Click-on bionic arm could help amputees do the simple things

VIENNA (Reuters) – Edmund Rath, a 53-year-old from Austria, wants to do simple things such as brush his teeth and slice bread.

Edmund Rath shows an artificial hand prosthesis during the Ottobock media day in Vienna, Austria October 23, 2018. REUTERS/Leonhard Foeger

Most people take such activities for granted but not Rath, who lost his arm just below the shoulder in a truck accident last year that ended his career as a builder. That bad luck was followed by a stroke of fortune.

He was chosen by Austrian surgeons as the first person to have a single operation in May to install a click-on prosthesis that the brain controls with signals to the missing hand.

The procedure, known as ‘osseointegration’ (OI), involved implanting a metal rod into the bone of his residual limb. The rod has an external attachment that anchors his prosthesis to his upper arm bone.

During the operation – which was screened live to an industry congress in Vienna – doctors also took nerves once used to control his hand and connected them to muscles in his upper arm, a procedure called ‘Targeted Muscle Reinnervation’.

Now when he imagines moving his hand, the muscles in his shoulder contract and are read by electrodes in his prosthesis that does the intended movement.

Rath’s challenge is to build up strength and learn the skills to make the so-called ‘simple’ activities possible.

“I don’t want to change the world, but everyday things are my goal and I want to be able to do these things as quickly as possible,” Rath told Reuters.

His experience could have global implications. Millions of people live with limb loss, including around 2 million in the United States alone. And the numbers are expected to grow due to rising prevalence of diseases like diabetes.

Demand is particularly strong among U.S. soldiers who lost limbs in wars in the Middle East, according to Horst Aschoff, an expert in OI at the Hannover Medical School in Germany.

SENSE OF TOUCH

The technology to fuse prostheses to the body has changed little for centuries.

They are connected to the amputee’s stump via a customized socket but they can become sweaty, cause skin irritations and restrict movement so users often end up not wearing them.

OI was first discovered in the 1950s by Swedish researcher Per-Ingvar Branemark and is used for dental implants.

The first amputee to receive an OI implant was in Sweden in 1990. The surgery is conducted in the West, mainly on lower limb amputees. Experts in Europe, Australia and the United States are leading a drive to find solutions.

Rath said the OI implant allows him to move his arm freely compared to the restricted movement afforded by the socket.

But learning to use his robotic arm, which was supplied by artificial limb maker Ottobock, takes daily practice.

“You need to fully concentrate when you want to properly control it (the arm) and that sap’s one energy,” he said at Ottobock’s research center in Vienna.

It took six weeks for the implanted nerves to grow into his muscles and he can now control six different functions of his robotic arm, such as opening and closing his hand.

One feature of OI is that users can feel some sensation from mechanical vibration in their skeleton, otherwise known as osseoperception, but there is currently no commercially-available product to restore a sense of touch.

That may happen one day.

Slideshow (10 Images)

British start-up Cambridge Bio-Augmentation Systems (CBAS) is working on a ‘Prosthetic Interface Device’ (PID), a neural interface that is integrated into the bone, the skin and the nervous system. Out from the end of the limb is a standard connector that can plug onto a range of devices.

The PID could give users control of any limb, alongside sensory feedback by applying a small electric current to the nerve that can be sent back to the brain and perceived as touch and temperature, said Oliver Armitage, co-founder and chief scientific officer.

“We think of it like a USB connector from the body.”

Additional reporting by Matteo Witt; Editing by Matthew Mpoke Bigg

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France investigates reports of babies born without arms in rural areas

PARIS (Reuters) – France has launched a nationwide investigation into why some two dozen babies have been born without hands or arms in a handful of rural areas since 2000 after several new cases were reported this week, the health minister said on Wednesday.

FILE PHOTO: French Health and Solidarity Minister Agnes Buzyn attends the Congress of the National Union of Communal Centers of Social Action in Nantes, France, October 15, 2018. REUTERS/Stephane Mahe/File Photo

A separate investigation has also been opened into reports that calves and possibly chickens have been born without limbs in the same three heavily agricultural areas, an official told Reuters.

Public health agency Santé Publique France said it had identified 11 additional cases of babies born with limb defects between 2000 and 2014 in the rural Ain department of eastern France, near the Swiss border, where seven cases were already reported in 2009-14.

There have also been malformed births in two departments in western France: four in the Morbihan, Brittany area between 2011 to 2013, and three in neighboring Loire-Atlantique in 2007 and 2008. Ain and Morbihan are several hundred kilometers apart.

The reports have raised alarm among the French public that some kind of toxin in food, water or air could be responsible.

