Monday, November 10, 2014
As NPR reported this morning, researchers in England may soon use genetic therapy to treat diseases that result from defects in mitochondrial DNA.
Mitochondria create energy for cells, and they have their own genes, distinct from the genes that help determine our looks, behavior, and other traits. Because mitochondrial activity is critical to normal cell functioning, abnormalities in mitochondrial DNA can be devastating. Some babies die in a matter of hours.
But because the therapy involves genetic manipulation, it is controversial. While critics are right to insist that we proceed carefully with genetic therapy, many of their arguments are misguided.
Monday, January 20, 2014
What are We Learning About Brain Death from the McMath and Munoz cases?
By Jennifer S. Bard, J.D., M.P.H., Ph.D.
With the understanding that this is one of those topics that health law professors are supposed to know something about, here is a quick update of what’s going on. Along with my own views about the possible misuse by hospitals of declaring brain death in what are really medical futility cases.
Jahi McMath, age 12, in California who lost consciousness after a routine tonsillectomy and Marlize Munoz, age 32 in Texas who collapsed on her kitchen floor have both become involuntary public figures as their families struggle to make sense of both their medical conditions, which are complex, and of the laws which have declared them both legally dead based on a lack of brain activity. In legal terms, a person declared “brain dead” has the same status as any other dead person. Each state is entitled to make its own decision of whether or not to adopt a brain death statute. California’s and Texas’ are similar in that they require the “complete cessation” of all brain activity. The declaration of death is, in all states, a legal act. Most hospitals have a policy similar to this one which set criteria and require the participation of at least two doctors. A declaration of death cuts off any rights of the individual. The family of someone declared dead is no longer a surrogate decision maker. Rather, they have something like property rights to the disposal of the remains. More pointedly, a declaration of death ends all eligibility for medical insurance, including Medicaid and Medicare. If a family decides to release the organs for donation, their host becomes not a patient but rather a “heart beating organ donor.”
When a family wants to donate their loved one’s organs, a declaration of brain death is helpful mechanism for doing so. Indeed, a series of high profile cases involving anencephalic infants in the 1990s pointed out the frustrations of parents who wanted to donate their children’s organs but could not because they retained minimal brain function. However, there is never any legal need for a declaration of brain death in order for a family to withdraw life sustaining treatment. In 1993 bioethicist Robert Veatch wrote an important article in the Hastings Center Report in which he pointed out that “no one really believes that literally all functions of the entire brain must be lost for an individual to be dead.” And indeed, no one really believes that a piece of paper converts a warm, breathing body from alive to dead.
Many families in the McMath’s situation would have, even in their shock, heeded the doctors advice and stopped treatment. Although we do not, yet, know what actually happened, I suggest that it is possible that cases like the McMath’s can arise when hospitals and doctors seek to pressure families into withdrawing treatment by, essentially, taking away their right to receive care. This can be a lot more direct than the often times consuming and complex process of withdrawing "futile" care. Indeed, in the actual absence of all brain function there are no interventions that can replace the complex functions of the human brain and deterioration and decay are inevitable.
Although it is easy enough to say that Jahi’s family’s refusal to accept reality stems from ignorance or grief, it is not fair, as some have done, to call them crazy for mistrust of a diagnoses that is based in theory, not reality. Jahi may be irrevocably brain injured, but there are increasing signs that she may indeed have some brain function. Her thrashing movements may be reflex, not purposeful—but corpses do not have reflexes. This week, neonatologist Dr. Paul Burn notes, without citation so we do not know if it is true, that Jahi, has regained sufficient hypothalamus function to regulate her own body temperature. A corpse does not regulate its own body temperature.
This is not to suggest that the doctors are wrong about the amount of brain damage she has sustained or her chances of even retaining a sliver of consciousness—but that is not the same as “complete cessation” of all brain activity.
In contrast to the case in California, Marlize’s family, in Texas, want to let her go. The hospital is invoking a provision of the Texas Advanced Directives Act law which prohibits a hospital from withdrawing life sustaining treatment from a pregnant women. It may be, as bioethics experts law Tom Mayo at SMU explain, that this law does not apply after a declaration of death, but only when the mother is in a permanent coma. But, again, this points out the limits of using the legal concept of brain death to describe the medical condition of any particular person. Marlize may well be dead, but her fetus certainly is not. But until Marlize’s family gets clarification in the case it has filed in Tarrant County, or, ultimately, the Texas Supreme Court this distinction does not change their situation.
So where does that leave a health law professor? One of the reasons brain death is so hard to define is that we know relatively little about how the brain works. As the American Academy of Pediatrics Guidelines Determination Of Brain Death In Infants And Children,“ No randomized control trials examining different strategies regarding the diagnosis of brain death exist.” It even seems increasingly likely that we are not even sure where all of what we consider to be brain function happens—it turns out-—as folk wisdom has always believed—that a lot of it may happen in our guts. .
It may be that these two cases spur changes to the law—although other equally publicized situations have not-but for teaching purposes they both are helpful in exposing law students to how much we actually do not know about the human body and, especially, our brains.
