WND has another one of their advocacy pieces in drag. (This sort of “news” article is why I don’t read WND much anymore.) In this one the scare comes courtesy of Dr. Richard D. Ackerman of the “The Pro-Family Law Center”, a “California pro-family group”. He claims that a proposed FDA rule would allow doctors to perform “Nazi-like experiments” on patients without their permission.
“This is reminiscent of the days of Hitler and Dr. Mengele,” he said. “The idea that research can be performed on a human being without informed consent is antithetical to the very meaning of human self-determination and dignity.”
Once you invoke Nazis, your argument merits skepticism.
First, look at the proposed rule change.
Under the regulations in 21 CFR 50.24, and the conforming amendments contained in 21 CFR parts 56, 312, 314, 601, 812, and 814, an exception may be requested from the requirement to obtain informed
consent from each subject, or the subject’s legally authorized representative, prior to enrollment in a clinical investigation. The narrow exception applies to emergency research for which, among other things, the following conditions exist: (1) An investigational new drug application (IND) or investigational device exemption application (IDE) is required; (2) that involves human subjects who have a life-threatening medical condition (for which available treatments are unproven or unsatisfactory); (3) that involves subjects who because of their medical condition (e.g., unconsciousness) cannot give informed
consent; and (4) where, to be effective, the intervention must be administered before informed consent from the subjects’ legally authorized representative is feasible. Studies involving an exception from the general requirement of informed consent may proceed only after a sponsor has received prior written permission from FDA, and the IRB has found and documented that specific conditions have been met.
This sounds to me more like doctors are going to be given the option of taking extraordinary measures to save lives. If they determine that a patient is about to die, they’re being allowed to try something that might ordinarily be against the rules.
A friend, and regular reader of Buttle’s World, who happens to be a doctor running an ER at a major hospital, concurs. He points out that the above paragraph, where it references “investigational drugs” is key.
Investigational drugs and devices are those that have already passed animal trials and are ready for use in people. The doctors (and the FDA and the institutional review boards) are all working with a reasonable expectation of safety and efficacy. Hardly like lone-wolf Dr. Mengele at all.
It was by bending the rules (“compassionate use”) that AIDS drugs became available before FDA testing was complete. As we know, AIDS was a death sentence back then, so what was there to lose?
This very issue has been a sticking point in emergency medicine research. You’re doing CPR on a guy. Which drug is more likely to save him, A or B? He can’t give his consent to the trial, and the family hasn’t shown up yet.
There was talk (and I’m not sure of the outcome) of relaxing the informed consent rules in ER studies.
If the FDA is ready to relax rules to let doctors save more lives, I’m all for it.
