Sunday, August 31, 2008

Problems with Boniva, Actonel & Fosamax

Many are taking Fosamax, Boniva and other similar drugs designed to stave off osteoporosis. Here's two articles we encourage you to read:

Fosamax, Boniva & Actonel Linked To Jaw Bone Disorders

http://injury-law.freeadvice.com/drug-toxic_chemicals/fosamax-linked-to-jaw-bone-disorders.htm

Merck Braces for Flood of Fosamax Lawsuits
Osteoporosis Medication Can Destroy Patients' Jawbones

http://www.consumeraffairs.com/news04/2007/02/fosamax.html

Saturday, August 30, 2008

CDC Releases New Data on Epilepsy from Multiple States

A multi-state study by the Centers for Disease Control and Prevention has found that about one out of 100 adults have active epilepsy, and more than one-third are not getting sufficient treatment. The study, which examined the prevalence of epilepsy or seizure disorder in 19 states, was published in today’s Morbidity and Mortality Weekly Report.

Epilepsy affects an estimated 2.7 million people in the United States and costs about $15.5 billion in medical costs and lost or reduced earnings and productivity each year.

“Despite having recent seizures, more than one out of three adults reported not seeing a neurologist or epilepsy specialist in the past year,” said Dr. David Thurman, one of the study’s authors and a neurologist in CDC’s Division of Adult and Community Health. “These findings suggest that adults with uncontrolled seizures may not be receiving the optimal medical treatment they need and may face substantial impairments in their daily activities.”

The study found that nearly half (44 percent) of adults with active epilepsy reported having recent seizures. Of those, 65 percent said they had more than one seizure in the past three months. Inadequate medical treatment for epilepsy greatly increases a person’s risk for subsequent seizures, disability, injuries sustained during a seizure, and, in rare cases, death. However, many people with epilepsy lead normal productive lives.

The study, which is based on state-specific data from the 2005 Behavioral Risk Factor Surveillance System, collected data from more than 120,000 adults 18 and older.

Epilepsy is a chronic neurological condition that occurs when recurrent abnormal electrical activity in the brain causes involuntary changes involving body movement or function, sensation, awareness, or behavior.

Adults with epilepsy experience significantly worse health-related quality of life than those without epilepsy. The report found that adults with epilepsy were more likely to be unemployed, face limitations in their normal activities such as socializing with friends, and experience other health risks such as cigarette smoking and physical inactivity.

"While epilepsy is one of the most common neurological conditions, most people know very little about this disorder, or how to support those with epilepsy,” said Janet Collins, Ph.D., director, CDC’s National Center for Chronic Disease Prevention and Health Promotion. “We hope this report, which provides the largest and most comprehensive data on epilepsy in the United States, can help states and public health agencies better understand the prevalence of epilepsy, as well as epilepsy-associated conditions and limitations.”

For more information about CDC’s work on epilepsy, visit http://www.cdc.gov/epilepsy/.
CDC also works in partnership with the Epilepsy Foundation
(http://www.epilepsyfoundation.org/) to support educational programs for schools, police and emergency responders, employers, and the general public that raise awareness about epilepsy and reduce stigma associated with the condition.
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Iraqi Forces Struggle to Find Physicians for Medical System

Though Iraq's military medical system has gained significant capability over the past five years, recruiting qualified physicians remains a challenge, the coalition's top advisor to the Iraqi surgeon general said.

Only 160 out of 800 available positions for physicians in the Iraqi military medical system have been filled, U.S. Army Col. (Dr.) John Powell, director of health affairs for Multinational Security Transition Command Iraq, told bloggers and online journalists in a teleconference Aug. 26.

"The biggest piece right now," Powell said, "is personnel ... who have medical capabilities, who can do what's necessary to diagnose people and take care of them."

Powell said the Iraqi government hopes to entice physicians, who fled Iraq to neighboring countries, to return now that Iraq is more secure. The Iraqi Defense Ministry has a pending law offering special incentives to physicians who serve the military medical system, he said.

"They're working hard to get the people to come back who are trained and outside," Powell said. "And, mostly, those are senior folks that can come in and teach and help get things back on what we would call a direct road for taking care of folks."

However, he said, limits to the salaries Iraq's government can offer returning physicians may become an issue. "Right now, it's a matter of 'Can you pay what I can make someplace else?' and, probably, the answer is 'No,'" He acknowledged. "But that said, there's a lot of these people who want to come home."

Iraq also is growing its own new generation of physicians, Powell said, through its "very capable" medical school in Baghdad, though courses are taught in English, which makes it difficult for native-Arabic speakers.

"I find it kind of interesting how difficult they have [it], as far as getting through school goes, and learning everything and trying to put it back and forth into Arabic," Powell said. "But, they are growing their own physicians, and they're good physicians."

Despite the persistent challenge finding doctors, Powell said, the Iraqi military medical system has grown significantly in other areas since he was last in Iraq five years ago.

Iraqi army Brig. Gen. Samir A. Hassan, the surgeon general of Iraq's armed forces, had almost no capabilities and only a couple staff members five years ago, Powell recalled. Today, he said, Hassan has 70 staff members with expertise in multiple areas including logistics, training, and long-term teaching and capabilities.

In the field, he continued, Iraq's military medical system now employs around 100 nurses and about 2,000 employees in support positions, such as administrators, phlebotomists and ambulance drivers.

Along with the 160 physicians, Powell explained, these individuals run clinics located throughout Iraq, where active-duty Iraqi military and police are treated.

Powell assured that Hassan has a clear direction for Iraq's military medical system. However, he said, more physicians are needed before some of the surgeon general's loftier goals – such as extending care to military family members and widespread immunizations – can be realized.

Author Kristen Noel works for the New Media directorate of the Defense Media Activity.
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Wednesday, August 27, 2008

Piedmont Hospital Joins Spirit of Women

Piedmont Hospital announced today that it has joined Spirit of Women, a partnership of hospitals and healthcare systems across the country that provide educational health opportunities in an environment that is fun for women.

"Spirit of Women enables Piedmont Hospital to continue its focus on improving the health of its community while adding the strength and support of a national health and wellness network," says Tanya Abreu, president of Spirit of Women. "Piedmont can now choose from established, measurable programs that are based on a comprehensive set of performance guidelines that target the leading cause of illness and death in women.”

Spirit of Women guidelines are updated annually and guided by national standards, including Healthy People 2010. Because women make up to 85 percent of household healthcare decisions, the educational and motivational efforts of Spirit of Women positively impact the well-being of the entire family and community as a whole.

Piedmont Hospital will provide a wide variety of Spirit of Women inspired events that not only include the education, screenings and support groups that will reach women in all stages of their lives but also fun activities like mini-spa treatments for stress relief, dance lessons to get the heart pumping and Ask-the-Doctor social hours.

Women in the Atlanta community can become a lifetime Spirit of Women Rewards Member for free through September 19 by visiting www.piedmonthospital.org/spiritofwomen. After September 19, the cost will be $10 for a lifetime membership. Rewards members will enjoy discounts and benefits from program partners including: Natural Body Spa and Shoppe, Chick-fil-A, Bette Care (professional home care), the Welch Experience (personal training, self-defense, etc.), the TaylorMade Performance Lab at Reynolds Plantation, the Atlanta Ballet, the Fox Theatre, the Atlanta Opera, the WNBA Atlanta Dream and Atlanta Braves.
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FDA Clears Test to Help Doctors Manage Heart Transplant Patients

The U.S. Food and Drug Administration today announced it has cleared for marketing a non-invasive test that uses molecular expression techniques to assist doctors in managing heart transplant patients post-surgery for potential organ rejection.

"AlloMap can help contribute to an appropriate treatment plan by identifying those patients not experiencing post-operative heart transplant rejection," said Daniel G. Schultz, M.D., director of the FDA's Center for Devices and Radiological Health. "It is an example of how advancements in science and technology are leading to new medical care diagnostics."

AlloMap measures genetic information contained in the white blood cells (cells of the immune system that defend the body against invading viruses, bacteria or other foreign material) from a patient's blood sample.

Specifically the test measures gene expression—or how DNA transcribes its genetic instructions to RNA, the nucleic acid that translates and carries out those instructions—of 20 different genes, resulting in a score that indicates whether a heart transplant patient is unlikely to be rejecting the new organ.

