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Satellite Images Reveal How a New Island Was Born Off North Carolina – Live Science

Posted on July 14, 2017 by Danzig

Satellite images reveal a new barrier island forming off the coast of Cape Hatteras National Seashore in North Carolina.

How is a barrier island born? A new series of satellite images tells the tale.

Shots taken by an instrument aboard the Landsat 8 satellite between November 2016 and July 2017 show the formation of "Shelly Island," a mile-long (1.6 kilometers) spit off the coast of Cape Hatteras National Seashore in North Carolina. The island formed rapidly, adding most of its mass between April and May 2017. (The Landsat satellites are run jointly by NASA and the U.S. Geological Survey.)

New islands are quite common on this stretch of shore, where waves and tides sculpt sand into shapes that sometimes protrude above the ocean surface. The shallow undersea expanses of sand associated with the capes are called shoals, and it is from these shoals that new barrier islands form, experts say. [See Images of a Volcanic Island Birthed in Japan]

"A likely process would be a high tide or storm-driven water elevation that piled up sediment to near the surface, and then water levels went down, exposing the shoal," Andrew Ashton, a geomorphologist atWoods Hole Oceanographic Institution in Massachusetts, told NASA' Earth Observatory, which released the new satellite images.

Satellite images revealed the island formed some time between November 2016 (left) and July 2017 (right).

"Waves then continue to build the feature while also moving it about," Ashton said.

According to The Virginian-Pilot, the island got its moniker from a visiting 11-year-old, who explored the spot on Memorial Day weekend. (It was loaded with seashells.) But by June, officials were warning people not to try to get to the island, after a series of attempted visits necessitated rescues. A strong rip current makes the 50-yard (45 meters) crossing from the cape to the island dangerous, the newspaper reported.

The first snapshot taken by the Operational Land Imager (aboard Landsat 8) on Nov. 16, 2016, shows Cape Point, a prominent local fishing spot, before the island formed. By Jan. 28, 2017, the white froth of breaking waves is visible just off the point, hinting at the very shallow sand below. In the final image, taken July 7, 2017, the island is fully formed.

Barrier islands like Shelly Island are both changeable and resilient. They can be destroyed or shifted by major storms, which happened to many barrier islands during Hurricane Sandyin 2012. But when big storms steal the sand from barrier islands, it often ends up just offshore, so it's available when smaller waves return and start gently building the island back up again, Brian Romans, a sedimentary geologist at Virginia Tech, told Live Science in 2011.

This natural process can be disrupted by human activities, like the building of piers or redirection of sediment.

Original article on Live Science.

Satellite Images Reveal How a New Island Was Born Off North Carolina - Live Science

Rising seas threaten scores of species on Pacific islands with extinction – Carbon Brief

Posted on July 14, 2017 by Danzig

The Chuuk flying fox. The Black-spotted Cuscus. The Fijian crested iguana. The Mariana skunk. The greater monkey-faced bat. Poncelets giant rat.

Not exactly household names, but these creatures have something in common: theyre all critically endangered and they all live on islands in the Pacific Ocean that are at high risk from rising sea levels.

Thats the conclusion of a new study, published in the Nature journal Scientific Reports, which maps the distribution of 150 threatened species living on Pacific islands and their susceptibility to sea level rise.

Some of these creatures are found on just a single island, so losing their habitats to encroaching seas would mean global extinction, the lead author tells Carbon Brief.

A Mariana fruit bat named Babydoll hangs from a tree at the Guam National Wildlife Refuge in Guam May 20, 2013. The Mariana fruit bat (Pteropus mariannus) is currently listed as a threatened species. (U.S. Air Force photo by Staff Sgt. Melissa B. White/Released)

The new study focuses on a stretch of the southern Pacific Ocean from Palau in the west to the Pitcairn Islands in the east. Within this 85m square kilometre (sq km) area are more than 2,000 islands.

These islands come in all shapes and sizes most are volcanic or reefs but they are predominantly small and low-lying. Their average size is just 1.3 sq km some are just a tenth of that size and 42% of them have a maximum elevation of less than 10m.

These characteristics put the islands and the species that live on them at particular risk from sea level rise, storms and high waves, the study says.

On small islands, land-based creatures have fewer places to move to when their habitats are lost. In addition, through evolution, many island-living species no longer have the traits that would have helped them move on for example, many birds and insects have lost their ability to fly.

Putting all these factors together, species living on these Pacific islands are highly vulnerable to extinction, the paper says.

Indeed, the 1,779 islands assessed in the study area are home to 150 amphibians, mammals and reptiles that feature on the International Union for Conservation of Natures (ICUN) Red List of Threatened Species. Fifty-one of these species are classed as Vulnerable, 61 as Endangered and 38 in the most at-risk category of Critically Endangered.

Eighty-four of the 150 species arent found anywhere else on Earth. Fifty-four of them such as the Giant Bandicoot, the Goodfellows tree-kangaroo and the Taom Striped Gecko can only be found on a single island. Eleven species live on two islands and the remaining 29 live on three or more.

Goodfellows Tree Kangaroo (Dendrolagus goodfellowi). Credit: Minden Pictures / Alamy Stock Photo.

Using distribution data for the 150 species, the researchers mapped their locations across the islands. They then classified the susceptibility of each island to rising sea levels according to its size, elevation, shape and the hardness/softness of its rock.

In general, a small, low, narrow sandy island will usually be more vulnerable than a large, high, round volcanic island, explains lead author Prof Lalit Kumar from the University of New England in Australia. He tells Carbon Brief:

Islands that are of sandy/coral origin, that have low elevations, that are small in size and those that are thin and long are the most susceptible to climate change. Of course, there are other factors, such as where they are located tropical cyclone paths, significant wave heights, etc that will also impact the susceptibility.

You can see the results in the map below. The circles indicate islands that are home to at least one of the 150 threatened species. The colour of the circle shows how susceptible that island is to rising sea levels. The empty circles highlight islands that do not host any of the species.

Map of Pacific Ocean islands and threatened species. The circles indicate island that host at least one vulnerable, endangered or critically endangered terrestrial vertebrate species. The colour of the filled circles indicate that islands susceptibility rankings, from very high (red) to very low (dark green). Empty circles are islands that do not host any of the threatened species. Source: Kumar & Tehrany (2017)

Of the 1,779 islands, 674 were home to at least one of the 150 threatened species. Of these, the study classified 59 islands as having very high susceptibility to rising seas, followed by 178 for high, 152 for medium, 171 for low and 114 for very low.

Among the islands most susceptible to sea level rise are those of Tonga, Micronesia and the Marshall Islands.

Glossary

RCP8.5: The RCPs (Representative Concentration Pathways) are scenarios of future concentrations of greenhouse gases and other forcings. RCP8.5 is a scenario of comparatively high greenhouse gas emissions brought about by rapid population growth, high energy demand, fossil fuel dominance and an absence of climate change policies. This business as usual scenario is the highest of the four RCPs and sees atmospheric CO2 rise to around 935ppm by 2100, equivalent to 1,370ppm once other forcings are included (in CO2e). The likely range of global temperatures by 2100 for RCP8.5 is 4.0-6.1C above pre-industrial levels.

Using climate model projections of sea level rise and wave heights, the researchers mapped the regional risks of the islands being inundated with seawater. Local variations in wind patterns, ocean currents and sea surface temperatures mean that sea level change wont be the same across the region.

The map below shows the regional sea level risks under a climate change scenario where global CO2 emissions arent curbed (RCP8.5). The risk is categorised according to the maximum sea level for any month during the average year at the end of the century (against a baseline of 1986-2005).

The coloured circles show the islands that host threatened species. The background shading indicates the risk from rising seas, from low (green) to very high (red).

Map of sea level rise risk and threatened species on Pacific Ocean islands. The coloured circles indicate island that host at least one vulnerable (blue), endangered (pink) or critically endangered (brown) terrestrial vertebrate species. The background shading indicates sea level rise risk, from low (green) to very high (red) under RCP8.5 for 2081-2100, compared to a baseline of 1986-2005. Source: Kumar & Tehrany (2017)

The map highlights that some of the islands that are home to critically endangered species are at high risk from rising seas, the paper says:

The Northern Mariana Islands, islands in Fiji, Tonga and New Caledonia host most of the critically endangered species, and Fiji, Tonga and the Northern Mariana Islands all fall in the high and very high categories under RCP 8.5 projections.

Combining the susceptibility of the island with the risk from sea level rise, the study finds that the islands of Micronesia, Tonga, Tokelau and the Marshall Islands are the riskiest place for species to live. These islands are not home to any critically endangered species, but they are for many endangered species.

Fijian Crested Iguana, Brachylophus vitiensis, Kula Eco Park, Viti Levu, Fiji. Credit: Douglas Peebles Photography / Alamy Stock Photo.

The study concludes that many of these species may need to be reclassified as critically endangered. If they are lost from these islands, they will be lost to the world, warns Kumar:

These species are only found in this region of the world and so deserve extra attention since a loss of any of these species will mean global extinction.

Kumar, L. and Tehrany, M. S. (2017) Climate change impacts on the threatened terrestrial vertebrates of the Pacific Islands, Scientific Reports, doi:10.1038/s41598-017-05034-4

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Rising seas threaten scores of species on Pacific islands with extinction - Carbon Brief

3 New England islands are among the top 10 in the continental U.S. … – Boston.com

Posted on July 14, 2017 by Danzig

Three New England islands are among the best in the country, according to Travel + Leisure magazine readers.

As part of the magazines annualWorlds Best Awards, the publication released its list of Top 10 islands in the continental United States, and three New England spots made the list.

Nantucketis No. 2, second only to top dog Hilton Head, S.C. Mount Desert Island in Maine came in at No. 3 and Marthas Vineyardis No. 8. All three islands, as well as the seven others, offer the perfect vacation, according to the publication.

In the Massachusetts havens of Marthas Vineyard and Nantucket, as well as on Maines Mount Desert Island, joy comes from days spent picking berries and boating while the approaching evening brings in a fog, the publication wrote.

The islands were scored for their natural attractions and beaches, activities and sights, restaurants, friendliness, and value andthen given a numerical score based on those ratings.T+Ltabulated the results with the assistance of digital marketing firm Wylei.

Readers also rated airlines, airports, car rental agencies, cruise ships, destination spas, hotels, hotel brands, cities, tour operators, and safari outfitters. The results will appear in the August issue ofTravel + Leisure.

When packing for each of these islands, all that is necessary is a pair of binoculars, wonderful books, and a willingness to forget time, wrote the publication.

View the full list of islands here.

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3 New England islands are among the top 10 in the continental U.S. ... - Boston.com

Researchers study possible carnitine deficiency, autism link – Baylor College of Medicine News (press release)

Posted on July 14, 2017 by Danzig

Researchers are always looking for new clues to the causes of autism, with special emphasis on prevention or treatment. At Baylor College of Medicine, Dr. Arthur Beaudet has been following clinical and genetic clues in patients with autism spectrum disorder and experimental results in animal models that have led him to propose that the lack of carnitine, a nutrient needed for the normal development and workings of the brain, the liver, the heart and other muscles, might be involved in triggering mild forms of autism.

In a publication in the journal BioEssays, Beaudet, the Henry and Emma Meyer Chair and Professor of Molecular and Human Genetics, emphasizes that more research is needed to confirm this idea and speculates that, if confirmed, it could lead to the prevention of 10 to 20 percent of cases of autism by supplementing carnitine to infants.

In the Beaudet lab, graduate student Patricia Celestino-Soper discovered in 2009 that about 1 in 350 males in the population cannot synthesize their own carnitine; they have an inactive copy of the TMLHE gene, which is located on the X chromosome.

Of the nearly 460,000 males in the United States who have TMLHE gene deficiency, only about 3 percent develop autism. The remaining 97 percent become healthy adults, Beaudet said. Sometimes behavioral regression occurs.

The regression of skills might be as subtle as first having a social smile and playfulness at 6 to 8 months of age and then losing these skills. Sometimes, the regression of skills occurs later and is more dramatic. Although TMLHE deficiency is present in only about 1 percent of autism cases, Beaudet proposes that carnitine deficiency in the brain might cause a much larger fraction of autism.

We speculate that the individuals with a normal physical examination and normal brain imaging results in studies, which represents 10 to 20 percent of all cases of autism spectrum disorders, might have in common a mechanism that leads to a mild form of autism. This mechanism might involve brain carnitine deficiency, Beaudet said.

In the search for more evidence to support the link between carnitine deficiency and mild forms of autism that disproportionally affect males, Beaudet and colleagues looked for other genes on the X chromosome that might be involved with carnitine. They identifiedthe SLC6A14 gene that is linked to the transport of carnitine across the blood-brain barrier and is expressed differently in females. There is no mutation in the gene, but healthy girls will express more of this activity and perhaps more transport into the brain than healthy males.

The proposed involvement of SLC6A14 could be tested in animal models by assessing the transport of carnitine across the blood brain barrier and testing for abnormalities resulting from brain carnitine deficiency, Beaudet said.

How could carnitine deficiency lead to a form of autism in an apparently healthy infant?

The researchers believe that most infants are born with adequate carnitine because carnitine is usually delivered across the placenta, and most infants are born with adequate carnitine stores, Beaudet said.

In addition, carnitine is abundant in breast milk, infant formulas and cows milk, so infants will be protected from the deficiency as long as they are exclusively fed these products.

In many cultures, when the infant is introduced to new foods between 4 and 8 months of age, the first non-milk foods are fruits, juices, cereals and vegetables, all of which contain almost no carnitine, and meats are introduced later, Beaudet said. Eggs, dairy and meats all have more substantial amounts of carnitine. Red meats are particularly rich; 1 ounce of beef contains 2,000 times more carnitine than 1 ounce of white rice. When low-carnitine solid foods are added to the diet, the intake of carnitine drops in proportion to the reduction in milk intake. This reduction in carnitine might lead to brain carnitine deficiency and autism. Many parents of children with autism spectrum disorder report picky eating and this may also reduce the amount of meat in the diet.

Beaudet and colleagues speculate that both the individuals genetic makeup and the environment might contribute to this form of autism. The researchers hypothesize that although there are dozens of genes that affect the metabolism of carnitine in the body, each gene might have a small effect, but no one gene has a severe disabling effect, such as often occurs in the more severe forms of autism. The diet is an equally important factor in this hypothesis. In addition, the researchers propose, other factors also may contribute, such as certain medications, minor illnesses (especially gastrointestinal conditions) and perhaps changes in the microbiome that might deplete carnitine from the body.

Some evidence might not support this hypothesis. Although carnitine deficiency has been reported in autism, it is not reported as frequently as this hypothesis might suggest, Beaudet said.

One way to directly test this hypothesis could be by working with families who already have one child with a milder form of autism. In these families, the risk of having another child with autism spectrum disorder is high, especially if the child is a male.

Families such as these could be enrolled in a study to determine whether supplementation with carnitine will reduce the frequency of autism in the new siblings. This would be a very direct and powerful test of the hypothesis, Beaudet said.

Beaudet indicates that the possibility that carnitine deficiency might be involved in mild forms of autism brings to the table the question of whether there should be a Recommended Daily Allowance (RDA) for carnitine in normal infant diets. In the 1980s, experts indicated that an RDA for carnitine was not necessary because the human body can make its own.

We now know that 1 in 350 males indeed cannot synthesize carnitine. The need for an RDA for carnitine perhaps should be reviewed, Beaudet said.

Beaudet also is professor of molecular and cellular biology and of pediatrics at Baylor.

The evolution of this hypothesis was supported by past grants from the Simons Foundation Autism Research Initiative, Autism Speaks #7697 and currently the National Institutes of Health Baylor College of Medicine Intellectual and Developmental Disability Research Center grant P30 HD024064.

A video describing this research and the original publication can be found online.

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Researchers study possible carnitine deficiency, autism link - Baylor College of Medicine News (press release)

Too early to settle the Aryan migration debate? – The Hindu

Posted on July 14, 2017 by Danzig

The Hindu

Too early to settle the Aryan migration debate?
The Hindu
Another study published in The American Journal of Human Genetics (2011; 89:731-744) by Mait Metspalu and colleagues, where CSIR-CCMB was also involved, analysed 142 samples from 30 ethnic groups and mentioned that Modeling of the observed ...

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Too early to settle the Aryan migration debate? - The Hindu

Senate Health Care Bill Revisions Released In Attempt To …

Posted on July 14, 2017 by Danzig

Senate Majority Leader Sen. Mitch McConnell, R-Ky., on his to his office on Thursday at the Capitol in Washington, D.C. Alex Wong/Getty Images hide caption

Senate Majority Leader Sen. Mitch McConnell, R-Ky., on his to his office on Thursday at the Capitol in Washington, D.C.

