Free Seminar on Shingles in Lithonia Aug 19

The Patchwork of Hope NetworkTM (P.H.N.), together with a local quilting group and local physician Anthony Grasso, M.D., a pain management specialist at Non-Surgical Orthopaedics, P.C. and affiliated with Wellstar Health System, will host a free interactive seminar on shingles and after-shingles pain, or postherpetic neuralgia (PHN) at the Lou Walker Senior Center on Wednesday, August 19 from 10 a.m. to 12 noon.

Together the National Council on Aging (NCOA) and the National Pain Foundation (NPF) are spreading the word about PHN through the P.H.N. program. This often debilitating condition can affect not only those suffering, but their family and friends as well.

The campaign, which consists of six educational events throughout the year and across the country, will give attendees the chance to hear presentations about shingles and after-shingles pain, meet others affected by after-shingles pain, and contribute to the P.H.N. quilt. For more information, visit www.AfterShingles.com. This campaign is made possible with support from Endo Pharmaceuticals.

Approximately 1 million Americans will develop shingles each year, particularly those who are 50 years of age and older with weakened immune systems. One out of every five will go on to develop postherpetic neuralgia (PHN) or after-shingles pain. PHN results from nerve damage caused by the shingles virus, and for many the pain is often debilitating and can causes feelings of isolation.

WHEN: Wednesday, August 19
10 a.m. to 12 noon

WHERE: Lou Walker Senior Center
2538 Panola Road
Lithonia, GA 30058
(770) 322-2900

WHO: Dr. Grasso, a pain management specialist at Non-Surgical Orthopaedics, P.C. and affiliated with Wellstar Health System, will discuss shingles and after-shingles pain and ways to cope with after-shingles pain. A patient will share her personal experience with after-shingles pain and John Sebby, of the NPF, will discuss additional resources for dealing with the condition. The event will be emceed by Christine Harding, of the NCOA.
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Study Estimates Medical Cost of Obesity May Be As High as $147 Billion Annually

/PRNewswire-USNewswire/ -- The health cost of obesity in the United States is as high as $147 billion annually, based on a new study from Research Triangle Institute and the Centers for Disease Control and Prevention. The study, which appeared online July 27 in the journal Health Affairs, was released at CDC's Weight of the Nation conference in Washington, D.C.

The proportion of all annual medical costs that are due to obesity increased from 6.5 percent in 1998 to 9.1 percent in 2006, the study said. This total includes payment by Medicare, Medicaid, and private insurers, and includes prescription drug spending. Overall, persons who are obese spent $1,429 (42 percent) more for medical care in 2006 than did normal weight people. These estimates were compiled using national data that compare medical expenses for normal weight and obese persons.

The study is titled "Annual Medical Spending Attributable to Obesity: Payer- and Service-Specific Estimates." Recognizing the large health and economic burden of obesity, CDC has issued its first comprehensive set of evidence-based recommendations to help communities tackle the problem of obesity through programs and policies that promote healthy eating and physical activity.

The report, "Recommended Community Strategies and Measurements to Prevent Obesity in the United States," along with a companion implementation guide, appears in CDC's MMWR Recommendations and Reports. A companion implementation guide is also available on the CDC Web site.

"It is critical that we take effective steps to contain and reduce the enormous burden of obesity on our nation," said CDC Director Thomas Frieden, M.D., M.P.H. "These new recommendations and their proposed measurements are a powerful and practical tool to help state and local governments, school districts, and local partners take necessary action."

The Common Community Measures for Obesity Prevention Project was guided by a systematic process that included expert opinion and a review of the published scientific literature, resulting in the adoption of 24 recommended environmental and policy level strategies to prevent obesity.

The strategies promote the availability of affordable healthy food and beverages, support healthy food and beverage choices, encourage breastfeeding, encourage physical activity or limit sedentary activity, support safe communities that support physical activity, and encourage communities to organize for change.

"Obesity is a risk for a number of chronic diseases, including diabetes, cardiovascular disease, and some cancers," said William H. Dietz, M.D., Ph.D., director of CDC's Division of Nutrition, Physical Activity and Obesity. "Reversing this epidemic requires a multifaceted and coordinated approach that uses policy and environmental change to transform communities into places that support and promote healthy lifestyle choices for all people."

CDC partnered with the International City/County Management Association to pilot test an initial set of obesity prevention measures in 20 communities. The resulting 24 recommended strategies and suggested measures are now being pilot tested by Minnesota and Massachusetts state health departments in order to determine their success. The strategies include:

-- Communities should support locating schools within easy walking
distance of residential areas.

-- Communities should improve availability of affordable healthier food
and beverage choices


The community measures project is a collaborative effort among CDC, the Robert Wood Johnson Foundation, the Kellogg Foundation, Kaiser Permanente, and the CDC Foundation. ICF Macro serves as the coordinating center for the project and the international City/County Management Association pilot tested the measures for each strategy in 20 communities.

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FDA Authorizes Emergency Use of Another Test for 2009 H1N1 Influenza Virus

The U.S. Food and Drug Administration has announced it has issued an Emergency Use Authorization (EUA) for a another diagnostic test for the 2009 H1N1 influenza virus, whose spread has caused the virus to be characterized as a pandemic by the World Health Organization.

The EUA for the Focus Diagnostics Influenza H1N1 (2009) Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) diagnostic test is the third diagnostic test authorized under an EUA by the FDA since the public health emergency involving the 2009 H1N1 influenza virus was declared on April 26, 2009.

The EUA allows Focus Diagnostics to distribute the test to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high complexity tests. This test is not typically utilized in a doctor’s office—it is a complex laboratory test performed in an environment that has the necessary equipment. These tests are intended for use in the detection of the 2009 H1N1 influenza virus in patients with symptoms of respiratory infection.

“This authorization will contribute to the nation’s capacity for accurate testing for the 2009 H1N1 influenza virus,” said Daniel G. Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health.

The Focus Diagnostics test amplifies the viral genetic material obtained from swabs of the nose or throat, or from nasal discharges. A positive result indicates that the patient is infected with the 2009 H1N1 influenza virus. However, the test does not indicate the stage of infection. A negative result does not preclude influenza virus infection.

The EUA authority allows the FDA, based on the evaluation of available data and other things, to authorize the use of unapproved medical products or unapproved uses of approved medical products following a determination and declaration of emergency. The Focus Diagnostics test is an unapproved device whose use is authorized by the EUA. The authorization ends when the declaration of emergency is terminated or when the FDA revokes the authorization.

Emergency Use Authorization is part of Project BioShield, which became law in July 2004.

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FDA Issues Final Regulation on Dental Amalgam

The U.S. Food and Drug Administration yesterday issued a final regulation classifying dental amalgam and its component parts – elemental mercury and a powder alloy—used in dental fillings. While elemental mercury has been associated with adverse health effects at high exposures, the levels released by dental amalgam fillings are not high enough to cause harm in patients.

The regulation classifies dental amalgam into Class II (moderate risk). By classifying a device into Class II, the FDA can impose special controls (in addition to general controls such as good manufacturing practices that apply to all medical devices regardless of risk) to provide reasonable assurance of the safety and effectiveness of the device.

The special controls that the FDA is imposing on dental amalgam are contained in a guidance document that contains, among other things, recommendations on performance testing, device composition, and labeling statements.

Specifically, the FDA recommended that the product labeling include:

* A warning against the use of dental amalgam in patients with mercury allergy;
* A warning that dental professionals use adequate ventilation when handling dental amalgam;
* A statement discussing the scientific evidence on the benefits and risk of dental amalgam, including the risks of inhaled mercury vapor. The statement will help dentists and patients make informed decisions about the use of dental amalgam.

Dental amalgam is a “pre-amendment device,” which means that it was in use prior to May 28, 1976, when the FDA was given broad authority to regulate medical devices. That law required the FDA to issue regulations classifying pre-amendment devices according to their risk into class I, II, or III. Although the FDA previously had classified the two separate parts of amalgam – elemental mercury and the metal powder alloy – it had not issued a separate regulation classifying the combination of the two, dental amalgam. During this time, however, dental amalgam has been subject to all applicable provisions of the law.

Yesterday’s regulation also reclassifies the mercury component of dental amalgam from Class I (low risk) to Class II (moderate risk).

Over the past six years, the FDA has taken several steps to assure that the classification of dental amalgam is supported by strong science.

In 2002, the agency issued a proposed rule to classify dental amalgam and identify any special controls necessary for its safe and effective use.

Due to a high number of comments on that rule, the agency held an advisory committee meeting in 2006, inviting dental and neurology experts to review existing scientific data on dental amalgam, especially with regard to its toxicity in pregnant women and children.

The agency drafted a review of recent and relevant peer-reviewed scientific literature on exposure to dental amalgam mercury. The advisory committee asked that the agency conduct an even deeper review of the scientific literature on this topic. In all, the agency considered some 200 scientific studies.

On April 28, 2008, the FDA reopened the comment period on the 2002 proposed classification in order to elicit the most up-to-date comments and information related to classification of dental amalgam. Today’s rule reflects the years of agency review on this topic.

