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Wednesday, July 4, 2018

Dementia linked to ‘chronic, rather than temporary’ inflammation


Heightened levels of brain inflammation biomarkers have been linked to the development of dementia, but it remains unclear whether inflammation must be present long-term in order to affect brain health.
Last year, Medical News Today reported on a study suggesting that elevated inflammationlevels in midlife increased a person’s risk of experiencing loss of brain function and developing dementia later in life.
And recently, researchers from Johns Hopkins University in Baltimore, MD, have conducted a study analyzing data collected from 1,532 participants.
Of these, 61 percent were women and 28 percent were African-American.
Specifically, the team tracked levels of a blood biomarker of inflammation called C-reactive proteinand looked at its relationship with the risk of dementia.
“We found that individuals who had an increase in inflammation during midlife that was maintained from mid- to late life have greater abnormalities in the brain’s white matter structure, as measured with MRI scans,” says lead researcher Keenan Walker.
This suggests to us that inflammation may have to be chronic, rather than temporary, to have an adverse effect on important aspects of the brain’s structure necessary for cognitive function.”
Keenan Walker
The team’s findings are reported in the journal Neurobiology of Aging.

Inflammation and white matter damage

To gain a better understanding of how inflammation can affect an individual’s brain and cognitive abilities over a long period of time, Walker and colleagues looked at data collected through the Atherosclerosis Risk in Communities Study (ARIC), which examined cardiovascular risk factors among middle-aged and older people.
For the new study, the researchers evaluated participants’ brain structure, and to what extent its integrity was preserved over a period of 21 years from middle age to late life.
Alongside this, the investigators also assessed levels of the inflammation marker C-reactive protein, which is produced in the liver.
Throughout the 21-year period, the participants had five visits with ARIC researchers — around one every 3 years, on average. At their final follow-up visits, the participants had an average age of 76.
During the final visit, each person had an MRI scan to check for white matter damage. White matter — containing axons coated in a protective layer of myelin — is tasked with carrying information between nerve cells. In brain scans, white matter damage appears as intensely white patches.
At the second, fourth, and final visit, the researchers also collected blood samples from the participants, so that they could measure levels of inflammation.
Those who had under 3 milligrams per liter of C-reactive protein were judged to have low levels of inflammation throughout their bodies. Conversely, those with 3 milligrams per liter or more of the tell-tale biomarker were said to have high levels of inflammation.
Walker and colleagues’ analyses revealed that, of all the participants, the 90 individuals whose inflammation had increased to chronic (that is, persistently high) levels during midlife also presented the most white matter damage in the brain.
This remained valid even after potentially modifying factors — such as participants’ age, sex, levels of education, and risk of cardiovascular disease — were taken into account.
Furthermore, when the researchers looked at measurements of brain structural integrity, they also concluded that those participants who had elevated levels of C-reactive protein in middle age showed brain structure damage similar to that seen in people about 16 years older.

‘Inflammation may be a reversible factor’

Walker believes that the results obtained in this study suggest that there may be a cause and effect relationship between growing levels of inflammation in middle age that remain high until later in life and the development of dementia.
But, he cautions that this is still just an observational study, and more research into any underlying mechanisms is required in order to establish causality.
Walker explains that chronic inflammation is often caused by conditions such as cardiovascular disease, heart failurehypertension, and diabetes, as well as particular infectious diseases, including HIV and hepatitis C.
Although inflammation also normally increases with age, he adds that certain factors — including poor overall health — could make it worse.
“Our work is important,” notes senior study author Dr. Rebecca Gottesman, “because currently there aren’t treatments for neurodegenerative diseases, and inflammation may be a reversible factor to prolong or prevent disease onset.”
“Now, researchers have to look at how we might reduce inflammation to reduce cognitive decline and neurodegeneration,” she concludes.

Canopy Growth to detail Latam strategy


Canopy Growth is a company focused on firsts. As part of the Company’s ongoing global growth strategy, Mark Zekulin, President and Co-CEO will be holding a media availability by conference call to provide several exciting updates for Canopy Growth, its medical focused subsidiary Spectrum Cannabis, and the industry as a whole.
Mark will lead the call from the announcement location and following his updates, will hold a Q&A.
All interested media are asked to please RSVP for conference call details.
Date: Thursday, July 5, 2018
Time: 1:00-1:30pm EST
RSVP: Please contact Aly-Khan Virani to register your interest and receive the call-in details.

