New Paper on Coercion and the Constitutionality of the Affordable Care Act

I have a new paper on the Supreme Court’s decision on the Affordable Care Act, just published in the European peer-reviewed philosophy journal Ethical Perspectives. It is available for free download here.  Here is the abstract:

While NFIB v. Sebelius largely upheld the Affordable Care Act (ACA), it did not do so as as to the proposed expansion of Medicaid. Seven of the nine U,S, Supreme Court Justices (all except Justices Ginsburg and Sotomayor) endorsed a ‘coercion’ argument that gave individual States a right of objection grounded in the Constitution’s Spending Clause, wherein individual states could refuse to expand Medicaid as demanded by the federal government without being directly penalized by a denial of federal funding. Two Justices in dissent focused on the lack of judicial administrability of such a standard, and suggested it would open up a Pandora’s box of future constitutional challenges without any clear rules.

In this article, part of a symposium on philosophical analysis of the Court’s decision published in the peer-reviewed journal Ethical Perspectives, I discuss what I see as a more fundamental question: by what theory is the Medicaid expansion coercive, and even if coercive, by what theory is it coercive in a problematic way that justifies constitutional redress?

The Court’s failure to address this issue stems, in part, from confusion over what it means for an offer to be coercive. In some sense, Justice Kagan seemed to recognize this issue in a question to Paul Clement, the lawyer for the challengers to the ACA, at oral argument: “Why is a big gift from the federal government a matter of coercion?” Kagan asked. “It’s just a boatload of federal money for you to take and spend on poor people’s health care,” Kagan added. “It doesn’t sound coercive to me, I have to tell you.” The exchange is all the more curious because, despite her scepticism, Kagan signed on to the Court’s holding that the Medicaid expansion was coercive.

I will examine this issue by first discussing whether Medicaid itself and the ACA’s expansion are coercive (as stand-alone offers). I will then examine whether the offer to change from the existing Medicaid program to the ACA’s Medicaid expansion was problematic. I will analyze these questions under the assumption that the Court is not committing a category error by treating States as the kinds of entities subject to this kind of coercion inquiry. In my conclusion, however, I briefly consider whether that assumption is warranted.

Reminder, Upcoming Conference on Universal Health Coverage in Low-Income Countries

A reminder that the Harvard University Program in Ethics and Health annual conference, Universal Health Coverage in Low-Income Countries: Ethical Issues, will be held in Boston on April 18-19, 2013.

AGENDA

http://peh.harvard.edu/events/2013/universal_coverage/agenda.html

REGISTRATION

No fee. Space limited. Registration required. Please register on our registration website.

Impact of the Sequester on Health Care: By the Numbers

By: Katie Booth 

The looming sequester will have a significant impact on health care, including cuts to Medicare, FDA, CDC, NIH, and Affordable Care Act programs. Budget cuts could slow down the drug approval process, impede the tracking of infectious diseases, and lead to layoffs for hundreds of thousands of workers in the health care sector. Read on for sequestration by the numbers…

Medicare:

  • Medicare cut by 2% ($11 billion) (not set to begin until April 1st, 2013, unlike other sequestration cuts, which are set to begin on March 1, 2013)
  • Physicians’ payments cut by 2%
  • Hospital Medicare reimbursement cut by $5.8 billion
  • Hospitals could end up with especially large cuts under the sequester because other parts of healthcare system run on longer term contracts
  • Loss of almost 500,000 health care sector jobs in the first year of the sequester according to an American Medical Association and American Hospital Association study, including job losses for 40,000 practitioners such as physicians and dentists

FDA:

  • FDA cut by 8% ($318 million)
  • FDA public funding cut by $206 million
  • FDA industry user fees cut by $112 million (for an interesting discussion of user fee cuts and the sequester, see Patrick O’Leary’s Bill of Health blog post)
  • Cuts by department (assuming 8% across-the-board cuts): $71 million to Foods, $39 million to Human Drugs, $17 million to Biologics, $11.3 million to Animal Drugs, and $26.5 million to Devices
  • Longer drug approval process is likely
  • Layoffs and furloughs likely
  • 2,100 fewer food safety inspections

Read More

The High Cost of Health Care: Why Some Pay $240 for a $9 Bottle of Pills

By Jonathan J. Darrow

An earlier post discussed the equivocal efficacy of Propecia (finasteride) as a baldness remedy, ending with the provocative assertion that, efficacy aside, “there is little reason for anyone ever to buy or consume Propecia (finasteride), or any doctor ever to prescribe it, since a much cheaper and identical chemical sold under the trade name Proscar (finasteride), is available.” This post continues the discussion, addressing one small component of the rising cost of healthcare—the cost of finasteride.  It explores why consumers pay as much as $240 for a bottle of Propecia (finasteride) when a $9 bottle of an equivalent, FDA-approved supply of the identical chemical is readily and legally available at nearby stores.

