Regulation of Stem Cell Therapy Travel

Current Stem Cell Reports, July, 2018
by I. Glenn Cohen and Shelly Simana

From the abstract: Purpose of Review Stem cell therapies (hereinafter: SCT) hold tremendous promise for the treatment of a variety of diseases. Yet, alongside the medical potential, they pose significant… Read More

Despite The End Of China’s One-Child Policy, Births Are Still Lagging

NPR, July 16, 2018
by Scott Neuman and Rob Schmitz

Two years after China officially ended its one-child policy in order to counter the country's aging society and shrinking workforce, Chinese couples are not having babies fast enough. In 2017, there… Read More

Psychology Itself Is Under Scrutiny

New York Times, July 16, 2018
by Benedict Carey

[...] since 2011, the psychology field has been giving itself an intensive background check, redoing more than 100 well-known studies. Often the original results cannot be reproduced, and the… Read More

7,000 people fail to meet Arkansas Medicaid work requirement

AP, July 13, 2018
by Andrew DeMillo

LITTLE ROCK, Ark. (AP) — More than 7,000 people on Arkansas’ Medicaid expansion didn’t meet a requirement that they report at least 80 hours of work in June and face the threat of losing… Read More

Don’t Expect Brett Kavanaugh To Protect The Affordable Care Act

WBUR Cognoscenti, July 12, 2018
by Carmel Shachar

From the article:  Thanks to Brett Kavanaugh’s 12 years as a judge on the D.C. Court of Appeals, we have a well-developed record of the Supreme Court nominee’s positions on key… Read More

Health Care A Talking Point In Democrats’ Kavanaugh Strategy.

Kaiser Health News, July 12, 2018

KHN Morning Briefing: Summaries of health policy coverage from major news organizations Where as the GOP has picked one message to focus on for the Supreme Court nomination battle -- Brett Kavanaugh's… Read More

Bucking Trump, Health Insurers Expand Obamacare Footprints

Forbes, July 12, 2018
by Bruce Japsen

Undaunted by the latest attacks on Obamacare – both verbal and financial from the Trump administration – health insurance companies are forging ahead with expansion plans in the business of… Read More

Insurers Fall Short In Catching And Reporting Medicaid Fraud, Inspectors Find

Kaiser Health News, July 12, 2018
by Chad Terhune

Despite receiving billions of dollars in taxpayer money, Medicaid insurers are lax in ferreting out fraud and neglect to tell states about unscrupulous medical providers, according to a federal report… Read More

Startups Look to Mainstream Medical Tourism

Bloomberg Businessweek, July 12, 2018
by Ari Altstedter

About 14 million people spent $68 billion on medical tourism in 2016, according to consulting firm PwC. A growing number are Westerners headed to developing countries for cosmetic surgery or dental work,… Read More

​Administration Freezes Program That Pays Billions To Insurers

Kaiser Health News, July 9, 2018

KHN Morning Briefing: Summaries of health policy coverage from major news organizations Trump administration officials said they decided to suspend payments under the program because of a ruling in… Read More

U.S. Opposition to Breast-Feeding Resolution Stuns World Health Officials

New York Times, July 8, 2018
by Andrew Jacobs

A resolution to encourage breast-feeding was expected to be approved quickly and easily by the hundreds of government delegates who gathered this spring in Geneva for the United Nations-affiliated World… Read More

Vertex CEO complains to U.K. prime minister about stalled talks over a pricey drug

STAT, July 6, 2018
by Ed Silverman

[...] His missive follows a stalemate earlier this week in which the NHS called an offer from the company as “unsupportable,” citing an analysis that the drug would not… Read More

Proof of Children’s Vaccinations? Italy Will Now Take Parents’ Word for It

New York Times, July 5, 2018
by Gaia Pianigiani

ROME — Italian parents will no longer have to provide state-run schools with a doctor’s note to show that their children have been vaccinated, the country’s new populist government announced… Read More

When Health Insurance Prices Rose Last Year, Around a Million Americans Dropped Coverage

New York Times, July 3, 2018
by Margot Sanger-Katz

Last year, as insurance prices rose by an average of just over 20 percent around the country, people who qualified for Obamacare subsidies hung onto their insurance. But the increases appear to have been… Read More

Judge blocks Kentucky’s Medicaid work requirement

Politico, June 29, 2018
by Rachana Pradhan

A federal judge has blocked Kentucky from instituting the first-ever Medicaid work requirements, potentially dealing a major blow to the Trump administration's efforts to scale back the health care… Read More

Justices Back Pregnancy Centers That Oppose Abortion, in Free Speech Case

New York Times, June 26, 2018
by Adam Liptak

WASHINGTON — A state law requiring “crisis pregnancy centers” to supply women with information about abortion likely violates the First Amendment, the Supreme Court ruled Tuesday in blocking… Read More

FDA Green Lights Marijuana-Based Pharmaceutical Drug

NPR, June 25, 2018
by Allison Aubrey

The U.S. Food and Drug Administration has approved a marijuana-derived drug for the treatment of two rare and serious forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, that begin in… Read More

Fearing Deportation, Immigrant Parents Are Opting Out Of Health Benefits For Kids

Kaiser Health News, June 25, 2018
by Ashley Lopez, KUT

The fear of family separation is nothing new for many immigrants already living in the U.S. In fact, that fear, heightened in recent weeks, has been forcing a tough decision for a while. Advocates say… Read More

White House proposes a narrowing of FDA’s mission — and a new name

STAT, June 21, 2018
by Ike Swetlitz

WASHINGTON — The Trump administration has proposed a fundamental change to the mission of the Food and Drug Administration, one that would transfer most of the responsibility for regulating food… Read More

‘Holy Cow’ Moment Changes How Montana’s State Health Plan Does Business

Kaiser Health News, June 20, 2018
by Julie Appleby

[...] Instead of starting with the hospital’s list price and negotiating down for discounts, the state began telling these facilities how much it was willing to pay — a “reference price”… Read More

Canada’s Legislature Votes To Legalize Marijuana; Sales Will Begin In Weeks

NPR, June 19, 2018
by Bill Chappell

Recreational marijuana may soon be legal in Canada, after both the House of Commons and the Senate approved the Cannabis Act. Legal sales are likely to begin before the end of summer after the Senate voted… Read More

IRB Oversight of Patient-Centered Outcomes Research: A National Survey of IRB Chairpersons

Journal of Empirical Research on Human Research Ethics, June 14, 2018
by Joel S. Weissman, Eric G. Campbell, I. Glenn Cohen, Holly Fernandez Lynch, Emily A. Largent, Avni Gupta, Ronen Rozenblum, Melissa Abraham, Karen Spike

