New twist in debate over resident duty hours (Part I)

By Brad Segal

Amidst a roller-coaster presidential campaign, on November 4th the Accreditation Council for Graduate Medical Education (ACGME) presented a plan to change resident duty hour limits. That the specifics have largely flown under the radar is perhaps unsurprising given the current news cycle. But the understated revision to, “Resident Duty Hours in The Learning and Working Environment” is the latest twist in a relatively contentious issue within medical education (see 2016 NEJM op-ed vs. responses). The proposal is currently undergoing requisite comment period until December 19. This week I’ll briefly lay out the history of duty hours to help explain the significance of ACGME’s proposal, and I will then go through general empirical arguments for and against such a change. My next post will examine how well these argument hold in light of the most recent data available.

Today the physicians’ training experience immediately following medical school is no longer the whir of dangerous sleep deprivation lampooned in the House of God. Amid mounting evidence that resident sleep deprivation caused medical errors, and under threat of federal legislation, in 2003 the ACGME first introduced national guidelines restricting resident work hours to 80 hours per week (averaged over 4 weeks), and capped residents to 30 hours of continuous in-house call. Then in 2009 the Institute of Medicine (IOM) released a 427-page report reviewing scientific evidence on resident work hours, sleep deprivation, and fatigue-related errors. The evidence overwhelmingly suggests that sleep deprivation significantly impairs most aspects of cognition. Hence the IOM ultimately recommended that residents not exceed 16 hours of continuous work before dedicated rest.

The ACGME subsequently modified duty hour guidelines in 2011 and limited first-year residents (‘interns’) to working 16-hour stretches. The reason ACGME’s most recent proposal is curious, though, is that it back-tracks on the 2011 intern duty-hour limits, raising their in-house cap to 28 hours. In response to this proposal a national advocacy group, Public Citizen, claimed it, “would expose residents, their patients and the general public to the risk of serious injury and death.” Continue reading

Premature baby left to die alone in sluice room, report reveals: A looming patient safety crisis in the NHS?

By John Tingle

BBC News reported, 24/11/2016 on the Pennine Acute Hospitals NHS Trust review of its Royal Oldham and North Manchester General hospitals which identified several ‘unacceptable situations’. The BBC news item states that the review document

“…described how a premature baby had arrived “just before the legal age of viability” – at 22 weeks and six days – but staff did not find “a quiet place” for the child’s mother “to nurse her as she died and instead placed her in a Moses basket and left her in the sluice room to die alone”.

The report goes on to catalogue a number of other shocking events that occurred. Continue reading

NEW REPORT: Protecting and Promoting the Health of NFL Players – Legal and Ethical Analysis and Recommendations

fphs_lawethics_coverThe Football Players Health Study at Harvard University today released a set of legal and ethical recommendations to address a series of structural factors that affect NFL player health. The Football Players Health Study is a research initiative composed of several ongoing studies examining the health and wellbeing of NFL players.

The newly released report, nearly 500 pages long, is based on analysis performed over two years by researchers from the Petrie-Flom Center at Harvard Law School, and is unprecedented both in scope and focus. (Read the executive summary).

This is the first comprehensive analysis of the legal and ethical obligations of various stakeholders that influence the health of NFL players. While clinical interventions are essential, players’ health is also affected by the environment in which players work.

The report reviews and evaluates the roles of 20 relevant stakeholders, including the NFL, NFL Players Association (NFLPA), players, and Club (team) doctors.  In total, the report makes 76 recommendations.

Highlights of the key proposals are summarized below: Continue reading

CALL FOR ABSTRACTS, DUE 12/2! 2017 Annual Conference, “Transparency in Health and Health Care: Legal and Ethical Possibilities and Limits”

Medical care prices against a white background

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2017 annual conference, entitled: Transparency in Health and Health Care: Legal and Ethical Possibilities and Limits.