Updated 6:56 p.m. ET

Senate Republicans on Thursday released a revised version of the Better Care Reconciliation Act, their plan to replace the Affordable Care Act.

The new version comes after the Congressional Budget Office found that the original BCRA would in the next decade increase the uninsured population by 22 million over what it would otherwise be. Senate Majority Leader Mitch McConnell had hoped for a vote before July 4, but was forced to delay that because he couldn't garner the 50 votes he needed among the 52 GOP senators.

The question now is whether this version of the bill could pass the Senate. Shortly after its release, Maine Sen. Susan Collins and Kentucky Sen. Rand Paul both said they intend to vote against letting the bill go forward. With two no votes, Vice President Pence could provide the 51st vote needed for passage. But if three Republican senators defect, the bill cannot pass.

The new bill makes some big changes from the last BCRA draft, but it also leaves some major parts of the original Senate proposal intact it would still repeal the individual and employer mandates, it would still mean cuts to Medicaid spending, and it would still allow states to opt out of key parts of Obamacare.

In their summary of the bill, Senate Republicans laid out the major provisions. Here are some of those big changes that this new version of the bill would make to the original BCRA, and what they would mean:

Health savings accounts will be able to pay for premiums. Under IRS rules, people with high-deductible plans are eligible for health savings accounts (HSAs), accounts into which people can put money for health care expenses tax-free. Under this bill, people would for the first time be able to use that money for premiums. Americans' deposits in HSAs have ballooned over the last decade, according to HSA consulting firm Devenir. However, those accounts also tend to benefit higher-income people more than others, as Kaiser Health News' Michelle Andrews wrote in December for example, richer people are more likely to have the extra money to sock away for health expenses.

More money for the opioid epidemic. The Senate's initial bill offered $2 billion to address the opioid crisis for 2018. This version would offer about $45 billion over 10 years, which is what Republicans Ohio GOP Sen. Rob Portman and West Virginia Sen. Shelley Moore Capito had requested at one point. However, some experts say that around $4.5 billion a year is nowhere near enough for combating America's massive opioid epidemic, as the New York Times reported in June.

Keeping some Obamacare taxes. The first BCRA version would have repealed an array of Affordable Care Act taxes, which would have overwhelmingly benefited higher-income Americans. This newer version of the bill keeps some in place, including the net investment income tax and a payroll tax that hit higher-income Americans.

Allowing insurers to offer non-Obamacare-qualified plans. This mirrors an idea that Texas Sen. Ted Cruz and Utah Sen. Mike Lee had proposed in recent weeks: The Senate's bill would allow an insurer to offer skimpier plans. As long as an insurer does offer a plan on the individual insurance exchanges that meets the demands of Obamacare's Title I (for example, covering certain areas like preventive care and protecting people with pre-existing conditions), that insurer will be allowed to offer additional plans off of the individual insurance exchanges that don't meet those criteria.

That idea had created worries of a two-tiered insurance system one in which older and sicker people would opt into the more comprehensive plans, while younger and healthier people would choose the cheaper plans that covered less, potentially causing a "death spiral" on the exchanges for those older and sicker people.

Extra stabilization money, in part for high-risk customers. The original version of the BCRA provided $112 billion that would have allowed states to stabilize their markets or help high-risk customers in a wide variety of ways. In this version, that is bumped up to $182 billion. One function of this money is to mitigate some of the two-tier issues created by new, nonqualified plans. If an insurer offers a plan that meets the Obamacare criteria, that insurer would be eligible for money to help high-risk customers.

This all means that the new version doesn't make major changes to one big part of the BCRA: Medicaid. Under the original Senate bill, the Obamacare Medicaid expansion would be rolled back, and Medicaid spending would be capped states would either be allotted a certain amount per capita, or they could get a block grant instead. It also caps Medicaid spending growth in the medium-to-long-term. This bill doesn't change any of that.

According to the CBO, the original BCRA would have cut Medicaid spending by $772 billion over 10 years, and would have resulted in 15 million fewer Medicaid enrollees by 2026 than under current law.

A new CBO score on the bill is expected Monday or Tuesday. By the end of next week, there is likely to be a key procedural vote. That would put things on track for a final vote the following week.

Were this bill to pass the Senate, it would then have to be reconciled with the House's attempt to repeal and replace Obamacare, known as the American Health Care Act.

Meanwhile, Republicans Bill Cassidy of Louisiana and Lindsey Graham of South Carolina released an alternative plan Thursday morning.

A summary of the bill is embedded below. You can read the full draft here, and see the previous Senate version here.

Washington Desk editor Arnie Seipel contributed to this report.

This report has been updated to reflect that the extra $70 billion for stabilization funding will be in part used for helping insurers defray the costs of high-risk individuals.

Continued here:

Senate Health Care Bill Revisions Released In Attempt To ...

US spends big on health care but doesn’t get much back, study says – CNBC

Posted on July 14, 2017 by Danzig

Money doesn't always buy healthiness.

The U.S. spends more on health care than 10 other countries in a study by The Commonwealth Fund, but was found to have the worst health-care system.

Health-care spending accounts for 16.6 percent of the U.S. gross domestic product, 5 percentage points more than Switzerland, the next closest country. Yet in a measure of health-care system performance among 11 high-income nations, the U.S. ranked dead last.

The United Kingdom's health-care system was ranked the best, followed by Australia and the Netherlands. France placed second to last, and Canada placed third to last.

Of the countries studied, the U.S. is the only one that does not offer universal health insurance coverage. Each of the other 10 countries, though, uses a slightly different model.

The study's publication comes one day after the Senate Republicans released details of a new bill to repeal and replace the Affordable Care Act.

"We have not had time to digest the (Senate) bill, but in general, the proposals we've seen would actually reverse progress, especially on insurance coverage," said Eric Schneider, senior vice president of policy and research at The Commonwealth Fund.

The study identified four main problems plaguing the U.S. health-care system: a large number of uninsured patients, limited primary care, administrative burdens, and disparities in care between higher- and lower-income patients.

The House and Senate proposals do not address problems the Affordable Care Act, also known as Obamacare, does, specifically the availability of primary care, nor do they simplify the insurance system, said David Blumenthal, president of The Commonwealth Fund. The disparity of access would "likely not get better" because the proposals include cuts to Medicaid.

One part of the health-care debate has been whether to create high-risk insurance pools. The Netherlands, the second-highest ranked country in the study, does the opposite and makes sure the risk is balanced, Schneider said.

Countries that rely on minimal or no cost sharing health systems scored better than the U.S., said Blumenthal. Evidence suggests that cost sharing does not improve a country's health-care performance, he said.

US spends big on health care but doesn't get much back, study says - CNBC

US Charges 412, Including Doctors, in $1.3 Billion Health Fraud – New York Times

Posted on July 14, 2017 by Danzig

Arrests were made nationwide over the course of the last week, the Justice Department said, as part of a Medicare fraud task force established in 2007. The more than 400 prosecutions, a record for the task force, covered years of activity and were spread across more than 20 states.

In one case, prosecutors said, the owner and operator of a drug-treatment center in Delray Beach, Fla., recruited addicts to aid him in his schemes, attending Alcoholics Anonymous meetings and visiting crack motels to persuade people to move to South Florida to help him. He offered kickbacks in the form of gift cards, plane tickets, trips to casinos and strip clubs as well as drugs.

The owner, Eric Snyder, and an associate were charged with fraudulently billing insurance companies for more than $50 million for false treatment and urine tests over nearly five years, the authorities said.

Bruce Alan Zimet, a lawyer for Mr. Snyder, said that his client had been cooperating with investigators since 2014. We anticipate having additional communications with the government, Mr. Zimet said, and were hopeful theyll be listening carefully and evaluating whether this is a case that should go forward or not.

In New York, a Queens cardiologist was arrested at Kennedy Airport on Thursday and accused of engaging in kickback schemes with medical diagnostic facilities to whom he referred business. In Maine, an office manager was charged with embezzling funds from a medical office. In Connecticut, Indiana, Iowa, Texas and other states, people were charged in schemes involving the distribution of medically unnecessary drugs, including opioids.

Opioid addiction is an escalating public health crisis in America, with drug deaths rising faster than ever. Hydrocodone and oxycodone, two powerful opioids, are among the most commonly abused prescription drugs, and the Centers for Disease Control and Prevention estimates that 91 Americans die each day of an opioid-related overdose.

