Researchers Discover Strategy for Predicting the Immunity of Vaccines

In the first study of its kind, researchers at the Yerkes National Primate Research Center and Emory Vaccine Center, Emory University, have developed a multidisciplinary approach involving immunology, genomics and bioinformatics to predict the immunity of a vaccine without exposing individuals to infection. This approach addresses a long-standing challenge in the development of vaccines—that of only being able to determine immunity or effectiveness long after vaccination and, often, only after being exposed to infection.

The study, which used the yellow fever vaccine (YF-17D) as a model, is available in the online edition of Nature Immunology and represents a long awaited step forward in vaccine immunology and predictive health.

YF-17D is one of the most successful vaccines ever developed and has been administered to nearly half a billion people over the last 70 years.

"A single shot of the vaccine induces immunity in many people for nearly 30 years,” says Bali Pulendran, PhD, lead Yerkes researcher of the study and professor in the Department of Pathology and Laboratory Medicine at Emory University School of Medicine. “Despite the great success of the yellow fever vaccine, little has been known about the immunological mechanisms that make it effective,” he continues.

Pulendran’s team, including graduate student Troy Querec, PhD, in collaboration with Rafi Ahmed, PhD, director of the Emory Vaccine Center, Eva Lee, PhD, director of the Center for Operations Research in Medicine and Healthcare at Georgia Institute of Technology and Alan Aderem, PhD, Institute for Systems Biology in Seattle, sought to determine what makes such a vaccine effective so researchers can design new vaccines against global pandemics and emerging infections that repeat the success of this model vaccine.

The researchers used YF-17D to predict the body’s ability shortly after immunization to stimulate a strong and enduring immunity. Researchers vaccinated 15 healthy individuals with YF-17D and studied the T cell and antibody responses in their blood. There was a striking variation in these responses between individuals. Analysis of gene expression patterns in white blood cells revealed in the majority of the individuals the vaccine induced a network of genes involved in the early innate immune response against viruses.

A major challenge in the study involved the identification of discriminatory gene signatures—among over 50,000 genes—that can predict the responses of T cells and antibodies. Lee has developed powerful modeling, computational feature selection and predictive tools that overcome shortcomings of existing techniques, which often have limited ability to handle data sets involving heterogeneous, large-scale, ill-separated and mixed biological and medical data. Her approach offers a very robust classification framework that effectively handles such data sets and derives a classifier that often provides higher prediction accuracy and lower misclassification errors than classifiers derived from other methods.

"Using such a bioinformatics approach, we were able to identify distinct gene signatures that correlated with the T cell response and the antibody response induced by the vaccine,” says Pulendran. “To determine whether these gene signatures could predict immune response, we vaccinated a second group of individuals and were able to predict with up to 90 percent accuracy which of the vaccinated individuals would develop a strong T or B cell immunity to yellow fever,” continues Pulendran.

Pulendran and his colleagues are now working to determine whether this approach can be used to predict the effectiveness of other vaccines, including flu vaccines. The ability to successfully predict the immunity and effectiveness of vaccines would facilitate the rapid evaluation of new and emerging vaccines, and the identification of individuals who are unlikely to be protected by a vaccine.

"This type of research is essential to answer fundamental questions that can lead to better vaccinations and prevention of disease. Yerkes, as one of only eight National Institutes of Health–designated national primate research centers, is uniquely positioned to carry out such diverse research,” says Stuart Zola, PhD, director, Yerkes Research Center.


Funding for this study was provided in part by the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH), as part of the U19 Cooperative Centers for Translational Research on Human Immunology and Biodefense. Dr. Lee’s research is supported partially by the National Science Foundation, and the National Center for Research Resources at the National Institutes of Health, as part of the U54 Clinical and Translational Science Awards.

Reference: Systems biology approach predicts immunogenicity of the yellow fever vaccine in humans. Nature Immunology, early online publication. Troy D. Querec, Rama S. Akondy, Eva K. Lee, Weiping Cao, Helder I. Nakaya, Dirk Teuwen, Ali Pirani, Kim Gernert, Jiusheng Deng, Bruz Marzolf, Kathleen Kennedy, Haiyan Wu, Soumaya Bennouna, Herold Oluoch, Joseph Miller, Ricardo Z. Vencio, Mark Mulligan, Alan Aderem, Rafi Ahmed and Bali Pulendran.

The Center for Operations Research in Medicine and HealthCare, founded in 1999 with partial support from the National Science Foundation and the Whitaker Foundation, is a collaborative education and research center established between the School of Industrial and Systems Engineering at Georgia Institute of Technology and medical and healthcare researchers in different disciplines. The Center’s mission is to foster interdisciplinary education and research efforts involving the development and application of sophisticated techniques from the field of operations research to problems in medicine and healthcare.
Focusing on biomedicine and health systems, researchers in the center perform systems modeling, design and develop algorithms and software, and utilize decision theory analysis to advance various domains within medicine. Specific research areas include computational genomics, health risk prediction, disease diagnosis and early detection, optimal treatment strategies and drug delivery, healthcare outcome analysis and treatment prediction, public health and medical preparedness, large-scale medical decision analysis, quality improvement and clinical operations management.

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Do You Know You're Having a Stroke?

/PRNewswire-USNewswire/ -- A Mayo Clinic study shows a majority of stroke patients don't think they're having a stroke -- and as a result -- delay seeking treatment until their condition worsens. The findings appear in the current issue of Emergency Medicine Journal at http://emj.bmj.com/.

Researchers studied 400 patients who were diagnosed at Mayo Clinic's emergency department with either acute ischemic stroke or a transient ischemic attack (TIA), a temporary interruption of blood flow to part of the brain.

Less than half of the patients -- 42 percent -- thought they were having a stroke. In fact, most in the study did not go to the emergency room when symptoms appeared. The median time from onset of symptoms to arrival at the hospital was over three and a half hours. Most said they thought the symptoms would simply go away. The delay in seeking medical help was the same among men and women.

When asked how they knew about stroke symptoms, nearly one-fifth said they thought a stroke always came on gradually. Just over half (51.9 percent) said they thought that seeking medical care immediately was important.

Significance of the findings

"Time is crucial in treating stroke," says Latha Stead, M.D., emergency medicine specialist and lead author of the study. "Each individual's medical background differs and affects recovery, but in general the sooner a patient experiencing a stroke reaches emergency care, the more likely the stroke can be limited and the condition managed to prevent further damage and improve recovery." The researchers say their findings clearly indicate that better public understanding of stroke symptoms will lead to a faster response and better outcomes.

What you should know

Strokes can happen quickly or can occur over several hours, with the condition continually worsening. The thrombus or clot that is causing the stroke can frequently be dissolved or disintegrated so blood can again flow to the brain. In such cases, immediate treatment can mean the difference between a slight injury and a major disability. Interestingly only 20.8 percent of the participants knew about such treatment. By use of stents, medications and other technology, physicians can stop a stroke from spreading and greatly limit damage. Stroke symptoms include:

* Sudden numbness, weakness, or paralysis of your face, arm or leg -- usually on one side of the body

* Sudden difficulty speaking or understanding speech (aphasia)
* Sudden blurred, double or decreased vision
* Sudden dizziness, loss of balance or loss of coordination

* A sudden, severe "bolt out of the blue" headache or an unusual headache, which may be accompanied by a stiff neck, facial pain, pain between your eyes, vomiting or altered consciousness

* Confusion or problems with memory, spatial orientation or perception

In such cases, a stroke gives no warning. But one possible sign of an impending stroke is a TIA. The signs and symptoms of TIA are the same as for a stroke, but they last for a shorter period -- several minutes to a few hours -- and then disappear, without leaving apparent permanent effects. You may have more than one TIA, and the signs and symptoms may be similar or different. A TIA indicates a serious risk that a full-blown stroke may follow.

