Art Caplan on the NIH’s Agreement Regarding Control of Henrietta Lacks’ Cells

Art Caplan has a new opinion piece up at nbcnews.com on the longstanding controversy over the use of the cells of Henrietta Lacks, a poor African American woman who died of cervical cancer in 1951, for research that has generated billions of dollars through scientific research over more than six decades. This research was conducted without Lacks’ or her family’s consent. According to a new NIH agreement with the Lacks family:

Lack’s genome data will be accessible only to those who apply for and are granted permission. And two representatives of the Lacks family will serve on the NIH group responsible for reviewing biomedical researchers’ applications for controlled access to HeLa cells. Additionally, any researcher who uses that data will be asked to include an acknowledgement to the Lacks family in their publications.

The new understanding between the NIH and the Lacks family does not include any financial compensation for the family. The Lacks family hasn’t, and won’t, see a dime of the profits that came from the findings generated by HeLa cells. But this is a moral and ethical victory for a family long excluded from any acknowledgment and involvement in genetic research their matriarch made possible.

Read the full article here.

End the Ban on Blood Donation by Gay Men

By Dov Fox

86 members of the U.S. Congress have requested an end to the federal policy that prevents men who have had sex with men from giving blood. Advances in blood screening technology have discredited the medical justification for this exclusion. And our country’s current critical blood shortage makes it dangerous for public health.

The antidiscrimination objection is more complicated. The policy wasn’t born of illicit motivations and doesn’t seriously disadvantage gay men. That it doesn’t reflect bad intentions or effects, does not, however, vindicate the policy on equality grounds. The blanket exclusion, independent of individual risk levels, reflects a disparaging stereotype that gay men are sexually promiscuous or use illegal drugs, I argued in an op-ed last week. I have elsewhere called this objectionable social meaning the expressive dimension of donor deferral.

Secretary Sebelius should answer the congressional plea to end our exclusionary blood donation policy. In the meantime, those who already enjoy the opportunity to help save lives can serve the causes of public health and social equality by making an appointment to give today.

Bei Bei Shuai First Degree Murder Charges Dropped

By Michele Goodwin

Less than an hour ago, Indianapolis prosecutor, Mr. Terry Curry agreed to drop first degree murder charges against Bei Bei Shuai in an agreement that required her to plead to a misdemeanor.  The case was a month away from trial in what would have been the first prosecution of a pregnant woman in Indiana for attempting suicide.  Ms. Shaui ate several packets of rat poison in a desperate attempt to end her life after being abandoned by her boyfriend.  After being saved by friends and doctors, prosecutors filed first degree murder charges against Shuai, because her baby died.

Bei Bei Shuai’s case highlights the turn to criminal prosecution in fetal protection cases as a terrible national phenomenon.  Shuai was spared the horrible fate experienced by poor women, many of color, across the U.S., including Regina McKnight, Paula Hale, Melissa Rowland, and others. In a forthcoming article to be published in the California Law Review, I argue that these prosecutions represent the new constitutional battlefronts as they burden pregnant women’s due process interests while also imposing the type of cruel and unusual punishment disallowed by the Eighth Amendment. I have argued in prior works found here and here that such prosecutions often involve racial profiling and create hierarchies among women’s pregnancies.  Indeed, most often the pregnant women targeted for threatening harm to their fetuses are so poor that they lack adequate legal representation, relying on overworked public defenders who make valiant efforts, but lack the economic wherewithal to  properly aid in these cases.   Shuai’s case was different in that she had Linda Pence, a valiant, private attorney, who spent over two years providing excellent pro-bono legal aid.

Bei Bei Shuai’s release from murder charges also represents another victory for Advocates for Pregnant Women, the leading organization advocating on behalf of indigent pregnant women.

AALS Section on Law, Medicine & Health Care Call for Papers

2014 Annual Meeting Section Panel

Saturday, January 4, 2014, 2:00–3:45 p.m.

 Sustainability and Health

This panel will explore the effects of the environment on health in western nations and the role that sustainability initiatives play with regard to wellness. The panel will be interdisciplinary, broadly spanning topics in health, environmental, and animal law and policy as well as public health, land use, and urban planning. Possible topics include: the effects of urban planning on food access and obesity, the consequences of factory farming for human health, the effects of local and sustainable food movements on human health, the health impacts of environmental laws, the environmental impacts of health laws, and the link between ground water and air pollution and illness.

Interested speakers should submit an abstract of up to 300 words electronically by August 31, 2013 to: Ani B. Satz, Chair-Elect, AALS Section on Law, Medicine & Health Care, asatz@law.emory.edu. Selected speakers will have the option of publishing original papers not committed for publication or in print prior to the Annual Meeting in a special issue of the peer reviewed Journal of Law, Medicine & Ethics.

The Big Gulp Wins: Public Health Loses

By Wendy Parmet

Public health law took another hit this week. In a unanimous decision (starting on p. 22), the Appellate Division of the New York Supreme Court affirmed a trial court’s earlier ruling striking down the New York City Board of Health’s ban on the sale of large sugary drinks.

