Clinical Trial Ethics

Robert Waldmann

In the New York Times Amy Harmon has a long and fascinating article on the ethics of medical experiments on humans. She considers the argument that it is unethical to have a control group which doesn’t get the wonderful new experimental treatment.

I just note that the ethical rule imposed by the FDA and IRBs seems to be
first: do no harm.
second: do no harm.
third: do no harm.

The immense effort and delay required for approval of clinical trials basically forces anyone who doesn’t have tenure already to devote his or her efforts to treating sick mice and rats.

The article discusses two cousins undergoing melanoma cancer treatment,  one of whom is in the control group and dying. However, if any reader has malignant melanoma with metasteses but no metasteces to the brain or heart and no history of auto-immune diseases, I personally can arrange participation in a clinical trial without a control group.

I am absolutely 100% serious. Commenters with melanoma are most extremely welcome and eagerly sought.

update: Link added. This post does not discuss the ethics of including control groups in clinical trials. My points are that it is very extremely horribly difficult to get approval for clinical trials, and that this is a moral problem too.

Also, if you contact me soon, I might be able to get you into a phase 1 trial of treatment of melanoma. Phase 1 means no control group. This is an absolutely serious claim. I did not post contact information for the trial, as I don’t want the team burdened with general debate about ethics.