TOMORROW: Frances Kamm’s Bioethical Prescriptions: Book Talk and Panel Discussion

The Petrie-Flom Center Staff Leave a comment

Please join us on February 27 at 2:00pm in Wasserstein 1019 at the Harvard Law School as we launch Professor Frances Kamm’s latest book, Bioethical Prescriptions: To Create, End, Choose, and Improve Lives (Oxford University Press, January 2014). The book showcases Professor Kamm’s articles on bioethics as parts of a coherent whole, with sections devoted to death and dying; early life (on conception and use of embryos, abortion, and childhood); genetics and other enhancements (on cloning and other genetic technologies); allocating scarce resources; and methodology (on the relation of moral theory and practical ethics).

Panelists include:

  • Frances Kamm, Littauer Professor of Philosophy & Public Policy, Harvard Kennedy School of Government; Professor of Philosophy, Faculty of Arts & Sciences, Harvard University; Former Senior Fellow, Petrie-Flom Center
  • Norman Daniels, Mary B. Saltonstall Professor of Population Ethics and Professor of Ethics and Population Health, Harvard School of Public Health
  • Thomas (Tim) Scanlon, Jr., Alford Professor of Natural Religion, Moral Philosophy, and Civil Polity, Faculty of Arts & Sciences, Harvard University
  • Moderator: Christopher T. Robertson, Visiting Professor of Law, Harvard Law School; Associate Professor, James E. Rogers College of Law, University of Arizona

This event is free and open to the public. For questions, please contact petrie-flom@law.harvard.edu or 617-496-4662.

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics; Edmond J. Safra Center for Ethics at Harvard University; and the Countway Library of Medicine at Harvard Medical School; with support from the Oswald DeN. Cammann Fund.

Peter Orszag on Medical Malpractice Reform that Works

I. Glenn Cohen Leave a comment

Peter Orszag has a nice piece on the future of medical malpractice reform. In it he gives a big shout-out to former Petrie-Flom fellow (now Cornell Law Prof) Mike Frakes and discusses papers Mike worked on while at the Center. Hopefully policymakers are listening. From Orszag’s piece:

Capping damages for medical malpractice can do little to solve this problem, but changing the standard against which doctors are evaluated would. In particular, doctors should have a safe harbor from malpractice suits if they follow evidence-based protocols published by a professional medical association. The Center for American Progress and others have proposed exactly this type of approach, and have also provided details about how it could work.

Professor Michael Frakes of Cornell Law School has done pathbreaking research on the benefits of moving away from customary-practice rules. In a new analysis, Frakes and Anupam Jena, a professor of health-care policy at Harvard Medical School, examine how malpractice laws affect mortality rates, avoidable hospitalizations, adverse events to mothers during childbirth and other measures of health-care quality. They then assess two types of reforms: changes to damages caps and changes to the local customary-practice standard.

Petrie-Flom Seeks to Hire Senior Law & Ethics Associate for New Project with NFL Players Association

The Petrie-Flom Center Staff Leave a comment

In connection with our work on a sponsored research project with the National Football League Players Association, the Petrie-Flom Center seeks to hire a Senior Law and Ethics Associate immediately. (Please note that this is a distinct position from the one we recently advertised working with Harvard Catalyst on clinical and translational research.)

We are seeking a full-time doctoral-level hire (J.D., M.D., Ph.D., etc. in law, ethics, public health, social science, or other relevant discipline) with extensive knowledge of and interest in legal and ethical issues related to the health and welfare of professional athletes.  The position will be funded for at least two years, with renewal likely for an additional year or more.

View the full job description and apply here.  

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

Review of Minssen, “Assessing the Inventiveness of Biopharmaceuticals under the European and U.S. Patent Laws”

Timo Minssen Leave a comment
Harold C. Wegner reviews Petrie-Flom Visiting Scholar Timo Minssen‘s doctoral thesis. From the review:
Patent applicants seeking to gain global patent protection beyond their home country borders need a better comparative knowledge of key elements of the patent laws of the several countries. Professor Timo Minssen in his superb doctoral thesis directly challenges the seemingly identical statutory and treaty standards for patentability in Europe and the United States in his comparative study of the laws of Europe and the United States with respect to the treaty standard of an “inventive step.” Timo Minssen, ASSESSING THE INVENTIVENESS OF BIOPHARMACEUTICALS UNDER THE EUROPEAN AND U.S. PATENT LAWS (Goteborg, Sweden: Ineko AB 2012). Professor Minssen’s doctoral thesis represents required reading for anyone seeking to unmask the subtle differences between American and European practice (emphasis added).
Read the full review.

