When
drug company executives in gray suits shout, “Power to the
People!” in defense of their new ad strategy, something’s
fishy. But if the smell is bad, it hasn’t stopped direct- to-consumer
(DTC) advertising of prescription drugs from being wildly successful.
Nor has it stopped some non-profit consumer and health organizations
from leaping to the defense of DTC ads. Although drug company execs
say the ads educate patients, others say they result in the use
of expensive and riskier medications.
When
former ice skating champion Dorothy Hamill smiles into a television
camera lens and declares that Vioxx has miraculously cured her arthritis
pain, patients listen. The implication is clear; celebrities, with
their money and access to the best medical care in the world, would
only use the best and safest treatments.
But
Vioxx, it turns out, is the wrong drug for common arthritis. Acetaminophen
should be used as first-line therapy for osteoarthritis, according
to guidelines issued by the American College of Rheumatology. Vioxx,
which belongs to a class of anti-inflammatory drugs known as NSAIDS,
should be used if patients don’t get relief with acetaminophen
and then only with great care because of their side effects.
“NSAIDs
are not a good first choice for osteoarthritis,” says Larry
D. Sasich, a research associate with Public Citizen in Washington.
“Osteoarthritis, the most common form of arthritis, is caused
by wear and tear on the joints, not by inflammation. Using Vioxx
is unnecessary.”
The
use of Vioxx and other NSAIDS such as aspirin, ibu- profen, and
naproxyn, has resulted in dramatic rises in ulcers, bleeding, even
death. Approximately 16,500 people die every year from NSAID-induced
bleeding. There are over 100,000 hospitalizations annually in the
U.S. for this side effect of NSAIDs, at an estimated cost of $2
billion annually.
The
cost of the medication is another problem: A three-month supply
of Vioxx costs $206, while the same supply of acetaminophen can
be purchased for just under $40. In elderly patients who often take
eight or nine different drugs daily, the cost difference can be
overwhelming.
DTC
ads for Vioxx worry Sasich, “Acetaminophen is not only cheaper,
it doesn’t cause bleeding like NSAIDS. [This] puts patients
at risk, not just physically—but it causes them financial harm
as well,” says Sasich.
Despite
its huge costs and risky side effects, Vioxx skyrocketed to first
place in sales among all drugs promoted by DTC ads in 2000. Its
use increased 331 percent between 1999 and 2000. Merck ploughed
$146 million into DTC ads for Vioxx in 2000, beating out ad spending
for Budweiser beer and nearly matching Dell Computer’s ad spending
for its top computer. Merck’s reward? Over $1.5 billion worth
of Vioxx sold in 2000.
Altogether,
drug companies plunked down $2.8 billion on DTC ads in 2001, up
from $2.5 billion in 2000 according to the NDCHealth. The 50 most
heavily promoted drugs in 1999 through 2000 experienced a hefty
25 percent rise in sales—compared with an increase of 4 percent
for all other drugs combined.
IMS
Health, an “information partner to the pharmaceutical industry”
says DTC ads “empower” patients. In an article titled
“Power to the People, Reaching the ‘Smart Market’
of Empowered Consumers,” IMS spins the ads as “education”
that help patients make smart choices. Other advocates say DTC ads
provide an important counterweight to the paternalistic world of
medicine in which patients are often kept in the dark about their
medical care. Playing the “power to the people” card hit
pay dirt when several patient groups testified in U.S. Food and
Drug Administration hearings in 1995 in defense of DTC ads.
But
Madison Avenue slogans work best when money follows. Drug company
money is everywhere. The National Consumers’ League, one of
the three non-profit groups that testified in the FDA hearings in
support of DTC ads stated in the hearings that it received approximately
2 percent of its funding from drug companies that do DTC ads. They
did not address the question of how much drug company money they
received in all. The NCL did not respond to requests for documentation
of the funding they receive from drug companies.
The
second group to testify, the Allergy and Asthma Network/Mothers
of Asthmatics, Inc., (AANMA) did not disclose their financial ties
during the hearings. However, a visit to their website shows that
they have received funding from AstraZeneca Pharmaceuticals, Merck
& Co. Inc., Pfizer Inc., and Proctor & Gamble Company, among
others. An AANMA representative acknowledged that the group was
receiving drug-company funding at the time of the FDA hearings.
The
third group, the National Kidney Cancer Association, now known as
the Kidney Cancer Association, received in excess of $300,000 from
drug companies in 1995, according to their federal tax report. They
did not respond to questions about their funding at the time of
the hearings.
Besides
empowering patients, advocates say DTC ads bring large numbers of
patients in for under-treated conditions, like high blood pressure
and elevated cholesterol. They also argue that DTC ads create competition,
driving down drug prices.
Critics
say the ads don’t promote good medicine and that the newer
drugs promoted in DTC ads have poorly defined risk profiles, a point
made evident by a rash of recent drug withdrawals after patients
died or suffered serious side effects, including liver failure and
muscle breakdown caused by drugs such as Rezulin, Posicor, Duract,
Baycol, and others.
Critics
also challenge the idea that DTC ads drive down costs. Prescription
drug sales increased by 17.9 percent in 2001 and comprise the fastest
growing health care expense. Much of the increase was concentrated
among those drugs promoted by DTC ads and coincides with 12 to 46
percent increases in DTC ad expenditures every year since 1998.