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FDA Warns Consumers Not to Use Body Building Products Marketed as Containing Steroids or Steroid-Like Substances

The U.S. Food and Drug Administration today issued a Public Health Advisory (PHA) warning consumers to stop using body building products that are represented as containing steroids or steroid-like substances. Many of these products are marketed as dietary supplements.

The agency also issued a Warning Letter to American Cellular Laboratories Inc. for marketing and distributing body building products containing synthetic steroid substances. Although these products are marketed as dietary supplements, they are not dietary supplements, but instead are unapproved and misbranded drugs.

The PHA notifies consumers and health care professionals that the FDA has received reports of serious adverse events associated with the use of body building products that claim to contain steroids or steroid-like substances. Those adverse events include cases of serious liver injury, stroke, kidney failure and pulmonary embolism (artery blockage in the lung). The PHA also advises consumers to stop taking body building products from any manufacturer that claim to contain steroid-like substances or to enhance or diminish androgen-, estrogen-, or progestin-like effects in the body.

The FDA has received five adverse event reports, including serious liver injury, in men taking products marketed as dietary supplements by American Cellular Laboratories including TREN-Xtreme and MASS Xtreme. Acute liver injury is generally known to be a possible side effect of using products that contain anabolic steroids. Some of the cases resulted in hospitalization, but there were no reports of death or acute liver failure.

“Products marketed for body building and claiming to contain steroids or steroid-like substances are illegal and potentially quite dangerous,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “The FDA is taking enforcement action today to protect the public.”

The products listed in the Warning Letter to American Cellular Laboratories Inc., include “TREN-Xtreme,” “MASS Xtreme,” “ESTRO Xtreme,” “AH-89-Xtreme,” “HMG Xtreme,” “MMA-3 Xtreme,” “VNS-9 Xtreme,” and “TT-40-Xtreme,” and are sold on the Internet and in some stores. These products, which claim to contain steroid-like ingredients but in fact contain synthetic steroid substances, are unapproved new drugs because they are not generally recognized as safe and effective. In addition, the products are misbranded because the label is misleading and does not provide adequate directions for use.

Consumers taking body building supplements that claim to contain steroids or steroid-like substances should stop taking them immediately. Consumers should also consult a health care professional if they suspect they are experiencing problems associated with the products. Health care professionals and consumers are encouraged to report adverse events that may be related to the use of these types of products to the FDA's MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

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U.S. News & World Report Ranks Emory Among Nation's Best Hospitals for 2009

Emory University Hospital again joins the prestigious ranks of America's top medical institutions in the annual U.S. News & World Report guide to "America's Best Hospitals."

For 2009, Emory ranked among the nation's best hospitals in 11 specialties, including five top 20 rankings. Overall, Emory is one of only 170 hospitals, out of more than 5,400 medical centers in the country to be named in even one of the magazine's top 50 specialty rankings. Emory is the only acute care hospital in Georgia named in these rankings.

Emory is recognized in this year's comprehensive report for excellence in:

Specialty Rank
Ophthalmology 9
Psychiatry 10
Geriatrics 13
Heart and Heart Surgery 13
Neurology and Neurosurgery 14
Ear, Nose and Throat 22
Kidney Disease 25
Diabetes/Endocrinology 31
Gynecology 44
Urology 44
Cancer 46

“Emory Healthcare’s rankings reflect our ongoing promise to patients and families,” says John T. Fox, Emory Healthcare president and CEO. “That promise is a relentless commitment to quality, quality defined as excellence in clinical outcomes, patient safety and service. As an academic medical center, we are committed to sharing that remarkable synergy created by breakthrough research, exceptional clinical resources and compassionate care.

“Being ranked this year in three additional subspecialty areas also reflects Emory’s commitment to recruiting staff and physicians across all subspecialties who embrace the challenge of advancing the possibilities in diagnosis, treatment and prevention of disease,“ Fox continues.

The U.S. News rankings in 12 of the 16 specialties weigh three elements equally: reputation, death rate, and a set of care-related factors such as nursing and patient services. In these 12 specialties, hospitals have to pass through several gates to be ranked and considered a Best Hospital:

1. The first filter determines whether a hospital is eligible to be ranked at all by requiring that any of three conditions be met--to be a teaching hospital, to be affiliated with a teaching hospital, or to have at least six important medical technologies from a defined list of 13.

2. The second filter determines whether a hospital is eligible to be ranked in a particular specialty. To be eligible, the hospital had to either have at least a specified volume in certain procedures and conditions over three years, or had to have been nominated in our yearly specialist survey.

3. The third filter is whether a hospital does well enough to be ranked, based on its reputation, death rate, and factors like nurse staffing and technology.

In the four other specialties--ophthalmology, psychiatry, rehabilitation, and rheumatology--ranking is based solely on reputation, derived from the three most recent physician surveys.
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Emory to Participate in NIH Clinical Trials Testing 2009 H1N1 Influenza Vaccines

As part of a nationwide clinical trials network, Emory University will participate in several clinical studies gathering data about 2009 influenza vaccines, including two new H1N1 flu vaccines. The clinical trials will be conducted through the Vaccine and Treatment Evaluation Units (VTEUs) of the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH).

NIAID Director Anthony S. Fauci, MD, announced the launch of the new series of clinical trials last week.

Emory will begin recruiting healthy adults, seniors and children into these clinical trials, beginning in early August. The trials are being conducted in a compressed timeframe because of the possible fall resurgence of H1N1 flu infections that may coincide with the circulation of new seasonal flu strains in the Northern Hemisphere.

The trials are expected to gather critical information that will allow the NIH to quickly evaluate the new vaccines to determine whether they are safe and effective in inducing protective immune responses. The results will help determine if and how to begin a fall 2009 H1N1 flu vaccination program.

The United States government declared the H1N1 outbreak a public health emergency in April and two months later, the World Health Organization classified the outbreak a pandemic, reflecting its widespread nature.

“These clinical trials are critical in preparing for this fall’s vaccination program and in possibly preventing a widespread H1N1 pandemic when the flu season begins. We are pleased through our participation to include Emory and the city of Atlanta in this important national public health effort,” says Mark Mulligan, MD, principal investigator of the Emory VTEU, professor of medicine in Emory University School of Medicine and executive director of the Hope Clinic of the Emory Vaccine Center. “Time is critical. We are in a race against the return of the flu season this fall.”

Two adult clinical trials at Emory will enroll healthy adults and seniors and will be conducted at the Emory Vaccine Center’s Hope Clinic in downtown Decatur.

Two pediatric clinical trials will be conducted at the Emory-Children’s Center and will evaluate vaccine safety, tolerability and immune responses in infants older than 6 months, toddlers, children and adolescents up to 18 years.

“Children and young adults are considered among the most vulnerable populations for new and emerging strains of influenza, such as the current H1N1 pandemic,” says Harry Keyserling, MD, Emory professor of pediatric infectious diseases and co-director of the Emory VTEU. “Vaccines are our most effective public health weapon against influenza. We are pleased that Emory will participate in these essential studies.”

In addition to Mulligan and Keyserling, additional investigators in the flu clinical trials at Emory will include Srilatha Edupuganti, MD, Nadine Rouphael, MD, Paul Spearman, MD and Allison Ross, MD.

The two new H1N1 vaccines were manufactured by Sanofi Pasteur and CSL Biotherapies. Researchers also hope to determine whether 2009 H1N1 flu vaccine can be given at the same time as or shortly before or after the seasonal flu vaccine.

“We will also be evaluating the dosage required, and whether one dose versus two is needed,” says Mulligan. “With pandemic influenza, the population lacks prior immunity to the flu virus, so vaccination may require higher or more doses than for seasonal flu. Older persons may respond better to the novel H1N1 vaccine if they have been exposed to a similar H1N1 virus years earlier. This could also explain why most of the current pandemic cases are occurring in younger persons.”

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. They have conducted hundreds of clinical studies over the past four decades. Emory was designated a VTEU site in 2007 and received a seven-year contract of approximately $23.7 million.

An important strength of the VTEUs is their ability to rapidly enroll large numbers of volunteers into trials and to immunize the volunteers in a safe, effective and efficient manner. This rapid-response capability is especially important for testing vaccine designed to counteract emerging public health concerns. Results are expected to be available weeks after the trials begin.

In addition to Emory, VTEU sites are Baylor College of Medicine, Houston; Children’s Hospital Medical Center, Cincinnati; Group Health Cooperative, Seattle; Saint Louis University, St. Louis; University of Iowa, Iowa City; University of Maryland School of Medicine, Baltimore; and Vanderbilt University, Nashville. They will be joined for these studies by Children’s Mercy Hospital in Kansas City and Duke University Medical Center.

For more information about the Emory flu clinical trials, call 877-424-HOPE (4673) for the adult and senior studies, or 404-727-4044 for the pediatric studies, or email vaccine@emory.edu for further information about the upcoming trials.

Piedmont Physicians Group Welcomes India Nicole Calhoun Williams, M.D.

New Location Open in Palmetto

Piedmont Physicians Group (PPG) welcomes India Nicole Calhoun Williams, M.D., to its healthcare team. She has opened a new PPG location at 815 Weldon Road, Palmetto, Ga.

