Where Are We Now: Post 4, Looking in the Mirror, or 3 Games in Public Health

By Scott Burris

In a well-known exchange, Richard Epstein argued that modern public health had strayed far outside its traditional and proper work of preventing epidemics and injuries into a realm of social engineering in which it lacked both competence and legitimacy. William Novak, the historian, disagreed, emphasizing the continuity of our public quest for well-ordered, salubrious (and virtuous) communities. Deciding whether public health is winning or losing in the legal arena – and figuring out how we win more often — depends to some degree on what game it is we think we are playing – that is, on whether Epstein or Novak is right.

I think they both are, and it is worth considering how. I suspect that most of us think, without going too deeply, that we’re doing pretty much the same thing that Lemuel Shattuck was doing at the dawn of modern American public health: marshaling collective resources to use data to diagnose, treat and prevent harm to public health.  And if that’s what you think you’re doing, his report is still an excellent guide to making the case for legal action: evidence shows that we can prevent morbidity and mortality in a cost-effective way that does not significantly interfere with anyone’s rights and makes our society stronger and more competitive.

But law, at least, is a very good area for asking whether we are doing something quite different than our grandmother’s public health.  The use of law as a tool of intervention in public health – as a way of creating safer products and environments and incentivizing healthier behavior — has exploded since the 1960s. Yes, you can find public health law at work in the early 17th century, but when I was born in 1956, there was no OSHA, no EPA, no NHTSA. No warning labels on dangerous products. No safety belt standards or laws. Minimal limits on drinking and driving. No federal clean water or air standards. An unrecognizable FDA. And so on it goes.  In the great Novak-Epstein debate, Novak is right that we have a rich tradition of public health regulation, and plenty of paternalism and interference with individual rights based on epidemiological evidence of preventable harms. This is public health as sic utere, then and now largely a matter of showing how someone is doing something that demonstrably imposes costs on others. That’s why the debate Shattuck was waging sounds so familiar to contemporary ears. (And, by the way, that extends to the moralism implicit in our “scientific” recommendations about healthy lifestyles.)

But Epstein is right, too, I think, to observe that something is different. Public health is now a pillar of the regulatory state and the risk society, deeply enmeshed in the project of defining and minimizing risks great and, let’s face it, small.  We deploy complex regulatory systems, some of which work and some of which we continue to defend anyway, in spite of our own commitments to evidence. As matters like obesity and inequality take intervention further and further from proximate to distal links in the causal chain, our ability to back our proposals with evidence, and evidence that speaks to an everyday sense of causality, becomes severely attenuated. Much of what we propose rests on a vision of the good – salus populi – that is as much a matter of values as it is of evidence.  Failing to own that, we fool ourselves without winning over our audience.

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Regulatory Concepts in the News, Part I: FDA Efficacy Standards for Old Drugs

By Patrick O’Leary

While reading some of the great articles from the health section of the New York Times over the holidays it struck me that such articles, in their need to be concise and accessible, often give only passing treatment to regulatory concepts that can be fundamental to the story. Accordingly, I thought it might be useful to write a series of posts digging down a bit deeper into some of the regulatory foundations of health stories that percolate up to public attention through the news. In this post I’ll begin by looking at an interesting point relating to drug efficacy standards raised by an article about a newly expensive (but decades-old) drug.

In Andrew Pollack’s “Questcor Finds Profits, at $28,000 a Vial” we read that a drug called Acthar, first approved by the FDA in 1952 and used primarily to treat rare infantile spasms, has in recent years become a very expensive and (for it’s maker) lucrative treatment for conditions ranging from multiple sclerosis to rheumatologic conditions. The article is worth a read for its thoughtful discussion of drug pricing, but it also makes passing reference to a some important regulatory concepts that bear further examination. One issue that particularly stood out to me was Pollack’s statement that Questcor, Acthar’s manufacturer, has been able to market the drug for a variety of uses “without being required to prove that the drug actually works” because it was “essentially grandfathered” into an anachronistic efficacy standard by being “approved for use in 1952, before the [FDA] required clinical trials . . . .” On first read, that sounds fairly alarming, so I thought it might be worthwhile to unpack the law around such “grandfathered” drugs a little. While it is true that FDA did not require proof of effectiveness for new drugs until lawmakers included this requirement in the Drug Amendments of 1962, it isn’t the case that pre-1962 drugs simply get a free pass on proving effectiveness. The truth, as one might expect, is somewhat more complicated. Read More

Where Are We Now: Post 2, The Thrill of Victory

By Scott Burris

Between budget cuts and “nanny state” attacks, it’s easy to feel that public health is a perennial political loser.  As for the courts, the first two constitutional amendments alone are throwing up enough barriers to reasonable health regulation to keep us on the defensive for years. In this series of posts about how public health protagonists are faring in these politico-legal contests, I will criticize our side. There’s a great deal we do wrong, or at least fail to do well, and those failures are the first place to look if we want to stop being under-appreciated, underfunded and over-invalidated.  But before I put on the hair shirt, I will don satin with a post devoted to the very positive things there are to say about public health law and those who theorize and study it.

