Take a look at the answer this physician received about breaking his promise of confidentiality to a patient. The New York Times’ Ethicist describes this as a modern problem, but it seems to me this is age-old. And although the confession was not medical, the nature of the doctor-patient relationship and the historical trust it has cultivated can’t be ignored. The Ethicist says he expects vehement disagreement, and that’s one thing he’s right about for sure.
Last but not least! Our final conference panel focused on “Addressing the Challenges of and Harnessing New Technologies,” and was moderated by Fran Miller.
We heard first from Margaret Riley on “Twenty-First Century Technology with Twentieth Century Baggage: FDA Regulation of Regenerative Medicine.” Riley explained that regenerative medicine (i.e., the use of pluripotent stem cells) has the potential to cure disease, injury, and even remedy organ shortages. Of course, it is a hugely political issue and the debate is emotional, value-laden, and not necessarily logical. As a result, the legislation/regulation that results in this area may be far from ideal.
Focusing on FDA specifically, Riley explained that the agency’s approach to stem cell regulation is rooted in its regulation of gene therapy and tissue products, as initiated in the 1990s. FDA’s regulation of autologous stem cell therapies – in which a person’s own cells are removed, manipulated, and reintroduced – as a drug was recently upheld by the District Court of DC (US v. Regenerative Sciences, 878 F. Supp. 2d 248 (DDC 2012)), but is now on appeal to the DC Circuit. Riley is not sure what the outcome will be on appeal, but noted that getting BLA’s approved on a doctor-by-doctor basis will be very difficult and likely impossible. One possible outcome of FDA regulation is likely to be off-shoring and stem cell tourism; ironically, strict regulation may end up not protecting patients, who will end up going abroad.
Next up was Nathan Cortez, who asked “Is the FDA Equipped to Regulate Mobile Health Devices?”
[Posted on behalf of Holly Fernandez Lynch, Executive Director, Petrie-Flom Center (with the same disclaimer about the off-the-cuff nature of live blogging)]
For the last plenary session of the conference, we heard from Susan Winckler, President and CEO of the Food and Drug Law Institute, who discussed “Other Influencers of Food and Drug Law” – namely the media and Congress.
Susan began by contrasting media past and present – from newspapers, radios, and TV news, today the agency has to contend with the range of issues and challenges associated with social media. There has been a shift from dealing with a defined press corps focused (and expert) on FDA to a “media of the masses,” which requires some level of training and background on the agency’s mission and intricacies. The agency can now also speak directly to the public, and be more proactive, without the filter of reporters and news media editors.
Associated with this media shift, Susan identified several new realities and challenges:
- How to explain complex scientific and legal issues in 140 character tweets?
- How to speak with “one voice” despite the fact that every agency employee now has a media outlet?
- How to address the expectation that FDA make declarations in real time, giving immediate responses to new developments?
Another great conference session this afternoon: “Timing Is Everything: Balancing Access and Uncertainty.” This one was moderated by Jeff Skopek, with presentations by Shannon Gibson, Trudo Lemmens, and Efthimios Parasidis.
First, we heard from Gibson and Lemmens on “Overcoming ‘Premarket Syndrome,’” AKA the various problems associated with relying solely on premarket data for safety and efficacy determinations. These problems include the fact that industry studies have been shown to be more likely to be biased in favor of demonstrating a positive result, and premarket studies also cannot really demonstrate how a product will be used in clinical practice. Moreover, for niche market drugs (e.g., those for orphan indications or pharmacogenomics), which are becoming more and more popular, there are fewer patients available to serve as clinical trial subjects, thereby inherently limiting the data that may be generated prior to approval and increasing uncertainty around safety and effectiveness.
So what should we do? Develop an improved post-market research agenda, say Gibson and Lemmens, and explore “adaptive licensing,” by which they mean rendering regulatory decisions based on the entire body of evidence collected throughout a product’s life cycle. They argue that drug access decisions should not be binary, but instead, should be incremental and continually reassessed based on new data, including data that becomes available after a drug has been initially made available to patients. They closed by pointing out the importance of data transparency at all points in drug regulation.
