And this will help?

And this will help?

This past Friday the FDA announced they would be holding a meeting June 5th and 6th that will “review the independent readjudication of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Diabetes (RECORD) trial findings.”  Just as a cat has nine lives, it appears too that the Avandia controversy continues to rear its ugly head and won’t go away.  Now no one but the FDA knows what this “readjudication” of data will reveal, but one has to wonder just what the FDA hopes to accomplish here.

According to GlaxoSmithKline (NYSE:GSK), the makers of Avandia who has lost billions in sales and paid out billions in damages due to the controversy, there are now less than 3,300 patients still using Avandia. Which again begs the question, with the drug all but dead just what does the FDA hope to accomplish here. Or looked at from a different perspective what good, if any, will result from this meeting.

Let’s say for example this new data shows that the original meta-analysis which started this whole mess was incorrect and that Avandia was improperly punished. Or on the flip side, it confirms the actions already taken by the FDA. Or worse what happens should the data be inconclusive. The only fact known for sure is the damage inflicted by this controversy cannot be undone and that patients, the physicians who treat them and any company who’s submitted a new drug application for a drug targeted at patients with Type 2 diabetes have been irreparably harmed. An argument can also be made given the recent issue with GLP-1’s and DPP4’s that no drug, not even those already approved by the FDA and on the market for years, is immune to the impact of the Avandia controversy.

So we ask again just what does this FDA hope to accomplish here, what possible good can come from it. About the only thing we can think of is that once again the FDA is doing what it always does in situations such as these, namely cover their collective backsides.  As much as Diabetic Investor believes that this whole situation was handled poorly from the start and that Dr. Steven Nissen, the crusading cardiologist was more concerned with raising his profile than actually helping patients, no possible good will come from this meeting. We further believe that no matter what this data shows, it will just reignite a fire that was best left alone.

Even if it turns out the data shows GSK got the shaft, the company is unlikely to do anything other than say they got screwed. No physician in their right mind would start prescribing Avandia again, especially when there are credible alternatives available. Nor should anyone expect the good doctor to admit he was wrong and actually apologize for starting this whole mess. Although should the opposite be true and the data shows the good doctor was correct bet the ranch he’ll be on television saying so. This guy just loves the spotlight and will go out of his way to tell everyone just how smart he is.

To Diabetic Investor the worst possible outcome is more inconclusive conclusions, which we believe to be the most likely outcome. As badly as the FDA does not want to publicly admit they made a mistake when they originally approved Avandia or that they made even more mistakes once this controversy went viral, they do have a history of trying to play both sides of an issue. This unfortunately as they say is the nature of the beast.

Yet, even if by some miracle the data reaches a so-called definitive conclusion pro or con, the diabetes community who’s already divided on the subject will continue to be divided on the issue. This too is the nature of the beast as interrupting data such as this is like two people looking at an abstract painting; one sees a worthless piece of junk while the other sees a masterpiece worth millions.

So we will ask yet again; what good can come from this meeting.