Category Archives: Health Law Policy

More Commentary on Why Patients May Be Discriminated Against

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Given my recent piece in the New England Journal on discrimination against patients, particularly obese patients in the context of the Americans with Disabilities Act, I found this NY Times story particularly interesting: Disability and Discrimination at the Doctor’s Office. The Times story focuses on patients who are disabled in more traditional ways, but indicates that the main culprit behind the medical discrimination they may experience is not animus, but rather lack of proper equipment, which can be quite expensive.  Luckily, there may be hope on the horizon, thanks to the ACA.

Liability for Failure to Vaccinate

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By Art Caplan

Measles are breaking out all over Britain.  Getting fewer headlines is the fact that measles are back in the USA too.  In fact they are in our region.  A mini-epidemic is raging in Brooklyn.  Measles for cripes sake!  The disease that many of us over 60 had as kids that should never occur is back with a vengeance.  The reason for the diseases reappearance is simple—failure to vaccinate.  Maybe it is time to get tough on those whose choices put others at risk.

For decades, there has been a safe, effective vaccine that works exceedingly well against the measles–95% full protection for a kid who has been vaccinated– and nearly equally well at preventing transmission to others.  The more people have been vaccinated the tougher it is for measles to gain a foothold.

NY City health officials have reported 30 cases so far–26 in Borough Park and four more in Williamsburg.  The NY Daily News reports that the consequences of this outbreak have been dire:

“There have been two hospitalizations, a miscarriage and a case of pneumonia as a result of this outbreak,” a Health Department spokeswoman said. “All cases involved adults or children who were not vaccinated due to refusal or delays in vaccination.”

So far the outbreak has been among religious Jews some of whom shun getting the vaccine for their kids out of fear it causes autism Dr. Yu Shia Lin of Maimonides Medical Center in Borough Park told The News.

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Politics and Science

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By Joanna Sax

On April 29, Scott Burris blogged about a new bill that would allow Congress to set the scientific agenda, which would replace the traditional peer review process.  I echo his expressed concerns, but want to add more.  The idea that politicians, and not scientists, could determine the advancement of science is, frankly, a disaster.  In the past we have seen political leaders spar with scientists over many things – such as whether the earth is round, whether the earth is the center of the universe, etc.  If scientists did not or could not answer those questions, we might think we are walking on a flat earth.

Even now, there is a strong interaction between politics and science.  Evolution, a scientific theory with unequivocal consensus among the scientific community, still faces political opposition.  Recently, I’ve been thinking and writing in this area, that is, the interaction of politics and science.  Questions for scientific inquiry should be determined by scientists.  How we allocate and manage our resources requires, as others have argued, experts in many areas, including economics, management, and public policy.

To look at the interaction of science and politics, I conducted an empirical analysis comparing the type of information communicated to the public versus the consensus in the scientific community to determine whether politics is playing a role in scientific inquiry.  The study centers on the debate regarding the funding of embryonic stem cell research.  If you are interested in this area, please check out a recent draft here.  It’s an early draft and I welcome comments – you can email comments to me at jsax@cwsl.edu

Sex, People with Disabilities, Prostitution, and Universal Health Care: Reflections on “The Sessions”

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[Cross-Posted at PrawfsBlawg]

One of my favorite initiatives at Harvard Law School, where I teach, is that faculty members get to offer an optional 10-12 student not-for-credit “First-Year Reading Groups” on a topic of interest to them that is related to law in some way but not too law-class like. I’ve taught a reading group on bioethics and law through film that pairs films with papers/topics in bioethics (e.g., A.I. with readings on personhood, Minority Report and neuroscience and law and predicting criminality, Dirty Pretty Things and organ sale and exploitation, The Constant Gardener with clinical trials in the developing world, Eternal Sunshine for the Spotless Mind and therapeutic forgetting and “cosmetic neurology” and many others…)

