American Red Cross and American Heart Association Jointly Announce Revised First Aid Guidelines

/PRNewswire/ -- The American Red Cross and American Heart Association today announced changes to guidelines for administering first aid. Among the revisions are updated recommendations for the treatment of snake bites, anaphylaxis (shock), jellyfish stings and severe bleeding. The First Aid Guidelines are being published in Circulation: Journal of the American Heart Association.

Volunteer experts from more than 30 national and international organizations joined the Red Cross and the American Heart Association in reviewing 38 separate first aid questions. Experts analyzed the science behind them and worked to reach consensus on the treatment recommendations. Last revised in 2005, these recommendations form the recognized scientific basis for most first aid training around the world.

"It is vital that the first aid community come to consensus and speak in a clear voice on these life and death issues," said David Markenson, M.D., first aid science advisor to the American Red Cross. "We are proud to help set the standard for first aid training around the globe."

"Prompt and effective first aid can save lives and prevent many medical situations from worsening, so it's important that everyone learn about the changes the American Heart Association and American Red Cross have made to the first aid guidelines," said Jeff Ferguson, M.D., American Heart Association volunteer co-chair of the first aid guidelines writing group.

In looking at the treatment of jellyfish stings, the revised guidelines reaffirm the recommendation to use vinegar to treat the sting. The vinegar neutralizes the venom and may prevent it from spreading. After the vinegar deactivates the venom, immersing the area in hot water for about 20 minutes is effective for reducing pain. The treatment for snake bites has been amended slightly to recommend applying a pressure immobilization bandage to any venomous snake bite, with pressure being applied around the entire length of the bitten extremity.

Under the revised guidelines for treating anaphylaxis, if symptoms persist after a few minutes of giving the patient an epinephrine injection from a prescribed auto-injector and medical help is delayed, the first aid provider can give a second epinephrine injection from a prescribed auto-injector. The guidelines also recommend that the general public not routinely use hemostatic agents (substances used to help stop bleeding) to control bleeding because of significant variability in effectiveness and the potential for adverse effects. Tourniquets and hemostatic agents should be considered alternatives for professional rescuers when direct pressure is not possible or fails to control bleeding.

The expert panel also reaffirmed some key first aid recommendations, including use of aspirin when helping someone experiencing persistent chest pain or discomfort associated with a cardiac emergency. Bystanders should call 9-1-1 and activate the emergency medical services (EMS) system for anyone with chest discomfort. While waiting for EMS personnel to arrive, the person being treated may be advised to chew two low dose baby aspirin or one adult (non-enteric-coated) aspirin, if they are not allergic to aspirin or have had a stroke or recent bleeding.

-----
Community News You Can Use
Click to read MORE news:
www.GeorgiaFrontPage.com
Twitter: @gafrontpage & @TheGATable @HookedonHistory
www.ArtsAcrossGeorgia.com
Twitter: @artsacrossga, @softnblue, @RimbomboAAG
www.FayetteFrontPage.com
Twitter: @FayetteFP

FDA Revises Recommendations for Rotavirus Vaccines

The U.S. Food and Drug Administration today revised its recommendations for rotavirus vaccines for the prevention of the disease in infants and has determined that it is appropriate for clinicians and health care professionals to resume the use of Rotarix and to continue the use of RotaTeq.

The agency reached its decision based on a careful evaluation of information from laboratory results from the manufacturers and the FDA’s own laboratories, a thorough review of the scientific literature, and input from scientific and public health experts, including members of the FDA’s Vaccines and Related Biological Products Advisory Committee that convened on May 7, 2010 to discuss these vaccines.

The FDA also considered the following in its decision:

* Both vaccines have strong safety records, including clinical trials involving tens of thousands of patients as well as clinical experience with millions of vaccine recipients.
* The FDA has no evidence that PCV1 or PCV2 pose a safety risk in humans, and neither is known to cause infection or illness in humans.
* The benefits of the vaccines are substantial, and include prevention of death in some parts of the world and hospitalization for severe rotavirus disease in the United States. These benefits outweigh the risk, which is theoretical.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
Follow us on Twitter:  @GAFrontPage

Health Reform Needs Enforceable National Workforce Strategy

/PRNewswire/ -- Congressional leaders must ensure that health reform includes a health workforce planning body with sufficient authority to ensure implementation of an integrated, coordinated national health workforce policy, according to Dr. Steven A Wartman, president and CEO of the Association of Academic Health Centers (AAHC). "With each step in the legislative process, the Congress has progressed toward a more effective health workforce planning process," Wartman said. "Still missing from both House and Senate bills is a mechanism -- such as national health workforce commission recommendations that automatically go into effect unless overridden by Congress -- to ensure timely implementation of the recommendations," added Wartman, urging Congress to address this concern before finalizing the legislation.

