Category: Public Health

Book Review: Pharmaceutical Innovation, Competition and Patent Law – A Trilateral Perspective

Timo Minssen Leave a comment

By Timo Minssen

Following a request by the European Competition Law Review (Sweet Maxwell), I have today submitted a review of the recent publication  “Pharmaceutical Innovation, Competition and Patent Law – A Trilateral Perspective”, edited by Max Planck Director Josef Drexl and Finnish scholar Nari Lee (Edward Elgar 2013, 322 p., ISBN 978 0 85793 245 7). The full contribution (6 pp.) is curently undergoing peer-review.

In summary, I conclude that the editors, who also contributed with excellent papers, have succeeded very well in the difficult task of structuring, systemizing and arranging a compilation of very interesting papers written by high profile authors. This has resulted in a very readable book providing a superb overview and up-to-date analysis of recent developments that have such a substantial impact on a significant area of law and practice. But are there any flaws?

Considering the numerous useful case law citations, as well as the wide scope of the book, it is a little unfortunate that the book does not contain a table of cases or a bibliography of material cited by the respective authors. Also it might perhaps have been beneficial to include some contributions from the pharmaceutical industry, private practice or NGOs. There is of course no doubt that all papers have been written by very competent authors and address real-world issues with much devotion to facts, details and commercial realities. But additional contributions by the industry or “field workers” would probably have enriched the numerous debates that are placed in such an extraordinarily complex environment at the interface of business realities, competition, technological innovation, and access to health care.

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Infrastructure as a Social Determinant of Health in Developing Economies

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By Matthew L Baum

Recently in the New England Journal of Medicine, D.S. Jones described the history of a dangerous new technology, the detrimental health effects of which had clinicians very worried. That technology was the automobile. While the public health concern spanned from inactivity to new maladies like “automobile knee”, by far the greatest concern was automobile accidents. Jones describes that in 1912, accident mortality was such a big problem that a New York coroner’s clerk said “’our streets are becoming as perilous as a battlefield’” and by 1957 the evaluation was not much better:  “Harvard researchers described accident mortality as a ‘mass disease of epidemic proportions’.” Interestingly, Jones highlights that doctors viewed this epidemic not merely as a governmental problem, but one in which there was a moral imperative that doctors themselves play a role in both studying what factors lead to car crashes and (more controversially) identifying high-risk drivers and thus contributing more directly to prevention.

Now in many developing economies across the globe, an interesting twist on this story is emerging: while modern cars have long existed in these locations, only very recently has there been a massive expansion of well-paved roads. And along with new and improved transport routes, new risks to public health.

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Managed Care for Mental Health

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By Nathaniel Counts

Managed care and integration of primary care and mental health services are major foci of the Affordable Care Act, especially as more practices are encouraged to become Patient-Centered Medical Homes.  In managed care, vitals are used to track progress, and case managers can look over an individual’s blood pressure, weight, and blood-sugar levels to work with service providers and patients to ensure best outcomes.  If an individual is receiving mental health services, then the providers will share information about the patient’s current needs in both physical and mental health.  If the individual is not referred to or does not seek out mental health services, then there is no mental health component to manage.

Meanwhile in Massachusetts, every pediatrician is mandated to offer CANS (Child and Adolescent Needs and Strengths), a lengthy evaluation form that asks a patient (aged 5 to 20 for the link above) to evaluate their own life and mental health on sets of 0-3 scales.  CANS is used to monitor children’s mental wellbeing and identify potential problematic areas, including whether a mental health referral for serious emotional disturbance is necessary.  To the best of my knowledge, this information is not stored and used as an indicator for managed care, as blood pressure and weight are. Read More

Genetically Modified Crops

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The USDA’s Animal and Plant Health Inspection Service (APHIS) has released a Draft Environmental Impact Statement associated with its deregulation of a new generation of genetically modified herbicide-resistant crops.   While many in the agricultural industry hail this as a much-needed step in the development of new weed-control technologies, critics worry that it will accelerate an “herbicide treadmill” at the cost of more sustainable management strategies.

As a bit of background, the development of the first generation of genetically modified (GM) herbicide-resistant crops revolutionized agricultural weed management in the mid 1990s.  Prior to this development, weed management required significant skill and knowledge.  Farmers had to not only carefully manage the timing of various herbicide applications, but also integrate other nonchemical control practices.  Herbicide-resistant crops, by contrast, were effective and easy to use.

During the initial phase of development, a variety of GM options came to market, but Monsanto’s “RoundupReady” varieties (which are resistant to a broad-spectrum herbicide known as “glyphosate”) quickly became dominant.   By 2008, 63% of corn fields and 92% of soybean fields in the US were being planted with RoundupReady seeds.  The outcome of this single-track approach to weed management has been a dramatic increase in the number of weed species that are resistant to the herbicide glyphosate.

In response to the evolution of these “super weeds,” Congress has held hearings to assess whether additional government oversight is needed to address the problem.  The response of the seed and agrichemical industries, by contrast, has been to develop new GM seeds that are resistant to other broad-spectrum herbicides for which weeds have not yet developed resistance.  Read More

REGISTER NOW: “New Directions for Food Safety” conference at Harvard Law School

The Petrie-Flom Center Staff Leave a comment

This conference will bring together scholars to discuss a range of issues related to the Food Safety and Modernization Act, including FSMA and risk regulation strategy; regulating farm production; benefits, challenges, and gaps in FSMA’s approach; and international issues and trade implications.

