Health Class and Personal Preferences

By Nathaniel Counts

High school health classes that are effective in preventing high-risk behaviors employ two educational models: the social influences model and the life skills model.  The social influences model teaches children about social norms and techniques for resisting social influences.  The life skills focuses on developing child autonomy, self-esteem, and self-confidence to help children resist social influences and gain a sense of self.  There are two explanations for why health classes premised on these models would be effective: either they replace the preferences the children were likely to develop with different preferences or they help children develop their own preferences which, for some reason, consistently disfavor high-risk behaviors.

Continue reading

Announcing 2014-2016 Petrie-Flom Academic Fellow Rachel Sachs

We are pleased to announce that Rachel Sachs will be joining the Petrie-Flom Center later this summer as an Academic Fellow for the 2014-2016 fellowship term. In 2013, Rachel earned her J.D. magna cum laude from Harvard Law School, where she was the Articles Chair of the Harvard Law Review and a student fellow with both the Petrie-Flom Center and the John M. Olin Center for Law, Economics, and Business. Rachel has also earned a Masters in Public Health from the Harvard School of Public Health, during which she interned at the United States Department of Health and Human Services. She also holds an A.B. in Bioethics from Princeton University. After law school Rachel clerked for the Honorable Richard A. Posner of the United States Court of Appeals for the Seventh Circuit. Rachel’s primary research interests lie at the intersection of patent law and public health, with a particular focus on problems of innovation and access and the ways in which law helps or hinders these problems. Her past scholarship has examined the interactions between patent law and FDA regulation in the area of diagnostic tests, and explored the mechanisms behind the passage of patent-related legislation. Her current scholarship applies this focus on innovation and access to the intersection of patent law and drug reimbursement policies.
You can learn more about Rachel on our website.
Welcome Rachel!

5/2-3: Petrie-Flom Center Annual Conference, “Behavioral Economics, Law, and Health Policy”

Petrie-Flom Center 2014 Annual Conference: Behavioral Economics, Law, and Health Policy

May 2-3, 2014

Wasserstein Hall, Milstein East ABC, Harvard Law School, 1585 Massachusetts Ave.

Richard H. Thaler and Cass R. Sunstein’s book  Nudge: Improving Decisions About Health, Wealth, and Happiness brought behavioral economics to the masses, beginning a discussion of libertarian paternalism and the many ways that “choice architects” can help nudge people to make better choices for themselves without forcing certain outcomes on anyone. Some of their examples fall in the realm of health policy, as is also the case of Daniel Kahneman’s recent book, Thinking, Fast and Slow, which examines various cognitive errors people make in their judgments, choices, and conclusions, as well as how we might correct them.  But the conversation has only just begun.

Continue reading

New Profile of Petrie-Flom Annual Conf. Keynote Speaker Cass Sunstein

From the article. (Nadav Kander/Trunk Archive)

The Atlantic has just published a new piece profiling Harvard Law School Professor Cass Sunstein, “Our Nudge in Chief,” exploring “How, and why, Cass Sunstein believes laws and public policies should help save us from our irrational impulses.”

Sunstein, the Robert Walmsley University Professor at Harvard Law School, will deliver the keynote lecture at the Petrie-Flom Center’s upcoming annual conference, “Behavioral Economics, Law, and Health Policy,” on Friday, May 2. His talk is entitled “Choosing Not to Choose.” You can find out more about the conference here.

Read the full profile.

Research Round-Up: New Publications from the PHLR SciVal Experts Community

In honor of last week’s National Public Health Week, we have a lot of fresh, new PHLR. The latest crop of papers from public health law researchers touch on a number of important points and issues including transportation safety, implementation, tobacco control, and media presentation of public health law. Check out Scott Burris’s brief summaries after the jump!

Continue reading

FOR HARVARD STUDENTS: 4/16: Dallas Buyers Club: Free Film Screening and Discussion

Image by christian razukas from Wikimedia Commons.

Dallas Buyers Club: Free Film Screening and Panel Discussion

April 16, 2014 6:00 PM
Wasserstein Hall 1010, 1585 Massachusetts Ave.

