Fetal Consequentialism and Maternal Mortality

By Nadia N. Sawicki

It is well known that maternal mortality rates in the United States are higher than in other countries in the developed world, and that many of these deaths are preventable. But a report published by NPR last week, just a few days before Mother’s Day, drew a direct link between these poor maternal outcomes and health care providers’ focus on fetal health. The report quotes Barbara Levy, vice president for health policy and advocacy at the American Congress of Obstetricians and Gynecologists, who said, “We worry a lot about vulnerable little babies, [but] we don’t pay enough attention to those things that can be catastrophic for women.” According to the authors of the NPR report, “newborns in the slightest danger are whisked off to neonatal intensive care units … staffed by highly trained specialists prepared for the worst,” while new mothers are instead monitored by nurses and physicians “who expect things to be fine and are often unprepared when they aren’t.”

These patterns are consistent with what Prof. Jamie Abrams calls “fetal consequentialism” – the premise that the birth of a healthy child outweighs any harm to the birthing mother. The increase in U.S. maternal mortality rates highlighted in the NPR report is certainly a product of such fetal consequentialism. So is the practice of obstetric violence, described in my previous posts, where health care providers dismiss birthing mothers’ informed requests for minimal intervention during labor and delivery in an effort to reduce the risk of fetal harm, even when that risk is minimal. Fetal consequentialism is likely driven not only by providers’ judgments of the relative liability risks for harms to fetuses versus harms to mothers, but also by conservative societal trends (evidenced by increasing anti-abortion legislation) that preference fetal interests over maternal interests. Continue reading

A Quarter of the Work Force: International Medical Graduates and the Lives They Save

By Wendy S. Salkin

On Monday, May 1, 2017, International Workers’ Day, thousands took to the streets across the United States to demonstrate in support of immigrants’ rights in the United States and against immigration policies recently rolled out by President Trump.

Among the Presidential Actions taken by President Trump during his first hundred days in office has been the issuance of his “Buy American and Hire American” Executive Order, issued just two weeks ago on April 18, 2017, in which the President states that “[i]t shall be the policy of the executive branch to buy American and hire American.” What is meant by “hire American” is detailed in section 2(b) of the Executive Order:

Hire American. In order to create higher wages and employment rates for workers in the United States, and to protect their economic interests, it shall be the policy of the executive branch to rigorously enforce and administer the laws governing entry into the United States of workers from abroad, including section 212(a)(5) of the Immigration and Nationality Act (8 U.S.C. 1182(a)(5)).

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Birth Plans as Advance Directives

By Nadia N. Sawicki

There is growing public recognition that women’s autonomy rights during labor and delivery are being routinely violated. Though such violations rarely rise to the level of egregious obstetric violence I described in an earlier blog post, women recognize that hospital births, even for the most low-risk pregnancies, often involve cascades of medical interventions that lack evidence-based support and can have negative health consequences for both mother and child. Indeed, evidence suggests that an increasing number of women are pursuing options like midwife-assisted birth, delivery in free-standing birthing centers, and even home birth in an effort to avoid interventionist hospital practices. According to the 2013 Listening to Mothers Survey, nearly six in ten women agree that birth is a process that “should not be interfered with unless medically necessary.”

One tool that women frequently use to increase the likelihood that their autonomous choices will be respected during labor and delivery is the birth plan, a document that outlines a woman’s values and preferences with respect to the birthing process, and serves as a tool for facilitating communication with care providers. However, while most women view the creation of a birth plan as empowering, there is little evidence to suggest that the use of birth plans actually improves communication, increases women’s feelings of control, or affects the process or outcome of childbirth. In fact, there appears to be some resistance within the medical community to women’s reliance on birth plans, with one article describing “the two words ‘birth plan’ strik[ing] terror in the hearts of many perinatal nurses.”  Continue reading

TOMORROW: Critical Pathways to Improved Care for Serious Illness

Close up of helpful carer hand and happy old man

Friday, March 10, 10:30am – 2:30pm

Harvard Law School, Wasserstein Hall, Milstein East BC, 1585 Massachusetts Ave.

Join leading health care executives, experts, policymakers, and other thought leaders as they embark upon a project to develop a guiding framework for providing improved care for people with serious illness. You are invited to observe the inaugural working session where distinguished panelists will discuss innovations in program design and pathways for delivering high quality care to an aging population with chronic illnesses, especially those with declining function and complex care needs.

Check out the full agenda and list of roundtable participants on the website!

