THE BIG CHILL - INSERTING THE DEA INTO END-OF-LIFE CARE

On October 5, 2005, the U.S. Supreme Court heard oral arguments in
Gonzales v. Oregon. On the surface, this case is about the legitimacy
of physicians' prescribing of medications under Oregon's Death with
Dignity Act and whether the federal government can overrule the
states in defining "legitimate medical practice." Just beneath the
surface, however, lies the risk of empowering agents of the Drug
Enforcement Agency (DEA) - whose traditional role is to prevent drug
abuse and diversion - to evaluate the end-of-life practices of
physicians whose patients die while receiving prescribed opioids or
barbiturates. A finding in favor of the Justice Department would not
only nullify the Death with Dignity Act, permitting the DEA to
penalize physicians for providing medications to hasten the deaths of
terminally ill patients, but also have a chilling effect on
physicians' willingness to treat patients' terminal symptoms.

Uncontrolled pain and other distressing symptoms are the primary
concerns and greatest fears of patients facing serious illness.(1)
More than 90 percent of the pain associated with severe illness can
be relieved if physicians adhere to well-established guidelines and
seek help, when necessary, from experts in pain management or
palliative care. For the infrequent instances in which all palliative
care alternatives have been exhausted without providing adequate
relief from the symptoms of advanced terminal disease, there is a
growing consensus that sedation to the point of comfortable sleep is
permissible.(2) Despite the efficacy of opioids and a commitment by
the medical profession to treat pain, abundant evidence suggests that
patients' fears of undertreatment of distressing symptoms are
justified.1 Although a lack of proper training and overblown fears of
addiction contribute to such undertreatment, physicians' fears of
regulatory oversight and disciplinary action remain a central
stumbling block.(3)

Several initiatives have lessened the adverse effects of regulatory
constraints on symptom management.(4) Many legislatures and
regulatory boards have adopted model pain statutes that encourage
compliance with established standards for the prescribing of
pharmacologic agents for pain and other symptoms and that protect
physicians who observe these guidelines from regulatory intrusion and
possible prosecution. Other states have simplified or eliminated
special prescribing rules (such as those requiring the use of
triplicate prescription pads) that were designed to control and
monitor prescribing but that had the (presumably unintended) effect
of discouraging all prescribing of controlled substances. California
now requires training in pain management and palliative care as a
condition of licensure.

Two cases in California highlight the legal consequences of
physicians' undertreatment of pain, providing a counterweight to the
fear of legal vulnerability for the prescribing of controlled
substances.(5) In 2001, in Bergman v. Chin, a jury found that a dying
patient had received inadequate pain management and convicted the
treating physician under the state's elder-abuse statute, awarding
the patient's family $1.5 million.

In 2003, in Tomlinson v. Bayberry Care Center, charges of inadequate
pain management were brought successfully against both the treating
physician and the patient's nursing home. Both cases demonstrate
that, in addition to representing an unacceptably poor quality of
care, the undertreatment of pain may carry legal risks and consequences.

Nevertheless, physicians continue to believe that regulatory
oversight translates into a high risk of disciplinary action for
prescribing opioids and other controlled substances. Consider the
following cases.

Patient 1, a young man, became acutely ill with an aggressive but
highly treatable cancer that caused severe acute chest pain. Since he
had to make quick and extremely difficult decisions about his
treatment options, he sought advice and pain medication from his
trusted primary care physician - only to learn that his physician,
wishing to be spared any possibility of regulatory suspicion, had
never applied for prescribing privileges for strong opioids.

At this critical juncture, the patient, who is himself a physician,
had to find a new doctor in order to receive standard pain treatment.

Patient 2, a middle-aged woman with progressive cancer that had
metastasized to bone, had accelerating pain requiring increasing
doses of morphine.

She ran out of pain medicine earlier than anticipated, but her
physician refused to refill her prescription for fear that she was
using it too much and that he might be reviewed for overprescribing.
When she went to the emergency department with a pain crisis, a
palliative care consultant recognized that her worsening pain and
increased morphine requirements were caused by the progression of cancer.

With a moderate increase in her dose, satisfactory pain control was
achieved, and the patient went home to live out her final months in
relative comfort.

Patient 3 had advanced metastatic lung cancer and had been receiving
opioids at home when he was admitted to the hospital with new
metastases to his thoracic spine.

He was confused, could not move his legs, had difficulty breathing,
and was in excruciating pain - screaming whenever he moved and
grimacing with each breath.

He was near death, and the primary goal of medical care was to
control pain, agitation, and dyspnea.

He was given a subcutaneous infusion of opioids at an equianalgesic
dose 30 percent higher than his usual dose, and the nurses were
instructed to give him another dose, equal to 10 percent of the total
daily dose, "as needed" every half hour if he appeared to be in pain
(the proper approach, according to standard guidelines). But several
nurses and physicians refused to give the "as needed" doses, despite
evidence of continuing distress, because they feared hastening his death.

