From The Journal of Palliative Medicine 1998
The
Double Effect of Pain Medication:
Separating
Myth from Reality
SUSAN ANDERSON FOHR, J.D., M.A.
The principle of double effect is used to justify the administration
of medication to relieve pain even though it may lead to the unintended,
although foreseen, consequence of hastening death by causing respiratory
depression. Although a review of the medical literature reveals that the risk of
respiratory depression from opioid analgesic is more myth than fact and that
there is little evidence that the use of medication to control pain hastens
death, the belief in the double effect of pain medication remains widespread.
Applying the principle of double effect to end-of-life issues perpetuates this
myth and results in the undertreatment of physical suffering at the end of life.
The concept of double effect of opioids also has been used in support of
legalization of physician-assisted suicide and euthanasia.
INTRODUCTION
In bioethics, the principle of double effect (PDE) is used to justify the
administration of medication to relieve pain even though it may lead to the
unintended, although foreseen, consequence of hastening death by causing
respiratory depression. For example, the Encyclopedia of Bioethics presents
as a standard illustration of the PDE the following scenario:
A physician seeks to alleviate a patient's pain by administering the
painkiller morphine but recognizes that the dosage is likely to shorten the
patient's life. The physician regrets this result but can avoid it only by so
reducing the dosage that the chemical will not have sufficient painkilling
effect.... The physician expects to kill but does not intend to do so .... 1
The PDE provides that an action with both a good and a bad effect is
ethically permissible if the following conditions are met:
1. The action itself must be morally good or at least indifferent.
2. Only the good effect must be intended (even though the bad or secondary
effect is foreseen).
3. The good effect must not be achieved by way of the bad effect.
4. The good result must outweigh the bad result.2
The PDE has its origins in Roman Catholic moral theology. In the paradigm
case, although a physician is not allowed to directly abort a fetus (even to
save the life of a woman), a physician is allowed to remove a diseased and
life-threatening uterus containing a fetus. Although the physician expects the
death of the fetus, he does not intend to kill it. Applying the PDE to the use
of pain medication, the good effect (pain control) is intended, whereas the bad
or secondary effect (hastening death) is foreseen but not intended.
The double effect of pain medication is a recurring theme in articles
discussing end-of-life issues. According to many commentators, the use of
medication to treat pain and other symptoms in terminally ill patients may
"hasten death,"3 "potentially" hasten death,4
"actually speed up the process of dying,"5 or
"indirectly and unintentionally contribute to a patient's death."6
One commentator even stated that in some cases, the unintended hastening of
death is the "unavoidable, known, and accepted consequence" of pain
medication.7 Another stated that the "unavoidable and accepted
consequence of [medication] may be to hasten death."8
Reading these articles, one would think that hastening death is an almost
unavoidable consequence of treating pain. Even if one accepts the PDE as
ethically correct, it is important to examine the medical reality behind it.
Does the use of opioids at the end of life cause respiratory depression? Are
patients dying sooner because their pain is treated?
If one accepts the application of the PDE in the administration of pain
medication at the end of life, one might argue that it makes little difference
whether the double effect of pain medication is real or not. However, the belief
in double effect does in fact affect the care of patients and results in
undertreatment of physical suffering at the end of life. The concept of double
effect also has been used in support of legalization of physician-assisted
suicide and euthanasia. Furthermore, using the PDE to justify using opioids to
treat pain in dying patients contributes to the belief in the double effect of
pain medication, which in turn leads to fear of hastening death and the
undertreatment of pain.
OPIOID-INDUCED RESPIRATORY DEPRESSION:
FACTS AND MYTHS
The double effect of pain medication is often discussed in the context of the
terminal cancer patient. Two thirds of cancer patients with far advanced disease
have significant pain that requires the use of analgesics.9 The World
Health Organization (WHO) has proposed the use of an "analgesic
ladder" in treating cancer pain, using in sequence a non-narcotic, a weak
opioid, and a strong opioid.10 The experience of the hospice movement
has proved the efficacy of the use of opioids to treat pain in cancer patients,
and professional organizations have published position papers recommending
regular and adequate use of opioid analgesics for the pain of advanced cancer.11,12
Because respiratory depression is potentially life threatening, it is
considered the most serious opioid side effect and is of great concern to
physicians and nurses. Opioids can depress both the rate and depth of
respiration. Although respiratory arrest is possible, it occurs in combination
with mental clouding and somnolence, allowing for a reduction or discontinuation
of medication if these symptoms develop. Naloxone hydrochloride can be given to
counteract the respiratory depressant effects of opioids, but it also reverses
the analgesic effect and so should be titrated carefully.13
An excessive dose can, of course, cause respiratory depression. The dose
should be titrated to give the minimum dose necessary to achieve pain control.
