StemCell Therapy

By Garrett Ohlmeyer Staff Writer

An 11-year-old from Raceland will be joining about 160 other kids and celebrities in Washington, D.C., next month to advocate continued support of Type 1 diabetes research.

Rory Monier was diagnosed with Type 1 diabetes in November 2007 when he was just 2 years old.This fall, he will be a seventh-grader at Lockport Middle School, and he doesnt let his disease stop him from being a normal kid. Monier plays on a soccer team, plays drums in his middle school band and is involved in school clubs.

He said he was happy to be selected by the Juvenile Diabetes Research Foundation to represent those who have the disease and to share his family's story with Congress.

I want my congressman to know that kids battling Type 1 diabetes have a constant reminder that we have diabetes every time we eat or want to take part in activities, Monier said. We have daily schedules that are important in saving our lives.

The children and other delegates will share personal experiences and explain the daily struggles associated with living with the disease. The goal is to push for continued support of the Special Diabetes Program, which pays for research projects related to the disease. The program is set to expire Sept. 30.

Nine celebrities will join the children in the event. They include athletes and actors.

Type 1 diabetes is a condition that causes a person's pancreas to stop producing insulin, a hormone that enables people to gain energy from food. This happens when the immune system attacks and destroys cells in the pancreas that create the insulin.

Since Moniers diagnosis, his family has been involved with the foundation and has raised about $123,000 over the past nine years, said his mother, Kristy Monier.

Rory will travel to the nations capitol to participate in the Juvenile Diabetes Research Foundation Childrens Congress July 24-26. He was selected out of six applicants in Louisiana and more than 1,300 throughout the country.

-- Staff Writer Garrett Ohlmeyer can be reached at (985) 850-1149 or garrett.ohlmeyer@houmatoday.com. Follow him on Twitter @GOhlmeyer.

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Raceland boy to advocate diabetes research - Daily Comet

Johnson & Johnson still faces troubles over its Invokana diabetes drug. (Kadmy-Fotolia/stock.adobe.com)

Johnson & Johnson's (JNJ) diabetes drug, Invokana, cut down on cardiovascular events during a long-termstudy but Eli Lilly (LLY) stands to benefit most asdoctors steer clear of the medication on worries it increased the risk of amputation.

The study, dubbed Canvas, was presented late Monday. In it, Dow stock Johnson & Johnson said Invokana reduced the risk of cardiovascular death, nonfatal heart attack and nonfatal stroke by 14% vs. a non-drug placebo.

Additional analysis showed that Invokana lowered the risk of hospitalization for heart failure by 33%. Invokana also delayedthe progression of albuminuria the presence of a specific chemical in the urine indicating kidney disease.

RBC analyst Glenn Novarro says the Canvas study is unlikely to reverse the negative trajectory of Invokana sales. In the first quarter, Invokana and Invokamet sales dropped 17% year over year. For 2017, Novarro forecasts a 6% dip in sales to $1.2 billion.

Eli Lilly, on the other hand, will benefit from Johnson & Johnson's study as Merck (MRK) trails, analysts say.Lilly's Jardiance is a SGLT2 inhibitor, which works by helping the kidneys to lower blood glucose levels. Merck's Januvia is a DPP-4, which blocks glucagon release, triggering insulin secretion.

"Validated cardiovascular benefits should boost the SGLT2 class," Credit Suisse analyst Vamil Divan wrote. In a similar study, Lilly's Jardiance also showed a 14% benefit on cardiovascular outcomes. Jardiance also cut the risk of cardiovascular death and all mortality.

Even without the Canvas study, Lillywaspoised to grab a chunk of Invokana's sales after the Food and Drug Administration required Johnson & Johnson to warn physicians of the potential for amputation associated with Invokana.Invokana doubled the risk of amputation in a recent study.

Experts cited by Leerink analyst Seamus Fernandez say the amputation worry could be the "biggest differentiating factor" in physicians' decision to prescribe Jardiance over Invokana, as both show a similar cardiovascular benefit in diabetes patients.

At the close on the stock market today, Johnson & Johnson stock ticked up 0.2% to finish the regular trading session at 132.02. Lilly stock added 0.4% to 81.25 and shares of diabetes drugmaker Merck dipped 1% to end the day at 63.27.

IBD'S TAKE:Johnson & Johnson stock has an IBD Composite Rating of 77, meaning it outperforms more than three-quarters of all stocks in terms of key growth metrics. For more of IBD's ratings visit IBD Stock Checkup.

Meanwhile, the DPP-4 class of diabetes drugs, which includes Merck's Januvia, could face incremental pressure, Credit Suisse's Divan said.

"Over time, however, we expect the enthusiastic response to the Canvas efficacy data driving use of the SGLT2 class earlier in the course of treatment, while concurrently pushing the DPP-4s further back," he said in a note to clients.

Merck and Pfizer (PFE), a Dow stock, are jointly working on an SGLT2 inhibitor called ertugliflozin.Regulators could approve the drug in December, but it won't have data on cardiovascular outcomes for several years.Pfizer will take a chunk of thosesales, meaning a shift from Januvia toertugliflozin will be a net negative for Merck.

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Dow's J&J Hosted A Diabetes Study And Lilly Will Benefit Most - Investor's Business Daily

El Grecos Resurrection

A rabbi has issued a warning after concluding that raising the dead is clearly possible.

Its not for man to do.

The comments come from Rabbi Moshe Avraham Halperin and were reported by Breaking Israel News.

If they are able to revive a person from total brain death, it will be considered techiyat hamaytim [resurrection], he told BIN. Torah laws puts limits on man, forbidding him from some areas which are strictly divine. Reviving the dead is one of them.

Further, another rabbi said such experiments never will succeed.

The Rambam states that we must believe that the resurrection of the dead will happen when it is Gods will for it to take place and at no other time, Rabbi Yosef Berger, of King Davids Tom on Mount Zion in Jerusalem, told the news agency.

Transhumanism: Recreating humanity reveals the secret ways scientists are using technologyto pursue immortality, omniscience and ultimate power. Now available in the WND Superstore.

He was citing the 13 Principles of Faith set down by Rabbi Moses ben Maimon, whose 12th century work established him as a Torah authority and gave him the acronym Rambam.

He stated, I believe by complete faith that there will be a resurrection of the dead at the time that will be pleasing before the Creator.

That, Berger suggested, means: Not only does this effort by scientists go against this principle of faith, but we know that true resurrection can only happen by Divine will. Resurrection of the dead is described in depth, and it is proof of Gods rule over the physical world. But it is also stated that before the Messiah, there is no return from the grave.

The comments come on the heels of plans by a biomedical company, Bioquark, a startup based in Pennsylvania, to experiment with stem cells in an attempt to revive brain-dead patients.

BIN reported the company said it would launch experiments before the end of the year on such patients.

The trial will involve a multi-pronged approach, involving injecting stem cells and peptides into the spinal cords, electrical nerve stimulation, and laser therapy. The researchers hope this will grow new neurons and spur them to connect to each other, bringing the brain back to life, BIN reported.

What do YOU think? Sound off on scientific efforts to revive dead people

The story pointed out that Bioquark reportedly tried such an experiment in India in 2016 but it was not with the approval of the nations drug regulators.

Amar Jesani, editor of the Indian Journal of Medical Ethics in Mumbai, cautioned that even partial success would traumatize families that had come to terms with a situation they believed irreversible. In point of fact, no families permitted their loved ones to be part of the experiment, BIN reported.

Halperin said, This is like using genetics to create a new form of life. There are realms that are strictly divine. Resurrection of the dead is clearly possible. It is definitely going to happen after the Messiah, but it restricted to God.

It was reported about a year ago that Bioquark and another company were embarking on the Reanima project, using a new drug formula involving stem cells.

Their plan was to use neurons, proteins, peptides and more that would create a microenvironment in which the stems cells can mature.

The report said, Inspired by organisms like salamanders that can regrow severed or damaged tails, Bioquark researchers have been developing regenerative treatments for a host of uses, from cancer to spinal cord injuries.

WND had reported when the company was given the green light on the visionary project.