Other Mayo researchers involved in the study were Lekshmi Vaidyanathan, M.B.B.S.; Maria Bellolio, M.D.; Rahul Kashyap, M.B.B.S.; Anjali Bhagra, M.B.B.S.; Rachel Gilmore, M.B.B.Ch.; Wyatt Decker, M.D.; Sailaja Enduri, M.B.B.S.; Shaily Mishra, Ph.D.; Helen Wood, R.N.; Ayman Yassa, M.D.; Ann Hoff, M.D.; and Robert Brown, M.D. Dr. Stead is supported by the Mayo Emergency Medicine Research Career Development Award and Mayo Clinic.

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Exercise Helps Overweight Children Reduce Anger Expression

Regular exercise seems to reduce anger expression in overweight but otherwise healthy children, researchers said.

The first published study on the topic looked at 208 typically sedentary 7- to 11-year-olds who participated in a 10-15 week afterschool aerobic exercise program or maintained their usual inactive routine. The Pediatric Anger Expression Scale, used to gauge common anger expressions such as slamming doors and hitting, was given before and after the program.

"Exercise had a significant impact on anger expression in children," said Dr. Catherine Davis, clinical health psychologist in the Medical College of Georgia School of Medicine. "This finding indicates that aerobic exercise may be an effective strategy to help overweight kids reduce anger expression and aggressive behavior."

The finding fits with evidence that exercise reduces depression and anxiety in children and with what's considered common knowledge that exercise helps adults manage anger, she said.

It also gives parents and other caregivers another reason to get and keep children moving. "I think it's reasonable to encourage children to exercise for a lot of good reasons," said Dr. Davis whose research on overweight children has shown regular physical activity not only reduces fatness but improves cognition and reduces insulin resistance – which can lead to diabetes.

"I think if teachers could see that exercise helps kids control their behavior and get along, they would be the top proponents of physical activity for kids," said Dr. Davis, noting that other studies suggests overweight children are more likely to be bullies and to be bullied. High levels of anger and hostility have been associated with delinquency in children, cardiovascular disease in adults and metabolic syndrome - which can lead to heart attack, stroke and diabetes - in adolescents.

The new finding, published in the November issue of Pediatric Exercise Science, appears to apply to overweight children generally, regardless of factors such as race, gender, socioeconomic status or even fitness or fatness levels, the researchers wrote. In fact, even though all participants in the exercise portion lost a significant amount of weight, they remained overweight at the study's conclusion.

With help from a five-year $3.6 million grant from the National Heart, Lung and Blood Institute, Dr. Davis already is looking to see if the finding holds in a similar group of children, who are part of a study on the impact of exercise on cognition. The goal is to determine if it was the exercise or participation in an after-school program that made the difference.

Extra attention from adults and time away from usual routines that could include disagreements with siblings and watching violence on television definitely could have a psychological impact. "With a psychological outcome like cognition or anger control, positive interaction with adults can make a big difference," Dr. Davis said.

In the published study, only the exercising children came to MCG's Georgia Prevention Institute after school. In the new study, both groups are coming to the institute, with non-exercisers enjoying arts, crafts and games. "We are trying to make it so the only difference is exercise," said Dr. Davis.

By Toni Baker
Medical College of Georgia

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Mayo Researchers Explore Issues Related to Multiple Myeloma Treatment

Multiple myeloma (MM) is a cancer of plasma cells that affects approximately 3 in 100,000 people each year. Although there is no cure for this disease, researchers have developed treatments that help relieve pain, control complications, and slow the progress of MM in many patients. Unfortunately, some of the most effective therapies also have toxic side effects that can pose serious health risks and reduce quality of life. In the October issue of Mayo Clinic Proceedings, two articles authored by Mayo researchers address the issue of how to balance the risks and benefits associated with MM treatments.

Outpatient vs. Inpatient Stem Cell Transplants

Since the 1990s, autologous stem cell transplant (ASCT) has become a standard treatment for many patients with MM. This treatment involves using high-dose chemotherapy along with transfusion of previously collected immature blood cells (stem cells) to replace diseased or damaged marrow. While ASCT often provides an effective method of controlling MM, hospitalized patients receiving this treatment are at increased risks for complications such as hospital-acquired infections, some of which are potentially fatal. In addition, the hospital care necessary to treat these complications can be costly.

In a brief report, Mayo researchers led by Mayo Clinic hematologist Morie Gertz, M.D., share study data that demonstrates the benefits of offering stem cell transplantation for MM patients in an outpatient setting. In this study, the Mayo research team followed 716 patients undergoing stem cell transplant for MM at Mayo Clinic from Jan. 1, 2000 through Oct. 31, 2007.

Not all of the MM patients studied were eligible for outpatient treatments, and some required hospitalization after ASCT began due to complications. Of the 716 BMT patients studied, 278 patients (39 percent) completed the transplant procedure as outpatients. The Mayo researchers noted that patients who received this care as outpatients had a high survival rate (99 percent at 100 days). And among those patients who began the treatment as outpatients but required some hospital care, the median hospitalization period was only four days.

"Our experience shows that outpatient transplant is feasible for all patients with multiple myeloma and results in shorter hospital stays and low treatment-related mortality rates," writes Dr. Gertz.

Other authors on this article include Stephen Ansell, M.D., Ph.D.; David Dingli, M.D., Ph.D.; Angela Dispenzieri, M.D.; Francis Buadi, M.D.; Michelle Elliott, M.D.; Dennis Gastineau, M.D.; Suzanne Hayman, M.D.; William Hogan, M.B.B.CH.; David Inwards, M.D.; Patrick Johnston, M.D., Ph.D.; Shaji Kumar, M.D.; Martha Lacy, M.D.; Ivana Micallef, M.D.; Luis Porrata, M.D.; Barbara Schafer and Mark Litzow, M.D., from Mayo Clinic's Division of Hematology; Nelson Leung, M.D., from Mayo Clinic's Division of Nephrology and Hypertension; and Robert Wolf, Ph.D., from Mayo Clinic's Hospital Pharmacy Services.

Cure vs. Control

In a related commentary, Mayo hematologist S. Vincent Rajkumar, M.D., discusses the need to re-examine the goals of clinical research and treatment for patients with MM. Given that MM is generally considered to be incurable, Dr. Rajkumar poses two important questions about treatment goals:

"Should we treat patients & with the goal of potentially curing a subset of patients, recognizing that the risk of adverse events and effect on quality of life will be substantial? Or should we address myeloma as a chronic incurable condition with the goal of disease control, using the least toxic regimens, emphasizing a balance between efficacy and quality of life &?"

Dr. Rajkumar explains that for decades, this "cure vs. control" debate was not necessary because it was assumed that a cure was unattainable. However, since the 1990s, several new effective combination treatments have emerged and produced impressive results. While these advances are encouraging, Dr. Rajkumar advises that treatment decisions must still take into account patients' needs, goals and attitudes toward overall survival vs. quality of life.

"Although cure is the ultimate goal of our long-term research, we need more data from randomized trials before resorting to highly intense therapy that is more toxic and unlikely to lead to a cure outside the setting of a clinical trial."

