Is anyone paying attention?

Is anyone paying attention?

According to a press release from Amylin (NASDAQ:AMLN) and Lilly (NYSE:LLY) this morning the companies “released results from a retrospective study of nearly 375,000 type 2 diabetes patients evaluating the incidence of events related to cardiovascular disease (CVD) and all-cause hospitalizations among initiators of BYETTA® (exenatide) injection compared to initiators of other commonly used diabetes medications.”

The release goes on to state; “In the study, BYETTA was associated with a lower incidence of CVD-related events than insulin, thiazolidinediones (TZDs) and sulfonylureas and a comparable incidence versus metformin and Januvia® (sitagliptin). BYETTA was also associated with a lower incidence of all-cause hospitalizations than insulin, TZDs and sulfonylureas; a comparable incidence versus metformin and a higher incidence than Januvia.”

Diabetic Investor is not surprised by this news; our only question here is- Is anyone at the FDA paying attention? As everyone knows the FDA has delayed approving Bydureon the once-weekly version of Byetta. Without getting overly technical the FDA basically wants to make sure that Bydureon does not carry an undue risk of adverse cardiovascular events. Although this study does not necessarily prove that Bydureon is free from adverse cardiovascular events, it should carry a strong message to the folks at the FDA as Bydureon is basically a line extension of Byetta. While the two drugs are not exactly the same they are close enough.

We’re also curious how Dr. Nissen will interrupt this new data, if we use history as a guide Diabetic Investor is fairly certain the good doctor will find fault with the study. While the noted cardiologist seems to believe his conclusions are beyond reproach, 100% correct and should not be questioned by anyone for any reason; he’s very quick to find fault with any research that does not have his name attached to it.

It would be the ultimate irony if the good doctor somehow questioned the study design or methodology. As these are the same questions Diabetic Investor raised when his now famous meta-analysis was leaked to the media. Unlike a meta-analysis, which is really nothing more than fuzzy math, this study used real data. According to the press release; “The study used data accrued over nearly four years from the IMS LifeLink™ Health Plan Claims Database, comprised of medical and pharmaceutical claims for more than 65 million patients from 98 health plans across the U.S. The incidence of CVD-related events was assessed in approximately 22,000 patients who were treated with BYETTA relative to nearly 353,000 patients who were treated with other diabetes therapies. Baseline lipid levels, blood pressure, obesity and evidence of prior cardiovascular disease were higher in patients treated with BYETTA than patients treated with most other therapies.” (Highlighting added by Diabetic Investor)

It is this last sentence we find most interesting as it basically states the patients being treated by Byetta were actually at a higher risk of an adverse cardiovascular event yet they had a lower incidence rate for CVD related events, imagine that. Amylin and Lilly did not combine data from a group of studies and then select which of these studies they actually wanted to use, they simply looked at real data and made some simple calculations.

Diabetic Investor is not aware of any situation where the FDA basically admitted they made a mistake and went back to a company and approved their drug. Frankly admitting mistakes is just not something the FDA does. However, there is a growing body of data that states Bydureon is at worse neutral when it comes to adverse cardiovascular events and perhaps even has positive cardiovascular benefits. Still, the FDA seems intent on ignoring real scientific data and continues to proceed down a path of destroying innovation and hope for millions of patients with diabetes.

Like Dr. Nissen, the FDA believes their methods are correct and should not be questioned no matter how many people are needlessly suffering and being denied a new therapy that would help them more effectively manage their diabetes. Perhaps this is why the FDA and the good doctor get along so well, as they both seem intent on being heard rather than actually helping patients. Never mind that diabetes continues to grow at epidemic rates and that according to the governments own data 1 in 3 people will have diabetes by 2050. Never mind that patients need new and better drugs and devices to help them more effectively manage their diabetes. Never mind that nearly two-thirds of all patients with diabetes are not properly controlling their diabetes which leads to devastating healthcare and economic consequences. Better to let millions suffer than to admit a mistake, this is the height of hypocrisy.