Nexus - 0221 - New Times Magazine-pages

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his doctor. The other one, Bush LeCam, is a very close friend. trol. (Publisher's note: This means you compare the patient's My wife shares a birthday with him, and his daughter is a patient. _ health before and after the use of medication, rather than compar- We're very close. ing the average result of an experimental group of people who get So we're very familiar with the people who developed the dou- _ the medication against the average of those who don't get the treat- ble-blind, placebo-controlled study. And we know what they ment.) know about medicine and science, and they all admit that they You follow biochemical parameters of | progression and regres- don't know anything about it. sion of the disease. For example, if you did a double-blind, place- The problem with the placebo-controlled, double-blind stady is bo-controlled study of insulin in diabetes and used that as an influ- that you are using two human beings as controls against one __ ence, that would be what the average physician does today. another. There is no species more outbred on Earth than two On the other hand, if you measured blood glucose you could get human beings. A person from the North Pole can procreate with a _ more information without the suffering. person from the South Pole, and can have an infant. There is no The difficulty is that the physician has to understand blood glu- animal on Earth that is as out-bred as human beings, including two _ cose. It's that simple. That's what we're dealing with today. identical twins. They are not the same because as soon as the The average so-called 'medical scientist’ really doesn't know sci- zygote divides there are different positions, there are different ence. When you get to the situation where you are trying to study antigens to which they are exposed. the efficacy of AIDS drugs—and I got into this situation—I was G: But in the experiments they are not done on just two people. measuring different parameters, B- and T-cells, T-4s, T-8s, -Beta-2 L: Let me go on. Two human beings are different from one marker globulin, P-24, sed (sedimentation) rates, all sorts of bio- another. That's the first problem. chemical parameters, and I was adjusting treatments according to The other problem is the problem of diagnosis. Diagnosis is these biochemical parameters. The problem was that I got a lot of simply a pigeon-hole into which a doctor places a patient. So Mr _ flack. Why? Because these people were doing their double-blind, A has 'A's Disease’ and Mr B has ‘B's Disease’, and they share _ placebo-controlled studies using death as an end-point. - some symptoms and lab tests so we call them ‘diabetic’. But they But I said: "Well, why don't you use these biochemical parame- don't have the same disease, they are not ters?” And they screamed and hollered, going to respond to the same treatment and then they called them "surrogate mark- course, and they are not going to respond : & ers", and I said: "Well, fine. So now you to the same doses. "Whether a drug makes It tO are following surrogate markers." Well, So if I took 100 people that the compe- ta ‘ : ‘respiration’ is a surrogate marker for ‘life’. tent physician would diagnose as ‘diabetic’ market simply means that ' ‘Pulse’ is a surrogate marker for ‘living’. today 4 followed them ws ten years, someone has had enough Right? { mem, bullshit they are surrogate some of them will have eye disease, some markers! of them will have heart disease, some of money to put it through and These are what real doctors use (bio- os — kidney oy _ _ of pay y the right politicians. —- _—_ This is what cm em will have gangrene of the big toe. i 1. is is is how you treat patients. You Some guy ten years from now will say: That S all. It doesn t mean it don't wait for them to die. “How could this stupid guy make this diag- | works or it doesn't work." Well, why do you (academics) call them nosis of ‘diabetes’ on Mr Jones who had “surrogate markers"? Because you don't gangrene of the big toe, and Mr Smith who = understand what they are. You aren't well has eye disease?" enough trained in science to understand The bottom line is that this is simply a pigeon-hole into which what a P-24 antigen is, and what it means. You are not well to place a patient to give you helpful guidelines for treatment, but enough trained to know what a T-4 cell is. But you're a ‘professor it is not hard and fast. It is not locked in granite. What you've got of medicine’ at UC San Francisco, and you are supposed to be an is that you are trying to make a diagnosis; and you make a diagno- _ expert on AIDS and you 'pooh-pooh' it (biochemical parameters). sis of diabetes on two different people who are two different ani- It doesn't mean anything, right? mals with two different diseases, and then you are studying the The bottom line is that these double-blind, placebo-controlled effects of this. So you need large numbers, and you need statisti- studies are run by people who don't know much about science. cal significance, so basically what you do is you expand the num- Let me give you another very classic one. It's done by this guy, bers. Frederick Stare, who was a professor. (Publisher: At Harvard, I Well, a double-blind, placebo-controlled study may make sense _ believe.) if you had 100,000 people in each arm, but you don't, Usually you G: Oh, I know, the ‘nutrition doctor’ who said vitamins are no have about 30 or 40 or 50, or maybe 1,000 on each arm, even then good? it's not enough. But when you do this you get into a situation that L: Right. if you get five people who are absolutely cured and 95 who go on G: He said: “Chocolate-chip cookies are good (for you)?" and have the same disease process, you probably have a cure for L: Chocolate-chip cookies. Sugar is good for you. five people, and that's a subset of the disease that is cured by ‘Drug G: He's a scandal. x. L: But he's a classic. But if you went to the double-blind, placebo-controlled study, it G: Right. But everyone cites him, right? would probably wash out because it is not statistically significant. L: Oh yeah, yeah. But that's the bottom line, That's what it's (Publisher's note: This means that the ‘double-blind’ study ignores all about. So these are the kind of people you get, and they are a significant amount of information which could help certain peo- being used by the drug companies because—who cares? It's the ple.) same kind of thing. "I don't care if the thing works; I just want to Now what is the alternative? How do you do these studies so make money on it." So that's what's happened. you know what's going on? You use the patient as their own con- Basically, we have the situation where we have the full-time 42°NEXUS AUGUST - SEPTEMBER 1994