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IJ's lawsuit challenging NOTA ban on compensating bone marrow donors drawing mixed reviews.

On October 28, 2009 the Institute for Justice (IJ) filed a law suit against US Attorney General Eric Holder asking that he be enjoined against enforcing the federal criminal prohibition on compensating bone marrow donors contained in the National Organ Transplant Act of 1984 (NOTA). The lawsuit was filed in the US District Court for the Central District of California on behalf of the California-based MoreMarrowDonors.org, a number of patients who have needed or will need a bone marrow transplant, and John Wagner, MD, an expert in bone marrow transplantation at the University of Minnesota. The Cato Institute joined the IJ after the law suit was filed.

The legal action by the IJ and the Cato Institute marks the first time since it was enacted 25 years ago that the NOTA has been subject to a constitutional challenge.

As expected, the announcement of the lawsuit has resulted in a plethora of pro and con articles and statements over the merits of the case, whether it stands any chance of being successful, and what impact the suit could have on the efforts by a variety of individuals and organizations advocating a trial to see if offering financial incentives would increase people's willingness to donate organ.

Here is an overview of some of the comments being made by organizations, and individuals on the pros and cons of the lawsuit and the IJ's challenge over the NOTA valuable consideration ban on offering compensation (in some form) to bone marrow donors.

Statement by the National Marrow Donor Program (NMDP), reported by American Medical Association's amednews.com (12/23/09)

The NMDP has facilitated more than 35,000 marrow or blood cell transplants since 1987. The group said it agrees with the World Health Organization and the World Marrow Donor Association that paying donors is a bad idea.

"The rational for the current law is to ensure patient and donor safety. Offering compensation to potential donors might compel them to withhold personal health information that would negatively impact the patient. The safety of the donors is equally important. Offering compensation to potential donors might also compel them to withhold personal health information that would normally defer them from donating."

The plaintiffs have a steep legal hill to climb, said Robert Burt, a law professor at Yale Law School in Connecticut, who has written extensively on biomedical ethics and constitutional law.

"To show that (NOTA) is an equal protection violation--the basic argument they're making is that the law's irrational, that equal things have to be treated equally," Burt said. "But there is a rational reason for it ... We may end up with more (marrow), but in terms of the distribution of who gets it, it would turn into a bidding war, and that commercializes the value of life."

Jeff Rowes, Senior Attorney, Institute for Justice (12/28/09)

"Without getting too deep in the constitutional weeds, the federal courts will be reviewing our claims under what is called the rational basis test, meaning that the law is presumed constitutional and will be upheld unless we can establish its irrationality. Part of our argument is that applying NOTA to marrow is irrational because doing so conflicts with clear legislative intent. The Conference Report of the House and Senate that went to President Reagan's desk with the NOTA bill that he signed stated that nothing in this law should be construed to prohibit compensation for replenishable tissues such as blood and sperm. Marrow cells are just immature blood cells (technically, hematopoietic stem cells). Congress was ignorant that marrow is just a loose collection of immature blood cells so it is irrational to enforce NOTA against marrow cells when there is no plausible reason to believe that Congress actually intended to outlaw what a marrow transplant is (technically, marrow may be an organ insofar as marrow is defined as the spongy tissues within the bones that provide spaces for hematopoietic stem cells colonies to proliferate, but doctors don't transplant marrow; they transplant stem cells, which have no structural or connective characteristics and thus don't seem to meet the definition of either tissues or organs). Also, because HLA matching is so difficult in the marrow context, it is improbable that markets could arise, though we hope to show, market-like incentives could be useful. We're not asking the courts to allow us to set up the highest bidder markets.)"

Our Space, by American Blood Commission CEO Jim MacPherson "Paid Stem Cell and Marrow Donors" (1/22/10)

"It isn't clear, other than principle, what is driving the suit, but the two Institutes' (Ed. Note--The CATO Institute has joined the suit with the IJ) claim is based on conjecture: they argue that with payment there will be more matches for patients. True, people crawl out of the woodwork when money is offered. But with 4 million volunteers in the US registries and that many or more around world, do we need (or want) them? Problem matches are usually for mixed-race minorities and it is unclear how offering money helps. Hundreds and often thousands of volunteers already turn out every time a match can't be found for a minority patient. And if the US is the only country allowing payment, how does that help patients in other countries?

Aside from the logistical and philosophical arguments, the reason we don't pay for organs, tissue, and stem cells, of course, is safety. Until we can rid cells of the most potential pathogens (like we can for plasma), we know that someone selling a body part is more likely to hide a disqualifying condition, and therefore less safe than an altruistic volunteer.

As a point of comparison, the arguments being made in the suit are reminiscent of those made in the 1970s about paid vs. volunteer donors. Then, the Food and Drug Administration came up with a novel solution. Rather than ban paid donors (which the agency did not have the authority to do), each product for transfusion is prominently labeled as to donor type. The risks in using "PAID DONOR" blood drove us to an all-volunteer system."
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Publication:Transplant News
Date:Feb 1, 2010
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