Transparency is a relatively new concept to the world of health and health care, considering that just a few short decades ago we were still in the throes of a “doctor-knows-best” model. Today, however, transparency is found on almost every short list of solutions to a variety of health policy problems, ranging from conflicts of interest to rising drug costs to promoting efficient use of health care resources, and more. Doctors are now expected to be transparent about patient diagnoses and treatment options, hospitals are expected to be transparent about error rates, insurers about policy limitations, companies about prices, researchers about data, and policymakers about priorities and rationales for health policy intervention. But a number of important legal and ethical questions remain. For example, what exactly does transparency mean in the context of health, who has a responsibility to be transparent and to whom, what legal mechanisms are there to promote transparency, and what legal protections are needed for things like privacy, intellectual property, and the like?  More specifically, when can transparency improve health and health care, and when is it likely to be nothing more than platitude?

This conference, and anticipated edited volume, will aim to: (1) identify the various thematic roles transparency has been called on to play in American health policy, and why it has emerged in these spaces; (2) understand when, where, how, and why transparency may be a useful policy tool in relation to health and health care, what it can realistically be expected to achieve, and when it is unlikely to be successful, including limits on how patients and consumers utilize information even when we have transparency; (3) assess the legal and ethical issues raised by transparency in health and health care, including obstacles and opportunities; (4) learn from comparative examples of transparency, both in other sectors and outside the United States.  In sum, we hope to reach better understandings of this health policy buzzword so that transparency can be utilized as a solution to pressing health policy issues where appropriate, while recognizing its true limitations.

Call for Abstracts

We welcome submissions on both the broad conceptual questions described above and more specific policy issues, including: Continue reading

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. Continue reading

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 Continue reading

Medical Errors – The Third Leading Cause of Death in the US

Source: http://www.lawbbg.com/images/top-banner/medical-malpractice.jpgBy Matthew Young

John James, PhD, became involved in the movement to bring greater attention to patient safety and rampant medical errors by way of tragedy. In 2002, Dr. James lost his 19-year-old son as a result of problematic care provided by cardiologists at a hospital in central Texas. A toxicologist by training, Dr. James taught himself cardiology in order to piece together the events that led to the death of his son despite an extensive evaluation by a team of cardiologists. His journey is chronicled in his book, “A Sea of Broken Hearts: Patient Rights in a Dangerous, Profit-Driven Health Care System.” From there, Dr. James became an advocate for patient safety and a crusader against medical errors. His website is called Patient Safety America.

Major media outlets around the globe extensively covered the recent British Medical Journal article showing that medical errors are the third leading cause of death in the US.  In 2013, Dr. James published a related paper in the Journal of Patient Safety that showed how nearly 440,000 lives per year are lost to medical errors in the American healthcare system.

I wanted to provide Bill of Health readers with a summary of how Dr. James’s paper in many ways pre-saged and perhaps even exceeds the recent BMJ article. A KevinMD article provides further context in this debate.

Continue reading

Medical Malpractice Under a National Health System and the ACA

By Matthew H. H. Young

What will happen to the current medical malpractice system under a single-payer system?

To answer this question, I started by looking at the information provided by Physicians for a National Health Program, whose mission is to replace the ACA (Affordable Care Act) with single-payer. On their website under Single-Payer FAQs, it says:

What will happen to malpractice costs under national health insurance?

They will fall dramatically, for several reasons. First, about one-fourth of all malpractice awards go to pay present and future medical costs (e.g. for infants born with serious disabilities). Single payer national health insurance will eliminate the need for these awards. Second, many claims arise from a lack of communication between doctor and patient (e.g. in the Emergency Department). Miscommunication/mistakes are heightened under the present system because physicians don’t have continuity with their patients (to know their prior medical history, establish therapeutic trust, etc) and patients aren’t allowed to choose and keep the doctors and other caregivers they know and trust (due to insurance arrangements). Single payer improves quality in many ways, but in particular by facilitating long-term, continuous relationships with caregivers. For details on how single payer can improve the quality of health care, see “A Better Quality Alternative: Single Payer National Health Insurance.” For these and other reasons, malpractice costs in three nations with single payer are much lower than in the United States, and we would expect them to fall dramatically here. For details, see “Medical Liability in Three Single-Payer Countries” paper by Clara Felice and Litsa Lambkros.

