Petrie-Flom Interns’ Weekly Round-Up, 2/21-2/28

By Chloe Reichel

1) The Food and Drug Administration has proposed a new format for nutrition facts. The design would prominently feature calorie count and serving size to clearly communicate the nutritional content of the food.

2) A new blood test that screens fetal DNA has been found to be more accurate at predicting Down syndrome and Trisomy 18 than standard blood testing and ultrasounds. This new method of testing is “cell-free” and less invasive than amniocentesis, but positive results would have to be confirmed through traditional methods given the incidence of false-positives.

3) A new method of IVF which utilizes three different sources of reproductive material is being considered by the FDA. The method implants the nucleus of one egg into an enucleated donor egg in order to avoid potential diseases caused by mitochondrial DNA.

4) A glitch with Maryland’s health exchange has left the state without the capacity to decide which of the state’s residents are eligible for Medicaid. The state has decided to keep making payments, despite not knowing the eligibility status of the recipients.

5) Health care co-ops introduced after the implementation of the Affordable Care Act have been struggling to get enrollments. The existence of larger, well-established insurance providers has made it difficult for co-ops to gain a foothold in the market.

6) The San Diego City Council passed legislation this past Tuesday that permits no more than 32 medical marijuana dispensaries to open in the city. This was a revision from the initial plan, which allowed for 131 dispensaries.

7) Gene sequencing has proven itself a valuable technology in diagnosing and informing treatment decisions for uncommon diseases. This technology is predicted to be a promising tool in the realm of more common diseases as well.

8) Mayor Vincent C. Gray, of Washington, D.C., reiterated on Thursday that insurers in the District must cover treatment for gender dysphoria. This policy, which bans medical discrimination on the grounds of gender identity, initially went into effect in March of 2013.

Caplan: Three-Parent Babies Are an Ethical Choice

Art Caplan has a new op-ed out on the three-parent baby issue.  Here’s an excerpt:

In my view, trying the technique to fix a terrible disease even with risks of failure makes ethical sense. The FDA may ask for more studies in monkeys, but that really wont settle the safety issue in humans. Given the severity of mitochondrial diseases it is worth trying the technique.

The big worry is not so much safety, but where will allowing this form of genetic engineering lead. If we let doctors try to repair defective eggs today, who is to say they won’t be trying to make superbabies or designer babies tomorrow by transferring other genes into eggs?

The answer to that is that how far we go in engineering future generations through genetic manipulations is up to us. We can enact laws and treaties that say yes to gene therapies but no to cosmetic genetic engineering. Holding families hostage by saying they cannot try to repair broken genes to treat diseases because we worry that we cannot put steps or handrails on the slippery slope to designer babies seems wrong to me.

Take a look here.

How Coke might help cure obesity

Coca-Cola has an interesting symbolic presence the world of public health.

Its delivery system is the envy of vaccine programs: the committed global health workers who’ve trekked for days through harsh and inhospitable lands to reach even the most distant communities are likely to find a refreshing, cold Coke already waiting for them at the village store.

For those who focus on non-communicable chronic diseases (NCD), (regular) Coke is the scourge that is providing the extra calories that fuels the obesity epidemic. Many experts believe that eliminating the calories contained in a single, 16oz serving of regular Coke from daily diet would be more than enough to revert the trend towards rising obesity and return average weight in the population back to where it was 30 years ago. 

But the symbolic presence of Coca-Cola in US culture and politics is perhaps even more interesting, and the resulting dynamics could have some unexpected consequences in terms of population health.

Continue reading

Tips from a former medical student – Part I

By Deborah Cho

As a student in the Disability Litigation Clinic, one of the many fantastic clinics here at Harvard Law school, I’ve come to appreciate the value of hands-on experience as an essential component of legal education.  One issue that we as students are often faced with, however, is a lack of familiarity with the particular subject matter we are assigned to work with.  Now, I know that topic-specific knowledge typically comes on the job, but I’m starting to see that many of us trying to practice law touching the medical field never really have a chance to learn the basics of the medical world and just how essential that basic knowledge really is.

As a short introduction to this post, I will say that I spent several of my college years volunteering and doing research at various hospitals and clinics, went to medical school for two years, have an M.A. in Bioethics (noting this to add to my hours spent in a hospital), have interned in the health care division in state government, have interned in a health law nonprofit firm, and, as noted above, am enrolled in the Disability Litigation Clinic right now.  All that to say, please take everything I write here with a grain of salt.  I am by no means an expert on this, but have found that this information has helped me throughout my healthcare-related legal experience so far and I hope that this will spark dialogue and interest on this subject.