Make a list of the biggest health threats that have faced our people in the last fifty years. That list will certainly include lung cancer, cardiovascular disease, motor vehicle crashes, gun violence, communicable diseases, lead poisoning, mental illness and, more recently, drug overdose and obesity.  Now consider what law has done or is doing to address these threats.

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Film Review: How to Survive a Plague

By Suzanne M. Rivera

How to Survive a Plague is a moving chronicle of the onset of the AIDS epidemic as seen through the lens of the activists who mobilized to identify and make available the effective treatments we have today.  Beginning at the start of the epidemic, when little was known about the HIV virus and even hospitals were refusing to treat AIDS patients out of fear of contagion, the film follows a group of leaders in the groups ACT-UP and TAG.  Using existing footage interspersed with current-day interviews, it tells the story of how patients and concerned allies pushed the research community to find a way to treat what was then a lethal disease.

The film’s portrayal of the U.S. Government, specifically then-President George H. W. Bush and high ranking officials in the Food and Drug Administration, is damning.  As hundreds of thousands of people became infected with HIV and the death toll rose, prejudice against marginalized groups (especially gay men, IV drug users) contributed to a lack of urgency about the need to learn how stop the spread of the virus and how to treat the opportunistic infections that killed people with full-blown AIDS.  In contrast, footage of demonstrations, meetings, and conferences highlights the courage of the activists who risked and endured discrimination, beatings and arrests to bring attention to the need for more research.

But How to Survive a Plague is more than a documentary about the power people have to make change when they join together to demand action.  It also is a provocative commentary about unintended consequences.  I saw the film while attending the annual Advancing Ethical Research Conference of Public Responsibility in Medicine and Research (PRIM&R).  In that context, I was especially interested in the way How to Survive a Plague highlights an interesting ethical issue in clinical research. Namely, the problem of protecting people so much from research risks that the protection itself causes harm. Read More

Reminder, TODAY – The Guatemala STD Inoculation Studies: What Should We Do Now?

TODAY
12:30-2:00
Wasserstein Hall, Classroom 3019
Harvard Law School

In the late 1940s, US and Guatemalan researchers conducted a host of experiments on vulnerable Guatemalan subjects, purposefully exposing them to, and infecting them with a number of STDs without their consent.  The experiments were kept hidden for more than half a century, until they were discovered and exposed only recently by historian Susan Reverby.  The US government has since apologized for what happened, but a class action suit brought on behalf of the Guatemalan subjects was dismissed in June and efforts to directly compensate the victims have not been forthcoming.   Please join Harvard Law School’s Petrie-Flom Center and Human Rights Program for a panel discussion of the study and possible legal and political responses that may be available now, both domestically and from an international human rights perspective.  Panelists will include:

  • Susan Reverby, Marion Butler McLean Professor in the History of Ideas, Professor of Women’s and Gender Studies, Wellesley College
  • I. Glenn Cohen, Assistant Professor of Law, Faculty Co-Director, Petrie-Flom Center, Harvard Law School
  • Holly Fernandez Lynch, Executive Director, Petrie-Flom Center, Lecturer on Law, Harvard Law School
  • Wendy Parmet,  George J. and Kathleen Waters Matthews Distinguished University Professor of Law, Northeastern University School of Law
  • Fernando Ribeiro Delgado, Clinical Instructor and Lecturer on Law, Human Rights Program, Harvard Law School

This event is free and open to the public.  Lunch and refreshments will be served.

Pharmacy Compounding: Federal Law in Brief

by Jonathan J. Darrow

Until recently, most ordinary people had never heard of “pharmacy compounding.”  Then, a number of deaths and illnesses caused by a drug that was compounded in a Framingham, Massachusetts pharmacy propelled drug compounding to the national spotlight (see, e.g., Denise Grady et al., Scant Oversight of Drug Maker in Fatal Meningitis Outbreak, N.Y. Times, Oct. 6, 2012).

Compounding is the practice of preparing a drug for an individual patient’s needs, and is used when those needs cannot be met by a mass-produced drug.  See Thompson v. Western States Medical Center, 535 U.S. 357, 360 (2002).  For example, if a patient is allergic to a particular excipient (inactive ingredient) in an FDA-approved medicine, a doctor may order a special compounding pharmacy to prepare the medicine without that excipient. Because of the very small scale of compounding, Congress in 1997 attempted to exempt (via 21 U.S.C. § 353a) the industry from a number of provisions of the Food Drug and Cosmetic Act, including the requirement to submit a new drug application prior to interstate sale (21 U.S.C. § 355), the requirement that the drug labeling bear “adequate directions for use” (21 U.S.C. § 352(f)(1)), and the need to strictly follow good manufacturing practices, or GMP (see 21 U.S.C. § 351(a)(2)(B)).  A number of controls on compounding were included, however, such as the requirement that there be a valid prescription from a licensed practitioner (21 U.S.C. § 353a(a)(1)), that the drug be compounded by a licensed pharmacist (or physician) (21 U.S.C. § 353a(a)(1)), and that the drug be compounded from ingredients that meet certain quality standards (21 U.S.C. § 353a(b)(1)(A)–(B)).

