Organs and Overdoses (Part II): ‘Higher risk’ donors

By Brad Segal

In my last post I characterized how overdoses from the surging opioid epidemic have become the fastest-growing cause of mortality among organ donors. In this update, I raise one potential consequence with ethical and policy implications: so-called donor-derived infections. To be clear, I focus primarily on organ recipients as deaths from drug overdose, and drug addiction more broadly, should be prevented regardless of any implications for transplantation. With this in mind, consider how the population of injection drug users shoulders a heavy burden of HIV, hepatitis B (HBV) and hepatitis C (HCV) (Table 1). First I will focus on screening guidelines, and then will move on to transplantation of organs known to carry an infection. table-1

Screening guidelines can help reduce the incidence of donor-derived infections, but the lab tests recommended in any policy must balance two potential concerns. First, lab tests have a rate of false negative results. Transplants of these organs will accidentally increase donor-derived infections. The policy question, then, is whether or not transplanting organs donated by individuals with higher risk of recent disease exposure will expose an unacceptable proportion of recipients to infection. This unintentional harm could undermine a duty of non-maleficence to organ recipients. Further complicating a potential screening policy is that the basic lab tests for HIV, HBV, and HCV detect the presence of human antibodies, which work well among a low-risk population, but antibodies might not appear in the blood until weeks after infection (Table 2).Recent infections are better detected by nucleic acid amplification (NAT) testing.To mitigate risk of infection,then, transplant screening policies should require a heightened level of surveillance among donors with a history of illicit drug use. Read More

Drug prices: Where do we go after the Election?

By Rachel Sachs, Washington University in St Louis
[Originally published on The Conversation]

Martin Shkreli. Valeant Pharmaceuticals. Mylan. These names have become big news, but just a year ago, most Americans devoted little time and attention to the question of pharmaceutical pricing. Now, a Kaiser Health Tracking Poll released Oct. 27 suggests many people care more about the increasing prices of drugs than they do about any other aspect of health care reform.

Nearly three in four, or 74 percent of respondents, said that making sure that high-cost drugs for chronic conditions are affordable for patients should be a top priority for the next president and Congress. And 63 percent similarly said that government action to lower prescription drug prices should be a top priority.

This poll comes on the heels of highly publicized scandals involving individuals and companies who hike the prices of products like the EpiPen, a life-saving anaphylaxis treatment whose price roughly quintupled in five years, to more than US$600, or Daraprim, a drug used to treat parasitic infections whose price increased by 5,000 percent overnight. Read More

Driven to Abstraction: The Implications of McRO for Diagnostic Patents

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Last month, the Court of Appeals for the Federal Circuit (“CAFC”) handed down their decision on the case of McRO, Inc. v. Bandai Namco Games Am. Inc (Fed. Cir. Sep. 13, 2016) (“McRO”). Commentators have already hailed the decision as providing significant clarity and guidance on subject-matter eligibility for patents under 35 U.S.C. §101 (“§101”) and on pre-emption. It has been lauded by Erich Andersen of Microsoft for providing key guidance for software developers. Others have remarked on the implications for those seeking patents on methods of medical diagnosis. Though not binding on the Supreme Court (and by no means a guarantee of the direction that Court might eventually take), I believe inventors in the medical arena can draw critical guidance on drafting patent claims from McRO. The decision might also signal a shift in attitude in the CAFC, towards a much more welcoming view of diagnostic patents.

In this post, I’ll briefly address the facts and decision in McRO. During that discussion, I believe a discussion of the facts and decision of last year’s CAFC case of Ariosa Diagnostics, Inc. v. Sequenom, Inc. 788 F.3d 1377 (Fed Cir. 2015) (“Sequenom”) will be illustrative. I’ll then briefly compare the two and discuss what the implications might be for biomedical patents moving forward.