Nearly every cell of the body contains a full set of chromosomes and identical genes but only a fraction of these genes are turned on or expressed in any given cell. Gene expression occurs when certain molecular information contained within DNA is transcribed to create molecules known as RNA. These molecules in turn make the proteins that perform most of the critical functions of cells.

Following a heart transplant, physicians regularly monitor patients for transplant rejection, a significant risk to patient survival. Rejection occurs when the patient's immune system fails to accept the new organ and begins to attack it. Successful heart transplants depend on a balanced immune system response—a response that is suppressed enough to accept the new organ but strong enough to protect the patient from infections.

Clinicians often rely on heart biopsy to gauge whether a patient is rejecting the transplanted heart. However, biopsies are difficult to perform and can be risky for the patient.

According to the National Heart, Lung and Blood Institute, half of all possible rejections happen during the first six weeks after surgery and 25 percent of patients have signs of possible rejection at least once during the first year following a transplant.

XDx Inc. developed AlloMap using blood and biopsy samples and other information collected from heart transplant recipients at nine U.S. heart transplants centers participating in the Cardiac Allograft Rejection Gene expression Observational study (CARGO). CARGO provided data from 153 patients on 300 medical visits at various times after heart transplant study.

According to the American Heart Association, there were more than 2,000 heart transplants performed in the United States during 2006.

AlloMap is the third in vitro diagnostic multivariate index assay (IVDMIA) cleared by the FDA. IVDMIAs are medical devices that combine the values of multiple variables to yield a single, patient-specific result.

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Saturday, August 23, 2008

Measle Scare

Jump in US measles cases linked to vaccine fears


By MIKE STOBBE, AP Medical Writer Thu Aug 21, 6:34 PM ET
ATLANTA - Measles cases in the U.S. are at the highest level in more than a decade, with nearly half of those involving children whose parents rejected vaccination, health officials reported Thursday.

http://news.yahoo.com/s/ap/20080821/ap_on_he_me/med_measles_outbreaks

Friday, August 22, 2008

FDA Approves First Bone Marrow Stimulator to Treat Immune-Related Low Platelet Counts

HHH Note: Congrats to Amgen on this achievement. ITP patients have been waiting a long time. If memory serves correctly, this is the first advancement since the PROSORBA protein A column was introduced some 20 years ago.


The U.S. Food and Drug Administration today approved Nplate (romiplostim), the first product that directly stimulates the bone marrow to produce needed platelets in patients with a rare blood disorder that can lead to serious bleeding.

The condition, which usually develops in adults, is known as chronic immune thrombocytopenic purpura (ITP), a disease that results in a low number of platelets, the blood components that help with clotting. In patients with chronic ITP, the immune system is believed to destroy platelets and the patient's bone marrow is often unable to compensate for this loss.

"This product is important in that it offers a new approach to the treatment of patients with an uncommon blood disorder who are often very ill," said Janet Woodcock, M.D., director, Center for Drug Evaluation and Research, FDA.

The estimated 140,000 people with chronic ITP are prone to bruising and at risk for life-threatening bleeding. Current medical treatment includes corticosteroids and immunoglobulin. Surgery to remove the spleen, a procedure known as a splenectomy, may help some patients. Nplate is approved only for patients with chronic ITP who do not respond sufficiently to current treatments.

FDA based its approval on two randomized clinical trials of about 125 patients who had received at least one prior ITP treatment. One study enrolled patients who still had their spleen, the other enrolled patients who did not.

During six months of treatment, patients who received Nplate had significantly higher platelet counts and maintained those higher counts compared to those who did not receive the drug. The response to Nplate was higher in those patients who still had their spleen than in those patients who had undergone a splenectomy. In those patients who did not receive Nplate, only one experienced a sustained increase in platelet counts.

Safety concerns with Nplate include fibrous deposits in the bone marrow and the possibility that once Nplate is stopped, platelet counts could drop below what they were before beginning treatment.

Additional risks include blood clots due to excessive increases in platelets and, if Nplate were given to patients with an abnormal blood condition known as myelodysplasia, a risk for a form of blood cancer known as acute leukemia. Myelodysplasia, which is associated with low platelet counts, predisposes some patients to leukemia. In a study of 44 patients who had myelodysplasia and received Nplate, four patients developed leukemia. Further clinical trials in patients with predisposing conditions for leukemia will be needed to determine whether the development of leukemia may relate to the use of Nplate. Nplate is approved only for use among patients with chronic ITP.

A Risk Evaluation and Mitigation Strategy (REMS) has been developed to address the risks of Nplate therapy. Under the Food and Drug Administration Amendments Act of 2007, FDA has determined that a REMS is necessary for the benefits of Nplate to outweigh the risks of the product. The REMS will include a Medication Guide for patients and requires that all prescribers and patients enroll in a special program to track the long term safety of Nplate therapy.

Nplate is manufactured by Amgen, Inc. of Thousand Oaks, Calif.

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Thursday, August 21, 2008

Nation's High School Students Showing Overall Improvements in Health-Related Behaviors

However, Hispanic Students Not Showing Progress in Some Key Areas

Today's high school students are less likely to engage in many health risk behaviors than high school students in the early 1990s, according to the 2007 National Youth Risk Behavior Survey (YRBS), released in June by the Centers for Disease Control and Prevention (CDC). Although the study documents substantial improvements over time in many health risk behaviors among all high school students, Hispanic students remain at greater risk for certain health related behaviors and have not matched the progress made over time by black students and white students in reducing some sexual risk behaviors.

"We are pleased that more high school students today are doing things that will help them stay healthy and avoiding things that put their health in danger. Unfortunately we are not seeing that same progress among Hispanic teens for certain risk factors," said Howell Wechsler, Ed.D., MPH, director of CDC's Division of Adolescent and School Health.

An analysis of trends from YRBS on sexual risk behaviors found the following:

* Significant decreases occurred overall in the percentage of black students who had ever had sexual intercourse (66 percent in 2007; 82 percent in 1991); and who had sex with four or more people during their lifetime (28 percent in 2007; 43 percent in 1991.) * Significant decreases also occurred in the percentage of white students who had ever had sexual intercourse - 44 percent in 2007; 50 percent in 1991; and who had sex with four or more people during their lifetime - 12 percent in 2007; 15 percent in 1991.

* No significant change occurred in the percentage of Hispanic high school students who had ever had sexual intercourse (52 percent in 2007; 53 percent in 1991); and who had sex with four or more persons during their life (17 percent in both 2007 and 1991)

* The percentage of high school students who were taught about HIV/AIDS in school did not change significantly among Hispanics (85 percent in 2007; 82 percent in 1991), but did increase during 1991-2007 among black students (90 percent in 2007: 84 percent in 1991) and white students (91 percent in 2007; 83 percent in 1991.)

The 2007 National YRBS found that Hispanic students were more likely than either black students or white students to attempt suicide, use cocaine, heroin or ecstasy, ride with a driver who had been drinking alcohol, or go 24 hours or more without eating in an effort to lose weight. Hispanic students were also more likely than both black students and white students to say they did not go to school on occasion because of safety concerns, were offered or sold illegal drugs on school property or drank alcohol on school property.

There were, however, some positive findings concerning Hispanic students. Compared with Hispanic high school students in the 1990s, Hispanic students in 2007 were more likely to wear a seat belt at least some of the time and to use condoms during their most recent sexual intercourse and less likely to smoke cigarettes, drink alcohol, use drugs such as marijuana and methamphetamines, or ride with a driver who had been drinking alcohol.

National, state and local YRBS studies are conducted every two years among high school students throughout the United States. These surveys monitor health risk behaviors that lead to unintentional injuries and violence; tobacco, alcohol and other drug use; and sexual behaviors that can lead to unintended pregnancy or sexually transmitted diseases, including HIV infection. The surveys also monitor high school students' dietary behaviors, physical inactivity, and the prevalence of obesity and asthma.

More than 14,000 U.S. high school students participated in the 2007 National YRBS. Data are presented only for black, Hispanic and white students because the sample size of students from other racial/ethnic populations was too small for a meaningful analysis. Parental permission was obtained for students to participate in the survey. Student participation was voluntary, and responses were anonymous. States and cities could modify the questionnaire to meet their needs. The 2007 report includes national data and data from surveys conducted in 39 states and 22 large urban school districts.

