Concussions, the N.F.L., & the Manufacture of Doubt

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{SHAMELESS SELF-PROMOTION ALERT}

A new article of mine is out in the Journal of Legal Medicine entitled “Mild Traumatic Brain Injury, the National Football League, and the Manufacture of Doubt: An Ethical, Legal, and Historical Analysis.”  I’ve written on the subject before, but in case anyone is interested, here is the Abstract of the current paper:

This paper integrates legal, historical, and ethical approaches in analyzing the National Football League’s conduct regarding the risks its players face of experiencing concussions and the long-term neurodegenerative pathologies to which such injury is linked.  Given that millions of children and adolescents play American football, and that the NFL concedes its behavior is a strong determinant of football culture, concussion issues are crucial matters of population health.  Examining over 500 pages of testimony generated during Congressional hearings in 2009 and 2010, the paper links claims issued by leading NFL representatives to past efforts by industrial actors to manufacture doubt.  The paper therefore argues that the history of public health is crucial to framing just public health policy in the present.  The paper applies two frameworks drawn from public health ethics to argue first that a robust process of public reason is stymied by the NFL’s insistence on privately holding information relevant to its attitudes, practices and beliefs regarding concussions, and second, that the unequal distribution of ‘football prevalence’ exposes already disadvantaged groups such as African-Americans to higher risks of concussions and neurological disease.  The paper concludes that this latter possibility may contravene mandates of social justice, and, if so, would be ethically suboptimal.

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Bioethicist Edmund Pellegrino Has Passed

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By Christopher Robertson

On June 13, 2013 Dr. Edmund Pellegrino died at the age of 92.  (Obituaries are available here and here.)  For bioethicists this is a time to reflect, but in particular affiliates of the Petrie Flom Center will recall that one of the very first events that that the PFC hosted was a distinguished panel to discuss the concept of human dignity in bioethics, featuring Martha Nussbaum, Nick Bostrom, Dan Brock, and Edmund Pellegrino.  (I recall attending the event as a student.)  The webcast is still available, at the bottom of the page, here.  This event commemorated the release of the Presidential Bioethics Advisory Commission’s new book on the topic of human dignity.  Dr. Pellegrino chaired the PBAC, and his contribution to the book is available online here.

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Guest Post: Crack Down on Those Who Don’t Vaccinate?: A Response to Art Caplan

The Petrie-Flom Center Staff

As of Friday, June 28, this post is closed to further comments. We want to thank the many readers who have engaged in a vigorous and civil discussion on the recent posts to the Bill of Health that engage questions related to the debate over vaccines. In general, we do not moderate discussions on the site. However, due to an increasing number of comments that violate our policies regarding abusive and defamatory language and the sharing of personal information, we are closing these posts to comment.

By Mary Holland, J.D.

Mary Holland is Research Scholar and Director of the Graduate Legal Skills Program at NYU Law School. She has published articles on vaccine law and policy, and is the co-editor of Vaccine Epidemic: How Corporate Greed, Biased Science and Coercive Government Threaten Our Human Rights, Our Health and Our Children (Skyhorse Publishing, 2012). 

Dr. Art Caplan recently posted an editorial, “Liability for Failure to Vaccinate,” on this blog. He argues that those who contract infectious disease should be able to recover damages from unvaccinated people who spread it. If you miss work, or your baby has to go to the hospital because of infectious disease, the unvaccinated person who allegedly caused the harm should pay. Dr. Caplan suggests that such liability is apt because vaccines are safe and effective. He sees no difference between this situation and slip-and-fall or car accidents due to negligence. Arguing that “a tiny minority continue to put the rest of us at risk,” he suggests that public health officials can catch the perpetrators and hold them to account through precise disease tracing.

