Medicine by averages

Yesterday, Pfizer "voluntarily" withdrew its leukemia drug Mylotarg from the market (read: withdrew "voluntarily" because the FDA would have made Pfizer pull it otherwise) after a post-FDA-approval study showed that it didn't slow the advance of leukemia or extend patients' lives...

...in the aggregate, that is.

But, as Dr. Peter Marks of Yale-New Haven Hospital says, "Pfizer’s recall of the drug is 'very bad news' for leukemia patients who haven’t responded to other treatments...'There are some people who I can honestly say would not be on this earth were it not for this drug.'"

This is a perfect example of how practicing medicine by averages, which is what the FDA does (and what your doctor will increasingly have to do as ObamaCare sets in), screws patients over. Just because a drug did poorly over the aggregate group of patients in a study, does not mean that it did poorly for every patient in the study. Perhaps a minority of patients benefited from the drug. But, because the average is bad, other patients who didn't participate in the trial, but who are like that minority and could benefit from the drug, won't get to have it. No consideration is paid to the doctor's or the patient's judgment. Perhaps the doctor, in his medical knowledge, might understand why some patients do well and not others, and would then recommend the drug to those patients whom he believes need it -- or he could change the dose or the schedule of the medication in order to mitigate the side effects, as Dr. Marks does. Perhaps the patient, mindful of the fact that she has a terminal illness, might be willing to take a risk on the treatment because she knows that the treatment might kill her but the cancer definitely will.

Now, patients who had already been receiving Mylotarg will have to fill out all kinds of paperwork if they want to keep getting it, as will researchers who want to continue clinical studies with it -- because of course a bureaucrat's judgment is better than a doctor's or a patient's.

Practicing medicine by averages, rather than considering the individual needs and characteristics of each patient, is detrimental to patients who don't fit the "average" mold -- and that is exactly the kind of medicine we are going to get more of, the more government gets involved.