FDA Approves Drug for Treatment of Aggressive Brain Cancer

The U.S. Food and Drug Administration recently approved Avastin (bevacizumab) to treat patients with glioblastoma multiforme (GBM) when this form of brain cancer continues to progress following standard therapy.

GBM is a rapidly progressing cancer that invades brain tissue and can impact physical activities and mental abilities. It affects about 6,700 persons in the United States every year. Following initial treatment with surgery, radiation, and/or chemotherapy, the cancer nearly always returns.

“This type of cancer is very resistant to therapy and thus challenging to treat,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. “Avastin provides a therapy for patients with progressive GBM who have not responded to other medications.”

Avastin is a laboratory-produced molecule known as a monoclonal antibody that mimics the antibodies produced by the body’s immune system to defend against harmful substances. The medication inhibits the action of vascular endothelial growth factor that helps form new blood vessels. These vessels can feed a tumor, helping it to grow and can also provide a pathway for cancer cells to circulate in the body.

The drug was first approved in 2004 to treat metastatic cancer of the colon or rectum and has since been approved for treatment of non-squamous, non-small cell lung cancer and metastatic breast cancer.

In two clinical trials, about 25 percent of patients with GBM responded to Avastin with an average duration of response of about four months.

The most serious side effects associated with Avastin, in some cases resulting in death, are gastrointestinal perforation, wound healing complications, hemorrhage, and blood clots. Other serious side effects of Avastin are severe high blood pressure, nervous system and vision disturbances, decreased white blood cell counts, infection, stroke, myocardial infarction, and kidney problems.

The most common adverse reactions were nose bleeds, headache, high blood pressure, runny nose, excess proteins in the urine, taste alteration, dry skin, rectal bleeding, excessive tearing, and skin peeling.

Avastin is manufactured by Genentech Inc. of San Francisco.

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City Leaders Launch Medicare Diabetes Screening Project in Augusta

/PRNewswire/ -- Senator Ed Tarver (D - District 22), Jeanette Cummings, Director, Central Savannah River Area Regional Development Center (CSRA RDC) Area Agency on Aging (AAA), and other city and community leaders today urged all Augusta area seniors to learn more about their personal risk for diabetes, as they launched the Medicare Diabetes Screening Project (MDSP) in Augusta before a crowd gathered at the Henry H. Brigham Senior Center on Golden Camp Road. On a national level, the MDSP is co-chaired by the American Diabetes Association, the Health Care Leadership Council, and Novo Nordisk, and is supported by more than 20 organizations representing the interests of seniors and health care providers.

"Today, I am proud to announce the start of the Medicare Diabetes Screening Project in Augusta," said Sen. Tarver. "When diabetes is undiagnosed and untreated, it can be devastating, and new government statistics show that our senior citizens are especially vulnerable."

According to a study in the February 2009 issue of Diabetes Care, 32% of adults ages 65 and older have diabetes. What's more, almost half (46%) of those seniors with diabetes don't know they have it - they have not been diagnosed. In addition to those with diabetes, another 40% of adults ages 65 and older have pre-diabetes, putting them at very high risk of developing diabetes and heart disease, and it is likely that most of them are unaware of their status. When these statistics are applied to Richmond County, it is estimated that approximately 3,400 seniors ages 65 and older have undiagnosed diabetes, and an additional 9,300 seniors ages 65 and older have pre-diabetes.

"These statistics show why it is crucial that we create awareness of the benefits that Medicare offers for diabetes screening, and motivate our seniors to ask their health care providers about being tested for diabetes," said CSRA AAA Director, Jeanette Cummings.

Since 2005, Medicare has offered benefits for diabetes screening, but usage of these benefits has been minimal. For people who are ages 65 and older and have one risk factor for diabetes, Medicare offers a free diabetes-screening test in a health care provider's office, with no deductible and no co-pay. If seniors are found to have pre-diabetes, they are eligible for another free screening in six months.

To encourage use of these benefits, the Medicare Diabetes Screening Project was conceived and launched in 2007 in Columbus, Georgia. City and community leaders in Columbus developed a model for public awareness and outreach, and that model is being adapted for implementation here in Augusta.

"Augusta elected officials and other leaders from the community immediately saw the need for the Project," said Commissioner Jerry Brigham, "and they have quickly developed ideas and networks for reaching out to seniors and their health care providers with messages of what Medicare offers for diabetes screening. This type of collaboration represents the best of Augusta."

The MDSP will reach out to Augusta-area primary care physicians and their office managers via a letter signed by diabetes specialist Dr. Charles Shaefer of University Primary Care. "To complement public awareness activities, it is important that we directly inform physicians and their staff about the MDSP and the screening benefits that Medicare offers their patients," said Dr. Shaefer.

