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Friday, October 5, 2018

First user-fitted hearing aid approved


The first hearing aid that doesn’t require the assistance of an audiologist or other health care provider has been approved by the U.S. Food and Drug Administration.
The Bose Hearing Aid is a user-fitted  for people aged 18 and older with mild-to-moderate  loss, the agency said Friday in a news release.
“Today’s marketing authorization provides certain patients with access to a new hearing aid that provides them with direct control over the fit and functionality of the device,” said Dr. Malvina Eydelman, director of the FDA’s Division of Ophthalmic, and Ear, Nose and Throat Devices.
Some 37.5 million adults in the United States report having hearing loss of some degree, the FDA said. Common risk factors include aging, exposure to loud noises and certain medical conditions.
The Bose device was evaluated in clinical studies involving 125 people. When participants self-fitted the device and used a cellphone app to program and make adjustments to the device settings, they “generally preferred those  settings over … professionally-selected settings,” the FDA said.
While users may fit, program and control the device on their own, some state laws require that hearing aids be obtained from a licensed dispenser, the agency said.
Bose Corp. is based in Framingham, Mass.

Health insurers may discourage use of non-opioid alternates for lower back pain


Public and private health insurance policies in the U.S. are missing important opportunities to encourage the use of physical therapy, psychological counseling and other non-drug alternatives to opioid medication for treating lower back pain, a study led by researchers at Johns Hopkins Bloomberg School of Public Health has found.
The Bloomberg School researchers looked at Medicaid, Medicare and major commercial ‘ 2017 coverage policies for non-drug options for treating chronic lower back pain—a common pain condition that is often treated inappropriately with . They found that insurers have inconsistent  terms for non-drug treatments, and provide little or no coverage for interventions such as acupuncture and psychological counseling, treatments which do have some scientific backing.
A key finding was that insurers did not have clear and consistent coverage policies for several lower back pain treatments that have been found effective in some studies. Acupuncture, for example, was expressly covered by only five of the 45 examined plans.
“This study reveals an important opportunity for insurers to broaden and standardize their coverage of non-drug pain treatments to encourage their use as safer alternatives to opioids,” says study senior author Caleb Alexander, MD, MS, associate professor of epidemiology at the Bloomberg School.
The study, to be published Oct. 5 in the online journal JAMA Network Open, follows a complementary study by the same research team of major insurers’ policies on prescription drugs for pain, published in the same journal in June. The two studies are the most comprehensive of their kind, and were conducted with funding and technical assistance from the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC).
CDC officials estimate that 49,031 Americans died from  overdoses in the 12-month period ending in December 2017. In 2016, more than 40 percent of those deaths were due to prescription opioids. This epidemic has been encouraged by a several-fold increase in opioid prescriptions since the turn of the century—most of which are thought to be medically unnecessary. Current CDC guidelines note that “Non-opioid therapy is preferred for chronic pain outside of active cancer, palliative, and end-of-life care.” HHS has urged insurers to design their coverage policies accordingly.
To gauge how far insurers have moved towards this goal, Alexander and colleagues examined 15 Medicaid, 15 Medicare Advantage and 15 major commercial insurer plans for 2017 covering non-drug treatments for lower back pain. The 45 plans were applicable in 16 states, chosen for the diversity of their geography, wealth and opioid-epidemic impact.
Of the fifteen Medicaid plans assessed for psychological coverage, just three plans covered psychological interventions. “We were perplexed by the absence of coverage language on psychological interventions,” Alexander says. “It’s hard to imagine that insurers wouldn’t cover that.”
Even for , an important and well-established method of relieving lower back pain that was covered by nearly all plans, specific coverage policies were inconsistent. “Some plans covered two visits, some six, some 12; some allowed you to refer yourself for treatment, while others required referral by a doctor,” Alexander says. “That variation indicates a lack of consensus among insurers regarding what model coverage should be, or a lack of willingness to pay for it.”
The researchers interviewed 43 executives representing the evaluated plans; these individuals indicated that their organizations have been trying to expand access to non-drug therapies in response to the opioid epidemic. Overall, however, their remarks suggested that insurers were not yet doing enough to coordinate non-drug and drug coverage policies, such as requiring patients to try physical therapy for their lower back  before covering long-term opioids.
Alexander emphasizes that while many of the covered non-drug therapies, such as acupuncture and chiropractic interventions, might seem untested, there is significant evidence for their effectiveness in treating .
The findings, to Alexander and colleagues, suggest that there is still a lot of room for improvement in coverage policies, particularly an expansion and standardization of non-drug  coverage and policy terms—a change that should encourage more use of non-drug treatments by patients before they resort to opioid painkillers.
“In the last few years we have seen many insurers modifying their policies to reduce the vast overuse of opioids, but clearly we still have a long way to go,” says Alexander.
More information: “Coverage of Non-Pharmacologic Treatments for Lower Back Pain Among Public and Private Insurers in the United States” JAMA Network Open (2018).