The company said then it was capable of creating dynamics in mature tissues that are normally only seen during human fetal development, as well as during limb and organ regeneration in organisms like amphibians.

Christian author and filmmaker Tom Horn, at that time, said scientists are redefining what it means to be human, with the goal of transcending humanity.

Right here in North Carolina at your university, they have what is called a transgenic lab, which means they have mice that have human genetic material, for testing to see if the human parts in that animal are responding, he told TV host Sid Roth in a recent interview.

Using a gene-editing technique, one university lab cured cancer in a group of rats, but the unintended consequences were that the rats started aging very quickly and died at half-life, and nobody knows why that happened, Horn said. There is a danger in playing God because youre not God and you dont know.

Transhumanism: Recreating humanity reveals the secret ways scientists are using technologyto pursue immortality, omniscience and ultimate power. Now available in the WND Superstore.

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Rabbi has warning after concluding reviving dead 'clearly possible' - WND.com

Christian Guardino brushed off his nerves and blew audiences away with his powerful performance!

The 16-year-old boy from Long Island, New York earned the coveted Golden Buzzer from judge Howie Mandel on Tuesdays Americas Got Talent with a soulful rendition ofThe Jackson 5s 1969 single Whos Lovin You.

You were like a little mouse that turned into a lion. You are one of my favorite contestants Ive seen this year. Not only in terms of your voice. I just like you. Theres something about you, and its just the best possible feeling when we meet someone like you, Simon Cowell told Christian, who teared up on stage.

And when Mandell asked the singer if he could make one wish come true, Christian said: Probably the golden buzzer.

The Golden Buzzer puts Christian directly through to the hit NBC talent competitions upcoming live rounds.

On Tuesdays episode, Christian and his mother, Elizabeth, opened up about his journey of being blind for most of his life before an experimental treatment gave him back his sight.

Christian was diagnosed with a retinal disease called Leber congenital amaurosis (LCA), according to his September 2016 profile in National Geographic. He was cured of blindness after receivinggene therapy treatment andnow can see well enough to read enlarged notes on sheet music.

Christian has plenty of singing experience.He has previously performed four times at theApollo Theater in Harlem, New York.

Mandels Golden Buzzer recipient is the third one this season, following Mel Bs 12-year-old singing ventriloquist Darci Lynne Farmer and Cowells 29-year-old deaf singer Mandy Harvey. Judge Heidi Klum still has yet to select her Golden Buzzer contestant.

Americas Got Talent airs Tuesdays (8 p.m. ET) on NBC.

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WATCH: Long Island Teen, 16, Cured from Blindness Earns Golden Buzzer on America's Got Talent - PEOPLE.com

In the 1800s, as today, people overcame challenges to make great accomplishments.

Although many people dont know who he is, the subject of this weeks story has been called our greatest American historian.

Francis Parkman was born in Boston in 1823. His grandfather was a wealthy merchant whose estate provided him with enough money to be a man of independent means.

In 1846, Francis graduated Phi Beta Kappa from Harvard. After graduation, he became intrigued with the French and Indian Wars from 1689 to 1763, and decided to write a book. For background material, he felt it was necessary to get a picture of the Indian before the arrival of the Europeans.

Realizing he was no longer able to do that with the northeastern Indians, Francis headed west. On June 15, 1846, he arrived at Fort Laramie, Wyo. Over the next six months, he lived with the Oglala Sioux and discovered these blood-thirsty savages were actually a warm and generous people who indulged their children to excess and were devoid of greed. The result was an important book about the ethnicity of the Indian titled, The Oregon Trail.

Because of an illness that plagued him throughout his life, he had to return east after six months. In a short time, Francis became virtually blind, making it impossible for him to see what he wrote. He had to use a device called a noctograph that had spaced wires so he could write on a straight line. For five years, he couldn't concentrate for more than a few minutes at a time.

In spite of these handicaps, Francis Parkman's passion for chronicling the true history of the United States kept him working. During his life, he wrote more than 30 books and is considered one of our great writers.

Dakota Livesay is the editor of the Chronicle of the Old West. For more information about the Old West visit http://www.ChronicleoftheOldWest.com. You can hear Dakota at 10 a.m. each day on KZUZ 93.5 in Show Low and KZUA 92.1 in Holbrook.

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Despite blindness, Parkman successfully chronicled US history - White Mountain Independent

1. What is Agricultural Biotechnology?

Agricultural biotechnology is a range of tools, including traditional breeding techniques, that alter living organisms, or parts of organisms, to make or modify products; improve plants or animals; or develop microorganisms for specific agricultural uses. Modern biotechnology today includes the tools of genetic engineering.

2. How is Agricultural Biotechnology being used?

Biotechnology provides farmers with tools that can make production cheaper and more manageable. For example, some biotechnology crops can be engineered to tolerate specific herbicides, which make weed control simpler and more efficient. Other crops have been engineered to be resistant to specific plant diseases and insect pests, which can make pest control more reliable and effective, and/or can decrease the use of synthetic pesticides. These crop production options can help countries keep pace with demands for food while reducing production costs. A number of biotechnology-derived crops that have been deregulated by the USDA and reviewed for food safety by the Food and Drug Administration (FDA) and/or the Environmental Protection Agency (EPA) have been adopted by growers.

Many other types of crops are now in the research and development stages. While it is not possible to know exactly which will come to fruition, certainly biotechnology will have highly varied uses for agriculture in the future. Advances in biotechnology may provide consumers with foods that are nutritionally-enriched or longer-lasting, or that contain lower levels of certain naturally occurring toxicants present in some food plants. Developers are using biotechnology to try to reduce saturated fats in cooking oils, reduce allergens in foods, and increase disease-fighting nutrients in foods. They are also researching ways to use genetically engineered crops in the production of new medicines, which may lead to a new plant-made pharmaceutical industry that could reduce the costs of production using a sustainable resource.

Genetically engineered plants are also being developed for a purpose known as phytoremediation in which the plants detoxify pollutants in the soil or absorb and accumulate polluting substances out of the soil so that the plants may be harvested and disposed of safely. In either case the result is improved soil quality at a polluted site. Biotechnology may also be used to conserve natural resources, enable animals to more effectively use nutrients present in feed, decrease nutrient runoff into rivers and bays, and help meet the increasing world food and land demands. Researchers are at work to produce hardier crops that will flourish in even the harshest environments and that will require less fuel, labor, fertilizer, and water, helping to decrease the pressures on land and wildlife habitats.

In addition to genetically engineered crops, biotechnology has helped make other improvements in agriculture not involving plants. Examples of such advances include making antibiotic production more efficient through microbial fermentation and producing new animal vaccines through genetic engineering for diseases such as foot and mouth disease and rabies.

3. What are the benefits of Agricultural Biotechnology?

The application of biotechnology in agriculture has resulted in benefits to farmers, producers, and consumers. Biotechnology has helped to make both insect pest control and weed management safer and easier while safeguarding crops against disease.

For example, genetically engineered insect-resistant cotton has allowed for a significant reduction in the use of persistent, synthetic pesticides that may contaminate groundwater and the environment.

In terms of improved weed control, herbicide-tolerant soybeans, cotton, and corn enable the use of reduced-risk herbicides that break down more quickly in soil and are non-toxic to wildlife and humans. Herbicide-tolerant crops are particularly compatible with no-till or reduced tillage agriculture systems that help preserve topsoil from erosion.

Agricultural biotechnology has been used to protect crops from devastating diseases. The papaya ringspot virus threatened to derail the Hawaiian papaya industry until papayas resistant to the disease were developed through genetic engineering. This saved the U.S. papaya industry. Research on potatoes, squash, tomatoes, and other crops continues in a similar manner to provide resistance to viral diseases that otherwise are very difficult to control.

Biotech crops can make farming more profitable by increasing crop quality and may in some cases increase yields. The use of some of these crops can simplify work and improve safety for farmers. This allows farmers to spend less of their time managing their crops and more time on other profitable activities.

