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Issue No. 93
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August 4, 2015
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TACT is working to transform healthcare within the industry - YOUR industry, agriculture. Improving the quality of your insurance needs; focusing on prevention, wellness and disease management; reining in costs for all of Texas Agriculture. As the industry of ag and the industry of insurance grows and evolves, TACT continues striving to be a source of leadership and strength. We serve the members that we protect, giving you the freedom to look to the future in confidence. With TACT, YOU are our business. How may we help?
Now serving ALL of Texas Agriculture -
Contact us for more information
TACT - Dedicated Insurance Professionals
you know and trust...like Family.
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The Month of August -
National Immunization Awareness Month
People of all ages can protect their health
with timely vaccination.
For school, for prevention, for general health -
Each year in August, National Immunization Awareness Month (NIAM) provides an opportunity to highlight the value of immunization across the lifespan. Activities focus on encouraging all people to protect their health by being vaccinated against infectious diseases. Below are ways that NIAM can be used:
- Encourage parents of young children to get recommended immunizations by age two;
- Help parents make sure older children, preteens, and teens have received all recommended vaccines by the time they go back to school;
- Remind college students to catch up on immunizations before they move into dormitories
- Educate adults, including healthcare workers, about vaccines and boosters they may need
- Educate pregnant women about getting vaccinated to protect newborns from diseases like whooping cough (pertussis)
- Remind everyone that the next flu season is only a few months away
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HHS partnership advances experimental Ebola drug
One of the nation's centers dedicated to developing and manufacturing drugs and vaccines for emergencies will produce a novel therapeutic drug to treat Ebola virus disease under a task order issued by the U.S. Department of Health and Human Services (HHS). This is the first task order to a Center for Innovation in Advanced Development and Manufacturing (CIADM) and will support the ongoing global public health response to the Ebola epidemic in West Africa.
"Preventing, detecting and treating Ebola infections remain critical not only for the current epidemic in West Africa but also to minimize the impacts of future outbreaks," explained Robin Robinson, Ph.D., director of HHS' Biomedical Advanced Research and Development Authority (BARDA), the office that will oversee the program. "The development of this experimental drug represents significant progress in making Ebola therapeutics available. Our CIADM partners have the expertise, capacity, and state-of-the-art facilities required to make promising therapeutic candidates quickly."
Under the two-year, $19.7 million task order from BARDA, Emergent BioSolutions of Gaithersburg, Maryland, will begin advanced development and manufacturing activities for an experimental monoclonal antibody drug at its Baltimore Bayview CIADM.
The Emergent facility is one of three CIADMs established as public-private partnerships with BARDA in 2012 to respond rapidly to national needs for medical countermeasures. Over the last three years, the CIADM partners have been designing and building the necessary physical infrastructure, including facilities and manufacturing lines, for the CIADMs.
Under this first task order to a CIADM, Emergent will transfer manufacturing processes and materials from the early-stage development work of other companies on this experimental drug to the CIADM to begin advanced development. Emergent also will manufacture the experimental drug for use in nonclinical and clinical studies and will conduct the work necessary to scale up production to commercial volumes if studies prove successful.
The experimental drug is similar to ZMapp, made by Mapp Biopharmaceuticals of San Dieco plants. This new drug uses a combination of the same three monoclonal antibodies as ZMapp, but is produced using special mammalian cells rather than tobacco. Monoclonal antibodies bind to key viral proteins and neutralize a virus, decreasing the amount of the virus in the body that the patient's immune system has to fight.go using tobac
Because large quantities of cell-based monoclonal antibodies can be produced more quickly than tobacco-based monoclonal antibodies, this CIADM project will provide more product for clinical studies and, if clinical studies are successful, for potential stockpiling.
The CIADMs were established in the wake of the 2009 H1N1 influenza pandemic and are a component of BARDA's National Medical Countermeasures Response Infrastructure that provides core services for private partners to speed development, manufacturing and availability of drugs, vaccines and medical devices including diagnostic tests. Additional core services available through this response infrastructure include a nonclinical studies network, a clinical studies network, and a fill-finish manufacturing network.
