Tuesday, September 30, 2008

FDA Clears New CDC Test to Detect Human Influenza

The U.S. Food and Drug Administration (FDA) today cleared a new test
developed by the U.S. Centers for Disease Control and Prevention (CDC)
to diagnose human influenza infections and the highly pathogenic
influenza A (H5N1) viruses.

The device, called the Human Influenza Virus Real-Time RT-PCR Detection
and Characterization Panel (rRT-PCR Flu Panel), uses a molecular biology
technique to detect flu virus and differentiate between seasonal and
novel influenza.

The device is used to isolate and amplify viral genetic material present
in secretions taken from a patient's nose or throat. The viral genetic
material is labeled with fluorescent molecules, which are then detected
and analyzed by a diagnostic instrument called the Applied Biosystems
7500 Fast Dx, also cleared today by the FDA for diagnostic use
simultaneously with the CDC's rRT-PCR Flu Panel.

The test panel and diagnostic system can detect and identify commonly
circulating human influenza viruses as well as influenza A (H5N1)
viruses. Results can be available within four hours and the system can
test multiple samples at once.

"This is a significant achievement for public health surveillance," HHS
Secretary Mike Leavitt said. "The test allows us to better support
laboratories on the front line of influenza testing in the United States
and abroad."

"The application of the test to detect an emergent influenza virus would
be especially important in the early stages of a pandemic," Secretary
Leavitt added. "This breakthrough allows for a more timely detection of
a pandemic virus, which helps in determining when to begin broad control
strategies as well as life-saving mitigation measures, such as closing
schools, cancelling social gatherings and informing businesses to begin
work-at-home policies."

The test will be available to CDC-qualified laboratories for diagnosing
influenza this fall, and some laboratories will be able to obtain
reagents (certain substances used in the testing process) at no cost.
This test should help ensure the accuracy of influenza testing results
among the different qualified laboratories that conduct influenza
subtype testing.

"This new test provides us another tool in our toolbox to fight seasonal
influenza, a virus that unfortunately kills thousands of people each
year in the United States," said CDC Director Dr. Julie Gerberding.
"We'll now be able to detect influenza in the community faster, which
allows us to take steps more quickly to protect and save lives."

Since influenza viruses are always changing, test reagents need to be
evaluated regularly against circulating viruses to ensure the
sensitivity and specificity of the test to diagnose current influenza

"Because the test can tell the difference between seasonal human
influenza viruses and novel viruses, it will also provide qualified
laboratories with a means to rapidly detect new influenza viruses that
have not been identified yet and that could pose a pandemic risk," said
FDA Principal Deputy Commissioner and Chief Scientist Dr. Frank Torti,
M.D., M.P.H.

The CDC, Applied Biosystems of Foster City, Calif., and the Association
of Public Health Laboratories collaborated on the development of this
new test. State public health laboratories in Virginia, Iowa,
California, Massachusetts, Wisconsin, and Washington performed clinical
evaluations of the new flu panel.

Scientists around the world are concerned that the H5N1 virus could one
day mutate and acquire the properties needed to quickly spread between
people, resulting in a pandemic. H5N1 viruses circulate widely in birds
in Asia, Africa and Europe and have caused human illness and death.
These viruses have never been detected in the Americas.

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Vitamin D Added to FDA Osteoporosis Risk-Reduction Health Claim

PRNewswire/ -- As a result of a 2004 petition from the Beverage Institute for Health & Wellness (hereafter the Institute) of The Coca-Cola Company (NYSE:KO) , the US Food and Drug Administration (FDA) announced today that it has amended its osteoporosis risk reduction health claim to reflect the importance of vitamin D, in combination with calcium, in promoting long-term bone health. The amended rule also includes a broader definition of the populations that could benefit from consuming calcium and vitamin D to include both men and women of all ages and races.

The amended labeling regulation explains that vitamin D is required for the normal absorption of calcium, and authorizes the health claim: "Adequate calcium and vitamin D throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis."

"Osteoporosis is a growing public health crisis, and all Americans, men and women alike, will benefit from knowing that vitamin D along with calcium can help delay or prevent the onset of this disease," said Robert P. Heaney MD, FACP, John A. Creighton University Professor and Professor of Medicine at Creighton University in Omaha, Nebraska. "Along with weight-bearing exercise, the most valuable intervention for maintaining bone health is an overall healthful diet that supplies adequate amounts of all nutrients such as vitamin D."

The US National Osteoporosis Foundation predicts that by 2010, about 12 million people over the age of 50 will have osteoporosis and another 40 million will have low bone mass. These numbers are expected to continue climbing. To help address this significant public health issue, the FDA developed this health claim for manufacturers to include on labels of appropriate foods and dietary supplements. The new labeling can help consumers identify products with adequate calcium and Vitamin D that can help to reduce their risk of osteoporosis.

Increasing Awareness and Consumption of Vitamin D

"We initiated this petition because we believe consumers will benefit from efforts to increase awareness of the link between calcium and vitamin D and bone health," said Dr. Rhona Applebaum, Vice President and Chief Scientific and Regulatory Officer for The Coca-Cola Company. "Revising the osteoporosis risk reduction health claim to include both vitamin D and calcium will help the food industry communicate the importance of these nutrients to consumers."

According to Carolyn E. Moore, PhD, RD, Principal Scientist with The Coca- Cola Company's Institute, studies sponsored by the Institute at the Boston University Medical Center and ENVIRON Health Sciences, demonstrated that many consumers are not getting enough Vitamin D from food and dietary supplements. The groups at greatest risk in the US include teenage girls, women, the elderly, and African-American and Mexican-American adults.

It was The Coca-Cola Company who sought approval to add vitamin D to calcium-fortified juices and juice drinks from the FDA, through research the Company sponsored at the Vitamin D and Bone Health Research Laboratory at Boston University Medical School. Results from this research demonstrated that vitamin D is readily absorbed by the body when added to skim milk and

orange juice. The FDA approved the addition of vitamin D to calcium-fortified juices in 2003.

The Importance of Vitamin D for Strong Bones

Vitamin D requirements of all age groups can be met under conditions of adequate exposure to sunlight. However, several factors can reduce the production of vitamin D from the skin including the use of sunscreens, increased skin pigmentation, normal aging, and insufficient exposure to sunlight.

The primary function of Vitamin D is to aid in the body's absorption of calcium, helping to form and maintain strong bones. Without Vitamin D, the body absorbs 10 - 15 percent of calcium consumed in the diet. With Vitamin D, the absorption level increases to 30 - 50 percent.

Emerging Research on Vitamin D

Vitamin D has been the subject of extensive basic and clinical research in the past several years, which has generated valuable insights about this vital nutrient.

-- In a recent study supported in part by the Institute, researchers from Boston University School of Medicine found that vitamin D2 (found naturally in plants) is equally as effective as vitamin D3 (produced as a result of sun exposure and found in some food sources such as cod liver oil and oily fish) in maintaining circulating blood levels of vitamin D.

-- With support from the National Institutes of Health and the Institute, the United States Department of Agriculture's Nutrient Data Laboratory is in the process of conducting an updated analysis of vitamin D content in a wide range of whole and processed foods, including, for the first time, specific forms of vitamin D, i.e., D2 and D3.

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Monday, September 29, 2008

Giving from the Heart: Auxiliary Donates Funds for Cardiac Rehab

The Piedmont Mountainside Hospital Auxiliary recently donated more than $60,000 to provide cardiac rehabilitation services at the hospital. It is the largest single donation ever made by the Auxiliary to the hospital since the Auxiliary was chartered in 1970. There are more than 90 men and women who volunteer in the PMH Auxiliary.

“This is a much needed service for our community and we are pleased to be able to provide the funds for this new service,” said Margo Coleman, president of the Piedmont Mountainside Hospital Auxiliary. “Establishing cardiac rehab here at Piedmont Mountainside should lessen the drive for those seeking rehab. Currently, the nearest rehab facility is nearly 40 miles away.”

The Piedmont Mountainside Hospital Cardiac Rehabilitation Center will be housed in one of the physician office buildings adjacent to the hospital. Cardiac Rehabilitation is designed to help patients with heart disease recover faster and return to full and productive lives. The outpatient program is designed for the diagnosed heart patient, as well as, those who are at high risk for developing heart disease. Under the supervision of a physician, the rehabilitation staff combines prescriptive exercise training with coronary risk factor modification educational services.

“The PMH Auxiliary continues to be a vital part of this hospital and a vital part of this community,” said Mike Robertson, interim CEO of Piedmont Mountainside Hospital. “This is an invaluable service for all of our cardiology patients.”

Charted on November 5, 1970, the Auxiliary has made many contributions to the hospital over the years. Its primary goal is to give financial support to the hospital to enhance the care of patients. The PMH Auxiliary has contributed items such as a fetal heart monitor for the maternity ward; a golf cart for visitor/patient transportation from parking lots; new furniture for the hospital chapel; hand-knitted caps for newborns; Teddy bears and dolls for children in the hospital; new bassinets for labor and delivery suites; a TV and video player for the ED pediatric room and surgery waiting room; and two new wheelchairs and benches for the front entrance. Annual fundraising activities include a fashion show luncheon, jewelry and book sales, and other sales, in addition to its Love Light program in which community members make donations in honor or in memory of loved ones.