Biotech crops may provide enhanced quality traits such as increased levels of beta-carotene in rice to aid in reducing vitamin A deficiencies and improved oil compositions in canola, soybean, and corn. Crops with the ability to grow in salty soils or better withstand drought conditions are also in the works and the first such products are just entering the marketplace. Such innovations may be increasingly important in adapting to or in some cases helping to mitigate the effects of climate change.

The tools of agricultural biotechnology have been invaluable for researchers in helping to understand the basic biology of living organisms. For example, scientists have identified the complete genetic structure of several strains of Listeria and Campylobacter, the bacteria often responsible for major outbreaks of food-borne illness in people. This genetic information is providing a wealth of opportunities that help researchers improve the safety of our food supply. The tools of biotechnology have "unlocked doors" and are also helping in the development of improved animal and plant varieties, both those produced by conventional means as well as those produced through genetic engineering.

4. What are the safety considerations with Agricultural Biotechnology?

Breeders have been evaluating new products developed through agricultural biotechnology for centuries. In addition to these efforts, the United States Department of Agriculture (USDA), the Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA) work to ensure that crops produced through genetic engineering for commercial use are properly tested and studied to make sure they pose no significant risk to consumers or the environment.

Crops produced through genetic engineering are the only ones formally reviewed to assess the potential for transfer of novel traits to wild relatives. When new traits are genetically engineered into a crop, the new plants are evaluated to ensure that they do not have characteristics of weeds. Where biotech crops are grown in proximity to related plants, the potential for the two plants to exchange traits via pollen must be evaluated before release. Crop plants of all kinds can exchange traits with their close wild relatives (which may be weeds or wildflowers) when they are in proximity. In the case of biotech-derived crops, the EPA and USDA perform risk assessments to evaluate this possibility and minimize potential harmful consequences, if any.

Other potential risks considered in the assessment of genetically engineered organisms include any environmental effects on birds, mammals, insects, worms, and other organisms, especially in the case of insect or disease resistance traits. This is why the USDA's Animal and Plant Health Inspection Service (APHIS) and the EPA review any environmental impacts of such pest-resistant biotechnology derived crops prior to approval of field-testing and commercial release. Testing on many types of organisms such as honeybees, other beneficial insects, earthworms, and fish is performed to ensure that there are no unintended consequences associated with these crops.

With respect to food safety, when new traits introduced to biotech-derived plants are examined by the EPA and the FDA, the proteins produced by these traits are studied for their potential toxicity and potential to cause an allergic response. Tests designed to examine the heat and digestive stability of these proteins, as well as their similarity to known allergenic proteins, are completed prior to entry into the food or feed supply. To put these considerations in perspective, it is useful to note that while the particular biotech traits being used are often new to crops in that they often do not come from plants (many are from bacteria and viruses), the same basic types of traits often can be found naturally in most plants. These basic traits, like insect and disease resistance, have allowed plants to survive and evolve over time.

5. How widely used are biotechnology crops?

According to the USDA's National Agricultural Statistics Service (NASS), biotechnology plantings as a percentage of total crop plantings in the United States in 2012 were about 88 percent for corn, 94 percent for cotton, and 93 percent for soybeans. NASS conducts an agricultural survey in all states in June of each year. The report issued from the survey contains a section specific to the major biotechnology derived field crops and provides additional detail on biotechnology plantings. The most recent report may be viewed at the following website: https://www.ers.usda.gov/data-products/adoption-of-genetically-engineered-crops-in-the-us.aspx

For a summary of these data, see the USDA Economic Research Service data feature at: https://www.ers.usda.gov/data-products/adoption-of-genetically-engineered-crops-in-the-us.aspx

The USDA does not maintain data on international usage of genetically engineered crops. The independent International Service for the Acquisition of Agri-biotech Applications (ISAAA), a not-for-profit organization, estimates that the global area of biotech crops for 2012 was 170.3 million hectares, grown by 17.3 million farmers in 28 countries, with an average annual growth in area cultivated of around 6 percent. More than 90 percent of farmers growing biotech crops are resource-poor farmers in developing countries. ISAAA reports various statistics on the global adoption and plantings of biotechnology derived crops. The ISAAA website is https://www.isaaa.org

6. What are the roles of government in agricultural biotechnology?

Please note: These descriptions are not a complete or thorough review of all the activities of these agencies with respect to agricultural biotechnology and are intended as general introductory materials only. For additional information please see the relevant agency websites.

Regulatory

The Federal Government developed a Coordinated Framework for the Regulation of Biotechnology in 1986 to provide for the regulatory oversight of organisms derived through genetic engineering. The three principal agencies that have provided primary guidance to the experimental testing, approval, and eventual commercial release of these organisms to date are the USDA's Animal and Plant Health Inspection Service (APHIS), the Environmental Protection Agency (EPA), and the Department of Health and Human Services' Food and Drug Administration (FDA). The approach taken in the Coordinated Framework is grounded in the judgment of the National Academy of Sciences that the potential risks associated with these organisms fall into the same general categories as those created by traditionally bred organisms.

Products are regulated according to their intended use, with some products being regulated under more than one agency. All government regulatory agencies have a responsibility to ensure that the implementation of regulatory decisions, including approval of field tests and eventual deregulation of approved biotech crops, does not adversely impact human health or the environment.

The Animal and Plant Health Inspection Service (APHIS) is responsible for protecting U.S. agriculture from pests and diseases. APHIS regulations provide procedures for obtaining a permit or for providing notification prior to "introducing" (the act of introducing includes any movement into or through the U.S., or release into the environment outside an area of physical confinement) a regulated article in the U.S. Regulated articles are organisms and products altered or produced through genetic engineering that are plant pests or for which there is reason to believe are plant pests.

The regulations also provide for a petition process for the determination of non-regulated status. Once a determination of non-regulated status has been made, the organism (and its offspring) no longer requires APHIS review for movement or release in the U.S.

For more information on the regulatory responsibilities of the FDA, the EPA and APHIS please see:

https://www.fda.gov

https://www.epa.gov

APHIS Biotechnology Regulations

Market Facilitation

The USDA also helps industry respond to consumer demands in the United States and overseas by supporting the marketing of a wide range of agricultural products produced through conventional, organic, and genetically engineered means.

The Agricultural Marketing Service (AMS) and the Grain Inspection, Packers, and Stockyards Administration (GIPSA) have developed a number of services to facilitate the strategic marketing of conventional and genetically engineered foods, fibers, grains, and oilseeds in both domestic and international markets. GIPSA provides these services for the bulk grain and oilseed markets while AMS provides the services for food commodities such as fruits and vegetables, as well as for fiber commodities.

These services include:

1. Evaluation of Test Kits: AMS and GIPSA evaluate commercially available test kits designed to detect the presence of specific proteins in genetically engineered agricultural commodities. The agencies confirm whether the tests operate in accordance with manufacturers' claims and, if the kits operate as stated, the results are made available to the public on their respective websites.

GIPSA Link: https://www.gipsa.usda.gov/fgis/rapidtestkit.aspx

GIPSA evaluates the performance of laboratories conducting DNA-based tests to detect genetically engineered grains and oilseeds, provides participants with their individual results, and posts a summary report on the GIPSA website. AMS is developing a similar program that can evaluate and verify the capabilities of independent laboratories to screen other products for the presence of genetically engineered material.

2. Identity Preservation/Process Verification Services: AMS and GIPSA offer auditing services to certify the use of written quality practices and/or production processes by producers who differentiate their commodities using identity preservation, testing, and product branding.

GIPSA Link: https://www.gipsa.usda.gov/fgis/inspectionweighing.aspx

AMS Link: https://www.ams.usda.gov/fv/ipbv.htm

Additional AMS Services: AMS provides fee-based DNA and protein testing services for food and fiber products, and its Plant Variety Protection Office offers intellectual property rights protection for new genetically engineered seed varieties through the issuance of Certificates of Protection.

Additional GIPSA Services: GIPSA provides marketing documents pertaining to whether there are genetically engineered varieties of certain bulk commodities in commercial production in the United States. USDA also works to improve and expand market access for U.S. agricultural products, including those produced through genetic engineering.