A peer-review 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
Mayo Clinic Proceedings.
http://www.mayoclinic.org/news2008-rst/5015.html?src=email-release
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FDA Approves Tapentadol Immediate-Release Tablets for Relief of Moderate to Severe Acute Pain

/PRNewswire/ -- Millions of Americans with moderate to severe acute pain and their health-care providers will soon have a new treatment option. Today, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., (J&JPRD), announced that the U.S. Food and Drug Administration (FDA) approved tapentadol immediate-release tablets for the relief of moderate to severe acute pain in adults 18 years of age or older.

Tapentadol is a new centrally acting oral analgesic. It has two mechanisms of action, combining mu-opioid receptor agonism and norepinephrine reuptake inhibition.

Tapentadol tablets have been approved in 50 mg, 75 mg and 100 mg doses.

The approval was based on data from clinical studies involving more than 2,100 patients. The studies, which were presented at the 27th Annual Scientific Meeting of the American Pain Society earlier this year, showed that tapentadol provided significant relief of moderate to severe acute pain compared to placebo.

Following today's FDA approval, and as per Federal regulation for all controlled substances, tapentadol will be reviewed by the U.S. Drug Enforcement Agency for scheduling, and it cannot be sold until it receives a scheduling classification.

A trade name for tapentadol has not yet been determined.

"We are pleased with the FDA's approval today. Tapentadol represents a new treatment option in pain management, and I am excited that we are able to bring this new choice to patients who are suffering from pain," said Joanne Waldstreicher, M.D., Global Head, Research and Development for CNS/Internal Medicine, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

More than 25 million Americans experience acute pain each year as a result of injuries or surgery, and it is the most common reason people seek medical attention.

"We welcome new proven options that can help people with pain," said Mark Rasmussen, President/CEO, The National Pain Foundation, Denver, CO.

PriCara(R), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., will market tapentadol in the United States. J&JPRD and Ortho-McNeil-Janssen Pharmaceuticals, Inc. are wholly owned subsidiaries of Johnson & Johnson.

Approval Based on Results of Phase 3 Studies

Multiple Phase 3 studies presented at the 27th Annual Scientific Meeting of the American Pain Society in May showed tapentadol offers patients significant relief of their pain when compared to placebo, and that the medicine was generally well tolerated in these studies.

The studies were conducted in different patient groups, including those who had a bunionectomy, a standard foot surgery associated with predictable levels of moderate to severe pain, and in those with pain from end-stage joint disease.

At the same meeting, a Phase 3 safety study of tapentadol immediate-release tablets was presented. This study evaluated tapentadol in patients with low back pain or pain from osteoarthritis of the hip or knee. It demonstrated that tapentadol offers pain relief and is generally well tolerated. (http://www.jnj.com/connect/news/all/20080509_160001)

Two Mechanisms of Action

Mu-opioid agonists are drugs that bind to and activate mu-opioid receptors in the central nervous system. These drugs modify sensory and affective aspects of pain, inhibit the transmission of pain at the spinal cord and affect activity at parts of the brain that control how pain is perceived. Norepinephrine reuptake inhibitors are a type of central nervous system medication that increases the level of norepinephrine in the brain by inhibiting its re-absorption into nerve cells; these compounds have analgesic properties.

IMPORTANT SAFETY INFORMATION

Tapentadol is contraindicated in any situation where mu-opioid agonists are contraindicated (i.e., significant respiratory depression, acute or severe bronchial asthma or hypercapnia); in patients with paralytic ileus; or in patients currently using or within 14 days of using monoamine oxidase inhibitors (MAOI).

Due to its mu-opioid receptor agonism, respiratory depression is a possible adverse event of tapentadol. Tapentadol should be administered with caution to the elderly, debilitated patients, and patients with conditions accompanied by hypoxia, hypercapnia or decreased respiratory reserve such as: asthma, chronic obstructive pulmonary disease or cor pulmonale, severe obesity, sleep apnea syndrome, myxedema, kyphoscoliosis, CNS depression, or coma. Patients receiving other mu-opioid agonist analgesics, general anesthetics, phenothiazines, other tranquilizers, sedatives, hypnotics, or other CNS depressants (including alcohol, opioids or illicit drugs) concomitantly with tapentadol may exhibit an additive CNS depression. Interactive effects resulting in respiratory depression, hypotension, profound sedation, or coma may result if these drugs are taken in combination with tapentadol. When such combined therapy is contemplated, a dose reduction of one or both agents should be considered.

Like other drugs with mu-opioid agonist activity, tapentadol should not be used in patients susceptible to increased intracranial pressure, impaired consciousness, or coma. It should be used with caution in patients with head injury, intracranial lesions, or other sources of preexisting increased intracranial pressure. Tapentadol should be used with caution in patients with pancreatic or biliary tract disease, and moderate hepatic impairment. Because elderly patients are more likely to have decreased renal and hepatic function, consideration should be given to starting elderly patients with the lower range of recommended doses.

Tapentadol can be abused in a manner similar to other mu-opioid agonists, legal or illicit. This should be considered when prescribing or dispensing tapentadol in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. Abuse of tapentadol poses a risk of overdose and death. This risk is increased with concurrent abuse of tapentadol with alcohol and other substances. Monitor patients closely for signs of abuse and addiction.

Tapentadol may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Tapentadol should be prescribed with care in patients with a history of a seizure disorder or any condition that would put the patient at risk of seizures.

The development of a potentially life-threatening serotonin syndrome may occur with use of SNRI products, including tapentadol, particularly with concomitant use of serotonergic drugs such as SSRIs, SNRIs, TCAs, MAOIs and triptans, and with drugs which impair metabolism of serotonin (including MAOIs).

The most common adverse events (greater than or equal to 10% in any tapentadol dose group) in clinical trials were nausea, dizziness, vomiting, somnolence and headache.

For information about the package insert for tapentadol, consult the FDA Web site.

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Final Rule Issued for Patient Safety Organizations

The U.S. Department of Health and Human Services has issued a final rule
for Patient Safety Organizations (PSOs).

The rule becomes effective on Jan. 19, 2009. It provides final
requirements and procedures for PSOs, new entities, with which
clinicians and health care providers can work to collect, aggregate and
analyze data -- within a legally secure environment of privilege and
confidentiality protections -- to identify and reduce patient care risks
and hazards.

"I expect the final rule and the creation of Patient Safety
Organizations to greatly improve the quality of health care for all
Americans," HHS Secretary Mike Leavitt said. "By making it easier for
clinicians and health care organizations to report and learn from
adverse events without fear of new legal liability, we will be able to
improve our nation's health care systems and minimize factors that can
contribute to mistakes."

Under interim guidance issued on Oct. 8, AHRQ has already listed 15
PSOs. During the remainder of the interim period, these organizations
will maintain their status as PSOs. However, these and other PSOs listed
throughout the interim period are expected to comply with the final rule
once it takes effect.

"The Patient Safety Organization final rule describes the clear, legally
protected framework for how hospitals, clinicians, and health care
organizations can work together to improve patient safety and the
quality of care nationwide," said AHRQ Director Carolyn M. Clancy, M.D.

The listing of PSOs is authorized by the Patient Safety and Quality
Improvement Act of 2005 (Patient Safety Act). The Patient Safety Act is
intended to encourage voluntary, provider-driven initiatives to improve
the safety of health care through the establishment of legal protections
to ensure that providers who report patient safety information do not
incur new legal liability; to promote rapid learning about the
underlying causes of risks and harms in the delivery of health care; and
to share those findings widely, thus speeding the pace of improvement.

