Anti-Bullying Legislation: Safer Schools through Legal Intervention
By Marizen Ramirez, PhD, MPH
Bullying is the most frequent form of peer victimization in schools, impacting about 10-25% of all children across the United States. The effects of bullying on children have been well-documented, from psychological and physical harm, poor academic performance, alcohol and drug use, and violent behaviors. In its most extreme form, relentless bullying has even driven some young people to suicide. The 2011 documentary, Bully, depicts the tragic stories of Tyler Long and Ty Smalley, who, because of the chronic ridicule and physical harassment they faced, took their own lives.
Stories like Tyler’s and Ty’s have pushed bullying into the public eye, making it a public health issue of national importance. Across the country, efforts abound to prevent bullying and to help provide safe, welcoming environments for our children when they are at school.
Bullying prevention is being approached in a few different ways. National campaigns like Stop Bullying Now! work to increase awareness about bullying and strategies for prevention. Since its inception, the Stop Bullying Now! campaign has provided resources, including an online toolkit of educational materials, to schools and youth clubs throughout the country. Schools have also implemented a variety of anti-bullying curricula to improve school climate and prevent bullying behaviors in schools. Among these programs are the famous Olweus program developed in Norway in the 1980s, and Positive Behavior Interventions and Supports (PBIS), a program targeting the reduction in school-wide behavioral problems including bullying. The effectiveness of curricula, such as Olweus and PBIS, in reducing rates of bullying in American schools has yet to proven, however.
14th Annual Hospital & Health Law Conference 2013
Implementation of Federal and State Health Reform:
PPACA + Chapter 224 = opportunities, dynamism, and risk
12:00 Noon – 5:00 P.M.
Thursday, May 9, 2013
MCLE Conference Center,
10 Winter Place, via Winter Street
Addressing the growing cost of health care, desire to leave no person uninsured, and expectation that care should be delivered at the highest levels of quality have caused major changes to the health care landscape in the Commonwealth over the past several years. In 2012 there were two significant developments propelling these changes. First, Federal Health Reform, through the Patient P—assured by the Supreme Courts ruling and the reelection of President Obama. Second, Massachusetts has embarked on Health Reform II through the passage of Chapter 224 of the Acts of 2012. These two forces combine to make 2013 a busy year for lawmakers, regulators, payors, providers, drug and device manufacturers, patients, and the lawyers who serve these diverse groups.
This cutting-edge Conference is designed to address these dramatic changes in the Massachusetts health care marketplace and beyond from a sophisticated legal perspective. What do lawyers need to anticipate in order to advise clients? What new business opportunities await the industry and their legal counsel? What should organizations be doing now to prepare for change in the near term?
With many important perspectives to be heard about these developments, the Conference seeks to bring together diverse viewpoints and experiences to give attendees both breadth and depth on these important subjects. Hear from health lawyers as well as health care industry insiders living with a dynamic market. Lawyers that help their clients respond to a market in flux, exposing both risks and opportunities, are providing a critical service at this time. This Conference distills and addresses key issues and provides essential insight on the skills of lawyering in this evolving practice area.
Registration information and agenda available at the conference website.
Of Evergreening and Efficacy
By Ryan Abbott
An important case was decided yesterday that may have a significant impact on access to medicines for patients in developing countries. India’s high court rejected an appeal by the pharmaceutical company Novartis to grant a patent for its cancer drug Glivec.
The case involved a challenge to Section 3(d) of the Indian Patents Act which was designed to prevent patent holders from extending the duration of their patents by making minor changes to existing formulations—a practice referred to as “evergreening.” Section 3(d) stipulates that “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance” is not eligible for patent protection.
The drug Glivec was initially invented and patented as a compound in its free base form. Novartis subsequently obtained a patent in the U.S. and Europe on a beta crystal version of the compound, which was found to possess 30% greater bioavailability. In yesterday’s case, one of the central questions before the court was whether the “new” drug form qualified for a new patent under Section 3(d). The court ruled that it did not.
To arrive at this conclusion, one of the more interesting issues the court had to resolve was how to define efficacy. It elected to define efficacy as therapeutic efficacy, but even within that definition the court was presented with multiple visions.
On the one hand, efficacy could be thought of as the capacity of a drug to produce an effect. That is, the property of a drug that causes a stimulus at a receptor site, as distinct from characteristics such as affinity, potency, and bioavailability. A broader conception of efficacy would include considerations such as improved safety or reduced toxicity.
Theoretically, I suspect a more holistic approach is justified.
On Scientific Journals as a Bulwark Against Research Misconduct
I’ve been thinking a lot lately about how our society regulates the integrity of scientific research in an era of fierce competition for diminishing grants and ultracompetitive academic appointments. When I shared a draft paper on this topic a few weeks ago, several colleagues urged me to think more about the role played by academic journals, so I was interested to see this article in Nature last week about a recently uncovered criminal scam defrauding two European science journals and countless would-be authors. It caught my attention because it seems to belie the notion that the journals and the honest scientific community are sophisticated enough actors to be trusted to root out the fabrication, falsification, and plagiarism that constitute “research misconduct” under Federal law. Needless to say, it takes a different kind of expertise to discern scientific misconduct than to uncover a more mundane phishing scam like the one these cons were running, but the anecdote stands as a nice reminder of the fallibility even of great minds.
