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Sunday, May 27, 2018

How to talk to patients' families


As a nurse, you already know communicating with patients and their families is one of the most important parts of your job. You are likely often busy with many tasks and may be looking after multiple patients, but taking the extra moment to connect can be vital to patient care, or in some cases, a matter of life and death.
Loved ones, such as spouses, parents, and children, may have questions, concerns, or information they need to share with you. Here are some tips that can help you navigate those emotionally challenging situations.
1. Listen
Many people think of communication as talking. But listening is as important, or arguably, more important. Listening isn’t just being quiet when the other person talks. Really listening requires being fully present. Try to avoid distractions (we know it’s almost impossible for a nurse, but even for a few seconds). Don’t interrupt. Slow down, and take a moment to understand what the patient’s loved ones are saying. Take in not only the words, but also the visual cues from their facial expressions or body language.
After the family member has finished speaking, summarize it. Repeating their communication back to them in your own words is a great way to let them know you understand what they are saying. It also helps you solidify that information in your own memory.
Don’t forget to ask follow-up questions. According to Harvard Business Review, “asking a good question tells the speaker the listener has not only heard what was said, but that they comprehended it well enough to want additional information.”
2. Look
Words are only one part of what you may be saying. Nonverbal communication, such as body language and tone of voice, are just as important. A famous study by psychology Albert Mehrabian, PhD, concluded that non-verbal communication may account for 93% of what a listener takes away from an interaction.
A more recent British study that examined patient relationships with general practitioners (GP) suggested nonverbal communication is especially important in the medical profession. “Nonverbal communication is an important factor by which patients spontaneously describe and evaluate their interactions with a GP. Family GPs should be trained to better understand and monitor their own nonverbal behaviors towards patients,” the study authors stated.
In this study, tone of voice was perceived as the most important aspect of nonverbal communication by patients. When interacting with a patient’s family members, it may be helpful to use a kind, warm tone of voice and to steer clear of sounding angry or nervous.
Eye contact was perceived as the second most important nonverbal cue. Patients interpreted lack of eye contact as a lack of care or attention, and perceived eye contact as caring and involvement.
While this particular study looked at patients rather than patient families, these principles are likely to be helpful for communicating with anyone in a high-stress medical situation.
3. Stay Legal
The Health Insurance Portability and Accountability Act (HIPAA) protects patient privacy and information. All nurses should be familiar with the details of this law, as violating it may harm patients or potentially cause a lawsuit. Patients generally must consent for their information to be released, even to the police. In some circumstances, family members may want medical information you are not legally able to give.
You can usually give medical information to family members involved in treatment or payment for treatment, provided the patient does not object. If you have any sense that the patient objects to their medical information being shared with a family member, it’s best to err on the side of caution. When in doubt, ask.
This story was originally published by Minority Nurse, a trusted source for nursing news and information and a portal for the latest jobs, scholarships, and books from award-winning publisher, Springer Publishing Company.