The final rule is consistent with many of the provisions of the proposed
rule issued on Feb. 12. However, it also includes new requirements for
PSOs, such as:

* The requirement that a PSO notify providers if the patient
safety work product it submits is inappropriately disclosed or its
security is breached
* Requirements for how a component PSO maintains separation
between itself and its parent organization(s) have been made more
flexible.

The final rule also makes several important changes from those in the
proposed rule regarding the listing and delisting of PSOs and the ways
in which PSOs must comply with statutory requirements, including:

* Expansion in the types of entities and organizations excluded
from listing as PSOs
* Revisions to how PSOs should disclose certain relationships with
health care providers
* Increased flexibility in how PSOs can store patient safety work
product
* Automatic expiration of Departmental listing after 3 years
unless a PSO's listing is continued by the Secretary and
* An expedited delisting process for PSOs in a limited number of
serious circumstances

AHRQ administers provisions dealing with PSO operations, and the HHS
Office for Civil Rights (OCR) enforces confidentiality provisions. The
final rule addresses concerns regarding how providers may efficiently
collect and analyze patient safety event information with privilege and
confidentiality protections while complying with existing reporting
requirements that seek similar information.

"OCR is pleased to partner with AHRQ to protect and ensure the
confidentiality of the information used by providers and PSOs to improve
the safety and quality of patient care nationwide," said OCR Director
Winston Wilkinson.

To read the final rule and access more information about PSOs, including
background on the rulemaking process, visit AHRQ's PSO Web site at
www.pso.ahrq.gov. Additional information about the confidentiality and
disclosure of patient safety work product may be found at OCR's Web site
at www.hhs.gov/ocr/psqia/.

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FDA Acts to Avoid Shortage and Strengthen the Safety of Sucraid

The U.S. Food and Drug Administration today issued an expedited approval of a supplemental application that allows for changes in the manufacturing of Sucraid (sacrosidase) Oral Solution. The approval will prevent a product shortage by allowing the sole manufacturer of the drug, QOL Medical, to obtain Sucraid's active ingredient from a different manufacturer.

Sucraid provides drug replacement therapy for patients that have been diagnosed with a congenital (inherited) disease called Congenital Sucrase-Isomaltase Deficiency (CSID). Worldwide, approximately 400 CSID patients have been prescribed Sucraid, 140 in the United States alone. Patients who suffer from CSID lack the necessary enzyme sucrase located in their gut that is required to digest sucrose (table sugar) which is in many foods. A lack of this enzyme causes diarrhea, abdominal pain and severe cramping when eating these products. Sucraid enables them to digest sucrose containing foods more readily.

To avoid interruptions in treatment, on Oct. 24, 2008, the agency authorized QOL Medical to provide the newly manufactured product to patients prior to the FDA's final action on the manufacturing supplement. The FDA also has taken new steps to protect the patients who use this treatment. The agency is requesting the company implement measures designed to evaluate the risks of adverse events associated with the new supply of Sucraid.

"The FDA has expedited its approval of the newly manufactured Sucraid," said Julie Beitz, M.D., director, Office of Drug Evaluation III, the FDA's Center for Drug Evaluation and Research. "However the manufacturing changes could lead to more frequent allergic reactions. To continue our rigorous oversight, FDA is requiring the manufacturer to inform prescribers and patients of the changes, and conduct a postmarketing study."

Sucraid, was originally approved by the FDA as an orphan drug on April 9, 1998. CSID is found amongst Alaska Natives and people from Nordic populations. Some patients are as young as 5 months old.

The FDA is concerned that the newly manufactured Sucraid may contain increased levels of papain, an enzyme known to cause allergic reactions in some people. Papain could be introduced into the drug via the manufacturing process of its active ingredient, sacrosidase, a disaccharide-cleaving enzyme isolated from the yeast Saccharomyces cerevisiae. In order to extract the enzyme, the yeast cell wall is digested with papain, a proteolytic enzyme obtained from the papaya fruit. Papain is introduced early in the manufacturing process, and later removed by subsequent process steps. The new manufacturing process provides for an increased amount of papain used to digest the yeast cell wall. Since no tests for papain in the drug are performed either during manufacture or at release, FDA cannot exclude the fact that some level of papain contamination of the drug substance may be present.

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CHS and Georgia Tech Announce Completion of Workforce Health Assessment Model

(BUSINESS WIRE)--Workforce illnesses are among the most costly expenses for employers, with billions of dollars lost each year in time, productivity and associated treatment.

Determining the most common illnesses affecting the workplace—and the best strategies to reduce these risks—is the goal of a new health assessment model developed by Comprehensive Health Services, Inc. (CHS), a leading national workforce health management company, and the Health Systems Institute (HSI) at Georgia Tech and Emory University.

A first-of-its-kind project, the Workforce Health Assessment Model (WHAM) is currently in use with select CHS clients. WHAM provides the ability to estimate various health risks in the workplace and assists in finding cost-effective strategies to reduce those risks and the burdensome long-term costs.

“By identifying the prevalence of the most expensive medical conditions faced by employees, our model enables organizations to proactively analyze the cost-effectiveness of various health programs and strategies, in particular, programs designed to prevent and/or reduce those risks,” said Leanne Metcalfe, Ph.D., a research engineer with HSI whose thesis work formed the basis for the model.

WHAM represents an opportunity not only for employers, but researchers aiming to map out research models that analyze and anticipate various trends.

“For the academic community, it provides a template of how abstract statistical research in predictive modeling meets challenges of real-life tests for its quality and performance,” said Brani Vidakovic, Professor of Bioengineering Statistics at The Wallace H. Coulter Department of Biomedical Engineering and an HSI researcher notes. “I am pleased to see that WHAM meets these challenges and we at HSI are committed to support and further fine-tune the model.”

With the project now complete, the model will enter its second phase of development, which involves CHS and Georgia Tech researchers enhancing and refining the model. Planned improvements include incorporating richer demographic data, enabling meta-analysis by geographic region and industry type, and support for real-time updates.

“CHS is investing in this remarkable project because we believe that onsite health centers can greatly impact the cost and quality of care for employees, retirees and dependents,” said Mel Hall, CEO of CHS. “Armed with this important tool, our customers are discovering new ways to utilize preventive measures and improve the health of an employee population, such as lowering the rate of chronic diseases. We are proud to offer WHAM to our clients as we expand into our high-growth international market.”

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FDA Approves New Drug to Treat Severe Form of Epilepsy

The U.S. Food and Drug Administration has approved a new drug, Banzel (rufinamide), for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome.

"This approval offers another treatment option for patients who suffer from these debilitating, severe seizures," said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research.

Lennox-Gastaut syndrome is a severe form of epilepsy that usually begins before 4 years of age, and can be caused by brain malformations, severe head injury, central nervous system infection and inherited degenerative or metabolic conditions. In 30-35 percent of cases, no cause can be found. Patients may have periods of frequent seizures mixed with brief, relatively seizure-free periods; and suffer from varying types of seizures including tonic (stiffening of the body, upward deviation of the eyes, dilation of the pupils, and altered respiratory patterns), atonic (brief loss of muscle tone and consciousness, causing abrupt falls), atypical absence (staring spells), and myoclonic (sudden muscle jerks).

Most children with Lennox-Gastaut syndrome experience some degree of impaired intellectual functioning or information processing, along with developmental delays and behavioral disturbances.