For more information on joining the Piedmont Mountainside Hospital Auxiliary, please contact Regina Camp at 706-301-5300 or via email at regina.camp@piedmont.org. For more information on Piedmont Mountainside Hospital, visit www.piedmontmountainsidehospital.org.
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FDA Analysis Shows Cholesterol Lowering Medications Do Not Increase the Risk of "Lou Gehrig's Disease"

A U.S. Food and Drug Administration's analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as "Lou Gehrig's Disease." The analysis was reported on Monday, Sept. 29, 2008 in Pharmacoepidemiology and Drug Safety.

"The FDA's review, which began in 2007, is an example of the agency working to analyze products - throughout their lifecycle - to keep health care professionals and patients informed of new and emerging safety data," said Mark Avigan, M.D., director, Division of Pharmacovigilance I, Center for Drug Evaluation and Research, FDA.

The FDA analysis, undertaken after the agency received a higher than expected number of Adverse Event Reporting System reports of ALS in patients on statins, is based on data from 41 long-term controlled clinical trials. The results showed no increased incidence of the disease in patients treated with a statin compared with placebo.

Statins -- HMG-CoA-reductase inhibitors -- are the most commonly-prescribed medications to treat elevated cholesterol levels in the United States. ALS is a fatal neurodegenerative condition with an overall annual incidence of 1 to 2 per 100,000 people in the general population. The incidence of ALS increases with age.

Statins have also been shown to reduce the risk of heart disease in a wide variety of patients. Based on currently available information, health care professionals should not change their prescribing practices for statins and patients should not change their use of statins.

The FDA's paper, "An evaluation of a data mining signal for amyotrophic lateral sclerosis and statins detected in the FDA's spontaneous adverse event reporting system," documents that during the course of long-term placebo-controlled clinical trials, nine of about 64,000 patients treated with a statin and 10 of about 56,000 patients treated with placebo were diagnosed with ALS. From this data, the incidence of ALS in patients treated with statins was 4.2 cases per 100,000 patient-years and the incidence of ALS in patients treated with placebo was 5.0 cases per 100,000 patient-years.

"While the FDA finds the lack of an increase in the incidence of amyotrophic lateral sclerosis (ALS) in patients treated with statins in clinical trials reassuring, given the extensive use of this class of drugs and the serious nature of ALS, continued study of this issue is warranted," said Dr. Avigan.

The FDA is anticipating the completion of a case-control or epidemiological study of ALS and statin use that is being conducted by Dr. Lorene Nelson, Chief of the Division of Epidemiology, Stanford University School of Medicine, and colleagues at the Division of Research, Kaiser Permanente. Results from this study should be available within 6-9 months. FDA is examining the feasibility of conducting additional epidemiologic studies to examine the incidence and clinical course of ALS in patients taking statins.

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Sunday, September 28, 2008

Piedmont Hospital Earns Gold and Bronze

Piedmont Hospital’s Heart Failure Resource Center and its stroke program have been recognized for performance excellence by the American Heart Association (AHA). The Heart Failure Resource Center received the 2008 Gold Performance Achievement Award and the stroke program received the 2008 Bronze Performance Achievement Award, announced recently in the “Best Hospitals” issue of U.S. News & World Report.

Piedmont Hospital is one of two hospitals in Georgia to get the Gold and one of 13 Georgia hospitals to earn the Bronze. Selected hospitals across the country were recognized for their commitment to quality care for heart disease and stroke patients by earning a Get With The Guidelines (GWTG) Achievement Award. GWTG is an evidence-based program for in-hospital quality improvement, developed by the American Heart Association and American Stroke Association. GWTG helps hospitals improve the quality of care they provide to patients with heart disease, heart failure and stroke by aligning treatment with the most current scientific guidelines—turning guidelines into lifelines.

“We are pleased Piedmont Hospital was recognized by AHA for our treatment and care of stroke and heart failure patients,” said Robert Maynard, president and CEO of Piedmont Hospital. “This national recognition shows our efforts to provide the best quality patient care.”

Piedmont Hospital demonstrated at least 85 percent compliance in each of the five core GWTG heart failure measures and in each of the seven core GWTG stroke measures. The gold award recognizes two years or more of sustained performance achievement and the bronze award recognizes initial performance achievement for 90 consecutive days.

Get With The Guidelines has been turning guidelines into lifelines since 2000, with more than 1,330 U.S. hospitals implementing the program. Hospitals, physicians, nurses and other healthcare providers who use GWTG are armed with the latest evidence-based guidelines and immediate access to clinical decision support. Clinicians and patients alike are assured that treatment is aligned with best-practice medicine and is therefore likely to produce improved patient outcomes.

For more information on Get With The Guidelines, search www.americanheart.org.
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New Laparoscopic Procedure Performed at Piedmont Fayette Hospital

Coweta County resident Mary Finnegan woke up feeling nauseated every morning for six weeks. It turned out that the way her gall bladder was functioning was making her feel ill, and her doctor informed her that to feel better she would have to have it removed. So Finnegan underwent an innovative new laparoscopy procedure through a single incision at her belly button at Piedmont Fayette Hospital (PFH).

“This innovative single-incision laparoscopic cholecystectomy is an improvement because it looks better, creates less stress, pain and a quicker recovery time for patients,” said John Goza, M.D. “It’s awesome – my patients leave the recovery room one hour after surgery and you can not tell that they have even had surgery. They return to the office two weeks later and are completely back their normal lives.”

Unlike traditional surgery on the colon or other parts of the intestines where a long incision down the center of the abdomen is required, laparoscopic surgery requires only small “keyhole” incisions in the abdomen. The standard procedure is to make four incisions through the abdominal muscle. With the new single site incision, a surgeon makes only one small incision approximately two centimeters in length at the belly button.

Using the single site procedure through the belly button shortens the recovery time for patients from about six weeks to only one week. As surgeons continue to develop this advanced minimally invasive procedure the benefits will expand to other applications like exploratory surgeries, appendectomies and removing ovaries. Laparoscopy is usually done under general anesthesia, although sometimes a spinal anesthetic may be used.

“I was waterskiing two weeks after my surgery,” said Finnegan. “I feel great and I am happy to report that my scar is practically hidden in my belly button, so it isn’t noticeable at all.”

Dr. Goza is one of approximately six surgeons in metro Atlanta performing this single site laparoscopic cholecystectomy. He performs laparoscopies at Piedmont Fayette Hospital. For more information on PFH’s laparoscopic services visit www.fayettehospital.org.
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National Birth Defects Prevention Study Finds Pre-pregnancy Diabetes

Women who receive a diagnosis of diabetes before they become pregnant are three to four times more likely to have a child with one or even multiple birth defects than a mother who receives a diagnosis of diabetes while pregnant or a mother who is not diabetic, according to a study by the Centers for Disease Control and Prevention (CDC), released in the American Journal of Obstetrics and Gynecology.

The article from the National Birth Defects Prevention Study (NBDPS), "Diabetes Mellitus and Birth Defects," shows that pregnant women with pre-gestational diabetes mellitus (pre-pregnancy diagnosis of diabetes, such as type 1 or type 2 diabetes) are more likely than a mother with no diabetes or a mother with gestational diabetes mellitus (pregnancy-induced diabetes) to have a child with various types of individual or multiple birth defects. This includes heart defects, defects of the brain and spine, oral clefts, defects of the kidneys and gastrointestinal tract and limb deficiencies. This study is the first to show the broad range and severity of birth defects associated with type 1 and type 2 diabetes.

"The continued association of diabetes with a number of birth defects highlights the importance of increasing the number of women who receive the best possible preconception care, especially for those women diagnosed with diabetes," says Adolfo Correa, M.D., M.P.H., Ph.D., lead author and epidemiologist at CDC's National Center on Birth Defects and Developmental Disabilities. "Early and effective management of diabetes for pregnant women is critical in helping to not only prevent birth defects, but also to reduce the risk for other health complications for them and their children."

Researchers also found that some of the pregnant women with gestational diabetes were more likely to have a child with birth defects. Because birth defects associated with diabetes are more likely to occur during the first trimester of pregnancy and before a diagnosis of gestational diabetes is made, the observed associations suggest that some of the mothers with it probably had undiagnosed diabetes before they became pregnant. However symptoms went unnoticed until pregnancy.

Further, the associations of gestational diabetes with various birth defects were noted primarily among women who had pre-pregnancy obesity, which is a known risk factor for both diabetes and birth defects. Preconception care also should be considered and promoted for women with pre-pregnancy obesity to prevent birth defects and reduce the risk for health complications.

The NBDPS is a population-based, case-control study that incorporates data from nine birth defect centers in the United States-Arkansas, California, Georgia, Iowa, Massachusetts, New York, North Carolina, Texas and Utah. These centers have been working on the largest study of birth defects causes ever undertaken in the United States. Researchers have gathered information from more than 30,000 participants and are using this information to look at key questions on potential causes of birth defects.

Birth defects affect one in 33 infants and are a leading cause of infant mortality. For some birth defects, some risk factors or causes have been identified; however, for the majority of birth defects the causes remain unknown.

