New Data Show Drinking While Pregnant Still a Problem

The number of women who drink alcohol while pregnant is not decreasing, according to a 15 year-study by the Centers for Disease Control and Prevention. Approximately 1 in 8 women drank any amount of alcohol while pregnant, the study says.

The drinking patterns persisted despite repeated warnings from surgeons general about the dangers of drinking alcohol while pregnant. The surgeons general have told pregnant women, and women who may become pregnant to abstain from alcohol consumption in order to eliminate the chance of giving birth to a baby with alcohol related birth defects.

The CDC analysis, as well as a study also published today by the U.S. Substance Abuse and Mental Health Services Administration shows that far too many women use substances (especially alcohol) during their pregnancies.

The CDC study, “Alcohol Use Among Women of Childbearing Age, United States, 1991-2005,” is in the CDC′s Morbidity and Mortality Weekly Report.

The CDC study also found that 1 of every 50 pregnant women engaged in binge drinking each year during the 15 years.

“Exposure to alcohol can cause lifelong physical and mental disabilities that are preventable by avoiding alcoholic drinks while pregnant,” said Edwin Trevathan, director of the CDC′s National Center on Birth Defects and Developmental Disabilities. “All women should know that there is no known safe amount of alcohol to drink or safe time to drink it during pregnancy. We encourage all women to pay attention to the surgeon general warnings.”

The study found that pregnant women most likely to report any alcohol use were 35-44 years of age (17.7 percent), college graduates (14.4 percent), employed (13.7 percent), and unmarried (13.4 percent). Pregnant women who binge drink were more likely to be employed and unmarried than were pregnant women who did not binge drink. This study did not examine the reasons why women are still drinking while pregnant.

Any alcohol use was defined as at least one drink of any alcoholic beverage in the past 30 days. Binge drinking was defined as having five or more drinks on at least one occasion in the past 30 days.

“By screening and advising women about the risks of drinking while pregnant, health care providers can play a key role in reducing rates of fetal alcohol syndrome,” said Clark Denny, a CDC epidemiologist and primary author of the study. “This study revealed that there is still a great need for health care professionals to routinely ask all women who are pregnant or at risk of being pregnant about their alcohol consumption.”

The study examined data from 533,506 women aged 18-44 years, of whom 22,027 reported being pregnant at the time of the interview. The data were obtained from the Behavioral Risk Factor Surveillance System (BRFSS). The BRFSS is a state-based system of health surveys that collects information on health risk behaviors, preventive health practices, and health care access primarily related to chronic disease and injury. Data are collected monthly in all 50 states, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, and Guam.

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FDA Approves Besivance to Treat Bacterial Conjunctivitis

The U.S. Food and Drug Administration today approved Besivance (besifloxacin ophthalmic suspension 0.6 percent) for the treatment of bacterial conjunctivitis (non-viral), a contagious condition marked by irritation of the eyes and a discharge from the mucous membranes.

“Bacterial conjunctivitis is a common condition that affects people of all ages,” said Wiley A. Chambers, M.D., acting director of the Division of Anti-Infective and Ophthalmology Products in FDA’s Center for Drug Evaluation and Research. “It is important to have a variety of treatment options available to health care professionals and patients because an effective drug therapy can reduce the duration of the illness and reduce the chances of infecting others.”

Bacterial forms of conjunctivitis are common in childhood, but they can occur in people of any age. Symptoms of bacterial conjunctivitis can include red eyes, swelling, eyelids sticking together, itching, watering and a white or yellow sticky discharge from the eyes. Bacterial conjunctivitis is generally a condition that runs its course in 7-14 days.

Patients using the drug in clinical trials had a faster rate of resolution of the infection than those treated with a solution containing only a preservative. The drug was shown to be effective in treating patients age one year and older.

Adverse events were reported in less than 3 percent of patients in clinical trials. Adverse reactions included redness of the eyes, blurred vision, eye pain, irritation and itching, and headache. Besivance is an eye drop for topical use on the eyes only. It should not be injected into the eye.

Besivance is made by Bausch & Lomb, Rochester, N.Y.

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FDA Approves New Total Ankle Replacement System

The U.S. Food and Drug Administration today approved a total ankle replacement system for arthritic or deformed ankles that may preserve some range of motion in the joint.

The new prosthesis is a mobile-bearing device, which relies on bearings that move across a surface of polyethylene, a flexible plastic. The device is the first of its type.

Once arthritis or injury destroys the cartilage that cushions the ankle bone, the joints can become painful enough to warrant total ankle replacement.

The Scandinavian Total Ankle Replacement (STAR) System is an alternative to fusion surgery and may allow for greater rotation and movement in the joint. Fusion surgery involves cementing the shin bone (tibia) – the thicker of the two bones in the lower leg – to the talus bone in the ankle. The procedure stabilizes the ankle, but significantly decreases the ability to move the foot up and down.

“This device offers another treatment alternative to fusion surgery, and more closely imitates the function of a natural ankle,” said Daniel G. Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health. “For the first time in the United States, a patient may retain some ankle mobility with this non-constrained, mobile-bearing device.”

The FDA has already cleared several fixed-bearing ankle devices, which are also options to fusion surgery. In fixed-bearing ankle system, the articulating surface is molded, locked or attached to one of its metallic components.

For two years, researchers followed a subgroup of a 224-patient clinical study and found that the STAR system demonstrated similar rates of adverse events, surgical interventions and major complications as fusion surgery.

As a condition of FDA approval, the company will evaluate the safety and effectiveness of the device during the next eight years.

The STAR Ankle is owned by Small Bone Innovations Inc. of Morrisville, Pa.

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Metastatic Colon Cancer: In a Randomized Phase II Clinical Study, Antineoplaston Therapy Doubled 5-Yr Survival Rate‏

The Burzynski Research Institute, Inc.(BRI) is pleased to announce the results of a randomized Phase II clinical study of antineoplaston therapy (ANP therapy) in metastatic colon cancer following curative resection of hepatic metastases. The study was performed at the Kurume University School of Medicine (Japan) in the Department of Surgery. A report of the study results is currently in press.

The study population consisted of 65 colon cancer patients who had undergone curative resection of hepatic metastases and were randomized to 1) intrahepatic infusion of 5-FU (33 patients), or 2) intrahepatic infusion of 5-FU plus IV ANP therapy (32 patients). ANP therapy consisted of a) 50-100 g IV infusion of Antineoplaston A10 given daily for seven days following hepatic resection and b) 10 g of oral Antineoplaston AS2-1 given daily for one year.

There was a significant difference in overall survival between the two groups: with the five-year survival rate in the 5-FU plus ANP therapy arm being 62% versus 32% in the 5FU-only arm. The mode of recurrence was also different in the two study arms. In the 5FU-only arm, recurrences affected multiple organs in 69%, while in the 5-FU plus ANP therapy arm, recurrences affected multiple organs in only 34%, which provided for a higher complete second resection rate in the 5-FU plus ANP therapy arm (61% versus 35%).

Dr. Stanislaw R. Burzynski, Chairman and CEO of BRI stated, "We are very pleased with the results of this study, and thankful to our Japanese colleagues. The results indicate that ANP therapy may find application not only in the treatment of brain tumors as reported previously, but also in the more common colorectal cancer."

Kurume University is among the oldest and most successful medical universities in Japan. Its Department of Surgery has a strong interest in the development of successful treatments for colorectal and liver cancers.

Burzynski Research Institute, Inc. (BRI) is a biopharmaceutical company committed to developing treatment for cancer based on genomic and epigenomic principles. Research and development efforts are now focused on basic research and Phase III clinical trials.

Forward-looking statements in this release are made pursuant to the safe harbor provisions of the federal securities laws. Burzynski Research Institute, Inc. cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Information contained in forward-looking statements is based on current expectations and is subject to change, and future events may differ materially from those discussed herein due to a number of factors, including, but not limited to, risks and uncertainties related to BRI's ability to obtain regulatory approval for Antineoplastons A10 and AS2-1, risks associated with BRI's ability to raise sufficient capital from the development of its technology towards commercialization, and other risks described in BRI's periodic reports filed with the Securities and Exchange Commission. BRI does not undertake to update any such forward- looking statements or to publicly announce developments or events relating to the matters described herein.

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Mayo Researchers Help Discover Genetic Cause for Primary Biliary Cirrhosis

Researchers have discovered a novel molecular path that predisposes patients to develop primary biliary cirrhosis, a disease that mainly affects women and slowly destroys their livers. Primary biliary cirrhosis has no known cause.

The finding, significant because it is a first step toward developing a targeted treatment and a cure, will be published in the June 11, 2009, issue of the New England Journal of Medicine.

"Now that we better understand the molecular basis of primary biliary cirrhosis, we can look for ways to specifically fix those elements," says Konstantinos Lazaridis, M.D., a Mayo Clinic hepatologist and a senior researcher in the study.

Currently, treatments for primary biliary cirrhosis can slow progression of the disease, which affects 1 in 2,500 Americans, 90 percent of them women. However, about half of patients do not respond to medical therapy. For some patients, a liver transplant cures the condition. But not all patients qualify for a transplant, and some transplant recipients experience a recurrence within five to 10 years.