Students from across Harvard are invited to view a free screening of the Academy-award winning film Dallas Buyers Club and participate in a panel discussion about issues addressed in the film related to access to health care for the HIV community.  The panel discussion will address the following issues: the history of access to care and treatment for HIV; ongoing issues with fair pricing of HIV medications; the role of the FDA in access to experimental medicines; and the portrayal of HIV and LGBTQI individuals in the media as it impacts access to individual and public health resources. Panelists include:

  • Robert Greenwald, Director, Center for Health Law & Policy Innovation; Clinical Professor of Law, Harvard Law School
  • Christopher T. Robertson, Visiting Professor of Law, Harvard Law School; Faculty Affiliate, Petrie-Flom Center
  • Grace Sterling Stowell, Executive Director, BAGLY: Boston Alliance of Gay, Lesbian, Bisexual and Transgender Youth

This event is open to students from all Harvard schools.  No pre-registration is required.

This event is co-sponsored by the Center for Health Law & Policy Innovation; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics; and Lambda at Harvard Law School.

Is Medicare’s System for Challenging Coverage Determinations Unintentionally Unfair?

On March 25, Susan Jaffe published a blog post in the New York Times about Medicare’s recent change to cover skilled therapy (e.g. physical therapy, nursing care) where it is “reasonable and necessary” maintain a patient’s condition and to prevent deterioration, even when it is not likely that the patient will improve. Jaffe notes that the revisions will likely have a substantial impact on thousands of Medicare beneficiaries even though the change has been largely unnoticed.

The revision highlights a potential problem with the system in place for challenging Medicare coverage. The revision itself is unremarkable, reflecting what national Medicare policies professed, but what local contractors sometimes ignored. What is remarkable is the time it took for Medicare to make the revision, from when the controversy appeared to when Medicare posted the change in its manuals. This delay is problematic because it reflects a dichotomy in how coverage decisions are challenged and changed under Medicare – due not to medical necessity but to political and financial circumstances beyond patient control.

Constituents can change Medicare coverage policies through two processes. One is through the litigation system. Judges can overturn Medicare coverage decisions after patients have exhausted Medicare’s internal adjudication process. Yet, litigation can take years and judges usually defer to Medicare’s judgment. National Coverage Determinations (NCDs) provide an alternative under which constituents can encourage Medicare to reconsider or overturn a prior coverage decision. NCDs supersede Local Coverage Determinations (LCDs) – coverage decisions that affect a region of the United States. When Medicare determines that the LCDs for a specific technology or service are “inconsistent or conflict with each other to the detriment of Medicare beneficiaries,” Medicare can decide to issue an NCD to provide uniform coverage.

Continue reading

Is Finding Malaysia Airlines Flight MH370 Worth 52,192 years of children’s lives?

[Note: This post is meant to be provocative and press a public policy question in the most thought-provoking way possible. Losing a loved one is among the most heart-wrenching experiences in a life time and my heart goes out to all those with loved ones on the flight waiting for answers. But one of the major points of this post is to highlight our tendency to spend more on identified lives not statistical ones for just these kinds of reasons and ask if it is justified.]

The search for Malaysia Airlines Flight MH370 is likely run to “Hundreds of Millions of Dollars” according to the most recent estimate from ABC News. This is based on extrapolation of the difficulties involved and the experience of searching for Air France 447 which cost 50 million USD. Let’s take a conservative estimate of 100 million USD to find the plane, probably on the low end. Let us put aside the possibility that even with that expenditure the plane will never be found, again an assumption that counts against the argument I will be making. This is 100 million dollars spent, roughly speaking, on “helping.” It is very unlikely that there are any survivors, so I don’t think this can reasonably be thought of as “life-saving” (I will assume it is not, but if it were  that wouldn’t make that much of a difference in the argument I will offer though it will require confronting the question of Should the Numbers Count for life saving?).

Instead the money is being spent (1) to satisfy the somewhat diffuse curiosity/grief of those who have watched this in the media, (2) to give answers to the very deep need for closure of the loved ones of those flying on these planes, and (3) to learn about what went wrong and potentially determine whether there is a systemic problem with these planes that might affect other planes.

