There is, however, one fundamental difference between drug advertisement
and all other forms of direct product marketing: the patient still
needs a prescription. That is why the persuasive voice in the ad says,
“Ask your doctor.” Here is the real “gatekeeper” function of the physician.
I hold the keys to the drugstore. The TV ad promises my patient that
a new sleeping pill will give him sweet dreams, inner peace, and a sunny
Polypharmacy 57
morning. The patient says to himself, “If only my doctor weren’t standing
in the way and would just give me the damned prescription.” Never mind
that the product may cause addiction, memory loss, sleep eating, or zombie
driving as side effects (no free lunch).
I, as the prescribing physician, will carry much of the legal liability for this
transaction when the drug is recalled two months later due to inadequate
post marketing evaluation. I will be the one accused of professional negligence.
Further, it seems to me, at least anecdotally, that where the indication
for treatment is the softest, the side effects are most consequential. It is true
that the TV drug ads do mention side effects, but they do so in small print,
at high speed, dumbed down, and in contradiction to the subliminal and
emotional message which is “It’s OK—Go ahead. Take the pill. Those side
effects are for other people.” Now is the time for us to modify our approach
to the direct-market advertising of pharmaceuticals. We need to restructure
policy so that U.S. citizens remain patients fi rst and consumers second.
By engaging the patient through TV ads to “ask your doctor,”
the drug company effectively seizes control of the exam room and hijacks
health care. Omitted is any discussion of nonmedical remedies such as
diet, exercise, or physical therapy. We go directly to the prescription pad.
The pressure to prescribe is not so subtle. Patients have told me outright
that if I don’t prescribe “the purple pill,” or whatever they want, then they
will fi nd a physician who will—and they do so. An older doctor, with a
well-established practice, may not feel particularly threatened. A new physician,
however, building the medical practice that is her livelihood, may be
more likely to buckle. Regardless, all primary care physicians are pressed
for time. It would take me a lot longer to explain why a patient should not
take the pill seen on TV than to “just write the damned prescription.”
Alternate Medical/pharmaceutical ADS
St judes / cancercare centers
Back pain /spine centers
Marketing has triumphed over science.
Pills taken by prescription are just the tip of the iceberg. For every prescription
medication ingested, many patients are likely to consume two or
three nonprescription capsules or tablets labeled as “nutritional supplements.”
These pills are obtained in a health food store, beyond the surveillance
of the FDA. Such patients in my practice were often quite reluctant
to admit the extent of their usage of supplements, herbals, or botanical
agents. Either they assumed that I would disapprove angrily, or they did
not consider these substances to be “drugs” worthy of inclusion in a list of
medications taken. A dramatic demonstration of the market penetration
of the supplement business could be had by instructing patients to come
to the offi ce with a large plastic bag containing every pill that they take,
including vitamins, minerals, herbs, or anything else procured at a health
food shop or by mail order. The bag would be emptied on the exam room
counter, and six or eight large, 500-pill plastic bottles would go rolling.
These would contain substances such as gingko biloba, echinacea, elderberry
extract, propolis (from bees), St. John’s wort, and black cohosh, to
mention a few.
The supplement industry is the “rest of the story” of polypharmacy,
lying beyond my prescription pad. What is the appeal of these
Polypharmacy 61
products? Why do my older patients, living on a fi xed income, readily
shell out good money on substances that are not of proven benefi t, are
not necessarily safe, are beyond FDA scrutiny, and which may not even
be present to any measurable degree in the pills that are pedaled? Why
do younger patients, sophisticated shoppers I am sure, readily accept
TV testimonials and embrace OTC supplements, tonics, and antioxidant
elixirs as panaceas without prescription? The polypharmacy of OTC
supplements, or “neutraceuticals,” thrives today because of the relaxation
of FDA regulations, which put consumerism ahead of drug safety
and effi cacy.
Traditionally, the demonstration of a drug’s safety and effectiveness
has been the responsibility of the pharmaceutical corporation. A putative
drug candidate must proceed through a lengthy, rigorous, and expensive
evaluation. This sequence involves preclinical animal studies
followed by small clinical trials designed specifi cally to ascertain only
that the drug is not too toxic (phase 1). After passing phase 1, the drug
then proceeds to further analysis involving a small group of patients to
demonstrate that it is in fact effective (phase 2). Assuming that the drug
is a winner in phase 2, larger clinical trials are established, involving
thousands of patients, to confi rm effi cacy using a randomized, doubleblind,
placebo-controlled methodology. By far, most drug candidates
don’t make it, and many of the small, innovative biotechnology fi rms in
the business don’t make it either. However, the manufacturers of nutritional
supplements were able to carve out their own special niche in the
FDA approval process through a sweet-deal piece of legislation called
the Dietary Supplement Health and Education Act of 1994, or DSHEA
(Nestle 2007).
