urges doctors to aggressively test pregnant women for Zika
The Centers for Disease Control and Prevention is calling on doctors to more
aggressively screen pregnant women for the Zika virus and to take advantage
of new testing technology to improve the diagnosis, follow-up and monitoring
of those who have been infected.
The guidance, published Monday, comes amid growing concerns about Zika,
which is spread by mosquito bite and sexually transmitted. If contracted by
pregnant women, it can result in severe birth defects ? including
microcephaly, which stunts children?s brain development. It has also been
implicated in miscarriages and diseases like Guillain-Barre, a neurological
disorder that causes temporary paralysis.
By urging testing for more pregnant women, the recommendations ?will improve
our ability to give definitive diagnoses of the Zika infection to those
women who are at the highest risk,? said Margaret Honein, who chairs the
CDC?s birth defects branch. She was also a co-author on the guidance.
Previously, Zika testing was only recommended for pregnant women if they or
their sexual partner had traveled to an area where the virus was actively
spreading, and if they showed symptoms. That?s changed ? even if a pregnant
woman or her partner doesn?t show symptoms, the CDC now says she needs to be
?They?re incorporating the fact that we know transmission can occur, even in
the absence of symptoms,? said Neil Silverman, a clinical professor of
obstetrics and gynecology at UCLA?s medical school, and an expert in
obstetric infectious diseases.
Zika has been spreading in many Latin American and South American countries,
along with Puerto Rico. Public health experts warn it could reach the
continental United States by summer?s end. In Florida, epidemiologists are
investigating two cases in which local mosquitoes may have transmitted the
virus. About one-fifth of those infected show symptoms, which can resemble
Another key part of the guidelines emphasizes the need for physicians to use
various testing methods.
For instance, both symptomatic and asymptomatic pregnant women should be
screened within two weeks of the date of possible Zika exposure through a
DNA-based test known as PCR. PCR has been in use already, but until
recently, was believed to only work within one week of exposure.
If the PCR test turns up negative or an at-risk pregnant woman missed that
initial two-week window, the CDC calls for screening with a test that
searches for antibodies the virus produces. That test, which is effective
for as long as 12 weeks after exposure, is considered a less reliable
indicator and has drawn some criticism because it can generate false
The CDC has been working with a number of physicians groups to help educate
doctors about when and how to use different tests, Honein said.
Beyond testing, the guidance says all pregnant women in the United States
and its territories should be ?assessed for possible Zika virus exposure?
whenever they get a prenatal care visit. That doesn?t necessarily mean
testing, especially if a patient hasn?t been exposed to the virus. But it?s
a firmer line than the government?s previously taken.
There?s no known cure for Zika. If pregnant women test positive for the
virus, the CDC recommends regular ultrasounds to gauge the fetus? health and
the level of risk the individual patient might face. Those recommendations
are similar to the agency earlier directions.
Visit Kaiser for the report.
launches early-stage yellow fever vaccine trial
The National Institute of Allergy and Infectious Diseases (NIAID), part of
the National Institutes of Health, has begun an early-stage clinical trial
of an investigational vaccine designed to protect against yellow fever
virus. The Phase 1 study is evaluating whether an experimental vaccine
developed by the Danish biopharmaceutical company Bavarian Nordic is safe,
tolerable and has the potential to prevent yellow fever virus infection.
Yellow fever virus is found in tropical and subtropical areas in South
America and Africa. It caused an estimated 84,000 to 170,000 severe cases of
disease and 29,000 to 60,000 deaths in 2013, according to the World Health
Organization (WHO). The virus is transmitted to people primarily through the
bite of infected female Aedes aegypti mosquitoes.
Mild cases of infection can cause fever, back pain, headache, nausea,
vomiting, fatigue and weakness. Most people recover, but approximately 15
percent of those infected develop severe disease manifested as yellow eyes
and skin (jaundice), hemorrhage and shock, resulting in potentially fatal
kidney, liver or heart conditions.
?Yellow fever has recently re-emerged as a major public health threat in
parts of Africa. Although a vaccine exists to prevent this serious disease,
it is currently in short supply, and it is not recommended for certain
populations, such as pregnant women and people older than 60 years,? said
NIAID Director Anthony S. Fauci, M.D. ?We must develop new options for
preventing this terrible disease.?
