Prevalence of Disordered Eating Behaviors in Diabetics Probed

Children with diabetes are at an increased risk for developing eating disorders and researchers want to know if it's their disease or treatment that's to blame.

"Diabetes treatment prescribes obsessive food behavior, such as carbohydrate restriction," said Dr. Deborah Young-Hyman, pediatric psychologist in the Medical College of Georgia's Georgia Prevention Institute. "We want to know if those prescribed behaviors contribute to disordered eating and/or whether there are physiological mechanisms which prevent children with diabetes from controlling their eating behavior. For example, treatment with insulin makes you hungry and can cause you to gain weight."

There is some unfortunate synergy: diabetes makes it difficult to control blood glucose and disordered eating behavior does as well, Dr. Young-Hyman said.

Over the next three years, with funding from the American Diabetes Association, she and researchers at Emory and Harvard universities will study 90 children age 10-17 newly-diagnosed with diabetes or transitioning to an insulin pump. They will monitor treatment patterns, weight, psychological adjustment and attitudes about weight and eating. They'll also look at changes in eating patterns and blood sugar levels in response to insulin.

Children and their parents will answer computer-based questionnaires about eating behaviors and psychological adjustment - in the context of their disease and its treatment.

These include questions about parental attitudes, family factors, personality of the child and parents and perceived societal attitudes.

"As they are diagnosed and are adjusting to diabetes treatment, children are already dealing with all sorts of issues that put them at an increased risk for eating disorders. The psychological issues that come with the diagnosis can add to that risk," she said. "There is also the existing drive for thinness that exists in our society, dealing with the diagnosis and management of a long-term illness and the psychological adjustment that comes with that."

Even the insulin the children must take may be a factor. "Large doses can lead to uncontrolled hunger, which can be mislabeled as disordered eating behavior. Patients with type 1 diabetes also lose amylin production - a hormone responsible for gastric emptying and associated with feelings of fullness - that can also lead to increased feelings of hunger," Dr. Young-Hyman said.

Study findings could support a different treatment approach.

"We might come to understand that putting a child or adolescent on an insulin pump sooner rather than later and providing them with a more flexible nutrition regimen could decrease their insulin needs and prevent excess hunger," she said. "If we don't approach weight control as dieting, place less emphasis on food restriction and focus on healthy nutrition and usual eating patterns, we can help patients gain more control over their eating behaviors and their treatment without adoption of maladaptive weight management strategies. Studies indicate that feeling in control of your illness is one of the keys to successful treatment and good psychological adjustment."

Jennifer Hilliard
Medical College of Georgia

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Blocking Immune Inhibitor Improves Response to HIV-Like Virus

By blocking PD-1 (programmed death-1), an immune receptor molecule known to inhibit the immune response to chronic viral infections, scientists have safely and significantly reduced the plasma viral load and also prolonged survival of rhesus macaque monkeys severely infected with simian immunodeficiency virus (SIV), the nonhuman primate version of human immunodeficiency virus (HIV). The therapeutic strategy worked by boosting the function of anti-viral killer cells (CD8 T cells) and improving antibody response to the virus.

Scientists at the Yerkes National Primate Research Center of Emory University, the Emory Vaccine Center, Dana-Farber Cancer Institute, Harvard Medical School and the University of Pennsylvania Medical School conducted the research, which will be published in the current online issue of Nature, Dec. 10.

"Our findings raise the possibility that PD-1 blocking antibody treatment not only could improve the anti-viral T cell response to chronic HIV infections, but it also could generate an effective antibody response against the mutated virus of the infected host," says Rama Amara, PhD, principal investigator of the study.

"It also is important to note that this therapy was effective without anti-retroviral drugs and in monkeys with severe AIDS. It is critical to induce protective immune responses targeting the mutated virus for developing a successful immune therapy to control HIV infection," Amara continues.

In the current study, which builds on findings from previous studies with mice, the researchers tested the potential of blocking PD-1 to control HIV infection using a macaque monkey model of SIV. They injected nine SIV-infected monkeys with an antibody to human PD-1 four times over 10 days. Gordon Freeman, PhD, of the Dana-Farber Cancer Institute and Harvard Medical School, provided the antibody.

Of the nine animals, five were infected for three months and four were infected for about 21 months at the time of antibody treatment. Another five SIV-infected monkeys received a control antibody at the same dose and schedule. The researchers then tested the function of the anti-SIV killer cells, antibody responses to the virus and plasma viral load.

Results showed that the improved anti-viral immune responses were associated with a reduction in plasma viral load and prolonged the survival of the infected animals. All nine animals receiving the PD-1 antibody survived more than seven months following initiation of treatment (the current time of the study), while four of the five animals receiving the control antibody died within four months following initiation of treatment.

The antibody treatment appeared to be safe and well tolerated. Within seven days of treatment, the number of anti-SIV killer T cells increased significantly and had improved function. This improvement was noted both in the blood and the gut, which is a major repository of SIV and HIV. The PD-1 antibody treatment also increased the proliferation of memory B cells and the level of antibody against SIV, a finding that had not been reported in earlier mouse studies.

