Thursday, September 26, 2013

HHS boosts stockpile of products to treat acute radiation syndrome



Contracts allow repurposing of a commercial cancer therapy for use in emergencies


Orders placed today under Project BioShield contracts will increase the national stockpile of leukocyte growth factors, a treatment for acute radiation syndrome. The products ordered by the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response could save lives of survivors exposed to high doses of radiation following a radiological or nuclear emergency.
Managed by ASPR’s Biomedical Advanced Research and Development Authority, Project BioShield is the chief mechanism through which the U.S. government supports the advanced development and procurement of new medical countermeasures – drugs, vaccines, diagnostics, and medical supplies – to protect health against chemical, biological, radiological and nuclear threats. 

This is the first time under Project BioShield that commercially available products are being purchased to establish a sustainable emergency response capability.

 “Today’s agreements are a prime example how Project BioShield can be leveraged to bring our nation the medical countermeasures we need to face threats from chemical, biological or radiological emergencies,” explained BARDA Director Robin Robinson, Ph.D.

Leukocyte growth factors, sometimes referred to as cytokines or colony-stimulating factors, stimulate bone marrow to produce infection-fighting white blood cells known as neutrophils. Leukocyte growth factors are approved by the U.S. Food and Drug Administration, and used for cancer patients undergoing chemotherapy to speed white blood cell recovery and reduce the risk of infection.

Acute radiation syndrome is a serious illness that occurs in people exposed to high doses of radiation. The condition involves injuries to the body’s organs, including the bone marrow, gastrointestinal tract, and lungs, and can cause neutropenia, an abnormally low level of neutrophils.

No drugs or products are approved by FDA to treat the effects of Acute Radiation Syndrome, but leukocyte growth factors potentially could be used after a radiological or nuclear attack with emergency use authorization from FDA.

HHS awarded a $36.5 million contract to sanofi-aventis of Bridgewater, N.J., for late stage development and procurement of a leukocyte growth factor called Leukine, and a 157.5 million contract to Amgen USA Inc. of Thousand Oaks, Calif., to purchase the leukocyte growth factor called Neupogen. 
The leukocyte growth factors acquired under this contract will remain in the possession of the manufacturers in vendor-managed inventory until they are needed. The companies will rotate this inventory to meet commercial demand so that the inventory does not expire. 

Under the Project BioShield Act of 2004, BARDA has supported the development and procurement of 12 medical countermeasures, including those needed to treat some of the health impacts of ionizing radiation, as well as drugs or products to treat illness from anthrax, smallpox, and botulism.
This work is part of BARDA’s comprehensive, integrated portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. In addition to radiological and nuclear agents, these threats include chemical and biological terrorism threats, pandemic influenza, and emerging infectious diseases.

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. 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.
To learn more about ASPR and preparedness, response and recovery from the health impacts of disasters, visit the HHS public health and medical emergency website, www.phe.gov. For information about medical countermeasures, go to www.medicalcountermeasures.gov. Contract opportunities and awards are announced at www.fbo.gov.

Wednesday, September 25, 2013

HHS pursues nerve agent anti-seizure drug for children and adults


New treatment for nerve agent seizures could be first approved in easy-to-use pediatric autoinjector.

An effective, faster acting and longer lasting medication to treat seizures caused by nerve agents will be studied and purchased under a Project BioShield contract from the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR). There are no currently approved medications to treat seizures caused by nerve agents.

Under today’s five-year, $60 million contract, Meridian Medical Technologies Inc. of Columbia, Md., a Pfizer company, will conduct studies of midazolam to seek approval from the U.S. Food and Drug Administration for the drug’s use in treating seizures caused by nerve agents. Meridian also will seek FDA approval of a midazolam autoinjector for children and adults, and seek approval of midazolam for use in treating common prolonged seizures.

Midazolam is approved as a fast-acting, highly effective pre-operative sedative for adults and children. Although not approved for treatment of seizures, the drug also may stop prolonged seizures including those caused by nerve agents. Nerve agents attack the nervous system by blocking an enzyme required for the proper control of nerve impulses, leading to the continual transmission of those impulses. In the brain, the result of this process is convulsions or seizures.