All of those are worthy goals. But are they worth 100 million USD? In the category of “helping” or “life-saving” what else could we do with the money? Let me draw on one estimate mentioned by Ezra Klein in the WaPo and Don Taylor at the Incidental Economist from a paper by Tammy Tengs “Five Hundred Life Saving Interventions and Their Cost Effectiveness

I chose the cheapest intervention, influenza vaccines for children age 5+ which is estimated to cost $1,300/life year saved in 1993 dollars. I then updated that to 2013 dollars with a conversion calculator to generate a cost of 1915.89 USD per life year saved (it may also be that this intervention is now cheaper than it was at the time of Teng’s paper). I then divided 100 million dollars by that number to get my 52,192 life years saved for children estimate. That is fairly back of the envelope and there are lots of tweaks you would do to get a more exact figure, but it is close enough to make the point: Why are we spending so much on Malaysia Airlines search when we could be saving so many lives?

Continue reading

Antibiotics, Farm Animals, and the FDA

On Wednesday, the Food and Drug Administration announced that 25 pharmaceutical companies that manufacture animal drugs will participate in voluntarily phasing-out the use of antibiotics for growth promotion purposes in farm animals.

The companies are acting in response to voluntary guidelines that the FDA issued in December, requesting that the companies change their labeling of “medically important” antibiotics in two ways: (1) removing production uses (e.g., animal growth promotion) from the approved indications for the drugs; and (2) requiring veterinary oversight, rather than allowing over-the-counter distribution, for the remaining therapeutic uses.

Of the 26 companies targeted by these guidelines, 25 have agreed to comply by either revising their labels or withdrawing the drugs from animal use completely.   The FDA did not name the one company that has not agreed to comply.

While this is undoubtedly an important step forward in the FDA’s efforts to reduce non-necessary uses of antibiotics in livestock production—and hopefully slow the evolution of drug-resistant bacteria—it is important to note that there are potential loopholes in the FDA’s approach, as I have previously discussed. Continue reading

It’s Doctors’ Duty to Promote Gun Safety With Patients

Art Caplan has a new opinion piece up at Medscape: “It’s Doctors’ Duty to Promote Gun Safety With Patients.” From the article:

There is a huge problem with guns in the United States, and there are many things that public health can do, and many things that doctors should do to try to minimize the threats that guns pose to children, families, and all of us. One of the leading problems with guns is that we don’t educate children to know what to do when they find a gun or see a gun. So, if a 5- or 6-year-old sees a gun, we need a program that teaches that child that if you see a gun, walk away, get out of the area, and then tell an adult. That is a public health program. It’s something that school nurses could do. It’s something that pediatricians should talk about with their child patients. It’s something that families should hear about. We need a campaign. Vivek Murthy, the Surgeon General candidate, thinks that it is an appropriate thing to do. Apparently, the NRA doesn’t.

You can watch or read the full piece on the Medscape website (access requires a login and password, but registration is free).

China Issues 2014-2020 Development Blueprint on Food and Nutrition

By Ching-Fu Lin

China’s highest executive organ, the State Council, put out the Food and Nutrition Development Outline 2014-2020 (the Outline) in February of 2014.  The Outline was jointly drafted by China’s Ministry of Agriculture (MOA) and National Health and Family Planning Commission.  The Ministry of Finance, Ministry of Education, Ministry of Commerce, Ministry of Science and Technology, and National Development and Reform Commission also participated in its development.  Based on a review of China’s growth and problems in food and nutrition, the Outline sets a seven-year plan that highlights basic policy objectives.  The areas of focus are food supply systems, nutrition intake and balance (especially amongst population sub-groups), regulatory and surveillance mechanisms, industry development, research, and education.

The Outline lays out its “guiding strategy” that the government should regard the effective supply of food, balanced nutritional profile, and production-consumption coordination as its chief missions.  To execute these missions, the government identifies certain key products (quality agricultural products, convenient processed foods, and dairy and soy foods), key areas (poor, rural, and newly urbanized areas), and key population groups (the pregnant women and nursing mothers, infants and children, and the elderly) as starting points to promote better food and nutrition development patterns.  Such points are further elaborated in the document.  The guiding strategy ultimately aims to improve public health and a well-off society.

Continue reading

NEJM Editorial on Murthy for Surgeon General (with some further editorial comments by me)

Our friends at the New England Journal of Medicine have a great editorial chastising Congress and the White House for potentially bowing to the NRA’s pressure not to confirm Vivek Murthy for Surgeon General. The whole thing is worth a read but here are a couple of key paragraphs.