Next year I will add The Sessions, a film I found very enjoyable starring John Hawkes, Helen Hunt, and William H. Macy from last year that I also found very bioethically interesting. The film is based on a true story and follows Mark O’Brien, a poet who lives in an Iron Lung due to complications from Polio. After unsuccessfully proposing to his caretaker, and believing the end of his life may be nearing, he decides he wants to lose his virginity. He hires Cheryl Cohen-Greene, a professional sex surrogate, who will offer him a maximum of six sessions but makes clear to him this is therapy not romance. I will stop there to avoid ruining the film, but on to the bioethics…

There are fairly clear issues raised about commodification, exploitation, the difference between sex therapy and prostitution, that I have written about in various forms in various places. These are certainly interesting issues but familiar enough. What the film newly prompted me to think about, though, is actually universal health care. In particular, as I have written about indirectly in a couple of papers, what would some of the most prominent theories explaining why we need universal health care say about whether the state should pay for sex therapy (or perhaps even prostitution) for people with disabilities like Mark who find themselves otherwise unable to have sex?

For example, in his wonderful book Just Health, my colleague Norman Daniels, coming from a more Rawlsian tradition (i.e., a liberal tradition focused on promoting liberty and distributive justice through giving priority to the worst-off), grounds the state’s role in promoting health in the obligation, as a matter of political justice, to ensure access to the “normal opportunity range” to pursue the “array of life plans reasonable persons are likely to develop for themselves.” Although Daniels’ focus is on health care, it seems to me that sexual satisfaction is also part of that normal opportunity range and part of a life plan most of us would like to pursue.

Similarly, Martha Nussbaum in her great book Frontiers of Justice, writing from a more aretaic (i.e., Aristotelian, focusing on character and virtue) perspective, has argued that the state’s role is to enable human flourishing by raising people above the threshold level on a number of “capabilities.” Among these she mentions “bodily integrity,” as including “having opportunities for sexual satisfaction and for choice in matters of reproduction.” I have previously discussed how this kind of approach may justify funding reproductive technologies, but it seems to me as though it also fairly directly establishes an argument for funding Mark’s attempts to lose his virginity.

Now this is meant to be provocative, of course. And for some this is no doubt a reductio ad absurdum against universal health care. Fair enough. But for those who believe there is a moral case for funding universal health care, does the argument also lead to funding these kinds of sex therapies? Health is important, of course, but let’s be frank (and my parents can stop reading at this point) so is sexual satisfaction, and both seem to me essential parts of the normal opportunity range and/or human flourishing.

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Privacy and Progress and the Deidentification of Whole Genome Sequence Data

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[Posted on behalf of Elizabeth Pike and Kayte Spector-Bagdady from the Presidential Commission for the Study of Bioethical Issues - and cross-posted here.]

In the most recent issue of the Hastings Center Report, Drs. Amy Gutmann and James Wagner of the Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission), contributed to the lively debate surrounding the identifiability of genetic data. In Found Your DNA on the Web: Reconciling Privacy and Progress, Gutmann and Wagner, Chair and Vice-chair respectively, argue that the paradigm of identifiability has become less relevant to individual privacy protections than restrictions on access and use.

In their commentary, Gutmann and Wagner continue the public deliberation of the Bioethics Commission’s report, Privacy and Progress in Whole Genome Sequencing, in which the Bioethics Commission took a forward-looking approach to the privacy concerns raised by whole genome sequencing—issues that have come to the forefront of this important science.

Under current law, health information that is deidentified—information for which there is “no reasonable basis” to believe it can identify an individual or that has been stripped of traditional identifiers—is afforded different legal protections than identifiable health information. However, whole genome sequence data are unique to only one person, making them more vulnerable to reidentification.

Recent articles have cast doubt on the extent to which whole genome sequence data can be deidentified. For example, in Identifying Personal Genomes by Surname Inference, published in Science in January, Melissa Gymrek, et. al. successfully uncovered full identities of 50 individuals.

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Public Health Law Research Call for Proposals Coming in June

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Public Health Law Research (PHLR) program of the Robert Wood Johnson Foundation will be opening its fifth call for proposals (CFP) in early June. Short-term studies are no more than 18 months long, and will be funded up to $150,000 each. Applicants are expected to submit a detailed proposal of no more than 23 pages.

