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. 

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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 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.

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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:  Read More

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. Read More

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.