In the United States, the prevalence of gestational diabetes has been increasing in recent years and currently affects about seven percent of all pregnancies, resulting in more than 200,000 cases annually. While it is usually resolved shortly after delivery, women who have had gestational diabetes are at increased risk of developing type 2 diabetes in the future.
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Thursday, September 25, 2008

CDC Awards $24 Million for Pandemic Influenza Preparedness Projects

The Centers for Disease Control and Prevention (CDC) has awarded $24 million to fund 55 projects in 29 state and local public health departments that could serve as innovative approaches for influenza pandemic preparedness.

“What is learned from these projects can benefit everyone because it could improve national, regional and local public health detection and response to a pandemic involving influenza,” said Richard Besser, MD, Director of CDC′s Coordinating Center for Terrorism Preparedness and Emergency Response. CDC intends for the recipients to implement promising practices or to develop effective approaches and models that can be replicated nationally, Dr. Besser said.

A total of 184 funding applications were submitted by state and local health departments in a competitive application process. Eligible applicants for the awards were limited to the 62 state, local and territorial public health departments that currently receive federal funding through CDC′s Public Health Emergency Preparedness (PHEP) Cooperative Agreement.

The 29 award recipients have one year to complete the projects, which begin on September 30, 2008. The projects focus on seven key areas and include:

1. Use of public engagement as part of the public health decision-making process
2. Electronic laboratory data exchange to support influenza pandemic monitoring
3. Integration of state-based immunization information systems to track distribution of influenza pandemic countermeasures.
4. Development of statewide electronic death reporting systems compliant with Public Health Information Network (PHIN) requirements
5. Collaborative planning among healthcare providers to ensure the delivery of essential services during an influenza pandemic
6. Development of interventions that promote preparedness for pandemic disease among identified vulnerable populations
7. Distribution and dispensing of antiviral drugs to self-isolated or self-quarantined persons in an influenza pandemic event

A list of the 29 award recipients and their projects can be found at http://emergency.cdc.gov/cotper/coopagreement/07/funding-schedule-pan-flu.asp.

The $24 million for the new projects are part of $600 million in PHEP supplemental funding appropriated by Congress to accelerate state and local influenza pandemic planning efforts. The focus of the funding, which was distributed in three phases beginning in 2006, was on practical, community-based procedures that could prevent or delay the spread of an influenza pandemic.

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Mayo Clinic Discovery May Help Diabetic Gastric Problem

Mayo Clinic researchers have found what may provide a solution to one of the more troubling complications of diabetes — delayed gastric emptying or gastroparesis. The researchers showed in animal models that a red blood cell derivative increases production of a key molecule, normalizing the digestive process. The findings appear in the current online issue of the journal Gastroenterology.

Gastroparesis occurs when the stomach retains food for longer periods. When that food eventually passes into the small intestine, insulin is released. Because the passage of food out of the stomach becomes unpredictable, maintaining a proper blood glucose level — critical for controlling diabetes — also becomes difficult. Gastroparesis can cause pain, nausea, vomiting, stomach spasms and weight loss due to inadequate absorption of nutrients. The abnormally high blood glucose levels cause chemical changes in nerves and in pacemaker cells which regulate digestive processes in the gut, and damage blood vessels that carry oxygen and nutrients to cells.

"If these data are confirmed in humans, it may point toward a treatment for this difficult problem," says Gianrico Farrugia, M.D., Mayo Clinic gastroenterologist and senior author on the study. "Our goal is to normalize gastric emptying and therefore improve a patient's quality of life and glucose control."

Science Behind the Findings

Previous studies in animals and humans showed that two aspects of gastroparesis were: 1) loss of Kit, a marker for interstitial cells of Cajal (ICC), and 2) loss of expression of neuronal nitric oxide synthase (nNOS). ICC cells produce electrical signals that regulate muscle contraction in the digestive tract. nNOS generates nitric oxide, which transmits nerve impulses in the digestive tract. Both are important for normal functioning but can be depleted by oxidative stress (an imbalance in ionic charges at the molecular level), a problem common in diabetes that also can lead to heart and kidney damage.

The research team decided to test a molecule known to protect cells against oxidative injury — heme oxygenase-1 (HO1). The team measured gastric emptying in a set of diabetic mice and then looked at expression of HO1. Results showed that production of HO1 was lost in all mice with gastroparesis and nNOS expression was decreased. When the team induced HO1 production by introducing hemin, a red blood derivative, gastric emptying returned to normal and Kit and nNOS expression were restored, despite the diabetes. The team says that future research should target the HO1 pathway as a means of reversing the affects of diabetic gastroparesis.

Others researchers were Kyoung Moo Choi, Ph.D.; Simon Gibbons, Ph.D.; Tien Hguyen; Gary Stoltz; Matthew Lurken; Tamas Ordog, M.D.; and Joseph Szurszewski, Ph.D., all of Mayo Clinic. The research was funded by the National Institutes of Health.
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Big Waistline in Women Could Lead to Heart Trouble

A heart expert at Johns Hopkins is calling for all women with a waistline measuring more than 35 inches to get an annual check-up and detailed risk assessment for heart problems because excess abdominal fat, even in the mildly obese and overweight, leads more than a third of women to underestimate their lifetime risk of having a heart attack, stroke or chest pain (angina.)

Cardiologist Erin Michos, M.D., M.H.S., who plans to make her pitch Sept. 23 directly to colleagues during a special lecture at The Johns Hopkins Hospital, says the recommendation is based on a national, multicity screening of 8,936 women, ages 35 to 63, for heart disease risk factors. The screening, she says, found a strikingly high number of overweight American women whose stretched girth was tied to a serious underestimation of risk using traditional tools to assess heart health.

In a report published in the August issue of the Journal of Women’s Health, the research team showed that 39 percent of women screened were overweight (having a body mass index between 25 and 30) and 35 percent were obese (having a body mass index over 30, often overweight by more than 30 pounds.) And when waistlines 35 inches and larger were factored into the risk assessment, 55 percent of these women were found to have hearts at increased risk of disease.

“It is time for physicians and patients to pull out their measuring tapes and for overweight women in particular to start shedding some pounds,” says Michos, an assistant professor at the Johns Hopkins University School of Medicine and its Heart and Vascular Institute.

She points out that traditional risk-factor scoring leaves out waist size, taking into account only such other factors as age, blood pressure, blood cholesterol levels, smoking and diabetes. These measures have long been used as part of the Framingham Risk Assessment, which only assesses people’s 10-year risk of heart disease.

But the team’s latest assessments – drawn from a 2006 annual public screening in 14 communities across the United States, in which women were asked to undergo a short physical check-up and fill out a health questionnaire – changed significantly when expanded waistlines were factored into their calculations.

More than half (59 percent) of the 85 percent of women originally thought to be at low risk of heart trouble were now found to have one or two additional risk factors. And 19 percent of those at low risk and nearly half (41 percent) of the women originally ranked at intermediate risk actually had three or more risk factors.

“These women have a high lifetime risk of cardiovascular disease even though their 10-year risk may be predicted as low,” says Michos, who points out that the presence of a single, major risk factor for heart disease by the age of 50 cuts back on women’s median lifespan compared to women with no risk factors.

“Our results really emphasize the growing epidemic of obesity in America and showcase its potential for misreading or masking future harm to women’s heart health,” she says. “Even if they are not experiencing immediate problems, they could soon be in trouble. Overweight people are more likely to develop risk factors that lead to cardiovascular problems, such as high blood pressure, blood sugar imbalances and excess blood lipid levels. And the reverse is also true: Losing weight, especially abdominal fat, is the first step in lowering blood pressure and getting blood cholesterol levels under control.”

Michos notes that other research has shown a loss of just five pounds lowers people’s risk of pre-diabetes by 31 percent. Losing 10 pounds lowers blood pressure by 5 millimeters of mercury.

Michos says she has started her campaign with local physicians because it will take a few years to amass the necessary additional evidence to change national clinical guidelines. Results from the 2007 screenings, coordinated by the Maryland-based Sister to Sister, Everyone Has a Heart Foundation, will not be ready until later this year.

“Physicians and others have unfortunately become too accustomed to seeing heavy- set people, and there is a risk that we overlook or dismiss being overweight and obesity as a potential and future source of heart problems,” says Michos. “Even if the problems are not evident now, it is more important to start screening women at a younger age to forego heart problems later in life.

“Community screening events have confirmed that many women are unaware of their risk factors and the screenings have proven effective at identifying those women at risk and, hopefully, we will be able to expand these programs in the future,” she adds, noting that 48 percent of women with high cholesterol levels were newly diagnosed with the condition, as were 7 percent of women with hypertension. “Awareness is the first step to implementing heart-healthy lifestyle changes to reduce their risk,” says Michos. The next Sister to Sister community screening event will take place in February 2009.

Furthermore, Michos says annual survey results, though specific to women, also bear significance for men, for whom a waistline greater than 40 inches is considered obese.
Researchers say their next steps are to monitor screened women to see how well follow-up treatments worked at not only lowering risk, but also in lowering actual heart problems and whether or not this stretches out lifespan.