"These findings are important not only because they highlight a potential therapy for HIV, but also because of the insights they offer for other challenging chronic infectious diseases such as hepatitis C virus and tuberculosis," says Emory Vaccine Center Director Rafi Ahmed, PhD, who is a Georgia Research Alliance Eminent Scholar. "Through the Grand Challenges in Global Health initiative, which also funded the current study, we soon will begin testing the effectiveness of the PD-1 blockade against HCV in nonhuman primates."

Several years ago, Ahmed and his colleagues discovered that the immune receptor PD-1 essentially functions as a molecular switch to turn off an effective immune response by overwhelming T cells in their fight against chronic viral infections. By injecting an antibody that binds to PD-1 into mice infected with chronic lymphocytic choriomeningitis virus (LCMV), they were able to switch the immune response back on and control the virus. Dr. Ahmed is a co-principal investigator of the current study.

Other studies have since shown that anti-viral CD8 T cells express high levels of PD-1 during many human chronic infections, including HIV, hepatitis C virus and tuberculosis. However, until now the safety and effectiveness of blocking PD-1 in an appropriate animal model for these human viral infections had not been shown.

The current research team plans to continue testing the antibody therapy in combination with anti-retroviral drugs to try and improve its effectiveness. They also will explore the benefits of prolonged treatment (up to three months as opposed to 10 days in the current study). In addition, they are studying the effectiveness of antibodies against PD-1 ligands (target molecules), a strategy that was part of the earlier mouse research.

The National Institutes of Health (NIH), the Bill & Melinda Gates Foundation, the Foundation for the NIH through the Grand Challenges Global Health Initiative, the Yerkes National Primate Research Center and the Emory Center for AIDS Research supported the current research.

First authors of the paper are Vijayakumar Velu and Kehmia Titanji of the Yerkes National Primate Research Center and the Emory Vaccine Center.

Reference: Enhancing SIV-specific immunity in vivo by PD-1 blockade. Velu, V., Titanji, K., Zhu, B., Husain, S., Pladevega, A., Lai, L., Vanderford, T.H., Chennareddi, L., Silvestri, G., Freeman, G.J., Ahmed, R., Amara, R.R. Nature Online Publication Dec. 10, 2008.

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Georgia State Hosts International Symposium on Ingestive Behavior

Georgia State University will host the Second Annual Frontiers in Ingestive Behavior Symposium Friday, Dec. 12, featuring international experts exploring the environmental and physiological controls of eating and drinking behavior.

The event of the Society for the Study of Ingestive Behavior will be held in Room 212 of the Natural Science Center.

With obesity becoming an increasing problem worldwide, members of the SSIB are working to better understand the physiology and underlying controls which can help explain ingestive behaviors, said Tim Bartness, Georgia State Regents’ Professor of Biology and president of the SSIB.

“The hope is that we will be able to take this research and translate it into treatments for overeating, as well as under eating, in some cases,” Bartness said.

Leading SSIB scientists from across Europe and the United States will present on a wide variety of topics, such as the roles of neurotransmitters in food intake, biological aspects of night eating syndrome, and gene-environment interactions in promoting obesity.

“These colleagues are the cream of the crop in the field, and have made significant contributions in the field, as well as to the organization,” Bartness said.

The symposium is supported by the Georgia State University Research Foundation, the Georgia State Neuroscience Institute, the Georgia State College of Arts and Sciences, the Georgia State Departments of Biology and Psychology, the Center for Behavioral Neuroscience and the Georgia State Center for Neuromics.

For more information about the Society for the Study of Ingestive Behavior, visit www.ssib.org. For a list of speakers and a program of the symposium, contact Jeremy Craig at jcraig@gsu.edu or 404-413-1357.

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Leading U.S. Cancer Organizations Unite Against the Growing Global Cancer Burden

/PRNewswire-USNewswire/ -- Despite the recent good news that cancer incidence and death rates for men and women in the United States continue to decline, cancer is projected to become the leading cause of death worldwide in the year 2010, and low- and middle-income countries will feel the impact of higher cancer incidence and death rates more sharply than industrialized countries. The nation's leading cancer organizations joined forces today at an event called Conquering Cancer: A Global Effort, to focus attention on the growing global cancer burden and discuss efforts needed to address the problem. The International Agency for Research on Cancer (IARC) released the new edition of the World Cancer Report. The American Cancer Society, the Lance Armstrong Foundation, and Susan G. Komen for the Cure discussed how each organization is addressing the global cancer problem and together issued a call to action for the incoming United States presidential administration and Congress. In addition, a new international documentary film entitled "Cancer Is..." was premiered.

According to the new report, the burden of cancer doubled globally between 1975 and 2000. It is estimated that it will double again by 2020 and nearly triple by 2030. This translates to far greater numbers of people living with - and dying from - the disease. The report estimates that there were some 12 million new cancer diagnoses worldwide this year, and more than seven million people will die from the disease. The projected numbers for the year 2030 are 20-26 million new diagnoses and 13-17 million deaths.

