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Saturday, April 20, 2019

Increased Screen Time in Preschool Tied to Worse Inattention

Increased screen time in preschool is associated with increased odds of clinically significant externalizing problems and clinically significant inattention problems, according to a study published online April 17 in PLOS ONE.
Sukhpreet K. Tamana, Ph.D., from the University of Alberta in Edmonton, Canada, and colleagues examined the correlations between screen time and preschool behavior using data from the Canadian Healthy Infant Longitudinal Development study. Children’s total screen time was reported, including on gaming and mobile devices, and was categorized according to the recommended thresholds of two hours/day for five years or one hour/day for three years. Screen-time data were available for 2,322 children.
Mean screen time was 1.4 and 1.5 hours/day at five and three years, respectively. The researchers found that children watching more than two hours/day had a 2.2-point increase in externalizing T-score compared with children with less than 30 minutes/day; they also had fivefold increased odds for reporting clinically significant externalizing problems and were 5.9 times more likely to report clinically significant inattention problems. The risk for meeting criteria for attention-deficit/hyperactivity disorder was increased 7.7-fold for children with more than two hours of screen time per day. No significant correlation was identified between screen time and aggressive behaviors.
“Our findings indicate that preschool may be a critical period for supporting parents and families on education about limiting screen-time and supporting physical activity,” the authors write.
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Investigators incorporate randomized trial within dialysis care delivery

A recent clinical trial fully embedded into the routine delivery of care at dialysis facilities sought to determine if hemodialysis sessions that are longer than many patients in the United States currently receive can improve patients’ health. Although the trial accomplished most of its objectives, uptake of the intervention was insufficient to determine whether longer sessions are beneficial. The findings, which appear in an upcoming issue of JASN, indicate that embedding trials into dialysis care will require more effective strategies for engaging clinicians and patients.
The trial’s investigators had 2 goals: to develop approaches for embedding large randomized trials into the routine delivery of clinical care, and to determine whether patients benefit from hemodialysis sessions that are longer than usual. In the Time to Reduce Mortality in ESRD (TiME) trial, 266 dialysis facilities randomized to the intervention adopted a default hemodialysis session duration of at least 4.25 hours for new dialysis patients; those randomized to usual care had no trial-specified approach to duration. Trial implementation was highly centralized, with no on-site research personnel and complete reliance on clinically acquired data.
The team demonstrated that a trial embedded into clinical care delivery with no on-site research personnel could efficiently enroll a large number of participants using an opt-out approach to informed consent. (The trial enrolled 7,035 patients.) The trial was also able to obtain useful treatment and outcomes data from hundreds of medical facilities and monitor trial conduct and safety through a centralized approach.
The trial was discontinued at a median follow-up of 1.1 years because of an inadequate between-group difference in session duration. Average session duration was 216 minutes for the intervention group and 207 minutes for the usual care group. Investigators found no reduction in mortality or hospitalization rates for the intervention vs. usual care.
“There is a pressing need for data from randomized trials to guide clinical practice in dialysis,” said lead author Laura M. Dember, MD (University of Pennsylvania Perelman School of Medicine). “Pragmatic trials embedded in clinical care delivery have tremendous potential for efficiently producing evidence that is highly generalizable to the non-research setting; however, experience with this approach is limited. The TiME trial provides an important foundation for future pragmatic trials in dialysis as well as in other settings.”
Story Source:
Materials provided by American Society of Nephrology. Note: Content may be edited for style and length.
Journal Reference:
  1. Laura M. Dember, Eduardo Lacson, Steven M. Brunelli, Jesse Y. Hsu, Alfred K. Cheung, John T. Daugirdas, Tom Greene, Csaba P. Kovesdy, Dana C. Miskulin, Ravi I. Thadhani, Wolfgang Winkelmayer, Susan S. Ellenberg, Denise Cifelli, Rosemary Madigan, Amy Young, Michael Angeletti, Rebecca L. Wingard, Christina Kahn, Allen R. Nissenson, Franklin W. Maddux, Kevin C. Abbott, J. Richard Landis. The TiME Trial: A Fully Embedded, Cluster-Randomized, Pragmatic Trial of Hemodialysis Session Duration. Journal of the American Society of Nephrology, 2019; ASN.2018090945 DOI: 10.1681/ASN.2018090945
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HHS Touts Study Aimed at Slashing Opioid Deaths

Health and Human Services Secretary Alex Azar announced a new study that aims to dramatically cut opioid overdose deaths in four states within 3 years.
The HEALing Communities study aims to lower the overdose death rate by 40% within 3 years in select communities in four states: Kentucky, Ohio, New York, and Massachusetts.
The program is part of a broader trans-agency program known as the Helping to End Addiction Long-Term (HEAL) initiative.
Azar spoke Thursday alongside leaders from the NIH and the Substance Abuse and Mental Health Services Administration (SAMHSA), as well as Kentucky Gov. Matt Bevin (R), all of whom stressed the study’s science-based, holistic approach.
“It takes a whole community to beat this crisis. It takes doctors, nurses, cops, courts, teachers, mayors, employers, parents, coaches, young people, faith leaders. It takes everybody,” Azar said.
HEAL awarded grants to academic institutions in the four states, an NIH press releasenoted, each of which will partner with at least 15 communities to assess “the impact of integrating evidence-based prevention, treatment and recovery interventions across primary care, behavioral health, justice and other settings in highly affected parts of the country.”
“We’ve been doing it in isolation, but we’ve never done something as ambitious as this” with an integrated effort, said Nora Volkow, MD, director of the National Institute on Drug Abuse (NIDA).
“The communities themselves are going to be the laboratory that is going to allow us to learn how to address the crisis,” she added.
While there’s strong consensus that medication-assisted treatment (MAT) should be the standard of care, it often doesn’t reach the people most in need of evidence-based therapy.
Speaking at the press briefing, Alex Elswick, 28, founder of Voices of Hope in Lexington, Kentucky, and a person in long-term recovery, said he was initially prescribed painkillers following the removal of his wisdom teeth. He then became addicted to opioids, then heroin.
Elswick spent time in jail and on the streets while cycling through periods of recovery and relapse.
“The entire time that I was addicted I never initiated on medication for opioid use disorder, because none of the health professionals I interacted with ever presented it to me as a legitimate option, despite the fact the research tells me that it’s the gold standard for treating my condition.”
Elswick said he sought help for his addiction.
“[E]very time I left the treatment center, they called it a graduation, and they handed me a pamphlet with a list of ’12 step’ meetings … and every time I relapsed and I devastated my family, because there was never a meaningful linkage to long-term recovery support services.”
Elswick said he’s been to more funerals than weddings due to the epidemic and is heading to another funeral — that of a young man from his college who overdosed — on Friday.
“I’m sorry to say that HEAL came too late for him, but HEAL is just in time for the tens of thousands of lives it’s going to save going forward,” he said.
Elements of the study include increasing distribution of naloxone and connecting those within the criminal justice system to treatment for opioid use disorders, noted the NIH press release.
Asked about stigma as a barrier to treatment and the oft-repeated line that MAT is just “replacing one drug with another,” NIH Director Francis Collins, MD, PhD, called them “destructive.”
“If you’re setting up a treatment for opioid addiction, it has to include medication,” Collins told MedPage Today, citing a March report from the National Academies of Sciences, Engineering, and Medicine. “Without medication the failure rates are dramatically high.”
While psychosocial supports are important in combination with medication, Collins added, “what we really need less of, and I know this is hard for people to hear … are 28-day ‘detox’ programs that send people out, after 28 days, without medication treatment and without a plan. That is often the area of greatest risk for somebody to fall back into the same pattern and end up with an overdose and even a death.”
The HEALing Communities study will cost more than $350 million.
The NIH will oversee the research study in combination with SAMHSA, which already funds many of prevention, treatment, and recovery support services that will be involved in the study, and in partnership with state and local government officials, said Adm. Brett Giroir, MD, HHS’s assistant secretary for health and its top opioid policy advisor.
The four academic institutions partnering in the study include the University of Kentucky in Lexington; Boston Medical Center; Columbia University in New York City; and Ohio State University in Columbus.
RTI International, based in North Carolina, will be responsible for coordinating the study as well as managing “data analysis, health economics research, and widespread dissemination of research findings over the course of the study.”
A SAMHSA spokesperson reminded the press and clinicians that digital tools for identifying treatment centers can be found through SAMHSA’s treatment locator.
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White House Continues to Tackle Opioid Abuse With $350 Million R&D Initiative

The White House is expanding its war on opioid addiction with a $350 million addiction research and treatment initiative.
The goal of this investment is to reduce opioid-overdose deaths by as much as 40 percent in communities across four states that have been hit hard by the epidemic. According to the U.S. Department of Health and Human Services, 116 Americans die daily from opioid overdoses. The new initiative will focus on about 60 towns across Kentucky, Ohio, Massachusetts and New York, the Wall Street Journal reported this morning. The funding will be used to support different treatment options for opioid-abusers, including an increase of naloxone and other overdose treatments. Last year, the U.S. Food and Drug Administration voted in favor of a plan that would encourage prescribers to think of adding naloxone when prescribing opioids to certain patients who may be at risk of overdose. In addition to increasing the availability of naloxone, the funds will be used to support enhanced law enforcement measures, as well as substance-abuse counseling resources, the Journal reported.
The National Institute of Health is also focusing its research efforts on the study of basic neuroscience in an effort to produce new drug and behavioral treatment methods. The Journalnoted. Part of the White House’s plan includes research grants to the University of Kentucky in Lexington; Boston Medical Center; Columbia University; and Ohio State University, in Columbus, the Journal said.

Last month, the U.S. Department of Health and Human Services released an additional $487 million to supplement first-year funding through its State Opioid Response (SOR) grant program. The funds are part of HHS’s Five-Point Opioid Strategy and the Trump administration’s tireless drive to combat the opioid crisis. The additional funding released adds up to $1.4 billion in SOR grants. HHS said the funding will expand access to treatment that works, especially to medication-assisted treatment with appropriate social supports.
Also in March, the White House released its outlined plan to stop opioid abuse and reduce drug supply and demand in the United States. The White House initiative is aimed at addressing various factors fueling the opioid crisis, including over-prescription, illicit drug supplies, and insufficient access to evidence-based treatment, primary prevention and recovery support services. For over-prescribing, the White House plan includes a nation-wide evidence-based campaign to raise public awareness about the dangers of prescription and illicit opioid use, as well as other drug use. The plan also takes aim at encouraging the development of non-opioid pain relief medications.
“We will work to strengthen vulnerable families and communities, and we will help to build and grow a stronger, healthier, and drug-free society,” President Donald Trump said in a statement.

The new funding announced by the government comes in the wake of multiple arrests for the illegal prescribing and distribution of opioids. The indictments include doctors, nurses and pharmacists from across the Appalachia region.
Not only have physicians who allegedly wrote illegal prescriptions of opioids been targeted, so too have some of the companies that manufacture opioid drugs. Last month, embattled Purdue Pharma has agreed to pay $270 million to settle a lawsuit brought against the company over the marketing of its opioid painkiller OxyContin. The lawsuit filed against Purdue points to the company’s aggressive marketing tactics used to gain wide-spread use of its pain killer. The state of Oklahoma had been seeking more than $20 billion in damages from Purdue, as well as other opioid manufacturers, such as Teva Pharmaceutical and Johnson & Johnson. While Purdue has settled this case, there are still numerous others it faces, including one in Massachusetts. The Bay State has attempted to place blame on the company for 670 opioid-related deaths in the state since 2009.
In February, the U.S. Food and Drug Administration drafted new plans that will allow it to address past mistakes regarding the opioid crisis and “get ahead” of the situation that claims the lives of over 100 Americans per day. Gottlieb said the FDA intends to “make sure that we’re acting forcefully enough to address new threats that could extend this crisis.”
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What a 30-day break from smoking marijuana does to your brain

Here’s something pot-using teens should remember: Swearing off marijuana for a month may improve memory.
A recent study from Massachusetts General Hospital offers “convincing evidence” that adolescents and young adults who abstain from marijuana for 30 days are better at acquiring and storing new information compared to their counterparts who persist in the pot puffing.
The memory improvements — specifically the capacity to absorb new information and access it at a later date — could be seen as early as a week into abstinence, researchers said in the findings, published in the peer-reviewed Journal of Clinical Psychiatry.
‘This study provides convincing evidence that adolescents and young adults may experience improvement in their ability to learn new information when they stop using cannabis.’
“Declarative memory, particularly encoding of novel information, was the aspect of memory most impacted by cannabis abstinence,” it concluded.
“This study provides convincing evidence that adolescents and young adults may experience improvement in their ability to learn new information when they stop using cannabis,” they wrote, noting adolescent marijuana use is “widespread” and will likely increase. Researchers worked from a sample of 88 Boston-area marijuana smokers between the age of 16 and 25. The people selected to forgo marijuana had to take urine tests.
In fact, some teens are more likely to use weed than they are to drink alcohol. The majority of the 55 million recreational marijuana users in the U.S. are millennials, according to a 2017 Yahoo News poll. Meanwhile, millennials drink far less alcohol than past generations, an annual national survey of 50,000 adolescents and young adults in America from the Monitoring the Future Study found.
More U.S. states have legalized marijuana
The study comes as fully legalized marijuana use is taking root in some parts of the U.S. and nationwide in Canada. Recreational marijuana use is legal for ages 21 and up in the District of Columbia and nine states, including Massachusetts.
Other states, including New Jersey, are eyeing full legalization. Medical marijuana is legal in another 22 states, as doctors note the drug’s benefits for conditions like chronic pain and glaucoma. Canada legalized the use of recreational marijuana on Oct. 17.
Meanwhile, cannabis companies are also getting a lot of investor attention these days — even with the market recently harshing a good buzz. Monday capped another tough day for cannabis companies including Aurora CannabisACB, +0.45% Aleafia Health Inc. ALEAF, +8.90%  and Cronos CRON, -1.07%
Those who maintained abstinence learned more words than those who continued to use cannabis.
“In this era of widespread cannabis legalization, we need to be mindful of more prevention programs for adolescents and young adults,” Randi Schuster, the study’s lead author, told MarketWatch. The study noted that two years ago high-school senior perceptions of regular marijuana use as harmful were “at or near historic lows.”
Schuster, an assistant professor of psychiatry at Harvard Medical School, and senior author A. Eden Evins noted that the findings focus on a critical time in a person’s life, while their brain is still maturing and they are going to school.
Evins, a psychiatry professor at Harvard Medical School, said the study included “weekend users” who might be under the impression that a hazy Saturday night didn’t matter for an upcoming test. “That may not be the case,” Evins said. “They may be okay for the test in a week’s time.”
The authors said the study was the first of its kind to examine whether cognitive improvement happened with abstinence, and when that improvement happened. “What we found was surprising,” said Schuster. There was a lot of improvement in just one week, the study found.
The tell-tale differences were found in participants’ ability to absorb new information, like a broader vocabulary.
The tell-tale differences were found in participants’ ability to absorb new information, like a broader vocabulary. “Those who maintained abstinence learned more words than those who continued to use cannabis,” the study said.
Experimenters acknowledged they lacked a non-using control group to measure the improvements. A broader version of the experiment is planned, using 13- to 19-year-olds and a control group comprised of people, Schuster said.
The forthcoming study will look into memory and attention, but also other mental tasks like decision-making, she noted. Including a non-using control will help researchers determine if abstinence returns certain cognitive tasks back to a normal baseline, Schuster said. Findings are expected in about a year.
The newly-released study noted marijuana is thought to impact brain maturation through tetrahydrocannabinol (THC). THC is the chemical that causes the user’s high and the study involved changes in THC levels.
But there’s a whole other angle to the budding cannabis market, and its effects are still being studied as well. Another component of marijuana is cannabidiol,which reportedly helps with anxiety and inflammation without any high. The CBD market is estimated to grow to $2 billion by 2020.
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Friday, April 19, 2019

Second death in Novartis gene therapy trials probed

Novartis AG, which this week announced positive interim trial results for its experimental gene therapy for spinal muscular atrophy, on Friday said investigation is underway into whether a second trial death could be related to the treatment.
Novartis has filed for U.S. Food and Drug Administration approval of the gene therapy, Zolgensma, and a decision is expected within weeks. The FDA submission was based on findings from a trial of 15 babies treated with Zolgensma.
But Novartis has expanded its clinical trial program – presenting on Tuesday at an Orlando, Florida meeting of the Muscular Dystrophy Association interim results for 22 babies with Type 1 SMA, the most serious form of the disease. The data showed that Zolgensma treatment resulted in encouraging progress in motor skills such as the ability to sit up. One patient died from respiratory failure, which was deemed by the investigator and an independent monitor to be unrelated to the gene therapy.
SMA, which can lead to paralysis, breathing difficulty and death, is the leading genetic cause of death in infants.

Novartis officials also disclosed that in addition to that death, a 6-month-old patient with Type 1 SMA had recently died after undergoing Zolgensma treatment in the company’s European trial.
“Preliminary findings indicate this occurred in the context of a severe respiratory infection followed by neurological complications in a symptomatic SMA Type 1 patient, and was deemed possibly related to treatment by the investigator,” Novartis spokesman Eric Althoff said in an emailed statement on Friday.
He said an autopsy has been performed and results are pending. Meanwhile, trial investigators and regulatory authorities have been informed.
Gene therapies use engineered viruses to carry healthy genetic material into a person’s cells to replace faulty or mutated genes that cause a disease or condition. Zolgensma

“As we learn more, we will provide further updates,” Althoff said.
Novartis estimates that without treatment, 50 percent of babies with SMA Type 1 will not survive or will need permanent breathing support by the time they are 10.5 months old.
The company has said its price for Zolgensma will be determined in negotiations with health plans, but it believes the gene therapy would be cost effective at $4 million to $5 million as a one-time treatment.
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Gene-editing technique opens door for HIV vaccine

The human body cannot naturally defend itself against HIV—not usually, at least. But in very rare cases, infected individuals generate broadly neutralizing antibodies, or bNAbs, that fight the virus. Now, Rockefeller scientists have devised a way to grant this HIV-fighting power to otherwise average immune cells.
Michel C. Nussenzweig, whose work on bNAbs has produced new HIV treatments showing promise in early clinical trials, has now set his sights on a second goal: immunization against the virus.
In a recent study, described in the Journal of Experimental Medicine, Nussenzweig and his colleagues used CRISPR-Cas9 gene editing technology to modify B cells, a type of white blood cell that secretes antibodies. Specifically, the researchers engineered mouse B cells to make human bNAbs on their own. Cells altered in this way, the researchers found, produced antibody levels sufficient to protect the animals against HIV—suggesting that this technique could eventually be used as an immunization tool.
While this research is still in an early stage, it demonstrates the feasibility of enhancing immune response via gene editing. Importantly, the technique does not affect germline  and therefore evades the ethical concerns sometimes raised by CRISPR interventions. If realized, this novel approach to immunization could be useful not only against HIV, but against any disease that is sensitive to a specific antibody.
Explore further
More information: Harald Hartweger et al. HIV-specific humoral immune responses by CRISPR/Cas9-edited B cells, The Journal of Experimental Medicine (2019). DOI: 10.1084/jem.20190287
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