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.
Friday, October 17, 2014
The announcement by Apple and Facebook that they will cover the costs of egg freezing predictably provoked some controversy—predictably because it involves reproduction and also because too many people do not trust women to make reproductive decisions.
Interestingly, the challenge to women’s autonomy can come from both sides of the political spectrum, as has happened with several assisted reproductive technologies. Scholars on the left criticized surrogate motherhood on the ground that surrogates were exploited by the couple intending to raise the child, and other new reproductive technologies are criticized on the grounds that women will feel obligated to use them rather than free to use them. Indeed, this concern about coercion drives some of the objections to egg freezing.
Some women freeze their eggs because they face infertility from cancer chemotherapy; other women may not have found a life partner and want to suspend their biological clock until that time comes.
But some observers worry that with the option of egg freezing, some women will succumb to the pressures of the workplace and choose egg freezing not because they really want to but because they feel that have to. After all, if a woman can delay procreation and put in long hours at the office, why shouldn’t she do so? Employers might think that women who forgo egg freezing are not really committed to their jobs.
These concerns are legitimate, but are people too willing to invoke them? Egg freezing is not a simple procedure, nor is its success a certainty. Even if covered by insurance, women are not likely to choose egg freezing lightly. We should worry that egg freezing critics may be too ready to question the decision making capacity of women contemplating their reproductive choices.
Thursday, October 9, 2014
While controversial among some ethics experts, uterus transplantation has been performed several times, most commonly in Sweden. A few weeks ago, a mother for the first time gave birth to a baby gestated in a transplanted uterus.
Should we worry about uterus transplants? Transplanting life-extending organs, like hearts, livers, lungs and kidneys, has become well-accepted, but observers have raised additional questions about transplantation for life-enhancing body parts like faces and hands. As long as transplant recipients have their new organs, they must take drugs to prevent their immune systems from rejecting the transplanted organs. The risks can be substantial. For example, the immunosuppressive drugs put people at an increased risk of cancer. It is one thing to assume health risks for the possibility of a longer life, but are the risks of being a transplant recipient justified by improvements in the quality of life?
Thursday, July 31, 2014
On July 29, 2014, the U.S. Court of Appeals for the Fifth Circuit issued an as-applied ruling in a case involving Mississippi’s statute requiring that all physicians affiliated with a Jackson clinic providing abortion services have admitting and staff privileges at local hospitals. All local hospitals were unwilling to grant privileges to two of the clinic’s physicians who were involved most directly in abortion services because of the nature of their practices. Had the state’s statute been enforced, the clinic—Mississippi’s only facility offering abortion services—would have been ordered to close.
Mississippi’s argument was that ordering the clinic to close would not impose an undue burden on Mississippi women’s constitutional rights because women would be able to travel to nearby states for abortion services. The Fifth Circuit reasoned to the contrary: “Mississippi may not shift its obligation to respect the established constitutional rights of its citizens to another state. Such a proposal would not only place an undue burden on the exercise of the constitutional right, but would also disregard a state's obligation under the principle of federalism—applicable to all fifty states—to accept the burden of the non-delegable duty of protecting the established federal constitutional rights of its own citizens.” Jackson Women’s Health Organization v. Currier, 2014 WL 3730467 (July 29, 2014).
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.
Sunday, January 19, 2014
While Jahi McMath’s family had to fight to maintain treatment for their daughter after she lost brain function and was declared dead, Marlise Munoz’ family is fighting to stop her treatment after she lost brain function and reportedly was declared dead. Ms. Munoz is pregnant, and the hospital hopes that doctors there will be able to deliver her child after it becomes viable.
Should Ms. Munoz’ pregnancy make a difference? Many observers do not think so, and have denounced the hospital that is continuing to provide artificial ventilation and other intensive care (e.g., here and here). But there is no clear answer in ethics or law for cases like this. Reasonable people can differ, and reasonable hospitals can come down on either side of the question whether Ms. Munoz’ family can refuse further care on her behalf or whether the hospital should try to bring her fetus to term.
Indeed, courts have disagreed on the question whether even a mentally competent pregnant woman can refuse medical treatment that is needed to protect the health or life of her fetus. Some courts have sided with the woman’s right to decide; others have sided with the public interest in preserving fetal health. Courts have been especially willing to require treatment when it would not pose any risk to the woman’s health. If Ms. Munoz is dead, continued medical care cannot cause any harm to her health.