The National YRBS is one of three HHS-sponsored surveys that provide data on substance abuse among youth. The others are the National Survey on Drug Use and Health (NSDUH), sponsored by the Substance Abuse and Mental Health Services Administration and a primary source of statistics on substance use among Americans age 12 and over (www.oas.samhsa.gov/nhsda.htm), and the Monitoring the Future (MTF) Study funded by the National Institute on Drug Abuse and conducted by the University of Michigan's Institute for Social Research (http://monitoringthefuture.org). MTF tracks substance use among students in the 8th, 10th and 12th grades.

The 2007 Youth Risk Behavior Survey data are available at www.cdc.gov/yrbs.
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Tuesday, August 19, 2008

Autism 101 Seminar and Resource Fair for Newly Diagnosed Families

Saturday, September 6, 2008
Northstar Church
3413 Blue Springs Road
Kennesaw, Georgia 30144

“Autism 101” is a seminar and resource fair sponsored by the Autism Society of America - Greater Georgia Chapter for families of newly diagnosed children with Autism Spectrum Disorders (ASD). The seminar provides information that educates, enables and empowers these families as they begin the journey of caring for, planning for, and treating their child. Additionally, there is a resource fair for families to meet and interact with local providers of autism related goods and services.

Pre-registration Required
$10 per person
Please visit the ASA-GGC website at www.asaga.com or call (770)904-4474 to register or for additional information.

Vendor space available

Autism 101 Schedule

8:00am-8:30am
Check in and receive materials

8:30am-9:00am
What is autism and how is it diagnosed?
Dr. Steve Hobbs, Pediatric Psychology Associates

9:00am-9:30am
Services, Funding, and Advocacy
Stacey Ramirez, University Center on Excellence in Developmental Disabilities

9:30am-10:00am
The Basics of Applied Behavioral Analysis
Drs. Coby & Janet Lund, Integrated Behavioral Solutions

10:00am-10:30am
The Sensory Connection
Margaret Kuneyl, OTR/L, Peach State Pediatric Therapy

10:30am-11:00am
Behavior Strategies and Positive Behavior Supports
Dr. Robert Montgomery, Reinforcement Unlimited

11:00am-11:30am
Promoting Language Skills
Charlie Coleman, Emory Autism Center

11:30am-Noon
Enhancing Social and Play Skills
Charlie Coleman, Emory Autism Center

Noon-1:30pm
Lunch and Resource Fair

1:30pm-2:00pm
Sleeping, Feeding, and Toileting Issues
Jason Cavin, Marcus Institute

2:00pm-2:30pm
Using Visual Supports
Karen Barineau, Dekalb County Schools

2:30pm-3:00pm
Biomedical and Diet Interventions
Stefanie Smith, Eating Away Autism

3:00pm-3:30pm
Music & Autism: Therapeutic Possibilities
Beth Hampshire-Coyle, NMT, MT-BC,
Music Therapy Services of Greater Atlanta

3:30pm-4:00pm
Accessing Educational Services
Mary O’Connell & Nan Britt, SPECTRUM

4:00pm-5:00pm
Autism’s impact on the family
Elizabeth Newman, Living the Mosaic

5pm-6pm
Resource Fair

Topics and/or presenters subject to change without notice.
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Fearsome-Smelling Gas Could Have Beneficial Uses in Medicine

A single breath of hydrogen sulfide, a gas best known for its rotten-egg smell, can kill. But at low concentrations, hydrogen sulfide could protect vital organs during surgery, research conducted by a new Emory University School of Medicine professor suggests.

David Lefer, PhD, professor of surgery, came to Emory this summer from Albert Einstein College of Medicine in New York.

Lefer and his co-workers recently showed that delivering hydrogen sulfide to the liver can reduce damage caused by loss and restoration of blood flow in a mouse model of liver surgery. The results are published in the August issue of the American Journal of Physiology, Heart and Circulatory Physiology.

"As a gas, hydrogen sulfide has a number of advantages," Lefer says. "It diffuses across cell membranes, it can be delivered quickly and it protects cells via several basic biochemical pathways."

The authors show that hydrogen sulfide reduces inflammation and oxidative stress when blood flow to the liver is cut off. In the study, hydrogen sulfide is given intravenously, but Lefer says it may be possible to deliver it via inhalation or orally.

Lefer says liver surgery is just one example of a situation where hydrogen sulfide may be beneficial. He and colleagues at Albert Einstein previously showed that hydrogen sulfide can limit scarring and inflammation in the heart muscles of mice after a simulated heart attack. It appears to do so by protecting the mitochondria, the cell's mini-power plants, from structural damage.

Lefer notes that hydrogen sulfide resembles another poisonous gas that has attracted considerable scientific attention over the last decade, nitric oxide. Both gases regulate blood pressure and play key roles in controlling oxidative stress.

Oxidative stress means an abundance of reactive oxygen species, harmful oxygen-containing molecules that interfere with relaxation of blood vessels and trigger the formation of lesions leading to heart attack and stroke.

Lefer says he came to Emory because of opportunities to collaborate with several scientists who work on oxidative stress.

The research was funded by the National Institutes of Health, the American Diabetes Association and a research grant from the biotechnology firm Ikaria Holdings. Lefer is a paid consultant for Ikaria, which is developing technology for hydrogen sulfide delivery.

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Sunday, August 17, 2008

Emory Eye Center Awarded Grant from Research to Prevent Blindness

Research to Prevent Blindness (RPB) has given Emory Eye Center a $110,000 unrestricted grant to fund research. RPB is the world's leading voluntary organization supporting eye research.

To date, RPB has awarded grants totaling $3,112,100 to Emory University School of Medicine for eye research. RPB's research at Emory Eye Center will be directed by Timothy W. Olsen, director, Emory Eye Center and chair, Department of Ophthalmology.

"RPB is a tremendous organization that supports the type of funding that allows true innovation in ophthalmic research," says Olsen. " I'm truly honored to help steward these funds to the key research efforts at Emory Eye Center."

This year's RBP funding at Emory Eye Center will be used for innovative start-up projects and fostering teamwork and collaborative research teams.

Founded in 1960, RPB has channeled hundreds of millions of dollars to medical institutions throughout the United States for research into all blinding diseases.
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Saturday, August 16, 2008

“Losing Your Bite?” to Debut August 18

One of Clayton State University’s most notable service learning programs is making its video debut on Monday, Aug. 18.

The 13-minute long documentary DVD produced by Clayton State graduate Christian Bowen, entitled “Losing Your Bite?” features the Clayton State Department of Dental Hygiene’s 2008 Service Learning Program. Funded by a sub-grant from the Morehouse School of Medicine in partnership with the Clayton State University Department of Dental Hygiene to recognize and promote student involvement and participation in community service and health care activities, the 2008 Serve and Learn programs focused on children’s oral health, and the oral health of the homeless. The Morehouse grant is from the Corporation of National and Community Service in Washington, D.C.

“Losing Your Bite?” stars Clayton State senior Dental Hygiene students (and now graduates) Jakia Poythress (Atlanta), Melka Argaw (Clarkston), Clara Gandolfi (McDonough), Noella Eugene (McDonough), and Raschelle Porter (Jonesboro), and details their efforts and experiences with the Central Presbyterian Outreach and Advocacy Center, 201 S. Washington Street, Atlanta, working with the homeless men, women and children who come to the Outreach Center for assistance. Also providing commentary are Dr. Rodger Bates, dean of the Clayton State College of Professional Studies, Dr. Susan Duley, head of the Clayton State Department of Dental Hygiene, and the Service Learning Program’s clients. The first public showing of the documentary will be at the Department of Dental Hygiene’s “White Coat” ceremony which will run from 10:30 a.m. to 1:30 p.m. in room 101 of the Harry S. Downs Center on Aug. 18.

Special individual media showings of “Losing Your Bite?” along with interviews with the five Clayton State graduates, Bates and Duley, are available upon request from the Clayton State Office of University Relations.

A unit of the University System of Georgia, Clayton State University is an outstanding comprehensive metropolitan university located 15 miles southeast of downtown Atlanta.
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Friday, August 15, 2008

FDA Approves First Drug for Treatment of Chorea in Huntington’s Disease

The U.S. Food and Drug Administration has approved Xenazine (tetrabenazine) for the treatment of chorea in people with Huntington’s disease. Chorea is the jerky, involuntary movement that occurs in people with this disease.

Xenazine is a new drug and is the first treatment of any kind approved in the United States for any symptom of Huntington’s disease. Currently there are no other drugs that are FDA-approved to treat chorea.

Serious side effects reported with use of Xenazine include depression and suicidal thoughts and actions. Xenazine should not be used in patients who are actively suicidal or in patients with untreated depression. Concerns about the risk of suicide are heightened in all patients with Huntington’s disease.

“Xenazine represents hope for patients and families dealing with this difficult disease,” said Timothy Coté, M.D., M.P.H., director of FDA’s Office of Orphan Products Development. “For the first time, there is a treatment that can help patients with this disease gain some quality of life.”

Huntington's disease is a rare, inherited neurological disorder affecting about 1 in 10,000 people in the United States. The disease results from genetically programmed degeneration of brain cells. The deterioration causes uncontrolled movements, loss of intellectual faculties, and emotional disturbance. Huntington’s disease is passed from parent to child through a gene mutation. Each child of a parent with the disease has a 50 percent chance of inheriting the mutation.

About 30,000 people in the United States have Huntington’s disease and another 200,000 are at risk of developing the condition. Symptoms commonly develop between ages 30 and 50. The disease progresses slowly and a person may live for another 15-20 years after the onset of symptoms.

Xenazine decreases the amount of dopamine available to work at relevant synapses in the brain. Dopamine is a chemical that communicates between certain nerve cells in the brain. In patients with Huntington’s disease, this system is overactive and results in the abnormal movements called chorea. Xenazine decreases the amount of dopamine available to interact with certain nerve cells, thereby decreasing the involuntary movements.

The effectiveness and safety of Xenazine was established primarily in a randomized, double-blind, placebo-controlled multi-center clinical trial. Patients treated with Xenazine had a significant improvement in chorea compared to patients treated with placebo. Other studies provided additional support for this effect.

The most common side effects reported by patients using Xenazine in clinical trials include insomnia, depression, drowsiness, restlessness and nausea.

While the drug has been shown to decrease chorea in the short-term, it also showed slight worsening in mood, cognition, rigidity, and functional capacity in clinical trials. Health care professionals and family members of patients taking the drug should pay attention to all of the facets of the disease.

Xenazine has been approved with a required Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drug outweigh its risks, particularly the risks of depression and suicidal thoughts and actions. REMS is a strategy to manage a known or potential serious risk associated with a drug or biological product.

The REMS includes educational materials for prescribers, pharmacists and patients (and their caregivers) to help minimize adverse effects associated with Xenazine. It also includes a Medication Guide, which informs patients and their caregivers about the risks of depression, suicidal thoughts and actions, and other side effects. The FDA requires that the Medication Guide be handed out with every prescription for the drug dispensed.

Xenazine was granted orphan drug designation by the FDA. A drug is eligible for orphan drug designation if it is intended to treat a disease or condition that affects less than 200,000 people in the United States. A drug is also eligible for orphan drug designation if it is intended to treat a disease or condition that affects more than 200,000 people in the United States, but there is no reasonable expectation that the cost of developing and making available a drug for the disease or condition will be recovered from sales of the drug.


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Thursday, August 14, 2008

Governor Announces Launch of Together Rx Access For Georgia Card

Today Governor Sonny Perdue and Together Rx Access announced the launch of the Together Rx Access® FOR GEORGIA Card to help eligible uninsured Georgians gain access to immediate and meaningful savings on prescription medicines and products right at the pharmacy counter. The FOR GEORGIA Card is the first state-specific Together Rx Access Card, offering cardholders the same savings as the regular Together Rx Access Card.

"Access to affordable prescriptions will help Georgians take better care of their health and the health of their families," said Governor Sonny Perdue. "Georgia is proud to be the first state in the nation to embark on this important journey with a program that is doing great work to improve access to prescription medications for uninsured people around the country."

The co-promotion fully opens the state's communication and outreach avenues to reach more uninsured Georgians throughout the state. The co-promotion costs nothing to the state while having the potential to help thousands of residents access the medicines they need to take care of what's most important...their health.

As part of their missions to improve the health of Georgians, the Georgia Department of Community Health and Georgia Department of Human Resources will begin reviewing policies and methods to inform Georgia residents who may qualify for the card of its benefits. In 2005, Governor Perdue praised the initial launch of Together Rx Access, calling the program a great example of the private sector stepping forward, in partnership with the state, to meet the health needs of low-income Georgians. Currently, nearly 60,000 Georgia residents have enrolled in Together Rx Access. Those in Georgia who have used the Together Rx Access Card have saved $3.5 million on their prescription medicines. About 10,000 uninsured people enroll for the card every week nationwide.

“This unique co-promotion marks a significant milestone for Together Rx Access and opens the door to better prescription access for many more uninsured people across the state of Georgia,” said Roba Whiteley, Executive Director of Together Rx Access. “We are grateful for the tremendous program support of Governor Perdue and hope this partnership encourages many other states to follow Georgia’s lead in reaching out to residents in need with available resources.”

The Together Rx Access FOR GEORGIA Card will have the same look as the standard Together Rx Access Card, except for the words FOR GEORGIA in the lower right hand corner. These words will signify a Georgia resident’s participation in this co-promotion.

About Together Rx Access

The Together Rx Access Card was created by leading pharmaceutical companies to help hardworking Americans and their families gain access to immediate and meaningful savings on prescription products right at their neighborhood pharmacy. Most cardholders save 25 to 40 percent on brand-name prescription products. More than 300 brand-name prescription products are included in the program. Savings are also available on a wide range of generics. Medicines in the program include those used to treat high cholesterol, diabetes, depression, asthma, and many other common conditions. The Card is free to get and free to use.

Together Rx Access also directs individuals to the Partnership for Prescription Assistance (PPA), a clearinghouse for more than 475 public and private assistance programs, including 180 offered by pharmaceutical companies. Those who are eligible for the Together Rx Access Card may qualify for additional savings on prescription medicines, or even free medicines, through other patient assistance programs in the PPA. The PPA also connects people to free health clinics in their community.

To qualify for the free Together Rx Access Card, applicants cannot be eligible for Medicare or have public or private prescription drug coverage. To be eligible, household income of less than $30,000 for a single person or $60,000 for a family of four (income eligibility is adjusted for family size) is required. Applicants must be legal residents of the United States or Puerto Rico.
The companies participating in the Together Rx Access Program include Abbott Laboratories; Bristol-Myers Squibb Company; GlaxoSmithKline; Janssen, L.P.; Johnson & Johnson Wound Management, a Division of ETHICON, Inc.; King Pharmaceuticals, Inc.; LifeScan, Inc.; McNeil Pediatrics, a Division of McNeil-PPC, Inc.; Novartis Pharmaceuticals Corporation; Ortho Biotech Products, L.P.; Ortho-McNeil, Inc.; Ortho-McNeil Neurologics, Inc.; OrthoNeutrogena, a Division of Ortho-McNeil Pharmaceutical, Inc.; Ortho Women’s Health & Urology, a Division of Ortho-McNeil Pharmaceutical, Inc.; Pfizer Inc; PriCara, a Unit of Ortho-McNeil, Inc.; sanofi-aventis U.S. LLC.; Takeda Pharmaceuticals North America, Inc.; TAP Pharmaceutical Products Inc.; Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P.; and Vistakon Pharmaceuticals, LLC.

For more information about the Together Rx Access FOR GEORGIA Card, visit www.TogetherRxAccess.com or call 1-800-979-3569.
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Airman Helps Injured Warriors 'Face' World

Photos: Maxillofacial prosthetic technician Air Force Senior Airman Justin Jones creates new facial features using various techniques and tools to reconstruct facial features of wounded warriors. His techniques are used to aid patients in their physical and psychological recovery from injuries to the neck and face. Jones is assigned to 59th Dental Squadron at Lackland Air Force Base, Texas. U.S. Air Force photo by Staff Sgt. Erin Peterson, 59th Medical Wing
The characteristics of a person's face are unmistakable. They are the uniqueness that makes people recognize family members, friends, co-workers. Now imagine suddenly being stripped of those defining characteristics.

Facial injuries are becoming more prevalent among wounded warriors. The features that protrude the most on a person's face are at a high risk for injury.