In the exorbitantly priced landscape of prescription drugs, there is at least one low-cost oasis: Wal*Mart.  Though some find reason to criticize the discount store, few would disapprove of the dozens of prescription medications Wal*Mart offers for an unbeatable $4 for a 30-day supply.  Cost-sensitive consumers can purchase everything from blood thinners to antidepressants to antibiotics at this price, while a 90-day supply is only $10 (and this price includes shipping to your doorstep).  A handful of drugs that cannot be sold at $4 per month sell for a still-modest $9.  For the 300 or so drugs on Wal*Mart’s list, this means there is no longer a need for $10 co-pays or snowy treks to the pharmacy in 15 degree weather.  That’s right: the Wal*Mart total price is less than most insurance company co-pays.  Finally, a major industry player seems to have put effective downward pressure on prescription drug prices.  Read More

Finasteride as an FDA-Approved Baldness Remedy: Is It Effective?

By Jonathan J. Darrow

Questionable baldness remedies have been peddled since the beginning of medicine. According to Pliny (23-79 A.D.), ashes of seahorse could cure baldness.  Almost 2000 years later, the British Medical Association warned the public of the increasing “number of preparations put forward for the cure of baldness,” particularly those which “are not applied locally but taken internally.”  The purported active ingredient? “[H]aemoglobin.”  (see Secret Remedies (1909), page 114).

While the medicinal use of a seahorse or dried blood matter may sound fanciful to modern ears, one has to wonder whether today’s public is any less credulous: Worldwide, consumers have spent over $400 million per year on a modern baldness remedy known by the trade name Propecia (finasteride).  Has science finally triumphed over a medical condition that has persisted through millennia? Today’s consumers might rationally believe that its has, given that Propecia is FDA-approved for the treatment of alopecia (baldness).  FDA-approved remedies must, according to federal law (21 U.S.C. § 355(d)), prove their efficacy in well-controlled, clinical investigations.

Yet one need only walk through a crowded street to see that, if a baldness cure has truly arrived, a surprising number of people have not availed themselves of it. Is Propecia, then, not effective? Let us take a look at the official data. Read More

Accentuate the Negative

by Suzanne M. Rivera, Ph.D.

While attending the annual Advancing Ethical Research Conference of Public Responsibility in Medicine and Research (PRIM&R) last month in San Diego, I had the opportunity to hear a talk by Dr. John Ioannidis, in which he debunked commonly accepted scientific “truths.”  Calling upon his own work, which is focused on looking critically at published studies to examine the strength of their claims (see his heavily downloaded 2005 paper “Why Most Published Research Findings Are False”), Ioannidis raised important questions for those of us who think about research ethics, and who oversee and manage the research conducted at universities and scientific institutes across the country.

Ioannidis persuasively argued that our system for publishing only studies with statistically significant positive findings has resulted in a bizarre kind of reality where virtually no studies are ever reported that found “negative” results.  Negative results are suppressed because nobody is interested in publishing them.  Editors and reviewers have a major role in this problem; they choose not to publish studies that are not “sexy.”  This artificially inflates the proportion of observed “positive” results and influences the likelihood a scientist will even write up a journal article because she knows what it takes to get published.

But isn’t there an ethical obligation to publish so-called negative results?  In human research, people give their time and undergo risks for the conduct of a study.  Their sacrifices are not meaningful if the results are never shared.  Furthermore, negative results tell us something important.  And if they are not published, some other research team somewhere else may unknowingly repeat a study, putting a new batch of subjects at risk, to investigate a question for which the answer is already known.  Finally, to the extent a study is conducted using taxpayer dollars, the data derived should be considered community property, and there are opportunity costs associated with unnecessarily repetitive work.  Read More

Conference Announcement: Universal Health Coverage in Low-Income Countries: Ethical Issues

The Harvard University Program in Ethics and Health announces its annual conference, Universal Health Coverage in Low-Income Countries: Ethical Issues, to be held in Boston on April 18-19, 2013.

Description

Until very recently, universal coverage (“UC”) has been achieved in the health systems primarily in the wealthiest countries. Though there have been notable exceptions, including Cuba, it has been assumed that most of the world’s peoples would have to wait until economic development in their countries lifted them into the world’s upper class. The successful UC initiatives of middle-income countries such as Mexico, Thailand, and Taiwan demonstrated that UC was achievable without very high national GDP.