Next, we heard from Efthimios Parasidis on “Innovative Regulating as a Public Health Imperative.” Parasidis focused on the ways in which FDA can leverage its existing post-market regulatory authorities granted under the Food and Drug Administration Amendments Act of 2007, including requiring post-market studies and imposing Risk Evaluation and Mitigation Strategy requirements (REMS).
We’re well on our way into the Petrie-Flom Center’s Annual Conference, FDA in the 21st Century, and we’ll be live blogging the sessions today and tomorrow here at Bill of Health.
Today’s sessions opened with a fantastic plenary from Peter Barton Hutt, who’s had more than five decades of experience with Food and Drug Law, including 4 years as Chief Counsel to the FDA.
Peter addressed a wide variety of topics in his talk on “Historical Themes and Developments Over the Past 50 Years.”
1. FDA Management
Peter discussed various management approaches utilized by different FDA commissioners over the years, from Commissioner Edwards in the 1970s who ran the agency like a management consultant, meeting with every Center every week, to Commissioner McClellan who viewed his post through the lens of an economist. Different management styles have been needed as the agency has grown tremendously, from 6,500 employees in 1976 to a $4 billion appropriation and more than 12,000 employees today. As a result of that growth, the Commissioner and Center directors necessarily know less and less about what the organization is doing. This creates tremendous possibilities for inconsistencies, mistakes, and loss of control, and ultimately, policy is now made from the bottom-up.
Peter described the fundamental shift in FDA’s approach to rulemaking over its history. Before 1970, the agency relied heavily on a combination of guidance and litigation, primarily as a result of the fact that the four general counsels in that role from 1906 to 1971 were all litigators, and viewed lawsuits as the appropriate way to develop government policy. It became clear in the 1970s that this approach couldn’t work for everything, and as a result, the agency reinterpreted an obscure provision of the Act allowing it to issue regulations for “efficient enforcement” of the law to permit substantive rulemaking, rather than just procedural rules. This allowed huge programs to be created administratively, from nutritional labeling to OTC drug review to FOIA regulations. Equally important was FDA’s approach to developing lengthy explanatory preambles to its regulations.
The gist? The law prohibits many, but not all, grounds for discrimination against potential patients. Race, religion, sex, and disability are among the most uniformly protected categories, whereas less than half of states prohibit health care discrimination based on sexual orientation or gender identity, for example. Moreover, the rejection of patients because they smoke, play contact sports, or engage in other risky behavior is legally within the realm of physician discretion, as is discrimination based on other characteristics not protected by law.
So what about obesity discrimination by healthcare providers? Perhaps one of the last comparatively socially acceptable bases for discrimination, weight has not traditionally been treated as a protected category under civil rights laws. But one possible strategy is to consider the scope of prohibitions against disability discrimination. This is actually a pretty unsettled area of law – but the bottom line, to the extent there is one, is that rejection of an overweight or obese patient who is neither impaired to the extent of being disabled nor regarded as disabled would be legally permissible under the Americans with Disabilities Act. Rejection of an obese patient who is disabled could also be permissible, so long as the disability was not the reason for the rejection. The only problem would come up if a disabled obese patient were to be rejected on that basis, and could prove that to be the case. So this may not be the most helpful approach to address obesity discrimination in the healthcare context, and in my opinion, reliance on simple medical professionalism and the commitment to caring for those in need has much more to offer.
On Monday, the World Medical Association opened a 2-month public consultation on proposed revisions to the Declaration of Helsinki. The Declaration was most recently revised in 2008, and according to the WMA, the current round of proposed changes is intended “to provide for more protection for vulnerable groups and all participants by including the issue of compensation, more precise and specific requirements for post-study arrangements and a more systematic approach to the use of placebos.”
You can see a side by side analysis of the proposed revisions and explanatory comments here. We’ll see what happens down the road, but a few things are worth noting:
- The working group responsible for the revisions explicitly acknowledges that it cannot literally be true that the well-being of the individual research subjects must take precedence over all other interests (new paragraph 8/old para. 6). Nonetheless, it retains that language for aspirational purposes – a strange choice, IMHO, which could conceivably lead to less respect for the Declaration as a whole.