As of July 21, 2016, the WHO has reported a total of 3,682 suspected yellow
fever cases with 361 deaths in the African country of Angola. Meanwhile,
another 1,798 suspected cases have been reported in the Democratic Republic
of The Congo (DRC), including 85 deaths. Cases with links to Angola have
also been reported in Kenya and China.
More than 105 million people in Africa have been vaccinated against yellow
fever in mass campaigns since 2006, according to the WHO. Despite this
success, vaccine supplies are limited.
In addition, in very rare cases, the current yellow fever vaccine can
produce severe adverse complications, such as neurologic side effects,
multiple organ system dysfunction and death. For this reason, the vaccine
should not be given to infants, the elderly, pregnant women and those with
compromised immune systems.
Bavarian Nordic?s experimental yellow fever vaccine, dubbed MVA-BN-YF, is
based on the company?s proprietary MVA-BN platform, which uses an attenuated
(weakened) version of the Modified Vaccinia Ankara (MVA) virus as a vaccine
vector to carry yellow fever virus genes into the body. According to
Bavarian Nordic, more than 7,600 people, including 1,000 individuals who are
immunocompromised, have been safely vaccinated with MVA-BN-based vaccines.
Previous laboratory and animal studies have suggested that combining MVA-BN
with ISA 720, an experimental immune-boosting adjuvant that has been used in
prior clinical trials, induces a strong immune response after a single dose
of vaccine. One goal of the study will be to assess whether two doses of
unadjuvanted vaccine or a single dose of ISA 720 adjuvanted vaccine could
provide protection against yellow fever.
The multi-site clinical trial will be conducted by NIAID-funded Vaccine and
Treatment Evaluation Units (VTEUs) at the University of Iowa in Iowa City
and Saint Louis University in Missouri. Emory Vaccine Center in Decatur, GA
will assist in evaluating data.
Visit NIH for the report.
recommends that Vestagen discontinue claims that their hospital scrubs
The National Advertising Division (NAD) has recommended that Vestagen
Protective Technologies, Inc., discontinue certain advertising claims for
the company?s Vestex fabric, including claims that garments made with Vestex
fabric protect healthcare workers and their patients from pathogens,
dangerous contaminants and healthcare-associated infections.
The claims at issue were challenged by Strategic Partners, Inc. (SPI), the
maker of competing scrubs and other hospital garments.
Vestagen agreed to permanently discontinue certain claims during the course
of the proceedings. However, NAD routinely reviews all claims that are
?live? at the time that the challenge is filed.
NAD is an investigative unit of the advertising industry?s system of
self-regulation. It is administered by the Council of Better Business
NAD reviewed claims that included:
transforms healthcare garments into apparel that helps guard workers and
patients from pathogens and other contaminants.
is effective against MRSA.
provides protection from pathogen transmission.
is effective against a broad range of bacteria, including disease-causing
with Vestex fabric lead to a safer environment.
fabric is registered with the FDA as a Class 1 medical device.
is clinically proven to prevent or reduce the acquisition and retention of
contaminants on clothing, reducing methicillin-resistant Staphylococcus
aureus (MRSA), by 99.99% compared to traditional uniforms.
The claims at issue appear in internet and print advertising and in
marketing and promotional materials.
In reviewing all the claims at issue, NAD concluded that the advertiser?s
language reasonably conveyed the unsupported message that Vestex garments
prevent transmission of healthcare-associated infections (HAIs), MRSA,
contaminants, pathogens and disease-causing bacteria to healthcare workers.
Claims from the advertiser?s website link the rates of illness of healthcare
professionals, the prevalence of their exposure to body fluids resulting in
bacterial colonization on apparel, pathogen transmission, and the protection
In support of its claims, the advertiser primarily relied on a published
peer-reviewed study to assess the effectiveness of Vestex antimicrobial
scrubs in limiting the bacterial burden on healthcare workers? hands and
clothing in a clinical setting, and on U.S. Food and Drug Administration
(FDA) classification language and Environmental Protection Agency (EPA)
Registration regulations and guidance. The study was commissioned by
NAD noted in its decision that the advertiser?s study ? the Bearman Study ?
drew tentative conclusions about the potential clinical utility of apparel
with antimicrobial properties, that ?the impact of antimicrobial scrubs on
HAIs remains unknown,? and found that ?a prospective trial is needed to
assess the incremental impact of antimicrobial impregnated apparel on the
control of hospital acquired infections.?