The risk of respiratory depression is greatest when opioids are first begun.14
Tolerance to the respiratory side effects develops rapidly, allowing
"aggressive upward dose titration."15 Patients in pain also
respond differently to opioids than do persons without pain. Pain acts as a
natural antagonist to the respiratory depressant effect of opioids. As pain
increases, the level of opioid necessary for relief goes up, but so does the
tolerance to respiratory side effects.14 If tolerance to the
analgesic effect of an opioid occurs, analgesia may be safely obtained by upward
titration of the dose because there are "parallel curves for the
development of tolerance to the analgesia and to respiratory depression."16
With careful titration, even very large doses may be safely administered."17
Data on the clinical importance of opioid-induced respiratory depression come
from three sources. One body of literature has addressed the effect of opioids
in drug addicts, patients with acute postoperative pain, and volunteers without
pain who received a single opioid dose. Although this literature has clearly
established that opioid use can lead to respiratory depression, much of this
data may not be relevant to dying patients receiving opioids for chronic pain
relief.14
A second source of data is derived from clinical studies evaluating oral and
parenteral opioid use in cancer patients with chronic pain. In 1982, Twycross
noted the results of a study by Walsh of seven cancer patients who were pain
free on morphine and who did not have depressed respiratory rates or elevated
arterial carbon dioxide pressure (Pac02).18
A clinical study by Citron et al.
published in 1984 examined the safety of 15 courses of continuous intravenous
morphine in 13 patients.19 After changes in arterial oxygen pressure
and arterial carbon dioxide pressure during the first 24 hours in a minority of
patients, blood gas levels tended to remain at or return toward baseline values.
Although continuous morphine infusion tended to decrease the respiratory rate,
only bradypnea in the presence of marked somnolence (which occurred in one
patient) was a cause for dose reduction. The authors concluded that
"continuous intravenous morphine is a safe and effective means of relieving
pain, even in patients with borderline pulmonary status."
Because he found reports of respiratory
depression being uncommon in patients receiving oral morphine to be
"surprising in view of the known effect of opiates on respiratory
function," Walsh in 1984 conducted a prospective study of 20 patients who
had been receiving morphine for at least 7 days. Finding an elevated PaC02 in
only one patient, he concluded that "chronic ventilatory failure appears to
be neither common nor severe when oral morphine is used to treat chronic severe
pain in advanced cancer-even in the presence of pre-existing respiratory tract
disease."20
Grond et al. studied the efficacy of the WHO
cancer pain guidelines in 401 dying patients in Germany. They found the use of
drugs according to WHO guidelines to be an "efficacious, safe, and simple
method for relief of cancer pain until death." Of the 70% of the patients
who needed opioids to control pain, none showed clinical signs of respiratory
depression.21
A third, and much larger source of
information, comes from the extensive clinical experience reported by recognized
experts in cancer pain, hospice, and palliative care. In 1982, writing about his
experiences at Sir Michael Sobell House, a hospice in Great Britain, Twycross
referred to the fear of respiratory depression as one of a number of myths that
overemphasize the dangers of morphine. Even with large doses of morphine,
respiratory depression "is rarely seen" because pain is a powerful
antagonist to respiratory depression. Twycross found that "The use of
morphine in the relief of cancer pain carries no greater risk than the use of
aspirin when used correctly" [emphasis in the original]. Rather
than hastening death, "the correct use of morphine is more likely to
prolong a patient's life ... because he is more rested and pain-free."22
Levy in 1985 stated that "Appropriately
prescribed narcotics rarely cause clinically significant respiratory
depression. The threshold for such depression is always above the sedative
threshold which itself is above the analgesic threshold. "23 K.
M. Foley, chief of the Pain Service at Memorial Sloan-Kettering Cancer Center,
stated that "respiratory depression is not a significant limiting factor in
the management of patients with pain because with repeated doses, tolerance
develops to this effect." Patients with pain can be treated "with
escalating doses without respiratory compromise."9 Portenoy and
Coyle, also from Memorial Sloan-Kettering Cancer Center, noted that respiratory
depression is "extremely rare," and "the development of new
respiratory symptoms is virtually never a primary drug effect in patients who
have been receiving stable doses or who are undergoing dose increases following
substantial prior opioid intake."15 Nevertheless, these
investigators pointed out that respiratory depression is a "constant
concern" of practitioners, who assume respiratory symptoms in cancer
patients to be opioid induced. Cancer patients who develop respiratory symptoms
usually have some other primary disease process. Even in those cases where
improved respiratory function follows treatment with naloxone, the respiratory
failure should not be assumed to be primarily drug related.