To prevent convulsions or seizures, anticonvulsant medications make brain cells resistant to this overstimulation and limit the spread of electrical activity through the brain. In a chemical attack, anticonvulsant medications must be administered as quickly as possible to prevent neurological injury and death. An auto-injector allows for quick administration during emergencies.

An autoinjector, a hypodermic syringe used to inject a patient with a premeasured single dose of medication, is used commonly to administer insulin for diabetes and lifesaving medication for allergic reactions such as bee stings. The nerve agent anticonvulsant currently in the Strategic National Stockpile for emergency use can only be administered to children using multi-dose vials, which is more time-consuming than using autoinjectors.

The work supported by this contract builds on Meridian’s participation in a large study in which midazolam was used to treat prolonged seizures. The study indicated that as an anticonvulsant for common prolonged seizures midazolam works faster, is easier to inject, and hurts less at the injection site than the anticonvulsant currently in the stockpile to treat seizures caused by nerve agents.

Data from this and other studies could support FDA in authorizing emergency use of midazolam in a chemical weapons attack prior to the drug’s approval. The contract includes purchase of midazolam in autoinjectors for adults and multi-dose vials for adults and children for emergency use while the company conducts the additional studies.

“Midazolam is the eleventh product to be developed or purchased through Project BioShield in less than 10 years, so we’re making unprecedented progress in becoming a more prepared nation, which is critical, especially in light of current chemical threats,” said Robin Robinson, Ph.D., director of ASPR’s Biomedical Advanced Research and Development Authority, which oversees the program. “The repurposing of existing drugs like midazolam shows the flexibility of Project BioShield and the strength of the federal government’s enterprise approach to developing products that protect health from chemical and bioterrorism weapons.”

Project BioShield is the chief mechanism through which the U.S. government supports the advanced development and procurement of new medical countermeasures – drugs, vaccines, diagnostics, and medical supplies – to protect health against chemical, biological, radiological and nuclear threats. 

Under the Project BioShield Act of 2004, BARDA has supported the development and procurement of two anthrax antitoxins to treat people with anthrax disease and an anthrax vaccine, as well as drugs or medical products to protect health against smallpox, botulism, and radiation injury.

BARDA, within the HHS Office of the Assistant Secretary for Preparedness and Response, provides a comprehensive integrated portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing infrastructure for vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear threats, pandemic influenza, and emerging infectious diseases.

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. The Office of the Assistant Secretary for Preparedness and Response (ASPR) is an HHS leader 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.

For more information on national public health and medical preparedness, visit www.phe.gov and to learn more about medical countermeasures go to www.medicalcountermeasures.gov

Thursday, September 19, 2013

Mondays In Plymouth: Mental Health First Aid - Mon Sept 30


The Arc of Amador & Calaveras and Hospice of Amador & Calaveras Partner to Present: Supporting Individuals with Intellectual and Developmental Disabilities Through Life-Ending Illness, Grief and Loss


Each year the Hospice Foundation of America (HFA) presents a nationally recognized distance learning program to more than 125,000 people in 2,000 communities. For more than a decade, HFA’s educational events have been instrumental in educating healthcare professionals and families on issues affecting end-of-life care. This program provides an opportunity for a wide variety of professionals to share and exchange ideas and obtain continuing education credits.  This program is practical for all levels of professions – entry level, intermediate or advanced.  The information provided by the expert panel will be useful to parents, nurses, social workers, counselors, nursing home administrators, case managers, funeral directors, psychologists, marriage and family therapists, caregivers, and those working in palliative and hospice care, long-term care, or home care. 

This year’s New Perspectives Program focuses on “Supporting Individuals with Intellectual and Developmental Disabilities Through Life-Ending Illness, Grief and Loss.” The ethical, medical management and psychosocial issues for individuals with intellectual and developmental disabilities who face death, grief and loss can be complex. This two-hour educational program focuses on the critical challenges of providing and accessing optimal end-of-life care and bereavement support for this population.

Moderated by Frank Sesno, Director of the School of Media and Public Affairs at The George Washington University, the program will be shown at Hospice of Amador & Calaveras, Amador Office from 11:30 am to 2:00pm. Please download the required registration form at www.arcofamador.org.  The program is free but we ask for a recommended donation of $10.00 to support both The Arc of Amador & Calaveras and Hospice of Amador and Calaveras.

