Call for Abstracts: ACA Book

We’ll occasionally be posting event announcements here, as well as calls for papers, etc. that are likely to be of interest to our readership.  Speaking of which, one such announcement came in today (from Fritz Allhoff in the Philosophy Department at Western Michigan University):

A few months ago, we put out a call for a special issue of Public Affair Quarterly focusing on the Affordable Care Act decision.  The response was overwhelming, and we received far more submissions than we could accommodate in a single journal issue.  We’re now expanding the project to include–in addition to the special issue of the journal–an edited volume.  If anyone is interested in participating, please submit a 500-750 word abstract to Fritz Allhoff (fallhoff@umich.edu) directly. The coverage will still be the same as the earlier call, available here: http://www.wmich.edu/medicalhumanities/files/ACA_CfA.pdf

 

Generic Drugs: Grabbing a Bigger Slice

by Jonathan J. Darrow

The expiration of the patent on $11-billion-per-year Lipitor® (atorvastatin calcium) last November received wide media attention and was eagerly greeted by consumers, reflecting public excitement that seems to have not yet dissipated.  In the following months, prices “plunged from about $175 a month for Lipitor to about $15 for generics,” according to a recent article in the New York Times. At times it felt as if legions of consumer Davids had triumphed over a corporate Goliath.

Although the public’s euphoria over the availability of cheaper generic versions of drugs is an understandable cause for celebration, price decreases in themselves should not be mistaken for net gains to society.  The societal gains represented by new drugs, to the extent there are any gains at all, come from the new therapeutic benefits that those drugs offer to patients. The entrance of generic competition, on the other hand, merely represents a shift of wealth from one unit of society (originator manufacturers) to another (patients, and also generic drug companies and insurers).

While individual consumers may care little about “net gains to society,” policy-makers should care: If there are no net gains to society from the high prices preceding patent expiration, then perhaps the patent system should be abolished entirely.  That option, however, has not been a serious topic of discussion in the United States since the 1870s. Instead of debating the underlying issues, however, the public’s attention is focused on what is easiest to see: When can I pay less?  One has to wonder, however, what the innovative landscape would look like if more attention were paid to baking a bigger pie, rather than celebrating the newfound ability to grab a bigger slice.

When Common Ground Becomes a Healthcare Battleground

By Cassie Chambers

The addition of Paul Ryan to the Republican presidential ticket has brought the healthcare proposals of both parties to the forefront. To listen to the Sunday morning talk shows, you’d think the platforms were definitively and irreconcilably split on every health-related issue. Examining healthcare proposals from both sides, however, shows that they have more in common than you might realize.  Yet we seem to have reached a point where this common ground isn’t something to celebrate, but rather a reality to retreat from as quickly and decisively as possible.

Let’s start by rewinding a few years.

  Read More

Broadening “Innovation Law & Policy” (and “Human Subjects Research”)

By Michelle Meyer

In legal scholarship and education, innovation law and policy is virtually synonymous with intellectual property in general, and with patent law in particular. This is curious and, I think, misguided. We expend considerable effort designing optimal incentives for innovation. We expend similar effort ensuring that socially useful knowledge, once produced, is widely and accurately disseminated. But if knowledge-producing activities themselves are suboptimally regulated, neither upstream incentives to engage in them nor downstream mechanisms to disseminate their fruits will much matter.

In Regulating the Production of Knowledge: Research Risk-Benefit Analysis and the Heterogeneity Problem, I

critically examine[] that regulatory framework, adopted by more than one dozen federal agencies in the U.S. and many other countries, which governs the vast majority of those knowledge-producing activities that have the greatest potential to affect human welfare: research involving human beings, or “human subjects research” (HSR). [The Article] focuses on the primary actors in the regulation of HSR — licensing committees called Institutional Review Boards (IRBs) which, before each study may proceed, must find that its risks to participants are “reasonable in relation to” its expected benefits for both participants and society. It argues for a particular interpretation of this risk-benefit standard and, drawing on scholarship in psychology, economics, neuroscience and other fields, argues that participant heterogeneity prevents IRBs from carrying out their regulatory duty. Instead, the regulatory system implicitly responds to the heterogeneity problem with risk aversion that is costly not only to researchers and society but, critically, to would-be research participants. The Article concludes by laying out the policy options that remain in the wake of the heterogeneity problem’s intractability: continuing the legal fiction of risk-benefit analysis, honestly embracing the heterogeneity problem and its costs, or jettisoning IRB risk-benefit analysis. A companion Article develops the possibility of the third option.