- The revised Declaration would (in line with almost every other ethical body to consider the issue) add a new paragraph indicating that “Adequate compensation and treatment for subjects who are harmed as a result of participating in the research must be ensured” (new para. 15). The current version (old para. 14) states only that the protocol should include “provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study.” The nature of the Declaration is such that it doesn’t provide much detail, but even this revised statement is a step in the right direction. Will US regulators ever take the hint?
- The revisions would take a harder stance toward research involving disadvantaged or vulnerable populations, permitting research with these groups only when it could not be carried out in a non-vulnerable population (new para. 20/old para. 17). I understand the sentiment…really I do. But this approach seems to unduly discount the real benefits that accrue to research participants and communities just by virtue of having the research done there. And if research is responsive to population/community needs and priorities AND the population/community stands to benefit from the research – two standards that remain in the revised Declaration – why do we need the third criterion that research couldn’t be conducted in an alternative population? Continue reading
By now, most of you have heard about the controversial study that sought to evaluate how much oxygen to give premature newborns to preserve both their lives and their sight. Below, Laura Stark lays out some of the key details about the study and OHRP’s response, and concludes that part of the problem may have been a result of the difficulties associated with approving multi-site research.
Maybe so, but let me offer a more fundamental challenge: perhaps IRBs are just ineffective – or not as effective as we hope they would be – at protecting human subjects. In retrospect, it looks like all 23 IRBs that reviewed the study, all of which were applying the same regulatory standards, failed to do what OHRP, many news outlets, and as awareness grows, much of the public thinks they ought to have done to protect the babies and families involved in this study. How could they all have gotten it wrong? Are the regulations insufficient? Are the procedures insufficient? Is it all just a matter of interpretation?
These questions lead to another fundamental issue: the lack of empirical evidence on IRB effectiveness. We have data on whether IRBs follow the regulations, data on adverse events, data on OHRP warning letters, data on IRB-imposed research burdens and delays – but these all nibble around the edges of the real questions: what are IRBs supposed to be doing, are they doing it well, and how would we know? The counterfactual – a world without IRB review – is pretty tough to study, but I’m working with a group of colleagues at the Petrie-Flom Center and elsewhere to think through some empirical methods to get at precisely these issues. And we’d love to hear your thoughts!
Finally, as a side note, one point that seems to be getting lost in coverage of this preemie story is that although there seems to have been some major problems with the consent process, the study question itself was a very important one to ask.
Piggy-backing on Glenn’s post below, I just wanted to point you to my contribution to the same symposium issue of Ethical Perspectives. The paper, “Religious Liberty, Conscience, and the Affordable Care Act,” can be downloaded here, and copied below is the abstract:
Broadly applicable legal requirements often come into conflict with moral or religious standards that individuals and organizations feel more strongly compelled to obey. Making room for such moral and religious standards in secular society is important, but can be difficult, since any exemptions or accommodations cannot be allowed frustrate the purpose of the general law, and must also be fair to those who remain subject to it without any special arrangements.
This essay briefly surveys the ways in which the Affordable Care Act might come into conflict with moral and religious beliefs held by both individuals and institutions, and describes the government accommodations that have been offered or considered to date. In particular, it focuses on the requirement that employers offer insurance coverage for free contraceptives and the requirement that individuals purchase insurance coverage that may include services they find objectionable. In both cases, I conclude that the proffered accommodations should be altered to enhance fairness as between objectors and non-objectors.
If you couldn’t make it to our inaugural session on Health Law Year in P/Review, co-hosted by the Petrie-Flom Center and the New England Journal of Medicine, you’re in luck! You can watch the video here:
Topics and speakers included:
The ACA and Health Care Reform
Contraceptives Coverage and Personhood Amendments
Immigrants’ Access to Health Care
Affirmative Action and Medical School Admissions
Tobacco and Obesity Policy and the First Amendment
Summary and Wrap Up
Closing Remarks from Dean Martha Minow
For an excellent perspective on the legal challenges to the contraceptives coverage mandate being brought by for-profit, secular companies with religious owners, check out Bill Keller’s recent NYT op-ed. A brief snippet:
“Also, courts tend to distinguish between laws that make you do something and laws that merely require a financial payment. In the days of the draft, conscientious objectors were exempted from conscription. A sincere pacifist could not be obliged to kill. But a pacifist is not excused from paying taxes just because he or she objects to the money being spent on war. Doctors who find abortions morally abhorrent are not obliged to perform them. But you cannot withhold taxes because some of the money goes to Medicaid-financed abortion.”