After treating some 2000 terminally ill
patients, Storey reported that shortness of breath and pain "can be
effectively palliated by administering narcotic analgesics," which can be
safely used "if the dose is carefully titrated against the symptom."24
And in an article by Silverman and Croker, respiratory depression is again
referred to as one of several myths about opioids. Respiratory depression
"is not clinically significant when patients are treated with regular doses
of oral narcotics."25
Hill noted that the fear of respiratory
depression is "greatly exaggerated" and "rarely occurs in
patients with severe pain." When respiratory depression occurs, it usually
is in "opioid-naive patients after acute administration of an opioid"
and is accompanied by sedation or mental confusion. Because tolerance to
respiratory depression develops rapidly, opioids can be used for chronic pain
"without significant risk."14
Bonica found that with proper titration,
clinically significant respiratory depression does not occur because "pain
is a powerful respiratory stimulant and counteracts the narcotic-induced
depression."26 According
to Cain and Hammes, the "feared shortening of life with side effects is not
likely."27 Inturrisi and Hanks found that opioids can be used
without "significant risk."13 Portenoy noted that for
cancer patients treated with chronic opioid therapy, serious respiratory
compromise is "exceedingly rare."28 And Cundiff reported
that "with skillful management ... no evidence exists that [opioids]
shorten life."29
Dahl, a pharmacologist, noted that
"Respiratory depression is one of the most feared and misunderstood
potential side effects of the opioids." Because pain is a stimulus to
respiration, "clinically significant respiratory depression is rare."30
And, Berry, a pharmacist, found respiratory depression to be "an often
stated but seldom observed side effect of opioid use." This is because pain
is "nature's own antidote to respiratory depression."31
REPORTED
CASES OF HASTENING DEATH
The literature contains little data to
support the belief that appropriate use of opioids hastens death in patients
dying from cancer and other chronic diseases. In their 1983 case report of a
patient dying of lung cancer, Meier and Cassel reported that "Narcotic
analgesics given in doses adequate to relieve pain suppressed her breathing,
threatening respiratory arrest and death.... Her breathing slowed and became
more shallow after each dose of narcotic."32 Nurses who were
uncomfortable with the administration of sufficient narcotic were reassigned.
Dosing adequate to relieve pain was continued, and the patient became
unresponsive and died 3 days later. Although members of the health care team
believed that adequate medication placed the patient at risk of an earlier
death, it is not clear from the facts as described that the patient died sooner
as a direct result of the narcotic analgesics. Moreover, in their discussion of
the case, the investigators noted that "only in very rare cases does the
administration of adequate pain medication pose a serious risk to life."
More recently, one of these authors, Meier, along with Manfredi and Morrison,
referred to the "myth that opioids, when used for the treatment of pain,
are associated with a substantial risk of respiratory depression and
death," and stated that "the clinical impression of those treating
pain in the terminally ill with opioids is that the patient's death is related
to the progression of the disease, not to the use of opioids, and that proper
treatment of pain may actually prolong life rather than hasten death."33
Cranford, a neurologist and ethicist, has
described the death of his wife's mother from lung cancer.34 Although
he was never the treating physician, he followed the case closely, and while a
thousand miles away, suggested a "treatment plan" (a course of comfort
medications) to the attending physician. Because radiation therapy was stopped
and a switch to morphine to treat her pain resulted in sedation and was followed
by death less than 12 hours later, Cranford was certain that they had hastened
her death. But he acknowledges that death was probably due to pneumonia
(discovered at autopsy), and it is not clear that the morphine she received
hastened her death.
Even when physicians and nurses intend to
hasten death, it is not clear that the medication given has this effect. Wilson
et al. studied why and how sedatives and analgesics were ordered and
administered during the withholding or withdrawal of life support.35
The patients in this study, the majority of whom were being removed from a
ventilator, were expected to die within hours, and physicians were more likely
to err on the side of too much rather than too little medication. Though almost
40% of intensive care unit physicians and nurses listed hastening death as a
reason (although never as the primary reason) for giving sedatives and
analgesics, the researchers found "no evidence that death actually was
hastened by the administration of drugs" and no evidence that "an
apparent intent to hasten death actually did hasten it ..." Of course, this
study did not prove that the administration of medication did not cause these
patients to die sooner than they would have otherwise. It would be difficult to
design a definitive study to determine whether opioid analgesics (or other
central nervous system [CNS] depressant drugs) hasten death. A clinical trial
that withheld medication from a control group would be unethical. However, the
evidence from the body of literature reported above indicates that the double
effect of pain medication used to treat pain in the dying patient is more myth
than reality and that opioid analgesia can be effectively used without fear of
hastening death.
It is important to emphasize that there is
no debate among specialists in palliative care and pain control on this issue.
There is a broad consensus that when used appropriately, respiratory depression
from opioid analgesics is a rarely occurring side effect. The belief that
palliative care hastens death is counter to the experience of physicians with
the most experience in this area. No studies have shown that patients' lives
have been shortened through the administration of appropriate pain medication. A
review of the literature yielded no evidence to support the notion that
appropriate and effective treatment of cancer pain results in the earlier deaths
of patients. Of course, it is possible that treatment by inexperienced
physicians may lead to unintentional overdoses of medication, but this is
neither inevitable nor unavoidable.