As drug resistance grows, combining antibiotics could turn up new treatments


Combining certain antibiotics could help them pack a one-two punch against harmful bacteria, according to a new study published Wednesday in Nature.
Nassos Typas and his colleagues at the European Molecular Biology Laboratory in Germany tested 3,000 different combinations of antibiotics with each other or with drugs, food additives, and other compounds on three common types of bacteria that infect humans.
“Antibiotic resistance is increasing, and because we haven’t been developing new drugs for the past 20 years, we’re running out,” Typas said. He and his colleagues set out to discover combinations that might be helpful in the clinic — and were on the hunt for patterns that might illustrate why certain pairs work.
They turned up hundreds of combinations that made antibiotic treatment more effective (along with many that didn’t). Pairs of drugs that targeted the same cellular processes were much more likely to be successful than combinations that worked in two different ways.
And many of the interactions were species-specific — that is, a combination might work well together to tackle one type of bacteria, but not another. That finding might one day be beneficial for finding drug combinations that don’t harm the rest of the gut’s microbes.
“If you have a broad-spectrum antibiotic, it doesn’t only eradicate your infection, it also eradicates your gut microbes,” Typas explained. That’s why antibiotics can sometimes come with gastrointestinal side effects. But the effects of the drug combinations are highly selective and, in many cases, only affect a few kinds of bacteria. In the future, it might be possible for researchers to find drug combinations that attack harmful pathogens while preventing any damage to healthy bacteria.
“You could find the drug that works as an antidote for the commensal microbes, but not as an antidote for the pathogens,” Typas said.
In theory, that could also curb the development of antibiotic resistance, Typas said, since healthy bacteria might not have to evolve antibiotic resistance, which can be transferred to harmful pathogens.
The researchers also found that several of the combinations were effective at treating bacteria that’s resistant to several other antibiotics, both in cell models and in studies on moths. They’re now testing some of the combinations in mice.

Sessions: Reversing Obama rules promoting college admission ‘diversity’


Attorney General Jeff Sessions on Tuesday rescinded a series of Obama-era guidelines aimed at promoting diversity in higher education.
The documents laid out legal guidelines for how colleges could properly consider race in admissions decisions in order to promote campus diversity. Rescinding the guidelines does not change official U.S. policy, but marks a return to the George W. Bush-era approach of “race-neutral” college admissions.
The guidelines were among 24 that Sessions pulled back on Tuesday, deeming them “unnecessary, outdated, inconsistent with existing law, or otherwise improper.”
The Trump administration has argued that the rules violate Supreme Court precedent on affirmative action.
“The Supreme Court has determined what affirmative-action policies are constitutional, and the Court’s written decisions are the best guide for navigating this complex issue,” said Education Secretary Betsy DeVos in a statement.
The move has been harshly criticized by civil rights groups, who say that rescinding the guidances will be detrimental to students of color in the U.S.
The American Council on Education has already vowed to ignore the decision, saying that the administration is sending “precisely the wrong message” to institutions of higher education.
But Sessions argued that the decision to rescind the policies was intended to undo what he described as government overreach and previous administrations’ efforts to “impose new rules on the American people without any public notice or comment period, simply by sending a letter or posting a guidance document on a website.”
“That’s wrong, and it’s not good government,” he said.
Still, abandoning the Justice Department guidelines does not change current U.S. law, and schools are allowed to operate as they choose, so long as their actions fit within existing legal precedents.
The move came days after Justice Anthony Kennedy announced that he would retire from the Supreme Court this summer. His departure means that the court will lose a key swing vote on affirmative action issues, while allowing President Trump to nominate a more conservative replacement.
Affirmative action in college admissions is the subject of one high-profile lawsuit alleging that Harvard University has discriminated against Asian-American applicants in order to free up spots for other racial minorities.
The Justice Department weighed in on the side of the Asian-American applicants in April, asking a federal judge to order the release of years of Harvard admission records.

Exelixis says Celestial Phase 3 results published in NEJM


Exelixis announced that The New England Journal of Medicine published results from the Celestial Phase 3 pivotal trial of cabozantinib in patients with previously treated advanced hepatocellular carcinoma.1 The data, originally presented at the 2018 American Society of Clinical Oncology’s Gastrointestinal Cancers Symposium in January, demonstrate that cabozantinib provided a statistically significant and clinically meaningful improvement in overall survival versus placebo, the company said in a statement. Median overall survival in Celestial was 10.2 months with cabozantinib versus 8.0 months with placebo. Median progression-free survival was more than doubled, at 5.2 months with cabozantinib and 1.9 months with placebo. “Patients with this form of advanced liver cancer have very limited treatment options once their disease progresses following treatment with sorafenib,” said Ghassan K. Abou-Alfa, M.D., Memorial Sloan Kettering Cancer Center, New York and lead investigator on Celestial. “These results suggest that, if approved, cabozantinib could become an important addition to the treatment landscape that may help slow disease progression and, critically, improve survival for these patients.”

