Now Available: Bioethical Prescriptions by Frances M. Kamm

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Bioethical Prescriptions: To Create, End, Choose, and Improve Lives

By Frances M. Kamm, Littauer Professor of Philosophy and Public Policy at Harvard’s Kennedy School of Government, Professor of Philosophy in the Harvard University Faculty of Arts and Sciences, and Petrie-Flom Academic Fellow alumna

This book is a collection of Frances M. Kamm‘s articles on bioethics, which have appeared over the last twenty-five years and which have made her among the most influential philosophers in this area. Kamm is known for her intricate, sophisticated, and painstaking philosophical analyses of moral problems generally and of bioethical issues in particular. This volume showcases these articles – revised to eliminate redundancies — as parts of a coherent whole. A substantive introduction identifies important themes than run through the articles. Section headings include Death and Dying; Early Life (on conception and use of embryos, abortion, and childhood); Genetics and Other Enhancements (on cloning and other genetic technologies); Allocating Scarce Resources; and Methodology (on the relation of moral theory and practical ethics).

Worth Reading This Week

Nicolas P. Terry Leave a comment

By Nicolas Terry

A “Torrent of Studies” on Direct-to-Consumer Advertising: Is FDA Shoring Up Its Defenses?

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By Kate Greenwood

Cross-Posted at Health Reform Watch

At Regulatory Focus earlier this week, Alexander Gaffney wrote about what he characterized as “a torrent of studies” that FDA is conducting or has proposed conducting on prescription drug promotion, and, in particular, on direct-to-consumer advertisements.  The studies include, among others, a survey study aimed at sussing out “the influence of DTC advertising in the examination room and on the relationships between healthcare professionals and patients”, a study exploring similarities and differences in the responses of adolescents and their parents to web-based prescription drug advertising, and a study that will use eye tracking technology to collect data on the effect of distracting audio and visuals on participants’ attention to risk information. 

Gaffney speculates that “the proposed studies could indicate coming changes in FDA’s regulatory approach toward advertising[.]”  Another possibility is that the studies are part of an effort by FDA to build up the evidence base supporting its current regulatory approach.  In a Tweet commenting on Gaffney’s article, Patricia Zettler–a  Fellow at Stanford Law School’s Center for Law and the Biosciences who was formerly an Associate Chief Counsel for Drugs at FDA’s Office of Chief Counsel–asks whether the data generated by the studies could help insulate FDA from First Amendment challenges. Read More

Animals, the WTO, and Public Morality

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Last week, a World Trade Organization panel ruled that EU restrictions on the import of seal products are justified under a free trade exception for trade restrictions that are “necessary to protect public morals.”  This is the first time that the WTO has backed a trade restriction grounded on concerns for animal welfare.

At issue in the case was a challenge to EU regulations that generally ban the import and marketing of seal products in the EU, with exceptions to the ban when certain conditions are met (such as when the seal products are derived from hunts conducted by Inuit or indigenous communities, or when the hunts are conducted for marine resource management purposes).

The panel ruled that the EU must alter its application of the exceptions (as it has thus far treated imported and domestic seal products differently), but concluded that the “objective of addressing EU public moral concerns on seal welfare” was a valid ground for imposing trade restrictions.   Thus, if the EU applies the exceptions consistently, the restrictions will be permitted.

One reason that this ruling is significant is that it paves the way for other trade restrictions based on animal welfare concerns.  Read More

12/9 conference: “Companies’ Global Health ‘Footprint’: Could Rating Help?”

The Petrie-Flom Center Staff Leave a comment

Imagine a rating or accreditation system for companies’ “global health footprint.” Such a system would rigorously assess companies’ overall impact on human health, including the health of the world’s poorest and sickest populations, then disseminate this information in ways that users could readily understand and act upon. If successful, such a system would inform and enhance choice for ethically-minded corporate executives, board members, investors, business partners, workers, consumers, and regulators.

Bringing together leaders and experts in ethics, global health, business, law, communication, and health-related quality and safety certification, this conference will discuss dilemmas, share best practices, and seek to identify forms of global health impact monitoring and labeling that could be affordable, rigorous, reliable, sensitive to community needs, and user-friendly.

The conference is free and open to the public, but registration is required. For more information, including the full conference agenda and registration links, please visit our website.

Organized by:
Nir Eyal, Associate Professor of Global Health and Social Medicine
Jennifer Miller, Edmond J. Safra Lab Fellow

Co-sponsored by the Edmond J. Safra Center for Ethics at Harvard University; the Division of Medical Ethics at Harvard Medical School; the Harvard Global Health Institute; and the Petrie-Flom Center, with support from the Oswald DeN. Cammann Fund.

