Commentary: Drug Ads Need Stronger Medicine

New FDA guidelines may not go far enough

Thanks to ubiquitous advertising, Celebrex, Lipitor, and other prescription drugs have become almost as familiar as classic brands like Jaguar or Gucci. There are some advantages to that. Since taking off in the late 1990s, direct-to-consumer (DTC) drug ads have prodded more people to see their doctors and get needed treatments.

At the same time, however, the ads may cause some medications to be overprescribed and inappropriately used, leading to lower quality care and higher drug costs. And several recent studies have concluded that direct-to-consumer ads typically minimize the risks and overstate the benefits of pharmaceutical products. "Research shows that consumers are not getting the full story," says Food & Drug Administration Associate Commissioner Peter J. Pitts.

Recognizing the problem, the FDA is making changes. In early February, the agency is expected to propose that drugmakers be allowed to replace the misnamed "brief summary" -- the full page of tiny type in printed drug ads, filled with jargon about side effects and other information -- with a more readable format.

The FDA will also tweak the guidelines to discourage promotions that don't mention side effects. Currently, drugmakers are permitted to run ads that alert consumers to a disease or that mention a drug name without specifying the condition it's meant to treat. These ads aren't required to include information on risks. By packing such ads together in a series, drug companies can plug products almost as if they were risk-free.

The FDA is moving in the right direction. Unfortunately, its initiative only goes part way. The most pressing concern is that ads will still make drugs appear more effective and safer than they really are. "There is a public perception that the benefits of these drugs are large -- and that the FDA only allows ads for very effective ones," explains Dr. Lisa M. Schwartz, associate professor of medicine at Dartmouth Medical School.

Not so. The vast majority of drugs only work in half the people who take them, or fewer, explained Dr. Allen Roses, vice-president of GlaxoSmithKline PLC (GSK ), at a recent conference. Current Alzheimer's drugs offer only a tiny effect, and that occurs only in about 30% of patients. Cancer drugs typically work in just one out of four people. And for many individuals, heavily advertised painkillers Celebrex and Vioxx provide no more relief than older, cheaper medicines, such as ibuprofen.

Consumers are unlikely to learn that from advertisements. The spots for the painkillers, for instance, show arthritis sufferers getting a new lease on life and gamboling through fields. That's "very different from the reality," says Dr. Barbara Mintzes, a researcher at the University of British Columbia.

RISK TABLE. One promising solution has been proposed by Schwartz and colleague Dr. Steven Woloshin: Add a table to drug ads presenting actual data on benefits. For Merck & Co.'s (MRK ) painkiller Vioxx, for instance, Schwartz and Woloshin's sample compares the brand name with ibuprofen and shows that for both drugs, 9% of patients reported excellent relief of symptoms, while 48% and 41%, respectively, reported fair, poor, or no effects.

The idea works even better, say the researchers, when data about risks are added. Tamoxifen, for instance, has been advertised as a preventive treatment for breast cancer. While fewer women who took the drug in a trial got breast cancer compared with those getting placebos, the women on tamoxifen had higher rates of uterine cancer, strokes, and other problems. Dr. Sidney Wolfe, director of the Public Citizen's Health Research Group, points out that only some people get the benefit of any drug, while most will be at risk for the side effects. For tamoxifen, he says, "when you add up the risks and benefits, it turns out that the risks outweigh the benefits."

Tamoxifen's maker, AstraZeneca (AZN ), responds that information about the drug always includes an FDA-required warning describing side effects. And for women at high risk for breast cancer, the company argues, the benefits outweigh the dangers. What's more, many drugmakers say that a table with clinical trial results may itself be misleading. Different trials can produce varying results -- and the general population may respond differently than patients in carefully controlled clinical trials.

Granted, results vary. But a table can also explain any limitations in the data. And getting real information into the hands of consumers is good for health care. For one thing, it helps address a big concern about DTC ads -- that patients are walking into doctors' offices demanding and getting drugs that may not be the best for their conditions. For instance, drugs known as diuretics, which reduce fluid in the blood stream, are often the best first-line treatment for high blood pressure. But they are underused because they are low-cost, generic drugs that aren't worth advertising. Putting information in ads for newer blood pressure drugs that compares their effects to those of diuretics could improve treatment for this condition.

Drug companies are leery of providing additional scary-sounding details about side effects. They shouldn't be. Recent surveys of patients show that when an ad clearly describes all the risks, consumers are more likely to trust the ad and to discuss the drug with their doctors.

Because of fears that DTC ads are misleading, most countries don't allow them. But in the U.S., with its long tradition of commercial free speech, such ads are never going away. "The genie is out of the bottle," says the FDA's Pitts. But we can do a better job of putting this genie to work improving public health instead of just boosting drug industry profits.

By John Carey

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