Speakers include:

  • KEYNOTE: Peter Barton Hutt, Harvard Law School/Covington & Burling – The Food Safety Modernization Act in Historical Perspective

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Quantitative Analytical Support Needed for Public Health Law Research

Temple University Center for Public Health Law Research Leave a comment

The National Program Office (NPO) for Public Health Law Research (PHLR), a nationally recognized program sponsored by Robert Wood Johnson Foundation for the evaluation of the health impact of laws and legal practices, seeks a postdoctoral fellow who will provide quantitative analytical support to the PHLR team. The successful candidate holds a Ph.D. with significant experience in quantitative methods and law/health policy or a J.D. with strong quantitative and health policy research skills. The individual will produce empirical papers using the quantitative legal data currently on LawAltas.org and provide literature and systematic review support for journal publications, white papers, and grant submissions. This person will become a full member of the NPO for PHLR at the Temple University Beasley School of Law for a period of two years. PHLR staff and affiliated scholars will mentor this person in public health law research methods and provide networking opportunities with leaders in the field of public health law research. The postdoctoral fellow will be required to attend the PHLR Annual Meeting each year.

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Down with Antipaternalism!

Scott Burris 2 Comments

As the holidays approach, I have a chance to catch up on reading.  The Sept-Oct issue of the Hastings Center Report had a paper by Larry Gostin on Michael Bloomberg’s health policy career in New York, and I have seen some of a series of responses by other scholars that will appear in due course. With his usual facility, Gostin recounts the story of Bloomberg’s health department and its innovations in policy – it’s a great piece for a health law class.  The piece is also typical Gostin in its framing of the issue of paternalism as a key driver of opposition to many of Bloomberg’s initiatives.  And if it is typical Gostin, it is really representative of our field, since Gostin has both drawn on and helped reinforce a widely held belief that the politics of public health are strongly driven by a tension between individual liberty (inscribed legally in civil rights and culturally in individualism and antipaternalism) and public health.

In this framework, paternalism is a premise, not a hypothesis. Gostin writes, “The societal discomfort with Bloomberg’s agenda is grounded, at its core, in distrust of government influence on how autonomous adults conduct their lives.” He describes how health policy-makers are driven to rely on the harm principle to justify policies by “American antipathy toward paternalism.”  Yet, and this is also typical of the discourse in our field, he also follows the Sunstein-Thaler line that ultimately denies the empirical assumptions upon which anti-paternalist claims depend: “The public health approach rejects the idea that there is such a thing as unfettered free will, recognizing instead that the built environment, social networks, marketing, and a range of situational cues drive complex behaviors.”

Public health law has been stuck here for a while, accepting that public health policy has and always will be subject to the arbitrary dominion of a mass delusion of autonomy.  I think this log-jam is starting to break – and that proponents of effective health laws should be doing all they can to properly discredit and abandon this old trope.  A few signs:

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Managing All Care

The Petrie-Flom Center Staff Leave a comment

By Nathaniel Counts

Health insurers are beginning to realize the importance of downstream cost-saving.  By paying to keep people healthy now, health insurers avoid major expenditures later when they must cover chronic conditions and hospitalizations.  For example, by paying for nutrition counseling and fitness programs for prediabetics, health insurers can reduce the rate of transition to diabetes for their clients, which both saves the insurer thousands of dollars and keeps their clients happier and healthier.   This type of innovation is possible because the law requires certain expenditures, i.e. doctors must treat individuals at the emergency room, and these expenditures tend to be quite large if incurred.

Social services in general could enjoy this type of innovation if funding were pooled between government services, and healthcare, housing, food, and direct welfare were all managed together.  Currently, each is conceived as a separate welfare program, so one can only recognize reduction within a program, not how the programs interact.  For example, it may be that the expansion of SNAP benefits would decrease emergency room visits and end up being cost-saving overall.  It may also be that certain types of subsidized housing reduce the need for other services and are more cost-saving than others, but this is hard to recognize when each program is segregated.  One could imagine that subsidized housing built in areas with better access to quality food and jobs would be more expensive upfront, but could save in money overall by reducing the need for other benefits.  Because social services currently have a system of mandatory spending in the form of entitlements, there is an incentive to ensure that individuals transition away from use of the more expensive services.

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1/31: Second Annual Health Law Year in P/Review conference

The Petrie-Flom Center Staff Leave a comment

Please join us for our second annual Health Law Year in P/Review event, co-sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the New England Journal of Medicine. The conference will be held in Wasserstein Hall, Milstein East C at Harvard Law School on Friday, January 31, 2014, from 8:30am to 5:00pm.

This year we will welcome experts discussing major developments over the past year and what to watch out for in areas including the Affordable Care Act, medical malpractice, FDA regulatory policy, abortion, contraception, intellectual property in the life sciences industry, public health policy, and human subjects research.

The full agenda is available on our website. Speakers are:  Read More

Art Caplan on Mandela’s AIDS legacy of silence and courage

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Art Caplan has a new piece over at NBC News online on Nelson Mandela’s AIDS legacy:

[…] It had been an enormous mistake to ignore the epidemic, made even worse by installing an AIDS denialist as his favored successor.

In 2003 Mandela began to speak out plainly and forcefully about AIDS. And he acted. He created a foundation to fight HIV/AIDS, the Nelson Mandela Foundation, and began a fundraising campaign to support HIV prevention and public health efforts called 46664, his identification number when he was imprisoned by the apartheid government on Robben Island. For the rest of his life he urged people to talk about HIV/AIDS “to make it appear like a normal illness.” And he used his reputation to make HIV prevention and AIDS treatment an international issue. In his retirement, he put AIDS at the top of his personal agenda.

[…]

Mandela vigorously took on critics, speaking courageously about AIDS and the importance of using the best science and public health knowledge to defeat it. Our greatest ethical leaders like Mandela are never more instructive than when we learn not just from their triumphs, but also from how they recognize and respond to a mistake.

Read the full article.