Wisconsin Pulls Plug on Trans Health Care – Daily Beast

As of Feb. 1, the health plans of Wisconsin state employees exclude procedures, services, and supplies related to surgery and sex hormones associated with gender reassignment.

Wisconsin officially ended its exclusion of transgender-inclusive health benefits for state employees on Jan. 1, 2017.

Alina Boyden, a transgender graduate student at the University of Wisconsin-Madison, put in her request for sex reassignment surgery the next business day.

But less than a month later, the state effectively said never mind.

In a press release dated Feb. 1, the Wisconsin Department of Employee Trust Funds (ETF) announced that the state had reinstated the precious exclusion in its employee health plan on any procedures, services, and supplies related to surgery and sex hormones associated with gender reassignment, effective immediately.

Boydens surgical requeststill unfulfilledis now pointless.

I could argue medical necessity but they still wouldnt cover it because theyll say its an exclusion of the plan, she told The Daily Beast. Sometimes you cant win.

The return of the exclusion was first reported by the Wisconsin State Journal, which has been tracking the states stance on transgender health care for several months.

Last July, the 11-member Group Insurance Boardhoused within the ETFvoted unanimously to remove the exclusion on benefits and services related to gender reassignment or sexual transformation, according to meeting minutes (PDF).

ETF lawyers had recommended that the exclusion be removed in order to bring Wisconsin into compliance with an Affordable Care Act provision known as Section 1557later clarified by a May 2016 Obama administration rulethat prohibits discrimination in health care on the basis of transgender status.

Most major medical associationsincluding the American Medical Association and the American Academy of Family Physiciansalso support transgender health care.

But Wisconsin governor Scott Walker moved quickly to have the exclusion reinstated.

In August, Wisconsin joined Texas, Nebraska, Kentucky, and Kansas in a multi-state lawsuit against the Obama administration over the May 2016 rule. That same month, Wisconsin Deputy Attorney General Andy Cook also sent the Group Insurance Board a five-page memo urging them to reconsider their decision to lift the exclusion. (That memo was sent at Governor Walkers request, as the Wisconsin State Journal later reported.)

The former tactic ended up workingat least, for the time being. On Dec. 31 of last year, a federal judge in Texas issued a temporary injunction against the Affordable Care Act regulation.

But the afternoon before that preliminary injunction was issued, the Group Insurance Board held what the Wisconsin State Journal called an unusual special meeting. At that meetingwhich was closed to the public for over three hours, as the meeting minutes show (PDF)the Group Insurance Board laid the groundwork for the reinstatement of the transgender health care exclusion, specifying conditions for its return, including a future court ruling on the subject.

The injunction conveniently satisfied that condition the next day.

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From what I could tell, they tried to do everything under the radar so to speak, which seemed incredibly fishy, Violet Byrns, a local LGBT activist who attends the Madison Area Transgender Association group, told The Daily Beast.

Byrns, who was present for the mere 13 minutes of the Dec. 30 meeting that were open before it was closed to the public, called the preemptive move a slap in the face to the trans community.

When asked why the Group Insurance Board would convene prior to the Texas judges final decision, ETF communications director Mark Lamkins told The Daily Beast that the meeting was held in anticipation of the courts injunction before January 1 when benefits were effective for the new plan year.

The sudden reinstatement of the transgender health care exclusion has already scuttled at least one state employees health care plans besides Boydens.

CV Vitolo-Haddad, a transgender communication doctoral student at the University of Wisconsin-Madison who prefers to go by the gender-neutral pronoun they, told The Daily Beast that they were on their third week of waiting for surgical pre-authorization when the exclusion went back into effect this month. They had started preparing for this surgery all the way back in September.

There was very little warning or respect for those of us who had begun the process, Vitolo-Haddad, who also directs the schools debate team, told The Daily Beast.

Vitolo-Haddad was also in attendance at the fateful Dec. 30 meeting.

I watched a board of individuals, none of them transgenderas far as I knowrip my health care out from under me, they recalled. How can I feel anything other than worthless?

There are still no estimates for the number of people who have been impacted by the reinstatement of the exclusion.

According to Lamkins, the ETF is still compiling data on the utilization of the states transgender benefits in January. (Boyden was one of two clients represented by the ACLU of Wisconsinthe other being transgender University of Wisconsin-Madison researcher Shannon Andrewswho had filed complaints with the Equal Employment Opportunity Commission over the exclusion.)

But however many transgender state employees and dependents there are in Wisconsin, they wouldnt have cost the state very much money.

As the Wisconsin State Journal reported, a state consultant estimated the annual cost of covering transgender people under the plan to range from $100,000 to $250,000 annuallyless than two-tenths of 1 percent of the health program budget at most. As The Daily Beast has previously reported, transgender health care benefits tend to have very low program costs, according to data collected in both the public and private sector.

Wisconsins reinstatement of the exclusion comes on the heels of a similar decision made by the University of Arkansas system.

Because the Texas injunction temporarily prevents the U.S. Department of Health and Human Services from enforcing the Section 1557 regulations, the University of Arkansas system announced last month that it would be suspending transgender-inclusive health benefits in March. That decision also threw transition plans up in the air, as The Daily Beast reported last week.

For transgender state employees in Wisconsin, there is no telling whenor ifthe benefits will return, short of federal action or a future court decision.

On behalf of the ETF, Lamkins told The Daily Beast, At this time, the Group Insurance Board does not have a condition in place to reverse or reconsider the exclusion.

But while the ACLU of Wisconsin evaluates its next course of action, Boyden has vowed to keep fighting however she can.

I made a promise that I wasnt gonna stop until no other state employee in Wisconsin had to put up with [this], she told The Daily Beast. So Im going to keep going until I fulfill that promise.

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Wisconsin Pulls Plug on Trans Health Care - Daily Beast

Chicago health-care and insurance entrepreneur: Obamacare overhaul more likely to be ‘rename and reface’ – MarketWatch

Repeal and replace is actually going to be rename and reface. Glen Tullman

Shifting fault lines in health care are shaking up even the most seasoned executives, but Chicago-based Glen Tullman says hes not worried.

