While there may not be quite as many Januvia cancer lawsuits as there are for a competing diabetes drug Actos, the stakes are still considerable for Merck, the manufacturer of sitagliptin (Januvia). It was reported that Januvia and its related drug Janumet had global sales of $5.7 billion between the two in 2012. But there is concern over the potential for Januvia-related pancreatic cancer, a very serious illness for which there is no cure. The sad truth is that most pancreatic cancer patients are dead within a year.
A recent study found a doubling of the risk for acute pancreatitis. Dr. Peter C. Butler, chief of endocrinology, diabetes and hypertension at the University of California has done his own studies, the outcomes of which have been a cause for concern. Dr. Butler was originally invited by Januvia manufacturer Merck to test its drug on rats to determine if incretin mimetics such as Januvia could rid diabetic rats of Type 2 diabetes.
Dr. Butler says that Merck agreed to fund the study, but he declined the offer initially. When he later agreed to do the Januvia side effects study, Dr. Butler was concerned by what he found. There were worrisome changes in the pancreases of the rats under study – changes that could lead to Januvia pancreatic cancer – according to Dr. Butler. Both the U.S. Food and Drug Administration and the European Medicines Agency took notice and they are continuing their own investigations. It should be noted that Dr. Butler’s critics view the data as inconclusive. For example, Dr. Robert E. Ratner, chief scientific and medical officer with the American Diabetes Association, has said that even if excess risk was a factor at all, that risk would remain “exceptionally low.”
However, Dr. Butler, who is also the former editor of Diabetes, the journal of the American Diabetes Association, also has his defenders. Dr. Butler himself notes that studies undertaken prior to the approval of incretins by the FDA tended to involve younger, healthier animals that might not be expected to emerge with pancreatic cancer. What’s more, any patient or potential Plaintiff concerned about the potential for Januvia cancer would be interested in Dr. Butler’s latter study of human pancreases obtained, according to the report, from 34 organ donors who died due to circumstances unrelated to disease of the pancreas.
Eight of the donors were taking incretins, and Dr. Butler found pancreases of those eight people tended to have more precancerous lesions than the organs of the diabetics who had not taken those drugs, or those of the non-diabetics. There was also one case of a neuroendocrine tumor, a type of pancreatic cancer, amongst the pancreases inherent with the incretin users. Also, the pancreases of the users presented as heavier with faster growth of certain cells. Seven of the eight incretin donors had been taking Januvia.
Dr. Butler’s study on human pancreases also has its detractors, including Dr. Fred Gorelock, a professor of medicine and cell biology at Yale, who noted the precancerous lesions found had been early-stage ones. Many middle-age people have these, and they often do not lead to cancer. But Dr. Gorelock did say, however, that the study “raised several red flags.”
Patients concerned about the potential for Januvia pancreatitis might be well advised to pay close attention to information due for release later this summer, according to a Herald Tribune report. Results from randomized clinical trials studying any potential association between incretins and heart issues will also likely reveal any increased risk of pancreatitis. The National Institutes of Health met recently to study the association between diabetes, diabetes drugs and pancreatic cancers. Hopefully, there will be more information coming from the studies. Since pancreatic cancer carries a virtual death sentence, it’s important information for patients taking Januvia.
Lawyers in our Mass Torts section are currently investigating claims involving pancreatic cancer. If you have any questions on the subject, contact Melissa Prickett, a lawyer in the section, at 1-800-898-2034 or by email Melissa.Prickett@beasleyallen.com.
Contact us today for a free legal consultation with an experienced attorney.
Fields marked *may be required for submission.
If you would like to subscribe to the Jere Beasley Report digital edition, simply visit our Subscriptions page and provide the necessary information or call us at 800-898-2034.
Attorney Advertising - Prior results do not guarantee a similar outcome.