Doctors buried by drug data

Volume of advisories from the FDA has some seeking clarity from private sources


WASHINGTON -- Embarrassed by reports of deaths linked to painkillers and suicides related to antidepressants in 2004, the Food and Drug Administration went into information overdrive.

It issued more safety alerts, revised more drug package inserts and posted more updates on its Web site than ever before - all to keep doctors informed about the medications they prescribe.

But critics say sheer volume isn't enough. Physicians, academics and health company officials complain that they are still not getting enough practical help.

"If something's not working, don't do it harder," said Dr. Kevin Ferentz, medical director of a family practice in Baltimore who gets the warnings "on a consistent enough basis that it all blurs."

Well before the nation renewed its interest in drug safety, studies showed that doctors frequently ignored safety warnings, and that many had trouble understanding and navigating information that the FDA works with drug companies to provide.

As a result, many doctors have turned to private collections of drug information, such as the Physicians Desk Reference, which synthesize complex medical advisories in a user-friendly form.

Today, with PCs and hand-held computers so common, many doctors like Ferentz also subscribe to electronic services for their drug safety data - including some information collected from unofficial sources.

FDA officials worry about that. They question the accuracy of information coming through private channels and fear it could be shaped by commercial interests. While acknowledging their own system's deficiencies, officials say the agency is addressing doctors' frustrations - and will reduce an estimated 300,000 medication errors each year.

Recently the FDA proposed making package inserts for drugs - normally crammed full of small print - easier to understand. The agency is also developing two Web sites for quick access to the latest drug information, along with alerts about possible drug risks that haven't been confirmed.

"It's a bit of the Wild Wild West out there. We think we can provide some order to the chaos," said Dr. Rachel Behrman, a deputy director in FDA's drug review office who oversaw efforts to make the package inserts more user-friendly.

She said the agency has "completely overhauled, revamped and revolutionized" the inserts to help doctors keep pace with the "explosion of information."

For years, the FDA has paid careful attention to drug labels and package inserts. It believed that telling doctors about each drug's appropriate use and side effects was a key to protecting patients. Traditionally, the agency approved the inserts, letters and other materials that pharmaceutical companies provided to physicians.

In response to recent criticism that it sat on information about dangers posed by the painkiller Vioxx, other anti-inflammatory drugs and the antidepressant Paxil, the agency has stepped up its distribution of safety data.

Almost weekly, the FDA discloses new findings. For example, a drug might produce color blindness, or endanger liver function, or shouldn't be prescribed to diabetics. Last year, the agency issued 112 safety alerts for drugs, compared with 45 in 2004 and 33 in 2003, according to a review of FDA postings. So far this year, it has released 21.

"It's very tough for individual physicians in community practices to drink from this fire hydrant of unmanaged information coming at them," said Dr. Susan Levine, associate executive director of the Permanente Medical Group Inc. in Oakland, Calif.

Dr. Ronald P. Bangasser, a family practitioner and medical director at a hospital in Redlands, Calif., says he receives more drug information mailings and e-mails than ever - three or four a week.

Although he reads the most dire "black box" warnings, with 30 patients a day visiting his office, Bangasser doesn't have time to pore over all the additional material. And if he did, would he remember the advice when he's considering the drug for a patient six months later?

Likewise, Bangasser says he doesn't have time to keep an eye on the FDA's Internet alerts. "Having more stuff on their Web site hasn't changed my behavior," he said.

Medical school researchers who study drug safety say that time pressures, advertising and a doctor's experience with a medicine have more influence than FDA safety publications. Another problem with the official material, physicians complain, is the limited practical guidance it provides.

Doctors often prescribe a drug for a medical condition that the FDA hasn't approved - which means that they won't find dosage and other important safety information about that use in the FDA's literature.

An FDA alert that an antidepressant causes suicidal thinking in 4 percent of patients - rather than 2 percent - doesn't always mean much to Ferentz when he's deciding whether to prescribe the drug in Baltimore.

"The FDA may put out a warning, but the warnings aren't necessarily clinically helpful," he said.

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