Fetal Burial Is Dead (for now)

By John A. Robertson

The Supreme Court’s 2016 decision in Whole Women’s Health v. Hellerstedt (WWH) struck down a Texas law targeting abortion providers by allowing judges to balance the health benefits of the regulation against the burdens on a woman’s access to abortion.  In doing so, the Court effectively gutted the efforts of anti-abortion legislators to limit the core right to abortion recognized in Roe v. Wade and Planned Parenthood v. CaseyRobertson Whole Women  Until either Justices Anthony Kennedy or Ruth Bader Ginsburg retire and are replaced by a Republican President, Roe, Casey, and WWH should limit the reach of anti-abortion legislation.

A good example of the blocking effect of WWH is the difficulty states will now have enforcing statutes that aim at protecting fetal status prior to viability.  Typical of such efforts are laws in 10 states that require that aborted fetuses be handled as if they were stillborn or dead children and adults, i.e., interment or cremation and interment.   The practice for many years had been to teat fetal remains as other medical waste–incineration and deposition in a sanitary landfill, or grinding and flushing down a drain. Continue reading

ACA Repeal and the End of Heroic Medicine

Last week, I saw Dr Atul Gawande speak at Health Action 2017. Healthcare advocates and activists sat around scribbling notes and clutching at their choice of whole-food, cold-pressed, green and caffeinated morning lifelines. Gawande speaks softly, lyrically and firmly; the perfect bedside manner for healthcare advocates in these early days of the Trump presidency. He calmly announced to the congregation that the age of heroic medicine is over. Fortunately, he continued, that’s a good thing.

Gawande’s remarks echoed a piece he published in the New Yorker. He writes that for thousands of years, humans fought injury, disease and death much like the ant fights the boot. Cures were a heady mixture of quackery, tradition and hope. Survival was largely determined by luck. Medical “emergencies” did not exist; only medical “catastrophes”. However, during the last century, antibiotics and vaccines routed infection, polio and measles. X-rays, MRIs and sophisticated lab tests gave doctors a new depth of understanding. New surgical methods and practices put doctors in a cage match with Death and increasingly, doctors came out with bloody knuckles and a title belt. Gradually, doctors became heroes and miracles became the expectation and the norm. This changed the way we view healthcare. Gawande writes, “it was like discovering that water could put out fire. We built our health-care system, accordingly, to deploy firefighters.”

But the age of heroic medicine is over. Dramatic, emergency interventions are still an important part of the system. However, Gawande insists that the heavy emphasis on flashy, heroic work is misplaced. Much more important is “incremental medicine” and the role of the overworked and underappreciated primary care physician.

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“There are millions of people who are living below subsistence”: Black Panther Party Founder Bobby Seale as Public Health Activist

By Wendy S. Salkin

Picture it: Tuesday, February 14, 2017. It is four o’clock and the Tsai Auditorium of the Center for Government and International Studies is packed to the gills, abuzz with energy. Harvard faculty, students, staff, and community members fill every seat, line the steps, and stand shoulder-to-shoulder in the back. They are turning would-be attendees away at the door. The occasion for such excitement is this: The Hutchins Center for African & African American Research here at Harvard hosted the event, “Bobby Seale in Conversation with Jim Sidanius.”

Jim Sidanius is the John Lindsley Professor of Psychology in memory of William James and of African and African American Studies. His work spans broadly across both decades and areas of inquiry. He and his co-author Felicia Pratto are famously responsible for formulating social dominance theory, “a general model of the development and maintenance of group-based social hierarchy and social oppression.” He has also pioneered work in other areas of political psychology, including such research areas as “political ideology and cognitive functioning, the political psychology of gender, group conflict, institutional discrimination and the evolutionary psychology of intergroup prejudice.”

And Bobby Seale, as you may know, co-founded the Black Panther Party for Self Defense (BPP). I had never before seen Bobby Seale speak and did not know what to expect. And, ultimately, I am pleased not to have watched any of his interviews in advance, as I was able to have the experience with fresh eyes. (It’s worth noting that many of his interviews and speeches are easily accessible on YouTube. It’s worth watching them, including his 2015 New York Times interview with R&B artist D’Angelo.) His energy and enthusiasm captivates his audience, as when, during his talk last week, he recited from the Declaration of Independence, and while so doing impersonated both John Wayne and Rev. Dr. Martin Luther King, Jr. He recited this passage:

“[W]hen a long train of abuses and usurpations, pursu[ed] invariably…evinces a design to reduce [a people] under absolute Despotism, [then it is the] right [of the people]…to [alter and change that] Government, and [] provide new Guards for their future security.”