From the abstract:  Patient-centered outcomes research (PCOR) is becoming increasingly common. However, there is little evidence regarding what novel ethical challenges, if any, are posed by PCOR… Read More

Most Under-35s OK With Insurers Digital Spying If It Cuts Prices

Bloomberg, June 19, 2018
by Julie Edde

The majority of people between 18 and 34 would be willing to let insurance companies dig through their digital data from social media to health devices if it meant lowering their premiums, a survey shows.… Read More

More Good News For CVS-Aetna With AMA Quiet On Deal

Forbes, June 14, 2018
by Bruce Japsen

It’s been a good week for CVS Health and Aetna with a judge clearing the AT&T-Time Warner merger and now the nation’s largest doctor group staying quiet on the drugstore chain’s… Read More

As Medicaid Costs Soar, States Try A New Approach

Kaiser Health News, June 15, 2018
by Phil Galewitz

[...] state officials say Medicaid is busting Minnesota’s budget, particularly with patients like Dowland and its system of paying hospitals for each admission, ER visit and outpatient test.… Read More

Dozens of abortion curbs challenged in lawsuit by Texas clinic

Politico, June 14, 2018
by Renuka Rayasam and Jennifer Haberkorn

AUSTIN, Texas — A group of Texas abortion clinics and nonprofits filed a sweeping lawsuit against the state Thursday challenging dozens of abortion laws, some of which were passed at least two decades… Read More

The New Obamacare Lawsuit Could Undo Far More Than Protections for Pre-existing Conditions

New York Times, June 12, 2018
by Margot Sanger-Katz

A new Trump administration court challenge is explicitly aiming to remove a central promise of Obamacare — its protections for people with pre-existing health conditions. But… Read More

JAMA Forum: The Risks and Benefits of Expedited Drug Reviews

JAMA Forum, May 23, 2018
by Austin Frakt, citing paper co-authored by Jonathan J. Darrow (Student Fellow Alumnus)

From the article: The US Food and Drug Administration (FDA) oversees several programs that expedite approval of certain drugs that treat serious conditions and address unmet medical needs. On average,… Read More

Vermont legislators pass a drug importation law. So what?

Salon, May 27, 2018
by Shefali Luthra, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: Importation backers — including the National Academy for State Health Policy (NASHP), which helped craft Vermont’s bill and has worked with state lawmakers — hope he’ll… Read More

Judge Tells Maine It Must Implement Voter-Approved Medicaid Expansion…

Kaiser Health News, June 5, 2018

Judge Tells Maine It Must Implement Voter-Approved Medicaid Expansion That Governor Has Been Stonewalling HN Morning Briefing: Summaries of health policy coverage from major news organizations Maine… Read More

Criticism of ‘right to try’ law for experimental drugs after it passes in US

Chemistry World, June 5, 2018
by Anthony King, quoting Jonathan J. Darrow (Student Fellow Alumnus)

From the article:  The US government has controversially announced that it will allow unapproved, experimental drugs to be given to terminally ill patients. The ‘right to try’ law passed… Read More

High court rules in dispute over immigrant teen’s abortion

Associated Press, June 4, 2018
by Jessica Gresko

WASHINGTON (AP) — The Supreme Court ruled Monday in a case about a pregnant immigrant teen who obtained an abortion with the help of the American Civil Liberties Union, siding with the Trump administration… Read More

Gun Studies

NPR, June 4, 2018
by Martin Kaste

In the wake of the Parkland high school massacre, there's been renewed interest in "red flag" laws, which allow courts and police to temporarily remove guns from people perceived to pose a threat.… Read More

After Years of Trying, Virginia Finally Will Expand Medicaid

New York Times, May 30, 2018
by Abby Goodnough

WASHINGTON — Virginia’s Republican-controlled Senate voted on Wednesday to open Medicaid to an additional 400,000 low-income adults next year, making it all but certain that the state will… Read More

Ireland votes resoundingly to repeal abortion ban

CNN, May 26, 2018
by Kara Fox and Dakin Andone

Dublin, Ireland (CNN)Ireland has voted an emphatic "Yes" to amend the country's constitution to enable legislation that would allow women to have an abortion in a historic and emotionally charged referendum.… Read More

HIPAA and Protecting Health Information in the 21st Century

JAMA, May 24, 2018
by I. Glenn Cohen (Faculty Director) and Michelle M. Mello

Faculty Director I. Glenn Cohen has co-authored a new opinion piece in JAMA that addresses the adequacy of HIPAA in protecting electronic health data in light of the launch of the Trump administration's… Read More

Trump official on defensive as critics scoff at drug plan

The Hill , May 19, 2018
by Peter Sullivan, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: President Trump's health chief is struggling to show that the administration is serious about taking on drug companies after its proposals for lowering prices last week left big companies… Read More

Is This Hospital Takeover Permitted? Ask the Catholic Church

Wall Street Journal, May 14, 2018
by Melanie Evans

This article is behind a paywall. Harvard affiliates can access the full text via Hollis. It isn't just the Federal Trade Commission scrutinizing U.S. health-care mergers these days. The Vatican… Read More

Trump spoke on lowering drug prices. The tweets rolled in

Stat, May 11, 2018
by Andrew Joseph, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: Given that President Trump is famous for his Earth-shaking tweets, it seems appropriate to comb through Twitter reactions to his administration’s new drug pricing plan, which… Read More

Trump Administration Imposes New Abortion Restrictions On Federally Funded Family Planning Clinics

Kaiser Health News, May 18, 2018

KHN Morning Briefing: Summaries of health policy coverage from major news organizations The policy would mirror similar restrictions in place during the Reagan administration. The policy has been… Read More

FDA website to post names of drug makers blocking development of cheaper generics

Marketplace, May 17, 2018
by Dan Gorenstein, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: The FDA plans to unveil a website today naming pharmaceutical companies that have blocked the development of generic drugs by failing to provide samples to competitors. This public posting… Read More

After controversy over industry funding, NIH halts enrollment in moderate drinking study

STAT, May 17, 2018
by Andrew Joseph

The National Institutes of Health has suspended enrollment in a studyaimed at investigating whether moderate alcohol consumption helps cardiovascular health following concerns over the alcoholic beverage… Read More

HHS Secretary Clarifies Trump Administration’s Plan To Reduce Prescription Drug Prices

NPR, May 17, 2018
by Alison Kodjak

[...] KELLY: First start just by reminding us what this proposal is. The president came out and made an announcement about drug prices last Friday in the Rose Garden. What exactly did he say? KODJAK:… Read More

‘Will You Be My Emergency Contact?’ Takes on a Whole New Meaning

New York Times, May 17, 2018
by Heather Murphy

Will you be my emergency contact? When you’re dating, the question is a sign that you’ve made it to the this-is-really-serious category. When you’re friends, it’s a sign that you’re… Read More