UNDERTREATMENT
OF PAIN DUE TO
BELIEF IN
THE DOUBLE EFFECT
Misperceptions
about opioids are a major cause of undertreatment of cancer pain. For example,
Von Roenn et al. found that 65% of the respondents to a survey of physicians
from the Eastern Cooperative Oncology Group acknowledged that concerns about
managing side effects limited their use of analgesics.36 A study by
Solomon et al. revealed that although 89% of physicians and nurses agreed that
"Sometimes it is appropriate to give pain medication to relieve suffering,
even if it may hasten a patient's death," 41% agreed that "Clinicians
give inadequate pain medication most often out of fear of hastening a patient's
death."37 Fried et al. also have studied physicians' attitudes
and practices regarding end-of-life decisions. One of five clinical scenarios
presented in a survey was of a dying patient needing "larger and
larger" doses of narcotics with a resultant concern that the patient would
die of respiratory compromise; 86.3% of the respondents reported that they would
give potentially lethal doses of pain medication to a dying patient in this
situation.38
Although a large majority of physicians in
these last two surveyed groups claimed that they would administer pain
medication that might result in an earlier death, that number is not 100%. Some
physicians remain unwilling to administer appropriate comfort medication if they
believe that it could result in the patient dying an earlier death. What is
needed is not just an increased ethical awareness of the rights of patients to
receive optimal palliative care, but an education on the medical facts:
appropriate pain medication need not hasten death.
In a 1996 article in the New England
Journal of Medicine, a primary care physician described the events of a
"typical damn day," which included a call from a nursing home
concerning a new cancer patient he had just accepted but had not yet seen. The
patient was dying, had deteriorating vital signs, and was racked with pain. The
physician refused to order morphine because the family refused to consider
naloxone and oxygen if the patient's respiration was suppressed. "What do
they want from me-the oncologist who unloaded this patient on me, the family who
cannot bear the moans of their dying father? Give them Jack Kevorkian's number,
I mutter. No, I will not order the lethal injection. I don't know this patient,
or the family, or the disease."39 The physician apparently
failed to recognize the situation for the medical emergency it was, and his
mistaken belief that opioid use will directly cause the patient's death
prevented him from fulfilling his duty to care for this patient.
Buchan and Tolle, reporting on the case of a
dying patient who presented in an emergency room with severe pain, stated,
"When emerging problems are poorly controlled, patients may die earlier
than predicted when pain control is finally instituted."40
Although achieving pain control in such a situation may be difficult, even here
the chance of pain medication hastening a patient's death is only a possibility,
not a probability. What is disturbing is their advice that physicians who find
it morally unacceptable to hasten death should refer the patient to another
physician. It is well accepted that physicians (or nurses) should not be
required to participate in activities they find morally repugnant, such as
abortion or, if legalized, euthanasia. But it would be a tragedy for a physician
to refuse to care for a patient based on the mistaken factual belief that the
administration of pain medication will hasten the patient's death. A patient in
extreme pain presents a medical emergency. Even in a situation where there is a
risk that respiratory depression may occur, a physician is not justified in
withholding analgesia.4,11 Every physician has a duty to provide
relief to a patient dying in pain.
One article in the nursing literature
actually seemed to caution against aggressive pain control. In an article
entitled "Pain Control: Euthanasia or Criminal Act?," the author, both
a nurse and an attorney (and director of risk management of an insurance
company) advised nurses "to review their exposure to liability"
relative to "the aggressive use of pain medication."41 Her
fear is based on the false premise that medication adequate to relieve pain may
hasten the patient's death and expose the nurse (standing right beside the
physician) to liability for euthanasia. This nurse further advised other nurses
that the underlying issue in pain management is the nurse's "intolerance of
a patient's pain or suffering." This line of reasoning concluded with,
"Just as a physician must learn that lack of a cure does not equate with
failure, a nurse must learn that the presence of pain [in the dying patient]
does not mean failure." One would hope that caregivers never become
accepting of their patients' suffering!
Situations can arise in which the patient's
family will resist any treatment that might hasten death. Disagreement between a
physician and the family over other aspects of a patient's care may result in
less than optimum analgesia to avoid even the appearance of hastening death.
Even if a physician knows that the administration of an opioid is appropriate
and will not hasten death, placating a family may take precedence over duty to
the patient. Truog et al. described a case in which physicians were reluctant to
suggest stronger sedation because doing so may have been perceived as a
suggestion to hasten death.42
BIOETHICAL
DISCUSSIONS
OF THE
DOUBLE EFFECT
Relieving pain and
providing comfort care is one of the primary duties of physicians and as such is
a matter subject to ethical concern. Unfortunately, in ethical articles
discussing end-of-life issues, any discussion of relieving pain is invariably
followed, almost in the same breath, by a discussion of the double effect. Even
when meant to encourage the use of opioids to relieve pain, these double effect
discussions have the effect of reinforcing the misperception that cancer
patients must die in pain unless medication that hastens death is administered.
No data and little evidence can be found to support the notion that the use of
medication to relieve pain is responsible for hastening the death of dying
cancer patients. Yet, the ethical literature assumes it is a common occurrence.
Few articles argue the point. It is just assumed to be true.
