Capitalizing on Fecal Transplants

By Deborah Cho

Last summer, the FDA reversed its previous decision that required researchers to file INDs for fecal transplants to treat Clostridium difficile.  This decision came without much official explanation as to the reasoning behind the reversal, but can be understood as a result of the unusually high success rates of fecal transplants in treating the deadly infection and the impracticality of applying IND requirements to the procedure.  As the FDA guidance notes, however, the agency’s “exercise of discretion regarding the IND requirements” affects only the use of fecal transplant to treat C. difficile and does not apply to the treatment of other diseases or conditions.

Despite the peculiarity of this type of treatment, researchers and patients alike seem to have embraced it for its ability to cure more than just life-threatening infections that have few other viable options.  In fact, a physician in Seattle studied the effects of fecal transplants on inflammatory bowel disease.  And, as it goes with many drugs, there even seem to be clinics claiming to use fecal transplants to treat weight loss. 

Continue reading

Big Week for Big Data

By Nicolas Terry

For privacy advocates the last week contained something of a gut-check when the UK’s splendidly descriptive Health and Social Care Information Centre announced something of a bonanza for big data companies; the NHS’s care.data program, here, will make anonymized clinical data broadly available to researchers and commercial interests with few limitations, here.

For once, however, the US attitude to the growing big data phenomenon has appeared more robust. Writing on the White House Blog, here, Presidential counselor John Podesta announced he will be leading “a comprehensive review of the way that ‘big data’ will affect the way we live and work; the relationship between government and citizens; and how public and private sectors can spur innovation and maximize the opportunities and free flow of this information while minimizing the risks to privacy.” Results are promised in 90 days.

For health lawyers, however, the most interesting recent development has been the FTC’s denial of LabMD’s motion to dismiss, here. The LabMD complaint involves the data security practices of a clinical testing laboratory. The FTC alleged “unfair . . . acts or practices” under Section 5(a)(1) of the FTC Act. One of LabMD’s arguments for dismissal was that the specific HIPAA and HITECH statutes dealing with the health privacy and security obligations of covered entities blocked the FTC from enforcing its more general authority. According to the FTC:

Nothing in HIPAA, HITECH… reflects a “clear and manifest” intent of Congress to restrict the Commission’s authority over allegedly “unfair” data security practices such as those at issue in this case. LabMD identifies no provision that creates a “clear repugnancy” with the FTC Act, nor any requirement in HIPAA or HITECH that is “clearly incompatible” with LabMD’s obligations under Section 5.

LabMD is an important development. I have argued at length, here, that big data activities outside of HIPAA-protected space have illustrated the gaps in data protection because of the manner in which the US has regulated discrete vertical industries. LabMD suggests that the FTC is prepared to fill in the gaps.

Ethics and Ontology in Deep Brain Stimulation

Petrie-Flom Center Student Fellow Michael J. Young has published a new piece in AJOB Neuroscience on “Ethics and Ontology in Deep Brain Stimulation.” From the article:

Rapid advancements in the fields of neurology and neuroscience over the past decade have enabled unprecedented progress toward the development of brain-modulating technologies and therapeutics. Central to these advancements are cross-disciplinary translational research efforts to engineer systems that can reliably deliver electrical, ultrasound, or magnetic impulses to specific deep cortical areas and neural circuits, with the ultimate goal of influencing abnormal patterns of neural activity implicated in disorders of the brain and nervous system (Famm et al. 2013). As knowledge of the brain’s dynamic synaptic networks and microcircuitry expands, it is anticipated that deep brain stimulation (DBS) technologies will begin to target neural activity with increasingly greater precision and functional efficiency (Warner-Schmidt 2013). While research in these domains carries tremendous promise for treating many neurologic and psychiatric conditions that have long been considered refractory to traditional treatments (Lozano and Lipsman2013; Nestler 2013; Warner-Schmidt 2013), they introduce a complex array of ethical, social, and legal questions.

Read the full article here.

Petrie-Flom Interns’ Weekly Round-Up, 1/24-1/30

By Daniel Albert-Rozenberg

1) After the United Network for Organ Sharing implemented new rules for kidney sharing last week, the medical community is now calling for reformation of the heart allocation system. As it stands, the risk of dying within 90 days of being placed on a heart transplant wait list is 10 times greater for patients with the most risk factors than for those with the fewest.