A native of north Georgia, Dr. Williams was part of the first graduating class of Creekside High School in Fairburn, Ga., in 1991. She received her Bachelor of Science from Spelman College in Atlanta, Ga., and earned her medical degree from Meharry Medical College School of Medicine in Nashville, Tenn. She then completed her residency in family medicine at the University of Mississippi Medical Center in Jackson, Miss.

Prior to joining Piedmont Physicians at Palmetto, Dr. Williams served as an emergency physician and hospitalist with Rush Health Systems in Mississippi while also working part time as a family practitioner with Outreach Health Services of the Federally Funded Community Health Centers in Shubuta and Heidelberg, Miss. She is board-certified in family medicine and a member of the American Academy of Family Physicians.

“Dr. Williams has a gift for serving her patients and community,” said Berney Crane, CEO of Piedmont Medical Care Corporation, the administrative parent corporation of the Piedmont Physicians Group. “We are excited to have such a professional in the Piedmont Healthcare family.”

Dr. Williams accepts most major insurance plans. Office hours are Monday through Friday, 8 a.m. to 5 p.m. To schedule an appointment, please call 678-593-1900. For more information visit piedmontphysicians.org.
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Piedmont Fayette Hospital offers New Breast MRI Services

Piedmont Fayette Hospital is proud to offer breast magnetic resonance imaging (MRI) services utilizing the Invivo Breast Coil and the Siemens Magnetom Espree MRI scanner. The Magnetom Espree’s extra-large opening means it can comfortably accommodate patients of all sizes and is perfect for those who get anxious or claustrophobic during an MRI or anyone who just likes more space. This enhanced technology means Fayette community members now have access to diagnostic MRI services for breast cancer in addition to regular screening and diagnostic mammograms, and breast ultrasound scanning.

Breast MRI — is an imaging technique that captures multiple cross-sectional pictures of the breast. Breast MRI involves combining the images and using a computer to generate detailed 2-D and 3-D pictures. A breast MRI isn't used routinely for breast cancer screening, but can be performed when your doctor needs more information than a mammogram, ultrasound or clinical breast exam can provide.

“Breast MRI’s should not be considered as a replacement procedure for mammograms,” said Debora Coursey-Prah, M.D., of Piedmont Fayette Hospital’s Women’s Imaging Center and board-certified radiologist. “Mammography is still a very important component of early detection, but the availability of breast MRI’s will allow us to better treat and diagnose patients so they continue to receive the best quality care possible.”

The breast MRI procedure is relatively simple and painless. It is performed through the use of a large magnet, radio waves, and a computer to process the scan information. The images created provide a comprehensive picture of the entire breast, chest wall, and surrounding tissues.

“This is a sophisticated diagnostic procedure, administered by our staff of highly-trained and experienced radiologists and technologists, using state-of-the-art diagnostic imaging equipment,” said Darrell Cutts, president and CEO Piedmont Fayette Hospital. “We are committed to providing access to the best technology we can in order to find breast cancer early and, in turn, treat it successfully.”

The American Cancer Society recommends annual MRI’s for women at high risk due to strong family history, a genetic predisposition or other reasons. As many as 1.6 million women in the U.S. fall into this high-risk category. The guidelines stress that the exams should be done in addition to annual mammograms as well as regular physical exams in the hope of driving down the death toll from the common and widely feared malignancy.

A breast MRI may be recommended if:

You've been diagnosed with breast cancer and your doctor wishes to determine the extent of the cancer.
Your doctor finds a suspicious area on your mammogram.
You or your doctor can feel a mass or other lump in your breast, but it's not detectable on mammogram or ultrasound.
You notice a breast lump or other breast change after surgery or radiation therapy and it's not detectable on mammogram or ultrasound.
Your doctor wants to monitor your opposite breast after you've been newly diagnosed or treated for breast cancer in the other breast.
You have a suspected leak or rupture of a breast implant.
You're at high risk of breast cancer, defined as a lifetime risk of 20 percent to 25 percent or greater.
You have a strong family history of breast cancer or ovarian cancer.
You have very dense breast tissue and your prior breast cancer wasn't detected on mammogram.

Conversation with your physician is the best place to start. For more information on the PFH Women’s Imaging Center and breast cancer services, please call 770-719-6629 or visit http://www.fayettehospital.org/.
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Study Says Pregnant Women Are More Severely Impacted by Novel H1N1 Influenza Virus

Pregnant women infected with 2009 novel H1N1 had a higher rate of hospitalization and greater risk of death than the general population due to the H1N1 flu, according to a study in the Aug. 8 issue of the British medical journal Lancet.

The data collected and analyzed by the Centers for Disease Control and Prevention (CDC) are the most comprehensive available to date on the impact of this novel H1N1 flu virus among pregnant women.

"The death of a pregnant woman is always heartbreaking, and unfortunately we have been hearing reports of otherwise healthy women dying from H1N1. If a pregnant woman feels like she may have influenza, she needs to call her healthcare provider right away," said CDC’s Dr. Denise Jamieson, lead author of the study. “Clinicians who treat pregnant women should have a system in place for triaging pregnant women with influenza-like symptoms and they should not delay in initiating appropriate antiviral therapy. Some clinicians hesitate treating pregnant women with antiviral medications because of concerns for the developing fetus, but this is the wrong approach. It is critical that pregnant women, in particular, be treated promptly. "

Six deaths of pregnant women with H1N1 were reported to CDC between April 15 and June 16, 2009, representing 13 percent of the total 45 deaths reported to CDC during that time period. All were healthy prior to infection of H1N1 and subsequently developed primary viral pneumonia leading to acute respiratory distress requiring mechanical ventilation. All pregnant women who died did not receive antivirals soon enough to benefit their treatment. CDC recommends that pregnant women with suspected or confirmed influenza infection receive prompt treatment with antiviral medication.

Based on past influenza pandemics and on seasonal influenza epidemics, pregnant women have increased rates of illness and death from influenza infection.

Despite recommendations from the Advisory Committee on Immunization Practices and the American College of Obstetricians and Gynecologists for inactivated flu vaccine for all pregnant women, seasonal flu vaccine coverage among pregnant women is very low (less than 14 percent).

CDC has posted clinical guidance for treatment and prophylaxis of pregnant women with suspected or confirmed pandemic H1N1 2009 influenza at http://www.cdc.gov.h1n1flu/clinician_pregnant.htm.
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Mayo Researchers Find Anesthesia Not Harmful for Babies During Birth Process

Mayo Clinic researchers have found that children exposed to anesthesia during Cesarean section are not at any higher risk for learning disabilities later in life than children not delivered by C-section. These findings are reported in the current issue of the journal Anesthesiology.

"We found that the incidence of learning disabilities was equal between children who were delivered vaginally and those who were delivered via C-section but with general anesthesia," says Juraj Sprung, M.D., Ph.D., a Mayo Clinic anesthesiologist who led the study. "It's reassuring that the anesthetics required for Cesarean delivery do not appear to cause long-term brain problems."

The study was conducted with data from the Rochester Epidemiology Project. Researchers analyzed the medical records of 5,320 children born between 1976 and 1982 to mothers living in Olmsted County. They compared birth records with scholastic achievement and IQ tests administered to the children later in life as part of their schooling.

The study builds on a previous project, reported in March, which found that children exposed to a single dose of anesthesia during the first three years of life had no increased risk for learning disabilities, but those exposed multiple times had an almost doubled risk for later identification of learning disabilities.

Prolonged exposure to anesthetics has been shown to cause brain abnormalities in young animals, which was the impetus behind these two studies. Scientists think that the brains of young animals and humans are more vulnerable to a variety of problems because they are undergoing rapid growth. The brain is forming vital connections between cells during this time.
Not only did the researchers find that the use of anesthesia during delivery was not harmful to the baby, they found that babies delivered by Cesarean using an epidural anesthetic (which numbs only the lower region of the body and does not involve the mother going to sleep) had a substantially reduced risk for learning disabilities later in life. "The risk was reduced by about 40 percent compared to children delivered vaginally and those delivered via Cesarean section but with general anesthesia," says Dr. Sprung.

Study co-author and Mayo Clinic anesthesiologist Randall Flick, M.D., cautions that because this study is preliminary, changes to medical practice should not be considered at this point. "What we've found is an association between two things," says Dr. Flick. "One is the way a child was delivered, either vaginally or under regional or general anesthesia. The other is a difference in the incidence of learning disabilities as the child attended school. It's important to recognize there may be many other factors that impact learning disabilities."

The team is investigating whether use of an epidural on a mother during natural labor has similar effects on the incidence of learning disabilities in children as a C-section with an epidural.
Dr. Flick says the research team also is working with the U.S. Food and Drug Administration (FDA) on a related study that looks more closely at young children with specific medical conditions who have been exposed to anesthesia and compares them to children with similar medical conditions who were not exposed to anesthesia. The study is part of a national SAFEKIDS Initiative that the FDA is undertaking with several academic and clinical institutions to study the effects of anesthetics and sedatives on brain development in infants and young children.