An updated analysis of the current House and Senate bills released today by the AAHC identifies additional strengths and weaknesses in the bills when measured against the AAHC's own health workforce recommendations:

-- The AAHC recommends that development and implementation of an
integrated, coordinated, strategic national health workforce policy be
the primary objective of any advisory committee or national
commission. The House bill contains a clear statement that the
purpose of its advisory committee is "to develop and implement an
integrated, coordinated, and strategic national health workforce
policy reflective of current and evolving health workforce needs,"
while the Senate bill only lists national health workforce policy as
one of several priorities.
-- The AAHC recommends the list of enumerated issues to be addressed by
the advisory committee or national commission include the
harmonization of conflicting national and state-based regulatory and
private self-regulatory standards (e.g., licensure, scope of practice,
accreditation). The Senate bill expressly directs its national
commission to "identify barriers to improved coordination at the
Federal, State, and local levels," but the House bill does not
expressly address the need for harmonization.
-- The AAHC recommends the creation of a permanent, independent advisory
committee or national commission that serves as a continuously
available policy research and consultative resource. The Senate bill
creates an independent national commission composed of members
appointed by the Comptroller General, while the House bill only
creates an advisory committee appointed by and reporting through the
Secretary.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

Sebelius Statement on New Breast Cancer Recommendations

HHS Secretary Kathleen Sebelius issued the following statement today on new breast cancer screening recommendations from the U.S. Preventive Services Task Force:

"There is no question that the U.S. Preventive Services Task Force Recommendations have caused a great deal of confusion and worry among women and their families across this country. I want to address that confusion head on. The U.S. Preventive Task Force is an outside
independent panel of doctors and scientists who make recommendations. They do not set federal policy and they don't determine what services are covered by the federal government.

"There has been debate in this country for years about the age at which routine screening mammograms should begin, and how often they should be given. The Task Force has presented some new evidence for consideration but our policies remain unchanged. Indeed, I would be very surprised if any private insurance company changed its mammography coverage decisions
as a result of this action.

"What is clear is that there is a great need for more evidence, more research and more scientific innovation to help women prevent, detect, and fight breast cancer, the second leading cause of cancer deaths among women.

"My message to women is simple. Mammograms have always been an important life-saving tool in the fight against breast cancer and they still are today. Keep doing what you have been doing for years - talk to your doctor about your individual history, ask questions, and make the
decision that is right for you."

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

Lives Will Be Lost With Proposed Changes to Mammography Guidelines

/PRNewswire/ -- "The recommendation to change breast screening is a huge step backwards," says Dr. Marisa Weiss, a leading breast oncologist and founder and president of Breastcancer.org.

The proposed new guidelines call for mammograms to start at age 50 and to be done every other year instead of every year starting at age 40, as recommended by current guidelines.

"The data simply does not account for the human perspective. It would be an enormous mistake to allow outdated data using older technology provided by computer-generated analysis to dictate how health care professionals screen women for early detection of breast cancer. These are real people with their lives at stake ... for whom mammography has a proven survival benefit."

The letter to the Breastcancer.org community follows:

Dear Breastcancer.org Member:

The U.S. Preventive Services Task Force recently recommended dramatic changes to current breast cancer screening guidelines. Breastcancer.org is strongly opposed to these recommendations.

The proposed new guidelines recommend starting regular screening mammograms at age 50, rather than at age 40 as current guidelines recommend. They recommend screening before age 50 only for women with a much-higher-than-average risk of breast cancer. The proposed new guidelines also call for mammograms to be done every other year instead of every year, as recommended by current guidelines.

