An Analysis of Five Years of Cerebral Palsy Claims in the UK

By John Tingle

NHS Resolution, an arm’s length body of the Department of Health that manages clinical negligence and other claims brought against the NHS in England, have just published a report on cerebral palsy legal claims. These claims are complex and result in large awards of compensation. In 2016-17, whilst the obstetrics specialty accounted for only 10% of the 10,686 claims received, they represented 50% of the £4,370 Million value of claims received.

Once case may cost £20 Million or more for one child. The report shows that the same errors are often being repeated and that key patient safety lessons go unlearned. The report analyses the data held by NHS Resolution on its claims management system on compensation claims for cerebral palsy that occurred between 2012-2016.There were 50 claims between this period that were suitable for review with a potential financial liability greater than £390 Million. This figure excludes the costs of defending the claim and the wider cost impact on the NHS as a whole. The results of the report are split into two parts. Part one looks at the quality of the serious incident (SI) investigation reports and part two looks at arising clinical themes. Read More

Democratized Diagnostics: Why Medical Artificial Intelligence Needs Vetting

Pancreatic cancer is one of the deadliest illnesses out there.  The five-year survival rate of patients with the disease is only about 7%.  This is, in part, because few observable symptoms appear early enough for effective treatment.  As a result, by the time many patients are diagnosed the prognosis is poor.  There is an app, however, that is attempting to change that.  BiliScreen was developed by researchers at the University of Washington, and it is designed to help users identify pancreatic cancer early with an algorithm that analyzes selfies.  Users take photos of themselves, and the app’s artificially intelligent algorithm detects slight discolorations in the skin and eyes associated with early pancreatic cancer.

Diagnostic apps like BiliScreen represent a huge step forward for preventive health care.  Imagine a world in which the vast majority of chronic diseases are caught early because each of us has the power to screen ourselves on a regular basis.  One of the big challenges for the modern primary care physician is convincing patients to get screened regularly for diseases that have relatively good prognoses when caught early.

I’ve written before about the possible impacts of artificial intelligence and algorithmic medicine, arguing that both medicine and law will have to adapt as machine-learning algorithms surpass physicians in their ability to diagnose and treat disease.  These pieces, however, primarily consider artificially intelligent algorithms licensed to and used by medical professionals in hospital or outpatient settings.  They are about the relationship between a doctor and the sophisticated tools in her diagnostic toolbox — and about how relying on algorithms could decrease the pressure physicians feel to order unnecessary tests and procedures to avoid malpractice liability.  There was an underlying assumption that these algorithms had already been evaluated and approved for use by the physician’s institution, and that the physician had experience using them.  BiliScreen does not fit this mold — the algorithm is not a piece of medical equipment used by hospitals, but rather part of an app that could be downloaded and used by anyone with a smartphone.  Accordingly, apps like BiliScreen fall into a category of “democratized” diagnostic algorithms. While this democratization has the potential to drastically improve preventive care, it also has the potential to undermine the financial sustainability of the U.S. health care system.

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The Problematic Patchwork of State Medical Marijuana Laws – New Research

By Abraham Gutman

The legal status of medical marijuana in the United States is unique. On one hand, the Controlled Substance Act of 1970 classifies marijuana as a Schedule I drug with no acceptable medical use and high potential for abuse. On the other hand, as of February 1, 2017, 27 states and the District of Columbia have passed laws authorizing the use of medical marijuana. This discrepancy between federal and state regulation has led to a wide variation in the ways that medical marijuana is regulated on the state level.

In a study published today in Addiction, our team of researchers from the Temple University Center for Public Health Law Research and the RAND Drug Policy Research Center finds that state laws mimic some aspects of federal prescription drug and controlled substances laws, and regulatory strategies used for alcohol, tobacco and traditional medicines.

In the past, studies on medical marijuana laws have focused on the spillover effect of medical marijuana to recreational use and not on whether the laws are regulating marijuana effectively as a medicine. Using policy surveillance methods to analyze the state of medical marijuana laws and their variations across states, this study lays the groundwork for future research evaluating the implementation, impacts, and efficacy of these laws.

The study focuses on three domains of medical marijuana regulation that were in effect as of February 1, 2017: patient protections and requirements, product safety, and dispensary regulation.

Here’s some of what we found:

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Making Health Care Safer: What Good Looks Like

It’s fair to say that patient safety and health quality reports in recent years have tended to focus on what is going wrong in the NHS and what needs to be done to put things right.We have had some dramatic health care systems failures which have resulted in unnecessary deaths of patients.The naming and shaming of errant health care providers has taken place and we have now through the CQC (Care Quality Commission), a much more open, stronger, intelligent and transparent way of regulating health care quality than we have ever had before.

The health care regulatory system does seem to be making a positive difference to NHS care judging from recent CQC reports with some good examples of health quality and safe care practices taking place. Other trusts can learn from these practices.

The CQC have just published a report which includes several case studies illustrating some of the qualities shown by care providers that are rated good or outstanding overall. These hospitals known as hospital trusts in the NHS have been on a journey of improvement some going from special measures to good (CQC inspection ratings). The views of some of the people involved in the care improvement initiatives are stated in the case studies revealing important insights on improvement strategies and the nature of the problems overcome. Read More

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. Read More

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.”  Read More

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.