"Conflict is the beginning of consciousness"
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| Kaitlyn Dmyterko, Staff Writer |
The drug has been under scrutiny since 2007, when Dr. Steve Nissen and co-author Kathy Wolski of the Cleveland Clinic first published in the New England Journal of Medicine that the drug could be linked to an increased risk of cardiovascular event rates in diabetic patients.
Since then, entities of the industry, including a major investigation by the FDA and members of the Senate, have all taken turns backing or bashing the drug's safety profile.
After Nissen and Wolski made these data public, the FDA called for the committees to hold a meeting to answer the hard-hitting questions that surrounded the drug. But, even while there was evidence that Avandia posed risks (20 to three vote), a 22 to one vote by members concluded back in 2007 that the drug stay on the market.
Now, three years later and another two-day committee meeting down, the fate of Avandia once again hangs in the balance.
Fervently debated at Tuesday and Wednesday’s meeting were results of the RECORD trial, which most members pinpointed as inconclusive at best. Dr. Thomas A. Marciniak, of the FDA, accused GSK of bias during the RECORD trial due to improper documentation and missing data, while others questioned the trial's open-label design.
Even after hours of discussion about whether Avandia is better or worse than alternatives, results of the vote were still mixed. While 12 members voted that the drug be pulled from the shelves due to concern of increased harm, 20 other members voted the drug be continued on the market with additional restrictions and warnings. One member abstained.
While members went back and forth, Dr. Michael A. Proschan, of the NIH, a committee member, said that evidence has repeatedly shown that rosiglitazone has proven to increase risks of HF. “How many more things does it have to be bad for before you say enough is enough?” he asked.
Additionally, this week results of the BARI 2D trial found that Avandia didn’t increase the risk of death, stroke or MI, while a study in the Archives of Internal Medicine, found Avandia did increase MI.
And in other news surrounding Avandia, it was reported that GSK made a $460 million offer to settle 10,000 product liability suits linked to the drug.
Dr. Lamont G. Weide, of the University of Missouri-Kansas City, yesterday quoted Claude Bernard and said, “Among the experiments that may be tried on man, those that can only harm are forbidden, those that are innocent are permissible, and those that may do good are obligatory.”
Even after years of scrutiny and evidence connecting Avandia to CV risk, the fate of the drug is still a puzzle. Do comparable drugs like pioglitazone work as effectively as Avandia without less room for patient risk? Or, does Avandia's ability to enhance glucose control by 1.5 percent outweigh its risk?
The FDA now holds the key to clarifying this complicated, muddled puzzle.
On these issues or others, please feel free to contact me.
Kaitlyn Dmyterko
KDmyterko@cardiovascularbusiness.com