Funding for this study was provided in part by the Mayo Clinic Center for Translational Science Activities (CTSA). The Mayo Clinic CTSA is part of a national consortium working to improve how biomedical research is conducted across the nation. The consortium, funded through Clinical and Translational Science Awards, shares a common vision to accelerate the time it takes for laboratory discoveries to become treatments for patients and to engage communities in clinical and translational science. It is also fulfilling the critical need to train the next generation of clinical researchers. The CTSA initiative is led by the National Center for Research Resources at the National Institutes of Health.

Additional co-authors include Robert Wilder, M.D., Ph.D.; Slavica Katusic, M.D.; Tasha Pike; Mariella Dingli, M.D.; Darrell Schroeder; William Barbaresi, M.D.; Andrew Hanson; and David Warner, M.D. Another co-author is Stephen Gleich, M.D., of the Primary Children's Medical Center, Salt Lake City.
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Community Hospitals: Dying Breed or Community Cornerstone?

/PRNewswire/ -- In the widespread discussion of universal health insurance and soaring medical costs, one of America's most cherished traditions -- the hometown community hospital -- has been largely forgotten.

Many analysts suggest that small community hospitals are especially vulnerable -- with smaller populations, limited services, and small medical staffs. Yet their value is unquestioned. A 2007 AHA study on The Economic Contribution of Hospitals documented the importance of hospitals to communities beyond healthcare, with each hospital job supporting two additional jobs, and goods and services purchased by hospitals creating additional economic value.

Yet while governmental attention focuses largely on cost controls and insurance for all, Atlanta- based Hospitalogic(TM), a family of companies providing physician services, consulting and hospital management, is championing change to ensure their viability for future generations.

"Our vision is for financially successful community hospitals across America," says Hospitalogic CEO Jim Burnette. "We believe it is attainable by approaching the challenge differently."

Financial distress, rooted in the late 1990's when Medicare and commercial insurers systematically reduced prices paid to hospitals and physicians, turned the industry revenue model upside down, causing pressures. This transformation caused most hospitals to struggle, with nearly 80% having lost money at some point over the last 5 years.

Although propped up by such Federal programs as Critical Access Hospital reimbursement, reduced revenues and rising costs squeezed profits or caused losses for many -- triggering financial deterioration and hospital closures impacting hundreds of communities since 2000.

Viewing soaring costs and reduced reimbursements as symptoms rather than causes of the problems, Hospitalogic's leadership has owned, re-opened, and operated small community hospitals -- pioneering new approaches and achieving profitability while doing so.

"We know what it takes to succeed, and our methodology is proven. We've sat in the Board member's and CEO's chair, negotiated with lenders, met payrolls and worked with regulators," states Burnette. "We take on transformation projects without regard to condition because we understand first-hand the difficulties hospitals face."

In 2000, Hospitalogic purchased and reopened Tattnall Memorial Hospital in Reidsville, Georgia. The hospital continues to operate successfully today in a service area with a population of 18,000.

For-profit North Oak Regional Medical Center in Senatobia, Mississippi had lost money for 10 straight years and was within days of closing when Hospitalogic took over in 2002. Within 18 months, the hospital was at break-even. By 2004, the organization's unique emergency and inpatient medical practice had achieved a 936% return on investment, with profitability continuing annually since.

Sometimes the distress call comes too late, admits Burnette. Hospitalogic successfully re-opened a community hospital in Brownsville, Pennsylvania in 2008, overcoming regulatory and financial hurdles. Yet the hospital closed nine months later following a multimillion judgment against the hospital's board dating to the facility's prior ownership.

"America needs successful community hospitals," Burnette adds. "They are essential to community success. With passion and the right approach, it can be done."

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Congress Must Recognize Homecare as Cost-Effective Part of Health Care Reform

/PRNewswire/ -- In their effort to find savings in the healthcare system, the Obama administration and Members of Congress have been eyeing Medicare's home medical equipment (HME) sector for cuts. This sector provides medical oxygen, respiratory therapy, hospital beds, wheelchairs, walkers and other equipment and services that allow people to get the care they need at home instead of in a hospital or nursing home.

Already in 2009, Medicare payments for the most commonly prescribed home medical equipment categories have been cut by 9.5 percent. Medical oxygen reimbursement has been cut by 27 percent so far this year. Another measure aimed at cutting HME costs further is so-called "competitive" bidding.

"The American Association for Homecare urges Congress to recognize that home care is a cost-effective alternative to more expensive forms of care, and should therefore be a critical component -- not a casualty -- of American health care reform. Current and proposed cuts to Medicare's home medical equipment sector are not an effective way to reduce overall Medicare spending. These cuts are likely to increase Medicare costs over time by forcing more seniors into nursing homes and hospitals, blocking preventative care, and causing more frequent visits to emergency rooms.

"Quality home medical equipment and services facilitate hospital discharges, reduce hospital readmissions and emergency room visits, and help to keep seniors and people with disabilities out of more expensive institutional settings. As Congress debates health care reforms, it is important that it keeps these facts in mind and recognizes home care as a partner in improving the quality of American health care and reducing overall health care costs.

"Most home medical equipment costs just dollars a day. The cost of providing the equipment and service for home oxygen, for example, is less than $7 per day under Medicare. Compare that to the average daily cost of about $200 for a nursing facility and more than $5,000 per day for a hospital stay under Medicare.

"According to a recent study in the New England Journal of Medicine, up to one-fifth of all Medicare patients are readmitted to hospitals within one month of being discharged. These unplanned visits cost Medicare an estimated $17 billion in 2004. One reason for the high readmission rates is the lack of continued interaction and guidance once patients are dismissed. Home medical equipment providers help to fill this gap by smoothing the transition from hospital to home with the equipment and services patients need.

"This year, Medicare payments for the most commonly prescribed home medical equipment categories have been cut by 9.5 percent, including complex rehabilitative power wheelchairs. Medical oxygen reimbursement has also been cut by 27 percent so far this year. Home oxygen is a critical, life-sustaining medical treatment prescribed to nearly 1.5 million Medicare patients each year who suffer from respiratory illnesses such as chronic obstructive pulmonary disease.

"Another measure aimed at cutting HME costs further has been labeled 'competitive' acquisition. A regulation enacted in the final hours of the Bush administration would selectively contract with a small number of home care providers based on a race to bid the lowest payment. Even among those who agree to new bid-determined payment rates, Medicare only allows a select few to provide the items, which will have the long-term result of reducing the number of companies competing to offer home care products.

"These cuts in reimbursement are having a negative impact on the quality of equipment and the level of services that providers are able to furnish to consumers who have severe disabilities and who are in greatest need of mobility products and services.

"Home medical equipment and service is already the most cost-effective slowest-growing portion of Medicare spending, increasing only 0.75 percent per year, according to the latest National Health Expenditures data from Medicare. That compares to more than 6 percent annual growth for Medicare spending overall. Moreover, home medical equipment represents only 1.6 percent of the Medicare budget.

"As Congress deliberates cuts to Medicare, they would do well to recognize that cuts to home medical equipment will increase long-term Medicare costs. The home medical equipment sector should be seen as a key element in reducing overall Medicare costs."

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FDA Approves Vaccine for 2009-2010 Seasonal Influenza

The U.S. Food and Drug Administration today announced that it has approved a vaccine for 2009-2010 seasonal influenza in the United States.

The seasonal influenza vaccine will not protect against the 2009 H1N1 influenza virus that resulted in the declaration of a pandemic by the World Health Organization (WHO) on June 11, 2009. The FDA continues to work with manufacturers, international partners and other government agencies to facilitate the availability of a safe and effective vaccine against the 2009 H1N1 influenza virus.

Although this year’s seasonal vaccine is directed against other strains of influenza expected to be circulating and will not provide protection against the 2009 H1N1 influenza virus, it is still important for those Americans for whom it is recommended to receive the seasonal influenza vaccine. No vaccine is 100 percent effective against preventing disease, but vaccination is the best protection against influenza and can prevent many illnesses and deaths.

“The approval of this year’s seasonal influenza vaccine is an example of the FDA’s important responsibility to assure timely availability of vaccine to help protect the health of the American public,” said Margaret A. Hamburg, M.D., commissioner of food and drugs. “A new seasonal influenza vaccine each year is a critical tool in protecting public health.”

The six vaccine brand names and manufacturers are: Afluria, CSL Limited; Fluarix, GlaxoSmithKline Biologicals; FluLaval, ID Biomedical Corporation; Fluvirin, Novartis Vaccines and Diagnostics Limited; Fluzone, Sanofi Pasteur Inc.; and FluMist, MedImmune Vaccines Inc.

Each year, experts from the FDA, WHO, U.S. Centers for Disease Control and Prevention (CDC), and other institutions study virus samples and patterns collected from around the world in an effort to identify strains that may cause the most illness in the upcoming season.

Based on those forecasts and on the recommendations of the FDA’s Vaccine and Related Products Advisory Committee, the FDA determines the three strains that manufacturers should include in their vaccines for the U.S. population. The closer the match between the circulating strains and the strains in the vaccine, the better the protection against the disease.