Hospice of Amador & Calaveras Executive Director, Dan Riordan; and The Arc of Amador & Calaveras Executive Director, Shawnna Molina are working together to broaden their reach and deepen their impact to service in Amador and Calaveras Counties.

“Venturing out and developing this new relationship and partnership with Hospice of Amador and Calaveras is only enhancing what The Arc of Amador and Calaveras has to offer to our community – being community partners just makes sense.” Molina said. “This partnership is affording us the opportunity to open trainings up to the community, while supporting our staff and our mission. We are very grateful to Hospice of Amador & Calaveras for recognizing the benefits and importance of collaborating and offering this training to Amador and Calaveras counties, we wouldn’t have been able to do it without them.”

“ I agree with Shawnna”, says Riordan. “A partnership like this is a natural extension of the fine work being done in the community by both agencies. We were delighted to be invited to participate and look forward to a good turn out!”

Each year this award-winning program is produced by Hospice Foundation of America, a not-for-profit organization, which acts as an advocate for the hospice concept of care through ongoing programs of professional education, public information and research on issues relating to illness, loss, grief and bereavement.






U.S. Department of Health & Human Services replenishes nation’s supply of anthrax antitoxin

News Release

U.S. Department of Health & Human Services
News Division
Contact: HHS Press Office
202-690-6343
media@hhs.gov 
FOR IMMEDIATE RELEASEThursday, September 19, 2013
HHS replenishes nation’s supply of anthrax antitoxin
Contracts provide new surge capacity, maintain stockpile for public health emergencies

The nation’s supply of anthrax antitoxin will be maintained until 2018 under Project BioShield contracts issued by the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR). Orders placed today will replenish the stockpile of anthrax antitoxin as doses currently in the Strategic National Stockpile expire. The contracts also establish, for the first time, a surge capacity to produce antitoxin if an anthrax attack occurs.

Project BioShield is the chief mechanism through which the U.S. government supports the advanced development and procurement of new medical countermeasures – drugs, vaccines, diagnostics, and medical supplies – to protect health against chemical, biological, radiological and nuclear threats. 

Through the Project BioShield Act of 2004, ASPR’s Biomedical Advanced Research and Development Authority (BARDA) has supported the development and procurement of two anthrax antitoxins to treat people with anthrax disease and an anthrax vaccine, as well as drugs or medical products to protect health against smallpox, botulism, and radiation injury.

“Project BioShield’s long-term funding and planning encourage companies to partner with the federal government on products like anthrax antitoxin that they otherwise would not pursue, but that our nation would need in a crisis,” said BARDA Director Robin Robinson, Ph.D. “The acquisition of additional anthrax antitoxin to replenish expiring stocks will provide for greater national health security against this threat through 2018 and beyond.”

Anthrax antitoxins, vaccine and antibacterial drugs will be needed to protect health in an anthrax attack. In 2001, when anthrax-laden letters were sent through the mail, antibacterial drugs were the only products available to treat people who had been exposed to anthrax but were not yet showing signs of illness.

HHS awarded the Project BioShield contracts, valued a minimum of $100,000, to Cangene Corporation of Winnipeg, Canada; Elusys Therapeutics Inc. of Pine Brook, N.J.; Emergent Product Development of Gaithersburg, Md.; GlaxoSmithKline in Research Triangle Park, N.C., and PharmAthene of Annapolis, Md.

Under these contracts, HHS will order approximately $196 million in antitoxin from GlaxoSmithKline. In addition, HHS will purchase materials to manufacture antitoxin. The materials include blood plasma from Cangene for approximately $63 million and a total of $1.6 million in cells from GlaxoSmithKline, PharmAthene, and Emergent. PharmAthene and Emergent have antitoxin at earlier stages of development than the GlaxoSmithKline and Cangene products.

Today’s actions build on efforts by all five companies and the federal government to develop anthrax antitoxins.   Human Genome Sciences (acquired by GlaxoSmithKline) and Cangene began delivering antitoxin to the stockpile in 2009 and 2007, respectively. 

The U.S. Food and Drug Administration (FDA) approved GlaxoSmithKline’s Raxibacumab, in December 2012 to treat inhalational anthrax in combination with other antibiotics in people exposed to anthrax spores. The drug also is approved to prevent inhalational anthrax infection when alternative therapies are not available or cannot be used. Cangene’s Anthrax Immune Globulin Intravenous (AIGIV) could be used with emergency use authorization from the FDA. The development of both products was supported by Project BioShield funds.

