Late-life high blood pressure may harm the brain

Decades ago, hundreds of nuns and priests made an extraordinary decision: They agreed to donate their brains upon death to science, hoping to help solve mysteries about Alzheimer’s and other diseases. Now, a study that used their gifts is giving some clues. It reveals that high blood pressure late in life might harm the brain.

Autopsies on nearly 1,300 older people, including about 640 clergy members, found more signs of damage and one of the hallmarks of Alzheimer’s disease in the brains of those with higher blood pressure than among those with pressure closer to normal, researchers reported Wednesday.

The study does not prove cause and effect, and it does not yet provide a comparison of rates of dementia or its most common form, Alzheimer’s—those results will take longer to parse. But it challenges a theory that high pressure is not as harmful in old age as it is when people are younger.

“We can’t be alarmist. This is preliminary data” that needs to be validated by others, said the study leader, Dr. Zoe Arvanitakis of Rush University Medical Center in Chicago. “It’s far too soon to make recommendations about blood pressure in older people based on this study.”

The research began in 1994 and combined people from three studies of aging who agreed to donate their brains for autopsy upon their death, including the Religious Orders Study of Catholic clergy throughout the United States. All were over 65 and without known dementia at the start and were followed until they died—at an average age of 89 and after an average of eight years in the study.

Two-thirds had high blood pressure, defined as a top reading of 140 or more when the study began (it’s now 130 under new guidelines adopted last fall.) Their pressures were measured once a year during the study—a strength of this work over some previous research that just relied on people to say whether they had high pressure or not.

After each participant died, researchers examined their brains for areas of dead tissue caused by lack of blood supply. These blighted areas can be tiny and cause no symptoms, so they’re sometimes called evidence of “silent strokes.”

About half of the study participants had one or more of these, and the risk was greater for those with higher blood pressure. For example, people with an average top reading of 147 had a 46 percent greater risk of having one or more of the bad spots than those with an average top reading of 134. People with higher bottom blood pressure readings also had a greater risk for this problem.

Researchers also found a link between higher pressure and one of the signs of Alzheimer’s—tangles of a protein called tau—but not another Alzheimer’s hallmark, amyloid plaques. This needs further research to understand the implications, Arvanitakis said.

“It’s a pretty strong study,” said James Hendrix, director of global science initiatives at the Alzheimer’s Association. “Autopsy data is really powerful” and has been the gold standard for diagnosing Alzheimer’s for many years, he said.

With Alzheimer’s, changes in the brain occur a decade or more before symptoms do, so high blood pressure may have been doing damage well before the age when these people enrolled in the study, he said.

How might high pressure do harm?

“Lower blood pressure reduces the risk of those blood vessel blockages” that can cause a silent stroke, said another independent expert, the Mayo Clinic’s Dr. David Knopman. The work shows that “treating blood pressure throughout the lifespan is important.”

Knopman is a spokesman for the American Academy of Neurology, whose journal, Neurology, published the study. Federal grants paid for the work.

 Explore further: Higher blood pressure may be linked to brain disease, Alzheimer’s

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Dog illness can spread to owners

A bacteria carried by dogs that haven’t been neutered can produce flu symptoms in humans and potentially jeopardize a pregnancy, a new study suggests.

Brucellosis infection is most commonly spread by livestock like sheep, cattle, goats and pigs.

But a strain of the bacterium carried by dogs — Brucella canis — could be widespread in humans, warned lead researcher Martha Hensel, a veterinarian with Texas A&M University.

“We don’t really know how prevalent this disease is in the United States,” Hensel said. “The information we have to draw conclusions on the public health risk is outdated, to say the least — something like 30 to 40 years old.”

B. canis is carried by dogs that can still reproduce, Hensel noted. It’s not clear exactly how the bacteria might spread to humans, but it’s most likely passed through contact with reproductive organs or urine.

People who regularly handle such dogs — vets, dog shelter employees, dog breeders — are most at risk for contracting brucellosis, Hensel said.

However, pet ownership is a likely risk factor for infection, particularly for young children and people with compromised immune systems, Hensel and her colleagues explained.

The researchers highlighted some case studies:

• A 3-year-old New York City girl came down with brucellosis in 2012 after exposure to an infected puppy recently purchased from a pet store.
• Several people with HIV have developed brucellosis in recent years, all linked to intact dogs they owned that were later diagnosed with B. canis infection.