In their article, "The Physician's
Responsibility Toward Hopelessly Ill Patients: A Second Look," Wanzer et
al. urged the use of appropriate medication to better treat pain and stated that
the "balance between minimizing pain and suffering and potentially
hastening death should be struck clearly in favor of pain relief." Although
these commentators made a very forceful argument for the need to increase the
dosage of narcotics to whatever level is necessary to provide adequate pain
relief, they still extended the myth that palliative care is often fatal because
such action is ethical "even though the medication may contribute
to the depression of respiration or blood pressure, the dulling of
consciousness, or even death "[emphasis added].4
It is often a nurse who must administer pain
medication. In 1991, the American Nurses Association adopted a position
statement on "Promotion of Comfort and Relief of Pain in Dying
Patients":
Nurses should not hesitate to use full and
effective doses of pain medication for the proper management of pain in the
dying patient. The increasing titration of medication to achieve adequate
symptom control, even at the expense of life, thus hastening death secondarily,
is ethically justified.12
In the Encyclopedia of Bioethics, Brock,
discussing the risk of respiratory depression and earlier death from
"larger and larger doses of morphine," stated that "when caring
for dying patients, health professionals frequently take actions that may and
sometimes do shorten the patient's life."43 Brock's statement is
not untrue, but it is misleading. Without a doubt, health professionals
"frequently" give pain medications to dying patients. And there may be
"some" times when an apparently appropriate dose "may"
shorten a patient's life, but as a review of the medical literature reveals,
that "some" time is a very rare event.
In the widely cited "Decisions Near the
End of Life," the American Medical Association's Council on Ethical and
Judicial Affairs gave the following scenario as an example of the double effect:
"gradually increasing the morphine dosage for a patient to relieve severe
cancer pain, realizing that large enough doses of morphine may depress
respiration and cause death." And under a heading that reads
"Providing palliative treatments that may have fatal side effects,"
the council stated that "the level of analgesia necessary to relieve the
patient's pain, however, may also have the effect of shortening the patient's
life." The only reference given to support these statements is a 1988
report by the AMA's Council on Euthanasia.44
Cavanaugh, in "The Ethics of
Death-hastening or Death-causing Palliative Analgesic Administration to the
Terminally Ill," stated that: "Sometimes, the administration to a
terminally ill patient of an opioid analgesic hastens or causes the patient's
death insofar as it depresses respiration."45 He cited three
references in support of this statement. The first citation was to a chapter in Advances
in Pain Research and Therapy, "Opioid Analgesics for Cancer
Pain," by Inturrisi.46 In this chapter, under the subheading
"Respiratory Depression," Inturrisi stated that "respiratory
depression is potentially the most serious adverse effect [of opioids]."
But in the same paragraph, he goes on to say:
"When respiratory depression occurs, it
is usually in opioid-naive patients following acute administration of an opioid
and is associated with other signs of CNS depression including sedation and
mental clouding. Tolerance develops rapidly to this effect with repeated drug
administration, allowing the opioid analgesics to be used in the management of
chronic pain without significant risk of respiratory depression
[emphasis added]."
The second source cited by Cavanaugh was an
ethics article by Latimer in which she discussed, among other things, the issue
of the double effect of treating pain. She referred to the ". . . knowledge
of potential risk for shortening life," but then included the following
statement in parentheses: "...in actual practice, the risk may be quite
low."47 The third citation was an ethics article by Brescia, in
which he referred to morphine as a therapeutic measure "that could shorten
life."48 However, Brescia gave no citations in support of this
statement, so this trail of citations runs out with no evidence that hastening
death by the giving of opioid analgesics is any more than a mere possibility.
This mistaken view that treating pain in the
dying patient hastens death is expressed in the popular press as well as in the
biomedical literature. In an article entitled "End of Life Issues" in
the Catholic Herald, the publication of the Archdiocese of Milwaukee,
Archbishop Weakland wrote about "the comfort expressed by a terminal cancer
patient when he understood ... that accepting pain killing medication, even if
it shortened his life, was permitted."49 And in an op-ed article
in The New York Times, an opponent of legalized physician-assisted
suicide stated, "Sometimes physicians perform acts that cause or hasten
death.... They administer pain-relieving medications to patients with advanced
terminal conditions after advising them that the risk of death will thereby be
increased."10 But a patient need not think that shortening his
life is part of the bargain when he accepts pain medication.
Of course the commentators, with few
exceptions, urge the use of sufficient medication to control pain. When they
speak of the double effect, it is to reassure that use of opioids is ethical
even at the risk of hastening death. However, it is one thing to say, as the
pain specialists seem to, that opioids can be safely titrated upward without
undue fear of hastening death, and it is quite another to say that use of
opioids is permissible despite hastening death. Ethical or not, patients or
their families may not want to hasten death, and physicians and nurses may wish
to avoid even the appearance of doing so.