2) The Supreme Court has granted Little Sisters of the Poor, a religious nonprofit organization that takes care of the elderly poor, temporary reprieve on enforcement of the contraceptive coverage mandate.  SCOTUS will hear two other cases on the mandate brought by secular, for-profit corporations in March.

3) On Tuesday, the House passed a bill to ban health law subsidies for abortion coverage. The bill stands virtually no chance of being passed by the Democratic-controlled Senate and has already been threatened by the white house to be vetoed, should it ever get that far.

4) The Obama administration is encouraging defense lawyers to suggest inmates whom the president might let out of prison early as part of an attempt to undo sentencing discrepancies that began during the crack epidemic decades ago. These discrepancies targeted primarily poorer, African-American drug users who purchased crack, rather than more expensive powder cocaine.

5) After Marlise Muñoz has been laid to rest, her family is speaking out about the law that prevented her end-of-life wishes from being carried out. After a lengthy trial weighing Marlise’s rights against the rights of her unborn fetus (championed by the Texas hospital and pro-life base), the judge ruled that Marlise legally died when the medical community ruled her “brain dead” on November 28, 2013.

6) Following the death of a 14-year-old who walked away from his Queens school, the U.S. federal government will finance devices to track children with autism or other conditions that put them at risk for fleeing their caregivers. The federal government already finances similar measures for elderly people with Alzheimer’s.

Prioritizing Parks and Patients

By Nathaniel Counts

During the government shutdown in October 2013, a battle in part over the future of healthcare reform, a non-negligible amount of media attention focused on the shutdown of public parks.  Perhaps because the parks were the least expected casualty of the shutdown, or the most ludicrous – many are, after all, large outdoor spaces that functioned for millions of years before there were federal funds for them – Americans were frustrated or amused that they could not walk around outside some places because politicians in D.C. could not agree on a budget.

The healthcare reform debate pitted those who believed that everyone should have health insurance or that access to healthcare was a right against those who believed that health spending was already too high or that everyone does not have a right to access to healthcare.  In a world of infinite resources, where everyone could have complete access to healthcare without anyone having to give up anything of their own, it is difficult to imagine that anyone would say that there should not be universal access to healthcare, that some are not deserving of the service.  It would be strange to require a threshold public showing of effort to obtain health insurance through employment if there was no cost to giving the healthcare – if fairness is an issue, as it appears to be a concern for some, there are certainly other services that could be denied.  It is likely that for most the fairness concern only becomes salient in the face of resource constraints where these same funds could fund other programs or allow others to pursue their interests.

Continue reading

TOMORROW: Second Annual Health Law Year in P/Review

Please join us for our second annual Health Law Year in P/Review event, co-sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the New England Journal of Medicine. The conference will be held in Wasserstein Hall, Milstein East C at Harvard Law School on Friday, January 31, 2014, from 8:30am to 5:00pm.

This year we will welcome experts discussing major developments over the past year and what to watch out for in areas including the Affordable Care Act, medical malpractice, FDA regulatory policy, abortion, contraception, intellectual property in the life sciences industry, public health policy, and human subjects research.

The full agenda is available on our website. Speakers are:  Continue reading

Unconstitutional Time Bars in Washington

By Alex Stein

Schroeder v. Weighall — P.3d —-, 2014 WL 172665 (Wash. 2014), is the second Washington Supreme Court’s decision that voids the Legislature’s time bar for medical malpractice suits.  The first decision, DeYoung v. Providence Medical Center, 960 P.2d 919 (Wash. 1998), voided an eight-year repose provision for violating the constitutional prohibition on special privileges (Article I, section 12). This statutory provision benefited healthcare providers and their insurers at the expense of injured patients whose cause of action accrued over a long period of time and consequently tolled the statute of limitations.  The Court held that the Legislature had no rational basis for blocking suits filed in connection with more-than-eight-years-old incidents of medical malpractice. The Court based that decision on the finding by the National Association of Insurance Commissioners that old medical malpractice incidents account for “less than one percent of all insurance claims nation-wide.” This finding convinced the Court that the “relationship between the goal of alleviating any medical insurance crisis and the class of persons affected by the eight-year statute of repose is too attenuated to survive rational basis scrutiny.”