The study was conducted at the University of Toronto using blood samples of patients collected at several medical centers in Canada and at Mayo Clinic's campus in Rochester, Minn., through its Primary Biliary Cirrhosis Genetic Epidemiology Research Resource. This resource comprises the biospecimens of hundreds of primary biliary cirrhosis patients and individuals who do not have the disease (controls) --matched for age, sex, race and state of residence. Mayo Clinic and the University of Toronto are among the largest treatment centers in North America for primary biliary cirrhosis.

The University of Texas MD Anderson Cancer Center in Houston provided historical controls and conducted the statistical analysis of the study.

The genetic link to primary biliary cirrhosis has been well-established by previous studies. "Indeed, mothers, sisters and daughters in the same family have a significantly higher tendency to develop the disease compared with the general population," says Dr. Lazaridis.

To learn more about the cause of the illness, researchers designed a three-phase study to identify genetic markers associated with the disease. In phase one, researchers conducted a genome-wide association analysis, comparing the genotypes of 536 patients with primary biliary cirrhosis to those of 1,536 people who did not have the disease. Researchers looked at more than 300,000 single-nucleotide polymorphisms (SNPs), the most common genetic variations, among the approximately 11 million known to be present in the human genome.

"There were significant differences between the patients with primary biliary cirrhosis and the control group," says Dr. Lazaridis. As a result, researchers narrowed their focus to 16 SNPs significantly linked to primary biliary cirrhosis.

In phases two and three, researchers conducted "replication" and "fine-mapping" studies to confirm the initial results and to further detail the genetic variations most closely linked to primary biliary cirrhosis.

Researchers discovered that variants of two genes, interleukin 12A (IL12A) and interleukin 12RB2 (IL12RB2), were strongly associated with primary biliary cirrhosis. These two genes constitute a pathway of the immune system. Potential therapeutic manipulation of this pathway provides new possibilities for more effective treatments of these patients, says Dr. Lazaridis.

Researchers also confirmed that the human leukocyte antigen (HLA) region of the genome is linked to primary biliary cirrhosis, an association which had been identified in previous research.

"Although both the HLA region and the IL12 pathway are equally involved with susceptibility to primary biliary cirrhosis, HLA is very complicated to dissect genetically, with multiple pathways," says Dr. Lazaridis. "It will be difficult to modulate with the intention to treat, while IL12 is a single pathway and thus more amenable to treatment."

The reliability of the newly discovered association is very strong; statistically, there's about a one in 10 trillion chance that the pathway isn't linked to primary biliary cirrhosis, Dr. Lazaridis noted.

"That strong association is remarkable, given that the researchers started by looking at 300,000 genetic markers across approximately three billion base pairs that comprise our entire genetic material," he says. "Needle in a haystack doesn't begin to convey the challenge of this search."

Dr. Lazaridis describes this finding as the "end of the beginning" in learning more about the predisposing genetic factors to primary biliary cirrhosis. The newly discovered IL12 pathway does not account for all instances of primary biliary cirrhosis. There is more work to be done on additional genetic links, and exactly how IL12A and IL12RB2 contribute to primary biliary cirrhosis remains unknown. But researchers now have, for the first time, the knowledge to begin to develop targeted treatments and better predict outcomes for some patients with primary biliary cirrhosis.
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Sinusitis and Allergies: What You Need to Know Living in Atlanta

Spring has sprung and summer is just around the corner. While much of the tree pollen has come and gone, the sniffling and sneezing associated with grass pollen is just getting underway. Those suffering from grass pollen will continue battling their allergies from May through the summer months. Seasonal allergens can also trigger sinus attacks or sinusitis.

Emory experts will host a free seminar for the community called “Sinusitis and Allergies – What You Need to Know Living in Atlanta” on May 28 at 6:30 p.m. at Emory University Hospital Midtown. This is an opportunity for allergy and sinus sufferers to hear about the latest treatments, therapies and research, as well as to ask the physicians questions on the topics.

“This seminar will give participants a chance to learn more about the nose and sinuses, conditions commonly experienced, as well as environmental and food allergies and their treatments,” says John DelGaudio, MD, director of the Emory Sinus, Nasal and Allergy Center. “Participants will also hear about the latest ideas about these conditions.”

While Atlanta is known for its desirable spring and summer months, it comes with side effects for many.

“This is the time of the year when we see patients feeling the effects of the pollen and mold season,” says C. Sekhar Ghosh, MD, private practice internist at Emory University Hospital Midtown. “Patients come to our office for first-line treatment related to their seasonal allergies, sinusitis and asthma attacks. Over the counter remedies work for some, but others may need more intervention.”

Join us as four experts in the field talk sneezing, sniffling and stuffy nose. Details are below:

WHAT: Sinusitis and Allergies - What You Need to Know Living in
Atlanta Seminar
WHEN: Thursday, May 28, 2009, 6:30 – 8 p.m.
WHERE: Emory University Hospital Midtown
Glenn Auditorium
550 Peachtree St., NE
Atlanta, Ga., 30308
COST: Free. Call Emory HealthConnection to 404-778-2000 to register.
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CDC Foundation Partners with Amgen, CDC to Reduce Infections Among Cancer Patients

/PRNewswire / -- The Centers for Disease Control and Prevention (CDC) Foundation, CDC and Amgen today announced the launch of a three-year campaign to reduce infections among cancer patients. The campaign will provide resources and educational tools to help patients, families and healthcare providers better prevent and manage treatment-related infections.

"Cancer patients undergoing chemotherapy are at a higher risk for infections, which can impact their treatment success, lead to hospitalization and cause life-threatening complications," says Charles Stokes, president and CEO of the CDC Foundation. "This partnership between the CDC Foundation, CDC and Amgen brings together experts and resources from government and the private sector to address a critical health issue for cancer patients."

Each year, according to a 2005 study published in Cancer, 60,000 cancer patients in the United States are hospitalized for chemotherapy-related neutropenia - or low white blood cell count - which is a risk for serious infection, and a patient dies every two hours from this complication.

Healthcare professionals are highly concerned about the impact that infections have on treatment outcomes. According to a new Harris Interactive, Inc. survey of oncologists, infectious disease (ID) specialists and patients, 92 percent of oncologists say it is extremely to very important to prevent infections to achieve successful outcomes in chemotherapy patients.

Physicians are also concerned about emerging antibiotic resistance in this population, with 96 percent of ID specialists and 79 percent of oncologists reporting an increase in antibiotic-resistant infections in cancer patients over the past five years.

"We know that patients who acquire drug-resistant infections have more severe illness and higher risk of death," says Arjun Srinivasan, M.D., a medical epidemiologist in the Division of Healthcare Quality Promotion at CDC. "Programs to improve infection control in cancer patients, whose immune systems may be compromised by chemotherapy, will aid in saving the lives of these high-risk patients."

The comprehensive education campaign will include curricula for healthcare professionals on infection control for cancer patients and appropriate antibiotic management to prevent resistance. It will also include an online education program for patients and caregivers.

"We believe joining forces with the CDC Foundation and CDC on this important public health initiative helps us achieve our mission to serve patients by bringing together experts in infectious disease and cancer to improve infection control and promote appropriate antibiotic stewardship for these high-risk patients," says Sean Harper, M.D., chief medical officer and head of Global Development at Amgen.

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Mayo Study Finds That Team Preop Briefing Improves Communication, Reduces Errors

A short, preoperative team briefing prior to cardiac surgery - where each person on the team speaks - improves communication and reduces errors and costs, according to a pilot study conducted at Mayo Clinic.

Mayo researchers believe this is the first such study to use real-time observations to measure the effect of preoperative briefings on specific disruptions to surgery. Disruptions were categorized as patient-related issues, equipment or resource issues, procedural knowledge issues and miscommunication events. Results from the Mayo Clinic pilot are published online in the Journal of the American College of Surgeons.

"The goal of the briefings was to get everyone used to talking when there wasn't a problem, so they would be more likely to speak up when problems occur," says Thoralf Sundt, M.D., Mayo Clinic cardiac surgeon who volunteered his surgery team for the study. "We know that miscommunication is a major cause of sentinel events, an unexpected death or serious injury."

Fifty-six surgical staff members filled out questionnaires and participated in focus groups to develop the format for the briefings. Among the participants were surgical assistants and technicians, registered nurses, nurse anesthetists, and perfusionists, who operate the heart-lung machine during most cardiac surgeries.

The briefings were conducted in the operating room immediately prior to the first surgical procedure of the day, before the patient arrived in the room. Each team member discussed his or her role in the procedure and any concerns specific to the patient. The briefings lasted from one to eight minutes.

"The briefing was not a checklist review," says Dr. Sundt. Checklists are most helpful in preventing predictable errors, such as confirming if and when medications are administered prior to surgery. No checklist can cover the unexpected scenarios that might occur in surgery.

"Because of the complexity of what we do, errors do happen," says Dr. Sundt. "Each team member needs to feel comfortable enough to identify errors. Then we catch them and correct them."

