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July 28, 2016   Download print version

CDC urges doctors to aggressively test pregnant women for Zika

NIH launches early-stage yellow fever vaccine trial

NAD recommends that Vestagen discontinue claims that their hospital scrubs protect patients

New antibiotic, found in the nose, could treat deadly infections

Stroke patients heading directly to endovascular centers could get treatment faster

Alzheimer?s patients face flurry of fees while waiting for specialized care

Being unfit may be almost as bad for you as smoking

CMS proposes bundled payments for cardiac care, hip fracture

 
 
 



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CDC 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 tested.

?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 the flu.

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 positives.

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.

 

NIH 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.

 

NAD recommends that Vestagen discontinue claims that their hospital scrubs protect patients

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 Bureaus.

NAD reviewed claims that included:

?         Vestex transforms healthcare garments into apparel that helps guard workers and patients from pathogens and other contaminants.

?         Vestex is effective against MRSA.

?         Vestex provides protection from pathogen transmission.

?         Vestex is effective against a broad range of bacteria, including disease-causing bacteria.

?         Garments with Vestex fabric lead to a safer environment.

?         Vestex fabric is registered with the FDA as a Class 1 medical device.

?         Vestex 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 from illness.

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 Vestagen.

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.

 

New 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 enterococcus.

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 faster

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 Medical Center.

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 hospitals.

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 all-inclusive package.

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 national registry.

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 cholesterol levels.

Visit the New York Times for the article.

 

CMS proposes bundled 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 new models:

?         acute myocardial infarction (AMI)

?         coronary artery bypass graft (CABG)

?         surgical 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.