Ohio state flags waving in front of the Ohio State House

Ohio’s Efforts to Centralize Control Over Opioid Claims

By Daniel Aaron

On October 21, two Ohio counties are slated to present their opioid claims in a federal trial. However, last week, 13 states and the District of Columbia signed onto a brief requesting that the 6th Circuit Court of Appeals stay the upcoming trials. Their reasoning? States should control lawsuits for harms within the state; cities and counties do not have authority to sue on their own. While it makes sense that Ohio’s attorney general, spearheading this effort, would want more power and control over opioid claims, the move has the potential to harm public health by disempowering local governments from addressing public health crises. Ohio’s three main arguments will be discussed in turn.

Argument 1: Violation of State Sovereignty

First, Ohio argues that the county lawsuits violate state sovereignty and disrupt the “federal dual-sovereign structure” of the United States:

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Photograph of Purdue Pharma headquarters

The Role of Attorneys General in the Opioid Litigation

By Daniel Aaron

People following the opioid lawsuits might have noticed some strange headlines as of late. Virtually every state’s attorney general (AG) is suing Purdue Pharmaceuticals, maker of the blockbuster drug OxyContin. Purdue filed for bankruptcy and is hoping to settle for “$10 billion.” However, the deal only includes $4.4 billion in cash, which is less than the Sackler family, owners of Purdue, transferred to personal accounts over the past decade. In other words, the amount of money the Sacklers made from the opioid epidemic is more than what they will pay more than forty states to help abate the crisis. Is anyone supporting this deal?

Yes, in fact, and this is where the plot thickens. With several exceptions, support for the deal falls along party lines: Republican AGs support the deal, and Democratic AGs oppose it. Why does a decision about settling with an opioid company appear to be political? What is the role of an attorney general? And are they supposed to defend public health?

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First-person perspective photograph of a health care worker holding up a mask used to prevent the spread of germs

The Big Winner in Trump’s Newest Immigration Policies: The Flu

By Robert Field

The influenza virus gained an important ally during the past few weeks: the Trump Administration. If you have been rooting for a widespread and virulent flu epidemic this winter, several of its new immigration policies should give you reason to cheer.

The first bit of good news for flu fans is a decision to withhold vaccination from children held in Customs and Border Protection detention centers. These facilities are supposed to hold migrants for no longer than three days, but many remain much longer, and the centers are often severely overcrowded. Since the flu can be quite serious, this puts the thousands of children held in them at increased risk of major illness or death.

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Photograph of a young girl receiving a vaccination from a doctor

New York’s Strict Vaccine Mandate Goes to Court

By Dorit Reiss

On June 13, 2019 New York repealed the religious exemption from its school immunization mandates. While the actual repeal went fast – the bill passed the Assembly health committee, the Assembly floor, the Senate floor and the Governor’s office on the same day – the bill has been in the process since January, and activists on both sides were active in the lead up to the vote. The bill was a response to a large measles outbreak in New York that sickened hundreds of people and hospitalized over a hundred, sending tens to the ICU.

Not surprisingly, opponents filed lawsuits against the new law. Two of these lawsuits were led by the Children’s Health Defense organization, an anti-vaccine group led by Robert F. Kennedy, Jr., though with two different lead lawyers. Eight additional ones were recently filed by two unassociated lawyers in eight different counties.

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A white hospital hallway

The Latest in the Continuing Cycle of NHS Patient Safety Inquiries

There does not seem to be a week that goes by without an NHS (National Health Service) patient safety crisis hitting the headlines and this has been the case for many years. Major public inquiry reports into patient safety and health quality failings are published. Recommendations are made, and then another crisis event follows soon afterwards spawning yet other reports, broadly saying the same thing.

The NHS has built up a huge back catalogue of inquiry reports into patient safety crisis’s, spanning decades containing a lot of deep thinking, useful analysis and valuable recommendations. Analysing present and past patient safety crisis inquiry reports is a very useful educational exercise and can help inform future policy development in the area. Some of the seemingly intractable, stubbornly persistent patient safety problems that beset the NHS, both past and present are identified and discussed. Revisiting reports and analysis can also refresh our perspective on patient safety issues and provides an information bedrock on which we can base change.

Patient safety inquiry reports also provide a momentum for change through their recommendations which the government of the day can accept or reject. Read More

blurry, shadowy human figure in black and white

Measuring the Opioid Crisis: The Need for Standardized Cause-of-Death Reporting

By J. Alexander Short

All too often, the modern opioid epidemic is reduced to numbers. Over 70,000 drug overdose deaths occurred in the United States in 2017. This marked a substantial increase from the more than 63,000 deaths reported in 2016. So many news articles, books, and even policymakers depend on these numbers as an accurate measure of the opioid crisis. However, can we rely on their accuracy?

Unfortunately, there are surprising inconsistencies in the reporting of drug overdose deaths that warrants further investigation. Read More

Seeking out global patient safety research

By John Tingle

Unsafe health care is a problem of global proportions .The remedies and solutions to many patient safety problems are unlikely to be found in just one countries health care system. Health is one of the world’s great generics, it transcends countries borders, we are all dealing with the health of human beings which is the common denominator. Whilst country contexts may change the subject matter, the patient, remains constant. WHO state:

“Ensuring the safety of patients is a high visibility issue for those delivering health care – not just in any single country, but worldwide. The safety of health care is now a major global concern. Services that are unsafe and of low quality lead to diminished health outcomes and even to harm. The experience of countries that are heavily engaged in national efforts clearly demonstrates that, although health systems differ from country to country, many threats to patient safety have similar causes and often similar solutions (p.1).