The growing cancer burden includes global increases of incidence of about one percent each year, with larger increases in China, Russia, and India. Reasons for the increased rates include adoption of Western habits in less developed countries, such as tobacco use and higher-fat diets, and demographic changes, including a projected population increase of 38 percent in less developed countries between 2008 and 2030.

In addition to increases in cancer incidence and death rates, the report identifies challenges in cancer care, especially in Africa, where pain management and palliative care are very limited because any use of narcotics is prohibited by law in several countries.

Sharing the stage were John R. Seffrin, Ph.D., chief executive officer, American Cancer Society; Lance Armstrong, founder and chairman, Lance Armstrong Foundation; Hala Moddelmog, president and chief executive officer, Susan G. Komen for the Cure; Peter Boyle, B.Sc., Ph.D., D.Sc.(Med), director, International Agency for Research on Cancer; Alejandro Mohar Betancourt, M.D., Sc.D., director, National Cancer Institute of Mexico, and Bill Gregory, a throat cancer survivor.

The American Cancer Society's Seffrin said, "For all of our 95 years the Society has pursued the vow of our founders to eliminate cancer in all humankind. We recognize that cancer strikes without regard to borders or socioeconomic status, and we support cancer control initiatives in more than 20 countries, and fund capacity building and tobacco control grants in some 70 countries - including the launch next week of our tobacco Quitline(R) in India. It is my hope that by bringing proven interventions to places in the world impacted most by this disease, we can diminish needless suffering and save many lives."

Armstrong explained his foundation's international work, saying, "Since announcing the launch of our international cancer awareness campaign at the Clinton Global Initiative less than three months ago, we are already in discussions with more than 20 nations, NGOs and business leaders to advance this issue. Even in a challenging economy, people realize that with cancer there is progress to be made and prevention measures to be taken."

"Breast cancer alone will be diagnosed in 25 million women over the next 25 years. Susan G. Komen for the Cure already has changed the way we talk about and treat breast cancer in the United States, and we're bringing what we've learned to developing countries in Asia, Africa, Latin America, the Middle East and Eastern Europe. This 'global health diplomacy' approach, with its focus on better access to care, is already educating and empowering women worldwide, and it is critical if we're to save lives and resolve the growing global cancer crisis," said Hala Moddelmog, president and CEO of Susan G. Komen for the Cure.

Explaining the results of the report, Dr. Boyle said, "The rapid increase in the global cancer burden represents a real challenge for health systems worldwide. However, there is a clear message of hope: although cancer is a devastating disease, it is largely preventable. We know that preventive measures such as tobacco control, reduction of alcohol consumption, increased physical activity, vaccinations for hepatitis B and human papillomavirus (HPV), and screening and awareness could have a great impact on reducing the global cancer burden."

"We appreciate the opportunity to stand with leading cancer organizations in the United States to make global cancer a priority. In Mexico, we have seen the power of the government working with the NGO's, and look forward to collaborating globally to conquer cancer," said Dr. Mohar of Mexico's National Cancer Institute.

The six call to action steps issued by the three U.S. organizations include: 1) making vaccines that prevent cancer causing infections more widely available to low-income nations, including specifically combating cervical cancer through Global Alliance for Vaccines and Immunizations (GAVI) efforts to make the HPV vaccine accessible and affordable; 2) committing to a comprehensive tobacco control approach in the U.S., which includes taking measures proven effective in reducing smoking rates and having Congress grant the Food and Drug Administration (FDA) authority to regulate tobacco; 3) ratifying immediately the Framework Convention on Tobacco Control (FCTC), the first ever global public health treaty that sets forth comprehensive measures to reduce health and economic impacts of tobacco; 4) supporting efforts of non-governmental organizations to build advocacy and resources, empower survivors and reduce suffering in low- to middle-income countries by working with governments, medical professionals and the corporate sector to enable individuals to adopt healthier behaviors; 5) promoting culturally sensitive risk reduction and education campaigns by leveraging our own successful U.S. efforts to help build capacity of nongovernmental organizations in other countries; and 6) investing in cancer research and expanding access to prevention and early detection measures in the U.S., with a specific focus on increasing federal funding of medical research.

The news conference also featured the domestic launch of a new documentary film series focused on the global cancer problem titled "Cancer Is..." The documentary is narrated by former U.S. President George H. W. Bush, and was produced by France's Cemil Alyanak, a renowned expert on global health communications.

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Overweight Siblings of Children With Type 2 Diabetes Likely to Have Abnormal Blood Sugar Levels

/PRNewswire-USNewswire/ -- Overweight siblings of children with type 2 diabetes are four times more likely to have abnormal glucose levels compared to other overweight children. Because abnormal glucose levels may indicate risk for diabetes or diabetes itself, these children could benefit from screening tests and diabetes prevention education.

Researchers from The Children's Hospital of Philadelphia published their findings today in the online edition of the Journal of Pediatrics.