F.D.A. Names and Shames Drug Makers to Encourage Generic Competition

New York Times, May 17, 2018
by Sheila Kaplan

Pharmaceutical companies that spend billions of dollars to develop new drugs do not want competitors to profit from inexpensive generic copies of blockbuster medicines. To avoid rivals, they fight for… Read More

Trump’s Drug Pricing Speech Breaks Little New Ground, Largely Spares Industry

Health Affairs Blog, May 14, 2018
by Rachel Sachs (Academic Fellow Alumna)

From the article: On Friday, President Donald Trump delivered a highly anticipated speech about drug pricing. The speech, coupled with the release of a “blueprint” providing more detail on… Read More

Circumvention Medical Tourism and Cutting Edge Medicine

Indiana Journal of Global Legal Studies, May 12, 2018
by I. Glenn Cohen (Faculty Director)

From the article: “Medical Tourism” is the travel of patients from a home country to a destination country for the primary purpose of receiving health care. “Circumvention Tourism”… Read More

How to Make a Dent in Crazy-High Drug Prices

Bloomberg, May 11, 2018
by By Austin Frakt, citing Rachel Sachs (Academic Fellow Alumna)

From the article: There’s no good reason to pay a lot for prescription drugs that don’t work well. But that’s what lots of Americans are doing. Some drug prices far outweigh any reasonable… Read More

Do NFL Safety Concerns Mean Regulators Should Get in the Game?

Bloomberg Environment, April 26, 2018
by Fatima Hussein, featuring report by the Law and Ethics Initiative of the Football Players Health Study at Harvard University

From the article: Concussions involving NFL players have been an increasing worry. Now a debate has resurfaced about whether federal safety regulators should be able to fine teams found guilty of inflicting… Read More

Drug made famous by Shkreli’s 5,000% price hike is still $750 a pill

Ars Technica, May 4, 2018
by Beth Mole, quoting W. Nicholson Price II (Academic Fellow Alumnus)

From the article: Disgraced ex-pharmaceutical executive and hedge fund manager Martin Shkreli is now behind bars, facing a seven-year prison sentence for securities fraud. Yet the drug-price hike… Read More

For Shame: ‘Pharma Bro’ Shkreli Is In Prison, But Daraprim’s Price Is Still High

Washington Post, May 4, 2018
by Shefali Luthra, quoting W. Nicholson Price II (Academic Fellow Alumnus)

From the article: The continued high price of the drug is a cautionary tale to those who hope that public shaming of a few “bad actors” can curb escalating drug prices, because the problem… Read More

What your government can’t tell you about drug prices

CBC News, May 3, 2018
by Kelly Crowe, Suit brought by Jean-Christophe Belisle Pipon (Visiting Researcher)

From the article: It took three years of fighting for access to confidential drug information, but a Quebec bioethicist has punched a tiny hole in the iron wall of secrecy surrounding patented drug prices.… Read More

Vaccine against Meningitis

La Presse, April 25, 2018
by Marie-Claude Malboeuf, Suit brought by Jean-Christophe Belisle Pipon (Visiting Researcher)

From the article: Quebec has agreed to pay twice as much as the United Kingdom for a new vaccine against meningitis, the effectiveness of which seemed uncertain. The disclosure of the price paid by Quebec… Read More

Supreme Court rules that patent reviews detested by pharma are constitutional

STAT, April 24, 2018
by Ed Silverman, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: In a blow to the pharmaceutical industry, the U.S. Supreme Court ruled that a controversial procedure for reviewing patent disputes does not violate the constitutional rights of patent… Read More

Federal Appeals Court Finds State’s Drug Price-Gouging Law Unconstitutional

Shots: Health News From NPR, April 17, 2018
by Shefali Luthra, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: States are continuing to do battle with budget-busting prices of prescription drugs. But a recent federal court decision could limit the tools available to them — underscoring the… Read More

The breakthrough therapy designation for promising cancer drugs is good for patients

STAT, April 27, 2018
by Jeff Allen, quoting Jonathan J. Darrow (Student Fellow Alumnus)

From the article: One exciting component of the Food and Drug Administration Safety and Innovation Act was the creation of the breakthrough therapy designation. It allows an all-hands-on-deck… Read More

Assessing the FDA’s Breakthrough Drug Program After Six Years

ASH Clinical News, April 25, 2018
by ASH Clinical News, quoting Jonathan J. Darrow (Student Fellow Alumnus)

From the article: In the first four years of the U.S. Food and Drug Administration’s (FDA) breakthrough-therapy designation program, the agency approved 31 “breakthrough” drugs, but many… Read More

Parenting of the future: Many embryos, each with DNA profile

The Washington Post , April 18, 2018
by Malcolm Ritter, quoting I. Glenn Cohen (Faculty Director)

From the article: Once the genetic profile is done, could it come back to haunt a child if, say, a life insurer or nursing home demanded to see it to assess disease risk? How would the large number of… Read More

New Article Examines the Possibility of Applying Workplace Safety Rules to the NFL

Part of the Law and Ethics Initiative of the Football Players Health Study at Harvard University, April 17, 2018
by Article authored by Adam M. Finkel, Chris Deubert, Orly Lobel, I. Glenn Cohen (Faculty Director), and Holly Fernandez Lynch (Former Executive Director

Could occupational health and safety laws be applied to better protect NFL players? A new analysis, published on April 17 in the Arizona Law Review, explores this very possibility. The article, written… Read More

The Work of the Supreme Court

Hosted by the Department of Global Health and Social Medicine at Harvard Medical School, April 11, 2018

PLEASE NOTE: A Harvard ID is required in order to attend this event.  Harvard affiliates: RSVP now! Read More

Drug Approval in a Learning Health System

Minnesota Law Review, Forthcoming, March 29, 2018
by W. Nicholson Price (Academic Fellow Alumnus)

From the article: The current system of FDA approval seems to make few happy. Some argue FDA approves drugs too slowly; others too quickly. Many agree that FDA—and the health system generally—should… Read More

Prevalence of Publicly Available Expanded Access Policies

Clinical Pharmacology & Therapeutics, March 23, 2018
by Emily Jung (Petrie-Flom Student Intern), Patricia J. Zettler, Aaron S. Kesselheim

From the Article: The Food and Drug Administration's expanded access program allows patients with serious or immediately life‐threatening conditions to seek access to experimental drugs and treatments… Read More

Brain Scans in the Courts: Prosecutor’s Dream or Civil Rights Nightmare?

