Health-care waiver talks dragging on

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By Michael Norton

State House News Service

BOSTON -- A federal waiver critical to the efforts in Massachusetts to pursue universal health-care coverage, rein in cost increases and deploy payment delivery reform is hung up in secret talks between outgoing Gov. Deval Patrick's administration and the Obama administration.

In late 2011, when Patrick announced the current $26.7 billion, three-year waiver, he said more than 98 percent of Massachusetts residents were insured and predicted the waiver would help the state tame health-care cost growth. Now, as his time in office winds down and with the state's Medicaid rolls growing, negotiating details of a new waiver represents one of his biggest remaining responsibilities.

The Patrick administration last September applied for a five-year extension of the waiver, calling it "the centerpiece of the state's health-care reform," but talks over conditions of the waiver have extended beyond the scheduled waiver start date of July 1 and will continue into September, the News Service learned on Friday.

"Of all the fiscal risks facing the state in the near future, the outcome of these negotiations is far and away number one," Michael Widmer, president of the Massachusetts Taxpayers Foundation, said this week. "There is a huge amount at stake in getting the maximum possible federal funding. I mean, the state's Medicaid costs are soaring so it's absolutely critical that we get as much federal support as possible."

Federal officials have agreed to two monthly extensions of the current waiver and on Friday, a Patrick administration official said another extension, through Sept. 12, has been received. "We are now doing shorter extensions as we move closer to finalizing the waiver agreement," said Health and Human Services spokeswoman Julie Kaviar.

Administration officials will not discuss negotiations, but people familiar with the underlying issues believe points of conflict could be funding levels for so-called safety net hospitals in Massachusetts, cost sharing for problems that have arisen during the rollout of the Affordable Care Act, as well as the length of the new waiver.

The waiver -- known as the Massachusetts Section 1115 Demonstration Project -- dates back to 1997. It provides a base of support to the extensive and expensive efforts within state government to pursue universal insurance access under a 2006 state law, enact cost containment and new payment models authorized in a 2012 state law, and implement elements of the federal Affordable Care Act.

Josh Archambault, senior fellow at the Pioneer Institute for Public Policy, said that since Gov. Mitt Romney signed the state's universal health-care law in 2006 "negotiations with the federal government have seemed to take longer and longer" on waiver renewals and updates.

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Health-care waiver talks dragging on

Christian health-care sharing group offers alternative to ACA

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OMAHA, Neb. If you are a committed Christian, the contract begins, you do not have to violate your faith by purchasing government-approved health insurance.

Every year, Gary Duff signs an updated version of these 40-page terms, which detail one way Americans can avoid buying private insurance or paying into the Affordable Care Act.

The deal, made possible by a little-known provision in the health-care law, has one particularly important requirement: The Duff household of nine must abstain from general debauchery.

Samaritan Ministries, a health-care sharing group, will charge its national network to cover the familys medical bills, but only if they agree to forsake binge-drinking, extramarital sex, illegal drugs and tobacco (with the exception of celebratory, post-birth cigars). The organization describes itself as a Biblical approach to health-care, guided by Galatians 6:2: Bear one anothers burdens.

This appeals to Duff, a 60-year-old former missionary and international business instructor. He and his wife, Sheryl, have home-schooled all seven of their children and taught them to avoid MTV-approved anything.

Samaritans rules, however, extend beyond the religious realm to the practical one of saving money. Sinful behavior threatens more than a souls entrance to Heaven, Duff and his cohorts believe: It damages the earthly body and amplifies the price of health-care.

Christians are just healthier people, he says. Think of all the physical problems we can attribute to a sinful lifestyle.

The ACA, the Samaritan contract states, is undesirable because it covers costs that result from immoral practices, such as STD treatments or out-of-wedlock births. The law creates a moral dilemma for Duff, who now works as an assistant pastor in downtown Omaha.

Simply put, he says, I dont want to pay for that or encourage it in any way.

Neither do the estimated 100,000 other Samaritan users. The health-care sharing ministry, recognized in ACA as a viable insurance alternative, covers up to $250,000 per need. About 37,000 households are in the network.

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Christian health-care sharing group offers alternative to ACA

Medicine's Next Big Mission: Understanding Wellness

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The bioengineering pioneer Leroy Hood has seen vast changes in medicine over his decades in the biz, in part thanks to his own work on automated DNA sequencing. But he's not much for looking back he's too busy envisioning a future model of medicine. "Contemporary medicine is all about disease, and not about wellness," he says. Hood says the medical profession must learn to measure and maximize wellness, and he's happy to show the way.

At the annual meeting of the IEEE Engineering in Medicine and Biology Society, Hood presented his vision for "P4 medicine," which is predictive, preventive, personalized, and participatory. In a keynote speech, he described the 100K Wellness Project he launched this year as president of the Institute for Systems Biology. The ambitious study aims to enroll 100,000 participants and track their biometrics over 20 years (funding permitting). Hood wants to quantify wellness, and also to provide "actionable information" to the participants.

