HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Saturday, March 26, 2011

John Petrila & Corine De Ruiter: "The Competing Faces of Mental Health Law: Recovery and Access versus the Expanding Use of Preventive Confinement"

John Petrila, Profesor at the University of South Florida, and Corine De Ruiter posted "The Competing Faces of Mental Health Law: Recovery and Access versus the Expanding Use of Preventive Confinement" on SSRN:

Mental illnesses are an enormously important public health issue. Many nations are struggling to create adequate treatment capacity, based on advances in treatment philosophies, treatment modalities, and the codification of the rights of people with mental illnesses. However, preventive confinement is increasingly used to indefinitely confine classes of individuals based on sometimes substandard clinical testimony on diagnosis and future risk. The expanding use of preventive confinement threatens to draw already scarce resources from the treatment of many people with serious mental illnesses to focus on a handful of individuals thought to be dangerous to society. This has serious implications for the future of public mental health care.

March 26, 2011 | Permalink | Comments (0) | TrackBack (0)

Gaia Bernstein: ""Direct-to-Consumer Genetic Testing: Gatekeeping the Production of Genetic Information"

Gaia Bernstein, Associate Professor of Law at Seton Hall University School of Law, posted "Direct-to-Consumer Genetic Testing: Gatekeeping the Production of Genetic Information" on SSRN:

Bernstein-gaia-lg Traditionally, the practice of genetic testing was governed by the Diagnostic Paradigm. Under the Diagnostic Paradigm an individual tested for a disease that was prevalent in his family and a medical professional guided the testing process. Yet, recently, a new genetic testing paradigm has emerged - the Consumer Paradigm. Under the Consumer Paradigm, direct-to-consumer genetic testing companies are offering online packages of multiple genetic tests that are bundled together. The individual purchases the package and undergoes testing for a large battery of tests usually without the guidance of a medical practitioner.

This Essay argues that the emergence of the Consumer Paradigm signals a new step in the genetic revolution and creates a need for an additional policy focus. While in the past legal discourse focused on the removal of barriers for innovation and access, it should now also consider the need to regulate and filter the production of genetic information. Specifically, this Essay underscores the necessity of having a medical professional as a gatekeeper of the production of genetic information.

This Essay argues for the need for a law mandating the guidance of a medical professional not only at the interpretation stage but also at the outset of the process - to guide individuals through the selection of tests. Not all genetic information is made equal and not all test results are similarly desirable for all people. A medical practitioner can guide individuals in selecting the genetic tests that reflect their preferences and produce the genetic information that is beneficial for them.

March 26, 2011 | Permalink | Comments (0) | TrackBack (0)

Richard J. Bonnie: "Responsibility for Addiction"

Richard J. Bonnie, Professor of Law at the University of Virginia School of Law, posted "Responsibility for Addiction" on SSRN:

Bonnie1496_best Taking as its starting point the characterization of addiction as a "brain disease" by the nation’s leadership in public health and biomedical science, this paper explores the implications of recent developments in neuroscience for the concept of responsibility. The terrain is divided into three parts: responsibility for becoming addicted; responsibility for behavior symptomatic of addiction; and responsibility for amelioration of addiction. In general, the paper defends the thesis that recent scientific developments have sharpened but not erased traditional understandings in the first two areas, while recent legal developments have exposed new and intriguing theories of responsibility for managing.

March 26, 2011 | Permalink | Comments (0) | TrackBack (0)

Friday, March 25, 2011

Victoria Lazariu, Chengxuan Yu & Craig Gundersen: "Forecasting Women, Infants, and Children Caseloads: A Comparison of Vector Autoregression and Autoregressive Integrated Moving Average Approaches"

Victoria Lazariu, Chengxuan Yu and Craig Gundersen posted "Forecasting Women, Infants, and Children Caseloads: A Comparison of Vector Autoregression and Autoregressive Integrated Moving Average Approaches" on SSRN:

Under the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), each state receives a fixed federal grant for the operation of WIC in the upcoming federal fiscal year. Accurate forecasting is vital because states have to bear the expenses of any underestimation of WIC expenditures. Using monthly data from 1997 through 2005, this paper examined the performance of two competing models, autoregressive integrated moving average (ARIMA) and vector autoregression (VAR), in forecasting New York WIC caseloads for women, infants, and children. VAR model predicted over $120,000 less per month in forecast errors in comparison to the ARIMA model.

