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.

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Happy Public Health Week: “We’re Good Enough, We’re Smart Enough, and Doggone It, People Like Us”

By Scott Burris

We may be living in a golden age of group-think. A weekly reminder is poor Paul Krugman railing against the apparently universal belief in America and Europe that we’ve got to cut budgets right now or disaster will strike. He calls this a Zombie idea, a false claim that has been falsified with plenty of stakes in the heart, silver bullets and blows to the head, but will not stay in the grave.

Closer to home for us in public health is the claim that Americans don’t like government rules regulating their behavior and meddling with their preferences.  Cass Sunstein and Richard Thaler have delivered some solid blows to the idea that paternalism typically messes with solid preferences. As we celebrate Public Health Week, I want to highlight two recent papers that show that Americans, like the children in Mary Poppins, actually like their nannies, who do some pretty great things.

Public Health Law Research has recently posted the manuscript of a paper that Evan Anderson and I have prepared for the Annual Review of Law and Social Science. The paper describes the dramatic rise of law as a tool of public health since the 1960s in five major domains: traffic safety, gun violence, tobacco use, reproductive health and obesity.  These topical stories illustrate both law’s effectiveness and limitations as a public health tool. They also establish its popularity by the most apt of metrics – the willingness of legislators to enact it. The one picture worth a thousand words, below, depicts the rapid adoption of a variety of interventions by state legislatures. (By the way, the five examples also show that public health law research can and does influence the development and refinement of legal interventions over time.)

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Reducing Gun Violence in America

Typically, we would avoid such a shameless plug for our researchers — we’d be a little more subtle. But, we can’t help it this time. This book is the best $10 you’ll spend all year.

A little less than a month ago, Johns Hopkins University convened more than 20 of the world’s leading experts on gun violence and policy to summarize their research and recommend policy changes. This 282-page book features empirical research from the leading experts in the field covering the topics of mental health and gun violence, gun law enforcement, high-risk guns, international case studies of responses to gun violence, the Second Amendment, public opinion on gun policy, and concludes with a summary of the recommendations for reforms to Federal policies.

Chapter 3, “Preventing Gun Violence Involving People with Serious Mental Illness,” features research conducted by Jeffrey Swanson, PhD, and his team of researchers based at Duke University. The research presented was funded by PHLR and the National Science Foundation.

Seriously. Check it out.

Raffles for IVF access?

As the New York Times reports (quoting me on the ethics), some American IVF clinics are now running raffles where the prize is IVF services. The contests give clinics publicity and sometimes serve charitable causes. Are IVF raffles unethical? Should we ban them?

Gambles and contests over the ability to have babies represent a new level of commodification—if you will, a new frontier. But they are not always unethical. Clinics do not owe infertile couples free access to IVF services. In some cases, the state and insurers don’t owe it to them either—legally or morally. IVF is expensive and some medical services are needed even more badly. Uninterested couples can avoid these raffles. What these raffles do is to give infertile couples opportunities that they would lack otherwise for obtaining an important benefit, opportunities that go beyond what clinics owe them. Lotteries, in particular, are not necessarily unfair means of distributing resources. Some philosophers deem them very fair. Even when couples with means can buy several raffle tickets, impoverished couples still get better chance of IVF access than under the current system. Money speaks, but it speaks less vocally than in much of American healthcare. In this respect, these raffles are a good parody of our unjust system.

 These contests are games. Conservatives worry that they take infertility or the beginnings of human life too lightly. But light-heartedness could be a good thing in this area. It might reduce the anxiety and the stigma that too often accompany infertility treatment. Associating the conception of new human life with fun? Traditional procreation can do that, too!

In short, not everything that’s odd is unethical. Notwithstanding initial “yuck” feelings, raffles for IVF access are not always morally wrong. It would have been morally more ideal if clinics offered free IVF services to everyone, or prioritized the neediest and the underserved, or gave rich and poor equal chance. But acting less than ideally is not doing wrong. Continue reading

Infrastructural Law: The Lesser-Known Cousin

by Jennifer Ibrahim, PhD, MPH

An article by Julia Costich, MPA, JD, PhD, and Dana Patton, PhD, in the October 2012 edition of the American Journal of Public Health reveals the tip of the iceberg on a highly discussed and yet insufficiently researched topic: the legal infrastructure. While the team reports a significant impact of the legal infrastructure of local health departments on population health outcomes, the paper also raises questions regarding the role of law more generally in the functioning of health departments.

While we “see” law all the time in action, we rarely “see” law as an important factor influencing the way health agencies operate. Sure, we understand law as a way to drive the behavior of individuals by regulating sugar-sweetened beverages or prohibiting texting while driving or preventing smoking in indoor spaces — this is called interventional law — but there is a lesser-known cousin, infrastructural law, that desperately needs our attention.

While public health officials, policy-makers, advocates and academics regularly discuss the funding and organization of health departments at both the state and local levels, they less often step back to think about what is driving the process — law. As states are facing significant fiscal crisis, funds are a major concern, but it is important to remember that appropriations are made through law. Additionally, in recent years, during natural disasters such as hurricanes in the south and major floods in New England, there were questions in the news about which agencies should be doing what and when. The authority for a health department to act and/or to act in concert with another agency is derived from law.

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