In March, the project enrolled 108 healthy people to take part in the pilot study. At the end of 2014 the project will scale up to 1000 participants, with the big steps to 10,000 and then 100,000 people expected in the next few years.

Each participant gets their whole genome sequenced at enrollment, and then every three months provides samples of blood, saliva, urine, and stool for analysis. Users also submit data from self-trackers like the Fitbit activity tracker and Omron blood pressure monitor.All that information is integrated to create a dynamic picture of the person's biological state. As the years go by, "patients will either stay well or transition into disease," Hood says. The collected data will not only define the biological parameters of wellness when a participant is diagnosed with a disease, researchers can go back through that patient's data to identify early warning signs.

In a conversation with Spectrum, Hood described the study's first results. All 108 people were found to have some actionable possibility, and received counseling from the project's health coaches. For example, 85 people had low levels of vitamin D. The researchers then checked those people's genomes, and identified some people with a genetic variation that makes it difficult for their bodies to absorb vitamin D. The health coaches could therefore tell each of those 85 people how much vitamin D they needed to take to bring up their levels.

One of the participants received even more critical information. Blood testing revealed that his iron levels were very high, and the health coaches advised him to go to a doctor. It turns out he had a dangerous genetic condition called hemochromatosis that damages the organs and eventually leads to heart attack, but that can be managed by bringing down iron levels. "So instead of having an individual who is sick for the last 20 years of his life, we have a healthy individual," Hood says. That substitution is not just a good health outcome, it's also a significant cost saving for the health care system.

Hood thinks his study of wellness is of such national importance that he's considering pitching it to Congress as "a second Human Genome Project." He would argue that the study would bring about great innovations and cost savings in health care, and would let the United States lead a revolution in medicine. "I think the arguments are actually better for this than they were for the genome project," Hood says.

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Tute Genomics and Patients Know Best Partner to Bring Precision Medicine' a Step Closer

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Provo, Utah (PRWEB) August 27, 2014

Tute Genomics is today teaming up with UK-based Patients Know Best the worlds first fully patient controlled medical records system to make precision medicine a reality to patients across the globe.

Operating a cloud-based software platform, Tute Genomics specializes in genome analysis, creating meaningful reports of an individuals full genomic profile that doctors and patients alike can interpret and use to gain meaningful and actionable insights about their health.

The partnership between the two companies will mean that for the first time a patients full genetic profile and one that is easy to work with and understand can be stored within their healthcare record. For the patient, this will ultimately result in receiving healthcare services that are precision-made for their particular condition based on their individual genome sequence.

Dr Reid Robison, CEO of Tute Genomics said,Were enthusiastic about this new partnership with Patients Know Best because we share the same philosophies about pushing genomic medicine forward. Patients Know Best believes in creating a system that will reduce errors and raise quality of healthcare and that is the purpose of the Tute genomics platform; enabling precision medicine. Tute Genomics is working hard to make genomics more accessible to healthcare, research and even consumers, in order to advance individualized, genome-guided medicine.

Over the past few years genomic sequencing 'mapping out' a persons full DNA has become far cheaper and therefore far more feasible. Full genome sequencing involves testing 25,000 separate genomes and 'reading off' 6 billion letters (3 billion base pairs) in any given human genome. Approximately 10 years ago it cost over $100 million to sequence a persons full genome. Today, the cost stands at around $1000.

Dr Mohammad Al-Ubaydli, CEO of Patients Know Best said, When doctors know an individuals genomic profile they can design plans that exactly treat their condition. For example, gene tests can predict whether or not a patient with breast cancer will benefit from a certain type of chemotherapy, or a patient with an infection can safely receive powerful antibiotics. We believe that before long, everyone will get his or her genome sequenced. Tute is providing the most powerful genetic analysis in the hands of patients.

About Patients Know Best Patients Know Best is the worlds first patient-controlled medical records system. It is a fully secure online tool which enables patients to better organise, manage and control their own health care provision it also saves the time of physicians through allowing secure, online consultations. Founded by Dr. Mohammad Al-Ubaydli, a physician, programmer and expert in IT in healthcare, Patients Know Best has won social enterprise awards for its focus on patient care. Patients Know Bests first customers include Great Ormond Street Hospital, St Marks Hospital and NHS South Devon. Patients Know Best integrates fully into the NHS secure network and is available for use by any patient with any clinician anywhere in the world. It is now used by over 30 hospitals in the UK, USA, Holland, Ireland, Kuwait, Australia and Hong Kong. Patients Know Best complies fully with UK NHS information governance requirements as well as the EU data protection act and US HIPAA legislation for dealing with medical data. http://www.patientsknowbest.com