The Foreign Agricultural Service (FAS) supports or administers numerous education, outreach, and exchange programs designed to improve the understanding and acceptance of genetically engineered agricultural products worldwide

1. Market Access Program and Foreign Market Development Program: Supports U.S. farm producer groups (called "Cooperators") to market agricultural products overseas, including those produced using genetic engineering.

2. Emerging Markets Program: Supports technical assistance activities to promote exports of U.S. agricultural commodities and products to emerging markets, including those produced using genetic engineering. Activities to support science-based decision-making are also undertaken. Such activities have included food safety training in Mexico, a biotechnology course for emerging market participants at Michigan State University, farmer-to-farmer workshops in the Philippines and Honduras, high-level policy discussions within the Asia-Pacific Economic Cooperation group, as well as numerous study tours and workshops involving journalists, regulators, and policy-makers.

3. Cochran Fellowship Program: Supports short-term training in biotechnology and genetic engineering. Since the program was created in 1984, the Cochran Fellowship Program has provided education and training to 325 international participants, primarily regulators, policy makers, and scientists.

4. Borlaug Fellowship Program: Supports collaborative research in new technologies, including biotechnology and genetic engineering. Since the program was established in 2004, the Borlaug Fellowship Program has funded 193 fellowships in this research area.

5. Technical Assistance for Specialty Crops (TASC): Supports technical assistance activities that address sanitary, phytosanitary, and technical barriers that prohibit or threaten the export of U.S. specialty crops. This program has supported activities on biotech papaya.

Research

USDA researchers seek to solve major agricultural problems and to better understand the basic biology of agriculture. Researchers may use biotechnology to conduct research more efficiently and to discover things that may not be possible by more conventional means. This includes introducing new or improved traits in plants, animals, and microorganisms and creating new biotechnology-based products such as more effective diagnostic tests, improved vaccines, and better antibiotics. Any USDA research involving the development of new biotechnology products includes biosafety analysis.

USDA scientists are also improving biotechnology tools for ever safer, more effective use of biotechnology by all researchers. For example, better models are being developed to evaluate genetically engineered organisms and to reduce allergens in foods.

USDA researchers monitor for potential environmental problems such as insect pests becoming resistant to Bt, a substance that certain crops, such as corn and cotton, have been genetically engineered to produce to protect against insect damage. In addition, in partnership with the Agricultural Research Service (ARS) and the Forest Service, the Cooperative States Research, the National Institute of Food and Agriculture (NIFA) administers the Biotechnology Risk Assessment Research Grants Program (BRAG) which develops science-based information regarding the safety of introducing genetically engineered plants, animals, and microorganisms. Lists of biotechnology research projects can be found at https://www.ars.usda.gov/research/projects.htm for ARS and at https://www.nifa.usda.gov/funding-opportunity/biotechnology-risk-assessment-research-grants-program-brag for NIFA.

USDA also develops and supports centralized websites that provide access to genetic resources and genomic information about agricultural species. Making these databases easily accessible is crucial for researchers around the world.

USDA's National Institute of Food and Agriculture (NIFA) provides funding and program leadership for extramural research, higher education, and extension activities in food and agricultural biotechnology. NIFA administers and manages funds for biotechnology through a variety of competitive and cooperative grants programs. The National Research Initiative (NRI) Competitive Grants Program, the largest NIFA competitive program, supports basic and applied research projects and integrated research, education, and/or extension projects, many of which use or develop biotechnology tools, approaches, and products. The Small Business Innovation Research Program (SBIR) funds competitive grants to support research by qualified small businesses on advanced concepts related to scientific problems and opportunities in agriculture, including development of biotechnology-derived products. NIFA also supports research involving biotechnology and biotechnology-derived products through cooperative funding programs in conjunction with state agricultural experiment stations at land-grant universities. NIFA partners with other federal agencies through interagency competitive grant programs to fund agricultural and food research that uses or develops biotechnology and biotechnology tools such as metabolic engineering, microbial genome sequencing, and maize genome sequencing.

USDA's Economic Research Service (ERS) conducts research on the economic aspects of the use of genetically engineered organisms, including the rate of and reasons for adoption of biotechnology by farmers. ERS also addresses economic issues related to the marketing, labeling, and trading of biotechnology-derived products.

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Biotechnology FAQs | USDA

iShares Nasdaq Biotechnology Index Fund (IBB) Stock Rating Upgraded by Vetr Inc. The Cerbat Gem iShares Nasdaq Biotechnology Index Fund logo Vetr upgraded shares of iShares Nasdaq Biotechnology Index Fund (NASDAQ:IBB) from a hold rating to a buy rating in a report issued on Wednesday, May 17th. They currently have $303.00 target price on the ... The iShares NASDAQ Biotechnology Index (IBB) Position Boosted ...BangaloreWeekly iShares Nasdaq Biotechnology Index Fund (IBB) Position ...BBNS iShares Nasdaq Biotechnology Index Fund (IBB) Position Raised by Pinnacle Associates Ltd.Transcript Daily Chaffey Breeze -Stock Observer all 11 news articles »

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iShares Nasdaq Biotechnology Index Fund (IBB) Stock Rating Upgraded by Vetr Inc. - The Cerbat Gem

A new, non-invasive knee procedure could bring some relief for patients suffering from debilitating chronic pain, for whom surgery is not an option.

The treatment, recently approved by the Food and Drug Administration, is called cooled radio frequency ablation and is a less drastic option for people with moderate to severe osteoarthritis pain who are not ready to have knee replacement surgery, or who have health conditions that dont make them a good candidate for surgery.

Marketed as "Coolief", the procedure uses radio frequency to target and mute the nerves responsible for sending pain signals from the arthritic knee to the brain. Coolief doesnt repair arthritis in the knee, but eases the pain, helping patients go back to activities without discomfort and fewer medications.

What we're changing is the wiring of the knee so we're taking away the pain signal and interrupting it," Dr. Amin Sandeep, a pain specialist at Rush University Medical Center in Chicago who performs the procedure, told NBC News.

One 2016 study compared Coolief to popular cortisone injections, with patients reporting greater, longer-lasting pain relief with the new treatment than injections. Coolief reduces pain for about to 6 to 12 months, depending on how fast the nerves in the knee regenerate.

Related: Common Knee Surgery May Not Help You

Osteoarthritis can affect any joint when the cartilage wears off over time, often striking big joints like the knee, causing pain, swelling and stiffness. According to the American Academy of Orthopedic Surgeons, nearly 10 million Americans had osteoarthritis of the knee in 2010.

The three current recommended approaches for knee arthritis pain are physical therapy, non-steroidal anti-inflammatory drugs such as ibuprofen and naproxen, or the opioid painkiller tramadol.

But those didn't help Felicia McCloden, a 65-year-old grandmother from outside of Chicago. The excruciating pain in her right knee made simple tasks like grocery shopping impossible.

I had inflammation, swelling, and my knee was like the size of a golf ball, McCloden told NBC News. "The arthritis was so bad that I could barely step down without severe pain.

Because she wasnt eligible for a knee replacement she tried cortisone injections, physical therapy, medications nothing relieved her pain.

"I thought I was going to limp for the rest of my life," she said.

Related: What Really Helps Knee Pain? The Answer May Surprise You

In May, McCloden underwent the Coolief treatment and the result was instant.

I couldn't even imagine first of all, not having the pain," she said. "It erased all of that.

The outpatient procedure typically takes about 40 minutes, is performed with local anesthesia and doesnt require an incision. Instead, doctors use specialized needles that emit radio frequencywaves into the knee. The cost of the treatment is between $2,000 and $4,000. Because it was just approved by the FDA in April, the treatment is not widely available yet, but pain centers across the country are beginning to offer it.

Some of the reported risks from the procedure include bleeding and infection. "Though patients have a risk of the physician hitting the wrong nerve, that is extremely rare in the hands of an experienced professional, Amin said.

Recovery time is minimal, with most patients walking immediately after the procedure and resuming normal activities in a day or two.

For some patients with structural problems of the knee, the procedure won't help, said pain specialist Dr. Edgar Ross, associate professor of anesthesia at Brigham and Womens Hospital.

"But lets say a patient is younger, instead of going for a total knee replacement early, which might have to be repeated later on, Coolief can postpone the need for the total knee replacement," Ross told NBC News.

Coolief can be repeated if necessary, but it's not a permanent solution. While it reduces pain, it can't stop the progression of osteoarthritis.

"While it can delay total knee replacement, knee replacement may still eventually be necessary in a big number of patients," said Dr. Dennis Cardone, associate professor of orthopedic surgery at NYU Langone Medical Center.

Link:
Cool' New Knee Procedure Eases Arthritis Pain Without Surgery - NBCNews.com

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It affects more than 690,000 people in the UK, of which over 500,000 are women and around three-quarters are of working age.

Experts believe the Mediterranean diet is effective in suppressing rheumatoid arthritis - but the elements responsible for this currently remain unknown.

Now researchers from Osaka City University in Japan, have set out to investigate what part of the diet - which constitutes oily fish, olive oil, fruit and vegetables - could help ease symptoms of the disease.

A study looked at 208 patients with rheumatoid arthritis and 205 healthy volunteers from the same age group.

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Their food and nutrient intake was assessed using a questionnaire, a Mediterranean diet score was calculated and the prevalence of the disease in 28 joints was analysed.

Experts found the consumption of MUFA - monosaturated fatty acids, alcohol, pulses, vegetables, meat milk and dairy products were significantly lower among participants with RA.

The study authors said: Intake of monounsaturated fatty acids (MUFA) was significantly lower in the RA, than in the control group (P=0.003) and the ratio of consumed monounsaturated to saturated fatty acid significantly differed within the RA group.

What are monosaturated fats?

Monounsaturated fats can help reduce levels of bad cholesterol in the blood - reducing the risk of heart disease and stroke. Examples of foods which are high in monounsaturated fats include olive oil, sesame oil, avocados, peanut butter and nuts and seeds.

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Daily MUFA intake, a component of the Mediterranean diet score, might suppress disease activity in rheumatoid arthritis patients

Experts have also revealed eating a diet high in monounsaturated fats can reduce belly fat and encourage weight loss.

The study concluded: Daily MUFA intake, a component of the Mediterranean diet score, might suppress disease activity in RA patients.

People with rheumatoid arthritis experience a range of symptoms, including pain and swelling in the joints, tiredness and depression which can affect their daily lives, from their ability to do basic everyday tasks like buttoning a shirt, to the possibility of having to stop work as a result of their condition.

The study was published in the journal Clinical Nutrition.

Experts, writing in The Lancet Diabetes and Endocrinology last year said eating a Mediterranean diet with no limit on calories and plenty of olive oil is the best way to stay healthy.

Researchers said guidelines promoting low-fat, low-calorie diets had created an unnecessary fear of the fats present in food loved by the southern Europeans.

The study looked at more than 7,000 participants who were either given an unrestricted Mediterranean diet or a low-fat diet where the advice was to avoid all dietary fat.

On average, those in all groups lost some weight with the greatest loss seen in the group eating the Mediterranean diet with olive oil.

Dr Aseem Malhotra, cardiologist advisor to the National Obesity Forum, said: A high fat Mediterranean diet which I follow and tell my patients to not only doesnt lead to weight gain but is also the most protective dietary pattern against heart disease, cancer and dementia.

Read the original post:
Diet to cure arthritis: Eating THIS part of the Mediterranean diet could suppress symptoms - Express.co.uk

Kansas City Star

Watch: Chiefs' Charcandrick West sings to raise awareness for childhood arthritis Kansas City Star Chiefs' running back Charcandrick West has a busy summer ahead as he battles for positioning on the depth chart. But West, who was diagnosed with arthritis at 14 years old, realizes life goes beyond football. So before organized team activities began ...

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Watch: Chiefs' Charcandrick West sings to raise awareness for childhood arthritis - Kansas City Star

In the corner, a wrinkling woman turned her wrists and massaged her fingers. A few chairs away, a graying man rubbed his knees while sitting on his walker. Others hoisted themselves up by cane.

It was a full house Monday for San Joaquin Community Hospitals monthly lecture series that this week went over a topic Dr. Thomas Ferro said would most likely affect everybody if they live long enough: arthritis.

Its the No. 1 cause of disability, loss of wages, and pain and suffering in the United States, Ferro told the room of more than 150 mostly aging onlookers.

And it was no surprise why they were there. When Ferro asked how many experienced arthritic pain on a daily basis, most hands went up.

Many were so desperate for relief that they interjected throughout Ferros presentation to ask questions.

Whats the root cause of arthritis?

We dont really fully understand it, Ferro said, adding that it sometimes runs in the family. He compared older bodies to cars with 300,000 miles on them: they might look good, but probably have lots of issues, and letting them get that old without having some parts replaced is almost unheard of, albeit ideal.

What about exercise should those with arthritis stop altogether?

Moving the bones and keeping the muscles going is good, and low-impact aerobics are the hallmark of arthritis exercise.

It was the best-attended lecture San Joaquin Community Hospital has ever seen, said Administrative Director of Marketing and Communications Jimmy Phillips.

These are people with chronic and constant pain who want relief, Phillips said.

Public Health offers community-wide CPR training

Passersby might see lots of folks performing CPR along city sidewalks Wednesday, but it won't be because dozens of people were suddenly stricken with cardiac arrest.

It's simply a training exercise.

Kern County Department of Public Health Services is hosting a community-wide hands-only Cardio Pulmonary Resuscitation event from 8:30 a.m. to 4 p.m. right on city sidewalks.

The chest compressions, which don't include mouth-to-mouth breathing, focus on the first moments of a sudden cardiac arrest, allowing blood to flow to vital organs.

"By teaching community members hands-only CPR, victims of sudden cardiac arrest will be more likely to survive," said Dr. Kristopher Lyons, EMS medical director. "It only takes five minutes to learn this simple skill that can save a life."

Harold Pierce covers education and health for The Californian. He can be reached at 661-395-7404. Follow him on Twitter @RoldyPierce

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HEALTH ROUNDUP: Arthritis lecture at San Joaquin Community Hospital draws big crowds - The Bakersfield Californian

EVAN HARDING

Last updated17:39, June 13 2017

John Hawkins

Arthritis sufferer Thelma Buck, of Invercargill, is devasted a pain relief product has been blocked from entering New Zealand.

An Australian-made supplement which has given some arthritis sufferers in Southland a new lease on life has been blocked from entering the country, devastating users.

The liquid supplement, Arborvitae, is marketed as an arthritis pain reliever and health supplement across the Tasman.

Until recently it was being imported into New Zealand and onsoldto Kiwis by a Canterbury-based company, whileother New Zealanders were buying it online directly from Australia.

John Hawkins

Arborvitae, arthritis pain relief supplement, blocked from entering New Zealand.

However, the Ministry for Primary Industries says it poses a biosecurity risk and has banned it from entering the country.

Among the users of Arborvitaeare two Invercargill women who say the product has deadened their arthritic pain andallowed them to live a better quality of life.

However, they now fear the pain will return if they can no longer access the product.

A Ministry for PrimaryIndustriesspokesman saidArborvitaewas not allowed into New Zealand because it did not meet New Zealand's biosecurity requirements.

It contains a level of honey that is prohibited unless it has been heat-treated to ensure potential bugs are destroyed.

In order to clear biosecurity requirements, the product requires an official declaration stating the honey hasbeen heat treated.

"MPI has communicated this requirement to the importer," the MPI spokesman said.

"While we sympathise with those who wish to buy the product, we must apply New Zealand's biosecurity rules evenly because any exceptions could lead to incursions of bugs and pests."

Arthritis sufferer Thelma Buck, of Invercargill, said she was devastated the product was no longer allowed in the country.

She turned to the product when her GP said she should nolonger take pillsfor her arthritis because it affected her blood pressure.

The 72-year-old had been buying Arborvitaefor three months months off a Christchurch company that was importing it from Australia.

Buck said she had suffered from arthritic pain for 30 years and had tried many things to help ease the pain, but Arborvitae was the best.

Before she began taking Arborvitae, she used a walker to get around town and now she only needs a walking stick.

She can also sleep through the night, having previously being unable to sleep for the pain.

