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July 02, 2007

Article Review

I apologize for the slower blogging recently.  I should have an installment of Who's Who up sometime this week, and there are a number of interesting posts in the blogosphere on access and health policy that are worth pointing out.

Today's article review features articles on the following topics:

  • enhancing global health development;
  • tort reform;
  • market effects of generic entry;
  • new mandatory reporting for dietary supplements;
  • federal and state tax exemption policy for nonprofit hospitals.

(full-text unless otherwise noted)

Non-Communicable Diseases and Global Health Governance: Enhancing Global Processes to Health Development

Roger Magnusson (University of Sydney -- Law)

Globalization and Health, Vol. 3, No. 2, pp. 1-16, May 2007


This paper assesses progress in the development of a global framework for responding to noncommunicable diseases, as reflected in the policies and initiatives of the World Health Organization WHO), World Bank and the UN: the institutions most capable of shaping a coherent global policy. Responding to the global burden of chronic disease requires a strategic assessment of the global processes that are likely to be most effective in generating commitment to policy change at country level, and in influencing industry behaviour. WHO has adopted a legal process with tobacco (the WHO Framework Convention on Tobacco Control), but a non-legal, advocacy-based approach with diet and physical activity (the Global Strategy on Diet, Physical Activity and Health).

The paper assesses the merits of the Millennium Development Goals (MDGs) and the FCTC as distinct global processes for advancing health development, before considering what lessons might be learned for enhancing the implementation of the Global Strategy on Diet. While global partnerships, economic incentives, and international legal instruments could each contribute to a more effective global response to chronic diseases, the paper makes a special case for the development of international legal standards in select areas of diet and nutrition, as a strategy for ensuring that the health of future generations does not become dependent on corporate charity and voluntary commitments. A broader frame of reference for lifestyle-related chronic diseases is needed: one that draws together WHO's work in tobacco, nutrition and physical activity, and that envisages selective use of international legal obligations, non-binding recommendations, advocacy and policy advice as tools of choice for promoting different elements of the strategy.

Yet again, one can see how much influence theories of disease causality have on public health policy.  The more I think about this, the more convinced I become of just how significant such theories are in setting policy and social attitudes.

An Empirical Study of the Impact of Tort Reforms on Medical Malpractice Settlement Payments

(Abstract only)

Journal of Legal Studies, forthcoming

Ronen Avraham (Northwestern -- Law)


This study evaluates the impact of six different types of tort reforms on the frequency, size and number of total annual settlements in medical malpractice cases between 1991 and 1998. Previous studies have failed to correctly identify the effective dates of reforms, to account for the retroactive applicability of striking down reforms, or used highly selected samples of jury verdicts or litigated cases. I employ a new legal data set of tort reforms, which carefully evaluates effective dates as well as when certain laws were overturned. Medical malpractice data comes from the National Practitioner Data Bank, which contains more than 100,000 malpractice settlement payments in the study time frame. The data represent the universe of cases in which doctors paid a positive settlement. Thus, the present study has significant advantages over previous work for being the first study to systematically and adequately explore the impact of tort reform on settlements (in contrast to judgments). Of the six tort reforms examined, two reforms (caps on pain-and suffering damages and limitations on joint and several liability) reduced the number of annual payments, and two reforms (caps on pain-and-suffering damages and the periodic payment reform) reduced average awards. Caps on non-economic damages had an effect on total annual payments, although the statistical significance of that effect was weak. The joint effect of enacting all six reforms was statistically significant for reducing the number of cases but not the state level average award or total payments.

The studies continue to fly back and forth.

Market Effects of Generic Entry: The Role of Physicians and of Non-Bioequivalent Competitors

Working Paper


Patent expiration represents a turning point for the brand losing patent protection as bioequivalent generic versions of the drug quickly enter the market at reduced prices. In this paper, we study how physician characteristics and their prescribing decisions impact the competition among molecules of a therapeutic class, once generic versions of one of these molecules enter the market. Specifically, we study the evolution of the Selective Serotonine Reuptake Inhibitors (SSRIs) after the introduction of generic versions of fluoxetine (brand name Prozac) in the United Kingdom (UK).

Our results suggest that, to fully understand the market evolution after generic entry, public health officials need to consider the marketing activities of pharmaceutical companies and determine how (1) individual physicians prescribe all competing drugs, and (2) respond to drug prices and marketing actions. For example, we find that a group of physicians sensitive to detailing switch from fluoxetine to non-bioequivalent branded alternatives after patent expiration, as Prozac significantly reduces its marketing support. Consequently, the market share of fluoxetine decreases despite being available at significant price discount under generic form, and despite the increase of prescriptions by price-sensitive physicians. Hence, governments interested in assessing generics diffusion should consider the prescribing across all competitors, whether or not bioequivalent, and determine the size of physician segments sensitive to pharmaceutical marketing activity and prices.

Generics continues to be a hot topic, and the connection to detailing (a term in economics which basically translates as industry marketing) makes this an important study.  Whatever one's opinion on the dollars industry spends on marketing, no one should deny the influence of such monies.  Pharma are the most successful corporations in the nigh on 400 year history of the Western corporation.  It is highly unlikely they would be expending serious funds on marketing over time if they were not getting a return on those investments. 

We've touched on generics here and here.

New Mandatory Reporting Requirements for Dietary Supplements and Nonprescription Drugs Solve Very Little

Katherine L. Wong (Harvard -- Law)

Journal of Law, Medicine and Ethics, Vol. 35, no. 3 (2007): 336.


Despite packaging and labeling designs that often make them appear very similar to prescription drugs, dietary supplements and nonprescription drugs are subject to a regulatory scheme more often characterized by what the FDA cannot do than by what it can. As the Ephedra scare demonstrated, FDA oversight has not assured that supplements are safe or even contain the ingredients listed on their labels. Amid calls for increased oversight of this $20 billion per year industry, Congress recently enacted the Dietary Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA) in 2006. This legislation institutes new reporting requirements for serious adverse events linked to the use of dietary supplements and nonprescription drugs. This short article, which first provides a brief review of the Act, concludes that while the legislation may address some shortcomings, it is unlikely to substantially increase manufacturer or supplier accountability.

Federal and State Tax Exemption Policy, Medical Debt and Healthcare for the Poor

John D. Colombo (University of Illinois -- Law)

St. Louis University Law Journal, Vol. 51, no. 2 (2007)


A substantial number of commentators and state legislatures have suggested that tax exemption for nonprofit hospitals should be tied exclusively to the amount of charity care the hospital provides. This paper recounts both recent state legislative activity on this front and presents policy reasons both for and against such a move, and suggests that an exclusive charity care standard may not be the best policy approach for tax exemption of nonprofit hospitals.

Obviously, the term "nonprofit" is a legal term of art, and ought not be taken literally.  I am no expert in tax law, but it is extremely important in shaping the regulatory and financial climate as to hospital policy.


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