"To our knowledge, previous studies have not specifically looked at the risk of abnormal glucose tolerance among siblings of children diagnosed with type 2 diabetes. This group has a unique combination of genetic and environmental risk factors," said Sheela N. Magge, M.D., M.S.C.E., pediatric endocrinologist at The Children's Hospital of Philadelphia and primary author of the study. "Clinical experience suggests that children with type 2 diabetes often have an obese sibling, which makes siblings an appropriate target for prevention trials."

The study looked at 62 children: 20 obese subjects with a sibling who had type 2 diabetes and a control group of 42 obese children. The groups were similar for age, gender, racial distribution (predominantly African American), pubertal status and body mass index over 95th percentile.

The researchers found that overweight siblings of children with type 2 diabetes had four times greater odds of having abnormal glucose levels (impaired glucose tolerance or type 2 diabetes) than other overweight children. However, investigators found no significant differences in insulin resistance, as measured by the homeostasis model assessment.

Type 2 diabetes is caused by a combination of both genetic and environmental factors. Known risks include obesity, decreased physical activity, race/ethnicity, family history and insulin resistance. Obesity decreases insulin sensitivity, as does puberty, when all adolescents experience a period of relative insulin resistance. In obese adolescents already at risk of developing type 2 diabetes, the increase in insulin resistance during puberty may be enough to unmask disease. Family history is also important; 74-100 percent of children with type 2 diabetes have a first- or second-degree relative who also has the condition.

Not all children with a family history of type 2 diabetes, insulin resistance or obesity develop type 2 diabetes, cautions Dr. Magge.

The researchers also add that identifying groups at high-risk for type 2 diabetes during childhood, such as obese siblings of children with type 2 diabetes, could help guide screening of obese children for abnormal glucose tolerance by primary care providers. This could also help to identify children who might benefit from participation in future type 2 diabetes prevention studies.

Dr. Magge's coauthors were: Nicolas Stettler, M.D., M.S.C.E., Abbas Jawad, M.Sc., Ph.D., and Lorraine E. Levitt Katz, M.D. all of The Children's Hospital of Philadelphia and the University of Pennsylvania.

The research was supported by grants from the National Institutes of Health and the National Center for Research Resources.

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Families Fighting Flu and CDC Encourage Parents to Vaccinate Kids Against Flu

/PRNewswire-USNewswire/ -- Families Fighting Flu, Inc. (FFF), together with the Centers for Disease Control and Prevention (CDC) are designating today, December 9, the second annual Children's Flu Vaccination Day to remind parents that it's not too late to get their children vaccinated against influenza, or "the flu." The day highlights the critical need for all children aged six months through 18 years to get vaccinated against the flu. According to the CDC, vaccination is the single best means of protecting children from the flu and preventing the spread of influenza, which can lead to hospitalization and even death. Children's Flu Vaccination Day occurs during the CDC's annual National Influenza Vaccination Week (December 8-14, 2008).

"There is a misconception that after Thanksgiving it's too late to get children vaccinated against the flu. That is one of the reasons why we have designated today as Children's Flu Vaccination Day - to remind parents that it's not too late to get their children vaccinated. In fact, flu activity typically does not reach its peak until January or February, and it can occur as late as May," said Anne Schuchat, M.D. Assistant Surgeon General and Director, National Center for Immunization and Respiratory Diseases at the CDC.

Children die every year in the United States from influenza and its complications. In fact, over the past five flu seasons more than 400 children have died from influenza, and more than 20,000 children under the age of five are hospitalized due to influenza each year. Only 22 percent of children six to 23 months of age were fully vaccinated against influenza during the 2007-2008 flu season, even though the CDC recommends that all of these children get vaccinated every year.

But, it's not just kids who need to get immunized. Parents should also get vaccinated against the flu to better protect their family and loved ones from spreading the disease. A new national FFF survey of mothers of children in child care revealed that 56 percent of mothers said they have not received an influenza vaccination for themselves within the past two years.

"We know that come December many parents, unfortunately, think that flu season has already passed. But the reality is it hasn't even started in some areas of the country and is just starting in others. Our hope is that by designating today as Children's Flu Vaccination Day we will help remind parents that their children are still susceptible to getting the flu, and that the best way to help protect their family is to get themselves and their children vaccinated as soon as possible," said Julie Moise, FFF board member. Moise's 6-and-1/2-month-old son, Ian, died suddenly in December 2003 from influenza.

FFF has created a new e-card that's available at www.familiesfightingflu.org designed to be distributed starting today and throughout the rest of flu vaccination season (March 2009) to parents to remind them to get their children vaccinated against the flu. Contact your healthcare provider or local health department to find out when and where to get a flu vaccine.

Who Should Get Vaccinated?

The CDC recommends that all children aged six months through 18 years get vaccinated against the flu every year, as well as all persons who want to reduce the risk of becoming ill with the flu or transmitting it to others. This includes (but is not limited to): children with certain medical conditions; household contacts (parents, siblings, grandparents, etc.) and caregivers of children less than five years old; and household contacts of other high-risk individuals.

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Hospira Issues Voluntary Recall of One Lot of 20meq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP

Hospira Issues Voluntary Recall of One Lot of 20meq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP Due to Incorrect Bar Code Label

Hospira, Inc., a global specialty pharmaceutical and medication delivery company, is following up on a nationwide voluntary recall issued Sept. 18 of one lot (lot number 65-620-FW, expiration date May 1, 2010, NDC 0409-7902-09) of 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP in 1000 mL flexible plastic containers because a small number of the containers may be incorrectly labeled with a bar code for 5% Dextrose Injection, USP (NDC 0409-7922-09). The incorrect bar code could lead to a medication error resulting in the wrong drug being delivered to a patient if a bar code system is used to confirm the medication. Potential adverse events related to an error of this type include electrolyte imbalance, cardiac dysfunction, gastrointestinal disturbances, paresthesia and mental confusion.

The product contains 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride. The product name and National Drug Code (NDC) number printed on the container are correct. The affected lot was shipped to U.S. customers between July 2008 and September 2008. No other lots are affected by this recall.

Hospira has not received any reports of adverse health events in connection with the recalled lot. Hospira has identified the root cause of the error and taken action to prevent its recurrence.

Anyone with an existing inventory should quarantine the product immediately and call Hospira Customer Care at 1-877-946-7747 for instructions on how to return it. Customers who have medical questions should contact Hospira Medical Communications at 1-800-615-0187. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

Any adverse reactions experienced with the use of these products, and/or quality problems may also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

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Rite Aid to Spread Holiday Cheer to Patients at Children's Healthcare of Atlanta

Associates Bearing Toys, Games & Holiday Happiness Visit Children’s as Part of Rite Aid's Commitment to Children's Miracle Network

A team of Rite Aid elves from the Atlanta area will visit Children’s Healthcare of Atlanta at Egleston, to bring the magic of the holidays to children who may not be able to celebrate the season at home with their families and friends. The Rite Aid elves will festively frolic to Children’s at 1 p.m. Friday, December 12, to give gifts of toys and games to every child.

“Children love the magic of the holidays, and every child deserves to have fun and enjoy the season. Rite Aid associates support Children’s Healthcare of Atlanta year round, but it’s especially important for us to make the holiday season as special as possible for children who may have to be in the hospital during this time of the year,” said Toni Bowen, Rite Aid Regional Pharmacy Vice President.

"We are so pleased that Rite Aid will help bring holiday cheer to Children’s Healthcare of Atlanta,” said Terilyn Walton, Program Coordinator at Children’s Healthcare of Atlanta. “Representatives of Rite Aid stores in the area will visit the children and give them gifts, but they will receive the greatest gifts of all in return when they see the children’s faces light up!"

The holiday visit is part of Rite Aid’s corporate sponsorship and ongoing commitment to Children’s Miracle Network, a non-profit organization helping to raise funds and awareness for 170 hospitals caring for children in North America. Rite Aid has raised more than $35 million since 1994 for pediatric hospitals supported by the Children’s Miracle Network. One hundred percent of funds raised at Rite Aid stores go directly to the local hospitals. Rite Aid associates across the country will be visiting 18 different pediatric hospitals during the holidays.

Rite Aid Corporation is one of the nation’s leading drugstore chains with more than 4,900 stores in 31 states and the District of Columbia with fiscal 2008 annual sales of more than $24.3 billion. Information about Rite Aid, including corporate background and press releases, is available through the company’s website at http://www.riteaid.com.

Children’s Healthcare of Atlanta, a not-for-profit organization, is committed to enhancing the lives of children through excellence in patient care, research and education. Managing more than half a million patient visits annually at three hospitals and 15 satellite locations, Children’s is one of the largest clinical care providers for children in the country. Children’s offers access to more than 30 pediatric specialties, and has been consistently ranked among the top children’s hospitals by Child magazine and U.S.News & World Report. With generous philanthropic and volunteer support, Children’s has made an impact in the lives of children in Georgia, the United States and throughout the world. Visit www.choa.org or call 404-250-KIDS for more information.
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Terumo Cardiovascular Systems Issues Urgent, Nationwide/Worldwide Recall of Pediatric Arterial Cannulae

Terumo Cardiovascular Systems (Terumo CVS) is issuing an urgent, nationwide/worldwide recall of its Tenderflow™ Pediatric Arterial Cannulae involving 21 lot codes (see information below). Terumo received five reports of difficulty retracting the introducer from the cannula. When the introducer cannot be retracted from the cannula, the cannula must be removed and replaced, a process that may lead to aortic damage, blood loss and/or death.

There have been no reports of patient injury or death associated with the product.

Tenderflow™ Pediatric Arterial Cannula Catalog and Lot Numbers Affected

Catalog Number Lot Number

813568 0501639, 0512002

813567 0501557, 0512008

813570 0502200, 0513069

813569 0502199, 0513068, 0517852

813572 0507121, 0512918

813571 0507120, 0512919, 0518680

813574 0509240

813573 0509238, 0517874

813576 0509241

813575 0500759, 0513331

813578 0500760

813577 0502878

An arterial cannula is a disposable tube inserted in the aorta during many cardiac bypass surgery procedures and is used to perfuse the ascending aorta. The cannula is inserted using an introducer, which stabilizes the cannula during insertion and is then removed.