Inside Science, March 14, 2018
by James Gaines, quoting Francis Shen (Senior Fellow in Law and Applied Neuroscience)

From the article:  One of the foundations of the U.S. legal system is the Bill of Rights, which enshrines the idea that there are certain individual liberties and inalienable freedoms that governments… Read More

Risk and Resilience in Health Data Infrastructure

Colorado Technology Law Journal, Volume 16, Issue 1 (2017)
by W. Nicholson Price II (Academic Fellow Alumnus)

From the journal article: Today’s health system runs on data. However, for a system that generates and requires so much data, the health care system is surprisingly bad at maintaining, connecting,… Read More

Payments to Study Participants: Experts Discuss Potential Framework

RAPS, February 27, 2018
by Michael Mezher, featuring NEJM article produced as part of the Harvard Catalyst Project

Members of the Petrie-Flom Center's collaboration with the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst | The Harvard Clinical and Translational Science… Read More

A Framework for Ethical Payment to Research Participants

NEJM, February 22, 2018
by Luke Gelinas (Clinical Research Ethics Fellow), Emily A. Largent (Student Fellow Alumna), I. Glenn Cohen (Faculty Director), Susan Kornetsky, Barbara

Members of the Petrie-Flom Center's collaboration with the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst | The Harvard Clinical and Translational Science Center at… Read More

Preventing Mitochondrial Disease

Obstetrics & Gynecology, March 2018 - Volume 131 - Issue 3
by Eli Y. Adashi and I. Glenn Cohen (Faculty Director)

Abstract: In a possible first, the heritable transmission of a fatal mitochondrial DNA disease (Leigh syndrome) may have been prevented by replacing the mutation-bearing mitochondria of oocytes with donated… Read More

Trump fires first salvo on drug prices

The Hill, February 12, 2018
by Peter Sullivan, referencing Rachel Sachs (Academic Fellow Alumna)

From the article: President Trump is beginning to move on high drug prices, unveiling a series of modest proposals in his budget request released Monday. It’s the first time Trump has issued major… Read More

Budget, White Paper Provide Insight Into Trump Administration’s Strategy On Drug Pricing

Health Affairs, February 12, 2018
by Rachel Sachs (Academic Fellow Alumna)

From the article: During his first year in office, President Donald Trump spoke often about the problem of high drug prices but took no action on the subject. President Trump’s new budget proposal and… Read More

Hundreds sign on to letter opposing ‘right to try’ drug bill

The Hill , February 5, 2018
by Rachel Roubein, reporting on Holly Fernandez Lynch (Former Executive Director and Academic Fellow Alumna)

From the Article:  Several hundred "right to try" critics sent a letter to House Energy and Commerce Committee leaders expressing their “strong opposition” to the bill President… Read More

Trump’s abandoned promise to bring down drug prices, explained

Vox, February 2, 2018
by Dylan Scott, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: One year into Donald Trump’s presidency, as he delivered his first State of the Union address, he has more or less abandoned his outspoken pledges to bring down the cost of America’s… Read More

The Regulatory Accountability Act of 2017 — Implications for FDA Regulation and Public Health

NEJM, February 1, 2018
by Jonathan J. Darrow (Student Fellow Alumnus), Erin C. Fuse Brown, and Aaron S. Kesselheim

From the article: In the past year, federal health policy has been characterized by pervasive uncertainty, but a consistent theme from the Trump administration and some prominent legislators has been opposition… Read More

Privacy experts alarmed as Amazon moves into the health care industry

Washington Post, January 30, 2018
by Abha Bhattarai, quoting I. Glenn Cohen (Faculty Director)

From the article: Amazon.com on Tuesday announced a joint partnership with Berkshire Hathaway and JP Morgan to create an independent health-care company for their employees, putting an end to months… Read More

Physicians, ethicists urge Congress not to pass ‘right to try’ legislation

STAT News, February 1, 2018
by Ike Swetlitz reporting on Holly Fernandez Lynch (Former Executive Director and Academic Fellow Alumna)

From the article: Dozens of doctors, medical ethicists, and lawyers are warning Congress that legislation to allow Americans with life-threatening conditions access to unapproved, experimental drugs risks… Read More

Trump Pledges To Lower Drug Costs — Can We Do It?

NPR, January 31, 2018
by Anthony Brooks, interviewing Rachel Sachs (Academic Fellow Alumna)

From the podcast: President Trump says in his State of the Union that going after the high cost of prescription drugs is a top priority. Politicians have promised for years to bring them down. We’ll… Read More

Petrie-Flom Center launches Project on Precision Medicine, Artificial Intelligence, and the Law

Harvard Law Today, January 31, 2018
by Q & A with I. Glenn Cohen (Faculty Director)

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Center for Advanced Studies in Biomedical Innovation Law (CeBIL) at the University of… Read More

The Petrie-Flom Center Launches the Innovative Funding Models in Translational Research Project

The Petrie-Flom Center, January 29, 2018

January 30, 2018 - The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is launching the Innovative Funding Models in Translational Research Project to… Read More

The Federal Right to Try Act of 2017

JAMA Internal Medicine, January 22, 2018
by Alison Bateman-House and Christopher T. Robertson (Academic Fellow Alumnus)

From the article: In 2017, President Trump said that “one thing that’s always disturbed”1 him is that the US Food and Drug Administration (FDA) denies access to experimental drugs… Read More

Research Fellow for Precision Medicine
Petrie-Flom Center, Harvard Law School

Deadline: Position has been filled.

Duties & ResponsibilitiesThis is a newly created full-time term appointment for a post-doctoral employee needed to support the work of the Petrie-Flom Center on a sponsored research project in collaboration… Read More

The Petrie-Flom Center Launches New Project

Petrie-Flom Center, January 23, 2018

The Project on Precision Medicine, Artificial Intelligence, and the Law will seek to better understand the frontiers of big data in health care diagnostics, through interdisciplinary analysis of important… Read More

Cops, Docs, and Code: A Dialogue between Big Data in Health Care and Predictive Policing

UC Davis Law Review, Vol. 51, No. 437, 2017
by I. Glenn Cohen (Faculty Director) and Harry Graver

Abstract: “Big data” has become the ubiquitous watchword of this decade. Predictive analytics, which is something we want to do with big data -- to use of electronic algorithms to forecast… Read More

Patient-Centered Outcomes Research

The Hastings Center, January-February 2018
by Emily A. Largent (Student Fellow Alumna), Joel S. Weissman, Avni Gupta, Melissa Abraham, Ronen Rozenblum, Holly Fernandez Lynch (Academic Fellow Alumn

Abstract:  The Patient-Centered Outcomes Research Institute (PCORI), the leading research institute in the United States for patient-centered outcomes research (PCOR), funded our multiyear mixed-methods… Read More

It’s time to levy penalties for failing to report clinical trial results

STAT, January 17, 2018
by Holly Fernandez Lynch (Academic Fellow Alumna and former Executive Director)

