[Congressional Record (Bound Edition), Volume 145 (1999), Part 21]
[Senate]
[Pages 30569-30572]
[From the U.S. Government Publishing Office, www.gpo.gov]



                       PAIN RELIEF PROMOTION ACT

  Mr. NICKLES. Madam President, on June 23, 1999, Senator Lieberman and 
I introduced S. 1272, the Pain Relief Promotion Act, which addresses 
two specific concerns. First, it provides federal support for training 
and research in palliative care. Second, it clarifies federal law on 
the legitimate use of controlled substances. On October 27, 1999 the 
House passed its companion measure H.R. 2260 by the resounding 
bipartisan vote of 271 to 156. It is my hope that the Senate will soon 
have the opportunity to debate and vote on this important legislation.
  In anticipation of that debate, and in light of inaccurate 
characterizations of the second aspect of our bipartisan legislation, I 
believe it is important for me to ensure that the record reflects 
precisely how this bill will--and will not--affect current federal law 
with regard to Drug Enforcement Administration (DEA) oversight of the 
use of federally controlled substances.
  To understand the effect the Pain Relief Promotion Act will have on 
pain control, we must begin with what the law is now. The Controlled 
Substances Act, CSA, of 1970 charged the DEA with the responsibility of 
overseeing narcotics and dangerous drugs--including powerful 
prescription drugs which have a legitimate medical use but can also be 
misused to harm or kill. In asserting its authority over these drugs, 
Congress declared in the preamble of the Controlled Substances Act of 
1970 that ``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'' (21 U.S.C. 801 (6)).
  In 1984, Congress amended the CSA due in part to a specific concern 
regarding the misuse of prescription drugs in lethal overdoses. The 
then Democratic-controlled House and a Republican Senate further 
strengthened the Act, empowering the DEA to revoke a physician's 
federal prescribing

[[Page 30570]]