In a single four-month clinical trial studying patients 4 to 30 years old, patients taking Banzel had improved seizure control when compared to those taking placebo. The observed effect was approximately a 41 percent reduction of tonic plus atonic seizure frequency over placebo and 20 percent reduction of total seizure frequency over placebo. In addition, overall improvement was reported as measured by a parent/guardian evaluation.

Common adverse reactions reported by patients using Banzel in clinical trials included headache, dizziness, fatigue, drowsiness, gait disturbance, double-vision, nausea and vomiting. Banzel's labeling will include a warning that antiepileptic drugs increase the risk of suicidal thoughts or behaviors in patients taking the drug for any indication. Patients taking antiepileptic drugs should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and unusual changes in mood or behavior. This warning is based on the results of analyses performed by the FDA on nearly 200 controlled clinical trials with 11 FDA-approved antiepileptic drugs. Banzel was not included in these analyses, but the results are considered to apply to all chronically administered antiepileptic drugs, including Banzel. As discussed at a July 2008 public advisory committee meeting, the FDA is working with manufacturers of all antiepileptic drugs to include similar warning statements in prescribing information. The FDA is requiring that a patient Medication Guide be given to patients and caregivers when Banzel is dispensed. The Medication Guide will describe the risk of suicidal thoughts and behavior associated with the class of antiepileptic drugs.

Banzel is manufactured by Eisai Medical Research Inc., Woodcliff Lake, N.J.

Banzel 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 fewer than 200,000 people in the United States. This designation can also be extended to drugs for diseases or conditions that affect a larger number of patients if there is no reasonable expectation that the cost of developing such medications and making them available will be recovered from sales.

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New Cytogenetics Tests Can Help Clarify Pediatric Diagnosis of Complex Developmental Abnormalities

Breakthroughs in cytogenetic technologies, which focus on subtle alterations in genes and chromosomes, are enabling a new level of detail and accuracy in the diagnosis of complex and unexplained developmental problems in children.

The availability of this new information can help clinicians shift to a "genotype first" model of diagnosis, according to David H. Ledbetter, PhD, Woodruff professor of human genetics at Emory University and director of the Division of Medical Genetics.

Ledbetter's editorial on "Cytogenetic Technology--Genotype and Phenotype," is published online this week by the New England Journal of Medicine. It accompanies an article by Heather Mefford and colleagues about using new cytogenetic technologies to identify microdeletions and microduplications in a specific region of chomosome 1q21.1 in patients with unexplained mental retardation, autism or congenital anomalies

Cytogenetic arrays that reveal DNA microdeletions and additions, including single-copy changes of a few hundred base pairs, beadchips that detect single-nucleotide polymorphisms (SNPs) and tests called comparative genomic hybridization have led to an exciting renaissance of genetics-based syndrome delineation, says Ledbetter in his editorial.
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"In the early 1960s we began discovering the relationship between chromosome imbalance and diseases and syndromes, such as Down syndrome," says Ledbetter. "This was based on identifying multiple patients with the same cytogenetic abnormality and similar clinical symptoms. Ever since then, technology breakthroughs have allowed us to identify new syndromes and ever more subtle genetic differences."

The current proliferation of new genetic information has led researchers to discover that many small genetic variations are common and mostly benign in the human population. This means the relationship between DNA variations and disease must be analyzed even more carefully in order to find accurate connections. In order to prove that a genetic difference is directly related to a particular syndrome, notes Ledbetter, researchers must show that the difference is never found in normal control individuals or at least is found with significantly less frequency.

Also, researchers have found that a particular genetic variation may have only a mild effect in a parent but a much more severe effect in a child who inherits the same variant. And a group of children may have a variety of different problems resulting from the same gene variation. Whole-genome cytogenetic arrays are becoming much more common, however, which is bringing genetic testing to the level of everyday medicine.

"So many variations of developmental disorders and syndromes have been discovered that genetic testing has become essential for making a specific clinical diagnosis," says Ledbetter. "Although more information has made the job of a diagnostician even more challenging, it also is leading to more accurate diagnoses and should lead to much more effective treatments."
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Where a Woman Lives May Affect Her Risk for Preterm Birth, Study Finds

Unique characteristics that distinguish one city from another -- such as region, size and local economy -- may impact preterm birth rates among U.S. women, according to a study in the September-October 2008 issue of Public Health Reports.

These city characteristics may also help to explain some of the long-observed, but poorly understood racial disparities that contribute to a higher preterm birth rate among black women in the U.S., says lead study author Michael Kramer, MS, MMSc, an epidemiology researcher at the Rollins School of Public Health, Emory University.

Kramer and team examined the impact of city size, region of the country, and differences in the economic and educational characteristics of 168 U.S. metropolitan cities on the very preterm (VPT) birth rate among white, black and Hispanic women. Very preterm birth is a birth that occurs before 32 weeks gestation. A full-term birth occurs at or after 37 weeks.

The study found that the city-to-city variation of very preterm births was higher among black women than white women. In each of the cities, black women experienced 2-3 times greater risk for very preterm birth than white women, Kramer says. The difference between highest- and lowest-risk cities for blacks was three times the difference between highest- and lowest-risk cities for whites.

"While it is well reported that there is an overall racial disparity in very preterm birth, this study is one of the first to look at the impact that cities may have on preterm births," says Kramer. "The size of the racial gap between black women and white women changed from one city to another, and suggests that there may be something about the actual places where these women live that could be intervened upon to lower women's risk for preterm birth."

The seven Georgia metropolitan areas included in the analysis mirrored the overall analysis with black women at higher risk for very preterm birth. The risk for VPT birth for white women varied from a low of 0.8 percent in Athens, Ga. to the highest at 1.4 percent in Macon, Ga., while the risk for black women varied from a low of 2.7 percent in Atlanta to the highest at 4.3 percent in Athens, Ga.

Very preterm birth is the leading cause of U.S. infant mortality and one of the strongest risk factors for pediatric disabilities such as cerebral palsy. Decades of research have identified a handful of preterm birth risk factors, but none of which explains the increased risk experienced by U.S.-born black women.

"We already know that public health efforts to reduce racial disparities in pregnancy outcomes must target individual needs," says Kramer. "Now we must also consider characteristics of the places women live if we are to eliminate racial disparities associated with preterm birth."

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In addition to Kramer, study authors included Carol Hogue, PhD, MPH, Jules and Deen Terry Professor of Maternal and Child Health, Department of Epidemiology, Rollins School of Public Health, Emory University, and director of the Women's and Children's Center, Rollins School of Public Health, Emory University.

The study was funded by the Health Resources and Service Administration (HRSA), a branch of the U.S. Department of Health and Human Services (HHS).

Reference: Public Health Reports, September-October 2008, Volume 123
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Single-Incision Laparoscopic Surgery Reduces Scars and Helps Patients Heal More Quickly

Several Emory Crawford Long Hospital surgeons are now using a single entry point in the abdominal wall to remove gallbladders, appendixes and parts of the colon, rather than the standard four to six skin incisions used during standard laparoscopic surgery.

Some weight-loss and reflux surgeries can also be performed using this single laparoscopic incision. Reducing the number of incisions will decrease scarring and chances of infection, while also helping the patient to heal more quickly.

The procedure, known as single-incision laparoscopic surgery, or SILS, allows surgeons to make one single incision, about a half of an inch in length, through the umbilicus, or belly button. Through that entryway, the surgeons place an access port, which holds their special cameras and instruments during surgery.