From the article: I started my first job as an attorney in the fall of 2007, days after President George W. Bush signed the Food and Drug Administration Amendments Act (FDAAA) into law. As part… Read More

Tip of the Iceberg II

11 NYU Journal of Law & Liberty 770, January 12, 2018
by Christopher T. Robertson (Academic Fellow Alumnus) and Victor Laurien

Abstract In recent years, the Food and Drug Administration’s pre-market approval process has come under increasing scrutiny as an infringement on liberty and a regulation of speech. In the first… Read More

A New Approach to Treat Childhood Leukemia: Novartis’ CAR-T Therapy

The Journal of Law, Medicine & Ethics, January 10, 2018
by Frazer A. Tessema and Jonathan J. Darrow (Student Fellow Alumnus)

From the article: On August 30, 2017, the US Food and Drug Administration (FDA) announced the approval of tisagenlecleucel (Kymriah; CTL019), Novartis' new treatment for B-cell acute lymphoblastic… Read More

Federal Right-to-Try Legislation — Threatening the FDA’s Public Health Mission

NEJM, January 10, 2018
by Steven Joffe and Holly Fernandez Lynch (Academic Fellow Alumna and former Executive Director)

From the article: The Food and Drug Administration (FDA) is the gatekeeper of the country’s drugs and medical devices. Originally created to prevent the misleading of patients, it was later tasked… Read More

Court to weigh if one parent has the right to use frozen embryos if the other objects

Washington Post, January 9, 2018
by Ariana Eunjung Cha, quoting I. Glenn Cohen (Faculty Director)

From the article: On Tuesday, the Colorado Supreme Court will hear oral arguments in the Rookses' case. Although several other cases have made their way to states' high courts, legal… Read More

A Big Pharma-funded charity that helps patients pay for drugs just sued the government

Washington Post, January 8, 2018
by Carolyn Y. Johnson, quoting Christopher T. Robertson (Academic Fellow Alumnus)

From the article: These charities help patients out, but they also provide a lucrative philanthropic option for donors. Drug companies get reimbursed by government health programs or private… Read More

Drug Policy: The Year In Review, And The Year Ahead

Health Affairs Blog, January 4, 2018
by Rachel E. Sachs (Academic Fellow Alumna)

From the article:  Last year was an unquestionably busy time for health care news of all kinds. Media and policy coverage rightly focused on the many attempts to repeal the Affordable Care Act, but… Read More

India’s Hospitals Are Filling Up With Desperate Americans

Foreign Policy, January 2, 2018
by Daniel Block, quoting I. Glenn Cohen (Faculty Director)

From the article:  Medical tourism thus presents both opportunities and risks. At its best, the industry can help India grow its health care system, using the revenues generated from international… Read More

Speed, Safety, and Industry Funding — From PDUFA I to PDUFA VI

The New England Journal of Medicine, December 7, 2017
by Jonathan J. Darrow (Student Fellow Alumnus), Jerry Avorn, and Aaron S. Kesselheim

From the paper: In August, President Donald Trump signed into law the sixth version of key legislation for the Food and Drug Administration (FDA), known as the Prescription Drug User Fee Act (PDUFA VI).… Read More

Will inter partes review speed US generic drug entry?

Nature Biotechnology, Issue 35
by Jonathan J Darrow (Student Fellow Alumnus), Reed F Beall & Aaron S Kesselheim

From the paper: Patents are ubiquitous in the pharmaceutical industry and are used by brand-name drug manufacturers to prevent low-cost generic competition and maintain high drug prices. Patents are granted… Read More

Explaining the Absence of Surgical Procedure Regulation

Cornell Journal of Law and Public Policy, Vol 27, Issue 189
by Jonathan J. Darrow (Student Fellow Alumnus)

From the paper: Each year in the United States, surgeons perform approximately 64 million surgical procedures, ranging from tooth extraction to open heart surgery.2 Yet, notwithstanding the frequency of… Read More

Trump’s zeal for deregulation could gum up the FDA, experts say

STAT, December 20, 2017
by Meghana Keshavan, quoting Jonathan J. Darrow (Student Fellow Alumnus)

From the article: President Trump quite literally cut a stretch of red tape last week to emphasize his slash-and-burn stance on government deregulation. But what would sweeping regulatory change… Read More

Encouraging New Uses for Old Drugs

JAMA, December 4, 2017
by Rachel E. Sachs (Academic Fellow Alumna), Paul B. Ginsburg, and Dana P. Goldman

From the paper: US Food and Drug Administration (FDA) approval of a new drug typically coincides with a period of patent protection, during which the manufacturer will often apply for additional indications… Read More

2017’s Word Of The Year In Health Law And Bioethics: Uncertainty

Health Affairs, December 8, 2017
by Carmel Shachar (Executive Director) and I. Glenn Cohen (Faculty Director)

Note: This post is the first in a series of Health Affairs posts from the Sixth Annual Health Law Year in P/Review event, held at Harvard Law School on Tuesday, December 12, 2017. … Read More

The Health 202

The Washington Post, November 30, 2017
by Paige Winfield Cunninghamm, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: If the opioid epidemic was simply a problem of supply – people being able to access drugs too easily – than a targeted new effort in Appalachia announced… Read More

NOW AVAILABLE! Big Data, Health Law, and Bioethics

Cambridge University Press, Forthcoming, March 2018
by Edited by I. Glenn Cohen (Faculty Director), Holly Fernandez Lynch (former Executive Director), Urs Gasser, and Effy Vayena

This edited volume stems from the Petrie-Flom Center’s 2016 annual conference, which brought together leading experts to identify the various ways in which law and ethics intersect with… Read More

FDA-Approved Digital Pill Causes Concerns

KJZZ Radio, November 28, 2017
by Steve Goldstein, interviewing I. Glenn Cohen (Faculty Director)

The first so-called digital pill has been approved by the Food and Drug Administration. It’s a version of the antipsychotic drug Abilify and contains a tiny sensor that will send a signal to a patch… Read More

Germ-Line Gene Editing and Congressional Reaction in Context

Journal of Law and Health, Vol. 30 (2017), Issue 1
by Russell A. Spivak, I. Glenn Cohen (Faculty Director), and Eli Y. Adashi

Abstract: On December 18, 2015, President Obama signed into law a policy rider forestalling the therapeutic modification of the human germ line. The rider, motivated by the science’s potential unethical… Read More

The Debate over Postmortem Sperm Retrieval of Fallen Soldiers

Jerusalem Post, November 22, 2017
by Avishalom Westreich (Visiting Scholar Alumnus)

This essay is based in part on the workshop the Petrie-Flom Center hosted on October 23, 2017, in which then-Visiting Scholar Avishalom Westreich presented his research-in-progress to a diverse group of… Read More