license if he or she uses it to endanger ``health and safety'' 
regardless of whether state law has been violated (21 U.S.C. 824, 
referencing 21 U.S.C. 823). The chairman of the Health subcommittee in 
the House agreed: ``Drugs legally manufactured for use in medicine are 
responsible for a substantial majority of drug-related deaths and 
injuries'' (Rep. Waxman, Hearing of July 31, 1984, Hearing Record No. 
98-168, p. 365). Congress' view was that while the states are the first 
line of defense against misuse of prescription drugs, the Federal 
Government must have its own objective standard as to what constitutes 
such misuse--and it must have the authority to enforce that standard 
when a state cannot or will not do so. Congress' 1970 and 1984 
decisions have been upheld time and time again by federal courts.
  It is clear that federal law is intended to prevent use of these 
drugs for lethal overdoses, and contains no exception for deliberate 
overdoses approved by a physician. Nowhere in the Controlled Substances 
Act has death or assisting death ever been considered a ``legitimate 
medical purpose'' for use of these drugs. In the past, physicians who 
were involved in the use of these drugs for suicide or other lethal 
overdoses have lost their federal authority to prescribe controlled 
substances on the grounds that they had endangered ``health and 
safety.''
  In 1997, Congress passed the Assisted Suicide Funding Restriction Act 
of 1997 without a dissenting vote in the Senate and by an overwhelming 
margin of 398-16 in the House. President Clinton stated in signing the 
bill that ``it will allow the Federal Government to speak with a clear 
voice in opposing these practices.'' He further warned that ``to 
endorse assisted suicide would set us on a disturbing and perhaps 
dangerous path.'' I would add only that authorizing a federal agency to 
endorse the use of controlled substances for assisted suicide would 
similarly ``set us on a disturbing and perhaps dangerous path.''
  In November 1994, the State of Oregon adopted by referendum the so-
called ``Death with Dignity Act,'' allowing physicians to prescribe 
medication for the purpose of assisting patients' suicides. The week of 
that vote, Professor George Annas of Boston University pointed out the 
inconsistency between the Oregon referendum and the Controlled 
Substances Act in an article in the New England Journal of Medicine. He 
questioned whether such a state law was compatible with existing 
federal laws governing federally controlled drugs, ``since the drafters 
of the federal statute certainly did not have this purpose [assisting 
suicides] in mind.''
  However, on June 5, 1998, overturning a previous determination by her 
own DEA Administrator, the Attorney General issued a letter carving out 
an exception for Oregon so it can use federally-controlled substances 
for assisted suicide. She claimed that Congress did not ``intend to 
override a state determination as to what constitutes legitimate 
medical practice in the absence of a federal law prohibiting that 
practice.'' The Pain Relief Promotion Act will respond to the Attorney 
General's challenge, by clarifying that the intentional misuse of these 
drugs to cause patients' deaths is not authorized by Congress in any 
state, nor has it ever been.
  On October 27, 1997, Oregon's ``Death with Dignity Act'' became 
effective. In the first year at least 15 patients have committed 
suicide with doctor's assistance under the new Oregon law. We really do 
not know the total number, because all reporting of cases is left 
completely in the hands of the doctors themselves, and the Oregon 
Health Division admits it has no idea how many unreported cases there 
are. But regarding those 15 reported cases we know one thing: Every one 
of those patient's deaths was caused by a federally controlled 
substance, prescribed with a federal DEA registration number, using 
federal authority. Today, without any decision to this effect by 
Congress or the President, the federal government is actively involved 
in assisting suicides in Oregon.
  To hear some of the critics of this bill you might think that the 
Pain Relief Promotion Act creates a new authority on the part of the 
DEA to revoke doctors' registrations if they use controlled substances 
to assist suicide. On the contrary that authority has existed for 29 
years and it exists now. Attorney General Janet Reno was very clear on 
this matter in her letter of June 5, 1998: ``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.''
  What does this mean for current law and practice? First, the DEA has 
full authority to revoke a DEA registration for assisting suicide in 
any of the 49 states where assisting suicide is not authorized by state 
law. While critics of the Pain Relief Promotion Act have said that 
empowering the DEA to investigate physicians in such cases will have a 
``chilling effect'' on the treatment of pain, the fact is that such 
authority already exists in 49 states.
  What about the one State, Oregon, where the Attorney General said the 
DEA will not take adverse actions against physicians for assisting 
suicide in compliance with the Oregon law? Even in Oregon many cases of 
assisting suicide remain illegal under state law. The state law 
authorizes assisting the suicide of those who are terminally ill, but 
not others. Under the Attorney General's determination, then, the DEA 
can continue to review cases of assisting suicide to make sure they do 
not involve those who are not terminally ill, and it can scrutinize 
whether a given use of pain medication was really intended to assist 
suicide. All aspects of the Oregon guidelines for legally valid 
assisted suicide are also subject to DEA investigation, since the 
Attorney General has only authorized physicians to use federally 
controlled drugs for assisted suicides when they fully comply with 
those state guidelines.
  Thus, as interpreted by the Attorney General, a registration to 
prescribe federally controlled substances can be revoked under the 
current Controlled Substances Act if these substances are used to 
assist suicide in any state in the Nation, with the exception of 
certain cases of assisted suicide that Oregon has legalized for the 
terminally ill. If DEA scrutiny of doctors' prescribing practices were 
going to ``chill'' the practice of pain control, that would already be 
occurring under current law.
  How does the Pain Relief Promotion Act impact this situation? It 
establishes that, for the first time in federal law, the use of 
controlled substances for the relief of pain and discomfort is a 
``legitimate medical purpose,'' even if the large doses used in 
treating pain may unintentionally hasten death. Intentionally causing 
death or assisting in causing death remains forbidden. Thus this bill 
does not increase the DEA's regulatory authority at all. On the 
contrary, its only effect in 49 states (and even in Oregon, in cases 
involving those who are not terminally ill) is to provide new legal 
protection for physicians who prescribe controlled substances to 
control pain.
  In Oregon, this bill eliminates the Attorney General's artificial 
exception designed to accommodate assisted suicides that are no longer 
penalized under Oregon law. The DEA can meet its responsibility here 
simply by looking at the reports required by Oregon law, in which 
doctors must identify the drugs used to assist suicide. Those records 
will make it clear whether federally controlled drugs were used; and 
since the physician is clearly reporting that his or her own intent was 
to help cause death, there will be no question of murky intentions or 
ambiguity. Thus this bill will not lead to any increase in the DEA 
trying to ``second guess'' or infer physicians' intentions, even in 
Oregon.*****-*****- -Name: -Payroll No. -Folios: J1S/13-J1S/14 -Date: -
Subformat:
  What of any unreported cases in which physicians assist the suicides 
of terminally ill patients? Those assisted suicides are already a crime 
under Oregon law, and thus already subject to adverse action by the DEA 
as well