Of 150 women who were screened as high risk in 2006, 71 percent followed up with a visit to their physician, 64 percent changed diet, 47 percent lost weight, 61 percent monitored their blood pressure levels, 6 percent stopped smoking, and 23 percent checked their waistline against the 35-inch benchmark.

According to the latest statistics from the American Heart Association, one in three American women has some form of cardiovascular disease. Sixty-nine million women are overweight, including more than 36 million who are obese.

Funding for this study was provided by the Sister to Sister, Everyone Has a Heart Foundation. Besides Michos, other researchers from the Johns Hopkins Ciccarone Preventive Cardiology Center involved in this study and the Sister to Sister annual screenings were Brian Kral, M.D., M.P.H.; Catherine Campbell, M.D.; M. Dominique Ashen, Ph.D., C.R.N.P.; and Roger Blumenthal, M.D. Other researchers included Irene Pollin, Ph.D., M.S.W., and Laurene McKillop, Ph.D., from Sister to Sister; Teresa Shattuck, Ph.D., Michele Debarthe Sadler, Ph.D., and Karen Boyle, Ph.D., from Shattuck & Assoc.; Khurram Nasir, M.D., M.P.H., from Massachusetts General Hospital in Boston; Rita Redberg, M.D., from the University of California San Francisco; and Karlynn Brintzenhofeszoc, Ph.D., M.S.W., from Catholic University of America in Washington, D.C.

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Most Parents Are Unaware of Expanded CDC Flu Vaccination Recommendations

PRNewswire-USNewswire/ -- Only one in 10 parents is aware of the recommended age range for children to be vaccinated against the flu, according to a new survey. The Centers for Disease Control and Prevention (CDC) expanded the flu vaccination recommendations in February 2008 to include all children from 6 months through 18 years old, expanding vaccinations to 30 million more school-age children.

The survey also found that during the past two years, nearly 60 percent of parents did not get their children vaccinated against the flu. To drive awareness of the new recommendations and the importance of flu vaccinations, Families Fighting Flu (FFF) -- a group of parents who have lost a child to the flu -- the Visiting Nurse Associations of America (VNAA) -- the largest non-profit network of flu immunizers -- and The Clorox Company have teamed up to help educate families about the broadened recommendations and to increase the number of people getting flu vaccinations nationwide through the Say "Boo!" to the Flu program.

"My wife and I didn't realize how important one flu vaccination could be until we lost our daughter, Amanda, to the flu," said Richard Kanowitz, President of FFF. "That is why this program is so important to us -- Say 'Boo!' to the Flu educates parents on the importance of getting their kids vaccinated and other steps they can take to help prevent the spread of the flu virus."

In its third year, the Say "Boo!" to the Flu program educates families nationwide on how to treat the entire family to a healthier, happier flu season. The program features a bus tour that will travel across the country, stopping along the way to vaccinate families in 12 cities and give them the tricks they need to fight the flu virus this flu season.

"It's crucial that parents stay informed and make it a priority to vaccinate their families against the flu every year," said Mary Ann Blade, a VNAA representative. "Say 'Boo!' to the Flu brings flu prevention to the whole family, since the CDC says that household contacts and caregivers -- moms, dads, grandparents, nannies and other child care providers -- should also get vaccinated."

Everyone is Saying "Boo!" to the Flu!

The Say "Boo!" to the Flu bus tour will kick off September 27 in Atlanta, bringing flu vaccinations and simple prevention tips to families across the country throughout the month of October, before flu activity peaks. Halloween games and giveaways like stickers, t-shirts and Clorox Disinfecting Wipes are part of every event.

In addition to the traveling Say "Boo!" to the Flu tour, other groups will be signing on to help say "boo!" to the flu, too. Visiting Nurse Associations across the country, pediatricians' offices, flu shot clinics, child care centers and moms' groups nationwide will receive Say "Boo!" to the Flu materials, resources and tools to help prevent the spread of the flu virus in their communities.

Visit www.SayBooToTheFlu.com for the complete tour schedule, downloadable family activities, a flu clinic locator and simple flu prevention tips.

News for Parents

The survey, conducted by the Say "Boo!" to the Flu program partners, also found:

Parents need to brush up on their flu facts.

-- Only 10 percent of parents knew that the CDC recommends the flu
vaccination for children from 6 months through 18 years.

-- Ninety percent of parents did not know that a child can be contagious
for more than seven days after becoming sick.

-- Flu vaccinations are not a top priority on parents' winter to-do
-- When parents think about fall and winter woes, most name the high cost
of heating fuel as their biggest dread this coming season. Only 15
percent said they most dread the possibility of a family member
catching the flu.
-- A majority of parents (52 percent) are only slightly or not at all
concerned that their child or children will catch the flu within the
next six months.
-- Nearly 60 percent (57 percent) of parents have NOT gotten their
children vaccinated against the flu in the past two years.
-- Most parents who don't get their children vaccinated against the
flu say they don't think the vaccine is necessary (29 percent).
-- Among parents who have not taken their children to get a flu shot
within the past two years, 58 percent said they would be likely to
do it if they could get the flu shot at locations such as schools,
shopping malls, grocery stores or public parks.

You Can Scare Away the Flu, Too!

Aside from getting vaccinated against the flu, there are other simple steps families can take to help prevent the spread of the flu virus -- and other potentially harmful bacteria and viruses -- in their homes:

-- Wash Hands Frequently: Wash hands with warm water and soap for at
least 20 seconds (the time it takes to sing the "Happy Birthday" song

-- Disinfect Germ Hot Spots: Kids can touch up to 300 surfaces in 30
minutes, so disinfect the surfaces kids touch most frequently -- like
doorknobs, light switches, faucets or plastic toys.

-- Do the Elbow Cough: Cough and sneeze into your elbow instead of your
hands to help prevent the spread of germs from touch.

-- Follow Good Health Guidelines: Eat right, exercise, and get plenty of
sleep to help boost your body's ability to fight the effects of colds
and the flu.

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Wednesday, September 24, 2008

Potential Treatment Option for Severe Emphysema Under Study

Emory University researchers are participating in a nationwide study to explore an investigational treatment for advanced widespread emphysema.

The EASE (Exhale Airway Stents for Emphysema) Trial focuses on airway bypass, a minimally invasive procedure designed to reduce excessive lung inflation and shortness of breath -- typical complications of emphysema - by making new pathways for trapped air to exit the lungs.

During the airway bypass procedure, new openings are created in the airway wall connecting the damaged lung tissue to the natural airway. These pathways are supported and kept open by several new drug-eluting stents.

"Emphysema permanently destroys lung function and there are currently limited treatment options for people with this devastating disease," says Rabih Bechara, MD, assistant professor and director of interventional pulmonology, Emory University School of Medicine. "This is an exciting study that could offer substantial relief to participants, and eventually possibly to the millions who suffer from the effects of emphysema."

Emphysema, usually caused by chronic tobacco smoking, is a persistent, progressive and irreversible lung disease characterized by shortness of breath and the destruction of lung tissue. Over time, the tiny air sacs in the lungs, or alveoli, are damaged and lose their elasticity.

This loss of the lungs' natural elasticity and the collapse of airways in the lung combine to make exhalation ineffective, leaving emphysema sufferers with hyperinflation because they are unable to get air out of their lungs. Breathing becomes inefficient and patients have to work very hard to breathe -- making normal activities, such as walking, eating or even bathing, difficult. There is no cure and few treatment options are available for most patients.

"By creating new pathways for airflow with the airway bypass procedure, we hope to reduce hyperinflation and improve lung function," says Bechara, principal investigator of the study at Emory. "Currently, patients are often in poor physical condition, struggling with each breath so if we can help patients breathe easier it is likely to improve their quality of life."

Physicians commonly use bronchoscopes to examine the airways within the lungs. Participants in the trial are randomized two to one to an airway bypass or a control group. If randomized to the airway bypass group, physicians will first use a Doppler probe inserted through the bronchoscope to identify a site in the airway that is away from blood vessels. A special needle is then used to make a small opening and the stent is placed in the passageway to keep it open. The procedure involves placing up to six Exhale® Drug-Eluting Stents -- manufactured by Broncus Technologies, Inc.

Although this procedure is still under clinical investigation, feasibility data suggest it may hold promise for patients with emphysema. Results from the open-label Exhale Drug-Eluting Stent feasibility study were published in the October 2007 issue of the Journal of Thoracic and Cardiovascular Surgery. Positive results included a statistically significant reduction in the amount of air trapped in the lungs and an improvement in breathing for patients at six months after the airway bypass procedure.

Anyone interested in participating in the EASE Trial at Emory may call 404.778.7777. For general EASE Trial information, please call 866-431-3273 or visit http://www.easetrialus.com/.
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Mayo Clinic to Premiere New Documentary About the Mayo Brothers Narrated by Garrison Keillor

In conjunction with Heritage Days, Mayo Clinic will host red-carpet premiere showings of a new documentary film, "My Brother and I / The Founding of Mayo Clinic." Narrated by Minnesota's own Garrison Keillor, "My Brother and I" tells the story of Dr. Will Mayo and Dr. Charlie Mayo, their lives and values, and how their vision continues to inspire Mayo Clinic today.

