FDA Panel Recommends Keeping Avandia on the Market

As I mentioned in my post Avandia Smackdown!! , I suspected that Avandia would likely stay on the market. The story is all over the headlines, including the Wall Street Journal’s FDA Panel Backs Keeping Avandia on the Market. The 12 panel members wanted to pull Avandia, but 20 said it should stay on the market. More interestingly, though the majority of the members felt there were signals of risk, the vote was 20 to 10 to proceed with the controversial TIDE trial, which Drs. Graham and Sen. Grassley said were unethical.

I have been following the hearing closely for the past few days via Twitter and live video feeds from CNN. Here are some initial thoughts.

1. Despite the panel’s concerns about Avandia safety, the clear majority felt that there was simply not enough data. Many were concerned that studies like Nissen’s meta-analysis were just not strong enough. Though they favored long term, randomized trials to definitely answer these questions, unfortunately, there were enough concerns about the RECORD study by some (low events, withdrawals, and some missing data) to be convincingly reassured.
2. The sentiment of many was because Actos didn’t show as strong signals, it remained a better option. Many who chose to pull Avandia stated for the RECORD that Actos’ availability was a deciding factor. This is concerning because the data for Actos safety is extremely weak (not that I think Actos is dangerous). One panelist stated what I have heard before, that “the absence of evidence does not equal the evidence of absence.”
3. Many panelist stated that they were putting on their “public health” hats, meaning that even though scientifically they were not convinced of real harm, because there was a possibility of harm, they voted to remove or proceed with caution. This is VERY important, because as a clinician (which many on the panel were not), you have to balance risk and benefit every day. Is the side effects of a particular medicine worth the benefits of the medicine? Is the potential harm of radiation worth the need for a CT scan? I think if more practicing doctors were on the panel, fewer would have voted to remove the drug.

What now?
Ultimately, the FDA will decide what to do. Since the FDA doesn’t have to agree with the panel and especially since the panel seemed split, the FDA could decide to remove Avandia anyway or keep on the market with certain restrictions. Given that 10 voted to have very strict warnings, it is likely that’s what the FDA will do. These stricter warnings will likely include something like requiring only a diabetes specialist, i.e. an endocrinologist be able to write a prescription for Avandia. This language will be crucial, because even if Avandia stays on the market, if the restrictions are tough enough, no doctor will ever write for the prescriptions.

Despite all the holes that Avandia’s opponents poked in the data, I remained convinved that the preponderance of the data points in Avandia’s favor. It doesn’t appear to cause increased heart attacks, it certainly doesn’t cause increased death, seems to decrease stroke, and clearly decreases the use of insulin. I will continue to write for the product unless it is pulled from the market, newer restrictions make it virtually impossible to prescribe, or my patients request being placed on a different medicine.

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