Even when meant to encourage the use of
opioids to relieve pain, these double effect discussions have the effect of
reinforcing the misperception that cancer patients must die in pain unless
medication that hastens death is administered. As Grond et al. have noted,
"Most doctors are much more aware of the side effects of opioids ... than
of the side effects of pain."21
There has been some recognition in the
ethical literature that the double effect of pain medications has been
overemphasized. As early as 1982, Angell, in her article "The Quality of
Mercy," noted the "very low incidence of important side effects [in
contrast with] the very high incidence of inadequate pain relief," and then
stated, "I can't think of any other area in medicine in which such an
extravagant concern for side effects so drastically limits treatment. We are
used to a closer balance between risks and benefits." However, while Angell
found concerns about addiction to narcotics to be "irrelevant" in the
patient with terminal cancer, she felt that concerns about respiratory
depression should be "secondary."51
Brody noted that the "persistent belief
that adequate doses of narcotics will lead to ... premature death" is a
barrier to good palliative care.52 But Mitchell, who recognized that
the fear that pain medication hastens death is a "common
misunderstanding," still felt the need to justify the giving of such
medication under the PDE.53 Quill wrote of "exaggerated patient
or physician fears about ... indirectly hastening death," but in the same
article stated that care in difficult cases "may often involve the
aggressive use of symptom relieving measures that might indirectly hasten
death," and that it is "accepted medical practice to give increasing
amounts of analgesic medicine until the pain is relieved even if it
inadvertently shortens life."54 Quill, along with others, has
criticized the use of the "rule of double effect" in end-of-life
decision making for a variety of reasons, including the difficulty of
determining intention.55,56 However, in the case of medication to
relieve pain in the dying patient, the PDE should be rejected not on ethical
grounds, but for a lack of medical reality.
It is not that respiratory complications can
never occur. But there is a difference between noting the small possibility of
respiratory depression and assuming that it will occur as a secondary effect of
analgesia. When a patient goes into surgery, there is a very real, although
small, risk of respiratory complications from anesthesia. However, we do not
justify this risk in terms of the PDE. The decision to recommend surgery is a
medical decision based on the perceived benefits from surgery outweighing the
risks. The practice of medicine always involves weighing the benefits and
burdens of treatment. Noting the slight possibility of a complication of
treatment is different from expecting the complication to occur. An overdose of
medication would be an accidental side effect, not a foreseen and expected
occurrence. The risk of respiratory depression may be increased for some
patients, for example, those for whom sedation is necessary or desired. A risk
that may be unacceptable in a patient with acute pain who is expected to recover
may be acceptable for a patient who is dying. But that is reflected in the
weighing of burdens and benefits. Only if the use of opioids would lead to an
expected and foreseen hastening of death would appeal to the PDE be useful.
Ashby and Stoffell recommended applying a
risk-benefit analysis to curative, palliative, and terminal modes of
intervention. In the terminal mode, we accept a risk of premature death,
although as they noted, there is "no evidence that the skilled and
appropriate delivery of palliative care measures (in particular the use of
opioid analgesics and anxiolytic drugs) shorten life. . ."57
Bleich noted that the connection of
respiratory depression with pain control is based more on myth than on medical
fact, and argued that the PDE should not be applied to the risk of hastening
death from pain medication. As he put it, the "assumption of prudent risk
is synonymous with life. It is only when the bad or immoral effect of an action
is foreseeable as a matter of certainty, near certainty or strong likelihood
that a moral dilemma arises." And although the hastening of death in this
situation is "within the realm of possibility, [it] does not rise to the
level of the foreseeable."58
THE ROLE
OF DOUBLE EFFECT IN THE
PHYSICIAN-ASSISTED
SUICIDE AND
EUTHANASIA
DEBATE
A troubling result of the mistaken belief in
the double effect of pain medication is its effect on discussions of euthanasia
and physician-assisted suicide. Giving pain medications is even referred to as
"indirect euthanasia,"59 "double effect
euthanasia,"60 or "accidental euthanasia."61
For example, in one article, the authors stated that "a common example of
indirect euthanasia is the administration of large doses of narcotics to a
terminally ill patient in unbearable pain"8 And although the
AMA's Council on Ethical and judicial Affairs, in its "Decisions Near the
End of Life," rejected euthanasia and physician-assisted suicide and
endorsed palliative care, the Council stated that the "ethical distinction
between palliative care that may have fatal side effects and providing
euthanasia is subtle. . ."11
In the past, the underlying theme of most
discussions of the double effect of pain medication, even when referred to as
indirect euthanasia, was that the administration of pain medications was
ethical. Recently there has been renewed interest in "double effect
euthanasia," equating it to, and using it to support, legalized
physician-assisted suicide or euthanasia. The argument usually takes one of two
forms or some combination of the two. First, because hastening death by drugs is
already being done and is ethical, perhaps we should extend medical practice to
allow physician-assisted suicide. The second argument is that because physicians
are already hastening death, we should legalize it to provide safeguards.
