ADA Wants Firms to Disclose Incretin Data

The American Diabetes Association (ADA) wants pharmaceutical companies to make available all patient-level data on their incretin products for an independent review "that could help settle the question of whether such therapies contribute to the development of pancreatitis or pancreatic cancer," the organization said.

Robert Ratner, MD, chief scientific and medical officer of the ADA, said that, "People who are taking these medications, or who may consider taking them, should have the benefit of all that is currently known about their risks and advantages in order to make the best possible decisions about their treatment and care in consultation with their healthcare providers."

The ADA said it will release a call for applications from academic and research organizations that can handle large experimental databases to conduct the studies.

The statement was released Monday, two days before the start of a two-day workshop with the National Institute of Diabetes and Digestive and Kidney Diseases and the National Cancer Institute looking at the relationship between diabetes, and pancreatitis and pancreatic cancer.

Several companies including Merck said they would cooperate with the ADA’s requests. In a joint statement, AstraZeneca and Bristol-Myers Squibb said they "support the ADA’s initiative … and look forward to a discussion with the ADA about the logistics of its proposal."

Earlier in the week, the issue of unpublished and withheld data on incretin therapies was raised in an investigation by BMJ, which found that drugmakers have been holding back data on potentially harmful effects of the drug class.

"On their own, the individual pieces of unpublished evidence may seem inconclusive, but when considered alongside other emerging and long-standing evidence, a worrying picture emerges, posing serious questions about the safety of this class of drug," Deborah Cohen, investigative editor for BMJ, wrote in the piece.

The issue of unpublished data being suppressed by drug companies started snowballing with the launch of British physician Ben Goldacre’s AllTrials.net, which aims to be a repository for all data on all drugs available on the market.

ADA News Release 6-18-2013