Simulated Side Effects: FDA Uses Novel Computer Model to Guide Kratom Policy

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.

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The cat is now truly amongst the pigeons in the debate about the high cost of clinical negligence in the NHS

By John Tingle

UK national and social media have been buzzing all last week about a letter sent on Monday 29th January 2018 by the NHS Confederation to the Justice Secretary and copying in the Secretary of State for Health.BBC  news set the scene under the banner headline, ‘Curb rising NHS negligence pay-outs, health leaders urge’.

The NHS Confederation is a charity and membership body that brings together and speaks on behalf of all organisations that plan, commission and provide NHS services. Members are drawn from every part of the health and care system. The letter coordinated by them had several co-signatories in the medical establishment including the Chief Executives of the doctor’s defence organisations, the British Medical Association (BMA), The Academy of Medical Royal Colleges. The letter said that the current level of NHS compensation pay-outs is unsustainable and is diverting significant amounts of funding away from front line care services. Last year the NHS spent £1.7 billion on clinical negligence claims, representing 1.5 % of front line health services spending. This annual cost has almost doubled since 2010/11 with an average 11.5 % increase every year:

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Innovation Gaps on Life Science Frontiers

Join us in wonderful Copenhagen at our CeBIL Kick-Off Conference: ”Innovation Gaps on Life Science Frontiers? From Antimicrobial Resistance & the Bad Bugs to New Uses, AI & the Black Box”. The  Conference marks the start of the Novo Nordisk Foundation’s Collaborative Research Programme in Biomedical Innovation Law which is carried out within a unique network of international core partners, including internationally renowned experts at Harvard Law School’s Petrie Flom Center, Harvard Medical School/Brigham & Women’s Hospital, University of Cambridge, University of Michigan, and UCPH’s Department of Food and Resource Economics (IFRO).

Leading international experts, including i.a. our distinguished Bill of Health colleagues Glenn Cohen, Aaron Kesselheim; Nicholson Price, and Kevin Outterson, will discuss legal, economic, societal and scientific aspects of selected Life Science areas.

Time: Monday, 5 March 2018 09:00 – 18:00 (followed by a reception in the Gobelin Hall)

Venue: The Ceremonial Hall (Festsalen), University of Copenhagen, Main Building, Frue Plads 4, DK-1168 Copenhagen K

More information on  speakers, agenda and registration is available here and here.

Extended background:

Biomedical innovation is experiencing changes of epic proportions. Rapid progress in many scientific areas, such as gene editing, pharmacogenomics, artificial intelligence and big data-driven precision medicine, has greatly advanced the promises and opportunities of the health and life sciences. Nevertheless, the total number of truly new and innovative drugs receiving market approval is unsatisfactory. At the same time, some of the more innovative therapies that actually could reach patients have become extremely expensive or ethically problematic. These new technological possibilities raise many complex scientific, legal and ethical issues affecting many stakeholders, such as medical practitioners, regulators, patients and the industry.

To support the in depth study of these developments, the Novo Nordisk Foundation has awarded a grant of DKK 35 million for a new Collaborative Research Programme in Biomedical Innovation Law (CeBIL). CeBIL’s overall aim is to help translate ground-breaking biomedical research into affordable and accessible therapies by scrutinizing the most significant legal challenges to biomedical innovation and public health from a holistic cross-disciplinary perspective. CeBIL is hosted by a new Centre for Advanced Studies at the University of Copenhagen’s Faculty of Law. The research is carried out within a unique network of international core partners, including internationally renowned experts at Harvard Law School, Harvard Medical School, University of Cambridge, University of Michigan, and UCPH’s Department of Food and Resource Economics (IFRO). Moreover, CeBIL will collaborate with a broad network of stakeholder organizations and international experts within law, economics, life science, medicine, sociology and pharmacy.

This Kick-Off Conference marks the start of CeBIL which opened its’ doors on January 1st, 2018. Reflecting the research projects that will be at the focus CeBIL’s research during the first 5 years, leading international experts will discuss legal, economic, societal and scientific aspects of selected life science areas and debate future challenges and opportunities.