About Tute Genomics Tute Genomics is a USA-based company developing innovative cloud-based solutions to accelerate genetic discovery and enable precision medicine. Tute created a clinical genome interpretation platform that assists researchers in identifying disease genes and biomarkers, and assists clinicians/labs in performing genetic diagnosis. Given sequencing data on a genome or a panel of genes, Tute can return over 125 annotations on variants and genes, perform family-based, case/control or tumor sample analyses to identify causal disease genes, and generate clinical reports for clinicians to focus on clinically relevant and actionable findings. Tute is built on the expertise that developed ANNOVAR, the most widely used genome annotation & interpretation technology with over 800 scientific publications. The genome revolution is here, and Tute envisions a future where clinical reports on genomes are interactive and integrated into medical records, and aims to be the 'dropbox for genomes' for clinicians and patients alike. To learn more please visit http://www.tutegenomics.com.

Contact: Chris Smith, Swarm Communications +44 (0) 7989 321 743 chris(at)swarmcommunications(dot)co.uk

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Tute Genomics and Patients Know Best Partner to Bring Precision Medicine' a Step Closer

Illumina Partners With Big Pharma To Create New Genetic Tests For Cancer

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Illumina Illumina, the leading maker of DNA sequencing equipment, is partnering with Sanofi Sanofi, AstraZeneca AstraZeneca, and Johnson & Johnson Johnson & Johnson to create a test for more mutations in dozens of genes that will be used first in clinical trials and, eventually, to help decide which patient should get which marketed drug.

The tool is necessary because new cancer drugs like Roches Zelboraf and Astras Iressa work only against cells that became cancerous because of particular genetic mutations. Detecting these mutations will allow doctors to pick drugs and cocktails of drugs aimed at the molecular machinery of a particular tumor. For instance, some research has shown that if a colorectal cancer tumor has a particular mutation, it might respond to the combination of a drug like Zelboraf and one like Iressa.

Illumina CEO Jay Flatley leads the innovative company.

Earlier this year, I met with Richard Klausner, Illuminas chief medical officer and the former director of the National Cancer Institute. He told me that he had been visiting large pharmaceutical companies with plans to develop a kind of master test. The idea is that companies would tell Illumina what cancer genes they are developing drugs targeted against. Then, using this information from all of these companies, it could create a genetic test that runs on its DNA sequencing machines that all companies could use in clinical trials, so that instead of developing tests one by one there would be a single test.

The goal is that everyone will use a universal panel, Klausner told me. This appears to be a step in that direction. Illumina says in its press release that the new test will look at at least 125 knownabout 60 or 70 cancer-causing genes. The test will run on MiSeqDx, the only next-generation DNA sequencing machine approved by the Food and Drug Administration. That could put Illumina in partial competition with some of its customers, like Foundation Medicine, which offers DNA sequencing tests for choosing cancer drugs, although Klausner told me he foresees technologies like Foundations being used for more complex analyses or more complicated cases. I think there is plenty of room, Klausner says.

The transition to patient-centered companion therapeutics marks a new era for oncology, and we are pleased to see pharmaceutical companies working with Illumina on a universal platform to bring life- saving treatments through their development pipelines, said Ellen V. Sigal, Ph.D., Chair and Founder of Friends of Cancer Research, in a prepared statement issued by Illumina. This is the type of collaboration that will make real progress for patients.

Klausner told me in an interview last night that the partnerships with the drug giants will be three-pronged: a technical partnership for creating the tests; a regulatory partnership for dealing with the FDA and other regulators; and a commercial partnership, in which Illumina guarantees it will make the tests available where companies sell their drugs.

As a regulatory framework, this could be disruptive. The FDA currently talks about companion diagnostics, that is, diagnostic tests that are paired with drugs. But Klausner says he is thinking in terms of companion therapeutics: in other words, all the drugs are paired with the same test. Its a big change, he says. The FDA is totally embracing it.

For more on Illumina, its history, and the potential of DNA sequencing, read my profile of the company and its CEO, Jay Flatley, in the current issue of Forbes.

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Illumina Partners With Big Pharma To Create New Genetic Tests For Cancer

Ancient DNA Could Return Passenger Pigeons to the Sky

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Genetic engineering could restore the once profuse North American bird after a century or more of extinction

PASSENGER PIGEON: The numerous bird went from abundant to extinct in less than 100 years. Louis Agassiz Fuertes

