My Home About Me

by Mark S. Senak
Eye On FDA



I don't know what the record is for announcing a Congressional investigation after breaking news, but the title may go to Congressman Henry Waxman (D-CA), under whose feet no grass grows. I think he may hold the record.

There has been more than one recent study announcement regarding the class of drugs known as thiazolidinediones (TZD's) to which Avandia, made by GlaxoSmithKline (GSK), belongs. On April 20, 2007, there was the news that the Journal of Clinical Oncology published data that showed that showed that researchers found a 33% reduction in lung cancer risk in men who had taken TZD's compared with men who hadn't. That is a benefit to be sure.

But then yesterday, around noon, the news hit the wires that Avandia had been associated with an increased risk for cardiovascular events. That touched off a nerve in the stock market and the GSK stock dropped 7.85 percent. It also, apparently, touched off a nerve on the Hill and by the middle of the afternoon, it was announced that there would be a Congressional hearing held into the FDA's handling of risk assessment to be held June 6. That's fast work.

Avandia, by the way, is a highly prescribed medication for diabetes, and a risk associated with diabetes involves cardiovascular complications.

Yesterday also, the FDA issued a press notice on Avandia.

FDA's analyses of all available data are ongoing. FDA has not confirmed the clinical significance of the reported increased risk in the context of other studies. Pending questions include whether the other approved treatment from the same class of drugs, pioglitazone, has less, the same or greater risks. Furthermore, there is inherent risk associated with switching patients with diabetes from one treatment to another even in the absence of specific risks associated with particular treatments. For these reasons, FDA is not asking GlaxoSmithKline, the drug's sponsor, to take any specific action at this time. FDA is providing this emerging information to prescribers so that they, and their patients, can make individualized treatment decisions.

I raise this "Tale of Two Cities" story here because it emphasizes the role today of risk over benefit. I am not taking sides on this issue by any mean, I haven't looked at the data and I am not a scientist. But let's face it, even to us laypeople, the risk/benefit ratio thing is a mess.

To my mind, this is not about Avandia. But it is about our willingness to accept risk when we are taking drugs. Any drugs. Clinical trials are designed to demonstrate safety and efficacy in a pretty limited population. When a drug enters a population larger than seen in clinical trials, then adverse events will be seen that are not seen in clinical trials. If we extend the period and size of clinical trials, we are also extending the cost. Are we willing to accept that? I have no opinion, but I do think we've begun to lose site of the role of risk and benefit among pharmaceutical interventions.

What is our risk/benefit ratio these days? I honestly don't think we know. And as long as we don't, hearings on the Hill nor hearings in advisory committee meetings are not going to be very beneficial. We need to admit that drugs have risks. We also need to acknowledge that we long for their benefits. And until we work out the ratio, hearings will not make a difference.



Source: EyeOnFDA.com

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