The proposed new guidelines are based on research that looks at the effect of breast cancer screening on society from a public health perspective. This means the researchers were looking at how changing breast cancer screening guidelines would affect the overall public, rather than individual women. In proposing the changes, the task force members said that starting mammograms later in life and doing mammograms less often would save a large amount of money. It also means that about 3% more women would die from breast cancer each year. The task force members felt that the amount of money saved (from fewer mammograms and side effects of extra biopsies and treatment) was greater than the value of more lives saved (3% fewer women surviving breast cancer).

At Breastcancer.org, we are deeply troubled by both the analysis that led to these proposed guideline changes and the effect these proposed changes would have on the health and lives of women. Our specific concerns:

-- The analysis was based on older mammography techniques, meaning the
researchers mostly looked at results from film mammograms instead of
digital mammograms.
-- The analysis was based on some inaccurate assumptions about optimal
treatment after breast cancer is diagnosed. For example, it assumed
that women diagnosed with hormone-receptor-positive, early-stage
breast cancer would receive and benefit from hormonal therapy but not
chemotherapy, even though we know that many of these women do receive
and benefit from chemotherapy after surgery. Inaccurate assumptions
like this may have caused the researchers to underestimate the number
of lives that would be lost should the proposed changes in screening
be adopted.
-- The analysis did not adequately consider the combined benefit of early
detection (with current screening guidelines) and new treatments that
have resulted in steadily improving survival rates in recent years.
Screening cannot be looked at in isolation as a snapshot. Screening
happens as we continue to improve both diagnosis and treatment. But we
can't treat what isn't diagnosed.
-- The proposed guideline changes would mean that many breast cancers
would be diagnosed at a later stage, making it harder to become
cancer-free. Later-stage diagnoses result in more women with
metastatic disease (that has spread to other parts of the body) and
more women with large or multiple cancers requiring mastectomy (too
late for breast-conserving treatments).
-- The proposed guideline changes would mean that younger women would be
diagnosed later. Breast cancer in younger women tends to be more
aggressive, so early diagnosis and treatment is more critical for
them. It is the lives and futures of younger women that would be lost
if the proposed changes are adopted.

Expressed as nameless, faceless numbers, the 3% decrease in breast cancer survival might seem like an acceptable trade-off when compared to the economic benefits of changing breast cancer screening policies. But breast cancer affects a very large number of women, so 3% of that number is not insignificant. The reality is that more women -- mothers, daughters, sisters, grandmothers, and aunts -- will die each year from breast cancer, which is neither reasonable nor acceptable.

We at Breastcancer.org encourage medical professionals and everyone affected in any way by breast cancer to raise their voices against these surprising and dramatic proposed changes in the guidelines for breast cancer screening. Our belief is that lives should be saved, not lost, and our commitment to you is that we will continue to strongly advocate for policies that support this fundamental mission.

Marisa C. Weiss, M.D.
President and Founder, Breastcancer.org
Director of Breast Radiation Oncology, Director of Breast Health Outreach
Lankenau Hospital

Maxine Jochelson, M.D.
Director of Radiology
Evelyn H. Lauder Breast Center
Memorial Sloan-Kettering Cancer Center
Professional Advisory Board, Breastcancer.org

Emily F. Conant, M.D.
Professor of Radiology, Chief of Breast Imaging
Hospital of the University of Pennsylvania
Professional Advisory Board, Breastcancer.org

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

Intercell Supports the Japanese Encephalitis Vaccination Recommendations of CDC's Advisory Committee on Immunization Practices

/PRNewswire/ -- Intercell AG (VSE: ICLL) today announced that the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) voted to update its previous recommendations and include IXIARO, a new Japanese Encephalitis (JE) vaccine for travelers to countries in Asia where the disease is endemic, as well as Americans living in such high-risk areas.

ACIP made significant changes to their previous Japanese Encephalitis recommendations, last updated in 1993, noting that many more travelers are now visiting areas where the disease is endemic. In addition to recognizing the recent licensure of IXIARO, the committee's expanded recommendations urged clinicians to consider vaccinating travelers visiting endemic areas during the transmission season, even those on short-term visits, if they plan to spend a substantial amount of time outdoors. The panel also concluded that IXIARO, which is derived from a well-established cell line and does not contain stabilizers or preservatives, has a lower risk of vaccine-associated adverse events than older Japanese Encephalitis vaccines.

