Monday, November 30, 2009

The Kenneth Rainin Foundation Announces $100,000 Innovator Awards Program for Inflammatory Bowel Disease (IBD) Research

/PRNewswire/ -- The Kenneth Rainin Foundation announced today its new Innovator Awards Program for Inflammatory Bowel Disease. The Program is designed to accelerate the pace of discovery in IBD research. Approximately four million people worldwide suffer from some form of IBD and most are diagnosed between the ages of 20 and 40.

"Launching the Kenneth Rainin Foundation's Innovator Awards Program for IBD research is very exciting for all of us," said Jen Rainin, president of the Kenneth Rainin Foundation. "Our Program is unique in that it encourages investigators from all scientific disciplines and from any non-profit research institution to collaborate to explore bold and innovative ideas that can expand our understanding of IBD, which, in turn, will have a major impact in finding a cure for IBD."

Jen Rainin is the daughter of the late founder, Kenneth Rainin, who suffered greatly from IBD. To further his memory and accomplish the Foundation's mission of no one suffering from IBD, the Innovator Awards Program is focused on finding applicants with diverse backgrounds who can help build a creative, conceptual paradigm for IBD with emphasis on the importance of nurturing interdisciplinary collaboration between fields. Alternative approaches that are nutrition-based or holistic in nature may also play an important role in our research.

Initial one-year grants of $100,000 will be awarded once annually. The first round of applications will be accepted February 15 - March 15, 2010. Applications must be submitted online, and selected applicants will be notified in July, 2010. Applications will be initially reviewed by our Scientific Advisory Board. Based on their recommendations, final selections will be made by the Foundation's Board. Successful projects will be eligible for significant multi-year funding based on the initial year's proof of principle work.

About Inflammatory Bowel Disease

Inflammatory bowel disease (IBD) is a group of inflammatory conditions of the gastrointestinal tract. The main forms of IBD are Crohn's Disease and ulcerative colitis. Symptoms include pain, bleeding and debilitation. Current therapeutic options for patients are largely limited to the use of anti-inflammatory steroids applied either systemically or locally for the treatment of the symptoms. Removal of the colon is the only cure at this time.

Fayette Front Page
Georgia Front Page

FDA Approves Agriflu Seasonal Influenza Vaccine

The U.S. Food and Drug Administration today approved Agriflu for people ages 18 years and older to prevent disease caused by influenza virus subtypes A and B.

Agriflu, manufactured by Novartis Vaccines and Diagnostics in Siena, Italy, was approved using the FDA’s accelerated approval pathway, which helps safe and effective medical products for serious or life-threatening diseases become available sooner. In this case, Novartis demonstrated that the vaccine induced levels of antibodies in the blood likely to be effective in preventing seasonal influenza.

Agriflu is administered as a single injection in the upper arm and is available in single dose, pre-filled syringes that do not contain preservatives.

“The approval of the new seasonal influenza vaccine, Agriflu, is an important step in adding to the production capacity to enhance the supply of vaccine for the United States for future influenza seasons,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research.

Common side effects in clinical studies included pain, swelling and redness at the injection site, headache, muscle aches and malaise. People with severe or life-threatening allergies to chicken eggs, or to any other substance in the vaccine, should not be vaccinated.

As part of the accelerated approval process, Novartis is required to conduct further studies to verify that the vaccine induces levels of antibodies in the blood that are effective in preventing seasonal influenza. The company also manufactures another licensed seasonal influenza vaccine, Fluvirin, for use in the United States. Fluvirinis approved for people ages 4 years and older. Agriflu is not intended to protect against the 2009 H1N1 influenza.

Fayette Front Page
Georgia Front Page

Thursday, November 19, 2009

Highest Rates of Obesity, Diabetes in the South, Appalachia, and Some Tribal Lands

Wide sections of the Southeast, Appalachia, and some tribal lands in the West and Northern Plains have the nation's highest rates of obesity and diabetes, according to estimates released today by the Centers for Disease Control and Prevention. In many counties in those regions, rates of diagnosed diabetes exceed 10 percent and obesity prevalence is more than 30 percent.

The estimates, in this week's Morbidity and Mortality Weekly Report, are the first to provide county-level snapshots of obesity across the United States. They also update diabetes county-level estimates released in 2008.

Eighty-one percent of counties in the Appalachian region that includes Kentucky, Tennessee, and West Virginia have high rates of diabetes and obesity. So do three-quarters of counties in the southern region that includes Alabama, Georgia, Louisiana, Mississippi, and South Carolina.

"Diabetes is costly in human and economic terms, and it's urgent that we take action to prevent and control this serious disease," said Dr. Ann Albright, director of CDC's Division of Diabetes Translation. "The study shows strong regional patterns of diabetes and can help focus prevention efforts where they are most needed."

The estimates come from the agency's Behavioral Risk Factor Surveillance System (BRFSS), which uses self-reported data from state-based adult telephone surveys, and 2007 census information. The information may help public health workers, health care providers, community organizations, and policymakers focus on high-risk regions to prevent type 2 diabetes and its complications as well as other chronic diseases linked to obesity, including heart disease, stroke, and some cancers.

The proportion of U.S. adults who are obese was 26.1 percent in 2008, according to BRFSS data. CDC estimates that nearly 8 percent of the population, or about 24 million people, have diabetes. Of these, 5.7 million are undiagnosed.

"The small-area estimates for obesity will be an important tool to help communities better understand and battle this serious public health problem. Communities are in the best position to prevent and reduce obesity among their citizens through innovative programs," said Dr. William H. Dietz, director of CDC's Division of Nutrition, Physical Activity and Obesity.

The medical costs of obesity reached an estimated $147 billion in 2008, and the medical costs of diabetes were $116 billion. People with diagnosed diabetes have medical costs that are 2.3 times higher than those without the disease.

Obesity is one of several factors linked to type 2 diabetes. Where people live, how much money they earn, their culture and their family history also play a role. An unhealthy diet, lack of physical activity, and socioeconomic factors contribute to both obesity and type 2 diabetes as well as to complications of diabetes. Some population groups also are at higher risk, including a number of racial and ethnic minorities.

CDC and its partners are working on a variety of initiatives to prevent type 2 diabetes and to reduce obesity. CDC has recommended 24 community strategies to prevent obesity, from providing greater access to healthy foods to redesigning communities to encourage more physical activity. The agency is also in a new partnership with state, federal, and nonprofit agencies targeting health disparities in Mississippi, which has the nation's highest obesity rate and one of the highest rates of diabetes. CDC's national diabetes prevention and control program provides resources and technical assistance to state health departments, national organizations, and communities.

