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Posted on 12.27.00
CERTs Program to Spread the Word About Managing Risk
By Pat French
"How to get effective therapies into the hands of people who need them, and ONLY those who need them, should be a primary focus of our efforts," says Dr. Robert Califf, director of the CERTs Coordinating Center.
The need for coordinated research and education about risk management, such as CERTs can provide, has never been more clear.
On November 28, 2000, Lotronex (alosetron), a drug for irritable bowel syndrome in women, was removed from the U.S. market. The drug, which had been approved for marketing in February 2000, was effective for its intended use. Within 9 months, though, the FDA had received reports of 70 serious adverse events, including 3 deaths. This occurred despite labeling changes warning of the possible harmful effects, and specific communications sent directly to pharmacists and doctors about them.
A similar scenario was seen in the case of cisapride (Propulsid). This treatment for gastric reflux was taken off the U.S. market in July 2000, after many changes in the labeling and targeted communications failed to reduce the rate of cardiac arrhythmias being reported to the FDA.
The CERTs Coordinating Center is more than just a clearinghouse for the research centers. It is often the first thing that people come across when they learn of CERTs. If Califf has his way, many more people will come to learn of the Coordinating Center and the CERTs effort in general.
"We have a tremendous opportunity with the CERTs," says Califf. "There aren't many other places to go for coordinated research efforts on so many fronts, from pharmacology to applied therapeutics."
The expertise contained in the 7 research centers is something that Coordinating Center aims to promote, highlighting that because of its unique, collaborative structure, CERTs can offer streamlined but thorough investigation of drugs, devices, and biological agents.
The Coordinating Center does face some obstacles. Number one: spreading the word about the CERTs efforts. As Califf notes, "If it's in the public interest, the challenge is to get CERTs involved."