Attendees are welcome to participate in Q&A sessions, and lunch will be provided. Please RSVP for lunch here.

This project is funded by the Gordon & Betty Moore Foundation, and this convening is part of the Project on Advanced Care and Health Policy, a collaboration between the Coalition to Transform Advanced Care (C-TAC) and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. 

Drained Swamps and Quackery: Some Thoughts on Efficacy

By Seán Finan

“What makes drug development long and expensive is the need to prove, beyond statistical doubt, that your damn drug works”

Michael Gilman, Biotech Entrepreneur

2017 is going to be terrific. Tremendous, even. Things are going to change, big league.

7770160314_61e7536762_kThe new President has promised fantastic reforms to the drug industry. He’s going to get the big players in the pharmaceutical industry around a table and negotiate huge price reductions. Of course, he’s not going to touch their bottom line. If anything, he’s going to improve it. Innovation is being choked by over-regulation and he’s going remove burdensome FDA hurdles. But he has Executive Orders to give and walls to build, so he’s drafting in the very best people to help. We’re still waiting for those people to be officially named. Meanwhile, the media have had a month and a half of fun and speculation. The volume and variety of names being thrown around make it feel like a food fight at a Chinese buffet. One of those names is Peter Thiel.

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March 10: Critical Pathways to Improved Care for Serious Illness

Close up of helpful carer hand and happy old man

Friday, March 10, 10:30am – 2:30pm

Harvard Law School, Wasserstein Hall, Milstein East BC, 1585 Massachusetts Ave.

Join leading health care executives, experts, policymakers, and other thought leaders as they embark upon a project to develop a guiding framework for providing improved care for people with serious illness. You are invited to observe the inaugural working session where distinguished panelists will discuss innovations in program design and pathways for delivering high quality care to an aging population with chronic illnesses, especially those with declining function and complex care needs.

Check out the full agenda and list of roundtable participants on the website!

Attendees are welcome to participate in Q&A sessions, and lunch will be provided. Please RSVP for lunch here.

This project is funded by the Gordon & Betty Moore Foundation, and this convening is part of the Project on Advanced Care and Health Policy, a collaboration between the Coalition to Transform Advanced Care (C-TAC) and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. 

NHS patient care and treatment errors: developing a learning culture.

By John Tingle

PACAC, the House of Commons, (Public Administration and Constitutional Affairs Committee) has just published its analysis of the PHSO’s, (Parliamentary and Health Service Ombudsman ) second report into the tragic death of Sam Morrish, a three year old child whose death from sepsis was found to have been avoidable. PACAC  is composed of MP’s (Members of Parliament) and its remit includes considering matters relating to the quality and standards of administration provided by civil service departments which includes the Department of Health. PACAC also examines the reports of the PHSO.

The PACAC report is very thorough and detailed and really gets to grips with the issues surrounding NHS (National Health Service) health adverse incident investigation. It addresses very clearly the current challenges and opportunities in this area and puts forward some major concerns which need to be fully addressed by the NHS before it can be said to have a listening and learning culture. It is clear from reading the report that the NHS has a very long way to go before it can be said to be even close to reaching its listening and learning culture attainment goal.

The PACAC report also identifies what could be regarded as some muddled thinking by the Department of Health on the concept of the ‘safe space’ in NHS investigations and identifies some important patient safety policy gaps.

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Artificial Intelligence, Medical Malpractice, and the End of Defensive Medicine

By Shailin Thomas

Artificial intelligence and machine-learning algorithms are the centerpieces of many exciting technologies currently in development. From self-driving Teslas to in-home assistants such as Amazon’s Alexa or Google Home, AI is swiftly becoming the hot new focus of the tech industry. Even those outside Silicon Valley have taken notice — Harvard’s Berkman Klein Center and the MIT Media Lab are collaborating on a $27 million fund to ensure that AI develops in an ethical, socially responsible way. One area in which machine learning and artificial intelligence are poised to make a substantial impact is health care diagnosis and decision-making. As Nicholson Price notes in his piece Black Box Medicine, Medicine “already does and increasingly will use the combination of large-scale high-quality datasets with sophisticated predictive algorithms to identify and use implicit, complex connections between multiple patient characteristics.” These connections will allow doctors to increase the precision and accuracy of their diagnoses and decisions, identifying and treating illnesses better than ever before.

