This will not turn out well

This will not turn out well

Over the past few days we’ve seen a flurry of announcements from the makers of DPP4’s and GLP-1’s supporting an independent review of these medications. According to Merck (NYSE:MRK), the makers of Januvia the leading DPP4, “Nothing is more important to Merck than the safety of our medicines and the people who take them. We welcome opportunities to discuss the data that support the safety profile of sitagliptin in the treatment of adults with type 2 diabetes. Type 2 diabetes is a disease with serious consequences if left untreated,” said Michael Rosenblatt, M.D., chief medical officer, Merck. “We are committed to participating in an independent review of our data, and will join the ADA in planning for such an initiative.”

Lilly (NYSE:LLY) and their partner Boehringer Ingelheim issued the following statement; “Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company (NYSE: LLY) support the American Diabetes Association (ADA) call for an independent review of the safety data of incretin-based therapies. At BIPI and Lilly, patient safety is our top priority, and we support ongoing efforts to further understand whether diabetes or certain diabetes treatments may affect the risk of pancreatitis and pancreatic cancer.”

Back on June 10th the American Diabetes Association (ADA) issued the following request: “The American Diabetes Association (the Association) is asking all pharmaceutical companies involved in the development or marketing of incretin-based medications, used to lower blood glucose levels, to make patient-level data on their products available for an independent review that could help settle the question of whether such therapies contribute to the development of pancreatitis or pancreatic cancer.”

Now Diabetic Investor is not in any away opposed to an independent review of these medications which are used by millions of patients, we’re just not sure what this review will accomplish. As we recently witnessed with the latest FDA meeting which seemed to clear Avandia, even “independent” reviews aren’t good enough for the zealots who want to see these drugs off the market. Let’s assume for a moment that this independent review shows what every other review of these medications has shown, that there is no clear link between usage of these medications and pancreatic cancer or pancreatitis. Let’s further assume that this review basically states what every other review has stated, that physicians and patients using these medications should be vigilant for any signs that would indicate an onset of pancreatitis or pancreatic cancer. What then?

Perhaps a more important question is what are the patients who use these drugs and their physicians do while this independent review is being conducted. This is the biggest problem for these reviews, the basic premise here is that there may be an issue, there may not be. An even bigger issue is that it’s unlikely there will ever be a clear cut, unquestionable answer to this issue. Like it or not this is one of those issues which will never be answered to anyone’s satisfaction. This is not like a patient who has a broken arm, puts that arm in a cast and an x-ray determines when the brake has healed. Diabetes is a complex, chronic disease state which has numerous complications one of which is patients with diabetes have a higher than normal incidence rate of pancreatitis.

All Diabetic Investor sees happening here is Avandia round 2. Just as the Avandia zealots did everything they could to discredit the recent FDA meeting, the same will happen here with DPP4/GLP-1 zealots. If we learned anything from the Avandia controversy, and this issues shows we haven’t learned much, it’s there are just some issues which can’t be answered clearly.  It’s understandable why people on both sides of this issue are gearing up for battle; it’s also unfortunate as once again patients who take these drugs will end up as the real losers.  Once again they will left wondering whether the drugs they take every day are safe, and just as we witnessed during the Avandia controversy, many will decide to stop taking their medications.

No matter how data is gathered, how well presented the arguments are one thing is certain – this is not going to turn out well. Sad but very true.