Concerns raised about popular blood pressure, diabetes drugs

Jun 1 2013

The Wall Street Journal reports that a senior FDA regulator is seeking stronger warnings about a class of blood pressure drugs that may be linked to higher cancer rates. Meanwhile, The New York Times details how a doctor hired by Merck to test a diabetes drug in rats found a possible link to pancreatic cancer, a discovery that turned the doctor into a crusader.

The Wall Street Journal: Dispute Flares Inside FDA Over Safety of Popular Blood-Pressure Drugs
The top-selling class of blood-pressure drugs is under attack from an unusual source: a senior regulator at the Food and Drug Administration. Bucking his bosses, Thomas A. Marciniak is seeking stronger warnings about the drugs known as angiotensin receptor blockers, or ARBs, according to internal documents reviewed by The Wall Street Journal. The drugs, which are taken by millions of people and generated $7.6 billion in U.S. sales in 2012, may be linked to higher cancer rates, Dr. Marciniak argues, a view shared by some outside doctors. Top FDA officials say evidence doesn't support a link (Burton, 5/30).

The New York Times: Doctor's Doubts Imperil Lucrative Diabetes Drugs
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. ... Merck no doubt now wishes [he] 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 (Pollack, 5/30).