FDA urged to demand greater transparency

August 21, 2009
Stephanie Sutton

Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Pharmaceutical Technology Europe PTE

Researchers from a university in the US are urging the FDA to demand that drug manufacturers state how new medications compare with similar treatments on product labels.

Researchers from a university in the US are urging the FDA to demand that drug manufacturers state how new medications compare with similar treatments on product labels. According to a news release issued by the Stanford University School of Medicine: "In many instances, these statements would indicate that there is no evidence that a new drug is more effective than older ones."

The researchers believe that making such information available may influence the decisions made by patients and healthcare insurers; new drugs are often more expensive than existing therapies and could be no more effective. "The public's appetite for the latest drugs might be curbed if patients understood that new treatments aren't necessarily more effective than existing ones," explained the news release.

"Drug and device manufacturers benefit from an unacknowledged information gap that develops as more and more products are tested against placebo, but not each other," Randell Stafford, Associate Professor of Medicine at the Stanford Prevention Research Centre, explained in the news release.

Stafford and his fellow researchers have published an essay on the subject in the New England Journal of Medicine. They recommended that the FDA require new drugs to carry a label that says, for example: "Although this drug has been shown to lower blood pressure more effectively than placebo, it has not been shown to be more effective than other members of the same drug class."

The researchers believe that "developing more informative labels is consistent with the agency's recently invigorated function as a public health agency."

http://med.stanford.edu