[[Page 30571]]

under the Attorney General's interpretation. Only if a physician 
officially reports the case to the Oregon Health Division is he or she 
exempted from state criminal penalties. So those cases are already 
covered by the same DEA authority that currently applies to assisted 
suicides in the other 49 states.
  Let me take this situation step by step.
  First, removing the Oregon exception to the existing nationwide 
policy cannot increase any ``chilling effect'' on pain relief outside 
of Oregon, because the bill does not increase one iota the authority of 
the DEA to investigate the misuse of controlled substances to assist 
suicide outside of Oregon. In fact, in those states its only effect is 
to provide a more explicit ``safe harbor'' for the practice of pain 
control, which is a significant advance and improvement for doctors and 
terminally ill patients. This is also true of assisted suicide cases 
within Oregon that do not comply with the state's reporting 
requirements or other guidelines. In all these cases, the Pain Relief 
Promotion Act gives the DEA no new mandate to investigate cases of 
assisted suicide more directly. Rather, it is expected to follow its 
longstanding practice of generally deferring to state authorities and 
allowing them to take the lead in investigating possible wrongdoing.
  Second, no new questioning of physicians' intentions is warranted to 
address the cases of assisted suicide that are now permitted under 
Oregon law. To be free of criminal penalties under state law in Oregon, 
a doctor who assists a suicide must submit a report to Oregon 
authorities that includes information on the drugs prescribed to assist 
the suicide. The Drug Enforcement Administration, DEA, can obtain those 
reports from the Oregon authorities. It already has the authority to 
subpoena them, if necessary; again, our legislation has no impact on 
this.
  Thus, even in Oregon, this bill will not result in any increase in 
DEA oversight or investigations of doctors based on their prescribing 
patterns or the dosages they use for particular patients. This is 
clearly stated in the House Judiciary Committee report on this bill, H. 
Rep. 106-378 Pt. 1, pp. 12-13.
  It follows that if this bill is enacted, any doctors in Oregon who 
prescribe controlled substances for pain relief need not fear any 
increase in DEA scrutiny of their practices, and therefore should not 
in any way be deterred from prescribing adequate pain relief.
  This bill cannot have a ``chilling effect'' on pain control, but will 
have the opposite effect. For the first time, it will place in the 
Controlled Substances Act, as the American Society of Anesthesiologists 
notes, ``recognition that alleviating pain in the usual course of 
professional practice is a legitimate medical purpose for dispensing 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.'' 
The American Medical Association says this bill, ``provides a new and 
important statutory protection for physicians prescribing controlled 
substances for pain, particularly for patients at the end of life.'' As 
the American Academy of Pain Management observes, this will protect the 
ability of ``prescribers to relieve pain without fear of regulatory 
discipline.''
  Those who are concerned about the possibility of a negative impact on 
pain relief if we pass this bill need to answer this question: do they 
believe that now the Drug Enforcement Administration is having a 
chilling effect on pain relief because federally controlled substances 
cannot be used to assist suicide in 49 states and even, in many cases, 
in Oregon?
  If the answer is ``no,'' then there is no basis to be concerned about 
this bill--for this bill will not increase investigations or oversight 
into the dosages of drugs used for pain relief, and in fact instructs 
the DEA to be even more sensitive to physicians' need to prescribe 
large doses of these drugs for pain control.
  If the answer is ``yes,'' then there is a great need for this bill--
because for the first time it adds specific protections for doctors who 
prescribe controlled substances for pain control--resulting in a 
decrease in any ``chilling effect'' that may exist under current law.
  Let me quote from the American Medical Association:

       The bill would not expand existing criminal penalties in 
     the CSA for persons whose unauthorized use of a controlled 
     substance leads to someone's death. . . . The bill would not 
     expand the DEA's authority concerning jurisdiction, 
     investigations or enforcement regarding the CSA. In fact, the 
     inclusion of a recognition of the ``double effect'' in the 
     CSA provides physicians in all jurisdictions an additional 
     statutory protection in cases of alleged [physician-assisted 
     suicide]. The bill has the potential, through its educational 
     provisions, of sensitizing law enforcement personnel to the 
     multiple issues of end-of-life care and prescribing.

