Allergic to Generics

Allergic to Generics
Troyen A. Brennan, MD, and Thomas H. Lee, MD
A 69-year-old woman with several medical problems believes that
she is allergic to generic medications. She frequently conflicts with
her long-time primary care physician, who, as required by the
patient’s insurance coverage, refuses to prescribe brand-name
drugs when generic alternatives are available. This conflict inten-
sifies to a crisis when the patient develops life-threatening prob-
lems and still will not take prescribed generic medications. The
presentation of this real case is accompanied by a discussion of
the ethical dilemmas of the patient’s physician, who must weigh
the interests of a patient who clings to beliefs that the physician
thinks are unfounded against the interests of a just rationing
program and the broader population it serves.
Ann Intern Med. 2004;141:126-130. www.annals.org
For author affiliations, see end of text.
See related article on pp 131-136.
A 69-year-old woman with diabetes mellitus and supraven-
tricular tachycardia believes that she is allergic to generic med-
ications. Her primary care physician has cared for her for 12
years. Her medical problems include arthritis, diabetes melli-
tus, hypertension, dyspepsia, and depression. She frequently
comes to the office or the emergency department with symptoms
that do not have an apparent physiologic basis. Over the last
decade, she has undergone a wide range of diagnostic proce-
dures that have not shown clinically significant abnormalities.
A psychiatric consultation 4 years ago led to the conclusion that
she had somatization disorder. On the advice of the psychia-
trist, the primary care physician sees the patient frequently in
the office and tries to minimize diagnostic testing and new
medications.
Three years ago, the patient received a generic preparation
of glyburide and developed a rash typical of a drug allergy. The
patient concluded that she was allergic to generic medications
and refused to fill prescriptions for any generic drug. She could
not be convinced that allergy to all generic medications, but
not to their brand-name counterparts, was impossible. She
refused referral to an allergist, asserting that “I know my
body.” Her physician continued to insist on trials of generic
medications when appropriate for her problems and refused to
prescribe brand-name drugs when generic alternatives were
available, as mandated by her insurance program, the state
Medicaid program. She occasionally would agree to try a ge-
neric medication. However, she developed diffuse itching
within a few minutes of taking the medication and would
then discard the rest of the prescribed medication.
The patient’s refusal to take generic drugs became a con-
stant focus of her relationship with the primary physician,
which had been generally warm and effective. Discussions of
this issue added several minutes to most visits. Since their
conflict about treatment with generic drugs was unresolved,
her physician suggested that she might prefer to seek another
physician, but she declined. Her physician compromised:
When she needed medication for problems that were not po-
tentially serious, he would insist on prescribing a generic med-
ication and leave it to the patient to decide whether to fill the
prescription. She generally left the office with the prescription
but did not take the medication. When she had a serious
problem, the physician would prescribe a brand-name drug,
even when an effective generic alternative was available. For
example, when he treated her for hypertension, he prescribed
an angiotensin-receptor blocker, for which no generic alterna-
tives exist, instead of a generic angiotensin-converting enzyme
inhibitor. The patient asked the physician to write a letter to
Medicaid indicating that she was allergic to generic medica-
tions. He refused.
This patient’s fears about using generic medications
have led to constant conflict between her and her primary
care physician. Most physicians have “problem patients” or
“difficult patients.” Literature on ethical and practical is-
sues with such patients and management strategies for
dealing with them has increased. Difficult patients are of-
ten defined as those who engender a negative reaction from
their physicians (1–3). Estimated prevalence of difficult pa-
tients in a primary care panel ranges from 15% to 30% (4,
5). Many of these patients have underlying psychological
disease; personality disorders are especially common (5).
While most of this literature focuses on the patient,
the “problem patient” does not exist in a vacuum. As this
case shows, the adjective “difficult” actually characterizes
the relationship between these patients and their physicians
as they address conflict, including clinical issues that arise
because of the socioeconomic environment of medical
practice. The physician–patient relationship is a complex
interplay of personalities. In this case, the physician’s rather
zealous support for policies aimed at reducing inefficiency
in health care contribute to the conflict in their relation-
ship.