This is the first time that the NRA has flexed its political muscle over the appointment of a surgeon general. The NRA has taken this action even though the surgeon general has no authority over firearm regulation and even though Murthy made it clear in his testimony before the Senate HELP Committee that if he is confirmed, his principal focus will be on the important national problem of obesity prevention, not firearm policy. Still, 10 Senate Democrats are apparently prepared to vote against Murthy’s confirmation because of his personal views on firearms — a demonstration of just how much political power our legislators have ceded to the NRA.

The critical question is this: Should a special-interest organization like the NRA have veto power over the appointment of the nation’s top doctor? The very idea is unacceptable.

Despite the continuing American tragedy of mass shootings — Newtown, Aurora, Fort Hood, Virginia Tech — the NRA has redoubled its efforts to prevent enactment of stricter firearm regulations. Lawmakers who run afoul of the NRA face political retribution. By obstructing the President’s nomination of Vivek Murthy as surgeon general, the NRA is taking its single-issue political blackmail to a new level. With the record of past surgeons general as their guide, senators should do what is right for the health of our country by confronting the NRA and voting their own conscience. Dr. Murthy is an accomplished physician, policymaker, leader, and entrepreneur. He deserves the President’s continued backing and should be confirmed.

I think this is very well said and largely sympathetic. The one point on which I will slightly veer off course (disagree with is too strong) from NEJM has to do with the connection between gun safety and health. I do think it is legitimate to view gun safety and firearm deaths as a HEALTH issue, even if not particularly a HEALTH CARE issue. It is a staple part of public health regulatory studies, along with drugs, alcohol, obesity, and tobacco. While we have the CDC as a kind of public health federal executive power, as its name suggests communicable and non-communicable disease has always been its focus. I think it would be great if we understand the “top doc” of the United States’ role as being about HEALTH and not just HEALTH CARE, so I would not (and to be clear I don’t think NEJM has) draw too strong a line between these two in an attempt to salvage this nomination. Doctors (not exclusively of other actors in the system, of course) should view themselves as agents of HEALTH not just HEALTH CARE, and I would hate for Murthy or other doctors’ efforts in the broader sphere to be dismissed as “frolicks” or “extracurricular.”

 

Evidence in Policy Innovation

In the last few decades, there has been a broad effort to strengthen the use of evidence-based law as a tool for the promotion of population health. There are two major fronts in the campaign, each essential, and both largely successful, though much work also remains. One aims to increase the quantity and quality of empirical research on the health effects of existing policy choices. The other focuses on how best to get such knowledge into action in the form of policy and practice. In a new PHLR Theory Practice and Evidence paper, Evan Anderson and I draw attention to a third front: the formulation of new legal interventions. Though policy experimentation is inevitable, it has been the subject of relatively little systematic study. For proponents of evidence-based public health law, policy experimentation presents a paradox: if a legal intervention is truly innovative, there will not yet be direct evidence of its impact. Yet direct evidence from policy evaluations is never the only source of research knowledge relevant to a policy decision, even under conditions of novelty and uncertainty. And few interventions are truly new in a broad sense; in most instances, similarly designed laws have been deployed before, just not for the same specific purpose.

We use the case of youth sports concussion and Washington’s Lystedt Law as a case study of how even new legal strategies dealing with new problems can be built on evidence. We show  how evidence about the problem lawmakers are addressing, combined with widely-used analytic tools like the Haddon Matrix and an understanding of the generic mechanisms through which law influences behavior and outcomes, can bring existing research knowledge into the crafting of even very innovative legal interventions for newly perceived problems.  While we don’t expect the policy sausage factory to suddenly start looking like a research lab, there’s no question that legislators typically care about getting policy right and want evidence.  The point of our paper is to get the research world to think about ways we can help even when no one has yet studied the specific law at issue.

New regulatory pathways and incentives for sustainable antibiotics: Recent European & US Initiatives

Please find attached a ppt presentation on “New regulatory pathways and incentives for sustainable antibiotics: Recent European & US Initiatives” given on March 7, 2014 at the Broad Institute of MIT and Harvard.  The presentation was followed by a discussion moderated by US patent attorney Melissa Hunter-Ensor, Partner at Saul Ewing, Boston.

