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[Editor's note: Claire W. Gilbert, Ph.D., Publisher of Blazing Tattles newslettte, con ducted this interview with Alan S. Levin, M.D., immU1lologist, brave medico .amhe/f declared "quack". Dr Levin provides a rare insider's view and courageously speaks 'on the record'. This illterview is a unique document, clarifying some ofthe pastfew decades' little-known andlittle-understood boutsofmilitary andmedicalmadness.] DOUBLE-BLIND STUDIES ARE UNSCIENTIFIC Levin [L]: About that same period of time we lost Kennedy, well prior to that, we had this 'thalidomide scare', and with the thalidomide scare, the mandilte of the Food, and Drug Administration (FDA) expanded dramatically. So all of a sudden we had a law where you had to prove the 'efficacy'-you had to prove your drug worked-so instead of simply identifying 'toxicity', you had to identify efficacy. In order to identify efficacy, you had to do some strange, so-called 'scientific' studies. They are not very scientific. The double-blind, placebo-controlled studies are totally unscientific! I'll go into that later. I am a scientist. Gilbert [G): I am, too. Doctors swear by ,that (the double-blind studies). L: Doctors are not very well trained in science.-That's the problem. G: Research, scientific logic and all that. I agree. L: Basically, then, fue mandate for bringing drugs to market became totally unrealistic. So the average drug that may have cost a million dollars to go to market in 1963 now would cost $200 million to go to market, and much of the money goes (0 investigators, patent attorneys and clerks. G: Because they need to prove that 'it works'. L: Right. So you have this strange situation where you have this non-scientific way of proving a drug-this double-blind, placebo control-which means nothing. Wheth~r a drug makes it to market simply means that someone has had enough money to put it through and pay the right politicians. That's all. It doesn't mean it wor}cs or it doesn't work. And you can think of the FDA as you do the Post Office. It's the same mentality, the same level of competence. So, basically, we have this very strange situa tion and, in addition to that, we have the concept of capitation grants. Now, what happened was that the novemment thought doctors were too busy as .small business people, you know" worrying about income tax, rent, personnel management and all that, and that if they took these people and put them into the universities, and took all these responsibilities away, then these ,physicians would be totally dedicated to teaching and research, and be more effective. And that sounded great! Prior to that, the full-time academic was considered to be a nerd. The old saying was: "If you c-an't do it, teach it." When I was in medical school, we used to wait for the 'real' doctors to come in and teach us real medicine, because the guys in medical school had never seen patients and they didn't know anything. But then, after that, the drug compa nies kind of took over and they started funding these full-time academics. So basically you've got this nefarious tie between the drug companies, who are trying to prove something that couldn't be proved, and the academics, who really had no responsi bility for patients. The av.erage full-time academic today-physician, professor of medi cine-has at least four people between him and the patient. You have the fellow, the resi dent, the medical student, and the intern, and then you have this entire institution protect ing him. So the average academic physician really is not prepared to handle sick people. G: I want to backtrack a second. What's your critique of the double-blind experiment? L: First of all it was designed by people, both of whom are friends of mine. One con tinues to be a very close friend of mine. The first one, Joe Nehman died, and my wife was AUGUST -SEPTEMBER 1994 NEXUS • 41