These analogies are helpful, but I’m not sure I’m totally convinced that the employers here are only being asked to make a financial payment equivalent to a tax. Certainly they don’t have to take contraceptives themselves, but they aren’t being asked to just pay money to the government – they are being asked to directly arrange coverage for something they find morally objectionable. So I’m really on the fence here.
Ultimately, I don’t want to be too quick to dismiss the complicity objections raised by these employers as just the same as tax objections that are easily waived off as completely unworkable. We can’t have every Tom, Dick, and Harry refusing to pay taxes for things they find objectionable – but we could come up with a system for accommodating the religious objections of secular business owners: namely the accommodation being offered to religious employers. If insurers can bear the burden of handling contraceptives coverage completely on their own for religious employers like hospitals and universities, why couldn’t they do the same across the board?
And let me reiterate once again that all of this just demonstrates that employers really have no place whatsoever in our healthcare system.
Last week, the Indian government issued revised rules governing “compensation in case of injury or death during clinical trial.” You’ve really got to read the whole thing, but some of the provisions are pretty remarkable:
- “In the case of an injury occurring to the clinical trial subject, he or she shall be given free medical management as long as required.” Note that this doesn’t say anything about the injury being study-related.
- If an injury is related, then the subject is also entitled to financial compensation above any medical expenses.
- If the subject dies as a result of clinical trial participation, his or her “nominees” would be entitled to financial compensation.
- Injury or death will be considered related to trial participation in a variety of usual circumstances, including adverse effects of the investigational product and protocol violation or negligence. But here’s the kicker: injury or death will be deemed trial-related, and therefore eligible for care/compensation, if it results from “failure of investigational product to provide intended therapeutic effect” or “use of placebo in a placebo-controlled trial”. Read that again – if an investigational product doesn’t work, the sponsor will be liable for free medical care and further financial compensation.
|FOR IMMEDIATE RELEASE
February 1, 2013
|Contact: HHS Press Office
Administration issues Notice of Proposed Rulemaking on recommended preventive services policy
The Obama administration today issued proposed rules for public comment regarding contraceptive coverage with no cost sharing under the health care law. The proposed rules provide women with coverage for preventive care that includes contraceptive services with no co-pays, while also respecting the concerns of some religious organizations.
Today’s Notice of Proposed Rulemaking reflects public feedback received through the Advance Notice of Proposed Rulemaking issued in March 2012. In addition, these proposed rules are open for public comment through April 8, 2013.
“Today, the administration is taking the next step in providing women across the nation with coverage of recommended preventive care at no cost, while respecting religious concerns,” said Health and Human Services Secretary Kathleen Sebelius. “We will continue to work with faith-based organizations, women’s organizations, insurers and others to achieve these goals.”
The proposed rules lay out how non-profit religious organizations, such as non-profit religious hospitals or institutions of higher education, that object to contraception on religious grounds can receive an accommodation that provides their enrollees separate contraceptive coverage, and with no co-pays, but at no cost to the religious organization.
With respect to insured plans, including student health plans, these religious organizations would provide notice to their insurer. The insurer would then notify enrollees that it is providing them with no-cost contraceptive coverage through separate individual health insurance policies.
With respect to self-insured plans, as well as student health plans, these religious organizations would provide notice to their third party administrator. In turn, the third party administrator would work with an insurer to arrange no-cost contraceptive coverage through separate individual health insurance policies.
Insurers and third party administrators would work to ensure a seamless enrollment process. The proposed rules lay out how the costs of both the insurer and the third party administrator would be covered, without any charge to either the religious organization or the enrollees.
Additionally, the proposed rules simplify and clarify the definition of “religious employer” for purposes of the exemption from the contraceptive coverage requirement. These employers, primarily houses of worship, can exclude contraception coverage from their health plans for their employees.