As with past CFPs, PHLR will look favorably on multidisciplinary teams that seek to investigate laws broadly impacting public health.

More information about the call is available on PHLR’s website, and more detailed instructions outlining the proposal elements, selection criteria and eligibility criteria will be released in June.

A New Collection of PHLR

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By Scott Burris

The latest issue of the Journal of Health Politics, Policy and Law showcases the range of projects and researchers filling out the field of Public Health Law Research.  An excellent introduction by the editors, Michelle Mello and Wendy Parmet, says it better than I could, but here’s a taste:

Two studies look at public health policy-making – Abiola et al on HPV vaccination, and VanSickle-Ward and Amanda Hollis-Brusky on statutory ambiguity in contraceptive mandates.   Two studies evaluate local legal interventions to address lead poisoning – a sweeping ordinance in Rochester and a novel specialty enforcement court in Philadelphia.  Sampat and Amin quantitatively examine the impact of a provision of Indian patent law that was widely expected to prevent evergreening, finding signs that the law on the books may not be working as advertised in practice.  Finally, Cannon and colleagues bring new methods and attention to the question of whether zoning laws can deliver better health, in this instance through increasing the walkability of neighborhoods.

The group of authors includes doctors, lawyers, economists, sociologists, historians and health researchers. Mello and Parmet offer some pithy thoughts on what all this shows us about the current state of PHLR’s development.  Worth a read.

The Oregon Health Study and the Medicalization of Health Policy

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According to the website, the Oregon Health Study “is the first randomized controlled  experiment to examine the causal effects of having some type of insurance coverage versus having no insurance at all.”  The findings, released a few days ago, have unleashed a storm of commentary on what the investigators did and did not find in terms of links between coverage and health outcomes.  Writing  over at The Incidental Economist, Harold Pollack quotes Joseph Newhouse for the notion that the “Oregon Medicaid experiment ‘is a Rorschach test of people’s views on the ACA.’”  After the jump, I am going to try to defend that claim, although likely not in the way that good readers of Bill of Health might expect.

So here’s the funny thing: even though I am an attorney, an historian, and a bioethicist who researches health inequalities, stigma, and social justice, I actually am less of an expert on the delivery of health care services than virtually every blogger here, and likely a goodly portion of the readership, too.  When interviewing for a job as a prawf some years ago, I was asked for my opinion on the fate of the ACA (then still in Congress), and I had to shrug and say that I really was not up to date on all of the provisions of the bill nor of its likely passage, nor of its potential impact.  (No, I did not get the job!).

This is not because of anti-intellectualism, I believe (and hope!).  This is rather because of my engagement with the overwhelming evidence that access to health care services is simply not a prime determinant of health and its distribution in human populations.  In a seminal 2007 essay in Health Affairs, Paula Lantz, Richard Lichtenstein, and the good Dr. Pollack himself note that “Lack of access to health care is not the fundamental cause of health vulnerability or social disparities in health” (p. 1256).*  The authors go on to warn of the limits of medicalizing health policy, and suggest that if we want to use laws and policies to improve overall population health and compress health inequities, we need to go way beyond simply expanding access to basic health care services.

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Live Blogging from FDA in the 21st Century Conference, Panel 4: Timing Is Everything

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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).

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More on NSF and NIH Funding

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By Scott Burris

Here’s where some in Congress would like us to go:

ScienceInsider reports:

The new chair of the House of Representatives science committee has drafted a bill that, in effect, would replace peer review at the National Science Foundation (NSF) with a set of funding criteria chosen by Congress. For good measure, it would also set in motion a process to determine whether the same criteria should be adopted by every other federal science agency.

Whether or not you think of this as a partisan attack on science, it challenges the idea of science as an independent way of pursuing knowledge. The fact that this is even on the table, and could be taken seriously, shows how effective the attack on science has been.  It seems to reflect a terrible paradox:  on the one hand, social scientists are pissing some people off in a big way, which is a good sign we are doing something right in the inconvenient truth department; but on the other hand, I don’t see a lot of people rising to our defense, which suggest we matter to fewer people than we should.

