Feds say doctors don't heed drug warnings 

LAURAN NEERGAARD / AP 12dec00

WASHINGTON--With a series of blockbuster-selling drugs being yanked off the market for killing or injuring Americans, many banned because doctors ignored safety warnings and prescribed them to the wrong patients, the government's drug chief warned physicians to straighten up or expect even more bans.

Since 1997, 11 popular prescription drugs have been pulled from pharmacies after causing deaths or serious injuries. The latest, Lotronex, was banned two weeks ago for causing deadly intestinal side effects just nine months after it began selling. Likewise, five others were withdrawn roughly a year after hitting the market.

Increasingly frustrated FDA scientists say the main problem--largely to blame for seven bans--is that doctors ignored or never read warning labels that could have prevented deaths.

If that doesn't change, "additional effective drugs are likely to be withdrawn, and some drugs may never become available in the first place," warned FDA drug chief Dr. Janet Woodcock in an unusual letter to doctors in the Journal of the American Medical Association.

Doctors say they lack time to read the pages of fine print, and can't remember all the warnings anyway. Most learn about new drugs from salesmen unlikely to stress risks.

The FDA is debating whether to limit early sales of new drugs or even restrict which drugs can be prescribed by which doctors. Such restrictions may come next year for the birth defect-causing acne pill Accutane; observers say at least two experimental drugs now under review could be candidates, too.

But the problems raise a bigger question: Should a savvy patient ever swallow a new medicine until it's been sold for a year? After all, that first year of sales often is when bad side effects are spotted.

"I sure wouldn't," says Dr. Raymond Woosley, a leading drug-safety expert and cardiologist at Georgetown University. "I don't personally, and I don't usually prescribe it unless I have to."

Even the Food and Drug Administration's commissioner urges consumers to be cautious. It's advice Dr. Jane Henney says she'd follow herself: Closely question when your doctor wants to switch to a brand-new remedy.

Ask, "How is this different? Why are you recommending this one over something I'm already taking?' If it's just because " `it's new and let's try it,' that's not a good enough reason," Henney said.

Some critics say the FDA approves new drugs too quickly. Under congressional pressure, the FDA has sped up: Average review time for new drugs was 14.6 months in fiscal 2000, down from 34.3 months in 1993. Drugs deemed breakthroughs, and drugs whose makers pay special fees to FDA, can get a speedier six-month review.

But few of the recently banned drugs got "fast-track" approval.

Dr. Sidney Wolfe of the consumer advocacy group Public Citizen says the cases show FDA should ban drugs faster because warnings don't work.

Some computer systems can flag risky drugs. But too often, even computers are wrong, Woosley complained. Shortly before the heartburn drug Propulsid was banned, he tested a highly touted pharmacists' system and found it allowed prescription of a deadly Propulsid-antibiotic mix.