Outsourcing the Up Goering of My Job Talk Paper to Forbes: Personalized Medicine, Personalized Regulation

By Michelle Meyer

So, one thing they say about being on the law teaching market is that you likely will never before have enjoyed — and, less happily, will likely never again enjoy — so much attention to your work and so many opportunities to discuss it. That’s totally true, and it’s totally fabulous. But there’s a flip side of that that they don’t tell you: after a while, you get burned out on talking about the same paper over and over again. You’ve likely moved on to other projects and are more excited about them, even if (or because) those projects build on your job talk paper. At this point in the process, your recitation of your job talk paper may have become rote and uninspired. You may, like me, have come to dread the act of rattling off your job talk paper’s thesis and why it matters.

And so it is that, having promised some months ago to blog my job talk paper on what I call the “heterogeneity problem” in research regulation, I have yet really to do so. I’ve blogged around the edges, to be sure (see, e.g., here, here, here, and here), but I can’t bring myself to explain the central thesis one more time. I also owe book editors (holla, Glenn and Holly!) a chapter on the challenges of heterogeneity for the growing global trend in “risk-based regulation” across many industries, and I’ve been procrastinating that, too, I think, largely because it requires me first to provide the reader with a précis of the heterogeneity problem. All of this is annoying, because there are lots of things that build on that central thesis that I’d like to write about, if only I could get over this strange aversion.

Enter physician-scientist David Shaywitz, whose overly kind piece yesterday in the Pharma & Healthcare section of Forbes.com, Personalized Regulation: More Than Just Personalized Medicine — And Urgently Required, highlights my work and, essentially, Up Goers it for me. It of course doesn’t cover all of the points I make in the paper, and in other ways it extends my thesis beyond what I defend in the paper, but it gives readers the gist. Thank you, David! (Let this also serve as supplemental answers to hiring committee questions about “What does your work have to do with the law?” and “Aren’t you ‘just’ a bioethicist whose work has no relevance for health or administrative law?”)

And now, with that out of the way, in my next post I’ll feel free to apply the heterogeneity problem to this question I was asked on Twitter. I can almost guarantee you that it will be my first and last post about football.

[Cross-posted at The Faculty Lounge]

Part I- Fragmentation in Health Care: The Patient’s Perspective

This past September, I had the unfortunate and ironic experience of transitioning from conducting research on the American healthcare system to being a patient in the American healthcare system.  In September, I was diagnosed with testicular cancer, while working as a research assistant for Professor Einer Elhauge, scouring the Affordable Care Act for regulatory powers with potential for defragmenting our national healthcare system.

Professor Elhauge, recently described fragmentation as a systemic lack of coordination between physicians, as well as between physicians and hospitals.  This fragmentation results in increased medical cost and medical errors.  My experience as a patient has led me to believe that defragmentation could help reduce other, less quantifiable, emotional and psychological costs to patients.  I will attempt to demonstrate this through recounting the first half of my story.[1]

Read More

Twitter Round-Up 1/1-1/13

By Casey Thomson

Due to the string of December holidays and some traveling by the round-up author, this post belatedly summarizes tweets from the end of 2012 to the beginning days of the new year. The round-up will resume a regular schedule following the conclusion of this week. Read below for this (extended) round-up:

  • Frank Pasquale (@FrankPasquale) posted an article about China’s growing obesity problem, one that shocks those who remember the Great Famine of 1958-61 and which is still largely minimized by government officials. The total number of obese individuals in China has risen from 25% in 2002 to 38.5% in 2010, according to the World Health Organization. (1/1)
  • Frank Pasquale (@FrankPasquale) also tweeted this blog post on the possibilities of cyborgs, a potential reality that a recent BBC article notes may not be too distant. Such an invention could potentially result in direct mental control of machines, augmented intelligence, augmented learning, and mood modification, among other benefits, postulates the article author. (1/1)
  • Frank Pasquale (@FrankPasquale) additionally posted a piece addressing the idea of love between humans and robots. (1/3)
  • Alex Smith (@AlexSmithMD) announced the release of PREPARE, an online advanced care planning tool meant for individuals to foster communication skills and prepare for decision-making rather than make premature plans. The project in part is meant to help empower individuals rather than have them tied to the medical establishment. (1/4)
  • Dan Vorhaus (@genomicslawyer) included a blog post on crowd-funding personalized bioscience, particularly summarizing companies aiming to contribute outside the genetics realm. This includes sequencing the gut microbiome and noting biomarker concentrations through the blood. (1/7)
  • Michelle Meyer (@MichelleNMeyer) posted an article decrying the paternalistic attitudes surrounding the release of genetic information to patients. Not only does this article claim that “People are smarter & more resilient [re #genetic info] than ethic debates give them credit for”, as Meyer references from the article, but it also recognizes that the complexities of the genome do not make it less necessary for doctors to figure out how to discuss it with the public. (1/7)
  • Michelle Meyer (@MichelleNMeyer) also posted about the Supreme Court’s decision regarding a case on government funding of embryonic stem cell research. SCOTUS declined to hear an appeal to stop the research, which opponents claimed was in violation of the 1996 Dickey-Wicker law. (1/7)
  • Daniel Goldberg (@prof_goldberg) posted about a recent study on the influence of body weight and gender on courtroom judgments. The Yale Rudd Center for Food Policy and Obesity found that only an obese female was punished when in consideration along with a lean male, an obese male, and a lean female. Goldberg notes in his tweet that the results are “unreal but sadly [unsurprising]”. (1/8)
  • Alex Smith (@AlexSmithMD) retweeted an article lamenting the continued fall of fellowship trained geriatricians, which noted that the decrease in numbers is surprising considering that a boost from the Affordable Care Act raises a geriatrician’s annual salary by 12 percent through 2015. (1/9)
  • Arthur Caplan (@ArthurCaplan) shared a link on a sperm donor custody case in Kansas where the sperm provider thought he had absolved any connection to the child that his sperm would create, but is now being called upon to pay child support. While similar cases have not received as much media attention, the concept – being responsible financially as a result of having genetic ties to a child – has come up in cases involving fathers who were deceased yet were called to pay through their estate, and even in a similar sperm donor case in Pennsylvania in 2011. (1/10)
  • Frank Pasquale (@FrankPasquale) posted an article discussing the recent move by  various healthcare centers requiring their health practitioners (doctors and nurses alike) to get a flu vaccine – possibly at the risk of their job. Should this be grounds for termination, or should the healthcare providers have the same choice to abstain from vaccination as does a patient? (1/13)

Note: As mentioned in previous posts, retweeting should not be considered as an endorsement of or agreement with the content of the original tweet.

Tell Patients: It’s Not All About YOU

By Art Caplan [cross-posted on MedScape]

This flu season is proving to be a doozy. The Centers for Disease Control and Prevention (CDC) in Atlanta say that this is one of the worst flu seasons ever. The agency reported severe flu cases in 46 states during the last week of December 2012. Eighteen states are considered to be at epidemic levels.

Hospital emergency rooms are swamped with flu patients. Hospitalizations from the flu are already in the thousands. Days of work being lost are escalating rapidly.

Boston Mayor Thomas Menino has declared a public health emergency in that city because of a sharp rise in cases of flu. Boston has had nearly 700 confirmed cases of influenza since the season began last October. That is a 10-fold jump over the 70 confirmed cases in the previous year.

Eighteen children and infants are dead because of the flu this season. The CDC doesn’t track flu deaths of people over 18. But many more people who are in the highest-risk groups — the elderly, the immune-compromised, those who have respiratory or cardiac conditions — certainly have died over the past few months from the flu.

The best protection against the flu is a flu shot. This year the efficacy of the flu shot is about 70%. That’s not a great number, but it’s good enough to require that doctors and nurses make sure that their patients are vaccinated.

Keep reading . . .

At $28,000 a Dose, How Effective Is Acthar?

By Jonathan J. Darrow

In a well-researched, recent post, Patrick O’Leary addresses the FDA’s efficacy requirements as applied to an old drug, Acthar (corticotropin), that was first approved in 1952 and granted an orphan designation in 2010 for the treatment of infantile spasms. The initial approval therefore occurred before the Drug Amendments of 1962, which instituted a “new” statutory requirement of efficacy (more on this below). O’Leary points out that Acthar’s “grandfather” status does not entirely exempt it from the FDA’s efficacy requirements, and that the drug did survive an efficacy evaluation under the DESI program. But how effective is Acthar?