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NEXT WEEK (11/1): The Challenge of Protecting the Public and Promoting Innovation – Dr. Robert Califf, Commissioner, US Food & Drug Administration

robert_califfThe Challenge of Protecting the Public and Promoting Innovation: Dr. Robert Califf, Commissioner, US Food & Drug Administration
Tuesday, November 1, 2016 4:00-5:30
Harvard Kennedy School
Malkin Penthouse, 4th Floor, Littauer Building
79 JFK Street, Cambridge, MA

Robert M. Califf, MD, is the Commissioner of the Food and Drug Administration. He is committed to strengthening programs and policies that enable the agency to carry out its mission to protect and promote the public health. The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation. Before joining the FDA in March 2015 as Deputy Commissioner for Medical Products and Tobacco, Dr. Califf ran the Duke Clinical Research Institute. He trained as a cardiologist.

Moderated by Amitabh Chandra, Malcolm Wiener Professor of Social Policy, Harvard Kennedy School

Sponsored by Harvard Kennedy School Healthcare Policy Program, Mossavar-Rahmani Center for Business and Government, Institute of Politics

Biosimilars – In The Pipeline or Still a Pipe Dream?

By Jonathan Larsen, JD, MPP and Adrienne R. Ghorashi, Esq.

The US Food and Drug Administration (FDA) approved the first biosimilar for use in the United States in March 2015. The approval came after several years of regulatory process development authorized by the Biologics Price Competition and Innovation (BPCI) Act of 2009, a component of the Affordable Care Act.

Biosimilars are highly similar, but not identical, copies of FDA-approved biologics, known as “reference” products. Biologics are used to treat a variety of diseases and medical conditions, including cancer. For many years, biosimilar development was thought to be too complex and too costly to advance, and exclusivity patents for reference biologics prohibited developers from marketing competing biosimilars. Now that those patents have started to expire, biosimilar development can finally begin, at a potentially huge benefit to patients.

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TOMORROW (10/27): Concurrent Surgeries – Medical, Legal, and Ethical Issues

concurrent_surgeriesConcurrent Surgeries – Medical, Legal, and Ethical Issues
October 27, 2016 12:00 PM
Pound Hall 101, Ballantine Classroom
Harvard Law School, 1563 Massachusetts Ave., Cambridge, MA

Concurrent, or overlapping, surgeries involve the simultaneous scheduling of substantial portions of two or more surgeries under the supervision of a single surgeon, requiring delegation of responsibility to trainees and assistants if necessary. The practice is not uncommon, especially at teaching hospitals, but patients often have no idea that their doctor may also be operating on someone else at the same time. This panel discussion will describe the practice, its risks and benefits, and recommended approaches to preserve patient trust and safety.

Panelists

  • Jonathan Saltzman, Reporter, The Boston Globe Spotlight Team (contributor to “Clash in the Name of Care”) – Setting the Stage: Key issues and concerns raised by concurrent surgeries, patient experiences and outcomes
  • Griffith R. Harsh IV, MD, MA, MBA, FACS, Professor of Neurosurgery and Associate Dean, Postgraduate Medical Education, Stanford University – Surgeon’s Perspective: Pros and cons of concurrent scheduling, pressures to schedule this way, potential impact on patients, and the recent statement by the American College of Surgeons
  • I. Glenn Cohen, JD, Professor, Harvard Law School; Faculty Director, Petrie-Flom Center – Legal and ethical perspectives: Institutional risk, medical malpractice, informed consent, and applicable regulations
  • Moderator: Robert Truog, MD, Frances Glessner Lee Professor of Medical Ethics, Anaesthesia, & Pediatrics and Director, Center for Bioethics, Harvard Medical School; Executive Director, Institute for Professionalism & Ethical Practice and Senior Associate in Critical Care Medicine, Boston Children’s Hospital

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

Improving the safety of maternity care in the National Health Service (NHS) and other medico-legal matters

By John Tingle

There are some very interesting Government patient safety and access to justice policy development activities currently going on in England.

