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Government

HHS vs. Cancer Patients

HHS vs. Cancer Patients
Chuck Muth
November 18, 2013

(NN&V Staff) – In the midst of its takeover of the nation’s health care system, the Department of Health and Human Services is now looking to implement a rule to undo a lifesaving court ruling from this past year which allowed compensation for bone marrow donors.

Last week, the Institute for Justice, which won the victory in court on behalf of cancer patients from across the nation, announced a plan to oppose proposed new regulations. IJ’s victory in Flynn v. Holder made clear that it is legal to offer compensation to most bone marrow donors. HHS’s effort, however, would reverse the ruling and re-instate a decades-long ban on donor compensation.

“Every day, people die while waiting to find a compatible bone marrow donor,” explained IJ Senior Attorney Jeff Rowes, lead counsel for the plaintiffs in Flynn v. Holder. “The goal of our lawsuit was to enable researchers to find out if donor compensation would lead to more donors. Our victory made that possible, but now HHS once again wants to make it a felony punishable by up to five years in prison just to do basic research on a promising, lifesaving initiative.”

The original landmark case began in October 2009 when the Institute for Justice filed suit against the U.S. Attorney General on behalf of cancer patients, the parents of children with deadly diseases, a renowned bone marrow doctor, and a nonprofit group to challenge the prohibition on compensating bone marrow donors set forth in the National Organ Transplant Act (NOTA) of 1984. NOTA made it a serious crime to compensate someone for a human organ for transplantation. The Act defined bone marrow as an organ.

In a ruling that became final in the summer of 2012, however, the 9th U.S. Circuit Court of Appeals ruled that the ban on donor compensation could not be applied to the most common method of marrow donation. Most modern bone marrow transplants now occur using a technique that extracts marrow cells from the bloodstream rather than from the hip bone, which was the traditional method of donation. Because this technique is almost identical to the technique used by donors of other blood parts like plasma, the court held that Congress could not have meant to include it when it banned compensation for “organs.”

Under the new regulations, though, this ruling would be reversed. The Department of Health and Human Services has proposed a rule that would define “organ” to include marrow cells donated through the bloodstream, effectively re-imposing the ban on compensation.

“The federal government’s proposed rule is illegal and unconstitutional because it is based on a falsehood,” said Rowes. “Cells taken from your bloodstream aren’t ‘organs,’ which is why no one has ever thought NOTA prohibits paying people for platelets. The Constitution does not allow government agencies to simply redefine words in order to grant themselves more power.”

The proposed regulation would ban marrow compensation just when empirical research has begun into the effects of compensating donors. A team of economists—Nicola Lacetera of the University of Toronto, Mario Macis of Johns Hopkins University, and Robert Slonim of the University of Sydney—were in the process of finalizing a research proposal that would have investigated the effects of donor compensation when they learned of the new rule.

“These new regulations make it impossible for researchers to obtain the necessary evidence to inform policy. Our proposed studies would be made illegal by these new provisions,” explained Macis, who, along with Lacetera and Slonim, has published some of the leading work showing that economic incentives can be effectively used to increase blood donations without affecting blood supply safety. “Properly designed compensation for bone marrow donors could similarly lead to significant increases in donations, thus giving potentially hundreds or thousands of people in need of a transplant every year a greater chance of survival. At a minimum, the federal government should not make it illegal for researchers to find out whether incentives can help address the shortage of bone marrow donors.”

“I don’t think that anybody should go to jail just for trying to save somebody’s life,” added Doreen Flynn, who has three children with Fanconi anemia, a blood disease that frequently requires a bone marrow transplant and who was the lead plaintiff in the original lawsuit. “If paying donors results in more marrow donations, we should pay them. And it shouldn’t be a crime to investigate it.”

“We know what doesn’t work,” said Robert McNamara, also a senior attorney with the Institute and co-lead counsel in the case. “We have 30 years of experience with an altruism-only marrow-donor program, and we know that has not succeeded in recruiting enough donors. The only question is whether offering compensation can achieve better results. We will not allow the federal government to make it a felony to find out the answer. Hopefully, we will do that by persuading the government not to adopt this rule, but if we have to, we will sue them again. And we will win—again.”

The proposed regulation is currently open for a period of public comment through December 2, 2013. Individuals who have been impacted by blood-borne cancer or bone marrow donations are encouraged to leave comments on the Department of Health and Human Services’ website: http://www.regulations.gov/#!submitComment;D=HRSA_FRDOC_0001-0115.

Individuals who support the efforts of Doreen Flynn and the researchers looking to improve the number and quality of bone marrow donors are encouraged to leave their comments on the HHS comment site.

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