Many Drug Ads Are Misleading, Study Finds
Many drug advertisements in medical journals--long believed to influence doctors’ decisions about prescribing--are unbalanced, misleading and in apparent violation of federal regulations governing drug promotion, UCLA researchers have found.
In the first large study of its kind, medical specialists reviewed 109 prescription drug ads published in 10 leading medical journals. They concluded, among other things, that more than half the ads studied had little or no educational value.
They found that advertisers frequently failed to balance information on a drug’s effectiveness with information on its side effects and risks. Some ads studied, they suggested, could encourage inappropriate, even dangerous use of drugs.
The study’s conclusions, published today, could be significant in light of the documented role of drug promotion in physician decision-making--particularly at a time when new drugs are proliferating and many doctors have little time to keep up.
“The problem is not that (federal authorities) need new regulations,” said Dr. Michael S. Wilkes, a UCLA professor of medicine and lead author of the paper in the Annals of Internal Medicine. “They need to enforce the regulations that already exist.”
Drug companies spend hundreds of millions of dollars annually advertising their products in medical journals. Research suggests that such ads are highly effective in encouraging physicians to prescribe the latest--and often most expensive--drugs.
Under federal rules, pharmaceutical advertisers must be honest about the side effects, contraindications and effectiveness of their products, and must offer a fair balance between information on effectiveness and risks.
Recently, critics have complained that many advertisers’ claims are false or misleading. Fearing that such ads could prompt inappropriate prescribing, they have accused the Food and Drug Administration of failing to enforce its rules.
“The main point is that drug advertising, to the extent that it is false or misleading, can result in patients being injured or killed,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, a Washington-based consumer organization.
The Pharmaceutical Manufacturers Assn., which represents many large drug companies, objected sharply to the conclusions of the UCLA researchers. In a statement, officials of the manufacturers group challenged the suggestion that FDA regulations are being flouted.
“It is unfair to review 109 unidentified advertisements and claim that (most) of them potentially do not comply with FDA standards, thus impugning the reputation of an entire industry,” the association officials said.
In the study, Wilkes and two colleagues examined ads published in early 1990 in general and specialty journals. The drugs, used by 11 specialties, ranged from antibiotics to sleeping pills. The journals included, among others, the New England Journal of Medicine.
The researchers asked two physicians in each specialty plus an academic pharmacist to evaluate each ad consistent with FDA criteria. They were also asked to judge the ad’s educational value and to say whether the journal should have published, altered or refused the ad.
In 57% of cases, two or more reviewers found that the ads had little or no educational value. Overall, they would have advised against publishing 28% of the ads and would have required major revisions in 34% before publication.
In 30% of cases, two or more reviewers disagreed with the advertisers’ claim that the drug was the “drug of choice.” In 40%, they thought that information on efficacy was not balanced with information on side effects and contraindications.
Finally, the reviewers found that 32% of ads contained headlines that misled the reader about the drug’s effectiveness. They thought that 44% of the ads would lead to improper prescribing if a physician had no other information about the drug.
“I’m not super-critical, I am a realist,” Wilkes said in an interview, saying he is no knee-jerk opponent of pharmaceutical companies and federal regulators. “But we’ve got a big problem here.”
The researchers did not identify the ads or products. But Wilkes said examples of what they found included sleeping pills promoted for the elderly when they are unsafe in older people, and anti-vomiting drugs promoted for children when there are safer alternatives.
Dr. Jerry Avorn, an associate professor of medicine at Harvard Medical School and the Brigham and Women’s Hospital, said the biggest problem is that doctors are not exposed to “countervailing voices” promoting less lucrative drugs or non-drug treatments.
Pharmaceutical companies tend to push their newest products--before the 17-year patent expires and competition ratchets down the cost. In Avorn’s view, those are often the most high-tech and pricey drugs, rather than cheaper, less sophisticated but proven alternatives.
Better enforcement of drug ad regulation “almost certainly would result in savings to the nation as a whole if there were less emphasis on trendy prescribing and more emphasis on cost-effective prescribing,” Avorn said.
In an editorial accompanying the study, Dr. David A. Kessler, the FDA commissioner, noted that the agency recently doubled the size of its staff assigned to regulating promotional activities. It has also cracked down in the last year on several offenders.
But Kessler argued that the FDA alone cannot control the problem. The pharmaceutical industry must scrutinize more closely its marketing practices, and medical schools must “teach students to critically examine promotional information.”
In a separate editorial, the editors of the journal, Drs. Suzanne and Robert H. Fletcher, contended that it would be inefficient and costly for journals such as theirs to independently review all ads, as some critics have urged.
Instead, they suggested setting up a multidisciplinary review body, such as the one that reviews medical journal ads in Canada. But in the long run, the Fletchers said, critical readers “are the last line of defense against misinformation of any kind.”