Thats because Tullmans focus remains on preventive care and technology, priorities he argues cant be undermined by Donald Trump, who at first pledged to toss out the Affordable Care Act wholesale, then walked back those comments.

This is not a Republican or Democratic issue, nor is our business, Tullman told Crains Chicago Business. Everybody wants lower costs. ... [N]o matter who it is, they need solutions for chronic diseases.

Read: Trump updates Obamacare repeal-and-replace timetable in OReilly interview

How Congress proceeds remains to be seen; the Republican leadership has pledged repeal but hasnt yet forwarded a replacement plan.

Although cost and physician selection were among the chief gripes with the Affordable Care Act, select features of Obamacare were popular even among Trump voters, including coverage for pre-existing conditions and extending the age of covered children. And that means repeal and replace is actually going to be rename and reface, said Tullman.

Tullman, whom Crains called Chicagos elder statesman among entrepreneurs, has invested in at least 20 businesses mostly over the past two decades. That includes his latest venture, Livongo, which contracts with companies to use cloud-based technology to help their employees manage diabetes. But hes likely best known for his 15-year run as CEO of medical-records company Allscripts MDRX, -1.02% before a split with the board.

Tullman, a Democrat who says he leans more conservative on economic and defense policies, finds himself in stark contrast with Trump on most matters. And yet in Illinois hes given far more to Republican Gov. Bruce Rauner than to any other candidate, Crains reported.

Dont miss: 8 things you didnt realize were in Obamacare

The big [health care] breakthroughs will come from new discoveries and new technology, he said. Those arent driven by regulations, per se, and they arent prevented by regulations.

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Chicago health-care and insurance entrepreneur: Obamacare overhaul more likely to be 'rename and reface' - MarketWatch

The dabbawala approach to healthcare delivery – CIO

The dabbawalas of Mumbai, India, preserve a tradition that started over a century ago by Mahadeo Havaji Bachche of Pune, India: picking up lunchboxes from houses and delivering them to workplaces. Whether we're talking about delivering lunches or providing medical care, it sounds simple. Its not.

We look outside our business for answers. Our exploration typically looks for answers within technologically advanced industries. Today, well explore a less advanced industry, 7,786 miles from New York City the system of the dabbawalasin Mumbai. The dabbawalas are a world leader in efficiency without technological luxuries. Healthcare can learn a thing or two from the dabbawalas.

Translated literally, the Hindi word dabbawala means one who carries a box, according to the official website of Mumbai Dabbawala, which explains that dabba means box usually a cylindrical tin or aluminium container and that the closest meaning of dabbawala in English would be lunchbox delivery man. A network of 5,000 dabbawalas delivers 350,000 lunches every day to commuters across Mumbai, home to a population of 22 million. The preference for home-cooked food (ghar ka khana) has fueled the demand for dabbawalas. Diverse dietary preferences Muslims, Hindus, Parsis, Jains, Buddhists and dieters reinforce the need for home-cooked meals.

An exploding population creates a chaotic environment when boarding trains, making it impractical to carry a dabba. Instead of taking their own lunches to work, people pay dabbawalas to transport the dabbas to and from their offices. And the dabbas arent just used to carry lunches these days. Messages, cellphone chargers and others things that people might have forgotten at home also make their way into the containers.

The dabbawalas pick up the dabbas at commuters' homes and then transport them by train, bus and bicycle and deliver them to workplaces across the city. This entire process all occurs before lunchtime. After lunch, the dabbawalas retrieve the empty dabbas from thousands of delivery points and return the lunchboxes to their owners' homes all in a daily cycle.

How is efficiency achieved in this supply chain? Teamwork. The dabbawalas are not overpaid, and all dabbawalas are equal. The cost for this service is the equivalent of $7 to $14 (U.S.) a month, depending on the time and distance required to travel for pickup and delivery. Also, dabbawalas are paid the same regardless of tenure: about $180 per month. Job security and respect are earned privileges for many dabbawalas, who typically have limited education.

In the United States, lean supply chains rely heavily on technology advancements, as in the reinvention of Domino's Pizza. The unmatched record for speed and accuracy makes them different. The dabbawalas have a near perfect delivery rate one error per 6 million deliveries, which is better than Six Sigma (3.4 errors per 1 million opportunities). Companies inside and outside of India have been extremely curious about how this efficiency is possible without technology.

The dabbawalas have to negotiate time-bound trains and maneuver through dense urban communities to complete the round-trip deliveries. The dabbas are picked up around 9 or 10 a.m. and travel an average of 25 miles using a hub-and-spoke distribution system. Railway stations (hubs) are used as sorting facilities, and each hub has delivery routes (spokes) that connect to distribution points. Without the use of technology, teamwork becomes essential.

The dabbawalas, or warriors of the road, do not write down customers home addresses. However, they do use a code of delivery featuring colors, numbers and letters to help with sorting and distribution logistics. These codes are painted on the lids of the dabbas. For example, a code of delivery might look like 11LBNO5 LALIT, with the LLBN05 LALIT in light blue, the ones in green and the whole sequence underlined in light blue. Collectively, this symbol is circular and represents the pickup destination, the code of the originating dabbawala, the delivery destination, floor and customer name, and the source station.

The level of precision might lead you to believe that the dabbawalas carefully track the 5,000 dabbawala employees and accurately maintain a list of customers. But there is no list of dabbawalas, and no list of customers. The network cohesion maintains order.

What is the greater antagonist to patients: the inconvenience associated with science or the breakdown of functional systems? Waiting, scheduling and the distribution of information may be improved by establishing loose networks and cutting down hierarchies weaved through the U.S. healthcare delivery system. Why are dabbawalas able to manage a network of 200,000 lunches delivered to almost as many offices with a rate of failure lower than annual medical errors in the U.S.?

A recent study by John Hopkins Medicine found that out of 35,416,020 hospitalizations, 251,454 deaths stemmed from a medical mistake. Researchers forecast that these mistakes translate to 9.5 percent of all yearly deaths in the U.S. Is the delivery of healthcare that much more complicated than the urban challenges which face the dabbawalas in Mumbai? Id offer its not.Treatment is complicated, but delivery is simply access or care delivery.