“Single-incision laparoscopic surgery is an evolving technology which is showing great promise for patients who need minimally-invasive surgery,” says Charles R. (Rick) Finley, MD, chief of general surgery at Emory Crawford Long Hospital and private practice community physician. “Because there are fewer incisions, there is less chance of infection, less scarring and better cosmetic results, meaning patients can recover faster.”

Laparoscopic surgery has been around for years, but the need to refine the technology is growing, according to experts. That means there is also a need for improved surgical equipment.

“We’ve been working closely with some of the device companies in hopes of helping them develop better instrumentation for SILS,” says Edward Lin, DO, assistant professor of surgery, Emory University School of Medicine and director of the Emory Endosurgery Unit, which oversees minimally-invasive surgery and training at Emory. “As we move forward, we expect to see this technique being applied to more and more general laparoscopic surgeries, hence the need for more efficient devices.”

In some cases, the surgeons may need to make a second, small incision in the patient’s abdomen to complete the surgery. Excess weight, severe adhesions, significant infection or prior surgeries might increase the need for a second incision.

Laparoscopic surgery, has in many cases, replaced the need for traditional open surgeries in the abdominal or pelvic cavities. The abdomen is usually insufflated, or distended like a balloon, with carbon dioxide to create a working and viewing space. The carbon dioxide is then removed at the end of the procedure. Because there is no large, open incision, patients can often go home the same day of their procedure or have only a short hospital stay.

In addition, some Emory University Hospital surgeons perform SILS.
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National Birth Defects Prevention Study Shows Assisted Reproductive Technology is Associated with an Increased Risk of Certain Birth Defects

Infants conceived with Assisted Reproductive Technology (ART) are two to four times more likely to have certain types of birth defects than children conceived naturally, according to a study by the CDC. The report, “Assisted Reproductive Technology and Major Structural Birth Defects, United States,” was released in the journal Human Reproduction.

“Today, more than 1 percent of infants are conceived through ART and this number may continue to increase,” says Jennita Reefhuis, Ph.D., epidemiologist at CDC′s National Center on Birth Defects and Developmental Disabilities. “While the risk is low, it is still important for parents who are considering using ART to think about all of the potential risks and benefits of this technology.”

The study shows that among pregnancies resulting in a single birth, ART (which includes all fertility treatments in which both eggs and sperm are handled, such as in vitro fertilization) was associated with twice the risk of some types of heart defects, more than twice the risk of cleft lip with or without cleft palate and over four times the risk of certain gastrointestinal defects compared with babies conceived without fertility treatments. Despite these findings, the absolute risk of any individual birth defect remains low. In the United States, cleft lip with or without palate affects approximately 1 in every 950 births; doubling the risk among infants conceived by ART would result in approximately 1 in every 425 infants being affected by cleft lip with or without palate.

The study examined multiple births separately from single births because ART increases the chance of a multiple birth. Children born as part of a multiple birth are more likely to have a birth defect regardless of use of ART. The study showed use of ART did not significantly increase the risk of birth defects among multiple births.

However, ART might contribute to the risk of major birth defects by directly increasing the risk of defects among single births. It may also have an indirect impact because ART increases the likelihood of having twins, which is a risk factor for many types of birth defects. Researchers believe this suggests the need for further studies to determine risk for ART in pregnancies with multiple births.

The study examined data from 281 births conceived with ART and 14,095 conceived without infertility treatments. The National Birth Defects Prevention Study is a population-based study that currently incorporates data from birth defects research centers in Arkansas, California, Georgia, Iowa, Massachusetts, New Jersey, New York, North Carolina, Texas and Utah. These ten centers have been working on the largest study of birth defects causes ever undertaken in the United States. Information is gathered from more than 30,000 participants to look at key questions on potential causes of birth defects. While the causes of most birth defects are unknown, studies show that smoking, alcohol, and obesity increase a mother's risk of having a child with a birth defect.

Since 1981, ART has been used in the United States to help women become pregnant. It is defined as any procedure that involves surgically removing eggs from a woman’s ovaries, combining them with sperm in the laboratory, and returning them to the woman’s body or donating them to another woman. ART does not include treatments in which only sperm are handled (i.e., intrauterine—or artificial—insemination) or procedures in which a woman takes medicine only to stimulate egg production without the intention of having eggs retrieved.

The number of infants born after ART doubled in the United States from 1996 through 2004. According to data from the 2002 National Survey of Family Growth, almost 12 percent of U.S. women aged 15-44 years have reported using infertility services. In 2005, more than 134,000 ART procedures were performed and approximately 52,000 infants were born as a result of these procedures.

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Alzheimer's Gene Slows Brain's Ability to Export Toxic Protein

PRNewswire-USNewswire/ -- The only known genetic risk factor for Alzheimer's disease slows down the brain's ability to export a toxic protein known as amyloid-beta that is central to the damage the disease causes, scientists have found.

The research, published Nov. 13 by the Journal of Clinical Investigation, provides new clues into the workings of a protein known as apolipoprotein E4, or ApoE4. People who carry two copies of the gene have roughly eight to 10 times the risk of getting Alzheimer's disease than people who do not.

The new results mark a step toward resolving a longstanding question that scientists have had about exactly how ApoE4 increases a person's risk for the disease. The findings point to differences in the way that amyloid-beta is removed from the brain depending on which ApoE protein is involved.

Scientists found that when ApoE4 is present, the brain is less efficient at ridding itself of the toxic material, because a molecule that is much slower at removing the substance becomes much more involved.

The new results are in line with a body of research amassed over the last 15 years by the leader of the team, Berislav Zlokovic, M.D., Ph.D., of the University of Rochester Medical Center, that blood circulation plays a key role in the disease. His team has identified much of the molecular machinery that allows amyloid-beta to sidestep the body's safeguards and enter the brain, and he has discovered molecules that falter when the toxic protein accumulates in the brain.

"Our latest findings help explain one of the major risk factors for Alzheimer's disease," said Zlokovic. "ApoE4 changes the brain's ability to rid itself of amyloid-beta. It's becoming more and more apparent that the brain's ability to clear out amyloid-beta, through the vascular system and across the blood-brain barrier, is central to the development of Alzheimer's disease."

In the latest work the Rochester team, working with colleagues at Washington University School of Medicine in St. Louis, found that a molecule known as very low-density lipoprotein receptor, or VLDLR, is an active - but slow - player in the removal of amyloid-beta from the brain. That step is crucial: Once amyloid-beta gets out of the brain and into the body, it can be eliminated easily.

"It's as if you have a pile of trash building up in the brain, and you need to move the trash away before it becomes toxic," said Rashid Deane, Ph.D., one of the authors of the paper and research professor of Neurosurgery at the University of Rochester Medical Center.

"We've known that the brain uses a molecule called LRP1, which is extremely efficient and acts like a fast ferry to remove amyloid-beta. Now we've found that there is another molecule involved, which works much more slowly, and it's especially active when amyloid is coupled to ApoE4," Deane added.

The team showed that speedy LRP1 is central to removing amyloid-beta when ApoE2 or ApoE3 is involved, with the slower VLDLR picking up some of the slack. But when the form of the gene that puts people at risk, ApoE4, is involved, VLDLR nearly alone is responsible for hauling the amyloid-beta away.