Wired Magazine, in August 2011, ran a fascinating article called, “7 Creepy Experiments That Could Teach Us So Much (if they weren’t so wrong). These “7 Creepy Experiments” include some truly creepy things like using “a synthetic virus” to insert into an embryonic cell a “reporter” gene (green fluorescent protein, for example) in order to track embryonic development throughout the life cycle or deliberately separating twins at birth in order to study them.” I use it in my Human Subject Research Law class to get students thinking about the limits of consent, but more generally it and these cases tell us something about the reality that we need to make and enforce law in the face of limited information.
Tuesday, July 2, 2013
Teaching the regulation of human subject research gives me the ability to demonstrate, just about every class period, how blurry the line can be between what is legal and what is ethical. What individuals must do as a matter of law and what they cannot do as a matter of law are very different from what they should do. I tell my students that outside the assessment of legal risk, "should" is a business decision, a science decision, an ethics decision, a public relations decision or some combination of all four--and it's one other people (clients) are going to make for themselves.
A tip of the hat Fran Miller who clued me in to some very recent events that provide a perfect example of the relationship between law, ethics and science in human subject research. Many will have read the New York Times article about a letter sent by the Office of Research Protection (OHRP) to the lead researcher University of Alabama at Birmingham (UAB) criticizing a study they had run in 23 major medical centers involving infants requiring oxygen support in the neonatal intensive care unit (NICU). Called the SUPPORT Study (and please follow the links--the complexities here are beyond a blog post), it was intended to find out the safe, but effective, limits for providing a premature infant supplemental oxygen. Too little oxygen, of course, affects breathing but too much oxygen, we have known for a long time, causes blindness. The babies were randomized to receive different levels of oxygen and the results measured.
Whether or not the study should have ever been approved is a matter of debate-the fact that many of the babies involved had worse results than they would have under standard of care and even the fact that one of the babies involved does not, in and of itself, mean that the study was illegal or unethical. Here's the explanation by the researchers themselves. This is the Government version.
The issue under dispute is not the study itself--it's the consent process. Soon after the letter became public and OHRP began the process of assessing wehther there should be sanctions, what in theory is OHRP's sister institution, the NIH which provided funding for the study, criticized the warning and supported the SUPPORT study (these puns are invevitable). And soon afterwards OHRP backed down--agreeing to hold a public hearing.
What's so interesting about this dispute for lawyers is cogently explained by Lois Shepherd, the Peter A. Wallenborn, Jr. and Dolly F. Wallenborn Professor of Biomedical Ethics, Professor of Public Health Sciences, and Professor of Law at the University of Virginia in her analysis posted at the Hasting's Center Bioethics Forum Blog. She points out that the ethicists and scientists supporting UAB don't necessarily disgree that the parents lacked complete information about the risks. That the law, in other words, wasn't complied with. But, they argue, the importance of the study outweighed a flawed consent process--and moreover, in a letter published by the New England Journal of Medicine they challenge OHRP's ability to, in essence, substitue it's judgment of whether disclosure was sufficient for that of the IRB giving initial approval.
That's a big deal. 45 CFR 46.116 specifies that consent for human subject research funded by the federal government must include (among other things--read the whole thing yourself) that "a description of any reasonably foreseeable risks or discomforts to the subject”; and “a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.” According to OHRP and those who support it, UAB's experiment did not meet that standard because, among other things, it did not disclose to the parents that there was a risk of death.
But who decides whether or not the information was sufficient?
As a lawyer, I would say that the fact that Congress, in its infinite wisdom, set up a system in which OHRP has the power to review the decisions of individual IRB's answers this question immediately. Of course OHRP can substitute its judgment for that of the individual IRBS approving this study-that's what it's there for.
But in the real world, things are not so clear and it's always possible for Congress to change the balance of power. In my view that would be a huge mistake--it's hard to imagine what else has to happen in order to prove the point that when it comes to protecting human research subjects science cannot reglate itself. There must be outside oversight that reflects the view of the electorate at large--the general population of human subjects--rather that of those whose primary goal is to advance science.
Is it possible to have a system where the needs of the many outweigh those of the few? Where in the face of great benefit to all future premature infants it is acceptable to give some premature infants less than the standard of care? Sure--it's possible. But it's not how, so far, the United States has chosen to regulate human subject research.
Tuesday, June 25, 2013
Once again, we have a judicial ruling that undermines efforts to encourage fathers to take responsibility for their children. The Supreme Court today sided with adoptive parents over a man who wants to raise his biological daughter.
To be sure, the man had relinquished his parental rights when the birth mother was pregnant, and he had not provided any financial assistance during the pregnancy or the first four months of his daughter's life. But he did object to the adoption when he was notified about it and asked that he be able to raise his daughter. If we want fathers to take responsibility for their children, we should not interfere with their reasonable efforts to assert their paternal roles.
Today's case unfortunately follows in the footsteps of other Supreme Court precedents which give mothers greater rights than fathers. For example, in 1983 case (Lehr v. Robertson), Court held that biological mothers always are entitled to notice about adoption proceedings, while biological fathers may forfeit their rights to notice if they do not take enough steps to assert their paternity.
When we have a serious problem with absent dads, we should do all we can to foster relationships between children and their fathers.
[The case, Adoptive Couple v. Baby Girl, involved interpretation of Native American law, with the interpretation driven by the Court's inadequate concern for fathers.]