Pre-procedure briefings are not common in operating rooms, but they are standard in other high-risk industries such as aviation and in the military, according to Douglas Wiegmann, Ph.D., the lead researcher on the Mayo study.

"This approach reflects a change in culture in the surgical field - that everyone has a unique contribution to the outcome and care of the patient," says Dr. Wiegmann, who has since moved to the University of Wisconsin as an associate professor of human factors engineering.

While staff are expected to speak up during surgery, they don't or don't always, according to Dr. Wiegmann. Other research has shown that information conveyed in the operating room is often shared in a tense, ad hoc manner that is not conducive to comfortable communication. Previous Mayo Clinic research found that only 32 percent of nonphysician caregivers in cardiovascular surgery thought that surgeon communication was effective. In the same study, 59 percent of nonphysician respondents thought that surgeon attitudes and personalities negatively impacted teamwork.

To measure the briefings' effectiveness, a trained observer monitored six surgeries where briefings were conducted and 10 surgeries where no briefing occurred. The observer was a medical student who was familiar with cardiac surgery and trained to record errors and flow disruptions.

When the briefings were conducted:

Miscommunication events were reduced by 53 percent. None of the miscommunication events observed during the study resulted in adverse events. Examples include the surgeon asking for a medication to be given the anesthesiologist not hearing the request. There were significantly fewer delays, with fewer interruptions to clarify procedures. And, nurses made fewer trips outside the operating room to retrieve supplies.

Waste of medical supplies was reduced because the team better anticipated specific needs for each surgery.

Dr. Sundt says his team has embraced the briefings and continues to conduct them prior to the first procedure of the day. Other surgical teams have since requested implementation of the briefings.

"It's time well spent that tunes us in to the specific patient's needs," says Dr. Sundt. In addition to specific concerns about the surgery, the briefings include information about the patient's prior procedures, other diagnoses, risks and emotional concerns, such as the patient's biggest worry regarding surgery.

"It sets the tone for the day. Now, I'm uncomfortable when we don't do it," says Dr. Sundt, who was initially skeptical about the benefits of the briefings.

There are barriers to conducting briefings for every procedure. "The structure of the operating room is not conducive to this," says Dr. Sundt. With multiple surgical suites, surgery times overlap, creating difficulty in assembling the team prior to each procedure. During long, complex surgeries, shift and staff changes occur.

Additional study and pilots are needed to determine ways to incorporate the briefings more broadly, researchers say.
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Piedmont Mountainside Hospital Encourages Community to Check Their Bones

May is Osteoporosis Awareness Month

May is Osteoporosis Awareness Month and Piedmont Mountainside Hospital (PMH) is encouraging members of the community to learn more about osteoporosis and bone health. According to the National Osteoporosis Foundation, an estimated 10 million Americans are afflicted with osteoporosis and another 34 million are estimated to have low bone mass.

Osteoporosis, or porous bone, is characterized by low bone mass and structural deterioration of bone tissue, leading to bone fragility and an increased susceptibility to fractures of the hip, spine, and wrist. It is referred to as the “silent disease” since many patients are often not aware of their condition until after a fracture occurs.

“Osteoporosis can have a debilitating effect on the lives of patients, if not properly treated. We are here to help our patients develop a personalized treatment plan that will help them to lead an active lifestyle,” says Linda Stead, Chief Nursing Office, PMH. “In fact, my mother has osteoporosis and had a spontaneous fracture of her pelvis due to the osteoporosis before it was discovered. We are now careful to make sure she has her screening exams and has follow-up check-ups with her physician to monitor her medications he prescribed for osteoporosis."

This preventable and treatable disease affects women and men. However, women are more susceptible to osteoporosis due to changes that occur during menopause. This disease can only be diagnosed with a physician administering a bone mineral density (BMD) screening.

Warning signs may include collapsed vertebra which may initially be felt or seen in the form of severe back pain, loss of height, or spinal deformities such as kyphosis, or severely stooped posture. Taking the time to meet with your physician and to get a BMD screening can help to decrease your risk of developing osteoporosis. Knowing your risk and taking essential steps to prevent the disease can have a major effect on treating or even preventing the disease. Some common risk factors of osteoporosis include age, gender, family history and certain medications.

While many risk factors are non-modifiable, there are a few lifestyle changes that can be made to lower your personal risk for osteoporosis:

· Feel the burn: Adapting a regular exercise routine improves bone health and increases muscle strength, coordination and balance.
· Take your vitamins: Calcium and Vitamin D help build strong bones.
· Stop Smoking : Smoking is bad for your bones as well as for your heart and lungs.

All of these changes will not only help you to decrease your risk for osteoporosis, but they will also aid your overall health. For more information about preventing and treating osteoporosis, call Piedmont Mountainside Hospital at 706-692-2441 or visit www.piedmontmountainsidehospital.org.
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Specialty Care Costs for Patients With Bipolar Disorder are Higher Than Diabetes and Other

Mayo Clinic researchers have found that bipolar disorder is more costly than other chronic conditions such as diabetes, depression, asthma or coronary artery disease. These findings are based on a review of health care claim costs. Specialty care costs (the costs of seeing any specialist and all tests ordered) were especially higher for bipolar patients. Results of this review are being presented today at the Annual Meeting of the American Psychiatric Association in San Francisco.

"Psychiatric care costs represented only a portion of the specialty care costs for these chronic conditions," explains Mark Williams, M.D., a Mayo Clinic psychiatrist and lead researcher. "This suggests that many of the specialty costs for bipolar patients are not directly related to seeing a mental health provider."

A data review of health care claims over a four-year period, showed patients with bipolar disorder had significantly higher total per member per month costs compared with patients who had the other conditions. Only patients with both coronary artery disease and diabetes had higher costs than patients with bipolar disorder. Total costs, specialty care visits, specialty care costs, outpatient psychiatric costs, and outpatient psychiatric visits were compared. "The goal of this study is to drive practice changes that improve the efficiency and value of care for bipolar disorder with hopes to improve care while reducing costs," explains Dr. Williams.

Other authors on the Mayo Clinic study include Nilay Shah, Ph.D.; Mark Frye, M.D.; Jeanette Ziegenfuss, Ph.D.; Amy Wagie; and Douglas Wood, M.D.

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Maternity Center at Piedmont Fayette Hospital Offers Classes for Expecting Parents

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

Prepared Childbirth Class - This course, recommended for women 20 to 28 weeks into pregnancy, provides an eight hour childbirth education class that teaches mom and her partner about what to expect during labor and delivery. The instructor will discuss the stages of labor, relaxation, breathing techniques, common concerns, comfort measures and much more. Participants will need to bring two pillows and a blanket or towel. The fee for the course is $85 and includes light refreshments. The class will be held Saturday, June 20 from 9 a.m. to 5 p.m. in the 1279 Building, Conference Room C. To register, call Link2Health toll-free at 1-866-900-4321. For more information call 770-719-6005.

Breastfeeding Basics - The Maternity Center at Piedmont Fayette Hospital offers a three hour group participation discussion on the benefits and how-to's of breastfeeding. This class includes preparing for breastfeeding and getting started in the hospital and at home, special situations and growing a breastfeeding family. The class is best if done prior to delivery, but participants are welcome at any time. Fathers and grandparents are welcomed and encouraged to attend also. This class is now offered every month, and the next class is Saturday, June 13 from 9 a.m. to noon in the Dietary Conference Room on the ground floor of the hospital. For more information or to register, call 770-719-6005.

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

Maternity Center Tours - The Maternity Center at Piedmont Fayette Hospital welcomes expectant mothers and their families to take a tour of the facility. The tour will be offered on Monday, June 1 at 6 p.m.; Saturday, June 13 at 12:30 p.m.; and Saturday, June 20 at 6 p.m. The tour will provide information on the hospital's approach to maternity care and how physicians and staff help new mothers and their babies before and after delivery. Families, including siblings, are welcome. Please meet in the Maternity Center lobby (third floor, enter through the West Entrance). For more information call 770-719-6005.

Fayette County Safe Kids Child Passenger Safety Training Class - Fayette County Safe Kids will offer a car seat safety class to teach parents how to keep children safe, especially while traveling by car. The course will be offered Monday, June 8 from 2 to 3:40 p.m. in Conference Room A on the third floor of the hospital's 1279 Building. This class is offered the second Monday of each month. For additional information contact Debbie Straight, 770-305-5148.

Sibling Class - Siblings ages three to ten, accompanied by a parent, are welcome to attend. The class includes a brief tour of the hospital, and will cover the adjustments of becoming a big brother or big sister, as well as what happens to the mother while she is in the hospital. The course will be offered Saturday, June 13 from 2 to 3 p.m. This class is offered the second Saturday of each month. Please meet in the Maternity Center lobby (third floor, enter through the West Entrance) and sign in. For more information or to register, call 770-719-6005.
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Mayo Clinic Proceedings:The Evolution of Migraine from Episodic Headache to Chronic Disorder

Patients living with migraine have strong reason for new optimism concerning a positive future. Two review articles and an accompanying editorial, "The Future of Migraine: Beyond Just Another Pill," in the current issue of Mayo Clinic Proceedings, are the basis for an ironic premise.