As it improves, the introduction of AI to medical diagnosis and decision-making has the potential to greatly reduce the number of medical errors and misdiagnoses — and allow diagnosis based on physiological relationships we don’t even know exist. As Price notes, “a large, rich dataset and machine learning techniques enable many predictions based on complex connections between patient characteristics and expected treatment results without explicitly identifying or understanding those connections.” However, by shifting pieces of the decision-making process to an algorithm, increased reliance on artificial intelligence and machine learning could complicate potential malpractice claims when doctors pursue improper treatment as the result of an algorithm error. In it’s simplest form, the medical malpractice regime in the United States is a professional tort system that holds physicians liable when the care they provide to patients deviates from accepted standards so much as to constitute negligence or recklessness. The system has evolved around the conception of the physician as the trusted expert, and presumes for the most part that the diagnosing or treating physician is entirely responsible for her decisions — and thus responsible if the care provided is negligent or reckless. Continue reading

Maybe For-Profit Hospitals Aren’t So Bad

By Shailin Thomas

For-profit hospitals have taken their fair share of flack over the years. Much maligned by many in the medical community, they are seen as money-hungry corporate machines that pervert the medical profession by putting the bottom line before patient care. This skepticism of profit-driven hospitals feels right. Medicine has long been the purview of charitable organizations and religious institutions. It’s supposed to be a calling — a public service to which practitioners are drawn — not a check to cash at the bank.

As for-profit hospitals proliferated, there was research done suggesting they had quality and cost issues stemming from their profit motives. For-profit hospitals had higher mortality rates, employed fewer trained professionals per bed, and were more expensive than their non-profit and government counterparts. Researchers speculated that this was the result of duties owned to shareholders by corporate leaders or compensation incentives for executives based on profitability rather than quality of care. These studies seemed to confirm what many thought they already knew: medicine and money don’t mix well.

More recent studies, however, suggest that for-profit hospitals may have turned over a new leaf. Since 2010, for-profit hospitals have out-performed non-profits in the “Top Performer” evaluation carried out by The Joint Commission — an organization that accredits hospitals in the US — with a higher percentage of for-profit hospitals qualifying for the honor than non-profits. A study published in JAMA from the Harvard T.H. Chan School of Public Health found that hospitals that converted from non-profit to for-profit improved their financial position by increasing their total margins and experienced no change in mortality rates.

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Missed opportunities to learn from patient deaths in the NHS

By John Tingle

The National Health Service (NHS) in England’s quality regulator, the Care Quality Commission (CQC) has recently published a highly critical report on the way patient deaths are investigated in the NHS. The investigation follows events at the Southern Health NHS Foundation Trust where a number of failings were identified in the way patient deaths were identified and investigated. Certain groups of patients including people with a learning disability and older people receiving mental health care were far less likely to have their deaths investigated by this Trust. The Secretary of State for Health called for a CQC investigation into how acute, community and mental health NHS facilities across the country investigate and learn from deaths. The findings of the report are not good and major improvements in this area are needed across the NHS.

There are failings in openness, transparency and missed opportunities to learn important patient safety lessons. Families of patients and carers told the CQC reviewers that they often have a poor experience of investigations and are not always treated with kindness, respect, honesty and sensitivity. The CQC states that across their review they were unable to identify any NHS healthcare facility that could demonstrate good practice across all aspects of identifying, reviewing and investigating deaths and ensuring that learning from the events is implemented. Continue reading

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

CMS Prohibits Arbitration Clauses in Long-Term Care Facility Contracts

By Wendy S. Salkin

On Wednesday, the Centers for Medicare and Medicaid (CMS)—an agency within the Department of Health and Human Services (HHS)—released a final rule that “will revise the requirements that Long-Term Care facilities [LTCs] must meet to participate in the Medicare and Medicaid programs” (1). (Almost all LTCs receive funds from Medicare or Medicaid.) This is the first time that these requirements have been “comprehensively reviewed and updated since 1991” (6)—that is, in the past 25 years. One of the most striking changes to the regulation is found in §483.65, where CMS “require[es] that facilities must not enter into an agreement for binding arbitration with a resident or their representative until after a dispute arises between the parties” (12) which means that CMS is “prohibiting the use of pre-dispute binding arbitration agreements” (12). Among the reasons provided by CMS for this change is a recognition of the notable power differential between LTCs and their residents:

There is a significant differential in bargaining power between LTC facility residents and LTC facilities. LTC agreements are often made when the would-be resident is physically and possibly mentally impaired, and is encountering such a facility for the first time. In many cases, geographic and financial restrictions severely limit the choices available to a LTC resident and his/her family. LTC facilities are also, in many cases, the resident’s residence. These facilities not only provide skilled nursing care, but also everything else a resident needs. Many of these residents may reside there for a prolonged period of time, some for the rest of their lives. Because of the wide array of services provided and the length of time the resident and his/her family may have interactions with the LTC facility, disputes over medical treatment, personal safety, treatment of residents, and quality of services provided are likely to occur. Given the unique circumstances of LTC facilities, we have concluded that it is unconscionable for LTC facilities to demand, as a condition of admission, that residents or their representatives sign a pre-dispute agreement for binding arbitration that covers any type of disputes between the parties for the duration of the resident’s entire stay, which could be for many years. (402-403)

As The New York Times reported, when the rule was first proposed in July 2015, it was “aimed at improving disclosure.” But, this final version of the rule “went a step further than the draft, cutting off funding to facilities that require arbitration clauses as a condition of admission.”

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Regulating the Statutory Duty of Candour

By John Tingle

Patients are very much the weaker party in the care equation. Doctors and nurses are always in a much more powerful position as they have the command of a discrete, specialised body of professional knowledge which the patient has not got and often urgently needs. To make the National Health Service (NHS) much more patient centered and to improve the quality of care we need to take account of this imbalance in the care equation which favours healthcarers. We can do this by explaining more carefully to patients about their treatment options and respecting their autonomy as individuals.

All organisations and those working in them need to be honest, open and truthful in all their dealings with patients and the public. A statutory duty of candour now exists in law in the NHS through regulations and is enforced by the Care Quality Commission (CQC), Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Regulation 20. The CQC can prosecute for a breach of parts 20(2) (a) and 20(3) of this regulation and can move directly to prosecution without first serving a Warning Notice. Additionally, CQC may also take other regulatory action.

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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

General Medical Practice: Complaint Handling Issues

By John Tingle

There is a new report from Health Service Ombudsman (HSO) on GP (General Medical Practitioner) complaint handling and major failings are revealed. The HSO makes the final decisions on complaints that have not been resolved in England and lies at the apex of the NHS complaints system. The report reveals that some GP practices are failing to handle patient complaints properly. The report is based on evidence from HSO casework files and intelligence gathered by the Care Quality Commission (CQC) , NHS England and Healthwatch England. One hundred and thirty-seven closed complaint cases from November 2014 – November 2015 were analysed. General medical practice forms 90% of all NHS interactions with the general public.The quality of complaint handling by GPs was found to be highly variable:

“…over half of the cases were either good (46%) or outstanding (9%). However, over a third required improvement (36%) and a tenth were inadequate (10%) (p7).”

The report states that there are five areas where general practice has the most scope for improvement: Continue reading

CPC+: Opportunities and Challenges for Primary Care Transformation

In recent days there has been a lot of action around CMS’ Comprehensive Primary Care Initiative (CPCI). First, the next phase of the program was announced, expanding the program in size and scope. Several days later, an evaluation of the first two years of the initiative was published in the New England Journal of Medicine.

The original CPCI demonstration began in October 2012 and included 502 practices in seven regions (states or smaller areas within states). The regions were determined largely by payer interest, as commercial and state health insurance plans are essential partners in this multi-payer model. The CPCI involves risk-stratified care management fees for participating practices and the possibility of sharing in net savings to Medicare (if any). In turn, the practices must invest in practice redesign around: access and continuity, chronic disease management, risk-stratified care management, patient and caregiver engagement, and care coordination across a patient’s providers, e.g., managing care transitions and ensuring close communication and collaboration.

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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

From Chance to Choice to Court

[Cross-posted from the Huffington Post Blog]

By Dov Fox

It used to be that whether you got the child you wanted — or one you hadn’t planned on — was left to cosmic fate or the randomness of reproductive biology. Now, new powers of reproductive medicine and technology promise to deliver us from the vagaries of the natural lottery.

The likes of voluntary sterilization and embryo screening give people who can afford them greater measures of control over procreation. Except, that is, when reproductive professionals make mistakes that frustrate efforts to pursue or avoid pregnancy or parenthood.

When, for example — just a few recent cases — a pharmacist fills a woman’s birth control prescription with prenatal vitamins. Or when a fertility clinic implants embryos carrying the hereditary disease that a couple underwent in vitro fertilization (IVF) to screen out. Just this week comes another report of losing IVF embryos.

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