Health sense

Drug ad alert

The FDA is considering major changes in the ways consumers learn about medications

By Judy Foreman
Globe Correspondent / April 6, 2009
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For years, consumers have been bombarded with overhyped advertising for prescription drugs. On average, Americans spend more time - 16 hours a year - watching drug ads on TV 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." While research shows Lipitor can indeed help prevent heart attacks, someone viewing the ad might well conclude that the risk of heart attack for that age group is greater than it really 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 pharmacoepidemiology division 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, for example, the Food and Drug Administration 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.

Last month, an advisory committee to the FDA unanimously recommended what could be the biggest change: 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 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 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 and newspaper 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 percent" - which tells you nothing unless you know "50 percent 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 tells you the risk was modest to begin with.

Drug manufacturers say their ads are not misleading. The Pharmaceutical Research and Manufacturers of America, an industry group, notes, "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, new research shows the ads fall short of fully educating consumers.

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 relabeled "Maxtor," and Pepcid became "Amcid" - to negate 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" 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 conclusion by reading the fact box. "We chose the drugs to have one clear winner," said Schwartz.

All 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 choose.

The results: 68 percent of the subjects with the drug fact box chose "Maxtor," the more effective drug; among those who had only ad information, only 31 percent 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."

Avorn also praised the idea, but cautioned that the Dartmouth study revealed a risk: Information in the drug box sometimes reduced enthusiasm for drugs that people might benefit from.

But there is no question, he said, that consumers need more reliable information. In an editorial accompanying the Dartmouth study, Avorn and his Harvard colleague, Dr. William Shank, note that, until now, medication information has been a "user-hostile welter of tiny print" in direct-to-consumers ads.

Other studies show how ads can mislead. In 2007, a study published in the Journal of Health Communication said 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, said, "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 percent 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.

That said, greater regulation of drug ads seems inevitable - although some would like 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, the women's health advocacy group. "These ads should never have been out there."

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, said Fischhoff, the advisory panel chairman: "I find the staff very supportive of the committee, so I am optimistic."

Judy Foreman can be reached at

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