PADs elevator speech

Temple University Center for Public Health Law Research Leave a comment

By Jeffrey Swanson, PhD

Effective salespeople often practice something called an “elevator speech,”—a clear, persuasive pitch for their product that’s so succinct they can deliver it on the ride between the lobby and the mezzanine.  Recently I found myself giving exactly such an impromptu presentation, literally on an elevator in a conference hotel in Atlanta, trying to explain to a fellow conferencista the nature and significance of our study with Assertive Community Treatment (ACT) teams implementing Psychiatric Advance Directives (PADs) in North Carolina.

“So, there are these legal documents called psychiatric advance directives, or PADs,” I said.  (We were attending the annual conference of the Robert Wood Johnson Foundation’s Public Health Law Research Program; she wasn’t a mental health specialist.)  “They’re similar to ‘living wills’ but they’re for people with serious mental illnesses who want to plan ahead for their own treatment during a future mental health crisis.  At a time when they’re feeling well, people can complete a PAD to document their treatment choices and preferences and also appoint someone they trust to make treatment decisions for them.  Ideally, PADs are a ‘recovery tool’ that helps people to obtain treatment they prefer—something that works for them during a mental health crisis—including medication and hospitalization, when needed, but without involuntary commitment. In the meantime, PADs can help clear the lines of communication between the person with mental illness and clinicians and even family members; just the exercise of completing one of these documents can make people feel more in control of their own lives, and give them some peace of mind.”

“Wow!  That’s the best new idea I’ve heard all day,” my elevator-companion responded.  Just then the elevator doors opened on the hotel lobby and the ride was over.  Unfortunately, my speech was just getting started; I guess I’d make a terrible salesperson. But now my new friend seemed interested and didn’t walk away, and so we stood there in the lobby and I kept talking.

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FSMA Conference Part 2: FSMA and Risk Regulation Strategy

W. Nicholson Price Leave a comment

[Ed. Note: On Friday, 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) co-sponsored a conference at HLS called “New Directions for Food Safety: The Food Safety Modernization Act and Beyond.”  This week, we will be sharing a series of blog posts from the event, and video will follow shortly.]

After Peter Hutt’s teriffic keynote speech, our first panel addresses the Food Safety Modernization Act and risk regulation strategies.  The speakers are Professor Jake Gersen of Harvard Law School, Director of the Food Law Lab, and Professor Michael Roberts, Founding Executive Director of UCLA Law School’s Resnick Center on Food Law and Policy. Read More

A solution to the contraceptives coverage mess?

Holly Fernandez Lynch Leave a comment

While prepping for a guest lecture on the contraceptives coverage mandate currently before SCOTUS, I had the opportunity today to review the merits briefs filed in the Hobby Lobby case.  I think both petitioners and respondents put out their absolute strongest arguments, as one would expect at this highest level of review.  The government asserts a fairly convincing case that for-profit corporations were not meant to be covered by the Religious Freedom Restoration Act (RFRA) and that individual shareholders are not burdened by the mandate, and the respondents convincingly argue that RFRA does indeed apply and the numerous exemptions already offered by the government have eviscerated any claim that refusing religious exemptions to for-profit corporations is necessary to achieve a compelling government interest.

The respondents, Hobby Lobby and its family owners, articulate a variety of less restrictive alternative methods to achieve the government’s interest in promoting public health and gender equality, including having the government provide free access to contraceptives rather than demanding that employers do so. Interestingly, however, the respondents do not suggest simply extending the existing accommodation available to religious non-profits to for-profit corporations with religious objections.  This accommodation allows a religious non-profit that objects to contraceptives to sidestep the mandate, instead requiring that its insurance company exclude contraceptives from the employer’s plan and itself bear responsibility to provide preventive services without cost-sharing.   The rationale is that it should be at least cost-neutral for insurance companies to provide this coverage, on the grounds that preventing pregnancy is cheaper than covering new dependents.  (And for self-insured plans, there is a similar approach by which third party administrators bear the burden, and are compensated via adjustments to Exchange user fees.)

I can’t be certain why the respondents omitted this obvious alternative, but one possibility has to do with the fact that the accommodation is currently being challenged (e.g., by the Little Sisters of the Poor) as insufficient because objecting employers argue that they are still being required to facilitate access to objectionable services, even if they do not have to pay for them.

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Dov Fox on the FDA’s ruling on 23andMe

Dov Fox Leave a comment

Dov Fox has a new piece up at the Huffington Post on the 23andMe controversy: “Genetic Testing Needs a Nudge.” From the article:

Mail-away genetic testing promises to revolutionize the way that people learn about and manage their health. Already half a million Americans have sent their saliva to find out their risk of genetic disease — no doctors needed.