The vaccine for the 2009-2010 seasonal influenza contains:

* an A/Brisbane/59/2007 (H1N1)-like virus
* an A/Brisbane/10/2007 (H3N2)-like virus
* a B/Brisbane/60/2008-like virus

There is always a possibility of a less than optimal match between the virus strains predicted to circulate and the virus strains that end up causing the most illness. Even if the vaccine and the circulating strains are not an exact match, the vaccine may reduce the severity of the illness or may help prevent influenza-related complications.

According to the CDC, between 5 percent and 20 percent of the U.S. population develops influenza each year. More than 200,000 are hospitalized from its complications and about 36,000 people die. Older people, young children, and people with chronic medical conditions are at higher risk for influenza-related complications. Vaccination of these groups is critical.

Additionally, influenza immunization of health care personnel is important in protecting them and others from influenza.

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Sen. Judson Hill (GA): All Health Care Reform is Not Created Equal

With Democratic control of both the White House and Congress, national health care reform has a better chance of passing now than any time in recent history. Americans agree that change in our health care system is necessary. Escalating health care and insurance premiums are unsustainable for most families, businesses and all levels of government. Every day it becomes more and more evident that all health care reform is not created equal.

Conservatives have worked for years to change the fundamentals of health care and health care financing to achieve a patient centered, prevention focused, free market system. Many moderates and liberals want government-based health care reform in which the government provides for everyone and health care is “free.” National leaders are advancing numerous reform proposals. Yes, America needs health care reform, but be careful which version you ask for because as the saying goes, “choose your rut in the road carefully since you’ll be in it for the next 100 miles”.

Political experts today will tell you that some sort of health care reform will pass. Any national health care reform measures that survive the political hurdles necessary to become law will be very difficult to change in the future. You and I have a vested interest in which reform proposal actually becomes law.

Early free market successes have begun in several states. These conservative initiatives offer healthier outcomes, stabilized costs, and tax savings and incentives for individual responsibility. For example, Georgia law now incentivizes people to choose healthy behaviors by actually allowing health insurance companies to partially refund premiums to people who stay healthy. But to date, no insurance company has refunded premiums. It’s time we ask them why not?

Three simple conservative steps would improve health care, lower costs and reduce the number of people without health insurance. First, all insurance should be owned by the individual so your financial security and health care coverage is not at risk just because you left your job and lost your company’s insurance. Second, everyone should be able to pay for health care and health insurance with before tax dollars. And third, we should reward personal responsibility and healthy choices with lower insurance premiums.

Governments can and should transform their health care programs. Taxpayers cannot afford to expand and sustain Medicare and Medicaid programs. Instead millions of dollars can be saved by allowing qualified, lower income earners to use their government health care assistance subsidy as a scholarship to buy private health insurance through their employer. In most cases this is a much less expensive option that provides better and more accessible health care. Under such a plan, physician reimbursements for government programs are higher and state taxpayers would save millions of dollars.

If America chooses a national more socialized plan similar to government plans in Western Europe, there will be a huge price to pay. The consequences of this choice are monumental and long-term. European and Canadian health care is characterized by delayed treatments, rationing of care, exorbitant taxpayer costs and sometimes the loss of life. In these countries people with higher incomes purchase private insurance to get to the” head of the line” for better treatment for themselves and their families. Those who chose to buy private insurance continue to pay much higher taxes for national care to cover everyone else. Europeans and Canadians even come to the U.S. to find better health care with easier access for treatment, and yet our government wants to put forth a similar government plan.

Earlier this year the Obama Administration and the Democrat controlled Congress quickly rushed through billions of government spending in the federal “stimulus” bill. Health care reforms cannot be rushed. Health care delivery and financing is too complex. Although Democrats in Congress may have the votes, now is not the time to “just pass” health care reform legislation and then fill in the blanks later. This is not the time to experiment. The details matter too much because lives are at risk.

As we work toward health care reform, everyone should answer three questions and then call their representatives. “What type of reform do you want - patient centered or government centered?” “Should our government be in the health care business or should we incentivize physician-patient relationships?” And finally, “Which health care reform measure encourages and incentives personal responsibility for your health?” Your answers to these questions are vital because if you think health care is expensive now, just wait until you see the costs when it is “free.”
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Piedmont Fayette Hospital Now Offers Weekend Heart Disease Screening

Saturday Morning Appointments Available for CT Coronary Calcium Scans

Cardiovascular disease remains the number one killer of Americans according to the Centers for Disease Control (CDC). The American Heart Association’s 2008 Heart Disease and Stroke Statistics Report estimates that one in three American adults suffers from one or more types of cardiovascular disease. In order to increase awareness and promote early detection and education, Piedmont Fayette Hospital (PFH) is now offering CT Coronary Calcium Scans, a quick and painless method for the detection and risk assessment of coronary artery disease, on Saturday mornings.

“To better accommodate our community, we are happy to now offer this service on Saturdays,” says Dr. David Bodne of PFH. “CT Coronary Calcium Scans help physicians determine patients’ risk for heart disease, even if they do not currently have symptoms. Early detection can make an enormous difference in treating heart disease.”

A 64-slice CT (computed tomography) scanner is used for cardiac scoring, a statistical estimate of your likelihood of getting heart disease. The multi-slice scanner takes pictures of your heart and determines how much calcium build-up is in your arteries, a direct indication of heart disease. Calcium build-up is associated with atherosclerosis, which can harden the arteries and restrict the blood flow to the heart, potentially leading to a heart attack.

This simple non-invasive procedure only takes 15 minutes. The multi-slice CT scanner provides multiple images of the heart. The “slices” are actual pictures taken in tiny increments, one at a time, to get the sharpest image of the human heart.

Based on the amount of calcium build up, each patient is given a score. Typical scores range from zero to a high of 3,000. A “zero” calcium score is great news and indicates a reduced chance that a heart attack will occur. A score of 125 in any of the three coronary arteries suggests a more than 50 percent chance that there will be narrowing of at least 50 percent of the artery. After the CT scan your results and score are forwarded to your physician who will use them to assess your risk of heart disease.

PFH has a variety of cardiac and preventative health services available to patients in order to help them to lower their risk for heart disease and continue to lead healthy and active lives. These include a cardiac rehabilitation program, regular health screenings and the PFH Rehabilitation and Fitness Center.

A doctor’s referral is required for the CT Coronary Calcium Scan. Patients should consult with their physician in order to learn more about this screening. Appointments are required, as a limited number of spaces are available per Saturday. The cost of this procedure is $125 and must be paid at the time of registration. Please call 770-719-7007 to schedule an appointment, or for more information visit www.fayettehospital.org.
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Piedmont Hospital Named 2009 Most Wired Hospital for Sixth Consecutive Year

Piedmont Hospital has been named one of the nation’s Most Wired hospitals, according to the results of the 2009 Most Wired Survey and Benchmarking Study released in the July issue of Hospitals & Health Networks magazine. Three of the five Georgia hospitals named to the list are part of the Piedmont Healthcare system.

Piedmont Hospital has been named for six consecutive years, while Piedmont Fayette Hospital, also a winner this year, has been recognized for five consecutive years. Both hospitals are the only two in the metro Atlanta area to be named to the 2009 list. This is the second year for Piedmont Mountainside Hospital in Jasper, Ga., to be named in the small and rural category.

“We are proud the Most Wired Survey and Benchmarking Study has recognized Piedmont Hospital for the sixth year in a row as a Most Wired hospital,” said Robert Maynard, president and CEO of Piedmont Hospital. “This recognition shows our dedication to quality and excellence in the use of information technology to improve patient care and safety.”

The Most Wired Survey is conducted annually by Hospitals & Health Networks magazine, the journal of the American Hospital Association, which uses the results to name the 100 Most Wired hospitals and health systems. It focuses on how the nation’s hospitals use information technologies for quality, customer service, public health and safety, business processes and workforce issues.

“The economic slowdown is forcing hospitals to look closely at IT spending,” says Alden Solovy, executive editor of Hospitals & Health Networks magazine. “Most Wired hospitals are doing their best to stay the course.”

To complicate matters, the great unknown of healthcare reform looms in the near future and a number of regulatory changes are already heading down the pike, including the shift to ICD-10, which hospitals use to code the signs, symptoms and causes of injury or diseases.

“As the health reform debate continues, it’s clear that IT will play an even more important role in the health system of tomorrow,” says Rich Umbdenstock, president and CEO of the American Hospital Association (AHA). “Most Wired hospitals help illustrate IT in action—improving efficiency, quality and safety of care while helping to control costs.”

Hospitals also continue to invest in IT that supports quality and safety initiatives. Investment in electronic medication management is considered one of the fundamentals of using IT to improve care. The 2009 Most Wired Survey and Benchmarking Study shows an overall increase in both provider order entry of medications and electronic bedside matching at the time medications are administered.

Hospitals & Health Networks conducted the 2009 survey in cooperation with McKesson Corp. and the College of Healthcare Information Management Executives. The July H&HN cover story detailing results is available at www.hhnmag.com.
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Glucose Challenge Test is Accurate and Economical for Diabetes and Prediabetes Screening

A test commonly used to help identify women with diabetes during pregnancy may be an accurate, convenient and inexpensive way to screen the general population for unrecognized diabetes and prediabetes, according to Emory University researchers.

The results of the study, "Glucose challenge test screening for prediabetes and undiagnosed diabetes" will be published online and in print in the journal Diabetologia.