"Itabsolutely deadens the pain from arthritis. You don't feel the pain.

"Now I can walk around the house whereas I was thinking I might have to go into a home."

Buck's sister-in-law, Ray Riley, who also suffers from arthritis,said it had made a massive difference to her life.

She is in less pain than previously and can move around more than she could in the past.

"It's madea hellof a lot of difference."

Andrew Thorman, owner of Jet Trading Ltd in Christchurch which was importing Arborvitaefrom Australia for three months until a fortnight ago, said he had since received calls from upset Kiwi customers unable to buy it.

"It's had huge success in Australia and I am trying to make it available in New Zealand so people can reap its benefits."

He sells a number of products but Arborvitae was a "standout as far as making a noticeable difference very quickly to people's lives".

Vic Davidson, the Australian businessman who "invented" the Arborvitaesupplement, said it waslisted with the TGA in Australiaas a "complementary medicine", which was a medicine that did not contain drugs.

The TGA [Therapeutic Goods Administration] regulates therapeutic goods in Australia.

"We sell 3000 to 4000 bottles a week in Australia, it's in a lot of chemist shops.

He was trying to get the issue resolved so it could be sold in New Zealand.

Former Canterbury Bankstown rugby league player Graeme Hughes haspublicly endorsed the product online.

-The Southland Times

Excerpt from:
Arthritis sufferers devastated pain reliever not allowed in NZ - Stuff.co.nz

By combining an experimental stem cell treatment with a nanoparticle delivery system, researchers may eventually stop MS and other autoimmune diseases.

An innovative stem cell therapy could change how we treat multiple sclerosis (MS), but are we any closer to a cure?

The work of Dr. Su Metcalfe, founder and chief scientific officer of the biotech company LIFNano, appears to be breathing new life into that hope.

Metcalfe and her team developed a way to fight MS by using the bodys own natural mechanisms but it hasnt been tested in humans yet.

MS is an inflammatory and neurodegenerative autoimmune disease that can result in an array of neurological symptoms including fatigue, muscle spasms, speech problems, and numbness. It is caused by the immune system attacking myelin, the insulating coating that runs along the outside of nerve cells. The result is damage to the brain and central nervous system.

The disease currently affects roughly 2.5 million people worldwide. About 200 new cases are diagnosed each week in the United States.

LIFNano uses a new treatment based on LIF a stem cell protein that forms naturally in the body to signal and regulate the immune systems response to myelin.

LIF, in addition to regulating and protecting us against attack, also plays a major role in keeping the brain and spinal cord healthy, Metcalfe recently told Cambridge News.

In fact it plays a major role in tissue repair generally, turning on stem cells that are naturally occurring in the body, making it a natural regenerative medicine, but also plays a big part in repairing the brain when its been damaged, she said.

Metcalfe has spent years studying LIF, but only recently realized its potential for treatment likening it to an on/off switch for the immune system.

However, once she discovered its potential, there were almost immediate problems in its application. One of the earliest was how quickly LIF breaks down once it is administered into the body.

If you try just to inject it into a patient, it dissipates or disappears in about 20 minutes, Olivier Jarry, CEO of LIFNano, told Healthline.

That makes it unusable in a clinic. You would have to have some kind of pump and inject it continually.

A breakthrough came for Metcalfe when she took findings from her studies of LIF and applied them to nanotechnology. The treatment she is now developing relies on nanospheres derived from a well-established medical polymer known as PLGA, which is already used in materials like stitches. And because it is biodegradable, it can be left to dissolve inside the body.

Storing LIF inside these PLGA nanospheres before administering them into the bloodstream allows for a sustained dose over the course of several days.

The process differs significantly from the current drugs used to treat MS. These treatments most often fall under the category of drugs known as immunosuppressors, which inhibit the bodys overall immune system response.

LIF is theoretically much more precise than immunosuppressors, and should keep the immune system functioning against harmful infections and disease.

Were not using any drugs, said Metcalfe. Were simply switching on the bodys own systems of self-tolerance and repair. There arent any side effects because all were doing is tipping the balance. Autoimmunity happens when that balance has gone awry slightly, and we simply reset that.

The team cautions that LIF therapy is still several years away.

While some outlets have run wild with Metcalfes research, announcing that a cure for MS is right around the corner, those headlines are speculative.

Some MS advocacy groups have even made public statements calling coverage of her work premature and irresponsible.

Jarry told Healthline that LIFNano is expecting to enter FDA phase I trials in 2020. This would be the first time that it is used in human subjects. But even if the treatment proves to be safe and effective, the soonest it could be on the market is 2023, he estimated.

The main focus of LIF therapy is now on MS. But it has potential for treating other autoimmune diseases including psoriasis and lupus.

We are optimistic in the sense that we may provide a long-term remission for patients with MS, said Jarry.

Is it a cure? Wed love at some point to use the term cure, but we are very cautious.

Link:
Stem Cell Therapy Offers Hope for Multiple Sclerosis Remission - Healthline

"At StemGenex, we are committed to helping people achieve optimum health and better quality of life through the healing benefits of their own stem cells," said Alexander. "Specifically, we use adipose-derived adult stem cell therapy for patients battling conditions such as Multiple Sclerosis, Parkinson's disease, COPD, Rheumatoid Arthritis and Osteoarthritis. We are also committed to the science of stem cell therapy and sponsor five clinical outcome studiesregistered with theNational Institute of Health (NIH) for these diseases."

"What I personally witnessed before the start of StemGenex were patients who had exhausted conventional medical treatments but wanted to try alternative therapies. I was one of them, suffering from severe Rheumatoid Arthritis. Ihad only three options; I could seek a clinical trial, travel to outside of the U.S. to try alternative therapies such as stem cell treatment or petition the FDA for access to drugs under the agency's "expanded access," or "compassionate use" program. Now, new state laws like the one just passed in Texas, built on model legislation from the Goldwater Institute in Arizona, will allow doctors and patients to make their own informed decisions on treatments that have cleared the safety phase of FDA testing."

Last year, in a move that was seen by some as a response to "Right to Try" laws, the 21st Century Cures Act, a landmark piece of legislation focused on medical innovation and medical research, was signed into law by President Obama. This Act provides the FDA with the flexibility to accelerate how it evaluates regenerative medicine treatments, such as stem cell therapies, while maintaining its high standards of safety and efficacy.

"We're on the cusp of a major change on how patients can access stem cell therapy," saidAlexander. "Today, new treatments and advances in research are giving new hope to people affected by a wide range of autoimmune and degenerative illnesses," said Alexander. "StemGenex Medical Group is proud to offer the highest quality of care and to potentially help those with unmet clinical needs improve their quality of life."

ABOUT StemGenex Medical Group

StemGenex Medical Group is committed to helping people achieve optimum health and better quality of life through the healing benefits of their own stem cells. StemGenex provides stem cell therapy options for individuals suffering with inflammatory and degenerative illnesses. Committed to the science and innovation of stem cell treatment,StemGenex sponsors five clinical outcome studiesregistered with theNational Institutes of Health (NIH) for Multiple Sclerosis, Parkinson's Disease, Rheumatoid Arthritis, Chronic Obstructive Pulmonary Disease (COPD) and Osteoarthritis. These have been established to formally document and evaluate the quality of life changes in individuals following adipose-derived stem cell treatment.

Contact: Jamie Schubert, Director of Media & Community Relations jschubert@StemGenex.com, (858) 242-4243

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/stem-cell-therapy-becomes-law-in-texas-300472809.html

SOURCE StemGenex Medical Group

http://www.stemgenex.com

See more here:
Stem Cell Therapy Becomes Law in Texas - PR Newswire (press release)

This overestimate could lead a doctor to target a black patient's blood sugar levels aggressively, causing dangerously low blood sugar.

"I believe our study, for the first time, definitively shows there is a component of higher A1c that is due to biologic or genetic differences in glucose attaching to the red blood cell," said Dr. Richard Bergenstal, executive director of the International Diabetes Center in Minneapolis and lead author of the study.

The study notes that race only partially explains the hemoglobin A1c differences, and more research is needed to identify social and economic factors that may influence blood sugar levels in various groups of people.

