Clinical Drug Trials Aren’t All That Fair

“Studies in Confusion” (April 30) should also have pointed out that so-called randomized clinical trials aren’t really randomized, skewing their results. All participants in clinical studies are filtered through the Karnofsky Performance Scale to assure that only those who are least seriously ill with the affliction being researched are admitted to the trial. Typically, any person with a Karnofsky rating below 60 is excluded.

This ensures that the results are good, which means that the drug companies get rapid FDA approval, have an impressive marketing pitch and are on their way to making big money.

The problems, however, are several: First, seriously ill patients could be given false hope from taking drugs that don’t work for them. Second, health insurance companies are spending billions of dollars on drugs that might only help people who aren’t seriously ill. Third, research for drugs to help the seriously ill simply isn’t being done.

JOHN ROSSMAN

Tustin

Bravo to Linda Marsa for her sober and informative appraisal of medical research. It’s important for people to understand something of research methodology so that they can better evaluate the “latest breakthroughs” that are given prominence in the media almost every week.

But the media plays a role in the feeding frenzy that follows reports at conventions and in journals. Feeling the pressure to be first and dramatic in reporting the latest in research, the media often overstate the findings--sometimes aided by overly enthusiastic researchers eager to show that the grant moneys spent on them have been worthwhile and eager also to strengthen their chances of obtaining the next grant. Moreover, particular care must be taken when new data are reported at professional meetings, for the criteria for having a paper accepted at a convention are usually far less stringent than those applied to manuscripts submitted to the top-tiered peer-reviewed journals.

GERALD C. DAVISON

Professor of psychology

USC