“An average, healthy adult would probably not contract this disease unless they were exposed to a really high concentration of bacteria,” Hensel said.

Brucellosis primarily causes symptoms similar to the flu — fever, sweats, fatigue, headache and muscle pain, according to the U.S. Centers for Disease Control and Prevention.

The disease also can cause long-term or recurring symptoms, such as arthritis, swelling of the testicles, swelling of the heart, neurologic symptoms and chronic fatigue, the agency noted.

Brucellosis can also mean trouble for a pregnancy, said Dr. Amesh Adalja, a senior scholar with the Johns Hopkins Center for Health Security.

“Though brucellosis is a common cause of animal [miscarriages], it is also linked to fetal problems in women who are pregnant when they contract it — though at a lesser degree than with other animal species,” Adalja explained. “The diminished role is due to the lack of a specific compound produced in human placenta [erythritol] as well as anti-brucella activity in human amniotic fluid.”

The CDC recommends that pregnant women talk with their doctor if they’ve been exposed to brucellosis, saying that a short course of antibiotics could be “lifesaving for the fetus.”

Hensel and her colleagues suggested that better diagnostic tools should be developed to help determine the prevalence of B. canis in both dogs and humans.

“At this point, we don’t know what the incidence in the United States is, and how many dogs are carrying this bacteria,” Hensel said. “We would like to put that out there for clinicians to think about, in terms of the risk of transmission from dogs to people.”

The new study was published online July 11 in the journal Emerging Infectious Diseases.

More information

The U.S. Centers for Disease Control and Prevention has more about brucellosis.

SOURCES: Martha Hensel, DVM, Texas A&M University, College Station, Texas; Amesh Adalja, M.D., senior scholar, Johns Hopkins Center for Health Security, Baltimore; July 11, 2018, Emerging Infectious Diseases, online

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3 of 4 Black Americans have high blood pressure by age 55

A startling 75 percent of black people in the United States develop high blood pressure by the age of 55, a new study finds.

That’s a far higher rate than seen among either white men (55 percent) or white women (40 percent), the researchers said.

“We started to see differences between blacks and whites by age 30,” said lead researcher S. Justin Thomas.

“We need to start focusing on preventing hypertension [high blood pressure], particularly in blacks, at an early age,” he added.

Thomas is an assistant professor at the University of Alabama at Birmingham’s department of psychiatry.

It isn’t known why black Americans are more prone to high blood pressure at an earlier age than white Americans, Thomas said. But he speculated that a combination of lifestyle and genetics may explain why.

Thomas said preventing high blood pressure needs to start with getting kids to develop healthy habits.

“I don’t think you can start too early,” he said. “It should start at elementary school. If kids are told frequently that this is important, they will adopt it.”

High blood pressure can lead to serious health problems over time, the researchers noted.

Dr. Gregg Fonarow explained that high blood pressure “is a leading risk factor for heart attack, heart failure, stroke, kidney disease and premature cardiovascular death.” He is a professor of cardiology at the University of California, Los Angeles, and was not involved with the new study.

Black men and women in the study had twice the risk of high blood pressure than white men and women, even after adjusting for other differences, he added.

“Prevention, awareness, treatment and control of high blood pressure is essential, as cardiovascular disease remains the leading cause of fatal and non-fatal cardiovascular events, disability, hospitalizations and financial hardship,” Fonarow explained.

For the study, Thomas and his colleagues collected data on nearly 3,900 young adults who were part of a heart disease risk study.

The participants were enrolled in the study when they were 18 to 30 years old, and they didn’t have high blood pressure at the time.

High blood pressure is defined as a systolic pressure (the upper number) of 130 mm Hg or higher and a diastolic pressure (the lower number) of 80 mm Hg or higher.

These blood pressure benchmarks were first released in 2017, replacing the previous definition of high blood pressure of 140/90 mm Hg.

This lower threshold for defining high blood pressure means even more Americans will be diagnosed with high blood pressure at younger ages, Thomas said.

Excess weight was the biggest risk factor for developing high blood pressure, regardless of sex or race, the researchers found.

Blacks and whites who kept to a DASH (Dietary Approaches to Stop Hypertension) diet were able to lower their risk for high blood pressure, the study findings showed.

The DASH diet is rich in fruits, vegetables, whole grains, low-fat or fat-free dairy, fish, poultry, beans, seeds and nuts, and low in red meat and salt.