 

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House of Commons Report: Managing the Costs of Clinical Negligence in NHS Hospitals

By John Tingle

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

The Opioid Crisis Requires Evidence-Based Solutions, Part III: How the President’s Commission on Combating Drug Addiction Dismissed Harm Reduction Strategies

Drug overdose is a leading cause of death in Americans under 50. Opioids are responsible for most drug-related deaths killing an estimated 91 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

Civil Commitment and the Opioid Epidemic: A Call for Research

By Scott Burris, JD

There is a lot of interest in civil commitment these days, as a possible tool to fight two big health problems. As we continue to watch the rates of opioid-related deaths climb, and in the wake of an unfunded emergency declaration by President Trump, some policymakers are looking to involuntarily commit overdose survivors for drug treatment. On the gun violence side, experts like Jeffrey Swanson have argued for applying gun-access restrictions that now cover people subject to long-term civil commitment to those subjected to short-term civil commitment.

With those kinds of ideas in the air, it is important to recognize how little modern data we have on commitment and its effects. In a recent article in the Washington Post discussing commitment for opioid treatment, Michael Stein and Paul Christopher emphasize how little we know. I entirely agree on the need for more research, and offer a couple of things to help.

The first is the Policy Surveillance Program’s LawAtlas dataset that maps civil commitment laws across all 50 states and the District of Columbia. If we’re going to examine these laws and their impact, this is the place to start. We also put out the call to anyone interested in studying this to work with us not only to update this data through 2017, but also to make sure we’re mining these laws and their characteristics for the right information in these circumstances — Are we asking the right questions? Continue reading

The Opioid Crisis Requires Evidence-Based Solutions, Part II: How the President’s Commission on Combating Drug Addiction Ignored Promising Medical Treatments

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.

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The Opioid Crisis Requires Evidence-Based Solutions, Part I: How the President’s Commission on Combating Drug Addiction Misinterpreted Scientific Studies

By Mason Marks

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 Service Safety Investigations Body (HSSIB):The New Kid On The Patient Safety Block

By John Tingle

The Department of Health and the government in England have published a draft Bill for discussion which will create a Health Service Safety Investigations Body (HSSIB) with powers enshrined in law. The HSSIB replaces the current Healthcare Safety Investigation Branch (HSIB) which operates under the umbrella of NHS Improvement and came into operation in April 2017. Unlike the HSIB, the new HSSIB will be independent of the NHS, and have its own statutory power base. The HSSIB will not be responsible for investigating all serious patient safety incidents in the NHS and existing frameworks will remain.

Eight fact sheets have been published by the Department of Health to accompany the draft Bill which explain its purpose and rationale and how everything will work. It is expected that the HSSIB will investigate up to 30 serious patient safety issues a year and will have an annual budget of £3.8 Million.

It will be important for the HSSIB to manage public and NHS expectations of what it can actually achieve given its small budget, staffing and the number of investigations that it intends to carry out. There are around 24,000 serious patient safety incidents a year in the NHS. The small-scale operation of the HSSIB can be justified as it will act as an exemplar of good investigative practice and will cascade down standards into the NHS.

The Bill Continue reading

The NHS in England: Running to Stand Still?

By John Tingle

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

Housing Equity Week in Review

Here’s the latest news from housing law and equity, for the week of November 6-10, 2017:

  • The Public Health Institute released a study that calculates the number of children with lead poisoning in the United States.
  • A new law in Seattle will prevent landlords from screening tenants based on their criminal history, via The Regulatory Review.
  • “It’s time to stop ignoring our crumbling housing code enforcement” — coverage of APHA2017 sessions on housing code enforcement, featuring CPHLR Director Scott Burris and the Five Essential Public Health Law Services Framework developed in collaboration with ChangeLab Solutions and the Network for Public Health Law, via Public Health Newswire.
  • San Jose has a new plan to get downtown landlords to clean up their vacant storefronts using a pilot program that would create a registry of vacant buildings and fine property owners who are neglecting their properties, via NextCity.
  • Civil rights groups are fighting the suspension of a HUD rule they say helps low-income families move to better neighborhoods, via CityLab.
  • Texans voted to loosen some of the tightest home lending restrictions in the country. via Governing.

The Care Quality Commission (CQC) in England: End of Term Report Card

By John Tingle

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

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. Continue reading

States Tackle Youth Sports Concussions – New Data!

By Benjamin Hartung, JD, Joshua Waimberg, JD, and Nicolas Wilhelm, JD

While brain injuries and studies associated with professional football get the majority of media attention, student athletes, especially young football and soccer players, are also at risk for similar brain injuries. Each year, as many as 300,000 young people suffer from traumatic brain injuries (TBIs), more commonly known as concussions, from playing sports.