In some ways, the argument for continued care is weaker with a dead pregnant woman. In the cases involving mentally competent women refusing treatment, the women want to bear the child. They just want to do so without certain medical interventions. Ms. Munoz' family believes she would not want to bear the child at this point, and they do not want her to bear the child either. It’s not only unwanted medical treatment that is being imposed. There also is unwanted parenthood being imposed on Ms. Munoz and her husband.
Moreover, unlike the usual pregnancy, Ms. Munoz’ fetus will not become viable if left alone. All in all, this is a very hard case, and it is important to treat it as such. The interests of Ms. Munoz and her family are important, but so is the societal interest in protecting fetal life. Harsh condemnation of the hospital and its medical staff is not warranted.
[cross-posted at Faculty Lounge and orentlicher.tumblr.com]
Friday, November 15, 2013
An article in the New York Times nicely illustrates a point I usually make when I discuss living wills in class or other settings. I typically advise my audience that it is probably more important for patients to read their physicians' living wills than to write their own. As a practical matter, the views of physicians about end-of-life care are much more important than the preferences of their patients when end-of-life decisions are made. (For a discussion of this point, click here.)
Just as patients with cancer often consider whether different oncologists are aggressive or conservative in their approaches to cancer treatment, so should patients contemplating their end-of-life care consider whether different physicians are aggressive or conservative in their approaches to treatment at the end of life. Finding a physician with a similar perspective may be the most important way to ensure that a patient is treated as s/he would want to be treated.
Monday, August 26, 2013
Challenges designed to spur innovative uses of data are springing up frequently. These are contests, sponsored by a mix of government agencies, industry, foundations, a variety of not-for-profit groups, or even individuals. They offer prize money or other incentives for people or teams to come up with solutions to a wide range of problems. In addition to grand prizes, they often offer many smaller prizes or networking opportunities. The latest such challenge to come to my attention was announced August 19 by the Knight Foundation: $2 million for answers to the question "how can we harnass data and information for the health of communities?" Companion prizes, of up to $200,000, are also being offered by the Robert Wood Johnson Foundation and the California Healthcare Foundation.
Such challenges are also a favorite of the Obama administration. From promoting Obamacare among younger Americans (over 100 prizes of up to $30,000)--now entered by Karl Rove's Crossroads group--to arms control and identification of sewer overflows, the federal government has gone in for challenges big time. Check out challenge.gov to see the impressive list. Use of information and technological innovation feature prominently in the challenges, but there is also a challenge for "innovative communications strategies to target individuals who experience high levels of involuntary breaks ("churn") in health insurance coverage" (from SAMHSA), a challenge to design posters to educate kids about concussions (from CDC), a challenge to develop a robot that can retrieve samples (from NASA), and a challenge to use technology for atrocity prevention (from USAID and Humanity United). All in all, some 285 challenges sponsored by the federal government are currently active, although for some the submission period has closed.
These challenges are entertaining, call on crowdsourcing for knowledge production, find new sources of expertise way beyond the Beltway or even US borders, encourage private sector groups rather than government to bear costs and risks of development (or failure), and may bring novel and highly useful ideas to light. So what's not to like? I may be just grumpy today, but I have some serious worries about the rush to challenges as a way to solve persistent or apparently intractable problems.
Challenges may be more hype than achievement, more heat than ultimate light. They may emphasize the quick and clever--the nifty over the difficult or profound. They may substitute the excitement of awarding and winning a prize for making real progress on a problem. Most troubling to me, however, is the challenge strategy's potential to skew what government finds interesting and what it is willing to do. Many challenges have private partners in industry, appear likely to result in for-profit products, or set aside values that may be more difficult to quantify or instantiate.
Take the HHS Datapalooza, for example. Now entering its fifth year, the Datapalooza is an annual celebration of innovations designed to make use of health data available from a wide variety of sources, including government health data. "Data liberation" is the watchword, with periodic but limited references to data protection, security and privacy. A look at the 2013 agenda reveals a planning committee representing start-ups and venture capital. It also reveals a $500,000 prize awarded by Heritage Provider Network, a managed care organization originally located in Southern California but now expanding in markets in Arizona and New York and serving many Medicare Advantage patients. The prize was for a model to predict hospitalizations accurately and in advance--so that they could be avoided. The winning team, powerdot, didn't reach the benchmark needed to win the full $3m prize. So . . . Heritage is continuing the competition, making more (and apparently no longer deidentified) data available to a select set of leading competitors in the original competition in order to improve the accuracy of the modeling. (A description of deidentification methods for the data made available to all entrants in the original competition is available here.) There are of course real advantages in developing a good predictive model--for patients in avoiding hospitalizations, and for Heritage in saving money in patient care. This is potentially a "win win"--as Mark Wagar, the executive awarding the prize stated, "it's not just about the money; it's personal." But "it's not just about the money" is telling: the risk of these challenges is that they are about the money, and that the money will come to dominate personal or other values unless we are careful.