The conflict might not exist except for the state Med-
icaid program’s limitations on its pharmacy benefit. The
Medicaid program in Massachusetts does not cover brand-
name drugs when generic counterparts are available unless
physicians explain in writing why the brand-name drugs
are medically necessary. Most states’ Medicaid programs
are struggling to meet their budgets today, partly because
the Medicaid programs’ average annual rate of growth for
prescription drugs costs was 19.7% from 1998 to 2002.
Forty-eight states report that pharmacy costs were a top
reason for Medicaid expenditure growth (6). In this case,
the state is therefore taking the perfectly rational step of
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not covering brand-name drugs when equivalent generic
drugs are available.
One year ago, the patient was hospitalized through the
emergency department because of dyspnea and a sensation of
chest pressure. She was in supraventricular tachycardia, which
responded to a ␤-blocker. She did not have evidence of myo-
cardial injury, was discharged symptom-free, and received ge-
neric atenolol after a 1-day stay. When she filled her discharge
prescription for atenolol, she discovered that her physician had
prescribed a generic medication. She did not take the atenolol.
Her primary care physician warned her that she was risking
her life, and she insisted that he prescribe a brand-name
␤-blocker. He refused, pointing out that the low-cost generic
drug was equivalent to the brand-name drug.
At this point in the case, the ethical issues have be-
come clear. The physician is in a classic conflict of interest
situation. A conflict of interest occurs when the will to
achieve certain secondary objectives inappropriately influ-
ences progress toward a primary objective (6). In this case,
the primary objective is the well-being of the patient. The
secondary interest is the cost-effective generic drug policy
of the Medicaid program.
Twenty years ago, few would have joined the debate
about what to do: Most ethicists would have instructed the
physician to ignore the requirements of the insurer and
simply treat the patient with the more expensive brand-
name medication. According to this traditional under-
standing of medical ethics, the physician’s altruistic com-
mitment to the patient would trump the interests of the
state. As Pellegrino (7) persuasively stated: “Physicians are
healers first, and in this role, financial incentives and com-
modification of health care must be ignored.”
However, medical ethics has slowly evolved to a dif-
ferent view of such issues. Wikler (8) neatly formulated
what many others agree is an important evolution in med-
ical ethics (8). In the first stage, ethical behavior was merely
a matter of adherence to codes of professional ethics. In the
second stage, which marked the birth of bioethics in the
1970s, the focus was the physician–patient relationship.
Ethical behavior is rooted in a personal commitment to an
altruistic model of this relationship. In the third stage, bio-
ethicists placed the physician–patient relationship into the
larger structure of health care in society.
Once medical ethics recognizes the social context of
disease and care, it must consider issues of justice, includ-
ing the distribution of scarce health care goods. As health
care costs have increased, the gap between health care for
the wealthy and health care for the poor has widened.
Medical ethics in the United States has increasingly recog-
nized this disparity as an urgent ethical issue and has re-
sponded by incorporating the just distribution of resources
into its framework for ethical behavior. Of course, the no-
tion of scarcity and rationing as a response is not new. The
Health Care and Medical Priorities Commission of Swe-
den’s Ministry of Health and Social Affairs has noted that
rationing is “inevitable; rationing has always been part of
health care. . . [A]ny rationing scheme must [have] three
core principles, all human beings are equally valuable, so-
ciety must pay special attentions to the needs of the weak-
est and most vulnerable, and cost efficiency, all else being
equal must prevail” (9). Today, growing consensus deals
with scarcity, and developing reasonable methods of ra-
tioning is an integral part of medical ethics.
If one accepts the important role of justice in a frame-
work for ethical behavior in health care, the ethical analysis
of the present case resolves itself into answering 2 ques-
tions: First, is the rationing mechanism just? Second, is the
physician taking the right actions to resolve the conflict?
On the first question, Emanuel (10) has suggested that at
least 3 principles must be considered in allocating health
care resources justly: Improving health should be the pri-
mary goal, patients should be well-informed, and patients
should have the opportunity to consent.
