Harvard Grad Students: Apply Now! Petrie-Flom Center Student Fellowship, 2017 – 2018

PFC_Logo_300x300The Center and Student Fellowship

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is an interdisciplinary research program at Harvard Law School dedicated to the scholarly research of important issues at the intersection of law and health policy, including issues of health care financing and market regulation, biotechnology and intellectual property, biomedical research, and bioethics. The Student Fellowship Program is designed to support closely-mentored student research in these areas. For more information on our recent fellows and their work, see our website and check out profiles of some of our past Fellows in the PFC Spotlight.

Eligibility

The student fellowship program is open to all Harvard graduate students who will be enrolled at the University during the fellowship year and who are committed to undertaking a significant research project and fulfilling other program requirements. Although the fellowship is open to all graduate students, including those in one-year programs, we encourage those who are in multi-year programs to wait until after their first year to apply. Continue reading

Advancing the Global Patient Safety Agenda

By John Tingle and Jen Minford

All too often it seems that patient safety and health quality policy makers work in their own silos unaware of what is taking place in other countries, wasting valuable resources by trying to re-invent the wheel. There is a clear need to have a way of cascading the news down on what is happening in patient safety globally. Developing and transitioning countries do not always have the resources to build up patient safety infrastructures, tools and policies and letting them know about initiatives going on in other countries fulfils a very important global public health need.

There is also the concept of ‘reverse innovation’.  Developed countries’ patient safety practices and policies can be informed by the experiences of developing and transitioning countries who may be using them in a different and novel way. Patient safety learning can be a two-way street. Continue reading

Changing the Paradigm of Advance Directives to Avoid Prolonged Dementia

by Norman L. Cantor

In the early days of living wills — the 1970’s and 1980’s – a major objective was to avoid being maintained on burdensome medical machinery in a highly debilitated status at the end stage of a fatal affliction.  The contemporaneous legislation endorsing advance directives was typically geared to “terminal illness” (meaning likely death within 6 months).  The distasteful specter was a moribund patient tethered to burdensome interventions like a respirator or a dialysis machine despite an unavoidable, looming demise.  A common short-form living will rejected life support that “only prolongs the dying process” for a patient in “a terminal condition.”[i]

Another specter was being medically sustained in an utterly dismal quality of life – such as permanent unconsciousness without awareness or interaction with one’s environment.  The contemporaneous legislation explicitly authorized advance directives seeking to avoid medical maintenance in a permanently vegetative state.  And several landmark cases authorizing surrogate end-of-life determinations involved permanently unconscious patients. See Quinlan (N.J. 1976); Brophy, (Mass. 1986); Browning (Fla. 1990); Schiavo (Fla. 2005).

With the increasing prevalence of Alzheimer’s disease and similar degenerative dementias, the focus of advance directives has changed for some people.  The primary specter is neither an unavoidable looming demise nor the insensate limbo of permanent unconsciousness.  Rather, the emerging concern is protracted maintenance during progressively increasing cognitive dysfunction and helplessness.  For some, being mired in a demented state is an intolerably degrading prospect well before the advanced stage when the person no longer recognizes loved ones and is totally uncomprehending.

For people like me who see even moderate dementia as an intolerably demeaning status staining their life image, their advance directive may seek to facilitate death by declining even simplistic medical interventions like antibiotics.  Our hope is that death will soon ensue when an infection is left untreated or when artificial nutrition and hydration is withheld in the face of an eating disorder.  Continue reading

Jelly Beans, Booze, and B-Vitamins

The FDA’s policy guidelines on nutritional fortification include the so-called “jelly-bean rule:” the FDA considers it inappropriate to fortify candy or soda with nutrients because to do so would allow “misleading health claims” to be made about a putatively unhealthy product. Candy companies that tried to add vitamins their products to market them as “healthier” have already been targeted by the FDA. But take a quick glance at the shelves of any convenience store: the “healthy”, vitamin enriched snacks and drinks are so full of sugars, flavors and sweeteners that it would take a doctorate in metaphysics, rather than medicine, to distinguish them from the candy and soda. So, maybe the FDA’s stance on adding a spoonful of sugar to help the medicine go down has relaxed. With that in mind, here’s a little thought experiment. I’d like to bring a proposal back from the eighties: that inexpensive alcoholic beverages be fortified with allithiamine, a fat-soluble analogue of Vitamin B1.[1] Why? The fortification could dramatically reduce the incidence of Wernicke’s encephalopathy and Korsakoff’s Syndrome among the homeless and alcoholic population.

