Crichton Warns of "New Body Snatchers"
Best selling author Michael Crichton warned in last Friday's Wall Street Journal (no link available) that people's cells and body substances are no longer necessarily their own, once removed from the body. Scientists can use your cells and blood to conduct research upon, and if they are fortunate, develop into medical products that will make them billions. And you have no right, apparently, to stop them or to share in the wealth that were, in part, generated by your body parts.
But what about the terms of consent agreements? Apparently, courts often refuse to enforce limiting terms put in to protect patients. This matter arose most recently in a case out of Washington University in Missouri. Prostate cancer patients had agreed to allow their tissues to be used in research. But, Crichton writes, a court refused to enforce the limitations in the consent forms they signed! "The decision surprised many. As a recipient of federal funds, Washington University was required to follow the federal regulations on informed consent for tissues received from patients. This included acknowledging in writing that the tissues would be used only for prostate research, that patients had the right to withdraw from the study at any time, and to have their tissue samples destroyed upon request.
"However, Judge Limbaugh ruled that patients had no such rights. In his view, the right to withdraw merely meant the right not to contribute more tissues. The right to have the tissues destroyed meant only that the samples would be used anonymously. The guarantee that tissues would only be used for prostate research could be ignored, and WU was free to use the tissues for any purpose whatever." So once again, words become meaningless as definitions are changed to suit desired ends.
Crichton's conclusion illustrates the growing power of the Science-Industrial Complex, in which universities are becoming almost despotic in their drive to make fortunes through biological research unfettered by societal-desired ethical constraints. He writes: "Research universities around the country greeted the ruling with unseemly enthusiasm, and hastily joined forces to prevent a successful legal appeal. Although the National Institutes of Health and other federal centers conduct research under the federal guidelines, universities now claim that these rules are impossibly onerous and impede research. Unless researchers are allowed to do whatever they want, they warn patients, the flow of life-saving miracles will dry up.
"...For universities, perhaps the most damaging outcome may be the loss of confidence that patients feel in major centers of research and healing. There was a time when physicians were ranked just below Supreme Court justices. Those days are long gone. Our university hospitals and major medical centers still command respect. But the perception that they are businesses like any other is growing stronger every day. Except, they're not--they're non-profits, exempt from most of the rules and disclosures that are required of American businesses. In short, caveat patiens, keep copies of everything you sign, bring a lawyer to every medical appointment, and always, always watch your back."
Meanwhile, these warnings are generally ignored by the cheer leader media and lost amidst the torch parades in which everyone yells, "CURES! CURES! CURES!"


5 Comments:
"are no longer necessarily their own, once removed from the body"
This isn't exactly new, but I guess it is under-reported. In property, we read this case where a man with a very, very rare liver disease donated his liver cells and the scientists derived a very lucrative medicine from it. But I think the intellectual input by the scientists was actually quite low, something along the line of just routinely culturing his cells. He sued for a piece of the pie, but the court held the worth of his donation to be few dollars, i.e. the tissue's worth AT THAT MOMENT in time, not its potential worth.
I certainly sympathize and think it is unfair that donors are not adequately compensated with the huge wealth that may be derived from their body tissue.
But, on the flip side, with our capitalist structure, the more financial incentive, the more likely a cure will be found. Compensating donors would only add a roadblock.
If I had to balance, I'd say that the compensation to the donor should be scaled against the intellectual input by the scientists. Alternatively, a negotiated flat fee.
For the latter - if you need a lawyer, please use me ;)
But is the current system fair? Absolutely not.
Is it pragmatic and good for overall public health? I think so.
I knew about that old case and think it was wrongly decided. People should have a right to consent or refuse to have their body tissues and substances used in research. If they consent, the terms of the consent agreement should be enforced, not cast aside as apparently happened in the Washington U. case.
The idea that something is good for public health can cover an awful lot of injustices.
The idea that something is good for public health can save lives too. That itself is a form of "justice."
But alas, the issue that it raises is one of conflicting priorities and interests: saving lives, individual autonomies, and some notion of morals like "justice."
But I don't know how to evaluate the balance between them without first coming to grips with what are acceptable government intrusions, both domestically and internationally.
The latter I throw in as it ties into your prior posts on China/North Korea, human slavery, and T E Fine's comments on canibalistic Africans. But basically, if we want to tell China/NK, East European human traffickers off and say "international human rights opinion condemns that", then we must conform to international human rights opinions ourselves. Otherwise, we are hypocrites.
Based on America's love affair with the death penalty and lack of universal health care, I don't think America really wants to do that.
So, we would have options:
1 - ignore the human rights abuses elsewhere in the world, or
2 - get America up to speed with the international human rights standard
I say #2.
But we already have high standards (perhaps not high enough), as in the Common Rule for human subjects research. We also must adhere to the rule of law. I am very supportive of medical research, but I am becoming worried that rather than being one good in the mix of several, to be weighed and balanced, it is becoming the trump card. And that can lead to a crass utilitarianism that will victimize the weak. We see that already in some of the abuses in mental health drug research.
I agree with #2. And we should insist that others live up to minimal standards, as we live up to them ourselves; lead that is, not follow.
godan: Thanks for your input. Here is a note I received from a lawyer who read the case. He had a far different take than you: "I appreciated your post on the Washington University v. Catalona U.S. District Court case. I read the opinion a few weeks ago, but seeing additional commentary on the case has helped me to put it into better perspective. One of the problems from having one judge writing an opinion without dissents is that it allows a judge to give a too-rosey or otherwise slanted picture to everything. It certainly struck me that if there is to be any background assumption, it should be that persons should be able to demand their samples be given back or destroyed unless they clearly say otherwise. The result of the case seems to have it going the other way. And construing a consent form to mean a person can stop contributing future samples is completely ridiculous. Talk about a worthless form! I'll have to keep an eye out for the 8th Circuit's decision on this case, although I know that could be some tim e from now.
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