March 25, 2011 | Permalink | Comments (0) | TrackBack (0)

Raghav Gaiha, Raghbendra Jha & Vani S. Kulkarni: "Child Undernutrition in India"

Raghav Gaiha, Raghbendra Jha, and Vani S. Kulkarni posted "Child Undernutrition in India" on SSRN:

We have constructed a composite indicator of anthropometric failure (CIAF) that refines the Waterlow-3 tier classification, using a recent nation-wide household survey. The CIAF and its disaggregation into subcategories of undernourished 5 years old children reveal a grimmer story of child undernutrition than conventional anthropometric indicators do. Besides, simultaneous occurrence of anthropometric failures (e.g. stunting and underweight, and stunting, wasting and underweight) is pervasive. Our analysis of determinants of CIAF yields some new insights-specifically, the important role of food prices. Investigation of the links between different anthropometric failures and prevalence of infectious diseases (viz. Diarrhoea and acute respiratory infection), however, offers some justification for the disaggregated classification of undernourished children used here. Specifically, those with more than one failure were worse-off in this respect than children with no failure. There is a strong case for income growth together with food price stabilisation in curbing child undernutrition. Education has the desired effect but it is less strong than expected. Improvement in the quality of home environment makes a difference too but it is not conditional on income or wealth alone.


March 25, 2011 | Permalink | Comments (0) | TrackBack (0)

Robert A. Mikos: "A Critical Appraisal of the Department of Justice's New Approach to Medical Marijuana"

Robert A. Mikos, Professor of Law and Co-Director of the Program of Law and Government at Vanderbilt University Law School, posted "A Critical Appraisal of the Department of Justice's New Approach to Medical Marijuana" on SSRN:

227photo The Obama Administration has embarked upon a much-heralded shift in federal policy toward medical marijuana. Eschewing the hard-ball tactics favored by earlier Administrations, Attorney General Eric Holder announced in October 2009 that the Department of Justice (DOJ) would stop enforcing the federal marijuana ban against persons who comply with state medical marijuana laws. Given the significance of the medical marijuana issue in both criminal law and federalism circles, this Article sets out to provide the first in-depth analysis of the changes wrought by the DOJ’s new Non Enforcement Policy (NEP). In a nutshell, it suggests that early enthusiasm for the NEP is misguided; on close inspection, the NEP represents at most a very modest change in federal policy. First, the NEP won’t necessarily stop federal agents from pursuing criminal prosecutions of marijuana dispensaries. In a twist of irony, the non-enforcement policy itself is not enforceable. It doesn’t create any legal rights a court could invoke to dismiss a criminal case. And the DOJ itself will have a difficult time ensuring that federal prosecutors comply with the agency’s stated policy. Second, even assuming the NEP would block criminal prosecutions, federal law could still obstruct state medical marijuana programs by imposing - or enabling others to impose - a wide range of civil and private sanctions on medical marijuana users and their suppliers. The problem is the NEP doesn’t repeal the federal ban on marijuana. Marijuana technically remains illegal under federal law, and the possession, cultivation, or distribution of the drug trigger a host of civil sanctions not addressed by the NEP. For example, the Department of Housing and Urban Development (HUD) can deny federal housing subsidies to medical marijuana users, and pharmaceutical companies could potentially bring civil RICO actions against marijuana dispensaries. What is more, the federal ban arguably preempts states from shielding marijuana users and dispensaries from sanctions imposed by private parties. For example, employers can likely skirt liability under state law for discriminating against employees who use marijuana for medical purposes. Metaphorically, the federal ban is a hydra, only one head of which has been severed by the NEP (and one that could too easily be regrown). The labor of ending federal prohibition is not yet complete.