NAD concluded that the Bearman Study did not constitute competent and
reliable evidence sufficient for advertising claim substantiation purposes ?
particularly the health claims made by Vestagen. They also concluded that
the study was insufficient to substantiate Vestagen?s ?clinically proven? or
?proven? claims promising specific results from use of its product.
NAD further concluded that the advertiser provided a reasonable basis for
its EPA-permissible non-public health claims such as ?Product contains an
antimicrobial to inhibit the growth of bacteria/fungi (or microorganisms) on
the fabric,? or ?Antimicrobial properties built in to protect the garment ??
NAD also recommended the advertiser discontinue the claim ?with Vestex ...
99% of pathogens [are] destroyed ? reducing risk of contact with the wearer
and those around them.?
Finally, NAD recommended that any articles authored by current or former
employees that appear at the company?s website, in advertising and sales
materials or on its blog, clearly and conspicuously disclose the material
connection to the advertiser and/or be labeled as advertising.
Vestagen, in its advertiser?s statement, said the company ?agrees to comply
with NAD?s decision and recommendations, and will work within the framework
of allowable language and claims afforded our technology given the
regulatory pathway earned.?
Visit ASRC for the report.
antibiotic, found in the nose, could treat deadly infections
German scientists credit bacteria in the humble human nose with producing an
antibiotic that appears powerful enough to kill dangerous skin infections.
The antibiotic is produced by a type of staph bacteria found in about 10% of
people's noses, according to a study published online Wednesday in Nature.
Although many people associate bacteria with disease, the human body is
actually home to trillions of beneficial bacteria that help us digest our
food, synthesize vitamins and fight infections.
Some bacteria make their own chemical weapons, in the form of antibiotics,
to thwart their rivals. For 70 years, humans have used these substances to
treat infections. While most antibiotics come from bacteria that live in
soil, scientists in recent years have found antibiotics in the human body,
including one produced by beneficial bacteria in the vagina.
The discovery of an additional antibiotic in the nose suggests that these
earlier findings weren't just flukes. In fact, the human body could be a
source of many new antibiotics, said study coauthor Andreas Peschel, a
professor at the University of T?ingen in Germany, which has filed for a
patent on the new antibiotic.
Antibiotics aren't easy to develop. Many experimental ones prove too toxic
to use in humans, said David Weiss, director of the Emory Antibiotic
Resistance Center in Atlanta. The last new class of antibiotics was released
more than 30 years ago. Antibiotics approved in recent years have been
similar to others already in use, making it easier for bacteria to become
resistant to them, he said.
In tests on mice, researchers found that the new antibiotic, which they
called lugdunin, could cure skin infections caused by a type of bacteria
called MRSA, or methicillin-resistant Staphylococcus aureus, which is
resistant to a variety of medications. In addition to the skin, MRSA also
can infect the bloodstream and lining of the heart. Tests found that
lugdunin also killed another dangerous type of bacteria called VRE, or vancomycin-resistant
Doctors haven't yet tested the new antibiotic in humans, Peschel said.
But the study hints at ways that studying the body's microbes, collectively
called the human microbiome, could lead to new treatments for disease, said Kjersti
Aagaard, an associate professor
at Baylor College of Medicine in Houston.
The antibiotic discovery is "a wonderful observation" that "speaks to the
power of innovation and sound scientific insights," Aagaard said. "When we
regard the human body, as well as the world around us, as an elegant
ecosystem, there will be endless wonders to be discovered at our fingertips,
or the tip of our nose.?
Visit USA Today for the article.
Stroke patients heading directly to endovascular centers could get treatment
Stroke patients who go directly to an endovascular center could receive
treatment 99 minutes earlier, according to a new study presented today at
the Society of NeuroInterventional Surgery's (SNIS) 13th Annual Meeting.
