Clinical Trials an Ethics

I always do a unit on ethics and writing with my students, because I think they should be aware of how they will deal with ethical dilemmas once they enter the workforce.

Ethics, I tell them, deals with gray areas -- things that aren't technically against the rules, but which might keep you up at night. An ethical dilemma is, by definition, an ethical problem with no clear right answer. No matter what you decide to do, someone is going to get screwed.

I read a really thought-provoking article from the New York Times last week on clinical trials and doctors who try to bend the rules to get their patients entered into a trial. It's a classic ethical dilemma.

Doctors have an obligation to their patients, to do whatever they can to see that the patient gets well. That's a kind of immediate obligation. They also have an obligation to see that their patients might be helped in the future, a long-term obligation.

Some doctors have patients who are no longer being helped by available treatments. But they know that some treatments available in clinical trials might be of some help. That's their immediate opbligation. But the patients don't necessarily qualify for the trial because they might have advanced cancer or other health probelms. So what do you do?

If you get the treatment to the patient, it might help. But if you bend the rules and get the patient into the trial, and it doesn't work (it's unproven, which is why it's ina trail) it might also throw off the trial results ("Wait -- we had a patient die while in the trial? We need to stop this now and investigate"). And there's the long-term obligation to the trial, ensuring the treatment is being tested fairly and properly.

Oy.

Some drug companies have "compassionate use" policies that allow unapproved drugs still in trial to be given to patients who wouldn't qualify for the trial, once the FDA approves the one-time use, and, I would imagine, the patient assumes all of the risk.

Someone in the support group gavce a link for a blog by a breast cancer patient. The blog is called The Assertive Cancer Patient, and the author, a former journalist, is in the middle of a compassionate use fight with Wyatt/Pfizer. The fight isn't going well. I wish her luck.

(Incidentally, The Assertive Cancer Patient is a pretty good blog. The author is very down on some aspects of Breast Cancer Awareness Month, which is a really nice idea, but which she finds to be exploitative in some ways, especially by companies that Put on the Pink but don't seem to be giving any monetary support to breast cancer research. Click around her blog for posts from the last month.)

Anyway, it's a very interesting dilemma, and while compassionate use seems like a reasonable solution, it apparently isn't an easy one. But then again, with cancer, there never really are any easy answers, are there?