New targets to inhibit pulmonary fibrosis


In a study out this week in Science Translational Medicine, an international team led by researchers at Vanderbilt University Medical Center sheds new light on the cause of pulmonary fibrosis and demonstrates a way to impede the disease in mice.
The study results imply that certain drugs already at market might be able to be repurposed to inhibit or halt this major respiratory disease.
“I’m very excited by the implications of our study for drug repurposing and the important benefits that might accrue for a great many patients with lung disease,” said Wonder Drake, MD, professor of Medicine and Pathology, Microbiology and Immunology, who led the study with Lindsay Celada, Ph.D., research instructor in Medicine.
“I’m doubly excited at the prospect of these clinical trials proceeding right here at VUMC. A combination of clinical investigative talent and research infrastructure makes VUMC the natural place to advance our lab’s findings into the clinical realm.”
People with pulmonary  are perpetually short of breath. Connective tissue in their lungs has become thickened or scarred, reducing the supply of oxygen to the blood.
Fibrosis occurs in a number of diseases affecting the lungs, among them sarcoidosis and  (IPF). Median survival with IPF is approximately three years. Pulmonary fibrosis can also occur in response to bleomycin, a drug in use since the 1960s to treat cancer.
Pursuing cues from an assortment of previous findings, the new study uncovers a common immunological mechanism underlying these three distinct disease types.
In both IPF and bleomycin-induced fibrosis, previous studies had indicated connections with a pro-inflammatory cell signaling protein called interleukin-17 (IL-17A). Meanwhile, people studying sarcoidosis had found dysfunction in a type of white blood cell, the CD4+ T cell.
Drake had traced this dysfunction to upregulation of PD-1, or programmed cell death protein 1, a  that inhibits autoimmunity.
Fibroblasts are cells that produce the structural framework of animal tissues, including wound-healing tissues. IPF in particular has been shown to involve overactivation of .
The team placed normal lung fibroblasts in culture with CD4+ T cells harvested from people with IPF or sarcoidosis. Type 1 collagen production, a hallmark of fibrosis, results in both these cultures; but not so in the case of CD4+ T cells from patients with healthy lungs.
Employing an array of techniques and covering a lot of ground, the study introduces a causal story that starts with PD-1 upregulated CD4+ T cells, leading to increased expression of a gene transcription activator called STAT3, and then on to increased production of IL-17A, resulting in fibrosis.
“Though they haven’t typically been considered important in pulmonary fibrosis, we’re showing a central role in a range of diseases for CD4+ T cells with PD-1 upregulation,” Celada said.
With its wide scope, the study brings attention to three potential drug targets for which drugs are already available: blocking PD-1 can significantly reduce fibrosis in mice, the team shows; using human  in vitro, they show that chemical inhibition of STAT3 reduces components of fibrosis, such as collagen production; and finally, the study brings added attention to the role of IL-17A in sarcoidosis .
More information: Lindsay J. Celada et al. PD-1 up-regulation on CD4+ T cells promotes pulmonary fibrosis through STAT3-mediated IL-17A and TGF-β1 production, Science Translational Medicine (2018). DOI: 10.1126/scitranslmed.aar8356

