Month: May 2017

When a Nurse Needs an Attorney: US Quarantine Policy

The Petrie-Flom Center Staff 1 Comment

We are pleased to present this symposium featuring commentary from participants in the “Between Complacency and Panic: Legal, Ethical and Policy Responses to Emerging Infectious Diseases” conference held on April 14, 2017, at Northeastern University School of Law. The conference was sponsored by the Center for Health Policy and Law and the American Society for Law, Medicine, and Ethics (ASLME), with support from The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Stay tuned for more posts!

By Kaci Hickox, MPH, MSN, RN

As new cases of Ebola in the Democratic Republic of Congo (DRC) are announced, I am reminded of the importance of applying lessons learned from U.S. quarantine policies during the 2014 West Africa Ebola outbreak. I watched the suffering of entire families and communities facing the largest Ebola outbreak in history. During my Ebola training in Brussels, I will never forget hearing an Ebola expert explain, “Remember to have compassion because this disease turns peoples’ loved ones into a biological hazard.” I remember the moment I understood Ebola with my heart, not merely my head, when a young woman admitted to the Doctors Without Borders/Médecins Sans Frontières (MSF) Ebola Treatment Unit in Bo, Sierra Leone, explained, “Nineteen of my family members have died of Ebola.”

Yet, in the midst of extreme fear and suffering, I also witnessed the profound courage of the staff responding to stop the outbreak. On my last day in the unit we had celebrated the discharge of 39 Ebola survivors. Offering isolation, testing, and treatment for persons who developed symptoms of Ebola was necessary to stop disease transmission and finally, after two years of response, the outbreak was declared over in December 2015! In this globalized world, we must be prepared to react not only to Ebola, but to any infectious disease threat with courage instead of fear, science instead of politics.

How do we ensure courageous responses to infectious disease threats? Read More

New Blog Symposium: Between Complacency and Panic – Legal, Ethical and Policy Responses to Emerging Infectious Diseases

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We are pleased to present this symposium featuring commentary from participants in the “Between Complacency and Panic: Legal, Ethical and Policy Responses to Emerging Infectious Diseases” conference held on April 14, 2017, at Northeastern University School of Law. The conference was sponsored by the Center for Health Policy and Law and the American Society for Law, Medicine, and Ethics (ASLME), with support from The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Stay tuned for more posts!

By Wendy E. Parmet and Jennifer L. Huer

Public health is often invisible. In contrast to health services, public health interventions usually operate behind the scenes, reducing risks to broad populations. No one can say who was saved, what deaths were prevented.

For public health, this invisibility presents political and budgetary challenges. Without clear beneficiaries, public health has lacked the political support and dollars allocated to health services. This challenge may be even more formidable today as the Trump Administration seeks enormous cuts to public health programs, while questioning settled public health science.

In the face of such challenges, it may be tempting for public health advocates to emphasize the dangers of emerging infectious diseases. Over the last forty years, a multitude of new or previously tamed infectious diseases such as HIV/AIDS, SARS, Ebola, and Zika have emerged, wrecking morbidity and mortality, and causing panic around the globe. During these outbreaks, public health’s importance becomes, at least briefly, all-too-apparent. Read More

Housing Equity Week in Review

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We’re back this week with more news from the field of housing law and equity. Here’s the  latest for the week of May 22-29, 2017:

  • The Atlantic ran an investigative piece on one of the largest lead crises in the history of the US – New Orleans in the 1990s.
  • The Mayor of Denver revealed an action plan of 30 short-term items to address housing affordability in the city using a holistic approach. The plan spans renter eviction assistance, employment opportunities, guidance for LIHTC, mental health counseling, and many more. Coverage via the Denver Post.
  • The New York Times’ Editorial Board confronts the proposed 15 percent cut to HUD’s budget, saying it “cuts the poor.”
  • Allowing land banks to be established is a legal lever to handle blight properties. However, having a land bank is not enough by itself. The experience of different cities can teach us plenty! NextCity covers the New York land banks.
  • There is an ongoing debate in Ohio about the state government’s role in lead poisoning prevention. After Cleveland announced a rental inspection program and Toledo passed a lead inspection ordinance, Ohio republicans are attempting to preempt local efforts to address the issue. Cleveland.com has the story.