Also planned are a series of educational seminars at local senior centers, to be coordinated and implemented by the CSRA Area Agency on Aging. And according to Rev. Robert Ramsey, Pastor of the Gospel Water Branch Baptist Church, seniors and their family members will also hear about the MDSP and Medicare diabetes screening via the faith-based community. "Communicating health information to our congregants is not only possible, it's been proven successful," said Rev. Ramsey, who recently participated in a diabetes prevention faith-based program as part of a research study funded by the National Institutes of Health (NIH).

The most currently-available estimates from the Centers for Disease Control and Prevention (CDC) show that the prevalence of diabetes is 25% higher in the state of Georgia as compared to the national average (10% versus 8%, respectively). The CDC also estimates that 10.3% of all adults ages 20 and older in Richmond County have diabetes.

The Medicare Diabetes Screening Project in Augusta is a community-based effort to reach and motivate seniors who have undiagnosed diabetes or pre-diabetes, and encourage them to see their doctors or other health care providers, and take advantage of the free diabetes screening benefits offered by Medicare. To learn more, visit www.screenfordiabetes.org.

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Gallup - Swine Flu Worries Subside; Americans Assess Media Coverage

The percentage of Americans worried about swine flu has declined to 17% in Gallup’s most recent polling. While 46% of Americans say the news reports about swine flu are about right, 45% say the news media are exaggerating the dangers.
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Testosterone Gel Safety Concerns Prompt FDA to Require Label Changes, Medication Guide

The U.S. Food and Drug Administration today announced that it is requiring manufacturers of two prescription topical testosterone gel products, AndroGel 1% and Testim 1%, to include a boxed warning on the products’ labels. The agency is requiring this action after receiving reports of adverse effects in children who were inadvertently exposed to testosterone through contact with another person being treated with these products (secondary exposure).

The gels are approved for use in men who either no longer produce testosterone or produce it in very low amounts. Both products are applied once daily, to the shoulders or upper arms. Only AndroGel 1% is approved for application to the abdomen. Precautions in the current labels instruct users to wash their hands after using the product and to cover the treated skin with clothing.

“These drugs are approved for an important medical need, but can have serious, unintended side effects if not used properly,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “We must ensure that the adults using them are well-informed about the precautions needed to protect children from secondary exposure.”

In 2007, 1.4 million prescriptions for AndroGel—the most commonly dispensed gel form of testosterone—were dispensed by U.S. retail pharmacies. Approximately 25,000 of those were dispensed for off-label use in women. During the same period, some 370,000 prescriptions were dispensed for Testim, according to data from SDI: Vector One National.

Despite the currently labeled precautions, as of Dec. 1, 2008, the FDA has received reports of eight cases of secondary exposure to testosterone in children ranging in age from nine months to five years. Since that time, additional reports of secondary exposure have been received by the agency and are presently under review.

Of the fully reviewed cases, adverse events reported in these children included inappropriate enlargement of the genitalia (penis or clitoris), premature development of pubic hair, advanced bone age, increased libido, and aggressive behavior.

In most cases, the signs and symptoms regressed when the child no longer was exposed to the product. However, in a few cases, enlarged genitalia did not fully return to age-appropriate size and bone age remained modestly greater than the child’s chronological age.

In some cases, children had to undergo invasive diagnostic procedures and, in at least one case, a child was hospitalized and underwent surgery due to a delay in recognizing the underlying cause of the signs and symptoms.

Signs of inappropriate virilization (development of male secondary sexual characteristics) in children and the possibility of secondary testosterone exposure should be brought to a health care provider’s attention.

In most of the cases, users of these products failed to follow appropriate use instructions, resulting in direct contact between treated skin and the child.

The required label changes will provide additional information about the risk of secondary exposure and the steps that should be taken to reduce this risk. The FDA also is requiring that the manufacturers of these products develop a Medication Guide as part of a Risk Evaluation and Mitigation Strategy to ensure that the benefits of these products continue to outweigh their potential risks.

The FDA recommends the following precautions be taken to minimize the potential for secondary exposure:

* Adults who use testosterone gels should wash their hands with soap and warm water after every application;
* Adults should cover the application site with clothing once the gel has dried;
* Adults should wash the application site thoroughly with soap and warm water prior to any situation where skin-to-skin contact with another person is anticipated;
* Children and women should avoid contact with testosterone application sites on the skin of men who use these products; and
* Adults should note that use of any similar, but unapproved, products from the marketplace –including the Internet– that can result in the same serious adverse effects should be avoided.

Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of these gels to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

--Online: www.fda.gov/MedWatch/report.htm
--Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
--Fax: (800) FDA-0178
--Phone: (800) FDA-1088

AndroGel 1% is manufactured by Marietta, Ga.-based Solvay Pharmaceuticals. Testim 1% is made by Auxilium Pharmaceuticals, Malvern, Pa.