The public is invited to the red-carpet showing of the 35-minute film at 7 p.m. on Tuesday, Sept, 30, in Phillips Hall of the Siebens Building, 100 Second Ave. S.W. The event is free, with seats available on a first-come basis. No reservations are necessary. Free parking is available in city ramps. Street parking near the Siebens Building is limited.

Made possible with a generous gift from John T. and Lillian G. Mathews, the film includes rare home movies and vintage radio recordings, along with interviews of Mayo family members and colleagues who worked with Dr. Will and Dr. Charlie. "My Brother and I" features high-definition cinematography and an original score by Emmy Award-winning Minnesota musician Chan Poling.

Additional showings of the film will take place at different times and locations around Mayo Clinic throughout Heritage Days, Sept. 30–Oct. 3, 2008.

Starting Oct. 6, DVD copies of "My Brother and I" will be sold in Mayo-affiliated gift shops.

Heritage Days is an annual weeklong celebration. This year's theme is "My Brother and I: Inspiring Teamwork." Live musical performances are scheduled during the Ice Cream Social on Oct. 2, from 2 to 3:30 p.m., in the Edith Graham Mayo Courtyard of Saint Marys Hospital, and from 2 to 4 p.m., in Annenberg Plaza between the Plummer and Mayo buildings.

Musical concerts will be held Monday through Friday at several campus locations from 11:45 a.m. to 12:45 p.m. Commemorative displays featuring Mayo Clinic's significant anniversaries can be found in Mathews Grand Lobby in the Mayo Building.

The public is welcome to participate in the week's festivities. Information is posted on the Heritage Days Web page.
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Emory Healthcare Opens New School of Medical Technology

Emory Healthcare is working to address the community's need for more medical technologists with the opening of its new School of Medical Technology (SMT), and welcomed its inaugural class on Sept. 4.

The Emory Healthcare School of Medical Technology (EHSMT) is a full-time, hospital-based program for applicants with a bachelor's degree (preferably in science) and an interest in laboratory science. Students will be awarded a certificate in medical technology after the completion of the 12-month program.

The initial class consists of seven students and a diverse group of instructors that include experienced medical technologists, pathologists and residents of Emory pathology and laboratory medicine.

"This is an exciting time for Emory as we work to fulfill our educational mission and answer the growing shortage of medical technologists," says John T. Fox, president and CEO of Emory Healthcare.

The program administrators include John D. Roback, MD, PhD, medical director; Marilea Grider, MS, MT (ASCP) program director; and Stacy Steward, MPH, MT (ASCP), laboratory education coordinator.

Currently, the United States is experiencing a labor shortage for medical technologists, with student enrollment in medical technology (MT) programs steadily declining.

EHSMT offers incoming students with a new financial assistance option. A 'service-cancelable' financial loan allows students to defer repayment while enrolled in good standing in the EHSMT and an option to cancel repayment in exchange for service work after graduation as described in the promissory note. The loan is designed to help students finance their education and to assist Emory Healthcare recruit and retain well-prepared professional medical technologists.

Emory is currently the only medical technology school in the Atlanta area and, according to Steward, the program is in the process of earning NAACLS accreditation. "Our initial application and preliminary report have been approved and we are in the process of developing our 'self-study' report," notes Steward. "After submitting the self-study report, a site-visit will be conducted by NAACLS representatives and a decision will be made regarding an award of accreditation. We fully anticipate receipt of accreditation."

Aside from Emory, there are currently only three other universities in the state that offer accreditation for medical technology: Medical College of Georgia in Augusta, Armstrong University in Savannah, and Thomas University in Thomasville.
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Tuesday, September 23, 2008

80 Georgia Lawmakers to Meet with Trauma Care Specialists Monday

80 Georgia lawmakers to meet with trauma care specialists Statewide briefing on trauma care on Monday, September 29 is free and open to health care providers, business and community leaders, educators, and the media at the Georgia Railroad Freight Depot in downtown Atlanta

More than 80 Georgia legislators will meet next Monday, September 29, with dozens of trauma care professionals, other health care providers, and active stakeholders to brief government and the public on the status of the Georgia statewide trauma care system. Some 118 state lawmakers have signed on as hosts and supporters of this project, and they are working to develop a permanent funding source.

The Trauma Care in Crisis statewide briefing is expected to draw several hundred participants to the Georgia Railroad Freight Depot in downtown Atlanta for the luncheon forum from 10 AM till 1 PM.
The event is free and open to health care professionals and others interested in trauma care.

Topics covered by speakers and panelists will include an overview of the statewide trauma system, legislation, preparedness, the regional approach, communication, business, funding, and prevention.

Speakers representing major hospitals, emergency medical services (EMS), universities, the Governor's Office of Highway Safety, and business organizations will present a variety of perspectives on how to establish and fund a comprehensive statewide trauma care system to serve all the people of Georgia.

The briefing is sponsored by Healthcare Georgia Foundation, a non-profit grantmaking institution that has funded a series of roundtables and forums facilitated by Atlanta-based Reece & Associates, a group that specializes in public policy and government relations.

Register online now > or call Christine Jordan at (404) 586-2100.

About Healthcare Georgia Foundation
Healthcare Georgia Foundation is a statewide, private independent foundation. The Foundation's mission is to advance the health of all Georgians and to expand access to affordable, quality healthcare for underserved individuals and communities. Through its strategic grantmaking, Healthcare Georgia Foundation supports organizations that drive positive change, promotes programs that improve health and healthcare among underserved individuals and communities, and connects people, partners and resources across Georgia.

For more information, please visit the Foundation online at www.healthcaregeorgia.org

FDA Warns Companies to Stop Marketing Unapproved Ophthalmic Balanced Salt Solution Drug Products and Topical Drug Products Containing Papain

The U.S. Food and Drug Administration (FDA) today announced that companies marketing unapproved ophthalmic balanced salt solutions (BSS) and unapproved topical drug products containing papain must stop manufacturing and marketing these products or risk enforcement action. FDA is taking these actions because it has received reports of serious adverse events associated with their uses.

Companies must stop manufacturing unapproved BSS products on or before Nov. 24, 2008, and must stop shipping such unapproved products on or before Jan. 21, 2009. After these dates, all unapproved BSS products must have FDA approval to be manufactured or shipped in interstate commerce. Companies that continue to market unapproved BSS products after these dates may be subject to immediate FDA enforcement action, such as seizure and/or injunction against the company.

Today's action does not affect approved ophthalmic BSS products.

Companies marketing any unapproved topical drug products containing papain must stop manufacturing them on or before November 24, 2008. Companies or others engaged in shipping these products must stop shipping these products on or before Jan. 21, 2009. After these dates, all topical products containing papain must have FDA approval to be manufactured or shipped in interstate commerce. Companies that continue to market unapproved topical papain products after these dates may be subject to immediate FDA enforcement action, such as seizure and/or injunction against the company.

No topical drug product containing papain has been approved by the FDA.

Companies that do not comply with the designated timelines may face further FDA action, including enforcement action. If FDA takes enforcement action against a company that continues to market an unapproved product after the stated timeframes, the FDA may simultaneously take additional action regarding any other violative products that the company may be marketing, including any other unapproved drugs.

"These unapproved products have put consumers health in jeopardy, from reports of permanent vision loss with unapproved balanced salt solutions to a serious drop in blood pressure and increased heart rate from the topical papain products," said Janet Woodcock, M.D., director for the Center for Drug Evaluation and Research. "Consumers need to be assured that all drug products are manufactured according to the high quality standards required for FDA approval and that they are safe and effective."

About Unapproved Ophthalmic Balanced Salt Solutions (BSS):
Ophthalmic balanced salt solutions are used to irrigate the eye during surgery on the eye, including cataract and other ocular procedures. FDA has received reports of serious injuries to the eye from unapproved ophthalmic BSS. Users of these unapproved products have reported to FDA injuries including eye inflammation, cloudy vision, and permanent loss of visual acuity. Inspection of these products revealed contaminants and other product defects. Thus, FDA urges doctors and others who use these products to switch to approved versions of BSS made by Alcon and Akorn. FDA oversight of the manufacturing of ophthalmic BSS products helps to ensure that they are properly made and to reduce the risk of contamination and associated injuries.

Topical drug ointments containing papain are used to remove dead or contaminated tissue in acute and chronic lesions, such as diabetic ulcers, pressure ulcers, varicose ulcers, and traumatic infected wounds. Trade names for these products include Accuzyme, Allanfil, Allanzyme, Ethezyme, Gladase, Kovia, Panafil, Pap Urea, and Ziox. Other products are marketed under the names of the active ingredients, for instance, papain-urea ointment.

The FDA is taking action today against these products because it has received reports of serious adverse events in patients using products containing papain. Reports include hypersensitivity (allergic) reactions that lead to hypotension (low blood pressure) and tachycardia (rapid heart rate). In addition, patients who are allergic to latex can also be allergic to papaya, the source of papain. Therefore, patients with latex sensitivity may be at increased risk of suffering an adverse reaction to a topical papain drug product.

FDA urges consumers who are using topical drug products containing papain, and who have questions or concerns, to contact their health care provider about discontinuing treatment with these products. There are a number of FDA-approved topical products that have been found safe and effective as wound healing agents and that do not contain papain.