In Schroeder, the Court used the same constitutional prohibition to void a new statutory provision that eliminated tolling of the statute of limitations for minors in medical malpractice actions. Continue reading

2/3 Petrie-Flom Health Law Workshop: Paper Now Available

Kevin Outterson will join us on Monday, February 3, for the first spring meeting of the Petrie-Flom Center’s Health Law Policy Workshop. He is a Professor of Law and Professor of Health Law, Bioethics, and Human Rights at Boston University. Professor Outterson teaches health law and corporate law, and his interests include global pharmaceutical markets, finance and organization of health care systems, antimicrobial resistance, poverty tourism, and health disparities. He serves as the editor-in-chief of the Journal of Law, Medicine & Ethics, the faculty co-advisor to the American Journal of Law & Medicine, the immediate past chair of the Section on Law, Medicine & Health Care of the AALS, and a member of the Board of the American Society of Law, Medicine & Ethics. Before teaching, Professor Outterson was a partner at two major U.S. law firms.

His research work focuses on the organization and finance of the health sector. Areas of specialization include global pharmaceutical markets, particularly antibiotics and other antimicrobials that can degrade in usefulness over time through resistance.

On Monday, Professor Outterson will discuss his paper “New Business Models for Sustainable Antiobiotics.” For more information on the Health Law Workshop, including meeting time and location, and to download the paper, please visit our website.

Would Marlise Munoz’s Fetus Have Survived? Should It Have?

This is post is part of The Bioethics Program’s ongoing Online Symposium on the Munoz and McMath cases, which I’ve organized, and is cross-posted from the symposium. To see all symposium contributions, in reverse chronological order, click here.

Had the hospital not relented and removed the ventilator from Marlise Munoz’s body, could the Munoz fetus have been brought to term, or at least to viability? And if so, would the resulting child have experienced any temporary or permanent adverse health outcomes? Despite some overly confident commentary on both “sides” of this case suggesting a clear answer one way or the other—i.e., that there was no point in retaining the ventilator because the fetus could never be viable or was doomed to be born with catastrophic abnormalities; or, on the other hand, that but for the removal of the ventilator, the “unborn baby” was clearly on track to being born healthy—the truth is that we simply don’t know.

Before getting into the limited available data about fetal outcomes in these relatively rare cases, a bit of brush clearing. The New York Times juxtaposed reports about possible abnormalities in the Munoz fetus with the hospital’s stipulation about the fetus’s non-viability in ways that are likely to confuse, rather than clarify:

Lawyers for Ms. Muñoz’s husband, Erick Muñoz, said they were provided with medical records that showed the fetus was “distinctly abnormal” and suffered from hydrocephalus — an accumulation of fluid in the cavities of the brain — as well as a possible heart problem.

The hospital acknowledged in court documents that the fetus was not viable.

Whether intentionally or not, the nation’s newspaper of record implies — wrongly, I think — that the hospital conceded that the fetus would never be viable because of these reported abnormalities. In court, the hospital and Erick Munoz stipulated to a series of facts, including that Marlise was then 22 weeks pregnant and that “[a]t the time of this hearing, the fetus gestating inside Mrs. Munoz is not viable” (emphasis added). The hospital conceded nothing at all about any fetal abnormalities. In short, the Times, and many other commentors, have conflated “non-viability” as a function of gestational age with “non-viability” as a way of characterizing disabilities that are incompatible with life. As I read this stipulation, the hospital was not at all conceding that the fetus would never have been viable, had the ventilator remained in place. Rather, given the constitutional relevance of fetal viability, the hospital was merely conceding the banal scientific fact that the Munoz fetus was, at 22 weeks, not currently viable. There is nothing surprising in the least about the hospital’s “concession” about “viability” in the first sense, above: 22-week fetuses are generally not considered viable. Continue reading

Encouraging Innovation in Chronic Care Management

By Michael Young

The growing burden of managing chronic illness has long been a critical issue for policy makers and clinicians seeking to improve the quality, cost and efficiency of healthcare systems in the United States. According to the Institute of Medicine, the costs of treating and managing the segment of the population living with chronic illnesses currently represents nearly $1.5 trillion of the over $2 trillion in annual healthcare spending in the U.S.  Over 90% of Medicare costs are allocated to beneficiaries living with two or more chronic conditions, with close to 50% of spending on individuals living with 6 or more chronic conditions (approximately 14% of beneficiaries).  The immense share of healthcare spending attributable to chronic illness is expected to climb as the population ages. 

