As I prepare to teach the health law survey course here at HLS in the spring, I am putting together some exercises for students to work on “open questions” in the field. For example, I am thinking about tasking a group of students to explore ways that insurers could or already do structure their contracts with patients and providers to prevent pharmaceutical companies from using coupons to undermine cost-sharing burdens. (Medicare simply does so with the anti-kickback statute.) I have another question about whether the inventor of a new medical device could use crowd-sourcing (e.g,. kickstarter) to raise funds for product development, without running afoul of the FDA proscriptions on unapproved marketing. I would love to get your ideas about open questions in other areas, including bioethics, medical malpractice, public health law, scope of practice, etc. Please post them in the comments or contact me. I’m happy to reciprocate.
Today, there are two big stories that relate to the “institutional corruption” of medicine (aka conflicts of interests). For those who have been working long and hard on these issues, they are cause for hope. The needle does move.
First, one of the biggest pharmaceutical companies, GlaxoSmithKline, has decided that it will stop paying doctors to promote their drugs. My prior work has shown that such payments are quite common (e.g., 61% of urologists and 57% of gastroenterologists taking money), and that they likely influence the prescribing decisions of the doctors who take such money. In recent months, Glaxo has made several such moves towards greater transparency and integrity, often as a result of threatened or actual criminal prosecutions. (See their newfound commitment to opening up their clinical trial data too.)
The NYT story quotes an industry consultant suggesting that the move to stop paying physicians is a result of the Affordable Care Act’s “sunshine” requirement that such payments will be disclosed, and that several other drugmakers are considering similar moves. I am a bit skeptical that the disclosure mandate had such an effect, since the disclosures were already required by Massachusetts and other states, and as part of the “corporate integrity agreements” that came of several federal prosecutions. My sense is that such disclosures are not likely to reach patients in a useable way, so its hard to understand how the transparency could really impose much of a disincentive on the companies. Yet, something has caused Glaxo to change course.
Second, the National Football League has decided to give the National Institute of Health $30 million to study brain injuries. The counterfactual is that the NFL could have kept the money, of course. But the more interesting alternative is that the NFL could have just spent the money itself, hand-picking the researchers and carefully specifying how the research should be performed, in order to buy the scientific conclusions that it preferred. This has been the classic strategy of industries facing litigation risk, from tobacco, to asbestos, and now the paper industry, whose law firm actually commissions scientific studies on its behalf. The NFL’s move instead proves that it is possible for a self-interested party to nonetheless fund independent, credible, gold-standard research, by using an intermediary, such as the NIH.
This is exactly the sort of reform that I have called for, as an alternative to the false dichotomy between public funding and private interest. For companies that have a bona fide interest in discovering and publicizing the scientific truth, a credible intermediary like the NIH can reassure consumers of scientific information that it is valid. Now, if only we can get big pharmaceutical companies to make the same move for their clinical trials and other scientific research studies. Perhaps the first-movers will be the most innovative companies who have bona fide products and are tired of them being lost in the cheap talk? If physicians making prescribing decisions continue to give greater credence towards NIH-funded research, such integrity could be rewarded.
EDIT: Corrected link to NFL story on NYT, and corrected amount from $100M to $30M. Also, disclaimer: I am not involved in this Petrie Flom Center collaboration with the NFL, and the views expressed here are entirely my own.
So reads the cover of the MIT Technology Review this month. The article is available for free online. The article begins with the story of Kalydeco, which is priced at $294,000 per year.
The company also pledged to provide it free to any patient in the United States who is uninsured or whose insurance won’t cover it. Doctors and patients enthusiastically welcomed the drug because it offers life-saving health benefits and there is no other treatment. Insurers and governments readily paid the cost.
Hold on. If patients can get the medicine for free even when their insurers decline to pay the cost, why would insurers “readily pay the cost?”
This year, the PFC’s annual conference will focus on “Behavioral Economics, Law, and Health Policy” (the call for abstracts deadline is next week). Apropos, last week, Reuters featured a story by Jill Priluck “The Overselling of Behavioral Economics,” which itself seems to be a press release for a new article by NYU’s Rick Pildes and Ryan Bubb, called “How Behavioral Economics Trims its Sails and Why.” In several fields, including consumer finance, Pildes and Bubb chronicle examples where policymakers tried to put behavioral economics principles into practice, and seem to have failed to produce desired results or have caused unintended consequences. Some of their examples are controversial (in terms of both the interventions tried and the success of the outcomes), but those points are best addressed by the experts in those fields.
