In This Issue

September 2009 | Bradford H. Gray

What is the role of public health agencies regarding noncommunicable diseases? Among the many innovative actions taken by the New York City Department of Health and Mental Hygiene in recent years is a program that tracks A1C, which is a measure of blood sugar control and a marker of risk of complications. In “Tracking Diabetes: New York City’s A1C Registry,” Shadi Chamany, Lynn Silver, Mary Bassett, Cynthia Driver, Diana Berger, Charlotte Neuhaus, Namrata Kumar, and Thomas Frieden describe the rationale and the operation of a program, begun in 2006, in which clinical laboratories are required to report to the department the hemoglobin A1C results from city residents. It was the first such mandate in the United States, and the scale is impressive: by early 2009, the department had received some 4.2 million A1C results for nearly 1.8 million individuals.

The department has built an A1C registry to be used for two purposes. The first is a classic public health surveillance function: monitoring blood glucose control over time and looking at variations by age, sex, and geographic location. The second is distributing support tools to medical providers and patients. Providers receive quarterly reports listing their patients’ two most recent A1C results, beginning with those who have the highest readings and are at the greatest risk for diabetes and its complications. In an approach being pilot tested in the South Bronx, providers also can authorize the department to send letters on the provider’s letterhead to patients with elevated A1C test values, informing them about their results, explaining the risks of complications, and recommending that a return visit be scheduled.

In addition to describing how the program works and its results to date, Chamany and colleagues address concerns that have been expressed regarding privacy, confidentiality, and intrusion into areas that are normally the province of the doctor-patient relationship. They also present the results of early evaluations of the program.

The program is significant because of sharply upward trends in diabetes and because it represents a new public health approach to risk factors for chronic disease and was developed under the leadership of Thomas Frieden, President Obama’s choice to head the Centers for Disease Control and Prevention.

The article by Chamany and colleagues is followed by commentaries from three perspectives. First, Amy Fairchild puts the program described in this article into the context of the history of public health. Then Michelle Mello and Lawrence Gostin provide a legal analysis. Finally, Jonathan Fielding analyzes the program from his perspective as director of the Los Angeles County Department of Public Health.

The next article in this issue is “Comparative Effectiveness Research in Ontario, Canada: Producing Relevant and Timely Information for Health Care Decision Makers,” by Danielle Whicher, Kalipso Chalkidou, Irfan Dhalla, Leslie Levin, and Sean Tunis. This is the second article on this topic that the Quarterly has published since legislation was passed earlier this year allocating $1.1 billion for comparative effectiveness research (CER) in the United States. The previous article (Chalkidou et al. 2009) described CER programs in Australia, France, Germany, and the United Kingdom.

Comparative effectiveness research generates information about treatment alternatives for use by doctors, patients, and the decision makers who determine which products and services should be covered by public or private health insurance programs. The Ontario Health Technology Advisory Committee was created in 2003 to be arm’s length from the government and to set priorities for evaluating evidence, provide recommendations on coverage decisions, and identify topics on which more research evidence is needed. Whicher and colleagues describe the Ontario program, which is designed to link evidence and decision making in a transparent and timely way. They also draw lessons for the United States regarding ways to establish a stable and effective way to use evidence to provide decision support for payers, patients, and physicians regarding the use of medical technologies, devices, and drugs. Such lessons are of particular interest as this country moves forward with its own CER agenda.

The next two articles in this issue examine aspects of America’s reliance on market forces to control costs and improve performance. First, David Dranove and Andrew Sfekas address a topic that is of great interest to economists and government agencies responsible for antitrust law: mergers and acquisitions that could reduce competition among health care organizations. In “The Revolution in Health Care Antitrust: New Methods and Provocative Implications,” Dranove and Sfekas focus on the central question in antitrust cases: whether a merger or acquisition will have an anticompetitive effect. As analyzed for antitrust purposes, this depends on the number of competitors that would remain in the market. A key issue, therefore, is what defines a market, and it is in that definition that the antitrust revolution is occurring.

Dranove and Sfekas describe the traditional method for defining hospital markets—a method that has generally led to favorable antitrust rulings for hospitals—and a newer method that defines hospital markets more narrowly and should strengthen antitrust efforts. They illustrate the two methods using data from hospitals in two cities in which mergers were recommended, for cost containment purposes, by a commission in New York State.

Brian Elbel and Mark Schlesinger’s article, “Responsive Consumerism: Empowerment in Markets for Health Plans,” examines a different aspect of the operation of market forces in health care: the extent to which enrollees in health plans respond to problems in health plans by either complaining or exiting plans. Such “responsive consumerism,” the authors argue, could lead to better performance by health plans and improve the market. Using national survey data, Elbel and Schlesinger measure the extent to which enrollees have used the voice and exit options after experiencing problems, and they use regression analysis to examine factors that could influence the use of these options. They conclude with skepticism about the extent to which either exit or voice will be strong forces for improvement.

The final article in this issue, “Columbia University’s Axel Patents: Technology Transfer and Implications for the Bayh-Dole Act,” by Alessandra Colaianni and Robert Cook-Deegan, uses the commercial history of an important biomedical discovery in the late 1970s as a case for assessing the implications of public policy that allows individuals and institutions that receive support from federal research dollars to patent discoveries arising from their research. The Axel patents, a scientific method to introduce foreign genetic material into nucleated cells, were held by Columbia University and then licensed to many drug manufacturers, leading to the development of many drugs used to treat a variety of conditions and diseases.

By allowing discoveries growing out of federally supported research to be patented by grantees, the Bayh-Dole legislation sought to facilitate the practical application of research by allowing companies to license such discoveries and develop commercial products. Colaianni and Cook-Deegan suggest that the experience of the Axel patents, which eventually generated $790 million for the researchers and the university, suggests that Bayh-Dole had an additional effect—the generation of substantial revenues for inventors and the research institutions that employ them. This possible consequence of the legislation received little attention during the debate leading to its passage in 1980. The Bayh-Dole Act did stipulate that such revenues be used for research and education, but the authors contend that there has been little public accountability regarding the use of such funds.

Bradford H. Gray
Editor, The Milbank Quarterly

Reference
Chalkidou, K., S. Tunis, R. Lopert, L. Rochaix, P.T. Sawicki, M. Nasser, and B. Xerri. 2009. Comparative Effectiveness Research and Evidence-Based Health Policy: Experience from Four Countries. The Milbank Quarterly 87(2):339–67.

Author(s): Bradford H. Gray

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Volume 87, Issue 3 (pages 543–546)
DOI: 10.1111/j.1468-0009.2009.00567.x
Published in 2009