To create surge capacity, the contracts allow HHS to place future delivery orders if an anthrax attack occurs, in addition to replenishing the current stockpile as needed over the next five years. The cost of future orders would be determined on a case-by-case basis, up to a maximum of $350 million per order. To receive a future order, the company must have antitoxin that is eligible for emergency use authorization or is FDA-approved at the time of the order.

The replenishment and surge capacity are part of a governmentwide effort to prepare the nation to respond to security threats from chemical, biological, radiological or nuclear weapons. Federal agencies, including HHS agencies and the departments of Homeland Security, Defense, and Veterans Affairs coordinate closely to ensure programs and requirements are aligned. 

BARDA provides a comprehensive integrated portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing infrastructure for vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. In addition to chemical, biological, radiological, and nuclear weapons, and these threats include pandemic influenza and emerging infectious diseases.

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. ASPR is an HHS leader 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.

For more information on national public health and medical preparedness, visit www.phe.gov

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Saturday, September 14, 2013

Prostate Cancer Awareness Month – September 2013

Prostate Cancer Awareness Month – September 2013
Men, what can you do to be one of the survivors rather then one of the deaths?
The American Cancer Society’s estimates for prostate cancer in the United States for 2013: are about 238,590 new cases, resulting in an estimated 29,720 deaths. 1 man in 6 will get prostate cancer during his lifetime.
Prostate cancer is the second most common type of cancer found in American men with skin cancer being the first. It is the second leading cause of cancer death in men, behind only lung cancer.
More than 2 million men in the United States who have had prostate cancer at some point are still alive today. Routine preventative checkups are the key.  The early detection of prostate cancer when it is a very treatable cancer is the key.  The 5 year survival rate for prostate cancer is 100% if treated early, but the rate drops to 28% if the cancer was not detected early and has spread to other parts of the body.
As early detection is a key to the successful treatment, every man should have an annual medical exam that includes the test for prostate cancer.  Your annual exam should include both a prostate specific antigen (PSA) blood test and a digital rectal exam (DRE). Prostate cancer usually doesn’t have symptoms in the early stages and that is why regular screening is important. Detection early allows for much broader treatment options. These options include several types of radiation and surgeries and other options.
If you are diagnosed with prostate cancer your primary care doctor will refer you to a specialist. The specialist may be in one of several fields: urology, radiology, medical oncology, and sometimes doctors in more than one field collaborate.  With early diagnosis you will have time to learn more about the various treatment options and decide which is best for you.
There are many sources for this information: The American Cancer Society, second opinions from other doctors, web research (sources such as the National Cancer Institute and National Institutes of Health) and support groups.
Support groups are an excellent source of information. The local Prostate Cancer Support group meets at the Sutter Amador Hospital in the Oakview Conference Room on the second Tuesday of each month at 6:00 P.M. Contact Tamara Harding at 223-7478 or Jerry Trottier at 223-9133 for more information.

Sunday, September 8, 2013

Prostate Cancer Information and Support Group Meeting – Tues Sept 10



The Amador County Prostate Cancer Information and Support Group will hold its regular meeting on Tuesday September 10, 2013 starting at 6:00 pm. The location is Sutter Amador Hospital in the Oakview Conference Room on the second floor
The October meeting will be on 8th of October at 6:00 in the Oakview room.
The group was formed to support men and their families and anyone who wishes to know more about Prostate Cancer. Meetings are open to all and includes men who have recovered from Prostate Cancer as well as those recently diagnosed, and those in treatment. The types of treatments range in scope from taking a watchful waiting active surveillance approach to radiation or surgery. Periodically meetings offer guest speakers, videos and updates on research
.
The meetings have information with regards to nutrition and prostate cancer. We encourage anyone who wants to learn more about cancer and nutrition to attend

For more information about the group and its meetings contact Jerry Trottier, 223-9133.

Thank You

Jerry Trottier




Wednesday, September 4, 2013

NYF introduces Laura Clark as new Fitness Manager

 

Sutter Health Donates $100,000 to Red Cross Fire-Relief Effort


Contribution is part of organization’s ongoing investment in people and communities

SACRAMENTO, Calif., Sept. 3, 2013― Sutter Health announced a $100,000 donation to the American Red Cross Capital Region Chapter to support fire-relief efforts across several Northern California and Central Valley communities.