As health law considers its relationship to behavioral economics, I think a larger point is in order. Allow me to be provocative: there is no such thing as behavioral economics.
Instead, the core of what we have called “behavioral economics” is just a set of observations (usually from lab experiments) where idealized and assumption-laden economic models have failed to actually predict human behavior. At least at this stage of its development, behavioral economics is best understood as a negative project, not a positive one. Of course, we do put labels on those documented failures like “regret aversion” or “social norming” or “optimism bias,” and it is then tempting to make things out of those labels. Instead, when the limits of those simplistic economic models are found, that should simply return social scientists and policymakers to a domain of open-minded common sense about how people will actually behave when we take them outside the lab and try to regulate them.
While the behavioral economics literature does provide its own theoretical frameworks, which can generate new hypotheses, the best teaching of behavioral economics is simply fallibilism and empiricism. That is why the “Nudge Unit” (aka Behavioral Insights Team) in the United Kingdom has prioritized the use of randomized experimentation to evaluate every “nudge” that it tries, and the sister initiative here in the United States is doing likewise. I am optimistic of that approach.
Over at the Hoover Institute’s blog, Richard Epstein recently offered a scathing critique of the Obamacare rollout, making dire predictions about adverse selection that will lead to a “death spiral.”
[In defending the rollout, President Obama] hasn’t addressed the composition of the applicant pool, which clearly attracts individuals with known healthcare conditions who will receive extensive public subsidies to join the ranks of the insured. There is no way that the government exchanges can remain viable without attracting large numbers of healthy young persons, all of whom are well-advised to stay away in droves, until they become sick and can sign up with the plan of their choice, no questions asked. Obamacare can only remain solvent with an enormous public subsidy.
Today, the New York Times ran a story about the 360,000 Californians that have signed up for healthcare on its exchange, since it opened on October 1. The early enrollment results seem promising, suggesting that adverse selection and public subsidies are not so problemmatic:
Officials said 18- to 34-year-olds made up 22.5 percent of the nearly 31,000 Californians who selected a private health plan in October. The same age group makes up 21 percent of the state’s population. … People who did not qualify for a subsidy enrolled in significantly higher numbers than those who did. The state reported that 4,852 people who selected a private plan in October were eligible for tax credit subsidies, which are based on income, compared with 25,978 who did not qualify.
The new American Heart Association and American College of Cardiology guidelines on how patients should manage their cholesterol are likely to dramatically increase the sales of statins. (E.g., check out the bump to Pfizer’s stock price.) Yet, the new guidelines have become instantly controversial, with prominent cardiologists calling them into doubt. In addition to the substantive scientific dispute, there are also questions about whether the guidelines panel may have suffered from biases, due to conflicting interests. As PharmaLot reports:
Of the 15 panelists that authored these new guidelines, six reported having recent or current ties to drugmakers that already sell or are developing cholesterol medications. And among the half dozen who disclosed these relationships was one of the two panel co-chairs, which contradicts an Institute of Medicine suggestion about managing conflicts on such panels. Each of the six panelists disclosed they worked as a consultant and received funding for personal research. And among the 10 expert reviewers, half listed consulting relationships.
I, of course, do not know the right answer about statins on the merits. As a layperson, I must use proxies and heuristics to decide, and to some extent busy non-specialist physicians must do the same. That is the whole point of the guidelines — so that each individual physician does not have to review the science himself or herself. They are supposed to be able to simply rely on the guidelines, as the state of the art. Yet, the conflicts of interests undermine our confidence in the AHA/ACC guidelines, making them less impactful on our prior beliefs. (My own research has documented this sort of discounting, among both physicians and laypersons). That sort of discounting is perfectly rational.
Some have argued that it is unrealistic to find experts who do not suffer from such conflicting interests. But what if the AHA/ACC had just proceeded with the nine unconflicted panelists, and the five unconflicted reviewers? Regardless of whether the panel reached the same outcome, it might have then better served the bona fide interests of the AHA and ACC, as well as the interests of public health. If that panel did reach the same pro-statin outcome, which boosted Pfizer’s stock price, all the better.