Alnylam says Apollo Phase 3 trial of patisiran published in NEJM


Alnylam Pharmaceuticals announced that the pivotal study results from the Apollo Phase 3 trial of patisiran were published online today in The New England Journal of Medicine. The study showed that patisiran improved measures of polyneuropathy, quality of life, activities of daily living, ambulation, nutritional status, and autonomic symptoms relative to placebo in patients with hereditary transthyretin-mediated amyloidosis, the company said. Patisiran treatment also led to favorable effects on exploratory endpoints related to cardiac structure and function in patients with cardiac involvement, it added. Further, the frequency and severity of adverse events were similar in patients receiving patisiran and placebo, with the exception of peripheral edema and infusion-related events which were higher in patisiran-treated patients and generally mild to moderate in severity. “We are extremely pleased with the publication of this landmark manuscript, the first-ever pivotal RNAi clinical trial to be published in a top-tier, peer-reviewed medical journal,” said Akshay Vaishnaw, President of Research and Development at Alnylam

CMS Seeks to Simplify Home Health Recertifications


Physicians would no longer have to predict how much longer a particular Medicare patient will need homecare in order to have the service re-certified, according to a regulation proposed Monday by the Centers for Medicare & Medicaid Services (CMS).
“In an effort to make improvements to the health care delivery system and to reduce unnecessary burdens for physicians, CMS is proposing to eliminate the requirement that the certifying physician estimate how much longer skilled services are required when recertifying the need for continued home health care,” the agency said in a fact sheetabout the proposed rule.
“This proposal is responsive to industry concerns about regulatory burden reduction and could reduce claims denials that solely result from an estimation missing from the recertification statement. We estimate that this proposal would result in annualized cost savings to certifying physicians of $14 million beginning in [calendar year] 2019.”
In addition to eliminating that requirement, “we’re releasing several proposals to modernize Medicare by increasing access to remote patient monitoring,” CMS administrator Seema Verma said Monday on a phone call with reporters.
“This will allow more patients to share real-time data [with providers]. Last year we made changes to allow physicians to bill for remote patient monitoring,” she said. “Home health agencies, however, couldn’t bill for the new code. So in today’s proposal we address that disparity.”
CMS also is beginning to implement a new home infusion therapy benefit — using a transitional payment until the full benefit takes effect in 2021 — and proposing health and safety standards for home infusion therapy.
The rule also removes seven measures for the home health quality reporting program that were either unnecessary or “topped out” — that is, everyone was doing extremely well on them so there was no need to continue measuring them, Verma explained. Contrary to messages released by some groups, “none of the measures we’re eliminating will reduce transparency or patient safety,” she added, noting that the burden reduction achieved by eliminating the measures is expected to result in a net savings of $60 million.
In addition, CMS is proposing to remove five outcome measures from its Home Health Value-Based Payment model currently used for reimbursement:
  • Influenza Immunization Received for Current Flu Season
  • Pneumococcal Polysaccharide Vaccine Ever Received
  • Improvement in Ambulation-Locomotion
  • Improvement in Bed Transferring
  • Improvement in Bathing
The agency also plans to add two proposed composite outcome measures: Total Change in Self-Care and Total Change in Mobility.
Looking ahead to 2020, Verma noted that Congress has mandated the agency stop using the number of therapy visits made to determine payments “because some patients have complex needs that don’t involve a lot of therapy…. We’ve proposed a Patient-Driven Groupings model that is relying more heavily on clinical characteristics to determined the amount of payment and eliminate the use of the therapy threshold.”
Not everyone is happy with that idea, however. “It appears that the 2020 model is a modestly adjusted and “warmed-over” version of the highly criticized Home Health Groupings Model [HHGM] re-labeled as the Patient-Driven Groupings Model,” William Dombi, president of the National Association for Home Care & Hospice (NAHC), said in a statement. “Many of the same weaknesses present in HHGM exist in this new version.”
“NAHC remains very concerned that the new model still includes a significant ‘behavioral adjustment’ based on assumptions that would trigger a 6.42% reduction in base payment rates,” he continued. “Many of these assumptions are driven by CMS’s design with unnecessary changes to the current model.”
“We do not want to prematurely judge the 2020 version of payment reform as it is complex, detailed, and will require deep analysis,” Dombi said. “However, we are concerned that CMS may have been relegated to using too much from its HHGM design because CMS is pressed by a deadline. We hope that Congress can recognize the value of providing a more flexible timeframe to CMS.”
“We will be addressing all of our concerns with CMS through the rulemaking process and enlisting Congressional support as needed to develop reasonable payment reform,” he concluded. “These proposals … warrant close and critical review by the industry before any judgment is made. Still, an early review indicates that the proposed system needs more work.”
The proposed rule is open for comment until 5 p.m. on Aug. 31. CMS is also is expected to release payment rules for other providers, including the physician payment rule, in the coming days.