Standards of Care and Patient Advocacy in Religiously Affiliated Hospitals

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By Nadia N. Sawicki

The New York Times reported today that the ACLU has filed a lawsuit against the United States Conference of Catholic Bishops on behalf of Tamesha Means, a patient at Mercy Health Partners in Michigan.  The suit alleges that Means suffered physical and emotional harm as a result of the Conference of Bishops’ ethical directives relating to pregnancy termination, which Mercy, as a Catholic health institution, is required to follow.

According to the ACLU press release and the Times article, when Means’ water broke 18 weeks into her pregnancy, she rushed to Mercy Health, the only hospital in her county.  According to medical experts, the fetus had “virtually no chance of surviving” and posed a significant risk to Means’ health.  Mercy physicians did not share this information with Means, and discharged her without informing her that terminating the pregnancy and extracting the fetus was the safest course of action from a medical perspective. Means returned to the hospital twice in the next two days, suffering from infection and extreme pain, but it wasn’t until she miscarried that the staff at Mercy attended to her medical needs.   An obstetrician at the University of Wisconsin Medical School quoted in the Times described Mercy’s treatment of Means’ condition as “basic neglect.”

Rather than suing Mercy Health Partners, Means and the ACLU are suing the Conference of Bishops.  They argue that by directing Catholic hospitals to avoid terminating pregnancies or providing referrals (even when a woman’s health is at risk), the Conference of Bishops is ultimately responsible for the harms suffered by Means and other women in her position.  According to Louise Melling, deputy director of the ACLU, “This isn’t about religious freedom, it’s about medical care.”

There are a host of legal, ethical, and religious issues associated with the Tamesha Means case.  But in this post, I’d like to focus on only one – the division of legal responsibility between health care providers and third parties when it comes to patient advocacy and quality of care. Read More

Great piece on ER pricing

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By Nicholson Price

The New York Times has posted another installment of its excellent series, “Paying Till it Hurts,” by Elisabeth Rosenthal, this time on the astonishingly high costs of emergency room visits.  The piece is worth a read in full for its infuriating detail—really, I think the whole series is—but the message is pretty clear.  I’d also be remiss in not noting that the basic message, with its own set of excruciating details, was laid out in Steven Brill’s piece in Time magazine back in March.  But it’s such a big issue that it deserves this kind of attention.

The basic point is that the costs charged by hospitals are incredibly high, highly variable, and invariably opaque.  Hospitals price procedures, products, and everything else based on the typically secret (but not in California!) “chargemaster,” which lists sticker prices for everything.  Hospital executives speaking about the chargemaster say no one pays sticker price.  That may be true, but the discounts from sticker are almost totally opaque, which hampers the market’s cost-checking role (the Times piece describes Sutter Health contracts as having “gag clauses” so that insurers who negotiate with Sutter can’t tell the employers who are paying for the insurance what rates have been negotiated).  In addition, lots of locales are dominated by one or two hospital systems, which consolidate then raise prices without worrying much about competition.  Finally, most people aren’t comparison shopping for an ER visit anyway – even if they could.

The effect of opacity and consolidation looks to be pretty regressive—even if no one plays the sticker price, the people paying closest to it are those without insurance, who have no prenegotiated discounts and no one to argue on their behalf.  Cal. Pacific’s CEO, Dr. Warren Browner, argues for opacity for pseudo-progressive goal of fleecing rich foreigners (“You don’t really want to change your charges if you have a Saudi sheikh come in with a suitcase full of cash who’s going to pay full charges.”), but that seems a lot rarer than near-poor coming in to ERs uninsured and getting billed full fare (especially if, a la a certain recent presidential candidate, ERs are our health care system for the uninsured).

As in the rest of the US health care system, higher costs appear to be totally divorced from quality of care or outcomes (national variation here (pdf), international comparison here).

It’s hard to see what effect PPACA/ACA/Obamacare might have on this problem.  The Independent Payment Advisory Board has lots of power (or will once it has members), but is still Medicare-focused.  Cost-savings in Medicaid or Medicare payments might spill over into the private insurance market, but if the opacity and market power mechanisms remain, it’s not obvious to me how and why that would really happen.  Medicare is already paying by care episode much more than private insurers, who are still usually fee-for-service.  More competition and transparency might help (More vigorous antitrust enforcement?  Required disclosure of billed/paid costs? (maybe, but maybe not)).  Maybe the fact that more people will be insured will make a difference; if the biggest burden is borne by the uninsured, who have little leverage, lowering that numbermight lower the burden.  But it could also just make it even more unfair for those who remain outside the system.

