the Cornell 
University, had this to say about the Nickles-Hatch legislation, ``In 
short, the underpinnings of this legislation are not based on 
scientific evidence. It would be unwise to institutionalize the myth 
into law that pain medications hasten death.''
  Renowned medical ethicist, and Director of the Center for Bioethics 
at the University of Pennsylvania, Arthur L. Caplan, Ph.D., also 
appeared before the Senate Judiciary Committee on April 25, 2000. He 
testified that: ``Doctors and nurses may not always fully understand 
what the law permits or does not, but when the issue requires an 
assessment of intent in an area as fraught with nuances and pitfalls as 
end of life care then I believe that this legislation will scare many 
doctors and nurses and administrators into inaction in the face of 
pain.''
  Dr. Scott Fishman, the Chief of the Division of Pain Medicine and 
Associate Professor of Anesthesiology at the University of California 
Davis School of Medicine wrote of the Hatch substitute: ``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.''
  Dr. Foley, who also assisted the Institute of Medicine committee that 
wrote the report ``Approaching Death,'' further testified that, ``The 
Pain Relief Promotion Act, by expanding the authority of the Controlled 
Substances Act, will disturb the balance that we have worked so hard to 
create. Physician surveys by the New York State Department of Health 
have shown that a strict regulatory environment negatively impacts 
physician prescribing practices and leads them to intentionally 
undertreat patients with pain

[[Page S4312]]

because of concern of regulatory oversight.''
  The New England Journal of Medicine editorialized against these 
legislative approaches to overturning Oregon's law out of concern for 
its impacts on pain management nationwide, saying: ``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 could make this bad situation worse.''
  It is worth noting that many people and organizations with expertise 
in pain management and palliative care are both opposed to physician 
assisted suicide and opposed to the Nickles-Hatch bill. There are over 
thirty organizations representing doctors, pharmacists, nurses, and 
patients who oppose the legislation, including: 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; and, Oregon Hospice Association.
  Physician-assisted suicide is not a cry for help from people 
experiencing the failure of patents, copyrights and trademarks. 
Physician-assisted suicide is a cry for help from people who, in many 
cases, are experiencing a failure in the health system. And those 
failures occur across our nation; not just in Oregon. In one study 
reported in the August 12, 1998, issue of JAMA, over 15 percent of 
oncologists admitted to participating in physician-assisted suicide or 
euthanasia. The February 1997 New England Journal of Medicine published 
a report finding that 53 percent of physicians in a large, San 
Francisco-based AIDS treatment consortium admitted assisting in a 
suicide at least once. Personally, I am troubled and saddened that so 
many of our loved ones are so dissatisfied with their end-of-life 
options that they seek physician-assisted suicide, instead.
  Whether or not this Congress decides to overturn Oregon's law, I 
believe it is critical that whatever we do must result in a reduced 
demand for physician-assisted suicide, not only in Oregon, but across 
our nation. Many reputable experts believe the ``Pain Relief Promotion 
Act'' will cause physicians--far beyond Oregon's borders--to provide 
less aggressive pain care to their suffering and dying patients. If 
this occurs, not only will millions of our elderly and dying 
constituents suffer needlessly, we may unwittingly increase the demand 
for suicide at the end of life.
  I urge my colleagues, regardless of where they stand on the issue of 
Oregon's law, to join with me in supporting the restoration of the HELP 
Committee's jurisdiction. It would be unconscionable for the Senate to 
fail to correct an honest mistake that could contribute to a 
devastatingly significant change in health policy. With so much at 
stake, shouldn't we follow the regular order of the Senate? Shouldn't 
we insist that the Senate's best qualified health policy experts fully 
consider the complex policy implications before taking such an 
extraordinary risk for our constituents, our friends, and our families?
  Mr. President, I ask unanimous consent that the text of the bill be 
printed in the Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 2607

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     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

[[Page S4313]]

     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.
                                 ______