March 12, 2011 |
We’ve all seen them in newspapers and magazines, on TV and the Internet -- cheerful people in glossy, picturesque ads claiming that by taking a little magic prescription pill their lives were immeasurably improved.
As the TV ad fades, a cautionary voice quietly recites a host of “risk factors,” potentially catastrophic consequences that could result from taking the magical pill. One can’t but wonder if the cure is worse than the ailment.
A well-known ad features Dr. Robert Jarvik, a pioneer in the development of the artificial heart, pitching Pfizer’s cholesterol drug Lipitor. He comes across as a trusted expert with your best interest at heart, but viewers would not know that he is neither a cardiologist, nor licensed to practice medicine. (Lipitor’s 2009 sales were $5.4 billion.)
Another ad features Dorothy Hamill, the Olympic skating champion, skating effortlessly while promoting Merck's arthritis drug, Vioxx. The viewer would not know that Merck had for years knowingly withheld incriminating research from the Food and Drug Administration (FDA). The data would have barred the drug’s commercial release and may have saved the lives of an estimated 27,000 people who suffered heart attacks and sudden cardiac deaths after taking it. After Merck made billions, the drug was taken off the market.
These are two of a never-ending barrage of pharmaceutical advertisements known as direct-to-consumer (DTC) ads that bombard Americans day in and day out. Such ads are permitted only in the U.S. and New Zealand. They are intended to provoke an individual consumer to request a specific prescription drug from their doctor. In 2009, the pharmaceutical industry spent an estimated $4.5 billion on such advertising. Total 2007 U.S. pharma industry sales were $315 billion.
DTC ads give viewers the illusion that they can and should be their own doctor; they are designed to make viewers believe that they can and should prescribe for themselves. By fostering a false sense of demand for prescription-required drugs, DTC drug ads undermine the real knowledge that doctors should have when, in consultation with the patient, a treatment plan is established.
Next time you see one of these ads, make sure you are aware of the detailed risk factors that are either buried at the bottom of the page or mentioned at the commercial’s end. These risks tell only half the story of the drug’s real potential harm; the other half usually doesn’t get told: how the pharmaceutical industry is harming the health of Americans.
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Federal regulation of drugs was the result of public outrage over scandals exposed by early-20th-century muckrakers, most notably Upton Sinclair, who revealed widespread adulterated food products and poisonous patent medicines. This led to the passage of the Pure Food and Drug Act of 1906. In 1938, Congress passed the Food, Drug and Cosmetic Act that gave the FDA authority over drug company marketing materials. In 1962, FDA authority was further extended to regulate advertisements of prescription drugs.
However, things began to change in the 1980s. In 1981, Merck published the first DTC ad for a prescription drug, Pneumovax, in Reader’s Digest. It was followed by numerous print ads, and in 1983, the first television prescription drug ad for Boots Pharmaceutical’s Rufen, prescription strength ibuprofen.
Over the next decade-plus, the pharmaceutical industry, emboldened by the Reagan-era belief in “limited government,” steadily pushed to deregulate DTC ads. In 1997, the FDA loosened advertising rules leading to an enormous increase in DTC ad spending. For example, in 1996, less then $1 billion ($985 million) was spent on DTC ads out of the industry’s total promotional spending of $11.4 billion; in 2005, total pharma promotional spending nearly tripled to $29.9 billion and the amount spent on DTC ads quadrupled to $4.2 billion.
According to an invaluable 2007 study led by Dominick Frosch, “Creating Demand for Prescription Drugs,” a typical American television viewer can expect to spend 16 hours per year watching DTC drug commercials. This does not include the ads on radio, newspapers and magazines, billboards and the Internet. DTC ads typically focus on a handful of chronic conditions like depression, erectile dysfunction and insomnia.
Nevertheless, a perfect target for pharmaceutical intervention is America’s children and youth, and no condition has been more aggressively pursued than Attention Deficit/Hyperactivity Disorder (ADHD). Shire introduced Vyvanse in 2007 to replace its old blockbuster drug, Adderall XR, which had just lost its patent protection. The drug is targeted at children 6 to 12 years old, so the first DTC ads were placed in women’s magazines.
Some raised concern that the DTC ads violated the UN’s 1971 Convention on Psychotropic Substances, but the FDA brushed it off. The drug did include the following ominous warming: “MISUSE OF AMPHETAMINE MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.” Gone unstated in the DTC ads was the fact that Vyvanse is chemically based on methamphetamine, a Schedule II controlled substance like methadone, morphine and oxycodone. (Vyvanse’s 2009 sales were $660,000.)
Scheming pharma execs and ad agency hacks are not above inventing an illness to sell a new drug. A couple of years ago, Eli Lilly discovered a "new" female condition, Premenstrual Dysphoric Disorder (PMDD), to promote Sarafem, a form of Prozac. It was the first and only FDA-approved prescription drug to treat a woman’s menstrual cycle. Menstruation can be painful, and for some women even debilitating. Lilly exploited this, turning one of nature’s most primal bodily functions into a "disorder." The ad promised women that the drug would "help you feel more in control."
This new condition was a surprise to the American Psychiatric Association, which did not recognized PMDD as a disorder. It has proved so profitable because it turned a real, bodily experience (with, for many, pain and discomfort) into a disorder that can be cured. A magic capsule could now control an all-too-human condition that is as old as humanity itself, one that facilitates the species’ reproduction. Science had become witchcraft -- and with a hefty profit.
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A DTC drug ad is designed to address two pharmaceutical industry concerns. First, it is intended to promote both new and established prescription drugs. Second, it is used to offset a drug’s competitive challenge from a generic drug.
Two questions determine a DTC drug ad’s effectiveness. First, does it work in terms of medical factors; i.e., does it help a person effectively address a medical condition? And, second, does it work as measured in corporate terms; i.e., does it get consumers to ask their doctors about the drug, get a prescription and get a sale?
While an answer to the first question remains unresolved, the answer is clear with regard to the second question. In 2010, Thomson Reuters polled some 3,000 Americans about drug advertising. The study’s principal findings were revealing:
- Nearly two-thirds of respondents say they've seen, heard or received some kind of advertising for a prescription drug in the last six months.
- One-third of respondents say they talked to their doctor about a drug and got a prescription for it.
- Three-fifths of respondents said their doctor was the principal source for information about the prescription drug.
Not surprising, given the way people watch television, the study also found that many people didn’t pay much attention to the ads. Dr. Ray Fabius, chief medical officer for Thomson Reuters' health care and science business unit, noted "at least one-third of people aren't hearing them or tune them out."
Clearly, effectiveness of DTC ads is in the eyes of the beholder, whether measured against medical or business criteria. The pharma industry’s principal lobbying group, the Pharmaceutical Research and Manufacturers of America (PhRMA), supports DTCs, since “getting that information to patients and consumers is the goal of direct-to-consumer (DTC) advertising about prescription medicines.”
And DTCs seem effective, particularly in generating new sales. According to a Kaiser study, Americans in 1992 got an average of seven prescriptions per year; however, in 2008, the average number of prescriptions nearly doubled to 12 prescriptions a year. Either people have gotten a lot sicker or DTC ads are doing their job. The report notes, DTCs have “added about $180 billion to our medical spending.”
Direct-to-consumer drug ads are ostensibly educational or informational messages designed to help Americans address critical medical issues. While the jury is out as to their medical efficacy, the ads' contribution to the bottom line is undeniable. The question that remains unanswered is how much DTC ads are harming the health of Americans.
David Rosen lives in New York and can be reached at drosennyc@verizon.com.
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