A sick child lies in a hospital bed. An IV pole is visible in the foreground

Ethical Reflections on the Recent Critical Shortage of Pediatric Cancer Drug

By Beatrice Brown

Recently, news broke that there is a critical shortage of vincristine, a drug that is integral for treating pediatric cancers. According to the Children’s Oncology Group, Pfizer communicated that they were experiencing a shortage of the drug due to a manufacturing delay. Pfizer is now the sole supplier of vincristine in the United States after the other supplier, Teva Pharmaceuticals, ceased production of the drug after making a “business decision.” Although the FDA announced that deliveries of the drug should resume in late October, it is predicted that there will still be a supply shortage until December or January.

Vincristine is “the single most widely used chemotherapeutic in childhood cancer,” according to Yoram Unguru, MD, a pediatric hematologist and oncologist at the Herman and Walter Samuelson Children’s Hospital at Sinai and Johns Hopkins Berman Institute of Bioethics in Baltimore, Maryland. Unguru stated, “Nearly every child with cancer in the U.S. will receive multiple doses of vincristine over the course of their treatment. For some children with cancer, vincristine comprises one half of all chemotherapy administered.”

The shortage is even more critical given that there is no other manufacturer that can pick up the slack. According to Unguru, the shortage was predictable once Teva halted production. Given that there is no substitute for vincristine, doctors are in a tough position. Thus, there are two ethical issues I wish to explore here: 1) the issue of resource allocation/drug rationing; and 2) the moral obligations of pharmaceutical companies to patients. I will take up each of these issues in turn. Read More

close up of human eye

The Luxturna Debate: Why Ethics Needs a Seat at the Drug Pricing Table

By Clio Sophia Koller

Jack Hogan can now ride his bike home at dusk after an afternoon of playing with his friends. Is that childhood rite-of-passage worth $850,000?

Recently, the Health Policy and Bioethics Consortium convened by Harvard Medical School’s Center for Bioethics and the Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham and Women’s Hospital met to discuss the implications of Spark Therapeutics’ new gene therapy treatment—along with its staggering price tag.

Luxturna, a novel therapy approved by the FDA last year, treats a rare form of inherited blindness known as retinitis pigmentosa. The therapeutic agent targets the RPE65 gene, associated with the disorder, and is shown to improve vision in a population with progressive vision-loss and an inability to see in dim light. Read More

shopping trolley with medicine

Step therapy explained: An increasingly popular tool for cost control

News that the Centers for Medicare and Medicaid Services will allow Medicare Advantage programs to enact “step therapy” programs for drugs under Part B as part of an effort to combat rising drug prices has been making rounds in the health policy world recently.

Step therapy is used by all major private insurers and is aimed at curbing expenditures on expensive drugs. It requires that a patient to try a less expensive alternative treatment. Those who fail treatment with the less expensive drug would then be eligible for coverage of the more expensive treatment. Note that it is very similar to prior authorization, a ubiquitous policy tool in which a drug is approved for coverage only after ensuring certain clinical criteria are met.

What was once a relatively rare tool is now commonly used. I examined UnitedHealthcare’s list of step therapy drugs and there are now over 100 listings. This is an order of magnitude increase from the number of drugs listed just four years ago, when I first got interested in this issue.

Drugs listed for step therapy tend to be either new, extremely expensive therapies (e.g., 3rd-line biologics for rheumatoid arthritis, sofosbuvir for hepatitis C) or more expensive formulations of common drugs (e.g., extended release formulation of quetiapine).

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Are Ordeals a Viable Way to Improve Health Care Delivery?

By Thomas W. Feeley

We constantly hear that the American health care system is broken and badly in need of repair. Our system provides poor value in that our per capita spending is more than any other nation in the world and yet we do not have the best health outcomes.

For many years, incremental solutions have been brought forward as solutions to our health care delivery problem. Approaches such as using evidence-based guidelines, focusing on patient safety, requiring prior authorization of expensive procedures, making patients pay as customers, adopting lean, six-sigma, electronic records, and using care coordinators, to name just a few, have failed to solve the problem.