Mr. Sessions has emphasized cracking down on drug crime as a priority, directing the nations prosecutors in May to pursue the toughest charges for such crimes, even when they may carry mandatory minimum prison sentences.

Last year, the fraud task force charged 301 people for some $900 million in false billings. Since its creation a decade ago, it has charged more than 3,500 people for what prosecutors said were over $12.5 billion in false billings.

Thanks to these efforts, fewer criminals will be able to exploit our nations opioid crisis for their own gain, said Tom Price, the secretary of health and human services. He cited the Trump administrations budget request for a $70 million investment in the health care fraud control program as a sign of its commitment to rooting out such crimes.

I know we overuse certain words in the lexicon like unprecedented and historic and unique, said Chuck Rosenberg, acting administrator of the Drug Enforcement Administration, who cited an estimated 59,000 deaths from drug overdoses in the United States last year. But this is an epidemic.

Get politics and Washington news updates via Facebook, Twitter and in the Morning Briefing newsletter.

A version of this article appears in print on July 14, 2017, on Page A11 of the New York edition with the headline: U.S. Arrests 412, Saying They Bilked Health Aid.

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US Charges 412, Including Doctors, in $1.3 Billion Health Fraud - New York Times

Major Health Care Changes in the Senate GOP Bill – NBCNews.com

Posted on July 14, 2017 by Danzig

Sen. Ted Cruz, R-Texas, speaks to members of the media on Capitol Hill on July 13. Pablo Martinez Monsivais / AP

The Senate bill would change that. It includes a modified version of a proposal by conservative Senators Ted Cruz, R-Texas, and Mike Lee, R-Utah, that would allow insurers to sell plans that do not meet Obamacares regulations.

That means they dont have to not cover essential health benefits, which include everything from hospitalization to maternity care. They could also deny plans to people with pre-existing conditions or charge them more based on their health.

Customers would not be able to use federal subsidies to buy these plans, which would likely have much lower premiums than other coverage, along with high deductibles. That could interest people who dont qualify for tax credits and dont have any immediate medical needs, but still want some limited insurance.

If you have expensive medical needs, though, youd have to turn elsewhere.

The Senate GOP bill creates a temporary $70 billion fund to help insurers pay for more expensive patients, but only if they sell comprehensive plan that contain essential health benefits and meet other Obamacare regulations. Since these plans would be far more attractive to sicker patients and the skimpier plans far more attractive to healthy people, the premiums would likely become more expensive.

AHIP, the main lobby for insurance companies, has

For plans that are eligible for subsidies on Obamacare's exchanges, there could be changes to "essential health benefits" as well. The Senate bill would allow states to waive the benefit rules in favor of their own version. In states that reduced or eliminated these benefits, healthy people could gravitate toward cheaper and less generous plans, further driving up costs for more comprehensive coverage.

Treatments left out of essential health benefits could also become subject to annual or lifetime limits by insurance companies, a practice that was banned under Obamacare.

This change could potentially affect benefits for employer plans as well, according to some health experts who have examined the bill. Current regulations require employers to provide coverage that's consistent with essential benefit rules in a state of their choosing. That means if one state deregulates their plans, it could give employers around the country the ability to adopt their rules and provide plans with fewer benefits and with annual and lifetime limits.

The Senate bill would reduce Medicaid spending dramatically compared to current law.

It would gradually eliminate Obamacares Medicaid expansion, which covers people making up to 138 percent of the federal poverty line (about $16,500 for individuals) in participating states. About 11 million people have gained coverage under this provision.

Going further than rolling back Obamacare's Medicaid provisions, it would also reorganize Medicaid and cap federal spending on a per-person basis, which is a major change from the current system that matches states based on their own contribution to the program.

The bill would also grow future Medicaid spending at whats expected to be a slower rate than current law, leading to deeper reductions in spending over time.

The CBO found these changes, which were in the previous version of the bill, would reduce Medicaid spending by $772 billion over the next decade in comparison to current law and cover 15 million fewer people. States would have to either raise taxes or cut spending elsewhere to make up the difference or reduce benefits for Medicaid recipients like nursing home residents and people with disabilities.

There are some tweaks in the new version. It includes a mechanism that would let states increase Medicaid spending if theres a health emergency that drives up per-person costs. The bill also changes a formula to help hospitals pay for low-income patients in a way that benefits states with more uninsured people, which would likely help states that chose not to expand Medicaid.

The CBO and outside experts will have to weigh in on the new provisions, but theyre unlikely to offset the old version's spending reductions by large amounts.

The Senate bill will eliminate Obamacares taxes on medical companies and remove its penalties on individuals who dont buy insurance and employers who dont provide it.

Notably, though, it will keep taxes on high-income households that were created to finance Obamacare: A 3.8 percent tax on investment income for families making over $250,000 a year and a 0.9 percent Medicare payroll tax. The bill also keeps a tax on health insurance CEOs personal earnings.

This frees up the bill to spend more elsewhere and addresses complaints by moderate Republicans over criticism that the previous version cut spending for low-income households and used the savings to lavish tax cuts on the rich.

The new bill does add a tax break favored by conservatives that primarily helps higher-income families. It allows people to pay for premiums on individual insurance plans using their tax-exempt contributions to a Health Savings Account. Since lower income households usually dont have extra cash to contribute to an HSA, the change is unlikely to benefit them much. The tax benefits are also proportionally bigger for people in higher income tax brackets.

A health care activist lifts signage promoting Planned Parenthood during a rally as part of the national "March for Health" movement in front of Trump Tower on April 1, 2017 in New York City. Kevin Hagen / Getty Images

The bill would cut off Planned Parenthood from receiving Medicaid payments. The organization is already barred from accepting federal contributions for abortion, but is reimbursed by the government for other treatments.

Insurers would also not be allowed to offer individual plans eligible for subsidies that cover abortion. Under Obamacare, insurers can include abortion coverage, but the provision is paid for separately using premiums and not federal subsidies.

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Major Health Care Changes in the Senate GOP Bill - NBCNews.com

President Trump says health-care reform is ‘more difficult’ than getting peace between Israel and Palestinians – CNBC

Posted on July 14, 2017 by Danzig

Trump noted the fact that revisions to health-care bills in both the Senate and the House have been made to draw support from wavering legislators. But in the process, those revisions lose support from other lawmakers who might have supported earlier versions of a bill to significantly reform the Affordable Care Act.

"You get a couple here and you say, great, and then you find out you just lost four over here," Trump said.

"Health care is tough," said Trump.

"But," the president added, "I think we're going to have something that's really good and that people are going to like."

"We're going to find out over the next you know, we just extended for two weeks," Trump said, referring to Senate Majority Leader Mitch McConnell's decision to delay the Senate recess to get a health bill passed, along with other legislation.

Two GOP senators, Susan Collins of Maine and Rand Paul of Kentucky, said they were opposed to the revised bill as currently written. At least five other Republican senators indicated they were undecided. If GOP leaders have three defections on the bill from their own caucus, they will be unable to get the 50 votes they need to pass the bill.

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President Trump says health-care reform is 'more difficult' than getting peace between Israel and Palestinians - CNBC

Senate health care bill, take two – USA TODAY

Posted on July 14, 2017 by Danzig

Editors, USA TODAY Published 5:37 p.m. ET July 13, 2017 | Updated 7:16 p.m. ET July 13, 2017

Sen. Ted Cruz, R-Texas,, second from left, waits for President Donald Trump to join a meeting of Republican senators on health care in the East Room of the White House in Washington, Tuesday, June 27, 2017.(Photo: Susan Walsh, AP)

If at first you don't succeed, try, try again. Senate Republicans unveiled a new version of their health care bill Thursdaythat would allow the sale of cheap, bare-bones insurance plans as a way towoo conservatives to support the measure. Moderates also got a win in the new version, with $43 billion more funding to fight opioid addiction. The new bill still isn't a shoo-in to pass. Insurers warn the changes could cause premiums to skyrocketfor older Americans and those with pre-existing conditions. Two Republicans enough to derail the plansaid they wouldn't even vote for a procedural motion to allow a vote on the bill next week. If the measure does pass,here's a run down of what it means for Medicaid funding (deep cuts) and private insurance subsidies (could still lose all or some of them) and other aspects.

