10 December 2002 23:15 GMT

by Rabiya S. Tuma

Philadelphia - With more and more reports of adverse drug effects falling between the cracks, what's needed is a drug safety board independent of the US Food and Drug Administration, one expert said today at the American Society of Hematology here. Unfortunately, his message went unheard by those who most need to heed it.

Charles Bennet, a hematologist at Northwestern University in Illinois, has spent the last several years raising awareness within the medical community about adverse drug side effects. Still, the barriers to disseminating such information are overwhelming, and people who need to hear it aren't listening, says Bennet.

"Did you see about 35 people leave before my talk?" Bennet asked BioMedNet News. Bennet pointed out that the talk that preceded his presentation focused on a pharmaceutical-sponsored study on Ortho's Epoetin Alfa, "a drug that is under fire right now in Europe" for causing a type of permanent anemia. But "the people who could have benefited from my talk didn't want to hear it," he said. "They left."

Although often dismissed as such, the issue is neither minor nor rare, Bennet says. Drug complications cause 100,000 deaths each year, and more than 50% of drugs have serious toxicities that are only detected after FDA approval. Even when physicians recognize that a patient is reacting badly to a drug, he adds, only one in ten will report it to the FDA.

Bennet describes three steps to publicizing potentially fatal adverse drug responses: Identifying the problem; collecting data on enough cases to demonstrate an effect; and disseminating the information. The last, Bennet says, should be done through drug package inserts (which he admits even most clinicians don't read), and letters from manufacturers to doctors, journals and the popular press.

The delays between observing and disseminating the information often consumes years, Bennet says. For example, in the case of nevirapine, a drug used to prevent HIV infection after exposure, scientists first observed the first case of liver failure in 1996. But the "Dear Doctor" letter didn't materialize until the fall of 2000, and a journal article was published only earlier this year.

There are several reasons for the protracted delays, Bennet says. First, initial case reports are variable and many occur during off-label or unapproved uses for a given drug. For example, although the FDA recently approved thalidomide for use in leprosy, the drug is primarily used as to treat cancer - where it is known to cause thromboses in one out of every four patients, if they aren't given proper supportive care.

But the real issue, says Bennet, is that monitoring of such drug-induced problems doesn't fall under the specific purview of any one government agency. The FDA's MedWatch collects nearly 300,000 reports of adverse drug effects each year but does not have the staff or the funding to follow up on them.

Bennet and others, including some in recent articles in the Lancet, have advocated that there should be an agency separate from the FDA, perhaps called the National Drug Safety Board, to oversee adverse drug events. He likens the situation to the Federal Aviation Association, which regulates planes and air traffic, but transfers authority to the National Transportation Safety Board when a plane crashes.

The main barrier is not detection, but in publicizing the information, noted a researcher who chaired the session. "Many of these side effects come up in phase III clinical trials, and is in the information submitted to the FDA for drug approval," he said. "But when you ask practitioners what the major complication is with thalidomide, for example, most people don't cite deep vein thrombosis."

Another member of the audience noted that the American Medical Association has, in recent years, neglected its duty, leaving patients and doctors alike without the information they need.

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