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Not: Does it prolong your life. What did the label accomplish. The blood thinner Coumadin is another example.” That is the typical attitude of the FDA culture. What we have to do is overcome that influence with evidence, and then rely on the fact that at the end of the day the Congress will do what's best for the American people. In other words, if this was all good for humanity, then Joe would be both healthy and wealthy. Whether or not you decide to get the flu shot, you should do everything you can to strengthen your immune system. Wouldn't it seem that consumers have no influence whatsoever on the success of a prescription drug, so advertising should be directed entirely toward doctors. The culture also views industry as the client. In fact, when a former office director for the Office of Drug Safety criticized me and tried to get me to change a report I'd written on another drug – Arava – he said to me and to a colleague who was a coauthor on this report that “industry is our client. GRAHAM: In a perfect world, I think the FDA would need to be restructured. These benefit analyses should be done as a matter of routine. The fine print is all on the next page. Where do they learn about drugs. Maybe you'll take it because you have high cholesterol. It's a really pernicious system. DR. So of course I went peaceably.” The problem is that nobody reads the labels so how do they protect anyone. Then the question is, how quickly do we identify the problem and how quickly do we take effective action against it. It looks bad if you miss your PDUFA deadlines. Case in point: pharmaceutical companies. Consumers do not actually write their own prescriptions, but they practically do, based on whatever drugs they see advertised on television.

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