In a high-stakes bid for conservative support, Senate Majority Leader Mitch McConnell has agreed to demands from Republican Sen. Ted Cruz of Texas to allow insurers to sell low-cost, skimpier plans as part of a new health care bill. Time

Don't freak out, but Game of Thrones won't win an Emmy this year. The HBO hitdidn't premiere early enoughto make the cut for the 2017 awards and defendits two-year-long winning streak in the Best Drama category. Who's filling the Thronesvoid? HBO'sWestworldtopped the list with 22 nominations, andSaturday Night Livealso snagged 22 nods, filling out the comedy side of the list. Stranger Things(#JusticeForBarb) and Feud: Bette and Joanwere also among the top contenders. And, as always, there werenotable snubs, likeLena Dunham and Jimmy Fallon.Find out here if your favorite show madethe cut.

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President Trump not only won the election last year, but a new study shows he also was the winner of the 2016 Presidential Twitter War over theHillary Clinton faithful.A University of Edinburghstudy found pro-Trump tweets nearly doubled that of Clinton in the final two months of the campaign. In fact, Clinton was criticized nearly three times more than she was praised. Thats despite her sending more negative tweets aboutTrump than he posted of her. Some silver lining for the #Imwithher crowd, she did get the help of the Sultan of Salaciousness himself, Jerry Springer. More on Trump today, beyond the tweets:

A jailed man confessed to killing four missing Pennsylvania men after authorities had identified him as a person of interest earlier Thursday, his attorney said. Cosmo DiNardo, who was initially charged with trying to sell illegally one of the dead friends' car, now plans to plead guilty to four counts of first-degree murder. The body of Dean Finocchiaro was found along with other human remains in a 12 foot common grave Wednesday on a 70-acre farm owned by DiNardo's parents. Along with Finocchiaro, Mark Sturgis, Tom Meo, and Jimi Tar Patrick were also missing. Patrick was last seen Wednesday, while the other three vanished Friday.

The body of Dean Finnocchiaro, one of four missing men, and other human remains were found buried 12 feet underground on a Pennsylvania farm. USA TODAY

This sounds encouraging: Americans are saving more money. The labor market remains strong, and steady paychecks have helped boost overall deposits in the countrys banks. The average U.S. checking account deposit has risen from $1,000 in 2007 to about $3,600 great, right? Well, while saving is a personal finance virtue, most consumers are making very little return off of the money stashed in their checking account, since interest rates are still historically low. Got extra cash and need advice on what to do with it? Heres are some smart ways to invest $1,000.

What else is happening this week?Bookmark our calendar.

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Senate health care bill, take two - USA TODAY

At-home genetic test leads to breast cancer diagnosis – ABC2 News

Posted on July 14, 2017 by Danzig

BALTIMORE, Md. - Lara Diamond spit in a tube then put it in the mail. She was expecting to find distant relatives, instead she received a diagnosis.

They told me that I had this BRCA2 mutation, which was a complete shock to me, and I was able to follow-up with my doctor and genetic counselor from that point, said Diamond, a genealogist and author of the blog Laras Jewnealogy.

BRCA genes have been linked to breast and ovarian cancer. Diamond had no knowledge of any family history of either disease.

I was sent for my first ever mammogram, which was clear, and only because I had a BRCA mutation I was sent for an MRI and that wasn't clear. So, they did a biopsy and it turned out I already had cancer, Diamond said.

Diamond was diagnosed with stage I breast cancer.

There were no symptoms. I mean I wouldn't have gotten screened for years. The fact that a mammogram couldn't see it, ultrasound couldn't see it, it would've been a couple more years until there were any symptoms that would've made us question anything, said Diamond.

Thanks to the early notice, doctors were able to remove the 6 mm tumor.

And while the test enabled Diamond to be proactive about her health, it's very rare for someone to have a similar experience. In fact, the FDA put an end to 23andMe BRCA testing back in 2013 because of risks associated with false positive findings.

The majority of people who come in with reports from direct-to-consumer companies are misinterpreting it to either mean they either have some sort of rare condition or they might be at risk for something, and in reality that's not what's going on, said Natalie Beck, a certified genetic counselor at the Johns Hopkins Institute of Genetic Medicine.

Beck said its a good thing that theyve been seeing an increase in appointment requests from people ordering direct-to-consumer tests, however, the National Society of Genetic Counselors suggests that consumers proceed with caution. They recommend consumers consider seeing a genetic counselor to help them determine why they want to get tested and help interpret their results.

It's not as simple as one single variant or one single gene and giving people an absolute increase or decrease risk for their health. And that challenge of patients trying to interpret their own genetic test results I think can lead to a lot of false anxiety or maybe even false reassurance, Beck said.

The tests, however, are inspiring intrigue as well as a desire to learn more about personal health and the people you're connected with.

They want a crystal ball for their health care, and so I think that's adding to people's desire to know more, Beck said.

Diamond credits her genealogy addiction with potentially saving her life.

Yes, I'm very glad that I'm obsessed with genealogy, because my life would be very different in many ways otherwise, said Diamond.

Diamond has tried three different direct-to-consumer tests. 23andMe was the only one with a medical component, however, there are more tests that now offer health screenings. The FDA also recently granted approval to 23andMe to test for gene sequences linked to 10 health risks including Parkinsons disease and late onset Alzheimers.

If you have any family history of disease, it's advised that you meet first with a genetic counselor and not rely on any direct-to-consumer tests.

The cost of direct-to-consumer tests vary from around $100 to nearly $1,000.

Editor's Note: This story has been updated to reflect the National Society of Genetic Counselors' position on direct-to-consumer tests.

At-home genetic test leads to breast cancer diagnosis - ABC2 News

Baby Charlie Gard’s medical condition: What you need to know – ABC News

Posted on July 14, 2017 by Danzig

The ongoing story of Charlie Gard - a baby born in London with a rare genetic disorder known as Mitochondrial Depletion Syndrome - has gained international attention, with such prominent figures as Pope Francis and President Donald Trump commenting on his familys ordeal.

Charlie, born on August 4, 2016, has been on life support for several months at the Great Ormond Street Hospital in London. As his condition continues to deteriorate, his parents are battling with the European courts over how to move forward with his care.

Last week, New York Presbyterian/Columbia Medical University Hospital offered to administer experimental treatment therapy to Gard as long as the British government approves a safe medical transfer to the United States. Thus far, the courts have denied the transfer, but Charlies parents have continued their battle with the legal system.

Meanwhile, Charlies incredibly rare form of mitochondrial disease has generated global attention. Here are some of the common questions about Mitochondrial Depletion syndrome.

MDS is one of a suite of rare disorders that affect the mitochondria - often described as the tiny powerhouses of the cell. Certain genes ensure that these mitochondria are healthy and produce the energy the cells need. Genes come in pairs, one copy comes from the mother and one from the father. When a baby has MDS, it means that both copies received from the parents for this particular gene - the one that keeps mitochondria healthy - are defective. The result is progressive muscle weakness and devastating multi-organ damage.

This disease is very uncommon, with perhaps fewer than 100 cases in the range of related disorders reported worldwide, according to a 2014 study.

Initially, development may appear normal; however, before these children reach 24 months of age, they usually start exhibiting certain signs of muscle weakness -- for example, weakening of eye muscles leading to droopy eyelids and facial weakness. These children may also exhibit signs of organ failure, such as brain and nervous system problems leading to seizure activity, hearing loss, liver damage and difficulty walking, talking, and swallowing.

The prognosis, unfortunately, is very poor. Many children with this condition begin having lung muscle weakness early in life. Normally, this progresses rapidly to respiratory failure and death within a few years of onset. The most common cause of death is infection of the lungs.

Although supportive therapy is available to help treat the conditions that accompany this syndrome - such as the seizures and hearing loss - there is currently no cure for MDS. Experimental therapies tested on mice are intended to target specific defective areas of the mitochondria. Thus far, these treatments have shown only modest success in these animals and some have begun to be tested in a few children. The parents of an American child with a different type of mitochondrial disorder spoke to Gard's parents, according to the Associated Press, about a nucleoside therapy treatment they have been using for their now 6-year-old son who appears to have shown some modest improvement.

Devika Umashanker, M.D., is a recent graduate of the Obesity Medicine fellowship at Weill-Cornell Medical College.

