Acomplia – The First Avandia Causality
Sanofi-Aventis (NYSE:SNY) has withdrawn its application to gain US approval for Acomplia. This move comes after a panel voted unanimously against recommending approval for the treatment.
Although this decision by Sanofi is not totally unexpected it comes on the heels of the Avandia controversy which Diabetic Investor believes factored into the decision. The FDA is under the microscope for how they approve new drug applications and the Avandia controversy is complicating matters. While most people in the industry know that when a NDA is submitted to the FDA, the FDA does not see all the study data. The general public, on the other hand, believes companies submit everything they have done. Something that is getting more attention as the Avandia controversy plays out.
The public relies on the FDA to serve as a watchdog over drugs and needs the agency to provide accurate and understandable information so they and their physicians can make an informed choice before taking any medication. It is also true that there is no realistic or economic way to insure that any drug won’t develop complications 5 years or more after it hits the market. Drug companies, physicians and the public would scream bloody murder if the FDA required trials to run over an extended period of time. This places the FDA in the uncomfortable position of coming up with a drug approval process that protects the population yet is economically feasible.
Still it would be beneficial for all involved if companies were required to disclose all study data, published and unpublished. This would avoid what we are going through today with Avandia as the implication is that GlaxoSmithKline (NYSE:GSK) was hiding information that could have assisted the agency when Avandia was going through the NDA process.
Diabetic Investor is not optimistic, nor are we sure it’s realistic, that the FDA can design a process that will satisfy all concerned. This places a new and potentially dangerous obstacle to the entire pharmaceutical industry. When it comes to diabetes drugs under development companies must be wondering if the FDA will change their standards for approval. This is akin to a baseball game being played under one set of rules for five innings and another for the last four.
Prior to Avandia glycemic control was of paramount importance, the belief being that patients who achieve good control stand a greater chance of avoiding the many complications associated with diabetes.
The Avandia situation also opens a Pandora’s Box as it has been accurately pointed out by several respected physicians and researchers’ diabetes and cardiovascular complications are linked. Dr. Nissen’s point is that when you have a patient population more susceptible to CV events, the drugs they take should not increase the likelihood of such an event. From the GSK point of view the data is unclear whether Avandia does this or if these patients due to their diabetes were already at greater risk for CV events.
As anyone can see there are no easy answers here. However, a good place to start is full disclosure of all data.
David Kliff
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