Last week, the NIH ran a workshop to examine the safety of several widely used diabetes drugs and whether a definitive link can be established to acute pancreatitis and pancreatic cancer, which were the subject of recent studies that generated considerable controversy. The outcome was inconclusive, but the FDA may want further studies.
The drugs, which mimic a hormone called GLP-1 to stimulate natural insulin production, include Merck’s Januvia (MRK); Onglyza, which is sold by Bristol-Myers Squibb (BMY) and AstraZeneca (AZN); Byetta, which is also sold by Bristol-Myers; the Tradjenta med sold by Eli Lilly (LLY) and Boehringer Ingelheim, and Novo Nordisk’s Victoza.
One recent study examined insurance records for more than 2,500 diabetics and found patients hospitalized with pancreatitis were twice as likely to have taken Januvia or Byetta than a control group of Type 2 diabetics without pancreatitis. The study did not examine meds not available at the time (back story). Another found that in humans, the drugs caused “marked” cell proliferation and damage, and displayed a potential for eventually transforming into cancer (back story).
In response, the American Diabetes Association wants an independent review and all drugmakers to provide patient-level data (see this). Not surprisingly, this was met with caution. Merck committed to working with the ADA on a review, while Eli Lilly and Boehringer-Ingelheim said they “welcome future discussions.” AstraZeneca and Bristol-Myers say they “recognize there can be value in pooling patient level data from trials of agents in a class for the purpose of an independent meta-analysis” and support making "scientifically valid results of a pooled analysis of safety data available to the public and scientific communities through an independent review, and look forward to a discussion” with the ADA. Novo did not issue a statement.
However, none agreed to provide patient-level data, which is a controversial issue. Drugmakers are concerned releasing data will compromise confidential and proprietary information. The PhRMA trade group recently lambasted the idea and AbbVie is trying to prevent the European Medicines Agency from releasing data for its Humira rheumatoid arthritis treatment. Only Glaxo has taken such a step and this was done in response to the Avandia scandal (see this and this).
The ADA plans to solicit academic and research organizations “capable of integrating large experimental databases,” but the ADA did not specify the extent to which the data may be disseminated. For instance, the ADA has not indicated whether the data itself should be made public or confined to the review.
In any event, the drugmakers have, for now, taken a necessary step toward muting unrest. By agreeing to engage the ADA in discussing a review, they can forestall criticism about appearing uncooperative or worse. Of course, any review will likely take time to sort out and even then may be inconclusive. Meanwhile, registers ring even as uncertainty lingers. But what do you think? CLICK 'READ MORE' TO TAKE THE POLL