To see county-level estimates of obesity and diagnosed diabetes, go to For more information on diabetes and preventing the disease, visit To learn more about CDC s efforts in the fight against obesity or for more information about nutrition, physical activity, and maintaining a healthy weight, go to


Fayette Front Page
Georgia Front Page

American College of Surgeons Voices Strong Support for American Cancer Society Screening Mammography Guidelines

/PRNewswire/ -- The American College of Surgeons (ACoS) today released comments strongly supporting current American Cancer Society (ACS) screening mammography guidelines that recommend women get a mammogram every year, starting at age 40. The College is supporting the ACS guidelines despite the recommendations from the U.S. Preventive Services Task Force stating the women should have regular mammograms once every two years beginning at the age of 50. The College believes the ACS guidelines have resulted in an effective approach toward dealing with the possibility of breast cancer and that women should continue to follow them in consultation with their physicians.

The federal panel's position that regular mammography screening in women under the age of 50 may do more harm than good was dismissed by David P. Winchester, MD, FACS, Medical Director of ACoS Cancer Programs, and Chair of the National Accreditation Program of Breast Centers. Dr. Winchester was particularly concerned about the panel's belief that mammography may cause an increased risk of false-positive results in younger women who have denser breast tissue, observing that "the term unnecessary biopsy is misleading. In most cases," he said, "biopsy -- done by either surgeons or radiologists -- is the reliable way to rule out cancer at any age."

The College notes that the American Cancer Society has long recognized mammography "as the gold standard for early detection of breast cancer,"* and ACoS encourages women to take an active role in partnering with their physicians to determine at what age, and what interval, they should undergo screening mammography. The College agrees with the ACS that factors such as a woman's family history of the disease and her overall medical condition are some of the issues that should be addressed, particularly for women who are known to be at an increased risk for developing the disease.

"Many surgeons in this country have the tremendous responsibility and privilege of caring for breast cancer patients each day. While recognizing that mammography is not perfect and supporting continuing research for improved methods, the surgical community believes that the American Cancer Society's screening mammography guidelines offer an optimal approach to detecting breast cancer early, when it can be most successfully treated," Lamar S. McGinnis, Jr., MD, FACS, President of the American College of Surgeons and former president of the American Cancer Society, said. "Mammography is a good and safe tool, which we will continue to improve. In the meantime," he added, "let's save lives as best we can. The lives of women, mothers, and grandmothers are invaluable. Our progress has been significant, and it will continue. Let us not confuse our patients and the public with mixed messages."

About the American College of SurgeonsThe American College of Surgeons is a scientific and educational organization of surgeons that was founded in 1913 to raise the standards of surgical practice and to improve the care of the surgical patient. The College is dedicated to the ethical and competent practice of surgery. Its achievements have significantly influenced the course of scientific surgery in America and have established it as an important advocate for all surgical patients. The College has more than 77,000 members and is the largest organization of surgeons in the world. For more information, visit

In the field of cancer care, the American College of Surgeons Commission on Cancer (CoC) is a pioneer in measuring performance. All hospitals and freestanding cancer treatment facilities approved by the CoC report clinical data through the National Cancer Data Base and receive evidence-based benchmark comparison reports based on accepted standards of care for breast and colorectal cancers. These measures are endorsed by the National Quality Forum. In addition, the College administers the National Accreditation Program for Breast Centers (NAPBC), a consortium of national, professional organizations dedicated to the improvement of the quality of care and the monitoring of outcomes for patients with diseases of the breast.

Fayette Front Page
Georgia Front Page

$10 Million in Grants Aimed at Enrolling American Indian, Alaska Native Kids in Health Care to be Awarded

HHS Secretary Kathleen Sebelius today announced the availability of up to $10 million in grants to help reach American Indian and Alaska Native (AI/AN) children who qualify for, but are not yet enrolled, in Medicaid and the Children's Health Insurance Program (CHIP).

These new grants are part of a broader effort to find and enroll uninsured children who are eligible for Medicaid or CHIP but not enrolled. The Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA) set aside $100 million for fiscal years 2009-2013
expressly to help find and enroll eligible uninsured children, including $10 million specifically for Indian health providers.

As called for in CHIPRA, grants will be awarded by the Centers for Medicare & Medicaid Services (CMS) to applicants whose outreach, enrollment and retention efforts will target geographic areas with high rates of eligible but uninsured American Indian and Alaska Native
children, who often live in isolated areas and are uninsured at higher-than-average rates.

"American Indian children are often uninsured, although many are eligible for Medicaid and CHIP," Secretary Sebelius said. "These grants will help Tribes and Indian health providers reach out to children and families to ensure more children get the health care they need."

Grants will be awarded to applicants that will be able to demonstrate increases in enrollment and improved retention of children already in Medicaid and CHIP. Grantees will report to CMS the number of new enrollees and those who retained coverage that are directly attributable
to the grant activities. Grantees will also report activities they believe were the most effective in finding, enrolling and maintaining coverage for eligible children.

"States have been effective in enrolling over 28 million children in Medicaid and more than 7 million children in CHIP, but there are still millions of uninsured, low-income children who are not enrolled in these programs even though they are eligible" said Cindy Mann, the director of
the CMS Center for Medicaid and State Operations. "We are looking forward to innovative grant proposals that will put new outreach, enrollment and renewal systems in place to ensure that uninsured Indian children get enrolled and stay enrolled for as long as they are eligible."

Applications are due by Jan. 15, 2010, and the grants will be awarded on April 15. Grants will be available to:

* The Indian Health Service;
* Tribes and Tribal organizations operating a health program; and,
* Urban Indian organizations operating a health program.

Fayette Front Page
Georgia Front Page

Secretary Pulls Cover Off the Work of Government Medical Panel

/PRNewswire/ -- U.S. Health and Human Services Secretary Kathleen Sebelius is to be commended for publicly stating the government panel opposing mammograms is "an outside independent panel of doctors and scientists who ... do not set federal policy and ... don't determine what services are covered by the federal government."

ZERO - The Project to End Prostate Cancer has long criticized this panel, known as the U.S. Preventive Services Task Force (USPSTF), for being out of touch due to its steadfast opposition to recognize the need for prostate cancer early detection as an important men's health issue.

Now, this panel is criticizing the need for mammograms.

Based on its advisory opinions on both breast cancer and prostate cancer, USPSTF has created much confusion among millions of women and men who are now being told that preventive health measures should not be followed as a means to detect cancer.

"Prostate cancer is essentially 'the forgotten illness' as far as this outside government panel is concerned," said ZERO's CEO Quentin "Skip" Lockwood.

"We're pleased the Secretary is speaking up in defense of a woman's right to continue receiving mammograms to protect her health," he said.

"We now call upon the Secretary to address the importance of prostate cancer early detection for men as well, since USPSTF has turned its back on this issue."

Advocates for mammograms and prostate cancer testing also question the membership of the USPSTF panel due to the glaring omission of medical specialists relating to women's and men's health in the fields of radiology, oncology and urology, for example.

Earlier today, the American College of Radiology called upon the Secretary to ensure the panel included "experts from the areas on which they will be advising lawmakers and submit their recommendations for comment and review," as is done with Medicare guidelines.