Over at the Volokh Conspiracy, Jonathan Adler has a quick take on whether President Obama has legal authority for his decision to allow non-compliant health insurance policies to remain in effect. The White House has suggested that this is merely a routine question of enforcement discretion, just like prosecutors use everyday. (See e.g., AZ v. US, affirming this power under the immigration laws.)
Professor Adler asks, “Does this make the renewal of non-compliant policies legal?” And he at first answers, “No. The legal requirement remains on the books so the relevant health insurance plans remain illegal under federal law.” Adler suggests that this illegality may become important if, for example, a patient were to make an insurance claim under a non-compliant policy for a procedure that would have been covered under a compliant policy. Adler suggests that the Affordable Care Act (ACA) would force coverage, regardless of what President Obama says.
At the end of the post, however, Adler adds an update, which comes around to what I think is probably the better analysis. Under the Affordable Care Act, only compliant plans “may be sold on exchanges or satisfy the minimum coverage requirement (the individual mandate). So the [ACA] does not expressly prohibit insurance companies from offering such plans (assuming they are allowed by state insurance commissions).” Thus, they are not “illegal” in the first place. [UPDATE: Adler has updated his post a third time, citing 42 USC 300 gg-6, providing that insurers in the small group and individual markets shall ensure that such coverage complies with the essential health benefits package.]
In the end, the President’s new decision really does seem to be about declining to enforce the [proscription against these plans being offered] and declining to enforce the tax penalty on individuals that have non-compliant insurance policies. He is saying that, as far as the Federal Government is concerned, “if you like your policy, you can keep it” (for now).
Over at our sister blog for the Edmond J. Safra Center for Ethics, Gregg Fields has an insightful discussion of the way Obamacare has relied on private sector contractors to get its enrollment website up and running. Gregg quotes Safra-affiliate Bill English, who explains the allure of public-private partnerships: they “enable the public sector to harness the expertise and efficiencies that the private sector can bring to the delivery of certain facilities and services traditionally procured and delivered by the public sector.” HHS Secretary Kathleen Sebelius gets the understatement of the year award: “Unfortunately, a subset of those contracts for HealthCare.gov have not met expectations.”
The Economist has a long, detailed, and readable piece about the difficulties of inferring anything from the published findings of biomedical science. There are all sorts of problems that fall short of scientific fraud, including the the biases caused by industry-funding of biomedical science, the biases of unblinded raters who see what they want to see, and the biases of journal editors towards only publishing “positive” findings. (I am particularly enamored with this graphic, which shows the fundamental problem of inference.) It is rare for researchers to even bother to attempt to replicate prior findings, but when replications are attempted, they often fail.
The Economist piece can be read as something close to an outright assault on empiricism, at least as we now know it. In practical terms, it is prudent for physicians, patients, and payors to be wary of the findings presented in even the top journals.
One of the beauties of our scientific system is that it is wildly decentralized. Scientists (and their funders) can test any hypothesis that they find interesting, and they can use whatever methods they prefer. Likewise, journal editors can publish whatever they want. While such academic and market freedom is attractive, it results in quite a hodgepodge of science, with replication studies and publication of null results being afterthoughts. The NIH and NSF have in the past functioned to set an agenda and demand rigor, but as their funding wanes, the chaos waxes.
The problems are scientific, but any solution will be institutional (and thus legal). I have argued for a partial solution to industry bias in my short article, called “The Money Blind: How to Stop Industry Influence in Biomedical Science Without Violating the First Amendment.” Independent scientific testing could be conducted by a neutral intermediary, which would pool funds. In a similar vein, there is also a new project of the Science Exchange, called “The Reproducibility Initiative.” This program offers to be the independent scientific agency, which attempts to validate known results. But there is not yet a large-scale funding model in place. If biomedical journal editors would at least put disclosures in their structured abstracts (an intervention we have tested), over the long run that may also nudge industry to use such gold-standard independent testing, when they have something that is truly provable. And, at least in the domain of the products regulated by the FDA, the agency should consider using its current statutory authority to push companies towards independent, robust, and replicated science.
Enjoying the fall foliage in Mt. Auburn Cemetery yesterday, I came across this marker for Benjamin Waterhouse. In the overwrought language that is appropriate on a grave marker: “In 1800 he introduced to the new world the blessing of vaccination. Overcame popular prejudice and distrust by testing it on his own children and thus established a title to the gratitude of future generations.”