Air Force Senior Airman Justin Jones, a maxillofacial prosthetic technician with 59th Dental Squadron here, works to help servicemembers who have suffered disfiguring facial injuries.

After he enlisted in the Air Force in December 2002, Jones was a dental lab technician for three and a half years before switching to his current specialty through on-the-job training. His position was previously occupied by a civilian contractor, now retired.

Jones' qualifications come from studying art in high school and college, where he gained an understanding of color and light. He has experience with oil painting, watercolor and clay sculpting. He is now the only full-time maxillofacial prosthetic technician in the Air Force.

According to the Baylor College of Dentistry, maxillofacial prosthodontics is a subspecialty of dentistry that deals with the rehabilitation of patients with acquired and congenital defects of the head and neck region. Facial prosthetic devices are an essential part of restoring the physical and psychological well-being of patients with missing or disfigured facial structures.

Jones is brought in when a patient could benefit from a facial prosthetic. He often uses a pre-injury photo of the patient as a guide in restoring a patient's facial features. On one occasion, a patient's father was even brought in to shape an ear and match the pigment exactly.

His goal is to improve patients' quality of life, Jones said, allowing them to live without drawing attention to a specific aspect of their physical appearance. He works directly with the patients, perfecting the prosthetic until it suits each person precisely.

"I get to know my patients, and they let me know exactly what they want. I love the work that I do," Jones said.

Maxillofacial prosthetics staff members work mainly with patients from Brooke Army Medical Center and burn units in San Antonio. Air Force Col. (Dr.) Jose Villalobos, program director of maxillofacial prosthetics, praised Jones' work.

"With all the war casualties coming in right now, it is important that we use our capabilities to help those wounded warriors," he said. "Senior Airman Jones has an artistic background, and he uses his knowledge of sculpting, color and contours to restore missing or altered facial features. He has a passion for his craft, and he is filling big shoes right now."

Author Air Force Staff Sgt. Erin M. Peterson serves in the 59th Medical Wing Public Affairs Office.
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Wednesday, August 13, 2008

Study Shows Promising Results in Deep Brain Stimulation for Patients with Treatment-Resistant Depression

Highlights:

• A study from the University of Toronto initiated by Emory University neuroscientist Helen Mayberg, MD, concludes that deep brain stimulation (DBS) in the subcallosal cingulate region (Cg25) of the brain is safe and provides improvement in depression symptoms.
• Study patients who were unresponsive to most other treatments, including medication, psychotherapy and electroconvulsive therapy got better as early as one month after the initial DBS treatment.
• An expanded study continues at Emory's School of Medicine that includes bipolar II depression patients and refinement of the targeting and selection of the electrodes by using new imaging techniques.

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New data from a study of patients with treatment-resistant depression who underwent deep brain stimulation (DBS) in the subcallosal cingulate region (SCG or Cg25) of the brain shows that this intervention is generally safe and provides significant improvement in patients as early as one month after treatment. The patients also experienced continued and sustained improvement over time.

The data are reported in the online issue of Biological Psychiatry by scientists from the University of Toronto and Emory University School of Medicine.

The study began at the University of Toronto in 2002, led by Helen S. Mayberg, MD, and collaborators Andres Lozano, MD, PhD, neurosurgeon, and psychiatrist Sidney Kennedy, MD.

Mayberg is now a professor in the Department of Psychiatry and Behavioral Sciences and the Department of Neurology at Emory University School of Medicine. This clinical trial is the culmination of Mayberg's 20 years of research using brain imaging technology that has worked to characterize functional brain abnormalities in major depression and to identify the mechanisms of various antidepressant treatments.

A report on the first six patients in the study was published in the Journal Neuron in 2005. The new paper reports on an expanded sample of patients and an extended period of clinical follow-up.

DBS uses high-frequency electrical stimulation targeted to the specific areas of the brain involved in neuropsychiatric disease. Twenty patients received SCG DBS for 12 months. Twelve of 20 patients experienced a significant decrease in depressive symptoms (defined by a 50 percent decrease in the Hamilton Depression rating scale) by six months, with seven patients essentially well with few remaining symptoms (remission, defined as a Hamilton Depression Rating Scale score <8). Benefits were largely maintained at 12 months with continued stimulation. No long-term side effects were reported.

Each study patient was implanted with two thin wire electrodes (one on each side of the brain) in the white matter adjacent to SCG. The other end of each wire was connected under the skin of the neck to a pulse generator implanted in the chest -- similar to a pacemaker -- that directs the electrical current. The researchers regulated the intensity of the current according to the response of the patient. Only patients who were unable to get better with most other types of antidepressant treatment -- including medication, psychotherapy and electroconvulsive therapy -- were included in the study.

"In previous studies using brain imaging, we found the subcallosal cingulate region was a key region in an emerging emotion regulation circuit implicated in major depression," explains Mayberg.

"We postulated that if stimulation worked for the treatment of other neurological disorders where abnormal function of specific circuits was well established, such as Parkinson's disease, then stimulation of the Cg25 region within this apparent depression circuit might provide significant benefit for patients with treatment-resistant depression."

The researchers were able to track the clinical response of the patients over a 12-month period using standard depression rating scales as well as various quantitative measures of behavior and general functioning, neuropsychological testing and scanning of both regional brain blood flow and glucose metabolism using positron emission tomography (PET).

PET imaging of these patients demonstrated that metabolic activity changed locally at the site of stimulation but also throughout the previously identified depression network, providing evidence that modulating the circuit and not just a single region was likely responsible for the antidepressant effects.

"We see depression as a complex disturbance of the specific circuits in the brain responsible for regulating mood and emotions," Mayberg says. "We hypothesized that if DBS could locally modulate a critical central location within this mood circuit, such modulation would result in clinical improvement -- and it appears it does."

Mayberg initiated an expanded version of her Toronto study at Emory in 2007 with psychiatrist Paul Holtzheimer, MD, and neurosurgeon Robert Gross, MD, PhD, and with grant support from the Woodruff Fund, The Stanley Medical Research Institute and the Dana Foundation.

The new Emory clinical trial is tackling a number of unanswered issues including the testing of patients with bipolar II depression and refinement of the targeting and selection of the electrodes using new imaging techniques. The Emory study will enroll 20 patients and will be conducted over a period of at least three years.

The Toronto study was funded in part by a Distinguished Investigator Award from National Alliance for Research in Schizophrenia and Depression (HSM).

Reference: Biological Psychiatry published online July 2008 DOI: 10.1016/jbiopsych.2008.05.034

Dr. Mayberg is an inventor on patents covering the technology discussed in this article. Dr. Mayberg is also a paid consultant for ANS, which has licensed the technologies. Dr. Holzheimer is also a paid consultant for ANS. These relationships have been reviewed and approved by Emory University in compliance with its policies on conflicts of interest.
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Tuesday, August 12, 2008

Low Vitamin D Levels Pose Large Threat to Health

Researchers at Johns Hopkins are reporting what is believed to be the most conclusive evidence to date that inadequate levels of vitamin D, obtained from milk, fortified cereals and exposure to sunlight, lead to substantially increased risk of death.

In a study set to appear in the Archives of Internal Medicine online Aug. 11, the Johns Hopkins team analyzed a diverse sample of 13,000 initially healthy men and women participating in an ongoing national health survey and compared the risk of death between those with the lowest blood levels of vitamin D to those with higher amounts. An unhealthy deficiency, experts say, is considered blood levels of 17.8 nanograms per milliliter or lower.

Of the 1,800 study participants known to have died by Dec. 31, 2000, nearly 700 died from some form of heart disease, with 400 of these being deficient in vitamin D. This translates overall to an estimated 26 percent increased risk of any death, though the number of deaths from heart disease alone was not large enough to meet scientific criteria to resolve that it was due to low vitamin D levels.

Yet, researchers say it does highlight a trend, with other studies linking shortages of vitamin D to increased rates of breast cancer and depression in the elderly. And earlier published findings by the team, from the same national study, have established a possible tie-in, showing an 80 percent increased risk of peripheral artery disease from vitamin D deficits.

Researchers note that other studies in the last year or so in animals and humans have identified a connection between low levels of vitamin D and heart disease. But these studies, they say, were weakened by small sample numbers, lack of diversity in the population studied and other factors that limited scientists’ ability to generalize the findings to the public at large.