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Obstetric Battery

Nadia N. Sawicki

In 2013, Kimberly Turbin came to Providence Tarzana Medical Center for a momentous occasion – the birth of her first child. In the delivery room, she was surrounded by supportive family members. Her mother stood by her side with a video recorder, hoping to capture the once-in-a-lifetime event for posterity.

And this is where Kimberly’s birth story veers off course. According to the complaint filed in Los Angeles County Superior Court against her OB/GYN, Dr. Alex Abbassi, Kimberly is a survivor of sexual assault who had confided in the medical staff that she had previously been raped. She requested that the staff ask permission before touching her, and asked them to “be gentle.” And when Dr. Abbassi told Kimberly during delivery that he would be performing an episiotomy – a surgical procedure in which the perineum and vaginal wall are cut to provide more room for the baby to pass through the vaginal canal – Kimberly objected. When she asked why the episiotomy was necessary, Dr. Abbassi provided no medical justification. He responded, “What do you mean, Why? I am the expert here! … You can go home and do it! You go to Kentucky!” Kimberly continued to object, loudly saying “No!” and “No, don’t cut me!” numerous times. Dr. Abbassi proceeded nevertheless, cutting her perineum twelve times. A video of this entire encounter, which is extremely graphic and difficult to watch, is viewable on YouTube.

These allegations, if true, present a textbook case of battery – the defendant intended to cause contact with the patient, the contact was harmful and offensive, and the contact was neither consented to nor justified by any emergency. And yet, when Kimberly filed suit for battery and intentional infliction of emotional distress, Dr. Abbassi moved to dismiss her suit – he argued that because Kimberly’s claim was grounded in the failure to obtain informed consent, it constituted negligence under California’s medical malpractice laws and therefore was barred by a shorter statute of limitations. In June of 2016, however, Judge Benny Osorio denied Dr. Abbassi’s motion to dismiss the battery claim, holding that the “alleged act of proceeding against the express wishes of Plaintiff … is premised on intentional misconduct and not professional negligence.”

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Housing Equity Week in Review

The past week seems to have been full of ratings and rankings. Here’s the round up of news for housing law and equity for the week of February 13-19, 2017

  • Although there were some gains in home ownership among black Americans since the 1960s and the Fair Housing Act, the rates are currently at the lowest they have been in half a century, and is lower than any other group in the United States. Experts from the Urban Institute discuss why and look ahead.
  • Center City Philadelphia is experiencing a housing boom, via PlanPhilly.com
  • The National Low Income Housing Coalition on the importance of healthy and energy efficient housing infrastructure, via HFront.org
  • Market Watch rated the most unhealthy cities in America in terms of food, fitness, green space, and health. Hopefully we can make the connection between housing and health even stronger so that next year in this rating, housing will be assessed as well.
  • The de Beaumont Foundation launched CityHealth.org — an initiative and website that rates how the nation’s 40 largest cities fare in nine policies based in research, backed by qualified experts and shown to have bipartisan support. The policy areas include affordable housing/inclusionary zoning, Complete Streets, and clean indoor air laws, among others.

Global Genes, Local Concerns: A Symposium on Legal, Ethical and Scientific Challenges in International Biobanking

I am happy to announce our “Global Genes, Local Concerns Symposium on Legal, Ethical and Scientific Challenges in International Biobanking” to be held at the University of Copenhagen (DK) on 16 March 2017, 08:00-18:30. Among the many prominent experts speaking at this conference  we find the PFC’s very own Glenn Cohen and several speakers with a PFC “history” or close PFC links, such as Bartha Knoppers, Tim Caulfield, Nicholson Price and Jeff Skopek.

A detailed program and further information is available here and here.

This Symposium marks the final phase of the Global Genes-Local Concerns project. In accordance with the goals of this large cross-faculty project, the Symposium deals with legal, ethical and scientific challenges in cross-national biobanking and translational exploitation. Leading international experts and invited speakers will discuss how national biobanks contribute to translational research, what opportunities and challenges regulations present for translational use of biobanks, how inter-biobank coordination and collaboration occurs on various levels, and how academic and industrial exploitation, ownership and IPR issues could be addressed and facilitated. Special emphasis will be laid on challenges and opportunities in addressing regulatory barriers to biobank research and the translation of research results, while at the same time securing ethical legitimacy and societal interests.