“I want to know, I think all of France wants to know,” Health Minister Agnès Buzyn told BFM TV. “It could be an environmental factor. Maybe it is due to what these women ate, drank or breathed in.”

An initial inquiry in early October found the incidence of limb defects in the affected regions to be no greater than elsewhere in the country, but now the probe has been widened.

The new inquiry will be run jointly by the health agency and the sanitation, food and environment agency, Buzyn said.

“It is very complicated, we need to investigate the history of families in cases which sometimes date back ten years or more,” she said.

First conclusions were due by Jan. 31, and a full report by June.

Epidemiologist Emmanuelle Amar, who first revealed the birth defects in Ain, told Reuters the only thing mothers of the affected babies had in common was that they lived in cereal-growing areas amid fields of corn and sunflower.

She said most of the defects had been reported between 2009 and 2014 and that since then there had been no new cases. She criticized the health ministry’s initial findings and said congenital defects in the affected regions had been way higher than what would normally be expected.

“It is a terrible tragedy for the families,” said Amar.

The parents of a girl born without forearms in the village of Guidel, in the Morbihan, said the inquiry should focus on the 2011-13 period, when most of the cases appeared.

“No point in looking ahead. Focus on what happened then,” the girl’s father Samuel Bernard told BFM TV earlier this month.

Amar said that in the Ain region farmers had also reported calves being born without tails and without flanks.

An official at the national food safety agency Anses told Reuters it had now opened a separate investigation into legless calves in the three same regions. Poultry may also be investigated as there are suspicions about chickens being affected.

Hospital registries show limb defects occur in 1.7 of every 10,000 births, or about 150 cases per year in France. Birth defects can have multiple causes, including chromosome disorders, drug use or exposure to toxic substances.

In the late 1950s and early 1960s, about 10,000 babies worldwide were born with malformed or missing limbs after their mothers received the drug thalidomide to treat morning sickness.

Additional reporting by Sophie Louet, Sybille de la Hamaide and Lucien Libert in Paris; Writing by Geert De Clercq; Editing by Luke Baker and Richard Balmforth

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Individuals with integrated medical, behavioral, and pharmacy benefits are more engaged in their health, well-being

A study by global health service company Cigna Corporation shows that individuals whose medical, behavioral and pharmacy health benefits are connected and administered by Cigna are more engaged in their health and well-being than those whose benefits are not fully integrated across medical, behavioral and pharmacy. As a result, people experience improved health and employers experience cost savings.

“A person’s physical and mental health are connected, and health care is best delivered – and produces the best outcomes – when it is connected as well,” said Scott Josephs, M.D., national medical officer at Cigna. “The results of this study demonstrate the value of our integrated, holistic approach to health care, and we’ll continue to advocate for more integration on behalf of the people we serve.”

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Results from this year’s study showed positive health outcomes for individuals and lower medical costs for employers who offer integrated medical, comprehensive behavioral and pharmacy benefits administered by Cigna, including:

  • Employers see an average medical savings of $193 annually for each covered person and $645 annually for each person with a known health improvement opportunity.
  • 22 percent more people engage in health coaching and case management programs.
  • Employers see annual medical cost savings of $9,792 for engaged customers with a specialty condition, such as multiple sclerosis or rheumatoid arthritis. When people being treated for diabetes are engaged, the savings is $5,900.
  • A 9 percent reduction in high cost medical claims for customers with integrated benefits.
  • Customers with integrated benefits had a 10 percent reduction in out of network claims.

“When people are actively engaged in their health and well-being, we see improvement across all metrics,” said Jon Maesner, PharmD, chief pharmacy officer at Cigna. “Offering a fully-connected pharmacy benefit allows us to maximize every opportunity available to engage the people we serve, and we’re encouraged by the consistent value shown by connecting medical, behavioral and pharmacy benefits.”

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With One Hand, Administration Boosts ACA Marketplaces, Weakens Them With Another

In the span of less than 12 hours last week, the Trump administration took two seemingly contradictory actions that could have profound effects on the insurance marketplaces set up by the Affordable Care Act.

First, officials issued guidance Monday morning that could weaken the exchanges set up for people who buy their own insurance. The new approach makes it easier for states to get around some ACA requirements, including allowing the use of federal subsidies for skimpier plans that can reject people with preexisting conditions.

Yet, the other move — a proposed rule unveiled Monday evening — could bolster ACA marketplaces by sending millions of people with job-based coverage there, armed with tax-free money from their employers to buy individual plans.

Both efforts play into the parallel narratives dominating the bitter political debate over the ACA.

