Doctor’s Doubts Imperil a Lucrative Diabetes Drug
J. Emilio Flores for The New York Times
Dr. Peter C. Butler's latest study on the diabetes drug Januvia has prompted investigations by the Food and Drug Administration and the European Medicines Agency.
By ANDREW POLLACK
Published: May 30, 2013 18 Comments
LOS ANGELES — Dr. Peter C. Butler initially declined a request by the drug maker Merck to test whether its new diabetes drug, Januvia, could help stave off the disease in rats.
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“I said, I’m not interested in your money, go away,” Dr. Butler recalled.
Merck no doubt now wishes it had. When Dr. Butler finally agreed to do the study, he found worrisome changes in the pancreases of the rats that could lead to pancreatic cancer. The discovery, in early 2008, turned Dr. Butler into a crusader whose follow-up studies now threaten the future of not only Januvia but all the drugs in its class, which have sales of more than $9 billion annually and are used by hundreds of thousands of people with Type 2 diabetes.
“I knew some stuff that I thought was a worry and I was obliged to pursue it,” said Dr. Butler, the chairman of endocrinology at the University of California, Los Angeles.
Based on his latest study, both the Food and Drug Administration and the European Medicines Agency have begun investigations that could lead to new warnings on the drugs, or even to their removal from the market.
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