Society or population, social diversity. Flat cartoon vector illustration.

European Skew in Genetic Research Databases Won’t Abate Without More Concerted Effort

By Robert I. Field, Anthony W. Orlando and Arnold J. Rosoff

The “pangenome” project that is mapping the genetic sequences of 47 diverse human beings from around the world is a much-needed step forward for science and humanity. The lack of racial diversity in genetic databases used in research has been noted for some time, and it has raised growing concerns about the development of clinical applications based on research results. The pangenome does not eliminate these concerns, but it calls greater attention to the significant racial underrepresentation that remains in most databases currently used in research.

For genomic medicine to have widespread effectiveness, it is important that it be based on the study of a diverse pool of subjects. This is especially true in the development of “precision medicine,” in which therapies are tailored to a patient’s genetic characteristics. If a patient’s genetic traits are not represented in a database that was used for the research that led to a treatment, that treatment may be less effective or even risky for them.

Black Americans, as well as members of other racial and ethnic minorities, are most commonly underrepresented in medical research, yet they are the ones most vulnerable to the effects of such underrepresentation. This can create yet another instance of racial disadvantage in health care. However, a recent study of genetic researchers found that investigators tend to give only limited consideration to demographic diversity when selecting a database to use, with more attention paid to ease of access and other logistical considerations.

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Emergency room.

Hospitals in Poor Rural Counties Face the Greatest Financial Threat from COVID

By Robert I. Field and Anthony W. Orlando

The latest wave of COVID cases and hospitalizations has raised concerns about the financial resilience of many hospitals in the United States. Throughout the pandemic, we have witnessed shortages of medical supplies, exhaustion of frontline workers, and the overflow of patients beyond the physical capacity of hospital beds and buildings. Now, after nearly two years of repeated COVID surges, there is a real danger that some institutions might run so low on funding that they will need to downsize or close altogether.

Large hospitals in metropolitan areas have, for the most part, weathered the storm. Ample financial resources enabled them to survive with fewer lucrative elective procedures and sudden overwhelming demand for less profitable intensive care for COVID patients. But in many parts of the country, especially rural regions, smaller hospitals lack such financial cushions. For them, COVID could be an existential threat.

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Illustration of a man and a woman standing in front of a DNA helix

A Proposal for Localized Review to Safeguard Genetic Database Privacy

By Robert I. Field, Anthony W. Orlando, and Arnold J. Rosoff

Large genetic databases pose well-known privacy risks. Unauthorized disclosure of an individual’s data can lead to discrimination, public embarrassment, and unwanted revelation of family secrets. Data leaks are of increasing concern as technology for reidentifying anonymous genomes continues to advance.

Yet, with the exception of California and Virginia, state legislative attempts to protect data privacy, most recently in Florida, Oklahoma, and Wisconsin, have failed to garner widespread support. Political resistance is particularly stiff with respect to a private right of action. Therefore, we propose a federal regulatory approach, which we describe below.

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First-person perspective photograph of a health care worker holding up a mask used to prevent the spread of germs

The Big Winner in Trump’s Newest Immigration Policies: The Flu

By Robert Field

The influenza virus gained an important ally during the past few weeks: the Trump Administration. If you have been rooting for a widespread and virulent flu epidemic this winter, several of its new immigration policies should give you reason to cheer.

The first bit of good news for flu fans is a decision to withhold vaccination from children held in Customs and Border Protection detention centers. These facilities are supposed to hold migrants for no longer than three days, but many remain much longer, and the centers are often severely overcrowded. Since the flu can be quite serious, this puts the thousands of children held in them at increased risk of major illness or death.

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Photograph of a Medicare for All rally

Medicare-for-All Wouldn’t be Medicare if it Eliminated Private Insurance

By Robert Field

Should Medicare-for-All replace private insurance? That question, although central to many current health reform debates, presents a fundamental contradiction. If Medicare-for-All were to eliminate private coverage, it wouldn’t be Medicare, which has made room for private insurers from the start.

Medicare could have been designed as a pure single payer with comprehensive coverage for all health care needs. However, that approach would have risked alienating several important constituencies, including the insurance industry, and provoking their opposition. Before the program was enacted, private Insurers enjoyed a sizeable market through which they sold coverage of some sort to about half the nation’s elderly. Medicare eliminated that market but created an attractive new one to replace it. It did this by enabling insurers to sell Medigap policies that filled some of the program’s most significant coverage gaps, such as coverage for vision and dental care, and that reduced or eliminated its sizeable copayments and deductibles. When the program launched, more than 80 percent of beneficiaries who had previously maintained private coverage purchased these new supplemental policies. Medicare also gave some insurers the chance to earn additional revenue by administering claims as carriers and intermediaries.

