To the Editor:
In regards to your Nov. 26 article, "Merck's Vioxx withdrawal illustrates power of regulation by trial lawyers," as we, the "baby boomer" generation ages, rheumatoid arthritis is becoming a serious medical problem affecting millions of us over 50.
Anticipating a lucrative market for prescription painkillers and anti-inflammatory medications, pharmaceutical manufacturers have invested hundreds of millions of dollars in the development of treatments for every degree of this potentially disabling medical condition.
We have produced an entire generation of investigators in medicine who believe that the only valid form of cliinical research is to perform prospective, randomized trials in which patients are randomized to receive one empiric drug combination versus another empiric drug combination. Strike that, against a placebo, not another established drug combination.
There is a mindset that pushes tens of thousands of physicians and scientists toward the goal of finding the tiniest improvements in treatment rather than genuine breakthoughs, that rewards academic achievement and publication over all else. There is a national problem in the way we treat the problem.
One must be objective and decide at what point the benefits of such drugs "truly" outweigh the risks they present. Of course, some of the risks are minor and others, though serious, are tolerable in that they are reversible, short-term or non-life threatening. Many of the risks, however, are extremely serious and are difficult to balance against relief from anything but the most severe arthritis-related symptoms. Clearly, for some people the risks may be acceptable, for others, not.
Drug companies have developed drugs aimed at the widest possible population. That is the most profitable strategy but one that ignores a basic fact in biology, people are different. Bringing a new drug product to market is an expensive business costing tens of millions of dollars. It takes place in a culture of maximum possible sales for maximum possible profit, although the fact is that most drugs don't work for most people.
Even when a drug has been approved in terms of safety and efficacy, whether it does what the label says it should do, few people realize just how poorly they perform in real life.
Gregory D. Pawelski
To the Editor: