An earlier version of this article was published in STAT.
The National Institutes of Health wants your DNA, and the DNA of one million other Americans, for an ambitious project called All of Us. Its goal — to “uncover paths toward delivering precision medicine” — is a good one. But until it can safeguard participants’ sensitive genetic information, you should decline the invitation to join unless you fully understand and accept the risks.
DNA databases like All of Us could provide valuable medical breakthroughs such as identifying new disease risk factors and potential drug targets. But these benefits could come with a high price: increased risk to individuals’ genetic data privacy, something that current U.S. laws do not adequately protect. Continue reading →
Our National Health Service turns 70 in July and has made remarkable achievements since its inception on July 5, 1948. The NHS is quite rightly an institution to be proud of, and it is envied across the world. Admittedly, the NHS does have its problems, but these should not detract from an overall appreciation of its core value to our society.
In 70 years a lot has happened. Nursing and medicine have evolved, new treatments, and medicines have been developed to cope with new diseases, and our concept of health has also changed.
Health is no longer just the absence of disease; it’s a far more holistic concept today.
Since its inception, the NHS has had to deal with clinical negligence claims. Today there is mounting concern that the high level and costs of clinical negligence claims threaten the very existence and fabric of the NHS.
Exactly what must be done to reduce levels and costs remains a topic of intense speculation and conjecture.
Tragic stories of mental health care failings leading to injury and in some cases death have featured strongly in the English media in recent years. The reports reveal common threads such as poor resources, inadequate staffing levels, limited service availability, poor inter-agency cooperation, poor patient engagement, poor understanding of the Mental Capacity Act 2005 and so on. This care area seems to largely remain a Cinderella health care service provision, existing in the shadows, with the focus being predominantly on physical acute care. There are however now welcome and firm Government commitments to drive improvement into mental health care supported by a raft of promising initiatives.
When patient stories of learning disability and autism care failings are read from several reference sources a picture emerges. Care for people with learning disability and autism can be seen to share many of the patient safety and health quality problems that beset patients who are classified as being mentally ill: Continue reading →
Following the Cambridge Analytica scandal, it was reported that Facebook planned to partner with medical organizations to obtain health records on thousands of users. The plans were put on hold when news of the scandal broke. But Facebook doesn’t need medical records to derive health data from its users. It can use artificial intelligence tools, such as machine learning, to infer sensitive medical information from its users’ behavior. I call this process mining for emergent medical data (EMD), and companies use it to sort consumers into health-related categories and serve them targeted advertisements. I will explain how mining for EMD is analogous to the process of medical diagnosis performed by physicians, and companies that engage in this activity may be practicing medicine without a license.
Last week, Facebook CEO Mark Zuckerberg testified before Congress about his company’s data collection practices. Many lawmakers that questioned him understood that Facebook collects consumer data and uses it to drive targeted ads. However, few Members of Congress seemed to understand that the value of data often lies not in the information itself, but in the inferences that can be drawn from it. There are numerous examples that illustrate how health information is inferred from the behavior of social media users: Last year Facebook announced its reliance on artificial intelligence to predict which users are at high risk for suicide; a leaked document revealed that Facebook identified teens feeling “anxious” and “hopeless;” and data scientists used Facebook messages and “likes” to predict whether users had substance use disorders. In 2016, researchers analyzed Instagram posts to predict whether users were depressed. In each of these examples, user data was analyzed to sort people into health-related categories.
FDA Commissioner Scott Gottlieb issued a statement on Tuesday about the controversial plant Mitragyna speciosa, which is also known as kratom. According to Gottlieb, kratom poses deadly health risks. His conclusion is partly based on a computer model that was announced in his recent statement. The use of simulations to inform drug policy is a new development with implications that extend beyond the regulation of kratom. We currently live in the Digital Age, a period in which most information is in digital form. However, the Digital Age is rapidly evolving into an Age of Algorithms in which computer software increasingly assumes the roles of human decision makers. The FDA’s use of computer simulations to evaluate drugs is a bold first step into this new era. This essay discusses the potential risks of basing federal drug policies on computer models that have not been thoroughly explained or validated (using the kratom debate as a case study).
Kratom grows naturally in Southeast Asian countries such as Thailand and Malaysia where it has been used for centuries as a stimulant and pain reliever. In recent years, the plant has gained popularity in the United States as an alternative to illicit and prescription narcotics. Kratom advocates claim it is harmless and useful for treating pain and easing symptoms of opioid withdrawal. However, the FDA contends it has no medical use and causes serious or fatal complications. As a result, the US Drug Enforcement Agency (DEA) may categorize kratom in Schedule I, its most heavily restricted category.
In tort law we have a very well-known Latin phrase, ‘Res Ipsa Loquitur’ (the thing speaks for itself). An inference of negligence can be raised by the events that occurred. In the National Health Service (NHS) in England there is a similar concept,‘the Never Event’. The Never Event concept is a USA import into the NHS and was introduced from April 2009. The list of what is to be regarded as a Never Event has been revised over the years in the NHS and is currently set out by NHS Improvement.
Never events include, wrong site surgery, wrong implant/prosthesis, retained foreign object post procedure, mis-selection of a strong potassium solution, administration of medication by the wrong route and so on. Never Events are defined in NHS policy documentation as:
“…patient safety incidents that are wholly preventable where guidance or safety recommendations that provide strong systemic protective barriers are available at a national level and have been implemented by healthcare providers. Each Never Event type has the potential to cause serious patient harm or death. However, serious harm or death does not need to have happened as a result of a specific incident for that incident to be categorised as a Never Event.” (p.6)Continue reading →
The House of Commons Committee of Public Accounts (Committee of Public Accounts) has recently considered the issue of managing the increasing clinical negligence costs in NHS (National Health Service) hospitals in a report. They make a number of important recommendations as well as putting into the spotlight a number of developing trends and themes. The report is linked to a report recently published by the National Audit Office on managing clinical negligence costs.This report is closely examined by the Committee with witnesses giving oral and written evidence.
The high cost of clinical negligence litigation
The report begins with a statement on the high and increasing cost of clinical negligence which sets the scene and tone for the rest of the report The Committee has raised concerns about the rising costs of clinical negligence on a number of previous occasions going back as far as 2002. The questions and answers of witnesses called by the Committee do reveal some very interesting and telling insights into the issues and the problems faced. Continue reading →
Drug overdose is a leading cause of death in Americans under 50. Opioids are responsible for most drug-related deaths killing an estimated91 people each day. In Part I of this three-part series, I discuss how the President’s Commission on Combatting Drug Addiction and the Opioid Crisis misinterpreted scientific studies and used data to support unfounded conclusions. In Part II I explore how the Commission dismissed medical interventions used successfully in the U.S. and abroad such as kratom and ibogaine. In this third part of the series, I explain how the Commission ignored increasingly proven harm reduction strategies such as drug checking and safe injection facilities (SIFs).
In its final report released November 1, 2017, the President’s Commission acknowledged that “synthetic opioids, especially fentanyl analogs, are by far the most problematic substances because they are emerging as a leading cause of opioid overdose deaths in the United States.” While speaking before the House Oversight Committee last month, the Governor of Maryland Larry Hogan stated that of the 1180 overdose deaths in his state this year, 850 (72%) were due to synthetic opioids. Street drugs are often contaminated with fentanyl and other synthetics. Dealers add them to heroin, and buyers may not be aware that they are consuming adulterated drugs. As a result, they can be caught off guard by their potency, which contributes to respiratory depression and death. Synthetic opioids such as fentanyl are responsible for the sharpest rise in opioid-related mortality (see blue line in Fig. 1 below). Continue reading →
Last year more than 64,000 Americans died of drug overdose, which is “now the leading cause of death” in people under 50. Opioids kill an estimated 91 Americans each day and are responsible for most drug-related deaths in the US. This public health crisis requires solutions that are supported by science and reason instead of emotion and political ideology. In Part I of this three-part series, I discuss how the President’s Commission on Combating Drug Addiction and the Opioid Crisis misinterpreted scientific studies and used data to support unfounded conclusions. In this second part of the series, I explore how the Opioid Commission ignored medical interventions that are used successfully in the U.S. and abroad. In Part III, I will discuss non-medical interventions such as drug checking and safe injection sites. The Commission’s failure to consider these options is likely driven by emotions such as fear and disgust rather than a careful review of scientific evidence.
Medical marijuana is currently accepted in 29 U.S. states and the District of Columbia. It is also permitted in at least 10 countries. However, the Opioid Commission outright rejected calls to consider the use of medical marijuana as an alternative to opioids for managing pain. Prior to the Commission’s first meeting, it solicited input from industry and members of the public on how to address the opioid crisis. In response, it received over 8,000 public comments. According to VICE News, which obtained the documents by submitting a Freedom of Information Act (FOIA) request, most comments were submitted by individuals urging the Commission to “consider medical marijuana as a solution to the opioid epidemic.” A spokesman for the Office of National Drug Control Policy, a body of the Executive Branch that provides administrative support to the Opioid Commission, reports receiving “more than 7,800 public comments relating to marijuana.” Despite these comments, in its final report, the Commission dismissed the notion that marijuana should play a role in treating chronic pain and opioid addiction. Its report cited a recent study from the American Journal of Psychiatry, which concluded that marijuana use was associated with an increased risk of opioid abuse. However, this study relied on data that was collected over twelve years ago. One of its authors, Columbia Medical School Professor Mark Olfson, told CNN that if the data were collected today, they could yield different results.
The opioid crisis kills at least 91 Americans each day and has far-reaching social and economic consequences for us all. As lawmakers explore solutions to the problem, they should ensure that new regulations are based on scientific evidence and reason rather than emotion or political ideology. Though emotions should motivate the creation of policies and legislation, solutions to the opioid epidemic should be grounded in empirical observation rather than feelings of anger, fear, or disgust. Legislators must be unafraid to explore bold solutions to the crisis, and some measured risks should be taken. In this three-part series on evidence-backed solutions to the opioid crisis, I discuss proposals under consideration by the Trump Administration including recent recommendations of the President’s Commission on Combating Drug Addiction and the Opioid Crisis. Though the Commission made some justifiable proposals, it misinterpreted the conclusions of scientific studies and failed to consider evidence-based solutions used in other countries. This first part of the series focuses on the misinterpretation of scientific data.
Last year more than 64,000 Americans died of drug overdose, which is “now the leading cause of death” in people under 50. Opioids are responsible for most of these deaths. By comparison, the National Safety Council estimates about 40,000 Americans died in auto crashes last year, and the Centers for Disease Control reports that 38,000 people were killed by firearms. Unlike deaths due to cars and firearms, which have remained relatively stable over the past few years, opioid deaths have spiked abruptly. Between 2002 and 2015, U.S. opioid-related deaths nearly tripled (from about 12,000 deaths in 2002 to over 33,000 in 2015). Last year, synthetic opioids such as fentanyl contributed to over 20,000 deaths and accounted for the sharpest increase in opioid fatalities (See blue line in Fig. 1 below). Continue reading →
The Health and Social Care Regulator of the NHS in England, the Care Quality Commission (CQC) has published its latest annual report on the state of health and adult social care in England 2016/17.When reading the report ,the reader is left wondering whether the NHS as currently established can cope adequately with current future health and social care demands. The NHS turns seventy years of age next year and there is much to celebrate but there is also a lot of increasing concern about NHS efficiency, sustainability, safety and quality. The number of people aged 65 is projected to increase in all regions of England by an average of 20 % between mid-2014-and mid-2024.People are also increasingly presenting with complex, chronic or multiple conditions. The total number of people with Dementia is projected to reach one million by 2027.We are also living longer. Life expectancy at birth, 2013-2015 is 79 years for men and 83 for women. All these factors test the model of NHS care that we have and its long-term sustainability.