"Removing unapproved topical drug products containing papain and unapproved ophthalmic balanced salt solutions is yet another step forward for patient safety," said Deborah M. Autor, director, Office of Compliance for CDER, FDA.

These actions are part of FDA’s unapproved drugs initiative. That initiative seeks to ensure that all drug products marketed in the United States are shown, through the drug approval process, to be safe and effective and to meet appropriate standards for manufacturing and labeling. This represents the eighth and ninth actions taken by the agency against a class of unapproved drugs since issuing a compliance policy guide (CPG) on marketed unapproved drugs in June 2006. The CPG describes FDA’s risk-based enforcement approach to marketed unapproved drugs.


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Monday, September 22, 2008

Indian Spice Reduces Size of Hemorrhagic Stroke

By: Amy Connell
Medical College of Georgia
2008 September 22

You might want to make curcumin part of your daily diet.

This active ingredient of the Indian curry spice, turmeric, not only lowers your chances of getting cancer and Alzheimer's disease, but may reduce the size of a hemorrhagic stroke, say Medical College of Georgia researchers.

Second-year medical student Jay McCracken is working with Dr. Krishnan Dhandapani, neuroscientist in the MCG School of Medicine, using animal models to study curcumin's effect on intracerebral hemorrhages, bleeding in the brain caused by ruptured vessels.

Patients with this type of stroke are often treated for symptoms – such as headache and nausea – with medications, but not the stroke itself. Invasive surgery to remove the clot is usually needed, but some patients may not be good candidates, says Mr. McCracken. About 17 percent of strokes are hemorrhagic, according to the American Stroke Association, and usually occur in people with high blood pressure.

"We found that curcumin significantly decreases the size of a blood clot, but we're not sure why it happens," says the Alpharetta native. He thinks it may be because curcumin is a potent anti-inflammatory and antioxidant. For the study, he dissolved the yellow powder, which gives turmeric its color, in corn oil and injected it into the abdomen of an animal model of hemorrhagic stroke three times over three hours. He suspects less may work and is trying to establish the optimal dose and timing.

Timing is critical for patients who often don't know they have had a stroke and may not be seen by a physician for several hours. "Usually, patients can experience other symptoms like seizures, vision or cognitive problems, so they come to the (emergency room) fairly quickly under most circumstances," says Dr. Dhandapani. "Many patients also arrive due to head trauma and are seen within an hour or so. However, treating these injuries, even after an hour, can be tricky."

Patients likely will need to get curcumin intravenously. The researchers believe it may also help prevent strokes; they intend to pursue this line of study with the idea of also making it available in a concentrated tablet form for those at-risk.

Mr. McCracken has worked on this project since May as part of the School of Medicine Dean's Summer Research Fellowship, which enables rising sophomore students to design and participate in cutting-edge basic and/or clinical research. He is among 25 students presenting their findings today from noon to 1 p.m. in the lobby of the Carl T. Sanders Research and Education Building. School of Medicine Dean D. Douglas Miller will recognize students for their work and talk about the importance and role of research.

Mr. McCracken will continue his research through the year. "I like the research, and I think it's good preparation for residency," he says. He hopes to pursue a neurosurgery residency after graduation.

A graduate of the University of Georgia, where he received biochemistry and microbiology degrees, it was a high school football injury that inspired Mr. McCracken to pursue medicine.

"I snapped my ankle, and when I met the orthopedic surgeon, I thought he was so nice and interesting," says Mr. McCracken. "And then, for an anatomy class, we had to interview someone in science or health care, and I chose my surgeon. He let me shadow him, and I thought it was the best thing in the world."

During his first year at MCG, Mr. McCracken found he really enjoyed anatomy, especially neuroanatomy.

"I think it's interesting and challenging," he says. "I've seen patients come in who have terrible tumors or hemorrhages, and neurosurgeons can change their life in a matter of hours. Patients come in expecting three months to live, and surgeons give them years to live. It's amazing."

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Saturday, September 20, 2008

FDA Updates Health Information Advisory on Melamine Contamination

On September 12, 2008, in light of reports from China of melamine contaminated infant formula, the FDA issued a Health Information Advisory to proactively reassure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell such products in the United States. That advisory also warned members of Chinese communities in the United States that infant formula manufactured in China, possibly available for purchase at Asian markets, could pose a risk to infants.

The FDA had contacted the companies who manufacture infant formula for distribution in the United States and received information from the companies that they are not importing formula or source materials from China.

At the same time, the FDA—in conjunction with state and local officials—began a nation-wide investigation to check Asian markets for Chinese manufactured infant formula that may have been brought into the United States. In particular, this effort focused on areas of the country with large Chinese communities, such as Los Angeles, San Francisco, Seattle and New York. To date, investigators have visited more than 1,000 retail markets and have not found Chinese infant formula present on shelves in these markets.

In addition, the FDA is advising consumers not to purchase infant formula manufactured in China from internet sites or from other sources.

FDA has taken, and will continue to take, proactive measures to help ensure the safety of the American food supply. In conjunction with state and local officials, FDA will continue to check retail stores for food items imported from China that could contain a significant amount of milk or milk proteins. Additionally, FDA is sampling and testing milk and milk-derived ingredients and finished food products that could contain these ingredients from Chinese sources. Milk-derived ingredients include whole milk powder, non-fat milk powder, whey powder, lactose powder, and casein. This sampling and testing is done when these ingredients or products are imported into the United States or found during visits to Asian markets. If the products are adulterated because they contain melamine and/or a melamine analog, FDA will take action to prevent the products from entering the U.S. food supply.

In addition to state and local governments, FDA is working in close cooperation with Customs and Border Protection within the U.S. Department of Homeland Security, the U.S. Department of Agriculture, other federal agencies, and foreign governments.

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Friday, September 19, 2008

CDC Expands Testing Recommendations For Chronic Hepatitis B Virus Infection

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

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

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

Highlights of the recommendations

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

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

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

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

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


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Thursday, September 18, 2008

FDA Issues Draft Guidance on Regulating Genetically Engineered Animals

The U.S. Food and Drug Administration, part of the Department of Health and Human Services, today released for public comment draft guidance on the regulation of genetically engineered (GE) animals. The guidance document is intended to clarify the FDA's regulatory authority in this field, as well as the requirements and recommendations for producers of GE animals and products derived from GE animals.

The comment period for the draft guidance, titled "The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs," runs for 60 days and closes Nov. 18, 2008. The 25-page document is available online at http://www.fda.gov/cvm/GEAnimals.htm.

"Genetically engineered animals hold great promise for improving human medicine, agriculture, the environment, and the production of new materials, and the FDA has long been involved in their scientific evaluation," said Randall Lutter, Ph.D., deputy commissioner for policy. "Our guidance provides a framework for both GE animals and products made from them to reach the market."

Genetic engineering generally refers to the use of recombinant DNA (rDNA) techniques to introduce new characteristics or traits into an organism. When scientists splice together pieces of DNA and introduce a spliced DNA segment into an organism to give the organism new properties, it's called rDNA technology. The spliced piece of DNA is called the rDNA construct. A GE animal is one that contains an rDNA construct intended to give the animal new characteristics or traits.

GE animals can be divided into several classes, based on their intended use. They include animals that produce human or animal pharmaceuticals (biopharm animals); animals that serve as models for human diseases; animals that produce high-value industrial or consumer products, such as fibers; and food-use animals with new traits such as improved nutrition, faster growth or lower emission levels of environmentally harmful substances (such as phosphate in their manure).

Genetic engineering already is widely used in agriculture to make crops resistant to pests or herbicides. In medicine, genetic engineering is used to develop microbes that produce drugs and other therapeutic products for use in humans. In food, genetic engineering is used to produce microorganisms that aid in baking, brewing, and cheese-making.

Using the animal drug provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA's Center for Veterinary Medicine (CVM) has been working with developers of GE animals to make them aware of their responsibilities to ensure that food from these animals does not enter the U.S. food supply unless the FDA has authorized such use.

The FD&C Act classifies "articles (other than food) intended to affect the structure or any function of the body of man or other animals" as drugs. An rDNA construct that is in a GE animal and intended to affect the animal's structure or function meets the definition of a new animal drug, whether the animal is intended for food, or used to produce another substance. Developers of these animals must demonstrate that the construct and/or any new products expressed from the inserted construct are safe for the health of the GE animal.

Under the draft guidance, in those cases in which the GE animal is intended for food use, producers will have to demonstrate that food from the GE animal is safe to eat. The FDA will review this information as part of its food safety assessment, consistent with that recommended in the recently adopted Codex Alimentarius Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Animals. Codex is a worldwide food safety organization sponsored by the United Nations.

The draft guidance also describes a sponsor's responsibility in meeting the requirements for environmental assessment under the National Environmental Policy Act.

Depending on the species of animal and its intended use, the FDA will coordinate with agencies in the U.S. Department of Agriculture (USDA) and with other federal departments and agencies, such as the Environmental Protection Agency, in regulating GE animals. The draft guidance indicates the areas in which the FDA will be working with those agencies to develop a coherent policy under the Coordinated Framework for the Regulation of Biotechnology. USDA has published in the same issue of the Federal Register a "Request for Information" that seeks input on what types of actions and approaches it should consider under the Animal Health Protection Act (AHPA) that would complement FDA's guidance. The AHPA gives the Secretary of Agriculture authority to take specific actions to prevent the spread of diseases and pests of livestock.

