'Treat Them Like Human Beings': What We Heard This Week

"I think we should close the camps, and if we can't do that, at least do the absolute minimum for people who are imprisoned in these camps, and that is treat them like human beings who deserve medical care." -- Zack Berger, MD, discussing the immigrant detainees at the Mexican border.

"We're not evangelists claiming to offer a cure for smoking." -- Jerry Loftin, an executive for a company that makes e-cigarette products, during a House hearing on teen vaping.

"The bottom line is: Show me the data." -- Derek Chu, MD, PhD, of McMaster University in Ontario, Canada, on the many unanswered questions regarding the newly approved oral immunotherapy for peanut allergy.

"For some neurological disorders, we found a four to fives times higher suicide rate when compared with the general population." -- Annette Erlangsen, PhD, of the Danish Research Institute for Suicide Prevention/Mental Health Centre Copenhagen, on the elevated risk of suicide among neurology patients.

"We were always correct that this is not a safe drug." -- Steven Nissen, MD, of the Cleveland Clinic, on a new meta-analysis of rosiglitazone (Avandia).

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EHR Vendor Pays $145M to Settle Opioid Kickback Charges

An electronic health record (EHR) system developer agreed to pay $145 million to settle charges that it was involved in a kickback scheme to increase opioid prescriptions, the U.S. Department of Justice (DOJ) said in a press release.

Practice Fusion, a cloud-based EHR vendor based in San Francisco, admitted that it received a nearly $1-million payment from a "major opioid company" to develop software that encouraged doctors to prescribe more opioids.

That money came out of the unnamed drugmaker's marketing budget, DOJ said.

The startup implemented clinical decision support (CDS) alerts -- a key function of health information technology platforms -- that marketed extended-release opioids to healthcare providers, according to DOJ.

It will pay $26 million in criminal fines and $118.6 million in civil settlements. This is the first time criminal action has been taken against an EHR vendor, according to DOJ.

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When Pregnant Moms Are Distressed, Fetal Brains May Suffer

Psychological distress -- a term encompassing anxiety, stress, and depression -- was more prevalent than expected in a sample of healthy, well-educated pregnant women and was associated with impaired fetal brain development, a prospective study suggested.

Among 119 pregnant women with uncomplicated pregnancies, 27% scored high on a perceived stress questionnaire, 26% had high scores for anxiety, and 11% had elevated symptoms of depression, according to Catherine Limperopoulos, PhD, of the Center for the Developing Brain at Children's National Hospital in Washington, D.C., and colleagues.

Increases in trait anxiety scores were associated with reductions in left hemisphere fetal brain volume, and elevated maternal stress and anxiety levels were tied to increased fetal gyrification (cortical folding) in frontal and temporal lobes, they reported in JAMA Network Open. Elevated maternal depression scores also were associated with reductions in fetal creatine and choline levels.

The study involved a group of well-resourced, well-educated women, and while the research is preliminary, "it points to prenatal psychological distress being alarmingly prevalent and clinically under-recognized," Limperopoulos said.

"We did not expect these findings among women expecting normal babies. These women had no indication of any mental health disorder, which leads us to worry that many women with similar maternal distress are slipping below the radar during routine clinical encounters," she told MedPage Today.

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More Flavonol, Less Alzheimer's

Higher flavonol intake was linked to lower risk of Alzheimer's dementia in a prospective cohort study of older adults.

After adjusting for genetic, demographic, and lifestyle factors, people who consumed the highest dietary intake of flavonols were 48% less like to develop Alzheimer's dementia than people with the least intake, reported Thomas Holland, MD, of Rush University in Chicago, and colleagues, in Neurology.

"This research lends a further understanding of the contents of the foods we eat," Holland said. "The bioactives in foods -- which from our research would be specifically flavonols found in kale, spinach, tomatoes, tea, olive oil, apples, pears, and over 20 other foods -- have antioxidant and anti-inflammatory properties that have the potential to protect against cellular damage due to oxidative stress and sustained inflammation," he told MedPage Today.

Flavonols are a type of flavonoid, a group of phytochemicals found in plant pigments. "Technically speaking, we knew little regarding flavonols, specifically, and Alzheimer's dementia," Holland said. Earlier research has looked at antioxidants and Alzheimer's risk, but no studies have researched whether dietary intake of flavonoid subclasses is associated with Alzheimer's dementia, he added.

This work complements other studies that show fruit and vegetables support brain health, observed Robert Friedland, MD, of the University of Louisville, who wasn't involved with the study.

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Heart Disease Risks Fall for Most Survivors of Childhood Cancer

(MedPage Today) -- Study Authors: Daniel A. Mulrooney, Geehong Hyun, et al.; Mike Hawkins, Alex Brownsdon, Raoul ReulenTarget Audience and Goal Statement: Oncologists, cardiologists, pediatricians, family physicians, primary care physicians...
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Magic Mushrooms Ease Cancer Anxiety; Olanzapine/Samidorphan NDA Accepted

Just one dose of synthetic psilocybin -- the compound in magic mushrooms -- alleviated anxiety and depression in cancer patients for up to five years. (Journal of Psychopharmacology)

Based on the ENLIGHTEN program, the FDA accepted Alkermes' application for its schizophrenia and bipolar disorder treatment ALKS 3831 (olanzapine/samidorphan) with an expected action date of November.

Although it was FDA approved in March 2019, esketamine nasal spray (Spravato) was not recommended for inclusion as a reimbursable drug in the U.K. by the National Institute for Health and Care Excellence (NICE) due to the safety profile. (BBC)

A Rhode Island cohort study found that girls received an autism diagnosis roughly 1.5 years later on average than boys. (Autism Research)

Antidepressant-related sexual dysfunction may continue long after stopping treatment. "Some likely comfort themselves with the thought that once they stop treatment, they will get back to normal, when in fact they may be even less able to function," stated David Healy, MD, of Bangor University, writing in a commentary in the Journal of the Royal Society of Medicine.

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Repurposed Mucolytic Shows Promise for Neuroprotection in Parkinson's Disease

(MedPage Today) -- Study Authors: Stephen Mullin, Laura Smith, et al.Target Audience and Goal Statement: Neurologists, radiologists, neuropsychologists, pulmonologists, family physiciansThe goal of this study was to assess the safety, tolerability...
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Brilinta Shines in Stroke Prevention; Leadless Pacing Expands; Triglyceride Drug Clears Hurdle

Adding ticagrelor (Brilinta) to aspirin reduced risk of stroke and death among people at high risk due to a recent minor acute ischemic stroke or high-risk transient ischemic attack in topline results from the THALES trial, AstraZeneca announced.

FDA approved a new version of Medtronic's leadless pacemaker, Micra AV, that has atrial sensing, allowing the large population with atrioventricular block to avoid a dual-chamber pacemaker. (MassDevice)

FDA also cleared the SoundBite Crossing System for peripheral chronic total occlusions, SoundBite Medical Solutions announced. (Cath Lab Digest)

Another phase II trial came up positive for an antisense drug: APOCIII-LRx reduced triglycerides in patients with hypertriglyceridemia with or at risk for cardiovascular disease, Akcea Therapeutics announced in topline results, following publication of phase II results with its APO(a)-LRx agent against lipoprotein(a).

Visit-to-visit systolic blood pressure variability may flag young adults at higher risk of developing cardiovascular disease, a study showed in JAMA Cardiology.

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'Overworked and Burned Out': What We Heard This Week

"It calls attention to how overworked and burned out so many of us are." -- Brandon Peplinski, MD, of the University of Washington, discussing a residents' "sick in" to protest stalled contract negotiations.

"I now believe that it is essential to review older clinicians." -- Leo Cooney, MD, of Yale Medical School, discussing Yale New Haven Hospital's policy to implement mandatory cognitive testing of clinicians age 70 and older.

"People say 'Oh, this week, there's been a slight decline' -- they shouldn't be lulled into a false sense of security." -- Aaron Glatt, MD, spokesperson for the Infectious diseases Society of America, on this influenza B dominant flu season.

"They can't conduct cannabis research until they can show cannabis has a medical use, but they can't demonstrate cannabis has a medical use until they conduct research. It doesn't make sense." -- Rep. Anna Eshoo (D-Calif.), chair of the House Energy and Commerce Health Subcommittee, in a hearing called to discuss the health effects of cannabis.

"People are being put in a position where they're putting their health at risk because of affordability." -- Bari Talente, of the National Multiple Sclerosis Society, talking about the rising cost of MS drugs.

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Rare Shrew-Borne Illness Tied to Fatal Encephalitis

Additional evidence emerged in Germany that Borna disease virus, which resides in shrews, was associated with fatal encephalitis in people there.

Analysis of brain tissue in eight cases of encephalitis believed to have a viral origin -- going back as far as 20 years ago -- showed RNA and reactive antibodies from Borna disease virus 1, reported Martin Beer, MD, of Friedrich-Loeffler-Institut in Germany, and colleagues, in the Lancet Infectious Diseases.

Borna disease is described as a mostly fatal neurological disorder of "horses, sheep and other domestic animals" in southern and eastern Europe, including parts of Germany, Austria, and Switzerland. They noted that the bicolored white-toothed shrew is the only known natural reservoir of Borna disease virus, which causes neurotropic illness and encephalitis when transmitted to horses and sheep.

However, the mechanism for transmission to humans remains unclear, and the authors cited that as a main study limitation, though they noted that living in rural or suburban areas, agricultural work, or animal contacts -- such as owning a cat -- could be risk factors for the infection. In addition, they said that there is no indication of human-to-human transmission.

The authors cited a decades-long "unresolved scientific dispute" about the zoonotic potential of the disease, with prior research showing links to depression and schizophrenia. But they added that in 2018-2019, Borna disease virus was found in three cases of encephalitis in solid organ transplant recipients from the same donor, as well as two transplantation-independent cases.

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Bad News for Tau PET Tracer in CTE

The PET tracer 18F-flortaucipir (FTP) may have limited utility as a tau pathology biomarker in chronic traumatic encephalopathy (CTE), findings from a case report suggested.

In a former National Football League (NFL) player with pathologically confirmed CTE, flortaucipir PET findings during life showed only a modest correspondence with postmortem CTE pathology, reported William Mantyh, MD, of the University of California San Francisco (UCSF), and colleagues, in JAMA Neurology.

This is the first report to describe a PET-to-autopsy correlation in a patient with CTE, Mantyh noted.

Currently, CTE can be diagnosed only after death. Last year, Boston University researchers reported that FTP PET scans showed elevated tau levels in brain regions affected by CTE in living former NFL players, suggesting FTP could detect CTE pathology in life.

While the UCSF researchers found a similar FTP pattern to what was seen in the Boston University study and other research, "when we compared this signal to the amount of tau pathology, there was only a modest correlation," Mantyh told MedPage Today.

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Alzheimer’s Vaccine; Parkinson's PET Tracer; Fitness and Cognition

An Alzheimer's vaccine that reduced amyloid and tau buildup in mice could be ready for human trials in 18 months. (Alzheimer's Research & Therapy; PhillyVoice)

Targeting the messenger RNA that encodes alpha synuclein may slow down Parkinson's disease progression. (PNAS)

The FDA approved Fluorodopa F18, a PET tracer to help see damaged or lost nerve cells in people with Parkinsonian syndromes. (Radiology Business News)

Infants breastfed by mothers who used antiepileptic drugs had substantially lower concentrations of antiseizure medications in their blood than their mothers did. (JAMA Neurology)

The American Headache Society issued imaging guidelines for migraine. (Headache)

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Teenager in Psych Crisis Waits 25 Days in ED for Admission

On the flat-screen television in the emergency department at Baltimore Washington Medical Center that tracks how many hours have passed since check-in, one name remained as others cycled through: KRIDEL.