The last lonely bird of a species that once numbered three billion or more died on September 1, 1914. Martha, as she was known, had been the last passenger pigeon since her mate George died in 1910. The last of a social species, she lived out her days in solitary confinement in a cage in the Cincinnati Zoo. Her corpsestuffed and primpedcan now be seen at the Smithsonian Institution. But what if the passenger pigeon could be brought back? That's the idea behind de-extinction. Take DNA harvested from specimens stuffed in museum drawers, like Martha. Figure out which genes matter and then use the fast growing field of genetic engineering to edit the DNA of a closely related species into some version of the extinct species. If all goes well, a chimera of the long-lost Martha could be born and, one day, flocks of passenger pigeons could be restored to the regrown eastern North American woodlands. Would-be de-extinction pioneer Ben Novak is working at the University of California, Santa Cruz, to make this exact scenario come true. A joint venture between the Revive and Restore effort of The Long Now Foundation (an organization dedicated to long-term thinking) and the ancient DNA lab at U.C. Santa Cruz, Novak's effort is focused on acquiring genetic information from stuffed passenger pigeons and sequencing the genome of the closely related band-tailed pigeon. So far, 32 samples have had the genetic code in their mitochondria sequenced. All of the samples come from birds killed between 1860 and 1898, according to Novak. "That's right in the range when the bird was going extinct," he notes. Outside efforts have helped as well, including nearly complete sequencing of three individuals that showed passenger pigeons have been through booms and busts before. "If passenger pigeons survived through several population bottlenecks during their evolutionary history, perhaps we don't need to create billions of them in order for their populations to be sustainable," notes paleogenomicist Beth Shapiro of U.C. Santa Cruz, whose lab hosts Novak and this effort.

"All of our birds are all very, very similar to each otherlike everybody being cousins, essentiallywhich is the effect of this recent rapid population expansion," Novak adds. "What we're really interested in is figuring out when that population expansion happened." If the population explosion happened more than 400 years ago, then it is unlikely that the European arrival in North America precipitated the boom that produced billions of birds, as some have suggested. To figure out when the last boom occurred will require finding DNA from fossil samples thousands of years olda few of which Novak has begun to examine. With ancient samples and those from the 19th century, Novak and his peers could begin to piece together the actual ecology of the bird in the wild. And understanding how the passenger pigeon existed makes it more likely people could bring the bird back and have the species thrive in the woods that are available today as well as in the future as the climate changes. "Nothing in the data so far to shout at us to turn back now and not bring back the passenger pigeon," Novak says. The team has not yet completed the band-tailed pigeon sequencing required to begin resurrecting the passenger pigeon, but experiments in cell cultures from the band-tailed pigeon may begin as soon as next year, Novak says. This work would be similar to experiments being done at Harvard Medical School to see if the woolly mammoth might be resurrected through its still living relative, the Asian elephant. And the passenger pigeon work may be helped along by similar germ cell efforts in the chicken and houbara bustarda rare bird prized by oil sheikhs with the funds to attempt a genetic rescue. If cell cultures thrive and genetic engineering works, the only remaining challenge would then be to teach the resulting hybrid band-tailed and passenger pigeons how to be passenger pigeons. This will likely even more challenging than the genetic work, given experience from rearing California condors with puppets or teaching cranes to migrate with ultralight airplanes. Thats why Revive and Restore, for one, is not putting all its de-extinction eggs in the passenger pigeon basket (as it were). The foundation-funded outfit might undertake a similar effort to revive the heath hen in Martha's Vineyard, if they can get funding from outside donors. But, assuming breeding, sequencing and cell-culture experiments go well, birds that carry the now extinct genes of the passenger pigeon could be flapping around a California facility by the end of the decade, according to Novak. These de-extinction projects may prove too ambitious, however. Similar efforts that stretch back 30 years have so far failed to produce a quagga, an extinct species of zebra, although acquiringquagga genetics from museum specimens did kick off the entire ancient DNA field in 1984. And the 2003 experiment that resurrected a bucardo for seven minutes has yet to be repeated. Nevertheless, even the International Union for Conservation of Nature has set up a committee to examine how the genetics used for de-extinction might be used to preserve endangered animals and plants or bring them back if they die out. De-extinction is not just for extinct species, after all. It could also be used to save a plant or animal that is on the verge of extinction. The black-footed ferret has been bred back from just seven viable individuals in the 1980s to thousands today, but the species may need a genetic transfusion to protect the new animals from the perils of inbreeding, which include reproductive problems, susceptibility to disease and genetic drift. So Revive and Restore has sequenced four ferret genomes, including two that had been stored in cell cultures from deep freeze at the Zoological Society of San Diego for the Frozen Ark Consortium, a global project to save the DNA and viable cells of endangered species. If genetic information from such frozen samples could be used to infuse robust genetics into a living population, it would be a first in the annals of conservation. "The northern white rhino has only four living individuals left. They are not viable," says Ryan Phelan of Long Now, who has petted the last individuals of this functionally extinct species. "Do we use genomic techniques and advanced genetic technology to keep that species alive or let it march over to the right on the continuum of extinction and become extinct?" But there are advantages to work with an animal that is already extinct, not least of which is the absence of urgency. After all, Martha died 100 years ago. "If we succeed, the world gets a new organism," Novak says. "If we fail, we learn things that are valuable and the world isn't left with another extinct species."