Continue reading

Limits of Technological Solutions to Moral Problems

By Matthew L Baum

In my last blog post, I suggested that we consider incentivizing scientists and engineers to develop technologies that side-step ethical dilemmas entangling certain current technologies. I highlighted that these morally modifying technologies 1) neither resolve a moral debate nor do they take a side, 2) usually do not function empirically better than existing technology, and 3) make a moral dilemma less practically problematic by providing a technological work-around. I highlighted induced pluripotent stem cells, blood recirculators, and fixed-time ventilators as three examples of morally modifying technologies. But when is it a bad idea to encourage the development of morally modifying technologies?

In response to an excellent comment on that post by Joanna Sax, I would like to extend my initial description of technological solutions to moral problems to a discussion of their limits and the potential problems that might accompany them. I will begin here with the three externalities Joanna suggested and start a discussion on how they might be avoided.

Continue reading

TOMORROW: “Transgender Identity, Mental Health, and Human Rights: The DSM-5 and Beyond”

“Transgender Identity, Mental Health, and Human Rights: The DSM-5 and Beyond”

When: 12:00 – 1:00 p.m.

Where: Hauser 102

Please join us for a discussion with panelists: Sara Kimmel, staff psychologist at Harvard University Student Mental Health Services; Eszter Kismödi, international human rights lawyer on sexual and reproductive health law, policy, and research; Zack Paakkonen, staff attorney with GLAD’s Transgender Rights Project; and moderator Mindy Roseman, Academic Director of the Human Rights Program and Lecturer on Law, Harvard Law School.

Cosponsored by the Human Rights Program, the Radcliffe Institute, HLS Lambda, and the Petrie-Flom Center. Light lunch will be served.

Inaugural Issue of the new Journal of Law and the Biosciences Now Online (Free Access)

I am very pleased to announce the the first-ever issue of The Journal of Law and the Biosciences is now online. I serve as one of three Editors In Chief (along with Nita Farahany and Hank Greely). The journal is a co-production of Harvard, Duke, and Stanford Law schools and Oxford University Press and is the first peer-reviewed journal of its kind.

Here is the table of contents for the first issue:

Edward S. Dove, Bartha M. Knoppers, and Ma’n H. Zawati, Towards an ethics safe harbor for global biomedical research, J Law Biosci (March 2014) 1 (1): 3-51 doi:10.1093/jlb/lst002

Rebecca Dresser, Public preferences and the challenge to genetic research policy, J Law Biosci (March 2014) 1 (1): 52-67 doi:10.1093/jlb/lst001

Hannah Maslen, Thomas Douglas, Roi Cohen Kadosh, Neil Levy, and Julian Savulescu, The regulation of cognitive enhancement devices: extending the medical model, J Law Biosci (March 2014) 1 (1): 68-93 doi:10.1093/jlb/lst003

Timothy Caulfield, Sarah Burningham, Yann Joly, Zubin Master, Mahsa Shabani, Pascal Borry, Allan Becker, Michael Burgess, Kathryn Calder, Christine Critchley, Kelly Edwards, Stephanie M. Fullerton, Herbert Gottweis, Robyn Hyde-Lay, Judy Illes, Rosario Isasi, Kazuto Kato, Jane Kaye, Bartha Knoppers, John Lynch, Amy McGuire, Eric Meslin, Dianne Nicol, Kieran O’Doherty, Ubaka Ogbogu, Margaret Otlowski, Daryl Pullman, Nola Ries, Chris Scott, Malcolm Sears, Helen Wallace, and Ma’n H. Zawati, A review of the key issues associated with the commercialization of biobanks, J Law Biosci (March 2014) 1 (1): 94-110 doi:10.1093/jlb/lst004

t

Pivotal Politics and the Extension of Canceled Insurance Policies

By Jeremy Kreisberg

I think it is fair to say that the conventional wisdom surrounding the administration’s decision to temporarily allow insurance companies to continue selling plans that do not meet the minimum standards established by the ACA to its existing beneficiaries (a.k.a., the “like it / keep it” fix) is that this decision was primarily motivated by political pressures.

Perhaps the conventional wisdom here is at least partially right.  But I want to develop an additional explanation that has lurked within the news coverage — one that sounds in policy and legislative strategy (and happens to be related to a paper I’m currently writing).  In short, I think it’s feasible to explain the administration’s fix as a policy that was designed to forestall an unpalatable legislative proposal that, in the president’s eyes, would have had adverse consequences for the ACA.  As one might imagine, this basic strategy of using administrative leeway to preempt undesirable legislation is not novel.  In fact, after the jump, I’ll recount how it was used by President Reagan to the same effect.  But the larger point I want to make here is that, while some policy analysts have criticized the administrative fix due to the complications it creates for the law, when viewed in light of the alternative legislation it may have replaced, the administrative fix might be viewed as a sounder policy than we would otherwise think.