Let me address the most salient part of the above argument, which states that the significant burden of malpractice recoveries composed of future medical costs will be alleviated because all individuals will be insured. Continue reading

Legal Dimensions of Big Data in the Health and Life Sciences

Please find below my welcome speech at last-weeks mini-symposium on “Legal dimensions of Big Data in the Health and Life Sciences From Intellectual Property Rights and Global Pandemics to Privacy and Ethics at the University of Copenhagen (UCPH).  The event was organized by our Global Genes –Local Concerns project, with support from the UCPH Excellence Programme for Interdisciplinary Research.

The symposium, which was inspired by the wonderful recent  PFC & Berkman Center Big Data conference,  featured enlightening speeches by former PFC fellows Nicholson Price on incentives for the development of black box personalized medicine and Jeff Skopek on privacy issues. In addition we were lucky to have Peter Yu speaking on “Big Data, Intellectual Property and Global Pandemics” and Michael J. Madison on Big Data and Commons Challenges”. The presentations and recordings of the session will soon be made available on our Center’s webpage.

Thanks everybody for your dedication, inspiration, great presentations and an exciting panel discussion.

“Legal Dimensions of Big Data in the Health and Life Sciences – From Intellectual Property Rights and Global Pandemics to Privacy and Ethics”

Continue reading

Healthcare complaints matter: the need to improve the system

Today consumerism is an essential part of the fabric of British society and complaint systems are heralded in many retail and professional environments. The British public have got used to complaining over the years and this attitude has seeped into the provision of health care services.

Records levels of complaints about the National Health Service (NHS) can be seen to be made every year but the NHS just does not seem to be able to get to grips with developing a good patient complaints handling system.

The Health Service Ombudsman (HSO) lies at the top of the NHS complaints structure and makes the final decisions on complaints that have not be resolved by the NHS in England. The HSO has looked into the quality of NHS complaint investigations where serious or avoidable harm has been alleged.Systemic failings in complaint, patient safety investigations were revealed. Failures which unsurprisingly have appeared in numerous complaints reports over the years before.

For the report, the HSO reviewed 150 NHS complaint investigations where avoidable harm or death was alleged. The HSO also spoke to six different trusts and surveyed over 170 NHS complaint managers to gain insights. An advisory group was later convened by the HSO to test findings.

Continue reading

Proposed CMS Sanctions Threaten Theranos’ Future

By Katherine Kwong

The news for blood testing company Theranos has gotten even worse since this blog’s last discussion of the company’s woes. Despite the company’s statements at the end of March that it would correct all of the issues CMS had found, new reports have emerged that Theranos’ California lab may see its federal license revoked. Additionally, Theranos’ founder, Elizabeth Holmes, and Theranos’ president, Sunny Balwani, may be banned from owning or operating any testing laboratories for two years. These potential sanctions have been proposed after regulators concluded Theranos has failed to adequately address concerns raised about its tests by the Centers for Medicare and Medicaid Services (CMS).

How did Theranos get to this point? Continue reading

The Curious Case Of The Docs Versus The Glocks: Firearms, The First Amendment, And Physician Speech

This new post by Wendy Parmet appears on the Health Affairs Blog as part of a series stemming from the Fourth Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 29, 2016.

On February 3, 2016 the full U.S. Court of Appeals for the 11th Circuit agreed to rehear the appeal inWollschlaeger v. Florida, commonly known as the case of the “docs versus the glocks.” Wollschlaegerconcerns a Florida law that bars physicians from routinely asking their patients whether they have guns or store them safely. In agreeing to rehear the appeal, the full court vacated a decision issued last December by a three-judge panel which had replaced two of its own prior opinions. Each of the panel’s three decisions upheld the law, and each raised serious questions about the ability of health professionals to provide their patients with relevant health information.

Public health professionals have long viewed gun safety as a major public health problem. Likewise, many physicians believe that good primary care includes questioning and counseling patients, especially those with children, about firearm safety, just as they talk to patients about seatbelts, cigarettes, and the need to exercise. […]

Read the full post here.

Patient safety perspectives from other countries: introducing the WHO Geneva safe childbirth checklist

By John Tingle

Healthcare providers and policy makers can avoid the expense of reinventing the wheel if they try and look beyond their shores for solutions to patient safety problems. In the UK the work of the patient safety unit of WHO in Geneva helps NHS healthcare providers through the development of patient safety tools and other projects. The  WHO multi-professional patient safety curriculum guide is one example. The learning from error – video and booklet is another. Recently launched by WHO is the Safe Childbirth checklist and guide to implementation.