Dr. Caplan’s assertions to the contrary, vaccines are neither completely safe nor completely effective. In fact, from a legal standpoint, vaccines, like all prescription drugs, are “unavoidably unsafe.”  [See, e.g., Bruesewitz v. Wyeth, 562 U.S. __ (2011).‎] Industry considered its liability for vaccine injury so significant that it lobbied Congress for the 1986 National Childhood Vaccine Injury Act, providing doctors and vaccine manufacturers almost blanket liability protection for injuries caused by federally recommended vaccines. [See Authorizing Legislation.] The liability risk was so serious that the federal government created a special tribunal under the 1986 Act, the Vaccine Injury Compensation Program, to pay the injured. Moreover, the Supreme Court in 2011 decided Bruesewitz v. Wyeth, prohibiting any individual from filing a civil suit for a defectively designed vaccine in any court in the country. Industry’s extraordinary protection against liability for vaccine injury does not correspond with glib statements, like those of Dr. Caplan, that vaccines are safe and effective. On the contrary, the law acknowledges that vaccines cause injury and death to some, with no screening in place to mitigate harm.  Read More

The First Amendment Meets Public Health Again — The US AID Case

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By Wendy Parmet

Sometimes it seems as if the First Amendment is the leading legal threat to public health. Not today. In Agency for International Development v. Alliance for Open Society International the Supreme Court in a 6-2 decision struck down on First Amendment ground the so-called “anti-prostitution pledge” imposed by § 7631(f) of the  Leadership Act which prohibited the award of anti-HIV grants to groups or organizations that do “not have a policy explicitly opposing prostitution and sex trafficking” constituted an unconstitutional condition. Critical to the Chief Justice Roberts’ opinion was the fact that § 7631(f) did not simply limit grantees’ ability to use federal funds to support prostitution. Rather, it compelled a “grant recipient to adopt a particular belief as a condition of funding.”  According to the Court, the government can limit what grantees do with federal funds, but it cannot restrict what they believe.

Although the Court ‘s opinion focused on core First Amendment issues, rather than the public health impact of the anti-prostitution pledge, its decision should remind us of the complex and sometimes ambivalent relationship between public health and the First Amendment. Since the early years of the HIV epidemic, the First Amendment has been a crucial public health ally, limiting government’s ability to censor controversial but critical public health information. In many other cases, however, such as those challenging regulations aimed at tobacco or pharmaceutical advertising, a robust interpretation of the First Amendment seems to hinder public health protection. For public health law advocates, a key question is whether the First Amendment can be interpreted so as to protect health in both sets of circumstances. Equally critical is understanding how we can achieve public health goals without relying on the regulation of speech. Alliance for Open Society may offer some clues, but it clearly does not provide the answers.

WSJ on Health Law Jobs

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By Christopher Robertson

The Wall Street Journal has a new article this week celebrating the flood of new jobs for lawyers created by the Affordable Care Act.  The WSJ article rattles off a dozen or so examples of legal questions that arise from the new legislation and litigation, providing lots of fodder for a health law class.  This comes after a provocative session at ASLME’s health law professors conference last week, discussing an effort by the American Health Lawyer’s Association to create a model law school curriculum, starting with a survey course and broadening into a range of courses that could constitute a “certificate program.”

New JAMA paper “The Looming Threat of Liability for Accountable Care Organizations and What to Do About It”

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The Journal of the American Medical Association (JAMA) has just posted online (ahead of print) a new article by Ben Harvey and I entitled “The Looming Threat of Liability for Accountable Care Organizations and What to Do About It.” We discuss the Accountable Care Organizations (ACOs) that that the Affordable Care Act seeks to incentivize, the malpractice and other liability claims they may, and how the lack of an Employee Retirement Income Security Act (ERISA) shield of the kind enjoyed by Managed Care Organizations will impact the liability environment ACOs will face. We also discuss self-help remedies available to ACOs as well as potential congressional intervention to deal with these issues.

Supreme Court Decision on FTC v. Actavis paves the way for development of cheaper drugs

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Zachary D Caplan JD, attorney at law firm in Philadelphia that filed amicus brief on behalf of drug wholesalers and pharmacies in FTC v. Actavis

Arthur Caplan PhD, Division of Medical Ethics, NYU Langone Medical Center

Amidst all the news about various Supreme Court decisions there is one that ought not be overlooked for its impact both on public health and healthcare reform—FTC v. Actavis.  Today the Court decided, by a vote of five to three, that Big Pharma companies can be sued over deals with generic companies to not bring generic drugs to market.  In so deciding, the Court endorsed the idea that Big Pharma companies with weak patents on their drugs may not pay off other companies that want to make cheaper generic versions to not do so.  This practice, known as pay-for-delay, has run rampant in the pharmaceutical industry over the last two decades costing American consumers billions and restricting access to cheaper versions of drugs.