Continue reading

Social Signaling and the Undoing of the Harm Principle

By Nathaniel Counts

In On Liberty, John Stuart Mill asserted that “[t]he only purpose for which power can be rightfully exercised over any member of a civilized community, against his will, is to prevent harm to others.”  This has since become known as the harm principle and is foundational for much of American political discourse, especially for libertarianism and civil rights.  At the time of Mills’ writing, On Liberty having been published in 1859, this logic could protect a lot of conduct that involved consenting adults or did not appear to directly impact others.  If the harm principle was controlling, we could never have a soda ban.  Today however, with our advances in social science, clear lines of harm and no harm have become fuzzy.

Few people buy cigarettes in a vacuum.  Someone offers you cigarettes or you see other people smoking and then you buy cigarettes.  This phenomenon, in which we make decisions based on the decisions of others in relationship to our esteem for them (if we see someone we respect smoking, we will be more likely to smoke; if we see someone we do not respect smoking, we will be less likely to smoke) is called social signaling (The Origin, Development, and Regulation of Norms is a great article on a related topic, the generation of norms, which explains this phenomenon quite well).

Continue reading

Dov Fox quoted on pre-natal DNA testing

Dov Fox is quoted in a story in this morning’s Boston Globe on a new study recommending pre-natal DNA testing as a superior method for detecting chromosomal abnormalities in a fetus. 

“This technology is certainly only in its infancy as the range of testable conditions expands, physical conditions, cognitive conditions, even behavioral ones,” said Dov Fox, an assistant professor of law at the University of San Diego School of Law. “That will only further complicate how parents decide what counts as healthy or acceptable in the children that they have.”

Read the full article.

 

FSMA Conference Part 4: Benefits, Challenges, and Gaps in FSMA’s Approach

[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 Jeffrey Skopek

Lewis Grossman, Washington College of Law, American University – New Governance, New Challenges

Professor Grossman opened the panel by locating FSMA in the context of the “new governance” movement that has arisen in response to the limits of command and control regulation.   Continue reading

3/11: Evaluating the Revised Diagnostic and Statistical Manual of Mental Disorders (DSM-5)

Evaluating the Revised Diagnostic and Statistical Manual of Mental Disorders (DSM-5)

Tuesday, March 11, 2014, 12:00pm

Wasserstein Hall 3018, Harvard Law School, 1585 Massachusetts Ave.

The DSM is the reference used by clinicians, researchers, and insurers to diagnose and classify mental disorders, with the intent to provide specific, objective criteria by which to assess symptoms and determine whether to pay for treatment.  The American Psychiatric Association released the manual’s fifth edition in May 2013, nearly twenty years after the fourth edition, to substantial public and professional criticism.  Please join us for a discussion of the new revisions and their implications for patients, medical practice, research, and the law.

Panelists:

  • Steven E. Hyman, Director of the Stanley Center for Psychiatric Research at the Broad Institute and Harvard University Distinguished Service Professor of Stem Cell and Regenerative Biology
  • Anne Becker, Maude and Lillian Presley Professor of Global Health and Medicine, Harvard Medical School
  • Nita Farahany, Professor of Law, Professor of Genome Sciences & Policy, and Professor of Philosophy at Duke University
  • Moderator: I. Glenn Cohen, Professor of Law, Harvard Law School; Faculty Co-Director, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics

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

This event is supported by the Oswald DeN. Cammann Fund.

Global Health Governance: Call for Submissions

Global Health Governance will be publishing a special issue on a proposed Framework Convention on Global Health (FCGH) in December 2014. The proposal for an FCGH would create a new international framework, grounded in the international human right to health, that would support health at the national and global levels.

For this FCGH special issue, Global Health Governance invites submission of theoretical and empirical policy research articles that examine and analyze how the FCGH could improve health through improved governance and realization of the right to health. We have particular interest in articles on: Continue reading

Twitter Round Up

This week’s twitter round up features a variety of topics from our contributors, from the correlations between cancer survival rates and funding to blog posts about possible criminalization of drinking while pregnant.

Frank Pasquale tweeted that “there’s a direct correlation between funding and survival rates” regarding cancer from an entry of the blog “Every Breath I Take: A Blog about my Journey with Lung Cancer.”