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ALJASSAR: The merits of GMOs

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Genetically modified foods should not require distinguishing labels by Nazar Aljassar | Aug 28 2014 | 08/28/14 10:57pm

A new brand of Luddism has erupted in America. In spite of ample scientific evidence that corroborates the biosafety of genetic modification of crops, over half of Americans believe genetically modified foods are unsafe, with 93 percent in favor of mandatory labels on genetically modified food.

Part of the objection to genetically modified crops stems from a belief that natural foods are superior to unnatural foods a naturalistic fallacy. Nothing is intrinsically virtuous about consuming food crops that are grown naturally. Unfortunately, appeals to nature and tradition have hijacked the discourse surrounding genetic modification.

Its important to note that all agriculture is unnatural. Any claim about the extent to which food crops are natural is meaningless. Agriculture is the largest and most enduring human intervention into the natural world. Through selective breeding, farmers have artificially created several crops for human consumption. Kale and kohlrabi were developed from wild mustard after decades of careful heredity manipulation. Artificial selection has given rise to high-quality strains of soybeans, wheat and corn, all of which have been a boon to civilization. Artificial selection and artificial mutation through genetic engineering both alter food crops on the same microbiological level. The primary distinction is that the latter method can be used to obtain desired traits with greater speed and efficiency.

Genetic modification of organisms is not a novel concept. We have been doing it for thousands of years. Genetic modification through DNA extraction, gene cloning, gene design, transformation and backcross breeding is simply a faster, better way to achieve the results sought through traditional artificial selection.

Despite left-wing insistence that the right wing is anti-science, some of the most strident opposition to genetic modification of food crops comes from progressives. Although liberals are often stalwart supporters of clean energy laws and evolution education, many are fervently in favor of mandating labels on genetically modified foods. Vermont became the first state to enact such legislation, and pressure currently mounts for similar laws in liberal states such as New York, California, Oregon and Massachusetts.

Vermont Governor Peter Shumlin defended his states GMO labeling law, maintaining that consumers have the right to know what they buy. The problem with this line of thought lies in the fact that it suggests dangers immanent in genetically modified food. The scientific consensus, according to the American Association for the Advancement of Science, is that crop improvement by the modern molecular techniques of biotechnology is safe. After allocating over 300 million to research, the European Union revealed in a report its findings on the safety of genetically modified crops: the main conclusion to be drawn from the efforts of more than 130 research projectsis that biotechnology, and in particular GMOs, are not per se more risky than e.g. conventional plant breeding technologies. Among other organizations that have affirmed the biosafety of genetically modified crops are the World Health Organization, the American Medical Association, the U.S. National Academy of Sciences and the British Royal Society.

For liberal legislators to yield to the publics fears about genetic modification only advances scientific misinformation about an agricultural innovation that provides plants resistant to infectious disease, superior foods with longer shelf lives and large crop yields to permit more efficient land use.

There are legitimate criticisms of genetic modification. Economically, introducing genetically modified food to market demands significant time and cost, endangering smaller farms that cannot afford to compete with large agricultural biotechnology companies. Genetic modification also presents a few environmental risks such as reduced biodiversity through genetic homogeneity and resulting from extensive monoculture crop production.

But we shouldnt ignore its efficiency because of these few flaws. Like any scientific advancement, genetic modification will continue to improve with research for which public and political support is crucial. In the face of concerns about genetic modification, we should not jettison the benefits of genetic modification of crops, nor should we propagate the falsehoods that infect scientific discussion by encouraging labels that imply biohazards associated with genetic modification.

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ALJASSAR: The merits of GMOs

Bioengineers Close To Creating Painkillers Without Using Opium From Poppies

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By Tom Abate, Stanford School of Engineering

A decade-long effort in genetic engineering is close to creating yeast that makes palliative medicines in stainless steel vats.

For centuries poppy plants have been grown to provide opium, the compound from which morphine and other important medicines such as oxycodone are derived.

Now bioengineers at Stanford have hacked the DNA of yeast, reprograming these simple cells to make opioid-based medicines via a sophisticated extension of the basic brewing process that makes beer.

Led by Associate Professor of Bioengineering Christina Smolke, the Stanford team has already spent a decade genetically engineering yeast cells to reproduce the biochemistry of poppies with the ultimate goal of producing opium-based medicines, from start to finish, in fermentation vats.

We are now very close to replicating the entire opioid production process in a way that eliminates the need to grow poppies, allowing us to reliably manufacture essential medicines while mitigating the potential for diversion to illegal use, said Smolke, who outlines her work in the August 24th edition of Nature Chemical Biology.

In the new report Smolke and her collaborators, Kate Thodey, a post-doctoral scholar in bioengineering, and Stephanie Galanie, a doctoral student in chemistry, detail how they added five genes from two different organisms to yeast cells. Three of these genes came from the poppy itself, and the others from a bacterium that lives on poppy plant stalks.