Ironically, the supporting data used by USPSTF does indicate mammography screening reduces breast cancer deaths by 15 percent annually. For prostate cancer, USPSTF references an ongoing screening study where early detection (using the PSA test) has so far reduced deaths by 20 percent.

"It's obvious this government panel has some explaining to do and hopefully, with prodding from the Secretary, we will get some answers to explain their contradictory position," Lockwood said.

Similarities between breast and prostate cancer data in the U.S. are striking. Each is the most frequently diagnosed noncutaneous cancer and the second leading cause of cancer death for their gender. In 2009, new cases of each cancer were at about 194,000. One in six men is struck with prostate cancer annually; for breast cancer, it's one in eight women.

Fayette Front Page
Georgia Front Page

FDA Announces New Warning on Plavix: Avoid Use with Prilosec/Prilosec OTC

Patients should avoid using the stomach acid reducer Prilosec/Prilosec OTC (omeprazole) with the anti-clotting drug Plavix (clopidogrel), the U.S. Food and Drug Administration warned on Nov. 17.

New data suggest that when patients take both Prilosec and Plavix, Plavix’s ability to block platelet aggregation (anti-clotting effect) may be reduced by about half.

“Both of these drugs, when used properly, provide significant benefits to patients.” said Mary Ross Southworth, Pharm.D., of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research. “However, patients at risk for heart attacks or strokes who use Plavix to prevent platelet aggregation will not get the full effect of this medicine if they are also taking Prilosec.”

Plavix is used to prevent blood clots that could lead to heart attacks or strokes in at-risk patients. Omeprazole, the active ingredient of Prilosec and Prilosec OTC, is a proton pump inhibitor (PPI) used to reduce the production of stomach acid and prevent stomach irritation.

Plavix does not have anti-clotting effects until it is converted or metabolized into its active form with the help of the liver enzyme, CYP2C19. Prilosec blocks this enzyme, thereby reducing the effectiveness of Plavix.

After issuing an Early Communication in January about possible drug interactions involving Plavix, the FDA requested new studies from the drug’s manufacturers, sanofi-aventis and Bristol-Myers-Squibb. These new studies support the existence of a significant interaction that could negatively impact a person’s health. Based on the current scientific information, the Plavix label has been updated with new warnings about the use of Prilosec and other drugs that inhibit the CYP2C19 enzyme and that could interact with Plavix in the same way.

The new studies compared people who took Plavix and Prilosec together with people who took Plavix alone. A reduction in Plavix’s anti-clotting effect was found in those individuals who took the combination. Similar results were seen irrespective of whether the two drugs were taken at the same or different times of day.

It is unknown how other PPIs may interfere with Plavix. Other drugs that should not be used with Plavix because they may have a similar interaction with CYP2C19 include Nexium (esomeprazole), Tagamet and Tagamet HB (cimetidine), Diflucan (fluconazole), Nizoral (ketoconazole), VFEND (voriconazole), Intelence (etravirine), Felbatol (felbamate), Prozac, Serafem, Symbyax (fluoxetine), Luvox (fluvoxamine) and Ticlid (ticlopidine).

Patients who take Plavix and need to take a drug to reduce stomach acid should discuss their therapy with a health care professional. Zantac (ranitidine), Pepcid (famotidine), Axid (nizatidine), and antacids do not inhibit the CYP2C19 enzyme and aren’t expected to interfere with the anti-clotting activity of Plavix.

Plavix’s manufacturers have agreed to continue conducting studies to explore this and other drug interactions. When the FDA has reviewed additional data, the agency will communicate any new recommendations or conclusions.

Fayette Front Page
Georgia Front Page

Wednesday, November 18, 2009

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."

Fayette Front Page
Georgia Front Page

Tuesday, November 17, 2009

FDA Approves New Drug Treatment for Long-Term Pain Relief after Shingles Attacks

The Food and Drug Administration (FDA) has approved the approval of Qutenza (capsaicin) 8% patch, a medicated skin patch that relieves the pain of post-herpetic neuralgia (PHN), a serious complication that can occur after a bout with shingles.

Shingles is an outbreak of rash or blisters on the skin that is caused by the same virus that causes chickenpox — the varicella-zoster virus. Anyone who once had chickenpox is at risk of shingles since the virus may become reactivated years after the initial infection. PHN is a condition affecting nerve fibers and the skin that can cause excruciating pain for weeks, months or even years. About 10 to 15 percent of patients who have shingles experience PHN and the complication is even more common in elderly patients.

Qutenza contains capsaicin, a compound found in chili peppers. Although there are over-the-counter products with lower concentrations of capsaicin that are marketed for the treatment of PHN, Qutenza is the first pure, concentrated, synthetic capsaicin-containing prescription drug to undergo FDA review . It was approved on Nov. 16.

“This new product can provide effective pain relief for patients who suffer from PHN,” said Bob Rappaport, M.D., director of the Division of Anesthesia, Analgesia and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.

The most frequently reported adverse drug reactions included pain, swelling, itching, redness, and bumps at the application site.

Qutenza must be applied to the skin by a health care professional since placement of the patch can be quite painful, requiring use of a local topical anesthetic, as well as additional pain relief such as ice or use of opioid pain relievers. The patient must also be monitored for at least one hour since there is a risk of a significant rise in blood pressure following patch placement.

The patch is manufactured by Lohmann Therapie-Systems AD of Andernach, Germany and distributed by NeurogesX Inc. of San Mateo, Calif.

Fayette Front Page
Georgia Front Page

Drug for Erectile Dysfunction and Pulmonary Hypertension Improves Heart Function in Children and Young Adults With Single Ventricle Heart Disease

/PRNewswire/ -- Heart function significantly improved in children and young adults with single ventricle congenital heart disease who have had the Fontan operation following treatment with sildenafil, a drug used to treat erectile dysfunction and pulmonary hypertension, say researchers from The Children's Hospital of Philadelphia.

Single ventricle defects are a collection of cardiac malformations that impair the heart's ability to pump blood. Examples include: tricuspid atresia, pulmonary atresia/intact ventricular septum and hypoplastic left heart syndrome.

The Fontan operation is a procedure that redirects systemic venous blood directly to the pulmonary arteries, bypassing the heart. It is the third surgery in a staged palliation for single ventricle heart defects.

Researchers hypothesized that sildenafil may help cardiac performance by directly improving the squeeze of the heart muscle and by allowing for better filling of the heart.

In this study, researchers randomized 28 children and young adults who had undergone the Fontan operation to receive placebo or sildenafil three times a day for 6 weeks. After a 6 week break, subjects were switched to the opposite treatment course. The researchers found significant improvement in heart performance during treatment with sildenafil.

"The enhanced heart performance may improve exercise performance and quality of life in these children and young adults," said David J. Goldberg, M.D., pediatric cardiologist at The Children's Hospital of Philadelphia, who presented the abstract today at the American Heart Association Scientific Sessions in Orlando, Fla.

Grants from The Mark H. and Blanche M. Harrington Foundation and from Big Hearts to Little Hearts provided funding for this study.