Earlier this month, a bipartisan bill entitled the Better Care, Lower Cost Act was introduced in Congress which aims to address the complex issues involved in chronic care management.  The legislation outlines three key innovations toward this end.

Continue reading

Media Matters: Fetal Abnormalities in the Munoz Case

Nadia N. Sawicki

The tragic case of Marlise Munoz is finally at an end, now that John Peter Smith Hospital has, pursuant to an order by Judge R. H. Wallace, Jr., taken Ms. Munoz off life support and released her body to her family.  A few questions about the media’s role in this case linger in my mind, however; I will be addressing them in a series of posts.

In the days immediately preceding the court’s ruling, media reports frequently mentioned that the fetus Ms. Munoz was carrying was “distinctly abnormal.”  My impression is that these reports were intended to strengthen the case, at least in the public’s eyes, for withdrawal of life support.  Maintaining a dead body on life support against the family’s wishes in order to preserve the life of an able fetus is one thing, commentators seemed to suggest, but the case for doing so when the fetus suffers from hydrocephalus, heart problems, and deformation of the lower extremities is less compelling.

In the eyes of pro-life advocates committed to preserving the potentiality of life at all costs, however, the fetus’ medical condition seems irrelevant.  Unless a fetus is definitively not viable (which in this case the hospital finally conceded it was), a true commitment to the preservation of fetal life would not waver in the face of likely disability upon the child’s birth.

The fervent media reporting about the abnormality of the Munoz fetus seems, at least to me, to reflect a disconnect between the public’s perception of the significance of fetal disability in such cases, and its significance to disability advocates and advocates of pro-life policy.  What lessons, if any, can we learn from this disconnect?

Patient Empowerment and 23andMe

For those interested in the FDA’s decision to regulate 23andMe’s direct-to-consumer genetic testing service, it is worth reading a recent comment in Nature by Robert Green and Nita Farahany.  The piece raises two core objections to the FDA’s decision that deserve further attention.

One objection is that the FDA’s decision runs contrary to “the historical trend of patient empowerment that brought informed-consent laws, access to medical records and now direct access to electronic personal health data.”  Green and Farahany suggest that 23andMe and manufacturers of other consumer medical products (such as mobile health apps) “democratize health care by enabling individuals to make choices that maximize their own health,” and that we must not “stifle all innovations that do not fit into the traditional model of physician-driven health care.”

While I agree with Green and Farahany that we should not be locked into physician-driven health care, I am not sure that the information provided by 23andMe and medical apps is unambiguously “patient-empowering” and “democratizing” (a framing of personalized medicine that pervades both marketing materials and academic journals). Continue reading

Pit Crews with Computers: Can Health Information Technology Fix Fragmented Care?

I recently posted this draft on SSRN. Feedback much appreciated. Here is the abstract:

Fragmentation and lack of coordination remain as some of the most intractable problems facing health care. Attention has often alighted on the promise of Health care Information Technology not least because IT has had such positive impact on many other personal, professional and industrial domains. For at least two decades the HIT-panacea narrative has been persistent even though the context has shifted. At various times we have been promised that patient safety technologies would solve our medical error problems, electronic transactions would simplify healthcare administration and insurance and clinical data would become interoperable courtesy of electronic medical records. Today the IoM is positioning HIT at the center of its new “continuously learning” health care model that is in large part aimed at solving our fragmentation and lack of coordination problems. While the consensus judgment that HIT can reduce fragmentation and increase coordination has intuitive force the specifics are more complicated. First, the relationship between health care and IT has been both culturally and financially complex. Second, HIT has been overhyped as a solution for all of health care’s woes; it has its own problems. Third, the HIT-fragmentation solution presents a chicken-and-egg problem — can HIT solve health care fragmentation and lack of coordination problems or must health care problems such as episodic care be solved prior to successful deployment of HIT? The article takes a critical look at both health care and HIT with those questions in mind before concluding with some admittedly difficult recommendations designed to break the chicken-and-egg deadlock.