Federal court cases
In 1997, the U.S. Supreme Court overturned
decisions by the Second and Ninth Circuits of the Federal Appeals Court, which
had held that state prohibitions against physician-assisted suicide in
Washington and New York are unconstitutional.61,63
In Quill v. Vacco, the Court of
Appeals for the Second Circuit had held that New York violated the Equal
Protection Clause because it allowed the hastening of death through withdrawal
of life support (which the court noted often requires the administration of
"palliative drugs which may themselves contribute to death") while
denying the right to physician-assisted suicide.64
In Compassion in Dying v. Washington, the
Ninth Circuit had held that prohibiting physicians from prescribing life-ending
medication for use by terminally ill, competent adults violates the Due Process
Clause of the Fourteenth Amendment. This ruling was based in part on the double
effect of pain medication. In a discussion of the state's interest in preventing
suicide, Judge Reinhardt, writing for the court, stated:
"Given current medical practices and
current medical ethics, it is not possible to distinguish prohibited from
permissible medical conduct on the basis of whether the medication provided by
the doctor will cause the patient's death. As part of the tradition of
administering comfort care, doctors have been supplying the causal agent of
patients' deaths for decades. Physicians routinely and openly provide medication
to terminally ill patients with the knowledge that it will have a "double
effect"-reduce the patient's pain and hasten his death.... It commonly
takes the form of putting a patient on a morphine drip, with full knowledge
that, while such treatment will alleviate his pain, it will also indubitably
hasten his death."65
Most palliative care specialists would see
little resemblance between the activity described above and the care they
provide for their patients. Later in the decision, Reinhardt stated:
"We see little, if any, difference for
constitutional or ethical purposes between providing medication with a double
effect and providing medication with a single effect, as long as one of the
known effects in each case is to hasten the end of the patient's life.... To the
extent that a difference exists, we conclude that it is one of degree and not of
kind."
If double effect medication is being given
which will "indubitably" hasten death, then it is a case of active
euthanasia and cannot be justified under the PDE. Foley pointed out the dangers
of blurring these distinctions:
"Physicians do struggle with doubts
about their own intentions. The courts' arguments [equating a lethal
prescription with withdrawing life-sustaining treatment and aggressive treatment
of pain] fuel their ambivalence about withdrawing life-sustaining treatments or
using opioid or sedative infusions to treat intractable symptoms in dying
patients...Yet saying that physicians struggle with doubts about their
intentions is not the same as saying that their intention is to
kill...Specialists in palliative care do not believe they practice
physician-assisted suicide or euthanasia."66
In reversing these two Appeals Court cases,
the Supreme Court held that state prohibitions against assisted suicide do not
violate the Due Process Clause or the Equal Protection Clause and are therefore
not unconstitutional. However, the opinions in these companion cases reveal that
the Supreme Court Justices assume the factual accuracy of the double effect of
pain medication. For example, in Vacco v. Quill, the court noted in a
footnote that a state may prohibit assisting suicide even though it may permit
palliative care "which may have the foreseen but unintended 'double effect'
of hastening the patient's death.,"63 Breyer, in a concurring
opinion, stated that there may be a constitutional "right to die with
dignity," but in the cases under consideration, patients are not being
deprived of this right because they have the right to sufficient pain
medications "despite the risk that those drugs themselves will kill."
Double effect euthanasia
The supposedly well-known practice of double
effect euthanasia is a recurring theme in arguments supporting physician
aid-in-dying. Angell, who supports legalizing physician-assisted suicide, noted
that both the United States and The Netherlands permit use of opioids that
"might predictably shorten life, although we have no data as to how often
this practice contributes to death."67 According to Peter
Goodwin, a leading supporter of the Oregon referendum that legalized
physician-assisted suicide, "Dying patients are given larger and larger
doses of morphine. We talk about the 'double effect,' and know jolly well we are
sedating them into oblivion, providing permanent relief, and we don't tell
them."68 Bert Keizer, a nursing home physician in The
Netherlands and author of Dancing with Mister D, is quoted in Time magazine
as saying, "Doctors all over the world shorten the lives of patients under
the cover of pain reduction. And only we are stupid enough to talk about
it."69 In Asch's report of a survey on the experiences of
critical care nurses with euthanasia, it is clear that some of the respondents,
and to a lesser extent, the author, confuse the giving of pain medication with
euthanasia.70 Nurses were asked if they had "ever administered a
medicine or performed some other act with the intent of causing or hastening
that patient's death-other than the withdrawal of life-sustaining
treatment?" Those answering yes to this question cited a range of
activities. Some reported giving medications for the withdrawal of a ventilator
or failing to decrease opiates when vital signs in an imminently dying patient
deteriorated, activities that may not have hastened death. However, some
activities described by the nurses would seem to constitute an abuse of
medications and intentional killing. For example, one nurse described giving a
higher dosage than prescribed and falsifying it as narcotic "waste."