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FDA Approves Pancreatic Enzyme Replacement Product for Marketing in United States

The U.S. Food and Drug Administration announced today that it has approved Creon (pancrelipase), a pancreatic enzyme replacement product designed to help patients with cystic fibrosis and others with exocrine pancreatic insufficiency (EPI) digest and absorb nutrients from foods. Creon is the first FDA-approved delayed-release pancreatic enzyme replacement product to be marketed in the United States as a result of the agency’s unapproved drugs initiative.

Creon, which contains a mixture of digestive enzymes extracted from the pancreas of pigs, helps patients lacking the enzymes needed to digest fats, proteins and sugars from food. Creon is approved for use in pediatric and adult patients.

The FDA had required the manufacturer of Creon to submit, and the agency has approved, a Risk Evaluation and Mitigation Strategy (REMS), which includes a Medication Guide, to advise patients on risks associated with high doses of Creon, and the theroretical risk of transmission of viral disease from pigs to patients. A rare bowel disorder, called fibrosing colonopathy, can result from a patient’s high-dose use of Creon. While this condition is serious and may require surgery, a patients’ chances of having this condition may be reduced through their adherence to dosing instructions in the labeling.

The risks of a rare bowel disorder and viral transmission described in the Medication Guide are considered to be risks related to all porcine (pig)-derived pancreatic enzyme products, including Creon.

Instructions for dosing based on weight and age should be followed carefully. Creon may be sprinkled on food. Because Creon is a delayed-release drug, patients should never crush or chew the capsule as this would cause an early release of the enzymes and a reduction in enzyme activity.

“The approval of Creon will allow patients to have access to an approved pancreatic enzyme replacement product that meets FDA standards for effectiveness, safety, and manufacturing consistency,” said Donna Griebel, M.D., director, Division of Gastroenterology Products within FDA’s Center for Drug Evaluation and Research (CDER).

The FDA’s Office of Compliance and Office of New Drugs within CDER worked with Creon’s manufacturer, Solvay Pharmaceuticals, through the agency’s unapproved drugs initiative to help the company come into compliance with federal laws by obtaining FDA approval. The agency continues to encourage the manufacturers of all other unapproved pancreatic enzyme products (PEPs) to work with the agency to obtain market approval. All PEPs must obtain FDA approval by April 28, 2010, or be removed from the marketplace.

“Like other medically necessary drugs, the FDA is exercising its enforcement discretion while it works with the manufacturer toward gaining approval of these drugs,” said Deborah Autor, director, Office of Compliance, CDER. “FDA approval is critical, and the manufacturers of these products have a responsibility to the American public to ensure that patients have drugs that meet our standards of safety, effectiveness, quality, and labeling.”

People who are allergic to pork and pork products, suffer from gout or kidney disease, have difficulty swallowing, are pregnant or who plan to become pregnant, or are breastfeeding, should discuss the use of Creon with their health care professional. Common side effects of Creon include flatulence (gassiness), abdominal pain, headache, and dizziness.

CREON and other pancreatic enzyme products are made from pancreatic organs of pigs used for food. There is a theoretical risk of contracting a viral infection from pig-derived medicines, but no human illness has been reported.

Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

--Online: www.fda.gov/MedWatch/report.htm
--Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
--Fax: 800-FDA-0178
--Phone: 800-FDA-1088

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FDA Approves Fanapt to Treat Schizophrenia

The U.S. Food and Drug Administration has approved Fanapt tablets (iloperidone) to treat adults with schizophrenia, a chronic, severe and disabling brain disorder.

"Schizophrenia can be a devastating illness requiring lifelong treatment and therapy," said Thomas Laughren, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. "Medications for schizophrenia can ease many symptoms, allowing people to live more independent lives."

Schizophrenia affects about 1 percent of the U.S. adult population, ages 18 and older, in a given year. The most prominent symptoms include hallucinations, delusions, disordered thinking and behavior, and abnormal expression of emotions. Hearing voices that other people don't hear is the most common type of hallucination. These experiences can make people with the disorder fearful and withdrawn.

Fanapt is included in the atypical antipsychotic class of drugs. All atypical antipsychotics contain a boxed warning, the FDA’s strongest warning. The warning alerts prescribers to an increased risk of death associated with off-label use of these drugs to treat behavioral problems in older people with dementia-related psychosis. Fanapt is not approved for patients with dementia-related psychosis.

Fanapt demonstrated efficacy in two placebo-controlled short-term clinical trials. In both, Fanapt was superior to placebo (sugar pill) in reducing the symptoms of schizophrenia.

The most common adverse reactions reported by patients using Fanapt in clinical trials were dizziness, dry mouth, fatigue, nasal congestion, sudden fall in blood pressure causing light-headedness upon standing (orthostatic hypotension), drowsiness, rapid heart rate (tachycardia) and weight increase.