Digital pill offers chance of new life to old drugs

Financial Times, November 22, 2017
by FT Staff, quoting I. Glenn Cohen (Faculty Director)

From the article: Amid broader concerns about how medical information may be used, Proteus says that its product complies with “all applicable laws and standards” on data protection. Patients… Read More

A patent ploy

The Economist, November 16, 2017
by Economist Staff, citing Rachel E. Sachs (Academic Fellow Alumna)

From the article: [...] The Mohawk tribe argues that it should be treated the same as a state institution. State universities have used sovereign immunity to dismiss challenges brought to the Patent… Read More

First Digital Pill Approved to Worries About Biomedical ‘Big Brother’

New York Times, November 13, 2017
by Pam Belluck, featuring I. Glenn Cohen (Faculty Director)

For the first time, the Food and Drug Administration has approved a digital pill — a medication embedded with a sensor that can tell doctors whether, and when, patients take their medicine. The approval,… Read More

Ohio’s Drug-Pricing Ballot Question Triggers Voter Confusion

Kaiser Health News, November 7, 2017
by By Shefali Luthra, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Drug pricing is complex and already has caused head-scratching among policymakers and academics, noted Rachel Sachs, an associate professor of law at Washington University in St. Louis,… Read More

7 ways biopharma would win — and lose — under the new tax bill

STAT News, November 2, 2017
by Rebecca Robbins, citing Rachel E. Sachs (Academic Fellow Alumna)

From the article: [...] The drug industry has fiercely defended this tax credit in the past, calling it essential to encourage investment in disease areas where patients have few options — even as… Read More

Desperate Quest For Herpes Cure Launched ‘Rogue’ Trial

Kaiser Health News, October 19, 2017
by Marisa Taylor, quoting Holly Fernandez Lynch (Former Executive Director, Academic Fellow Alumna)

From the article: As 20 Americans and Brits flew to a Caribbean island for a controversial herpes vaccine trial, many of them knew there were risks. The lead U.S. researcher, William Halford, openly acknowledged… Read More

Medicaid’s Best-Price Rule May Not Be Such a Big Problem

Physician's Weekly, October 23, 2017
by Physician's Weekly, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Rachel Sachs, J.D., M.P.H., from Washington University in St. Louis, and colleagues discussed Medicaid’s “best-price rule” and the extent to which it might frustrate… Read More

Ohio Issue 2 ballot initiative proponents overstate impact on EpiPen prices

Politifact, October 13, 2017
by Manuela Tobias, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: In addition to the Medicaid program, the state purchases drugs for state employees, prisons, and other state-run programs, but the campaign was unable to pin down the effect of the initiative… Read More

Innovative Contracting for Pharmaceuticals and Medicaid’s Best-Price Rule

Journal of Health Politics, Policy and Law, September 28, 2017
by Rachel E. Sachs (Academic Fellow Alumna), Nicholas Bagley, and Darius N. Lakdawalla

From the paper: In recent years, drug manufacturers and private payers have expressed interest in novel pricing models that more closely link a drug’s price to its value. Indication-based pricing,… Read More

Battle over drug prices shifts back to the states

The Hill, October 11, 2017
by By Rachel Roubein, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: President Trump has derided pharmaceutical companies as “getting away with murder,” but there’s been little action in Washington to rein in the costs of prescription… Read More

Letter to Allergan plc

The House of Representatives Committee on Oversight and Government Reform, October 3, 2017
by By Trey Gowdy, Elijah E. Cummings, Dennis A. Ross, and Peter Welch, citing blog post by Rachel E. Sachs (Academic Fellow Alumna)

From the letter: On September 8, 2017, your company announced the trans r of six patents related to its Restasis drug to the Saint Regis Mohawk tribe. 1 The unconventional maneuver has received considerable… Read More

Absent federal action, states take the lead on curbing drug costs

The Washington Post, September 29, 2017
by By Shefali Luthra, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Critics see these tailored efforts as falling short or potentially opening other loopholes. Requiring companies to report prices past a certain threshold, for example, might encourage… Read More

Your Money or Your Patient’s Life? Ransomware and Electronic Health Records

Annals of Internal Medicine, September 19, 2017
by By I. Glenn Cohen (Faculty Director), Sharona Hoffman, and Eli Y. Adashi

The mugger's demand “Your money or your life” is a familiar one. However, in an era of vast hospital computer networks and electronic health records, a novel risk to worry about is, “Your… Read More

Allergan’s deal with the Mohawks raises troubling questions about the future of generics

STAT , September 11, 2017
by By Ed Silverman, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: [...] Legal experts, however, say that tribal sovereignty may also thwart generic drug makers from filing a conventional lawsuit. If so, the ramifications may be far-reaching and ominous… Read More

Influence, integrity, and the FDA: An ethical framework

Science, Sep 1, 2017: Vol. 357, Issue 6354, pp. 876-877.
by Spencer Phillips Hey, I. Glenn Cohen (Faculty Director), Eli Y. Adashi, & Aaron S. Kesselheim

Summary: Among the core missions of the U.S. Food and Drug Administration (FDA) are protecting public health by assuring the safety and efficacy of drugs, biologics, and medical devices and advancing public… Read More

Obamacare survives its latest threat: Bare counties

POLITICO Pulse, August 21, 2017
by Dan Diamond, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article:  Trump quietly signs FDA reauthorization bill. The president didn't hold a signing ceremony on Friday, even though the bill has been one of the few major pieces of legislation… Read More

Questions About The FDA’s New Framework For Digital Health

Health Affairs Blog, August 16, 2017
by Nathan G. Cortez, Nicolas Terry, and I. Glenn Cohen (Faculty Director)

From the article: In June 2017, the new Food and Drug Administration (FDA) commissioner Scott Gottlieb pre-announced his agency’s Digital Health Innovation Action Plan that indicates… Read More

The One Time Congress Let the Public Comment on an Upcoming Bill

Pacific Standard, August 14, 2017
by Francie Diep, quoting Rachel E. Sachs (Academic Fellow Alumna)

[...] Congress doesn't typically ask for public comments on the bills it's considering. But, in January of 2015, the House Energy and Commerce Committee did just that, for a first draft of the 21st… Read More

Administering Health Innovation

Cardozo Law Review, Forthcoming 2018
by Rachel E. Sachs (Academic Fellow Alumna)

Abstract Scholars and policymakers have recently begun to focus on the role federal agencies charged with health-related missions can play in the development of innovative health technologies and promotion… Read More

Who’s Actually Using ‘Right-To-Try’ Laws?