March 25, 2011 | Permalink | Comments (0) | TrackBack (0)

Worth Reading This Week

If only Apple made EMRs

You don't need to be a geek to appreciate the value proposition of or to operate an iPad. In fact the opposite seems to be true, and may explain the incredible success of the device and its ecosystem. Most people don't love their computers and frequently find them difficult to work with. Why should we believe that a different relationship exists between doctors and EMRs? A new Perspective article in the New England Journal, available here, explores this very issue, arguing,

Although EHRs laudably provide immediate access to patient data and electronic messaging functions, clinicians have been frustrated by the difficulty of using them to support care delivery and coordination. Transforming EHRs into effective clinical tools rather than a means of capturing information primarily for documentation and billing purposes will require progress on multiple fronts.

Progress on several fronts is urged; interoperability, support for shared care, integration of clinical decision support systems, usability, and support. Absent such improvements "Today's EHRs do not sufficiently support aspects of care delivery that are vital to improving care and controlling costs." [NPT]

March 25, 2011 | Permalink | Comments (0) | TrackBack (0)

Tom Baker: "Health Insurance, Risk, and Responsibility after the Patient Protection and Affordable Care Act"

Tom Baker, Professor of Law at University of Pennsylvania Law School, posted "Health Insurance, Risk, and Responsibility after the Patient Protection and Affordable Care Act" on SSRN:

Thbaker This essay explores the new social contract of healthcare solidarity through private ownership, markets, choice, and individual responsibility embodied in the Patient Protection and Affordable Care Act. This essay first explains the four main health care risk distribution institutions affected by the Act – Medicare, Medicaid, the individual and small employer market, and the large group market – with an emphasis on how the Act changes those institutions and how they are financed. The essay then describes the “fair share” approach to health care financing embodied in the Act. This approach largely rejects the actuarial fairness vision of what constitutes a fair share while pointing toward a new responsibility to be as healthy as you can. This new responsibility reflects the influence of health economics and health ethics, and it is part of the embrace of risk first described in the insurance as governance literature. There are challenges to achieving the solidarity through individual responsibility envisioned in the Act – most significantly ”risk classification by design” and non-compliance with the mandates – but the Act contains regulatory tools that the states, the new Exchanges, and the Department of Health and Human Services can use to address these challenges.

March 25, 2011 | Permalink | Comments (0) | TrackBack (0)

Jinkook Lee: "Data Sets on Pensions and Health: Data Collection and Sharing for Policy Design"

Jinook Lee, Senior Economist at RAND Corporation, posted "Data Sets on Pensions and Health: Data Collection and Sharing for Policy Design" on SSRN:

A growing number of countries are developing or reforming pension and health policies in response to population ageing and to enhance the welfare of their citizens. The adoption of different policies by different countries has resulted in several natural experiments. These offer unusual opportunities to examine the effects of varying policies on health and retirement, individual and family behaviour, and well-being. Realizing these opportunities requires harmonized data-collection efforts. An increasing number of countries have agreed to provide data harmonized with the Health and Retirement Study in the United States. This article discusses these data sets, including their key parameters of pension and health status, research designs, samples, and response rates. It also discusses the opportunities they offer for cross-national studies and their implications for policy evaluation and development.

March 25, 2011 | Permalink | Comments (0) | TrackBack (0)

Guest Blogger Jennifer S. Bard: Securities Law Case Helps Increase FDA Authority to Monitor Post-Market Adverse Events

Bard The Supreme Court’s unanimous decision in Matrixx Initiatives Inc. v. Siracusano, No. 09-1156 that the makers of Zicam had to inform investors of information that its product caused permanent damage to some users’ sense of smell even though that information was not “statistically significant” is likely to prove very helpful to the FDA, and in turn consumers, in the Agency’s on-going efforts to pry information from drug companies about post-market adverse events.

Although an important Securities Regulation decision with wide implications for many different industries, Matrixx also serves as a way of increasing consumer access to information that up until now pharmaceutical companies usually kept to themselves.  Writing for the majority Justice Sotomayor noted that although there was no FDA reporting requirement at the time Matrixx was receiving the information but that “[In] 2006, Congress enacted legislation to require manufacturers of over-the-counter drugs to report any “serious adverse event” to the FDA within 15 business days. See 21 U. S. C. §§379aa(b), (c).”    Justice Sotomayor further wrote that, “[a] lack of statistically significant data does not mean that medical experts have no reliable basis for inferring a causal link between a drug and adverse events. As Matrixx itself concedes, medical experts rely on other evidence to establish an inference of causation. “

Based on the Court’s analysis in Matrix that serious “adverse events” need not be statistically significant, it is likely that this decision will prove a useful precedent for the FDA to argue that failure to disclose credible reports of serious adverse events are unlawful.