In FTC v. Actavis, the Federal Trade Commission had alleged a pay-for-delay arrangement between Solvay Pharmaceuticals and Actavis that was intended to keep Actavis from producing a generic version of Solvay’s blockbuster AndroGel testosterone drug.  A lower court—the Eleventh Circuit Court of Appeals—dismissed the FTC’s complaint.  Now the Supreme Court has reversed that dismissal.

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Supreme Court deals a major blow to reverse-payment settlements.

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By Nicholson Price

The Supreme Court keeps coming out with major opinions in the biotech/pharma area, with today seeing a major blow to reverse-payment settlements wherein brand-name pharma companies pay generic companies to delay their entry into the market.  This type of settlement shows the opposite pattern to that in most patent litigation, where the accused infringer (here, the generic drugmaker) usually pays the patent-holder, rather than the patent-holder paying the infringe, and is a result of the dynamics of generic drug market entry created by the Hatch-Waxman Act.  Since reverse-payment settlements result in the generic agreeing to stay out of the market in return for payment from the patent-holding brand name company, they look like antitrust violations – the question is whether the involvement of a patent (which creates a monopoly) means the settlements are acceptable under antitrust law.

Today, the Supreme Court came down on the side of protecting competition and sticking with traditional antitrust doctrines.  The Court didn’t go so far as to say that all reverse settlements are presumptive unlawful, instead requirings courts to apply a “rule of reason.”  But the Court firmly rejected the idea that a reverse payment settlement is immune from attack as long as it falls within the nominal scope of the patent.  The Court also noted that a large reverse settlement payment may itself provide evidence of a patent’s weakness, avoiding the need for a full determination of patent validity in the context of the antitrust action.  The opinion is here.

Prof. Einer Elhauge and Alex Krueger wrote about the economics of this question last year; their article can be found here.

Art Caplan on the Myriad Decision: Patenting natural DNA never made sense

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Bill of Health contributor Art Caplan weighed in on the Supreme Court’s decision in the Myriad case with an opinion piece at NBC:

“The Supreme Court has finally done what should have been done years ago — declared that genes which naturally exist in all of us cannot be patented.  For years Myriad Genetics, the company that sells the genetic tests used by Angelina Jolie and thousands of other women to assess their risk of breast cancer and ovarian cancer, has held back the development of better tests and access for many women to testing by invoking their patent claims on key genes. Now the Supreme Court has rightly said that kind of patent is not valid.

“Patenting a naturally existing gene never made any sense. Sure, it takes work to figure out what genes do, but the rewards for that are publications, tenure, professional honors and even a Nobel Prize — not a patent. Patents should be given not for discovery, but for inventions: What genes can you change; what test kit can you build; what program can you run to screen genetic risks?

“The implications of the decision could be far broader than Myriad, whose stock price went up after the ruling. Many companies have taken out patents on genes not only those found in humans but in animals, microbes and plants.  All of these are now in question — which may cause some reevaluation of the worth of some companies who have been touting their ownership of genes to Wall Street.”

You can read the full piece here: Patenting natural DNA never made sense.

Overdose Prevention Marches On

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By Scott Burris

Training lay people to reverse opiate overdose with naloxone continues to gain steam in the evidence base, popular media and legislatures. Here’s a great blog post the covers recent developments and links to a new film.  The Open Society Foundations and a group of harm reduction groups have launched a new website to promote these interventions.

This morning the House Energy & Commerce Health Subcommittee held the first of a series of hearings on prescription drug abuse.  ONDCP Director Kerlikowske & Dr. Doug Throckmorton of FDA have both testified and both discussed naloxone.

Meanwhile, last week, Vermont became the 13th state to pass a law expanding lay access to naloxone.