Neither O’Leary nor the New York Times article on which his post is based dig very far into the clinical trial data accepted by the FDA as supporting the efficacy of the drug as a treatment for infantile spasms, and I was curious to know what the evidence says about Acthar in this regard. Clinical trial data is presented—or perhaps more accurately, “buried”—in Section 14 of a drug’s FDA-approved label; in the case of “H.P. Acthar Gel” (NDA 022432), that label can be found here. What does the clinical trial data reveal?  The section is brief, just half a page, and notes that of “[t]hirteen of 15 patients (86.7%) responded to Acthar Gel as compared to 4 of 14 patients (28.6%) given prednisone (p<0.002).”  Nonresponders were then given the other treatment, with the following results. “Seven of 8 patients (87.5%) responded to H.P Acthar Gel after not responding to prednisone,” while “[o]ne of the 2 patients (50%) responded to the prednisone treatment after not responding to Acthar.”  As the p-value (0.002) indicates, the first figures, at least, are statistically significant.  These figures were also better than I expected: 86.7% efficacy with Acthar does seem much better than 28.6% efficacy with prednisone.  Read More

Researchers to Lawmakers: Naloxone Distribution to Prevent Overdose Death is Cost-Effective

By Scott Burris

Phil Coffin and Sean Sullivan have published a cost-effectiveness study of interventions that equip heroin users and others to administer naloxone in the event of a witnessed opioid overdose.  Naloxone is the standard antidote, and can easily be administered by lay people with a minimum amount of training.  Family members and friends of opioid users can quickly get the drug into an overdosing user via injection or a nasal spray. In an accompanying editorial, top brass at NIDA and FDA sum up the news like this: the study

“represents a significant step in the evolution of the science in this area: a detailed analysis of the cost-effectiveness of overdose intervention with naloxone administration for heroin abusers. The authors suggest that lay naloxone administration is likely to be highly cost-effective in this setting, a robust finding that holds up under various assumptions. Future analyses that extend their findings to the setting of prescription opioids would be welcome.”

The editorial flags one of the major legal issues that gets in the way of wider naloxone distribution – its status as a prescription drug approved for use by injection. Changing this is a torturous regulatory process. In the short term, though, lawmakers can do a lot to get distribution going where it is needed.  As of July of 2012, eight states had passed laws to clearly authorize or otherwise reduce legal barriers to the prescription of naloxone to drug users and other potential good Samaritans. That leaves 42 states where programs may have trouble operating out of concerns related to prescribing a drug for a lay person to administer. LawAtlas covers the law and has examples of the legislative approaches these states have taken.

One more thing: evidence that naloxone distribution looks to be cost-effective ought to motivate lawmakers to consider these programs.  Many places don’t have them at all: a study published last year in MMWR reported, among other things, that “Nineteen (76.0%) of the 25 states with 2008 drug overdose death rates higher than the median and nine (69.2%) of the 13 states in the highest quartile did not have a community-based opioid overdose prevention program that distributed naloxone.”  In others, programs are operating but with little or no public funding to purchase naloxone, whose price has been rising precipitously (that’s another story about our creaking system for producing essential medicines).

Special issue in the Journal of Philosophy & Technology on evolution, genetic engineering, and human enhancement

By Yu-Chi Lyra Kuo

A special issue published this month by the Journal of Philosophy & Technology features a collection of articles discussing evolution, genetic engineering, and human enhancement. Recent years have seen a rapidly expanding variety of approaches to exploring the normativity of human enhancement, by philosophers, bioethicists, physicians, and biologists. The articles in this special issue largely focus on the question: how can evolution and aetiological teleology inform biological ethics and theories of human enhancement?

For a separate collection of articles discussing the ethics of human enhancement from the perspective of the physician-patient relationship, see this special issue by the American Journal of Bioethics, published approximately a year ago.