These issues will be dealt with in 4 main sessions covering (1) BIG DATA AND MODES OF COLLABORATION; (2) PATIENT INVOLVEMENT; (3) TRANSLATIONAL MEDICINE & TECH TRANSFER, as well as (4) GUIDELINES & GOOD GOVERNANCE.

Speakers:

  • Bartha Knoppers, Mc Gill University (Canada)
  • Glenn Cohen, Harvard University (US)
  • Timo Minssen, University of Copenhagen (DK)
  • Tim Caulfield, University of Alberta (Can)
  • Michael Madison, University of Pittsburgh (US)
  • Jeff Skopek, University of Cambridge (UK)
  • Brian Clark, Director, Human Biosample Governance, Novo Nordisk A/S (DK)
  • Jane Kaye, University of Oxford (UK)
  • Anne Cambon-Thomsen, INSERM, Toulouse / CNRS Director (Fr)
  • Klaus Høyer, University of Copenhagen (DK)
  • Aaro M. Tupasela, University of Copenhagen (DK)
  • M. B. Rasmussen, University of Copenhagen (DK)
  • Åsa Hellstadius, Stockholm University (Sweden)
  • Peter Yu, A&M Texas University (US)
  • Esther van Zimmeren, University of Antwerp/Leuven (Belgium)
  • Nicholson Price, University of Michigan Law School (US)
  • Karine Sargsyan,  BBMRI/Head of Biobanking-Graz (Austria)
  • Eva Ortega-Paino,  BBMRI, Lund University (Sweden)
  • Nana Kongsholm, University of Copenhagen (DK)
  • Klemens Kappel, University of Copenhagen (DK)
  • Helen Yu, University of Copenhagen (DK).

For participation in the event please use this registration form no later than Friday, 10 March 2017, 12:00 at the latest.

We are looking very much forward to welcoming you in wonderful Copenhagen on 16 March 2017.

Best wishes/

Timo Minssen

Judy Solomon on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

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This week we discussed the future of the ACA with Judy Solomon of the Center for Budget and Policy Priorities. Judy is Vice President for Health Policy at CBPP, where she focuses on Medicaid and the Children’s Health Insurance Program. She is also an expert on issues related to the implementation of the ACA, particularly policies to make coverage available and affordable for low-income people.

As new alternatives to the ACA emerge, we discussed the wide range of policies that may be in the offing for state Medicaid waivers. CBPP has a fascinating and up-to-date series of posts on the transition from Obamacare to Trumpcare. Follow Judy on Twitter at @JudyCBPP, which includes links to her insightful blog posts and a number of other critical developments in health policy.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

The High Cost of Clinical Negligence Claims

By John Tingle

In the UK, the Department of Health (DH) have just published a consultation paper on introducing fixed recoverable costs in lower value clinical negligence claims. The document contains some controversial proposals which many claimant, patient lawyers are very concerned about. They feel the proposals will make it much harder for patients with lower value claims to find a solicitor to fight their case .The publication of the consultation paper comes in the wake of criticism that some clinical negligence claimant lawyers, solicitor firms , make excessive and unreasonable costs demands. The NHS LA (The National Health Service Litigation Authority) which manages negligence and other claims against the NHS in England states:

“Claimant costs for lower value claims are disproportionate and excessive. For claims where compensation is less than £10,000, claimant lawyers recover almost three times more in costs on average.”(p.10)

The DH Consultation Paper begins by stating the annual cost of clinical negligence in the NHS. It has risen from £1.2bn in 2014/15 to £1.5bn in 2015/2016.Legal costs were 34% of the 2015/16 expenditure.The consultation paper states that the current system of claims resolution is often lengthy and adversarial. This creates what can be termed a dual problem. Delaying possible learning of lessons from incidents and also escalating the costs of litigation when claims are brought. Continue reading

Call for Papers – European Pharmaceutical Law Review (EPLR)

Dear Colleagues,

I am happy to announce that I have just joined the Board of Editors of the new journal “European Pharmaceutical Law Review” (EPLR). One of my first tasks is to spread the news about our “Call for Papers”. Further information is available here.

The European Pharmaceutical Law Review (EPLR) reports on key legislative developments in the EU and the Member States, and identifies and analyses important judgments that shape the interpretation and application of EU pharmaceutical law, in particular those by the European Courts, international courts and tribunals such as the WTO’s Dispute Settlement Body, and higher national courts.