We can learn from the dabbawala system and improve healthcare. Nine immediate observations come to mind.

We would be hard-pressed to remove technology from healthcare. But it might not be a bad idea to reflect on the possibility of decreasing our heavy dependency on technology. We talk about regional healthcare challenges and confined health disparities, yet little action is taken. Incentives inspire action. Incentives also provide a catalyst for change. Healthcare needs new incentives where value, risk and profit are shared.

Peering into the world of the dabbawalas is a fun escape. Imagine an alternate world of healthcare.We can create a new world where healthcare organizations become places where people want to work.

This is not an endorsement for junking existing EMR systems or printing more copies to share information between providers. There is, however, a lesson from the dabbawalas for healthcare. The lesson is that we all have a lot to learn from areas that initially appear insignificant.

The system of dabbawalas started in 1885, when a Mumbai banker hired a man to pack and deliver his lunch. The opportunity to leverage the railway system (a new innovation at the time) and provide farmers a consistent income was identified by Bachche, one of the original delivery men. The first 35 farmers were warriors of the road, and these simple villagers were descendants of tribal warriors. These entrepreneurs established a flexible delivery system and network. They empowered each dabbawala by creating guidelines, not standards, and establishing shared ownership.

Why do we have monolithic standards in healthcare that push outdated technology into the hands of caregivers, resulting in counterproductive care? Its time to create a loosely managed network of home care. A new highly networked informal system that capitalizes on differentiation with guidelines, not standards.

This article is published as part of the IDG Contributor Network. Want to Join?

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The dabbawala approach to healthcare delivery - CIO

This Is How Trump’s US Protectionism Has Actually Helped Asian Healthcare – Forbes


Forbes
This Is How Trump's US Protectionism Has Actually Helped Asian Healthcare
Forbes
The TPP was an ambitious proposal, it included five Asian nations (with the notable exception of China), and hoped to cover a wide breadth of trade issues ranging from agricultural tariffs to labor standards. Its impact therefore extended beyond ...

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This Is How Trump's US Protectionism Has Actually Helped Asian Healthcare - Forbes

Paul Ryan Says Health Care ‘Legislating Is Going To Be Done This Year’ – TPM

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Paul Ryan Says Health Care 'Legislating Is Going To Be Done This Year' - TPM

Many high-risk patients with breast cancer aren’t getting genetic testing. Here’s why. – Washington Post

Doctors often fail to recommend genetic testing for breast-cancer patients, even those who are at high risk for mutations linked toovarian and other cancers, according to a study published Tuesday.

Researchers said the findings, which appear online in the Journal of the American Medical Association, are troubling because genetic tests can help guide women's choice of treatments for existing disease, as well as point to ways to reduce the risk of future cancer. Women who have a dangerous mutation might choose to have more stringent screening or opt to have surgery before a cancer develops, they said.

The study also found that many women who would benefit from genetic counseling do not receive it.

Genetic testing can be a powerful tool for certain women, said study author Reshma Jagsi, a radiation oncologist at the University of Michigan Health System. It is worrisome to see so many of these women at highest risk for mutations failing even to have a visit focused on genetic counseling.

Genetic tests can identify mutations of the BRCA genes, which are linked to ovarian, breast and other cancers. The tests were developed two decades ago but were initially costly. In recent years, faster, cheaper versions have become available.

[Why more men should be tested for mutations in breast cancer genes]

For the study, researchers surveyed more than 2,500 breast-cancer patients in two regions of the United States two months after they had undergone surgery in 2013 and 2014. They asked whether the women had been interested in genetic testing and whether they had received it.

Although two-thirds of the women reported wanting genetic testing, less than a third actually got it, the study found. About 8 in 10 women at highest risk for BRCA mutations because of family history or ancestry said they had wanted testing, but only a little more than half received it.

Many of the women said they didn't get tested because their doctors never recommended it. A smaller number said the testing was too expensive.

The results suggest that many doctors do not recognize the importance of genetic testing for high-risk women, researchers said.

This is our problem, said Theodora Ross, director of the University of Texas Southwestern Medical Center's cancer genetics program. How do we educate the doctors?

When it comes to cancer screening, most doctors are playing to where the puck is rather than where it's going, added Ross, who was not involved in the study.

Asian Americans and older women were among those most likely to not get testing.

Genetic counseling and testing are not well-matched to medical need, said Allison Kurian, associate professor of medicine and of health research and policy at Stanford University School of Medicine. Kurian, the lead author of the study, said that more genetic counselors are needed and that doctors should improve their skills in managing cancer risk and communicating with patients.

The researchers said the limitations of the study included the fact that it was based on patients' own accounts a point echoed by Ross. She said she would like to know what the doctorshad to say about these cases.

Read more:

Cancer death rates, while declining, remain higher for men than women

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Fears about IVF and cancer appear unfounded, study says

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Many high-risk patients with breast cancer aren't getting genetic testing. Here's why. - Washington Post

Studies point way to precision therapies for common class of genetic disorders – Medical Xpress

February 7, 2017 by Adam Hadhazy Two Princeton University studies are opening important new windows into understanding an untreatable group of common genetic disorders known as RASopathies that affect approximately one child out of 1,000 and are characterized by distinct facial features, developmental delays, cognitive impairment and heart problems. The researchers observed in zebrafish and fruit fly embryos how cancer-related mutations in the RAS pathway a biochemical system cells use to transmit information from their exterior to their interior caused severe deformations. Fruit-fly embryos (above) showed how signals at the early stage of development (red in top photo) activate genes (purple in middle photo) and pattern structures in the fly larva (bottom photo.) . Credit: Stanislav Shvartsman, Department of Chemical and Biological Engineering

Two Princeton University studies are opening important new windows into understanding an untreatable group of common genetic disorders known as RASopathies that are characterized by distinct facial features, developmental delays, cognitive impairment and heart problems. The findings could help point the way toward personalized precision therapies for these conditions.

Although not widely known, RASopathies are among the most common genetic disorders, affecting approximately one child out of 1,000. RASopathies are caused by mutations within the RAS pathway, a biochemical system cells use to transmit information from their exterior to their interior.

"Human development is very complex and it's amazing that it goes right so often. However, there are certain cases where it does not, as with RASopathies," said Granton Jindal, co-lead author of the two studies. Both Jindal and the other co-lead author, Yogesh Goyal, are graduate students in the Department of Chemical and Biological Engineering and the Lewis-Sigler Institute for Integrative Genomics (LSI). Jindal and Goyal do their thesis research in the lab of Stanislav Shvartsman, professor of chemical and biological engineering and LSI.

"Our new studies are helping to explain the mechanisms underlying these disorders," Jindal said.

These studies were published this year, one in the Proceedings of the National Academy of Sciences (PNAS) and the other in Nature Genetics online. The researchers made the discoveries in zebrafish and fruit fliesanimals commonly used as simplified models of human genetics and Jindal and Goyal's specialties, respectively. Due to the evolutionary similarities in the RAS pathway across diverse species, changes in this pathway would also be similar. Thus, it is likely that significant parts of findings in animals would apply to humans as well, although further research is needed to confirm this.

The first paper published Jan. 3 in PNAS presented a way to rank the severity of different mutations involved in RASopathies. The researchers introduced 16 mutations one at a time in developing zebrafish embryos. As each organism developed, clear differences in the embryos' shapes became evident, revealing the strength of each mutation. The same mutant proteins produced similarly varying degrees of defects in fruit flies. Some of the mutations the researchers tested were already known to be involved in human cancers. The researchers noted that these cancer-related mutations caused more severe deformations in the embryos, aligning with the medical community's ongoing efforts to adapt anti-cancer compounds to treat RASopathies.

"Until now, there was no systematic way of comparing different mutation severities for RASopathies effectively," Goyal said.

Jindal added, "This study is an important step for personalized medicine in determining a diagnosis to a first approximation." The study therefore suggested a path forward to human diagnostic advances, potentially enabling health care professionals to offer better diagnoses and inform caretakers about patients' disease progression.

The study went further and examined the use of an experimental cancer-fighting drug being investigated as a possible way to treat RASopathies. The researchers demonstrated that the amount of medication necessary to correct the developmental defects in the zebrafish embryos corresponded with the mutation's severitymore severe mutations required higher dosages.

The more recent paper, published online by Nature Genetics Feb. 6, reports an unexpected twist in treatment approach to some RASopathies. Like all cellular pathways, the RAS pathway is a series of molecular interactions that changes a cell's condition. Conventional wisdom has held that RASopathies are triggered by overactive RAS pathways, which a biologist would call excessive signaling.

The Nature Genetics study, however, found that some RASopathies could result from insufficient signaling along the RAS pathway in certain regions of the body. This means that drugs intended to treat RASopathies by tamping down RAS pathway signaling might actually make certain defects worse.

"To our knowledge, our study is the first to find lower signaling levels that correspond to a RASopathy disease," Goyal said. "Drugs under development are primarily RAS-pathway inhibitors aimed at reducing the higher activity, so maybe we need to design drugs that only target specific affected tissues, or investigate alternative, novel treatment options."

The Nature Genetics study also found that RAS pathway mutations cause defects by changing the timing and specific locations of embryonic development. For example, in normal fruit fly cells, the RAS pathway only turns on when certain natural cues are received from outside the cell. In the mutant cells, however, the RAS pathway in certain parts of fly embryo abnormally activated before these cues were received. This early activation disturbed the delicate process of embryonic development. The researchers found similar behavior in zebrafish cells.

"Our integrative approach has allowed us to make enormous progress in understanding RASopathies, some of which have just been identified in the last couple of decades," Shvartsman said. "With continued steps forward in both basic and applied science, as we've shown with our new publications, we hope to develop new ideas for understanding and treatment of a large class of developmental defects."

Princeton co-authors of the two papers include Trudi Schpbach, the Henry Fairfield Osborn Professor of Biology and professor of molecular biology, and Rebecca Burdine, an associate professor of molecular biology, as well as co-advisers to Goyal and Jindal; Alan Futran, a former graduate student in the Department of Chemical and Biological Engineering and LSI; graduate student Eyan Yeung of the Department of Molecular Biology and LSI; Jos Pelliccia, a graduate student in the Department of Molecular Biology; seniors in molecular biology Iason Kountouridis and Kei Yamaya; and Courtney Balgobin Class of 2015.

Bruce Gelb, a pediatric cardiologist specializing in cardiovascular genetics and the director of the Mindich Child Health and Development Institute at the Mount Sinai School of Medicine in New York, described the two new studies as "wonderful" in advancing the understanding of altered biology in RASopathies and developing a framework for comparing mutation strengths, bringing effective treatments significantly closer.

"At this time, most of the issues that arise from the RASopathies are either addressed symptomatically or cannot be addressed," Gelb said. "The work [these researchers] are undertaking could lead to true therapies for the underlying problem."

Explore further: New insight into RASopathy-associated lymphatic defects

More information: Granton A. Jindal et al. In vivo severity ranking of Ras pathway mutations associated with developmental disorders, Proceedings of the National Academy of Sciences (2017). DOI: 10.1073/pnas.1615651114

Yogesh Goyal et al. Divergent effects of intrinsically active MEK variants on developmental Ras signaling, Nature Genetics (2017). DOI: 10.1038/ng.3780

The RAS pathway is a cellular signaling pathway that regulates growth and development in humans. RASopathies are a group of diseases characterized by defects in RAS signaling.

Researchers have successfully targeted an important molecular pathway that fuels a variety of cancers and related developmental syndromes called "Rasopathies."

Investigators at Beth Israel Deaconess Medical Center (BIDMC) have identified a developmental cause of adult-onset cardiac hypertrophy, a dangerous thickening of the heart muscle that can lead to heart failure and death. ...