This bill may or may not go anywhere, but anyone who cares about evidence-informed governance and the ability of the US to solve its problems ought to be concerned.

 

A Tale of Two Polities

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By Scott Burris

Last week, Northeastern University’s effort to convene a much-needed conference on the future of health policy was a casualty of the successful manhunt for the Boston Marathon bombers.  One hardly wants to make too much of a stymied conference given all the human damage of the bombing and its aftermath, but all of us who had gathered for the meeting regretted that we would not hear from the panelists, and sympathized with organizers who had put so much into planning it.  In recognition of that, I am summarizing here what I planned to say there.  It is a tale of two polities that seem to compete for existence in our perceptions of the politics of public health.

One public health is incredibly popular with citizens and lawmakers alike – demonstrated by polling and passage of legislation.  I’ve recently blogged on this here.  The other public health is the despised nanny state, big government, the sequestered and slashed-to-the bone struggling provider of essential services that don’t get no respect and don’t deserve the meager tax dollars we still pay in. We see this in budget cuts, in hyperbolic allegations of “corruption,” and in disingenuous advocacy for a radical caveat emptor regime for all legal products.

What do we make of these two radically different views of where public health now stands in the public’s regard? My claim is that the former is largely the truth – public health is popular, not despised – but the latter view is what is driving budgets and a lot of policy. The action points follow: a sustained fight to mobilize public support and win more battles over budgets and laws. I see three main strands of work:

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While We Sleep?

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By Scott Burris

Nothing threatens a know-nothing more than the prospect of someone knowing something. Hence there has been increasing pressure on and from some in Congress to reduce government funding of social science research.  I hope every reader of this blog is aware that an appropriations rider added by Tom Coburn has drastically restricted NSF funding of political science research. That’s an ugly development, on par with the scandalous cuts to CDC that put paid to its gun research agenda years ago.

But the big funder of social and behavioral research in health is the NIH. In the past two weeks, I have heard via two different insiders that the agency is under pressure to significantly cut back on social and behavioral research, at least research with any important links to public policy. Now it is true that NIH does far too little policy-relevant research as it stands, but many fine researchers do important work related to law and policy with NIH support, and the important influence of law on health means we need more, not fewer, NIH-supported careers.

So I am hoping I am getting false information. What are you hearing?

Curbing Obesity: What Are We Doing?

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[Ed. Note: Posted on behalf of Sarah Fudin, who works in community relations for the George Washington University’s online Master of Public Health program, dubbed MPH@GW, which offers students the ability to earn their MPH online.] 

The whole world knows that Americans are increasingly becoming obese, but solving the problem isn’t as easy as pointing it out. While the individual implications of obesity have been painfully clear for some time, there has been more discussion in recent years of how obesity impacts the economy. According to an infographic by MPH@GW, “The Cost of Obesity,” lowering the national obesity rate by just five percent could eliminate 13 percent of the federal deficit over the next 20 years. Re-framing the obesity epidemic in economic terms could be a way to persuade Americans to tackle obesity through public health legislation.

Support for Anti-Obesity Laws

Although the conventional wisdom in recent years has been that the American public resists public health laws, a recent study indicates that the public might actually be more welcoming of legislation than first thought. The study demonstrated that Americans tend to support non-intrusive public health legislation — bans on smoking in public places, for instance, but not bans on smoking in private residences. The key factor in rallying public support for a bill seems to be that the bill’s authors understand the public’s values, which may mean that it will be easier to pass public health laws as our national conversation about obesity evolves.

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Will Your Law Firm (or Other Employer) Pay for Your Egg Freezing? Should It? (Online Abortion and Reproductive Technology Symposium)

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As John Robertson mentioned in his post earlier this week, in order to avoid age-related infertility many women are considering or will soon consider using egg freezing, as the technology has dramatically improved. As compared to freezing preembryos, for example, this is an attractive option since many of these women (heterosexual or otherwise) may not yet have chosen a reproductive partner, and also may want to hedge their bets to have options should they divorce. Still, the technology is not cheap.