"Migraine is a potentially chronic, progressive disease that substantially affects patients, families, workplaces, and society," according to the editorial written by Roger Cady, M.D., of the Headache Care Center in Springfield, Mo. "Ironically, this is the springboard for renewed optimism of a more positive future for patients living with migraine."

Traditionally, Dr. Cady explains, migraine has been considered a pain disorder involving separate or even sporadic episodes. Now, the condition is defined as an all-encompassing and progressive disease that negatively affects all aspects of an individual's life. Migraine can erode quality of life during what should be a person's most productive years, according to Dr. Cady. Because migraine patients' quality of life has not improved at a pace with medical advances, research is addressing the overall severity and potential progressive nature of migraine, especially migraine episodes as a forerunner of chronic migraine.

According to the three articles, these new insights and understandings are requiring professionals to explore well beyond traditional migraine management. "Understanding migraine as a potentially chronic disease mandates a collaborative health care model with patients and health care professionals working in a partnership toward common therapeutic goals," writes Dr. Cady, specifically intervention and prevention.

Physicians and patients must be encouraged to be partners, he says, and evaluation must go far beyond the physician just asking, "How are your migraines?" The models must include an invitation to comprehend and address all migraine-related health issues facing patients, Dr. Cady writes. In addition, understanding the evolutionary "stages" of migraine from sporadic to persistent offers an opportunity to develop new therapies that individualize and personalize care.

In the future, successful management of migraine will ideally be measured not by stopping an attack but by overall disease management and prevention, according to the researchers.

This new understanding of migraine as a chronic disease offers many challenges and rewards, according to Dr. Cady. "Today, the focus of care is rapidly changing from the event of the migraine to the patient with migraine," he notes. These changes present great promise for patients and health care professionals alike, representing assurances of a better future for patients with migraine, concludes Dr. Cady.

A peer-reviewed journal, Mayo Clinic Proceedings publishes original articles and reviews dealing with clinical and laboratory medicine, clinical research, basic science research and clinical epidemiology. Mayo Clinic Proceedings is published monthly by Mayo Foundation for Medical Education and Research as part of its commitment to the medical education of physicians. The journal has been published for more than 80 years and has a circulation of 130,000 nationally and internationally. Articles are available online at www.mayoclinicproceedings.com/.
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Swine Flu (H1N1) Infectivity to Increase Markedly and Lethality to Remain Low According to Latest Replikin* Peptide Genomic Data

/PRNewswire/ -- Amid all the speculation over what course the Swine Flu epidemic will take, Boston-based biotech firm Replikins Ltd. (www.replikins.com) last week analyzed the most recent peptide genomic sequence data available and determined that the infectivity of the H1N1 virus will increase markedly, while its lethality will remain relatively low for the immediate future.

The company's quantitative analysis of the most recent sequence data available on PubMed, a standard scientific repository for published papers, showed an increase of 46% in the Replikin Count* over the past five months. This points to a marked increase in infectivity in humans. At the same time, while the total number of replikins has gone up significantly, their composition appears to have changed in a way that makes them more closely resemble their counterparts in earlier pandemics.

The firm, which had predicted a year ago the likelihood of the current H1N1 outbreak, used its proprietary FluForecast(TM) software program to make these determinations. "The dual differentiation of these properties may provide advance warning of the future course of H1N1," noted Samuel Bogoch MD PhD, chairman and founder of Replikins Ltd. "Our understanding of the protein chemistry of rapid replication enables us to develop synthetic vaccines specifically tailored to destroy or restrict replication of the targeted virus strains prior to an outbreak."

Earlier this month, Replikins announced that it had succeeded in synthesizing the first H1N1 influenza vaccine, which is now ready for testing. It used the same approach to produce a peptide H5N1 (avian flu) vaccine that successfully blocked low path H5N1. It has not previously been possible to correlate virus structures with a virus outbreak or cessation of outbreak, let alone to predict six to 12 months ahead of the outbreak or its cessation. In 2001, Drs. Samuel and Elenore Bogoch first demonstrated this correlation retrospectively for whole-organism replikin counts in outbreaks and pandemics of the common influenza strains over the past century.

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FDA Approves Samsca to treat Hyponatremia

The U.S. Food and Drug Administration has approved Samsca tablets (tolvaptan) to treat hyponatremia, an abnormally low concentration of sodium in the blood.

“With the approval of Samsca, physicians will have an additional tool to treat hyponatremia,” said Norman Stockbridge, M.D., director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research.

Samsca is approved to treat hyponatremia associated with congestive heart failure, liver cirrhosis, and the syndrome of inappropriate antidiuretic hormone secretion.

When sodium levels drop in the fluid outside of cells throughout the body, water moves into cells to balance the sodium levels and causes the cells to swell. Swelling of the brain cells is thought to cause many of the symptoms of hyponatremia. Those symptoms may include fatigue, weakness, headache, nausea, confusion or decreased consciousness, and convulsions. Severe hyponatremia, which has not been studied with Samsca, can lead to coma and death.

Samsca helps raise sodium levels in the blood by removing extra body water in the urine. Patients using the drug in clinical trials had a greater degree of increase in sodium levels in the blood compared with patients taking a pill containing no active drug (placebo).

Samsca is being approved with a boxed warning to alert health care professionals and patients that the drug should be started only in a hospital where blood sodium can be monitored closely. Too rapid a rise in sodium can cause a serious condition called osmotic demyelination syndrome (ODS). ODS can lead to coma or death and can also cause symptoms such as trouble speaking, trouble swallowing, drowsiness, confusion, mood changes, seizures and trouble controlling body movement with muscle weakness in the arms and legs.

Although no cases of ODS were seen in clinical trials of Samsca, ODS is a known risk and it is essential that physicians be aware of it and avoid rapid rises in sodium. Additionally, the FDA is requiring a Risk Evaluation and Mitigation Strategy that requires a patient Medication Guide be given out when the drug is dispensed. The Medication Guide will provide information about the drug’s benefits and risks.

The most common adverse reactions with use of Samsca reported by patients in clinical trials include thirst, dry mouth, weakness, constipation, making large amounts of urine, urinating often, and increased blood sugar levels.

Samsca is marketed by Otsuka Pharmaceuticals Co. Ltd., Tokyo, Japan.

Emory Eye Center Starts Study for Infants with Blocked Tear Ducts

Highlights:

• No consensus exists on the optimal time to treat congenital nasolacrimal duct obstruction with nasolacrimal duct probing.
• Study researchers will determine whether there is any advantage to early probing, since many of these obstructions go away on their own.
• Researchers will determine the percentage of infants’ eyes that have resolution on their own by looking at the group that will receive no immediate probing.

Emory Eye Center will participate in third phase of a National Eye Institute (NEI)-sponsored multicenter clinical trial, the Nasolacrimal Duct Obstruction (NLDO) Study in late winter. The trial will evaluate which of two approaches is optimal in treating young infants with blocked tear duct: probing the obstruction immediately or waiting to see if the condition goes away on its own after six months, as is often the case.

Co-investigators Amy Hutchinson, MD, and Scott Lambert, MD, pediatric ophthalmologists, will enroll the first patients this spring. Infants must be between six and 10 months old. Half the group of children eligible for enrollment in the study will undergo immediate probing. The other half will wait six months for probing. The later group may receive eye massage at home, which in itself can be helpful.

An antibiotic eye drop may also be prescribed if necessary. At six months, if the obstruction persists, probing will be done within a month. Assignment to either of the two groups is randomly picked via computer.

“This trial will give important information that will help physicians provide the best, safest and most cost effective treatment to children with this very common disorder,” says Hutchinson.

“Doctors are trying to find the most cost-effective ways to treat diseases,” says Lambert. “This study should help us better understand where it is more cost-effective to treat blocked tear ducts during infancy or to wait until children are older.”

NLDO is common in infants and toddlers and presents in the first few months of life. It is caused by a blockage of the duct that drains the tears from the eye to the nose. NLDO often goes away on its own, but when it does not, the condition is often treated with a procedure called probing.

During probing, the physician passes a probe through the tear duct, typically clearing the blockage. In children one year and older, the procedure is performed in a hospital or surgery center using anesthesia. In children less than a year old, some doctors will perform the procedure in the office without putting the child to sleep.

More than 220 children will participate in the study throughout the country. The study is a part of the Pediatric Eye Disease Investigator Group of NEI of the National Institutes of Health. The NEI provides funding for the study.