Terumo CVS distributed this product directly to 68 U.S. hospitals, and has notified all of the hospitals of the voluntary recall in a letter dated Oct. 16, 2008. The product was also distributed from distribution centers in Australia, Canada and Europe. The notification letter recommended that customers not use the product unless medically necessary. In those cases, the cannula should be used without the introducer. Clinicians with questions may contact the company at 800-521-2818, or if calling from outside the U.S., 734-663-4145. Contact can be made Monday-Friday from 8:00 a.m. to 5:00 p.m. EST.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

* Online: www.fda.gov/medwatch/report.htm
* Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
* Fax: 1-800-FDA-0178

Terumo informed the U.S. Food and Drug Administration of this recall. Terumo Cardiovascular Systems Corporation is a global manufacturer and marketer of medical devices for cardiac and vascular surgery. The company is headquartered in Ann Arbor, Michigan with manufacturing operations in Ann Arbor; Elkton, Maryland; Ashland, Massachusetts; and Tustin, California. For more information, visit www.terumo-cvs.com.

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Diabetes Education Program at Piedmont Fayette Helps Peachtree City Resident Rethink Holiday Feast

Emmi Farnham was shocked to find out that she had diabetes. She had been experiencing increased fatigue and irritability, nothing seemingly out of the ordinary when she went to get routine blood work. Her doctor ran some blood tests, and this past July, the Peachtree City resident was diagnosed with diabetes and referred to the Piedmont Fayette Hospital (PFH) Diabetes Care Program. The program combines personalized attention, extensive training and follow-up care to provide the resources and education needed to manage diabetes with comfort and success.

“I was shocked, frustrated and angry,” said Farnham. “I had always tried to do the right thing, I don’t eat rice or pasta; I don’t even drink orange juice, and I was convinced the diagnosis couldn’t be right.”

Diabetes, a condition in which the body does not produce or properly use insulin – a hormone that is needed to convert sugar, starches and other food into energy needed for daily life – is a complex disease that requires constant care. With proper management, patients can feel healthier and reduce risks for developing such serious complications as heart disease, eye disorders, kidney disease, nerve damage and the possible loss of an arm or leg.

Promptly referred to Denise Bennett, MS, RD, LD, CDE, diabetes education coordinator with Piedmont Fayette Hospital, Farnham received a one-on-one consultation where she learned the processes of the body, details of diabetes as well as food exchanges, meal planning strategies, proper timelines and healthy practices to maintain her diabetes.

“Diabetes education is crucial to understanding how the disease affects the body and how to maintain good health while preventing further risk of serious complications,” said Bennett. “Our Diabetes Care program provides the resources our patients need to control and manage their diabetes successfully.”

A variety of factors can cause diabetes; genetics, physical health, lifestyle or even stress.
In the United States, 7.8 percent of the population (approximately 23.6 million children and adults) has diabetes. Unfortunately, nearly a quarter of the 23.6 million, approximately 5.7 million are unaware they have the disease.

“With the holidays approaching, individuals, especially those with diabetes need to focus on what they are eating and be mindful to eat healthy and sensible meals,” said Bennett.

This will be Farnham’s first holiday season living with diabetes.

“I know it’s going to be difficult to mind my eating habits this year,” she said. “Especially with all the delicious food and tempting sweets, but I just have to remember that when you cheat, you’re only cheating yourself.”

Farnham enrolled in PFH’s Intensive Diabetes Care Class, a day long session that is taught by certified diabetes educators. It reinforced what she learned from Bennett about portion size, understanding nutrition labels and eating with confidence.

“It was nice to have others going through it with you,” said Farnham. “The whole program was really great; now I feel more in control, I know that I have the support of my doctor and resources available to me. Knowledge is empowering, and I feel very much in command of my situation and my life now.”

Piedmont Fayette Hospital’s comprehensive Diabetes Care program, certified by the American Diabetes Association (ADA), provides education and training to individuals diagnosed with Type 1, Type 2 and gestational diabetes. Certified diabetes educators offer a comprehensive approach that includes nutrition and meal planning counseling, blood-glucose monitoring, medication and insulin delivery options and more. Participants in the program receive personal counseling and can attend diabetes care classes at the hospital, which focus on healthy meal planning, exercise and weight management and medication management in a group setting.

A physician referral is required for the Diabetes Care program. For more information about PFH's diabetes education services, call 770-719-7290. To learn more about Piedmont Fayette Hospital, visit www.fayettehospital.org
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Confirmed Rabies Case in Newnan

According to the city of Newnan animal warden, Cyndi Hoffman, there was a confirmed case of rabies in the city. There were no humans affected with the disease.

On Wednesday, December 5th, a resident reported a raccoon in her yard was acting strangely. Officer Hoffman went out to the resident off Pitts Street. The raccoon was then caught on a restraining pole and humanely euthanized. The body was sent to the lab where results came back positive for rabies.

