The drugs, meanwhile, take on a cultural life of their own. It costs a fortune to develop a new pharmaceutical - the price tag for a product like Viagra runs to about $400 million before it even gets to market - but it has the ability to create its own demand. After Prozac or the diet pill Redux came out, says medical historian Dr. David Rothman, doctors and patients alike changed the way they defined depression and obesity: sickness becomes whatever we think the chemical can treat. 

'Because the category of impotence is so elastic,' Rothman says, the potential for creep is enormous." Most men suffer dysfunction at some time or another: With drugs available, who's to say where impotence begins, or what level of sexual perfection truly qualifies as 'healthy? If we can be bionic it is no longer so swell to be merely mortal." (Newsweek Nov. 17, 1997 p.68)

The study reported yesterday about mevacor is another case in point. 
This study has not yet been published in any refereed journal so evaluating it is impossible. But the Washington Post today said the population was 6605 men and women at Lackland Air Force Base and at the University of North Texas Health Sciences Center in Fort Worth. Men between the ages of 45 and 73 and women from 55 to 73 with cholesterol readings of 220. Both drug and non -drug groups were instructed in lifestyle changes including exercise and low fat diet. The report does not say whether the study was double blind, but it does indicate that half of the participants were given placebo. 

The result was reported in glowing terms last night with heart attack reduced by a third and with women benefitting twice as much as men. Doctors, it was claimed, would wake up tomorrow to a different world where they would have to choose whether to give out prescriptions for this marvelous drug to all comers. Only the head of the FDA sounded a note of caution - that medicating healthy people for life was not necessarily in their best interest and that absolute safety was essential in such cases. And that this was one small study. 

The definition of "improvement" or "benefit" is interesting here. First heart attack and serious chest pain are lumped together. If the chest pain is not a heart attack and not angina then it isn't cardiac in origin, so it seems a little strange that chest pain would be included as a serious problem. And no one is suggesting that lowering cholesterol will prevent or treat angina. 

Next the raw numbers here would be interesting. We know that heart attack is not a frequent occurrence in women under 75. So how many of the women in this group actually had heart attacks is crucial to determining whether there is any clinical benefit to be gained here. In men too, heart attack is not that frequent. So the numbers here are likely to be very small.  But the financial implication for Merck, the company that makes this drug, is enormous. I called last night and found that mevacor costs about $US 50.00 a month. The suggested pool of patients "who might benefit according to this study," varies from 6.5 to 8 million people. Do the math, guys. And then when Merck brings out a new ad and quotes this marvelous study as a reason why "you should ask your doctor if it's right for you," remember that this is one unpublished study with a very small population and that may well be a statistical glitch.  But you may be certain that Merck will have ads touting it within a week. Let the buyer beware. Unlike Premarin, this time we can watch exactly how drug companies use minor, unpublished and possibly inconsequential studies to sell their products. 

Tetje