The Department of Ophthalmology and Emory Eye Center have a mission to conduct pioneering research into blinding eye diseases, to educate and train eye professionals, and to provide excellent patient care. The Department includes 35 ophthalmologists, seven optometrists, nine basic scientists, 11 post-doctoral fellows, and nine researchers in other Emory departments who hold joint appointments in the Department of Ophthalmology. Ophthalmology research is supported by $6 million in NIH funding. The Department remains in the top rankings (#9 – 2008) by U.S. News & World Report for the 12 years the magazine has held a ranking for Ophthalmology. It also ranks in the Top Ten in all four categories surveyed by Ophthalmology Times annual report. http://eyecenter.emory.edu
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New Report Forecasts Hepatitis C Virus Epidemic Among Baby Boomers; Untreated HCV Progressing to Severe Liver Disease

New Report Forecasts Hepatitis C Virus Epidemic Among Baby Boomers; Untreated HCV Progressing to Severe Liver Disease Seen Driving U.S. Costs to $85 Billion

(BUSINESS WIRE)--Over three million Americans, mostly baby boomers, are living with hepatitis C virus (HCV) and nearly 80% don’t know they’re living with a disease that, absent intervention, may give rise to advanced liver disease, including liver cancer. A new study prepared by the actuarial firm Milliman, Inc. reports that, without changes in how these patients are identified and managed, the annual cost of advanced liver disease in HCV patients will jump to $85 billion in the next two decades. Medicare costs will soar 500%, from $5 billion to $30 billion. Most individuals living with HCV were born between 1946 and 1964 and a disproportionate disease burden is borne by African Americans, who are almost twice as likely to have HCV as the general population. The $85 billion estimated cost includes overall direct medical costs for patients with HCV infection.

Consequences of Hepatitis C Virus (HCV): Costs of a Baby Boomer Epidemic of Liver Disease, a new study commissioned by Vertex Pharmaceuticals, projects the direct medical cost impact of HCV on commercial and government payers over the next 20 years assuming no changes to current HCV management. Milliman employed payer datasets, population survey results and disease progression information to project chronic HCV disease states and associated direct medical costs. Societal burdens other than costs of HCV disease were not considered in the study.

"Hepatitis C presents a looming and underappreciated public health epidemic, with vital consequences for our nation's health and health care costs. As with other chronic diseases, much more can and should be done to prevent it and its complications. By addressing viral hepatitis with urgency, we have a real opportunity to spare millions of people from the consequences of advanced liver disease and liver cancer and avoid billions of dollars in potential costs," said Dr. Mark B. McClellan, Director, Engelberg Center for Health Care Reform, Brookings Institution.

The authors point out that “receiving treatment for HCV prior to the onset of severe complications can reduce long-term, life-threatening consequences, though only an estimated 22% of those infected with HCV are diagnosed.” The report concludes that, “as the population ages and the disease progresses, government payers will bear the majority of the financial impact of chronic HCV infection.”

"Millions of patients are affected by hepatitis C and hundreds of thousands will experience serious consequences of advanced liver disease, many, if not most, within their retirement years. This report is the clarion call for increased focus and resources to address preventable consequences of this mostly unrecognized infection," according to Gary L. Davis, M.D., Baylor University Medical Center in Dallas, Texas.

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Victoria Australia Scientists Find Milk the Cream of the Crop in Heart Disease Battle

(BUSINESS WIRE)--Scientists in Victoria, Australia have discovered a compound in milk that could hold the key to combating a combination of disorders that increase the risk of cardiovascular disease and diabetes, Minister for Innovation Gavin Jennings announced today at the 2009 BIO International Convention in Atlanta, USA.

Metabolic syndrome is a combination of high blood pressure, high glucose and obesity that increases the risk of developing cardiovascular disease and diabetes, conditions suffered by 30 per cent of Australians that are an extreme burden on the medical system.

“This remarkable discovery – that a compound in milk can reduce fat-muscle ratios and thus improve health – is a genuine coup for public health,” Mr. Jennings said.

“Findings such as this, which were achieved using a diverse range of Victoria’s biotechnology research and manufacturing capabilities, show the Brumby Government is taking action to improve the quality of life of not only Victorians, but people all around the world.”

Researchers from Victoria’s Department of Primary Industries (DPI) and MG Nutritionals – a division of Murray Goulburn Cooperative Co Ltd – found that a compound, known as Regeneration Inducing Peptide for Tissues and Cells (RIPTAC), when given daily to mice caused them not only to build more muscle but also want to exercise. The findings also showed an increase in muscle in mice not given exercise.

A good muscle to fat ratio is an important factor in reducing the incidence of metabolic syndrome and greater muscle mass is also a factor in burning fat.

Mr. Jennings said metabolic syndrome was one of Australia’s greatest health challenges and that it was important that discussions were now underway to conduct trials of RIPTAC in people in Victoria.

“Results in mice so far have shown great promise highlighting once again the medicinal qualities of milk,” he said.

“This latest discovery builds on past work by the collaborating Victorian teams that have shown active proteins in milk can promote the health of the human digestive system.

“There is a growing worldwide trend towards functional food and complementary medicine and this research is of great interest because milk is a natural source of beneficial ingredients and is something most people have access to every day.

“In addition to the development of new milk-based health products, the discovery provides a basis for development of new pharmaceuticals.”

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New Global Vaccine Center Partnership, Center for Drug Discovery Coming to Georgia

Emory University-Queensland Institute partnership to develop new human vaccines;
World-renowned researcher to lead new Emory Institute for Drug Discovery

Governor Sonny Perdue announced today that two of the world’s leading vaccine research centers will combine their expertise to establish an international research program leading to the development of new human vaccines for infectious diseases and cancers.

The Emory Vaccine Center (EVC) will collaborate with the Australian Centre for Vaccine Development (ACVD) at the Queensland Institute for Medical Research (QIMR) in a new Queensland-U.S. Vaccine Technology Alliance funded in part by a three-year grant from the Smart Futures Fund of the Queensland National and International Research Alliance.

In addition, Governor Perdue announced that Emory University will establish a new Emory Institute for Drug Discovery (EIDD) focusing on commercially neglected diseases, global health partnerships and mentored research. The center will be led by internationally recognized scientist and entrepreneur Dennis Liotta, PhD, who co-invented drugs taken by more than 94 percent of HIV/AIDS patients in the U.S.

“These two groundbreaking initiatives by one of Georgia’s top-ranked universities reflect the exciting biomedical advances that thrive in our state,” said Governor Perdue. “Our business environment invites the kind of entrepreneurial innovation and global partnerships that will lead to the medical breakthroughs of the future.”

The Governor made the announcement with Emory officials during a press conference in the Georgia Pavilion at the 2009 BIO International Convention, the world’s largest gathering of the global biotechnology community. The convention is being held in Atlanta May 18 through May 21, its first-ever meeting in the southeastern United States.

“This exciting global partnership with Queensland and the Emory Vaccine Center, together with the new Institute for Drug Discovery, continue to strengthen Emory University’s depth of research capabilities and its impact on global health,” said James Wagner, president of Emory University.

The Emory Vaccine Center of Emory University is one of the largest academic vaccine centers in the world, renowned for its expertise in cellular immunity, immune memory, disease pathogenesis, vaccine research and development and clinical trials. The Australian Centre for Vaccine Development is an internationally recognized vaccine research center with expertise in antigen discovery, international and national grants and links with the biotech industry.

The Queensland-U.S. Vaccine Technology Alliance recently was awarded a three-year grant of $1.8M from the Smart Futures Fund of the Queensland National and International Research Alliances Program. Additional funding for the alliance will be provided by the two vaccine centers, with total project funding from all sources equaling $8.5M over three years. In addition, ACVD and EVC have an existing Memorandum of Understanding that allows academic exchange to further promote scientific research in the field of vaccine development. Over the past 12 months, through a joint funding program, the EVC has hosted ACVD scientists for advanced training in vaccine technologies.

“Despite our success in developing vaccines, many challenges remain in the fight against chronic infections and cancer,” said The Hon. Stephen Robertson MP, Queensland Minister for Natural Resources, Mines and Energy and Minister for Trade. “This project will combine expertise from two leading vaccine research organizations in a collaboration that will uncover new technologies for developing and improving vaccines. Both organizations have strong links with the biotech industry and health institutions, which will help bring the research from bench to bedside, improving outcomes for patients.”

The new funding from the National and International Research Alliances program will significantly enhance the two vaccine centers’ collaborative research programs and allow them to leverage funding from various agencies and foundations for large-scale vaccine research and development. The alliance also will provide ACVD scientists an opportunity to access new biotech industry links in the United States and give both institutions enhanced links with the international pharmaceutical industry.

The new Emory Institute for Drug Discovery will have the dual mission of carrying out early-stage discovery and pre-clinical drug research aimed at developing small-molecule therapeutics, and training new generations of researchers in a multidisciplinary drug discovery environment. Directed and staffed by recognized leaders in the field of drug discovery, the EIDD will build on Emory’s strong history of drug discovery research, including the invention of several of the world’s most successful and widely prescribed drugs for treating HIV/AIDS.

“We believe the EIDD is strategically positioned to make Emory one of the premier research and training institutions in the country for drug discovery, development and training,” said Dennis Liotta, PhD, Emory professor of chemistry and director of the EIDD. “Our EIDD model will preserve the academic independence of university-based laboratory research, while at the same time allowing us opportunities to closely partner with the pharmaceutical industry.”

As a co-inventor of drugs taken by more than 94 percent of patients in the U.S. with HIV/AIDS and by thousands around the globe, Liotta is a recognized leader and educator in university drug discovery. He also is a successful entrepreneur who has developed several biotechnology companies, and he has trained and mentored numerous young researchers in the science of drug discovery.