The administration, frustrated that Congress did not repeal the law, say some critics and policy experts, is working to undermine it by weakening the marketplaces and the law’s consumer protections. Those efforts make it easier for insurers to offer skimpier policies that bypass the law’s rules, such as its ban on annual or lifetime limits or its protections for people with preexisting conditions. Congress also zeroed out the tax penalty for not having coverage, effective next year. Combined, the moves could reduce enrollment in ACA plans, potentially driving up premiums for those who remain.

The administration and Republicans in Congress say they are looking to assist those left behind by the ACA — people who don’t get subsidies to help them buy coverage and are desperate for less expensive options — even if that means purchasing less robust coverage.

“These are people who were buying insurance before [the law] and then the rules changed and they could not buy it because they could not afford it,” said Joe Antos, a resident scholar at the conservative American Enterprise Institute. “They have been slowly dropping out of insurance coverage altogether.”

The efforts are dramatically reshaping the ACA and the individual insurance market to one that looks more as it did before the 2010 law, when regulation, coverage and consumer protections varied widely across the country.

Some states will do everything they can to keep individual markets strong and stable. Others won’t,” said Sabrina Corlette, research professor at the Center on Health Insurance Reforms at Georgetown University.

So what expectations should consumers have? Here are three key takeaways:

Protections for preexisting health problems are uncertain.

Polls show that keeping the ACA’s guarantees on coverage for people with medical problems is a top concern for Americans, and Democrats have made their defense of the health law a key part of their midterm election campaigns.

Republicans have gotten that message and even those who voted to repeal the ACA or joined a lawsuit by 20 red states to overturn it now say they want to protect people with preexisting conditions. Still, GOP lawmakers have not introduced any plan that would be as protective as the current law.

In August, the administration released a rule allowing expanded use of short-term plans, which are less expensive than ACA policies. To get those lower prices, most of these plans do not cover prescription drugs, maternity care, mental health or substance abuse treatments.

The move is unlikely to benefit people with health problems, as short-term plans can reject people with preexisting conditions or decline to cover care for those medical problems.

Under the rule, insurers can sell them starting in 2019 for up to a year’s duration, with an option to renew for up to three years, reversing an Obama-era directive that limited them to 90 days.

Administration officials estimate such plans could draw 600,000 new enrollees next year, and others have estimated the numbers could be far higher. The concern is if many healthy people in 2019 switch out of the ACA market and choose short-term plans, premiums will rise for those who remain, including those with preexisting conditions or make the ACA market less attractive for insurers.

Where you live matters more.

One of the biggest changes ushered in with the ACA was a standard set of rules across all states.

Before the law took effect, consumers buying their own coverage saw tremendous variation in what was offered and what protections they had, depending on the state where they lived.

Most states, for example, allowed insurers to reject people with medical conditions. A few states required insurers to charge similar premiums across the board, but most allowed wide variations based on age, gender or health. Some skimpy plans didn’t cover prescription drugs, chemotherapy or other medical services.

By standardizing the rules and benefits, the ACA barred insurers from rejecting applicants with medical conditions or charging them more. Women and men get the same premium rates and insurers could charge older people no more than three times what they charged younger ones.

Under the new guidance issued this week giving states more flexibility on what is offered, consumers could again see a wide variation on coverage, premium rules and even subsidy eligibility.

“It shifts pressure to state politicians,” said Caroline Pearson, a senior fellow at NORC, a nonpartisan research institution at the University of Chicago. That could play into the calculus of whether a state will seek to make broad changes to help people who cannot afford ACA plans, even if the trade-off affects people with medical conditions.

“You risk making some worse off by threatening those markets,” said Pearson. “That is always going to be hard.”

Millions more will join the “buy-your-own” ranks.

The proposed rule released Tuesday allows employers to fund tax-free accounts — called health reimbursement arrangements (HRAs) — that workers can use to buy their own coverage on the ACA marketplaces.

The administration estimates about 10 million people would do so by 2028 — a substantial boost for those exchanges, which policymakers say never hit the enrollment numbers needed to attract enough insurers and hold prices down.

John Barkett, senior director of policy affairs at Willis Towers Watson, a benefits consulting firm, said he expects employers to “seriously consider” the new market. The infusion of workers will improve options by attracting more insurers, he added.

“These people coming in will be employer-sponsored, they’ll have steady jobs,” Barkett noted, and will likely stick with coverage longer than those typically in the individual market.

Currently more than 14 million people buy their own insurance, with about 10 million of those using federal or state ACA marketplaces. The others buy private plans through brokers.

The proposed rule won’t be finalized for months, but it could result in new options by 2020.

If these workers seeking coverage are generally healthy, the infusion could slow premium increases in the overall ACA marketplace because it would improve the risk pool for insurers.

But, if employers with mainly higher-cost or older workers opt to move to the marketplaces, it could help drive up premiums.

In an odd twist, the administration notes in the proposed rule that the ACA has provisions that could protect the marketplace from that type of adverse selection, which can drive up prices. But most of the protective factors cited by the rule have been weakened, removed or expired, such as the tax penalty for being uninsured and the federal subsidies for insurers to cover lower deductibles for certain low-income consumers.

Benefits consultants and policy experts are skeptical about how many companies will move to the HRA plan, given the tight labor market. Continued uncertainty about the fate of the ACA marketplace may keep them reluctant to send workers out on their own, they say.

Health benefits are a big factor in attracting and retaining workers, said Chris Condeluci, a Washington attorney who previously worked for Sen. Chuck Grassley (R-Iowa) and served as counsel to the Senate Finance Committee during the drafting of the ACA.

“Most employers believe their group health plan will provide better health coverage than an individual market plan,” he said.

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Long-lasting HIV injection is a step closer after second GSK study

The GlaxoSmithKline (GSK) logo is seen on top of GSK Asia House in Singapore, March 21, 2018. REUTERS/Loriene Perera

LONDON (Reuters) – A once-monthly injection to control HIV proved as effective as daily pills in a second study by GlaxoSmithKline, paving the way for a new regimen that could be simpler for some patients to be filed with regulators.

The experimental two-drug injection of cabotegravir and rilpivirine was shown to suppress the HIV virus in a cohort of adults who had not been on a long-established daily three-drug oral regimen, GSK’s majority-owned HIV unit ViiV Healthcare said.

In the study, adults with HIV were first put on a 20-week three-drug program of daily tablets to suppress the virus before being switched to monthly injections. After 48 weeks, the injections maintained a similar rate of suppression as the pills, it said.

The results support an earlier major study, which involved adults who had been using a three-drug oral regimen to control the virus.

ViiV Healthcare’s chief medical officer John C. Pottage said the trial provided further evidence that a long-acting injection could offer an alternative to daily, oral therapy for people who had previously achieved viral suppression.

“This innovative dosing regimen could transform HIV therapy by reducing the number of days a person receives treatment from 365 to 12,” he said.

“Work on new methods of HIV treatment, including long-acting injectable therapies, supports our goal of making HIV a smaller part of the lives of people living with HIV.”

ViiV Healthcare, which is also owned by Pfizer and Shionogi, hopes that its work on developing two-drug therapies will help it compete against Gilead Sciences, the U.S. drugmaker that dominates the $26 billion-a-year HIV market.

The company said detailed results of the study would be presented at an upcoming scientific meeting.

Reporting by Paul Sandle; Editing by Emelia Sithole-Matarise

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Kids’ apps may have a lot more ads than you think

(Reuters Health) – Those cute little apps your child plays with are most likely flooded with ads – some of which are totally age-inappropriate, researchers have found.

A stunning 95 percent of commonly downloaded apps that are marketed to or played by children age five and under contain at least one type of advertising, according to a new report in the Journal of Developmental & Behavioral Pediatrics. And that goes for the apps labeled as educational, too, researchers say.

Often the ads are intrusive, spread across in a banner or even interrupting play, said study coauthor Dr. Jenny Radesky, an assistant professor of pediatrics at the University of Michigan and the University of Michigan C. S. Mott Children’s Hospital.

Perhaps the most insidious ads are the ones you need to click a little “x” to get rid of, Radesky said.

“The little ‘x’ doesn’t show up for about 20 seconds,” she explained. “If you’re a 2- or 3-year-old you might think the ad is a part of the game. And you don’t know what to do. You might click on the ad and that could take you to the app store. Many of these ads require you to do things before the ‘x’ will appear.”

Some ads are for products that aren’t appropriate for kids, Radesky said. “I’ve seen banner ads for bipolar treatment in some of these apps,” she added.

One app geared to young children had a popup that linked to a political game showing “a cartoon version of Trump trying not to push the red button that will send nukes,” Radesky said. “My son asked, ‘what is he talking about, is he going to blow up the world?’”

One big problem with ads in apps aimed at very young children is the kids often can’t tell where the game leaves off and the ad begins. “There’s science to show that children aged 8 and younger can’t distinguish between media content and advertising,” Radesky said.

Radesky originally was working on a study to explore how parents use their mobile devices. After noticing the kid-oriented apps on the parents’ phones, she and her colleagues decided this was a topic that should be looked at.

The researchers scrutinized 135 of the most downloaded free and paid apps in the “age five and under” category in the Google Play app store. Among them were free apps with 5 to 10 million downloads and paid apps with 50,000 to 100,000 downloads.

Of the 135 apps, 129, or 95 percent, contained at least one type of advertising, which included use of popular cartoon characters to sell products, teasers suggesting the purchase of the “full” version of the app, and advertising videos that interrupted play to promote in-app purchases or purchases of other products.