The First Human Body Transplant – Ethical and Legal Considerations

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By Ana S. Iltis, PhD

brain_glowingprofileTo what lengths should we go to preserve human life? This is a question many are asking after hearing that three men plan to make medical history by conducting the first human head transplant. Or, rather, whole body transplant. Italian neurosurgeon Dr. Sergio Canavero and Chinese surgeon Dr. Xiaoping Ren plan to provide a Russian volunteer, Valery Spiridonov, a new body. During the procedure, Spiridonov’s body and head would be detached and, with the help of a crane, surgeons would move the head and attach it to the donor body.  But is this ethical? What role might law and regulation play in monitoring them or in assessing their conduct after the fact?

Critics call the plan crazy, unethical, and sure to fail. The likelihood of success is very low and the risk of Spiridinov dying is high. Spiridonov says that as soon as animal studies confirm the possibility of survival, the risks will be worth taking. He has Werdnig-Hoffmann Disease, a genetic disorder that destroys muscle and nerve cells. He is confined to a wheelchair and has lived longer than expected. Body transplantation offers him the best chance at a life worth living. Read More

Laura Katz Olson on ‘The Week in Health Law’ Podcast

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By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

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Our guest this week is Laura Katz Olson, Professor of Political Science at Lehigh University. Laura is the author of eight books, including The Politics of Medicaid and Elder Care Journey. Olson has published widely in the field of aging, health care and women’s studies, her articles addressing such topics as Medicaid, Medicare, long-term care of the elderly, pensions, Social Security and problems experienced by older women. She has been a Scholar at the Social Security Administration, a Gerontological Fellow and a Fulbright Scholar. She is also on the editorial board of the Journal of Aging Studies and New Political Science.

Our conversation first focused on recent developments in federal health policy, including slashing cuts to Medicaid in proposed budgets. We then discussed Elder Care Journey, an insightful mix of Laura’s personal experience seeking long term care for her mother, and her connection of that experience to failures in US policy on aging. The personal is indeed political, and Laura connects negative experiences ranging from quotidian frustration to alarming neglect, to a set of health laws and policies that fails to offer adequate support to dementia patients and their caregivers.

Read More

Patient Safety in the NHS: The Culture Change Agents

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By John Tingle and Jen Minford 

It is important to take a broad holistic approach when looking at patient safety policy development and practice in the NHS. There cannot be a one size fits all approach and a number of possibly quite disparate organisations and stakeholders in the NHS and beyond must be consulted and involved so that effective and positive culture change takes place.

The  CQC (Care Quality Commission) is a major patient safety culture change agent whose job is to ensure that health and social care services provide people with safe, effective, compassionate and high-quality care. The CQC encourages care service providers to be on an upward trajectory of improvement. They have recently produced a report to analyse what impact they have on quality and improvement in health and social care. The report provides evidence that the CQC is having a significantly positive impact  on regulating care and ensuring good standards.

A majority of new providers and registered managers responding to a CQC survey said that their guidance and standards are clear. The CQC approach to regulation and their standards have an influence on how some providers measure their own quality. CQC inspection reports were also said to be useful. Read More

Factory farming, human health, and the new WHO Director General

Nir Eyal 1 Comment

By Nir Eyal

Last week, over 200 experts called on the next Director General of the World Health Organization to prioritize factory farming in an open letter. Announced in articles in the New York Times and The Lancet, the letter argues that factory farming is a major barrier to better global health. The letter does not make this argument on animal rights grounds – although this argument is certainly strong – but instead focuses on factory farming’s contribution to antibiotic resistance, climate change, and the rise of chronic diseases. These three issues formed the core of the last Director General’s agenda, although limited attention was paid to factory farming, which the authors argue, “connects the dots among them.”

One of the authors is Scott Weathers, a Global Health and Population MSc student at the Harvard T.H. Chan SPH. The other is Sophie Hermans, a doctoral student from Cambridge U. Their letter received overwhelming response. On twitter, their announcement of the letter was the #1 trending tweet on all relevant hashtags for the recent World Health Assembly.

Congratulations, Scott and Sophie!

(I am among the letter signatories.)