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Bureaucracy Can Save Lives – The Legacy of Dr. Frances Kelsey

By Robert Field

What adjective would most people associate with the word “bureaucrat”? For many, it would be “inefficient,” “inept,” or “incompetent.” But another that is just as descriptive is “lifesaving.”

Dr. Frances Kelsey, who died this month at the age of 101, was celebrated as an American hero for her work as a medical officer at the Food and Drug Administration (FDA). She saved thousands of lives and prevented untold suffering by using techniques that earn bureaucrats a bad name, delay and obstruction, to keep the drug thalidomide from reaching the market in the United States in 1961.

Thalidomide is a sedative that had been approved for sale in Europe four years earlier and was prescribed for morning sickness during pregnancy. The American manufacturer, Richardson-Merrell, saw a large potential market in the United States. However, Dr. Kelsey, who was assigned to review its application for marketing approval, was troubled by questionable safety data. The law in effect in 1961 required that she issue a decision within 60 days, but she was able to buy more time by asking for additional information.

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The D.C. Circuit Got it Wrong. Congressional Intent on Exchange Subsidies Is Clear, If You Know Where to Look

By Robert I. Field

Why would Congress have limited Affordable Care Act subsidies to residents of only some states – those that establish their own insurance exchanges? The law authorizes credits for the purchase of insurance “through an Exchange established by the State under section 1311.” The D.C. Circuit found that this wording excludes federally established exchanges and that Congress might have intended this to induce states to establish their own exchanges rather than letting the federal government take over.

But the Court acknowledged that there is no evidence of such intent in the legislative history. And such a purpose would conflict with the ACA’s overall goal of extending health insurance access to all Americans.

With no legislative history as a guide, is there another plausible explanation of Congressional intent? Is the best answer to the D.C. Circuit’s opinion that the phrase was a drafting error, as the dissent seems to imply? Why else would it have found its way into the law?

Inartful though it may be, the wording can be seen to serve a different purpose that is consistent with the rest of the ACA. It can be understood not as a way to distinguish exchanges established by a state from those established by the federal government but to distinguish those established publicly from those created privately.

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Introducing New Blogger Robert Field

FieldRobert Field is joining Bill of Health as a regular contributor.

Robert I. Field, JD, MPH, PhD is a nationally known expert in health care regulation and its role in implementing public policy.  He holds a joint appointment as professor of law at the School of Law and professor of health management and policy at the School of Public Health at Drexel University.  He is also a lecturer in health care management at the Wharton School of the University of Pennsylvania and a senior fellow of Penn’s Leonard Davis Institute of Health Economics.

Professor Field is the author of Mother of Invention: How the Government Created Free-Market Health Care, just released by Oxford University Press.  It presents an historical overview of four key health care sectors to demonstrate the underlying importance of government programs in creating and maintaining the health care system and to place health reform in the context of an ongoing evolutionary process.  He is also the author of Health Care Regulation in America: Complexity, Confrontation and Compromise, a comprehensive overview of health care regulation, also published by Oxford University Press.

Professor Field’s recent scholarly work has focused on health reform and is effects on the structure of the health care system, ethical issues in vaccines, and policy implications of genetic databases.  His work has appeared in the University of Pennsylvania Law Review, the Villanova Law Review, the Drexel Law Review, Health Affairs, Vaccine, and the Journal of Clinical Oncology.  He writes a blog for the Philadelphia Inquirer on health policy entitled the Field Clinic, which features 14 prominent Philadelphia health care leaders as regular contributors.

Professor Field speaks nationally on health care topics. He is frequently quoted in the press, including stories in the New York Times, Wall Street Journal, Washington Post, Boston Globe, Philadelphia Inquirer, and BusinessWeek and has discussed health policy issues on CNN, NPR, ABC, and numerous local television and radio stations.  He has also been a frequent commentator on WHYY, the NPR affiliate in Philadelphia.

Before joining the faculty of Drexel University, Professor Field founded and chaired the Department of Health Policy and Public Health at University of Sciences in Philadelphia, where he was also professor of health policy.  Previously, he led business planning and development for the primary care network of the University of Pennsylvania Health System. He has also conducted health policy research at the Institute of Medicine of the National Academy of Sciences and the Center for Law and Health Sciences at Boston University, practiced health law with the Philadelphia firm of Ballard Spahr, LLP, and directed public policy research for Cigna Corporation.

Professor Field earned a Ph.D. in psychology from Boston University, an M.P.H. from the Harvard School of Public Health, a J.D. from the Columbia Law School, where he was associate editor of the Columbia Journal of Environmental Law, and an A.B. magna cum laude from Harvard College.

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