No less today, there seems to be plenty of popular distrust of elite science. (And it doesn’t help that so much of contemporary science is infected by conflicts of interest.) Self-experimentation does have a long venerable history, which has recently become more prominent in the quantified self movement. (I’m not sure about experimenting on my kid though.)
Tomorrow, I’m heading to NYC to make a pitch to the Robert Wood Johnson Foundation’s Pioneer Fund, for major funding to launch a new project that would create a platform for robust, randomized experiments of lifestyle interventions (think: migraine management, diets, exercise regimens, nutritional supplements) for which there is virtually no FDA oversight and thus no regulatory imperative for rigorous scientific investigations. Nonetheless, these lifestyle factors are the primary drivers of health and healthcare costs. By crowdsourcing these sorts of experiments in an sound ethical framework robust against institutional corruption, I hope to develop gold-standard scientific knowledge with huge samples, but also build public engagement, public understanding, and public trust of health science.
The crowd uses Wikipedia to organize knowledge, and Indiegogo to invest in new health devices. The crowd needs a platform to create knowledge too, especially through randomized interventions, which have the potential to actually change behaviors for the better and eliminate the confounding factors that undermine observational studies.
So, wish me luck in NYC tomorrow: http://bit.ly/pioneerpitch
The Journal of Law, Medicine & Ethics plans to publish a symposium issue in Winter 2014 exploring ethical, legal, and clinical issues triggered by the increasing commercialization of health care in the United States. The symposium will address a variety of dynamics present in this quintessentially American medical marketplace, with a particular focus on how commercialism impacts practitioners, patients, and policy makers at all levels.
Papers from any perspective or disciplinary background and concerning any aspect of the “buying and selling of health care” are welcome.
Deadlines and submission instructions below the fold.
I recently posted my new article “When Truth Cannot Be Presumed: The Regulation of Drug Promotion Under an Expanding First Amendment“. The article is forthcoming next year in Boston U. Law Review, but I have plenty of time to make revisions. So I would love to get the feedback from BillofHealth readers.
One of the preliminary themes of the article is that the Food, Drug, and Cosmetic Act is predicated on the drugmaker’s own intent that a substance be used to treat a disease. The exact same chemical compound can be sold for other purposes without any FDA oversight. But once the drugmaker intends that the substance be used as a drug, it becomes a drug as a matter of law, and then each intended use must be proven as safe and effective to the FDA. For example, turpentine has had this dual-life as a paint-thinner and as “Hamlin’s Wizard Oil,” for which “there is no sore it will not heal, no pain it will not subdue.”
This intent-based system of regulation sets up a confrontation with the First Amendment, since the drugmaker’s own speech is often the best evidence of its intent. It is a pretty big confrontation too, since the intent concept is the very predicate for the entire FDA regulatory regime. On the other hand, it is hard to conceive of an alternative threshold for what counts as a drug. There was a time (e.g., the 1993 Mitchell case) when a ConLaw scholar could confidently say that such evidentiary use of speech presents no First Amendment problems at all, but the current Supreme Court has been eager to dispense with such formalisms (c.f., the 2012 Alvarez case).
In my research on this point, I found a few other intent-based regulations that metaphysically transform things into the objects of a regulatory regime. For example, the distinction between whether the Federal Aviation Administration regulates your family station wagon depends on whether the carmaker intends it to fly. (See note 20 of the paper.) Perhaps a broader analysis is in order. If the First Amendment undermines this mechanism of regulation, what other similar regulatory regimes may be threatened?
A minority of the Members of Congress are threatening to cause the United States government to default on its debts, unless the majority members agree to repeal or defund the Affordable Care Act, which Congress passed just a few years ago. There will presumably be some sort of negotiated solution. I worry that the negotiation range is being defined in a skewed way, between one pole and a moderate status quo, which is already the result of a prior negotiation. Seems like we have a one-way ratchet here.
My thought: perhaps the negotiations should go both ways, so that the end-result is more balanced. What if the Democrats made symmetric threats to cause default, unless:
- Medicare is expanded to cover all the poor who do not qualify for Medicaid (filling the gap the Supreme Court created in its “coercion” opinion),
- The Federal government creates a public health insurance option, to compete along with the corporate insurers (which was killed in final negotiations to pass the ACA),
- The Federal government gets explicit authority to provide insurance subsidies in the health insurance exchanges it sets up for states that have refused, oh and, as a kicker,
- Ronald Reagan International airport (DCA) is re-named Jimmy Carter International Airport.
