I am going to discuss some highlights of their just released report, but this is far from exhaustive and you should read the whole report.
For the non-cognoscenti this is the most important revision to the rules for U.S. human subjects research since their inception. The report is largely unfavorable to several key proposed rule changes on my first read, but you should read it yourself to make up your own mind.
I’ll share some choice passages from the analysis
The results of our review (Table 2) find significant opposition to most major proposals, with mixed support for mandated use of a single IRB and extending the Common Rule and greater support for the concept of standard security safeguards. In addition, a number of responses suggested that the NPRM is overly complex, poorly written, and not supported by data; highlighted areas that could have a substantial impact on a final rule but were not included in the NPRM (e.g., proposed security safeguards, a consent template, a list of minimal risk studies and a decision tool); and suggested that some of the proposals would adversely affect human health with little perceived benefit.
The majority of responses, approximately 1,520, addressed one or more of the proposed changes detailed above involving non-identified biospecimens. Of these responses, 94 – 100% of patients and members of the research community, including researchers, universities, medical centers and industry, opposed the changes. Those commenting suggested that the proposed changes will significantly reduce the availability of biospecimens for research, will have a significant negative impact on medical advances, and will adversely affect human health. Per one patient, “I am asking for life saving policy not life ending policies.” From a biorepository, “Respecting autonomy at the expense of patient lives is a significant ethical concern.”
More surprising was their finding that “Among members of the general public, 55% opposed and 45% supported one or more of the major proposed changes related to biospecimens.” (They do a better breakdown of the various sub-constituencies in the report).
In 2013 the Center for Medical Progress appeared to have secured tax-exempt status for a fake company it set up called Biomax Procurement Services. The company’s “representatives” contacted the non-profit women’s health provider Planned Parenthood staffers and led them into conversations that were secretly recorded. The result, according to their website (as reported by CNN), was “a 30-month-long investigative journalism study by The Center for Medical Progress, documenting how Planned Parenthood sells the body parts of aborted babies.”
The videos were edited down and released slowly in a way designed to paint Planned Parenthood in the worst light. While some have called it a “hoax,” that’s not a word I would use in this case. When I think of great journalistic hoaxes I think of Orson Welles’s War of the Worlds (though more recent historical work suggests that the panic it caused may have been mythological). Instead what happened here, I want to suggest, is what I will call a “manufactured controversy.” [..]
It is always dangerous to try to glean too much from oral argument, and I have only read the transcript (no recording yet) of today’s argument in Whole Women’s Health v. Hellerstedt, and finally I filed a brief in this case on the side of the law’s challengers so I may be suffering from some motivated reasoning. But with all those caveats, here goes:
Justice Scalia’s passing seems to have radically transformed this oral argument and likely this case. The 3 firm anti-abortion votes on the court (Alito and Roberts from their questions and earlier positions, Thomas we can infer from his earlier positions) left over after Justice Scalia’s passing seemed very much to be playing a defensive game. Many of their questions were aimed at convincing others on the Court (especially Justice Kennedy, the swing voter on these matters) to remand the case back to the lower court, much more so than focusing on giving Texas an outright win.
Appellant’s Counsel Toti’s argument barely was able to get to the merits questions in the case. Instead Justices Roberts, Alito, sometimes joined by Kennedy in these questions, repeatedly asked about evidence in the record on when various clinics closed, re-opened, and what evidence there was for the reason behind it. Toti tried to make use of the timing to her advantage as did the Justices more supportive of her side, but there was a lot of push on why this element of the record was not better developed. She was also repeatedly asked questions regarding the evidence on the capacity of remaining clinics to absorb extra patients needing abortions and what was developed in the record.
The same was true to a lesser extent in Appellee’s Counsel Keller’s argument. Justice Kennedy in particular focused on a line of questioning at page 44 of the argument that may also be significant in terms of remanding the case without resolving it:
“But I thought an underlying theme, or at least an underlying factual demonstration, is that this law has really increased the number of surgical procedures as opposed to medical procedures, and that this may not be medically wise?” Continue reading →
As I said in one of my earlier posts today one of the most interesting parts of the NAM report on mitochondrial replacement therapy was its recommendation that only male embryos be implanted and not female ones. The argument is that this will eliminate the risks of germ-line transmission of anything untoward. I will leave it to others more versed in the risk factors to discuss whether this is an over-reaction (the UK did not adopt this in their recommendation) or reasonable. In the last post I discussed why politically/ethically this may get them in some hot water, but here I want to raise a different question. Would such a recommendation be unconstitutional?