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REGISTER NOW! Ordeals in Health Care: Ethics and Efficient Delivery

Ordeals in Health Care: Ethics and Efficient Delivery
May 10-11, 2018 1:00 PM
Wasserstein Hall, Milstein East (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA
 

Economic ordeals are interventions that deliberately make access to products or services more difficult in an effort to improve resource allocation. In this vein, making patients wait in long lines to schedule an appointment with a specialist might discourage patients with needs that could be met by less qualified personnel from taking up the specialist’s time, thus freeing up time for those with complex needs. Similarly, putting brand-name medications at the bottom of a long list of options on clinicians’ computers might encourage them to prescribe a generic brand listed closer to the top.

Recent research in development economics, behavioral economics, and health policy suggests that some economic ordeals could help target health resources to patients who are more likely to utilize these resources, without the regressive effects of co-pays and other forms of financial participation on the part of patients. However, making health care deliberately less accessible raises ethical challenges. Is it not the case that ordeals discourage utilization by patients with acute needs? Do these ordeals affect some disadvantaged populations disproportionately? And do deliberate obstacles to health resource utilization violate the human right to health?

This workshop will bring together leading scholars in economics, ethics, health policy, public health, medicine, sociology, and law to explore these questions.

This event is organized by Nir Eyal, PhD, Associate Professor of Global Health and Population, Harvard T. H. Chan School of Public Health, and Anders Herlitz, PhD, Visiting Scientist, Harvard T. H. Chan School of Public Health and Researcher, Department of Philosophy, Linguistics and Theory of Science, University of Gothenburg, Sweden.

This event is free and open to the public, but seating is limited and registration is required. Register now!

Co-sponsored by the Harvard T.H. Chan School of Public Health; the Edmond J. Safra Center for Ethics at Harvard University; the Petrie-Flom Center for Health Law, Biotechnology, and Bioethics at Harvard Law School; the Mossavar-Rahmani Center for Business and Government at the Harvard Kennedy School of Government; and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund at Harvard University.

Register for and learn more about the event here!

REGISTER NOW! Ordeals in Health Care: Ethics and Efficient Delivery

Ordeals in Health Care: Ethics and Efficient Delivery
May 10-11, 2018 1:00 PM
Wasserstein Hall, Milstein East (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA
 

Economic ordeals are interventions that deliberately make access to products or services more difficult in an effort to improve resource allocation. In this vein, making patients wait in long lines to schedule an appointment with a specialist might discourage patients with needs that could be met by less qualified personnel from taking up the specialist’s time, thus freeing up time for those with complex needs. Similarly, putting brand-name medications at the bottom of a long list of options on clinicians’ computers might encourage them to prescribe a generic brand listed closer to the top.

Recent research in development economics, behavioral economics, and health policy suggests that some economic ordeals could help target health resources to patients who are more likely to utilize these resources, without the regressive effects of co-pays and other forms of financial participation on the part of patients. However, making health care deliberately less accessible raises ethical challenges. Is it not the case that ordeals discourage utilization by patients with acute needs? Do these ordeals affect some disadvantaged populations disproportionately? And do deliberate obstacles to health resource utilization violate the human right to health?

This workshop will bring together leading scholars in economics, ethics, health policy, public health, medicine, sociology, and law to explore these questions.

This event is organized by Nir Eyal, PhD, Associate Professor of Global Health and Population, Harvard T. H. Chan School of Public Health, and Anders Herlitz, PhD, Visiting Scientist, Harvard T. H. Chan School of Public Health and Researcher, Department of Philosophy, Linguistics and Theory of Science, University of Gothenburg, Sweden.

This event is free and open to the public, but seating is limited and registration is required. Register now!

Co-sponsored by the Harvard T.H. Chan School of Public Health; the Edmond J. Safra Center for Ethics at Harvard University; the Petrie-Flom Center for Health Law, Biotechnology, and Bioethics at Harvard Law School; the Mossavar-Rahmani Center for Business and Government at the Harvard Kennedy School of Government; and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund at Harvard University.

Register for and learn more about the event here!