RAPS, August 4, 2017
by Zachary Brennan, quoting Rachel E. Sachs (Academic Fellow alumna)

'The record with state-level right-to-try laws also suggests lackluster interest from industry. "It's telling that although 37 states have adopted these laws, when asked to provide examples of… Read More

Academic Fellow Alum Matthew J. B. Lawrence Joins Faculty at Dickinson Law (Penn State)

Dickinson Law, Penn State University, August 1, 2017

Matthew J.B. Lawrence has joined the faculty of Penn State’s Dickinson Law as assistant professor of law. An expert in the fields of health law and administrative law, Lawrence will teach Health… Read More

How New Technology Could Threaten a Woman’s Right to Abortion

Gizmodo, July 28, 2017
by Kristen V. Brown, quoting I. Glenn Cohen (Faculty Director)

From the article: [...] It could also complicate—and even jeopardize—the right to an abortion in an America in which that right is predicated on whether a fetus is “viable.” “The… Read More

Locked Out Of Asia, Americans Are Turning To Eastern Europe To Hire Gestational Surrogates

HuffPost, July 25, 2017
by Sarah Elizabeth Richards, quoting I. Glenn Cohen (Faculty Director)

From the article: [...] While it’s impossible to know “what’s presented to you versus what’s really occurring,” Harvard Law School Professor I. Glenn Cohen said, fertility… Read More

Petrie-Flom Welcomes New Senior Fellow in Law and Applied Neuroscience!

Petrie-Flom Center, July 21, 2017

We’re excited to announce our 2017–2018 Senior Fellow in Law and Applied Neuroscience, Francis X. Shen! Project on Law and Applied NeuroscienceThe Project on Law and Applied Neuroscience, now… Read More

Public Participation in Drafting of the 21st Century Cures Act

The Journal of Law, Medicine & Ethics, July 14, 2017
by Thomas J. Hwang, Rachel E. Sachs (Academic Fellow Alumna), Aaron S. Kesselheim

Abstract The 21st Century Cures Act is a major act of legislation that contains numerous changes to drug and device regulation. The House of Representatives passed the Act after considerable interest group… Read More

FDA to Speed Review of Generic Drug Applications Until It’s Approved Three of Them

STAT News, June 27, 2017
by Rebecca Robins, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: The Food and Drug Administration on Tuesday moved to try to spur more competition in the market for generic drugs, an effort aimed at driving down prices. In a policy change,… Read More

The FDA May Move to Shorten That Grim List of Side Effects in Every Drug Ad

STAT News, June 28, 2017
by Megan Thielking, quoting Holly Fernandez Lynch (Executive Director)

From the article: Warning: Watching TV drug ads may put you to sleep. That’s no surprise to many of us who’ve heard about the countless ways prescription drugs can harm us. But now, the Food… Read More

The Case for Giving Health-Care Consumers a ‘Nudge’

Wall Street Journal, June 25, 2017
by Lisa Ward, interviewing Christopher T. Robertson (Academic Fellow Alumnus)

The Case for Giving Health-Care Consumers a ‘Nudge:’ A law professor argues that people will make better choices if they’re asked the right way For example, some states encourage child… Read More

Panel: Weighing the Risks of Randomized Controlled Trials and Alternatives

The New York Academy of Sciences, June 21, 2017
by Panel featuring Holly Fernandez Lynch (Executive Director), Amrit Ray, Matthew Rotelli, Steve Usdin, and Robert Walker

On June 21, 2017, Executive Director Holly Fernandez Lynch participated in a panel discussion on "Weighing the Risks of Randomized Controlled Trials and Alternatives," which was part of the conference… Read More

Turning to the States to Solve the National Problem of Drug Pricing

STAT News, June 20, 2017
by Meghana Keshavan, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Drug pricing is a national problem. So a nonprofit wants to help hand off some of that burden to the states. The National Academy for State Health Policy just launched a new center, called… Read More

At Drug Hearing, Senators Discuss Meanings of Price and Value - and Debate Health Reform

Health Affairs Blog, June 20, 2017
by Rachel E. Sachs (Academic Fellow Alumna)

From the article by Rachel E. Sachs, (Academic Fellow Alumna): On Tuesday, June 13, the Senate Health, Education, Labor, & Pensions (HELP) Committee held the first of three planned hearings… Read More

Fellow and Visiting Assistant Professor
Regulatory Science Program, University of Arizona James E. Rogers College of Law

Deadline: Open until filled.

The University of Arizona seeks to hire an early-career scholar (post-doctoral) to support its innovative Regulatory Science Program, a collaboration between the James E. Rogers College of Law and… Read More

How a Supreme Court ruling on printer cartridges could have a big impact on drug prices

STAT News, May 30, 2017
by Meghana Keshavan, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: A Supreme Court ruling on international printer cartridge sales could have major implications for, of all things, drug pricing and global health. The case in question involves patents,… Read More

Legal Roundtable: Discussing abortion restrictions, health care, Supreme Court developments and more

St. Louis Public Radio, May 30, 2017
by Kelly Moffitt, featuring Rachel Sachs (Academic Fellow Alumna)

From the radio episode: On Tuesday’s St. Louis on the Air, Legal Roundtable panel returned to discuss pressing issues of the law. They discussed a number of topics, starting with national issues… Read More

Pre-order now and get 30% off! Specimen Science

MIT Press, September 2017
by Edited by Holly Fernandez Lynch (Executive Director), Barbara E. Bierer, I. Glenn Cohen (Faculty Director), and Suzanne M. Rivera

Pre-order through MIT Press and receive 30% off using discount code MSPECIMEN30: Order now! This edited volume stems from a conference in 2015 that brought together leading experts to address key… Read More

New Issue of the Journal of Law and the Biosciences

Journal of Law and the Biosciences (JLB), Vol. 4, No. 1, April 2017

The Journal of Law and the Biosciences, the open-access journal launched in 2014 by the Petrie-Flom Center and Harvard Law School in partnership with Duke University and Stanford University, has… Read More

The Sean Pendergast Show with Dr. Glenn Cohen, Harvard Law Professor

The TJ Show, AMP Radio 103.3 FM, May 28, 2017
by Interviewing I. Glenn Cohen (Faculty Director)

Harvard Law Professor [I. Glenn Cohen (Faculty Director)] joins Sean to discuss a study he and a Harvard group did on player safety in the NFL, how the game can be made more safe, and the future of… Read More

The Trump administration could bring down drug prices. But it would take guts

STAT News, May 15, 2017
by Ed Silverman, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: “If Price and [President] Trump are interested in lower-priced drugs, they have access to a tool that enables them to do that,” explained Rachel Sachs, an associate professor… Read More

The White House budget director dropped a hint about how Trump could bring drug prices down

Washington Post, May 12, 2017
by Carolyn Y. Johnson, quoting Rachel Sachs (Academic Fellow Alumna)

From the artcile: Trump has repeatedly said that drug prices are too high but has often suggested that increased bidding would be the best way to bring down prices. It has been unclear how that… Read More

New FDA Chief Scott Gottlieb: Medication Reformer or Big Pharma Shill?