"Widespread use of the glucose challenge test (GCT) to screen Americans for prediabetes and diabetes could provide a major opportunity to improve the health of more than 40 million people," said lead study author Lawrence S. Phillips, MD, Emory University School of Medicine Professor of Medicine, Division of Endocrinology.

The study screened 1,573 volunteer participants who had never been diagnosed with diabetes. At a first visit, at different times of the day and without restriction of meals, participants were given a 50-gram glucose drink. Glucose was measured both before the drink (random glucose) and an hour after the drink (GCT glucose).

At a follow-up visit held in the morning after an overnight fast, participants had measurement of hemoglobin A1c (a standard test used to monitor diabetes), and a 75-gram oral glucose tolerance test (OGTT). The OGTT is the "gold standard" for diagnosing diabetes and prediabetes.

After screening, researchers found that 4.6 percent of the participants had previously unrecognized diabetes, and 18.7 percent had prediabetes.

The GCT was the most accurate screening test for these problems, significantly better than the random glucose or A1c tests. Since the good performance of the GCT was unaffected by the time of day, or times after meals, the GCT could be performed during a routine office visit. If a patient's GCT glucose level is low, he/she wouldn't need to be screened again for another two or three years, but if the GCT glucose level is high, patients would need a confirmatory oral glucose tolerance test.

This approach is similar to screening women for diabetes during pregnancy. GCT screening is almost universal for women in their sixth month of pregnancy.

The GCT provided consistent results for a diverse group of patients – old and young, normal weight and overweight, men and women, with and without a family history of diabetes, etc. The GCT also appeared to be less expensive than other screening strategies.

Early diagnosis is a benefit both for people who have diabetes or prediabetes, and for their health care teams. Regular glucose challenge test screening (GCT first, then a follow-up OGTT if the GCT glucose is high) would be a way to assure early diagnosis, according to Phillips and team.

"Glucose challenge test screening could help improve disease management by permitting early initiation of therapy aimed at preventing or delaying the development of diabetes and its complications," says Phillips.

Diabetes is a disease in which the body does not produce or properly use insulin. Insulin is a hormone that is needed to convert sugar, starches and other food into energy needed for daily life.

According to the American Diabetes Association, 23.6 million U.S. children and adults, or 7.8 percent of the population, have diabetes. While an estimated 17.9 million have been diagnosed with diabetes, 5.7 million people are unaware that they have the disease.

Pre-diabetes is a condition that occurs when a person's blood glucose levels are higher than normal but not high enough for a diagnosis of type 2 diabetes. There are 57 million Americans who have pre-diabetes, in addition to the 23.6 million with diabetes.

In addition to Phillips, study authors were: David Koch, PhD, K.M. Venkat Narayan, MD, MSc, MBA, Mary Rhee, MD, Viola Vaccarino, MD, PhD, and David Ziemer, MD, of Emory University; Ranee Chatterjee, MD, of the Johns Hopkins University School of Medicine; and P. Kolm and W.S. Weintraub, of the Christiana Care Health System in Newark, Del.

The research was supported in part by the National Institutes of Health and the National Center for Research Resources, and by the Veterans' Administration. The work was presented in part at the June 2008 national meeting of the American Diabetes Association.

Teva Pharmaceuticals USA issues a voluntary user-level nationwide recall of Propofol Injectable Emulsion 10 mg/mL 100 mL vials

Teva Pharmaceuticals USA is initiating a voluntary recall of Propofol Injectable Emulsion 10 mg/mL 100 mL vials, lot numbers 31305429B and 31305430B. The product lots identified are being recalled due to the presence of elevated endotoxin levels in some vials within these lot numbers.

Teva has been notified of 41 propofol-treated patients who experienced post-operative fever, chills and other flu-like symptoms. Based on available information it appears that all febrile or flu-like reactions were self-limiting with spontaneous resolution.

Adverse health effects, such as fever, chills, or rigors, are possible with exposure to product with elevated levels of endotoxins. Serious adverse effects, such as disseminated intravascular coagulopathy, acute respiratory distress syndrome, shock, and death, are possible with exposure to product with high endotoxin levels.

For use as an anesthetic agent, propofol should be used only by professionals trained in the administration of general anesthesia. For sedation of intubated, mechanically ventilated patients in the Intensive Care Unit, propofol should be administered only by persons skilled in the management of critically ill patients.

Customers who have Propofol lots 31305429B and 31305430B in their possession are instructed to cease using the product and return it to their distributor.

Teva Pharmaceuticals USA is voluntarily recalling the aforementioned lots. FDA and CDC have been apprised of this action.

Consumers with questions may contact 1-866-262-1243 from 8:00 am – 8:00 pm EDT Monday – Friday.

Any adverse reactions experienced with the use of this product should also be reported to the FDA’s MedWatch Program by phone at 1-800 FDA-1088; by fax at 1-800-FDA-0178; by mail at MedWatch, HF-410, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

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Saint Joseph's Joins Landmark Study of Percutaneous Mitral Repair with the Mitraclip System

Saint Joseph’s Hospital has become a new clinical trial site for EVEREST II to evaluate the Evalve® MitraClip® system for the treatment of mitral regurgitation (MR). Cardiologists participating in the EVEREST II trial seek to repair the mitral valve non-surgically by using a catheter to place a tiny clip on the valve leaflets. A serious heart condition, MR can lead to arrhythmias, congestive heart failure, stroke and increased risk of sudden death if left untreated.

The mitral valve is a one-way valve that connects the left atrium to the left ventricle of the heart. With MR, the valve does not seal completely and blood leaks back into the left atrium. This reverse flow can cause the heart and lungs to become overloaded with fluid. Symptoms may include an audible heart murmur, shortness of breath and heart palpitations. It is estimated that four million Americans suffer from mitral valve regurgitation, with nearly 250,000 Americans diagnosed each year. According to the Society of Thoracic Surgeons, 40,000 Americans undergo surgery for MR annually.

“The MitraClip device is a natural progression of research treatment options from minimally-invasive approaches, such as robotic surgery, to non-surgical valve repair for patients with MR,” says Louis Heller, MD, interventional cardiologist and Principal Investigator for EVEREST II at Saint Joseph’s Hospital.

For most patients, traditional mitral valve repair requires a surgical procedure called a sternotomy which involves making an incision in the center of the chest to reach the heart. Patients must also undergo cardiopulmonary bypass using a heart lung machine to have their valve repaired or replaced with a tissue or mechanical substitute. The open procedure typically requires a three to five day hospital stay and a lengthy recovery period following hospital discharge.

Saint Joseph’s is one of the country’s leading hospitals for robotic-assisted mitral valve repair, under the leadership of pioneering cardiothoracic surgeon, Douglas Murphy, MD. Minimally-invasive robotic-assisted surgery allows surgeons to repair the mitral valve via four or five dime-size incisions avoiding the sternotomy. Recovery is significantly faster resulting in a shorter hospital stay and a faster return to normal activities. However, patients still must be placed on cardiopulmonary bypass during the robotic procedure.

“We are moving to more minimally-invasive procedures for patients and this trial may take us a step closer to non-invasive procedures,” says Dr. Murphy. “From a patient’s view, success of the EVEREST trial may eventually offer a less invasive approach with a shortened recovery period.”

In October 2007, preliminary results were released for the initial cohort of 107 patients enrolled in the non-randomized arms of the EVEREST (Endovascular Valve Edge-to-Edge Repair Study) studies. Results demonstrated ongoing effectiveness and durability up to 36 months of follow-up (N=81), with 76 percent of patients with one or more Clips implanted experiencing a reduction to ≤ Grade 2+ MR as assessed by the Independent Core Laboratory and graded per the American Society of Echocardiography guidelines (N=107). Statistically significant reverse remodeling of the left ventricle was reported in patients with matched data 12 months after a successful MitraClip procedure (N=54). In April 2008, results from the initial EVEREST Functional MR cohort (N=23) were reported. Results demonstrated 79 percent freedom from death, surgery for valve dysfunction and MR > 2+ at 1-year with preservation of surgical options and clinical improvement in 75 percent of patients with matched data (n=12), with 58percent of patients in NYHA Class I at 1-year. EVEREST II, the Phase II safety and efficacy trial, was recently approved by the IRB at Saint Joseph’s.

With the MitraClip system, the cardiologist guides a catheter (tube) through the vascular system from the groin to the heart's mitral valve, using echocardiographic and fluoroscopic imaging to show the way. The MitraClip device, located on the tip of the catheter, is then placed on the central portion of the valve leaflets, holding them together. The heart beats normally throughout the procedure. (This percutaneous technique is based upon an open surgical method known as the edge-to-edge surgical repair or Alfieri technique, in which a surgeon sutures the valve leaflets together at the location of the leak to reduce MR). During the procedure, the physician can evaluate the clip's effectiveness in reducing MR and can reposition the device as needed.

Once satisfactory MR reduction is achieved, the clip is deployed and the catheter system removed. The patient remains under general anesthesia throughout the procedure and is usually discharged home 1-2 days later. There is no surgical wound —just a Band-Aid over the incision where the catheter was placed. Patients take clopidogrel for a month and aspirin for six months; there is usually no need for a blood thinner, such as Warfarin.