“Our results make it much more clear that all men and women concerned about their overall health should more closely monitor their blood levels of vitamin D, and make sure they have enough,” says study co-lead investigator Erin Michos, M.D., M.H.S.

“We think we have additional evidence to consider adding vitamin D deficiency as a distinct and separate risk factor for death from cardiovascular disease, putting it alongside much better known and understood risk factors, such as age, gender, family history, smoking, high blood cholesterol levels, high blood pressure, lack of exercise, obesity and diabetes,” says Michos. Vitamin D is well known to play an essential role in cell growth, in boosting the body’s immune system and in strengthening bones.

“Now that we know vitamin D deficiency is a risk factor, we can better assess how aggressively to treat people at risk of heart disease or those who are already ill and undergoing treatment,” says Michos, who adds that test screening for nutrient levels is relatively simple. It can, she says, be made part of routine blood work and done while monitoring other known risk factors, including blood pressure, glucose and lipid levels.

Heart disease remains the nation’s leading cause of death, killing more than a million Americans each year. Nearly 10 percent of those with the condition have not one identifiable, traditional risk factor, which the experts say is why a considerable extent of the disease goes unexplained.

Michos, an assistant professor at the Johns Hopkins University School of Medicine and its Heart and Vascular Institute, recommends that people boost their vitamin D levels by eating diets rich in such fish as sardines and mackerel, consuming fortified dairy products, taking cod-liver oil and vitamin supplements, and in warmer weather briefly exposing skin to the sun’s vitamin-D producing ultraviolet light.

Aware of the cancer risks linked to too much time spent in the sun, she says as little as 10 to 15 minutes of daily exposure to the sun can produce sufficient amounts of vitamin D to sustain health. The hormone-like nutrient controls blood levels of calcium and phosphorus, essential chemicals in the body.

If vitamin supplements are used, Michos says there is no evidence that more than 2,000 international units per day do any good. Study results show that heart disease death rates flattened out in participants with the highest vitamin D levels (above 50 nanograms per milliliter of blood), signaling a possible loss of the vitamin’s protective effects at too-high doses.

The U.S. Institute of Medicine suggests that an adequate daily intake of vitamin D is between 200 and 400 international units (or blood levels nearing 30 nanograms per milliliter). Previous results from the same nationwide survey showed that 41 percent of men and 53 percent of women are technically deficient in the nutrient, with vitamin D levels below 28 nanograms per milliliter.

Michal Melamed, M.D., M.H.S., study co-lead investigator who started the research as a clinical fellow at Johns Hopkins, says no one knows yet why or how vitamin D’s hormone-like properties may protect the heart, but she adds that there are plenty of leads in the better known links the vitamin has to problems with muscle overgrowth and high blood pressure, in addition to its control of inflammation, which scientists are showing plays a stronger role in all kinds of heart disease. But more research is needed to determine the nutrient’s precise biological action.

Researchers say their next steps are to test various high doses of vitamin D to find out if the nutritional supplementation results in fewer deaths and lower incidence of heart disease, including heart attack or moments of prolonged and severe chest pain.

The team also plans to investigate what biological triggers, such as obesity or hypertension, might offset or worsen the action of vitamin D on heart muscle, or whether vitamin D sets off some other reaction in the heart.

Melamed says that because vitamin D levels are known to fluctuate in direct proportion with daily physical activity, the growing epidemic of obesity and indoor sedentary lifestyles lend more urgency to act on the vitamin D factor.

Funding for this study was provided by the National Institutes of Health, the P.J. Schafer Cardiovascular Research Fund and the Paul Beeson Physician Faculty Scholars in Aging Program. Michos has received previous consulting fees from vitamin D therapeutics manufacturer Abbott Pharmaceuticals. The terms of these arrangements are being managed by the Johns Hopkins University in accordance with its conflict of interest policies.

Besides Michos and Melamed, other Hopkins researchers involved in this study, conducted solely at Hopkins, were Wendy Post, M.D.; and Brad Astor, Ph.D. Melamed is now an assistant professor at the Albert Einstein College of Medicine of Yeshiva University in New York City.

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Monday, August 11, 2008

UGA's Center for Tropical and Emerging Global Diseases to Host Global Health Research Symposium

The University of Georgia’s Center for Tropical and Emerging Global Diseases will host an international research symposium, “Global Health through Research,” on Sept. 19 and 20 at the Georgia Center for Continuing Education Conference Center and Hotel on the UGA campus. The symposium will be held in conjunction with the 18th Annual Molecular Parasitology/Vector Biology Symposium.

To recognize and help celebrate the center’s tenth anniversary, symposium organizers planned the event as an expanded version of their traditional annual meeting. The program will feature ten of the world’s most prominent researchers who study human parasites and the insect vectors that spread them.

“This will be an exciting conference packed with cutting-edge presentations from the best investigators in the field,” said Boris Striepen, a symposium organizer. “We are also eager to present the outstanding work of UGA students and postdoctoral researchers to this highly accomplished audience.”

Scheduled speakers will discuss a wide range of scientific issues, including how parasites conquer their hosts, secure nutrients, and outwit the immune system to cause deadly diseases. Wielding sophisticated tools of molecular biology and genome science, these researchers work to reveal the parasites’ tricks and to develop urgently needed drugs and vaccines. Diseases to be discussed include malaria, sleeping sickness, leishmaniasis and several other diseases associated with AIDS.

The Center for Tropical and Emerging Global Diseases is a university-wide, interdisciplinary center established in 1998 to foster research, education and service related to tropical and emerging infectious diseases. Over the past decade CTEGD has grown into one of the nation’s preeminent institutes for tropical disease research. The center’s 18 members include faculty from eight UGA departments and four colleges. The center also benefits from the participation of adjunct faculty from the Centers for Disease Control and Prevention in Atlanta.

by Helen Fosgate
University of Georgia

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Thursday, August 7, 2008

Piedmont Fayette Hospital Welcomes Fellowship Trained Breast Surgeon

Piedmont Fayette Hospital is pleased to announce the addition of Nicole L. Sroka, M.D., as the first fellowship trained breast surgeon on staff. Dr. Sroka is part of the Piedmont Breast Surgical Specialists.

Among Georgia women, breast cancer is the most common cancer and the second leading cause of cancer death. According to data from the Georgia Comprehensive Cancer Registry, an estimated 5,600 new cases of breast cancer were diagnosed in 2005, and nearly 1,200 Georgia women were expected to die from this disease.

“Breast cancer affects numerous women in our community, and we are thrilled to have Dr. Sroka back as part of our Piedmont Fayette family,” said Darrell Cutts, president and CEO of Piedmont Fayette Hospital. “Having this specially trained breast surgeon at Piedmont Fayette will benefit women in Fayette County and the surrounding communities.”

Prior to joining Piedmont Fayette Hospital, Dr. Sroka completed a breast surgical oncology fellowship at Memorial Sloan Kettering Cancer Center (MSK) in New York City. She rotated at PFH for five years prior to her fellowship as part of her residency training in Georgia, where she also practiced at Atlanta Medical Center. Dr. Sroka grew up in Wisconsin, received a bachelor’s degree in molecular biology from the University of Wisconsin in Madison, Wis., and received her medical degree from the University of Wisconsin Medical School.

“I am glad to be back at Piedmont Fayette after having the opportunity to receive invaluable experience in an academic medical center dedicated to cancer research, patient care, and education. The training at MSK prepares physicians for leadership roles in the care of cancer patients around the world.” said Dr. Sroka. “Piedmont Fayette has a great reputation for quality patient care, and I look forward to providing the most advanced care for women with breast cancer, while giving them the personalized care they deserve.”

Dr. Sroka is a member of the Society of Surgical Oncology, American Society of Clinical Oncology, Southeast Surgical Oncology and the American Medical Association. Last year she received the Gold Medal awarded for Outstanding Resident Submission from the Southeastern Surgical Society.

Recently married, Dr. Sroka resides in the Fayette community with her husband, Jason Maveragames, a native of the area.

Testing by Marine Biologists Concludes That Jellyfish Squish(TM) Completely Eliminates Pain From Jellyfish Stings

PRNewswire -- Peter Verity, Ph.D., is recognized throughout the world as a leading authority on jellyfish, but despite more than 20 years of research he had never identified a reliable treatment for jellyfish stings until he tested several home remedies against a new product called Jellyfish Squish(TM) last year.