The Checklist will be a useful patient safety tool in developing, transitioning and developed countries. The scale of the problem is very disturbing. WHO calculate that in 2013, 289,000 women died during and following pregnancy and childbirth, and 2.8 million new-borns died within 28 days of birth. Most of these events could have been prevented and mostly occurred in low resource settings. Women and their babies are being very conspicuously failed by health systems which should be helping them. Continue reading

Minnesota: Leading The Way In Patient Safety

By John Tingle

The UK Government and the Department of Health are taking patient safety very seriously and, since the publication of ‘An organisation with a memory’ in 2000, the UK has like the USA been a world leader in the field of patient safety policies, practices and developments.

In the UK we have a very sophisticated patient NHS (National Health Service) patient safety infrastructure and system along with a NHS Adverse incident reporting system, the NRLS (National Reporting and Learning System). Despite having such a ‘Rolls Royce’, well-established patient safety infrastructure and system, terrible patient safety incidents such as that which happened in Mid Staffordshire a few years ago seem to plague the NHS. Patients died because of poor care and, according to the report, “[t]he Inquiry identifies a story of terrible and unnecessary suffering of hundreds of people who were failed by a system which ignored the warning signs of poor care and put corporate self-interest and cost control ahead of patients and their safety.”Our patient system missed the terrible care failings identified in this inquiry report. We are working hard on improving the system and my posts will provide regular updates on what is happening in the UK, Europe and beyond in patient safety.

Patient Safety: A World Problem Continue reading

Women, Girls, and Mass Incarceration: A Hidden Problem

Goodwin-Headshot11Mass incarceration’s invisible casualties are women and children.  Too often, they are the forgotten in a tragic American tale that distinguishes the United States from all peer nations.  Simply put, the U.S. incarcerates more of its population than anywhere else in the world–and by staggering contrast.  While the U.S. locks away over 700 men and women for every 100,000, here are comparable figures from our peer nations:  England (153 in 100,000), France (96 in 100,000), Germany (85 in 100,000), Italy (111 in 100,000), and Spain (159, in 100,000).  The U.S. accounts for less than 5% of the globes population, yet locks away nearly 25%.  Sadly, this has grave social, medical, psychological, and economic consequences.

Congressional Briefing on Women, Girls, and Mass Incarceration

In a recent essay, published in the Texas Law Review, I explained that, the population of women in prison grew by 832% in the period between 1977-2007—nearly twice the rate as men during that same period. More conservative estimates suggest that the rate of incarceration of women grew by over 750% during the past three decades. This staggering increase now results in more than one million incarcerated in prison, jail, or tethered to the criminal justice system as a parolee or probationer in the U.S. The Bureau of Justice Statistics underscores the problem, explaining in a “Special Report” that “[s]ince 1991, the number of children with a mother in prison has more than doubled, up 131%,” while “[t]he number of children with a father in prison has grown [only] by 77%.” Continue reading

Why Senator Markey’s Message Hurts Children

Last week, Senator Edward Markey (D-MA) placed a hold on the Senate’s nomination of Robert Califf’s as head of the Food and Drug Administration (FDA). The move was less against Califf and more as political leverage against FDA’s approval of OxyContin. In August 2015, FDA approved OxyContin, a prescription painkiller, for pediatric patients ages 11 to 17. OxyContin is the painkiller most associated with United State’s prescription drug abuse epidemic, accounting for an increase in drug overdose and death over the last decade. FDA’s approval of OxyContin for children drew concern from Markey and others that the approval would lead to an increase in drug misuse for children and their family members. Markey, who has prioritized the fight against opioid addiction in his legislative agenda, hopes he can use the hold to convince FDA to reverse its August decision.

Senator Markey’s message is well intentioned, but may ultimately do more harm than good for children.

