So the FDA advisory panel has finally come out to put a finger on the antidiabetic drug Avandia. Or has it?
The drug has been under scrutiny since about 2007, and it has been increasingly been associated with increasing risks of heart attacks. Now the FDA says yes the evidence is clear enough for an expanded warning to be included, but not clear enough for the drug to be yanked off the market. GSK, makers of the drug apparently didn't do a good job generating safety data. FDA expert, Dr David Graham was quoted as saying the GSK RECORD trial was "garbage". Furthermore, GSK apparently withheld information, and submitted poor data, including patient deaths, of patients on Avandia. GSK has already agreed to settle over US$400 million of lawsuits.
In the light of all this, the FDA appears to be waffling a whole lot in not wanting to withdraw the drug. Benefits outweigh the risk appears to be the mantra. Certainly the mantra being chanted by GSK sources.
But this is really not the point....
The critical issue should be whether the drug is as effective and as safe than alternative options. A Japanese (Takeda) alternative, Actos currently appears to do the same job but without associations of increased heart attack risks. So Anadia currently stands as a worse option. It is also not a case of patients currently on Avandia being forced out into a vacuum, should the drug be withdrawn. There are safer alternatives.
So FDA's pussyfooting round the issue is hard to comprehend. To what extent one wonders, is this wanting to allow GSK to recover as much of the drug development costs as possible. The bulk of pharma's drug development cost is recovered in the first few decade post registration. Despite falling sales, every year of delay in taking the drug off the market is a big pot on money for the company.
Let's hope other regulatory agencies, including our own HSA, will be a bit less muddleheaded.
5 years ago