  It is noteworthy that although the Justice Department expressed 
concern about the portion of the bill that would prevent the use of 
federally controlled substances to assist suicide in Oregon, it agrees 
that the bill would aid, and not hinder, pain relief. In a letter dated 
October 19,1999, the Justice Department wrote that the bill ``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. The Department accordingly supports those portions of 
[the bill] addressing palliative care.''
  This bill makes it easier, not harder, to use controlled substances 
to relieve pain. That is why so many major medical organizations, 
including the National Hospice Organization, the American Academy of 
Pain Management and the American Society of Anesthesiologists, as well 
as the AMA, strongly support its enactment.
  Some may wish to abolish the Controlled Substances Act altogether. 
They may think that the federal government's longstanding insistence on 
monitoring the distribution of these powerful drugs is an unwarranted 
intrusion into medical practice. I disagree with that stand, but at 
least it can be understood as a consistent position. What is untenable 
is the claim that this particular bill, which clearly improves the 
law's sensitivity to medical judgments on pain control, somehow 
mysteriously worsens that situation. Once we understand what the 
current law is and what this bill does, that claim simply does not make 
sense.
  In short, the Pain Relief Promotion Act will foster pain control. It 
will improve existing law by adding significant new legal protections 
for physicians and pharmacists who prescribe and dispense controlled 
substances for pain control. It will reduce, and in no way increase, 
any possible ``chilling effect" that could deter adequate pain control. 
And by clarifying federal law so the federal government will not 
facilitate the medical institutionalization of assisted suicide in any 
state, this legislation may help discourage doctors from simply 
suggesting assisted suicide instead of working to address their 
patients' real problems of uncontrolled pain. As protectors of public 
health and safety we should be encouraging doctors to kill the pain, 
not the patient.
  Madam President, I ask unanimous consent that the following two 
editorials be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

              [From the Wall Street Journal, Nov. 4, 1999]

                    Don't Kill the Pain-Relief Bill

                          (By Wesley J. Smith)

       Last week, by a vote of 271-156, the House approved the 
     Pain Relief Promotion Act, designed to promote effective 
     medical treatment of pain while deterring the misuse of 
     narcotics and other controlled substances for assisted 
     suicide. The bill's passage prompted an outpouring of 
     hyperbole and misinformation from opponents. Here are the 
     facts about the act:
       It would not outlaw assisted suicide, Critics accuse 
     Congress of ``overturning'' Oregon's assisted-suicide 
     referendum. Would that it did. In fact, the act would outlaw 
     only the intentional use of controlled substances to cause 
     death. Lethal substances not controlled by federal drug 
     regulations could still be prescribed legally on Oregon for 
     use in assisted suicide.
       It would not interfere with states' rights. Under the 
     Controlled Substances Act the federal government, not the 
     states, has the authority to determine what is and is not a 
     proper medical use of the drugs specified in

[[Page 30572]]

     the act. Thus, as an editorial in the (Portland) Oregonian 
     noted, it is the Oregon law that ``barges into an area of 
     long-standing federal jurisdiction.'' Thus passage of the act 
     would return national uniformity to the enforcement of 
     federal drug laws.
       It merely reaffirms existing federal law. Because the act 
     declares that assisted suicide is not a ``legitimate medical 
     purpose'' under the Controlled Substances Act, critics have 
     wrongly accused supporters of granting new authority to the 
     Drug Enforcement Agency to punish doctors. In fact, DEA has 
     had that authority for nearly 30 years. Since 1980 it has 
     brought more than 250 enforcement actions for violating the 
     federal legal standard of ``legitimate medical purpose.''
       The medical community overwhelmingly favors it. Proponents 
     of the bill include the American Medical Association, the 
     National Hospice Organization, the Hospice Association of 
     America, the American Academy of Pain Management, the 
     American Society of Anesthesiologists and the American 
     College of Osteopathic Family Physicians. (True, support 
     isn't unanimous. Dissent within the medical community has 
     been led by the Rhode Island Medical Association.)
       It has broad bipartisan support. Seventy-one House 
     Democrats voted for the bill, and its Senate sponsors include 
     Joe Lieberman (D., Conn.), Chris Dodd (D., Conn.) and Evan 
     Bayh (D., Ind.).
       It would enhance pain control. If the act becomes law, pain 
     control will for the first time be specifically identified in 
     federal law as a proper use of controlled substances--even if 
     the use of pain-controlling drugs has the unintended side 
     effect of causing death. That is a much-needed legal reform, 
     because many doctors fail to treat pain aggressively because 
     they fear the government's second-guessing. Several states 
     have recently passed similar laws, leading to dramatic 
     increases in the use of morphine and other palliative 
     medications.
       The Pain Relief Promotion Act looks likely to pass the 
     Senate. If President Clinton truly feels our pain, he will 
     sign it the moment it hits his desk.
                                  ____


