The fight against Antimicrobial Resistance: Important recent publications

One of my previous blogs discussed the growing threat of antimicrobial resistance (AMR). I concluded that antimicrobial resistance is a growing and complex threat involving multifaceted legal, socio-economic and scientific aspects. This requires sustained and coordinated action on both global and local levels.

A recent medical review on drug resistant tuberculosis supports these findings and provides further fodder to the debate. In their study, which was published in April 2014 in The Lancet – Respiratory Medicine, the authors analyzed the epidemiology, pathogenesis, diagnosis, management, implications for health-care workers, and ethical and medico-legal aspects of extensively drug-resistant tuberculosis and other resistant strains. In particular, the authors discussed the increasing threat of functionally untreatable tuberculosis, and the problems that it creates for public health and clinical practice. The paper concludes that the growth of highly resistant strains of tuberculosis make the development of new drugs and rapid diagnostics for tuberculosis—and increased funding to strengthen global control efforts, research, and advocacy—even more pressing.

This was also recognized in the recent WHO’s Global Surveillance Report on AMR, which was published this April. It is the first WHO report that studied the problem of AMR on a global level. Noting that resistance is occurring across many different infectious agents, the report concentrates on antibiotic resistance in seven different bacteria responsible for common, serious diseases such as bloodstream infections (sepsis), diarrhoea, pneumonia, urinary tract infections and gonorrhoea. The results demonstrate a wide-spread growth of resistance to antibiotics, especially “last resort” antibiotics. In particular the report reveals that this serious threat is no longer a mere forecast for the future. AMR is a contemporary problem in every region of the world and has the potential to affect anyone, of any age, in any country. Consequently the WHO report concludes that antibiotic resistance is now a major threat to public health that needs to be tackled on a global level.

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National Conference on HIV Criminalization

By Sterling Johnson, JD

Grinnell College in Iowa will host the first National Conference on HIV Criminalization next week, June 2-5 on its campus.

One of the stated goals of the conference will be to discuss the recent legislative changes in Iowa and how to apply the lessons to other states with laws that apply specifically to people with HIV.

Currently, 43 states criminalize actions by HIV-positive individuals. Check out our map at LawAtlas.org for more details.

US states with HIV criminalization laws

In 2009, Iowa became the center of this battle when Nick Rhoades, who is HIV-positive, had a one-time sexual encounter with another man, Adam Plendl. Three months after, Mr. Rhoades was arrested on suspicion of engaging in intimate contact without disclosing his HIV-positive status. At the time of the sexual encounter, he used a condom, had an undetectable viral load and his sexual partner did not contract HIV; however, Nick Rhoades was sentenced to 25 years in prison and classified as a sex offender. The case is now is now on appeal and being argued by Lambda Legal. The Iowa court of Appeals affirmed the conviction and the case is now under review by the Iowa Supreme Court. Mr. Rhoades’s case led to community organizers lobbying to reform the HIV criminalization law in Iowa. Continue reading

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!

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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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Birth Control for Men?

We’re not talking vasectomies or condoms.

Medical Daily reports that the NIH has awarded a $4.7 million grant to come up with a “Pill” for men. Most previous attempts to develop such contraceptives used testosterone to reduce the number of sperm men produce. This one takes aim at its mobility instead, using a non-hormonal compound that promises fewer side effects, according to scientists. Clinical testing into its safety and efficacy, assuming the FDA grants permission, would take at least five to ten years before the agency could consider approving the drug for use.

The availability of male birth control would make it possible for men and women to share responsibility for contraception. Today, women alone shoulder the considerable physical and other burdens that come with the Pill. And only women enjoy the security that control of its use affords over the likelihood of unwanted pregnancy. Tomorrow, we could even things out a bit. That’d surely be a development worth embracing. Or would it? Sharing responsibility for contraception means leaving it to men to take the necessary measures to prevent the reproductive consequences that in our society fall far more heavily on women.

We might suppose that some such men, who have less at stake than their female partners, would be less vigilant about birth control and forget to take the pill. There is also evidence to suggest that other men might use greater control over conception for abusive purposes. A 2010 study found that 15% percent of respondents women ages 16-29 who sought care in several Northern California family planning clinics reported that their male partners had damaged condoms or otherwise sabotaged their birth control.*

Would birth control for men be cause for celebration, or concern? Would it revolutionize sexual equality, or change little at all?

*This “pregnancy coercion,” as the researchers call it, differs in respect of the gestation, abortion rights, and sex-differentiated social expectations involved from the reverse-gender cases that Glenn Cohen has analyzed in which courts “have imposed legal parenthood [] on fathers deceived into believing that their partners could not conceive” or under circumstances in which “conception took place without meaningful consent.”