Before FDA approved OxyContin in August, children who suffered from severe, chronic pain due to cancer, extensive trauma, or serious surgeries had few drugs approved to treat their pain. Many physicians treating severe pain in children prescribed OxyContin off-label, without proof that OxyContin could safely and effectively treat children. These physicians often relied on their experience or intuition to not under or overprescribe the drug. FDA’s approval in August meant the pharmaceutical manufacturer finally provided physicians with instructions, backed by controlled studies, explaining how physicians could safely use OxyContin to treat children with severe pain. Continue reading

Breaking News: NAM Releases Report on Mitochondrial Replacement Therapy (Part II My First Take)

By I. Glenn Cohen

My last post was a summary of the NAM’s Recommendations on Mitochondrial Replacement Therapy (MRT). Now here is my take on the report. But keep in mind the report was just released and all I could give it was a quick read, so these are really more like initial impressions: Continue reading

Fixing the Broken Law of Military Medical Malpractice for Birth-Related Injuries

Bill of Health bloggers Alex Stein and Dov Fox have just filed an amicus brief urging the Supreme Court to hear the case of U.S. Air Force Major Heather Ortiz and her baby, who were denied legal remedies for obstetric malpractice by military doctors that left the baby with severe brain damage. The case is No. 15-488 Ortiz v. U.S. ex rel. Evans Army Community Hospital. Professors Fox and Stein urge the Court to overturn the Tenth Circuit’s holding that the federal government’s immunity against liability for intramilitary torts extends to wrongful injuries like those sustained by Major Ortiz’s baby. They argue that this holding misinterprets the immunity, misapplies the Federal Tort Claims Act (FTCA), and constitutes no less than unconstitutional sex discrimination. Fox and Stein explain:

When a civilian spouse of a serviceman receives negligent prenatal care from military doctors and delivers an injured baby as a result of that malpractice, there is no question that Feres immunity does not apply and that the baby can sue the United States under the FTCA. When military medical malpractice injures the baby of a servicewoman, this baby should be equally able to obtain redress under the FTCA.  A system that would single out the civilian children of servicewomen for adverse treatment discriminates against women who serve in the armed forces. . . To interpret the FTCA as the Tenth Circuit did permits discrimination between these two classes of similarly situated victims of military malpractice and violates fundamental principles of equal protection.

To download this brief, click here.

Does FDA Need a Dietary Supplement User Fee Act?

By Elizabeth Guo

Dietary supplements are dominating headlines these days – and not in a good way. Last Wednesday, Nevada officials found basketball star Lamar Odom unconscious at a brothel after taking cocaine along with ten pills of Reload, a sexual enhancement dietary supplement. That same week, the New England Journal of Medicine released an article finding that dietary supplements lead to roughly 23,000 emergency visits a year. Following these events, some officials have called on the Food and Drug Administration (FDA) to take a stronger role in regulating the dietary supplement industry.

Dietary supplements have had a long and storied past. As early as 1973, FDA tried to regulate dietary supplements regarding vitamin and mineral potency. The dietary supplement industry responded by challenging FDA in court, and Congress subsequently enacted the Proxmire Amendment, limiting FDA’s authority to regulate dietary supplements. However, by the 1990s, as consumers increasingly began to rely on dietary supplements, Congress passed the Dietary Supplement Health and Education Act of 1994, expanding FDA’s authority to regulate supplements by enacting special rules related to dietary supplement labeling and manufacturing.

Currently, FDA regulates dietary supplements as a special category of foods. Unlike manufacturers of over-the-counter drugs, dietary supplement manufacturers do not need to be registered with FDA and do not need list possible adverse events on supplement labeling. As Joanna Sax points out, this is a major problem because not all dietary supplements are the same. For example, certain weight loss or sexual enhancement supplements often contain chemicals associated with potentially serious side effects while other supplements containing chemicals such as Vitamin C pose less serious safety concerns.

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Reproductive Malpractice and the U.S. Military

Check out the new op-ed at HuffPo by Bill of Health bloggers Dov Fox and Alex Stein on the unfair treatment of American servicewomen (and their children) under the Feres doctrine should they fall victim to medical malpractice during their pregnancy or delivery. Fox and Stein call for SCOTUS to fix the loophole it left open in the 1950 case, or for Congress to “set up a fund for compensating children whose disabilities were caused by substandard care at military medical facilities.”  Take a look at the full post here.