Fanapt is manufactured by Patheon Inc. of Mississauga, Ontario, for Vanda Pharmaceuticals Inc., Rockville, Md.

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VeroScience Announces FDA Approval of Cycloset for Treatment of Type 2 Diabetes

(BUSINESS WIRE)--VeroScience, in collaboration with S2 Therapeutics, Inc. (S2), announced yesterday that the U.S. Food and Drug Administration (FDA) approved its first-in-class drug Cycloset™ for the treatment of Type 2 diabetes. Cycloset improves glycemic control across a broad patient population as a monotherapy or as an adjunctive therapy to sulfonylurea, metformin plus sulfonylurea, and single or dual oral hypoglycaemic agent therapies.

Cycloset is the first drug to be approved subsequent to the FDA’s new guidelines that require studies demonstrating that diabetes drugs do not increase cardiovascular risk. A 52 week, double-blind safety trial of 3,000 patients treated with Cycloset did not show an increase in pre-specified and independently adjudicated adverse cardiovascular outcomes—a composite of myocardial infarction, stroke, hospitalization for unstable angina, congestive heart failure, and revascularization surgery—compared to patients taking a placebo (HR 0.58; CI 0.35-0.96).

“For patients newly diagnosed with Type 2 diabetes or those who cannot adequately control their blood sugar with currently available medications, Cycloset provides a completely new approach to treating diabetes,” said J. Michael Gaziano, M.D., Cardiologist, Associate Professor, Division of Aging, Brigham & Women’s Hospital and principal investigator of the Cycloset Safety Trial. “In addition, patients with Type 2 diabetes are at high-risk for cardiovascular events, so it’s important that Cycloset has been demonstrated not to increase the risk of cardiovascular events such as heart attacks, and may actually have potential to lower this risk.”

Cycloset represents a new therapeutic approach in the management of Type 2 diabetes. It is the first drug for patients with diabetes that targets the body’s dopamine activity, a chemical messenger between neurons, or nerve cells, within the nervous system. A dopamine agonist, Cycloset increases dopamine activity. While the specific mechanism by which Cycloset improves glycemic control in humans is unknown, the development of Cycloset for the treatment of Type 2 diabetes was based upon preclinical studies that have shown brain dopamine activity to be low in metabolic disease states and that this factor contributes to multiple metabolic dysfunctions such as insulin resistance—the loss of the body’s ability to respond to the blood sugar lowering effects of insulin—observed in Type 2 diabetes. Moreover, preclinical studies of diabetic animals have shown that treatment with a dopamine agonist as in Cycloset acts upon the central nervous system to reset and improve control of peripheral metabolism.

“This approval is a major milestone for VeroScience and also represents the culmination of many years of intense research and development activities. We’re very pleased that these prodigious efforts will now translate to provide patients with a new approach to treating Type 2 diabetes,” said Anthony H. Cincotta, Ph.D., President and Chief Scientific Officer, VeroScience.

Charles P. Sutphin, President and CEO of S2 Therapeutics, Inc. said, “We are extremely happy to have been able to support and work with VeroScience to bring this diabetes therapy to the U.S. market. With the United States approval, we will collectively initiate efforts to complete applications globally with an immediate focus in Europe and Canada.” S2 Co-chairman and co-founder Brian Schrader said “S2 Therapeutics and VeroScience intend to seek a partner to commercialize Cycloset in order to bring this important new therapy to patients as soon as possible.”

About Cycloset and the Biological Clock

Preclinical studies indicate that while an increase in dopamine activity leads to improvements in diabetes, the time of day of the increased dopamine activity is also important. Studies in diabetic animals have shown that increased dopaminergic activity at a particular time of day is most effective in “resetting” the biological clock neurochemistry to a physiology that improves diabetic dysmetabolism. Taken orally, once-a-day, in the morning, Cycloset provides a single brief pulse of dopamine agonist activity shortly after its administration. Morning Cycloset improves post-prandial glucose without increasing plasma insulin concentrations and the beneficial effects of Cycloset on post-meal glycemic control in patients with Type 2 diabetes are demonstrable many hours after the drug has been substantially cleared from the circulation, for example at lunch and dinner.

The Cycloset Safety Trial, a 3,000 patient, one-year study, demonstrated that Cycloset at doses up to 4.8 mg per day used to treat Type 2 diabetes was not different from placebo regarding the rate of occurrence of all-cause serious adverse events. None of the serious adverse events grouped by System-Organ-Class occurred more than 0.3 percentage points higher with Cycloset than with placebo. Cycloset can cause hypotension, including orthostatic hypotension, and syncope, particularly upon dose initiation or escalation. The primary reason for discontinuation from clinical trials of Cycloset was nausea, which was mild to moderate and transient during the beginning of therapy.

“Cycloset represents a new treatment paradigm for Type 2 diabetes. The clinical development of Cycloset involved the collection of a vast amount of safety data prior to the drug’s approval. The information compiled to date has demonstrated that this novel therapy is both safe and effective in treating Type 2 diabetes alone or in combination with other drugs used to treat Type 2 diabetes,” said Richard Scranton M.D., M.P.H., Chief Medical Officer, VeroScience.

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Amazing Face Transplant

Read more:

Wednesday, December 17, 2008
Cleveland Clinic Surgeons Perform Nation's First Near-Total Face Transplant
/PRNewswire/ -- A multi-disciplinary team of doctors and surgeons at Cleveland Clinic recently performed the first near-total face transplant in the United States...

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FDA Approves New Influenza Vaccine Production Facility

The U.S. Food and Drug Administration (FDA) today announced that it has approved a new manufacturing facility used to produce influenza virus vaccines. The facility is approved for seasonal influenza vaccine production and could be used for the production of vaccine against the new 2009 H1N1 influenza strain.

As part of its overall pandemic influenza preparedness efforts, the FDA meets with vaccine manufacturers to guide the efficient establishment of influenza vaccine facilities that comply with agency requirements. The agency promptly reviews applications and manufacturing supplements that could increase both the number of manufacturers and the overall supply of vaccine.

The facility, located in the United States, is owned and operated by sanofi pasteur, which manufactures Fluzone Influenza Virus Vaccine. This new facility will greatly increase sanofi pasteur’s production capability.

“This approval represents an important step towards increasing the availability of influenza vaccines,” said Karen Midthun, M.D., the FDA’s acting director of the Center for Biologics Evaluation and Research.

“Increased manufacturing capacity for influenza vaccine is critical to our preparedness for an influenza pandemic,” said Jesse Goodman, M.D., M.P.H., the FDA’s acting chief scientist and deputy commissioner for scientific and medical programs. “This action also enhances the ability to produce and provide vaccines to protect the public from seasonal influenza, still estimated to cause more than 30,000 deaths per year. Thanks to strategic investments by the federal government and proactive efforts and engagement by the FDA and the vaccine industry, our nation’s preparedness has come a long way over the last five years.”

The FDA has interacted with the company throughout the regulatory process to help ensure compliance with applicable requirements.

The bulk manufacturing facility will be used for the production of Fluzone, sanofi pasteur’s egg-based influenza vaccine.

Sanofi Pasteur is located in Swiftwater, Pa.

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Biosite Incorporated Issues Voluntary, Nationwide Recall for Cardiac Marker Test

Biosite Incorporated has initiated a voluntary, nationwide recall of one lot of Triage® Cardiac Panel. The test is used by healthcare professionals as an aid in the diagnosis of myocardial infarction (heart attack). The product has been recalled due to reports of low recovery of quality control samples containing Creatine Kinase MB (CK-MB), troponin I and myoglobin on the affected lot. Although there have been no reported issues of patient misdiagnosis associated with this lot to date, low recovery may lead to reporting of falsely low values for CK-MB, troponin I and myoglobin. A root cause investigation has been initiated.

The recall is limited to the Triage® Cardiac Panel, Catalog No. 97000HS, Lot #W44467B. Biosite Incorporated has notified its customers via overnight mail and has instructed them to discontinue use of the affected lot and discard any remaining product from the lot that is on hand. The identified lot was distributed to clinical labs in the United States between January and February 2009. Replacement product will be provided to clinical labs with remaining inventory of this affected product lot.

Biosite Incorporated has reported the action to the U.S. Food and Drug Administration.

As is noted in the package insert, the results of the Triage Cardiac Panel should not be used as absolute evidence of myocardial infarction and should be evaluated in the context of all the clinical and laboratory data available.

Customers with questions may contact the company at 1-877-441-7440, option 2 (24 hours a day, 7 days a week)

Any adverse reactions experienced with the use of this product, and/or quality problems can 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, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

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Emory/UGA Flu Center Is One of Six Centers Leading National H1N1 Research Response

In a multi-pronged attack against the H1N1 virus, researchers at Emory University are using a new method of rapidly producing highly targeted monoclonal antibodies to develop a diagnostic test as well as a temporary therapy to stave off the H1N1 (swine flu) virus. The antibodies, which can be isolated from a small amount of the blood of humans infected with the virus, could be targeted against H1N1 and rapidly reproduced to detect or attack the virus. The monoclonal antibody technology was described last April in the journal Nature and is being developed in collaboration with scientists at the University of Chicago.

In addition, Emory scientists, along with colleagues at the Centers for Disease Control and Prevention (CDC), are using virus-like particles (VLPs) to develop a quicker, more efficient alternative to the current method of making flu vaccine by growing it in chicken eggs. VLPs are empty shells that look like viruses but don’t reproduce. In March, the scientists described the effectiveness of their VLP vaccine in mice in the journal PLoS (Public Library of Science) One.