For black patients in America, who have traditionally faced a history of barriers and disadvantages in health care, those factors might also include having limited access to care or medications.

Bergenstal offered one specific question that concerned patients could ask their doctors: "Are we depending just on the hemoglobin A1c to measure how my diabetes control is doing, or are we actually looking at the blood sugars to get a little better reflection of my blood sugars?"

He added that "the A1c, you know, is kind of an average marker, and no patient is average. One of our take-home messages is, it's probably time to be looking at blood sugars and personalizing therapy for each individual a little more than just this average blood sugar test."

In the US, type 2 accounts for about 95% of all diagnosed cases of diabetes. Type 1 diabetes, which occurs most often in children and young adults but can appear at any age, accounts for about 5%.

High hemoglobin A1c levels tend to correlate with complications, Bergenstal said.

"Glucose attaching on to proteins in the eye, kidney, nerve and blood vessels may be one way diabetes with high glucose is part of the cause of complications -- like blindness, kidney disease and nerve disease and amputations," he said.

The new study included data on 104 black patients and 104 white patients with type 1 diabetes. The data were taken from 10 diabetes centers across the US between October 2015 and January of 2017.

Bergenstal has received grants from and served on consulting/advisory boards for Abbott Diabetes Care, as well as other health-care companies, including Novo Nordisk, Becton Dickinson, Boehringer Ingelheim, Bristol-Myers Squibb/AstraZeneca, and Johnson & Johnson, during the conduct of the study.

The researchers found that the average hemoglobin A1c levels in black patients were higher than those in white patients, with a difference of about 0.8 percentage points. Based on the average glucose concentrations in the patients, however, the difference should have been only about 0.4 percentage points, the researchers found.

Yet the study came with limitations.

"We didn't study type 2, but I think there's no reason to think the pathophysiology or the chemistry of how glucose attaches to red cells is any different in type 2 than type 1," Bergenstal said.

"We just studied non-Hispanic African-Americans," he added. "We did not study Asians or Native Americans or Hispanics to see if there is a difference from whites, but we have a good model of how to test that in the future."

Other diabetes researchers also have called for more research, but not necessarily with a focus on race.

The new study calls for more focus on personalized medicine, taking into account a patient's ethnic background as well as other factors, said Dr. Alvin Powers, president of medicine and science for the American Diabetes Association and a professor at the Vanderbilt University School of Medicine.

"The A1c is an important measurement that the person with diabetes should know and should monitor with his or her health care provider, because if the A1c is elevated, your chance of having diabetes-related complications increases," said Powers, who was not involved in the new study.

"So, moving the A1c as close to the goal determined by the patient and his or her doctor is important, but this study shows that in interpreting the A1c, there may be some variation, whether an individual is of African-American descent or of Caucasian descent," Powers said.

Though interesting, the new study findings should be interpreted with caution and not necessarily be applied clinically until more research is conducted, said Dr. Leonard Egede, a professor of medicine at the Medical College of Wisconsin, who was not involved in the study.

"The key thing is that when you look at racial differences, we have social factors, clinical factors, and we also have what some people would consider genetic factors. I think the social and environmental factors are larger contributors to differences than the genetic factors," Egede said. "When you look at what they're describing, the idea that glucose variability may differ ... I don't think that's enough to neglect the fact that we actually have major issues around access to care, quality of care, access to medications."

He added that the study "should not detract from the core message we've been trying to get across to patients, which is that they need to take ownership of their disease, and they need to be very aggressive in their diet, their physical activity and taking their medication."

All in all, "these findings suggest next steps for the field," they wrote.

Read the original:
Why a key diabetes test may work differently depending on your race - CNN

Johnson & Johnson's type 2 diabetes drug Invokana significantly reduced the risk of serious heart problems in patients with established heart disease or at elevated risk in a pair of large studies, according to data presented at a medical meeting on Monday.

The medicine also led to a reduced risk of hospitalization for heart failure and protection against kidney function decline. But the risk of amputations, particularly of toes or feet, was double versus placebo in the studies of 10,142 patients with type 2 diabetes.

On the study's main goal Invokana, known chemically as canagliflozin, reduced the combined risk of heart-related death, nonfatal heart attack and nonfatal stroke by a statistically significant 14 percent compared with placebo.

"What we actually got here was not just evidence of safety but evidence of benefit," said lead investigator Bruce Neal, professor of medicine at the University of New South Wales Sydney.

"It's a really positive result. This (heart disease) is the main thing that people with diabetes die from," said Neal, who presented the data at the American Diabetes Association meeting in San Diego.

The study was required to prove Invokana did not cause heart complications. The expectation bar was raised, however, after rival drug Jardiance from Eli Lilly and Co and Boehringer Ingelheim in 2015 demonstrated heart protective qualities in a similar large trial. Reduction of heart-related death is now included in the Jardiance label.

"We look forward to working with the FDA and regulators around the world with respect to getting this in the label," James List, head of cardiovascular and metabolism for J&J's Janssen unit, said of the new data.

Two-thirds of patients had confirmed heart disease and the rest were deemed at high risk. They were followed for an average of about four years.

The number of amputations was small but about double that of the placebo group. A warning of increased amputation risk was added to Invokana's prescribing label after it was discovered by safety monitors during an interim analysis of the study.

"Care is warranted in the use of canagliflozin in patients at risk for amputation," a New England Journal of Medicine article on the study said.

Invokana is the market leader among a newer class of type 2 diabetes treatments called SGLT-2 inhibitors, along with Jardiance and AstraZeneca Plc's Farxiga. They work by removing blood sugar through the urine.

Results from a large Farxiga heart safety trial are expected in 2019.

"I think we're going to see much greater use of canagliflozin and the class in type 2 diabetes," Neal said.

Invokana and related combination treatment Invokamet had sales $284 million in the first quarter, J&J reported.

(Reporting by Bill Berkrot in New York; Editing by Lisa Shumaker)

A federal jury has cleared Bayer AG and Johnson & Johnson of liability in the second trial to stem from thousands of lawsuits blaming injuries on the blood thinner Xarelto, the drug companies said on Monday.

Influential proxy firm ISS on Monday turned up the heat on Mylan NV, advising its institutional clients to voice their dissatisfaction with the generic drugmaker's board of directors and its chairman's pay package at its June 22 shareholder meeting.

Follow this link:
J&J diabetes drug shows heart benefit in large safety study - Reuters

A mans finger is pricked to test cholesterol and blood sugar on August 13, 2009 in Newark, New Jersey. Rick Gershon / Getty Images

Tests done in 67 adults with type-1 diabetes showed the drug appeared to boost their body's own production of insulin, Dr. Stephen Gitelman of the University of California San Francisco School of Medicine told a meeting of the American Diabetes Association.

On average the people that got the medicine used less insulin, Gitelman told NBC News.

He stressed that it is a small trial meant to show the drug can safely do in people what it did in mice.

We just wanted to get a sense if this showed some benefit in adults so we could get to the target population in kids, Gitelman said.

The conservative estimate is that beta cell function was maybe 19 percent better at one year. So its not a slam-dunk home run.

About 5 percent of the

Its an autoimmune disease, caused when the body mistakenly destroys pancreatic cells that produce hormones like insulin and glucagon that control blood sugar. High glucose levels damage tiny blood vessels, which in turn can lead to blindness, heart disease, stroke and kidney failure. People can lose toes, feet or legs to amputation.

Related:

When levels fall too low, patients can pass out and sometimes die.

There's no cure and the only treatment is to keep blood sugar under tight control with diet and insulin.

Most people with type-1 diabetes must constantly check their blood sugar throughout the day, administering insulin according to what they are eating and how much they are exercising.

If those dying pancreatic cells could be saved, they might have to do this less often.

That would be one potential pathway -- to use the drug to try to get in as early as possible when there are still as many beta cells remaining as possible and to slow down progression and potentially even keep people off insulin, said Andy Rakeman, director of discovery research at JDRF, the diabetes research charity that funded the study.