Different genetic mistakes driving skin cancer may affect how patients respond to the drug vemurafenib, providing grounds to screen people with melanoma skin cancer before treatment, a new study by Cancer Research UK scientists ...

May 5, 2016A cell-to-cell signaling network that serves as a developmental timer could provide a framework for better understanding the mechanisms underlying human heart valve disease, say University of Oregon scientists.

It's been more than 10 years since Japanese researchers Shinya Yamanaka, M.D., Ph.D., and his graduate student Kazutoshi Takahashi, Ph.D., developed the breakthrough technique to return any adult cell to its earliest stage ...

Two Princeton University studies are opening important new windows into understanding an untreatable group of common genetic disorders known as RASopathies that are characterized by distinct facial features, developmental ...

The world's biggest study into an individual's genetic make-up and the risk of developing lung disease could allow scientists to more accurately 'predict' - based on genes and smoking - your chance of developing COPD, a deadly ...

A poor diet during pregnancy can cause biological changes that last throughout life, according to research from Imperial College London.

UT Southwestern Medical Center researchers have identified a gene that protects the gut from inflammatory bowel disease (IBD).

In the largest, deepest search to date, the international Genetic Investigation of Anthropometric Traits (GIANT) Consortium has uncovered 83 new DNA changes that affect human height. These changes are uncommon or rare, but ...

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Studies point way to precision therapies for common class of genetic disorders - Medical Xpress

Genetic test to predict opioid risk lacks proof, experts say – Philly.com – Philly.com

It sounds like a godsend for America's opioid epidemic: genetic tests that can predict how a patient will respond to narcotic painkillers, as well as an individual's risk of misuse, addiction, and potentially deadly side effects.

Proove Biosciences of Irvine, Calif., claims its "opioid response" and "opioid risk" tests are the only precision medicine tools on the market to do all that, giving doctors information "to guide opioid selection and dosage decisions as well as treat side effects."

But while the concept is captivating, addiction researchers say it is not yet possible to use genetic variation to gauge the risk of drug abuse. And ECRI Institute, a Plymouth Meeting nonprofit center that evaluates medical technology, says Proove has not published independently reviewed studies to support its claims.

"We cant say it doesnt work. All we can say is, theres no evidence it does," said ECRI research analyst Jeff Oristaglio.

In an interview, Proove CEO Brian Meshkin defended his five-year-old products, which he said retail for $1,000 a test and were used by about 400 doctors last year in treating 50,000 patients. He said he expects scientific journals to publish results from studies "within the next six months." Three clinical trials of the opioid response test are ongoing.

Consumers may assume that such high-tech genetic tests have to demonstrate safety and effectiveness to win regulatory approval, but they do not. Even though these complex diagnostics use the latest gene-sequencing and data-crunching techniques, they can come to market under 1988 federal regulations designed to ensure the quality of clinical laboratories.

Two years ago, the U.S. Food and Drug Administration proposed a new framework for overseeing "lab-developed tests" that would take into account their complexity and riskiness, because inaccurate or false results can harm patients. But the agency withdrew the controversial proposal after the November election, saying it needed "to continue to work with stakeholders, our new administration, and Congress."

Proove is one of many companies in the fast-growing genetic-susceptibility testing market, a multi-billion industry built on trying to foresee and thus, forestall disease, disability, and death.

Opioid-related deaths have become an urgent public-health crisis. Every day, on average, 3,900 people start abusing prescription painkillers, 580 graduate to cheaper heroin, and 78 die of a narcotic overdose, according to federal data.

In theory, genetics provides an opportunity to reduce this toll. Researchers have linked a predisposition to opioid dependency to gene variants involved in the brain's signaling of reward and pleasure. Addictive behavior, particularly alcohol abuse, is known to run in families.

But addiction experts say risky behavior involves the largely unpredictable interplay of environmental, cultural, and biological factors.

"It is hard to conceive of a genetic test or a genetic score that would be valuable as a predictor of opiate abuse or addiction in general," said Michael Vanyukov, a University of Pittsburgh professor of pharmaceutical sciences, psychiatry and human genetics.

Vanyukov, who wasn't familiar with Proove's products, said heredity plays a relatively small role in determining variation in addiction risk, while choices and perceptions can play a big role. "If the individual is informed of, say, a 'low' risk score, this very piece of information will change the risk. The error of a genetic score is likely to be great, and reliance on it in practice may be dangerous."

Psychiatrist Charles OBrien, founding director of the University of Pennsylvania's Center for Studies of Addiction, was also unfamiliar with Proove's test, but echoed that sentiment: "I could not in good conscience recommend that someone spend money on these tests."

O'Brien's own center recently identified gene variants associated with response to naltrexone, a drug that blocks the intoxicating effects of alcohol. But when the center studied alcoholics on naltrexone, strong and weak responders had the same number of heavy drinking days.

"We were very disappointed because we're all looking for precision medicine," O'Brien said.

Proove's tests analyze DNA from a cheek swab. The opioid risk test gives the patient a score low, moderate, or high risk of opioid abuse that is based on detecting variants in 12 genes, combined with clinical information such as a history of depression. The company's website claims the algorithm is 93 percent accurate.

But when ECRI scientists looked to validate that claim, all they could find were brief summaries of two studies that the company presented at medical conferences. One studyof 290 patients compared the Proove risk test with the "opioid risk tool," a standard, one-minute screening questionnaire that doctors use to ask chronic pain patients about risk factors such as a history of mental illness or substance abuse.

"We cannot determine ... whether the test performs better or worse than the opioid risk tool in predicting opioid misuse," ECRI concluded.

Insurance plans either consider Proove's tests unnecessary or have no specific policies, ECRI found, although Meshkin said insurers are covering the cost "on a case-by-case basis."

"At some point, you've got to stop and produce the evidence if you want people to pay," said Diane Robertson, director of ECRI's health technology assessment service. "Why would anyone want to use something if there is no evidence that it has benefit?"