Fayette Front Page
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

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 community follows:

Dear Member:

The U.S. Preventive Services Task Force recently recommended dramatic changes to current breast cancer screening guidelines. 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, 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 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,
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,

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

Fayette Front Page
Georgia Front Page

Monday, November 16, 2009

FDA Approves Additional Vaccine for 2009 H1N1 Influenza Virus

The U.S. Food and Drug Administration announced that it has approved a fifth vaccine for protection against the 2009 H1N1 influenza virus. The vaccine is manufactured by ID Biomedical Corp. of Quebec, Canada, owned by GlaxoSmithKline PLC.

As with the four previous H1N1 influenza vaccines licensed by the FDA on Sept.15, 2009, ID Biomedical Corporation will manufacture its H1N1 vaccine using the established, licensed egg-based manufacturing process used for producing seasonal flu vaccine.

Potential side effects of this H1N1 vaccine are expected to be similar to those of the seasonal and H1N1 flu vaccines. The most common side effect is soreness at the injection site. Others may include mild fever, body aches and fatigue for a few days after the inoculation.

As with any medical product, unexpected or rare serious adverse events may occur. The FDA is collaborating with other government agencies to enhance adverse event safety monitoring during and after the H1N1 2009 vaccination program.

ID Biomedical’s H1N1 monovalent vaccine will be produced in multi-dose vials, in a formulation that contains thimerosal.

As with any medical product, unexpected or rare serious adverse events may occur. FDA is collaborating with the U.S. Department of Health and Human Services, including the Centers for Disease Control and Prevention, and other government agencies to enhance the capacity for adverse event safety monitoring during and after the 2009 H1N1 vaccination program.

Fayette Front Page
Georgia Front Page

FDA Expands Use of CSL Limited’s Seasonal and H1N1 Vaccines to Infants and Children

The U.S. Food and Drug Administration has approved the use of the CSL Limited’s seasonal and 2009 H1N1 influenza vaccines to include children ages 6 months and older. These vaccine were previously approved for use in adults, ages 18 years and older

“Because children are among those most vulnerable to the 2009 H1N1 virus, having a broader range of vaccines available for use in children is an important step in responding to the H1N1 outbreak,” said Margaret A. Hamburg, M.D., commissioner of food and drugs.

The company’s 2009 H1N1 vaccine is manufactured and tested using the same well-established licensing processes that have been in place for many years for the company’s seasonal flu vaccine.

The approval was based on a study of the company’s seasonal flu vaccine in children, showing both the vaccine's safety and its ability to induce antibodies expected to protect against influenza. These findings supported approval under FDA's accelerated approval regulations, which help safe and effective medical products for serious or life-threatening diseases to become available sooner to the public.

Common adverse events experienced by children after administration of seasonal and H1N1 vaccines typically include pain, redness and swelling at the injection site as well as, in some cases, irritability, loss of appetite and drowsiness.

As with any medical product, unexpected or rare serious adverse events may occur. FDA is collaborating with the U.S. Department of Health and Human Services, including the Centers for Disease Control and Prevention, and other government agencies to enhance the capacity for adverse event safety monitoring during and after the 2009 H1N1 vaccination program.

Because CSL’s seasonal and H1N1 monovalent vaccines contain a small amount of egg protein, they should not be administered to anyone allergic to eggs or egg products.

The vaccines will be available both in single-dose, preservative-free, pre-filled syringes and in multi-dose vials that contain thimerosal, a mercury derivative, as a preservative.

Both vaccines are manufactured by CSL Ltd. of Australia.

Fayette Front Page
Georgia Front Page

Sunday, November 15, 2009

Cardiac Science Notifies AED Customers of Nationwide Voluntary Medical Device Correction

Cardiac Science Corporation [NASDAQ: CSCX] is initiating a voluntary field correction after it was determined certain automated external defibrillators (AEDs) may experience a rare product issue in which the AED may not be able to deliver therapy during a resuscitation attempt. Device failure may affect resuscitation of the patient, which could lead to serious adverse events or death. These AEDs have electronic components which may fail and the failure may not be detected by the device's periodic self-tests. The affected models include the Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, and CardioVive 92531, 92532, and 92533 devices.

Cardiac Science has received a total of 64 complaints concerning four resistors within certain AEDs. Two of these complaints were associated with a failure to deliver therapy. This issue is predicted to occur in approximately one in 75,000 AEDs manufactured between August 2003 and August 2009. The company has also received 114 complaints regarding "Service Required" messages resulting from a specific relay switch failure. There have been no reported instances where this issue has resulted in an inability to deliver therapy.

Until a correction is available in May, 2010, the company strongly advises customers to check the status indicator on the front of the AED and follow the procedures documented in the materials accompanying the AED. The company advises that customers leave their AEDs in service.

"When customers choose a product from Cardiac Science, they expect outstanding reliability," said Dave Marver, president and chief executive officer. "We understand the role our products play in public health and are taking appropriate measures to further improve the performance of our products."

The company has implemented more stringent testing of the components and all AEDs produced since August, 2009 are unaffected. Customers in possession of an AED that may exhibit either of these issues will be notified immediately. A software update to address the resistor issue will be available by May, 2010. This software update will enhance the AED's self-test capabilities and improve detection of the issue. In the interim, the company advises customers to keep their AEDs in service and follow the normal testing and maintenance procedures found in the Operator and Service Manual. A copy of these procedures is available at At this site, customers may confirm if their AED is affected and register for automatic e-mail reminders to conduct scheduled maintenance.

If the AED is not rescue ready (the indicator is red) customers should contact the company immediately at 425.402.2000 (option 1) within the United States. Outside the US contact +44.161.926.0011 or the local Cardiac Science representative. Customers can also email the company at

Forward-Looking Statements

This press release contains forward-looking statements. The word "believe," "expect," "intend," "anticipate," variations of such words, and similar expressions identify forward-looking statements, but their absence does not mean that the statement is not forward-looking. Forward looking statements in this press release include, but are not limited to, predictions of AED component failure rates, the availability of software updates to improve detection of the component issue, and the effectiveness of the planned software update. These are forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results and performance may vary significantly from those expressed or implied in such statements. Factors that could cause or contribute to such varying results and other risks are more fully described in the Annual Report on Form 10-K filed by Cardiac Science Corporation for the year ended December 31, 2008, as updated by subsequent quarterly reports on Form 10-Q. Cardiac Science Corporation undertakes no duty or obligation to update the information provided herein.

Fayette Front Page
Georgia Front Page

Friday, November 13, 2009

FDA Approves Lysteda to Treat Heavy Menstrual Bleeding

The U.S. Food and Drug Administration today approved Lysteda tablets (tranexamic acid), the first non-hormonal product cleared to treat heavy menstrual bleeding (menorrhagia). Lysteda works by stabilizing a protein that helps blood to clot.

Heavy menstrual bleeding is reported each year by about 3 million U.S. women of reproductive age. Women with uterine fibroids may experience heavy menstrual periods. But in most cases, there is no underlying health condition associated with the condition.