"This is a cutting-edge technology that has significant implications, including real benefits, not just for human health, but also for animal health, such as developing disease-resistant animals," said CVM Director Bernadette Dunham, D.V.M., Ph.D. "We look forward to the public comments to help refine our thinking and approach."

The draft guidance describes how the FDA may exercise enforcement discretion, that is, not require premarket approval, for some GE animals depending on potential risk, as we did after reviewing information about Zebra danio, aquarium fish genetically engineered to glow in the dark. For example, the draft guidance states the FDA's intent to exercise enforcement discretion for laboratory animals used for research and kept in confined conditions. The agency does not expect to exercise enforcement discretion for animal species traditionally consumed as food and expects to require approval of all GE animals intended to go into the human food supply.

The draft guidance describes how the FDA regulates heritable rDNA constructs, that is, constructs inherited from one generation to the next. Non-heritable constructs, such as those used for gene therapy to treat individual animals, may be the subject of a subsequent guidance.


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Emory Begins Testing Vaccines Against Pandemic Influenza Threat

Emory University and its physician/scientists will play a leading national role in evaluating promising new vaccines against an "H5" avian flu (bird flu) virus thought to be a possible pandemic threat in the future. The Emory Vaccine and Treatment Evaluation Unit (VTEU) will conduct a clinical trial of a new bird flu vaccine along with collaborators at the Mayo Clinic in Rochester, Minn.

The eight national VTEUs are funded by the National Institute of Allergy and Infectious Diseases (NIAID), one of the National Institutes of Health (NIH), to conduct clinical trials for all infectious diseases other than HIV/AIDS.

The making and testing of vaccines is an important step in preparing for a pandemic. Vaccines for the various strains of bird flu could save thousands of lives and billions of dollars. Scientists estimate a bird flu pandemic in the United States could result in 90 million Americans being affected by flu-related illnesses and two million domestic deaths.

Several worldwide influenza outbreaks ("pandemics") have occurred during the past century, including Spanish Flu of 1918, Asian Flu of 1957, and Hong Kong Flu of 1968. The Spanish Flu pandemic of 1918 resulted in an estimated 60 million deaths worldwide.

"The upcoming bid flu vaccine trial is an important part of our U.S. national preparedness for a future influenza pandemic," says Mark Mulligan, MD, principal investigator of the Emory VTEU and executive director of the Hope Clinic of the Emory Vaccine Center.

"By preparing now, by figuring out the best vaccine strategies, we hope to reduce the potentially severe impact of the next pandemic. Emory University is proud to be participating. It is an opportunity for our Atlanta area study volunteers to contribute to an important public health effort. We are overdue for an influenza pandemic, so it is really a matter of 'when' not 'if.' This clinical trial is helping to get us ready for that 'when.'"

"Avian influenza remains a pressing and urgent international issue. This study hopes to find a solution--a preventive solution that might protect everyone and prevent the millions of deaths we have seen with other pandemics," says Gregory A. Poland, MD, director of the Mayo Vaccine Research Group. The VTEU network clinical trial will involve 500 healthy persons who have not been previously vaccinated against the H5 influenza strain, including 160 at the Emory clinical research site.

"The Atlanta community has been very supportive of our efforts at the Hope Clinic," according to VTEU supervising research nurse Jane Skvarich, "and we look forward to broadening our impact with the inclusion of a diverse group of participants committed to the prevention research aims of this important study."

In addition to Emory University and its affiliate sites, the study will be conducted at several nationwide sites including Saint Louis University and the Group Health Cooperative in Seattle, Washington.

For more information about this and other studies ongoing at the Emory VTEU sites, please see www.hopeclinic.emory.edu or contact Eileen Osinski at 877-424-HOPE or via email vaccine@emory.edu.

About VTEUs The VTEUs were established in 1962 as a vital research component of the NIAID. The units conduct clinical trials for all infectious diseases other than HIV/AIDS, including bacterial, viral and parasitic vaccines, therapeutics and other biologics and drugs for prevention and treatment of infectious diseases in people of all ages and risk categories. The VTEUs have conducted hundreds of clinical studies over the past four decades.

VTEU investigators have tested and advanced vaccines for many diseases, including influenza, pneumonia, whooping cough, Haemophilus influenzae infection, cytomegalovirus infection, malaria, smallpox, anthrax and tularemia. Childhood vaccines and combination vaccines are an important part of VTEU research.

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Wednesday, September 17, 2008

Emory Awarded $6 Million to Study Environmental Causes of Parkinson's

Emory University has received a $6.4 million grant from the National Institute of Environmental Health Sciences (NIEHS), a division of the National Institutes of Health (NIH), to examine the impact of environmental factors on the cause, prevention and treatment of Parkinson's disease and other related disorders, the NIH announced today.

The five-year grant will fund research at Emory's newly created Parkinson’s Disease Collaborative Environmental Research Center led by Gary W. Miller, PhD.

Parkinson's disease has been linked to pesticide exposure, mitochondrial damage and altered storage of the neurotransmitter dopamine. Miller and his team will probe how environmental and genetic factors interact to alter these functions in dopamine neurons. Identifying these mechanisms could lead to new treatments for the disease. The Emory team will also attempt to develop new biomarkers in the blood that will help identify people that may be at risk for developing Parkinson’s.

"This grant unites toxicologists, neurologists, biochemists, pharmacologists, statisticians and system biologists to determine how environmental factors influence Parkinson’s disease," says Miller, associate professor of environmental and occupational health, Rollins School of Public Health, Emory University, and study principal investigator. "Our goal is to devise new strategies to diagnose, prevent and treat the disease."

Other investigators involved with the project include: Mahlon DeLong, MD, Dean Jones, PhD, Zixu Mao, MD, PhD, Tianwei Yu, PhD, Younja Park, PhD, and Stewart Factor, DO, all of Emory University; and Eberhard Voit, PhD, and Kurt Pennell, PhD, of the Georgia Institute of Technology.

Parkinson's disease is a neurodegenerative disorder that affects nerve cells, or neurons, in several parts of the brain, including neurons that use the chemical messenger dopamine to control muscle movement. More than 1 million Americans suffer from Parkinson’s disease, with approximately 60,000 new cases reported each year.

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Tuesday, September 16, 2008

FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India

The Food and Drug Administration (FDA) today issued two Warning Letters to Ranbaxy Laboratories Ltd., of the Republic of India, and an Import Alert for generic drugs produced by Ranbaxy's Dewas and Paonta Sahib plants in India.

The Warning Letters identify the agency's concerns about deviations from U.S. current Good Manufacturing Practice (cGMP) requirements at Ranbaxy's manufacturing facilities in Dewas and Paonta Sahib (including the Batamandi unit), in India. Because of the extent and nature of the violations, FDA today issued an Import Alert, under which U.S. officials may detain at the U.S. border, any active pharmaceutical ingredients (API) (the primary therapeutic component of a finished drug product) and both sterile and non-sterile finished drug products manufactured at these Ranbaxy facilities and offered for import into the United States.

The problems at these two Ranbaxy plants relate to deficiencies in the company's drug manufacturing process. These actions are proactive measures that the FDA is taking in order to assure that all drugs that reach the American public are manufactured according to cGMP requirements. While this action does not involve removing products from the market, FDA has no evidence to date that Ranbaxy has shipped defective products. We will continue to monitor the situation.

Today's announcement does not impact products from Ranbaxy's otherplants which are not affected by today's actions. FDA has inspected those facilities and, to date, they have met U.S. cGMP requirements for drug manufacturing.

The FDA recommends that consumers continue taking their medications manufactured by Ranbaxyand not disrupt their drug therapy, which could jeopardize their health. Patients who are concerned about their medications should discuss their concerns with their health care professional.

Earlier today, the FDA informed Ranbaxy that until it resolves the deficiencies at each of these two facilities and the plants come into compliance with U.S. cGMP requirements, FDA's drug compliance office will recommend denial of approval of any New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) that list the Paonta Sahib or Dewas plants respectively as the manufacturer of APIs or finished drug products

Ranbaxy is one of the largest foreign suppliers of generic drugs to the United States. The company makes a number of drug products.

The FDA Import Alert covers more than 30 different generic drug products (Drug List) produced in multiple dosage forms and dosage amounts ( i.e., 25 mg, 50 mg, and 100 mg) at these two locations.FDA has evaluated whether these actions would create any potential drug shortages in the United States, and has determined that other suppliers can meet market demand, with one exception. Because Ranbaxy is the sole supplier to the U.S. of one drug product, Ganciclovir oral capsules (an antiviral drug), to avoid creating a shortage of the drug, FDA generally will not detain shipments of this product, and plans to arrange for additional oversight and controls until the company resolves these manufacturing issues.

"With this action we are sending a clear signal that drug products intended for use by American consumers must meet our standards of safety and quality," said Janet Woodcock, M.D., director, FDA's Center for Drug Evaluation and Research (CDER). "The FDA has notified other agencies and health care professionals to make them aware of today's actions so that they can take appropriate action and advise patients as needed." The Warning Letters issued today document the results of FDA investigations at these two sites.