Continue reading

DTC Genetic Risk Reports Back on Market

By Kayte Spector-Bagdady, JD, MBE & Michele Gornick, PhD, MA

On Thursday, April 6th, the FDA announced that it will allow the direct-to-consumer (DTC) genetic testing company 23andMe to market “Genetic Health Risk” (GHR) tests for 10 diseases or conditions including early-onset Alzheimer’s and Parkinson’s Diseases. This is in addition to 23andMe’s current offering of ancestry, wellness (e.g., lactose intolerance), trait (e.g., hair color), and autosomal recessive carrier screening (e.g., sickle cell anemia) test reports.

The decade since 23andMe entered the market has been a regulatory labyrinth of twists and turns. But what direction are we headed now?

The way we were

23andMe was a pioneer of the field, entering the DTC genetics market in 2007 with a product offering 13 health-related reports for $999. By December 2013, it was offering more than 250 reports; including carrier status, drug response, and over 100 GHRs. In response to a set of FDA Untitled Letters that went out in 2010, 23andMe filed for de novo 510(K) premarket clearance for some tests… but also concurrently marketed them in a national television and web campaign. Continue reading

Medical Records and the NFL Combine

This post is part of our Blog Symposium “Applying the Americans with Disabilities Act and Genetic Information Nondiscrimination Act to the NFL Workplace.” Background on the symposium and links to other blog posts are here

By Jessica L. Roberts

In our recent law review article, published by the University of Pennsylvania Law Review, my co-authors and I explore exactly what kinds of player health data the NFL and its Clubs can lawfully obtain from NFL hopefuls, as well as from current players.  While the Clubs and the NFL have strong interests in accessing all kinds of information about players, current federal employment laws—mainly the Americans with Disabilities Act and the Genetic Information Nondiscrimination Act—limit the collection of employee health data.  Significantly, these statutes not only restrict how an employer can use its employees’ health data.  They also restrict the ability of the employer to even ask.  Among the major takeaways of our paper was that, via National Football Scouting, the NFL and its Clubs may be violating these laws with the interviews and medical examinations that take place during the National Scouting Combine.  Our article focused primarily on evaluative technologies: things like physicals, athletic drills, wearables, ingestibles, and genetic tests.  But what about when the source of the player health data is not a technique or technology but rather simply a medical record?  In this blog post, I take a closer look at how the ADA and GINA apply to requests for medical records.

Medical Waivers at the Combine

As explored in-depth in a recent installment of this blog symposium, prospective players are particularly vulnerable because they are not yet members of the NFL Players Association (NFLPA), and thus cannot reap the benefits of the collective bargaining agreements it negotiates.  The inferior bargaining position of aspiring players is particularly apparent considering the medical waivers they sign to even participate in the Combine.  One waiver authorizes a mind-bogglingly long list of parties—including health care providers, physicians, mental health professionals, hospitals, schools, student health services, and former trainers and teams, even at the amateur level—to release and to discuss the players’ medical records with an equally long list of potential recipients—including National Football Scouting, the NFL and all its Clubs, their representatives, agents, medical staff, team physicians, and trainers, in addition to third-party physicians.  The player consents to share: Continue reading

Patenting Bioprinting Technologies in the US and Europe – The Fifth Element in the Third Dimension

I am happy to announce the publication of our new working paper on  “Patenting Bioprinting Technologies in the US and Europe – The 5th element in the 3rd dimension.” The paper, which has  been co-authored by Marc Mimler, starts out by describing the state of the art and by examining what sorts of bioprinting inventions are currently being patented. Based on our findings we then discuss what types of future innovations we can expect from the technological development and how far these would and/or should be protectable under European and US patent laws.

The paper is forthcoming in: RM Ballardini, M Norrgård & J Partanen (red), 3D printing, Intellectual Property and Innovation – Insights from Law and Technology. Wolters Kluwer, but the working paper is already available on SSRN. Continue reading

TOMORROW (4/5)! Crowdfunding Medical Care: Identifying Ethical Implications

April 5, 2017 12:30 PM 
Tosteson Medical Education Center, Room 227
Harvard Medical School, 260 Longwood Ave., Boston, MA

Register for this event

This event is free and open to the public, but seating is limited and registration is required. Please present a Harvard or other photo ID in order to enter the HMS campus. Register here.