Ethics and palliative care consultants were called in, and they
refocused the team on the professional obligation to relieve pain and
suffering.

The patient died hours after receiving the additional doses, and some
staff members remained unsettled about whether they might have been
legally liable for "causing" his death.

For better or for worse, the DEA sets the tone and drives physicians'
perceptions about the legal risk associated with prescribing Schedule
2 drugs (potentially addictive drugs with critical medical uses) for
seriously ill and dying patients.

Concerns about regulatory oversight have led some physicians, such as
Patient 1's provider, to avoid prescribing opioids entirely and have
rendered others, such as the physicians of Patients 2 and 3, fearful
or hesitant.

It is likely that such physicians will be further intimidated if the
role of the DEA is expanded as the federal government proposes - and
the risk of the inadequate management of symptoms during serious
illness will increase.

Two other attempts by the federal government to invalidate Oregon's
Death with Dignity Act preceded Gonzales v. Oregon. The first was the
Lethal Drug Abuse Prevention Act, which a year later was repackaged
as the Pain Relief Promotion Act (PRPA) of 1999. The PRPA contained
some valuable provisions that would have encouraged education and
research in pain management and palliative care, but the primary
purpose of both acts was to make prescribing controlled substances
under the Oregon law a violation of the Controlled Substances Act.

Although the regulation of medical practice is the legal province of
the states, the PRPA would have allowed the federal government to
undermine state law by making it a crime for physicians to provide
medications that humanely hasten death.

Furthermore, the PRPA would have empowered the DEA to investigate
whether or not such a violation had occurred, raising the specter of
DEA oversight of every death of a patient who had received
barbiturates or opioids.

After an outcry from both advocates and opponents of assisted
suicide, all of whom recognized the danger such legislation posed to
the practice of pain management and palliative care, the PRPA died in
committee.

Then, in November 2001, U.S. Attorney General John Ashcroft issued a
directive suggesting that the prescription of Schedule 2 medications
under the Oregon law violates the Controlled Substances Act, since
"assisting in a suicide is not a 'legitimate medical purpose.'" The
State of Oregon and several interested parties challenged this
directive, arguing that the definition of legitimate medical practice
is a responsibility of the states, not a function of the Controlled
Substances Act. If passed, this directive would allow the federal
government to overrule established state law, empower the DEA to
investigate whether a violation had occurred, and potentially open to
investigation every instance of prescribing of a controlled substance
for a dying patient.

The U.S. Court of Appeals for the Ninth Circuit supported the
arguments made by the State of Oregon, and the case was recently
heard by the Supreme Court. The Court has not yet announced its decision.

This type of DEA involvement in medical practice would adversely
affect far more patients than those few who seek assistance with a
hastened death in Oregon. If the government thus oversteps its
legitimate role and expertise, allowing DEA agents, trained only to
combat criminal substance abuse and diversion, to dictate to
physicians what constitutes acceptable medical practice for seriously
ill and dying persons, it will undermine palliative care and pain
management for the much larger number of seriously ill patients in all states.

Physicians may become hesitant to prescribe the best available
medications to manage the pain, agitation, and shortness of breath
that sometimes accompany the end stages of illness.

As a result, they may, in essence, abandon patients and their
families in their moment of greatest need.

SOURCE INFORMATION

Dr. Quill is a professor of medicine, psychiatry, and medical
humanities and the director of the Center for Palliative Care and
Clinical Ethics at the University of Rochester School of Medicine,
Rochester, N.Y.; Dr. Meier is a professor of geriatrics, medicine,
and medical ethics and the director of the Lilian and Benjamin
Hertzberg Palliative Care Institute and the Center to Advance
Palliative Care at the Mount Sinai School of Medicine, New York.

An interview with Dr. Quill and Dr. Meier can be heard at www.nejm.org.

REFERENCES

(1) Field MJ, Cassel CK, eds. Approaching death: improving care at
the end of life. Washington, D.C.: National Academy Press, 1997.

(2) Lo B, Rubenfeld GD. Palliative sedation in dying patients: "we
turn to it when everything else hasn't worked." JAMA 2005;294:1810-1816.

(3) Drayer RA, Henderson J, Reidenberg M. Barriers for better pain
control in hospitalized patients. J Pain Symptom Manage 1999;17:440-440.

(4) Gilson AM, Mauer MA, Joranson DE. State policy affecting pain
management: recent improvements and the positive impact of regulatory
health policies. Health Policy 2005;74:192-204

(5) Tucker KL. The debate on elder abuse for undertreated pain. Pain
Med 2004;5:214-217.