Although required to disclose “serious” information of adverse harm to the FDA, companies may well have been withholding information from the FDA as well as from shareholders on the grounds that it was not “statistically significant.”  So although not a “health law” case, the effect of this decision should be to increase the information available to the FDA and to consumers themselves.  

To put the decision in context, it is likely that the Court’s decision was influenced by the very public criticisms of Big Pharma by Iowa’s Senator Chuck Grassley  and others for withholding information about adverse events.  The most notable recent examples of this are the withholding of increased cardiac deaths from the drugs Avandia and Vioxx.  Although Avandia has been pulled from the market in Europe, it is still for sale in the U.S. with increased warnings and restrictions.    

I will soon be posting an article on SSRN considering ways to protect insiders who know of potential harms to come forward and this decision is likely to increase the flow of information by preventing companies from distinguishing between “statistically significant” and “non-statistically significant” reports of serious harm.

 -  Guest Blogger Jennifer S. Bard

March 25, 2011 | Permalink | Comments (0) | TrackBack (0)

Wednesday, March 23, 2011

Do Calorie Counts Matter?

In a provocative piece, Nicholas Bagley questions whether the new calorie count rules will help in the effort to reduce obesity in the United States.  A provision in the Patient Protection and Affordable Care Act (Section 4205) requires chain restaurants to post calorie counts for the foods they sell, and FDA will be issuing its proposed rules shortly.

The provision also applies to “similar retail food establishments,” that are part of a chain with 20 or more locations, and movie theaters are concerned that FDA will apply its rule to movie theater concession stands. 


March 23, 2011 | Permalink | Comments (0) | TrackBack (0)

Tuesday, March 22, 2011

Japan's Nuclear Crisis and International Law

One of the best sources for information about the radiation leaks coming from reactors in Japan is being generated by the International Atomic Energy Association (IAEA), the international body overseeing nuclear energy activites based in Vienna. Today’s update indicates that tests are now underway by the Japan Agency for Marine-Earth Science and Technology (JAMSTEC) to determine radionuclide concentrations found in sea water and dose rate, results to be available Thursday.

The overriding question is whether more legal oversight or protection measures would have prevented this catastrophic threat to public health. The IAEA’s Incident and Emergency Centre (IEC) is the global focal point for international preparedness and response to nuclear and radiological safety or security related incidents, emergencies, threats or events of media interest. But their role is only as strong as the agreements that the agency administers. Japan is a party to the Convention on Nuclear Safety (CNS), and the Convention on Physical Protection of Nuclear Material (CPPNM).

The CNS commits parties to minimize public exposure to radiation, conduct systematic assessment and verification of risks, and have adequate emergency preparedness. However, the effectiveness of Article 17, the siting of nuclear facilities, is one of the provisions that probably requires the most scrutiny in this case. The article is weak and provides only that “appropriate procedures are established and implemented” by parties to ensure that site-related safety factors are evaluated, and parties likely to be affected are consulted. Reporting requirements enable the IAEA to check on compliance, and other parties to express concern about decisions, but states are free to site plants in risky zones. The international community needs to promulgate binding standards to prevent siting of plants in earthquake and tsunami-prone areas, or at least require more emergency back-up plans and better safeguards if located in these places. One of the responses to this disaster should be more discussion about Article 17.

Japan is also a party to the Convention on Assistance in Case of a Nuclear Accident or Radiological Emergency and the Convention on Early Notification of a Nuclear Accident (Emergency Conventions) are the prime legal instruments that establish an international framework to facilitate the exchange of information and the prompt provision of assistance in the event of a nuclear accident or radiological emergency. These Emergency Conventions are probably responsible for the speed at which the international community has been informed of the incident and transboundary radiation threats. [MM]

March 22, 2011 | Permalink | Comments (0) | TrackBack (0)