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Baby Charlie Gard's medical condition: What you need to know - ABC News

FDA Panel Recommends Approval for Gene-Altering Leukemia Treatment – New York Times

Posted on July 14, 2017 by Danzig

One of those patients, Emily Whitehead, now 12 and the first child ever given the altered cells, was at the meeting of the panel with her parents to advocate for approval of the drug that saved her life. In 2012, as a 6-year-old, she was treated in a study at the Childrens Hospital of Philadelphia. Severe side effects raging fever, crashing blood pressure, lung congestion nearly killed her. But she emerged cancer free, and has remained so.

We believe that when this treatment is approved it will save thousands of childrens lives around the world, Emilys father, Tom Whitehead, told the panel. I hope that someday all of you on the advisory committee can tell your families for generations that you were part of the process that ended the use of toxic treatments like chemotherapy and radiation as standard treatment, and turned blood cancers into a treatable disease that even after relapse most people survive.

The main evidence that Novartis presented to the F.D.A. came from a study of 63 patients who received the treatment from April 2015 to August 2016. Fifty-two of them, or 82.5 percent, went into remission a high rate for such a severe disease. Eleven others died.

Its a new world, an exciting therapy, said Dr. Gwen Nichols, the chief medical officer of the Leukemia and Lymphoma Society, which paid for some of the research that led to the treatment.

The next step, she said, will be to determine what we can combine it with and is there a way to use it in the future to treat patients with less disease, so that the immune system is in better shape and really able to fight. She added, This is the beginning of something big.

At the meeting, the panel of experts did not question the lifesaving potential of the treatment in hopeless cases. But they raised concerns about potentially life-threatening side effects short-term worries about acute reactions like those Emily experienced, and longer-term worries about whether the infused cells could, years later, cause secondary cancers or other problems.

Oncologists have learned how to treat the acute reactions, and so far, no long-term problems have been detected, but not enough time has passed to rule them out.

Patients who receive the treatment will be entered in a registry and tracked for 15 years.

Treatments involving live cells, known as biologics are generally far more difficult to manufacture than standard drugs, and the panelists also expressed concerns about whether Novartis would be able to produce consistent treatments and maintain quality control as it scaled up its operation.

Another parent at the meeting, Don McMahon, described his son Connors grueling 12 years with severe and relapsing leukemia, which started when he was 3. Mr. McMahon displayed painful photographs of Connor, bald and intubated during treatment. And he added that chemotherapy had left his son infertile.

A year ago, the family was preparing for a bone marrow transplant when they learned about the cell treatment, which Connor then underwent at Duke University. He has since returned to playing hockey. Compared with standard treatment, which required dozens of spinal taps and painful bone marrow tests, the T-cell treatment was far easier to tolerate, Mr. McMahon said, and he urged the panel to vote for approval.

A third parent, Amy Kappen, also recommended approval, even though her daughter, Sophia, 5, had died despite receiving the cell treatment. But it did relieve her symptoms and give her a few extra months. Sophias disease was far advanced, and Ms. Kappen thought that if the treatment could have been given sooner, Sophia might have survived.

We hope that more families have a longer time with their children fighting this evil disease, and our children deserve this chance, she said.

The treatment was developed by researchers at the University of Pennsylvania and licensed to Novartis.

Use will not be widespread at first because the disease is not common. It affects only 5,000 people a year, about 60 percent of them children and young adults. Most children are cured with standard treatments, but in 15 percent of cases like Emilys and Connors the disease does not respond, or it relapses.

Analysts predict that these individualized treatments could cost more than $300,000, but a spokeswoman for Novartis, Julie Masow, declined to specify a price.

Although the figure may seem high, people with cancer often endure years of expensive treatment and repeat hospital stays that can ultimately cost even more.

Because the treatment is complex and patients need expert care to manage the side effects, Novartis will initially limit its use to 30 or 35 medical centers where employees will be trained and approved to administer it, the company said.

As to whether the treatment, known as CTL019 or tisagenlecleucel (pronounced tis-a-gen-LEK-loo-sell), will be available in other countries, Ms. Masow said by email: Should CTL019 receive approval in the U.S., it will be the decision of the centers whether to receive international patients. We are working on bringing CTL019 to other countries around the world. She added that the company would file for approvals in the European Union later this year.

By late November 2016, 11 of the 52 patients in the study who went into remission relapsed. Twenty-nine were still in remission. Eleven others had further treatments, like bone marrow transplants. One patient was not available for assessment. Three who had relapses died, and one who did not relapse died from a new treatment given during remission. The median duration of remission is not known because it has not been reached: Some patients were still well when last checked.

Researchers are still debating about which patients can safely forgo further treatment, and which might need a bone marrow treatment to give the best chance of a cure.

The treatment requires removing millions of a patients T-cells a type of white blood cell often called soldiers of the immune system and genetically engineering them to kill cancer cells. The technique employs a disabled form of H.I.V., the virus that causes AIDS, to carry new genetic material into the T-cells to reprogram them. The process turbocharges the T-cells to attack B-cells, a normal part of the immune system that turn malignant in leukemia. The T-cells home in on a protein called CD-19 that is found on the surface of most B-cells.

The altered T-cells are then dripped back into the patients veins, where they multiply and start fighting the cancer.

Dr. Carl H. June, a leader of the University of Pennsylvania team that developed the treatment, calls the turbocharged cells serial killers. A single one can destroy up to 100,000 cancer cells.

Because the treatment destroys not only leukemic B-cells but also healthy ones, which help fight germs, patients need treatment to protect them from infection. So every few months they receive infusions of immune globulins.

In studies, the process of re-engineering T-cells for treatment sometimes took four months, and some patients were so sick that they died before their cells came back. At the meeting, Novartis said the turnaround time was now down to 22 days. The company also described bar-coding and other procedures used to keep from mixing up samples once the treatment is conducted on a bigger scale.

Michael Werner, a lawyer and expert on gene and cell technologies and regulation, and a partner at Holland and Knight in Washington, said that results so far proved that T-cell treatment works.

The fact that it can be done means more people will go into the field and more companies will start developing these products. He added, I think were in for really exciting times.

Katie Thomas contributed reporting.

A version of this article appears in print on July 13, 2017, on Page A1 of the New York edition with the headline: F.D.A. Panel Urges New Living Drug To Fight Cancer.

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FDA Panel Recommends Approval for Gene-Altering Leukemia Treatment - New York Times

First gene therapy ‘a true living drug’ on the cusp of …

Posted on July 14, 2017 by Danzig

Food and Drug Administration advisers on Wednesday enthusiastically endorsed a first-of-its-kind cancer treatment that uses patients' revved-up immune cells to fight the disease, concluding that the therapy's benefits for desperately ill children far outweigh its potentially dangerous side effects.

The unanimous recommendation from the Oncologic Drugs Advisory Committee means the treatment could be approved by the FDA by the end of September, forging a new path in the immunotherapy frontier.

Timothy Cripe, a panel member who is an oncologist with Nationwide Children's Hospital in Columbus, Ohio, called the treatment the "most exciting thing I've seen in my lifetime."

Novartis, the drugmaker behind the CAR T-cell therapy, is seeking approval to use it for children and young adults whose leukemia doesn't respond to traditional treatments a group that numbers 600 or so patients a year in this country. But the approach also is being tested for a range of diseases from non-Hodgkin lymphoma and multiple myeloma to solid tumors.

If cleared by the FDA, it would be the first gene therapy approved in the United States. But unlike traditional gene therapy, the new treatment doesn't replace disease-causing genes with healthy ones. Instead, it uses technology to reprogram immune cells called T cells to target and attack malignancies.

When a patient is treated under the Novartis process, T cells are extracted from a patient's blood, frozen and sent to the company's plant in Morris Plains, N.J. There, the cells are genetically modified to attack the cancer, expanded in number, refrozen and shipped back to the patient for infusion.

Once inside the body, the cells multiply exponentially and go hunting for the CD19 protein, which appears on a kind of white blood cell that can give rise to diseases, such as leukemia and lymphoma. The turnaround time for manufacturing the therapy, called "vein-to-vein" time, will be an estimated 22 days, Novartis officials told the committee Wednesday.

From the start of Wednesday's meeting, committee members made clear that they were not concerned about the treatment's efficacy, which has been well established 83 percent of patients went into remission in the pivotal Novartis trial. Rather, the panel homed in on how to best to handle possible shot-term toxicities, as well as long-term safety risks and manufacturing quality.

