FDA and Drug Companies Face Off Over Diabetes Drugs' Link to Cancer

The FDA has announced that it may begin studies into the safety and possible harmful side effects of a range of Type-2 diabetes drugs, leading the manufacturers to defend the products at the National Institute of Health.

That’s a real challenge for patients out there who are taking this medicine and we have no conclusive evidence that there’s a problem and they’re being scared to death."

Merck & Co., Novo Nordisk A/S and Bristol-Myers-Squibb Co. could be asked to provide more information and data after the FDA suggested that current findings show a potential link between the companies’ drugs and pancreatic cancer. The first warning came in 2007 when the agency reported a high number of pancreatitis cases in patients taking Byetta, Bristol-Myers-Squibb’s drug. In 2009 a similar warning was given for Merck’s brand, Januvia. Earlier this year a study of insurance records suggested that use of the drug could double an individual’s risk of pancreatic cancer. Now, the FDA may require more research. Clinical trials, and longitudinal studies, could provide more accurate information.

That the FDA is considering further testing does not mean that the range of Type-2 Diabetes drugs are de facto the cause of pancreatitis. Robert Ratner, of the American Diabetes association, called for “calm heads” and a thorough look at all available data before passing judgment. Some FDA scientists are said to be skeptical that a direct and significant link exists. If insufficient data is available, then regulated trials may provide a final answer.

Alan Moses, chief medical officer for Novo Nordisk, maker of Victoza, seemed sympathetic to patients confused by conflicting reports. That’s a real challenge for patients out there who are taking this medicine and we have no conclusive evidence that there’s a problem and they’re being scared to death,” he said in an interview with Bloomberg News, adding that some data had been reported overzealously. All three manufacturers will provide the FDA with the required information.

While pancreatic cancer is known to be linked to diabetes, the relationship with the medications is unknown, and it is this which requires further investigation.