An Emory-University of Georgia Influenza Pathogenesis and Immunology Research Center (IPIRC) is a key component in a national scientific effort to address the H1N1 (swine flu) outbreak. The intensive U.S. research initiative, led by the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC), is centered in six national NIH Centers of Excellence for Influenza Research and Surveillance, including the one led by Emory University and UGA.

“Emory has one of the world’s leading groups of infectious disease experts, vaccine scientists, immunologists and microbiologists,” says David S. Stephens, MD, vice president for research in Emory’s Woodruff Health Sciences Center. “Our research and groundbreaking discoveries by scientists at the Emory Vaccine Center, the Yerkes National Primate Research Center, Emory University School of Medicine and collaborators at the University of Georgia provide a strong basis for our contribution to this coordinated national effort against H1N1.”

Emory scientists in the flu research center are conducting several key projects as part of the national research effort. These include determining how the H1N1 virus enters cells, is transmitted, and how that process might be interrupted; finding out whether prior exposure to other influenza viruses may help or hinder immune responses to the new virus; assessing possible pre-existing immunity to H1N1 in different age groups; analyzing the recovery of infected patients; developing a method to quickly make monoclonal antibodies targeted to the H1N1 virus; and beginning the initial stages of a new vaccine.

At the University of Georgia, scientists are studying how the H1N1 virus is transmitted between animals; finding out how the virus infects human airway cells; developing diagnostic tests to distinguish different virus strains; evaluating the stability of the virus; and testing vaccines and anti-viral drugs against the virus.

“Our scientific team is proud to be contributing to the public good as one of the six influenza research centers in the U.S.,” says Richard Compans, PhD, director of the Emory-UGA center. “The pairing of Emory's expertise with strengths at UGA in animal pathology creates a uniquely effective combination for studying crossover viruses such as 'swine flu.’ We expect to make significant contributions to this national research effort.”

The Emory-UGA IPIRC, along with the five other national flu centers, was established in April 2007 with a seven-year, $32.8 million contract from the NIH.

In the event of a public health emergency involving the emergence and spread of an influenza pandemic in humans, the network of centers is directed to “be on the frontline” to implement the NIAID Pandemic Public Health Research Response Plan.

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Cancer Wellness at Piedmont’s Programs and Services for May

Comprehensive Complimentary Services Offered to Anyone Affected by Cancer

Cancer Wellness at Piedmont offers comprehensive services and programs for anyone affected by cancer at any phase in his or her journey. For more information please visit http://www.piedmontcancerconnection.org/ or, to make a reservation for one of the classes listed below, call Carolyn Helmer at 404-605-1962, and please indicate which classes you plan to attend.

Classes offered every month include: Cancer Wellfit©, Gentle Yoga, Art Therapy, Guided Imagery and Relaxation for Optimal Health, Mindfulness Training 101 & 201, Breast Cancer Support, Gynecological Cancer Support, and A Guy’s Group.

Some special events for May:

Power Foods for Cancer Prevention - Be inspired to eat well and live well! Join Shayna Komar, registered and licensed dietician from Cancer Wellness at Piedmont, as she educates you on the power of food to fuel your body. This fun and interactive workshop will make you want to try new recipes and get moving to fight cancer. A light lunch will be provided using “power food” ingredients. Offered Wednesdays beginning May 6 from Noon until 2 p.m. To register for these workshops visit piedmontcancerconnection.org or call 404 605-4455.

Kick Up Your Heals - Pink Heals Foundation, Inc., in partnership with Cancer Wellness at Piedmont, presents programming to help survivors in their 20s, 30s and early 40s regain their strength, confidence and sense of self. Join Lisa Vingerling on Thursday, May 28 from 6:30 p.m. until 8 p.m.

Poetry Workshops with John Fox, Poet, Teacher and Author - Experience the power of writing to heal through your own words. John Fox, author and certified poetry therapist, will show you the power of your own words to deepen understanding, provide comfort and bring relief to life’s traumas. Three sessions available Monday, May 18 at 10 a.m., Noon, and intensive writing at 1 p.m. Film and lunch from 10 a.m. to 11:30 a.m. and poetry reading on Tuesday, May 19 at 4 p.m..

Depression and Cancer: What’s normal? What’s not? – Join Lynne Padgett, Ph.D., to discuss signs of depression, both physical and emotional, as well as how you can assess the severity of it along with ways of coping, including medication options, therapy and CAM therapies. Tuesday, May 12 from Noon until 1:30 p.m. (lunch provided)

For more information and a full list of classes please visit www.piedmontcancerconnection.org.
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Emory University Hospital Nursing Unit Wins Prestigious Beacon Award for Excellent Care

The Emory University Hospital 4A/5A Cardiovascular-Thoracic Critical Care Unit has received the Beacon Award for Critical Care Excellence from the American Association of Critical-Care Nurses (AACN) – formally recognizing the Emory team as one of the top intensive care units in the country.