This multi-species gene mashup was required to turn yeast into cellular factories that replicate two, now-separate processes: how nature produces opium in poppies, and then how pharmacologists use chemical processes to further refine opium derivatives into modern opioid drugs such as hydrocodone.

From Plants to Pills Today

Plant-derived opium has been used and abused for centuries, but a good place to begin the modern story is with the use of morphine during World War II.

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Bioengineers Close To Creating Painkillers Without Using Opium From Poppies

Do closed-loop insulin delivery systems improve blood glucose control in type 1 diabetes?

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PUBLIC RELEASE DATE:

25-Aug-2014

Contact: Kathryn Ryan kryan@liebertpub.com 914-740-2100 Mary Ann Liebert, Inc./Genetic Engineering News

New Rochelle, NY, August 25, 2014In a closed-loop control approach to managing type 1 diabetes, glucose sensors placed under the skin continuously monitor blood sugar levels, triggering the release of insulin from an implantable insulin pump as needed. The aim of this closed-loop insulin delivery system is improved control of blood glucose levels throughout the day and night. But a new study in adults and adolescents found that mean blood glucose levels remained at safe levels 53-82% of the time, according to the results published in Diabetes Technology & Therapeutics (DTT), a peer-reviewed journal from Mary Ann Liebert, Inc., publishers. The article is available free on the DTT website at http://online.liebertpub.com/doi/full/10.1089/dia.2014.0066 until September 25, 2014.

Howard Zisser, MD and an international team of researchers representing the Control to Range Study Group measured plasma glucose levels every 15-30 minutes in a group of individuals with type 1 diabetes who participated in the "Control to Range" multinational artificial pancreas study. They monitored the adults and teens over 22 hours, including three meals and periods of day and night. The authors describe the risks of hypo- and hyperglycemia, the variability between participants, and the differences in daytime/nighttime results, and also propose improvements needed in the design and implementation of closed-loop systems in the article "Multicenter Closed-Loop Insulin Delivery Study Points to Challenges for Keeping Blood Glucose in a Safe Range by a Control Algorithm in Adults and Adolescents with Type 1 Diabetes from Various Sites".

"It appears that we are getting closer to an Artificial Pancreas option for patients with type 1 diabetes," says DTT Editor-in-Chief Satish Garg, MD, Professor of Medicine and Pediatrics at the University of Colorado Denver. "The first version may need to be a hybrid system in which meals and exercise are announced with necessary dose adjustments along with Automatic Threshold Suspend for hypoglycemia."

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About the Journal

Diabetes Technology & Therapeutics (DTT) is a monthly peer-reviewed journal that covers new technology and new products for the treatment, monitoring, diagnosis, and prevention of diabetes and its complications. Led by Editor-in-Chief Satish Garg, MD, Professor of Medicine and Pediatrics at the University of Colorado Denver, the Journal covers topics that include noninvasive glucose monitoring, implantable continuous glucose sensors, novel routes of insulin administration, genetic engineering, the artificial pancreas, measures of long-term control, computer applications for case management, telemedicine, the Internet, and new medications. Tables of content and a sample issue may be viewed on the Diabetes Technology & Therapeutics (DTT) website at http://www.liebertpub.com/DTT. DTT is the official journal of the Advanced Technologies & Treatments for Diabetes (ATTD) Conference.

About ATTD

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Do closed-loop insulin delivery systems improve blood glucose control in type 1 diabetes?

Can auriculotherapy help relieve chronic constipation?

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PUBLIC RELEASE DATE:

25-Aug-2014

Contact: Kathryn Ryan kryan@liebertpub.com 914-740-2100 Mary Ann Liebert, Inc./Genetic Engineering News

New Rochelle, NY, August 25, 2014 Nearly 1 in 6 adults worldwide may suffer from chronic constipation and, over time, the disorder can cause serious complications. Auriculotherapy, a form of acupuncture that involves stimulating targeted points on the outer ear, may help in managing constipation. Evidence from numerous clinical studies published between 2007-2013 that evaluated the effectiveness of auriculotherapy in treating patients with constipation is presented and discussed in a Review article in The Journal of Alternative and Complementary Medicine, a peer-reviewed publication from Mary Ann Liebert, Inc., publishers. The article is available free on The Journal of Alternative and Complementary Medicine website until September 25, 2014.

Li-Hua Yang and coauthors from the Hospital of Nanjing University of Traditional Chinese Medicine, Jiangsu Province Hospital of Traditional Chinese Medicine, and Southeast University School of Public Health, Nanjing, China, analyzed the results of 17 published studies, comparing the effectiveness of auriculotherapy in managing and relieving constipation and in alleviating symptoms associated with constipation between affected patients and a control group. The authors present their data and conclusions in the article "Efficacy of Auriculotherapy for Constipation in Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials".

