Uninformed consent, part one

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Uninformed consent, part one

Here's an interesting and telling story that keeps coming up.

As you might recall, I've written a pair of past articles (Daily Doses, 4/23/2004 and 3/27/2006) about a blood substitute called Polyheme. And just to re-orient you on the significance of the story - finding a workable, universal substitute for human blood is more or less the "holy grail" of emergency medicine. I promised to keep you abreast of any developments in the story, and today, there are some…

In the last of these articles, I spoke a bit about the controversy surrounding this experimental product. According to the news reports at the time, there's quite a stink in the medical community about the way Polyheme is being tested - namely, WITHOUT the full (or even partial) informed consent of patients.

Of course, when I last wrote about it, I warned of the slippery slope that experimental medical trials that are administered without informed consent creates - even within the framework of lifesaving emergency measures (such that Polyheme and other blood substitutes are given under). The can of worms is this:

Where do you draw that line?

In other words, what would the standards be for what's "lifesaving" to give someone? I think just about everyone would agree that acute trauma victims who are losing copious amounts of blood fast would probably throw their right to informed consent to the wind every time for anything that would keep them alive in the short term. In these instances, I could get behind the experimental administration of new medical technologies…

But what about those on waiting lists for new livers or kidneys? The odds of surviving long-term certainly aren't good for a lot of these people - but does that give the medical community the right to turn them into unwitting volunteers for every new experimental blood product, bone marrow replacement, radiation treatment, or even drug that comes down the pike?

What about people like terminal cancer patients? According to the mainstream medical community (but not me), these people are as good as dead anyway - why not use them as guinea pigs? How about "lifers" in federal prison?

See what I mean? Abandoning informed consent is a dangerous precedent to set - even under the most tightly controlled regulation. More on this in the next Daily Dose.

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