Currently, the MitraClip device is the only device in clinical trials in the United States for percutaneous valve repair. Eligible patients will be invited to participate in the EVEREST II REALISM research study which will collect additional safety and effectiveness data to support the Pre market approval application.

“Today, Saint Joseph’s is recognized as a pioneer in minimally-invasive, robotic-assisted mitral valve repair,” says Dr. Murphy. “The MitraClip system moves us closer to becoming a leader in non-invasive care.”

For more information about the EVEREST II trial, call the Saint Joseph’s Research Institute clinical coordinator at 678-843-6165 or visit mitralregurgitation.org.
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Cancer Wellness at Piedmont Fayette Hospital Offers Cancer WellFit™

Cancer Wellness at Piedmont Fayette Hospital offers Cancer WellFitTM as part of Get a Move On, a combination nutrition and exercise program for breast cancer patients and survivors. Recent studies show the tremendous benefits a healthy diet and regular exercise can have for breast cancer survivors in reducing both the severity and rate of recurrence of the disease. Cancer WellFitTM is a safe, inviting exercise program to improve the physical health and quality of life for people with cancer.

The program offers eligible participants one-on-one exercise consultations with a degreed exercise physiologist plus twice weekly group exercise classes. The program is offered on Mondays and Wednesdays from 4 to 5 p.m. in the PFH Rehabilitation and Fitness Center in the Fayette Professional Center, directly across from the hospital.

To register call 770-719-7290 or for more information visit piedmontcancerconnection.org or fayettehospital.org.
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FDA Reviewing Preliminary Safety Information on Asthma Drug Xolair

The U.S. Food and Drug Administration announced today that it is conducting a safety review of Xolair (omalizumab), a drug used to treat certain adults and adolescents with moderate-to-severe persistent asthma.

Reviewers are looking for a possible association between patients who use Xolair and an increased risk of heart attack, abnormal heart rhythm, heart failure, and stroke. The possible association has been identified based on interim results from an ongoing study of Xolair known as Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS). The study is being conducted by the manufacturer, San Francisco-based Genentech Inc.

An FDA Early Communication is available online.

The Early Communication is in keeping with the FDA’s commitment to inform the public about its ongoing safety reviews of drugs. Once its review is completed, the FDA will communicate its findings and any resulting recommendations to the public. Until the evaluation is completed, health care professionals and patients should be aware that the agency is reviewing data that may suggest a risk of adverse events. The FDA is not advising a change in prescribing or use of the drug.

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FDA Approves Opioid Pain Reliever with Required Risk Reduction Plan

The U.S. Food and Drug Administration today approved Onsolis, medication intended for certain patients with cancer to help manage breakthrough pain – severe flares of pain that break through regular pain medication.

Onsolis is in a class of drugs that deliver the potent opioid fentanyl through the mouth’s mucous membranes. Onsolis delivers fentanyl via an absorbable film that sticks to the inside of the cheek. The drug is indicated for the management of breakthrough pain in patients with cancer, ages 18 and older, who already use opioid pain medication around the clock and who need and are able to safely use high doses of an additional opioid medicine. Such patients are considered opioid tolerant because of their current opioid medication use.

Because fentanyl is subject to abuse and misuse, Onsolis was approved with a Risk Evaluation and Mitigation Strategy, or REMS, which is a required plan for managing risks associated with a drug or biological product.

“Onsolis can provide strong pain relief to patients who are opioid tolerant. But for patients who are not opioid tolerant, it can lead to overdose, sudden serious breathing difficulties and death,” said Bob Rappaport, M.D., director, Division of Anesthesia, Analgesia and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research (CDER). “For this reason, Onsolis should be prescribed only under the safeguards provided by the FDA-required REMS and by health care professionals knowledgeable about Onsolis and the use of potent opioid medications.”

The Food and Drug Administration Amendments Act of 2007 gave the FDA the authority to require that drugs and biological products have a REMS to ensure that the benefits of a drug or biological product outweigh its risks.

As part of the REMS, Onsolis will only be available through a restricted distribution program called the FOCUS program. Under this program, only those prescribers, patients and pharmacies registered with the program will be able to prescribe, dispense, and receive Onsolis. The FOCUS program will provide training and educational materials to prescribers and pharmacy personnel, and a counseling call will be placed to patients prior to dispensing to ensure they have been adequately educated about the appropriate use of the drug. Prescription orders will be filled only by participating pharmacies that send the product directly to the patients’ homes.

Onsolis was approved with a boxed warning, which states that the medication should not be used for the management of migraines, dental pain, or postoperative pain or by patients who use opioids intermittently, or on an as-needed basis. It also warns that the drug should be kept out of the reach of children and should not be substituted for other fentanyl products.

In February, the FDA announced that it would require a REMS for a different class of opioids that offer long-acting and extended-release medication. The FDA has held a series of meetings with stakeholders, including a large public meeting, and also solicited written public comments to hear more about how to develop this REMS.

“The REMS for Onsolis was specifically tailored to that drug and should not be viewed as a model REMS for long-acting and extended-release opioid products,” said Douglas Throckmorton, M.D., deputy director of CDER. “Developing the comprehensive REMS for these other products is a complex undertaking. We will take the time necessary to review all of the public comments and will proceed in a deliberate manner toward the mutual goals of patient access and patient protection.”

Onsolis is manufactured by Aveva Drug Delivery Systems, Miramar, Fla., and marketed under license from BioDelivery Sciences International Inc. of Raleigh, N.C., by Meda Pharmaceuticals Inc., based in Somerset, N.J.

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National Advocacy Organization Representing Home Oxygen Patients Praises Introduction of Medicare Home Oxygen Therapy Act

/PRNewswire/ -- Providing a voice to home oxygen patients nationwide, including patients with chronic obstructive pulmonary disease (COPD) and other lung diseases, the National Emphysema/COPD Association (NECA) today called the Medicare Home Oxygen Therapy Act of 2009 (H.R. 3220) a patient-focused piece of legislation that protects the best interests of the nation's 1.5 million beneficiaries and promotes quality home oxygen care.

"Home oxygen provides patients with improved quality of life by allowing them to receive oxygen safely in their home, maintain activities of daily living and remain active in their communities. We appreciate that this legislation recognizes the important patient services that oxygen users need to feel secure in their care," said Barbara Rogers, President of NECA. "As a home oxygen user, I fully understand the critical importance of the services that accompany home oxygen care. NECA strongly supports the Medicare Home Oxygen Therapy Act and encourages Congress to adopt this legislation into healthcare reform."

The Medicare Home Oxygen Therapy Act of 2009 establishes a standard set of patient services that all oxygen providers must deliver to beneficiaries, including routine patient evaluations, patient monitoring, equipment training and maintenance and emergency services, all of which play a crucial role in ensuring oxygen users are receiving the medically appropriate level of oxygen that meets their needs and allows them to live safely and comfortably. By ensuring access to these services and important patient safeguards, this legislation recognizes that home oxygen is much more than a piece of oxygen equipment; it is a healthcare service that provides life-supporting oxygen, which enables patients to breathe.

"Without home oxygen, many patients would be housebound or in a long term care facility, so in a sense, home oxygen gives people their lives back by allowing them to maintain their independence," Rogers said. "The average oxygen user in our community is elderly, lives alone, has multiple co-morbidities and fully depends on their home oxygen services to avoid revolving emergency room visits and inpatient hospitalizations associated with their COPD or other lung condition. Legislation that strengthens our benefit by assuring much-needed patient services and education is good for all home oxygen patients, across the board."

Across the United States, more than 12 million Americans have been diagnosed with Chronic Obstructive Pulmonary Disease (COPD) and other degenerative lung conditions. COPD is currently the fourth leading cause of death and the second leading cause of disability in the United States, and is on the rise. According to the U.S. Department of Health and Human Services' National Heart, Lung and Blood Institute, approximately 12 million additional adults are thought to have undiagnosed impaired lung function, which indicates COPD is grossly under diagnosed. As a progressive, incurable disease that causes irreversible loss of lung function, COPD can severely confine patients by limiting their daily living activities. Home oxygen therapy is one of the only effective treatments for these patients when properly used.

"An oxygen benefit that puts the needs of patients first is what our community needs, which is why we support this bill," added Rogers.

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FDA Requires Labeling Change for Some Drugs Used to Prevent Rejection of Kidney Transplants

The U.S. Food and Drug Administration today said that it will require manufacturers of some immunosuppressant drugs used in kidney (renal) transplantation to update their labeling to reflect an increased risk of infections.

The required label changes affect the following immunosuppressant drugs used to help prevent rejection of transplanted organs:

* Rapamune (sirolimus)
* Sandimmune (cyclosporine) and cyclosporine generics
* Neoral (cyclosporine modified), and generics
* Cellcept (mycophenolate mofetil) and generics
* Myfortic (mycophenolic acid)

The FDA is requiring the labeling changes based on its review of reported adverse events. The labeling changes must reflect the reported increased risk for opportunistic infections, including activation of latent viral infections. These include BK virus-associated nephropathy, which can mainly affect kidney transplant patients. Such infections may lead to serious outcomes, including kidney graft loss.