Contracting to counter gene patents – a 21st Century solution to access and innovation

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By Sarah Ali-Khan and E. Richard Gold

As Precision Medicine becomes a reality, molecular tests are an increasingly critical part of patient care. While patients and their physicians would like to maximize access, they have confronted a roadblock in the form of patents covering genes and methods of diagnosis. Many hoped that the landmark 2013 Supreme Court of the United States decision in Myriad v AMP spelled the end of these patents, but the number of gene patents has actually increased since that decision. This is because, while limiting the availability of patents over genomic DNA, the court decision was narrow, leaving substantial grey zones such as over cDNA or where the patent covers a sequence of DNA used in a particular way. Patent agents have been assiduous in exploiting these grey zones to file for and obtain patents over molecular tests. This development points to continued adverse consequences of gene patents not only in the US, but around the world. Our recently published GIM article ‘Gene patents still alive and kicking: their impact on provision of genetic testing for Long QT syndrome in the Canadian public health-care system’, not only examines the impact of gene patents in one country, Canada, but shows how 21st Century contracting can provide a nuanced and pragmatic means to enabling both access and innovation around patented genetic tests.

In Nov 2014, in the first Canadian instance of a public interest ‘test case’ in intellectual property and public health, The Children’s Hospital of Eastern Ontario (CHEO) challenged five patents held by Transgenomic Inc. over a genetic test for Long QT Syndrome (LQTS), a potentially fatal cardiac disorder most commonly striking in children and youth. Widely reported, settled in March 2016, and named as one of the year’s cases having the most impact on intellectual property, the case produced the CHEO Public Health Access Agreement. The Agreement does not itself alter law– gene patents remain valid in Canada. Rather, it constitutes a contractual agreement between parties to the litigation, allowing for efficient, no-cost test implementation. The Agreement explicitly states that Transgenomic will freely grant a license to test the LQTS-associated genes to any entity providing services within Canada’s public healthcare system. That is, except for a marginal private market, all LQTS in Canada can now be provided free. Read More

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

Ameet Sarpatwari 1 Comment

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 April. The selections feature topics ranging from the effect of a shortage of baclle Calmette-Guérin (BCG) on treatment costs for bladder cancer, to a comparison of regulatory review of new therapeutic agents by the FDA and the EMA, to the impact of CVS pharmacy’s discontinuance of tobacco sales on cigarette purchasing. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Davies BJ, Hwang TJ, Kesselheim AS. Ensuring Access to Injectable Generic Drugs – The Case of Intravesical BCG for Bladder Cancer. N Engl J Med. 2017;376(15):1401-3.
  2. Downing NS, Zhang AD, Ross JS. Regulatory Review of New Therapeutic Agents – FDA versus EMA, 2011-2015. N Engl J Med. 2017;376(14):1386-7.
  3. Fralick M, Kesselheim AS. FDA Approval of Desmopressin for Nocturia. JAMA. 2017 Apr 6. [Epub ahead of print]
  4. Gyawali B, Prasad V. Drugs that Lack Single-Agent Activity: Are They Worth Pursuing in Combination? Nat Rev Clin Oncol. 2017;14(4):193-4.
  5. Polinski JM, Howell B, Gagnon MA, Kymes SM, Brennan TA, Shrank WH. Impact of CVS Pharmacy’s Discontinuance of Tobacco Sales on Cigarette Purchasing (2012-2014). Am J Public Health. 2017;107(4):556-62.
  6. Sharfstein J. Déjà Vu at the FDA. Milbank Q. 2017 Apr 4. [Epub ahead of print]

Is it legal for Trump to punish health insurers that do not support repeal of Obamacare?

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By Christopher Robertson

In a recent story about how the health insurance marketplaces are being destabilized by the Trump administration’s vacillation, the LA Times reports:

At one recent meeting, Seema Verma, whom Trump picked to oversee the federal Medicare and Medicaid programs, stunned insurance industry officials by suggesting a bargain: The administration would fund the CSRs if insurers supported the House Republican bill to repeal the Affordable Care Act.

For what its worth, the Trump administration denied that she had done so.  But if she did, is that legal?  Can politicians actually offer to give money from the Federal Treasury to companies in exchange for their political support (or withhold it for lack of that support)?  If Ms. Verma was corruptly offering a “quid pro quo” exchange (as TalkingPointsMemo says), that would fit the statutory definition of the crime of bribery, as I discuss in a 2016 paper, The Appearance and Reality of Quid Pro Quo Corruption. However, this case also implicates the First Amendment rights of the insurance companies to support or oppose the Obamacare repeal. Read More