For hours. Then days. Then weeks.

The final number of hours before admission: 603.

On Nov. 20, 2019, Rabbi Jeremy Kridel received a call from the school of his 15-year-old son, "Henry" (not his real name). The boy had been extremely agitated for about an hour, broke things in the classroom, and began to remove his clothes.

Two months prior, Henry had been hospitalized in a neuropsychiatric unit after a similar bout of aggression, and it looked like he would need crisis intervention again.

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Zika-Exposed 'Normal' Infants May Do Worse as Time Goes On

A small cohort of Colombian infants with exposure to Zika virus in utero, but who were not diagnosed with congenital Zika syndrome at birth, showed declines in adaptive and functional skills as they aged into toddlers, researchers found.

Because most newborns with prenatal Zika exposure do not have clinical manifestations of congenital Zika syndrome (such as microcephaly or abnormal brain imaging) at birth, "the spectrum of neurodevelopmental impairment" for these infants is of "major importance," Sarah Mulkey, MD, PhD, of Children's National Hospital in Washington, and colleagues reported in JAMA Pediatrics.

Infants without congenital Zika syndrome underwent developmental evaluation at one or two time points: age 4 months to 8 months and age 9 months to 18 months. Inclusion criteria were infants born from August 2016 to November 2017 who were normocephalic at birth, had normal fetal brain imaging, and had normal examination results without clinical evidence of congenital Zika syndrome. The majority also had postnatal brain imaging.

Assessments were performed using the Warner Initial Developmental Evaluation of Adaptive and Functional Skills (WIDEA) and the Alberta Infant Motor Scale (AIMS).

Of the 77 infants from Colombia who met the criteria, 70 had no evidence of congenital Zika syndrome and were able to undergo these assessments. There were 40 infants evaluated from ages 4 to 8 months (median of almost 6 months) and 60 infants evaluated from ages 9 to 18 months (median age of 13 months). There was no change in head circumference z scores, they said, when controlling for age of gestational exposure to Zika virus.

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Analysis Supports Acupuncture for Cancer Pain

Use of acupuncture and acupressure led to significant improvement in cancer-associated pain and a reduction in analgesic medication, a meta-analysis showed.

Seven randomized trials comparing real versus sham-controlled acupuncture collectively showed a 1.38-point difference in pain intensity favoring real procedures, as assessed on a scale of 0-10 (0=none, 10=most severe). However, the overall quality of the evidence was considered moderate given that the randomized trials exhibited substantial heterogeneity.

"The findings of this systematic review and meta-analysis suggest that, based on moderate-level evidence, acupuncture and/or acupressure may be associated with significant reductions in pain intensity and opioid use," Haibo Zhang, MD, of the Guangdong Provincial Academy of Chinese Medical Sciences in China, and coauthors concluded in JAMA Oncology.

"This finding suggests that more rigorous trials are needed to identify the association of acupuncture and acupressure with specific types of cancer pain and to integrate such evidence into clinical care to reduce opioid use," they added.

The analysis adds to an existing evidence base marked by inconsistent results for acupuncture and acupressure for cancer-related pain relief. Zhang and coauthors noted that more than 20 published systematic reviews failed to show conclusively that the techniques have a significant association with cancer pain.

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Study: Transcarotid Stenting Has a Leg Up Over Femoral Approach

A technique developed to reduce stroke risk in carotid artery stenting was associated with better outcomes compared to the conventional transfemoral approach to the carotids, a study showed.