Euro watchdog urges curbs on on fluoroquinolone, quinolone antibiotics


The European Medicine Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restricting the use of systemic and inhaled fluoroquinolone and quinolone antibiotics following a safety review.
“Very rarely, patients treated with fluoroquinolone or quinolone antibiotics have suffered long-lasting and disabling side effects, mainly involving muscles, tendons, and bones, and the nervous system,” the EMA said in a news release.
The PRAC also advised that some medicines, including all those that contain a quinolone antibiotic, be removed from the market.
The PRAC recommended that the remaining fluoroquinolone antibiotics should not be used to treat infections that might improve without treatment or are not severe (such as throat infections); to treat patients who have previously had serious side effects with a fluoroquinolone or quinolone antibiotic; or to treat mild or moderately severe infections unless other antibacterial medicines commonly recommended for these infections cannot be used.
They should also not be used to prevent traveler’s diarrhea or recurring lower urinary tract infections.
The PRAC further recommended that fluoroquinolone antibiotics be used with caution in the elderly, patients with kidney problems, patients who have had an organ transplantation, or those who are being treated with a systemic corticosteroid, as these patients are at higher risk of tendon injury caused by fluoroquinolone and quinolone antibiotics.
The PRAC recommends that healthcare providers advise patients to stop taking a fluoroquinolone antibiotic at the first sign of a side effect involving muscles, tendons, or bones (such as inflamed or torn tendon, muscle pain or weakness, and joint pain or swelling) or the nervous system (such as feeling pins and needles, tiredness, depression, confusion, suicidal thoughts, sleep disorders, vision and hearing problems, and altered taste and smell).
The PRAC safety review was announced in early 2017, as reported byMedscape Medical News, and covered the fluoroquinolone antibiotics ciprofloxacin, flumequine, levofloxacin, lomefloxacin, moxifloxacin, norfloxacin, ofloxacin, pefloxacin, prulifloxacin, and rufloxacin; and the quinolone antibiotics cinoxacin, nalidixic acid, and pipemidic acid.
In 2016, the US Food and Drug Administration (FDA) enhanced warnings about the link between fluoroquinolones and disabling and potentially permanent side effects involving tendons, muscles, joints, nerves, and the central nervous system.
In July, the FDA ordered label changes for fluoroquinolones to strengthen warnings about the antibiotics’ risks for mental health side effects and serious blood sugar disturbances, as reported by Medscape Medical News.
The PRAC recommendations will now be sent to EMA’s Committee for Medicinal Products for Human Use (CHMP), which will adopt the Agency’s final opinion.
The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU member states. The new restrictions on the use of fluoroquinolones and quinolones will become applicable after a Commission decision is issued.

Science Says: Wind Power Blows


If you care about global warming, you must like wind power, right? But what if wind power itself ends up contributing to a warmer climate? That appears to be the case, according to a new study.
The study, by Harvard researchers and published in the energy research journal Joule, found if the country relied entirely on wind power for energy, the average temperature in the continental United States would climb by almost a quarter of a degree Celsius.
Keep in mind that eliminating all CO2 emissions from electricity generation would, as most, cool temperatures by 0.1 degree Celsius. In other words, wind power would more than offset whatever gains came from drastic cuts in carbon emissions.