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About the Journal

The Journal of Alternative and Complementary Medicine is a monthly peer-reviewed journal publishing observational, clinical, and scientific reports and commentary intended to help healthcare professionals and scientists evaluate and integrate therapies into patient care protocols and research strategies. Complete tables of content and a sample issue may be viewed on The Journal of Alternative and Complementary Medicine website.

About the Publisher

Mary Ann Liebert, Inc., publishers is a privately held, fully integrated media company known for establishing authoritative peer-reviewed journals in many promising areas of science and biomedical research, including Alternative and Complementary Therapies, Medical Acupuncture, Brain and Gut, and Journal of Medicinal Food. Its biotechnology trade magazine, Genetic Engineering & Biotechnology News (GEN), was the first in its field and is today the industry's most widely read publication worldwide. A complete list of the firm's 80 journals, books, and newsmagazines is available on the Mary Ann Liebert, Inc., publishers website.

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Can auriculotherapy help relieve chronic constipation?

Efficacy of new gene therapy approach for toxin exposures shown in mouse study

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The current method to treat acute toxin poisoning is to inject antibodies, commonly produced in animals, to neutralize the toxin. But this method has challenges ranging from safety to difficulties in developing, producing and maintaining the anti-serums in large quantities.

New research led by Charles Shoemaker, Ph.D., professor in the Department of Infectious Disease and Global Health at the Cummings School of Veterinary Medicine at Tufts University, shows that gene therapy may offer significant advantages in prevention and treatment of botulism exposure over current methods. The findings of the National Institutes of Health funded study appear in the August 29 issue of PLOS ONE.

Shoemaker has been studying gene therapy as a novel way to treat diseases such as botulism, a rare but serious paralytic illness caused by a nerve toxin that is produced by the bacterium Clostridium botulinum. Despite the relatively small number of botulism poisoning cases nationally, there are global concerns that the toxin can be produced easily and inexpensively for bioterrorism use. Botulism, like E. coli food poisoning and C. difficile infection, is a toxin-mediated disease, meaning it occurs from a toxin that is produced by a microbial infection.

Shoemaker's previously reported antitoxin treatments use proteins produced from the genetic material extracted from alpacas that were immunized against a toxin. Alpacas, which are members of the camelid family, produce an unusual type of antibody that is particularly useful in developing effective, inexpensive antitoxin agents. A small piece of the camelid antibody -- called a VHH -- can bind to and neutralize the botulism toxin. The research team has found that linking two or more different toxin-neutralizing VHHs results in VHH-based neutralizing agents (VNAs) that have extraordinary antitoxin potency and can be produced as a single molecule in bacteria at low cost. Additionally, VNAs have a longer shelf life than traditional antibodies so they can be better stored until needed.

The newly published PLOS ONE study assessed the long-term efficacy of the therapy and demonstrated that a single gene therapy treatment led to prolonged production of VNA in blood and protected the mice from subsequent exposures to C. botulinum toxin for up to several months. Virtually all mice pretreated with VNA gene therapy survived when exposed to a normally lethal dose of botulinum toxin administered up to nine weeks later. Approximately 40 percent survived when exposed to this toxin as late as 13 or 17 weeks post-treatment. With gene therapy the VNA genetic material is delivered to animals by a vector that induces the animals to produce their own antitoxin VNA proteins over a prolonged period of time, thus preventing illness from toxin exposures.

The second part of the study showed that mice were rapidly protected from C. botulinum toxin exposure by the same VNA gene therapy, surviving even when treated 90 minutes after the toxin exposure.

"We envision this treatment approach having a broad range of applications such as protecting military personnel from biothreat agents or protecting the public from other toxin-mediated diseases such as C. difficile and Shiga toxin-producing E. coli infections," said Shoemaker, the paper's senior author. "More research is being conducted with VNA gene therapy and it's hard to deny the potential of this rapid-acting and long-lasting therapy in treating these and several other important illnesses."

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Efficacy of new gene therapy approach for toxin exposures shown in mouse study

Mice study shows efficacy of new gene therapy approach for toxin exposures

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29-Aug-2014

Contact: Rushmie A Nofsinger rushmie.nofsinger@tufts.edu 508-839-7910 Tufts University, Health Sciences Campus

NORTH GRAFTON, Mass. (August 29, 2014, 2 PM US Eastern Time)The current method to treat acute toxin poisoning is to inject antibodies, commonly produced in animals, to neutralize the toxin. But this method has challenges ranging from safety to difficulties in developing, producing and maintaining the anti-serums in large quantities.

New research led by Charles Shoemaker, Ph.D., professor in the Department of Infectious Disease and Global Health at the Cummings School of Veterinary Medicine at Tufts University, shows that gene therapy may offer significant advantages in prevention and treatment of botulism exposure over current methods. The findings of the National Institutes of Health funded study appear in the August 29 issue of PLOS ONE.