Crowdfunding for medical care—seeking financial contributions from a large number of donors, often via social networks, to pay medical expenses—is growing in popularity in both the US and Canada. While the practice can have tangible benefits for some patients, it also raises challenging ethical and equity questions at the social level and for individual donors and campaigners. In this lecture, Professor Valorie Crooks will examine some of these questions, identify important directions for ethics-focused research, and discuss what we know about the medical expenses people are seeking to have covered.

Valorie Crooks, PhD, is a Full Professor and health geographer at Simon Fraser University (Canada). She holds the Canada Research Chair in Health Service Geographies and a Scholar Award from the Michael Smith Foundation for Health Research. She has authored more than 150 articles, chapters, and commentaries and leads a well funded research program that examines health care mobility and access.

Responding: I. Glenn Cohen, JDProfessor of Law, Harvard Law School, and Faculty Director, the Petrie-Flom Center.

This event is free and open to the public and lunch will be provided, but seating is limited and registration is required. A Harvard or other photo ID to enter the HMS campus. Please register here.

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund at Harvard University.

No Seat at the Table: The Legal Status of Players at the NFL Scouting Combine

This post is part of our Blog Symposium “Applying the Americans with Disabilities Act and Genetic Information Nondiscrimination Act to the NFL Workplace.” Background on the symposium and links to other blog posts are here

By Michael McCann

In Evaluating NFL Player Health and Performance: Legal and Ethical Issues 165 U. Pa. L. Rev. 227 (2017), the authors (Jessica L. Roberts, I. Glenn Cohen, Christopher R. Deubert and Holly Fernandez Lynch) compellingly explain why the Americans with Disabilities Act and the Genetic Information Nondiscrimination Act supply legal protections to football players at the NFL Scouting Combine (“Combine”). In this blog post, I stress the need for such protections in light of the unusual—and vulnerable—legal status of players at the Combine.

The Combine and its relationship to the NFL Draft

Held in late February and early March, the Combine is the annual scouting spectacle for NFL teams. Over seven days, NFL teams evaluate college football players who are eligible for the NFL Draft. The NFL Draft, of course, is the exclusive method of entry for players into the NFL: only players who are either drafted or who are exposed to NFL Draft and not selected are eligible to play in the NFL.

Held each April, the NFL Draft is ostensibly designed to promote parity in the NFL. For teams that fail to make the playoffs, draft order is based on inverse order of teams’ records. This means that the very worst team obtains the first overall pick and thus the chance to draft the best available player. Continue reading

Playing the Long Game: Epigenetics and Public Health

Good investing takes time, foresight and patience. You have to thoughtfully spend now for a big return in ten years. But when it comes to investments in public health, everybody wants to make a quick and easy buck. I’ve written before about the need for more emphasis on preventive care over “heroic medicine”: it costs less, it’s easier to administer and it leads to better outcomes. But fully realizing the potential of preventive care and public health initiatives takes more than vaccines and check-ups. The government could invest in an unlimited buffet of hospital examinations and laboratory tests for all, but if people can only afford food that leaves them obese and diabetic or if they live in neighborhoods where crack dens and meth labs outnumber the schools, the investment is not going to pay off. Addressing the social determinants of health has incredible potential to improve outcomes on a population level.

Efforts are already being made. The government aims for “Health in All Policies” by promoting holistic education programs for poor youths and funding better food in stores in neglected communities. Other initiatives focus on fighting food insecurity among families or homelessness among pre and post natal mothers. The topic was covered well in this article from the Kaiser Family Foundation. They break the social determinants of health into the broad categories of social, economic and environmental factors. Things like economic stability, neighborhood and physical environment, education, food and social context play a massively underappreciated role in health outcomes. The article contains a graphic on the impact of different factors on the risk of premature death. Apparently, healthcare has the smallest impact at 10%. Individual behaviors carry the biggest single impact at 40%. The social and environmental factors that the article focuses on contribute 20%. The last factor was genetics, at 30%. As I was reading, I remembered seeing this article on epigenetics and it struck me that the separation of genetics from behavior and environmental factors might be a little artificial.

Continue reading

JOB OPPORTUNITY: The Petrie-Flom Center is searching for a new Executive Director!

PFC Logo-New-Horizontal_slideExecutive Director

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics

Harvard Law School, Cambridge, MA

Learn more and apply now online!