The EIDD will collaborate closely with and benefit from other drug discovery efforts already ongoing at Emory, including the Emory Chemical Biology Discovery Center, which is part of the National Institutes of Health Molecular Libraries Screening Center Network (MLSCN). Along with other scientists at Emory already focused on drug discovery, approximately 12 new research faculty will focus their efforts in the center. Eventually, approximately 30 faculty and staff will be part of the EIDD.
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Sleep Your Way to Better Health

May is Better Sleep Month

Tossing and turning throughout the night? Do you daydream about a good night’s sleep? While not getting the recommended seven to nine hours of sleep a night may seem like a minor problem, it can be more serious than most people think. While Don Davis was undergoing treatment at Piedmont Fayette Hospital (PFH) for another health problem, he found out just how serious a sleep problem can be.

In 2007, Davis’s PFH doctors began to notice a problem in his sleeping. He periodically stopped breathing during the night. This problem had been affecting him for about three years, but he did not think it was serious enough for him to seek treatment.

At the encouragement of his doctor, Davis decided to visit the Sleep Center at PFH to determine what was causing his sleep problems. He went to the Sleep Center for an initial consultation where they explained to him the entire process of his sleep study. Davis returned for his visit a few weeks later and thought that he slept soundly through the night of his study. Instead, he found out that he suffered from sleep apnea.

“I always knew that I was tired during the day, but I never knew that it was related to sleep apnea,” said Davis. “I was relieved to find out what the problem was and anxious to get it rectified.”

Davis returned to the sleep center to undergo a sleep evaluation for his treatment. He now uses a Continuous Positive Airway Pressure (CPAP) machine to help him sleep throughout the night. Davis returns to the sleep center for checkups and has noticed a great difference in his sleep since beginning his treatment.

“I would definitely recommend a trip to Piedmont Fayette’s Sleep Center for anyone who is tired in the middle of the day or has shortness of breath. It is well worth it, I have more energy and feel better,” said Davis.

Connie White-Daniel, RPSGT, clinical manager of the Piedmont Fayette Hospital Sleep Center, encourages individuals with sleep issues to learn about the diagnosis and treatment options available.

“The proper quality, as well as proper amount of sleep time can have an incredible effect on your health and your daily routine,” said White-Daniel. “We work with our patients to help them develop a healthy sleep pattern so they are able to have energy for the important activities in their lives.”

May is Better Sleep Month and Piedmont Fayette Hospital is encouraging you to make the effort to improve your sleeping habits. Approximately 70 million people in the United States are affected by a sleep disorder. Forty million Americans suffer from a chronic sleep disorder, and an additional 20-30 million are affected by intermittent sleep-related problems.

There are more than 80 different forms of sleep disorders affecting people of all ages. National Sleep Foundation (NSF) found that sleep deprivation and sleep disorders are estimated to cost Americans more than $100 billion annually in lost productivity, medical expenses, sick leave, and property and environmental damage. Common symptoms of sleep disorders to be aware of are daytime fatigue, inability to sleep for long periods of time, and breathing difficulties during sleep.

“Some things people do not realize about sleep are the effects it has on long and short-term memory as well as regulating hormones,” said White-Daniel. “This includes growth hormone which is important for children to grow but also affects the aging process in adults.”

Some of the more common sleep disorders are insomnia, sleep apnea and snoring. Insomnia is an experience of inadequate or poor quality sleep as characterized by one or more of the following sleep complaints: difficulty initiating and maintaining sleep and waking too early in the morning. Obstructive sleep apnea is a disorder in which breathing is briefly and repeatedly interrupted during sleep and can cause fragmented sleep and low blood oxygen levels. Snoring is defined as “breathing during sleep with hoarse or harsh sounds as caused by the vibrating of the soft palate.” Snoring can be an indication of sleep apnea, a risk factor for vascular complications such as hypertension and congestive heart failure. Snoring may cause fragmented sleep which may lead to daytime dysfunction.

Piedmont Fayette Hospital’s Sleep Center is a six-bed facility which provides diagnosis and treatment of all sleep-related disorders for adults and for children over the age of three. The Sleep Center works with primary care physicians and specialists to provide comprehensive care for adults and children who have trouble falling asleep and staying asleep during the night, excessive daytime sleepiness, insomnia, snoring, sleep apnea and other sleep-related conditions.
The Sleep Center has a group of seven multi-disciplinary physicians, all of whom are either board-certified or board-eligible sleep specialists. They are also board-certified in their respective primary fields of otolaryngology, neurology, or pulmonology. People who experience sleep-related problems should discuss their symptoms with the primary care physician or other medical specialist. For more information, call the Piedmont Fayette Hospital Sleep Center at 770-719-6031 or visit www.fayettehospital.org.
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Mutant Genes in High-Risk Childhood Leukemias Identified

/PRNewswire / -- A research team has pinpointed a new class of gene mutations, which identify cases of childhood acute lymphoblastic leukemia (ALL) that have a high risk of relapse and death. The finding suggests specific drugs that could treat this high-risk leukemia subtype in children, particularly because such drugs are already in clinical trials for similar blood diseases in adults.

While the cure rate in pediatric ALL has reached about 85 percent, the remaining high-risk cases have proven especially intractable because they arise from different, unidentified genetic mutations.

Discovery of the mutations was led by scientists from St. Jude Children's Research Hospital, the Children's Oncology Group (COG), the University of New Mexico Cancer Research and Treatment Center, Albuquerque, N.M., and the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). This research was done as part of the NCI Therapeutically Applicable Research to Generate Effective Treatments (TARGET) initiative, which seeks to utilize the study of genomics to identify therapeutic targets in order to develop more effective treatments for childhood cancers. The article appears online May 18 in the early edition of the Proceedings of the National Academy of Sciences.

"We have made such great progress in curing children with ALL that the main challenge is now the remaining high-risk patients," said St. Jude Scientific Director, James Downing, M.D., a co-senior author of the study. "We still do not know how to accurately identify these patients and effectively treat them to provide the highest chance for a cure. The problem is that this high-risk group is likely a heterogeneous mixture of biologic subtypes."

The new study builds on the researchers' previous genetic analysis of the leukemic cells from pediatric ALL patients.

"The findings from our previous studies have hinted that some high-risk ALL cases might arise from mutations in genes that produce enzymes called kinases, which function as biological on-off switches in cells," said Charles Mullighan, M.D., Ph.D., assistant member in the St. Jude Department of Pathology and a co-first author of the study. "Such mutations would cause those kinases to be stuck in the on position, triggering the uncontrolled proliferation of white blood cells that is seen in leukemia."

Thus, the researchers began to analyze the genetic sequences of many kinases known to be components of the proliferation machinery of white blood cells. The team analyzed the leukemic cells from 187 patients with high-risk ALL. That analysis revealed mutations in about 10 percent of the cases in a family of protein kinases called JAK, whose members were also known to be mutated in other types of leukemias and related diseases.

"Further studies of these mutant JAK proteins revealed that the changes in their molecular structures could switch them on to drive the blood cell proliferation that is characteristic of ALL," said Stephen Hunger, M.D., chairman of the COG ALL committee and a co-senior author of the study. "What's more, in test tube studies, we found that drugs blocking the activation of the mutant JAK kinases prevented uncontrolled growth suggesting that drugs that target JAK proteins might be effective in this subtype of ALL."

The researchers discovered, in some high-risk ALL patients, that mutations in JAK appeared to work in concert with another mutation -- in the gene IKZF1 -- which they had earlier found to underlie such cases.

"Our studies of these leukemia subtypes indicate that leukemia is not necessarily a single-cause disease," said Cheryl Willman, M.D., director and CEO of the University of New Mexico Cancer Research and Treatment Center and a co-senior author of the study. "A patient may have multiple different genetic lesions that target different cellular pathways to induce leukemia. Thus, it is very important to develop new therapies that target these specific mutations, and our discovery of JAK as target now allows us to begin to develop clinical trials with JAK inhibitors for children and adults with this form of disease."

In further studies, the researchers plan to identify mutations in kinase genes and other enzymes that underlie high-risk ALL, as well as explore how these abnormalities might work together to drive the cancers.

The discovery that mutations in JAK underlie some cases of high-risk ALL is enough to warrant clinical trials of inhibitory drugs to treat such cancers.

"JAK-inhibiting drugs are now moving into clinical trials for treatment of such adult myeloproliferative diseases as polycthemia vera, essential thrombocytosis and primary myelofibrosis," Downing said. "We expect that there will soon be initial clinical studies to assess the safety and effectiveness of these drugs in children with relapsed ALL in which JAK mutations have been identified within their leukemic cells."

Such studies would be coordinated by the COG, an international clinical trial cooperative group supported by the NCI.

