HEALTHBEAT: Feds say doctors must check safety warnings

Monday, December 11th 2000, 12:00 am

By: News On 6

WASHINGTON (AP) _ One after another, blockbuster-selling drugs are being yanked off the market for killing or injuring Americans. Many were banned because doctors ignored safety warnings and prescribed them to the wrong patients _ and the government's drug chief issued an unusual warning to physicians: Straighten up or expect even more bans.

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 in an interview.

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 Likewise, five others were withdrawn roughly a year after hitting the market.

Some critics say 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.

Instead, 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If that doesn't change, ``additional effective drugs are likely to be withdrawn, and some drugs may never become available in the first place,'' warned FDA drug chief Dr.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.

Every medication, even aspirin, has some risks. But new drugs are tested on only a few hundred to a few thousand patients, so no one knows just how many side effects will turn up when they're sold to millions.

First, FDA has to spot such risks. That's a problem. While pharmaceutical industry fees have enabled the FDA to hire dozens of employees to review and approve new drugs, just 82 workers track side effects once drugs are on the market. Congress repeatedly has refused additional funds to upgrade the $12 million program, which depends on doctors voluntarily reporting their patients' side effects _ something few do.

Once it spots a problem, the FDA often tries issuing warnings.

Take the heartburn drug Propulsid, pulled off pharmacy shelves last summer. For two years, FDA warned that prescribing it to people with kidney or heart disease, or those who take certain antibiotics or other pills, could cause lethal irregular heartbeats. Yet 80 deaths occurred.

Or consider the diabetes drug Rezulin. FDA's own scientists complained for months that patients didn't get tested for liver damage as warning labels required.

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

Why not? 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.

Some computer systems can flag risky drugs. But too often, even computers are wrong, Woosley complained. Shortly before Propulsid's ban, he tested a highly touted pharmacists' system and found it allowed prescription of a deadly Propulsid-antibiotic mix. Nor do those flyers many pharmacies hand out with prescriptions list all the side effects.

So FDA is debating tougher measures, such as limiting early sales of new drugs or even restricting which drugs can be prescribed by which doctors. Watch next year for such restrictions on the birth defect-causing acne pill Accutane; observers say at least two experimental drugs now under review could be candidates, too.

Meanwhile, consumers should demand that their doctors explain risks and why they choose one drug over another, Henney stressed.

``If you just willingly take that slip of paper out of your doctor's hand and walk off to the drugstore'' without questioning, ``you don't have enough information yet.''