Duties & Responsibilities

The Executive Director works in partnership with the Faculty Director on strategic planning and vision for the Center, and oversees the Center’s staff, activities, and collaborations, including sponsored research, fundraising, events and conferences, publications, programs for students, administration, finance, communications, and other programmatic activities.  S/he also engages in independent scholarly activities, including research and writing, lecturing, and occasional teaching, as appropriate.

Essential Functions

The Executive Director works with the Faculty Director and independently to build the Center and advance its public profile and impact among policymakers, academics, practitioners, and students.  Primary responsibilities include:

Continue reading

REGISTER NOW (4/5)! Crowdfunding Medical Care: Identifying Ethical Implications

April 5, 2017 12:30 PM 
Tosteson Medical Education Center, Room 227
Harvard Medical School, 260 Longwood Ave., Boston, MA

Register for this event

This event is free and open to the public, but seating is limited and registration is required. Please present a Harvard or other photo ID in order to enter the HMS campus. Register here.

Crowdfunding for medical care—seeking financial contributions from a large number of donors, often via social networks, to pay medical expenses—is growing in popularity in both the US and Canada. While the practice can have tangible benefits for some patients, it also raises challenging ethical and equity questions at the social level and for individual donors and campaigners. In this lecture, Professor Valorie Crooks will examine some of these questions, identify important directions for ethics-focused research, and discuss what we know about the medical expenses people are seeking to have covered.

Valorie Crooks, PhD, is a Full Professor and health geographer at Simon Fraser University (Canada). She holds the Canada Research Chair in Health Service Geographies and a Scholar Award from the Michael Smith Foundation for Health Research. She has authored more than 150 articles, chapters, and commentaries and leads a well funded research program that examines health care mobility and access.

Responding: I. Glenn Cohen, JDProfessor of Law, Harvard Law School, and Faculty Director, the Petrie-Flom Center.

This event is free and open to the public and lunch will be provided, but seating is limited and registration is required. A Harvard or other photo ID to enter the HMS campus. Please register here.

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and theCenter for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund at Harvard University.

PANEL (4/3): Opiate Regulation Policies – Balancing Pain and Addiction

Opiate Regulation Policies: Balancing Pain and Addiction 

April 3, 2017 12:00 PM

Austin Hall, West Classroom (111)
Harvard Law School, 1515 Massachusetts Ave., Cambridge, MA

Description

The current opiate epidemic has spurred long-overdue scrutiny on the pharmaceutical production and distribution of opiate medication, but it also raises questions of public policy and law regarding the regulation of medical access to and use of opiate medications with high potential for addiction. Expert panelists will address the challenges that arise from efforts to balance restrictions on access to opiates to limit addiction while also preserving sufficient access for legitimate medical management of pain.

Panelists

  • Monica Bharel, MD, MPH, Commissioner, Massachusetts Department of Public Health
  • David Borsook, MD, PhD, Professor in Anesthesiology, Harvard Medical School; co-director, Center for Pain and the Brain at Boston Children’s Hospital, Massachusetts General Hospital, and McLean Hospital; and affiliated faculty, Center for Law, Brain & Behavior at Massachusetts General Hospital
  • Rita Nieves, Deputy Director, Boston Public Health Commission
  • Moderator: Amanda C. Pustilnik, JDProfessor of Law, University of Maryland Carey School of Law; affiliated faculty, Center for Law, Brain & Behavior at Massachusetts General Hospital; and 2014-2015 Senior Fellow in Law and Applied Neuroscience as part of the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain & Behavior at Massachusetts General Hospital and the Petrie-Flom Center

This event is free and open to the public. Lunch will be provided.

Learn More

Check out the new EdX course “The Opioid Crisis in America,” developed by faculty at Harvard Medical School, to learn more about opioid addiction, evidence-based treatment models, harm reduction approaches that law enforcement and public health officials are using to reduce opioid overdose deaths, and non-opioid alternatives for medical pain management. This online course is free and self-paced; the first session will be available online on March 27, 2017.