If FDA were to adopt this rule it would clearly be state action. It seems to be a state-law that favors one gender (males) over another (females) in that only males can be produced in this way. If that is right, under existing Supreme Court precedent it would be judged under “intermediate scrutiny.” To pass intermediate scrutiny, the challenged law must further an important government interest by means that are substantially related to that interest. Would this rule satisfy that test? Continue reading →
My last post was a summary of the NAM’s Recommendations on Mitochondrial Replacement Therapy (MRT). Now here is my take on the report. But keep in mind the report was just released and all I could give it was a quick read, so these are really more like initial impressions: Continue reading →
As readers know I’ve written on mitochondrial replacement therapy and its attendant ethical and regulatory issues. Today the National Academy of Medicine (formerly known as the IOM) released a terrific report today with its recommendations. I’ll have a second post with my reactions but here is a summary from the report of their recommendations. The big headline is they have recommended FDA largely move towards allowing it to go forward under a regulatory pathway with restrictions, the most important of which is the transfer only of male embryos (to avoid germ-line issues).
In the NAM’s own words:
Recommendation 1: Initial clinical investigations of mitochondrial replacement techniques (MRT) should be considered by the U.S. Food and Drug Administration (FDA) only if and when the following conditions can be met: Continue reading →
Surrogacy is legal in many states. Some, like California, directly enforce gestational carrier contracts. Others, like Texas, Illinois, and Virginia, enforce only those contracts that are entered into by a married couple who need a surrogate for medical reasons which a judge approves before embryo transfer occurs. A Pennsylvania court has now shown why gestational surrogacy contract should be directly enforced in the absence of legislation. Its well-reasoned opinion suggests that more states may be open to this approach to surrogacy.
The Pennsylvania case, In re Baby S., arose out of a gestational surrogacy agreement involving embryos created with donor eggs and husband sperm. The written agreement was indisputably clear that that the intended parents would be the legal rearing parents, their names would appear on the birth certificate, and the carrier would have no rearing rights or duties. Unlike previous cases questioning the validity of a surrogacy contract, the challenge here came not from the carrier who now wished to assert rearing rights (see In re Baby M and Calvert v. Johnson) but from the wife (the intended rearing mother). She had praised the carrier’s willingness to help her have a child, which she repeated both at the embryo transfer and at a 20 week ultrasound at 20 weeks of pregnancy, which both intended parents attended. A month later she informed the parties that “irreconcilable marital difficulties” would make it difficult for her to co-parent the child with the intended father. She also refused to complete the paperwork for her name to appear on the birth certificate as the mother.
Imagine you had 10 million dollars to spend to save the life of one person whose name you knew or 10,000 whose name you didn’t? How would you spend it? What would you think of a government policy that chose to save the 1 person rather than the 10,000? I would think pretty badly of such a government, but that’s exactly what happens in some popular new movies. And the expectation of the filmmakers (and my own take on audience reaction) is that the audience cheers.
First, The Martian (spoiler alert) where America spends tens of millions and diverts the entirety of the space program to bring back one man left behind on Mars. Second, the new movie 33, which I have not seen yet but is based on a true story involving the successful attempt to save 33 Chilean miners trapped in a mine collapse at a huge financial cost. Continue reading →
This event will provide a discussion of the book, including questions like: How is the agency faring in the 21st century? What are the greatest challenges to the FDA’s success, and what does success look like? What lessons has it learned and how can it best meet the challenges of today? Should we keep the agency we have, pull it apart, or rebuild from scratch?
Daniel Carpenter, Freed Professor of Government, Harvard University and Director, Center for American Political Studies at Harvard University
I. Glenn Cohen, JD, Professor of Law and Faculty Director of the Petrie-Flom Center, Harvard Law School (co-editor)
Aaron S. Kesselheim, MD, MD, MPH, Associate Professor of Medicine, Harvard Medical School; faculty member, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hosptial
Here is HHS’s own summary of what has changed and what it thinks is most important:
The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have announced proposed revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991. A Notice of Proposed Rulemaking (NPRM) was put on public display on September 2, 2015 by the Office of the Federal Register. The NPRM seeks comment on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. It is expected that the NPRM will be published in the Federal Register on September 8, 2015. There are plans to release several webinars that will explain the changes proposed in the NPRM, and a town hall meeting is planned to be held in Washington, D.C. in October.Continue reading →
Three years ago today, we launched the Bill of Health blog to create a one-stop-shop for readers interested in news, commentary, and scholarship in the fields of health law policy, biotechnology, and bioethics. We have been thrilled at the blog’s success and reach so far.