Ok, that last one is silly, but it might make for a fun bargaining chip, since it symbolizes the strategic game that is now being played, as we re-legislate settled questions. Positional bargaining is not pretty or enlightened, but if these chips can be traded, we might end up in the fallback position of keeping the Affordable Care Act as the negotiated compromise that it already is. Of course, the ACA is also the default rule, which has a nice double meaning in this context.
Our friends at Loyola University Chicago’s health law program just announced the Fourth Annual L. Edward Bryant, Jr. National Health Law Transactional Competition. ”Three-person teams of J.D. students will prepare a legal memorandum that summarizes their legal and business advice for a hypothetical health care client. These students will then appear in a boardroom environment before distinguished attorneys serving as the client’s ‘Executive Management Team’ to present their analysis of the client’s position and recommendations on how the client should proceed.” More information is available on their website.
Arizona State University hosted a symposium on “The Intersection of Law, Science, and Policy to Protect the Public’s Health,” published in Jurimetrics, with excellent contributions by Wendy Parmet, David Hymen, Bernie Black, Vickie Williams, and many others. Here is part of the abstract for the foreward by James Hodge:
Revitalization, revolution, renaissance. In the modern era, these three words depict the foundational changes in the role of law to protect, promote, and preserve the public’s health. Since the early 1990s, public health law has transformed into a distinct, identifiable field through the coupling of phenomenal scholarly vision (including from several scholars in this symposium issue) and public health practitioners’ bold experimentation in novel, applied uses of law to improve public health outcomes. After decades of sheer decline, reluctance, and even reversal of known, effective applications, law and policy have emerged as primary tools for making change in public health. Whether via constitutional interpretation, statutory or regulatory enactments, judicial interventions, or policy adjustments within legal systems, the notion that law can effectively contribute to the public’s health in areas as diverse as tobacco control, obesity prevention, and product safety is now relatively well accepted.
On June 13, 2013 Dr. Edmund Pellegrino died at the age of 92. (Obituaries are available here and here.) For bioethicists this is a time to reflect, but in particular affiliates of the Petrie Flom Center will recall that one of the very first events that that the PFC hosted was a distinguished panel to discuss the concept of human dignity in bioethics, featuring Martha Nussbaum, Nick Bostrom, Dan Brock, and Edmund Pellegrino. (I recall attending the event as a student.) The webcast is still available, at the bottom of the page, here. This event commemorated the release of the Presidential Bioethics Advisory Commission’s new book on the topic of human dignity. Dr. Pellegrino chaired the PBAC, and his contribution to the book is available online here.
The Wall Street Journal has a new article this week celebrating the flood of new jobs for lawyers created by the Affordable Care Act. The WSJ article rattles off a dozen or so examples of legal questions that arise from the new legislation and litigation, providing lots of fodder for a health law class. This comes after a provocative session at ASLME’s health law professors conference last week, discussing an effort by the American Health Lawyer’s Association to create a model law school curriculum, starting with a survey course and broadening into a range of courses that could constitute a “certificate program.”
Many law schools are thinking about experiential education, and health law would seem to be a great opportunity. There is a bewildering range of ways to implement experiential training, from simulation-based courses, to in-house clinics, along with placement clinics and hybrid clinics, and externships too. Many of these seem to blur together on the margins.
The Center for the Study of Applied Legal Education’s 2010-11 Survey of Applied Legal Education (available on SSRN) found that of the 156 law schools responding, 17 had clinics whose “single predominate substantive focus” was defined as “health law,” which amounts to 1.5% of all clinics in the study. (See p7.) Also listed were 24 “elder law” clinics and 20 “disability law” clinics, which I suspect may overlap. The report also shows 29 field placement programs (out of 145 schools responding), which focus on health law. (See p8.) In particular, I am aware of Harvard’s Health Law and Policy Clinic. And SLU’s excellent health law program places clinic students in hospital settings. I have come across other programs at Pitt, Suffolk, GW, and Northeastern.