Introducing Ryan Abbott
Ryan Abbott, M.D., J.D., M.T.O.M., is Associate Professor of Law at Southwestern Law School. He has served as a consultant on health care financing and regulation, intellectual property, and public health for international organizations, academic institutions and private enterprises including the World Health Organization, World Intellectual Property Organization and University of California, Los Angeles. Professor Abbott has published widely on issues associated with health care law and intellectual property protection in legal, medical, and scientific peer-reviewed journals.
Professor Abbott is a licensed physician, attorney, and acupuncturist. He is a graduate of the University of California, San Diego School of Medicine and the Yale Law School, as well as a Summa Cum Laude graduate from Emperor’s College (MTOM) and a Summa Cum Laude graduate from University of California, Los Angeles (BS). Professor Abbott has been the recipient of numerous research fellowships, scholarships and awards, and has served as Principal Investigator of biomedical research studies at University of California. He is a registered patent attorney with the U.S. Patent and Trademark Office and a member of the California and New York State Bars.
Some of Dr. Abbott’s recent publications include: Read More
Public Health Protection under the EPA Lead and Copper Rule
Dr. Yanna Lambrinidou and Dr. Marc Edwards
It is generally safe to assume that, when it comes to contaminants in drinking water, consumers are protected by regulation and proactive water utilities.
One noteworthy exception is the federal law promulgated to protect the public from lead at the tap. Known as the Lead and Copper Rule (LCR), this law splits responsibility for minimizing exposures between utilities and consumers. The rationale for this “shared responsibility” approach is that in the majority of cases lead leaches into water from lead service lines (LSLs) (i.e., the pipes that connect water mains to individual homes) and lead-bearing home plumbing materials (e.g., lead solder, leaded brass). These sources of lead are often partly or fully inside the home – LSLs and lead solder were used routinely until 1986, and the use of leaded brass will continue to be legal until 2014. Moreover, differences in plumbing and water usage (e.g., volume, flow), make lead leaching in every house unique. Under the LCR, utilities are required to monitor a small number of homes considered “high risk” for lead in water, but consumers are responsible for having their own water tested and for adopting health-protective water-use practices that minimize the risk of exposure.
When utilities detect elevated lead levels in more than 10% of the homes they sample, they must tell consumers how to avoid exposure by, for example, flushing stagnant water before use and avoiding consumption of hot tap water (especially for reconstituting infant formula). They must also implement a LSL replacement program. Although full LSL replacement is the only way to eliminate the risk from lead pipes, the LCR requires utilities to replace only the portion of a LSL that they own. The consumer-owned portion of the line is left in place, unless homeowners agree to pay for its removal, which can cost several hundred to several thousand dollars.
Fox on “The Flawed Logic of Prenatal Discrimination”
Dov Fox has an interesting new piece up at HuffPo examining the constitutionality of the abortion restrictions just enacted in North Dakota:
As the Supreme Court heard oral arguments this week in the same-sex marriage cases, North Dakota enacted three of the most restrictive abortion laws in the country. Two of them are unlike any ever considered by U.S. courts.
One bans abortion wholesale after a fetal heartbeat is “detectable” (as early as six weeks into a pregnancy), unless termination would save the woman’s life. The other law forbids any abortion that’s sought on the basis of fetal sex or genetic anomaly, even fatal ones.
Both laws should be struck down as unconstitutional. But the selective abortion ban presents new legal questions for supporters of reproductive rights. Indeed, the Supreme Court in Roe v. Wade declined to insist that a woman “is entitled to terminate her pregnancy . . . for whatever reason she alone chooses.”
Keep reading…
New Paper on Conscience and the ACA
Piggy-backing on Glenn’s post below, I just wanted to point you to my contribution to the same symposium issue of Ethical Perspectives. The paper, “Religious Liberty, Conscience, and the Affordable Care Act,” can be downloaded here, and copied below is the abstract:
Broadly applicable legal requirements often come into conflict with moral or religious standards that individuals and organizations feel more strongly compelled to obey. Making room for such moral and religious standards in secular society is important, but can be difficult, since any exemptions or accommodations cannot be allowed frustrate the purpose of the general law, and must also be fair to those who remain subject to it without any special arrangements.
This essay briefly surveys the ways in which the Affordable Care Act might come into conflict with moral and religious beliefs held by both individuals and institutions, and describes the government accommodations that have been offered or considered to date. In particular, it focuses on the requirement that employers offer insurance coverage for free contraceptives and the requirement that individuals purchase insurance coverage that may include services they find objectionable. In both cases, I conclude that the proffered accommodations should be altered to enhance fairness as between objectors and non-objectors.
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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