Applying the first principle is perhaps most critical to
analyzing this case. Our struggle to apply it emphasizes the
difficulty that ethicists and physicians face in balancing the
twin imperatives of an altruistic physician–patient relation-
ship and just distribution of resources. In this case, the
physician would best serve the patient’s health by provid-
ing the brand-name ␤-blocker. However, if we consistently
allow patient choice to trump scientifically based, reason-
ably cost-effective treatment strategies, Medicaid funding
will be inadequate to meet the program’s responsibilities. A
fiscally compromised Medicaid program might have to
deny care for other patients, and the overall health of so-
ciety would be ill-served. So, the physician in this case is, in
essence, balancing the patient’s request for a brand-name
drug with the need to conserve resources so that the Med-
icaid program can serve as many legally entitled patients as
possible. The stakes in this case are lower than they would
be if the Medicaid program had to deny bone marrow
transplantation for a child with a controversial indication,
but the nature of the ethical conflict is the same. Medical
ethics has acknowledged that the conflict exists, which is an
important advance. However, a principle that leads to easy
resolution of individual cases has not been found.
A “generics-only” guideline seems reasonable from a
cost-effectiveness perspective. Use of generic drugs, which
in most circumstances are exactly like their much more
costly brand-name counterparts, is a noncontroversial
method of conserving resources. However, we must decide
on a case-by-case basis whether rationing by substituting a
less costly alternative is just. If the scientific rationale is
sound, the rationing mechanism is probably just (11). Bur-
ton and colleagues (12) analyzed the ethics of pharmaceu-
tical benefit management programs. They argued that a
limited formulary is a reasonable rationing mechanism and
that prohibiting prescription of a brand-name medication
is appropriate when a generic equivalent is available. We
conclude that insisting that a patient accept a generic drug
is a just method to allocate resources. The patient’s physi-
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cian was acting fairly when he used this principle in his
ethical framework for dealing with the patient.
The fairness of the allocation principle in this program
does not imply that all pharmaceutical benefit manage-
ment programs are just. Other situations may introduce
issues that change the way we ask about the appropriate-
ness of limiting access to pharmaceuticals. For example, if
the insurer was a for-profit corporation, the physicians
were capitated, or physicians received direct financial re-
ward if they adopted a generics-only prescribing policy,
physicians’ conflict of interest would be substantially
sharper, and we might conclude that they were acting un-
ethically because the secondary considerations involved
personal gain. Increasing the intensity or immediacy of the
incentive for physicians to reduce costs (for example,
through stronger financial incentives) would intensify the
conflict (13). On the other hand, effective negotiations
with pharmaceutical companies might reduce the pro-
gram’s expenses for brand-name drugs and decrease the
need for this conflict.
In this case, we have a public insurer and, at least as far
as we know, no financial pressure on the physician. A
Medicaid program, unlike a private insurer, has a relatively
clear mandate when it tries to resolve the trade-off between
increasing resources for an individual patient and increas-
ing the number of patients who can be eligible for cover-
age. Simply put, insisting that the patient use a generic
drug in this context improves health care. It is a “win” for
society and a “no lose” for the patient, at least if she takes
the drug.
We believe that improving health care is paramount.
In an earlier era of medical ethics, many ethicists might
have argued that the principle of beneficence, doing good
for patients, might lead a physician to prescribe brand-
name drugs for this patient. In the present era, fewer would
adopt this viewpoint. We do not think that the principle of
beneficence entails absolute deferral to the patient’s wishes.
The supporting statement from the Medicine as a Profes-
sion Managed Care Ethics Working Group in this issue
(14) gives carefully nuanced advice in dealing with insur-
ance companies and managed care.
We need to consider Emanuel’s other 2 principles of
just allocation (10). First, the requirement for the patient
to consent to treatment takes a different form when she is
the beneficiary of a public program. While the patient
clearly controls the choice of a therapeutic intervention,
such as whether or not to have surgery or take medication,
she cannot really choose medication when the public in-
surer adheres to its formulary. Wealthier individuals might
opt for a different insurer, which allows greater choice
about medications. Most public program recipients do not
have this option.