Dr. Byron Lee is director of electrophysiology laboratories and clinics at the University of California, San Francisco. He said that “in many ways, 55 is the new 65. We used to not worry about hypertension until we reached our mid-60s, but it’s clear now that many of us need to take action much sooner.”

Lee pointed out that high blood pressure is a “modifiable risk factor for heart attack and stroke. And if we don’t act on it, we are missing a major opportunity to decrease mortality.”

The report was published online July 11 in the Journal of the American Heart Association.

More information

For more on the DASH diet, visit the American Heart Association.

SOURCES: S. Justin Thomas, Ph.D., assistant professor, department of psychiatry, University of Alabama, Birmingham; Byron Lee, M.D., professor, medicine, director, electrophysiology laboratories and clinics, University of California, San Francisco; Gregg Fonarow, M.D., professor, cardiology, University of California, Los Angeles; July 11, 2018, Journal of the American Heart Association, online

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BioSight Launches Phase 2b Trial of 1st-Line Acute Myeloid Leukemia Treatment

BioSight Ltd., a pharmaceutical development company focused on the development of targeted oncology drugs, announced today that it has received the FDA and the Israeli Ministry of Health clearance to launch a Phase 2b clinical trial of BST-236 for treatment of Acute Myeloid Leukemia (AML).

The trial, which will be launched in the upcoming month, will be conducted in 25 medical centers in the US and Israel. BST-236 will be administered as a single agent treatment for newly-diagnosed AML patients, either de novo or secondary to myelodysplastic disorder (MDS) who are unfit for standard chemotherapy due to its severe toxicity. This population is estimated to account for a third to half of the AML patients.

In the Phase 1/2 study, presented at the Annual American Society of Hematology (ASH) Meeting and Exposition on December 2017, 26 acute leukemia patients were treated with BST-236 as a single agent. The study enrolled mainly older patients with poor prognosis baseline characteristics, including prior treatment with hypomethylating agents for MDS. BST-236 was found to be safe and well tolerated at high doses, with no neurological or gastrointestinal toxicities or renal failure, all of which are life-threatening toxicities associated with the existing chemotherapy and which often attenuate or prevent its use in older patients. This encouraging safety profile allowed the treatment of older and medically unfit patients with high doses of BST-236 and led to 2-3-fold higher response rates compared to currently approved treatments for this patient population. The aim of the Phase 2b study is to repeat the results of the Phase 1/2 study in a larger number of patients in the US and Israel.

Dr. Ruth Ben Yakar, BioSight’s CEO said: “We are excited to launch this Phase 2b clinical trial of BST-236 for treatment of newly-diagnosed AML patients who are unfit for standard chemotherapy. The encouraging results of the Phase 1/2 study suggest that BST-236 may serve as an improved treatment option compared to the approved drugs available today for this population, including for patients at the age of 75 years or more. We think it is very important to approach these patients, mainly due to the general increase in the population’s age and quality of life, and we believe we can provide them with a safer and more effective treatment.”

BST-236 is a novel pro-drug of the chemotherapeutic drug cytarabine. Cytarabine has been the backbone of first-line therapy for AML for the past 40 years, however, it is associated with severe bone marrow, gastrointestinal, and neurological toxicities which significantly limit its use, especially in older and medically unfit patients. BST-236 is designed to enable delivery of high cytarabine doses to leukemia cells with lower systemic exposure to the free drug and relative sparing of normal tissues. As such, BST-236 may serve as an ideal therapy for leukemia, particularly for delivering high doses of cytarabine to medically unfit or older adults.

BioSight is a private Israeli clinical-stage pharmaceutical development company, founded by Dr. Stela Gengrinovitch and headed by Dr. Ruth Ben Yakar. BioSight focuses on the development of novel caner-targeted pro-drugs. BioSight’s lead product BST-236 is under clinical development for acute leukemia.

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Medtronic Gets FDA Approval for Less-Invasive Heart Pump Implant Procedure

Medtronic plc (NYSE: MDT) has received United States
Food and Drug Administration (FDA) approval for a less-invasive implant approach
of its HVAD(TM) System, a left ventricular assist device (LVAD) for patients
with advanced heart failure. The HVAD System is the smallest commercially
available LVAD, and the only LVAD approved in the U.S. for implant via
thoracotomy, a small lateral, surgical incision between the patient’s ribs on
the left side of the chest.