One Warning Letter addressed problems at Ranbaxy's Dewas facility found during an inspection conducted by FDA in early 2008. During that inspection, FDA investigators documented significant cGMP deviations in the manufacture of sterile and non-sterile finished products and violations with respect to the manufacture and control of APIs. Specific areas of concern included the following aspects of the firm's quality control program:

  • The facility's beta-lactam containment program (measures taken to control cross-contamination), which appeared inadequate to prevent the potential for cross-contamination of pharmaceuticals;
  • Inadequate batch production and control records;
  • Inadequate failure investigations; (A failure investigation is done to address any manufacturing control or product rejection to determine the root cause and prevent recurrence); and,
  • Inadequate aseptic (sterile) processing operations.

The second Warning Letter addressed the Paonta Sahib facility following an inspection at its Batamandi unit, also in early 2008.This inspection documented various cGMP deficiencies, including the following:

  • The lack of assurance responsible individuals were present to determine the firm was taking necessary steps under cGMP;
  • Inaccurate written records of the cleaning and use of major equipment;
  • Incomplete batch production and control records; and,
  • Inadequate procedures for the review and approval of production and control records for drug products.

Following the two inspections, FDA provided Ranbaxy with a separate list of inspectional findings for each of the facilities. In mid-April and May, Ranbaxy responded in writing to these findings in lengthy submissions to FDA. The agency then evaluated its findings, Ranbaxy's responses, and the firm's overall inspectional history, an evaluation that required substantial time due to the complex scientific and technical nature of both the identified deficiencies, particularly at the Dewas site, and the firm's responses. Ultimately, FDA concluded that the firm's responses were not adequate and that the Warning Letters were the appropriate regulatory response.

"Today's actions are clearly warranted by the serious violations established by FDA's investigations at these two sites," said Deborah M. Autor, director, CDER's Office of Compliance, FDA. "Until the company addresses these deficiencies, APIs and finished drug products from these plants will remain on the Import Alert, and we will not approve any Abbreviated New Drug Applications or New Drug Applications that list either of the two facilities as the manufacturer of APIs or finished drug products."

This represents the second time in less than three years FDA has issued a Warning Letter to Ranbaxy. In 2006, FDA cited Ranbaxy for violations of U.S. cGMP at its Paonta Sahib facility.

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Fayette County Health Department Offering Flu Vaccine

Fayette County Health Department will hold a flu vaccine clinic October 14, 15 and16 at its health center by appointment only. Flu vaccine will continue to be offered each while supplies last. The vaccination is part of a flu campaign being implemented by the Board of Health to get the vaccine to as many people as possible.

In general, anyone who wants to reduce their chances of getting the flu can get vaccinated. However, certain people should get vaccinated each year. They are either people who are at high risk of having serious flu complications or people who live with or care for those at high risk for serious complications. High-risk categories are:

• adults aged 50 years and older
• persons of any age with underlying chronic medical conditions
• residents of nursing homes and long-term care facilities
• children aged 6 months to 4 years
• women who are pregnant during the flu season
• children aged 6 months -18 years on chronic aspirin therapy
• health care workers involved in direct patient care, and Influenza, commonly called "flu," is caused by influenza viruses that infect the respiratory tract. The influenza infection causes more severe illness than most other viral respiratory infections like the common cold.

Most people who get the flu recover in one to two weeks, but some people develop serious complications, such as pneumonia.

Every year, more than 200,000 people in the U.S. are hospitalized as a result of the flu. Influenza infection can even cause death, and in an average year, about 36,000 deaths are caused by the flu in the U.S. The young, the elderly, and people with chronic medical conditions are most at risk of developing serious complications from the flu.

For people who do not receive the flu vaccine, health officials encourage them to take the following steps to reduce their chances of getting the flu:

• Wash your hands regularly
• Cover coughs and sneezes
• Keep household surfaces clean
• Don’t attend work or school when ill
• Don’t share glasses or eating utensils

The cost is of the vaccine is $25.00. Checks (no out of state), cash, debit cards, credit cards, Medicaid and Medicare (part B) will be accepted. Persons must present a Medicaid/Medicare card at the time of service. Residents using Medicare need to bring their red, white and blue card as well as any other Medicare or insurance cards.

Influenza vaccine for the 2008-09 season does not provide protection against avian or pandemic influenza.

If you would like to make an appointment to receive a flu shot, please call the Fayette County Health Department at 770.305.5416.
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GT Designs Prosthetic Vein Valve to Improve Venous Blood Flow

Engineers at the Georgia Institute of Technology have developed a prosthetic vein valve to help improve the lives of those suffering from a condition known as chronic venous insufficiency. The condition, which affects more than seven million people in the United States alone, occurs when valves in a person’s veins can no longer ensure a one-way flow of blood back to the heart.

“Blood flows to the toes because of gravity, but the body uses vein valves to pump blood in one direction back to the heart,” said David Ku, the Lawrence P. Huang Endowed Chair in Engineering and Entrepreneurship and Regents’ Professor in the George W. Woodruff School of Mechanical Engineering at Georgia Tech. “However, sometimes a vein valve dissolves away after a blood clot. The loss of the valve leaflets allows blood to flow the wrong way, causing swelling in the legs and ankles.”

Ku is leading a research team that has developed a prosthetic vein valve to replace damaged, non-functioning valves. The prosthetic vein valve design and results from laboratory studies were presented at the Society for Biomaterials Fall Symposium in Atlanta on September 12. The research – under way for the past five years – is funded by the Wallace H. Coulter Foundation and the National Collegiate Inventors and Innovators Alliance.

Ku’s collaborators on this project include Rudy Gleason, an assistant professor with joint appointments in the Georgia Tech School of Mechanical Engineering and Department of Biomedical Engineering; Ross Milner, an assistant professor of surgery at Emory University; consultant Harris Bergman, a former Georgia Tech graduate student and now president of Amigent; former Georgia Tech graduate students Rahul Sathe and Laura-Lee Farrell; and current graduate students David Bark and Prem Midha.

Individuals with chronic venous insufficiency are commonly prescribed therapies – including anticoagulants, bed rest and compression hosiery – that target their symptoms rather than the cause. Damaged vein valves can sometimes be repaired, but when that isn’t possible, some surgical options are available to replace deep venous valves, such as valve transplantation. However, replacing the valve with a prosthetic one is likely the better option because finding a suitable donor valve in one of the patient’s legs can be difficult, according to Ku.

“Previous studies have shown that even if a donor valve is found, implanting it can cause significant trauma to the patient’s leg,” explained Ku, who has doctoral degrees in mechanical engineering and medicine. “To avoid these complications, other prosthetic vein valves have been designed, but most have demonstrated poor clinical potential for humans.”

Ku and his collaborators believe the valve they have developed will overcome previous difficulties. The one-way flap is made of poly(vinyl alcohol) cryogel, a material patented by Georgia Tech in 1999. The material has many useful attributes, including its biocompatibility with body tissue because of its attraction to water; the ability to adjust its mechanical strength; flexibility comparable to that of natural body tissue; and composition of organic polymer, rather than silicone.

The researchers will begin conducting preclinical animal trials at Emory University in October to test the in vivo biocompatibility and performance of the prosthetic vein valve prototype in sheep. Sheep were chosen because their cardiovascular geometry and physiology are similar to those of humans.

In each animal trial, two prosthetic vein valves will be implanted by Milner. The researchers will test the biocompatibility and performance of the devices for four weeks, using imaging techniques to check that the valves remain in the proper location, are open and allow blood to pass through the vein.

The animal trials will be conducted after several years of optimizing the valve design and testing it in the laboratory. When the Georgia Tech researchers started designing the valve, they wanted it to be as similar as possible to normal, anatomic venous valves. They focused on two major design criteria: the valve had to withstand high pressures without leaking and the valve had to open with small pressure gradients, even after 500,000 cycles of opening and closing, which is equivalent to a half year.

“It was important for us to test the long-term feasibility of these valves because they’re going to be implanted and used for years,” explained Ku. “But since test methods have not been well established for evaluating a prosthetic vein valve, we developed our own.”

Sathe conducted the initial laboratory tests and found that the valve met the mechanical design criteria – it could withstand pressures of more than 500 millimeters of mercury and opened with a pressure gradient of 2.6 millimeters of mercury, which matched physiologic vein valve function. Detailed laboratory testing procedures and results were described in the June 2007 issue of the Journal of Medical Devices.

Next, Farrell developed a laboratory method to test whether blood clots would form inside the prosthetic valve. Results showed that the new generation of valves remained open with no clot formation after 120 minutes of blood flow, whereas control valves lined with polyester closed up after approximately six minutes of perfusion and showed blood cells adhering to the valves.

The laboratory tests showed that the prosthetic vein valve exhibited low flow resistance, strong competency, fatigue-resistance, low clot formation probability and material flexibility, which allowed the researchers to move forward to the animal studies.

The next step after conducting the animal studies will be human clinical trials. The device will require an investigational device exemption from the Food and Drug Administration so that the device can be used in a clinical study to collect safety and effectiveness data.

“There are 400,000 patients per year who are just miserable with the complications from this disease and could benefit from these valves, so we’d like to help them as soon as possible,” added Ku.

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