The proposed rules are available here: http://www.ofr.gov/inspection.aspx
A fact sheet on today’s proposed rules is available here:
For more information on women’s preventive services and the Affordable Care Act, visit: http://www.healthcare.gov/news/factsheets/2011/08/womensprevention08012011a.html
I don’t even want to imagine the creative titles law students might come up with for a note on this topic, but it is a question worth asking/answering: how should the FDA regulate fecal transplants? Check out the NY Times article on the treatment here - apparently, it works!
Happy Thanksgiving! Today, we just wanted to give a big thank you to our loyal readers, dedicated bloggers, and excellent commenters. You’ve helped make Bill of Health a tremendous success in just a few short months, and we look forward to continuing to bring you excellent commentary and analysis on all things related to health law policy, biotechnology, and bioethics.
Enjoy the day with family and friends!
Best wishes and thanks from the Bill of Health Editors.
Following up on Chris Robertson’s and Kevin Outterson’s posts below (here and here), I just wanted to draw your attention to another federal district court opinion on the contraceptives coverage mandate. This one is from Nov. 19 and involves the owners of Hobby Lobby. The court denied their motion for a preliminary injunction on the following grounds:
Plaintiffs have not demonstrated a probability of success on their First Amendment claims. Hobby Lobby and Mardel, secular, for-profit corporations, do not have free exercise rights. The Greens [the individual owners] do have such rights, but are unlikely to prevail as to their constitutional claims because the preventive care coverage regulations they challenge are neutral laws of general applicability which are rationally related to a legitimate governmental objective.
Plaintiffs also have failed to demonstrate a probability of success on their Religious Freedom Restoration Act claims. Hobby Lobby and Mardel are not “persons” for purposes of the RFRA and the Greens have not established that compliance with the preventive care coverage regulations would “substantially burden” their religious exercise, as the term “substantially burdened” is used in the statute. Therefore, plaintiffs have not met their prima facie burden under RFRA and have not demonstrated a probability of success as to their RFRA claims.
There are tens of cases challenging the contraceptives mandate pending at the moment, and several have already been dismissed on procedural grounds. But my current count of the substantive cases is 3 preliminary injunctions granted (Newland, Weingartz Supply, and Tyndale House Publishers), 1 denied (Hobby Lobby), and 1 case holding outright that the mandate violates neither the First Amendment nor RFRA (O’Brien). Have I missed any?
Talk about perfect timing. Just on the heels of Tuesday’s fantastic event at HLS on the Guatemala STD Inoculation studies (video to come soon), the Presidential Commission for the Study of Bioethical Issues has released A Study Guide for “Ethically Impossible” STD Research in Guatemala from 1946 to 1948. This is the Commission’s first foray into pedagogy, and an absolutely fantastic way to keep the discussion going. Be sure to check it out, and to share widely.
Wasserstein Hall, Classroom 3019
Harvard Law School
In the late 1940s, US and Guatemalan researchers conducted a host of experiments on vulnerable Guatemalan subjects, purposefully exposing them to, and infecting them with a number of STDs without their consent. The experiments were kept hidden for more than half a century, until they were discovered and exposed only recently by historian Susan Reverby. The US government has since apologized for what happened, but a class action suit brought on behalf of the Guatemalan subjects was dismissed in June and efforts to directly compensate the victims have not been forthcoming. Please join Harvard Law School’s Petrie-Flom Center and Human Rights Program for a panel discussion of the study and possible legal and political responses that may be available now, both domestically and from an international human rights perspective. Panelists will include:
- Susan Reverby, Marion Butler McLean Professor in the History of Ideas, Professor of Women’s and Gender Studies, Wellesley College
- I. Glenn Cohen, Assistant Professor of Law, Faculty Co-Director, Petrie-Flom Center, Harvard Law School
- Holly Fernandez Lynch, Executive Director, Petrie-Flom Center, Lecturer on Law, Harvard Law School
- Wendy Parmet, George J. and Kathleen Waters Matthews Distinguished University Professor of Law, Northeastern University School of Law
- Fernando Ribeiro Delgado, Clinical Instructor and Lecturer on Law, Human Rights Program, Harvard Law School
This event is free and open to the public. Lunch and refreshments will be served.
