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News Briefs

FDA Approves New Epinephrine Injector For Anaphylaxis

Symjepi is latest alternative to Epi Pen

by Molly Walker, Staff Writer, MedPage Today/June 16, 2017

WASHINGTON -- The FDA announced the approval of an epinephrine injector product called
Symjepi, made by Adamis Pharmaceutical Corp. as the latest alternative to Mylan
Pharmaceuticals' EpiPen for the treatment of severe allergic reactions.

The product is a 0.3-mg prefilled syringe for the emergency treatment of allergic reactions,
including anaphylaxis, for patients who weigh 30 kg (66 pounds) or more. The agency noted in a
press release that the drug is not meant as an alternative to EpiPen Jr, which is intended for
patients weighing between 15 kg and 30 kg (or 33 to 66 pounds).

Symjepi will be available as both a single-pack and a two-pack of pre-filled syringes. The FDA
warned that along with administration of the drug, persons with these severe allergic reactions
should seek immediate medical care and more than two sequential doses of epinephrine should
only be administered under direct medical supervision.

EpiPen was surrounded by its fair share of controversy over its pricing in the past year, along with a
recall of a couple of its products in the spring. Other epinephrine injectors exist on the market, but
EpiPen is the most well-known.

NFL players with limited vocabulary could have brain damage: Study warns speech is the first
sign of CTE - starting 8 years before other symptoms
By CHeyenne Roundtree for Dailymail.com/June 2, 2017

Limited speech patterns could be a warning sign of brain disease in athletes, years before their
condition is diagnosed, a new study claims.

Within the past few years, more and more retired NFL players have revealed they were diagnosed
with degenerative brain diseases, such as dementia and Alzheimer's.

The former players are attributing their conditions to the repeated hits they took while playing

Several top athletes have pledged their brains to CTE research to help confirm a link between the
contact sport and the disease.

Now a small study is claiming to have found an early link between developing brain disease in
NFL players by the simple way that they talk.

For full article see Dailymail.com/Health

Read more: http://www.dailymail.co.uk/health/article-4567506/NFL-players-speech-point-brain-
Follow us: @MailOnline on Twitter | DailyMail on Facebook

Telemedicine Seen As OK For Concussion Evaluation In Football
Remote assessment could help address medical shortages in youth sports.
By Ryan Basen/Staff Writer/MedPage Today/April 3, 2017.

Neurologists examining college football players via a telemedicine robot made the same
decisions as onsite physicians on removal from play and reached similar diagnoses in a pilot
study, researchers said.

The findings suggest a potential solution to the shortage of immediate neurological care for
potentially injured young athletes.

Sports neurologist Bert Vargas, MD, of the University of Texas Southwestern Medical Center, and
colleagues studied the Northern Arizona University football team over two seasons, stationing a
VGo robot on the sideline during games monitored by remote neurologists,

in addition to the team's official caregivers. The motorized robot was equipped with a high-
resolution camera, microphones, speakers, and wireless internet connectivity. The researchers
followed 50 players, with 11 suffering suspected concussions.

The remote neurologists made the same decision on whether to remove injured players as the
onsite provider in all 11 cases (while blinded). They administered the diagnostic King-Devick (KD)
test on average within 0.7 seconds of the onsite providers and KD times were within 3 seconds in
all 11 cases (95% CI, 72%-100%).

Among the six players not already removed from play based on personal history and K-D scores,
Standardized Assessment of Concussion scores matched for all six. And, modified Balance Error
Scoring System scores were within 3 points for all six.

"This feasibility study suggests that teleconcussion evaluations are safe and effective for providing
accurate and rapid assessments of athletes and RFP determinations at the time of suspected
injury," the authors wrote in an article published online in Neurology.

Results suggest a telemedicine approach could help a high school sports population that lacks
the resources to universally address suspected brain injury immediately.

More than half of U.S. high schools did not have sideline medical personnel including athletic
trainers when the authors launched this study (and reports indicate that statistic has not improved

The problem is especially acute in rural areas, where the closest accessible medical professional
may be miles away during a Friday night football game.

Younger pediatric athletes face a similar deficit -- leading the National Athletic Trainers
Association, Korey Stringer Institute and Safe Kids Worldwide to call for more medical help to
address brain injury among other suggested guidelines released at a youth sports safety summit
in March.

"I see the possibility of being able to manage the entire spectrum of (sports) concussion care tele-
medically," Vargas said, noting promising evidence corresponding to each step is emerging.

The Arizona study is merely a pilot and featured college athletes, so authors cautioned against
drawing any conclusions.