In order to establish itself as a forum for dialogue between different stakeholders in pharmaceutical regulation and governance, it will invite contributions from academics, practitioners, regulators and civil society representatives. Topics covered by EPLR include:

  • Pharmaceutical law and policy in all jurisdictions (regional, national, international);
  • Commission decisions (EMA opinions) and regulatory guidelines;
  • National EU, and International Jurisprudence;
  • Medical devices;
  • Borderline cases: pharmaceuticals/food/cosmetics/chemicals
  • Patents /Trademarks;
  • Health Technology Assessment and pricing/reimbursement;
  • Digital health/Big data;

All contributions will be subject to double blind peer-review before acceptance for publication and are required to conform to the author guidelines.

We are looking forward to receive and review the first submissions!

Best wishes/ Timo

Housing Equity Week in Review

Some interesting local-level developments in housing, equity and law last week. Here’s our round-up of the news from last week, February 6-12, 2017:

  • What would happen if we stopped thinking about our home as an investment? Conor Dougherty of the New York Times argues that if we treated houses like we treat microwaves, the economy will improve and inequality will reduce.
  • Cleveland shared its timeline for first citywide housing inspection for lead
  • New York City will devote $90 million to offer legal representation for low income tenants in housing courts. This is a big victory for the “civil Gideon” right-to-council movement, via Gothamist.
  • The US Treasury and the Tennessee Housing Development Agency come together to provide funds for first time homebuyers down payments in Nashville, via NextCity

Did we miss any big housing, law and equity stories this week? Let us know!

TODAY, 2/13 at 5 PM! Health Law Workshop with Brandon Maher

February 13, 2017 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Download the Presentation: “Unlocking Exchanges”

Brendan S. Maher is a Professor of Law and the Director of the independently endowed Insurance Law Center at UConn School of Law. A graduate of Stanford University and Harvard Law School, Maher is the faculty advisor for the peer-reviewed Connecticut Insurance Law Journal and a nationally recognized expert in the regulation of insurance, pensions, and health care. He is a leading authority on the meaning of both ERISA and the Affordable Care Act. Maher also teaches and studies the procedural and evidentiary aspects of civil litigation in federal courts.

Maher is an appointed member of the Connecticut Retirement Security Board, a board created by the state legislature to develop a comprehensive proposal for the implementation of a public retirement plan. He is also the co-moderator of Connecticut’s Forum on Healthcare Innovation, a forum for scholars, investors, providers, scientists, and regulators to share ideas on optimizing health outcomes. He was the chairman of the law school’s “The Affordable Care Act Turns Five” conference, where former United States Secretary of Health and Human Services Kathleen Sebelius was the keynote speaker.

Maher regularly appears before the United States Supreme Court to litigate cases involving employee benefits, preemption, and procedure. One of his cases, LaRue v. DeWolff, Boberg & Associates, was described by The New York Times as “one of the most important rulings in years on the meaning of the federal pension law known as ERISA.” He also studies and is routinely consulted by states, medical providers, and employee organizations as to the applicability of federal law to their activities.

Maher is licensed to practice in several state and federal courts, including the U.S. Supreme Court.

PhRMA, Marathon Is Why You Can’t Have Nice Things

Yesterday, the FDA approved a steroid, deflazacort, for the treatment of Duchenne Muscular Dystrophy (DMD).  DMD is a rare, heartbreaking, and ultimately fatal genetic disease with few if any real treatments, and the steroid may be helpful to patients.  Deflazacort’s sponsor, Marathon, has offered the drug at a list price of $89,000 per year.  High, but actually much lower than the typical prices charged for new orphan drugs, which can easily run to $300,000 or more per year.

Here’s the big problem: deflazacort isn’t really a new drug.  As the Wall Street Journal and Endpoints have pointed out, the drug is approved in many other countries, and its list price is about $1,000-$1,600 in Canada and the UK.  Patients have been importing the drug and accessing it since the 1990s.  Now, patients will pay many times those prices for the same product they had already been purchasing.

But the drug had not previously been approved in the United States, and surely Marathon conducted new clinical trials to demonstrate the drug’s benefit?  Not clearly.  Marathon mostly relied on clinical trial data from the 1990s that had not been fully analyzed.  In return, Marathon gets 1) a seven-year market exclusivity period for the drug (as required by the Orphan Drug Act) and 2) a valuable priority review voucher (as required by law for rare pediatric diseases).