The donation will help provide food, shelter and other resources for those affected by the still-raging Rim fire threatening the Yosemite National Park area, as well as several smaller fires in areas served by the Sacramento-based chapter.

 “Part of being a great neighbor is looking beyond the walls of our care centers, out into the community, and supporting our neighbors in times of need,” said Sutter Amador Hospital CEO Anne Platt. “All of us who live in the Sierra Foothills are impacted and very concerned for the safety and well being of our neighbors.”

Sutter Health’s $100,000 donation will help Rim fire relief workers provide food, shelter and mental health services to residents evacuated from their homes, as well as similar services to sheriff’s department staff working at the front lines of that fire, the sixth largest ever recorded in the state.

Part of the donation will help those affected by recent or current fires threatening homes and displacing residents in El Dorado Hills, Red Bluff and Tehama County.

Sutter Health is a longtime supporter of American Red Cross disaster-relief efforts locally and globally. Over the years, the not-for-profit health care organization has made substantial donations to support humanitarian aid in disasters such as the earthquake in Haiti, the earthquake and tsunami in Japan and the many seasonal wildfires in California.
Disasters like these wildfires change lives in an instant, leaving those impacted with a lot of uncertainty,” said Kathleen Weis, CEO for the Capital Region Chapter. “It is the generosity of donors like Sutter Health that help us to provide comfort and relief, and ensure the people affected by such disasters have the resources they need to cope through such difficult times.”

Sutter Health physicians and hospitals share a common commitment to creating healthier communities through programs and services that respond to community needs. This includes an ongoing investment in care and services for poor and underserved people, which in 2012 was $795 million.

For information on how to support American Red Cross relief efforts, go to www.redcross.org.

The National Alliance on Mental Illness (NAMI Amador) - Tues Sept 24



The Amador County chapter of the National Alliance on Mental Illness (NAMI Amador) is holding an affiliate meeting and support group on Tuesday, September 24th in the Oak View Conference Room (2nd floor in the Education Department) at Sutter Amador Hospital in Jackson from 5:30 to 6:30 pm.  The guest speaker will be Renee Paul who is the psychiatric nurse at the Amador County Behavioral Health Department.  From 6:45 to 8:00 pm we will conduct a confidential Support Group for family members and caregivers of those with mental illnesses.   For information call NAMI Amador (at ATCAA) 209-223-1485 Ex. 266.

Tuesday, September 3, 2013

NAMI Amador Announces Special Events during Mental Illness Awareness Week in Octobe



NAMI Amador (the Amador Chapter of the National Alliance on Mental Illness) and Amador County Behavioral Health Services are pleased to announce two very special events during Mental Illness Awareness Week. These events are open to the public at
no charge. All are encouraged to attend as we begin an important conversation about  mental health in Amador County.

The first event, an Anti-Stigma Stroll, will take place Sunday, October 6 beginning at 4PM at First 5 on Broadway Street, around Sutter Amador Hospital, and ending back at First 5. Participants are encouraged to wear a t-shirt or pin with a positive message about mental health or wellness. Water and refreshments will be available.

The second event will take place Thursday, October 10 from 5:30-7:30PM at Thomi’s Ballroom on Highway 49 in Jackson. This event will feature key segments from PBS documentary “A New State of Mind,” narrated by Glenn Close, first-hand accounts of local experiences with mental illness, and a discussion of mental health in our community. For those interested in learning about the signs and symptoms of mental illness, and how to help, a brief introduction to Mental Health First Aid training will be provided, along with an overview of the groups and services offered by NAMI Amador.

A light meal will be served. NAMI Amador is a local nonprofit agency that  provides support, education and advocacy for persons with serious brain disorders (i.e., mental illnesses) and their families. For more information about NAMI Amador and the programs they offer, please contact Kelly Trottier at kjtrottier@volcano.net or at 209-223-1485, x226.

These events are funded by the Mental Health Services Act, through a competitive grant awarded to NAMI Amador from the California Mental Health Services Authority (CalMHSA). For more information about these special events, please contact Christa Thompson at cthompson@amadorgov.org or 209-223-684.1