The patient in this case study probably has nowhere
else to turn for health insurance, and, as an insurer of last
resort, Medicaid cannot provide the patient with much
choice. Choice is limited in public programs. Rather than
assert the patient’s right to choose between equivalent
forms of the same treatment as a safeguard to ensure fair-
ness, we must closely scrutinize the scientific rationale of
the cost-effectiveness measures that the public program
uses.
Continuing our analysis by using Emanuel’s principle
of patient consent (10), we note that the physician seems
to have been honest and direct in his discussions with the
patient. Although the case report is not completely clear on
this point, we are reasonably sure that the physician has
told the patient that he is insisting on generic atenolol
because the Medicaid program itself insists on it. He
doesn’t have a personal financial incentive. When physi-
cians have to “bluff or puff” about their financial incen-
tives, the physician–patient relationship changes for the
worse, often irretrievably. These awkward conversations
between uncomfortable physician and suspicious patient
have brought important ethical questions about certain
managed care techniques to public attention (15). If we are
going to ration, we must honestly explain our decision
making to our patients and respond when they voice their
concerns. Presumably, the physician in this case gave an
accurate explanation, although research by Pearson and
Hyams (16) has suggested that physicians are not always
completely honest about efforts to cut costs. They often
simply ask the patient to trust them (16).
In our analysis of this case, we should ask whether this
particular Medicaid program allowed physicians to petition
for a waiver from prescribing rules. If it did, the physician
could advocate the patient’s position and still play within
the rules. Should he do so? He would have to repress his
own convictions about just allocation of resources, but per-
haps the opportunity to petition for a waiver is the pro-
gram’s way of affirming that the patient’s need should
come first in the uncommon instance of an irreconcilable
conflict. However, programs usually grant these waivers
only when the approved medication has a clear contrain-
dication. As indicated in the Medicine as a Profession
Managed Care Ethics Working Group statement (14), we
could not sanction the physician if he lied to get a waiver
for this patient (although many patients and some physi-
cians might sanction it).
Finally, with regard to the conflict of interest itself, we
note that the physician has addressed the patient’s needs in
a graded fashion in the past. The physician was willing to
prescribe brand-name medications when the problem was
clinically significant, insisting on generic drugs only when
the problem was relatively clinically insignificant. Essen-
tially the physician weighed the best interests of the patient
against the interests of the just rationing program. We be-
lieve that many would find this compromise acceptable
and that it is a good example of bringing principles of
justice and health care rationing to the bedside. Most well-
designed Medicaid pharmaceutical benefit programs also
recognize that “problem” patients may require compromise
and have appeal programs that allow substitution of non-
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generic medications in some circumstances. At this point,
medical ethics still seems to give primacy to the physician’s
duty to advocate for the patient but, in contrast with the
past, now requires the physician to try hard to allocate
resources justly.
One week later, the patient had a heart rate of 160
beats/min at her adult day care program. The nurse called her
physician, who directed the nurse to tell the patient to take her
atenolol. The patient refused. The nurse suggested that the
patient go to another physician, but the patient said, “I want
him to write the prescription. If he won’t and I die, it will be
on his head.” When the nurse continued to encourage her to
switch physicians, the patient said, “I’ve known him for so
many years, and he knows me so well. I don’t want to start all
over with someone new.”
At this point, the conflicting forces are challenging the
physician–patient relationship. On one side are the pa-
tient’s beliefs about generic drugs. On the other side is the
physician’s commitment to practice according to guide-
lines that ensure just allocation of resources. With the on-
set of supraventricular tachycardia in an elderly, diabetic,
hypertensive woman, this conflict has intensified to a crisis.
A generic medication normally produces no decrement in
quality, unless the patient will not take it. However, be-
cause this patient adamantly refuses to use generic medica-
tions, her physician’s adherence to Medicaid’s policy now
threatens her health.
As medical ethics has evolved in the last part of the
20th century, notions of distributive justice have modified
the doctrine of patient autonomy. Still, patient autonomy
is, rightly, a potent ethical driver of daily practice. Accord-
ing to Burton and colleagues (12), autonomy issues weigh
strongly when the ethics of pharmaceutical benefit man-
agement are reviewed. We normally attempt to respect pa-
tient’s decision making about their use of health care re-
sources.