"It's like having a choice between a fast ferry and a slow ferry," said Deane. "For reasons we don't yet understand, when ApoE4 is involved, the slow ferry is used almost exclusively. This means that the amyloid-beta isn't removed as quickly as it otherwise would, potentially giving it a chance to accumulate, like we see in the brains of patients with Alzheimer's disease."

The team found that LRP1 is able to export amyloid from the brain about 20 times faster than VLDLR. Consequently, in mice with the more efficient versions of the ApoE protein, ApoE2 and ApoE3, amyloid is cleared out of the brain at a rate about twice or three times as fast as it is in mice with the ApoE4 protein. Amyloid deposits accumulate in the brains of mice with the ApoE4 protein in much higher amounts, about 10 to 15 times as much as in the brains of mice with either ApoE2 or ApoE3.

Not only do the ApoE proteins help determine how quickly amyloid-beta is removed from the brain; the proteins actually couple with amyloid-beta in the brain to form sticky complexes. This gunk gathers around cells and is much more difficult to remove from the brain than free-floating amyloid-beta. Companies are trying to develop drugs that would break up the relationship, freeing amyloid-beta and making it easier to remove from the brain.

The work described in the paper published in the Journal of Clinical Investigation was funded by a Senator Jacob Javits Award from the National Institute of Neurological Disorders and Stroke, and by the National Institute on Aging.

In addition to Zlokovic and Deane, other Rochester authors of the paper include instructor Abhay Sagare, Ph.D., who performed much of the research; technicians Katie Hamm, Margaret Parisi, and Steven Lane; and neuroscientist David Holtzman and graduate student Mary Beth Finn at Washington University School of Medicine.

Zlokovic is a founder of a company, Socratech, which is seeking to commercialize his team's discoveries about how amyloid-beta collects in the brain and how it might be removed more efficiently. He is also the Dean's Professor of Neurosurgery and Neurology and director of the Center for Neurodegenerative and Vascular Brain Disorders.

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HHS Issues Second Report on Personalized Health Care

HHS Secretary Mike Leavitt today released the second report from his
Initiative on Personalized Health Care, examining the potential for new
findings in genetics and other molecular-level medicine to improve the
quality and cost-effectiveness of health care.

The report, "Personalized Health Care: Pioneers, Partnerships,
Progress," includes reports from 10 institutions where personalized
health care techniques are beginning to be used. It also includes seven
commissioned papers examining the opportunities and challenges for
personalized health care from the perspectives of different stakeholders
in the health care sector.

"These sample case studies reflect a broad scope of approaches that are
already being tried, as well as partnerships for achieving higher levels
of effectiveness and personalization in health care," Secretary Leavitt
writes in a "Prologue" chapter in the report.

Personalized health care envisions medical care that is increasingly
differentiated between patients based on variations in their individual
biology. For example, differences in metabolism or other factors cause
a given prescription medication to work well with some individuals, but
not others. By measuring such individual variations in patients before
prescribing, drugs could be used more safely, effectively and at lower
cost.

Genetic and molecular medicine should also help spot diseases before
symptoms appear, enabling treatments to delay or preempt the disease and
avoid costly late-stage treatments. Personal genomic profiles may also
enable patients to learn their particular predisposition to disease and
take more effective disease prevention steps.

Secretary Leavitt says in the report that the potential for personalized
health care techniques to improve health and increase value in health
care make personalized health care a factor that should be targeted as
part of any plan to reform the nation's health care system. In
addition, current models of paying for health care, which reward volume
of care over value or quality, may hinder promising new avenues that
would avoid expensive late-stage treatments or prevent disease.

Secretary Leavitt launched his special Initiative on Personalized Health
Care in 2006. The report is available at www.hhs.gov/myhealthcare.

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New Biomarker for Heart Failure Identified

Blood levels of resistin, a hormone produced by fat cells, can independently predict an individual¿s risk of heart failure, cardiologists at Emory University School of Medicine have found.

Their findings were presented Nov. 12 at the American Heart Association Scientific Sessions conference in New Orleans.

"This is one of the strongest predictors of new-onset heart failure we've been able to find, and it holds up even when you control for other biomarkers and risk factors including high blood pressure and diabetes," says Javed Butler, MD, MPH, associate professor of medicine and director of heart failure research at Emory University School of Medicine.

The finding comes out of the Health ABC (Aging and Body Composition) study, sponsored by the National Institute on Aging of the National Institutes of Health. The Health ABC study followed 3000 elderly people in the Pittsburgh and Memphis areas over seven years starting in 1998.

Although scientists don't know the exact function of resistin, it appears to be associated with both inflammation and insulin resistance, says Vasiliki Georgiopoulou, MD, a post-doctoral research fellow with Butler who presented these findings. "Recent laboratory studies have also shown that resistin decreases the ability of rats¿ heart muscles to contract," she adds.

In the Health ABC study, the risk of new onset heart failure increased by 38 percent for every 10 nanograms per milliliter increase in resistin levels in blood. Resistin was a stronger predictor of heart failure risk than other inflammatory markers linked to heart disease, such as C-reactive protein, the researchers found.

"Considering the increasing number of people who are obese or have diabetes, very many of them are going to be at some level of risk for heart failure later in life," Butler says. "The value of a marker such as resistin may be in accurately identifying among this large population of at-risk individuals who is at the highest risk and then targeting interventions to those people."

Investigators from several institutions contributed to the study, including the University of Lausanne, Harvard Medical School, University of California San Francisco, University of Pittsburgh, Wake Forest University, Boston University and the National Institute on Aging.

About Emory Heart & Vascular Center Emory Heart & Vascular Center doctors are committed to providing clinically excellent cardiovascular patient care, pioneering innovative clinical research and training the best heart specialists in the world. A component of Emory Healthcare, the Center is consistently recognized by U.S. News & World Report as one of the top heart centers in the country. Emory Healthcare is the clinical arm of Emory University's Woodruff Health Sciences Center and is the largest, most comprehensive health care system in Georgia.

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Heart Association Call for Routine Screening of Heart Patients for Depresssion is Premature, Johns Hopkins Expert Says

A Johns Hopkins cardiologist well known for his studies on the links between depression and heart attack says there is not nearly enough evidence yet to support a recent call by the American Heart Association (AHA) to begin routine screening of millions of Americans for depression.

Roy Ziegelstein, M.D., says the September 2008 recommendation is "premature," and "a massive undertaking" that would consume a vast amount of clinic staff time and effort to analyze and follow-up on the questionnaires involved in screening, without a demonstrated benefit in improving patient care.

An estimated 80 million Americans have some form of heart disease.

Reporting on a collection of more than 1,500 clinical studies from around the world, from which 17 were selected for detailed review, Ziegelstein and his colleagues point to the absence of any scientific proof that depressed heart patients live longer or fare better over the long term if they are screened for depression and treated with drugs and other therapy.

The team's report, believed to be the largest, most comprehensive review of all research in the field, is set to appear in the Nov. 12 edition of the Journal of the American Medical Association. Its publication is timed to coincide with the AHA's annual Scientific Sessions in New Orleans.

"Our analysis showed that depression screening tools worked reasonably well in identifying who is depressed and who is not, based on such symptoms as feeling blue or suddenly withdrawing from routine activities," says Ziegelstein, a professor at the Johns Hopkins University School of Medicine and its Heart and Vascular Institute.

Yet he points out that that about one in five people with depression would not be picked up by screening and fewer than half of those identified as depressed by the screening process will actually be depressed when evaluated more thoroughly.