Part of the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain & Behavior at Massachusetts General Hospital and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

THURSDAY, 3/23! The Affordable Care Act: Past, Present and Future – A lecture by William B. Schultz, General Counsel of HHS, 2011-2016

17-03-23-aca-past-present-future-visixThe Affordable Care Act: Past, Present and Future: A lecture by William B. Schultz, General Counsel of HHS, 2011-2016

March 23, 2017 4:00 PM

Wasserstein Hall, Milstein East
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Enacting universal healthcare was a 65 year project, which cost two Presidents control of Congress and jeopardized their chance for reelection. From the time the Affordable Care Act was enacted in 2010 to the end of President Obama’s second term, its repeal was the number one priority of the Republicans in Washington, and it was deeply unpopular across the nation. Now that the Republicans have control of all branches of government, the repeal agenda is complicated by the new support for the law by voters and some Republican governors. This lecture will discuss the complicated politics surrounding the Affordable Care Act and the policy options for the future.

Speakers

Continue reading

Manufacturers Of Biosimilar Drugs Sit Out The ‘Patent Dance’

This new post by Claire Laporte appears on the Health Affairs Blog in a series stemming from the Fifth Annual Health Law Year in P/Review event held at Harvard Law School on Monday, January 23, 2017.

Believe it or not, the Patient Protection and Affordable Care Act (Obamacare, or here, ACA) has intellectual property provisions. In addition to establishing mandates, subsidies and insurance exchanges, the ACA also created a new pathway for the approval of biosimilar drugs, which are akin to generic drugs. That pathway appears in a corner of the ACA that has its own title: the Biologics Price Competition and Innovation Act (BPCIA). The BPCIA is rich with intellectual property (IP) provisions that are now the subject of litigation in the Supreme Court.

Background: Generic Drugs And Biosimilars

Many of us take generic drugs for granted, but we have them only because the Hatch-Waxman Act (1984) provided an abbreviated pathway by which FDA could approve them. Under this pathway, a generic drug could be approved based on the safety and efficacy of the branded drug, plus a showing by the generic that it was essentially identical to the branded drug. This pathway also included provisions by which generic drug manufacturers could challenge the validity of patents protecting the branded drug. […]

Read the full post here.

Genetic counselors, genetic interpreters, and conflicting interests

By Katie Stoll, Amanda Mackison, Megan Allyse, and Marsha Michie

The booming genetic testing industry has created many new job opportunities for genetic counselors. Within commercial laboratories, genetic counselors work in sales and marketing, variant interpretation, as “medical science liaisons” to clinicians, and providing direct patient care. Although the communication skills and genetics expertise of the genetic counselor prepare them well for these roles, they also raise concerns about conflicts of interest (COI).

Why are genetic counselors leaving clinics and hospitals for industry jobs? Alongside greater job flexibility and taking on new challenges, a big reason is better pay. Hospitals and clinics have difficulty competing with the higher salaries at commercial labs because of continuing challenges in insurance reimbursement. Apart from limited preventive care covered under the Affordable Care Act, genetic counseling is inconsistently covered by private payers. Medicaid reimbursement for genetic counseling is state-dependent, and Medicare does not recognize genetic counselors as reimbursable health care providers at all.

Genetic counselors’ primary objective has historically been to help patients navigate difficult medical genetic information and decisions, supporting their autonomy.  But as laboratory employees, they must also navigate their employer’s financial interests, including increasing the uptake of genetic testing. In this changing landscape, can the profession of genetic counseling maintain the bioethical principles of beneficence, informed consent, and respect for autonomy that have been its foundation and ethos? Continue reading

Reproductive Health Under Assault

This new post by Aziza Ahmed appears on the Health Affairs Blog in a series stemming from the Fifth Annual Health Law Year in P/Review event held at Harvard Law School on Monday, January 23, 2017.

American political, social, and religious history has made abortion a deeply partisan issue. This despite the reality that many women (as well as trans and gender non-conforming individuals) from diverse racial, cultural, class, and religious backgrounds regularly access abortion-related services. The outcome of the 2016 elections has set into motion an expected but nonetheless deeply damaging anti-abortion agenda that is slowly taking form in the Trump administration’s early days — aided by the Republican majority House and Senate. These early moves signal that the new administration aims to roll back gains made toward reproductive justice in 2016.

