Researchers Find Deadly Prescription Drug Effects Six Years Before FDA

Northwestern University's Charles Bennett, M.D., is a super sleuth of potentially deadly prescription drug reactions. He leads a national SWAT team of doctors called RADAR (Research on Adverse Drug Events and Reports) based out of Northwestern's Feinberg School of Medicine.

They swoop in to investigate early signs of trouble years before the Food and Drug Administration (FDA) takes notice.

A new study by Bennett, the A.C. Buehler professor in Economics and Aging at Northwestern's Feinberg School of Medicine, and a hematologist and oncologist at Northwestern Memorial Hospital, found RADAR identified serious drug reactions six years earlier than the FDA and drug companies.

RADAR's proactive safety efforts and reports also were much more comprehensive than those from the FDA or drug companies, according to the study. RADAR's reports provided doctors with important medical insights as well as guidance for prevention, diagnosis and treatment.
The study will be published in Archives of Internal Medicine.

Since Bennett launched RADAR in 1998, his research has resulted in black box warnings on billion dollar drugs like Plavix that may have saved thousands of lives. He has also provided guidance to help physicians more safely administer drugs. More than 100,000 people die each year from reactions to medications. The FDA is under attack for its passive and inefficient methods of learning about these problems.

Why is RADAR so nimble" Bennett's network includes hematologists and oncologists around the country and the world. His phone rings weekly with calls from concerned doctors alerting him to possible new trouble. After such a call, Bennett probes for clues that led to a life-threatening reaction to a drug. ‘What's the age and weight of the patient, x-rays, details of the physical exam and blood tests"' he'll ask. He'll canvas doctors to see if they've seen similar cases. If a vital piece of evidence is missing, Bennett even will track down a doctor at home on a Sunday and ask her to drive back to her office to check a chart. Then Bennett and his team fit all the puzzle pieces together to figure out what happened and how to prevent it in the future.

The new study also shows, however, that the FDA and drug companies were faster than RADAR to spread the word about serious adverse drug reactions. RADAR relies on publishing its studies in peer-reviewed medical journals, a process that takes longer than the FDA's warning letters to doctors and the drug companies' package inserts.

Thus, it's time for a formal collaboration between RADAR and the FDA to wed their strengths, said Bennett, who also is co-director for cancer control of the Robert H. Lurie Comprehensive Cancer Center.

"We need to work together as partners," Bennett says of the FDA. "Pharmaceutical side effects are one of the top five causes of death in this country. We want to move it out of the top five. This is the way to start that process and save thousands of lives."

Bennett envisions a formal partnership with the FDA in which he would share RADAR's investigations on safety issues, arrive at a joint insight on drug problems and have the FDA distribute the information to doctors.


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