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When drug company executives in gray suits shout, Power to the People! in defense of their new ad strategy, somethings fishy. But if the smell is bad, it hasnt 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 dont 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 doesnt cause bleeding like NSAIDS. [This] puts patients at risk, not just physicallybut 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 Computers ad spending for its top computer. Mercks 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 salescompared 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 dont 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 businesseclipsing 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 isnt 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 cant reach their doctor right away, or their doctor isnt willing to see them right away, where do they go? They come to me. Solomon explains that most patients with cold symptoms dont 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 drugand 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 theyve 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 theyve 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 dont 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 didnt 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 Avenues stock in trade is manipulating people into believing they need things they dont.
It isnt unreasonable, say doctors, to ask about a drug. But focusing on the symptoms causing concernrather 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 Medicines MedlinePlus: medline- plus.gov/ and Harvard Medical Schools InteliHealth website: www.intelihealth.com. Z
Lenzer has written for Harvard Medical Schools InteliHealth
(which receives no drug company funding).