The attack on abortion rights and, in turn, reproductive justice, by this administration is no surprise. The GOP Platform released during the elections makes many references to defunding or restricting abortion services. The document specifically attacks key victories for reproductive health including the 2016 Whole Woman’s Health v. Hellerstedt Supreme Court decision overturning key provisions of the 2013 Texas House Bill 2. The law required that doctors who provide abortion services must obtain admitting privileges at local hospitals no farther than 30 miles away from the clinic, and abortion providers comply with guidelines to become Ambulatory Surgical Centers. The Supreme Court found the regulations to be unconstitutional because they result in substantial obstacles in the path of women seeking pre-viability abortions — contrary to the claim made by the Texas Department of State Health Services that the laws make abortions safer. […]

Read the full post here.

All-Payer Claims Databases After Gobeille

This new post by Gregory Curfman appears on the Health Affairs Blog in a series stemming from the Fifth Annual Health Law Year in P/Review event held at Harvard Law School on Monday, January 23, 2017.

With health care spending approaching 20 percent of Gross Domestic Product (GDP), controlling health care costs is a top priority not only for the federal government, but also the individual states. To develop successful strategies for cost control, states need comprehensive data on utilization of and spending on health care services. Medicare data are valuable but not representative of the entire national population or of the prices that private payers pay. In private insurance, prices are not under administrative control as they are in Medicare, and they vary widely in different geographic regions.

All-payer claims databases (APCDs) were developed, first in Maryland in 1995, to provide comprehensive state-level data on health-care utilization and spending, and there are now 16 APCDs nationwide. As the name implies, APCDs collect data from all payers, and the spending data reflect the actual negotiated prices of services. Thus, APCDs are a valuable source of information for state health policymakers and health services researchers. For example, in Massachusetts, the Health Policy Commission uses the state’s APCD to set state-wide health care spending targets, which have been important in achieving state cost control. […]

Read the full post here!

Undocumented Organ Transplants

By Brad Segal

Manuel—not his real name—was admitted to the hospital with decompensated heart failure. As a child he had scarlet fever which, left untreated, had caused the valves of his heart to calcify and stiffen. Over time, pumping against increased resistance, his heart’s contractions began to weaken until finally, they lost all synchrony and the normal function of his heart spiraled out of control. At this stage, his fate was tied to whether or not he would receive a new heart in time.

He was in his 30’s and had no other illnesses. From a medical perspective, Manuel was the ideal candidate for a cardiac transplant. But a decade ago Manuel crossed the United States border in pursuit of a better life. As an undocumented immigrant, he was ineligible for the insurance coverage necessary to pay for a heart transplant. After being thoroughly evaluated by the hospital’s transplant center, given his modest financial resources and inability to obtain new insurance coverage, Manuel was not placed on the waiting list for a new heart.

The average heart transplant costs about a million dollars to perform. Subsequent follow-up care adds another $30,000 annually. Health insurance will usually cover most, if not all, of these costs. But uninsured patients are kept off transplant lists on the grounds that the inability to pay for care allegedly jeopardizes an organ’s long-term success. Continue reading

Epistemic Injustice, Procedural Fairness, and the Real Weight of Medical Evidence

By Wendy S. Salkin

March 6, 2017

In his lucid and fascinating February 2017 article in the AMA Journal of Ethics, “What is the Relevance of Procedural Fairness to Making Determinations about Medical Evidence?,” Govind Persad, an Assistant Professor in the Department of Health Policy and Management in the Bloomberg School of Public Health and in the Berman Institute of Bioethics, considers the following questions: How can fair procedures “help address epistemological and factual questions in medicine”?[1]

As Persad sees it, dilemmas in medical ethics and health policy often involve two questions. One is a factual or descriptive question concerning “which benefits an intervention will have.” (183) The other is an ethical question concerning “how to distribute those benefits.” (183) Persad provides the following example to tease out the distinction:

determining who should receive priority for scarce vaccines in a pandemic involves answering two questions: the descriptive (factual) question of which benefits these vaccines are expected to have for their recipients and the normative (value) question of how those prospective benefits should be distributed. (183)

Persad is interested in considering how fair procedures can be used to address questions of the first sort—the “epistemological and factual questions in medicine.” (183) He sets for himself the following task: to “consider how fair procedures have been and can be used to develop and weigh factual evidence in medicine.” (184) Persad foresees an increase in both the significance and frequency of “debates over the validity and weight of medical evidence” as the amount of medical evidence that is both required and amassed increases. He foresees an acceleration in this trend, which he credits to

the expansion of clinical data collection and analysis; the growing relevance of scientific evidence to medical practice…; and the use of evidence to support payment and insurance coverage decisions that have financial implications for patients and providers. (184)

Continue reading