National Resilience Strategy aims to reverse huge rise in ‘deaths of despair’

Startling increases in nationwide deaths from drug overdoses, alcohol, and suicides constitute a public health crisis – spurring an urgent call for a National Resilience Strategy to stem these “deaths of despair.” The proposal is outlined in a special commentary in the Journal of Public Health Management and Practice, published in the Lippincott portfolio by Wolters Kluwer.

John Auerbach, President and CEO of Trust for America’s Health, and Benjamin Miller, Chief Strategy officer of Well Being Trust, outline their organizations’ proposal for a National Resilience Strategy – a comprehensive approach to reversing these mortality trends while improving behavioral health services and prioritizing prevention by supporting healthier communities.

Proposed National Response to ‘Triple Epidemic’ of Drug, Alcohol and Suicide Deaths

“The United States is facing a triple set of epidemics – more than 1 million Americans have died from drug overdoses, alcohol, and suicides between 2006 and 2015,” Mr. Auerbach and Dr. Miller write. Last year, their organizations issued a report, titled “Pain in the Nation,” projecting that drug, alcohol, and suicide deaths could reach 1.6 million over the next decade, based on trends since 1999.

Updated projections using data from 2015-16 suggest that the number could exceed 2 million. “This would mean more than 287,700 individuals could die from these three causes in the year 2025, double the current number who died in 2016,” according to the authors. The most recent data show disproportionately large increases in drug deaths among racial/ethnic minorities, especially black Americans.

In their article in Journal of Public Health Management and Practice, the authors introduce their proposed National Resilience Strategy to the public health professionals who will play a key role in its design, implementation, and evaluation. Consisting of more than 60 research-based policies, practices, and programs, the Strategy includes:

• Improved pain management and treatment – including but not limited to responsible prescribing of opioids. Complementary efforts will entail increased education and training for healthcare providers, ongoing use of prescription drug monitoring programs, and increased public awareness of the risks of opioid dependence.
• Harm reduction services – including increased access to the overdose “rescue drug” naloxone and sterile syringes. Recommendations also call for expanding availability of misuse services that meet modern standards of care, with a focus on “treatment as prevention.”
• New approaches to suicide prevention – emphasizing a cultural shift to focus on identifying and providing targeted prevention strategies to high-risk individuals and groups, as well as national and statewide efforts to develop effective suicide prevention plans.

In addition, the National Resilience Strategy aims to expand and modernize behavioral health services, with a “whole health” focus that aligns and integrates mental health care and healthcare. This includes initiatives to bolster the behavioral health workforce and increase availability of Medication-Assisted Treatment and other best practices for opioid use disorder.

Another major goal is prioritizing prevention, supporting evidence-based programs to reduce risks for substance misuse, suicide, and other harms while promoting protective factors within individuals, families, and communities. Recommendations include development of multi-sector collaborative partnerships to build sustainable, scalable programs to programs to address the drug, alcohol, and suicide epidemics and to promote ongoing prevention efforts. Integrated approaches focus on early-children programs, modernizing the child welfare system, and various types of school- and community-based programs.

Despite the discouraging trends, Mr. Auerbach and Dr. Miller believe it’s not too late to reverse the catastrophic increases in deaths of despair. “All across this nation, communities are rising up to address these issues that take lives all too soon,” they conclude. “The resources and additional expertise needed to prevent more deaths should be provided as soon as possible-;and the nation must come together to support and implement a National Resilience Strategy.”​

Source:

https://wolterskluwer.com/

https://bit.ly/2IOA89z

NIH summit recommendations to spur Alzheimer’s treatment development

Experts from government, academia, industry, non-profit organizations put forward recommendations that provide a roadmap for an integrated, multidisciplinary research agenda necessary to inform priorities for Alzheimer’s disease and related dementias. The recommendations are designed to guide continued efforts to build a collaborative, multi-stakeholder research environment capable of delivering urgently needed cures for people at all stages of the disease. The recommendations are a result of a multi-step, iterative process culminating in the Alzheimer’s Disease Research Summit 2018: Path to Treatment and Prevention, which was convened by the National Institute on Aging (NIA), part of NIH at the U.S. Department of Health and Human Services, with support from the Foundation for the NIH. A reoccurring theme from the summit and in the recommendations is a precision medicine approach to Alzheimer’s treatment and prevention–the ability to develop interventions that can address the underlying disease process as well as the disease symptoms and be tailored to a person’s unique disease risk profile.

“This is a critical time in Alzheimer’s research, with new opportunities to build upon what we have learned,” said NIA Director Richard J. Hodes, M.D. “We must continue to foster creative approaches that leverage emerging scientific and technological advances, establish robust translational infrastructure for rapid and broad sharing of data and research tools, and work with funding partners and other stakeholders to cultivate and sustain an open science research ecosystem.”

The research recommendations build upon the framework established by previous summits in 2012 and 2015. They place emphasis on the approaches, tools, infrastructure and partnerships needed to understand disease heterogeneity by comprehensive study of disease risk and resilience across diverse populations; increase research rigor and reproducibility; and accelerate therapy development by integrating experimental and computational approaches and propagating open science practices.

The recommendations centered around several key topics:

Developing a better understanding of the complex and multifactorial causes of disease

• Enabling precision medicine research needed to develop interventions that can address the underlying disease process, as well as the disease symptoms and be tailored to a person’s unique disease risk profile for Alzheimer’s disease
• Enhancing the research infrastructure and developing translational tools to accelerate therapy development
• Supporting the development of novel therapeutics that target the many facets of Alzheimer’s disease
• Understanding the impact of the environment and its interaction with genetic and biological factors to advance effective prevention strategies for Alzheimer’s disease
• Leveraging emerging digital technologies and big data approaches to improve our ability to discover early markers of disease, better track responsiveness to treatment and provide better care
• Bringing together multiple stakeholders to build a new research ecosystem based on the principles of open science.

More than 80 leading experts joined to develop the research recommendations. They were considered and adopted by the National Advisory Council on Aging at its meeting on May 22 and 23 and will be used to update and expand specific milestones for achieving the prime research goal of the National Plan to Address Alzheimer’s Disease–to treat and prevent Alzheimer’s disease and related dementias by 2025.

Source:

https://www.nia.nih.gov/news/nih-summit-delivers-recommendations-accelerate-therapy-development-alzheimers-disease

https://bit.ly/2kxYLch

The Out of Print Book Hedge Funds Pay Thousands For

As the world’s largest network of buyside investment professionals, SumZero has a breadth of data on the hedge fund industry. One of the optional pieces of information that SumZero members can include on their membership profiles is their favorite investment book. We decided to compile our data and tabulate which books were the most popular.

The favorite by an overwhelming majority?: Seth Klarman’s ‘Margin of Safety’. Klarman published the book in 1991, a few years after taking the reins at the Baupost Group. It flew off the shelves at a $25 cover price, and soon went out of print. The book now sells for $700-$1200 used, and $2500+ new.

Given the industry’s focus on hard to find information, it’s unsurprising that ‘Margin of Safety’ took first place. Coming in second and third after ‘Margin of Safety’ were Ben Graham’s classic ‘The Intelligent Investor’ and Greenblatt’s ‘You Can Be a Stock Market Genius’.

TITLE	AUTHOR	% OF USERS THAT LISTED AS FAVORITE
Value Investing	Bruce C. Greenwald	1.96
The Essays of Warren Buffett	Lawrence Cunningham	2.05
Fooling Some of the People All of the Time	David Einhorn	2.31
Poor Charlie’s Almanack	Charlie Munger	2.67
Reminiscences of a Stock Operator	Edwin Lefevre	3.03
One Up On Wall Street	Peter Lynch	3.30
Common Stocks and Uncommon Profits	Philip Fisher	4.01
Security Analysis	Benjamin Graham and David L. Dodd	4.82
The Most Important Thing	Howard Marks	5.44
You Can Be a Stock Market Genius	Joel Greenblatt	6.24
The Intelligent Investor	Benjamin Graham	10.53
Margin of Safety	Seth Klarman	18.29

https://bit.ly/2KZHrry

Aptinyx seeks $80M IPO to push pain, PTSD, Parkinson’s drug platform

With the ink barely dry on a partnership deal with Allergan, Aptinyx has announced plans for an $80 million IPO to accelerate work on its drugs for neurological disorders.

The Evanston, Illinois-based biotech—founded three years ago—is focused on the development of drugs that interact with the NMDA receptor, and the company says it will use the funds to advance drugs for chronic pain, post-traumatic stress disorder (PTSD) and cognitive impairment in Parkinson’s disease.

The IPO play comes right after Allergan exercised an option to acquire rights to Aptinyx’s NMDA-based depression candidate AGN-241751, which came out of a research collaboration set up between the companies shortly after Allergan bought Naurex, from which Aptinyx was spun out in 2015. Allergan paid a $1 million option fee and Aptinyx says it will receive “no further economic consideration from this product candidate.”

According to the biotech’s IPO prospectus, lead drug NYX-2925—which has FDA fast-track status—will have a phase 2 readout in pain associated with diabetic neuropathy and fibromyalgia in the first half of 2019.

It estimates that painful diabetic neuropathy affects around 5.5 million people in the U.S., with another 5 million having fibromyalgia, and sees significant potential for a drug that can improve on current treatments—mainly opioid analgesics—that often lack efficacy and put people at risk of dependency.

Running pivotal trials in chronic pain will be costly, and Aptinyx acknowledges that even if it hits its IPO fundraising target, it will need more capital to take the NYX-2925 project through phase 3. It also made $70 million via a series B last December, and had raised a total of $135 million by the end of March.

Meanwhile, PTSD candidate NYX-783 will generate midstage results in the latter half of 2019, and the biotech also says it filed for FDA approval this month to start trials of third candidate NYX-458 in PD-related cognition. It’s aiming to have phase 1 results from that program early next year.

NMDA is a glutamate and ion channel receptor found on neurons that seems to play an important role in maintaining connections between nerve cells—a process known as synaptic plasticity—and is affected by a host of psychoactive drugs including the anesthetic ketamine and memantine, a drug used to treat cognitive deficits in Alzheimer’s disease.

Aptinyx’s take on NMDA is that its drug candidates bind to a different area of the receptor than current drugs that crudely switch it completely on or off. In contrast, says the biotech, its drugs act on a “pocket” in the receptor that “enables normalization” of the NMDA receptor’s function and enhances synaptic plasticity.

NYX-2925 and NYX-783 both emerged from the chemistry and discovery platform that gave rise to fellow NMDA modulator rapastinel, the depression prospect that underpinned Allergan’s takeover of Naurex.

JPMorgan, Cowen & Co, Leerink Partners and BMO Capital Markets are the joint bookrunners on the IPO.

https://bit.ly/2L2sepZ

Verrica seeks $86M IPO to take on compounded dermatology drug

Verrica Pharmaceuticals has filed to raise $86 million from public investors. The planned IPO will give Verrica the money it needs to take a treatment for viral skin infection molluscum through phase 3 and onto the market.

West Chester, Pennsylvania-based Verrica’s lead candidate is VP-102, a drug-device combination. The candidate consists of cantharidin—a drug already supplied by compounding pharmacies for the treatment of molluscum—and a device for applying the topical solution to warts. Verrica recently moved the candidate into two, 250-person phase 3 clinical trials.

The goal is to show the product is better than placebo at clearing the lesions of patients with molluscum, pick up an FDA approval, and corner a market currently fought over by compounded cantharidin and interventions including cryotherapy, curettage and laser surgery.

Successful execution of the strategy would likely see Verrica sell its product for a significantly higher price than is charged by compounding pharmacies. To justify the need for its product, Verrica points to the potential for compounded cantharidin to vary in purity and be manufactured outside of GMP environments.

Verrica has also paired its formulation to an applicator to enable more precise delivery than what is possible with the cotton-tipped swabs used by dermatologists today. And it has incorporated an agent that shows which lesions have been treated with cantharidin.