The passage of DSHEA represented a swing of the pendulum at the FDA,
from protecting patients’ safety to maintaining their rights as consumers,
not to mention enhancing the ability of manufacturers to sell their products
unencumbered by federal regulatory monitoring. DSHEA inverted the
paradigm for establishing the safety of supplements. Supplement manufacturers
could sell a product without any proof of safety. Instead, the onus
was thereafter on the FDA to prove a “neutraceutical” was unsafe after the
fact and to then have it removed from the shelves only after trouble had
already arisen
Producers of supplements cannot advertise that their product treats or
prevents a particular ailment or symptom (e.g., “cures cancer” or “prevents
a heart attack”). Under DSHEA, they are able to promulgate vague
claims that their pill can, in an undisclosed manner, enhance some aspect
62 Out of Practice
of bodily structure or function (“for healthy bones,” “promotes prostate
health,” or “supports your immune system”). The net result is obfuscation.
Because these phrases are hollow, it is left to consumers to fi ll in the
void and to take the product based on a belief that it must be good for
what ails them. Marketing has triumphed over science.
in my experience, mistakes occur because 1) drug names can sound
quite similar; 2) a drug may be fi lled one time as brand name, then later as
generic, so the patient takes both; 3) a new drug is substituted for a prior
one, but the patient mistakenly takes both new and old medication; or
4) elderly couples “share” prescriptions, either knowingly or not, resulting
in disaster
Moreover, the elderly patient may be seeing three or four different doctors
at any given time. Besides a primary care physician, she may be visiting
a cardiologist, urologist, rheumatologist, or other “-ologist,” each of
whom has a prescription pad. “Poly-doctoring” begets polypharmacy. The
specialists’ consultation reports, containing new and revised lists of medications,
may come to the primary physician’s attention in a week or two,
but in the meantime, there is opportunity for disaster through too many
cooks spoiling the broth (Tamblyn et al. 1996, 1177).
How can you convert the thousands of drug codes by different companies to simple pill codes
What is needed is a simple and universal code that uniquely identifi es
every pharmaceutical prescribed by any doctor, in all of its varied dosages.
Such a compendium of the U.S. pharmacopoeia should be federally established
to avoid confusion as a patient moves from one state to another. I
propose that all prescriptions fi lled carry a unique identifying alphanumeric
symbol, stamped in large, bold print, Braille, and bar code on the
bottle, box, or tube. For example, atenolol in 50-milligram tablets would
show “A50” on every bottle of that medicine and dose fi lled anywhere in
the United States. Digoxin .125-milligram tablets would be “D125.” Lipitor
10-milligram tablets, “L10.” It would be much easier for the patient to
request a refi ll of “C10” than to ask for cyclobenzaprine 10-milligram
tablets.
The full
it is also not a pretty sight to have a ninety-six-yearold
man in the offi ce crying, begging for Valium. Such a man is not at all
interested in the Beers criteria, which can be a dispassionate and arbitrary
barrier to personalized drug therapy. Contrary to Nancy Reagan, it is not
so easy to “just say no to drugs.”
The consensus approach of the Beers criteria, or any other canned
guideline of drug therapy, does not tell me what will work for the particular
patient who is sitting in my exam room, looking for a solution to her
problem. The precision and objectivity of modern pharmaceutical chemistry
doesn’t necessarily translate well into the highly subjective world of
geriatric care.
In the case of Mrs. C,
her brother the truck driver beat me at my own game. His slippery remedy
and his simple explanation for its effectiveness reached Mrs. C at a
level that I missed with my anatomical discussion and my prescriptions
for anti-inflammatory pills. I was “out-doctored.”
The only option at the top tier of drug therapy is government regulation
of prices. The few large pharmaceutical fi rms represent an oligopoly
similar to the electric or natural gas utilities, which provide other essential
public services. Therefore, in my view, it would be perfectly appropriate
for the federal government to set drug prices for the high-end pharmaceutical
agents such as the biologicals, where free-market competition does
not apply, as with the utilities. Reduced revenues to pharmaceutical fi rms
may very well slow research and development efforts, but, on the other
hand, there is no value in bringing a drug to market that no patient, and
no nation, can afford.
In the 1970s,
at some hospitals, cardiologists successfully blocked general physicians
from admitting patients with chest pain to the then relatively new facility
called a coronary care unit, or CCU. Quarterly physician staff meetings
at hospitals became battle zones with shouting, swearing, and threats of
legal action, one against another, for restraint of trade. Somebody had to
emerge at the top of the heap. General practitioners were placated by a
new oxymoronic appointment as “specialists of primary care.” In the new
age of specialty medicine, however, to paraphrase George Orwell, all doctors
were special, but some doctors were more special than others.