“Menorrhagia can be incapacitating for some women,” said Kathleen Uhl, M.D., FDA’s associate commissioner of women’s health. “Heavy menstrual periods can cause pain, mood swings, and disruptions to work and family life.”

Tranexamic acid was first approved by the FDA in 1986 as an injection, under the brand name Cyklokapron, and is used to reduce or prevent bleeding during and following tooth extraction in patients with hemophilia, a hereditary bleeding disorder caused by the lack of a blood clotting factor.

The most common adverse reactions reported during clinical trials by patients using Lysteda included headache, sinus and nasal symptoms, back pain, abdominal pain, muscle and joint pain, muscle cramps, anemia, and fatigue. There was a statistically significant reduction in menstrual blood loss in women who received Lysteda, compared with those taking an inactive pill (placebo).

Use of Lysteda while taking hormonal contraceptives may increase the risk of blood clots, stroke, or heart attack, according to Scott Monroe, M.D., director of the Division of Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research. Women using hormonal contraception should take Lysteda only if there is a strong medical need, and if the benefit of treatment will outweigh the potential increased risk.

Lysteda is manufactured by Xanodyne Pharmaceuticals of Newport, Ky.

Fayette Front Page
Georgia Front Page

Thursday, November 12, 2009

FDA Expands Approved Use of H1N1 Vaccines to Include Infants and Children

The U.S. Food and Drug Administration has approved the use of the CSL Limited’s 2009 H1N1 influenza vaccine to include children ages 6 months and older. This vaccine was previously approved only for use in adults, ages 18 years and older.

“Because children are among those most vulnerable to the 2009 H1N1 virus, having a broader range of children’s vaccines available is an important step in responding to the H1N1 outbreak,” said Margaret A. Hamburg, M.D., commissioner of food and drugs.

The company’s 2009 H1N1 vaccine is manufactured and tested using the same well-established licensing processes that have been in place for many years for the company’s seasonal flu vaccine. The expanded approval also covers the company’s seasonal flu vaccine.

The approval was based on a study of the company’s seasonal flu vaccine in children showing the vaccine's safety and efficacy in inducing antibodies to protect against influenza. These efficacy findings supported approval under FDA's accelerated approval regulation, which helps safe and effective medical products for serious or life-threatening diseases to become available sooner to the public.

Common adverse events experienced by children after administration of seasonal and H1N1 vaccines typically include pain, redness and swelling at the injection site as well as, in some cases, irritability, loss of appetite and drowsiness.

As with any medical product, unexpected or rare serious adverse events may occur. FDA is collaborating with the U.S. Department of Health and Human Services, including the Centers for Disease Control and Prevention, and other government agencies to enhance the capacity for adverse event safety monitoring during and after the 2009 H1N1 vaccination program.

Because CSL’s seasonal and H1N1 monovalent vaccines contain a small amount of egg protein, they should not be administered to anyone allergic to eggs or egg products.

The vaccines will be available in single-dose, preservative-free, pre-filled syringes and in multi-dose vials that contain thimerosal, a mercury derivative, as a preservative.

Both vaccines are manufactured by CSL Ltd. of Australia.

Fayette Front Page
Georgia Front Page

Emory, Georgia Tech, Children's Healthcare of Atlanta Team Up on Kidney Replacement Devices for Kids

When children need kidney dialysis because of disease or congenital defects, doctors are forced to adapt adult-size dialysis equipment. No FDA-approved kidney replacement devices exist that are specifically designed for children.

To address this problem, physicians and researchers from Emory University, Children’s Healthcare of Atlanta and the Georgia Institute of Technology have teamed up to develop a kidney replacement device capable of treating children.

Over the past five years, the three institutions have further solidified a cohesive relationship aimed at medical discovery, quality-care improvement and health care innovation.

The team has been awarded a Challenge grant of $1 million from the National Institutes of Health (NIH) to refine a prototype device. The grant is part of the American Recovery and Reinvestment Act (ARRA) funding. Challenge grants are part of a new NIH program to stimulate rapid advances in focused disease areas.

Matthew Paden, MD, assistant professor of pediatrics (critical care) at Emory University School of Medicine and a physician at Children’s Healthcare of Atlanta, is the grant’s principal investigator. Ajit P. Yoganathan, PhD, Regents’ Professor of biomedical engineering in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University, is the grant’s co-investigator.

“The adaptations doctors are forced to perform make adult kidney replacement devices inaccurate and potentially dangerous when used with kids,” Paden says. “We have invented a new continuous renal replacement therapy device that is designed specifically with kids in mind. It can be used accurately on a six-pound child, all the way up to a football linebacker.”

In the United States, it is estimated that at least 5,000 children per year, or 1 percent of the 500,000 children admitted to intensive care units, require some form of renal replacement therapy. Children may need kidney replacement therapy because of severe infections that lead to the kidney-damaging inflammatory condition called sepsis, or because of congenital defects, which can only be permanently remedied by a kidney transplant.

Paden says adult dialysis equipment can have a tendency to withdraw too much fluid from a pediatric patient, leading to dehydration and loss of blood pressure. Other possible problems resulting from inaccurate dialysis equipment include clotting or internal bleeding. Part of the problem is that the volume of blood required to fill up the tubes leading to and from the apparatus is too large, Paden says. As the child gets smaller, the proportion of blood outside the body gets larger.

Existing dialysis equipment for adults takes up space comparable to a refrigerator, while Paden says the team’s goal is to have a pediatric device the size of a shoebox.

The inventors:

Lakshmi Prasad Dasi, PhD, former research engineer at Georgia Tech, now assistant professor of mechanical engineering at Colorado State University.
James Fortenberry, MD, pediatrician in chief and medical director of critical care for Children’s Healthcare of Atlanta, and clinical associate professor of pediatrics (critical care) at Emory School of Medicine
Matthew Paden
Ajit Yoganathan

The team’s plan is to test their prototype in the laboratory and prepare for live experiments over the next two years, with the goal of being ready for clinical trials in five years.

“This is a project where we are taking technology from the laboratory bench to the basinet,” Yoganathan says. “First, we have to build a machine capable of reliably performing these tasks without damaging blood cells in the process.”

The team’s prototype device is also designed to work in tandem with equipment that replaces the function of the heart and lungs for severely ill patients. Extracorporeal membrane oxygenation (ECMO) equipment is commonly used in neonatal intensive care units for newborns whose lungs can’t work properly. Children requiring ECMO often have fluid overload and swelling. The demand for ECMO has been rising because of H1N1 influenza, which in severe cases leads to respiratory failure.

Emory, Georgia Tech and Children’s Healthcare of Atlanta are in the process of patenting the kidney replacement device. As the technology is developed further, it could be licensed to an existing company or a new start-up company.