Information about the increased risk for opportunistic infections already is included in the labeling of the immunosuppressive drug Prograf (tacrolimus).

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Cancer Wellness at Piedmont’s Programs and Services for July

Comprehensive Complimentary Services Offered to Anyone Affected by Cancer

Cancer Wellness at Piedmont offers comprehensive services and programs for anyone affected by cancer at any phase in his or her journey. All programs take place at Cancer Wellness at Piedmont, located in the Piedmont Hospital Cancer Center at Piedmont West Medical Office Park, 1800 Howell Mill Road, Suite 700, Atlanta, GA 30318. For more information please visit piedmontcancerconnection.org or, to make a reservation for one of the classes listed below, call 404-425-7944, and please indicate which classes you plan to attend.

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

The Life Lessons and Sacred Truths of the Chakras – Level 1 – This experiential workshop will introduce you to the seven sacred chakras. Explore and practice gentle yoga poses, meditation, breathwork, mantras and energy psychology principles that help you open and balance your mind, body and spirit energetically. Join Angela Buttimer, LPC, RYT, and Jody D. Iodice, Ph.D., on Wednesday, July 1, from 9:45 a.m. to 1 p.m. (lunch provided) and on Tuesday, July 21, from 5 to 8:15 p.m.

Becoming Grounded By Going Around in Circles – A Mandala Workshop - Join Edna Bacon, ATR, to examine the use of mandalas all over the world through the ages. A mandala is an artistic representation of the cosmos and a focus for meditation consisting of geometric designs and circles. Create mandalas individually and as a group with a variety of materials and consider the meaning they have for you. Friday, July 17, from 10 a.m. to 2 p.m. (lunch provided)

Plan Your Escape! – In collaboration with Pink Heals Foundation, Inc., Lisa Vingerling guides you on an evening of escape. Sip cocktails and enjoy worldly tapas and beautiful scenery. A guest photographer will show you how to take beautiful photographs with your own camera. Prepare to be inspired and leave ready to Plan Your Escape! Thursday, July 30, from 6:45 to 8 p.m. Please register by e-mailing RSVP@pinkheals.org.

For more information and a full list of classes please visit piedmontcancerconnection.org.
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Piedmont Physicians Group Welcomes Eden Fleming English, M.D.

New Location Opening in Ball Ground

Piedmont Physicians Group (PPG) welcomes Eden Fleming English, M.D., to its healthcare team beginning July 13. She will be opening a new PPG location at 470 Valley Street, Ball Ground, GA 30107.

Dr. English is an experienced physician specializing in internal medicine for adolescents and adults ranging in age from 16 and older. Her special interests include diabetes care, weight management and women’s health issues. She received her Bachelor of Science from Tufts University in Medford, Mass. and earned her medical degree from the Medical College of Georgia in Augusta, Ga. She then completed her internship and residency in internal medicine at Atlanta Medical Center.

Prior to joining Piedmont Physicians, Dr. English practiced at WellStar Cobb Medical Group and WellStar Physicians Group in Austell, Ga. She is also board-certified in internal medicine and a member of the American College of Physicians and the American Medical Association.

“We are very excited to have Dr. English joining us, and are thrilled to be opening Piedmont Physicians at Ball Ground,” said Berney Crane, CEO of Piedmont Medical Care Corporation, the administrative parent corporation of the Piedmont Physicians Group. “She brings new energy and expertise to the Piedmont Healthcare family.”

Dr. English accepts most major insurance plans and is available for appointments beginning Monday, July 13. Office hours are 8 a.m. to 5 p.m. Monday through Friday. To schedule an appointment, please call 678-454-6800. For more information visit piedmontphysicians.org.
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Mayo Clinic Study Using Structural MRI May Help Accurately Diagnose Dementia Patients

/PRNewswire / -- A new Mayo Clinic study may help physicians differentially diagnose three common neurodegenerative disorders in the future. The study will be presented at the Alzheimer's Association International Conference on Alzheimer's Disease on July 11 in Vienna.

In this study, Mayo Clinic researchers developed a framework for MRI-based differential diagnosis of three common neurodegenerative disorders: Alzheimer's disease, frontotemporal lobar degeneration, and Lewy body disease using Structural MRI. Currently, examination of the brain at autopsy is the only way to confirm with certainty that a patient had a specific form of dementia. The framework, which is called "STructural Abnormality iNDex" or STAND-Map, shows promise in accurately diagnosing dementia patients while they are alive. The rationale is that if each neurodegenerative disorder can be associated with a unique pattern of atrophy specific on MRI, then it may be possible to differentially diagnose new patients. The study looked at 90 patients from the Mayo Clinic database who were confirmed to have only a single dementia pathology and also underwent an MRI at the time of clinical diagnosis of dementia. Using the STAND-Map framework, researchers predicted an accurate pathological diagnosis 75 to 80 percent of the time.

"The STAND-Map framework might have great potential in early diagnosis of dementia patients," says Prashanthi Vemuri, Ph.D., a senior research fellow at the Mayo Clinic aging and dementia imaging research lab and lead author of the study. "The next step would be to test the framework on a larger population to see if we can replicate these results and improve the accuracy level we achieved in this proof of concept study. In turn, this may lead to better treatment options for dementia patients."

The senior author of this Mayo Clinic research study is Clifford Jack, M.D. Other members included Kejal Kantarci, M.D.; Matthew L. Senjem; Jeffrey Gunter; Jennifer Whitwell, Ph.D.; Keith Josephs, M.D.; David Knopman, M.D.; Bradley Boeve, M.D.; Tanis Ferman, Ph.D.; Dennis Dickson, M.D.; and Ronald Petersen, Ph.D., M.D.

This work was supported in part by National Institutes of Health (NIH) grants, Robert H. Smith Family Foundation Research Fellowship, Alexander Family Alzheimer's Disease ResearchProfessorship.

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FDA Approves Effient to Reduce the Risk of Heart Attack in Angioplasty Patients

The U.S. Food and Drug Administration has approved the blood-thinning drug Effient tablets (prasugrel) to reduce the risk of blood clots from forming in patients who undergo angioplasty, a common procedure to unblock a clogged coronary artery.

During an angioplasty, a balloon is used to open the artery that has been narrowed by atherosclerotic plaque.Often, a tiny wire mesh scaffold (stent) is inserted into the blood vessel to help keep the artery open after the procedure. Platelets in the blood can clump around the procedure site, causing clots that can lead to heart attack, stroke, and death.

Effient was studied in a 13,608-patient trial comparing it to the blood-thinning drug, Plavix (clopidogrel), in patients with a threatened heart attack or an actual heart attack who were about to undergo angioplasty.

The fraction of patients who had subsequent non-fatal heart attacks was reduced from 9.1 percent in patients who received Plavix to 7.0 percent in patients who received Effient.While the numbers of deaths and strokes were similar with both drugs, patients with a history of stroke were more likely to have another stroke while taking Effient. In addition, there was a greater risk of significant, sometimes fatal bleeding seen in patients who took Effient.

“Effient offers physicians an alternative treatment for preventing dangerous blood clots from forming and causing a heart attack or stroke during or after an angioplasty procedure,” said John Jenkins, M.D., director of the Office of New Drugs, in the FDA’s Center for Drug Evaluation and Research.“Physicians must carefully weigh the potential benefits and risks of Effient as they decide which patients should receive the drug.”

The drug’s labeling will include a boxed warning alerting physicians that the drug can cause significant, sometimes fatal, bleeding. The drug should not be used in patients with active pathological bleeding, a history of mini-strokes (transient ischemic attacks) or stroke, or urgent need for surgery, including coronary artery bypass graft surgery.

Effient is manufactured by Eli Lilly and Company of Indianapolis, in partnership with Tokyo-based Daiichi Sankyo Ltd.

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Kaiser Permanente of Georgia Continuing Medical Education Receives Recognition from Medical Association of Georgia

CME Program Becomes First in State to Receive This Honor

The Southeast Permanente Medical Group of Georgia, Inc. (TSPMG) has been honored with the highest possible accreditation status by the Medical Association of Georgia. TSPMG, which exclusively treats Kaiser Permanente patients in Georgia, was honored with “accreditation with commendation” for a 6-year term.

In garnering the honor, the TSPMG Office of Continuing Medical Education (CME) demonstrated excellence in all 15 basic criteria areas plus the seven optional criteria required for accreditation with commendation.

Kaiser Permanente is the first in the state to receive accreditation with commendation for a 6-year term under new, more stringent criteria. MAG is granted authority to accredit intrastate CME providers by the Accreditation Council for Continuing Medical Education (ACCME). Nearly 50 Georgia health care organizations apply for accreditation.

“The Office of CME strives to offer quality continuing medical education activities and considers it an honor to be recognized as one of the best in the state of Georgia”, said Sandra Gauthier, manager of Continuing Medical Education for TSPMG.

“We feel it is not enough to only have excellent CME activities, but also to be able to measure whether or not they make a difference in patient care,” she added. “The participation of CME Committee members, medical group leadership and the support and hard work of our dedicated staff made this recognition possible.”
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