Drug labels, ads at center of battle
For years, American consumers have been bombarded with overhyped advertising for prescription drugs. On average, they spend more time watching drug ads on TV -- 16 hours a year -- than talking with their primary care doctors.
The ads are often misleading. By ambiguously defining who might need or benefit from the products advertised, they focus “on convincing people that they may be at risk for a wide array of health conditions” rather than genuinely educating consumers, concluded a 2007 study in the Annals of Family Medicine.
In an ad for the cholesterol-lowering drug Lipitor, for example, a man says, “I never thought it could happen to me. A heart attack at 53 . . . Now I trust my heart to Lipitor.” Although research shows Lipitor can indeed help prevent heart attacks, the ad suggests the heart attack risk in this age group is higher than it actually is.
“The risks are often buried in a sea of unintelligible tiny print and benefits are often overstated, so it’s hard for both doctors and patients to make informed risk assessments,” says Dr. Jerry Avorn, chief of the division of pharmacoepidemiology at Brigham and Women’s Hospital.
But better ads and labeling may be on the way.
Regulators are becoming less tolerant of what they see as excessive claims. In January, the FDA began requiring Bayer HealthCare Pharmaceuticals, maker of the birth control pill Yaz, to launch a new ad campaign to correct earlier claims about treating headaches and acne -- uses not approved by the FDA.
And an advisory committee to the FDA has unanimously recommended what could be the biggest change yet: It urged the agency to adopt the “drug facts box” format as its standard -- a proposal that, if implemented, could radically improve drug information for consumers. A drug fact box is a concise summary of a drug’s benefit and side effects, similar to the nutrition information boxes on food labels.
Such fact boxes would, at a minimum, be included in the consumer handouts that pharmacists give patients with prescriptions. They might also eventually appear on the official FDA drug labels and in magazine ads, replacing the fine-print summaries that regulators now require.
Imagine having each drug package, or perhaps each ad, accompanied by a mandated fact box written in plain English. Rather than statements such as, “This drug reduced heart attack risk by 50%” (which tells you nothing unless you know “50% of what?”), a good label could say: “This drug reduced heart attack risk over 10 years from 6 out of 1,000 to 3 out of 1,000.” That would tell you the risk was modest to begin with.
Drug manufacturers maintain that their ads are not misleading. The Pharmaceutical Research and Manufacturers of America, an industry group, says: “Consistent with recently updated guidelines, PhRMA is committed to a fair balance of risk and benefit information in all direct-to-consumer advertising.”
But even when not misleading, the ads fall short of educating consumers.
Blind testing
Drug fact boxes are the brainchild of a husband-and-wife team -- physician-researchers Lisa Schwartz and Steven Woloshin -- at the Dartmouth Institute for Health Policy and Clinical Practice. In a revealing study published recently online by the Annals of Internal Medicine, the Dartmouth team tested how much consumers could benefit from understandable information on drug products.
Their answer: a lot.
For the study, researchers modified real direct-to-consumer ads for prominent heartburn drugs, altering the product name -- Prilosec was re-labeled “Maxtor,” for example; and Pepcid became “Amcid” -- so that consumers would view them free of preconceived notions.
The team also created a drug fact box for each, accurately describing how the drug worked. Maxtor was identified as a proton-pump inhibitor that blocks production of stomach acid, and Amcid was identified as an H-2 blocker that controls acid through a different mechanism.
Past scientific research has shown that proton-pump inhibitors are more effective than H-2 blockers in treating heartburn, and the study was designed to see if consumers would reach that same conclusion by reading the drug fact box. “We chose the drugs to have one clear winner,” Schwartz said.
All the study subjects were shown picture ads for both products; half were also shown the drug fact box, while the other half got the standard small-print drug information page -- text already required by the FDA. Then all were asked which drug they would chose to treat heartburn.
The results: 68% of the subjects with the drug fact box chose Maxtor, the more effective drug; among those who had ad information alone, only 31% chose the more effective drug.
The fact box “improved consumers’ knowledge” and “resulted in better choices between drugs,” the authors concluded.
Drug fact boxes are a “terrific idea,” said Baruch Fischhoff, a Carnegie Mellon University professor of psychology and decision science who chaired the FDA advisory committee. The goal is to “present information in a way so that most people will understand what they need to know in order to make a good decision.”
Other studies show how ads can mislead consumers. In 2007, a study published in the Journal of Health Communication showed that even some ads that detailed side effects managed to state them in a way that stressed benefits, not risks. For instance, instead of using a strong, declarative statement such as “common side effects are . . . ,” an ad for Flonase, a nasal allergy spray, says, “If side effects occur, they are generally mild and may include headache, nosebleed or sore throat.”
This is potentially worrisome because other studies, including one in 1999 in the Journal of General Internal Medicine, showed that direct-to-consumer ads are very powerful: 54% of people in one survey either asked for a prescription or asked a doctor for more information because of an ad. And ads are omnipresent; drug companies spent about $5 billion on direct-to-consumer advertising in 2007, more than twice the total FDA budget.
On the horizon
That said, greater regulation of drug ads seems inevitable -- although some would like a brisker pace of change. Although the FDA required Bayer to run corrective ads for its Yaz birth control pill, “They rarely require these corrective campaigns,” said Judy Norsigian, executive director of Our Bodies Ourselves, a women’s health advocacy group. “These ads should never have been out there.”
Perhaps they would not have been if drug fact boxes had been a reality. It’s now up to the FDA to decide the issue. History suggests that the FDA usually goes along with the advisory board that made the recommendation. There is no timetable and no certainty. But there is hope.
Said Fischhoff, the advisory panel chairman: “I find the staff very supportive of the committee, so I am optimistic.”
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Do the research
How does a consumer make informed choices about prescription drugs? For one thing, don’t get all your drug information from ads or labels.
Check out websites such as www.rxfacts.org, run by the Independent Drug Information Service, which is sponsored by the Pennsylvania Department of Aging and has no ties to any pharmaceutical companies.
Or go to www.consumerreportshealth.org, run by Consumer Reports, which also gets no support from pharmaceutical companies.