NPT

Fetuses, Organs and Brain-Death

One of the things that strikes me in the debate over whether a State has a sufficiently compelling interest in sustaining the physiological functions of a dead-brain pregnant woman in order to protect the life of the fetus, is that this very same rationale is not appealed to when we consider the many lives that are at stake when the deceased, or someone else — typically the next-of-kin — decides not to donate its organs after death. So, if the commitment of Texas — or any other State — with the protection of “human life” is sincere, if we can finally agree on that interest as being as compelling as to permit legislation restraining the woman’s right to refuse or terminate end-of-life care when she is pregnant, and their families’ right to bury or cremate their relative once it is pronounced legally dead, wouldn’t that rationale also legitimize the confiscation of dead-brain people in general in order to harvest their organs for the sake of saving the lives of others? I think coherence mandates so.

Actually, our reasons for such conscription in the case of organs’ harvesting are much more compelling than in the case of Marlise Muñoz if we take into account the fatal prognosis of the fetus, the experimental character of the continuation of pregnancy in a brain-dead woman, and the better expectations that we might nowadays have when we transplant organs.

This post is part of The Bioethics Program‘s Online Symposium on the Munoz and McMath cases. To see all symposium contributions, click here.

The Concept of Brain Death and the Tragic Cases of Marlise Munoz and Jahi McMath

Historically, death has been a very simple and intuitive thing to understand – it occurs when someone stops breathing and their heart stops. Visually, it is a dramatic change that anyone can comprehend.

However, we now live in an age where machines can keep people breathing, and their hearts beating, when they would otherwise die. These medical advances have been revolutionary, and they are vital to allowing living patients to recover after severe illness or injury. On the other hand, they can make it more difficult for people to accept and understand death, because it can make dead patients “appear” alive.

Brain death refers to the irrevocable loss of all functions of the brain, including the brainsteam. Someone with brain death is just as dead as someone who has stopped breathing and whose heart has stopped. Doctors confirm brain death through a neurological examination, and once diagnosed the patient is dead. That person will never have any brain functioning and will never return to life or “wake up.”

Continue reading

Online Symposium on Munoz and McMath Cases

UPDATE: Following Friday’s court order (discussed below), the hospital today (Sunday, Jan. 26, 2014) removed the ventilator from Marlise Munoz, who has met the criteria for brain death since Nov. 28, 2013.

Two high-profile, rapidly evolving cases involving death by neurological criteria — better known as “brain death” — raise vexing and sometimes novel legal, ethical, and medical questions at the edges of life and death. I’m organizing an online symposium on these cases over at The Bioethics Program Blog, and will be cross-posting my contributions here, beginning with this introduction to the symposium, which brings readers up to date with legal developments through today. Please contact me if you’re interested in participating.

The Marlise Munoz Case

On November 26, 2013, Erick Munoz found his wife, Marlise, unconscious on their kitchen floor. She was then 14 weeks pregnant with their second child. Erick resuscitated her and she was transported, alive, to John Peter Smith Hospital, where she was placed on a ventilator to assist her breathing and given other life-sustaining treatment. Not long thereafter, however, Erick says that the hospital told him that Marlise was brain dead.

Although Marlise did not have a written advance directive, according to Erick, both he and Marlise had

worked as paramedics during their marriage, and thus were knowledgeable of and had personally witnessed injuries that resulted in death, including brain death. Erick and Marlise frequently discussed their requests, beliefs and desires with each other, and expressed clearly to each other, family members and friends, their respective desires not to be resuscitated should either of them become brain dead.

Erick requested, with the “full support” of Marlise’s parents, that the ventilator be removed from her body and that he be given possession of it for burial.

The hospital refused. It argued that § 166.049 of the Texas Advance Directives Act (TADA) — which provides that “a person may not withdraw or withhold life-sustaining treatment under this subchapter from a pregnant patient” — prohibits it from removing the ventilator. It was not entirely clear whether the hospital believed that Marlise was in fact dead or not. The media was reporting as late as December 24 that the hospital had said that Marlise was in “serious condition,” and the hospital had not released Marlise’s medical records, which Erick said would show a diagnosis of brain death, to him.

After the jump, this week’s developments in the Munoz case, the McMath case, and a list of symposium participants.

Continue reading