The National Medical Countermeasures Response Infrastructure and development of Ebola therapeutic drugs are part of BARDA's integrated portfolio approach to advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear agents, pandemic influenza, emerging infectious diseases, and antimicrobial resistance.
BARDA is part of HHS' Office of the Assistant Secretary for Preparedness and Response (ASPR). ASPR leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities' ability to withstand adversity, strengthening health and response systems, and enhancing national health security. HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.
To learn more about Ebola, visit www.cdc.gov/ebola and for more about preparedness, response and recovery from the health impacts of emergencies, visit the HHS public health and medical emergency website,www.phe.gov. Information about medical countermeasures is available at www.medicalcountermeasures.gov.
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Legislation Creates
Federal Standard for
Voluntary GMO Labeling
Courtesy - Texas Ag Daily
Legislation that would keep states from issuing mandatory labeling laws for foods that contain genetically modified organisms (GMO) passed the House of Representatives, Friday, July 24.
Called the Safe and Affordable Food Labeling Act of 2015, the legislation would create a federal standard for the voluntary labeling of foods with GMO ingredients.
The legislation is aimed at preventing a patchwork of mandatory state labeling laws which could cause confusion and higher costs for consumers.
"Precisely zero pieces of credible evidence have been presented that foods produced with biotechnology pose any risk to our health or safety," Rep. Mike Pompeo, author of the bill, told The Hill. "We should not raise prices on consumers based on the wishes of a handful of activists."
The American Farm Bureau President Bob Stallman said the legislation supports farmer innovation that helps the environment and keeps food prices down for everyone.
"Consumers benefit from variety in the marketplace and should be free to make choices based on facts. The facts are that many farmers are growing more food with fewer resources, reducing their environmental impact, and keeping down costs-all thanks to advances in biotechnology," Stallman said.
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Breeding a Better Peanut Butter
Courtesy - Texas Ag Daily A new variety of peanut promises a better peanut butter. Called OLe', the new peanut has a longer shelf life and increased disease resistance compared to other varieties, and packs high amounts of a heart-healthy fatty acid called oleic acid. Kelly Chamberlin, a research biologist with USDA-ARS and part of the team that developed OLe', anticipates the new variety will benefit consumers, farmers and the peanut industry.
It contains large amounts of oleic acid, which is a heart-healthy monounsaturated fatty acid. Consumption of oleic acid had been linked to several health benefits, including better heart health, decreases in blood pressure and alleviation of some symptoms of type 2 diabetes.
The relative high amounts of oleic acid in OLe' peanuts increases their shelf life tremendously. The longer shelf life, health benefits and "nuttier" flavor of the OLe' peanuts make them very attractive to the peanut industry.
"There is a big demand (from the industry) for high-oleic peanuts and there is a premium paid at the buying point for them," Chamberlin said. "This makes a big difference for the farmers and to their overall profits."
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FDA approves new daily pill for common skin cancer
Courtesy Medical News Today
On the heels of UV Awareness Month, the US regulators have approved a new drug for the treatment of locally advanced basal cell carcinoma - a form of skin cancer.
Taken in the form of a daily pill, Odomzo (generic name sonidegib) is marketed by Novartis AG - a Swiss pharma giant with US headquarters in East Hanover, NJ.
The US Food and Drug Administration (FDA) say a trial showed the drug shrank or wiped out tumors in 58% of patients treated.
The regulators note that the drug is intended for patients with locally advanced basal cell carcinomas who are not candidates for surgery or radiotherapy, or whose tumors have recurred following such treatment.
Skin cancer is the most common cancer in the US. Most skin cancers are nonmelanoma cancers like basal cell carcinoma (BCC), which accounts for around 80% of nonmelanoma cancers.
Nonmelanoma skin cancers usually respond to treatment and rarely spread to other parts of the body.
The National Cancer Institute suggest the number of Americans diagnosed with nonmelanoma skin cancers is increasing every year.
