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 real possibility of an AIDS-free generation:” HIV Prevention and the Internet

By Clíodhna Ní Chéileachair

Last November, the National Health Executive (NHS) in the UK lost an appeal in the UK Court of Appeal regarding their failure to fund PrEP for individuals at risk of contracting HIV. PrEP, or Pre-Exposure Prophylaxis is a common term for regimes of anti-viral medication taken by individuals to lower their risk of being infected with HIV. Marketed as Truvada, clinical test results published by the National institute of Health in 2010 declared that the treatment could reduce the risk of contracting HIV by up to 90%, a rate that seemed farcical even in a world where information about HIV is more accessible than ever, and medical experimentation with cures has been steadily gaining steam. Based on those results, the U.S. Center for Disease Control issued interim guidelines for using the drug, despite the fact that it was over a year away from FDA approval, aware that doctors had been prescribing it off-label for HIV treatment. The titular quote is from former President Obama, speaking on World AIDS Day in 2011 about the breakthrough that PrEP represented. The story raises some fascinating questions about how doctors interact with experimental medicines when facing down diseases that will otherwise seriously compromise quality of life for patients, and even kill, but nonetheless remain unsanctioned by national healthcare providers and largely available through backchannels.

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The State of Care in Mental Health Services in England 2014-2017

By John Tingle

The Care Quality Commission (CQC) is the independent regulator of health and adult social care in England. They have recently published a report of inspections on specialist mental health services. The  report is very thorough and detailed and reveals both good and bad practices. When reading the report however the poor practices identified eclipse the good ones.

Patient safety concerns

Concerns about patient safety are a constant and overarching theme in the report. The CQC biggest concern in this care area is patient safety:

“For both NHS and independent mental health services overall, and for eight of the 11 core services, safe was the key question that we most often rated as requires improvement or inadequate. At 31 May 2017, 36% of NHS core services and 34% of independent core services were rated as requires improvement for safe; a further 4% of NHS core services and 5% of independent core services were rated as inadequate for safe “(29).

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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

WHO: Global Patient Safety Leadership

By John Tingle

The World Health Organisation (WHO) has just produced a very informative and helpful report on the need to view patient safety as a global concern and to highlight resources that they have made available to deal with the problem and those in development. Patient safety is a fundamental principle of health care and this is fully acknowledged in the report. The report begins by quoting several facts and figures which emphasize the fact that medical errors should be regarded as a matter of acute global concern:

“According to a new study, medical errors are the third leading cause of death in the United States. In the United Kingdom, recent estimations show that on average, one incident of patient harm is reported every 35 seconds. Similarly, in low- and middle income countries, a combination of numerous unfavourable factors such as understaffing, inadequate structures and overcrowding, lack of health care commodities and shortage of basic equipment, and poor hygiene and sanitation, contribute to unsafe patient care (p1).”

Approximately two-thirds of all adverse health events happen in low-and middle-income countries. Fifteen per cent of hospital expenditure in Europe can be attributed to treating patient safety accidents. Read More

The First Human Body Transplant – Ethical and Legal Considerations

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

Advancing the Global Patient Safety Agenda

By John Tingle and Jen Minford

All too often it seems that patient safety and health quality policy makers work in their own silos unaware of what is taking place in other countries, wasting valuable resources by trying to re-invent the wheel. There is a clear need to have a way of cascading the news down on what is happening in patient safety globally. Developing and transitioning countries do not always have the resources to build up patient safety infrastructures, tools and policies and letting them know about initiatives going on in other countries fulfils a very important global public health need.

There is also the concept of ‘reverse innovation’.  Developed countries’ patient safety practices and policies can be informed by the experiences of developing and transitioning countries who may be using them in a different and novel way. Patient safety learning can be a two-way street. Read More

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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