State governments have responded to the problem of brain injuries in youth sports by adopting laws aimed at reducing the harm that comes from injuries that occur during team practices or events. Delaware was the first state to pass a regulation relating to youth TBIs in 2008, with Washington State following shortly after in 2009. In the years since, all states have passed youth TBI laws, many modeled after the Washington law, that mandate when student athletes are to be removed from the field, how parents should be notified in the event of a concussion, what training is required of athletic coaches, when a student athlete may “return-to-play,” and who may allow this return to the field. Continue reading

Housing Equity Week in Review

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.
  • From the Brookings Cafeteria Podcast: How past racial segregation predicts modern-day economic (im)mobility.
  • Durham County, the county with the highest eviction rate in North Carolina, is taking on the eviction crisis by launching an eviction diversion program. Story via IndyWeek.
  • Bill de Blasio signed the first law in the nation to establish a right to counsel for the poor in housing cases. Story via CityLab.
  • New York Magazine and ProPublica collaborate on an in-depth look into Ben Carson’s HUD.

Biobanks as Konwledge Institutions – Seminar 11/3 at the University of Copenhagen

Biobanks as Knowledge Institutions

“Global Genes –Local Concerns” Seminar with Prof. Michael Madison (University of Pittsburgh, U.S.)

Join us at the University of Copenhagen on November 3rd, 2017 to discuss the legal implications of “Biobanks as Knowledge Institutions” with Professor Michael Madison. 

Abstract

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

Housing Equity Week in Review

Here is our weekly round-up of developments from the world of housing law and health. For the week of August 7-14, 2017:

  • HUD released its “Worst Case Housing Needs” report to Congress providing national data and analysis of the problems facing low-income renting families. CityLab offers a summary of the report here.
  • Is California’s housing laws making its housing crisis worse? Natalie Delgadillo at Governing analyzes the impact of the 1985 Ellis Act, which allows landlords to mass-evict tenants in order to leave the rental business.
  • A new study from University of Hawaii researchers finds homelessness and inadequate housing are major causes of unnecessary hospitalizations. Read more.
  • HUD is inviting paper submissions for a symposium on housing and health. Submissions will be accepted through September 30. Full details here.
  • A new Colorado law requires landlords to give 21-days notice of rent increases and lease terminations, via HousingWire.
  • Amy Clark at the National Housing Conference offers an explanation of YIMBYism — “yes, in my backyard” — via NHC’s Open House blog.

Breaking the Mold: Law and Mold Remediation after a Natural Disaster

By Nicolas Wilhelm, JD

We’re in the midst of the hurricane season here on the East Coast, and with hurricanes come a host of health-related concerns from emergency preparedness to the clean-up after a disaster.

One of the issues rarely discussed in the aftermath of hurricanes Katrina and Sandy —two of the costliest natural disasters in US history — is the mold growth that occurred in water-damaged homes. One study indicated that the concentration of mold in flooded areas after Hurricane Katrina was roughly double the concentration in non-flooded areas.

With natural disasters occurring with greater frequency in recent years (there were three times as many natural disasters occurring from 2000 through 2009 than from 1980 to 1989), law may play a role in keeping Americans safe.

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Copenhagen Conference: Legal Perspectives on Synthetic Biology and Gene Editing

Join us at the Centre for Information and Innovation Law (CIIR) Faculty of Law, University of Copenhagen on 20 November, 2017 to discuss Legal Perspectives on Synthetic Biology and Gene Editing.

CALL FOR PAPERS

Emerging technologies in Synthetic Biology and Gene Editing offer incredible opportunities and promising solutions to some of the most urgent challenges faced by humanity, such as climate change, environmental protection, growing population, renewable energy and improved health care. But the emerging applications also raise exceptional ethical, legal and social questions.

This conference marks the final phase of the participation of the Copenhagen Biotech and Pharma Forum (CBPF) Research Group at the Centre for Information and Innovation Law (CIIR) in the cross-faculty research project BioSYNergy. In accordance with the goals of this large cross-faculty project on Synthetic Biology, the event explores legal perspectives on synthetic biology, systems biology and gene editing. Dealing with the legal responses to ethical and scientific challenges raised by emerging life science technology. Continue reading

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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