Graphic: Three dimensions

Can Universal Coverage be achieved in even the world’s lowest-income countries? China’s recent health reform, which in three years has extended health coverage to 95% of Chinese citizens, including innovative financing initiatives in some of the poorest provinces, has focused the attention of governments of low-income countries on UC. The World Health Organization’s annual report of 2010, Health Systems Financing: The Path to Universal Coverage, identified the prospects for UC in even the least-developed countries and sparked an international effort to pursue this once-elusive goal.

While maintaining a constructive and optimistic frame of mind is essential for progress toward UC, it is necessary also to identify the key ethical dilemmas arising in trying to extend the health system to all with so few resources. The choices are unavoidable:

  • Between goals of UC (including financial protection against catastrophic medical expenses; health; and personal and national overall wellbeing);
  • Between dimensions of UC (who is covered; what is covered; what share of costs are covered); and
  • Trade-offs within and between each of these

Each country will resolve these dilemmas in its own way. Our hope is that this conference will enhance their capacity for ethical deliberation in UC, so that the ethical choices can be made responsibly and thoughtfully.

Dates and Times

Dates: Thursday and Friday, April 18-19, 2013
Times: 8:00 AM – 6:00 PM Each Day

Location

The Inn at Longwood Medical (Best Western Boston)
Longwood Hall, 342 Longwood Avenue, Boston, Massachusetts

Agenda

http://peh.harvard.edu/events/2013/universal_coverage/agenda.html

Registration

No fee. Space limited. Registration required. Please register on our registration website.

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

2012 Global Congress on Intellectual Property and the Public Interest

By Adriana Benedict

The 2012 Global Congress on Intellectual Property and the Public Interest has just come to a close in Rio de Janeiro, Brazil.  The conference brought together global leaders in intellectual property-related fields like access to medicines, access to knowledge, internet freedom, innovation and development, and open educational resources.  I was invited to participate in the various sessions concerning access to medicines, which focused on two sides of this global health challenge.

The first part of the access discussions focused on best practices and threats in the use of TRIPS flexibilities in developing countries.  Participants emphasized the need to look beyond the usual focus on compulsory licenses to set new priorities for understanding and leveraging less-developed flexibilities such as patentability criteria, patent opposition mechanisms and parallel importation.  An important overarching theme in these discussions was reframing flexibilities as rights, as they carry the same legal status as the intellectual property rights which make them necessary.

The other side of the discussions focused on innovation and research and development (R&D) for the developing world, primarily through recent advances by the WHO CEWG report in promoting a binding convention in this realm.  At the forefront of these proposals is the notion that incentives for innovation should be de-linked from product prices in order to address the needs of the developing world.  Participants emphasized that, moving forward, advocates should be careful to ensure that public and institutional debates on alternative R&D models do not narrow their focus from neglected populations to neglected diseases.

Read More

The Future of Biomedical Research Funding

By Patrick O’Leary

As I’ve written about previously on this blog, the consequences for the FDA of budget sequestration under the Budget Control Act of 2011 could be fairly severe (as well as raise some interesting legal questions). In a recent Online First piece for the Journal of the American Medical Association (JAMA), Hamilton Moses and E. Ray Dorsey note that sequestration would also have a serious impact–to the tune of $2.5 billion–on the National Institutes of Health (NIH), the primary source of public funding for biomedical research in the United States.

While Doctors Moses and Dorsey acknowledge that the immediate consequences of such a cut would primarily affect young researchers and new applicants for funding, “exacerbat[ing] tensions between large infrastructure projects . . . and small investigator-initiated grants, which historically have been the primary source of new clinical insights,” they also argue that sequestration presents an opportunity to reevaluate our emphasis on publicly funded biomedical research. In their telling, sequestration would be just the most recent step in a nearly decade-long trend of reducing federal funding, a trend that “presents an opportunity to reshape biomedical research.” Moses and Dorsey call for new private sources of research support, ranging from specialized financial instruments like Biomedical Research Bonds to an increased role for public charities and private foundations. The future of biomedical research, they argue, will be built on the private sector, not the federal government.

The challenges of shifting the burden of funding research to the private sector are many, of course. One particularly challenging question is whether private funds could effectively replace NIH’s significant role in funding “basic” research. Bhaven N. Sampat’s new article “Mission-Oriented Biomedical Research at the NIH” in Research Policy provides some context for the scale of the problem. Citing a 2010 study by Dr. Dorsey himself, Sampat notes that although NIH funding accounts for only about a third of U.S. biomedical research funding, “there is a sharp division of labor, with NIH funding concentrated further upstream, on ‘basic’ research than private sector funding” from private sector pharmaceutical, biotechnology, and medical device firms. Although the role of private foundations has grown in recent years, Sampat notes that NIH funding continues to exceed all such funding “by a factor of six . . . .” Assuming we continue to value basic research, the capacity and willingness of private actors to fund such research thus remains a major question mark.