Troubles just beginning for Glaxo
After what must have been a sleepless night the executives at GlaxoSmithKline (NYSE:GSK) are now bracing themselves for what surly will be the next step in the Avandia saga; class action lawsuits. Next to watching the SuperBowl class action lawsuits are one of America’s favorite pastimes. Lawyers have already begun trolling for clients and by the end of the day there likely will be several web sites on the subject. According to GSK nearly 1 million patients in America are taking Avandia and the franchise has racked up nearly $3 billion in sales last year.
Hopefully these lawsuits will not distract the diabetes community from what really is the bigger picture here. Besides the article by Dr. Nissen The New England Journal of Medicine also published an editorial yesterday “Rosiglitazone and Cardiovascular Risk” by Bruce M. Psaty, M.D., Ph.D. and Curt D. Furberg, M.D., Ph.D. The authors state “Unless new data provide a different picture of the risk-benefit profile, regulatory action by the Food and Drug Administration (FDA) is now warranted.” And yesterday the FDA did issue a Safety Alert which stated “Patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack should talk to their doctor about this new information as they evaluate the available treatment options for their type 2 diabetes.”
The authors went on to state “For lifelong conditions such as diabetes, how do the risk of weight gain, edema and adverse changes in play out against the benefits of improved glycemic control? For a drug that activates a large set of genes, what is the balance overall if risks and benefits?” These are the real questions which should concern every pharmaceutical company with a diabetes drug in their pipeline. Besides class action lawsuits, Glaxo must also deal with politicians seeking some face time who want to use Avandia as their soapbox for changes to the way FDA approves drugs. Some may recall another article that appeared in The New England Journal of Medicine where Dr. Nathan questioned the FDA’s quick approval of Januvia from Merck (NYSE:MRK). The gist of Dr. Nathan’s argument was that the FDA did not properly examine Januvia in light of the fact type 2 patients already have several choices of cheaper and effective drugs already on the market. Why the hurry?
Avandia is just the latest drug that was originally approved by the FDA only to develop issues after being on the market for several years. The question is will Avandia be the preverbal straw the brakes the camels back and bring about a change in the way the FDA approves new medications? For diabetes drugs does this mean that improving glycemic control, normally the standard used by the FDA, become only one of many items that must be satisfied before approval is granted? Will companies be required to conduct extensive and expensive post-market studies even after a drug is approved? And will these studies actually be done? As the authors of yesterday’s editorial accurately point out “During the period from 1998 through 2003, only about a quarter of the required phase 4 trials were completed, and as of September 30,2006, a total of 899 phase 4 studies remain pending.” Does this mean lawmakers will give the FDA the authority to impose fines or take some other action should these trials not be done?
The Avandia situation comes on the heels of Vioxx with it’s problems and we have an election coming. Just as lawyers are salivating over the prospects of a big payday from Avandia lawsuits, politicians in an election year love nothing better than calling for reform. There have already been calls for Congressional hearings. Whether or not all this attention will actually lead to any changes is uncertain. We heard these same rumblings after Vioxx yet little was actually done, in typical Washington fashion lots of hot air and no change. Is it possible politicians will make the same mistake twice? Fool me once shame on me, fool me twice shame on you.
Lost yesterday in all the banter over Avandia was prescription data that indicated for the first time since the Januvia hit the market new prescriptions were flat. Diabetic Investor is watching this data closely and one week does not necessarily indicate a trend. However, as we have pointing out Januvia’s performance has been rather lackluster and the drug’s non-responder rate appears to be above average. Given the news on Avandia it will be interesting to see how the data trends over the next few weeks. Will physicians begin converting their Avandia patients to Januvia or will Byetta from Amylin (NASDAQ:AMLN) be the primary beneficiary? One scenario not considered by the many analysts who are boosting their Januvia sales forecasts is physicians could actually move in the opposite direction and actually move patients back to metformin alone. It also quite possible physicians will use this news to move a greater percentage of their type 2 patients to insulin therapy. Diabetic Investor cannot imagine physicians taking no action, no matter how they interrupt the data, as they too could be the target of patient lawsuits.
A big loser here will be Novartis (NYSE:NVS) and their DPP4 Galvus, which is delayed at the FDA. Will the company decide to tough it out under what likely will be even greater scrutiny by the FDA or will they cut and run? Facing a similar decision is Bristol-Myers Squibb (NYSE:BMY) who’s DPP4 Saxagliptin is in late phase 3 trials.
Finally the biggest losers of all are the millions of patients with type 2 diabetes. It’s bad enough to have to live with diabetes 24X7X365 but it’s worse when you can’t trust the medication your on. Patient compliance with their medications is already woefully inadequate and the Avandia news gives patients one more reason to be concerned. The fact of the matter is patients will use any excuse they can some rational, some not to stop taking their medication. Hopefully cooler heads will prevail and patients will consult their physicians before taking any action. Perhaps something positive will results as this could prompt patients to seek more effective treatments options such as Byetta or insulin. We can only hope.