                   [From the Oregonian, July 1, 1999]

                    Kill the Pain, Not the Patients


 Congress should allow doctors to use controlled drugs for aggressive 
                   pain treatment instead of suicide

       It's no secret to any reader of this space that we oppose 
     Oregon's venture into physician-assisted suicide.
       But last year, when the American Medical Association and 
     the National Hospice Organization came out against a bill in 
     Congress giving medical review boards the power to deny or 
     yank the federal drug-prescribing license to physicians who 
     prescribed these drugs to assist in suicides, we took their 
     concerns seriously.
       The groups argued that the proposed law could reverse 
     recent advances in end-of-life care. Doctors might become 
     afraid to prescribe drugs to manage pain and depression--
     things that, when uncontrolled, can lead the terminally ill 
     to consider killing themselves in the first place. We thought 
     then that the problem could be worked out and that it was 
     possible to keep doctors from using federally controlled 
     substances to kill their patients without also preventing 
     them from relieving their terminally-ill patients' agonies.
       This Congress's Pain Relief Promotion Act proves it, and 
     the proposed legislation comes not a moment too soon. A new 
     report by the Center for Ethics in Health Care at Oregon 
     Health Sciences University shows that end-of-life care in 
     Oregon--which fancies itself a leader in this area--is far 
     from all it should be. Too many Oregonians spend the last 
     days of their life in pain.
       There's no real need for that--and the Pain Relief 
     Promotion Act of 1999 would go a long way toward addressing 
     these systemic and professional failures here and elsewhere. 
     The proposal would authorize federal health-care agencies to 
     promote an increased understanding of palliative care and to 
     support training programs for health professionals in the 
     best pain management practices. It would also require the 
     Agency for Health Care Policy and Research to develop and 
     share scientific information on proper palliative care.
       Further, the Pain Relief Promotion Act would clarify the 
     Controlled Substances Act in two essential ways.
       One, it makes clear that alleviating pain and discomfort is 
     an authorized and legitimate medical purpose for the use of 
     controlled substances.
       Two, the bill states that nothing in the Controlled 
     Substances Act authorizes the use of these drugs for assisted 
     suicide or euthanasia and that state laws allowing assisted 
     suicide or euthanasia are irrelevant in determining whether a 
     practitioner has violated the Controlled Substances Act.
       Technically, of course, the bill does not overturn Oregon's 
     so-called Death with Dignity Act. But it would thwart it, for 
     all practical purposes, because it makes it illegal for 
     Oregon doctors to engage in assisted suicide using their 
     federal drug-prescribing license. Suicide's advocates may 
     think of some other method, but none seems obvious.
       Is this a federal intrusion on a state's right to allow 
     physician-assisted suicide or euthanasia?
       To hear some recent converts to states' right talk, you 
     might think so. But you could just as easily argue that 
     Oregon's assisted suicide law intrudes on the federal domain. 
     The feds have long had jurisdiction over controlled 
     substances, even as states kept the power to regulate the way 
     physicians prescribe them. At best, it's a gray area.
       You'll recall that the Department of Justice declined to 
     assert a federal interest in all of this when it plausibly 
     could have, shortly after Oregon voters approved assisted 
     suicide. It's probably better--and high time--that Congress 
     asserts that interest explicitly.
       This act would establish a uniform national standard 
     preventing the use of federally controlled drugs for assisted 
     suicide. That, in itself, should advance the national debate 
     on this subject in a more seemly way than, say, the recent 
     efforts of Dr. Jack Kervorkian.
       Beyond that, it's high time that Congress made clear that 
     improved pain relief is a key objective of our nation's 
     health-care institutions and our Controlled Substances Act. 
     The Pain Relief Promotion Act will do all this. No wonder the 
     American Medical Association and the National Hospice 
     Organization are now on board.

                          ____________________