Like the previous year’s annual report,this year’s warns that the health and care system is operating at full stretch and that care quality in some areas is deteriorating. The situation can only get worse unless more resources are made available or new ways of the NHS operating are devised. The NHS faces an infinite public demand for its finite resources. Continue reading →
In terms of NHS health quality and patient safety regulation, the Care Quality Commission (CQC) occupies a pivotal role as the independent regulator of health and social care in England. How well it performs its function is fundamental to the health of the nation. The CQC functions and operations has been recently put under the microscope by the National Audit Office (NAO).The NAO scrutinises public spending for Parliament, making sure it is well spent. Both good and bad findings are made on the work of the CQC in the report and a number of recommendations are made.
On reading the report it’s fair to say that overall the CQC is doing a good job but there are deficiencies identified which need to be remedied. The report is divided into four parts: Continue reading →
The NHS (National Health Service) in the UK is 70 next year: it was founded on 5th July 1948 and celebrations are being planned. Clearly a lot has changed since it was founded. Our concept of wellness has changed, we go to the doctor for reasons that would never have been considered appropriate in 1948. Health today is not just about the absence of physical diseases.
What is clear is that ever since 1948 the NHS has been shortage of resources in the face of a seemingly insatiable demand for its services. Balancing finite resources against near infinite demands is no easy task. Seventy years on, it is most concerning that a vast amount of money in the NHS is now being spent on clinical negligence claims. In their latest annual report and accounts, NHS Resolution estimates the total amount for clinical negligence claims it owes is £65 Billion. Damages paid to patients rose significantly from £950.4 million to £1,083.0 million, an increase of 14%. The high cost of clinical negligence is not sustainable and something must be urgently done to reduce the number of claims against the NHS. The issues were recently considered by the National Audit Office (NAO), which found:
The cost of clinical negligence claims is rising at a faster rate year-on-year, than NHS funding.
Even if successful, NHS Resolution and the Department’s current actions are unlikely to stop the growth in the cost of clinical negligence claims.
The government lacks a coherent cross-government strategy, underpinned by policy, to support measures to tackle the rising cost of clinical negligence.
NHS Resolution (the new operating name for the NHS LA, National Health Service Litigation Authority) occupies a central role in the NHS clinical negligence claims environment. They manage clinical negligence claims on behalf of NHS trusts (hospitals) and other bodies. They also provide indemnity cover and have an increasing role in assisting the NHS with risk management and patient safety.
NHS Resolution have recently published their Annual Report and Accounts which contains important data, trends, case studies and other information on clinical negligence and patient safety. This report also very clearly signals the new more inclusive, upstream, closer to the problem approach that NHS Resolution is now taking to its work.
Here’s the latest news in housing law and equity, for the week of August 15-21, 2017:
The Urban Institute has released a new tool about using fair housing data. The report contains details on data sources related to demographics and segregation, housing, land use, disability, education, employment, environment, health, and public safety.
The Washington Post reports that California lawmakers are planning on putting housing as a top priority after the summer.
Richard Rothstein, author of the critically acclaimed book The Color of Law, writes an op-ed for the LA Times about the role law plays in maintaining racial segregation in Los Angeles.
The presentation characterizes the material and immaterial attributes of biobanks as knowledge resources, and it characterizes the broader questions that they pose as resource governance questions rather than as questions solely of law or of public policy. Biobanks are knowledge institutions. Professor Madison argues that despite the varied and diverse nature of biobanks today (indeed, precisely because of their diversity), their social and scientific importance dictates the need for a robust program of research of a comparative nature to identify shared features that contribute to their success (where they succeed) and features that likely contribute to problems or even failure. Both their importance and the associated governance challenges have only grown larger and more complex as biobanks meet the era of data science. In that regard Professor Madison points to emerging scholarly literature that focuses on governance challenges of material and data in biobank contexts, which builds on a knowledge commons governance framework. He concludes by suggesting directions for future work. Continue reading →
The Medical Protection Society (MPS) have recently published a report arguing that the rising costs of clinical negligence needs to be urgently controlled. They state that the NHS is struggling under the increasing burden of clinical negligence costs and suggest some reforms.The report is detailed and thorough and raises some good and interesting points but in reading it, it should be remembered that there is also a very good contrary position that can be advanced by those who act for patients in clinical negligence litigation. This report puts the issues to test.