Shoemaker has been studying gene therapy as a novel way to treat diseases such as botulism, a rare but serious paralytic illness caused by a nerve toxin that is produced by the bacterium Clostridium botulinum. Despite the relatively small number of botulism poisoning cases nationally, there are global concerns that the toxin can be produced easily and inexpensively for bioterrorism use. Botulism, like E. coli food poisoning and C. difficile infection, is a toxin-mediated disease, meaning it occurs from a toxin that is produced by a microbial infection.

Shoemaker's previously reported antitoxin treatments use proteins produced from the genetic material extracted from alpacas that were immunized against a toxin. Alpacas, which are members of the camelid family, produce an unusual type of antibody that is particularly useful in developing effective, inexpensive antitoxin agents. A small piece of the camelid antibody called a VHH can bind to and neutralize the botulism toxin. The research team has found that linking two or more different toxin-neutralizing VHHs results in VHH-based neutralizing agents (VNAs) that have extraordinary antitoxin potency and can be produced as a single molecule in bacteria at low cost. Additionally, VNAs have a longer shelf life than traditional antibodies so they can be better stored until needed.

The newly published PLOS ONE study assessed the long-term efficacy of the therapy and demonstrated that a single gene therapy treatment led to prolonged production of VNA in blood and protected the mice from subsequent exposures to C. botulinum toxin for up to several months. Virtually all mice pretreated with VNA gene therapy survived when exposed to a normally lethal dose of botulinum toxin administered up to nine weeks later. Approximately 40 percent survived when exposed to this toxin as late as 13 or 17 weeks post-treatment. With gene therapy the VNA genetic material is delivered to animals by a vector that induces the animals to produce their own antitoxin VNA proteins over a prolonged period of time, thus preventing illness from toxin exposures.

The second part of the study showed that mice were rapidly protected from C. botulinum toxin exposure by the same VNA gene therapy, surviving even when treated 90 minutes after the toxin exposure.

"We envision this treatment approach having a broad range of applications such as protecting military personnel from biothreat agents or protecting the public from other toxin-mediated diseases such as C. difficile and Shiga toxin-producing E. coli infections," said Shoemaker, the paper's senior author. "More research is being conducted with VNA gene therapy and it's hard to deny the potential of this rapid-acting and long-lasting therapy in treating these and several other important illnesses."

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Mice study shows efficacy of new gene therapy approach for toxin exposures

Lars Talks: On artificial intelligence and the singularity [Futurism Part 2] – Video

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Lars Talks: On artificial intelligence and the singularity [Futurism Part 2]
Previous video: On automation and the future of labor http://youtu.be/aBGYDfjSaUU Next video: On the politics and economics of tomorrow http://youtu.be/iRdHD...

By: Lars Talks

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Lars Talks: On artificial intelligence and the singularity [Futurism Part 2] - Video

Bow down: Beyonce was the reigning queen of Sunday's MTV Video Music Awards.

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It was an all-Philly affair on the Skate Park Stage in the early afternoon, with bouncy pop song of Cruisr (recently signed to Vagrant records) giving way to Nothing, Dominic Palermos dream-pop project, which debuted on Upper Darby metal label Relapse Records this year with Guilty of Everything.

Were backkkkk! Its day two at Made in America, and things promise to be hotter, sweatier, and generally more awesome.

"We've been waiting all summer for this, Made In America," Kenny Vasoli of the Philadelphia "nu-hula" smooth-grooves band Vacationer said as he got ready to kick off the action on the Liberty stage on Sunday.

Sunday began smartly with Brooklyn indie rockers MisterWives. They played an exotic brand of rock with subtle hints of Romany and Japanois.

Back in 2012, the biggest electronic dance music (EDM) act at this weekend's Budweiser Made in America festival on the Benjamin Franklin Parkway - he plays on Sunday, just before closing act Kings of Leon - pulled in $22 million. That put him atop Forbes magazine's inaugural list of Electronic Cash Kings, which ranks the highest-paid DJs in the world.

Under near-perfect skies, tens of thousands of music-lovers flocked to the Benjamin Franklin Parkway on Saturday for the first of two days of concerts at the Budweiser Made in America festival.

As it turns out, making it in Philly doesn't mean that you can make it anywhere. Or, at least that's what the critics of Los Angeles' Made in America festival are saying.

NEW YORK (AP) - A brotherly reunion is coming to the City of Brotherly Love: Family band Kings of Leon will play its first show Sunday in Philadelphia since drummer Nathan Followill injured his ribs.

The Budweiser Made In America festival, Philadelphia's third annual oversized musical block party, started Saturday with a mix of rock, hip-hop, and electronic dance music (EDM), comfortably cool temperatures, and two words of far greater importance than all others: Kanye West.

Philly-born producer and DJ Baauer, born Harry Baauer Rodrigues, who is perhaps most known for his 2012 hit "Harlem Shake."

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Bow down: Beyonce was the reigning queen of Sunday's MTV Video Music Awards.