“What we found,” Radesky said, “was lots and lots of advertising.”

The new findings “are frightening,” said Dr. Albert Wu, an internist and professor of health policy & management at the Johns Hopkins Bloomberg School of Public Health. “This strikes me as a Trojan horse for tots. Even being charitable to all these companies, I think these apps are deceptive at best and unethical at worst.”

Wu was especially disappointed to find “this even applies to apps labeled as educational. It’s giving ‘educational’ a bad name. And it really does beg for a bigger role for the government in regulation even if there are some voices out there calling for less government. I think it would be important for the FTC (Federal Trade Commission) to step in.”

The idea that there is so much advertising in the apps, “is giving me even more reason to want to restrict screen use in my own children,” Wu said.

The new findings have prompted advocates to file a complaint with the FTC. The Campaign for a Commercial Free Childhood, along with other child advocacy groups, plans to file the complaint in conjunction with the release of the study results.

SOURCE: bit.ly/2yFUz1k Journal of Developmental & Behavioral Pediatrics, online October 26, 2018.

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Baby ‘sleep sacks’ might be safer than blankets

(Reuters Health) – Infant sleeping bags, or sleep sacks, are at least as safe as other bedding in preventing sudden infant death syndrome (SIDS) and might be safer, a new analysis concludes.

SIDS is the sudden, unexplained death of a baby younger than 12 months. While little is known about the condition, factors like putting a baby to sleep face down, or using soft bedding, have been found to increase the risk of SIDS.

In response to prevention guidelines warning against putting infants to sleep with blankets, parents have been putting them to sleep in sleeping bags. These “bags” are sleeveless sacks that cover the shoulders, containing the rest of the body, with the arms outside of the sack to prevent it from rising over the head.

“Infant sleeping bags are used by many parents around the world but it is important not to assume that popularity is equivalent to safety,” said Alessandra Glover Williams of Britain’s Royal United Hospitals Bath.

Williams and her colleague Fiona Finlay analyzed four previous studies of Austrian, Mongolian, Dutch and English infants that examined the impact of sleeping bags on risk of SIDS or SIDS risk factors. They reported their findings in the journal Archives of Disease in Childhood.

“There are not many trials looking into infant sleeping bags and risk of SIDS but those available are of high quality,” Williams said.

Two of the studies looked at the effect of infant sleeping bags on the risk of SIDS. The other two considered temperature regulation.

The Dutch study, published in 1998, found that cotton sleeping bags lowered the risk of SIDS by 65 percent and that babies who wore them were less likely to turn prone or face-down.

The English study found at first that sleep sacks did decrease babies’ risk of SIDS. But after the researchers accounted for other factors affecting SIDS risk, they could no longer say for sure that the lower SIDS rate was actually due to wearing the sleep sacks.

The Austrian study found that infants stayed just as warm when they slept in sleep sacks as when wrapped in blankets. The study in Mongolian babies found similar body temperatures in infants wearing sleep sacks or swaddled.

The Lullaby Trust, a British charity that aims to prevent unexpected deaths in infancy, recommends sleeping bags for babies as a good alternative to blankets but does not specifically say they reduce the chance of SIDS.

“I think most UK parents are aware of SIDS,” said Dr. Joanna Garstang of the University of Warwick, who reviewed the paper.

“Most (SIDS) deaths in the UK now occur in socially deprived families who struggle to engage with safe sleep messages,” Garstang said. “Sadly, a very common scenario is of a baby dying co-sleeping with parents who have consumed significant amounts of alcohol or taken drugs.”

“Sleeping bags are generally used by higher income families who are anyway at the lowest risk of SIDS,” she adds.

Launched in the 1990s, the Back To Sleep public education campaign, now renamed Safe to Sleep, has strived to educate caregivers about SIDS and ways to reduce it. Since the campaign began, SIDS rates have fallen dramatically, although the condition remains a leading cause of death for American infants.

Because SIDS is rare, “it is hard to accumulate enough data to fully understand what factors might come together to cause (it),” said Dr. David Schwebel of the University of Alabama at Birmingham, who was not involved in the study.

Garstang said the main limitation of the new analysis is that it lacked data, since there are very few publications about sleeping bags and SIDS. Dr. Schwebel agrees.

“The studies reviewed are excellent, but there are few of them, and some of them (were small),” he said. “The overall conclusion is that there is some evidence these sleeping bags are safe when used properly, and at least some initial indication they could help to prevent SIDS. But the evidence is preliminary right now, not definitive.”

SOURCE: bit.ly/2RprvSR Archives of Disease in Childhood, online October 8, 2018.