Flu Vaccine Mandates for Health Care Workers

According to officials, the worst of this year’s devastating flu season should be over in most parts of the country. But in early January, the flu had hit 47 of 50 states. According to the CDC, a total of 78 influenza-associated pediatric deaths have been reported. Throughout this terrible flu season, there’s been much talk about vaccination mandates for health care workers.

States have started passing legislation regulating health care worker flu vaccination, and an increasing number of hospitals have started implementing policies in attempt to reach the Healthy People 2020 goal of having 90 percent of health care workers vaccinated. Only two-thirds of health care workers were vaccinated against the flu last year. This can leave patients at risk and hospitals short-staffed because of absenteeism.

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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.

PHLR Annual Meeting Post-Mortem

This past week, PHLR hosted 150 researchers, lawyers, public health practitioners and others for our fourth annual meeting. With our theme for the conference in mind, “Driving Legal Innovation,” our attendees shared results of evaluations of laws and regulations, offered up suggestions for new ways to use law to improve health, and attacked head on the issues facing the United States and our public health.

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Ohio Joins In

By Hosea H. Harvey, JD, PhD

Last week, Ohio joined the vast majority of states that have enacted laws designed to reduce long-term health consequences for youth athletes who suffer concussions (technically, traumatic brain injuries or TBIs) in organized youth sports activities.  Based on my research for an upcoming article “Reducing Traumatic Brain Injuries in Youth Sports” (forthcoming, American Journal of Public Health), it appears that Ohio has followed the lead of most other states by adhering to a common framework and (at the same time) has substantially innovated with respect to certain key provisions of such laws.

Most youth sports TBI laws are organized around three broad risk-reduction methods: 1) educating parents, youth athletes, and/or coaches, 2) requiring the removal of youth athletes suspected of having concussions, and 3) providing criteria that a youth athlete must meet prior to returning to athletic competition. Each of these methods are, in part, derived from legislation crafted after a tragic football injury to Zachary Lystedt in Washington, leading the state to pass the nation’s first such law in April 2009. (You can read the law on LawAtlas™)  Since then, adherence to the “Lystedt framework” has been a common feature of state-level youth sports TBI laws. In this fast-paced legislative environment, unprecedented in scope, Ohio is relatively late to the game. Yet, by moving later, Ohio’s deliberate speed has resulted in legislation that relies on the Lystedt framework but also contains innovations of uncertain efficacy.

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Preventing Teen Crashes with Stickers

By Scott Burris

Graduated Drivers’ License Laws have apparently been a major success in reducing crashes among novice drivers. (A couple of studies have suggested the laws might just be postponing crashes, but so far that hypothesis remains unproved, and the weight of expert opinion seems to be that the association is spurious.)  There has been a weak link in enforcement, though, which is that in the dark of night and flow of traffic, police officers can’t always spot an underage driver out past the curfew or chauffeuring too many passengers.

Enter the decal.  A number of European and Asian countries require new drivers to decorate their car with a special decal indicating probationary status. That way it is easy for police to detect possible GDL violations.

In 2010, New Jersey became the first state to require the decal, and this week a PHLR study published in the American Journal of Preventive Medicine found robust evidence of seriously positive impact.

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NIH + NFL = PHLR

By Scott Burris, JD

The National Football League has given the National Institutes of Health $30 million for research on traumatic brain injury. There is much we don’t know about the causes, effects, prevention and treatment of sports-related brain injury – but that doesn’t mean that we should put all our eggs into the basket of biomedical research. Since Washington state pioneered its youth-sports brain injury prevention model-law in 2009, 40 states have passed laws setting out rules aimed at the problem (We’re tracking these on LawAtlas, the new PHLR policy surveillance portal). Most of these laws work by promoting identification of concussions, regulating the athlete’s return to play, and educating parents and coaches.

To put it another way, the nation, through a majority of its state legislatures, has embarked on a major initiative to reduce sports-related injuries. Tens of millions of people will be affected in some way – athletes, parents and coaches. Limited school-based resources will be consumed to comply with these laws. And, most importantly, people worried about the problem will, to some extent, rely on implementation of these laws to protect student athletes.

If this public health intervention were a drug or a new technique for changing behavior, its efficacy would be rigorously tested by government-funded research. Why should things be different because this possibly magic bullet happens to be based in the law? So far, the CDC has funded implementation case studies of youth sports concussion laws in Washington and Massachusetts. PHLR is funding a more in-depth study in Washington, with results expected next year.

