The AOL Babies: Our Healthcare Crisis in a Nut

Nicolas P. Terry Leave a comment

By Nicolas Terry

Cross-posted from HealthLawProf Blog.
Where does one start with AOL CEO Armstrong’s ridiculous and unfeeling justifications for changes in his company’s 401(k) plan. Cable TV and Twitter came out of the blocks fast with the obvious critiques. And the outrage only increased after novelist Deanna Fei took to Slate to identify her daughter as one of the subjects of Armstrong’s implied criticism. Armstrong has now apologized and reversed his earlier decision.
As the corporate spin doctors contain the damage, Armstrong’s statements likely will recede from memory, although I am still hoping The Onion will memorialize Armstrong’s entry into the healthcare debate (suggested headline, “CEO Discovers Nation’s Healthcare Crisis Caused by 25 Ounce Baby”). But supposing (just supposing) your health law students ask about the story in class this week. What sort of journey can you take them on?

Are We Misusing the “Brain Death” Diagnosis to Hurry Along Families?

The Petrie-Flom Center Staff Leave a comment

Cross-posted from HealthLawProf Blog. Originally posted January 20, 2014.

What are We Learning About Brain Death from the McMath and Munoz cases?

By Jennifer S. Bard, J.D., M.P.H., Ph.D.

With the understanding that this is one of those topics that health law professors are supposed to know something about, here is a quick update of what’s going on.  Along with my own views about the possible misuse by hospitals of declaring brain death in what are really medical futility cases.

Jahi McMath, age 12, in California who lost consciousness after a routine tonsillectomy and Marlize Munoz, age 32  in Texas who collapsed on her kitchen floor have both become involuntary public figures as their families struggle to make sense of both their medical conditions, which are complex, and of the laws which have declared them both legally dead based on a lack of brain activity.  In legal terms, a person declared “brain dead” has the same status as any other dead person.  Each state is entitled to make its own decision of whether or not to adopt a brain death statute.  California’s and Texas’ are similar in that they require the “complete cessation” of all brain activity.  The declaration of death is, in all states, a legal act.  Most hospitals have a policy similar to this one which set criteria and require the participation of at least two doctors.  A declaration of death cuts off any rights of the individual.  The family of someone declared dead is no longer a surrogate decision maker.  Rather, they have something like property rights to the disposal of the remains.    More pointedly, a declaration of death ends all eligibility for medical insurance, including Medicaid and Medicare.  If a family decides to release the organs for donation, their host becomes not a patient but rather a “heart beating organ donor.” 

When a family wants to donate their loved one’s organs, a declaration of brain death is helpful mechanism for doing so.  Indeed, a series of high profile cases involving anencephalic infants in the 1990s pointed out the frustrations of parents who wanted to donate their children’s organs but could not because they retained minimal brain function.  However, there is never any legal need  for a declaration of brain death in order for a family to withdraw life sustaining treatment.  In 1993 bioethicist Robert Veatch wrote an important article in the Hastings Center Report in which he pointed out that “no one really believes that literally all functions of the entire brain must be lost for an individual to be dead.”  And indeed, no one really believes that a piece of paper converts a warm, breathing body from alive to dead.

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2/19: Patents without Patents: Regulatory Incentives for Innovation in the Drug Industry

The Petrie-Flom Center Staff Leave a comment

February 19, 2014 12:00 PM Wasserstein Hall 1015
1585 Massachusetts Ave., Cambridge

In the pharmaceutical industry, patents are the preeminent incentive for innovation in developing new drugs.  But patents aren’t the whole story; regulatory agencies also offer different forms of exclusivity—enforced by the agencies themselves—to encourage different forms of innovation in the industry.  This panel will discuss actual and potential roles for those rewards in the context of developing new drugs, new uses for old drugs, and new ways to make drugs, in both the United States and the European Union. Panelists include:

  • Benjamin N. Roin, Hieken Assistant Professor in Patent Law, Harvard Law School; Faculty Co-Director, the Petrie-Flom Center
  • W. Nicholson Price II, Academic Fellow, the Petrie-Flom Center
  • Timo Minssen, Associate Professor, University of Copenhagen Faculty of Law; Visiting Scholar, the Petrie-Flom Center
  • Moderator, Aaron Kesselheim, Assistant Professor of Medicine, Harvard Medical School; Director of the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital

This event is free and open to the public. Lunch will be served. For questions, contact petrie-flom@law.harvard.edu or  617-495-2316.

New PHLR (and George) Papers

Scott Burris Leave a comment

Laura Brennan, Ross Brownson and Tracey Orleans have come out with an important paper reviewing the evidence on policy and environmental strategies for reducing childhood obesity. Twenty-four strategies and 2000 published and gray literature documents are covered.  This is a menu of more-or-less evidence backed ideas for intervention.

Sam Harper and colleagues come out with an interesting new argument for primary seat belt laws, based on a disparities analysis. Looking through the lens of education level, they  (well, we, since I am one of the authors) find that, while primary enforcement has a powerful affect at every educational level, the impact is greater on people with less education.  Thus, existing SES differentials in seat belt use could be reduced if all states (finally) went to primary enforcement.

Even kids like paternalism?  Well, that may not be the best interpretation of this next study. Williams and McCartt surveyed New Jersey teenagers about three GDL requirements that are unique to that state: minimum licensing age of 17; application of full GDL rules to beginners younger than 21; and requiring license status decals on vehicle plates of GDL drivers.  84% liked licensing at 17, and 77% approved applying Gthe rules even to older novices.  The decal policy was approved by only 23% — but a PHLR study showed it works, so I say get used to it.