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WHO says air pollution kills 600,000 children every year

GENEVA (Reuters) – Air pollution kills an estimated 600,000 children every year and causing symptoms ranging from loss of intelligence to obesity and ear infections but there is a limited amount parents can do, a World Health Organization report said on Monday.

FILE PHOTO: Director-General of the World Health Organization (WHO) Tedros Adhanom Ghebreyesus attends a news conference after an Emergency Committee meeting on the Ebola outbreak in the Democratic Republic of Congo at the United Nations in Geneva, Switzerland, August 14, 2018. REUTERS/Denis Balibouse

Parents should try to avoid household air pollution by using less polluting fuels for cooking and heating and not smoking but to reduce child exposure to ambient pollution they should need to lobby politicians to clean up the environment, WHO experts said.

“Polluted air is poisoning millions of children and ruining their lives,” WHO Director-General Tedros Adhanom Ghebreyesus said in a statement. Large parts of Asia, Africa and Latin America are among the worst affected.

“This is inexcusable. Every child should be able to breathe clean air so they can grow and fulfill their full potential.”

The WHO report, “Prescribing clean air”, summarized the latest scientific knowledge on the effect on children of air pollution, which affects about 93 percent of children globally.

Maria Neira, WHO’s head of environmental determinants of health, said the worrying findings highlighted in the study, including evidence of pollution causing stillbirth and preterm birth, as well as diseases into adulthood, should lead to policy changes globally.

“Something that is critical as well is this issue of the neuro-development,” she said.

“Imagine that our children will have less cognitive IQ. We are talking about putting at risk a new generation of having a reduced IQ. This is not only new but terribly shocking.”

There was clear, consistent evidence of an association between ambient air pollution and otitis media, or ear infections, the study said, as well as some evidence of it causing obesity and insulin resistance in children.

Air pollution can also cause childhood cancers, asthma, poor lung function, pneumonia and other types of acute lower respiratory infection, the report said.

Reporting by Tom Miles; Editing by Matthew Mpoke Bigg

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Trump Adds A Global Pricing Plan To Wide Attack On Drug Prices, But Doubts Persist

President Donald Trump’s new pledge to crack down on “the global freeloading” in prescription drugs had a sense of déjà vu.

Five months ago, Trump unveiled a blueprint to address prohibitive drug prices, and his administration has been feverishly rolling out ideas ranging from posting drug prices on television ads to changing the rebates that flow between drugmakers and industry middlemen.

Thursday, Trump proposed having Medicare base what it pays for some expensive drugs on the average prices in other industrialized countries, such as France and Germany, where prices are much lower. The proposal is in the early stages of rule-making and awaiting public comments.

The U.S., Trump said, will “confront one of the most unfair practices, almost unimaginable that it hasn’t been taken care of long before this.”

The proposal was met with hope and skepticism, with several experts saying they were happy the administration was taking on Medicare Part B’s rising drug prices but questioning its approach.

Walid Gellad, director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh, said in an online post that the administration’s proposed solutions were unclear. And, he said, they would “face insurmountable challenges.”

While some industry watchers pointed to the announcement as a political move, Wells Fargo pharmaceutical analyst David Maris said that this is a broader effort by the president and his administration to attack the root causes of high drug prices.

“The reality is he could very easily not take this on and do what other administrations have done and let the prices keep rising.”

Trump, too, promised more to come and said he will soon announce “some things that will really be tremendous.” On Friday, Health and Human Services Secretary Alex Azar said that, as promised in the blueprint, there would be more changes to Medicare Part D, which covers most prescriptions. Ian Spatz, a public policy expert and senior adviser at Manatt Health, said the overall blueprint was “unprecedented in terms of how many different ideas and areas of ideas that it contained.”

Nothing would happen overnight. The proposal to require drug prices in TV ads could be delayed by litigation and notably, if implemented, does not include any penalties for companies who fail to post their prices.

The proposed rebate rule was delivered to the Office of Management and Budget in July. Matt Brow, president of industry consulting firm Avalere Health, said he expects the administration to publish the rule for comment by year’s end.

Trump’s international pricing plan is not as far along as the rebate proposal. Rather, it is an “advanced notice of proposed rule-making.” The proposed rule could come in spring 2019, and Azar said the new model could begin in late 2019 or early 2020.

Yet, on Friday, Azar signaled the proposal could change, telling an audience at the Brookings Institution that the administration is “open to any number of alternative ideas.”

Avalere’s Brow said there is a good chance the proposal will change significantly.

“The sweeping nature of the proposal makes the stakes higher and makes it harder to implement,” Brow said.