Splashed across TV sets nationwide this past summer was 23andMe’s invitation to discover “hundreds of things about your health,” including that you “might have an increased risk of heart disease, arthritis, [or] gallstones.”

Since the company’s inception in 2007, the government had allowed it to market and sell its at-home genetic tests free of regulation. For $99 and the click of a mouse, 23andMe promised a “first step in prevention” to “mitigate[e] serious diseases.”

But this winter, the Food and Drug Administration issued a letter forbidding sales of the test to diagnose health conditions unless there is evidence that it works for that purpose. Shortly after 23andMe announced that it had “suspended” all sales of its “health-related genetic tests to comply” with the FDA directive, consumers brought aclass action lawsuit against the company, alleging that it “falsely and misleadingly advertises” the genetic test “as providing ‘health reports on 240+ conditions'” in the absence of “analytical or clinical validation.”

The 23andMe controversy illustrates a stalemate over the role of direct-to-consumer genetic testing in American health care.

You can read the full piece here.

FDA, Mitochondrial Manipulation, Three Parent Children, and the NY Times

I. Glenn Cohen Leave a comment

In yesterday’s NY Times Op-Ed page Marcy Darnovsky writes about FDA’s consideration of mitochondrial manipulation therapies later this week. As she describes it:

The F.D.A. calls them mitochondrial manipulation technologies. The procedures involve removing the nuclear material either from the egg or embryo of a woman with inheritable mitochondrial disease and inserting it into a healthy egg or embryo of a donor whose own nuclear material has been discarded. Any offspring would carry genetic material from three people — the nuclear DNA of the mother and father, and the mitochondrial DNA of the donor. 

As she writes in her opinion:

Some media accounts about these techniques have misleadingly referred to “saving lives,” as if they were aimed at people who are sick and suffering. Others have failed to note how very few women would be candidates for even considering them. And they could turn to safer and simpler alternatives. An affected woman could adopt or use in vitro fertilization with another woman’s eggs. Of course, the resulting child would not be genetically related to her, but neither would the child be put at grave risk by an extreme procedure.

The F.D.A. advisory panel says that its meeting will consider only scientific aspects of mitochondrial manipulation and that any “ethical and social policy issues” are outside its scope. But those are precisely the issues that we must address. Simply being able to do something doesn’t mean we should do it.

That conclusion is a bit pat, though I don’t fault her too much given how tight op-ed word limits are, and maybe a tad reactionary. I do think she raises an interesting point about how this is not saving lives, though I think so for different reasons.

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FSMA Conference Part I: Peter Barton Hutt on the Food Safety Modernization Act in Historical Perspective

clin Leave a comment

[Ed. Note: On Friday, 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) co-sponsored a conference at HLS called “New Directions for Food Safety: The Food Safety Modernization Act and Beyond.”  This week, we will be sharing a series of blog posts from the event, and video will follow shortly.]

By Ching-Fu Lin

On February 21, a group of scholars gathered at HLS to discuss new directions for food safety and challenges to the implementation of the 2011 Food Safety Modernization Act (FSMA).  The conference featured a keynote speech delivered by Peter Barton Hutt, who is commonly recognized as the food and drug law expert in this country.

Hutt is a senior counsel at the Washington, D.C. law firm Covington & Burling.  He also served as chief counsel for the Food and Drug Administration (FDA) from 1971 to 1975. Hutt has taught a full course at HLS on food and drug law for over 20 years and has co-authored an influential casebook in this area.

Bringing in his expertise in the historical development of food law, Hutt began with what he called “still the best statute” from the English experience in 1266.  At around that time, the English Parliament codified some early regulatory statutes (assizes) that prohibited the sale of any “corrupted wine” or of any meat, fish, bread, or water that was “not wholesome for Man’s body.”  These laws continued to (with amendments and supplements) be of reference power in England until 1884.  As articulated by Hutt, it would be sufficient for the FDA to do what it needs to do even when we take the core principle “not wholesome for Man’s body” and get rid of the entire rest of the food law.

Hutt then turned to another landmark development in the history of food law.  In 1820, Frederick Accum, a German chemist working in England, published Treatise on Adulteration of Food and Culinary Poisons.  The treatise had an immediate impact worldwide and triggered the modern development of food regulatory statutes in the United States and Europe.  Indeed, the languages used in such statutes (such as prohibitions against adulteration) are reflected in the design of the 1906 and 1938 legislations in the United States.

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