Happy reading, and happy holidays! ~YK

Twitter Round-Up (12/2-12/8)

By Casey Thomson
This week’s Twitter Round-Up features an “American Idol-style” selection of research grant winners, the problems facing children in Syria attempting to be vaccinated, and a review of where we stand with current patient health information privacy and security.
  • Michelle Meyer (@MichelleNMeyer) retweeted an article about a newly emerging landmark case in the United Kingdom. In the suit, a childless couple denied IVF funding due to the woman’s age is suing Health Secretary Jeremy Hunt (because he is “ultimately accountable for healthcare in England”) on the basis of age discrimination. Thought to be the first venture to sue the Health Secretary concerning decisions about this NHS fund rationing, this case also will be the first instance where age discrimination laws have been employed to try for fertility treatment. (12/3)
  • Alex Smith (@AlexSmithMD) shared an article about a problem patients must deal with when approaching post-hospitalization care: Medicare’s offer to pay for hospice care or for a Skilled Nursing Facility (S.N.F.), but only rarely at the same time. Not only does the choice create a financial predicament, but it also has extensive repercussions for the patient’s health. Calls for a combined benefit process between hospice/palliative care and S.N.F. have been made, including a proposed “concurrent care” demonstration project in the Affordable Care Act. (12/6)
  • Dan Vorhaus (@genomicslawyer) linked to a summary of the Ponemon Institute’s Third Annual Benchmark Study on Patient Privacy & Data Security, reporting on the challenges still being faced to safeguard protected health information (“PHI”). (12/6)
  • Michelle Meyer (@MichelleNMeyer) additionally retweeted a link explaining Brigham and Women’s Hospital’s attempt to deal with the rising difficulty of choosing which research grants to support: an “American Idol-style” public online voting. With almost 6,500 votes cast, the public engagement experiment picked a project hoping to research methods for integrating genomic sequencing into newborns’ routine medical care. When future grant holders are struggling to award between a set of equally deserving project proposals, this push for public involvement (after having confirmed scientific rigor) may have intriguing implications. (12/6)
  • Daniel Goldberg (@prof_goldberg) also linked to a study in Denmark testing the relationship between socio-economic status (SES) and blood pressure levels. Despite having a healthcare system that is free and equal-access regardless of factors like SES, the study found that SES had a “significant effect on BP [blood pressure] control” in this survey. (12/7)
  • Arthur Caplan (@ArthurCaplan) posted a report by UNICEF on the efforts by parents in the Syrian Arab Republic to get their children vaccinated. With many medical centers destroyed by the conflict, and with health practitioners having to operate and transport supplies in the dangerous environment, children have been unable to receive routine vaccinations for several months. This campaign aims to provide such vaccinations (specifically for measles and polio) to children, having advertised via churches, mosques, schools, television, and even by SMS to get greater coverage. (12/7)
  • Frank Pasquale (@FrankPasquale) included a book review of Pharmageddon by David Healy, a look at how pharmaceutical companies are excessively influencing the medical industry particularly with “diagnostic categories and clinical guidelines.” The result, according to Healy: a society where people “think about their bodies as a bundle of risks to be managed by drugs,” with a workforce that is “getting ‘sicker,'” and with “major pharmaceutical companies…banking on further overdiagnosis and overtreatment,” all “undermining universal health care.” (12/8)

Note: As mentioned in previous posts, retweeting should not be considered as an endorsement of or agreement with the content of the original tweet.

Study Reveals Complexities of Disclosing and Compensating for Medical Mistakes

[Editor’s Note, I am guest posting this on behalf of my wonderful colleague Michelle Mello, at the Harvard School of Public Health]

Gridlock in many state legislatures over proposals to reform medical liability by capping noneconomic damages—and growing recognition that caps have only modest success in addressing the problems with the malpractice system—have led  health care providers and other stakeholders across the country to think hard about alternative approaches.  Alternatives that don’t require the passage of legislation are especially appealing.  Attention has focused in the last couple of years on a promising approach pioneered by a handful of hospital systems, including the University of Michigan Health System: “disclosure-and-resolution” programs, or DRPs.  In DRPs, healthcare facilities and their malpractice insurers disclose unanticipated care outcomes to patients and their families; investigate and explain what caused them; apologize; and, where appropriate, offer compensation without waiting for the patient to sue.

