How ironic is this?

How ironic is this?

Late yesterday Lilly (NYSE: LLY) announced that the FDA granted final approval for Basaglar® their biosimilar version of Lantus. Ironically the FDA also removed the Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone-containing medicines. Just as an FYI for anyone who has forgotten and those new to this wacky world rosiglitazone is also known as Avandia. With the REMS program now closed the Avandia saga finally and thankfully comes to an end. Yet the impact of this saga remains today.

Commenting on this news was that crusading cardiologist Dr. Steve Nissen, “The FDA notes that it removed the REMS in 2013. This is a nonevent….The drug is no longer used except in rare patients. It has been removed from the market by most other countries.” Again for anyone who has forgotten or is new to this wacky world it was Dr. Nissen’s infamous now debunked meta-analysis back in 2007 which started this mess.

Frankly Diabetic Investor is not surprised by the good doctor’s comment as it would be just too much to take if he actually did the honorable thing and actually admitted that he made a mistake, that perhaps his infamous meta-analysis and subsequent ambush of Avandia actually did more harm than good. That thanks to his doing the approval process for diabetes drugs takes longer and is more expensive than ever. That this focus on the cardiovascular impact of medications is noble but misguided.

We’re about to see the latest impact of the good doctor’s work when Johnson and Johnson (NYSE: JNJ) and AstraZeneca (NYSE: AZN) release data from their ongoing cardiovascular studies for their respective SGLT2’s. As everyone knows Lilly has already released their data for Jardiance and by all measures it was spectacular. Yet thanks to the good doctor JNJ and AstraZeneca will attempt to muddy the waters by parsing the Lilly data and noting the differences between their study participants and those in the Lilly study.

Unfortunately, this is what the diabetes drug world has come to thanks to the good doctor. The sad reality is we can longer get a simple answer to what seems like a simple question; are these drugs safe and correspondingly what real impact do they have related to cardiovascular events.   Thanks in large part to the good doctor any data set is analyzed six ways from Sunday making it virtually impossible to get a straight answer to any question let alone simple questions.

Back when the Avandia controversy first came to light this was our biggest fear, that while understanding any drugs adverse event profile is important, data analysis is as much an art as it is a science. That two very knowledgeable and respected researchers could look at the exact same set of data and draw two completely different conclusions, which is exactly what happened with the good doctor’s infamous meta-analysis.  Now thanks to advanced data analytics this parsing of data is being taken to a whole new level, making it even more difficult to reach agreement.

This unfortunately is the legacy the good doctor has left behind, thanks Steve.