Residents are urged to always keep family pets updated on vaccinations. Call your vetnarian as soon as possible to schedule an appointment.

“These vaccinations are critical to your families’ and pets’ well- being,” said Officer Hoffman. People do not realize the long and intense treatments needed for humans if bitten by a rabid animal and symptoms occur it is too late. Rabies has a 99% rate fatality for humans and animals,” continued Officer Hoffman.

Officer Hoffman wanted to remind everyone there is a leash law (4-41) and a vaccination law (4-44) in the city of Newnan. Citations will be issued if caught breaking these laws. If you need to review these ordinances please log onto www.ci.newnan.ga.us

Symptoms of Rabies for animals and humans

Symptoms usually develop between 20 and 60 days after exposure. Rabid animals may become aggressive, combative, and highly sensitive to touch and other kinds of stimulation. And they can be vicious. This is the "furious" form of rabies, the kind traditionally associated with mad dogs.
There is also a "dumb" form of the disease in which the animal is lethargic, weak in one or more limbs, and unable to raise its head or make sounds because its throat and neck muscles are paralyzed. In both kinds of animal rabies, death occurs a few days after symptoms appear, usually from respiratory failure.

Rabies infection in humans begins with symptoms such as fever, cough, or sore throat followed in several days by more serious and rapidly progressing symptoms such as restlessness, hallucinations and seizures. The final stage is coma and death.

Tips Residents for rabies prevention

Avoid wildlife.
Vaccinate your pets.
Do not approach any animal unknown to you or your family.
Secure trash in garbage cans with tight fitting lids.
Feed and water your pets inside your home to avoid attracting wild animals.

For city of Newnan residents to report animal related issues, please call animal control at 770-254-2355.
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New Wound Care Camera Computes Area of Wound

(BUSINESS WIRE)--Today, IP2Biz announced that a prototype wound measurement camera is being tested by wound specialty nurses at the Shepherd Center in Atlanta, Georgia. The handheld device determines and captures wound boundaries and wound area using proprietary software and low-cost hardware. The device provides fast, accurate and repeatable digital documentation of wound progression, a necessary component to validate payment from insurance and government agencies.

The Shepherd Center is a nationally recognized, not-for-profit hospital that focuses on medical care and rehabilitation for patients requiring highly-specialized care. Nurses using the device say that “the device easily fits in your hands, can be operated with just a click and gives us confidence that the measurements can be repeated consistently. It is a great improvement over our current methods.” The technology development was led by Stephen Sprigle, Associate Professor of Applied Physiology and Industrial Design at the Georgia Institute of Technology.

“We designed the device to address a key and growing need in wound management,” said Sprigle. “Our goal was to provide a low-cost, easy-to-use device that used the latest technology to provide measurements of the area of the wound.” The device does not require patient contact, thus providing maximum infection control. The simple design is intuitive to use and requires minimal training, thus making it ideal for use in a wide range of environments, including homecare.

Dr. John Hitt of IP2Biz sees a growing need for wound management. “Hospitals, rehabilitation clinics and specialized care centers all need to address the increasing requirements for pay-for-performance healthcare,” says Hitt. “This device enables healthcare providers to consistently document healing and meet validation requirements from Medicare/Medicaid and insurance agencies.” The technology is licensed exclusively to IP2Biz from the Georgia Tech Research Corporation.

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Global Measles Deaths Drop By 74%

/PRNewswire-USNewswire/ -- Measles deaths worldwide fell by 74% between 2000 and 2007, from an estimated 750,000 to 197,000. In addition, the Eastern Mediterranean region* which includes countries such as Afghanistan, Pakistan, Somalia, and the Sudan has cut measles deaths by a remarkable 90% -- from an estimated 96,000 to 10,000 -- during the same period, thus achieving the United Nations goal to reduce measles deaths by 90% by 2010, three years early.

The progress was announced today by the founding partners of the Measles Initiative: the American Red Cross, the United States Centers for Disease Control and Prevention (CDC), the United Nations Foundation (UN Foundation), UNICEF and the World Health Organization (WHO). The data will be published in the 5 December edition of WHO's Weekly Epidemiological Record and CDC's Morbidity and Mortality Weekly Report.

"This achievement is a tribute to the hard work and commitment of countries in the Eastern Mediterranean region to combat measles," said Dr Margaret Chan, WHO Director-General. "With only two years until the 2010 target date, I urge all countries affected by measles to intensify their efforts to immunize all children against the disease."

The significant decline in measles deaths in the Eastern Mediterranean region was the result of intensified vaccination campaigns including several countries with hard-to-reach areas. In 2007, more than twice the number of children were immunized in the region through such campaigns as compared to 2006.

"There are thousands of health workers and volunteers from our Red Cross and Red Crescent family who deserve much of the credit for this success. They give their time to literally go door-to-door informing, educating and motivating mothers and caregivers about the critical need to vaccinate their children," said Bonnie McElveen-Hunter, Chairman of the Board of the American Red Cross. "This mobilization helps us to consistently reach more than 90% of the vulnerable population and save countless lives."