At least one participant at the the bricks-in-mortar symposium reported to me that they knew of one Am Law 100 firm that will cover egg freezing for its lawyers. I would be grateful if folks in the comments section could indicate whether they knew whether their firm covers it as well. [Ed. Note: If you have any trouble with the comment function on the blog, which is still giving us trouble, send a note and we'll get it posted for you through the admin account.] My own impression is that this is not yet widespread, but that might change as the practice becomes more common and thus the market converges (perhaps with a push from Above the Law).

Should law firms cover egg freezingt? I have made the argument elsewhere for coverage of reproductive technologies by insurance more generally from a moral and economic perspective. In the case of law firms, I am curious about the PR implications for the firm. Would potential female associates welcome this option knowing that they can work hard early on and still reproduce, if they so desire, later on? Or would they take this as a signal that the firm thinks that working there as an associate and pregnancy are incompatible? Would this option help remedy the deficits faced by women who want to have children on the partnership track or would it in fact exacerbate discrimination against women who do choose to have families early on while at the firm, with the thinking being “she could have waited.” More generally, would this be a blow for or against gender equity at law firms?

Further On the Fake Anti-Government Electorate

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By Scott Burris

In recent posts, I have been pointing to research that suggests that government intervention for public health is actually rather popular as a general matter. Now comes a neat paper that takes on the question of whether politicians actually know what their constituents want.  I read it as further evidence that our politics is being shaped by a lot of well-supported anti-government noise-making that has been allowed to flourish unchallenged.

The paper in brief: the authors surveyed candidates for state-level legislative office, and used a technique called multi-level regression and post-stratification (MRP) to localize opinion poll data to legislative districts. They then compared what candidates think their constituencies believe on key issues (health care reform, gay marriage, welfare reform) with what the polls say their constituents believe.  They find that both conservatives and liberals significantly overestimate the conservatism of the people who elect them:

“In districts where supporters of these policies outnumber opponents by 2 to 1, liberal politicians appear to typically believe these policies enjoy only bare majority support while conservative politicians typically outright reject the notion that these policies command widespread support.”

The paper is worth reading for its findings (and to allow you to personally assess its limitations – this has not yet even been peer reviewed.) A more detailed summary with some of the charts is on Dylan Matthew’s Washington Post blog.

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Caplan on the Myriad Patent Case

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[Posted on behalf of Art Caplan]

On January 7, 1610 Galileo Galilei, the Italian physicist and astronomer, aimed his new invention, the telescope, at the sky and became the first human to observe three of the moons orbiting the planet Jupiter.  His discovery created a sensation since he had shown that there were objects in the universe that were not circling the Earth – throwing into doubt the view that his church, the Roman Catholic church, taught that the Earth was the center of the universe.

If Galileo had been alive today he might have been working for a private science company.  If so there is little doubt that they would have insisted he seek a patent for the marvelous telescope that revealed amazing secrets about the world.  If that company had been Myriad genetics they might have insisted that he not only patent the telescope but also everything he found when he looked through it, including Jupiter and its moons.  In a way, that is what Myriad did when in 1994 it, along with the University of Utah, sought a patent on an association scientists had discovered between a set of genetic mutations and a high risk of developing breast cancer.

The patents Myriad received have earned the company a pretty penny.  They have had a monopoly over all genetic testing for breast cancer for nearly two decades.  Doctors and patients have complained bitterly that Myriad’s high priced tests have limited access for many women and hindered efforts to conduct research that might have more rapidly improved the accuracy of testing.

I think the Myriad patents should not have been awarded.  Nor should any patent that relies solely on looking at genes as they exist in nature and finding associations with the risk of getting a disease.  The standard for a patent is not discovery but making something useful out of a discovery.  Patenting genes is too close to trying to patent the moons of Jupiter which Galileo discovered but did not create.  Myriad’s early patent arguably hindered the willingness of others to aggressively explore better tests for a terrible disease.  Other patents on other gene sequences could have the same effect.