Time is critical when it comes to ischemic stroke treatment: Patients need
to receive certain treatments within six hours to maximize their chances of
the best possible outcome.
Systems of Care Efficiency and Interhospital Transfer Delays in the STRATIS
Registry assessed the real world delivery to care, specific causes of
treatment delays and time lost due to interhospital transfers. The study
also calculated a hypothetical "bypass" scenario where stroke patients were
taken to an endovascular center instead of the nearest hospital.
For patients that received IV tPA treatment before undergoing endovascular
treatment, median alarm-to-treatment times between direct patients vs.
transfer patients were 169 and 268 minutes, respectively.
"Our study found that treatment is delayed by about an hour and a half if
patients must be transferred from one hospital to another. Based on earlier
studies, that means that the chance of a good outcome for those patients is
reduced by 30 to 40 percent," said Dr. Michael Froehler, lead author of the
study and Director of the Cerebrovascular Program at Vanderbilt University
According to Dr. Froehler, the results also suggest that in some
circumstances, patients might be better off taking a longer drive to a
hospital if it means arriving at a neurointerventional-ready facility.
To implement the critical observations of studies similar to this one, SNIS
earlier this year launched "Get Ahead of Stroke"-- a campaign focused on
organizing stronger stroke systems of care nationwide. The campaign seeks to
enact legislative change in all 50 states requiring emergency medical
services (EMS) to take ischemic stroke patients to neurointerventional-ready
Visit EurekAlert for the study.
Alzheimer?s patients face flurry of fees while waiting for specialized care
Lengthy waiting lists for rooms for Alzheimer?s patients are forcing
caregivers to put their loved ones in less specialized facilities ? which
often levy additional fees for every extra service required to keep those
vulnerable residents safe.
Does the patient need a daily prompt to take her medication? Tack $25 on to
the monthly bill. Does he need to be reminded to go to lunch and dinner?
That?ll be another $75 a month. Checking blood sugar might cost $55 a month.
Double that if the staff is also in charge of injecting insulin.
Showering. Dosing out medication. Clipping toenails. It all carries a fee.
?If they need extra help, there?s an additional charge,? said Sanford Finkel,
an expert on aging at the University of Chicago. And because Alzheimer?s is
a disease that can devastate for years, the cost can be staggering.
Relatives often try to place their loved ones in a dedicated facility that
specializes in treating patients with dementia. Those beds cost far more
than a typical assisted living facility ? up to several thousand dollars a
month more, depending on the quality and location. But that?s typically an
When there aren?t any available rooms in specialty facilities, Alzheimer?s
patients often end up in assisted living facilities that only cover the
basics ? food and shelter. In most facilities, any additional need comes
with a price tag. And patients with dementia have many additional needs.
Unlike ?memory care homes? that specialize in patients with dementia,
assisted living facilities may have just a handful of residents with those
needs, so they?re not equipped to handle them efficiently and
cost-effectively. More specialized homes, by contrast, are ?going to have
some economy of scale,? said Lauren Travers, who works on senior housing
issues at Caring.com, a site that helps connect seniors and caregivers with
residential facilities nationwide.
The federal Administration on Aging estimates senior housing prices will
nearly triple by 2037. And at the same time, the population in need of
memory care continues to grow ? 5.3 million Americans have Alzheimer?s
disease, with that number expected to spike to 16 million by 2050.
Visit Stat News for the report.
Being unfit may be almost as bad for you as smoking
Being out of shape could be more harmful to health and longevity than most
people expect, according to a new, long-term study of middle-aged men. The
study finds that poor physical fitness may be second only to smoking as a
risk factor for premature death.
It is not news that aerobic capacity can influence lifespan. Many past
epidemiological studies have found that people with low physical fitness
tend to be at high risk of premature death. Conversely, people with robust
aerobic capacity are likely to have long lives.
But most of those studies followed people for about 10 to 20 years, which is
a lengthy period of time for science but nowhere near most of our actual
lifespans. Some of those studies also enrolled people who already were
elderly or infirm, making it difficult to extrapolate the findings to
younger, healthier people.
So for the new study, which was published this week in the European
Journal of Preventive Cardiology, researchers from the University of
Gothenburg in Sweden and other institutions turned to an impressively large
and long-term database of information about Swedish men.