LVADs help the heart pump and increase the amount of blood that flows through
the body. They are typically implanted via median sternotomy, a surgical
procedure in which a vertical incision is made down the middle of the chest,
after which the sternum (or breastbone) is divided.

FDA approval for HVAD implantation via thoracotomy is based on data from the
LATERAL prospective clinical trial, in which 144 patients, with end-stage heart
failure who were eligible for heart transplant, were enrolled at 26 centers in
the U.S. and Canada. The primary endpoint of the trial demonstrated non-
inferiority of the HVAD implanted in patients via thoracotomy, where survival at
six months free from disabling stroke or device explant or exchange due to
malfunction was achieved in 88.1 percent of patients. Since the success outcome
exceeded the pre-specified performance goal of 77.5 percent, the trial achieved
its primary endpoint (p=0.0012). The key secondary endpoint revealed a
significant reduction in total length of hospital stay, from an average of 26.1
days down to 18 days (p<0.001). Overall survival among patients receiving an
HVAD via the thoracotomy procedure was 88.8 percent at one year. Detailed
outcomes of the LATERAL trial and its secondary endpoints were presented at The
International Society for Heart and Lung Transplantation (ISHLT) 2018 Scientific
Sessions.

“We have demonstrated that a thoracotomy is a safe and effective implant
technique for the HVAD System, which gives physicians added flexibility in
treating a broad range of patients,” said Edwin McGee, Jr., M.D., professor and
director, Heart Transplant & Ventricular Assist Device Program, Loyola
University Medical Center, Maywood, Ill., and principal investigator of the
LATERAL trial. “Implanting the HVAD via thoracotomy preserves the chest for a
subsequent procedure that patients may need, such as a heart transplant. It also
has been shown to result in shorter hospital stays.”

The HVAD System is the only LVAD approved in the U.S. and Europe for implant via
a thoracotomy as well as a median sternotomy. It is approved to treat patients
with advanced, refractory heart failure as a bridge to cardiac transplantation
and as destination therapy in patients for whom subsequent transplantation is
not planned.

In addition to this approval, new surgical implant tools tailored to assist
physicians with the thoracotomy approach for the HVAD System are now available
in the U.S. and in CE Marked countries.

“The thoracotomy approach showed significant improvements in patients’ quality
of life and functional capacity, supported by strong safety and effectiveness
data from the study,” said David Steinhaus, M.D., vice president and general
manager of the Heart Failure business, which is part of the Cardiac and Vascular
Group at Medtronic. “Further, the added flexibility for implant approach offers
a unique advantage of the HVAD System.”

The Medtronic portfolio of therapies, diagnostic tools and services for patients
suffering from heart failure includes CRT devices, including MR-conditional CRT-
Ds and CRT-Ps; mechanical circulatory support therapy for advanced heart failure
patients; heart failure diagnostics; and meaningful expert analysis through
Medtronic Care Management Services.

In collaboration with leading clinicians, researchers and scientists worldwide,
Medtronic offers the broadest range of innovative medical technology for the
interventional and surgical treatment of cardiovascular disease and cardiac
arrhythmias. The company strives to offer products and services of the highest
quality that deliver clinical and economic value to healthcare consumers and
providers around the world.

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Nevro may prevail in court against Boston Scientific: JMP

JMP Securities analsyt David Turkaly reiterated his Market Outperform rating and $105 price target on Nevro Corp (NYSE: NVRO) following daTuesday’s tentative ruling in the NVRO/BSX patent case.

Turkaly said while they are not legal experts, some of the language appears to question the validity of some of NVRO’s intellectual property being considered in the case.

“Specifically, it appears that the Court has pointed out potential issues with nonparesthesia producing language and with software and/or the programming aspect being the inventive concept,” he notes.

The analyst reiterated that this is not a final judgement and notes both companies have until July 11th to file post-hearing briefs. They note NVRO has been successful in defending its IP in the past (including in 2015 when the BTAP did not institute an inter partes review for any of the BSX challenged claims).

“Subject to further information and due diligence, we remain at a Market Outperform rating,” he concluded.

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Patients Aren’t Shopping Around for Healthcare, but ‘Experts’ Are No Help

The whole idea of giving patients financial “skin in the game” so they’ll be motivated to shop around and lower their healthcare costs hasn’t been working and needs to be rethought, several experts said here.