Jellyfish Squish is a patent pending, trademarked topical anesthetic that has been endorsed by the American Lifeguard Association and has undergone extensive testing for the U.S. Food and Drug Administration. The solution immediately and completely eliminates the pain from a sting while also neutralizing any nematocysts left on the skin when a jellyfish tentacle comes into contact with flesh.

Dr. Verity is a faculty member at the Skidaway Institute of Oceanography (SKIO) near Savannah, Ga., and a decorated marine biologist who has published his findings throughout the world. Verity and fellow SKIO faculty member Richard Lee, Ph.D., performed extensive clinical tests on volunteer sting victims to compare the effectiveness of traditional homeopathic treatments for jellyfish stings such as vinegar, ammonia, baking soda, meat tenderizer and urea against the Jellyfish Squish formula.

"In our testing, we found that the formula which would later be named Jellyfish Squish was the only product that provided true relief from the pain and irritation caused by a jellyfish sting," said Dr. Verity, who is the chair of the Scientific Technical Advisory Committee for the State of Georgia Coastal Comprehensive Plan and has done extensive research on jellyfish and the recent jellyfish population boom. "Specifically, our clinical tests proved conclusively that home remedies like vinegar, ammonia and meat tenderizer are completely ineffective in providing relief to a sting victim and in fact can exacerbate the pain. We believe this is due to the presence of acidic pH, which triggers the release of additional toxins."

In addition to the clinical tests conducted by Dr. Verity and Dr. Lee, thousands of field tests performed on jellyfish sting victims on beaches in Georgia, Florida and South Carolina in 2007 supported the findings of the marine biologists.

Many lifeguard teams and emergency service providers have embraced Jellyfish Squish, and the medical division officer for the Okaloosa Island Fire Department on Florida's gulf coast recently decided to place a 4-ounce bottle of Jellyfish Squish in all of his team's medical gear bags and recommend that the product be used exclusively to treat sting victims.

"Immediately, you could tell there was total relief, and I only used a small amount of Jellyfish Squish because it was a kid," said Captain Kevin Carvalho, medical division officer for the Okaloosa Island Fire Department. "I have also used the product on adults who said it felt much better within moments and walked away from the truck to go back on the beach."

Growing coastal populations and heavier tourist traffic to the beaches means an increased frequency of jellyfish stings, and research released in 2007 documented hundreds of thousands of stings in Florida and Virginia's Chesapeake Bay area. Changing oceanic conditions are contributing to the proliferation of jellyfish worldwide, and record numbers of jellyfish have been reported in media stories throughout the Atlantic seaboard, the Pacific Coast, the Gulf Coast and Hawaii. In Europe, the jellyfish infestation has become so severe that Mediterranean beaches have periodically been forced to close.

"Several factors, particularly increased bacteria levels along with overfishing and higher water temperatures, have resulted in an increased number of jellyfish in the water and that will mean more people are going to suffer stings," Dr. Verity said.
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Making Sudden Cardiac Arrest a National Health Priority: National Medical Association Issues White Paper on Sudden Cardiac Arrest

PRNewswire-USNewswire -- To help change the prevention and treatment paradigm for sudden cardiac arrest (SCA), the National Medical Association (NMA) released a white paper during their 2008 Annual Convention and Scientific Assembly that outlines directives for elevating SCA to a national health priority and bringing it to the forefront of the policy discussion. This white paper, Sudden Cardiac Arrest: Advancing Awareness and Bridging Gaps to Improve Survival, is based on input from more than 50 of the nation's leading cardiac care professionals, government officials and patient advocates during the 2008 SCA Leadership Conference held in April by the NMA.

SCA claims more than 300,000 lives every year -- nearly 1,000 people each day. It is estimated that 95 percent of SCA victims die before reaching a hospital or emergency help, even though nearly 75 percent show signs of a previous heart attack and 80 percent show signs of coronary artery disease.

Dr. Nelson Adams, NMA Immediate Past-President and program chair said, "sudden cardiac arrest is a leading cause of death in the United States. Particularly alarming is that it disproportionately affects African-Americans."

"Disparities in care for patients that are at risk for SCA, as indicated in the rates found among African American women are unacceptable," said newly elected NMA President, Carolyn Barley-Britton, MD.

Thought leaders who contributed to the white paper agreed that a successful change in SCA health outcomes requires continual involvement from community and health leaders, and the vital next step is implementation of programs and policies that will positively impact health outcomes. The white paper's "call to action" summarizes important next steps to make SCA a national health priority, and includes:

  -- Developing clinical performance measures for SCA prevention
-- Raising awareness of SCA among consumers and healthcare professionals
-- Increasing professional education on SCA
-- Encouraging policymakers to establish SCA as a public health priority

-- Creating cultural proficiency in prevention and treatment of SCA to combat health disparities

-- Enlisting insurers to increase support of SCA prevention and treatment in all populations

"Our goal is to raise awareness of the risk of SCA and galvanize healthcare professionals, researchers, patient advocates, policy makers and payors into action to reduce disparities in both primary and secondary prevention of the disease," said Dr. Mohammed Ahkter, Executive Director of the NMA.

About Sudden Cardiac Arrest

Sudden cardiac arrest is an abrupt loss of heart function (cardiac arrest). All known heart diseases can lead to cardiac arrest and sudden cardiac death. Most of the cardiac arrests that lead to sudden death occur when the electrical impulses in the diseased heart become rapid (ventricular tachycardia) or chaotic (ventricular fibrillation) or both. This irregular heart rhythm (arrhythmia) causes the heart to suddenly stop beating.

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Wednesday, August 6, 2008

Americans Made Over 1 Billion Hospital and Doctor Visits in 2006

Patients in the United States made an estimated 1.1 billion visits to physician offices and hospital outpatient and emergency departments in 2006, an average of four visits per person per year, according to new health care statistics released today by the Centers for Disease Control and Prevention.

The data come from various components of CDC's National Center for Health Statistics National Health Care Survey and are featured in a series of new National Health Statistics Reports. Some of the findings include:

* The number of visits to physician offices and hospital outpatient and emergency departments increased by 26 percent from 1996 to 2006, faster than the growth of the U.S. population, which rose by 11 percent. The rise in visits can be linked to both the aging of the population, as older people have higher visit rates than younger people in general.

* In 2006, seven out of 10 visits had at least one medication provided, prescribed, or continued, for a total of 2.6 billion medications overall. Analgesics (pain relievers) were the most common, accounting for 13.6 percent of all drugs prescribed, and were most often used during primary care and emergency department visits.

* The emergency department served as the route of admission to hospital inpatient services for roughly 50 percent of non-obstetric hospital patients in 2006, up from 36 percent in 1996.

* Patients with Medicaid use the emergency department more frequently than patients with private insurance - 82 per 100 persons for Medicaid vs. 21 per 100 for private insurance.

* Most emergency department visits occurred after business hours (defined as 8 a.m. to 5 p.m. on weekdays), when 63 percent of adults and 73 percent of children younger than age 15 arrived.

* The overall average waiting time to see a physician in the Emergency Department was nearly 56 minutes.

* Over the past 36 years, the percent of hospital inpatients who were 65 years of age and older grew from 20 percent in 1970 to 38 percent in 2006. Over the same time period, the percent of inpatients who were 75 years of age and older grew from 9 percent to over 24 percent.

* The rate of knee replacement for those aged 65 years old and over increased 46 percent between 2000 and 2006, and the rate doubled among those aged 45-64 years during the same time period.

* The rate of coronary atherosclerosis (clogged heart arteries) more than doubled during the 1990s but since 2002 declined for all age groups, particularly for those 65 years and over.

* Between 1996 and 2006, the percentage of visits to hospital outpatient departments made by adults 18 years and over with chronic diabetes increased by 43 percent and visits with chronic high blood pressure increased by 51 percent.

The new series of health care reports can be accessed at www.cdc.gov/nchs.
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Tuesday, August 5, 2008

FDA Approves 2008-2009 Flu Vaccines

The U.S. Food and Drug Administration (FDA) today announced that it has approved this year's seasonal influenza vaccines that include new strains of the virus likely to cause flu in the United States during the 2008-2009 season.

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

Approval information and specific indications can be found at http://www.fda.gov/cber/flu/flu2008.htm.