IXIARO received marketing approval from the U.S. Food and Drug Administration on March 30, 2009 on the basis of studies that showed the vaccine is highly immunogenic after only two doses. IXIARO has been shown to stimulate a long-lasting immune response and to be well tolerated. It is the only currently manufactured Japanese Encephalitis vaccine available in the United States. IXIARO was developed by Intercell AG; the rights to market and distribute the vaccine to the private sector in the United States are held by Novartis Vaccines.

"The consequences of contracting this disease can be devastating due to the high morbidity and mortality associated with the disease, making IXIARO a crucial preventive tool for those spending time in endemic areas. It is gratifying that the ACIP committee of the CDC has chosen to broaden its recommendations and to recognize the benefits of IXIARO," said Gerd Zettlmeissl, Chief Executive Officer of Intercell. "This underscores our commitment to serving the needs of the travelers' and of the military market and developing vaccines to address unmet needs."

The ACIP consists of 15 experts in fields associated with immunization who have been selected by the Secretary of the U.S. Department of Health and Human Services to provide advice and guidance on the control of vaccine-preventable diseases. ACIP develops written recommendations for the routine administration of vaccines to children and adults in the civilian population. The ACIP is the only entity in the federal government that makes such recommendations.

About Japanese Encephalitis

Japanese Encephalitis is a mosquito-borne infection that strikes 30,000 to 50,000 individuals a year, causing 10,000 to 15,000 deaths (both probably an underestimate due to underreporting and misdiagnosis). Up to 50 percent of survivors have persistent neurological sequelae. Japanese Encephalitis is the leading cause of viral neurological disease and disability in Asia and the most important viral encephalitis in Asia. The disease is most common in several developing countries in Asia, including India and China. As there is no specific treatment for JE, health care experts recommend vaccination as the only highly effective protection for the travelers and military personnel who live in or travel to areas where the virus circulates.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

FDA Announces New Recommendations on Evaluating Cardiovascular Risk in Drugs Intended to Treat Type 2 Diabetes

The U.S. Food and Drug Administration recommended today that manufacturers developing new drugs and biologics for type 2 diabetes provide evidence that the therapy will not increase the risk of such cardiovascular events as a heart attack. The recommendation is part of a new guidance for industry that applies to all diabetes drugs currently under development.

"We need to better understand the safety of new antidiabetic drugs. Therefore, companies should conduct a more thorough examination of their drugs' cardiovascular risks during the product's development stage," said Mary Parks, M.D., director, Division of Metabolism and Endocrinology Products, Center for Drug Evaluation and Research (CDER), FDA. "FDA's guidance outlines the agency's recommendations for doing such an assessment."

More than 23 million people in the United States have been diagnosed with type 2 diabetes or diabetes mellitus, a chronic metabolic disorder characterized by abnormally high blood sugar levels known as hyperglycemia.

Patients with diabetes have a two- to four-times greater risk of heart disease than their non-diabetic counterparts, and none of the currently approved antidiabetic therapies has been convincingly proven to reduce that risk. Because diabetes often requires life-long treatment, prescribers and patients need to know more about whether their antidiabetic therapies put patients at increased risk of heart attack. This is the purpose of today's guidance, which has benefited from the July 2008 recommendation from FDA's Endocrinologic and Metabolic Drugs Advisory Committee.

The guidance, which is effective immediately, defines more robust and adequate design and data collection approaches for Phase 2 and Phase 3 clinical trials than were previously required. Specifically, the guidance recommends that these studies demonstrate that new antidiabetic therapies do not increase cardiovascular risk in comparison with existing therapies -- especially when the drugs are used by patients of advanced age or by those with advanced diabetes or renal impairment.

The FDA also recommends that manufacturers have any cardiovascular events in their clinical trials analyzed by committees of outside cardiologists who are unaware of which patients received the tested products and which were on placebo. Based on these evaluations, the FDA can better ensure that product labeling includes comprehensive information on safety and effectiveness. This will enable prescribers and patients to make better-informed decisions on the management of type 2 diabetes.