However, § 353a—and with it, all of the provisions and exemptions just mentioned—was held unconstitutional in its entirety in Western States Medical Center v. Shalala, 238 F.3d 1090 (9th Cir. 2001), aff’d 535 U.S. 357 (2002), on the basis of certain restrictions on free speech that were also contained within the statute and which, according to the Ninth Circuit, could not be severed from the remaining provisions because “Congress intended to exempt compounding from the FDCA’s requirements only in return for a prohibition on promotion of specific compounded drugs.” See 535 U.S. at 366. Thereafter, the FDA promulgated a policy by which it would primarily “defer to state authorities regarding less significant violations” but would enforce a number of provisions relating to ingredient standards, unapproved substances, commercial scale production, adulteration, and promotion.  The FDA made clear that its enforcement activities “need not be limited to” these or any particular areas, however, thus negating any expectations that Congress’ now-invalidated exemptions might nevertheless provide a safe harbor through the weight of influence, if not law. Since then, the FDA has in fact exercised oversight of compounding pharmacies, as is evident from the handfuls of warning letters that it sends to non-compliant facilities each year.  These letters have addressed, for example, promotion that made unsubstantiated efficacy claims, contamination, and the large-scale manufacture of what were essentially copies of FDA-approved drugs.

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Call for Applications: Summer Ethics Fellowships at Auschwitz for the Study of Professional Ethics

The Fellowships at Auschwitz for the Study of Professional Ethics (FASPE) uses a unique historical lens to engage law students in an intensive course of study focused on contemporary legal ethics.  FASPE Fellows are granted an all-expenses paid 12-day trip to Germany and Poland to learn about the roles played by legal practitioners — lawyers and judges — in Nazi Germany, underscoring the reality that moral codes governing the legal profession can break down or be distorted with devastating consequences.  This historical perspective then becomes a launching point for discussions about ethical dilemmas facing lawyers in American today.  The program integrates historical, cultural, philosophical, and literary sources; survivor testimony; and on-site workshops in Berlin, Auschwitz, and Nuremberg.

FASPE Law was initially developed with the assistance of Professor Tony Kronman, former Dean of Yale Law School and other Yale Law School faculty members.  Since piloting the program in 2009, 43 Fellows have participated from law schools including Berkeley, Columbia, Georgetown, Harvard, Northwestern, the University of Arizona and Yale. The summer 2013 program will include 12-15 new Fellows chosen through a national application process.  The lead instructor for the 2013 program will be Eric Muller, the Dan K. Moore Distinguished Professor in Jurisprudence and Ethics at UNC School of Law. The Fellowships include all costs associated with the 12-day program, including international and European travel, lodging, and food.

FASPE Law Fellows examine such topics as:

  • Ethical approaches to truth and disclosure in the adversarial process.
  • The ethical challenges of ambition in professional development.
  • Ethics and government lawyering.
  • The Nuremberg Trials and post-war justice, in historic and modern contexts.
  • Ethics in the day-to-day practice of law.

The Fellows are provided with reading materials prior to meeting in New York; and the academic component of the program is intensive and interactive.  Daily Seminars are led by faculty and local experts who engage the Fellows in legal issues associated with the locations visited.

The tentative program dates for FASPE Law are May 26 – June 6, 2013.

Completed applications must be received by January 11, 2013.  Candidates of all religious, ethnic, and cultural backgrounds are encouraged to apply. To apply or to learn more about FASPE, please visit:  http://www.FASPE.info If you have any questions, please contact Thorin Tritter, Managing Director of FASPE, at ttritter@FASPE.info.

The Evolution of Public Health Law Research

By: Scott Burris, JD

Law has been used to protect and promote public health from the early days of European colonization of North America. Quarantine statutes and orders are reported from the mid-17th century. The 1793 yellow fever epidemic in Philadelphia, where our office is based, inspired the federal government’s first public health statute, authorizing relocation of the capital in the event of an outbreak.

By the mid-19th century, sanitarians like Boston’s own Lemuel Shattuck were articulating the idea that a considerable proportion of death and illness was preventable, and arguing that it was moral, feasible, and economical for the state to do the preventing. Law was a primary tool for prevention, and throughout the 19th century, and into the early twentieth, the extent and limitations of federal, state and local public health authority was litigated, debated in legislatures and defined in voluminous treatises by scholars like Freund, Tiedeman and Tobey.

And then, it got quiet.

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