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Researcher makes his mark— By establishing goals, Robert Ruffolo helped Wyeth step up its R&D game
The Star-Ledger, 4-25-07

This is a short, but very interesting, interview with Robert Ruffolo, head of research at Wyeth Pharmaceuticals. Ruffolo discusses Wyeth's metric driven research strategy and why the risks of drugs have to be measured against their benefits.

Every drug should be prescribed based on its risk and its benefit. It's a ratio. What frustrates me right now is the almost obsessive focus on risk is only one part of that ratio. Did you ever take your calculator and put in a number and divide it by zero. Do you know what it will tell you? Does not compute. You can't divide by zero. When I see and read debates about risk, risk, risk, it doesn't mean anything unless you put it in context with the benefit.

We spent a great deal of time hearing about the risk of heart at tack with Vioxx. Heart attack is a pretty bad side effect. But we also know oral contraceptives have a risk of heart attack. It's very low. We as a society, women, have decided reproductive freedom is worth the risk. If you take the benefit out of there, we have a meaningless debate.

Yes, these drugs will have some side effects. We don't know what they are. That's what we measure in our clinical trials. You can imagine the tolerability of the side effects will be far greater for a horrible disease like this than they would be for a drug that lowers blood pressure. Our clinical trials are getting larger and larger as people's and regulators' expectations for safety may be approaching the unachievable, which is my biggest fear and what I worry about in this office.

One of the reasons you can't just buy drugs is because they aren't meant to be totally and absolutely risk free. That's why you have to go to the doctor, get diagnosed and get a prescription. I don't know who promised the world that these things are risk–free, but I don't remember that promise.

Project FDA.
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