Other authors of the paper are Racquel Collins-Underwood, Letha A. Phillips, Xiaoping Su, Wei Liu and Brenda Schulman (St. Jude); Sarah Tasian and Mignon Loh (University of California San Francisco); Meenakshi Devidas (Children's Oncology Group); Susan Atlas, I-Ming Chen and Richard C. Harvey (University of New Mexico Cancer Research and Treatment Center, Albuquerque); Robert J. Clifford, Daniela Gerhard, Malcolm Smith and Jinghui Zhang (National Cancer Institute); William Carroll (New York University Cancer Institute); and Gregory H. Reaman (The George Washington University).

This research was supported in part by a supplement to the Children's Oncology Group Chair's award; a National Cancer Institute Strategic Partnering to Evaluate Cancer Signatures Program award; the National Institutes of Health/National Institute of General Medical Sciences Pharmacogenetics Research Network and Database; National Institutes of Health Cancer Center Core Grants; the Children's Oncology Group and Statistical Center; the Leukemia and Lymphoma Society Specialized Center of Research grant supporting University of New Mexico Cancer Center; CureSearch; St. Baldrick's Foundation; a National Health and Medical Research Council (Australia) CJ Martin Traveling Fellowship; and ALSAC.

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Turmeric Extract Suppresses Fat Tissue Growth in Rodent Models

Curcumin, the major polyphenol found in turmeric, appears to reduce weight gain in mice and suppress the growth of fat tissue in mice and cell models. Researchers at the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University (USDA HNRCA) studied mice fed high fat diets supplemented with curcumin and cell cultures incubated with curcumin.

“Weight gain is the result of the growth and expansion of fat tissue, which cannot happen unless new blood vessels form, a process known as angiogenesis.” said senior author Mohsen Meydani, DVM, PhD, director of the Vascular Biology Laboratory at the USDA HNRCA. “Based on our data, curcumin appears to suppress angiogenic activity in the fat tissue of mice fed high fat diets.”

Meydani continued, “It is important to note, we don’t know whether these results can be replicated in humans because, to our knowledge, no studies have been done.”

Turmeric is known for providing flavor to curry. One of its components is curcumin, a type of phytochemical known as a polyphenol. Research findings suggest that phytochemicals, which are the chemicals found in plants, appear to help prevent disease. As the bioactive component of turmeric, curcumin is readily absorbed for use by the body.

Meydani and colleagues studied mice fed high fat diets for 12 weeks. The high fat diet of one group was supplemented with 500 mg of curcumin/ kg diet; the other group consumed no curcumin. Both groups ate the same amount of food, indicating curcumin did not affect appetite, but mice fed the curcumin supplemented diet did not gain as much weight as mice that were not fed curcumin.

“Curcumin appeared to be responsible for total lower body fat in the group that received supplementation,” said Meydani, who is also a professor at the Friedman School of Nutrition Science and Policy at Tufts. “In those mice, we observed a suppression of microvessel density in fat tissue, a sign of less blood vessel growth and thus less expansion of fat. We also found lower blood cholesterol levels and fat in the liver of those mice. In general, angiogenesis and an accumulation of lipids in fat cells contribute to fat tissue growth.”

Writing in the May 2009 issue of The Journal of Nutrition, the authors note similar results in cell cultures. Additionally, curcumin appeared to interfere with expression of two genes, which contributed to angiogenesis progression in both cell and rodent models.

“Again, based on this data, we have no way of telling whether curcumin could prevent fat tissue growth in humans.” Meydani said. “The mechanism or mechanisms by which curcumin appears to affect fat tissue must be investigated in a randomized, clinical trial involving humans.”

This study was funded by a grant from the United States Department of Agriculture. Asma Ejaz, a graduate student who worked on this project received a scholarship grant from the Higher Education Commission of Pakistan.

Ejaz A, Wu, D, Kwan P, and Meydani M. Journal of Nutrition. May 2009; 139 (5): 1042-1048. “Curcumin Inhibits Adipogenesis in 3T3-L1 Adipocytes and Angiogenesis and Obesity in C57/BL Mice. 919-925.”
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Cimzia(R) (certolizumab pegol) Now Available for Self-Administration in Adult Patients With Moderate to Severe Crohn's Disease

UCB today announced that Cimzia(R) (certolizumab pegol), the only PEGylated anti-TNF (Tumor Necrosis Factor) approved in the U.S. for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderate to severe active disease who have had an inadequate response to conventional therapy, is now available for self-administration in a prefilled syringe designed in partnership with OXO GOOD GRIPS(R) a company dedicated to providing innovative consumer products that make everyday life easier.

"We looked at a variety of unmet needs for Crohn's disease patients and found that many prefer a prefilled syringe when taking biologic medications," said David Robinson, vice president and general manager of UCB's Immunology Business Unit. "This newly designed, easy-to-use syringe, developed with a renowned consumer products company like OXO(R), will enable many patients to conveniently self-administer their therapy every four weeks."

The Cimzia(R) prefilled syringe, designed by UCB in partnership with OXO GOOD GRIPS(R) is available exclusively for use with Cimzia(R). The companies recognized the importance of designing a syringe and packaging components with the patient in mind to provide ease of use, comfort, control and confidence.

The new syringe provides a soft, non-slip grip on the flange which allows the patients to hold the syringe steady using various grip positions so it is easy and comfortable to use. The large and soft thumb pad on the plunger makes it easy to push for patients. The rounded finger loop allows for easy removal of the needle cover. The easy-to-read syringe barrel helps to ensure patients receive the entire dose as they can see the medicine inside and know when they have injected all of the medication. Additionally, the packaging utilizes Velcro(R) for easy opening and resealing.

In addition, the new Cimzia(R) prefilled syringe carries the Arthritis Foundation(R) Ease-of-Use Commendation. The Arthritis Foundation(R) created the program to encourage manufacturers to design user-friendly products and packaging. Manufacturers submit their products for testing by an independent lab experienced in the design and evaluation of products that are accessible to people with functional limitations due to the effects of arthritis.

Cimzia(R) was approved by the U.S. Food and Drug Administration on April 22, 2008 for reducing the signs and symptoms of moderate to severe Crohn's disease and maintaining clinical response in adult patients who have had an inadequate response to conventional therapy. The new prefilled syringe is now available to Crohn's patients taking Cimzia(R) for subcutaneous self-administration once every four weeks after initial doses once a physician has provided instruction for proper use.

The Crohn's approval was based on safety and efficacy data from clinical trials in more than 1,500 patients with Crohn's disease. Cimzia(R) was also recently approved in the U.S. for the treatment of adults with moderately to severely active rheumatoid arthritis.

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UCB's CIMZIA(R) (certolizumab pegol) Approved by the U.S. FDA for Adult Patients Suffering From Moderate to Severe Rheumatoid Arthritis

/PRNewswire/ UCB announced today that the U.S. Food and Drug Administration (FDA) approved Cimzia(R), the only PEGylated anti-TNF (Tumor Necrosis Factor), for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). Cimzia(R) can be dosed at 400 mg initially and at weeks two and four, followed by 200 mg every other week; for maintenance dosing, 400 mg every four weeks can be considered.

In clinical trials with Cimzia(R), together with methotrexate (MTX), patients experienced a significant reduction in the signs and symptoms of RA at week 24 with some showing clinical responses within one to two weeks, compared with MTX alone. Additionally, radiographic data showed Cimzia(R), together with MTX, inhibited progression of joint damage, with a significantly smaller change from baseline in modified Total Sharp Score (TSS) at 24 and 52 weeks of treatment, compared with MTX alone (p<0.001).

"The approval of Cimzia(R) for moderate to severe rheumatoid arthritis in the U.S. is a major milestone for UCB, and most importantly, for people seeking a new treatment option to manage this debilitating condition," said Roch Doliveux, Chief Executive Officer of UCB. "UCB is committed to developing new therapies, such as Cimzia(R), to help meet the needs of patients living with rheumatoid arthritis and other immune diseases. I am also proud of our partnership with OXO(R) and of the fact that RA patients were directly involved in the design and development of our new prefilled syringe, which is designed to make self-administration easy for people living with rheumatoid arthritis."

The new prefilled Cimzia(R) syringe is now also available for subcutaneous self-administration to U.S. patients with moderate to severe Crohn's disease who have had an inadequate response to conventional therapy.

The FDA approval is based on UCB's comprehensive clinical program, including data from four multi-center placebo-controlled phase III trials, involving more than 2 300 patients with RA and over 4 000 patient-years experience. Cimzia(R) has been studied at dosing intervals of two or four weeks, and administered together with MTX or as monotherapy.

In the pivotal clinical trials, reported serious adverse reactions were infections including tuberculosis and malignancies including lymphoma. The most commonly occurring adverse events were upper respiratory tract infections, rash and urinary tract infections. A pooled analysis of the safety data show there was a low incidence of injection site pain (<2%) and a low level of discontinuations due to adverse events (5%).

"People with RA have pain and swelling of joints with stiffness and fatigue which makes it difficult for them to perform many activities of daily living, sometimes making it a struggle to even get out of bed," said Roy Fleischmann, MD, Clinical Professor in the Department of Internal Medicine at the University of Texas Southwestern Medical Center in Dallas. "With the approval of Cimzia(R), I now have another alternative to offer my patients in an easy-to-use treatment that improves quality of life and inhibits structural damage."