Its estimated that people at the time they are diagnosed with type 1 diabetes that they have anywhere between 10 and 15 or maybe even 40 percent of their beta cells still remaining, Rakeman added.

Some people maintain beta cell function for years. We used to think all or nearly all of the beta cells are destroyed very rapidly.

The organization is paying for research looking at several ways to preserve these cells. Gleevec would be a good candidate because its been around for nearly 20 years and while it causes side-effects such as a vomiting and rash, they are usually not severe in the diabetes patients.

Its taking an old drug and repurposing it for a new use, Rakeman said.

Gleevec, known generically as imatinib, and Sutent, known generically as sunitinib, interfere with an enzyme called tyrosine kinase. In patients with cancers such as chronic myelogenous leukemia, cutting back on this enzyme stops the cancer.

Related:

Cancer patients who also had autoimmune diseases who took Gleevec and Sutent reported that the drugs also appeared to ease the symptoms of the other conditions. Thats when a team at UCSF started testing Gleevec in mice bred to develop diabetes.

Gitelman says his team believes Gleevec may be taking some of the pressure off the pancreatic beta cells.

He is a little worried his study may be misunderstood. The team just finished the research last week and theyve rushed to put together a quick presentation to the Diabetes Association meeting. It will be weeks before they can analyze the data and put it into a form that can be reviewed by other experts in a medical journal.

Its early and the message could be misconstrued, Gitelman said.

This definitely does not show that Gleevec is curing type 1 diabetes, Rakeman stressed.

Related:

Plus, Gleevec is expensive.

It costs more than $140,000 a year, according to Dr. Hagop Kantarjian of the University of Texas MD Anderson Cancer Center, one of the original Gleevec trial leaders. A generic version, however, costs $400 in India.

Link:
Cancer Drug Gleevec Might Slow Type-1 Diabetes - NBCNews.com

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North DeSoto pitcher E.C. Delafield (right) has awarded her $1,000 stipend from Gatorade to the fight against diabetes in honor of Max Abernathy.(Photo: Jimmy Watson/The Times)Buy Photo

STONEWALL Max Abernathy sat curled up in a chair inside the North DeSoto field house Monday afternoon with his knees pulled up over his chin and his face partially hidden by his knees. No amount of encouragement could get the 7-year-old Stonewall youngster, who battles juvenile diabetes on a daily basis, to sit on the leg of Lady Griffins pitcher extraordinaire E.C. Delafield for a photo opportunity. The son of North DeSoto football coach and athletic director Scott Abernathy, Max has spent a lot of time around Delafield and the team that has won three consecutive LHSAA Class 4A state softball titles. Delafield babysat for Max during the past couple of years and the duo developed a bond.

EC Delafield and Max Abernathy talk about diabetes Jimmy Watson/The Times

Thats why the recent NDHS graduate and Northwestern State signee has decided where to assign the $1,000 stipend shell receive from The Gatorade Company for recently being selected the Louisiana Gatorade Player of the Year. I have decided to give the money to Shreveport Diabetes Sports, Inc. because of my buddy Max right here, Delafield said patting the youngster on the back as he leaned forward in his chair. Max has been a big part of my life since I came here to North DeSoto. Hes one of my best buds. Abernathy has watched his idol hurl inning after inning of softball to become perhaps the most decorated softball player in northwest Louisiana in at least a decade. She was the Most Valuable Player in the state title game after pitching and hitting the Lady Griffins (31-3) to a 10-0 run-rule-shortened victory over West Ouachita. She was chosen the Louisiana Sports Writers Association Outstanding Player on the recently released Class 4A All-State team. Her community service includes annually working in the Gladiators for Maximus, a 5K run designed to benefit the fight against diabetes through the SDS, Inc. Lindsay and Scott Abernathy serve on the board of the organization. Im really excited, said Max about Delafield selecting SDS, Inc. for the funding. She is really good. Delafield said she thanks all of the people who assist with the run. Its fun to see the people come out and support this little guy, she said. The donation is another step in a fight against a disease that affects at least 12 percent of the population and that can be especially difficult to control on youngsters like Max. When I feel low, I feel like my energy is half full, Max said. When Im low, I eat and I drink. Anyone who would like to help can donate at shreveportdiabetessports.com. Twitter: @JimmyWatson6

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North DeSoto's Delafield opts to support diabetes fight - Shreveport Times

Xconomy New York

Immunotherapy drugs known as checkpoint inhibitors have started to change how a variety of cancers are treated, but they have yet to break through in multiple myeloma, a progressive cancer of the bone marrow. There was a setback on that front today.

Merck (NYSE: MRK) Monday afternoon paused enrollment in two Phase 3 trials testing its immunotherapy drug, pembrolizumab (Keytruda), in combination with two established therapies, pomalidamide (Pomalyst) and dexamethasone, in patients with multiple myeloma. Merck stopped the trials, called Keynote-183 and Keynote-185, to collect more information and better understand more reports of death of the patients on its drug, according to a statement.

Merck didnt disclose additional details, other than to say additional pembrolizumab studies continue unchanged. The analyses need to be conducted, said spokesperson Pam Eisele. But the news offers a fresh reminder of the unknowns and potential safety perils of combining immunotherapy drugs with other treatments to expand their reach. As Xconomy reported last month, with the frenzy to test such combinations, many cancer experts worry that the field is moving too fast; that studies are not being designed with enough care; and that the glut of combination trials is bound to provoke a backlash. Unexpected safety problems have popped up during certain tests.

Merck shares slid 0.9 percent in post-market trading on Monday.

In multiple myeloma, the bone marrows plasma cellsa type of immune cell that normally churns out infection-fighting antibodiesgrow rapidly and abnormally and crowd out healthy red and white blood cells. According to the American Cancer Society, about 30,000 people in the U.S. will be diagnosed with multiple myeloma this year. Its the third most common blood cancer in the country after lymphoma and leukemia.

There are many treatment options available for myelomainjectable antibody drugs, chemotherapies, pills, stem cell transplants, and moreand theyve helped extend patients life expectancy dramatically from just a few decades ago. Yet there is no cure, and the disease progresses even if patients initially respond to treatment. So far, at least, there are no approved immunotherapy treatments for the disease, despite progress with such drugs in a variety of other cancers.

One form of immunotherapy, a cell therapy technique known as CAR-T, has shown early promise in treating handfuls of multiple myeloma patients who have failed several prior therapies. Those tests are early, however. Checkpoint inhibitors, like pembrolizumab and Bristol-Myers Squibbs (NYSE: BMY) nivolumab (Opdivo), are being tested too, and are further along. These drugs have been approved for lung, skin, bladder, and other cancers and have become the standard of care for some patients. While checkpoint inhibitors havent been effective on their own in multiple myeloma, they have shown positive signs when combined with existing treatment regimens. The latest results from Mercks prior multiple myeloma study, Keynote-023, for example, were presented at the American Society of Clinical Oncologys meeting earlier this month and showed that 44 percent of patients who could be evaluated responded to treatment with a combination of pembrolizumab, pomalidamide, and dexamethasone. Results from the Keynote-023 study have been published in the journal Blood.

That study didnt reveal any unexpected dangerous side effects. As ISI Evercore analyst Umer Raffat wrote in a research note, there was no clear hint in prior studies of a new safety problem when combining Mercks drug with pomalidomide and dexamethasone. Given Mercks news today, such problems are worth watching with other, similar combination trials currently underway: Bristol-Myers has a Phase 3 trial, Checkmate-602, that began in April 2016, while AstraZenecas Phase 2 study, FusionMM-003, started last July, according to a note from Raffat.

Ben Fidler is Xconomy's Deputy Biotechnology Editor. You can e-mail him at bfidler@xconomy.com

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In a Myeloma Setback, Merck Halts Studies Due to Patient Deaths - Xconomy

Toronto Sun

Cyclist sets his sights on fighting blindness Toronto Sun John Tomasino isn't just along for the ride he's leading it. Although severely sight impaired, the 55-year-old teacher is Ambassador for the Cycle For Sight Creemore fundraising event and he'll be putting in 150 km on June 24 to fight blindness ...

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Cyclist sets his sights on fighting blindness - Toronto Sun