The FDA remains confident that currently marketed antidiabetic therapies are safe and effective when used according to approved labeling and advises patients to work with their healthcare professionals to select the most appropriate therapy to achieve adequate blood glucose control. The FDA is continuing to evaluate how today's recommendations will be applied to already approved antidiabetic drugs and expects to release further guidance on this issue in the future.

The FDA's guidance and its ongoing evaluation of this issue supports our approach to drug regulation throughout the product life-cycle, by evaluating a drug's safety before and after its approval," said Janet Woodcock, M.D., director, CDER, FDA.

"Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes" is posted on FDA's website at http://www.fda.gov/cder/guidance/8576fnl.pdf. It will be published in the Federal Register on December 19, 2008. In addition, the FDA has provided written notice of the recommendations from this guidance to more than 100 manufacturers who have submitted investigational new drug applications for type 2 diabetes treatment.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

CDC Expands Testing Recommendations For Chronic Hepatitis B Virus Infection

The U.S. Centers for Disease Control and Prevention (CDC) today (September 18, 2008) published new recommendations for health care providers that are designed to increase routine testing in the United States for chronic hepatitis B, a major cause of liver disease and liver cancer. CDC recommends testing all individuals born in Asia and Africa, as well as testing additional at-risk populations, including men who have sex with men (MSM) and injection-drug users (IDUs). The recommendations, published today in CDC′s Morbidity and Mortality Weekly Report (MMWR) Recommendations & Reports, also for the first time give health professionals guidance for effective management of chronically infected hepatitis B patients.

“Chronic hepatitis B affects the lives of more than one million Americans, many of whom do not even know they are infected. These new recommendations are critical to identifying people who are living with the disease without the benefits of medical attention,” said John W. Ward, M.D., director of CDC′s Division of Viral Hepatitis. “Testing is the first step to identify infected persons so that they can receive lifesaving care and treatment, which can break the cycle of transmission, slow disease progression, and prevent deaths from liver cancer.”

In the United States, chronic hepatitis B is the underlying cause of an estimated 2,000 – 4,000 deaths each year from cirrhosis and liver cancer. The CDC recommendations are key to increasing the early diagnosis of chronic hepatitis B virus (HBV) infection, since many of the estimated 800,000 – 1.4 million Americans with chronic HBV infection have no symptoms and are unaware of their disease.

Highlights of the recommendations

The new testing recommendations build upon and reinforce past recommendations to test all pregnant women, infants born to infected mothers, household contacts and sex partners of infected individuals, and people with HIV.

Along with continued testing of those groups, routine testing is now recommended for additional populations, including:

* Individuals born in Asia, Africa, and other geographic regions with 2 percent or higher prevalence of chronic HBV infections: Previous CDC recommendations called for testing of people born in areas with 8 percent prevalence or higher. Expanded testing is essential since the rate of liver cancer deaths and chronic HBV in the United States remains high among foreign-born U.S. populations from these areas. For example, nearly one in 12 Asian Americans and Pacific Islanders living in the United States is HBV-infected, and one-third or more are unaware.
* Men who have sex with men and injection drug users: Routine testing is needed for these persons since both have a higher prevalence of chronic HBV infection than the overall U.S. population. Up to 3 percent of MSM and up to 6 percent of IDUs are estimated to be chronically infected with HBV, compared to three tenths of one percent of the general population.
* Persons with abnormal liver function tests (not explained by other conditions) and persons who require immunosuppressive therapy (e.g., chemotherapy for malignant diseases).

The new CDC report also gives recommendations for referral of HBV-infected persons to specialists for ongoing monitoring and medical care. Such guidelines are needed now to assist providers, since most of the effective medications for chronic HBV treatment have become available only in the last five years. In addition, the recommendations advise healthcare providers to provide culturally-sensitive ongoing patient education, begin lifelong monitoring for progression of liver disease, and ensure protection of household members and other close contacts of infected persons.

Testing recommendations are a critical component of CDC’s strategy to eliminate HBV transmission. CDC continues to work with the medical community to promote comprehensive prevention and treatment efforts for HBV, which include vaccination for all infants and at-risk adults; catch-up vaccination of previously unvaccinated children; routine screening for all pregnant women; treatment of newborns of infected or untested mothers; and testing household contacts and sex partners of HBV-infected persons.

-----

www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page