Developed in 2003 by the AACN, the Beacon Award for Critical Care Excellence recognizes individual critical care units that meet high-quality standards and provide exceptional care of patients and patients’ families while fostering and sustaining healthy work environments. There are an estimated 6,000 intensive care units in the United States, and only 132 of those units have been recognized for excellence by this award.

The Beacon Award is Emory’s first. It is the fourth award given in Georgia, and the first awarded to a cardiovascular intensive care unit in the state.

“This is a wonderful recognition for our nursing units, which have demonstrated a consistent drive and dedication toward delivering outstanding patient care for some of Emory’s most seriously ill patients and their families,” says Therese Baker, RN, cardiovascular unit department director. “As one of the very first units in the state of Georgia to earn a Beacon award, and the first at Emory, not only is this a tremendous honor for our unit, but for all of Emory Healthcare.”

Mary Zellinger, RN, MN, clinical nurse specialist at Emory University Hospital, says, "Our team of nurses deliver daily the very high standard of patient and family-centered care that Emory University Hospital promises to those who allow us to care for them each day. And while this prestigious award is the result of many months of preparation and hard work by each of our 75 nurses, the effort and commitment that go into fulfilling that promise day in and day out has made this honor even more special.”

To receive the Beacon Award, a unit must meet 42 different criteria in six categories – including innovation/excellence in recruitment and retention; education, training, and mentoring; evidence-based practice and research; patients’ outcomes; creating and promoting healing environments; and leadership and organizational ethics. Because the award program provides nursing care units a way to better measure their systems, outcomes and environment, this award is increasingly linked to patient quality and safety initiatives.

“Over the last 19 years, there has never been any doubt in my mind about the excellence of the 4A/5A nurses at Emory,” says James Ramsay, MD, professor of anesthesiology and medical director of the 4A/5A ICU at Emory University Hospital.

“Time and time again, I've seen the recovery of seemingly hopeless patients, which could certainly be credited in large part to the superb care given by these smart, interested, engaged, caring and collaborative professionals. It is a privilege and a pleasure to work with this entire team.”

The Emory award is designated for one year, and units must re-apply annually to continue their designation. As part of the overall evaluation process, an expert panel reviews each application against national quality standards measures. The association removes all references to the facility or location to avoid bias and protect the unit's confidentiality.

AACN is the largest specialty nursing organization in the world, representing the interests of more than 500,000 nurses who are charged with the responsibility of caring for acutely and critically ill patients. The association is dedicated to providing our members with the knowledge and resources necessary to provide optimal care to critically ill patients.
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Folic Acid May Help Treat Allergies, Asthma

Folic acid, or vitamin B9, essential for red blood cell health and long known to reduce the risk of spinal birth defects, may also suppress allergic reactions and lessen the severity of allergy and asthma symptoms, according to new research from the Johns Hopkins Children's Center.

In what is believed to be the first study in humans examining the link between blood levels of folate -- the naturally occurring form of folic acid -- and allergies, the scientists say results add to mounting evidence that folate can help regulate inflammation. Recent studies, including research from Johns Hopkins, have found a link between folate levels and inflammation-mediated diseases, including heart disease. A report on the Johns Hopkins Children's findings appears online ahead of print in the Journal of Allergy & Clinical Immunology.

Cautioning that it's far too soon to recommend folic acid supplements to prevent or treat people with asthma and allergies, the researchers emphasize that more research needs to be done to confirm their results, and to establish safe doses and risks.

Reviewing the medical records of more than 8,000 people ages 2 to 85 the investigators tracked the effect of folate levels on respiratory and allergic symptoms and on levels of IgE antibodies, immune system markers that rise in response to an allergen. People with higher blood levels of folate had fewer IgE antibodies, fewer reported allergies, less wheezing and lower likelihood of asthma, researchers report.

"Our findings are a clear indication that folic acid may indeed help regulate immune response to allergens, and may reduce allergy and asthma symptoms," says lead investigator Elizabeth Matsui, M.D., M.H.S., pediatric allergist at Johns Hopkins Children's. "But we still need to figure out the exact mechanism behind it, and to do so we need studies that follow people receiving treatment with folic acid, before we even consider supplementation with folic acid to treat or prevent allergies and asthma."

The current recommendation for daily dietary intake of folic acid is 400 micrograms for healthy men and non-pregnant women. Many cereals and grain products are already fortified with folate, and folate is found naturally in green, leafy vegetables, beans and nuts.