Two new tobacco law studies round out the week’s harvest.  Heikki et al. map the diffusion of health warning regulations since 1966, showing a big impact of the FCTC. Finally, in a paper that may start some arguments, Kevin Callison and Robert Kaestner report that adult smokers may not be as responsive to cigarette taxes as many believe.  They suggest it will take increases on the order of 100% to get a further 5% reduction in smoking rates.  Well, I’m okay with that.

Over on the George side of things, Peter Jacobson and Wendy Parmet have posted a thoughtful response to Larry Gostin’s Bloomberg commentary in the Hastings Center Report.  They are helping us move away from a habitual application of the paternalism critique and reminding us that public health can play in the democracy sandbox pretty well.

Art Caplan: Mandating Flu Shots Is the Moral Choice

acaplan Leave a comment

Art Caplan has a new piece at NBC News online arguing that the Rhode Island Department of Health is right to propose a new policy mandating that “all children between 6 months and 5 years of age would have to be vaccinated against the flu before entering daycare or preschool.” From the piece:

Not only is the ACLU inexcusably wrong about the value of flu vaccination for young children, it is way off the mark on the issue of liberty. The Rhode Island law is not about protecting kids. It is trying to prevent infected kids from killing or making other kids sick, especially those with asthma or immune diseases. It is trying to prevent killing grandma by infecting her, killing pregnant women’s fetuses or striking dead the neighbor who is getting chemotherapy or is post an organ-transplant who encounters an infected baby or child at the supermarket, train station or movie theater. Read More

Petrie-Flom Interns’ Weekly Round-Up, 1/31-2/7

The Petrie-Flom Center Staff Leave a comment

By Chloe Reichel

1) On February 11, the FDA will launch its “Real Cost,” anti-smoking campaign. The $115-million campaign is geared toward discouraging teenagers from smoking by emphasizing the “personally relevant” effects of smoking.

2) Lawsuits against the manufacturer of Pradaxa, Boehringer Ingelheim, have revealed internal documents about the dangers of the drug. The drug, a blood thinner, has been associated with over 1,000 deaths.

3) By October 2014, CVS will no longer sell tobacco products. CVS has decided to implement this ban because, increasingly they see their role as providing health care, and tobacco products cause negative health effects.

4) Naxolone, a drug that is used to reverse the effects of opiate overdoses, is now available to patients in California through their doctors. Prior to the creation of this law, the drug was much less widely available–primarily it was administered in emergency rooms.

5) Following the implementation of the Affordable Care Act, between 1 to 2 million Americans have enrolled in Medicaid. A study from Avalere Health states that this number increased only partially because of the ACA.

6) This Thursday, the Food and Drug Administration released regulations to guarantee that infant formula is safe for consumption. The regulations stipulate that certain nutrients are included in the product, and require tests for pathogens.

The bright side of antibiotic resistance

jurrutia Leave a comment

My parent’s generation grew up in fear of a nuclear apocalypse: the cold war was raging, team USA and team USSR were competing in a frightening arms race, and people were building bomb shelters in preparation for a nuclear end to the world. That’s like so 1950’s though; what’s hot now is the environmental apocalypse. We all know about rising water levels, and some doomsayers are even warning that enough methane is about to be released from the icecaps to cause the greatest mass extinction since the dinosaurs.

Me? I’m not too concerned about either of these scenarios, but it’s not because I’m much of an optimist. It’s because I’m convinced that bugs will kill most of us before we kill ourselves.

In 1928, Alexander Fleming discovered penicillin, and it was being mass produced by World War II. This means it has effectively been around for at least 70 years, and it still works against a broad range of bacteria. Superb; 70 years is a hefty amount of time–enough for billions of doses to have been administered–and we’re still going strong.

But bacteria don’t care. They’re (still) here, they’re (always) evolving, get used to it.

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2/21: “New Directions for Food Safety” — conference at Harvard Law School

The Petrie-Flom Center Staff Leave a comment

This one-day conference will bring together experts in food law and regulation to discuss a range of issues including food safety, agriculture, risk regulation strategy, and international issues.

Speakers are:

  • Keynote: Peter Barton Hutt, Harvard Law School/Covington & Burling
  • Alli Condra, Food Law and Policy Clinic, Harvard Law School
  • Marsha Echols, Howard University School of Law
  • Jacob E. Gersen, Food Law Lab, Harvard Law School
  • Lewis Grossman, Washington College of Law, American University
  • Ching-Fu Lin, Petrie-Flom Center, Harvard Law School
  • Sharon Mayl, Senior Advisor for Policy, FDA Office of Foods and Veterinary Medicine
  • Kuei-Jung Ni, Petrie-Flom Center, Harvard Law School/Institute for Technology Law, National Chiao Tung University, Taiwan
  • Margot Pollans, Resnick Food Law and Policy Program, UCLA School of Law
  • Michael Roberts, Resnick Food Law and Policy Program, UCLA School of Law
  • Denis Stearns, Seattle University School of Law
  • Stephanie Tai, University of Wisconsin School of Law

For the full agenda, including paper titles, please visit our website.

This event is free and open to the public, but space is limited and registration is required. To register, please click here.

For questions contact petrie-flom@law.harvard.edu or 617-496-4662.

Sponsored by the Petrie-Flom Center; the Food Law and Policy Clinic (a division of the Center for Health Law and Policy Innovation); the Food Law Lab; and the Harvard Food Law Society; with support from the Top University Strategic Alliance and the Dean’s Office at Harvard Law School.