Early adopters of this approach report remarkable success in reducing liability costs and believe they have markedly improved patients’ experience following a medical injury.  But they can’t tell how much of the benefit is attributable to disclosing errors and apologizing, versus offering compensation.  Is it the honesty and empathy, or the money, that matters?  And if it’s the money, how much is enough to get the outcomes healthcare providers want: reduced frequency of malpractice claims, lower defense and indemnity costs, quicker disposition, improvements in staff reporting of unanticipated care outcomes, and a clinical culture that supports open communication with patients?

A new study that I published with my colleagues, Lindsey Murtagh, Penny Andrew, and Tom Gallagher, in Health Affairs this week begins to answer these questions.  We used an experimental survey design to investigate the relative effects of disclosure, explanation, and apology on the one hand, and different kinds of compensation offers on the other, on people’s responses to learning that they were the victim of a medical error.  We fielded an online survey in which 2,112 American adults randomly received one of 16 vignettes in which they were informed of a medical error.  In all vignettes, a physician and administrator explained how the error occurred, took full responsibility, and apologized.  Some vignettes also included an offer of compensation—either waiver of medical bills, limited reimbursement of out-of-pocket expenses, or full compensation—while others included no compensation offer.  Respondents answered several questions about how they would react to the disclosure.  The survey sample was drawn from KnowledgePanel, a standing, probability-based panel of U.S. adults maintained by GfK (formerly Knowledge Networks).  The survey response rate was 65%.

What did we find?

Read More

Rationing Legal Services: Can Bioethics Help? My new article forthcoming in the Journal of Legal Analysis

There is a deepening crisis in the funding of legal services in the United States. The House of Representatives has proposed cutting the budget of the Legal Services Corporation (LSC), one of the main funders of legal assistance to America’s poor, to an all time low in inflation-adjusted terms. Other sources of funding, such as Interest on Lawyers Trust Account (IOLTA) are also way down due to low interest rates. More than 135 state and local organizations providing LSC assistance are now in a precarious position. The community was already decimated by the last round of cuts in January 2011, that led to the laying off of 1,226 lawyers and support staff at LSC-funded organizations, and 81,000 fewer low-income Americans receiving aid. This is all occurring at a time of extremely high unemployment and state budget cuts in services supporting low-income people, meaning demand for many of these services is going up.

The deepening crisis in funding of legal services only makes more pressing and manifest a sad reality: There is and always will be persistent scarcity in the availability of both criminal and civil legal assistance. Given this persistent scarcity, this Article will focus on how existing Legal Service Providers (LSPs), both civil and criminal, should ration their services when they cannot help everyone. To illustrate the difficulty these issues involve, consider two types of LSPs, the Public Defender Service and Connecticut Legal Services, that I discuss in greater depth below. Should the Public Defender Service favor offenders under the age of 25 instead of those older than 55? Should other public defenders offices with death eligible offenses favor those facing the death penalty over those facing life sentences? How should Connecticut Legal Services prioritize its civil cases and clients? Should it favor clients with cases better suited for impact litigation over those that fall in the direct service category? Should either institution prioritize those with the most need? Or, should they allocate by lottery?

These are but a small number of the difficult questions faced by those who have to ration legal services. Very little has been said as to what principles should govern the rationing of legal services. This is surprising given that civil and criminal LSPs are often funded through a mixture of government funding and charitable support in such a way that they should be answerable on questions of justice, and because their decisions whether or not to support a client is likely to have significant effects on that person’s life prospects. Thus, it seems as though the rationing decisions of LSPs deserve significant ethical scrutiny.

In my new article Rationing Legal Services, forthcoming in the peer-reviewed Journal of Legal Analysis (and available for free download in draft form now), I seek to remedy this deficit in the existing literature by engaging in a comprehensive analysis of how LSPs should allocate their resources given the reality of persistent scarcity. Luckily, this work does not have to begin at square one. There is a developed literature in bioethics on the allocation of persistently scarce medical goods (such as organs, ICU beds, and vaccine doses) that I use to illuminate the problems facing LSPs and the potential rationing principles they might adopt.