If the administration moves forward, it would bypass Congress and implement a pilot under the Center for Medicare & Medicaid Innovation’s purview. The pilot would phase in over five years and apply to 50 percent of the country. Azar said there would be no changes to Medicare benefits and no restrictions on patient access.

The proposal focuses on drugs covered under Medicare Part B, which are administered in hospitals, clinics and doctors’ offices. It also would alter the reimbursement formula for doctors and providers and would allow private-sector vendors to purchase drugs and then sell them to doctors and hospitals. Medicare would reimburse those vendors at the international pricing level.

Currently, doctors and hospitals administering Part B drugs are reimbursed the average price of a drug plus 6 percent. President Barack Obama’s administration attempted to alter Part B as well but drew intense lobbying opposition and eventually withdrew a proposed pilot project.

Allan Coukell, senior director for health programs at Pew Charitable Trusts, said removing incentives that reward doctors for purchasing costlier drugs and bringing in a new way to control prices “makes a lot of sense.” Drug spending within Medicare Part B reached $22 billion in 2015, and drug costs have increased by an average of 8.6 percent annually since 2007.

Stephen Ubl, president of the industry trade group Pharmaceutical Research and Manufacturers of America, or PhRMA, said imposing foreign price controls from countries with socialized health care systems would harm patients and hinder drug discovery and development.

Azar, a former executive at pharmaceutical manufacturer Eli Lilly, told reporters Thursday that “you may hear the tired talking points” that this will affect innovation. He disputed that idea, concluding that “less than 1 percent of pharma [research and development] could potentially be impacted by this change.”


KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

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Gun Store Owner Marshals Voters To Expand Medicaid In Idaho

BOISE, Idaho — Standing outside the gun shop she co-owns, next to her SUV sporting “NRA” on the license plate, Christy Perry pledges full support for President Donald Trump.

Christy Perry, a gun store owner in Boise and an Idaho legislator, is helping lead the campaign on a voter referendum to approve Medicaid expansion in the state. (Phil Galewitz/KHN)(Phil Galewitz/KHN)

“He’s doing a good job,” said Perry, a four-term Republican member of the Idaho legislature who has voted for a litany of conservative causes, including weakening labor unions, restricting abortion and boosting charter schools.

With those credentials, Perry hopes for another big win on Election Day — one that puts her at odds with Trump and GOP orthodoxy.

She’s helping lead the drive to persuade state voters to expand Medicaid — a central tenet of the Affordable Care Act, the 2010 law embraced by Democrats and derided by many Republicans.

Perry has been pushing for Medicaid expansion the past several years in the state legislature, but those efforts were thwarted by top House leaders. Now a ballot initiative, Proposition 2, puts the matter before Idaho voters.

Perry said Medicaid coverage is desperately needed by people struggling in low-wage jobs and the economics make sense for the state given the federal government will pay a 90 percent share. An expansion will reduce or eliminate the need for other Idaho-funded programs to help the uninsured, she said.

She said the state can’t wait any longer.

“The longer you wait, the more people die” because they miss out on care, she said.

If the push is successful on Nov. 6, about 62,000 Idaho adults would be added to the state-federal health insurance program that covers 73 million low-income Americans. It would be a major advance for Obamacare into one of the most conservative parts of the country.

Idaho is one of the remaining 17 GOP-controlled states where lawmakers have steadfastly resisted expanding Medicaid.

But voters in Idaho, Nebraska and Utah will decide next month whether to buck their political leaders and go forward with the expansion. The issue is also on the ballot in Montana, which expanded Medicaid in 2016. There, residents will decide whether to continue it past 2019.

Of those states, Idaho is arguably the least politically hospitable for Medicaid expansion. Trump carried Idaho by the largest margin — nearly 32 percentage points.

Last year, Maine became the first state to approve expanding Medicaid via a ballot referendum, although the GOP governor has stalled implementation.

Unlike Maine, where political power has been split between Democrats and Republicans in recent years, Idaho, Utah and Nebraska are solidly GOP territory.

Trump and Republican congressional leaders have vowed to repeal the health law, which made expansion possible by providing the bulk of the funding for those who qualify for new coverage.

Perry, 50, doesn’t see a problem getting Trump voters to back the expansion. She said that the Republican failure to repeal the law last year opened the door for conservative states to go forward.

“I think people here listen to that and it now falls to states to go ahead” with expansion, she said.

Supporters of the referendum were successful at garnering 70,000 signatures to put the vote on the ballot, but they face a steep challenge educating the electorate about the complexities of Medicaid financing.

Tim Dunnagan, dean of the College of Health Sciences at Boise State University, said few Idaho voters know that most states — including neighboring Oregon and Washington — have already expanded Medicaid. Because the issue can be confusing, he said, voters may gravitate to their long-held concerns about paying more taxes and government overreach.

