Doctors Dangerously Misled by Drug Ads, Consumer Group Says
Adding fuel to the debate over misleading drug advertisements, a consumer advocacy group charged Thursday that pharmaceutical manufacturers are providing physicians with “potentially dangerous misinformation on an extremely wide scale.”
The Public Citizen Health Research Group announced its conclusion after analyzing data that it obtained from a widely publicized UCLA study of advertisements in medical journals. That study, published in the June 1 issue of the Annals of Internal Medicine, found that about 60% of a sample of 109 recent ads were in apparent violation of federal regulations and warranted rejection or major revision.
But that study did not identify the drugs, their manufacturers or the specific criticisms that independent experts made of the ads.
According to additional data obtained by the consumer group, 27 of 39 pharmaceutical companies with ads in the study had at least one improper ad. The worst offender in the new analysis was SmithKline Beecham of Philadelphia; independent experts found that all 12 of the company’s ads considered in the study should be rejected or substantially revised.
These experts recommended rejection or major revisions for 75% or more of the ads for psychotropic drugs such as sleeping pills and anti-depression medications, birth control pills and asthma drugs. Ads for heart drugs fared better, with rejection or major revision recommended for only 40%.
The findings “confirm my notion that the people who are marketing drugs don’t have standards any better than the people who market used cars or laundry detergent,” said Dr. Sidney M. Wolfe, the director of the organization. “They stoop to whatever will work to sell their product.”
In response, the Pharmaceutical Manufacturers Assn., which represents many large drug companies, reiterated criticisms of the original study that it made in June. A spokesman for SmithKline Beecham said the company’s ads “are subject to a rigorous internal approval process. . . . We are confident our ads are responsible, accurate and meet all regulatory standards.”
Studies suggest that ads are a powerful influence on doctors’ decisions about prescribing medications. They are also a major source of income for medical journals and the medical organizations that publish them. In 1991, the pharmaceutical industry spent about $350 million on advertisements in medical and surgical journals.
Under U.S. Food and Drug Administration regulations, pharmaceutical ads must provide accurate information about the efficacy, side effects and contraindications of a product, as well as clear warnings about major problems.
The FDA has been criticized for failing to enforce its own rules. While many medical journals seek the opinions of outside experts before accepting scientific articles, most do not subject ads to comparable scrutiny.
In an interview, Wolfe said he hopes that release of the additional data will increase pressure on the FDA, medical journals and pharmaceutical manufacturers to improve the quality of ads. Wolfe also called for establishment of an independent board that would review and approve advertisements, such as the review board used in Canada.
The UCLA researchers sent copies of the ads under study to physicians and clinical pharmacists who are experts in the areas of medicine for which the drugs were used. The comments of these experts are in some cases colorful and explicit.
After reviewing an ad for Amoxil, a commonly prescribed antibiotic, a reviewer wrote: “ ‘Kids love ‘em--so do moms’--sounds like a peanut butter advertisement rather than an antibiotic.” An ad for Prozac, which is used to treat depression, was critiqued as “truly a promotional ad. . . . Very little data is presented for critical review.” An ad for Unasyn, another antibiotic, was deemed “fundamentally lacking in integrity.”
Wolfe said the data was obtained from the Office of the Inspector General of the federal Department of Health and Human Services, which in part funded the earlier UCLA study.
Dr. Martin Shapiro of UCLA, one of the authors of the study, declined specific comment on the release of data that the researchers had not made public.
Shapiro said the “most important” point of the study--that “there is a pervasive problem affecting a lot of pharmaceutical advertisements which calls for some kind of action”--could be made without naming individual ads or manufacturers.
Dr. Micheal S. Wilkes, the principal author of the study, urged “extreme caution in making any generalizations about an individual drug company, an individual journal or an individual class of drugs based on this data.”
Questionable Ads
These are two examples of misleading pharmaceutical advertisements that appeared in medical journals, according to the Public Citizen Health Research Group.
The consumer advocacy group analyzed the raw data from a UCLA study of drug ads in leading medical journals. As part of the study, the ads were reviewed by independent experts.
The drug: Phenergan.
Use: Nausea and vomiting.
Manufacturer: Wyeth-Ayerst Laboratories, Philadelphia.
Journal: Pediatrics, January, 1990.
The ad: Shows a little girl in a baseball uniform standing next to a station wagon. States that a “trip to the park can upset the works, just when children should be having fun.” Adds that with Phenergan “no one has to miss the ballgame.”
Potential side effects: Drowsiness, blurred vision and other central nervous system problems.
Public Citizen comment: Should not be given to children to prevent nausea before every car trip, as the ad seems to advocate. One reviewer said: “One of the worst ads I’ve ever seen. It promotes the use of a dangerous medicine for trivial indications.”
The drug: Noroxin.
Use: Bladder infections.
Manufacturer: Merck Sharp & Dohme, West Point, Pa.
Journal: New England Journal of Medicine, Jan. 4, 1990.
The ad: Advocates use to treat urinary tract infections.
Potential side effects: Rare.
Public Citizen comment: Noroxin costs as much as 10 times more than other antibiotics that cure most such infections. Drug should be reserved for rare instances involving bacteria that do not respond to less expensive drugs. One reviewer said: “Advertisements like this one are reasons why something must be done to avoid such terribly misleading information about a drug.”
