When Testing a Drug Means Withholding It
Only months before, a new drug had shown that it could safely slow the cancer’s progress in certain patients…. But when Mr. Ryan, 22, was admitted to the trial in May, he was assigned by a computer lottery to what is known as the control arm. Instead of the pills, he was to get infusions of the chemotherapy drug that has been the notoriously ineffective recourse in treating melanoma for 30 years.
Even if it became clear that the chemotherapy could not hold back the tumors advancing into his lungs, liver and, most painfully, his spine, he would not be allowed to switch, lest it muddy the trial’s results.
Full article on patients assigned to clinical trials by computer lottery.
Sinclair Lewis wrote about this 90 years ago in his classic, “Arrowsmith.” The doctor thinks he has a cure for the plague and goes to “test” his cure on an island infected with the plague.
In the end, he decides to vaccinate all of the people (therefore ruining the test). But, he saves most of them. (And wins Sinclair Lewis the Nobel prize.)
I guess his treatment wouldn’t have gotten FDA approval…
It wouldn’t be the first time I’ve heard of a study being abandoned when the evidence became conclusive one way or the other before the term of the study. But the studies I’m thinking of may not have been clinical trials for the purpose of gaining FDA approval.
I would think medical ethisists would have a conniption fit over trials like this.
We’ve been over this ground before. No one should have to ask the government’s permission to take a drug.