“There is a strong sentiment that if the federal government is involved, it is not a good thing,” he said. “There’s a fierce individualism out in the West.”

Perry and the broad coalition endorsing the referendum — including teachers, employers, county sheriffs and the health industry — seek to remind voters that they are already paying for the health law’s provisions through their federal taxes and the expansion would bring $400 million in federal funds into the state.

The expansion would cover residents with incomes below 138 percent of the federal poverty level, or nearly $17,000 a year for an individual. Currently, Idaho adults who do not have children and are not disabled are not eligible for Medicaid. Those with children can only qualify with incomes up to 26 percent of the poverty level, or $3,156 a year.

The expansion also would eliminate a gap for residents whose income is too low to qualify for government subsidies to buy private coverage but who earn too much to qualify for Medicaid.

Volunteers for Idahoans for Healthcare canvass a Boise neighborhood, talking to residents about the need for Medicaid expansion. (Phil Galewitz/KHN)

Scott Richey, of Nampa, Idaho, talks to Lauren Necochea, a volunteer for Idahoans for Healthcare, as she canvasses his neighborhood for votes on Medicaid expansion.(Phil Galewitz/KHN)

Supporters have canvassed neighborhoods across the state in recent weeks. Hundreds of volunteers use lists of registered voters and a special app on their phone to detail their results.

On a recent evening, about 20 people gathered about 10 miles east of downtown Boise, where a field organizer gave them voter lists and instructions on how to approach homeowners.

Tracy Olson, 54, a nurse turned real estate agent, and Jill Galanter, 55, a physical therapist, went to an upper-income planned community. About two-thirds of the people they met said they support expansion, and most of the rest had not heard about it. Only a couple of people said they oppose the ballot question.

In their one-minute pitch, Olson and Galanter explained the coverage gap for low-income residents and the millions in federal dollars the state can gain by expanding. They didn’t mention the ACA. That’s not an oversight, organizers said.

“Obamacare has a negative connotation here,” Perry said.

Mike Brown, 50, an engineer, told Olson he didn’t know the issue but added that his health costs have soared in recent years. He nodded as Olson explained whom the expansion would help.

“I can sympathize,” he said. They recorded him as a “leaning yes.”

Richard Rapp, 75, a retired head of the career center at Boise State University, said he will support the expansion for humanitarian reasons. “Too many people don’t have adequate coverage, and that ends up costing us all,” he said.

Organizers with Idahoans for Healthcare have been driving this green truck around the state.(Phil Galewitz/KHN)

Later that week, another volunteer, Lauren Necochea, also found support in the Nampa area, west of Boise.

Norm Holm, 67, listened to her pitch. “It makes sense to me,” said Holm, a registered Republican. “Everyone deserves a decent shot at health care.”

Asked if he knew that the Medicaid expansion is part of the ACA, Holm shook his head. “If they can’t do away with it, maybe this is a way to make it better,” he said, adding that he believes the health law has good and bad parts.

In contrast, opponents of the referendum stress how Medicaid expansion is part of what they call the “failed Obamacare.”

The Idaho Republican Party and the conservative Idaho Freedom Foundation are fighting the ballot initiative. Foundation officials say it would divert dollars that could be spent on roads and education.

“Medicaid expansion is a cornerstone of Obamacare, which has failed to cover everyone and has led to increasing health costs,” said Fred Birnbaum, vice president of the foundation.

His group plans to run radio commercials, use social media and put out flyers.

Lawmakers opposed to expanding Medicaid have argued that the state could not afford its share of the cost without having to raise taxes. Under the law, the federal government pays about 90 percent of the costs for expansion and states cover the rest.

But a state-funded report this year found it would cost Idaho relatively little — $105 million over 10 years, which includes savings from state and county funds that would no longer be needed to help the uninsured. Idaho’s budget tops $3 billion a year.

Brad Little, the GOP nominee for governor who is widely expected to win in November, said he would abide by the will of the voters.

Perry is not the only Republican state lawmaker who has come out in support of expansion, but she is one of the most prominent. Perry tried — and failed — to get lawmakers to expand Medicaid. She is not running for re-election.

“Christy is well-known among GOP women and well-liked,” said Toni Lawson, vice president of government relations at the Idaho Hospital Association, which supports the initiative. She said persuading GOP women to vote for expansion will be key to a victory.

Perry said her gun store ownership and mainstream conservative values will help gain voters’ trust on Medicaid.

“Idaho is a conservative, Christian and right-to-life state, and Medicaid expansion fits right in with our morals and values we have,” she said. “It’s about doing the right thing.”

Related Topics

2018 Elections Medicaid

Idaho Medicaid Expansion

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