STUDY: COMPANY EMPLOYEE WARNS THAT PANCREATITIS LINKED TO POPULAR DIABETES DRUG
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
By Charles Lee
The likelihood of pancreatitis is doubled and has been linked, according to Sonal Singha, a leading author of the study that examined diabetics over a span of three years, to the usage of diabetic drugs Januvia and Byetta. A scary phenomenon, pancreatitis is an inflammation of the pancreas that is associated with cancer and kidney failure. Both drugs have been extremely profitable and both makers of the drug-Merck, which produces Januvia, and Bristol-Myers Squibb's drug Byetta- are being uncomfortably reminded of their cancerous past when the FDA received numerous reports of their drugs in 2007.
Over 2,500 insurance records of diabetics were analyzed between February 2005 and December 2008, which revealed a "significant 2 fold increase with these drugs." Assistant Professor of Medicine at Johns Hopkins University, Singha, reveals that the study is the "first confirmation of the suspected link between GLP 1 based therapies and hospitalizations for acute pancreatitis." GLP-1, a hormone, is responsible for activating the production of insulin in a person's body.
Belinda Gier, prior to being hired as the medical science manager at Bristol in early February, co-authored a report saying that the "findings also raise caution about the potential long-term actions of these drugs to promote pancreatic cancer," and is also known to have questioned the "wisdom" of using the pair of drugs.
Ed Silverman of Pharmalot, who uncovered these developments, had asked a fundamental question: "Was anyone at Bristol-Myers aware that its new hire had recently penned a piece that takes a whack at its drugs?"
One analyst for ISI Group, Mark Schoenebaum, refutes Singh's study on the basis that it is "limited by its design and methodology." In reference to the popular diabetic drugs, Schoenebaum asserts that the drugs "have been on the market long enough that doctors have developed their own experience and comfort with the drugs." Questions of how the study's results could affect treatment practices were raised and were virtually left unanswered.
Pancreatic cancer has a much higher incidence in patients with pancreatitis. Our firm is investigating claims for clients who have used Byetta, Januvia, Janumet, and Victoza and developed pancreatic cancer. A recent medical study confirms the connection, as well as finding a higher incidence of thyroid cancer.