It is estimated that 5 million people suffer from RA globally. In the United States alone, an estimated 1.3 million people have the disease. Prevalence is not split evenly between genders, since women are three times more likely to be affected than men. Although RA can affect people of all ages, the onset of the disease usually occurs between 35-55 years of age.

Forward-looking statements

This press release contains forward-looking statements based on current plans, estimates and beliefs of management. Such statements are subject to risks and uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, effects of future judicial decisions, changes in regulation, exchange rate fluctuations and hiring and retention of its employees.

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Bloomberg - Video: In-Depth Look - Health Care Reform

An interview with Republican Senator John Cornyn of Texas saying that we need a deal with health-care costs. (Bloomberg News)



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A Skin Cancer Diagnosis for a Bride: Her advice during Skin Cancer Awareness Month

Piedmont Hospital Hosts Free Skin Cancer Screening

Every girl dreams of her perfect wedding day, including 27-year-old Brookhaven resident Jessica Cavey. She diligently checks items off of her wedding “to-do” list – photographer, caterer, flowers; but there is one item not on most brides’ lists – skin cancer treatment.

With her upcoming June wedding, Cavey was shocked at her diagnosis of basal skin cancer by Piedmont Hospital dermatologist, Jodi Ganz, M.D., in January of this year. Self-proclaimed a sun worshipper and tanning bed goddess, Cavey couldn’t imagine not being tan or in her words “having December skin.”

“I used to be the girl who went to tanning beds after lying out in the sun for hours,” said Cavey. “In high school, I would stay home from school the Friday before prom to lie out in the sun and then go to the tanning bed because I thought I looked thinner and healthier when I was tan.” Cavey now doesn’t leave her house without applying a minimum of SPF 30 sunscreen.

More than 90 percent of skin cancers are caused by sun exposure and more than 800,000 basal skin cancer diagnoses, such as Cavey’s, are made each year. With summer just around the corner, everyone needs to take precautions to protect their skin. Piedmont Hospital is hosting a free skin cancer screening Saturday, May 16, from 8 a.m. to noon on the 5th floor of the 77 Building at Piedmont Hospital 1968 Peachtree Road, Atlanta, GA 30309. Call 866-900-4321 for more information. Dermatologists and physician assistants will be screening “exposed skin” only, so wear appropriate attire, such as shorts and sleeveless shirts. Come by and pick-up free sun screen samples and register to win goodies and a complimentary beauty service package. Parking is available in the North Parking Deck behind the hospital.

“With careful inspection of the skin, most skin cancer can be found early and treated successfully,” said Dr. Ganz. “Early detection is key in the treatment process; however by taking simple sun safety precautions, many skin cancers can be prevented.”

Skin cancers are divided into two major groups. Cancers that start from the pigment-making cells of the skin (the melanocytes) are called melanomas. The second main type is called keratinocyte carcinomas or keratinocyte cancers because their cells look a lot like keratinocytes (the cells found most often in normal skin). Carcinoma is a medical word for a cancer that starts in a lining layer of cells such as the skin or the lining cells of the digestive system. There are many types of keratinocyte cancer, but the two most common types are basal cell carcinoma and squamous cell carcinoma.

Cavey’s basal skin cancer was caught early and Dr. Ganz was able to treat her with a topical lotion used for approximately six weeks. With only minor itching, scabbing and soreness, the affected area healed quickly and now Cavey says “it’s hard to find the spot.”

“I want to tell my story in hopes of preventing a skin cancer diagnosis for other young women. From my experience, you think you look healthier and thinner when you lie out without sunscreen or go to the tanning bed, but it’s really only making you more unhealthy,” said Cavey. “It is not worth it in the long run.”
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AS Medications Solution LLC. Announces a Nationwide Recall of All Lots of Digoxin Tablets 0.25mg Due to Size Variability

A S Medication Solutions, LLC, a drug repackage company, announced today that all tablets of Caraco brand Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of August, 2011, are being voluntarily recalled to the consumer level. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin. Caraco Pharmaceutical Laboratories, Ltd manufactured the recalled tablets. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Digoxin is a drug product used to treat heart failure and abnormal heart rhythms. It has a narrow therapeutic index and the existence of higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure. Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and slow heart rate. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of heart failure and abnormal heart rhythms.. Consequently, as a precautionary measure, A S Medication Solutions, LLC is recalling these tablets to the consumer level to minimize any potential risk to patients.

Consumers with the products with the following NDC codes that are within expiration should return these products to the place of purchase.

Product Identification

Caraco Digoxin
A-S Medication Solutions, Digoxin 0.25 mg is a scored round biconvex white tablet imprinted with “441”

NDC Numbers:
Digoxin Tablets, USP, 0.25 mg
54569-5758-0 (30-count)

Patients using A-S Medication Solutions, Digoxin tablets, USP, 0.25 mg, who have medical questions should contact their healthcare provider for additional instructions or guidance.

Healthcare providers who have this product should return the product to their place of purchase. Healthcare providers can call A-S Medication Solutions Recall Coordinator at (847) 680-3515, Monday through Friday, 8:00 a.m. – 4:00 p.m. CST, for instructions on how to return the affected product or for any other inquiries related to this action.

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

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New HIV/AIDS Vaccine Clinical Trials Begin at Emory Vaccine Center’s Hope Clinic

NIH-Supported HVTN Network Enrolls Healthy, Uninfected Adults in Phase 1 and 2 Studies

The Hope Clinic of the Emory Vaccine Center is enrolling volunteer participants in two new clinical trials of two different HIV/AIDS vaccines in healthy, uninfected individuals who are at low risk for acquiring HIV infection. Both studies are sponsored by the HIV Vaccine Trials Network (HVTN), which is funded and supported by the National Institutes of Health. HVTN is the largest worldwide clinical trials network dedicated to the development and testing of HIV/AIDS vaccines.

A phase 2a study, HVTN 205, will test the safety and immune-stimulating effectiveness of a vaccine developed by GeoVax, Inc., an Atlanta biotech company spun out of research at the Emory Vaccine Center and Yerkes National Primate Research Center. The vaccine consists of two components--a recombinant DNA vaccine and a recombinant modified vaccinia Ankara (MVA) vector-based vaccine. The DNA and MVA vaccines are used in a prime-boost protocol, with priming by the DNA vaccine and boosting by the MVA vaccine.

The protocol is designed to stimulate both anti-HIV T cell and anti-HIV antibody immune responses. The MVA virus is a vector used to deliver pieces of genetic material from HIV. Both vaccine components express the three major proteins of the AIDS virus: Gag, Pol, and Env, and produce non-infectious virus-like particles. These particles contain proteins that mimic more than half of the components of the AIDS virus, but cannot cause AIDS.

Harriet Robinson, PhD, formerly of the Emory Vaccine Center and Emory’s Yerkes National Primate Research Center, developed the core vaccine technologies with colleagues at the National Institutes of Health, the Centers for Disease Control and Prevention and GeoVax. Robinson currently is senior vice president of research and development at GeoVax.

HVTN 205 will enroll a total of 225 volunteers (150 vaccine recipients and 75 placebo recipients; ages 18 to 50 years) at 13 HVTN sites, including 11 in the United States and two in Peru. Sites include Emory; Harvard Medical School; Vanderbilt University; University of Rochester; Fred Hutchinson Cancer Research Center, Seattle; San Francisco Department of Public Health; University of Alabama, Birmingham; and sites at Columbia University, Union Square, and the Bronx in New York City; and Iquitos and Miraflores (Lima) in Peru.

A phase 1b study, HVTN 077, will test the safety and immune response to different combinations of an experimental HIV vaccine developed by the Vaccine Research Center of the National Institutes of Health. The vaccine consists of two components—a recombinant DNA vaccine and two recombinant adenovirus vector- vaccines. The DNA vaccine contains pieces of man-made DNA that are similar to the DNA found in HIV. The study vaccine does not contain any live HIV particle but only non-infectious virus-like particles that cannot cause AIDS. The other 2 “adenoviral vectors” are made out of 2 kinds of adenovirus. Adenoviruses are best known to cause colds and respiratory infections. The adenovirus vectors used in this study have been changed so they can not cause infections.

HVTN 077 will enroll a total of 192 volunteers (164 vaccine recipients and 28 placebo recipients) at 7 HVTN sites in the US, including: Atlanta, Birmingham, Harvard, Nashville, New York, Rochester, San Francisco Department of Public Health. Only healthy, HIV uninfected, low risk individuals between the age of 18 and 50 and who meet the inclusion criteria will be recruited to participate in the study.

“We are pleased to take part in these important clinical study of an HIV/AIDS vaccine,” says Mark Mulligan, MD, director of the Hope Clinic of the Emory Vaccine Center. “The search for an effective vaccine remains a critical goal in the fight against this challenging disease.”

Emory University has an equity interest in GeoVax and is entitled to sales royalties for the vaccine technologies being studied. Emory may financially benefit from these interests, if GeoVax is successful in marketing its vaccine.

For more information about these two clinical trials, visit http://www.hopeclinic.emory.edu or call 404-712-1371 or 877-424-HOPE.
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