This season's vaccines contain three strains of the influenza virus that disease experts expect to be the most likely cause of the flu in the United States.

Each season's vaccines are modified to reflect the virus strains most likely to be circulating. The closer the match between the circulating strains and the strains in the vaccines, the better the protection.

There is always a possibility of a less than optimal match between the virus strains predicted to circulate and what virus strains end up causing the most illness. Even if the vaccines and the circulating strains are not an exact match, they will provide some protection and may reduce the severity of the illness or prevent flu-related complications.

"One of the biggest challenges in the fight against influenza is producing new vaccines every year," said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research. "There is no other instance where new vaccines must be made every year. The approval of flu vaccines is a part of FDA's mission to promote the health of Americans throughout the year."

The FDA changed all three strains for this year's influenza vaccine—an unusual occurrence, as usually only one or two strains are updated from year to year. A list of the strains included in the 2008-2009 vaccine can be found at http://www.fda.gov/cber/flu/flu2008.htm. Of note, two of the three strains recommended for the U.S. this year are now in use for the Southern Hemisphere's 2008 influenza season, which is currently underway.

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

Based on those forecasts and on the recommendations of its Advisory Committee, the FDA each February decides on the three strains that manufacturers should include in their vaccines for the U.S. population. The FDA makes this decision early in the year so that manufacturers have enough time to produce the new vaccines.

Vaccination remains the cornerstone of preventing influenza, a contagious respiratory illness caused by influenza viruses. According to the CDC, every year an average of 5 to 20 percent of the U.S. population gets the flu, more than 200,000 are hospitalized from flu complications and there are about 36,000 flu-related deaths. Some individuals—the elderly, young children, and people with chronic medical conditions —are at higher risk for flu-related complications. Vaccination of these groups and of health care personnel is critical.

"Currently, only 40 percent of health care workers in the United States are vaccinated against influenza," said Department of Health and Human Services' Assistant Secretary of Health Joxel Garcia, M.D., M.B.A.

"Increasing the number of vaccinated health care personnel can be a strong front in the annual battle against the flu," said Garcia. "Health care workers can set an example for the patients they serve as well as decrease the likelihood of contracting and transmitting the virus."

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Monday, August 4, 2008

Study Highlights Risky Behavior, Lack of Care Among HIV-infected Crack Users

Highlights:
-- One fourth of 190 HIV-infected crack cocaine users interviewed at two hospitals in Atlanta and Miami reported having recent unprotected sex.
-- Half of the group had not seen an HIV specialist in the last six months and more than three fourths were not getting antiretroviral medication.
-- Women were more likely to report annual income less than $5,000, homelessness, lack of any health care and recent unprotected sex.

Doctors who treat HIV-infected crack users refer to them as "the forgotten population." A study being presented at this week’s International AIDS Conference in Mexico City reveals that these patients frequently lack outpatient health care, do not receive life-saving antiretroviral therapy and continue to engage in risky sexual behavior that likely contributes to HIV transmission.

Researchers interviewed 190 HIV-infected crack-using patients at Grady Memorial Hospital in Atlanta and Jackson Memorial Hospital in Miami over 14 months as part of an NIH/National Institute on Drug Abuse funded study.

One fourth of the group reported having unprotected sex in the last six months, half had not seen an HIV specialist in the last six months, and more than three fourths were not getting antiretroviral therapy, according to the interviews.

The five-year HOPE study (Hospital visit is an Opportunity for Prevention and Engagement) is a collaboration between the NIH funded Center for AIDS Research at Emory University School of Medicine and the NIH funded Developmental Center for AIDS Research at the University of Miami School of Medicine.

"At a time when life-saving medications are available to treat persons living with HIV, there continues to be a population of HIV-positive people who have fallen through the cracks," says Lisa Metsch, PhD, associate professor of epidemiology and public health at University of Miami School of Medicine. "Frequently, their only contact with the healthcare system is during a hospitalization."

Metsch is director of the University of Miami CFAR’s behavior, social sciences and community outreach core and principal investigator for the HOPE study.

Previous studies of crack users in urban hospitals found that their drug use bars them from getting HIV-related care. Drug treatment experts say the short, intense nature of the crack high and lack of a methadone equivalent make crack users a unique group, on top of the chaotic lives they share with other drug users.

In addition, the study’s interviews found that, compared with males, female HIV-infected crack users were more likely to report lack of HIV-related care (almost twice as likely) and recent unprotected sex (three times as likely), as well as annual income less than $5,000 and homelessness.

"We know that not being engaged in care and prevention services is not only bad for the individuals but is also bad for society, in that a substantial fraction of HIV-infected crack users engage in behavior that transmits the virus to others," says Carlos Del Rio, MD, professor of medicine and chief of medical services at Grady Memorial Hospital, co-director of the Emory Center for AIDS Research and co-principal investigator for the HOPE study.

The Emory and University of Miami researchers are testing the effectiveness of an eight-session intervention program that helps participants get into HIV care, teaches them about reducing risky sex practices and helps them into drug treatment if they are ready.

Del Rio says that the findings from this intervention study may be used to establish future interventions targeted to HIV-infected crack users to get them into care, keep them in care and allow them to benefit from care and prevention services available in HIV outpatient clinics.

"Hospitals like Grady and Jackson are doing the best they can in the face of a persistent problem, with limited resources," Del Rio says. "More needs to be done to address substance abuse and mental health in this population."
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Friday, August 1, 2008

New Uses for Old-Line Diabetes Monitoring Test: Screening and Diagnosis

A blood test currently used as the gold standard for monitoring people already under care for diabetes may have far wider use in identifying millions with undetected diabetes, a team led by a Johns Hopkins physician suggests.

The hemoglobin A1c test (HbA1c), based on a blood sample, is widely used to keep tabs on how well confirmed diabetics keep their blood sugar, or glucose, in check by showing how much glucose red blood cells have been exposed to for the past 120 days, the average lifespan of these cells.

"The test is a measure of long-term glucose control, but doctors don't typically use it to screen for or diagnose the disease, " says Christopher Saudek, M.D., professor of endocrinology and metabolism at the Johns Hopkins University School of Medicine and director of the Johns Hopkins Comprehensive Diabetes Center. "There's reason to believe it could help identify many of the estimated six million people in the U.S. who have diabetes but don't know it," he adds. The current screening and diagnostic tests measure only the amount of sugar present at the moment that blood sample is taken. Consequently, Saudek says, these tests are accurate only if patients fast for at least 10 hours before the test because glucose concentrations can vary greatly depending on a person's recent meals.

Even then, explains Saudek, the tests miss a significant portion of people who have diabetes or are at high risk to develop the disease since glucose also varies depending on a person's diet and exercise regimen for several days leading up to the blood draw.

"If a patient is scheduled for a physical, he or she may 'tune up' by changing their regimen for a few days and throw off their test results, causing doctors to miss the patient's usual pattern of high blood sugar," he says.

In a consensus statement published in the July Journal of Clinical Endocrinology and Metabolism, Saudek and his colleagues conclude that the HbA1c test should be used as a front-line method for identifying patients with diabetes, especially for those at high risk for the disease. Since the test does not require fasting and isn't affected by short-term changes in diet and exercise, the HbA1c test has significant advantages to current testing methods.

The consensus was reached by a group of diabetologists, pathologists and internists seeking to improve detection methods because of the serious consequences of untreated diabetes for patients and public health. They met recently in Chicago with financial support from Metrika Inc., a major manufacturer of diabetes testing equipment. The panel deliberations and manuscript preparation were made independently of the sponsor, according to its members.

After reviewing relevant published studies and available tests, the national panel recommended that individuals who score at least 6 percent on an HbA1c test may have or be at risk for diabetes and should be tracked with additional glucose or HbA1c tests. Those who score between 6.5 percent or above, if confirmed, should be considered to have diabetes.

"This is a first step towards changing medical practice," notes Saudek, and "could greatly enhance how well we're able to identify people with diabetes."

Others who contributed to the consensus statement include William H. Herman of the University of Michigan School of Medicine, David B. Sacks of Brigham & Women's Hospital and Harvard Medical School, Richard M. Bergenstal of the International Diabetes Center, David Edelman of Durham Veterans Administration Medical Center and Duke University, and Mayer B. Davidson of Charles R. Drew University.