Published: February 6, 2017 10:09 AM EST The Philadelphia Inquirer

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Gene therapy restores hearing in deaf mice, down to a whisper – Science Daily


Science Daily
Gene therapy restores hearing in deaf mice, down to a whisper
Science Daily
In the summer of 2015, a team at Boston Children's Hospital and Harvard Medical School reported restoring rudimentary hearing in genetically deaf mice using gene therapy. Now the Boston Children's research team reports restoring a much higher level of ...

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Gene therapy restores hearing in deaf mice, down to a whisper - Science Daily

Gene therapy: Deaf to hearing a whisper – BBC News


Medical News Today
Gene therapy: Deaf to hearing a whisper
BBC News
Deaf mice have been able to hear a tiny whisper after being given a "landmark" gene therapy by US scientists. They say restoring near-normal hearing in the animals paves the way for similar treatments for people "in the near future". Studies, published ...
Groundbreaking gene therapy restores hearing, balanceMedical News Today
Scientists restore hearing in deaf mice using advanced gene therapyRT
A better gene therapy vector out of Harvard is credited with restoring normal hearing in miceEndpoints News
FierceBiotech -Yahoo News -Daily Mail
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Gene therapy: Deaf to hearing a whisper - BBC News

Cardiovascular Angiogenic Gene Therapy Gets Fast Track Status – Monthly Prescribing Reference (registration)

Cardiovascular Angiogenic Gene Therapy Gets Fast Track Status
Monthly Prescribing Reference (registration)
The trial is intended to examine Generx as a one-time treatment for improving exercise tolerance in patients who have angina that is refractory to standard medical therapy and not amenable to conventional revascularization procedures (coronary artery ...

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Cardiovascular Angiogenic Gene Therapy Gets Fast Track Status - Monthly Prescribing Reference (registration)

Gene Therapy for Heart Disease Wins Fast-Track Status – P&T Community

Gene Therapy for Heart Disease Wins Fast-Track Status
P&T Community
The FDA has granted a fast-track designation for a phase 3 study of Generx (Ad5FGF-4, Angionetics Inc.) cardiovascular angiogenic gene therapy as a one-time treatment for improving exercise tolerance in patients with angina that is refractory to ...

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Stanford team is growing healthy skin for ill patients – The Mercury News

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Small sheets of healthy skin are being grown from scratch at a Stanford University lab, proof that gene therapy can help heal a rare disease that causes great human suffering.

The precious skin represents growing hope for patients who suffer from the incurable blistering disease epidermolysis bullosa and acceleration of the once-beleaguered field of gene therapy, which strives to cure disease by inserting missing genes into sick cells.

It is pink and healthy. Its tougher. It doesnt blister, said patient and research volunteer Monique Roeder, 33, of Cedar City, Utah, who has received grafts of corrected skin cells, each about the size of an iPhone 5, to cover wounds on her arms.

More than 10,000 human diseases are caused by a single gene defect, and epidermolysis bullosa is among the most devastating. Patients lack a critical protein that binds the layers of skin together. Without this protein, the skin tears apart, causing severe pain, infection, disfigurement and in many cases, early death from an aggressive form of skin cancer.

The corrected skin is part of a pipeline of potential gene therapies at Stanfords new Center for Definitive and Curative Medicine, announced last week.

The center, a new joint initiative of Stanford Healthcare, Stanford Childrens Health, and the Stanford School of Medicine, is designed to accelerate cellular therapies at the universitys state-of-the-art manufacturing facility on Palo Altos California Avenue. Simultaneously, itisaiming to bring cures to patients faster than before and boost the financial value of Stanfords discoveries before theyre licensed out to biotech companies.

With trials such as these, we are entering a new era in medicine, said Dr. Lloyd B. Minor, dean of the Stanford University School of Medicine.

Gene therapy was dealt a major setback in 1999 when Jesse Gelsinger, an Arizona teenager with a genetic liver disease, had a fatal reaction to the virus that scientists had used to insert a corrective gene.

But current trials are safer, more precise and build on better basic understanding. Stanford is also using gene therapy to target other diseases, such as sickle cell anemia and beta thalassemia,a blood disorder that reduces the production of hemoglobin.

There are several diseases that are miserable and worthy of gene therapy approaches, said associate professor of dermatology Dr. Jean Tang, who co-led the trial with Dr. Peter Marinkovich. But epidermolysis bullosa, she said, is one of the worst of the worst.

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It took nearly 20 years for Stanford researchers to bring this gene therapy to Roeder and her fellow patients.

It is very satisfying to be able to finally give patients something that can help them, said Marinkovich.In some cases, wounds that had not healed for five years were successfully healed with the gene therapy.

Before, he noted, there was only limited amounts of what you can do for them. We can treat their wounds and give them sophisticated Band-Aids. But after you give them all that stuff, you still see the skin falling apart, Marinkovich said. This makes you feel like youre making a difference in the world.

Roeder seemed healthy at birth. But when her family celebrated her arrival by imprinting her tiny feet on a keepsake birth certificate, she blistered. They encouraged her to lead a normal childhood, riding bicycles and gentle horses. Shes happily married. But shes grown cautious, focusing on photography, writing a blog and enjoying her pets.

Scarring has caused her hands and feet digits to become mittened or webbed. Due to pain and risk of injury, she uses a wheelchair rather than walking long distances.

Every movement has to be planned out in my head so I dont upset my skin somehow, she said. Wound care can take three to six hours a day.

She heard about the Stanford research shortly after losing her best friend, who also had epidermolysis bullosa, to skin cancer, a common consequence of the disease. Roeder thought: Why dont you try? She didnt get the chance.

The team of Stanford experts harvested a small sample of skin cells, about the size of a pencil eraser, from her back. They put her cells in warm broth in a petri dish, where they thrived.

To this broth they added a special virus, carrying the missing gene. Once infected, the cells began producing normal collagen.

They coaxed these genetically corrected cells to form sheets of skin. The sheets were then surgically grafted onto a patients chronic or new wounds in six locations. The team reported their initial results in Novembers Journal of the American Medical Association.