Fayette Front Page
Georgia Front Page
Arts Across Georgia

Tuesday, November 10, 2009

FDA Approves Drug Treatment for Rare Cancer

The U.S. Food and Drug Administration has approved Istodax (romidepsin), an injectable medication, for treatment of patients with a rare form of cancer known as Cutaneous T-cell Lymphoma (CTCL).

Cutaneous T-cell lymphoma is a slow-growing cancer of infection-fighting white blood cells called T-lymphocytes. Most cases start with dry skin, red rash, and itching that can become severe. The skin may develop tumors that can become ulcerated, causing infection. In some cases, CTCL spreads to the blood, lymph nodes, or internal organs. There are about 1,500 new cases of CTCL every year in the United States.

Patients with localized CTCL on the skin are treated with topical agents or phototherapy, but chemotherapy may be used if the cancer advances.

Istodax interferes with processes required for cell replication. It is intended to be used in patients when CTCL gets worse or comes back after at least one other type of chemotherapy has been used.

“This approval demonstrates FDA’s commitment to the development and approval of drugs for rare and uncommon diseases,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. The FDA approved Istodax on Nov. 6, 2009.

Previous approvals for CTCL included Zolinza (vorinostat), Ontak (denileukin difitox), and Targretin (bexarotene).

Istodax was evaluated based on two clinical studies involving a total of 167 patients. About 35 percent of patients in both of the trials experienced tumor responses, indicating a reduction of the size of tumors. Responses lasted a median of 15 months in one study and 11 months in the other study. Six percent of those studied had complete responses, indicating no apparent evidence of the tumor on physical, laboratory, and X-ray examinations.

Common side effects include nausea, fatigue, infections, vomiting, decreased appetite, decreased red blood cell count, decreased platelet count, and decreases in the components of white blood cells.

Istodax may cause changes in an electrocardiogram (ECG). Periodic blood tests should be done to monitor electrolytes, and periodic ECG monitoring should be considered in patients at risk for certain heart rhythm abnormalities. Istodax may harm a fetus and women should not become pregnant while taking the drug.

Istodax is marketed by Gloucester Pharmaceuticals Inc. of Cambridge, Mass.

Fayette Front Page
Georgia Front Page

Saturday, November 7, 2009

Emory Hospitals to Host Palliative Care Seminars Tuesday, Nov. 10

Emory University Hospital and Emory University Hospital Midtown will each host a public presentation as part of National Palliative Care Month. “Palliative Care: What Is It and Who Needs It?” will be held Tuesday, Nov. 10, at 5 p.m.

Palliative care is a medical specialty that focuses on the many ways serious illness affects patients and their families. The goal is to help the whole person by relieving the physical and non-physical suffering disease may bring through a network and team of physicians, nurses, social workers, chaplains and pharmacists. Emory's palliative care team physicians are certified by the American Board of Hospice and Palliative Medicine and the American Board of Internal Medicine.

Palliative Care: What Is It and Who Needs It?
The seminars will feature physicians and nurse practitioners on the Emory Palliative Care Team. Refreshments will be served, and there will be an opportunity for questions and answers after the presentation.

Tuesday, Nov. 10

5 p.m.

Emory University Hospital - Auditorium
1364 Clifton Rd. NE, Atlanta, Ga., 30322

Emory University Hospital Midtown - Glenn Auditorium
550 Peachtree St. NE, Atlanta, Ga., 30308
For additional information, please contact Debbie Gunter at 404-301-5014
Community News You Can Use
Follow us on Twitter: @gafrontpage

Friday, November 6, 2009

Maternity Center at Piedmont Fayette Hospital Offers Classes for Expecting Parents

Parents and expectant parents are invited to attend several informative classes offered by the Maternity Center at Piedmont Fayette Hospital (PFH). For more information on the Maternity Center at PFH, visit Community members are invited to take part in the following classes:

Prepared Childbirth Class - This course, recommended for women 20 to 28 weeks into pregnancy, provides an eight hour childbirth education class that teaches mom and her partner about what to expect during labor and delivery. The instructor will discuss the stages of labor, relaxation, breathing techniques, common concerns, comfort measures and much more. Participants will need to bring two pillows and a blanket or towel. The fee for the course is $85 and includes light refreshments. The class will be held Saturday, Nov. 21, from 9 a.m. to 5 p.m. in the Dietary Conference Room on the ground floor of the hospital. To register, call Link2Health toll-free at 1-866-900-4321. For more information call 770-719-6005.

Breastfeeding Basics - The Maternity Center at Piedmont Fayette Hospital offers a three-hour group participation discussion on the benefits and how-to's of breastfeeding. This class includes preparing for breastfeeding and getting started in the hospital and at home, special situations and growing a breastfeeding family. The class is best if done prior to delivery, but participants are welcome at any time. Fathers or support person are welcomed and encouraged to attend also. This class is now offered every month, and the next class is Saturday, Nov. 14, from 9 a.m. to noon in the conference room on the third floor of the hospitals 1279 building. For more information or to register, call 770-719-6005.

Moms in Motion - “Moms in Motion” is a fitness program designed to prepare women for the physiological changes that occur during pregnancy and postpartum. The class combines low impact aerobics, toning exercises, relaxation and breathing techniques and appropriate warm-ups/cool-downs perfect for both pregnant and postpartum women. The program provides not only a safe and effective exercise regime, but also provides valuable information on pregnancy, postpartum and child safety. Participants may register for this ongoing program at any time during or after pregnancy. Classes are held every Tuesday and Thursday from 5:15 to 6:15 p.m. in Suite 200 of the Piedmont Fayette Hospital Fitness Center at 1250 Hwy 54 West. Space is limited. The classes are FREE to fitness center members and $25 per month for non-members. Written approval from a physician is required. For more information or to register, call 770-719-7290.

Maternity Center Tours - The Maternity Center at Piedmont Fayette Hospital welcomes expectant mothers and their support partners to take a tour of the facility. The tour will be offered on Saturday, Nov. 14, at 12:30 p.m.; and Saturday, Nov. 21, at 6 p.m. The tour will provide information on the hospital's approach to maternity care and how physicians and staff help new mothers and their babies before and after delivery. Expectant mothers and their support partners are welcome. Please meet in the Maternity Center lobby (third floor, enter through the West Entrance). For more information call 770-719-6005.

Fayette County Safe Kids Child Passenger Safety Training Class - Fayette County Safe Kids will offer a car seat safety class to teach parents how to keep children safe, especially while traveling by car. The course will be offered Monday, Nov. 9, from 2 to 3:30 p.m. in Conference Room A on the third floor of the hospital's 1279 Building. This class is offered the second Monday of each month. For additional information contact Debbie Straight, 770-305-5148.

Sibling Class - Sibling classes are not being offered at the present time. For more information call 770-719-6005.
Community News You Can Use
Follow us on Twitter: @gafrontpage

HHS Orders Intravenous Antiviral Flu Medication to Help Patients Hospitalized with 2009 H1N1

The U.S. Department of Health and Human Services (HHS) today (November 5) announced contract awards for up to 120,000 treatment courses of intravenous (IV) antiviral drugs to help treat hospitalized 2009 H1N1 influenza patients.