BCCs arise in basal cells in the top layer of skin - the epidermis - usually in places that receive regular sun exposure or other forms of ultraviolet (UV) radiation. They occur most frequently on the head and neck, with the nose being the most common site.
Drug suppresses the Hedgehog molecular pathway
Locally advanced basal cell carcinomas (laBCCs) are basal cell cancers that have spread to nearby tissue (but not to the rest of the body) and do not respond to locally targeted treatment - that is, surgery and radiotherapy. They can be highly disfiguring.
Odomzo is a pill taken once a day. It works by suppressing the Hedgehog molecular pathway, which is active in basal cell cancers.
Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the Center for Drug Evaluation and Research at the FDA, says:
"Thanks to a better understanding of the Hedgehog pathway, the FDA has now approved two drugs for the treatment of basal cell carcinoma - just in the last three years."
In 2012, the FDA approved Erivedge (vismodegib) for the treatment of locally advanced and metastatic basal cell carcinoma. The drug is marketed by Genentech of San Francisco, CA.
58% of patients saw their tumors shrink or disappear
Odomzo was tested in a double-blind clinical trial of patients with laBCC. The trial randomly assigned 66 patients to take 200 mg of the drug a day and 128 patients to take 800 mg a day.
The results showed that 58% of patients who took 200 mg of Odomzo a day saw their tumors shrink or disappear. This effect lasted for between 1.9 and 18.6 months, with around half of the responding patients experiencing it for at least 6 months.
There was a similar response rate in patients who took the higher dose, but the side effects were more common at this dose.
Side effects include muscle spasm, hair loss, distortion in sense of taste, nausea, fatigue, various forms of pain (headache, myalgia, musculoskeletal and abdominal pain), diarrhea, loss of weight, loss of appetite, vomiting and itching.
The drug can also cause serious musculoskeletal side effects; the FDA also mention rare reports of muscle tissue breakdown.
The Boxed Warning alerts doctors that Odomzo may cause death or severe birth defects in a developing fetus when taken by pregnant women.
Doctors should check whether female patients are pregnant before giving them the drug, warn both male and female patients about these risks and advise them to use effective contraception, say the FDA.
Medical News Today recently reported how new research shows immunotherapy - the use of drugs to stimulate the immune response to a disease - promises to be highly effective for melanoma and heralds a new era for skin cancer treatment.
Written by Catharine Paddock PhD
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Texas Ag Coop Trust
915 Austin Street
Levelland, TX 79336 806-747-7894
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Texas Ag Coop Trust
Officers, Board of Trustees
Kimberly Tullo-Holcomb
TACT Executive Director
Lubbock, TX
Jim Turner, Chairman Dalhart Consumers Fuel Association
Dalhart, TX
Bret Brown, Secretary/Treasurer Ag Producers Co-op Sunray, TX
Craig Rohrbach
Parmer County Cotton Growers
Farwell, TX
Dean Sasser
Farmers Coop Elevator Levelland, TX
Tony Williams Texas Cotton Ginners' Association Austin, TX
Paul Wilson
United Cotton Growers Levelland, TX
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Texas Ag Coop Trust
is endorsed by:
Texas Grain & Feed
Association
Texas Cotton Ginners Association
Texas Coop Marketing Exchange
Texas Corn Producers
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These days, health insurance is something none of us can afford to be without. Texas Ag Coop Trust knows health and your livelihood go hand in hand and affect your family's well-being. We are dedicated to helping you find the plan that fits your health needs and that of your company. With TACT, you don't just rent your insurance company, you own it! You are part of this insurance company! YOU are our focus, YOU are our business. Questions? Concerns? How can we help? Give us a call! We are certain that we have answers.
You are a partner in decision making and you are partnered with a thriving coverage provider.
Keeping YOU the priority. Keeping YOUR NEEDS in perspective.
TACT - Dedicated Insurance Professionals
you know and trust...like Family.
Next Issue: August 18, 2015
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