The African region was the largest contributor to the global decline in measles deaths, accounting for about 63% of the reduction in deaths worldwide over the eight-year period. In 2007, measles outbreaks occurred in a number of African countries due to gaps in immunization coverage, reinforcing the need to continue immunization support.

"It's absolutely wonderful that so many children are off to a healthy start in life thanks to the progress we've made in combating measles through immunization," said Dr. Julie Gerberding, CDC Director. "Other children's lives are still at risk, however, so it's time we refocus our attention on sustaining our immunization efforts in countries where rates are low."

The progress in South-East Asia has been limited -- with just a 42% decline in measles deaths. This is due to the delayed implementation of large-scale vaccination campaigns in India, which currently accounts for two thirds of global measles deaths. Political commitment in India is essential if the 2010 global goal is to be achieved.

"The progress that has been made shows what can be achieved through measles vaccination campaigns, but much more needs to be done," said Ann M. Veneman, Executive Director of UNICEF. "It is a tragedy that measles still kills more than 500 children a day when there is a safe, effective and inexpensive vaccine to prevent the disease."

The world's success in reaching the 2010 measles goal depends on ensuring that all children receive two doses of measles vaccine including one dose by their first birthday, strengthening disease surveillance systems, and providing effective treatment for measles.

"Progress also depends on addressing the considerable funding gap," said Kathy Calvin, Executive Vice President and Chief Operating Officer for the UN Foundation. "The shortfall stands at US $176 million for 2009-2010, of which US $35 million is urgently needed for 2009. With continued funding and increasing ownership and commitment of countries, we can sustain our progress and achieve our goal by 2010. We ask our supporters to stay with us and strongly encourage new supporters to join us in our effort to save lives."

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Fayette Care Clinic Announces Partnership with Georgia Lions Lighthouse and Dr. Nancy Barr

Fayette Care Clinic is happy to announce a new partnership with Georgia Lions Lighthouse and Dr. Nancy Barr. Thanks to Georgia Lions Lighthouse and Dr. Barr, Fayette Care Clinic now offer vision care to their patients. Vision Care patients are seen every other month and referred by our providers. Please join us in welcoming both Georgia Lions Lighthouse and Dr. Nancy Barr to our group.

Fayette Care Clinic is located at 128 Sumner Rd. Fayetteville, Ga. 30214. www.fayettecareclinic.com; If you would like to get involved or need additional information, please call us at 770.487.4778.

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FDA Teams With WebMD For New Online Consumer Health Information

The U.S. Food and Drug Administration and WebMD today announced a collaboration that expands consumers' access to the agency's timely and reliable important health information. This joint effort reflects the FDA's emphasis on using innovative, technology-based strategies to carry out its foremost mission, which is to promote and to protect the public health.

WebMD, which attracts nearly 50 million unique visitors each month, provides consumers with credible and timely health news and information.

"We are enthusiastic about this collaboration with WebMD because it will enable us to reach more consumers with accurate, science-based information that can help them improve their health," said Andrew C. von Eschenbach, M.D., commissioner of food and drugs. "This is an important step forward in our effort to form partnerships to help bring timely safety alerts and other public health information to a wider audience in the most effective and convenient way."

The partnership includes:

* A new online consumer health information resource on WebMD.com (www.webmd.com/fda): Consumers can access information on the safety of FDA-regulated products, including food, medicine and cosmetics, as well as learn how to report problems involving the safety of these products directly to the FDA. In addition, WebMD will bring the FDA public health alerts to all WebMD registered users and site visitors that request them. The cross-linked joint resource will also feature FDA's Consumer Updates—timely and easy-to-read articles that are also posted on the FDA's main consumer Web page (www.fda.gov/consumer).
* The FDA contributions to WebMD The Magazine: FDA Consumer Updates will also be featured at least three times a year in WebMD's bimonthly magazine, which reaches nearly nine million consumers. The magazine is distributed to physician office waiting rooms across the country.

"As a leading brand of health information, we are pleased to be partnering with the FDA to provide consumers with public health and safety information, direct from the source," says Wayne Gattinella, WebMD president and chief executive officer. "This important partnership is consistent with WebMD's longstanding mission of providing for Americans access to credible and relevant health information."

Consumers have increasingly consulted all types of sources to find health information, and the Internet is their fastest growing resource, according to a national study released in August 2008 by the Center for Studying Health System Change. Researchers found that 32 percent of American consumers—70 million adults—conducted online health searches in 2007, compared with 16 percent in 2001.

The study also found that most consumers who researched health concerns reported positive outcomes. More than half of those surveyed said the information changed their overall approach to maintaining their health. Four in five said the information helped them better understand how to treat an illness or condition.

The complete terms and components of the partnership are described in a Memorandum of Understanding which is on display today at the Federal Register office and available online at http://www.accessdata.fda.gov/scripts/oc/ohrms/advdisplay.cfm.

An agency policy statement summarizing the criteria and processes for development of such partnerships is available on the FDA's Web site at www.fda.gov/consumer/cobrand_policy.html.

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