Most patients in the Novartis study experienced something called cytokine release syndrome, which causes fever and flulike symptoms that can range from mild to extremely severe, said Stephan Grupp, an oncologist at the Children's Hospital of Philadelphia who led the Novartis trial. Some patients in that study also had neurological problems, including seizures and delirium. But there were no cases of fatal brain swelling, as occurred in another company's trial, Grupp said.

To try to ensure safety, Novartis is limiting the therapy's availability to 30 to 35 medical centers where personnel have had extensive training with the treatment. The company also plans to post Novartis employees at hospitals using the therapy and to follow patients for up to 15 years.

During the committee meeting, hundreds of people packed the hearing room at FDA headquarters in Silver Spring, Md., including prominent scientists, such as Carl June of the University of Pennsylvania, who developed the treatment. Though the FDA isn't required to follow the guidance of its advisory committees, it usually does.

David Maloney, medical director for cellular immunotherapy at Fred Hutchinson Cancer Research Center in Seattle, said he was elated that the field is moving forward. "It represents a paradigm shift in treating cancers," said Maloney, who is extensively involved in CAR T-cell research but not in the Novartis product.

One of the big issues in CAR-T cell therapy the cost, which analysts say could be in the hundreds of thousands of dollars wasn't discussed because that is beyond the FDA's purview. Novartis hasn't released pricing information.

During the public comment portion of the hearing, Amy Kappen, whose 5-year-old daughter underwent CAR T-cell therapy in Philadelphia, called for approval. The treatment beat back her daughter's cancer and brought back "the sparkle" in her eyes. And while she died three months later, "our children deserve this chance," Kappen said.

For other parents, there were happier outcomes. Don McMahon, whose son Connor was treated at Duke Children's Hospital in North Carolina, said the therapy was far less debilitating than what he endured on standard chemotherapy during two relapses. The boy, an avid hockey player, is doing well now.

Thomas Whitehead, whose daughter was the first pediatric patient to receive the treatment, choked up while telling panel members about Emily's experience. She got CAR T-cell therapy when she was 6 and close to death from leukemia. The treatment almost killed her, but she recovered and today is cancer free.

"If you want to see what a cure looks like for relapsed ALL [acute lymphoblastic leukemia], she's standing right beside me," said Whitehead, his voice cracking.

CAR-T gene therapy for leukemia clears FDA hurdle – CBS News

Posted on July 14, 2017 by Danzig

A panel of cancer experts has voted unanimously in favor of a leukemia treatment which could be the first gene therapy available in the U.S.

The Food and Drug Administration advisory panel voted 10-0 on Wednesday to recommend approval of the treatment developed by the University of Pennsylvania and Novartis Corp. The one-time treatment would be for children and young adults with advanced leukemia.

The therapy could be the first of a wave of treatments custom-made to target a patient's cancer. Called CAR-T, it involves removing immune cells from a patients' blood, reprogramming them to create an army of cells to recognize and destroy cancer and injecting them back into the patient.

The FDA is not required to follow the panel's recommendation but often does.

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An FDA panel meets Wednesday to decide whether to recommend the first government-approved gene therapy. CAR T-cell treatment uses the body's own ...

"It's a pretty amazing new treatment," Dr. David Agus, director of the USC Norris Westside Cancer Center and CBS News medical contributor, said on "CBS This Morning." "They take the white [blood] cells out of a child with cancer, they send them to [a lab in] New Jersey, and they put in a gene to reprogram these cells to attack the cancer."

The vote came after lengthy discussion and impassioned pleas from the fathers of two young patients whose lives were saved by the therapy. The one-time leukemia treatment would be for children and young adults with the most common form of childhood cancer, known as ALL.

"Our daughter was going to die and now she leads a normal life," said Tom Whitehead, of Philipsburg, Pennsylvania. His daughter Emily, now 12, was the first child to receive the experimental therapy, five years ago. "We believe when this treatment is approved, it will save thousands of children's lives around the world."

In a key test, results were far better than chemotherapy and even newer types of cancer drugs. Of the 52 patients whose results were analyzed, 83 percent had complete remission, meaning their cancer vanished. Most patients suffered serious side effects. Eleven patients died, four from side effects and seven from their leukemia.

The FDA is expected to decide whether to approve the Novartis treatment in the next few months. The drugmaker is seeking approval to use the treatment for patients aged 3 to 25 with a blood cancer called acute lymphoblastic leukemia whose disease has spread or failed to respond to standard treatment. That happens to more than 600 patients in the U.S. each year. At that point, they have limited options all more toxic than the CAR-T therapy and survival chances are slim. ALL accounts for a quarter of all cancers in children under age 15.

After decades of setbacks and disappointments in efforts to fix, replace, or change genes to cure diseases, several companies are near the finish line in a race to bring CAR-T and other types of gene therapy to patients. Kite Pharma also has a CAR-T therapy under FDA review and Juno Therapeutics and others are in late stages of testing.

In March, CBS News chief medical correspondent Dr. Jon LaPookreportedon the results of a clinical trial in which 101 patients with advanced lymphoma who had failed previous therapy received the Kite Pharma CAR-T treatment. About eight months after a single treatment, 39 percent of patients had no evidence of cancer.

"That's actually quite remarkable knowing that at best only one out of 10 of these patients could have complete disappearance of their lymphoma with standard chemotherapy," said Dr. Frederick Locke, who helped lead the trial.

CAR-T therapy starts with filtering key immune cells called T cells from a patient's blood. In a lab, a gene is then inserted into the T cells that prompts them to grow a receptor that targets a special marker found on some blood cancer cells. Millions of copies of the new T cells are grown in the lab and then injected into the patient's bloodstream where they can seek out and destroy cancer cells. Doctors call it a "living drug" permanently altered cells that continue to multiply in the body to fight the disease.

During the patient testing, the whole process took about 16 weeks on average, which can be too long a wait for some desperately ill patients, the FDA advisers noted during Wednesday'smeeting in Silver Spring, Maryland. Drug company officials said they can now produce a treatment and get it to a patient in about three weeks.

Novartis said in a statement after the vote that it has long believed CAR-T therapy could "change the cancer treatment paradigm."

"It is encouraging to see the FDA panel's recommendation and continued momentum behind this innovative therapy," said the Penn team's leader, Dr. Carl June.

The cost of CAR-T therapy is likely to be hundreds of thousands of dollars, but it's only given once. Typically, cancer patients take one or more drugs until they stop working, then switch to other drugs, so treatment and side effects can go on for years.

The treatment's short-term side effects, including fever and hallucinations, are often intense as the body's revved-up immune system goes on the attack. The long-term side effects of the treatment are unknown. It's also unclear if patients whose cancer goes into remission will be cured or will have their cancer return eventually. The FDA panel recommended that patients who get the treatment be monitored for 15 years.

Other biotech and pharmaceutical companies are developing types of gene therapy to treat solid cancers and rare gene-linked diseases. A few products have been approved elsewhere one for head and neck cancer in China in 2004 and two in Europe, most recently GlaxoSmithKline's Strimvelis. That was approved last year for a deadly condition called severe combined immunodeficiency and launched with a $670,000 price tag.

UniQure's Glybera was approved for a rare enzyme disorder. It was used only once in five years, likely due to its $1 million-plus price tag, so uniQure is pulling it from the market.

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CAR-T gene therapy for leukemia clears FDA hurdle - CBS News

Gene therapy to kill cancer moves a step closer to market – CNET – CNET

Posted on July 14, 2017 by Danzig

A rendering of a T-cell that can be reprogrammed to attack cancer cells.

A new era of treating disease has moved a step closer to reality in the United States.

A Food and Drug Administration panel gave a thumbs-up Wednesday to a gene therapy that involves genetically engineering a patient's T-cells to fight a particular type of leukemia, The New York Timesreports.

If the FDA agrees with the panel's recommendation and moves to approve the treatment for commercial use, it would be the first such gene-altering treatment to make it to market.

In recent years, new techniques to "edit" genes, such as CRISPR-Cas9, have gotten lots of attention, but medical researchers and pharmaceutical companies have been racing for decades to bring a gene therapy with a targeted medical purpose to this point.

This particular treatment was first developed at the University of Pennsylvania and has been licensed by Novartis, which is seeking to make the milestone treatment known as CTL019 available on a limited basis at just few dozen medical centers nationwide.

Only a few thousand people are affected by the B-cell acute lymphoblastic leukemia that proves stubborn in the face of conventional treatments for about 15 percent of cases, most of them in children and young adults. Novartis is also working on other similar treatmentsfor additional types of cancer and an aggressive brain tumor.