[UPDATE 12/5/13: I missed Section 9007 of the act, which requires charitable hospitals to publish their chargemasters and prohibits charging chargemaster rates to individuals who qualify for financial assistance (instead, they’d be charged insurer-negotiated rates).  Unfortunately, the implementing regulations haven’t been promulgated by HHS or Treasury, so these provisions aren’t yet applicable.  But eventually they may help, once they’re implemented.  Steven Brill has a piece on this here, and Sarah Alder here.]

In any case, the Times piece is worth a read.  And so are the previous four entries (on colonoscopies, pregnancy, joint replacement (with a nice discussion of medical tourism), and prescription drugs).

Delay of the Small-Business Health Insurance Exchange Launch May be a Good Thing

The Petrie-Flom Center Staff 1 Comment

By Allison Hoffman

The Obama administration announced last week that the federally-run small-employer health insurance exchanges (or “SHOP” exchanges) will be delayed for a year, until November 2014.  This announcement, like others regarding delays in PPACA implementation, generated a flurry of negative reactions from the media and some members of the business community.  Critics lament that the lack of an online marketplace for small businesses in some states this year will make it more difficult for those businesses to compare options and to access tax credits (available to those with 25 or fewer employees and an average wage up to $50,000).  Their bottom line stated fear is that these impediments will deter some small businesses from offering their employees coverage at all.

But this delay – and any reduction in small-employer health insurance uptake – might not be all that bad.  To the extent this delay sends employees of small businesses into the individual-market exchanges instead, it might be a good thing in the long run, for both employees and employers.  I outline the reasons why in detail in an article published in the Iowa Law Review Bulletin, An Optimist’s Take on the Decline of Small-Employer Health Insurance.  In short, in the individual market, many employees will be able to buy good coverage at lower overall costs to them and their employers.  Many small-business employees would receive tax subsidies and will find as good or better risk pools.  Plus, their individual-market options are likely to be as good or better than the insurance they would get if covered through their jobs.  Small businesses won’t have to bear the burden of health insurance costs and administration and are exempt from employer penalties under the Affordable Care Act.  If businesses save money overall, it could slow the trend of income stagnation driven by increasing health care costs.  My article addresses other reasons why the decline of small-employer health insurance might be more socially efficient and equitable.

Paul Downs, a small business owner in Philadelphia, describes anecdotally cases where some of these reasons play out in an insightful November 25th New York Times blog post, Seven Conclusions About Small-Business Health Insurance (see especially his numbers 6 and 7).

Significant paper on GMO food risks retracted

W. Nicholson Price Leave a comment

By Nicholson Price

In the debate over whether genetically modified organisms should be allowed in the food supply or labeled when they’re used, a central question is whether GMOs are any more dangerous to people eating them than other foods.  This is far from the only concern raised by GMOs—that list includes things like the dangers of pervasive monoculture over diversity, intellectual property issues about crop ownership, the loss of traditional food sources, and the unintentional spread of modified organisms—but it’s a big one, and a major lever of consumer engagement.

In this debate, a significant piece of evidence frequently cited by the anti-GMO camp was a 2012 study by Seralini et al. that rats fed Roundup-ready corn were more likely to develop cancers (Roundup-ready corn is sold by Monsanto and is resistant to its popular herbicide Roundup).  I say was because the journal, Food and Chemical Toxicology, has just retracted the paper.  The paper was hugely controversial—which certainly isn’t justification for retraction—but that controversy prompted the editors to take a closer look at the raw data, after which they concluded that the number of rats studied was too low to justify the paper’s conclusions.

This episode unfortunately illustrates, among other things, the problems with intense media attention to early scientific reports, and with research-as-weapon rather than research-as-information.  Part of the hubbub came from the draconian embargo imposed on journalists before the article was published: because journalists weren’t permitted to seek any independent evaluation before publication of the article, many media reports ran enthusiastic coverage of the article before the scientific community started pointing out the many flaws in the research.  The eventual feedback from the scientific community—part two of peer review, when publications are criticized in the literature and addressed by letters and other publications—was certainly powerful, and led to the retraction.  But that doesn’t change the fact of its initial publication, and I’d bet quite a bit that the article will be cited for years to come as evidence that there’s not scientific consensus on this issue.  In fact, in a depressingly unsurprising development, Seralini is threatening to sue the journal over the retraction.

(For more on GMOs on Bill of Health, Kuei-Jung Ni just posted about the failure of the GMO-labeling initiative in Washington state, Glenn Cohen has written on the frankenburger, and I’ve written briefly about GMO crops spreading and intellectual property issues with GMO seeds.)