Churning the Air

Why? The researchers say that the warming comes from the fact that the wind turbines churn the air, and “the exchange of heat, moisture, and momentum between the surface and the atmosphere” cause temperatures to rise.
James Temple, writing in MIT Technology Review, said the study “raises serious questions about just how much the United States or other nations should look to wind power to clean up electricity systems.”
It also raises serious questions about why the U.S. spends billions of dollars each year subsidizing wind power.
That’s to say nothing of the fact that several states mandate that their utilities buy a percentage of their electricity from renewable sources like wind.
The combination helped boost wind power’s share of electricity generation from 1.5% in 2000 to more than 6% last year.
By the way, wind turbines aren’t just warming the climate, they’re slaughtering birds. The Audubon Society says existing wind farms kill up to 328,000 birds a year.

Land Hog

Wind energy is also a massive land hog (as is solar). One analysis found that wind farms require roughly 100 times as much land as a modern nuclear power plant to produce the same amount of energy. (Nuclear power doesn’t chop birds up or heat the climate, and produces zero carbon emissions. Yet for some reason it never factors in as a “clean energy alternative.”)
What’s more, because the wind doesn’t always blow, wind farms need other, more reliable, and usually CO2-producing, sources of energy to back them up.
The federal production tax credit for wind is set to phase out by 2020. But as anyone who follows these things knows, “temporary” tax subsidies have a way of becoming permanent.
In the meantime, will environmentalists rethink their love of climate-warming, bird-killing and land-grabbing wind power?

AstraZeneca’s old R&D site in multimillion pound science property plan

AstraZeneca’s new R&D headquarters in Cambridge may be having teething problems – but ironically the site at Alderley Park, Cheshire that it abandoned nearly five years ago is going from strength to strength.
The Anglo-Swedish pharma has still not completed the move to its new R&D site, which is behind schedule and over budget.
But its old site in Alderley Park (pictured above) in Cheshire continues to attract investment and is one of the major assets in a science commercial property joint venture announced today.
Bruntwood and Legal & General Capital (Legal & General) have established a 50:50 partnership to create the UK’s largest property venture dedicated to science and technology growth in and around regional cities.
The two partners will invest £360 million of capital, property and intellectual assets into a new company, Bruntwood SciTech, with a business plan supporting creation of over 20,000 high value jobs.
The deal is the largest made in science and technology property assets in Europe this year, and the partners plan to expand their assets from 1.3 million square feet to over 6.2 million square feet over the next 10 years.
This will increase the value of the portfolio to £1.8 billion, the partners said in a statement.
Bruntwood SciTech’s portfolio is already home to more than 500 science and technology businesses, including biotech start-ups as well as global life science companies.
It is centred around assets and development projects in Manchester, Birmingham and Leeds, and includes AstraZeneca’s old R&D base – now the life science campus in Alderley Park.
Liverpool also features strongly in its plans.
Alderley Park is already undergoing a £160m redevelopment, following its acquisition by Bruntwood in 2014. It is now home to 65 SMEs and 150 start-ups and is further focused on founding and growing life science sector businesses.
Alderley Park has two venture funds on site, one of which, the £42m Greater Manchester and Cheshire Life Science Fund has already invested in 25 businesses across pharmaceuticals, biotech, diagnostics, CROs and medical devices.
Next year, the 150,000 sq ft glasshouse building will open at Alderley Park, offering space for digital tech businesses.
Bruntwood SciTech will also develop and be home to a new precision medicine campus within Manchester’s Oxford Road Corridor Enterprise Zone.
The expanded campus will also complement the work by industry and the NHS in Greater Manchester to integrate electronic health data with genomic technology.
Bruntwood SciTech will be led by current Bruntwood’s chief commercial officer Phil Kemp as CEO, with the rest of the board including leaders from L&G, and also Dr Chris Doherty, managing director of Alderley Park.

Quest Diagnostics to sell India medical diagnostics business to Strand


Quest Diagnostics announced an agreement to sell its India medical diagnostics business to Strand Life Sciences, a Bangalore-based specialized diagnostics company. The two companies will work together to manage the transition, and aim to close the sale by the end of Q1 of 2019. Terms of this transaction were not disclosed.
https://thefly.com/landingPageNews.php?id=2800587