Patients hospitalized with 2009 H1N1 influenza are evaluated to determine if antiviral drugs will be useful; some patients are not able to take the drugs that are currently available as pills or liquid and may benefit from intravenous antiviral medications.

To help meet the potential need for IV medications to combat the H1N1 virus, HHS ordered 10,000 treatment courses each from BioCryst, Roche and GlaxoSmithKline, totaling $31.5 million. The contracts allow HHS to place additional orders of up to 30,000 treatment courses with each manufacturer over two years. Roche manufactures Tamiflu; GlaxoSmithKline, Relenza, and BioCryst manufactures Peramivir.

Because there are no Food and Drug Administration (FDA)-approved antiviral medications that can be administered intravenously to treat influenza, the FDA issued an emergency use authorization on Oct. 23 to allow use of intravenous peramivir, an investigational antiviral drug in the class of drugs known as neuraminidase inhibitors.

The HHS orders for intravenous oseltamivir (Tamiflu) and intravenous zanamivir (Relenza), also neuraminidase inhibitors, are predicated on FDA emergency use authorization for these medications.

FDA has not issued emergency use authorization authorizing the use of intravenous Tamiflu or Relenza. Orders for Tamiflu and Relenza are based on anticipated need of emergency use authorizations for additional IV drugs in the future. Tamiflu and Relenza) are FDA-approved in the form of pills or liquid, and studies are ongoing into the use of these two drugs intravenously for hospitalized H1N1 flu patients.

The emergency use authorization for IV peramivir allowed doctors to prescribe the drug to treat certain adults and children hospitalized with confirmed or suspected 2009 H1N1 infections. Specifically, IV peramivir is authorized only for hospitalized adult and pediatric patients for whom therapy with an IV drug is clinically appropriate.

To authorize emergency use of any product, the FDA commissioner must determine that in an emergency, based on the totality of scientific evidence available, it is reasonable to believe that the product may be effective in diagnosing, treating, or preventing the serious or life threatening disease or condition; that the known and potential benefits of the product outweigh the known and potential risks of the product in the emergency situation, and that there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such serious or life threatening disease or condition.

The Biomedical Advanced Research and Development Authority (BARDA) within the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) will manage the contracts. BARDA supported the advanced development of IV peramivir beginning in 2007 as part of a larger HHS initiative to develop promising new influenza medications and vaccines.

Fayette Front Page
Georgia Front Page

Wednesday, November 4, 2009

Three-Week Course of Breast Radiation May Be as Effective as Conventional Five to Seven Week Course for Early Breast Cancers, Says U.S. Study

/PRNewswire/ -- According to a study presented November 4, 2009, at the 51st Annual Meeting of the American Society for Radiation Oncology (ASTRO), a shortened, more intensive course of radiation given to the whole breast, along with an extra dose of radiation given to the surgical bed of the tumor (concomitant boost), has been shown to result in excellent local control at a median follow up of two years after treatment with no significant side effects.

"The observations to date suggest that a three-week course of radiation therapy with concomitant boost results in outcomes comparable to that of a five to seven week course for early stage-breast cancers. Additional studies with a larger body of data and longer follow-up period will help establish whether this type of radiation treatment should be routinely used," Manjeet Chadha, M.D., lead author of the study and a radiation oncologist at the Beth Israel Medical Center in New York, said.

This shorter treatment, called accelerated hypofractionated whole breast irradiation, is an especially attractive option because women can receive a full course of radiation therapy in half the time -- three weeks of daily treatments vs. five to seven weeks. In addition, the cost of this treatment is lower relative to the cost of the standard whole breast radiation and is also less expensive than other new approaches, such as partial breast irradiation (breast brachytherapy).

"Studies from Europe and Canada have used accelerated schedules for breast radiation therapy with favorable results reported on longer follow up. In the U.S., however, there is limited data on this topic," Dr. Chadha said. "Additionally, the radiation therapy technique used in our study is different from previously published experiences. For each patient, we developed a conformal, personalized plan using three-dimensional dosimetry data derived from the patient specific CT scan images. Radiation treatment was delivered to the whole breast using an accelerated hypofractionated schedule, with the simultaneous delivery of a boost dose given to the precise location from which the tumor was removed."

Many women with early-stage breast cancer undergo breast conserving therapy. Typically, this means they first have surgery to remove the visible cancer (a lumpectomy), and then receive a course of radiation therapy to kill any microscopic cancer cells that may remain. The standard whole breast radiation treatment takes 15 to 30 minutes every day, Monday through Friday, for five to seven weeks.

Beginning in June 2004, researchers studied 112 women with early-stage breast cancer who received accelerated hypofractionated whole breast irradiation plus concomitant boost. The results were reported on 105 patients who had completed therapy and had a minimum six-month follow up. The patient group had small breast tumors that had not spread to the lymph nodes. Women with early-stage breast cancer who received chemotherapy or underwent radiation to the lymph nodes were excluded from the study. Patients were followed at regular intervals after completion of treatment.

Findings show that the cancer did not return to the original site or to the surrounding region in these women. The median follow-up of the study was two years. Survival was greater than 95 percent for patients with five years of follow up. The study also shows there were no significant physical or cosmetic side effects from the radiation treatment.

In an era of personalized care, Dr. Chadha emphasizes, "Women with early-stage breast cancer interested in this shorter course should ask their radiation oncologists about this option to evaluate whether it is suitable for their individual case."

For more information on radiation therapy for breast cancer, visit

The abstract, "Results using 3-week Accelerated Whole Breast (WB) Radiation Therapy (RT) and Concomitant Boost for Early-stage Node Negative Breast Cancer," will be presented at a scientific session at 11:30 a.m. on Wednesday, November 4. To speak to the lead author of the study, Manjeet Chadha, M.D., please call Beth Bukata or Nicole Napoli November 1-4, 2009, in the ASTRO Press Room at McCormick Place West at 312-791-7005 or 312-791-7006. You may also e-mail them at or

Fayette Front Page
Georgia Front Page
Arts Across Georgia

Statins May Worsen Symptoms in Some Cardiac Patients

/PRNewswire/ -- Although statins are widely used to prevent heart attacks, strokes, and other cardiovascular disorders, new research shows that the class of drugs may actually have negative effects on some cardiac patients. A new study presented at CHEST 2009, the 75th annual international scientific assembly of the American College of Chest Physicians (ACCP), found that statins have beneficial effects on patients with systolic heart failure (SHF), but those with diastolic heart failure (DHF) experienced the opposite effect, including increased dyspnea, fatigue, and decreased exercise tolerance.

"Systolic heart failure is most often due to coronary artery disease and appears to have more of an inflammatory component than diastolic heart failure," said Lawrence P. Cahalin, PhD, PT, Northeastern University, Boston, MA. "It is possible that statins would help patients with systolic heart failure more than patients with diastolic heart failure due to the cholesterol-lowering and anti-inflammatory effects of statins."