Advice to Trina’s Diabetes Patients: Don’t Tell Other Doctors


MedPage Today and San Diego-based inewsource have been taking a close look at Trina Health, a national chain of diabetes clinics offering a proprietary and controversial regimen of insulin infusions, touted as halting or even reversing diabetic complications. Some clinics have now closed and the company’s founder was recently indicted on federal charges. Here, we detail questionable practices at one Trina clinic.
A type 1 diabetes patient, backed by her endocrinologist, said that treatments she received at a Trina Health clinic here run by James Novak, MD, not only didn’t relieve her health problems but actively worsened them.
Meghan Lynch, 35, said she would come home from the treatments and collapse, falling so soundly asleep that neither her two barking dogs nor her roommate could wake her. The issue, she said, was hyperglycemia, and if it got any worse, “I would have been hospitalized, definitely,” she said.
Lynch decided to tell her story after reading about Trina founder G. Ford Gilbert, JD, and his infusion procedure in a MedPage Today/inewsource report.
Novak told her not to tell any endocrinologist she was getting Trina treatments, Lynch said.
San Diego physicians who know their patients have undergone the Trina procedure at Novak’s clinic told MedPage Today/inewsource they could not recall Novak ever asking for medical records or sending them from Trina sessions.
One, Georges Argoud, MD, said he and his physician assistants have seen at least one patient who underwent Trina treatments at Novak’s clinic. Neither he nor his staff could recall ever receiving a request for a medical record from Novak or his clinic.
Some patients interviewed about the Trina infusions said they were reluctant to tell their doctors about them. One, John McCreary of Poway, a patient with type 2 diabetes, said he did not tell his endocrinologist that he was undergoing Trina treatments.
At least two patients interviewed also said Novak did not get medical records from their other physicians to document the history of their diabetes or any diabetes-related conditions before starting the infusions. They said Novak would listen to the patients describe their health status, check their blood sugar, and proceed from there.
Novak did not respond to numerous phone and email requests to discuss Lynch’s complaints. When a reporter visited his practice , she was told that Novak declined to comment. Because no one at the clinic would answer questions in recent weeks from MedPage Today/inewsource, it is unclear whether Novak still offers the diabetes infusions.
In a phone interview with Novak last November that included Gilbert, the doctor said his clinic was administering Trina insulin infusions to about 25 patients a week.
Novak said he was “interested in holistic treatments, and whatever we can do to return the body to a more natural balance.” He said he had been offering the Trina infusions since August 2016.
Looking for help
Lynch, who works in public relations for a New York-based company, saw a Facebook ad last summer for Novak’s Trina clinic and its “Artificial Pancreas Treatment.” She thought it might be the answer to lowering her blood sugar, which she hadn’t been able to keep under control since she moved to San Diego from New Jersey a year earlier.
She had doubts, she said, but the fact that Novak was in the Scripps Health network and was covered by her Blue Cross Blue Shield of Michigan health plan gave Novak and his clinic some credibility.
When she met with Novak the first time, Lynch recalled, “right away” he advised her not to consult with any endocrinologists or other diabetes experts, because they “wouldn’t understand the benefit of this type of treatment.”
After getting information from Novak, his clinic staff, and the Trina Health website, Lynch came away convinced that the infusions would work so well, “I wouldn’t need to worry about seeing an endocrinologist.”
Novak and his staff never used the word “cure,” but she said that’s what she believed would happen with her diabetes.
Lynch said she underwent eight Trina sessions over two months. After each one she became increasingly frightened. The sugary beverages she had to drink during the four-hour procedure spiked her blood sugar levels to 400 mg/dL and higher, and she was sent home with blood sugar levels that high.
After many of the treatments, she was in “a complete zombie-like state,” Lynch said.
“The next day I would have trouble waking up and I felt like my energy levels were zapping more going through that treatment,” she said.
Concerned, she made an appointment last fall with Amy Chang, MD, an endocrinologist at the Scripps Clinic, and told her about Novak’s insulin infusions. She assumed Chang would know about the Trina procedure since Chang and Novak were both in the Scripps Health network.
But Chang had never heard of Trina — or Novak — and was alarmed by what Lynch described.
In diabetes, “treatments are always aimed at achieving normal blood sugars within a reasonable range,” Chang said. “Above 400 is completely unreasonable and puts that patient at risk for diabetic ketoacidosis, which would require hospitalization.”
Chang said no doctor should ever tell a patient not to seek an opinion from another doctor and that it would have been “highly unethical” for Novak to have said that to Lynch.
The danger for Lynch was compounded, Chang said, because Lynch has battled thyroid cancer, a condition that requires medications usually prescribed and managed by clinicians — generally endocrinologists with special training in thyroid disease.
Under investigation
Chang said she reported Lynch’s story to physician leadership at Scripps Health, which Chang said launched an investigation. She said a quality oversight committee at Scripps Mercy Hospital also was looking into Novak’s clinic. Novak is listed as part of the medical staff at Scripps Mercy Hospital.
Asked about the status of that investigation, James LaBelle, MD, chief medical officer and senior vice president for Scripps Health, wrote in an email that “any investigation of Dr. Novak or any other member of Scripps medical staff” would be kept confidential and would take place under rules of peer review by the hospital medical staff.
He emphasized that in California, a hospital’s medical staff “does not have purview over a physician’s private practice, only their practice of medicine within the hospital.”
He said if Novak “has engaged in any unethical behaviors in his outpatient practice, Scripps Health and the San Diego community should be able to trust that the Medical Board of California would take appropriate action.”
The board would investigate if a complaint is filed, but none had been as of last week.
Now that she is seeing Chang, Lynch said, she is getting prescription medications that keep her blood sugar levels under much better control.
In retrospect, Lynch said, “I was naive to keep going [to Novak’s clinic] without going to see an actual endocrinologist.” When she remembers the conversations she had with Novak and his team, everything seemed to her like a “sales recruiting” pitch.
“And being in sales, I feel very dumb about the situation, because I should have seen the pitch,” Lynch said.

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.”​

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.

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’.

TITLEAUTHOR% OF USERS THAT LISTED AS FAVORITE
Value InvestingBruce C. Greenwald1.96
The Essays of Warren BuffettLawrence Cunningham2.05
Fooling Some of the People All of the TimeDavid Einhorn2.31
Poor Charlie’s AlmanackCharlie Munger2.67
Reminiscences of a Stock OperatorEdwin Lefevre3.03
One Up On Wall StreetPeter Lynch3.30
Common Stocks and Uncommon ProfitsPhilip Fisher4.01
Security AnalysisBenjamin Graham and David L. Dodd4.82
The Most Important ThingHoward Marks5.44
You Can Be a Stock Market GeniusJoel Greenblatt6.24
The Intelligent InvestorBenjamin Graham10.53
Margin of SafetySeth Klarman18.29

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.

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.