By avoiding the aortic arch with direct common carotid access and utilizing flow reversal prior to crossing the lesion, transcarotid artery revascularization (TCAR) led to fewer in-hospital events than transfemoral carotid stenting:

Stroke or death: 1.6% vs 3.1% (RR 0.51, 95% CI 0.37-0.72)Stroke: 1.3% vs 2.4% (RR 0.54, 95% CI 0.38-0.79)Death: 0.4% vs 1.0% (RR 0.44, 95% CI 0.23-0.82)

Ipsilateral stroke or death at 1 year also favored TCAR over transfemoral carotid artery stenting (5.1% vs 9.6%, HR 0.52, 95% CI 0.41-0.66), according to a group led by Marc Schermerhorn, MD, of Beth Israel Deaconess Medical Center in Boston, reporting online in JAMA.

Historically, carotid stenting has been linked to increased periprocedural stroke risk compared with endarterectomy. The CREST trial showed investigators similar outcomes between stenting and surgery long term.

TCAR marries concepts from carotid stenting and carotid endarterectomy. The downside of this procedure appeared to be a higher risk of access site complication resulting in interventional treatment (1.3% vs 0.8%, RR 1.63, 95% CI 1.02-2.61), according to Schermerhorn's group.

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Dementia Life Expectancy; Teens and Opioids; Duchenne Test for Newborns

A simple tool predicted life expectancy after dementia diagnosis to help guide care planning. (Neurology)

The levodopa paradox: why don't untreated Parkinson's patients have the "ineffective stepping" type of freezing? (JAMA Neurology)

Mice watching the opening scene of the Orson Welles film "Touch of Evil" shed new light on how neurons in the visual cortex work. (STAT)

Silent seizures in Alzheimer's patients may be due to a leaky blood-brain barrier. (Science Translational Medicine)

Older teens appeared to have similar risk factors for prescription opioid overdose as adults. (JAMA Pediatrics)

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The Price to Pay for Isolation and Lack of Environmental Stimulation

(MedPage Today) -- Study Authors: Alexander C. Stahn, Hanns-Christian Gunga, et al.Target Audience and Goal Statement: Neurologists, primary care physiciansThe goal of this exploratory study was to assess the effects of prolonged social isolation...
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Cannabidiol Cuts Seizures in Another Rare Epilepsy

BALTIMORE -- Adjunctive cannabidiol, or CBD, (Epidiolex) met its primary endpoint of reducing seizures in patients with tuberous sclerosis complex (TSC), a rare and severe form of childhood-onset epilepsy, a phase III pivotal trial showed here.

Seizure frequency dropped from baseline by 49% with daily doses of CBD at 25 mg/kg per day (P=0.0009) and by 48% with CBD at 50 mg/kg per day (P=0.0018), versus 27% with placebo, reported Elizabeth Thiele, MD, PhD, of the Massachusetts General Hospital in Boston, and co-authors at the American Epilepsy Society annual meeting.

"Our findings suggest this formulation of purified CBD offers patients with TSC a new treatment option for their very difficult-to-manage seizures," Thiele said in a statement.

Epidiolex is a pharmaceutical formulation of a highly purified oral solution form of CBD, a component of the cannabis plant that does not cause the high associated with tetrahydrocannabinol (THC). Drug maker GW Pharmaceuticals won FDA approval for Epidiolex to treat two other rare epilepsies, Dravet syndrome and Lennox-Gastaut syndrome, in 2018.

The majority (80% to 90%) of people with TSC -- a condition that causes benign tumors to form throughout the body -- also have seizures. TSC is a leading cause of genetic epilepsy and more than 60% of patients do not achieve seizure control with standard treatment.

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Managing Hep C; A New Migraine Therapy: It's PodMed Double T!

PodMed Double T is a weekly podcast from Texas Tech. In it, Elizabeth Tracey, director of electronic media for Johns Hopkins Medicine, and Rick Lange, MD, president of the Texas Tech University Health Sciences Center in El Paso, look at the top medical stories of the week. A transcript of the podcast is below the summary.

This week's topics include managing hepatitis C in disadvantaged populations, a new treatment for migraine, national suicide data, and treating swallowing disorders.

Program notes:

0:40 New treatment for migraine

1:40 Randomized to three groups

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