The Fix, May 18, 2017
by Paul Gaita, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: Gottlieb's position has earned cautious approval from medical industry observers like Washington University associate professor Rachel Sachs, who wrote, "As someone who understands… Read More

New York state wants its prescription drug money back—or else

USA Today, May 18, 2017
by Julie Appleby, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: New York’s Medicaid program, for example, has seen its drug spending rise on average 8% each year over the past three years, after taking into account existing rebates. The… Read More

Babies From Skin Cells? Prospect Is Unsettling to Some Experts

New York Times, May 16, 2017
by Tamar Lewin, citing I. Glenn Cohen (Faculty Director)

From the article: Three prominent academics in medicine and law sounded an alarm about the possible consequences in a paper published this year. “I.V.G. may raise the specter of ‘embryo farming’… Read More

Harvard Study Looks At Ways NFL Can Bolster Player Health

Law360, May 16, 2017
by Fola Akinnibi, quoting I. Glenn Cohen (Faculty Director) and citing Petrie-Flom's report

Law360, New York (May 16, 2017, 6:03 PM EDT) -- Harvard Law School published a report Monday exploring the National Football League’s health policies and practices, noting that the professional… Read More

New Report from the Law & Ethics Initiative of the Football Players Health Study

Petrie-Flom Center and Football Players Health Study at Harvard University, May 15, 2017

May 15, 2017 – While the NFL’s player health policies and practices are robust in some areas, there are opportunities for improvement in others, according to the findings of a newly released… Read More

Harvard’s Advice for NFL Player Health and Safety

MMQB, Sports Illustrated, May 15, 2017
by Jenny Vrentas, quoting I. Glenn Cohen (Faculty Director) and citing Petrie-Flom's report

From MMQB:  Today’s 255-page report comes from Harvard Law School’s Petrie-Flom Center for health law policy, biotechnology and bioethics, and it compares the NFL’s policies… Read More

Harvard study suggests some NFL health and safety changes

Washington Post, May 15, 2017
by Rick Maese, quoting I. Glenn Cohen (Faculty Director) and citing Petrie-Flom's report

From the Washington Post:  The physical demands are different. The types and severity of injuries are different. And the economics can vary wildly. But there are several common threads shared… Read More

Harvard study: NFL should offer treatment for performance-enhancing drug users

Boston Globe, May 15, 2017
by Travis Anderson, citing Petrie-Flom's report

From the Boston Globe:  The National Football League should consider providing treatment to any player caught using performance-enhancing drugs, according to a new Harvard University study. The recommendation… Read More

There’s a federal law to lower drug prices—and Louisiana may just use it

Ars Technica, May 4, 2017
by Beth Mole, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Rachel Sachs, a law professor at Washington University in St Louis, told the KHN that this makes a good argument for summoning 28 U.S.C. § 1498. “The case is strong,”… Read More

Louisiana proposes tapping a century-old patent law to cut hepatitis C drug prices

Kaiser Health News, May 2, 2017
by Sarah Jane Tribble, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Rachel Sachs, an associate professor of law at Washington University in St. Louis who attended the recent Johns Hopkins meeting, said she believes “the case is strong” in… Read More

Promoting demand-side innovation: prizes for payers

Journal of Law and the Biosciences, May 5, 2017
by Rachel E. Sachs (Academic Fellow Alumna)

From the paper: Promoting Healthcare Innovation on the Demand Side,1 the recent article by Professors Rebecca Eisenberg and Nicholson Price, is a thoughtful, detailed look at an issue that has gone… Read More

ORDER NOW & GET 20% OFF! Law, Religion, and Health in the United States

Cambridge University Press, July 2017
by Holly Fernandez Lynch (Executive Director), I. Glenn Cohen (Faculty Director), and Elizabeth Sepper

About the Book: While the law can create conflict between religion and health, it can also facilitate religious accommodation and protection of conscience. Finding this balance is critical to addressing… Read More

Revised ‘Common Rule’ Shapes Protections For Research Participants

Health Affairs, May 2017, Vol. 36, No. 5
by By Barbara E. Bierer, Mark Barnes, and Holly Fernandez Lynch (Executive Director)

From the article: Research with human participants funded by most federal agencies is governed by a set of rules and procedures designed to protect study participants while enabling the advancement of… Read More

Value-Based Pricing For Pharmaceuticals In The Trump Administration

Health Affairs Blog, April 27, 2017
by Rachel E. Sachs (Academic Fellow Alumna), Nicholas Bagley, and Darius Lakdawalla

From the article: Everyone seems to agree: Drug prices are too damn high. Scandalous prices for new drugs and enormous price hikes on old drugs have focused public ire on the pharmaceutical… Read More

Should We Study Human Embryos Beyond 14 Days?

NOVA Next, April 26, 2017
by Jenny Morber, quoting I. Glenn Cohen (Faculty Director)

From the article: [...] Some critics view calls to re-evaluate the 14-day rule as a pernicious moving of the goalposts. How meaningful can they be, the line of reasoning goes, if scientists want to change… Read More

As a competitor encroached, Mylan took one state to court to push EpiPen sales, documents

STAT News, April 24, 2017
by Ike Swetlitz, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article:  Three lawyers who reviewed the case at the request of STAT said they could not think of another instance when a pharmaceutical company sued to protect the status of its medication… Read More

Nonexceptionalism, Research Risks, and Social Media

American Journal of Bioethics, 17(5):W1-W3, 2017 (Published online April 21, 2017)
by Luke Gelinas (Research Ethics Fellow), Robin Pierce, Sabune Winkler, Glenn Cohen (Faculty Dir), Holly Fernandez Lynch (Executive Dir) & Barbara Bierer

We are grateful for the thoughtful commentaries on our target article “Using Social Media as a Research Recruitment Tool: Ethical Issues and Recommendations” (Gelinas et al. 2017),… Read More

Science Needs Your Cells

New York Times, April 21, 2017
by Holly Fernandez Lynch (Executive Director) and Steven Joffe

Biospecimens are essential to medical progress, but just medical waste to patients. Let's promote the science. From the op-ed: Many aspects of Ms. Lacks’s story reflect genuine injustice: the… Read More

Institutions as an Ethical Locus of Research Prioritisation

Journal of Medical Ethics, April 11, 2017 (Online)
by Luke Gelinas (Fellow in Clinical Research Ethics), Holly Fernandez Lynch (Executive Director), Barbara Bierer, I. Glenn Cohen (Faculty Director)

Introduction Ensuring that clinical trials, once launched, successfully complete and generate useful knowledge is an important and indeed ethically imperative goal, given the risks and burdens borne by… Read More