Healthy Skepticism Library item: 1722

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Publication type: news

Adams C.
FDA Is Inundated Trying To Assess Drug Ad Pitches
The Wall Street Journal 2002 Mar 14
http://online.wsj.com/article/SB1016053991820089240.html?mod=googlewsj

Full text:

In the escalating drug-advertising battle, Thomas Abrams is the referee.

As director of the Division of Drug Marketing, Advertising and Communications for the Food and Drug Administration, Mr. Abrams is charged with ensuring that drug ads and sales pitches are fair, balanced and truthful. But it’s become overwhelming trying to assess them all.

From 1996 through 2001, the number of ads submitted annually for FDA scrutiny, including television spots, magazine ads, Internet sites, even poster boards and pamphlets used by sales representatives, jumped nearly 35%, to more than 34,000 from 25,236. Yet the FDA has issued fewer citation letters to drug makers alleging that ads or marketing materials were false, misleading, or otherwise out of compliance, a review of FDA records shows. After FDA officials sent out more than 150 citation letters in 1996, 1997 and 1998, the number steadily decreased, hitting 71 in 2001.

Drug makers say the drop in citations shows that the advertisements are cleaner than before. A spokeswoman for Pharmaceutical Research and Manufacturers of America, the industry’s main trade group, says the companies are “much more knowledgeable” about what is within FDA rules today than they were in 1997, when new federal guidance opened the door for the flood of ads now on TV. The FDA’s Mr. Abrams says: “We don’t measure our success in terms of the number of enforcement measures we take.”

Indeed, Mr. Abrams says that with the division’s “limited resources” his staff couldn’t possibly dig into every ad even if he wanted to. In 1996 there were the equivalent of 28 full-time workers on his staff; in 2001, there were 30. In addition, many of the marketing pitches have gotten increasingly sophisticated and complicated, while monitoring them has become more difficult as companies use new technologies like hand-held computers to deliver their messages.

So, he and his team focus on the ads deemed most critical — those that appear on television, make unusual claims or raise a major public health issue. Reviewing a one-page ad in a medical journal, for example, is relatively straightforward, Mr. Abrams says. But catching drug sales representatives spinning tales or playing down a drug’s risks during a sales call is tougher. “You have to be sure what was said before you make any conclusions or allegations,” Mr. Abrams says.

Promotions for Merck & Co.‘s blockbuster arthritis drug Vioxx illustrate how complex the FDA’s ad-watching duties can be. In June 2000, a physician held a series of audio conference calls on Merck’s behalf to tout the drug. At the time, Vioxx was under scrutiny because a study had suggested that patients using Vioxx had a higher rate of heart attacks than patients who received an older drug, naproxen. One possibility was that naproxen helped reduce heart attacks, but the Merck speaker neglected to discuss another possibility: that Vioxx might have been a cause of the attacks.

But later, the FDA caught Merck painting a similarly rosy picture about Vioxx’s cardiovascular profile in other forums, including a May 2001 press release and during two out-of-the-way medical conferences. Finally, after more than a year of monitoring, the FDA in September sent a warning letter — its most serious type of citation — to Merck citing the “seriousness of these violations,” and requested that Merck cease all such messages and prepare a corrective statement. Says a spokesman for Merck: “We saw the issue; we corrected it quickly.” The company says it sent letters elaborating about possible heart troubles from Vioxx to 100 doctors and 2,000 pharmacists who may have had heard the previous messages.

In some cases, companies seem to push the limits until told to stop. On May 12, 2001, a FDA ad-watcher attended an oncologists’ meeting in San Francisco. While watching and listening to the drug sales representatives working exhibit hall booths, the official observed a pitch on behalf of Maxim Pharmaceuticals Inc.‘s proposed drug Ceplene, which is being tested for treatment of melanoma, leukemia and hepatitis. According to a citation letter the FDA later sent Maxim, the sales rep made repeated statements touting the drug as safe and effective even though it had yet to be approved — a violation of FDA rules. The rep boasted: “Phase III studies are showing a doubling of survival. … I would love to tell you more but I can’t in case you’re with the FDA.”

The FDA requested that Maxim’s sales reps immediately cease such promotional statements, and Maxim said they would, according to FDA records.

Despite its various monitoring efforts, such slaps on the wrist are about all the FDA ever issues for infractions. That leads critics of the FDA to counter that the agency is unwilling to take on the powerful drug industry. Sidney Wolfe, director of Public Citizen’s Health Research Group, a Washington-based watchdog organization, argues that the marketing pitches aren’t any more honest or balanced than in the past. He and consumer and insurance groups say the FDA should beef up Mr. Abrams’ division, as well as give it authority to levy stiff fines for companies that repeatedly violate advertising guidelines.

The FDA’s Mr. Abrams responds: “I think we’re doing a very effective job, I really do. … If we had more resources, we would do more.”

Write to Chris Adams at chris.adams@wsj.com4