Ethics Corner: Accepting Drug Ads a Risky Proposition

By: Allan Wolper The Nov. 19 front-page headline in The New York Times offered a scary scenario of sickness and serious side effects: "FDA Failing in Drug Safety, Official Asserts." The story was just as foreboding. Dr. David J. Graham, a reviewer for the Food and Drug Administration Office of Drug Safety, had alleged during a Senate Finance Committee hearing that Crestor, a cholesterol drug, and four others all had serious health issues. "We are faced with what may be the single greatest safety catastrophe in the history of the country and the history of the world," Graham testified.

Graham's bosses, known for their fealty to the country's legal drug lords, disagreed. Dr. Steven Galson, director of the FDA's Center for Drug Evaluation, called Graham's testimony "junk science," even though he later told The Washington Post he, too, had concerns about Crestor.

The Times made Graham their Man in The News and gave his 20 years at the FDA a mixed but generally favorable review. But his complaints could not compete with a four-color ad that same day that filled nearly a full page in the middle of the newspaper's sports section, celebrating Crestor as a safe, champion cholesterol killer.

In large blue type, the ad text read like it was written by Dr. Seuss: "Lowering cholesterol isn't a game/It's vital to know/not all drugs are the same/Ask your doctor about Crestor/Ask for it by name." Included in the ad was a coupon offering readers "15 days of Crestor 10mg free" with no clue that the bottom of the next page contained a blur of agate type listing all its possible side effects.

Those kinds of pharmaceutical ads present an ethical problem for newspaper sales acceptability departments, which love the revenue the ads bring in but worry that the claims associated with them will hurt the credibility of their news organization.

The impression is that newspapers like the Times would never accept advertisements for drugs whose safety was a matter of debate. Steph Jesperson, the Times' director of advertising acceptability, said he relies "on the FDA's expertise, rules, and controls ... to assure our readers that they are accurate and not misleading."

But the drug companies send their copy to the FDA at the same time they are submitted to the newspapers and are published before the agency can review them, according to FDA spokesperson Crystal Rice. She explained that the FDA's Division of Drug Marketing, Advertising and Communications might later consult with the drug companies after someone complains about an alleged misleading ad, but that conversation is never publicized.

Dr. Graham's Senate testimony received huge play in the international press because Crestor is prescribed in 63 countries, according to AstraZeneca, the pharmaceutical company that manufactures it. AstraZeneca responded with a massive media campaign, placing ads in the Times, The Boston Globe, the Chicago Tribune, the Los Angeles Times, The Wall Street Journal, the Washington Post, and USA Today. This was as controversial as the drug itself.

Those ads, citing the FDA's testimony before the Senate by Galson, had "publicly confirmed that Crestor is safe and effective; and that the concerns that have been raised [by Dr. Graham] have no medical or scientific basis." The ads did not include the fears that Galson had expressed immediately afterward to the Washington Post about Crestor's possible side effects.

Dr. Sidney M. Wolfe, director of the non-profit Public Health Research Group, claims Crestor appears "to have a higher rate of the life-threatening breakdown of muscle" than other anti-cholesterol drugs. He wrote a letter to the FDA demanding the ad be pulled. "If the FDA were doing its job, I wouldn't have to write letters like this," Dr. Wolfe recently told me in a telephone interview from his Washington, D.C., office. "That ad was a 100% false statement. "

Crestor stopped running that ad, but only because the company felt it had answered the concerns about its drug. "The ad served its purpose," said Emily Denney, a spokesperson for Crestor. "Doctors and patients were calling us. We had to let them know that Crestor was as safe as any other satin drug."

Should medical writers consult with their ad departments about which ads might be misleading? Carla K. Johnson, health writer for The Spokesman-Review in Spokane, Wash., and a member of the board of the Association of Health Care Journalists, insists reporters must keep their distance from the advertising department: "It's OK for the newspaper to check out those claims, but no one in the newsroom should be involved in the process."