Docs With ‘Radar:’ They Get Data FDA Doesn’t
Make a commentBy Ed Silverman // May 29th, 2007 // 4:43 pm
For the past several years, an independent group of researchers succeeded in gathering more comprehensive data about adverse-event reports than the FDA. And the effort may underscore the need for the agency to work closely with pharmacovigilance centers to better track side effects in order to launch investigations more quickly.
That’s the result of a study published this week in the Archives of Internal Medicine, which compared the work a team of doctors called RADAR, or Research on Adverse Drug Events and Reports, which is based at Northwestern University’s Feinberg School of Medicine. The study compared RADAR’s reports on serious events associated with 14 drugs and drug-coated cardiac stents to FDA and company reports.
Bottom line: The FDA had gathered many more reports than RADAR, but RADAR’s reports were more complete by a wide margin when it came to info on the incidence of drug reactions, outcomes and treatment or prevention. On the other hand, drug and devicemakers sent out safety notices two years earlier than RADAR reported its results in journals.
“Our hypothesis is that the quality, not the quantity counts,†says Charles Bennett, a hematologist and oncologist at Northwestern Memorial Hospital, who founded RADAR (that’s him you’re looking at). “A small number of very good case reports is better than a large number of very bad case reports.â€
Given the outcry over the FDA, Bennett and his co-authors make the pitch that establishing partnerships with centers such as RADAR makes sense. “By tapping into the interests and expertise of safety centers, while still maintaining control and focus, the FDA could highlight its strengths (sending rapid, nationwide feedback about new ADRs) while reducing bureaucratic burden.”
“The old way of doing business was a large number of incomplete reports that took an average of seven years to find adverse reactions to drugs,†says Bennett. “We propose with our system we can cut that to between one to two years. That’s a six-year savings. For a billion dollar drug, can you imagine how many people that’s affecting?â€
You can read the complete study here.