Historically, medical treatment has had limited options: excising a sick organ or giving medicine, said Dr. Anthony E. Oro of Stanfords Institute for Stem Cell Biology and Regenerative Medicine. When those two arent possible, theres only symptom relief.

But the deciphering of the human genome, and new tools in gene repair, have changed the therapeutic landscape.

Now that we know the genetic basis of disease, we can use the confluence of stem cell biology, genome editing and tissue engineering to develop therapies, Oro said.

Its not practical to wrap the entire body of a patient with epidermolysis bullosa in vast sheets of new skin, like a mummy, Oro said.

But now that the team has proved that gene therapy works, they can try related approaches, such as using gene-editing tools directly on the patients skin, or applying corrected cells like a spray-on tan.

A cure doesnt take one step, said Tang. It takes many steps towards disease modification, and this is the first big one. Were always looking for something better.

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Stanford team is growing healthy skin for ill patients - The Mercury News

Uber Taps NASA Expert to Make Flying Cars a Reality – Futurism

Uber Elevate

Ubers ride sharing concept didnt just revolutionize the transportation industry it carved a totally new business model. Its no surprise then, that the company is consistently investing in technology that will once again prove to be game changing.

Last October, Uber announcedplans to develop vertical take-off and landing (VTOL) aircraft to provide a cost-effective and efficient ride sharing service that can shuttle passengers around cities. Now, former NASA engineer Mark Moore will be joining the team to bring these flying, on-demand vehicles into reality.

Moore, who originally lent his engineering expertise for Ubers white paper on the VTOL craft, will now serve as the companys Director of Engineering for their new concept, dubbed Uber Elevate.

I cant think of another company in a stronger position to be the leader for this new ecosystem and make the urban electric VTOL market real, the 30-year NASA veteran shared with Bloomberg.

While Moore is intent on taking Ubers vision to new heights (literally), hes pragmatic enough to recognize the technological and logistical challenges of this project.

On the technical side, the company has to contend with improving vehicle efficiency and limited battery life, while making sure to address potential issues, like noise pollution. On the logistical front, the company has to lobby regulators to reduce air-traffic restrictions, and certify aircrafts for use. But, given Ubers 55-million-strong market, its in a prime position to demonstrate the potential of this technology, and maybe even pave the way for other innovators who are working to bring vehicles to the skies.

AeroMobil has been working on a prototype that combines the characteristics of a traditional car with a small airplane. Airbus Project Vahana is working on a similar, helicopter-style autonomous vehicle that can ferry passengers in the air. And Jetpack Aviation, a company primarily focused on developing jetpacks, is dipping their toes in the flying car industry.

Uber, along with all these companies, will inevitably create a new frontier in transportation defined by convenience, sustainability, and innovation.

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Uber Taps NASA Expert to Make Flying Cars a Reality - Futurism

Obamas to get Freedom of the City of Dublin – BBC News


IrishCentral
Obamas to get Freedom of the City of Dublin
BBC News
Former US President Barack Obama and his wife Michelle are to be granted the Freedom of the City of Dublin. Dublin City councillors voted to award the honour in recognition of Mr Obama's "moderating and progressive" influence on the world stage.
Barack and Michelle Obama to be honored with Freedom of Dublin CityIrishCentral
Barack and Michelle Obama to be awarded freedom of DublinIrish Times
Dublin councillors pass motion to give Obamas Freedom of CityRTE.ie
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Steer gets a taste of freedom after escaping butcher shop – Fox News

A steer made a run for its life after a escaping abutcherin the Parker County town of Weatherford, Texas -- the Cutting Horse Capital of the World.

The bovine escaped from the Hamilton Meats Butcher Shop last Thursday and roamed busy streets and evaded capture from police andanimalcontrol services for nearly two hours. Police say it even rammed a patrol car.

The steer almost made it home free until it ran into a couple of cowboys on horseback. Blake Davies and Justin Farber managed to rope down the steer in the middle of a busy street nearTacoBell and returned it to the butcher.

I just did what I had to do,Davies told the Weatherford Democrat.I justrunup there and thank God everybody stopped and seen me coming. I come blowing out that intersection right there towards at Walmart ... I was going fast and so was that cow.

The Weatherford Police Department posted the dashcamvideoof the determined bovine onFacebook and has gotten more than 6.2 million views.

No injuries were reported.

Story first appeared on FOX 4 NEWS.

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Steer gets a taste of freedom after escaping butcher shop - Fox News

Congressional tech forecast: Clouds with a chance of freedom – Conservative Review

After years of trying, Congress may, finally be set to update the laws surrounding the privacy of emails to the 21st Century. For the second consecutive Congress, the House has passed the Email Privacy Act by an overwhelming bi-partisan majority. After constant and inexplicable delays, perhaps this can be the year that basic due process protections for our online emails and files can make it into law.

The Email Privacy Act addresses a basic flaw in the Electronic Communications Privacy Act of 1986 (ECPA). Ironically, ECPA was designed, as its name indicates, to strengthen legal due process with respect to electronic data and communications. The goal, of course, was to bring legal protections up to date with modern technology at the time. But the law was more protective of communications in transit than of data at rest, especially with respect to third-party data storage.

The actual text of ECPA (18 U.S. Code 2703) provides the means for government agencies to demand that any remote computing service cough up the contents of a wire or electronic communication that has been in electronic storage in an electronic communications system for more than one hundred and eighty days via administrative subpoena. In English, this means that your communications and data stored external to your computer, like in Gmail, Dropbox, or any other cloud service, can be demanded by the feds without a warrant (and without you being notified), so long as the requested files are over 180 days old.

In 1986, this provision wasnt a huge deal because the modern web didnt exist. Data storage was expensive, so most computer users stored their email and other files on their own hard drives. In the present day, tens of millions of people routinely store years worth of their communications and personal files alike on third-party cloud servers. The lack of a basic warrant requirement to access these is an insane breach of privacy.

The need to reform ECPA is so completely self-evident, in fact, that the House of Representatives passed the Email Privacy Act by a vote of 412-0 in 2016. Yet it went nowhere in a Senate preoccupied by the upcoming election, despite bi-partisan support for ECPA reform in that chamber.