These features will come into play if Verrica wins approval and has to persuade payers and doctors to switch to the product, a task it plans to manage itself using a 50- to 60-person sales team. For now though, Verrica just has to show its candidate is safe and more effective than placebo.

Top-line data from the two phase 3 trials are due in the first half of next year. If the trials show VP-102 is better than placebo at clearing lesions after 84 days of treatment, Verrica plans to file for FDA approval before the end of 2019. The history of cantharidin use in the treatment of molluscum gives Verrica cause for confidence as it heads toward the readout.

Verrica also has data from two small, uncontrolled phase 2 trials, one of which is ongoing. As of the last data cutoff, the trial that featured Verrica’s applicator reported an 84-day complete clearance rate of 63%. That compares favorably to the performance of the placebo arms of phase 3 trials of imiquimod, which chalked up clearance rates of 26% and 28% after 126 days.

https://bit.ly/2LBjFU2

US Media Companies Forfeit Readers Rather Than Adjust To Europe’s GDPR

In the recent onslaught of privacy updates dispatched for compliance with Europe’s new law, a few missing companies went unnoticed.

But when the General Data Protection Regulation went into effect Friday, the nonparticipants stood out.

What Happened

Lee Enterprises, Incorporated LEE 2.04%, tronc Inc TRNC 1.55%and A&E Networks — a subsidiary of Walt Disney Co DIS 0.09% — were found to have forgone the costly risk of violating GDPR and pulled out of the European market altogether.

EU readers of Tronc’s Los Angeles Times, Chicago Tribune, New York Daily News and other web media are now greeted with notices that “our website is currently unavailable in most European countries.”

Lee’s The Arizona Daily Star and St. Louis Post Dispatch, among others, were similarly restricted, as were the A&E, History and Lifetime channel websites.

Why It Matters

The percentage of total visitors and subscribers forfeited by Lee, Tronc and A&E services is unknown.

The firms seemingly deemed the proactive loss less damaging than the threat of GDPR-related fines, which could amount to 4 percent of global revenue, according to The New York Times.

What’s Next

The story isn’t necessarily over for European readers, though.

“We are engaged on the issue and committed to looking at options that support our full range of digital offerings to the EU market,” Tronc’s notices read. “We continue to identify technical compliance solutions that will provide all readers with our award-winning journalism.”

https://bit.ly/2sbL8mi

FDA Approves AI-Based Software for Wrist Fracture Detection

The US Food and Drug Administration (FDA) approved computer-aided detection and diagnostic software called OsteoDetect to speed the diagnosis of wrist fractures in adults, the agency announced yesterday.

OsteoDetect, from Imagen, in New York City, uses an artificial-intelligence algorithm to detect fractures in the distal radius by analyzing standard x-ray images. The software then marks the image for further review by a clinician.

The software is designed for use in multiple settings, including primary care, emergency departments, urgent care, and specialty clinics, according to the FDA press release. “It is an adjunct tool and is not intended to replace a clinician’s review of the radiograph or his or her clinical judgment,” an FDA news release states.

Approval was based on two retrospective studies that included 1200 cases. In one study, the software’s detection rate was compared with that of three board-certified orthopedic hand surgeons on 1000 cases. “Both studies demonstrated that the readers’ performance in detecting wrist fractures was improved using the software, including increased sensitivity, specificity, positive and negative predictive values, when aided by OsteoDetect, as compared with their unaided performance according to standard clinical practice,” the agency release states.

An agency spokesperson told Medscape Medical News there was no advisory committee meeting prior to the approval, which was provided via the de novo premarket review pathway that is used for novel low- to moderate-risk devices.

This is the second FDA marketing approval for an artificial intelligence–based device. The first device, IDx-DR, was approved in April for use in the detection of diabetic retinopathy in adults. It was designed for use by nonspecialists.

A request for comment from the company as to whether there are any ongoing prospective trials of the product or plans to determine whether the software improves patient outcomes or the delivery of healthcare services was not answered before publication.

https://wb.md/2scerpu