REGISTER NOW! Ordeals in Health Care: Ethics and Efficient Delivery

Ordeals in Health Care: Ethics and Efficient Delivery
May 10-11, 2018 1:00 PM
Wasserstein Hall, Milstein East (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA
 

Economic ordeals are interventions that deliberately make access to products or services more difficult in an effort to improve resource allocation. In this vein, making patients wait in long lines to schedule an appointment with a specialist might discourage patients with needs that could be met by less qualified personnel from taking up the specialist’s time, thus freeing up time for those with complex needs. Similarly, putting brand-name medications at the bottom of a long list of options on clinicians’ computers might encourage them to prescribe a generic brand listed closer to the top.

Recent research in development economics, behavioral economics, and health policy suggests that some economic ordeals could help target health resources to patients who are more likely to utilize these resources, without the regressive effects of co-pays and other forms of financial participation on the part of patients. However, making health care deliberately less accessible raises ethical challenges. Is it not the case that ordeals discourage utilization by patients with acute needs? Do these ordeals affect some disadvantaged populations disproportionately? And do deliberate obstacles to health resource utilization violate the human right to health?

This workshop will bring together leading scholars in economics, ethics, health policy, public health, medicine, sociology, and law to explore these questions.

This event is organized by Nir Eyal, PhD, Associate Professor of Global Health and Population, Harvard T. H. Chan School of Public Health, and Anders Herlitz, PhD, Visiting Scientist, Harvard T. H. Chan School of Public Health and Researcher, Department of Philosophy, Linguistics and Theory of Science, University of Gothenburg, Sweden.

This event is free and open to the public, but seating is limited and registration is required. Register now!

Co-sponsored by the Harvard T.H. Chan School of Public Health; the Edmond J. Safra Center for Ethics at Harvard University; the Petrie-Flom Center for Health Law, Biotechnology, and Bioethics at Harvard Law School; the Mossavar-Rahmani Center for Business and Government at the Harvard Kennedy School of Government; and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund at Harvard University.

Register for and learn more about the event here!

Searching For Stability: The Political Future Of The Affordable Care Act

This new post by Benjamin Sommers and John McDonough appears on the Health Affairs Blog as part of a series stemming from the Sixth Annual Health Law Year in P/Review event held at Harvard Law School on Tuesday, December 12, 2017.

Efforts to repeal and replace the coverage expansions in the Affordable Care Act (ACA) as well as the tax increases that financed them were persistent throughout 2017. Even after the congressional Republicans’ highly visible failures earlier this year, they kept coming back—finally succeeding in zeroing out the penalties in the ACA’s individual mandate as part of federal tax cut legislation signed into law in late December.

Of keen interest and importance now is the question: What’s next for the ACA?

Originally, many ACA supporters assumed during the years of the Obama administration that once the law’s major coverage provisions took effect in January 2014, the reality on the ground of a successful coverage expansion and broader insurance benefits would transform the ACA into a popular program—growing in acceptance and inevitability as Social Security, Medicare, and Medicaid all did before it. […]

Read the full article here!

Save the Date, April 12-13, 2018! Diseases of Despair: The Role of Policy and Law

Description

Anne Case and Angus Deaton shocked the world with their 2015 report that noted an increase in all-cause mortality among middle-aged white non-Hispanic men and women in the United States. This pattern is not occurring in other groups within the United States and Europe. Their report, and others since then, have linked this trend to so-called deaths of despair (death from suicide, chronic substance use, and overdoses) and their linkage to other determinants of health (education, labor markets, marital patterns). A recent update to the report makes it clear that this trend is no longer limited to any particular geographic region within the United States.

This year’s NUSL Center for Health Policy and Law annual conference and associated scholarship will bring together experts, policymakers, and academics to discuss the causes behind such trends, and to explore potential political, policy, and legal responses for addressing broader determinants that affect the physical and mental health of Americans dying from these diseases of despair. Deeper examination into similar patterns among diverse populations, as well as analysis of continuing racial, ethnic, and socioeconomic disparities, will be central to the discourse.

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