Part of the hesitancy in passing ECPA reform has been protests from executive agencies like the Securities and Exchange Commission that they need the ability to quickly grab documents as part of their investigations into various regulatory and criminal offenses. But there is a simple reply: Get a warrant. Court orders dont take a ton of time to get if there is probable cause. Outside of emergency situations, the system isnt supposed to make violating the privacy of peoples files and communications easy or convenient.

But a new Congress means a fresh start, and the Email Privacy Act has not only already been reintroduced by original sponsors Rep. Kevin Yoder, R-Kan. (D, 65%) and Rep. Jared Polis, R-Colo. (F, 20%), but has already passed the House again, by an easy voice vote.

A great start. Now, in the spirit of better late than never, the Senate should take up the bill as soon as the major nomination crunch is over and send it to President Trumps desk.

Josh Withrow is an Associate Editor for Conservative Review and Director of Public Policy at Free the People. You can follow him on Twitter at @jgwithrow.

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Congressional tech forecast: Clouds with a chance of freedom - Conservative Review

Reality check: Donald Trump does not care about your ‘religious freedom’ – LGBTQ Nation

That's not how any of this works! Bil Browning

As Donald Trump and the GOP are trying to sell legal protections for discrimination with religious freedom language, heres a reminder that they dont care about freedom of religion at all. A person who wants to ban Muslims from entering the US does not care about religious freedom.

It really is that simple.

Donald Trump campaigned on a total and complete shutdown of Muslims entering the United States. He called for this repeatedly. He won the election because a lot of Republicans want to keep Islam out of the US.

If it wasnt enough for Trump to advocate a ban on immigrants who practice Islam, hes working to make it a reality. His recent executive order is a first step to that end. Republicans arent even hiding it. Rudy Giuliani told Fox News, When he first announced it, he said Muslim ban. He called me up. He said, Put a commission together. Show me the right way to do it legally.' And this is the result.

Someone who cares about freedom of religion does not advocate discriminating against those who practice one religion. Thats the opposite of religious freedom.

Look at the issues they hold up as examples of religious freedom being violated. The Hobby Lobby case was about an employer that didnt want its employees to be able to get contraception in the health care those employees earned and that the government subsidized. The Little Sisters case went one step further and argued that even filling out a form saying that an employer doesnt want to include contraception in health care their employees earn is too big of a burden.

No one is forcing employers to use contraception, and these employers are specifically saying that they want to be able to prevent others from using it because of their religious beliefs.

Thats not religious freedom.

The right wants adoption agencies to be able to discriminate against single parents and same-sex couples when placing children. No one is forcing those adoption agency workers to be gay or single, they just want to be able to discriminate against parents who dont follow the agencys religions tenets, no matter the religious practices of those parents.

Thats not religious freedom.

They say federal contractors religious rights are being violated by making them treat LGBT employees as they do other employees, by providing marriage benefits for same-sex couples and for allowing transgender employees to use an appropriate bathroom. No one is forcing the contractors to marry someone of the same sex or to use any bathroom, but the contractors religious freedom is being violated because they cant discriminate against LGBT employees.

Thats not religious freedom.

The rights definition of freedom of religion is Conservative Christians ability to impose their political beliefs on others, especially when it comes to how other people have sex. Thats not what religious freedom is.

Religious freedom cannot be unfettered because people have different religions and we have to get along. At some point there will be conflict between various freedoms, freedom of religion included, and we have ways of dealing with that.

In the US, people get a lot of freedom to practice their religion in the private sphere, and then we evaluate the burdens placed on them in the public sphere to see if those burdens are outweighed by other goals.

This is why encouraging Muslims convert to Christianity before studying, working, vacationing, visiting, or living in the US is so repulsive; the government should not be telling anyone how to pray, believe, or identify themselves.

Someone who cares about freedom of religion does not say that people of all religions are free to follow Christianity. Thats the joke definition of freedom of religion. If its your definition, then you dont believe in religious freedom.

Religious freedom is important, real religious freedom. We have centuries of history to look at what happens when we allow governments to spread one religion and squelch others.

Trump doesnt care about religious freedom. Religious freedom sounds nicer than freedom to impose ones beliefs on another persons private life if you follow the right religion.

Thats what makes it a good marketing tool, but youre a sucker if you actually believe it.

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Reality check: Donald Trump does not care about your 'religious freedom' - LGBTQ Nation

Freedom Caucus hissy fit: But we want Obamacare repeal right nooooooowwwww! – Daily Kos

Have fun with this, McConnell and Ryan. Campaign Action

The problem children of the House, the maniacs in the Freedom Caucus, are having a tantrum. They don't care if millions of people lose their insurance and health care. They don't care if it's complicated to unwind a law this complex. They don't care if there are consequences. They just don't care. They were promised Obamacare and they want it now.

Mr. Meadows said the Freedom Caucus planned to discuss Monday night whether to adopt an official stance in favor of immediate repeal of the law, which would require the support of 80% of their members. []

In the Senate, Republicans say they are working on fixing the health-laws failing components. We will repair the damage that Obamacare has caused millions of Americans, Sen. Lamar Alexander (R., Tenn.) wrote in a statement Sunday. We will do that by replacing Obamacare with better, lower-cost alternatives and repealing the parts of Obamacare that have caused the damage.

Rep. Jim Jordan (R., Ohio), another conservative leader, said conservatives are alarmed about the talk from centrist Republicans of stopping short of a full repeal of the ACA. That causes greater concern, he said.

What all this means is that there is still no replacement plan, which is nothing new. It also means there's no hope of getting a Republican replacement plan because the divisions in the party are just too huge. That is also not new. There's also no chance Democrats step up to help, because why would they? It's too satisfying to watch them continue to flounder. So Meadows' bright idea of getting Democrats to "negotiate in earnest" (or more plainly, bail them out) is just super pathetic.

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Freedom Caucus hissy fit: But we want Obamacare repeal right nooooooowwwww! - Daily Kos

The Surprising Origins of Wonder Woman – The Mary Sue

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