A few quick stats:
We have 90 contributors from 49 institutions around the globe.
More than 350,000 unique visitors from more than 200 countries have visited the blog since it was first launched.
The blog gets more than 17,000 page views per month.
We’ve clocked in over 2,000 blog posts covering a wide range of topics:
Health insurance, health care finance, health care reform
Reproductive health and rights
Food safety and regulation
Human subjects research
Personhood and animal rights
General health law, policy, and bioethics
As a sample, here are the top five most viewed posts from each academic year:
Thanks to our many contributors – and to our readers! We look forward to many more years of growth. And always, if you have any comments or suggestions, make sure to send them our way: firstname.lastname@example.org. Happy reading!
The Rubio-Huckabee claim that actual and legal personhood start at conception has drawn trenchant responses from Art Caplan on the medical uncertainty of such a claim and David Orentlicher, drawing on Judith Thomson’s famous article, that even if a fetus is a person, woman would not necessarily have a duty to keep it in her body.
Their debate claim that the fetus is already a legal person under the constitution also deserves a response, for it has no basis in positive law. In Roe v. Wade all nine justices agreed that the use of “person” in the Constitution always assumed a born person, and therefore that the 14th Amendment’s mention of person did not confer constitutional rights until after a live birth. In the years since Roe, when the make-up of the court has changed, no justice has ever disagreed with that conclusion, including those who would overturn Roe and Casey. Continue reading →
It’s been our great pleasure to collaborate with the Health Affairs Blog on this series stemming from theThird Annual Health Law Year in P/Review symposium at Harvard Law School. This annual event takes a look back over the prior year and previews the year to come with regard to hot topics in health law.
After the symposium, we asked our speakers to keep the conversation going online by expanding on their topics from different angles or by honing in on particularly intriguing features. These pieces were published on the Health Affairs Blog through the spring and into summer.
We heard more from Kevin Outterson on how to promote innovation in the development of new antibiotics, from Rachel Sachs on whether the Food and Drug Administration’s proposal to regulate laboratory-developed tests will really stifle innovation, and from Claire Laporte on the impact of recent Supreme Court decisions on bio-IP.
George Annas weighed in on the Ebola outbreak, which has already almost faded from public consciousness but offers important public health lessons, while Wendy Parmet and Andrew Sussman tackled important developments in tobacco control. […]
On May 21, along with my frequent co-author Eli Adashi, I published an op-ed in the New York Timesraising some questions about FDA’s proposed guidance recommending a ban on taking the blood on any man who has had sex with another man in the past year, or in other words imposing a one year celibacy requirement on gay men if they want to donate blood. This built on our critique last July in JAMA, wherein we argued that FDA’s then-lifetime ban on gay men and MSM donating blood was out of step with science and the practice of our peer countries, as well as potentially unconstitutional.
Thanks to our work, and a concerted effort by public health, medical, and gay rights groups, FDA has finally moved off of that prior policy and recognized that it was unjustified, and discriminatory.
Just to put this in context It took more than 30 years to convince FDA that it was problematic to ban blood donation for a lifetime any man who ever had sex with another man, even if both have repeatedly tested negative for HIV, while it imposed only a one year ban on people who had sex with individuals known to be HIV positive or a sex worker. FDA is appropriately a conservative agency, but on this issue of the lifetime ban its willingness to listen and reconsider has gone beyond conservatism to the point of lunacy. [By the way to be clear, I *love* FDA. I represented them while at the DOJ and have a new book coming out about FDA in the fall. You can think highly of an agency but think they have a bad track record on an issue. This is critique not hater-aide].
Well with that background, one should be not so quick to assume that a move to a one year ban — a de facto lifetime ban for any gay man who is sexually active, even one who is monogamously married with children — is the best policy. To put it bluntly, refusing to change a lifetime ban for such a long period makes me skeptical we should accept a “just trust us” line on their new restrictive policy.
The question we raised in our op-ed was whether FDA had adequately justified retaining a one year ban in light of the evidence from places like South Africa (with a much shorter time period ban), Italy (which does individualized risk assessment instead of stigmatizing all gay men as high risk for disease), etc.