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Using the Taxing Power for Public Health

By Scott Burris

In a Perspective in this week’s New England Journal of Medicine, Michelle Mello and Glenn Cohen, both professors at Harvard, write about the prospects for using the constitutional Taxing Power to adopt innovative laws to advance public health objectives.  Cueing off the Supreme Court’s decision in the Affordable Care Act litigation, Mello — who is also a member of PHLR’s Methods Core — and Cohen write that the Court appears to have opened the door for “more targeted, assertive interventions to promote public health” under the Taxing Power than Congress has previously pursued. “For example, instead of merely taxing tobacco sales, the federal government could require individuals to pay a tax penalty unless they declare that they haven’t used tobacco products during the year. It could give a tax credit to people who submit documentation that their bodymass index is in the normal range or has decreased during the year or to diabetic persons who document that their glycated hemoglobin levels are controlled. It could tax individuals who fail to purchase gym memberships. …These strategies depart from traditional uses of taxes by targeting omissions and noncommercial activities that are important drivers of chronic disease.”  Read the full article online at the New England Journal of Medicine online.

Needing a Lawyer on the Team

by Wendy Parmet

It’s easy to see the value of including scientists in public health law research teams; most public health lawyers lack the training to conduct rigorous empirical research.  It may be harder to see the need for adding lawyers to the research team, but their presence is no less critical. Sometimes scientists have as much trouble understanding the law as the lawyers have understanding the science.

The value of involving lawyers in public health law research became clear to me recently as I was working on a project relating to health policies affecting immigrants. One question I wanted to know was how the 1996 Personal Responsibility and Work Opportunity Reconciliation Act (PRWORA) affected immigrants’ access to health insurance in the United States.  So I decided to review the scientific literature. The results were dismaying.

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“Overcriminalization” and HIV

By Scott Burris

The concept of “overcriminalization” is gaining traction across the political spectrum.

The Heritage Foundation, which has a website devoted to the phenomenon, defines it as “the trend in America – and particularly in Congress – to use the criminal law to ‘solve’ every problem, punish every mistake (instead of making proper use of civil penalties), and coerce Americans into conforming their behavior to satisfy social engineering objectives.”   Others, like Michelle Alexander, drop the Ayn Rand tones and focus on mass incarceration as racialized social control. (My colleagues and I once calculated that African American males can expect to spend on average 3.09 years in prison or jail over their lifetime.) Douglas Husak argues that we need a theory of criminalization to help us get less of it.

One of the best examples of criminal law rushing in where angels fear to tread is the criminalization of HIV exposure. From the start, there was reason to fear that these laws would not reduce HIV transmission, and might exacerbate stigma and social hostility towards people with HIV. There was concern they might be used selectively, or just randomly.

This summer, the UN’s Global Commission on HIV and the Law advised states to repeal or abstain from enacting such laws.  The Commission drew on a set of background papers that reviewed the extent of the phenomenon globally and addressed the argument that these laws are justified by moral values even if they are ineffective.

In this country, the President’s National AIDS Strategy suggested states reconsider these laws, but no laws have been repealed and prosecutions continue.  Fortunately, so does research, and it continues to show that these laws are not promoting public health. This week, the American Journal of Public Health published a new PHLR-funded study by Carol Galletley. This video sums up her findings:

Evidence for Policy: Nice If You Can Get It

By Scott Burris

Sometimes researchers can tell policy makers pretty confidently what public health law interventions really make a difference. The PHLR website has more than 50 Evidence Briefs that summarize the results of systematic reviews of the evidence on interventional public health laws conducted by the Cochrane and Campbell Collaboratives, and the Community Guide to Preventive Services.. We know, for example, that  there is significant evidence to support water fluoridation as an effective public health intervention aimed at reducing tooth decay (Portland, are you listening?). We know that workplace smoking bans prevent heart attacks. For laws like these, we have numerous high quality studies, sometimes even experiments, that show whether or not the law is effective.

Unfortunately, problems don’t wait for evidence, and usually by the time there is a substantial body of evidence in place to review, most states have already made their policy decisions. What do we do when there is a problem that demands action, but there is no clearly effective legal action to take?

One of these days we’ll blog about what we think should happen. But for now, we can look at what often does happen. Usually, it resembles the fads we see in fashion: One state tries something, and other states follow, until a lot of states are doing something that might, or might not be working.

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The Evolution of Public Health Law Research

By: Scott Burris, JD

Law has been used to protect and promote public health from the early days of European colonization of North America. Quarantine statutes and orders are reported from the mid-17th century. The 1793 yellow fever epidemic in Philadelphia, where our office is based, inspired the federal government’s first public health statute, authorizing relocation of the capital in the event of an outbreak.

By the mid-19th century, sanitarians like Boston’s own Lemuel Shattuck were articulating the idea that a considerable proportion of death and illness was preventable, and arguing that it was moral, feasible, and economical for the state to do the preventing. Law was a primary tool for prevention, and throughout the 19th century, and into the early twentieth, the extent and limitations of federal, state and local public health authority was litigated, debated in legislatures and defined in voluminous treatises by scholars like Freund, Tiedeman and Tobey.

And then, it got quiet.

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