Solutions, if my concerns are well-founded? Trying to turn back the disruptive clock and fight the appeal of challenges is probably futile--although perhaps some of the initial enthusiasm may wane. One solution is to join in--after all, challenges are infectious and potentially innovative--encouraging more challenges aimed at different problems--say, challenges for privacy or security protection alongside challenges for data liberation and use. Or, challenges for improving patient understanding of their health conditions and informed consent to strategies for managing them--as some of the challenges aimed at patients with diabetes illustrate. Another solution is to watch very carefully what challenges are offered, who funds them, who wins them, and what is ultimately achieved by them.
August 26, 2013 in Bioethics, Biotech, Competition, Health Care Costs, Health Care Reform, Health IT, Health Reform, Obama Administration, privacy, Reform, Technology | Permalink | Comments (0) | TrackBack (0)
Monday, July 29, 2013
This month's Hasting Center Report contains a case study written by me and by Dr. Craig Klugman considering both the practice of "deporting" indigent patients who lack legal immigration status and the ability of a medical center to withdraw life sustaining treatment against a family's wishes.
The article considers a scenario occuring in Texas which, of course, has a highly structured mechanism to refuse to follow an advanced directive if it means providing care which the hospital believes not productive. However, the problem of how to assert the legal right not to have a DNR is one of growing in importance.
For example, organizations like the Texas Alliance for Life tried but failed this last legislative session to vote in laws that would bar physicans from writing DNR orders against a patient or her surrogate's objection.
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.
Friday, May 17, 2013
Two widely reported studies this week about bed rest for women at risk of preterm delivery and reduction of salt consumption in order to promote heart health highlight two things we don’t think about enough—that a lot of standard medical practices are without any foundation in science and a lot of legal ones probably are too. However, medicine has more and more taken the public health approach of examining the practices of individual doctors to see how effective they actually are in the general population. For example, it is old news that prescribing bed rest to pregnant women at risk of preterm delivery is not effective. But what this Obstetrics & Gynecology study found that “activity restriction”, such as quitting work, is still prescribed to one at three women at risk for preterm delivery. The accompanying “Bed Rest in Pregnancy: Time to Put the Issue to Rest” makes an ethical argument that continuing to prescribe bed rest in the absence of evidence of its effectiveness violates the principles of autonomy and beneficence.
The Institute of Medicine just issued this report Sodium Intake in Populations: Assessment of Evidence “found no consistent evidence to support an association between sodium intake and either a beneficial or adverse effect on most direct health outcomes other than some CVD outcomes (including stroke and CVD mortality) and all-cause mortality.”
We have similar research in law- a lot of it coming from the Empirical Legal Studies movement, including work done at the Center for Empirical Legal Research at Washington University Berkeley Emperical Legal Research , the Centre for Emprical Legal Studies at UCL (formerly known as University College London) among many others, but it is not as well funded or coming from as well established sources as the studies which attempt to find an evidence basis for medical practices. The salt reduction report was commissioned by the Institute of Medicine In contrast, the ACLU supports its empirical argument that the death penalty does not deter crime on an opinion survey of police chiefs. Translating information from research scientists to practicing physicians is still a slow process,—but no one questions the underlying principle that medical practice should be based on scientific evidence.
Part of the issue is funding. Medicine as a whole is in a constant quest to contain costs and stopping ineffective practices is an important component of that effort. But beyond a small number of progressive funders like the Robert Wood Johnson Foundation, there isn’t a lot of demonstrable interest, the kind supported by funding studies, in law making bodies in finding out what legal practices work and what do not.
This isn’t a new observation. Bryant Garth outlined the problem in 1997 when he explained the importance of more social science research into the foundational principles of practices civil procedure. But the steady flow of studies questioning conventional wisdom coming from the medical field has, as yet, no real counterpart in the world of law making.
Of course there will always be the problem of knowing the unknowable. But it would be interesting for law makers to consider taking a lesson from public health in challenging assumptions about the human body and mind or even more generally the physical world that underlie both common law and statutes.
May 17, 2013 in Bioethics, Comparative Effectiveness, Cost, Effectiveness, Health Care Costs, Health Law, Innovation, Policy, Public Health, Quality Improvement, Reform, Research | Permalink | Comments (0) | TrackBack (0)