Autonomy has limits. We expect patients to be re-
sponsible participants in their health care. As Daniels and
Sabin (17) pointed out, a reasonably just health care system
depends on health care organizations, insurers, physicians,
and patients all being accountable for their actions. Pa-
tients must use health care resources rationally. If they do
not, we cannot simply accede to irrational choices. But, at
times, we must be prepared to compromise principles of
equity with the needs of an individual patient.
Therefore, the physician must reconsider his stance.
Although the guideline prohibiting generic drugs is quite
rational, the high risk that the patient will harm herself,
albeit unintentionally, by not taking generic medications
must tip the physician in the direction of prescribing a
brand-name medication. In the end, he bows to the pa-
tient’s iron will, perhaps thinking that the Medicaid pro-
gram would be harmed if all patients behaved like this
woman but realizing that most patients behave more ratio-
nally than she.
When the nurse called the physician back to report that
the patient would not take any medication unless he prescribed
it, he relented and prescribed a brand-name, long-acting
␤-blocker.
This case study demonstrates the extraordinary intri-
cacies of the physician–patient relationship. Everyone who
has been or has treated a patient knows that this relation-
ship has nuances. The interdependence, respect, concern,
and affection in the physician–patient relationship con-
found the principles that form the basis of a market econ-
omy. Here, the patient has been battling with the physician
who will not give her brand-name medications, yet she
remains extraordinarily committed to that physician be-
cause she believes that he has her welfare at heart. From the
physician’s viewpoint, the duty to provide care tempers all
the difficulties and frustrations of dealing with an irrational
patient. Most relationships between 2 citizens in the liberal
state could not tolerate such a sharp division of belief over
a fundamental issue. But, the strong ties of the therapeutic
alliance, with its acceptance of human frailty, allow the
physician to continue to care for the patient and the pa-
tient to accept his care.
In this situation, the physician makes the appropriate
choice. The conflict among the patient’s fundamental right
to choose her treatment, her worsening health, and the
physician’s commitment to practice in a certain way be-
came too strong. Perhaps the physician became a utilitarian
at the end. He may have realized that the patient’s wors-
ening condition shifted the balance of benefit and harm (as
averaged across all participants affected by this episode,
including himself, the patient, and other Medicaid pa-
tients) to net benefit for prescribing a brand-name drug. In
any case, he heeded his commitment to the patient and
prescribed the more expensive medication.
We believe that this physician will continue to try to
instruct and educate his patient, perhaps to little avail. He
will continue to insist on accountable and reasonable be-
havior by the patient, but he will relent when necessary. He
may guide the patient toward psychiatric help.
This case illustrates the increasingly prominent role of
distributive justice as a principle of medical ethics. We now
expect physicians to balance their obligation to an individ-
ual patient with their obligations to all who may need
medical care. The accompanying Medicine as a Profession
Managed Care Ethics Working Group statement (14) il-
lustrates the extent to which this thinking has become part
of the mainstream of medical practice. This dual obligation
does create challenges, which try our patience and test our
patients’ loyalty to us. Ultimately, the physician and the
patient usually resolve the conflict and move on together.
From Brigham and Women’s Hospital, Partners Community Health-
care, Harvard Medical School, and Harvard School of Public Health,
Boston, Massachusetts.
Potential Financial Conflicts of Interest: None disclosed.
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Requests for Single Reprints: Troyen A. Brennan, MD, Brigham and
Women’s Hospital, 75 Francis Street, Boston, MA 02115; e-mail,
[email protected].
Current author addresses are available at www.annals.org.
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130 20 July 2004 Annals of Internal Medicine Volume 141 • Number 2 www.annals.org
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Current Author Addresses: Dr. Brennan: Brigham and Women’s Hos-
pital, 75 Francis Street, Boston, MA 02115.
Dr. Lee: Partners Community Healthcare, Inc., Prudential Tower, 11th
Floor, 800 Boylston Street, Boston, MA 02199.
W-16 20 July 2004 Annals of Internal Medicine Volume 141 • Number 2 www.annals.org
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