Poor FDA. It takes flak every time a drug spawns unexpected side effects. But when it tries to warn doctors about those side effects--and offers advice for preventing them--few physicians are listening. As AMedNews reports, researchers looked at 16 drugs that got new label warnings or were mentioned in "Dear Doctor" letters from 1990 to 2010. And they found that doctors' behavior often changed very little after those cautionary tales were told.
When the FDA recommended that patients using atypical antipsychotics--such as Eli Lilly's ($LLY) Zyprexa and AstraZeneca's ($AZN) Seroquel--be monitored for signs of diabetes, rates of blood-sugar testing in those patients didn't increase, AMedNews reports. When the agency repeatedly warned against combining the acid-reflux remedy Propulsid with the blood-pressure pill Atacand, prescribing habits didn't change for 18 months.
In other cases, the study found, warnings did change behavior--but not in the way FDA intended. Warnings against antipsychotic use in dementia patients ended up affecting prescription levels for on-label use in psychiatric patients.
The FDA's red flags were most effective when the messages were clear and communicated repeatedly, the study found. That conclusion prompted co-author G. Caleb Alexander to suggest borrowing from Big Pharma's marketing playbook. "The agency might learn a thing or two from the pharmaceutical firms that it regulates with respect to risk communication," Alexander told AMedNews. "They should be using principles of market segmentation to identify high-volume prescribers and then disseminating or conducting messaging of drug risks to those specific physicians."