We do not have a health law clinic at University of Arizona, but I have helped place my JD students in unofficial externships with the Tucson Family Advocacy Program, a medical-legal partnership that addresses some of the social determinants of health (e.g., a letter to a landlord to stop a roach infestation, to help address chronic child asthma). Some of my students have also externed in the general counsel’s office of our academic hospital. I also like to bring students with me to our clinical bioethics meetings, and some of those interactions have led to research projects and student presentations to the committee. I have also engaged some of our top law students in helping me lead discussion sections for undergrads on some of the big health law cases, such as Jacobson, Griswold, Roe, and Raich. (I firmly believe that teaching is a kind of experiential education, which develops core lawyering skills.)
I would love to hear from our readers in the comments section . Do you know of other experiential education programs that focus on health law? What do you do? What works well?
When does less information result in better decisions?
CALL FOR PROPOSALS
A Multidisciplinary Symposium on Blinding as a Solution to Institutional Corruption
Symposium: November 1-2, 2013
Proposal Deadline: February 15, 2013
With the support of the Edmond J. Safra Center for Ethics at Harvard University, Christopher Robertson (James E. Rogers College of Law at the University of Arizona) and Aaron Kesselheim (Harvard Medical School) are organizing a multidisciplinary symposium to examine potential solutions to institutional corruption that use the strategy of concealing biasing information from decision makers. The symposium will take place on November 1 and 2, 2013 at Harvard University.
This event is part of the Institutional Corruption Lab. Larry Lessig (Safra Center Director and Roy L. Furman Professor of Law and Leadership at Harvard Law School) has defined ‘institutional corruption’ as the consequence of an influence within an economy of influence that illegitimately weakens the effectiveness of an institution especially by weakening the public trust of the institution. The concept provides a more systematic approach to decision-making problems that can arise as a result of financial relationships and other conflicts of interest.
Institutional corruption may arise in many contexts, from medical research to forensic science, from political campaign finance to financial auditing. There are many potential solutions to institutional corruption, but we are particularly interested in practical mechanisms that acknowledge the existence of potential influences, but prevent that biasing information from reaching a decision maker. Such mechanisms may include blinding, masking, placebos, strategic ignorance, information aversion, veil of ignorance rules, blind trusts, walls of separation, or similar concepts. We are interested in reviews of relevant literature, and new laboratory, empirical, historical, and theoretical research that explores the functions, modalities, costs, benefits, and limitations of concealing a source of information to improve decision making. We are interested in established uses of blinding, and potential new applications.
We welcome contributions that have been previously published, as well works in progress. We plan for this symposium to generate collaborative research opportunities, and anticipate publishing many of the presented works in an edited volume from a major academic book press or journal.
To apply, please send a one-page abstract describing your proposed contribution by February 15, 2013, as a PDF attachment, to Professors Robertson and Kesselheim ( chris.robertson at law.arizona.edu and akesselheim at partners.org). Include a link to or copy of your CV. We encourage applications from newer scholars and practitioners, as well as those more established in their fields. Travel stipends will be available for some speakers. Please indicate whether you request such a stipend, and the likely origin of your travel. Please also indicate whether you would be interested in publishing your contribution in the edited volume, pending further information. The organizers also welcome preliminary inquiries about potential topics and approaches.
Here is a PDF of this Call for Proposals. Feel free to circulate.
This week, the New York Times Sunday Review has an editorial arguing that the shortage of primary care physicians could be reduced if we drew more heavily upon other professions, including pharmacists and nurse practitioners, who may be able to provide care more efficiently. The Affordable Care Act’s efforts to increase insurance coverage and eliminate cost-sharing for preventative care, will only exacerbate the shortage of primary care physicians. More to the point, the editorial alleges that various state and federal laws create barriers to the sort of integration of healthcare professionals to address the shortage.
Those “scope of practice” laws were enacted to either protect consumers from incompetent healthcare or protect physicians from competition in the healthcare marketplace, or likely some mixture of both. We know where mainstream physicians stand anyway. In the words of the American Medical Association’s own newsletter, ”physicians [have] fought a blitz of scope-of-practice expansions by other health professionals on legislative, legal and regulatory fronts.”
The shortage of physicians is also a product of the number of young doctors that our medical schools are producing. Although several new schools have launched in recent years, others are have actually shrunk due to budget cuts.