This at a time when the pharmaceutical industry enjoys a 19 percent
profit margin, the highest of any business—eclipsing the 5
percent median profits of all Fortune 500 firms.
Drug
companies, faced with the increasing use of formularies (lists of
drugs an institution recommends or supplies as cost effective) have
found that creating patient demand can be more effective than supplying
doctors with scientific evidence that their drug is more effective
or safer than another drug. Dr. Philip Alper of the University of
California at San Francisco wrote in the Journal of the American
Medical Association, “What could be simpler than doing
an end run around the cost- containment efforts of health managers
and physicians by going directly to the patients to create demand
that will be difficult to refuse?”
Caught
between patient satisfaction surveys and ever-pressing time constraints,
doctors feel they are under the gun when confronted with a patient
clutching an ad for a drug they want. A survey of family physicians
found that 71 percent felt DTC ads pressure doctors into prescribing
drugs that they would not normally prescribe. And, according to
a study by the Henry K. Kaiser Foundation, when patients request
a specific drug, doctors prescribe it 44 percent of the time.
Yet
patients are often in the dark about the nature of DTC ads and about
the risks of the drugs promoted. According to one study, one-half
of respondents erroneously believed that DTC ads received government
approval prior to release and 43 percent believed (also erroneously)
that only “completely safe” drugs could be advertised.
In
addition to adding cost and risk, the drugs promoted by DTC ads
are often for unnecessary or “lifestyle” drugs that fuel
the belief that there is a “pill for every ill.” Drugs
for thinning hair, toenail fungus, and other problems are heavily
promoted while important, inexpensive treatments, like water pills
for high blood pressure, are ignored.
For
emergency doctors, patient demand for drugs of marginal value can
create particularly daunting challenges. Dr. Robert Solomon, vice
chair of the Department of Emergency Medicine at Ohio Valley Medical
Center in Wheeling, West Virginia, feels he has no choice but to
spend time undoing the bad information his patients receive. This
isn’t easy when the emergency department is overflowing with
patients having heart attacks and other serious emergencies.
Solomon
relates a recent incident: “Roche has been waging an aggressive
marketing campaign for Tamiflu. The ad tells people some symptoms
and urges them to call their doctor immediately if they have any
of the symptoms. But, for all the patients who can’t reach
their doctor right away, or their doctor isn’t willing to see
them right away, where do they go? They come to me.” Solomon
explains that most patients with cold symptoms don’t have the
flu and even of those with a true influenza-like illness, only half
will actually be infected with influenza virus. Of those, only 70
percent or so will benefit from an antiviral drug—and then
only marginally, since the medication shortens symptoms by one day,
at best.
Doctors
Feel The Squeeze
Robert
Roth, MD, a family practitioner in Kingston, New York, thinks DTC
ads tend to interfere with proper treatment because some patients
are hell-bent on obtaining prescriptions for a particular drug.
He has seen patients who come in wanting a drug they’ve seen
advertised. “If they come in and say, ‘Doctor, is this
drug right for me?’ I can work with them and their condition.
But some patients insist that a drug they’ve seen advertised
is what they need.” In these situations, doctors with simple,
low-cost, and effective treatments in mind find themselves fighting
impressions formed by corporate ad campaigns calculated to seduce
the public into demanding products.
Recent
surveys have shown that patients are disappointed if they don’t
receive the requested drug. Forty-six percent of patients said they
would try to persuade their physician; 24 percent said they would
try to get the drug from another doctor; 15 percent said they might
change doctors if they didn’t get the drug they requested.
Some doctors admit that between time pressure and possible patient
dissatisfaction, they are tempted to give patients what they want.
But
this can backfire too.According to a review of DTC ads in Health
Affairs, in one scenario, a patient sees an ad for an antidepressant
and she recognizes her symptoms as those of a major depression.
She tells her symptoms to her doctor, who performs a careful history
and physical exam, orders some tests, and concludes that the patient
is hypothyroid. She is then successfully treated with thyroid hormone.
A
second patient presents with the same symptoms and shows the ad
for the antidepressant to his doctor and requests a prescription
for the medication. The doctor does a brief exam, confirms depressive
symptoms, and prescribes the requested medication. Six months later
the patient is hospitalized with severe hypothy- roidism.
What
Can Consumers Do?
First
of all, remember, Madison Avenue’s stock in trade is manipulating
people into believing they need things they don’t.
It
isn’t unreasonable, say doctors, to ask about a drug. But focusing
on the symptoms causing concern—rather than on advertised drugs
is crucial. Turning to a trusted medical practitioner with a clear
explanation of symptoms, rather than a mind made up about manufactured
remedies is a more direct route to resolution of medical difficulties.
In
addition, consumers should look to non-commercial resources for
health care information. Such sources are limited but options include
Consumer Reports health newsletter, the National Library of Medicine’s
MedlinePlus: medline- plus.gov/ and Harvard Medical School’s
InteliHealth website: www.intelihealth.com. Z
Jeanne
Lenzer has written for Harvard Medical School’s InteliHealth
(which receives no drug company funding).