Other findings of the study:

People with the lowest folate levels (below 8 nanograms per milliliter) had 40 percent higher risk of wheezing than people with the highest folate levels (above 18 ng/ml).
People with the lowest folate levels had a 30 percent higher risk than those with the highest folate levels of having elevated IgE antibodies, markers of allergy predisposition.
Those with the lowest folate levels had 31 percent higher risk of atopy (allergic symptoms) than people with the highest folate levels.
Those with lowest folate levels had 16 percent higher risk of having asthma than people with the highest folate levels.
Blacks and Hispanics had lower blood folate levels - 12 and 12.5 nanograms per milliliter, respectively - than whites (15 ng/ml), but the differences were not due to income and socio-economic status.

The Johns Hopkins team is planning a study comparing the effects of folic acid and placebo in people with allergies and asthma.

Asthma affects more than 7 percent of adults and children in the United States, and is the most common chronic condition among children, according to the Centers for Disease Control and Prevention. Environmental allergies are estimated to affect 25 million Americans, according to the CDC.

Co-investigator on the study: William Matsui, M.D, of the Johns Hopkins Kimmel Cancer Center.

The research was funded by the National Institutes of Health.

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Henry County Swine Flu / H1N1 Influenza A Confirmed; Cases Pending in other Counties

The State Public Health Lab has forwarded a lab specimen from a student at Eagles Landing Christian Academy to the CDC. Today it was confirmed for the novel strain H1N1 influenza A. Current CDC recommendations are to close schools for up to 14 days for suspected or confirmed cases of H1N1. School officials have elected to temporarily close according to CDC guidelines.

“We are in constant communication with the State Medical Director and lead state Epidemiologist regarding all cases,” said Michael Brackett, District 4 Medical Director. “We are coordinating with school officials to provide advice and support during this temporary closure. We will closely adhere to the most current CDC recommendations regarding H1N1.”

“At this time, we do not know if or how many more cases of H1N1 there are in this area or in the state,” said Brackett. “We will interview those involved in this case and recommend further treatments using CDC protocol. We are active participants in the collection of samples based on the CDC case definitions and suspicious samples are being forwarded to the State Public Health Lab for testing. You will be contacted by public health staff if you need to be evaluated, but if you are sick you should seek help from your medical provider. ”

"Georgia Public Health is actively engaging and addressing this issue with its many community, state and federal partners,” said Brackett “This case diagnosis is one result of that rapid and highly coordinated effort to protect Georgians from this novel virus. These efforts will continue unabated until this threat is resolved."

“I want to stress that there is no need for panic, locally or otherwise. We are further evaluating the situation and will continue to do so. The leadership of Eagles Landing Christian Academy have responded professionally and are on top of this situation. They have done an excellent job at keeping the community safe,” said Brackett.

At present, the symptoms of swine flu in people are similar to the symptoms of regular human flu and include fever, cough, sore throat, body aches, headache, chills and fatigue. Some people have reported diarrhea and vomiting associated with H1N1influenza. In the past, severe illness (pneumonia and respiratory failure) and deaths have been reported with H1N1 influenza infection in people. Like seasonal flu, H1N1 flu may cause a worsening of underlying chronic medical conditions.

If you become ill with influenza like symptoms seek medical care. There is medication available that can help.

There is no vaccine available right now to protect against flu. There are everyday actions that can help prevent the spread of germs that cause respiratory illnesses like influenza. Take these important everyday steps to protect your health:

• Cover your nose and mouth with a tissue when you cough or sneeze. Throw the tissue in the trash after you use it.
• Wash your hands often with soap and water, especially before you eat or after you cough or sneeze. Alcohol-based hand cleaners are also effective, if needed.
• Avoid touching your eyes, nose or mouth. Germs spread this way.
• Try to avoid close contact with people who are sick with flu-like symptoms.

If you get sick with influenza, CDC recommends that you stay home from work or school; and limit contact with others to keep from infecting them.

GDPH and the LaGrange Public Health District strongly recommend Georgia residents to:

1) Contact your health care provider if you are not feeling well and have recently traveled to areas that have high numbers of confirmed cases of H1N1 influenza.
2) Keep up healthy behaviors –such as washing hands, coughing or sneezing in tissue or crook of elbow, staying at home when you arefeeling sick, and following your health care provider’s recommendations.
3) Develop or update your Emergency Preparedness plan and Emergency Preparedness kit.

Visit www.ready.ga.gov/register to access online tools that will provide step-by-step guidance on how to create a plan and an emergency kit.

Regular updates are also ongoing on the CDC’s website http://www.cdc.gov/swineflu.

Georgia Public Health Hotline 1.888.899.9788 or locally 770.830.2828.

Note: Reports from the CDC indicate three other possible cases of the flu are being tested, one in Clayton County.
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