If Myriad discoveries the equivalent of the genetic testing telescope then great—let them have their patent.  But finding what is out there in nature be it Jupiter, the moon, or a sequence of genes gets you a place in history but not a patent.

Pool of Siloam in Tennessee? Brute luck in health care distribution

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I had recently come across this piece in the NYT. The first thing that came to my mind is the biblical story about the pool of Siloam, a tale that, with all due respect to believers, illustrates the unfair distribution of health, but mostly the unfair distribution of health care (if we take as “health care” the healing powers of the pool). I have tried to adapt the story, as told in the Bible (John 5, 1-8) to the crude reality of the Tennessee of our days, in which, as reported by the NYT, many of its citizens lack access to basic health care services and have to trust in a sort of “phony miracle”. My paraphrasing experiment gave the following result:

“Now there is in Tennessee a program ran by the State Government, called TennCare, which has a hotline for applications. In these lay a multitude of invalids–blind, lame, and paralyzed [waiting for the opening of the line;] [for the Governor went down at certain seasons and opens the line: whoever gets in first after the opening of the line was helped for whatever disease he had.] One man was there who had been an invalid for thirty-eight years. When people from the Legal Aid Society in Nashville saw him lying there and knew that he had already been there a long time they told him, “Do you want to be helped?” The sick man answered him, “Sir, I have no one to put me into the pool when the line is open, and while I am trying to go through another connects before me.” The people from Legal Aid said to him, “Get up, take up your bed, and dial.” And at once the man was healed, and he took up his bed and walked…”

[The original King James version’ of the Gospel can be read here]

Big Data and Pharmacovigilance, Part I

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By Dov Fox

So much new data are created every day that 90 percent of all data worldwide has emerged in just the last two years. This information revolution has the potential, argues Bill of Health guest blogger Ryan Abbott, to transform how we develop new drugs, set clinical practices, and finance health care. His interesting new article paints an alluring “vision of a drug regulatory system powered by big data”:

“When the Food and Drug Administration (FDA) approved the cholesterol-lowering drug simvastatin in 1991, it was based on pre-marketing controlled clinical studies that included a total of 2,423 patients. In 2011 alone, just in the United States, almost a hundred million prescriptions were written for the drug. Imagine the impact of being able to analyze data from every one of those patients to evaluate whether simvastatin is safe and effective.”

The surveillance of pharmaceuticals after they’ve gone to market will matter more and more, Abbott argues, as personalized medicines become more difficult – and perhaps less necessary – to regulate before they’re released. He proposes a new plan for the post-market regulatory system that relies on the health information exchanges (HIE) created by the HITECH and Affordable Care Acts. These exchanges are slated to amass a vast repository of data on individual patients. Their large size and inclusive nature will enable more accurate analyses in observational research, Abbott suggests, and in ways that minimize the bias and selectivity problems associated with current data sets.

There are at least three obstacles to the integration of these exchanges in drug regulation. First, HIEs will be expensive. While the federal government provided considerable funding to get these exchanges off the ground, Abbott recognizes that in order to remain viable, they will probably have to sustain themselves financially. Second, their meaningful impact on post-marketing surveillance will require consistent reporting standards and information-sharing mechanisms. Third are important patient concerns about the privacy of their personal health information. States are experimenting with different patient participation models to address privacy concerns. For example, Abbott notes that in some states HIEs are free to exchange information without patient consent, while in others patients can opt-out of information exchange altogether. Either is permitted by HIPAA, so long as the information is de-identified so it can’t be used to identify individual patients.

Abbott argues that it’s worth tackling such concerns that the adoption of HIEs pose for citizens, policy makers, health care providers, and the health care industry, so we don’t squander the opportunity to use health information exchanges to their full benefit. Public support for data collection isn’t enough. That data must be translated into a format that regulators can use—something I’ll address tomorrow in my next post on the subject.