Art Caplan tweeted about flu vaccinations again this week in order to bring the Rhode Island ACLU’s attention to the CDC’s determination that “getting the flu vaccine this season reduced risk of flu-related doctor’s visits by 61 percent.”

Amitabh Chandra tweeted an article from the Annals of Internal Medicine discussing bariatric surgery and its greater effects on weight loss and diabetes remission than nonsurgical measures to combat obesity.

Stephen Latham tweeted a link to his blog post about the “Criminalization of Drinking While Pregnant in the UK?” which discusses current “plans to bring legal action to establish liability for criminal damages by women who drink while pregnant, with resultant damage to their newborns.”

Professional Licensing Boards and Antitrust Liability

[Blogger’s Note: I am very pleased to share this post by my colleague at Seton Hall Law, Tara Adams Ragone, in which she discusses North Carolina Board of Dental Examiners v. FTC, drawing on both her scholarly work on the intersection of health care and antitrust law and on her deep experience prosecuting medical licensing actions for the state of New Jersey.]

By Tara Adams Ragone

Cross-Posted at Health Reform Watch

Should state professional boards, which regulate a growing and diverse array of professions and often are composed of professionals from the regulated community, be immune from federal antitrust liability if they engage in anticompetitive conduct?  The Federal Trade Commission thinks not in all cases, the Fourth Circuit agreed, and the North Carolina Board of Dental Examiners has asked the United States Supreme Court to review this decision.

Sasha Volokh recently devoted a 5-part series of blog posts to the major legal issues in play in this case.  He provides an overview of the antitrust state action immunity doctrine here, summarizes the facts underlying the case, North Carolina Board of Dental Examiners v. FTC, here, outlines the differing tests used in the circuits when applying the state action immunity doctrine to professional boards here, offers his opinion on how the Supreme Court ought to resolve these conflicts here (he leans towards the Fourth Circuit’s analysis), and suggests a possible way for the Board to work around the FTC’s injunction (by simply rephrasing its letters to threaten litigation) here.  Sasha’s posts provide an accessible and helpful primer on the case and relevant antitrust case law and are worth a read.

While we wait to learn if the Supreme Court will review this case, Professors Aaron Edlin and Rebecca Haw tackle the question of whether the actions of state professional licensing boards should be subject to antitrust scrutiny in their article, “Cartels by Another Name: Should Licensed Occupations Face Antitrust Scrutiny?” (available on SSRN and forthcoming in the University of Pennsylvania Law Review).  Although they use a question mark in their title, their characterization of licensing boards as cartels is a powerful tipoff to their ultimate conclusion – that licensing boards composed primarily of competitors regulating their own profession should not escape antitrust review: Continue reading

Hard Paternalism

Is hard paternalism in medicine ever justified?   In a recent NYT op-ed titled “When Doctors Need to Lie,” cardiologist and author Sandeep Jauhar provides a thought-provoking perspective on this question.

Dr. Jauhar begins with a description of a case in which the father of a 22-year-old patient requested that Jauhar temporarily lie and tell the patient that was going to be fine, even thought he was suffering from severe heart failure.  Jauhar agreed on grounds that the patient was not yet psychologically ready to hear the news and that withholding the information was therefore justified by the central principle that “physicians must do no harm.”

This example of temporary lying provides an avenue into a general discussion of the role of paternalism in medicine, which Jauhar argues should not be wholly displaced by respect for patient autonomy.   He argues that “when a doctor believes that a paternalistic approach is justified, he should aim to keep it as ‘soft’ as possible,” but that “there may be a place in medicine for hard paternalism, too.”

In support of hard paternalism, Jauhar describes a case in which one of his patients was bleeding into his lungs and was going to die without a breathing tube.   Jauhar knew that the patient had previously told other doctors that he never wanted to be intubated, but he did not know the quality of their discussion and could not find out because the patient was nearly unconscious.   So he intubated the patient, thereby saving his life.  And in the end, the patient thanked him.

But does this story actually offer support for hard paternalism? Continue reading

FSMA Conference Part 3: Regulating Farm Production: From Zero to Sixty

[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 Jason St. John, JD candidate, Harvard Law School

The third conference session, “Regulating Farm Production: From 0 to 60,” was moderated by Robert Greenwald, Director of the Center for Health Law Policy and Innovation at Harvard Law School. To make the presentations more cohesive, the presenters divided each of their fifteen-minute presentations into two seven-minute presentations. The panel discussed the FDA’s proposed Produce Safety rule under the Food Safety and Modernization Act (FSMA), the rule’s focus on produce and growing of food, and the large question of whether FSMA makes our food safer.

Continue reading

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

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 BioethicsEdmond 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

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.