But even in this situation, because undertreatment of pain is so widespread, the
administration of more than was prescribed may have only resulted in the giving
of an adequate amount. What is troubling is that 19% of the respondents believe
that they have intentionally hastened death, often without the request of the
patient or family. Noting that "practice often leads policy," the
investigator suggested that these results could be used to support euthanasia
"because by making procedures explicit, one can provide the oversight
essential for protecting both patients and health care professionals." But,
as pointed out by Scanlon, commenting on this study, equating such activities to
euthanasia "is inaccurate and may increase the already considerable
confusion surrounding justified care at the end of life, particularly the use of
opiates to manage pain."71
The concept of double effect euthanasia and
arguments for legalizing physician-assisted suicide also appear in the popular
press. In 1994, in one of a four-part series on euthanasia, the Milwaukee
Journal daily newspaper used the following front page headline,
"Morphine: When killing the pain kills the patient," and on an inside
page, "Euthanasia /morphine has double effect."72
The following Sunday, a journal editorial supported proposed
aid-in-dying legislation that had recently been proposed by a Wisconsin state
senator. Relying on the information in the previous articles, the editorial
staff stated that "even the routine practice of administering increasingly
heavy doses of morphine to pain-wracked cancer patients can hasten death, as
physicians well know. Legalities aside, there is a very fine line between giving
dying patients enough medicine to keep them pain-free and essentially overdosing
them." The editorial went on to state that the proposed legislation
"would provide the state with a better way of regulating a practice that
already occurs."73
Death by morphine drip
In an op-ed article in The New York
Times with the headline "Killing pain, ending life," Preston, a
well known proponent of legalized euthanasia in Washington and one of the
plaintiffs in the Compassion in Dying case discussed above, stated that "
'morphine drip' is euthanasia by another name."74 Preston
alleged that the practice of ending patients' lives with a morphine drip is
routine and occurs tens of thousands of times a year. He explained that this
practice, "society's wink to euthanasia," is known as the double
effect, and is even accepted by the Catholic Church. He went on to say that he
had "never found a colleague who thinks a morphine drip is wrong if the
patient is dying." He argued that it is important to legalize euthanasia to
bring this covert practice out into the open and regulate it. Rather than allow
physicians to "secretly and silently" hasten death, he advocated
allowing them to do so "openly and honestly."
Of course, an overdose of morphine or other
drug can hasten death. But if given to hurry things up and end the patient's
life, this would be direct euthanasia, not pain relief. If done without the
patient's knowledge and permission, such activity would amount to nonvoluntary
euthanasia. Commenting on Preston's article, Schwarz, an oncology pharmacist,
stated, "In those rare instances when a practitioner ... prescribes
morphine or any other agent at dosages that may cause clinically unjustified
harm, every health care professional has an obligation to deal with this
suspected abuse," and act as an advocate for the patient.75
Whether or not physicians routinely rely on
the "double effect of overdosing" to hurry up the death of their
patients is a factual issue. There are at present no reliable data on whether
death by "morphine drip" is a common occurrence or only another myth.
Use of a morphine drip to hasten death may reflect the unavailability of good
palliative care. For example, in another op-end piece in The New York Times,
with the highlighted quote, "Morphine eased my terminally ill
husband's pain, but hastened his death," the author wrote of the deaths of
three relatives, including her husband. A lack of palliative care left her to
choose the dosage of morphine, "to drive the engine of death," for her
dying husband.76
Billings and Block have written a thoughtful
article on death by morphine drip, which they refer to as "slow
euthanasia." They believe that hastening the death of a
"lingering" patient may be common. "Medication is adjusted with
the purpose of accelerating dying, not simply for providing comfort."77
Whether such a practice can ever be justified is beyond the scope of this
article. But hastening death can not be excused as a side effect of pain relief
and increasing the dosage of medication beyond what is necessary for pain relief
cannot be justified under the PDE.
Prescribing or administering appropriate
pain medication does not hasten death. For this reason it is not indirect or any
other type of euthanasia. It is important to place emphasis on this point
because the supposed inability to adequately treat pain is an important part of
the debate about euthanasia and physician-assisted suicide. Conflating the
giving of pain medication with euthanasia only distorts discussions on this most
difficult issue.
CONCLUSION
Clinical studies and decades of experience
by experts in pain management and palliative care have shown that the double
effect of pain medication has little basis in medical fact. Not only is it not
necessary to rely on the PDE to justify giving adequate pain medication to dying
patients, but such reliance on the PDE actually perpetuates the myth of the
double effect of pain medication, directly contributing to the undertreatment of
suffering at the end of life. It is ironic that an ethical principle that is
used to justify adequate opioid analgesics contributes to the undertreatment of
pain.
Pain is one of the most feared consequences
of cancer, and as noted by Wanzer et al., patients have reason to "fear
that needless suffering will be allowed to occur."4 Often it is
the inadequate management of pain or fear of future unrelieved pain that leads
to suicide ideation or the request for euthanasia.78 And it is the
fear of unrelieved pain that drives public support for assisted-suicide and
euthanasia.42 But as noted by Foley, "treatment of pain is never
a form of euthanasia."9 In end-of-life discussions, focusing on
the PDE and on a seldom occurring side-effect of pain medications diverts
attention from the larger ethical issue of the undertreatment of pain and
suffering in the dying patient. It is important that ethical analysis be
grounded in medical reality.