Governmental and insurance industry efforts at cost containment thus
far have aimed at clipping costs a bit here or there through favoring generic
prescriptions, by limiting drug selection within a covered formulary
to those medicines that are cheapest if not as effective as others, and by
pestering primary care physicians by fax, phone, mail, or e-mail to “consider
an alternative.” There is intense pressure on today’s physicians to
prescribe as they are told. Patients do not have to be health care economists
to sense that something is rotten in drug therapy when their prescription
medications are changed every few months based on the most
current negotiated low bid. There is a pervasive attitude among my patients
that they are being “screwed” by the insurance and pharmaceutical
companies, even if they are not exactly sure how this is so. A healthy relationship
between doctor and patient cannot blossom in such a poisoned
atmosphere of suspicion.
Most often I can tell that the patient is not complying with treatment
because I cannot achieve a target blood pressure, blood sugar, or other
parameter, no matter how hard I try. In other cases, a blood test for a drug
level reveals a counterproductive cost-saving scheme. The physician in
this situation takes on the undesired role of detective. Again, what is lost
are trust, confi dence, and a sense that both doctor and patient are on the
same team.
Some denials of appeal are downright paternalistic. Older men with
erectile dysfunction (ED) often seek to have their Viagra, or an equivalent
drug, covered by their insurance. Some insurance companies arbitrarily
will pay for the Viagra only if the ED is due to prior surgery for prostate
cancer, but not if it is from another medical cause. Some grumpy insurers
will pay grudgingly for two or three Viagra tablets per month, and no
more. I have often wondered if the exact number allowed was pegged
to the CEO’s own frequency of sexual intercourse. This is no rational way
to administer our modern pharmacopoeia.
a specialist is, in reality, one who knows more and more about less and less.
He possesses
a well-honed, albeit restricted, subset of clinical skills and experience
that is of special value only when selected appropriately and only
when applied wisely. In short, it is the primary care physician’s proper
and intelligent usage of consultation and referral service that makes the
specialist, well . . . special.
The specialist, in addition to enjoying the perquisites at the top of the
ladder, also appreciates the luxury of dealing solely with one organ and not
so much with the complex person who owns it. He may, after completing a
series of esoteric tests, diagnose a rare and devastating disease. The patient
and family, however, then will return promptly to their primary care doctor,
requesting that he “tell them what the specialist just said.” They will ask
him to “put it into English.”2 How will this new diagnosis affect their lives?
Should their son overseas in the military be notified and brought home?
What does it all mean, and what should they do? I would argue that, as a
patient, your true specialist is the doctor who knows you, and your family,
best and who can weave a plan of care that incorporates specialty consultations
along with other diagnostics and treatments. The patient is far more
than the sum of his parts. Organ by organ, fragmented care is bad medicine,
and, as patients well know, it is easy today to become overdoctored
Just as the number of pill bottles on the bathroom shelf grows with one’s
age, so does the number of doctors’ appointment cards magnetically stuck
on a patient’s refrigerator door. Geriatric patients are poly-doctored. Medicare
beneficiaries between 2000 and 2002 typically saw up to five specialists
each year (Anderson and Knickman 2001, 146). Those with multiple
chronic ailments may see up to sixteen physicians in a given year (Pham
Poly-Doctoring 75
et al. 2007, 1130). Such dispersed delivery of health care has the obvious
disadvantages of poor coordination, duplication of efforts, excessive testing
and procedures, and polypharmacy, with its attendant risk of serious
drug interactions. Even more troubling to me, this is a fragmented system
of care devoid of the warmth of relationship, and it can be a soulless
process that doesn’t see the big picture. To the patient it may appear that
nobody is driving.
How is it that in.
When the disease in question is chronic, the patient will always be provided
with a follow-up appointment. For reasons that include appropriateness
of care, avoidance of allegation of malpractice through abandonment,
as well as physicians’ financial interests, a specialist will rarely send a
patient home without setting a date for a return visit. Thus, the number of
doctors per patient can only grow with time. The process is limited only
by the number of organs possessed by the patient and by the number of
hours an older person can tolerate sitting in doctors’ waiting rooms
Specialty referrals are frequently established at the urging or insistence
of the family. They see that Mom is dwindling and they demand that “she
must see a specialist.” This is the “Do something” response. A son or daughter,
who visits from afar, after a long hiatus, is appalled to see that dad has
visibly declined. He or she promptly packs the elderly man off to the city
for consultation at a medical school or other tertiary care center, with the
frail, somewhat resigned, old man reluctantly hauled hundreds of miles.
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