As you have already heard a few times on this blog, Professor Einer Elhauge, the Petrie-Flom Center’s Founding Faculty Director and Petrie Professor of Law at Harvard Law School, has a new book out on health care reform called Obamacare on Trial. The book collects various essays that Prof. Elhauge published in popular media outlets, along with several postscripts, and it has received all sorts of glowing praise.
Prof. Elhauge has graciously agreed to answer some questions for us in the first ever Bill of Health e-interview. Check it out:
Bill of Health: So, first things first, did the Supreme Court get it right in NFIB v. Sebelius?
Prof. Elhauge: The Supreme Court got the tax issue right, and I think the Medicaid expansion as well, but I think the Supreme Court got the commerce clause issue totally wrong. Worse, the way they got it wrong portends trouble for the future.
Bill of Health: What were you most surprised by in the SCOTUS decision?
Prof. Elhauge: The fact that a majority of the Supreme Court was willing to use a methodology that clearly expanded judicial discretion to overrule the political branches, and that no one really ever called them on it either on the Supreme Court or in the briefing.
Bill of Health: You’ve noted that you didn’t originally take the constitutional challenges to the Affordable Care Act seriously. Why do you think they were able to gain such traction?
Prof. Elhauge: I think the big problem was that the government never directly rebutted either the claim that purchase mandates were unprecedented or the dreaded broccoli hypothetical. Instead they tried to evade the question, I guess because they thought it was unfavorable to them, but the iron rule of litigation is that if you don’t discuss your problematic issues, then you leave your opponents to be the only one that discusses them, and they are sure to frame them in the way most unfavorable to you. The government’s unwillingness to engage this issue left the Supreme Court with the entirely false impression that Obamacare fundamentally changed the relationship between the individual and government, and that thus the government faced a heavy burden to justify the health insurance mandate. I think the government should’ve directly argued that in fact federal purchase mandates were not at all unprecedented, but rather that health insurance mandates went all the way back to the framers, who adopted two health insurance mandates in the 1790s in Congresses that had many framers on them. The government should’ve also pointed out that the argument that courts can, in the name of “limiting principles”, create brand-new restrictions on congressional power that have no basis in the Constitution in order to restrain the possibility that Congress might exercise a power in a silly way, like adopting a broccoli mandate, amounts to a remarkable usurpation of political power by the judicial branches. One could equally say that because Congress might pass silly laws like a law prohibiting the purchase of broccoli, the federal courts should impose a new constitutional limit that prevents Congress from ever restricting commerce. Or because Congress might tax 100% of our income to buy broccoli or go to war to get more broccoli, the Supreme Court should invalidate Congress’s power to tax or declare war. The “limiting principles” argument that was employed here ironically has no limiting principle and looks benign but is actually a wolf in sheep’s clothing.
Well, hopefully we’ll know the fate of the ACA by tonight. But even if President Obama wins, there will still be uncertainty about the fate of the contraceptives coverage mandate.
A number of employers claim that the mandate violates their rights to religious freedom by requiring them to offer free coverage for medical products and services they find objectionable, and the administration has taken a number of steps to offer accommodations. But as a neutral law of general applicability, the mandate doesn’t violate the First Amendment under SCOTUS jurisprudence, and even under the Religious Freedom Restoration Act, there’s a strong argument that the mandate is ok, either on the grounds that it does not actually impose a substantial burden on religious exercise or that it is supported by a compelling government interest.
Nonetheless, federal courts have reached different conclusions as to the mandate’s permissibility. In July, a federal district judge in Colorado issued a preliminary injunction blocking enforcement of the mandate against a religious employer running a secular (HVAC) business, while in September, a federal district judge in St. Louis rejected a similar challenge by the religious owner of a mining company. Last week, a federal district judge in Detroit also issued a preliminary injunction against enforcement, indicating that while neither side had shown a strong likelihood of success on the merits, “The loss of First Amendment freedoms, for even minimal periods of time, unquestionably constitutes irreparable injury.” Several other challenges to the mandate remain pending.
So let’s just add this to the list of uncertainties that will remain after the results of today’s election are in – and to the list of reasons why employer-based health care really ought to be abandoned in favor of a single-payer, public system.
There, now that ought to get some discussion started…