The report begins by looking at the increasing costs of clinical negligence claims. Costs have increased over the years and the figures are stark. The report quotes figures from NHS Resolution, the new name for the NHS LA (National Health Service Litigation Authority) who estimates that the provision for future clinical negligence costs, relating to claims arising from incidents that have already occurred, stands at £56.1 billion:
“Expenditure on clinical claims by NHS Resolution increased by 72% (11.5% a year on average) over the five years to 2015/16. Should this trend continue it risks becoming wholly unsustainable for the NHS and wider society, which ultimately pays for these cost. Last year alone, nearly £1.5billion was spent and, put into context, this equates to the cost of training over 6,500 new doctors.(p4).”Continue reading →
Our latest round-up of the biggest stories in housing law and equity, for the week of June 12-18, 2017:
The Joint Center for Housing Studies of Harvard University released the yearly State of the Nation Housing report. The report encourages a renewed national commitment to expand the range of housing options available.
A NY State Appellate Court struck down a chronic nuisance ordinance in Groton, NY, because of provisions that led to the eviction of those who seek emergency services. Story via Ithaca.com
The Out of Reach report and tool that was published a couple of weeks ago by the National Low Income Housing Coalition is getting press around the country for showing the gap between current wages and rents in most US cities. This article, from CNBC highlights the lack of affordable housing for minimum wage workers.
An opinion piece in The Hill makes, again, the case for investment in housing as an investment in childhood development and health.
79 people are presumed dead in the fire at Grenfell Tower in London. Some argue that the tragedy should be a red light for distressed public housing in the US.
The Philadelphia Inquirer posted its second article in its Toxic City series. This most recent article investigates lead-poisoned soil in the city’s River Wards neighborhoods. While lead paint is often considered the biggest danger to children, in these areas and others, the soil may be a great danger.
Affordable housing was the biggest topic of conversation last week, May 29-June 4. Here’s the week in review for housing equity and the law:
Vox published an interactive tool with “Everything you need to know about the affordable housing debate.” It covers issues from “What is affordable housing?” to gentrification, section 8, and zoning.
California’s State Senate and Assembly passed multiple laws to tackle the affordability crisis in California cities. Laws include more funding and relaxed regulation to build affordable housing units. Coverage via KQED.
Last week, HUD secretary Ben Carson said that, to a large extent, “poverty is a state of mind.” Today, Carson clarified that “state of mind” is just one component. Affordable housing advocates like Diane Yentel, of the National Coalition of Low Income Housing, responded that housing poverty is due in large to HUDs budget, not state of mind. Coverage via NPR.
The mortgage interest tax deduction is a controversial program that many critique as being beneficial mainly to the rich. Eliminating the mortgage interest tax deduction could make houses much more affordable. CityLab offers a way to make homes 10 percent more afforable.
Five hundred people lined up to try to get an apartment in a 88 unit development in Philadelphia, shedding light on the city’s affordability and homelessness crisis. Coverage via Philly.com.
It is important to take a broad holistic approach when looking at patient safety policy development and practice in the NHS. There cannot be a one size fits all approach and a number of possibly quite disparate organisations and stakeholders in the NHS and beyond must be consulted and involved so that effective and positive culture change takes place.
The CQC (Care Quality Commission) is a major patient safety culture change agent whose job is to ensure that health and social care services provide people with safe, effective, compassionate and high-quality care. The CQC encourages care service providers to be on an upward trajectory of improvement. They have recently produced a report to analyse what impact they have on quality and improvement in health and social care. The report provides evidence that the CQC is having a significantly positive impact on regulating care and ensuring good standards.
A majority of new providers and registered managers responding to a CQC survey said that their guidance and standards are clear. The CQC approach to regulation and their standards have an influence on how some providers measure their own quality. CQC inspection reports were also said to be useful. Continue reading →