The treatment is complex and must be personalized for each patient. Essentially, millions of T-cells must be extracted, frozen and sent off to Novartis, where they are thawed, engineered using a disabled form of the HIV virus that reprograms them to kill cancer, then frozen again and sent back to be administered to the patient.

It's a little bit like sending your white blood cells off to be transformed into "Terminator" cells.

Some have predicted the treatment could cost as much as $300,000 (about 232,700, AU$390,690), the Times reports, but no official pricing estimates have been announced.

Once the stuff of science fiction, altering human genes has been creeping into reality of late. Also on Wednesday, researchers at Harvard announced they'd managed to encode video files into the genetic material of living cells, demonstrating the viability of a "molecular recorder" that could lead to more disease treatments in the future.

Technically Literate: Original works of short fiction with unique perspectives on tech, exclusively on CNET.

Crowd Control: A crowdsourced science fiction novel written by CNET readers.

Gene therapy to kill cancer moves a step closer to market - CNET - CNET

South Korea OKs First-in-Class Gene Therapy for Osteoarthritis – Genetic Engineering & Biotechnology News

Posted on July 14, 2017 by Danzig

South Koreas Ministry of Food and Drug Safety said today that it has approved the countrys first gene therapy for osteoarthritis, the lead product candidate of a Maryland-based regenerative medicine company.

Invossa-K Inj. was developed by Maryland-based TissueGene, whose Korean licensee, Kolon Life Sciences, won approval for the injectable treatment. According to the company, Invossa is a first-in-class cell-mediated gene therapy designed to treat moderate (Kellgren and Lawrence grade 3) knee osteoarthritis through regeneration of cartilage.

Invossa uses allogeneic human cartilage cells engineered to express transforming growth factor TGF-1. TissueGenes platform technology involves transducing the cells with a retroviral vector engineered to express TGF-1 at a specific therapeutic level and duration of time.

The modified cell lines are further selected and screened for cellular expression characteristics intended to minimize patient immune response to the injected cellsthen mixed with unmodified cells to create cartilage regeneration via Invossa, as well as bone, disc, and nerve regeneration through the companys other product candidates.

Invossa is designed for a single injection directly into the knee joint, allowing the cells to induce repair and regeneration of tissue by secreting therapeutic growth factors. The gene therapyincluded in GENs recent roundup of Top Trends in Tissue Engineeringis an alternative to surgery for arthritis patients, according to Kolon.

Kolon has said injection of Invossa has been shown in Phase III trials in Korea to ease the symptoms of about 84% of patientswhile 88% of U.S. patients treated with the gene therapy in Phase 2 trials reported improved symptoms for up to two years.

Invossa is being assessed in a Phase III trial in the U.S. after TissueGene and the FDA came to agreement on a Special Protocol Assessment (SPA) for the study. The company is seeking agency approval for the gene therapy as the first disease-modifying osteoarthritis drug (DMOAD).

Kolon has also inked an exclusive licensing and development agreement with Mitsubishi Tanabe Pharma to market the drug in Japan. Under that deal, Mitsubishi Tanabe agreed to pay approximately $24 million upfront plus up to $410 million in payments tied to achieving development, regulatory, and commercial milestones, plus double-digit sales royalties.

In Korea, Mundipharma plans to market and distribute Invossa to general and semiprivate hospitals, while Kolon focuses on general practitioners, under an agreement announced April 11.

With the Korean drug ministrys approval, Invossa became the 29th South Koreandeveloped novel therapy approved by the countrys drug regulatory agencyand one of only four cell gene therapies to have ever been approved globally. The others were approved to treat immunodeficiency diseases, genetic disorders, and cancer.

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South Korea OKs First-in-Class Gene Therapy for Osteoarthritis - Genetic Engineering & Biotechnology News

The Futurist: A vision for the future – Human Resources Online

Posted on July 14, 2017 by Danzig

Calling all L&D and corporate training professionals! Do not miss Asias premier conference on learning, training and corporate development strategy, Training & Development Asia. In Hong Kong, Kuala Lumpur, Philippines and Singapore in July/August 2017 Register Now.

Many employers have recognised the importance of employee wellbeing and work-life balance as key strategies to improving employee engagement, loyalty and retention.

Employers are increasingly searching for innovative offerings to address their employees demands; and employees are asking more and more for choice and benefit programmes that meet their personal and family needs.

One such new and exciting offering to the region is vision care. According to Euromonitors 2016 Eye Health Indicator Analysis, Hong Kong has the highest rate of nearsightedness difficulty seeing far away in Asia, impacting 76% of the population or 5.6 million people.

While having an ancillary vision offer is quite common in other parts of the world, it has recently become available locally as a low-cost, highly valuable option employers can add to their benefit suite.

A vision scheme provides access to annual comprehensive eye examinations and fashionable eye wear at little to no out-of-pocket costs for your employees.

With a comprehensive eye exam, you get more than just a standard vision test, you also get a thorough check of your eye health. Through a comprehensive eye examination, a registered optometrist can check for signs of chronic conditions such as diabetes, high blood pressure and high cholesterol.

A vision scheme can also help address issues that impact employees quality of life and productivity. According to a 2008 report by US-based vision advocacy group, The Vision Council, poor vision results in 32 times more productivity lost than absenteeism.

Digital eye strain is an example of a condition that impacts your staff. Per the Vision Council, more than 87% of adults report using digital devices more than two hours a day, yet many people neglect to care for their eyes, which can have unintended health consequences and impact work productivity.

Vision care schemes can play a major role in employee benefit programmes. Although many companies offer an annual health screening programme, a comprehensive eye examination is a good supplementary piece.

In addition to making your employee package more competitive and helping to retain valuable employees, a thorough vision care scheme can increase employee health awareness, leading to a healthier and more productive workforce.

Mara Swan, ManpowerGroups EVP for global strategy and talent, on why companies' efforts on gender diversity are failing. ..

To cut costs and restructure businesses, firms have fired as many as 60,000 staff. Here's a round-up of the job cuts reported late..

The special allowance, totalling RM3.16 million, would be given to permanent, contract and part-time staff...

To make things worse, employers in the Lion City are also grappling with challenges in engaging employees...

A Hong Kong academic is urging businesses and the government to offer a fair pay to the citys workers...

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The Futurist: A vision for the future - Human Resources Online

NASA Just Announced They Can’t Afford to Get Humans to Mars – Futurism

Posted on July 14, 2017 by Danzig

In Brief NASA admitted today that under the current budget they cannot afford to get humans to Mars. NASA's next steps will depend on its funding, but now more than ever, the future of Mars colonization rests in the hands of commercial space companies. Budget Bummer

NASA has been talking about getting humans to Mars for years, and continues to provide updatedplans for getting there. Unfortunately, though, NASAs chief of human spaceflight, William H. Gerstenmaier, just announced that the agency cant achieve the Mars goal on its current budget.

I cant put a date on humans on Mars, and the reason really is the other piece is, at the budget levels we described, this roughly 2 percent increase, we dont have the surface systems available for Mars, Gerstenmaier said during a propulsion meeting of the American Institute for Aeronautics and Astronautics on Wednesday. And that entry, descent, and landing is a huge challenge for us for Mars.

Essentially, the SLS rocket and Orion craft have cost the agency a lot. As a result, NASA hasnt even been able to begin designing vehicles to land on Mars or ascend from the surface.

NASAs next moves will depend on funding. Gerstenmaier indicated the agency might be interested in a Moon exploration mission one that is more extensive than the current plan to build the Deep Space Gateway in the Moons orbit. Beyond just being a launching pad for further space exploration, the gateway could support an extensive moon surface program, says Gerstenmaier.

Fortunately for our Red Planet dreams, it isnt just up to NASA. Getting humans to Mars is a team effort. Agencies like NASA are really at the mercy of political moods and budgetary restraints, so they need to do as much as they can with what resources are there. One way they can maximize impact is to partner with private companies.

This month Elon Musk announcedwe might be getting an update about the SpaceX Mars mission in September at the International Astronautical Congress (IAC) in Australia. For now, though, SpaceX has set a deadline of 2018 for an unmanned Mars mission and 2025 for a manned mission. Both Boeing and Blue Origin are also planning to put humans on Mars. It may turn out that the we in Vice President Pences remarks about putting American boots on Mars is the larger American we, and not the government or NASA.

NASA Just Announced They Can't Afford to Get Humans to Mars - Futurism

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