This paper is likely to piss off people both on the Left and the Right of the abortion issue, which I think of as a feature not a bug ;), but in any event I hope will prompt a good conversation. Here is the abstract:
There was a moment in the 2012 campaign, when Mitt Romney attempted to “pivot” to the center and get away from the statements of those like Todd Akin who made comments about how in cases of “legitimate rape,” the victims’ bodies “have ways to try and shut that whole thing down.” The way Romney did his pivot was to make clear that while he was against abortion, he would, of course, make an exception for women who had been raped or whose pregnancy was the result of incest. This has become something of a moderate orthodoxy among those who oppose abortion. Continue reading →
When I was young I wanted to be Alan Wertheimer. When I first read him as an undergrad in courses in ethics and in law and philosophy he was one of the twentieth century writers in the field I most admired (along with Bernard Williams, Joel Feinberg, and a few other august names). His clarity, his insight, and his thinking on topics like exploitation and coercion served to me as a model for what I wanted to do with my life.
Thus it was a true honor to, like Emily, get to know him personally over the last few years. To all the superlatives about him that jump out from the page I can add that in real life he was a real mentsch, an amazing reader and mentor, who I will miss very much.
What is perhaps most impressive about Alan is that he was not only a consummate philosopher’s philosopher, but also a lawyer’s philosopher. A quick search I did for his work in the secondary sources database in Westlaw show 442 separate law papers citing to his work. He has had a significant impact on not only bioethics, but contracts, law and sexuality, constitutional law, and the legal profession. Indeed, as a parting salute to this great thinker let me highlight one of his papers that never achieved the recognition I think it deserved (it inspired some of my own writing): The Equalization of Legal Resources from 1988 in Philosophy and Public Affairs.
Goodbye Alan, you will be missed, but very much remembered.
Cambridge, Mass., April 9, 2015 – A paper forthcoming on Friday in Science discusses the regulation of a new technology that gives hope to women who carry genetic disease. Mutant mitochondrial DNA gives rise to a broad range of heritable clinical syndromes. Cure of those affected remains out of reach. However, recently developed Mitrochondrial Replacement Therapy (MRT) – sometimes known as “three-parent IVF” — has raised the prospect of disease-free progeny for women carriers.
In the UK, legislation regulating the clinical application of MRT has recently been approved by the House of Commons and the House of Lords, after a 10-year process.
In the United States, the vetting of MRT, underway for a year, remains a work in progress. A new paper in Science released Friday, April 10, compares and contrasts the regulatory history of MRT in the UK and the United States, discusses the relevant ethical overlay, examines potential lessons learned, and charts the likely path forward in the United States. It is written by I. Glenn Cohen, Harvard Law Professor and Faculty Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; Eli Adashi, Professor of Medical Science at Brown University; and Julian Savulescu, Uehiro Chair in Practical Ethics at Oxford University and Director of The Oxford Centre for Neuroethics.
“There is much FDA and the U.S. can learn from the way in which the U.K. has evaluated and regulated MRT,” said Professor Cohen. “These lessons are particularly important because MRT is just one of a series of new reproductive and genetic technologies, including gene editing and In Vitro Gametogenesis, that FDA and regulators across the world will soon be confronting.”
On January 20, 2015, Michael J. Davidson, MD, a cardiothoracic surgeon, was fatally shot on the premises of the Brigham and Women’s Hospital in Boston, Massachusetts. In the year leading up to this tragic day, a total of 14 active shooter incidents occurred in hospitals throughout the United States, leaving 15 fatalities in their wake. This reality and its potential amplification by copycats has reignited the debate over the adequacy of current and future hospital security arrangements. In this Viewpoint, we discuss the evolving frequency of hospital-based active shooter incidents, the relevant legal framework, and the role of hospitals and physicians in countering this threat.
As defined by the US Department of Homeland Security, an active shooter incident is one wherein “an individual is actively engaged in killing or attempting to kill people in a confined and populated area.” By several accounts, the overall prevalence of this otherwise rare occurrence is increasing. A study by the Federal Bureau of Investigation (FBI) reveals the overall number of active shooter incidents to have increased from 6.4 per year (2000-2006) to 16.4 per year (2007-2013). Similar rates have been reported for the hospital setting wherein the average number of active shooter incidents has increased from 9 per year (2000-2005) to 16.7 per year (2006-2011), claiming 161 lives in the process. It would thus appear that the frequency of hospital-based active shooter incidents has evolved to constitute at least a monthly occurrence. […]
The political paralysis plaguing gun laws notwithstanding, hospitals are not without recourse in seeking to mitigate the threat of active shooter incidents. On the local advocacy front, advancing and enacting bills for gun-free zones in health care settings constitutes a worthy effort in that a comparable federal statute remains unlikely. Concurrently, selective locale-specific enhancement of hospital security arrangements may increase deterrence, thereby mitigating risk and civil liability. […]