“Maybe we need to rethink the value of the high-deductible health savings account,” Tara O’Neill Hayes, deputy director of healthcare policy at the American Action Forum, a right-leaning think tank, said here Tuesday at an event sponsored by the National Coalition on Health Care. “Maybe we put a little too much in that basket.”

Paul Ginsburg, PhD, director of the USC-Brookings Schaeffer Initiative for Health Policy at the Brookings Institution, a left-leaning think tank, agreed. He noted that when it comes to the idea of having consumers shop around to get cheaper care, “[Our] experience [with] providing good pricing [data] to consumers is not encouraging at all; they don’t go there. They don’t use it … Just having consumers be in high-deductible health plans and giving them price information is not the most effective way to get them to be better consumers.”

What would work better, Ginsburg said, is capping the amount of money for health insurance premiums that workers could exclude from their taxable income. That would force people to buy less expensive health plans from their employers “without all the bells and whistles,” he told MedPage Today.

At the event, the coalition presented its report on strategies for improving healthcare affordability. The report identified six drivers of healthcare costs:

• Chronic illness rooted in non-medical determinants of health
• Poorly coordinated, inefficient care delivery
• Misuse of provider market power, caused in part by providers who demand guaranteed inclusion in contracts
• Barriers to drug price transparency and competition
• Insurance and reimbursement rules that promote cherry-picking of healthier patient populations
• Cost barriers to high-value care, such as increasing deductibles

When it comes to that last item — barriers to high-value care — John Rother, the coalition’s president and CEO, pointed out that “not all healthcare has the same value. Certain procedures and interventions offer high value and there are others that offer low value, and yet we don’t distinguish [between them] and people with coverage often don’t understand the difference. By removing barriers to higher-value care, we could definitely make a positive impact on healthcare.”

The coalition offered several suggestions for improving affordability:

• Focus on the non-medical determinants of health. This would probably offer the best value, said Rother. “Investments in children in particular have a long-term payoff. There’s no question that dollar for dollar, investments in child health through Medicaid and through [the Children’s Health Insurance Plan] is the single best investment we can make”
• Make healthcare more efficient by promoting value-based care. “We need to build the infrastructure [for that], including more emphasis on primary care and a common set of performance measures that tell us how we’re doing and where investments have the best payoff,” he said
• Curb misuse of the market power of providers. “There is tremendous consolidation in healthcare going on today as providers look to enhance their own market power,” and fixing the problem will require leadership from the Federal Trade Commission as well as state lawmakers, Rother said
• Eliminate barriers to transparency and competition in drug pricing. “Drug pricing has gotten a lot of attention lately and I think deservedly so,” he said. “We’re seeing the price increases for brand-name drugs overwhelm the savings we get from generics, and it’s likely to increase in the future as more and more new drugs are very expensive biologics that run six figures a year.” Promoting more competition among drugmakers and a better pathway for biosimilars would help, as would broader formularies and a greater ability for Medicare to negotiate prices based on comparative effectiveness, Rother added
• Promote increased use of high-value healthcare. “We could exclude primary care from deductibles, and also exclude chronic care services. We need to think about what works and measure it, and perhaps implement it more broadly”

Gerard Anderson, PhD, of Johns Hopkins University in Baltimore, gave a historical perspective on the issue; he noted that in 2003, he and several colleagues, including the late Princeton University health economist Uwe Reinhardt, PhD, wrote a paper entitled, “It’s the Prices, Stupid,” which explained that the reason for the high cost of healthcare was payers’ willingness to put up with high prices.

“We were looking at the reason for these higher costs — we looked at defensive medicine, higher educational costs for physicians, the aging of the population, the administrative burden, and [the fact that] Americans were sicker,” said Anderson. “But [for each one] we said, ‘Yeah, that’s not the real reason’ … We found that it was the prices.”

Some of the researchers involved have redone their analysis “and most everything remained exactly the same in the last 15 years,” he continued. There was one difference: when the group wrote its original paper in 2003, the private sector and the public sector were paying about the same rate for healthcare, but now the private sector is paying much more.

“You can talk about cost-shifting, but for me, one of the main reasons for growth in last 15 years … is the willingness of the private sector to continue to pay ever-increasing prices for goods and services,” said Anderson. “The question is, can we mobilize them … or do we have to give them some government help?

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