In addition: "This study did not address whether using a robotic unit versus less-expensive, more
portable technology influences the ease and accuracy of assessments," they wrote, addressing
financial concerns. "The cost-effectiveness of these assessments, and the need for a face-to-face
provider to assist with the examination should also be appraised critically."

"We realize many school districts and individual schools wouldn't have money to buy a
telemedicine robot," Vargas said. But smartphones could be a viable long-term option, he added,
for such schools and youth club teams that can find people to monitor the phone onsite.

Vargas' team is planning to launch a larger study of providers' return-to-play decisions regarding
college and high school players, he said. He noted that the current study didn't address return-to-
play decisions for athletes benched because of head injuries.

Vargas also cautioned that the results in college players may not apply to younger athletes. The
researchers studied college players because sideline providers presented a "gold standard" for
comparisons with remote evaluators.

Primary Source: Neurology. Vargas B, et al "Feasibility and accuracy to teleconcussion for acute
evaluation of suspected concussion" Neurology 2017; DOI 10.12.12.

The Brain After Cardiac Arrest
Seminars in Neurology/Jonathan Elmer, MD, MS; Clifton W. Callaway, MD, PhD. 2017;37(1):019-

Cardiac arrest (CA) is the most common cause of death in the developed world, claiming over 17
million lives annually.[1–3] Despite advances in care, the majority of patients who are treated after
the return of spontaneous circulation (ROSC) will succumb to the sequelae of hypoxic-ischemic
brain injury before hospital discharge.

Similar to traumatic brain injury, hypoxic-ischemic brain injury after CA results in both primary and
secondary injuries, with distinct mechanisms and treatment strategies (Fig. 1).

High-quality cardiopulmonary resuscitation (CPR) initiated as soon as possible after collapse, and
early defibrillation to rapidly restore normal perfusion, are the most important interventions to
reduce the severity of primary brain injury.[4] It remains unclear whether care provided after ROSC
can reduce the severity of primary brain injury or if therapies after CPR improve outcomes only by
reducing the risk of secondary brain injury.

Evidence-based therapies in the hours to days after ROSC that improve neurologic outcomes
include targeted temperature management; early coronary revascularization; delayed, multimodal
neurologic prognostication; and postacute care rehabilitation.[5]

For full article see Medscape.

Alternative Medicine Becomes A Lucrative Business for U.S. Top Hospitals
by Ilene MacDonald/March 7, 2017/FierceHealthcare

Chinese herbal therapies, acupuncture, homeopathy and reiki are just a few of the offerings that
some prestigious medical centers now provide, despite the fact that in many cases there is no
evidence the therapies work.

The rise of alternative medicine has created friction within some of these hospitals as many
physicians believe it undermines the credibility of the organizations, according to an in-depth
investigation of 15 academic research centers by STAT.

The issue came to the forefront earlier this year when the Cleveland Clinic decided to rethink its
alternative medicine offerings and how they align with evidence-based practices after the director
of the organization’s wellness program went on an anti-vaccine rant in a blog post that sparked an
immediate backlash.

The clinic said the wellness center would stop selling some of the products, like homeopathy kits,
on its website and focus instead on items that improve diet and lifestyle.

But the STAT investigation noted that the Cleveland Clinic is just one of many that has a hand in
the $37-billion-a-year business. Other organizations include Duke University, Johns Hopkins, Yale
and the University of California, San Francisco. Some hospitals open spa-like wellness centers,
while others, like Duke, refer to them as integrative medicine centers.

Several of the hospitals highlighted in the STAT report declined to talk to the publication about why
they have embraced unproven therapies, but critics were quick to point out that patients are being
“snookered” and physicians who promote these therapies forfeit claims that they belong to a
science-based profession.

“We’ve become witch doctors,” Steven Novella, M.D., a professor of neurology at the Yale School of
Medicine and a longtime critic of alternative medicine, told STAT.

Others, however, say that alternative therapies have helped patients and modern medicine doesn’t
offer a cure for everyone. Linda Lee, M.D., who runs the Johns Hopkins Integrative Medicine and
Digestive Center, said the therapies offered are meant to complement, not supplement,
conventional treatment.

But Novella worries that when these unconventional treatments are offered by prestigious
institutions, patients will think they are legitimate. The problem only worsens when patients find
the treatments being sold online by the institution. Thomas Jefferson University Hospital, for
instance, sells homeopathic bee venom to relieve symptoms of arthritis.

Daniel Monti, M.D., who directs the integrative health center at the organization, admits the
evidence behind some of these treatments is largely anecdotal but said the hospital only offers the
treatment when there are few other options.

Twitter @atlantalegalRN

LInkedin Liz Buddenhagen

Liz Buddenhagen