Maternity Services

In maternity services, there is a clear recognition by Government that safety is inconsistent and that there is significant scope for improvement. Our still birth rates are amongst the highest in Europe despite the National Health Service (NHS) making advances in patient safety in this area. In the National Maternity Review we are reminded that half of the Care Quality Commission (CQC) inspections of maternity services result in safety assessments that are either ‘inadequate’ (7%) or ‘requires improvement (41%) (page 22). The CQC is the independent regulator of health and social care in England.

In a speech to the Royal College of Obstetricians and Gynaecologists (RCOG) in London, the Secretary of State for Health, 17th October, 2016, Jeremy Hunt laid out plans to make giving birth safer, including maternity safety funding and other related matters. The Government’s ambition is to halve neonatal death, stillbirth, maternal death and brain injuries caused during or shortly after labour by 2030 and a series of measures were  launched. There will be a £250,000 maternity safety innovation fund and a new national Maternity and Neonatal Health Quality Improvement Programme. New maternity ratings will also be published to help improve transparency, raise standards and will give families better information about the quality of local maternity services.

A safe space Read More

Scottish clinical guidelines on patients’ pressure ulcer care published

By John Tingle

Failures in assessing the patient properly for pressure ulcers can result in adverse incident reports, complaints and even litigation. A look at medical malpractice lawyer web sites in both the UK and USA will reveal a number of attorneys offering specialism in pressure sore litigation and publishing compensation awards. In the NHS poor pressure area care is a key patient safety issue and positive steps have been taken to reduce the occurrence of these incidents which can cause result in severe harm and even death to patients. The incidents also cost healthcare services a lot of money in remedying the problems of neglect.

The problem of poor pressure area care can also be seen in other countries. Health is a fairly generic concept, whilst the context of health care may well be different, valuable patient safety lessons can be learned from looking at the health quality reports of other countries. Developing an informed comparative patient safety perspective to issues can save both time and money by not reinventing the wheel.

There is new guidance from Scotland, Healthcare improvement Scotland (HIS) on the prevention and management of pressures ulcers which will be of interest to nurses and all those concerned with health quality and governance. Read More

Larry Singer on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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Subscribe to TWIHL here!

Our guest this week is Larry Singer, Professor of Law and Director of the Beazley Institute for Health Law and Policy at Loyola University Chicago.  Professor Singer is a nationally recognized expert on legal and strategic issues surrounding the organization of health care institutions. He has served as chair of a national health care system, and a board member of various charitable organizations. He has been inducted as a Fellow in the Institute of Medicine of Chicago.

For the lightning round, Nic covered a European decision on personally identifiable data, a Becker’s piece on MACRA agonistes, a critical take in JAMA on AI diagnostics, and an Indiana case concerning the chargemaster’s role in billing disputes. Frank addressed a Harvard Study on unaffordable cost sharing as a tool of discrimination, the trend toward polypharmacy, and counter-efforts to reduce excessive prescriptions. He also mentioned battles over pharmacist provider status and Medicaid’s equal access provision.

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Monday, 10/24, HLS Health Law Workshop with Lindsay Wiley

October 24, 2016 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Presentation: “Social Norms, Legal Foundations, and Noncommunicable Disease Prevention”

To request a copy of the paper in preparation for the workshop, please contact Jennifer Minnich at jminnich@law.harvard.edu.

Lindsay Wiley is Associate Professor of Law at the Washington College of Law at American University. She teaches torts, health law, and public health law. Her research focuses on access to health care and healthy living conditions in the U.S. and globally. She serves on the Board of Directors of the American Society for Law, Medicine, and Ethics and the National Conference of Lawyers and Scientists. Prior to joining the faculty at WCL, Professor Wiley was the Global Health Law Program Director at the O’Neill Institute for National and Global Health Law at Georgetown University. She had also previously worked at the Center for Law and the Public’s Health at the Johns Hopkins Bloomberg School of Public Health, the American Society for Law, Medicine, and Ethics, and Gordon, Feinblatt, Rothman LLC in Baltimore, MD. She received her AB and JD from Harvard, where she served on the Harvard Law Review, and her MPH from Johns Hopkins.