HSR is not, of course, unknown to the legal academy. Read More

No Doctor for the Obese?

by Nir Eyal

Yesterday, Boston public radio station WBUR interviewed a Massachusetts primary care physician who refuses to admit new obese patients. She claims that it’s because she lacks proper equipment, but she seems to have mixed motives. Earlier she had admitted that it’s rather because she feels that if they don’t lose the weight, “I’m paying the cost of other people’s choices.” I bet if she lacked the equipment for wheelchair-bound patients, she would go buy it.

In an upcoming post (09/07: update here), Holly Fernandez Lynch, who, along with Glenn Cohen, gets kudus for kicking off this blog, will explain whether it’s legal for doctors to reject obese patients. But before rejecting them becomes the next trend, is it right?

A whopping 35.7% of Americans are obese, and the trend continues upwards. Obesity increases risk for heart disease, stroke, type II diabetes, and various cancers. It costs the system a fortune. We must tackle this problem head on. But conditioning physician access on weight loss is not the way. Read More

Should Mitt Romney (or Others Who are Pro-Life) Support Rape and Incest Exceptions to Abortion Bans?

by Glenn Cohen 

As America’s attention focused on the Republican Convention and the Obama campaign tries to portray a “Republican War on Women” at the Democratic one, last week Mitt Romney tried to clarify his position on abortion, namely: while he is generally against abortion, he would make an exception for cases where the mother has been raped or is the victim of incest. While politically savvy, based on other beliefs Mitt Romney has, this position is hard to defend if not incoherent.  Here is why: 

Mitt Romney, like most people who would outlaw abortion, must subscribe to two core beliefs: (1) Fetuses are persons and get the full panoply of the rights of persons from early on in their development (for Romney, like many, at “conception”), or at least possess a right not to be killed. (2) The mother’s interest in protecting her bodily integrity, making important reproductive or life choices, etc, does not outweigh the fetus’ right not to be killed. This is why Romney and other pro-lifers would prefer that abortion be banned even in the first trimester.

This logic is not incompatible with exception for the health or life of the mother. Through the well-known doctrine of self-defense, the criminal law has long recognized that an individual may be justified in killing to protect his or her own life, or possibly health, and these exceptions merely reflect a similar view as to fetuses.

The rape and incest exceptions, though, are on a different footing entirely.

Read More

Making Sense of Tobacco Regulation: The First and Fifth Amendment Challenges

[posted on behalf of Richard Epstein]

The entire question of the FDA’s tobacco regulation is likely to spur extended commentary, given the split of opinions between the D.C. Circuit, which knocked out the packaging labels by a divided vote in RJ Reynolds v. FDA, and the earlier decision in the Sixth Circuit, that sustained the regulation.  The packaging regulations have to be resolved once and for all on a national level, so the case will go up even, I think, if the D.C. Circuit decides to follow the Sixth Circuit in an en bank opinion.  So what then should be done?

The issue is one that I have approached before.  In the interests of full disclosure, I am a fierce opponent of smoking, who worked in from the mid-1980s into the early 1990s as a consultant for the tobacco lawyers on tort liability issues.  After that time, I worked on a number of other issues, in some instances taking positions adverse to the industry.  This particular post is done solely and wholly on my own.

In thinking about this case, much of the doctrinal dispute revolved around the much mooted  Central Hudson test used in too many First Amendment Cases.

Read More

Our First Foray into the World of Blogging

The Petrie-Flom Center at Harvard Law School is in an exciting phase of expansion.  One of our new initiatives is this blog, which we hope you’ll visit regularly for insightful commentary on current issues in health law policy, biotechnology, and bioethics.  Petrie-Flom affiliates will be blogging their thoughts here, as will a number of other leading experts from Harvard and beyond – introductions (and lots of them!) can be found below, or on the About Us page.  We’ll also be posting news and announcements from around the world, from upcoming conferences and calls for papers to job openings and funding opportunities.

Our aim is for this site to become your go-to place for all things related to health policy, biotech, and bioethics – from the legal perspective.  If there’s something you’d like to see here (or something you’d like to see done differently), please let us know.  We’re new at this whole blogging thing, so we’ve got a lot to learn.  But we hope you’ll bear with us as we bring together a bunch of great people for some really great (virtual) conversation.  On that note, please join in the conversation yourself – and comment, comment, comment!