I started out by emphasizing increasing problems of antimicrobial resistance (AMR) on a global level, providing new statistics and facts. This was followed by a discussion of main reasons for these alarming developments, such as inappropriate use in agriculture and medicine, insufficient precautions, lack of education, climate change, travel behavior, insufficient collaboration and funding of R&D, scientific complexities, and the problem that incentives provided by the traditional innovation system model often fail in the case of antibiotics.

Next the presentation focused on a variety of solution models that could be discussed to fight AMR. These include both conservational and preventive approaches comprising use limitations, increased public awareness, and better hygiene, but also reactive push & pull strategies, such as increased investments, new collaborative models for R&D in antibiotics, prizes, “sui generis” IP-related incentives, regulatory responses and new pathways for approval.

Continue reading

Call for applications: Brocher Summer Academy 2014: Ethical Choices for DALYs and the Measurement of the Global Burden of Disease

Confirmed speakers: Christopher Murray (IHME)—Keynote, Matt Adler (Duke), Greg Bognar (La Trobe U), John Broome (Oxford), Dan Brock (Harvard), Richard Cookson (York U), Owen Cotton-Barratt (Oxford), David Evans (WHO), Marc Fleurbaey (Princeton U), Ned Hall (Harvard), Dan Hausman (U of Wisconsin, Madison), Elselijn Kingma (U of Eindhoven), Jeremy Lauer (WHO), Colin Mathers (WHO), Erik Nord (Norwegian Institute of Public Health, Oslo), Ole Norheim (U of Bergen), Andreas Reis (WHO), Joshua Salomon (Harvard and IHME), Abha Saxena (WHO), Erik Schokkaert (KU Leuven), Drew Schroeder (Claremont McKenna), Alex Voorhoeve (LSE), James Woodward (U of Pittsburgh).

Organizers: Daniel Wikler (Harvard), Nir Eyal (Harvard), Samia Hurst (U of Geneva)

The biennial Summer Academy in the Ethics of Global Population Health is hosted by the Brocher Foundation on the shores of Lake Geneva June 9-13 2014, introducing faculty and advanced graduate students to population‐level bioethics. This fast‐developing academic field addresses ethical questions in population‐ and global health rather than ones in individual patient care.

The Global Burden of Disease (GBD) project is a systematic, scientific effort to quantify the comparative magnitude of health loss due to diseases, injuries, and risk factors. From its inception in the early 1990s, scientists and philosophers recognized that ethical and philosophical questions arise at every turn. For example, it must be decided whether each year in the lifespan is to count alike, and whether future deaths and disabilities should be given the same weight as those in the present. These choices and decisions matter: the share of disease burden due to myocardial infarction could vary as much as 400% depending on what position is adopted on two of the ethical choices described in the GBD 2010 report.  Continue reading

Diagnosing Mental Disorders from Internet Use

By Nathaniel Counts

We live in a time when increasingly our personal information is publicly available on the internet.  This personal information includes our names and phone numbers, things we’ve written and things we’ve done, along with a good deal of information that only exists because we interact with others on the internet – thoughts that we might not have otherwise externalized, or that we certainly would not have saved so that others could read.

If all of this information is publicly available, all of this information can be gathered.  Already advertisers analyze our behaviors to better target products to us.  It is not hard to imagine a not so distant future where the government analyzes this data to determine whether we have a DSM mental disorder.  By looking at the online behaviors of those already diagnosed – the way the syndrome affects their usage patterns, the sites they visit, and how they interact with others online – it is likely that one can find statistically significant usage patterns that can distinguish individuals with a diagnosis from those without.  The available data could then be mined to identify other individuals that exhibit the usage pattern and allow for presumptive diagnosis.

Continue reading

Snotty Hand-Washing

Hand-washing is one of the mainstays of public health and of good clinical practice. Images of surgeons with their hands raised in the air, as they enter the OR to have a nurse help them don sterile latex gloves after having meticulously washing their hands, have been immortalized by pop-culture representations of medicine. Indeed, learning the “surgical hand-wash” is one of the glorified coming-of-age rituals for med students. It quite literally initiates aspiring physicians into being legally and morally allowed to cut people open for their own benefit.

Proper hand-washing is crucial for non-surgical clinical practice as well. At my hospital, clinicians are supposed to wash or sanitize their hands as soon as they enter a patient’s room, and after they have made any contact with a patient. And although the procedure for “clinical hand-washing” is much less thorough than its surgical counterpart, there’s still an evidence-based, 11 step process that WHO officially recommends in its annual “SAVE LIVES: Clean Your Hands Campaign.

