Three years ago, an FDA advisory committee voted 22-to-1 to permit GlaxoSmithKline’s Avandia diabetes pill to remain on the market. The move came shortly after a new meta-analysis found an increased risk of heart attacks and strokes associated with the drug. A similar scenario is unfolding this week as the FDA convenes another meeting to explore the same issue. We spoke with Arthur Levin, who heads the Center for Medical Consumers and was the lone vote in 2007 in favor of withdrawing Avania…

Pharmalot: It’s been three years since you voted in favor of withdrawing Avandia? Is this deja vu? Has anything really changed?
Levin: Well, a lot of time has gone by and what has changed is that we have a lot more evidence that this risk is real. It’s not like the alarm bells that went off in 2007 haven’t rung again. In the interim, we lost some people and some people lost their health.

Pharmalot: You’re not on the panel this time around (due to a scheduling conflict), but what do you make of the way the FDA is going about this?
Levin: There is a policy issue that rarely gets mentioned. We’re not a country that uses the cautionary principle – which is guilty until proven innocent. We’re innocent until proven guilty. The burden of proof is rather high in terms of taking something away. From my perspective, it shouldn’t be hard. But in a decision-making enviromment that puts the burden on the risk side, the amount of evidence needed to take something off the market is extremely high. If you set up a very high bar, it means there’s always the possibility for the drug to remain on the market.

Pharmalot: Your organization speaks for consumers. Aren’t there consumers who will say Avandia is helpful and they shouldn’t be robbed for a drug that keeps them well?
Levin: If you have a serious condition but no treatment or only one treatment that some people can’t tolerate, the calculus is different than when you have a condition that’s amenable with a number of treatments and another drug in the same class that appears to have at least equal efficacy and a better safety profile. Clearly, this is not a condition where we have a shortage of treatments.

On these issues, there is often a schism between some patients who believe a drug in trouble is their only hope and you’ll get a lot of tesmtony in the public session in which some say ‘Please, don’t take it off the market. I’m willing to take a risk.” Some of that could be coming from astroturfing, too, you know, someone connected to a drugmaker. In any event, I don’t know if it’s true for this drug that we’ll see a lot of people say that. With so many treamtments out there, I’m not sure how many could say there’s nothing else that could control my diabetes. From my perspective, I can not understand why in the world we would keep this drug on the market. One of the reasons we aggressively treat diabetes is to prevent cardiac events. It seems a cruel irony. What’s the point?

Pharmalot: Several of the questions the advisory committee must answer offer a third option - that options A and B don’t offer enough evidence to make a decision. What does that suggest?
Levin: A decision has to be made…I don’t think it’s a good thing. I think one could argue that it means, inherently, the drug will stay on the market, becauase that third option effectively says there’s not enough evidence to say it should be taken off the market.

Pharmalot: What’s your take on the outcome of the meeting?
Levin: They could manage the risk - change the labeling to say everything else should be tried before this one drug. that this is not a drug of first choice. Or patients have to be screened for cardiovascular risks. But why bother? I think part of the problem is that the (physician) specialty world hates to give up anything. I think there has to be a community out there besides the manufacturer that fights to keep this drug available. But it certainly looks like it’s going to be dueling studies – the strength of studies showing risk versus the strength of studies showing no risks.