Businessweek Archives

An Fda Rule That's Poor Science And Poor Policy


Top of the News

AN FDA RULE THAT'S POOR SCIENCE AND POOR POLICY

Researchers at Merck & Co. had plenty to crow about this year. In August, scientists at the National Heart, Lung & Blood Institute reported that Vasotec, a Merck hypertension drug, sharply cut the number of cardiovascular deaths and hospitalizations among people suffering from chronic congestive heart failure. Then, in early November, came news from the institute that the drug also curbed heart failure among patients with damaged hearts. Finally, in late November, word leaked out that researchers at the University of Southern California had found that a Merck cholesterol-reducer, Mevacor, halted hardening of the arteries and could even shrink arterial plaque deposits. That could make Mevacor a powerful weapon against heart attacks.

Merck couldn't do any crowing in public, though. No advertising. No press conferences. No publications. And minimal discussion when news reporters called. Even more problematic, the company's sales force couldn't give doctors copies of published studies about the new research or similar earlier studies. In fact, doctors can call the Food & Drug Administration toll-free to inform on companies giving out such information.

NO HINTS. Why the muzzling? Mevacor isn't approved as a heart-attack drug. Vasotec is O. K.'d only for hypertension. And the FDA doesn't let drugmakers so much as hint that their drugs might have potentially beneficial uses unless those uses have gone all the way through the protracted and expensive FDA approval process. Woe to the drugmaker that calls public attention to an unapproved use. The offending company faces discipline and possibly federal prosecution--even if the treatment in question could save thousands of lives.

At least one company has called down the wrath of the FDA and its tough-talking administrator, David A. Kessler. Johnson & Johnson in 1988 staged a press conference to showcase a researcher's work that suggested that Retin-A, the acne medicine, could have some cosmetic use in curbing wrinkles. Sales soared until dermatology patients starting complaining that the stuff irritated and reddened their skin. Demand withered. Now, J&J may be prosecuted for publicizing the research. Even if the company went too far in hyping the data, the marketplace was quick to administer punishment.

Much more than wrinkles are at stake with many of the drugs that are subject to FDA constraints. Many cancer drugs are used routinely for nonapproved treatments. The science is too unsettled and the markets too small for the companies to seek label changes for every potential use of a cancer drug.

And yet, under FDA policy no company may even circulate reprints of cutting-edge research into nonapproved uses--that would constitute promotion in the FDA's eyes. Bristol-Myers Squibb Co., a leader in cancer treatments, last spring stopped publishing a magazine distributed to physicians that routinely discussed nonapproved uses mf its drugs. The FDA's crackdown, says Patrick D. Maines, president of the Media Institute, a Washington-based think tank, "is deeply suspect both constitutionally, under the First Amendment, and in terms of the net public benefit."

Then again, shameless drug-company hucksterism is also suspect. But the FDA has no business choking off reliable, well-developed scientific news, even if the messenger is a self-interested drug company. For their part, companies that dispense half-truths or flimsy research to promote their drugs risk their credibility and that of the whole industry. With the health of patients at stake, there's no room for error. Ultimately, all parties will find that fair and balanced information contributes to the best medical practice.

OPEN TALK. To its credit, the FDA is starting to show signs of loosening the drug companies' muzzle. "We are trying very hard to make it easier for companies like Merck," says Ann M. Witt, the FDA's chief drug-advertising enforcer. "Not for them to hold press conferences, but for them to sponsor educational programs at which research can be freely discussed by independent experts."

That idea should be put to the test: Companies that are reluctant to underwrite medical meetings or sponsor impartial speakers at them should clear the meeting's program in advance with the FDA. Maybe then the companies can show that good science doesn't have to conflict with making money. And the agency then, too, could stop looking on every drugmaker's meeting as a one-sided sales session designed to flout agency rules.

What matters most is getting the news out. The stakes are way too high for either drugmakers or regulators to stand in the way of credible scientific research. Stifling information about medicine can only hurt the men, women, and children who need these drugs--sometimes desperately.Joseph Weber


Soul Searcher
LIMITED-TIME OFFER SUBSCRIBE NOW

(enter your email)
(enter up to 5 email addresses, separated by commas)

Max 250 characters

 
blog comments powered by Disqus