This is not acceptable.  Full stop.  It is the worst sort of gaming that other companies have engaged in over the years.  And at a time when the drug industry is under fire for its high prices, PhRMA cannot afford to have its members (of which Marathon is one) acting this way.  If PhRMA and patient groups funded by pharmaceutical companies are serious about drug pricing, here are three things they should do/encourage right now:

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Watching Out for the Rights of the Uninsured

Special Guest Post by Professor Howell E. Jackson, Harvard Law School

As Republicans strive to unwind the Affordable Care Act (ACA), public commentary is quite naturally focusing on the number of Americans who might lose health insurance coverage. The Congressional Budget Office last month estimated that eleven million individuals could drop off of insurance rolls immediately, with millions and millions more to lose coverage within the next few years.  These numbers are indeed troubling, but the fate of the uninsured deserves similar attention.

For those critical of the ACA, uninsured individuals are sometimes characterized as victims of government overreach: penalized with a tax assessment for not complying with the individual mandate, and denied access to the kinds of lower-cost insurance policies that a less regulated insurance market might provide.  And there is some truth to this critique:  Mandatory coverage terms under the ACA do drive up premiums, and of the estimated 27 million Americans now without health insurance coverage, some eight million are paying ACA penalties, totaling on the order of $8 billion a year.  But under the ACA, the uninsured are getting something for those penalties.  In fact, they are getting quite a lot.

As policy analysts often note, the ACA prohibits insurance companies from denying coverage or charging higher premiums based on pre-existing conditions.  This protection is most often discussed in the context of individuals seeking to obtain insurance coverage in the first instance or after losing employer-provided coverage.  A less heralded, but equally important feature of this aspect of the ACA is that it allows healthy Americans the freedom to forgo insurance in the first instance and then purchase reasonably priced coverage when the need arises.  The policies available to uninsured individuals have the full protections of the ACA, including limits on out-of-pocket expenses, as well as prohibitions on annual or lifetime coverage limits and mandated terms of coverage.  In addition, premiums are constrained and, for many individuals and families, premium assistance and cost sharing support are available.   While many despair that a large and possibly growing share of Americans lack insurance coverage, at least the ACA ensures that the uninsured have the right to buy a good health insurance policy at a reasonable price when the need arises. Continue reading

Artificial Intelligence and Medical Liability (Part II)

Recently, I wrote about the rise of artificial intelligence in medical decision-making and its potential impacts on medical malpractice. I posited that, by decreasing the degree of discretion physicians exercise in diagnosis and treatment, medical algorithms could reduce the viability of negligence claims against health care providers.

It’s easy to see why artificial intelligence could impact the ways in which medical malpractice traditionally applies to physician decision-making, but it’s unclear who should be responsible when a patient is hurt by a medical decision made with an algorithm. Should the companies that create these algorithms be liable? They did, after all, produce the product that led to the patient’s injury. While intuitively appealing, traditional means of holding companies liable for their products may not fit the medical algorithm context very well.

Traditional products liability doctrine applies strict liability to most consumer products. If a can of soda explodes and injures someone, the company that produced it is liable, even if it didn’t do anything wrong in the manufacturing or distribution processes. Strict liability works well for most consumer products, but would likely prove too burdensome for medical algorithms. This is because medical algorithms are inherently imperfect. No matter how good the algorithm is — or how much better it is than a human physician — it will occasionally be wrong. Even the best algorithms will give rise to potentially substantial liability some percentage of the time under a strict liability regime.

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2/22: Michael Sandel & author Yuval Harari discuss new book Homo Deus

Register for this event

Harvard Book Store and welcomes the bestselling author of Sapiens Yuval Noah Harari for a discussion of his latest book, Homo Deus: A Brief History of Tomorrow. Harari will be joined in conversation by Harvard’s Michael Sandel, author of Justice: What’s the Right Thing to Do? and What Money Can’t Buy: The Moral Limits of Markets.

This event is open to the public, but tickets are required. Tickets are available online only via the Harvard Book Store. Ticket price of $34.75 includes a copy of the book. Purchase tickets now! Continue reading

Rebecca Dresser on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

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This week features Professor Rebecca Dresser of Washington University. She is the author of Silent Partners: Human Subjects and Research Ethics (Oxford University Press, 2016) and When Science Offers Salvation: Patient Advocacy and Research Ethics (Oxford University Press, 2001), along with many other insightful articles on bioethics and law. Our discussion focused on Silent Partners, including Rebecca’s work’s relevance to current debates on research ethics and informed consent.