The rationale for all this rigor in medical practice is pretty obvious, and any hospital-based physician who doesn’t have overly dry skin without moisturizing is probably shirking an important responsibility. However, the clinical obsession over asepticism has spilled over to mainstream culture, but not without some controversy.

Relax: I’m not going to get into the debate over the hygiene hypothesis. I’m also not even going get back on the bacterial-resistance soapbox (except for one quick point–although asepticism in clinical settings certainly does help prevent resistance, it might be counterproductive beyond the clinical setting as wiping out benign bacteria might simply open more ecological space for nastier bugs).

I just want to point out that simple repugnance is probably a better explanation  for the hygiene-neurosis of current times than any legitimate public health concern. Normal people today would probably have seemed like obsessed germophobes fifty years ago. What’s interesting is there’s lots of neat evidence that even the most visceral types of disgust are socially constructed. For example, Norbert Elias’ treatise on snot in “The History of Manners” (1982) describes dinner-table behavior that was deemed perfectly polite by in the most sophisticated European social circles of previous centuries, but which would probably make even the coarsest sailor of today vomit in disgust. I’ll leave you with some highlights, taken from pages 143-148 of this wonderful (yet long, two volume) work by Elias.

Continue reading

3/20-21: Risk, Perception, and Response Conference at Harvard School of Public Health

Risk, Perception, and Response Conference

March 20-21, 2014

Harvard School of Public Health
677 Huntington Avenue
Boston, MA 02115

This event will be webcast. Link will be posted here on March 20 and 21.

View draft agenda and papers.

To register, click here. There is no charge for registration.

To receive related notifications, subscribe to our mailing list.

Sunstein to be Keynote Speaker

We are pleased to announce that Cass R. Sunstein will be the keynote speaker for HCRA’s Risk, Perception, and Response conference. Mr. Sunstein is the Robert Walmsley University Professor at Harvard and founded the Program on Behavioral Economics and Public Policy at Harvard Law School. He is the author of numerous articles and books, includingNudge: Improving Decisions about Health, Wealth, and Happiness (with Richard H. Thaler, 2008) and most recently Simpler: The Future of Government (2013). From 2009 to 2012, he was Administrator of the White House Office of Information and Regulatory Affairs.

Conference Overview 

How people react to scientific evidence of risk is mediated by many factors, including how risk information is perceived and communicated, how we react to social and cultural influences, and how choices are structured. Examples abound of situations where individuals’ risk perceptions lead them to act in ways that appear contrary to their own interests, overreacting to or neglecting risks. How can situations in which individuals are likely to respond poorly be identified, and what can be done to improve their responses? To increase our understanding of the factors that contribute to these behaviors and to develop better options for fostering sound decisions, the Harvard Center for Risk Analysis commissioned a series of papers that will be presented at this March 20-21, 2014 conference.develop better options for fostering sound decisions, the Harvard Center for Risk Analysis commissioned a series of papers that will be presented at this March 20-21, 2014 conference.

Click here to view the detailed agenda.

FDA’s Draft Methodological Approach to Identifying High-Risk Foods

By Ching-Fu Lin

Last month, the Food and Drug Administration (FDA) published a draft methodological approach for designating high-risk foods (HRFs) as required by section 204(d)(2) of the Food Safety Modernization Act (FSMA).  HRFs identified by the FDA are subject to additional record-keeping requirements, and more frequent foreign inspections and mandatory third-party certification requirements.  The FDA is seeking comments, scientific data, and information from stakeholders to revise this draft HRF approach and to create a preliminary HRF list.

Among many available risk tools (e.g. qualitative, semi-quantitative, and quantitative methods), a semi-quantitative risk ranking model has been selected by the FDA as the most appropriate methodology for the HRF list.  There are many reasons for choosing this model, including the fact that – as explained by the FDA – it is “data-driven and comprehensive, using explicit criteria related to public health risk; … adaptive to a variety of hazards; and … flexible to consider different foods or categories of food.”

Based on the draft semi-quantitative risk ranking model, the FDA is considering and evaluating a set of seven criteria that match the factors specified in section 204(d)(2)(A) of FSMA: Continue reading