In an opinion authored by Justice Dianne T. Renwick, the appeals court ruled that the Board of Health had “failed to act within the bounds of its lawfully delegated authority” in promulgating the so-called soda ban. Relying primarily on the Court of Appeals’ decision in Boreali v. Axelrod, the Appellate Division concluded that the soda ban was unlawful because 1) in framing the regulation, the board took into account factors other than public health; 2) the regulation was not an act of interstitial rule making; 3) the regulation concerned an issue that the legislature had considered and had failed to reach a decision; and 4) the regulations did not require expertise in the field of public health.

Although the Appeals Court did not repeat the trial court’s spurious suggestion that the board’s powers were greater when applied to infectious diseases than chronic diseases, it reiterated the erroneous belief in a binary distinction between public health factors and social and economic factors. In the court’s view, the only factors a health department should consider are “health factors,” which seem to exist totally apart from the social and economic environment. Any consideration of social and economic factors, including as the court noted, consideration of behavioral economics, is outside the scope and beyond the expertise of public health.

This dichotomization of public health and “non-health factors” relies on a false understanding of public health expertise. Read More

Petrie-Flom Intern’s Weekly News Round-Up: 7/25 – 8/1

By Aleeza Hashmi

Informed consent for organ donation?

By Seema Shah

In my last post, I discussed my view that brain death is not the same as death, but is a status legal fiction to allow organ donation when it is legally and ethically acceptable to treat individuals as dead. There are some important and unresolved questions in the debate on brain death and organ transplantation. In particular, does the public know the truth about brain death? If not, is it ethically acceptable to rely on the consent given by organ donors and their families? Although several surveys have been done on public attitudes towards brain death and organ transplantation, there is a compelling need for more and better data to determine what members of the informed public believe about the relationship between brain death, death, and vital organ transplantation.

Michael Nair-Collins wrote an interesting article recently in the Kennedy Institute of Ethics Journal entitled “Brain death, paternalism, and the language of ‘death.’” He argues that the lack of transparency in obtaining consent for organ donation calls into question whether donors and their family members give valid consent. For instance, he notes that the Department of Health and Human Services website states the following: “Patients who are brain dead have no brain activity and cannot breathe on their own. Brain death is not coma. Brain death is death.” Yet we know that brain dead individuals do continue to have some brain activity, including the secretion of vasopressin, and as discussed in my last post, there is good reason to distinguish brain death from a more traditional, biological conception of death. Nair-Collins raises important concerns about policy makers failing to inform the public with accurate information about brain death in order to try to increase rates of organ transplantation.

What Nair-Collins fails to acknowledge is that by focusing on the information about organ transplantation that policy-makers, doctors, clerks at the DMV, and all those involved in getting consent from potential organ donors, he is only looking at one piece of the puzzle.  Those who have family members who are brain dead have direct access to evidence about what brain death means. They can see for themselves that, with assistance from modern technology, brain dead individuals are warm to the touch, have hearts that beat, lungs that inflate, and in some cases, even have bodies capable of passing through puberty or gestating growing fetuses. No matter what family members are told about brain death, they have the ability to perceive with their own senses the difference between brain death and the conventional image of a dead person as a lifeless corpse. Many members of the public may also be able to see that although brain dead individuals are not actually dead, they are “as good as dead” for the purposes of organ transplantation. Read More

Art Caplan on teen organ transplants

Art Caplan has a new opinion piece up at nbcnews.com. In “Ethicist: Teens have high failure rates after organ transplants — but cut them some slack,” Caplan responds to a recent study showing that teen organ recipients have much higher failture rates than recipients in other age groups:

Remember the long fight over whether Sarah Murnaghan, the little 10-year-old girl from suburban Philadelphia who was dying from cystic fibrosis, should have a shot at getting a transplant from lungs taken from an adult? The fight hinged in part on whether there was sufficient evidence to show that adult lungs would work as well in Sarah, who is still struggling to recover from two lung transplants, as they would in another adult where they would fit better. Some, including me, argued that the best way to allocate scarce lungs for Sarah or anyone else is to determine who is most likely to live if they get them.

That may seem a sensible ethical policy to use when there are not enough organs for all. But there is a new study out that calls into question the merits of an efficacy-only rationing policy.

Read the full article here.

Chimpanzee Research and Animal Rights

Last month, two federal agencies took steps that together may come close to ending research on chimpanzees in the United States.

First, the Fish and Wildlife Service (FWS) proposed to list all chimpanzees, including those in captivity, as endangered.   (Currently, only wild chimpanzees are listed as endangered, while captive chimpanzees are listed as threatened).  This would require that almost all research on chimps be done with a permit, and the agency has suggested that these permits may only be granted for research that enhances the propagation or survival of the chimpanzee species.

Second, the National Institutes of Health (NIH) decided that more than 300 of the approximately 360 research chimpanzees that it owns will be retired and moved into sanctuaries.  This decision was based on an Institute of Medicine report finding that most current research on chimpanzees is unnecessary, and that chimps should be used only when public health is on the line, no other animals are appropriate, and ethical experiments on humans are not possible.  On the basis of these findings, the NIH is planning to keep a colony of about 50 chimps available for research that is not possible in any other way.

Comparing these two agency actions raises an interesting question:  In evaluating whether research on chimpanzees is ethical, does it matter whether the beneficiary of the research is the chimpanzee or the human species, and if so, on what grounds?   Read More