Rebecca is a past member of the President’s Council on Bioethics and National Institutes of Health Recombinant DNA Advisory Board. She is a prolific speaker and panelist at national and international symposia, conferences, and workshops on such topics as bioethics and cancer; advance treatment directives; stem cell research; biomedical research policy; and human cloning.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Defeating Death (And Taxes)

“It is one of the most powerful tools our species has created. It helps doctors fight disease. It can predict global weather patterns. It improves education for children everywhere. And now, we unleash it…on your taxes.”

Super Bowl 2017 was an absolute cracker. My passport is not American and my accent is not Bostonian, but somewhere amidst the drama and the crowd and the cheesy nachos, I was drawn in and hooked. I roared and gasped and choked on cheap beer all the way to that nail-biting finish. Go Pats.

But, as it was my very first Super Bowl, I was told to keep an eye on the ads. Sure enough, they were hilarious, inspiring, maddening and perplexing by turn. One of them, however, hit me harder than Keanu Neal.

This ad, from H&R Block, announced that they will be using IBM’s Watson to deliver their services. Watson is, perhaps, the most impressive artificial intelligence that our species has yet produced. H&R Block is a consumer tax services provider.

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Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of January. The selections feature topics ranging from pharmacist-industry relationships, to returns from six-month market exclusivity extensions, to financial conflicts of interest among patient advocacy organizations. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Ahn R, Woodbridge A, Abraham A, Saba S, Korenstein D, Madden E, Boscardin WJ, Keyhani S. Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study. BMJ. 2017;356:i6770.
  2. Califf RM. Benefit-Risk Assessments at the US Food and Drug Administration: Finding the Balance. JAMA. 2017 Jan 20. [Epub ahead of print]
  3. Hakim A, Ross JS. High Prices for Drugs With Generic Alternatives: The Curious Case of Duexis. JAMA Intern Med. 2017 Jan 23. [Epub ahead of print]
  4. Kesselheim AS, Rome BN, Sarpatwari A, Avorn J. Six-Month Market Exclusivity Extensions To Promote Research Offer Substantial Returns For Many Drug Makers. Health Aff (Millwood). 2017 Jan 18. [Epub ahead of print]
  5. Kesselheim AS, Treasure CL, Joffe S. Biomarker-Defined Subsets of Common Diseases: Policy and Economic Implications of Orphan Drug Act Coverage. PLoS Med. 2017;14(1):e1002190.
  6. Rose SL, Highland J, Karafa MT, Joffe S. Patient Advocacy Organizations, Industry Funding, and Conflicts of Interest. JAMA Intern Med. 2017 Jan 17. [Epub ahead of print]
  7. Saavedra K, O’Connor B, Fugh-Berman A. Pharmacist-industry relationships. Int J Pharm Pract. 2017 Jan 18. [Epub ahead of print]

A New Day For Oversight Of Human Subjects Research

This new post by Holly F. Lynch 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.

On January 19, 2017—President Obama’s last day in office—the Federal Register published a Final Rule to amend the Federal Policy for the Protection of Human Subjects, the set of regulations applicable to most human subjects research conducted or supported with federal funds, and more typically referred to as the “Common Rule.” This rule change had been a long time coming, with an Advance Notice of Proposed Rule Making (ANPRM) published in July 2011 and a Notice of Proposed Rule Making (NPRM) published in September 2015. The seriousness of its impact on the research community, patients, and the public is evidenced by the more than 3,300 public comments submitted during the rulemaking process. So what changed?

First, it is important to understand where things stood. The Common Rule was initially adopted in 1991, with each relevant agency codifying the same set of regulations (the Department of Health and Human Service’s codification is found at 45 C.F.R. Part 46). The primary functions of the Common Rule are to require that research with human subjects be approved by an Institutional Review Board (IRB) and that subjects provide informed consent to research participation, with some important exceptions on each front. (FDA has similar, but not identical requirements, for clinical investigations, which are now likely to be harmonized with the new Common Rule.) […]

Continue reading here.

Housing Equity Week in Review

This week was all about fair housing. Particularly, the Affirmatively Further Fair Housing rule and recent attempts to dismantle it. Here’s the round-up for last week, January 29 – February 5, 2017:

We’ve talked a little about fair housing before. In case you missed it, we interviewed Christopher Bonastia about his book, “Knocking at the Door” back in November.

Did we miss any big housing, law and equity stories this week? Let us know!