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Massachusetts Wants To Drive Down Medicaid Drug Costs: Why Is The Administration So Nervous?

This new post by Nicholas Bagley and Rachel Sachs appears on the Health Affairs Blog. 

Although drug formularies are ubiquitous in Medicare and the private insurance market, they’re absent in Medicaid. By law, state Medicaid programs that offer prescription drug coverage (as they all do) must cover all drugs approved by the U.S. Food and Drug Administration, however expensive they are and however slim their clinical benefits may be.

Massachusetts would like to change all that. In a recent waiver proposal, Massachusetts asked the Centers for Medicare and Medicaid Services (CMS) to allow it to adopt a closed formulary in Medicaid. That would allow Massachusetts to exclude certain brand-name drugs from Medicaid, increasing its leverage in price negotiations beyond what it can achieve through existing utilization management techniques like prior authorization.

Among Medicaid advocates, the proposal is controversial. Some fear that state budgets would be balanced on the backs of Medicaid beneficiaries, who could be denied access to expensive therapies. But Massachusetts thinks there’s room to drive down drug spending without threatening access to needed medications. In any event, the state has to do something. Drug spending in Massachusetts has increased, on average, 13 percent annually since 2010, threatening to “crowd out important spending on health care and other critical programs.”

By all rights, CMS should welcome Massachusetts’s proposal. Closed drug formularies are tried-and-true, market-based approaches to fostering competition over drug prices, and the Trump administration’s Council on Economic Advisers recently released a report saying that “government policy should induce price competition” in Medicaid. If Secretary of Health and Human Services (HHS) Alex Azar means it when he says that “drug prices are too high,” letting Massachusetts try out a formulary makes a ton of sense. […]

 Read the Full post here!

Systemic Oversight: a new approach for precision medicine and digital health

By Alessandro Blasimme and Effy Vayena

Imagine a clinical research protocol to test the efficacy of a nutritional regime on the aging trajectory of the participants. Such a study would need to be highly powered and include thousands of people in order to observe a credible effect size. Participants would remain enrolled in the study for many years, maybe decades. Endpoints would include novel measures of healthy aging such as functioning (the capacity to perform certain activities) and the quality of social life. Participants would thus be asked to provide enormous amounts of personal data covering at the same time their health state, their habits and their social activities – most likely with the help of smart appliances, sensor-equipped wearables, mobile phones and electronic records.

In a different scenario a research team aims to develop clinical protocols for cancer treatment according to the unique genomic signature of their tumor. They will need patients, willing to undergo whole genome germline and tumor sequencing right at the moment of diagnosis and be included in a basket trial. Therapy would then be targeted to the specific genetic alterations of each individual in the hope that a combination of targeted drugs would generate better medical outcomes than the current standard of care.

These two scenarios correspond to the prototypical form of, respectively, precision medicine and precision oncology studies. The first is likely to require large (very large) longitudinal cohorts of extensively characterized individuals – like the All of Us Research Program. The second will require sustained sharing of genomic data, information on patients’ clinical history and response to treatment, and possibly a unique repository in which such information would flow to – something akin the NCI’s Genomic Data Common.

This kind of data-intense research, in particular, introduces game changing features: increased uncertainty about foreseeable data uses, expanded temporal span of research activities due to virtually unlimited data lifecycles, and finally, the relational nature of data. This last feature refers both to the fact that, for instance, zip codes contain other types of sensitive information like information about ethnic background (redundant encoding); and to the fact that data about one person contain information about others– as is the case, for instance, with genetic data among family members. Read More

Taking action to prevent male suicide

By John Tingle

The issue of male suicide and prevention seems to have been an obscured or perhaps even a forgotten issue in reports discussing the care of vulnerable people. The UK media have recently focussed on this issue with the Project Eighty-Four campaign. This campaign  aims to raise awareness of male suicide with sculptures being placed on the top of a London tower block to mark this. The sculptures are on the top of ITV’s (Independent Television ) Buildings on London’s Southbank Promenade from 26th March 2018.The sculptures are designed to get people talking about the issue. Friends and families of the deceased men helped create them: “Each one, a poignant reminder of a real life lost and a call to society to come together and ultimately take a stand against male suicide.

BBC News has also covered the event. Project Eighty Four states that the statistics on male suicide are shocking. Every two hours a man in the UK takes his own life. Project Eighty Four is an initiative of the charity CALM (Campaign Against Living Miserably).CALM is dedicated to preventing male suicide and they say that male suicide and mental health is a big issue that cannot be ignored for any longer.

Interestingly they report in latest annual report and accounts a modest but noticeable increase in the number of female callers for help and advice. CALM’s focus is on men because of the high rate of male suicides.Helpline workers helped to directly prevent 409 suicides in 2016-17, up 19% on the previous year. Read More