The data set, prosaically named the Study of Men Born in 1913, involved
exactly that. In 1963, almost 1,000 healthy 50-year-old men in Gothenburg
who had been born in 1913 agreed to be studied for the rest of their lives,
in order to help scientists better understand lifetime risks for disease,
especially heart disease.
The men completed baseline health testing in 1963, including measures of
their blood pressure, weight and cholesterol, and whether they exercised and
smoked. Four years later, when the volunteers were 54, some underwent more
extensive testing, including an exercise stress test designed to precisely
determine their maximum aerobic capacity, or VO2 max. Using the results, the
scientists developed a mathematical formula that allowed them to estimate
the aerobic capacity of the rest of the participants.
Aerobic capacity is an interesting measure for scientists to study, because
it is affected by both genetics and lifestyle. Some portion of our VO2 max
is innate; we inherit it from our parents. But much of our endurance
capacity is determined by our lifestyle. Being sedentary lowers VO2 max, as
does being overweight. Exercise raises it.
Among this group of middle-aged men, aerobic capacities ranged from slight
to impressively high, and generally reflected the men?s self-reported
exercise habits. Men who said that they seldom worked out tended to have a
low VO2 max. (Because VO2 max is more objective than self-reports about
exercise, the researchers focused on it.)
To determine what impact fitness might have on lifespan, the scientists
grouped the men into three categories: those with low, medium or high
aerobic capacity at age 54.
Then they followed the men for almost 50 years. During that time, the
surviving volunteers completed follow-up health testing about once each
decade. The scientists also tracked deaths among the men, based on a
Then they compared the risk of relatively early death to a variety of health
parameters, particularly each man?s VO2 max, blood pressure, cholesterol
profile and history of smoking. (They did not include body weight as a
separate measure, because it was indirectly reflected by VO2 max.)
Not surprisingly, smoking had the greatest impact on lifespan. It
substantially shortened lives.
But low aerobic capacity wasn?t far behind. The men in the group with the
lowest VO2 max had a 21 percent higher risk of dying prematurely than those
with middling aerobic capacity, and about a 42 percent higher risk of early
death than the men who were the most fit.
Poor fitness turned out to be unhealthier even than high blood pressure or
poor cholesterol profiles, the researchers found. Highly fit men with
elevated blood pressure or relatively unhealthy cholesterol profiles tended
to live longer than out-of-shape men with good blood pressure and
Visit the New York Times for the article.
payments for cardiac care, hip fracture
The Centers for Medicare & Medicaid Services (CMS) has proposed new episode
payment models for cardiac care and extending the joint model to include
treatment for hip and femur fractures.
Advancing Care Coordination Through Episode Payment Models would test three
myocardial infarction (AMI)
artery bypass graft (CABG)
hip/femur fracture treatment excluding lower extremity joint replacement
For the new cardiac bundles, CMS would include acute care hospitals in 98
randomly selected metropolitan statistical areas (MSAs). As the hip/femur
fracture surgeries model builds upon the existing Comprehensive Care for
Joint Replacement model, CMS proposed to test these bundled payments in the
same 67 MSAs that were selected for that existing model.
As part of the five-year models, beginning July 1, 2017, hospitals would be
held financially accountable for meeting quality and cost measures for the
entire episode of care, from the date of admission through 90 days
post-discharge. Consideration and adjustments for transfers for cardiac care
are provided in the proposed rule. CMS proposed to phase in the repayment
responsibility, beginning in performance year two.
CMS also proposed a cardiac rehabilitation incentive payment model to
encourage use of cardiac rehabilitation services among beneficiaries
hospitalized for treatment of AMI or CABG.
Last, CMS proposed a pathway for physicians with significant participation
in bundled payment models to potentially qualify as Advanced Alternative
Payments Models through the recently proposed Quality Payment Program, which
implements the Medicare Access and CHIP Reauthorization Act (MACRA).
Comments on the proposal are due to CMS by Oct. 3. America?s Essential
Hospitals will send a more-detailed summary of the proposed rule to members
in coming days.
Visit America?s Essential Hospitals for the proposal.