Researchers from Northeastern University and Massachusetts General Hospital, Boston, MA, retrospectively reviewed the charts of 136 patients with heart failure in order to examine the effect of statins on pulmonary function (PF) and exercise tolerance (ET) in patients with DHF vs. SHF. A non-statin group (82 percent of patients had DHF) of 75 patients was compared with a statin group (72 percent of patients had DHF) of 61 patients. Atorvastatin was prescribed in 75 percent of the patients on statins.

Results of the analysis showed that overall PF and ET of patients in the statin group were significantly lower than patients in the non-statin group. Further subgroup analyses revealed that PF measures in the DHF statin group were 12 percent lower than PF measures in the DHF non-statin group. Furthermore, the amount of exercise performed by patients with DHF who were on a statin was almost 50 percent less than patients with DHF not on a statin.

"Some patients with diastolic heart failure may be more prone to the adverse effect of statins on muscle. It may be that patients with particular preexisting factors will experience unfavorable results from statin therapy, including exercise intolerance, dyspnea, and fatigue," said Dr. Cahalin.

Although the PF and ET measures in the SHF statin group were not significantly greater than in the SHF non-statin group, the PF measures were 11 percent to 14 percent higher, and the peak ET measures were 2 percent to 7 percent higher than the PF and ET measures of the SHF non-statin group, suggesting that statins did benefit patients with SHF.

"Not all statins are alike and not all patients are alike. Some statins are stronger than others and are likely to act differently, given particular patient characteristics, and produce different degrees of wanted and unwanted effects," said Dr. Cahalin. "In our continuing study, we hope to identify patient characteristics that are associated with favorable and less than favorable results from statin therapy."

Although the new data suggest that statins may actually worsen symptoms in patients with DHF, researchers feel that the benefits of using statins in patients with SHF and DHF outweigh the risks.

"Due to beneficial effects on lipids and other cardiovascular factors, statins are becoming a standard treatment for many patients with or without systolic or diastolic heart failure. It is likely that the use of statins for these conditions will continue to increase," said Dr. Cahalin. "However, if patients taking a statin are short of breath, fatigued, and unable to exercise or perform functional tasks, then exams of muscle strength and endurance, as well as pulmonary function and exercise tolerance, are warranted."

"Statins provide significant benefits for patients with cardiovascular disease," said Kalpalatha Guntupalli, MD, FCCP, President of the American College of Chest Physicians. "However, as for any new medication prescribed, clinicians should closely monitor the effects that different types of statins have on individual patients."

CHEST 2009 is the 75th annual international scientific assembly of the American College of Chest Physicians, held October 31-November 5 in San Diego, CA. The ACCP represents 17,400 members who provide patient care in the areas of pulmonary, critical care, and sleep medicine in the United States and throughout the world. The ACCP's mission is to promote the prevention and treatment of diseases of the chest through leadership, education, research, and communication. For more information about the ACCP, please visit the ACCP Web site at

Fayette Front Page
Georgia Front Page

Monday, November 2, 2009

Rep. Tom Price on Health Care

FDA: Byetta Label Revised to Include Safety Information on Possible Kidney Problems

The U.S. Food and Drug Administration today acted on new safety information about possible kidney function problems, including kidney failure, in patients taking Byetta (exenatide), a drug used to treat Type 2 diabetes.

From April 2005 through October 2008, the FDA received 78 reports of problems with kidney function in patients using Byetta. Some cases occurred in patients with pre-existing kidney disease or in patients with one or more risk factors for developing kidney problems.

Nearly 7 million prescriptions for Byetta were dispensed between April 2005 and September 2008. The 78 cases represent a small percentage of the total number of patients using the drug to control blood sugar (glucose) levels.

The most common side effects associated with Byetta include nausea, vomiting, and diarrhea. These side effects may have contributed to the development of altered kidney function. Kidney malfunction can result in a build-up of waste products in the blood, leading to serious illness or life-threatening conditions.

“Health care professionals and patients taking Byetta should pay close attention to any signs or symptoms of kidney problems,” said Amy Egan, M.D. M.P.H., of the Division of Metabolism and Endocrinology Products at the FDA’s Center for Drug Evaluation and Research. “Patients also should be aware that problems with kidney function could lead to changes in urine color, frequency of urination or the amount of urine, unexplained swelling of the hands or feet, fatigue, changes in appetite or digestion, or dull ache in mid to lower back.”

Patients who experience any of these symptoms should immediately discuss them with their health care professional.

To help health care professionals and patients better weigh the known risks and benefits of Byetta, the FDA worked with the manufacturer to update the drug’s prescribing information (label). A description of these label changes can be found online.

Byetta is manufactured by San Diego-based Amylin Pharmaceuticals Inc.

Fayette Front Page
Georgia Front Page

Alert: Two Overdoses of Tamiflu in Pediatric Patients in Pennsylvania

/PRNewswire/ -- Two pediatric patients in Pennsylvania hospitals received overdoses of the drug Tamiflu to treat their flu symptoms because of unawareness among staff as to the concentration of the drug given in an alternative liquid form. Both children were unharmed as a result of the errors, but details of the near misses have been published in a supplementary Pennsylvania Patient Safety Advisory to raise awareness of the issue.

For patients who have trouble swallowing Tamiflu capsules (usually elderly and children), a liquid form of the drug is available. For facilities that have a shortage of Tamiflu in liquid form, the U.S. Food and Drug Administration has approved directions listed in the product labeling for using the powder in the Tamiflu capsule to make a liquid form, which is a different concentration. However, reports show staff are unaware of the differences in the concentrations of these two products.

As of October 20, 2009, the Pennsylvania Patient Safety Authority has received two reports describing the dosage errors related to the varying Tamiflu concentrations. In each case, physicians prescribed 12 mg of the product to the patient in liquid form. However, due to shortages of the liquid form, which is available in a 12 mg/mL concentration, pharmacists compounded and dispensed a liquid form made from the powder of available capsules as a 15 mg/mL concentration, which was administered without adjusting the dose.

"We believe hospital staff -- prescribers, nurses, and pharmacists -- may be unaware of the potential for dosage errors due to the shortage of the drug in liquid form," Mike Doering, executive director of the Pennsylvania Patient Safety Authority said. "Doctors who are prescribing the Tamiflu in a liquid are unaware that the manufacturer-produced liquid form of the product is not available."

The Authority's subcontractor, the Institute for Safe Medication Practices (ISMP), alerted healthcare professionals on October 15, 2009, about the risk of overdoses and under doses.

"In light of flu season, this is a real-time problem so the Authority and ISMP are working to get the word out as quickly as possible so that healthcare professionals across the board are aware of the potential risks of compounding their own liquid form of the drug," Doering said. "Some strategies previously released by ISMP to help healthcare providers reduce and eliminate the risks are also provided in the Advisory."

Fayette Front Page
Georgia Front Page
Arts Across Georgia