PUTTING CLINICAL TRIALS AHEAD OF HUMAN LIVES (AGAIN).

PUTTING CLINICAL TRIALS AHEAD OF HUMAN LIVES (AGAIN). I have posted on this subject a number of times, for example here. This story from the weekend New York Times describes the efforts of the family of a young man with Lou Gehrig’s disease to get permission for him to use a potentially helpful drug. The obstacle has been the FDA, which “does not want patients to bypass clinical trials, which require that some participants receive a placebo and not the drug to determine reliably whether a drug works.” The drug in question has been approved by the FDA for use in treating children so presumably safety is not an issue. What would be learned by withholding the drug for some patients in a clinical trial? What can the FDA learn about what happens to people who don’t get the drug? Everybody knows what happens to patients with untreated Lou Gehrig’s disease. And how could withholding the drug in a small sample in a clinical trial ever add to what we know about what happens with untreated Lou Gehrig’s disease from the large numbers of people who have died from it? And how is it harmful to get more information by letting the patient try the drug?