First, do no harm  pg. 4

Many epidemiologists and pharmacologists in the field claim that this mode of communication is inherently flawed. “It’s hit or miss,” admits Vanderbilt’s Griffin, professor of Preventive Medicine.

Currently, MedWatch has little teeth for affecting change even if officials receive information warranting further investigation of adverse events. They can demand that a company conduct post-marketing surveillance on drugs, but they have no power to force a company to do so.

In effect, the FDA has only two options: demand a change of label, or to withdraw the drug from the market.

“The agency (FDA) has only a nuclear bomb (withdrawal) that they can bring to bear…or a powder puff, the powder puff being a change of label, which nobody reads and is totally ineffective,” says Raymond L. Woosley, M.D., Ph.D., a former Vanderbilt clinical pharmacologist whose work on Seldane led to the discovery of a safer antihistamine now marketed as Allegra.

Beyond that, even if a drug is found to cause a dangerous side effect in rare cases, there is no standardized mechanism for determining what happens next or what should be deemed “acceptable risk.”

“Should we deprive 100 people of ACE-inhibitors to prevent one episode of angioedema?” asks Griffin. “That’s a difficult question.”

Search for safety

In the past, drugs were usually given in limited courses of days or weeks to address an acute medical problem. Many of today’s medicines are administered to enhance quality of life and to prevent disease from occurring, and can be taken for years on end.

“When you’re giving drugs to generally healthy people, the standards have to be higher,” she continues. “If a drug is not saving your life, it better not be killing you.”

Seeking to advance the “optimal use” of drugs, medical devices and biological products, the federal government in 1999 launched the Centers for Education and Research on Therapeutics (CERTs) initiative.

Seven centers, including one at Vanderbilt, conduct a wide range of research on drug use and safety. Their reach is limited, however.

“When you try to take research into practice there’s a lot that’s lost in translation,” explains Ray, who heads up the Vanderbilt CERT. “We address drug safety, but also the problem of clinicians using interventions appropriately. For example, it doesn’t help if beta blockers prevent deaths if nobody prescribes them.”

Meanwhile, aggressive marketing, including direct-to-consumer advertising, has created a demand for new drugs, even among patients for whom the compounds may not be effective and may even be dangerous.

The ticket to better post-marketing surveillance might have to come from a complete redesign of the FDA’s framework.

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