The team also found that treating depression in people with heart disease only accounted for a 1 percent to 4 percent change in symptoms compared to those treated with placebo. Ziegelstein says this is "too low to expect meaningful benefits for many people, particularly since screening methods are not very precise in identifying people who would benefit from the treatment."

In addition, he says, before routine screening, physicians need to consider the potential for harm to people, as no studies have fully analyzed any negative impact from treatment side effects, or misdiagnosis and labeling of heart patients as depressed.

"Understandably, then, we cannot in good conscience support screening all heart patients," says Ziegelstein, vice chairman of medicine at Johns Hopkins Bayview Medical Center.

"This is a difficult call for us to make, but it is in the best interests of patients at this time," he adds.

The AHA estimates that one in four heart attack patients experiences feelings of sadness and develops a gloomy outlook as a result of the injury. Such depression more than doubles the risk of death, according to some studies.

But rather than massive, costly screening at this point, Ziegelstein says physicians need to "get to know their patients better, as real people," and to make clinical assessments of each patient's mood for signs of depression as they talk to them about other things related to their health, including exercise routines, dietary habits, and use of medications.

"Physicians can start by listening more to their patients during examinations and by not interrupting them, which research shows often happens within the first 20 seconds after patients initiate conversation," he says.

Making a diagnosis of depression is not difficult, he adds, "if they use their examination time well and ask the right questions," not focusing only on the physical issues but also on the patient's overall state of well-being and daily routine.

"Look and listen for signs of low mood or sadness, or find out if a patient has recently stopped or cut back on social contacts or things they used to do for fun," says Ziegelstein.

As part of the research review, an international team of researchers sorted over 1,500 clinical studies of depression to identify studies that looked at screening heart patients for depression, treating and monitoring them. From these, the team, led by Johns Hopkins-trained psychologist Brett Thombs, Ph.D., now an assistant professor at McGill University in Montreal, grouped together the data from 11 studies that used proven depression screening tests.

Selected screening studies covered more than 4,000 men and women, and most involved one of four commonly used questionnaires to diagnose depression. Results showed that these tests were on average 80 percent accurate in detecting people who were actually depressed.

Another half-dozen clinical trials were evaluated for the immediate health effects of drug treatment and counseling among nearly 3,000 men and women who had been screened and found to be depressed. Drug treatment mostly involved prescribing mood-raising selective serotonin reuptake inhibitors.

Researchers could not find a single study that screened heart patients for depression and then demonstrated lasting improvements to health or even a longer lifespan.

"We don't have any evidence that screening for depression will benefit people with heart disease. What we really need is more research on how best to help them adopt healthy behaviors that combat depression, such as how to stop smoking, exercise regularly and maintain a healthy weight," says Thombs.

Ziegelstein says the team's collective research will contribute to a better understanding of how depression influences heart disease. He also says it will increase physician support to broaden clinical care of depressed heart patients to include increased input from psychologists, psychiatrists and internists, as part of what he calls a more "collaborative care model" that encompasses as much care of the mind and overall body as it does the physical heart.

Funding support for Ziegelstein's research was provided by the National Center for Complementary & Alternative Medicine, a member of the National Institutes of Health, and by the Miller Family Scholar Program.

In addition to Ziegelstein and Thombs, other researchers who contributed to this study were Cheri Smith, M.L.S., and Karl Soderlund, B.S., at Johns Hopkins. International co-investigators were Peter de Jonge, Ph.D., at the University Medical Center Groningen, Netherlands; James Coyne, Ph.D., at the University of Pennsylvania School of Medicine, in Philadelphia; Mary Whooley, M.D., at the University of California, San Francisco; Nancy Frasure-Smith, Ph.D., also at McGill; Alex Mitchell, M.Sc., M.R.C. Psych, at the Leicester Royal Infirmary, United Kingdom; Marij Zuidersma, M.Sc., also at Groningen; Chete Eze-Nliam, M.D., M.P.H., at Interfaith Medical Center in Brooklyn, N.Y.; and Bruno Lima, at Federal University of Ceara School of Medicine, in Fontalez-ce, Brazil.

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First Holistic Guide to Primate Disease Covers Critical Gap in Global Health

Why are so many infectious diseases jumping from animals to humans? Why do we have so little capacity to predict epidemics, or avoid them? Some answers, and possible solutions, can be found in the first trench-to-bench guide to wild primate infectious diseases, to be published Nov. 17 in the Yearbook of Physical Anthropology.

"There is growing awareness that the majority of emerging pathogens in the world are coming from wildlife. And most of that wildlife is in tropical forests – in places where we have the least disease surveillance," says Thomas Gillespie, assistant professor of environmental studies at Emory University, and lead author of the article.

In addition to describing integrative approaches to studying primate infectious diseases, the article provides standardized, step-by-step guidelines for properly gathering and storing feces, blood and other specimens from wild primates for laboratory analysis.

"By giving researchers from a range of disciplines standardized guidelines for collecting data, and integrating that data across sites, we can build a baseline for patterns of primate disease. That may give us a chance to see something abnormal before it becomes an epidemic," says Gillespie, one of the world's leading primate disease ecologists.

The article was in response to a growing outcry among scientists for integrated approaches to studying how outbreaks get their start. A meta-analysis published in the journal "Nature" in February showed that more than 60 percent of epidemics between 1940 and 2004 began when a germ jumped from wildlife to humans.

Gillespie's co-authors on the Yearbook of Physical Anthropology article were Charles Nunn, a biological anthropologist at Harvard University; and Fabian Leendertz a virologist at the Robert Koch Institute and Max Planck Institute for Evolutionary Anthropology in Germany.

Risk of Primate, Human Pathogen Exchanges Up

The specialized field of primate disease ecology began around 1999, when the global HIV/AIDS pandemic was traced definitively to SIV-1 from chimpanzees. While HIV/AIDS and Ebola are the two most dramatic examples of human diseases linked to primates, many other viral, bacterial, fungal and parasitic pathogens found in apes and monkeys are readily transmissible to humans. Recent studies have also shown that potential pathogens are passing from people and domestic animals to primates, bolstering suspicions that primate epidemics of polio, measles and respiratory diseases came from humans.

"The close genetic relationship between wild primates and people, coupled with growing human activity in forests, is increasing the opportunities for the exchange of pathogens," Gillespie says.

One of Gillespie's current research projects, funded by the National Geographic Society, is tracking the ecology of pathogens among people and wild primates at logging sites in the Republic of Congo. The project is gathering data to support sustainable logging methods, as well as to protect the health of people and animals.

Integrated Research Key to Interventions

Gillespie is among the founding scientists of the Great Ape Health Monitoring Unit, a cooperative effort of the United Nations, academic institutions and non-governmental organizations. The unit strives to integrate research from anthropologists, health professionals, biologists, ecologists and other scientists who are studying wild primates in remote locales with the work of lab-based scientists and computer modelers.

"We want to reduce the risks of a pathogen jumping from animals to people and vice-versa," Gillespie says. "And if a pathogen does make the jump, we want to have enough data to develop effective interventions."

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March of Dimes Unveils New ANGEL II Neonatal Transport Ambulance at State Capitol

The March of Dimes is donating a new ANGEL II Neonatal Transport ambulance to Emory University's Regional Perinatal Center. The new ambulance, housed at Grady Memorial Hospital, will transport vulnerable premature newborns from hospitals throughout north Georgia to neonatal intensive care units (NICUs) in Atlanta-area hospitals.

The ANGEL II will be unveiled Wednesday, Nov. 12 at 8 a.m. at a press briefing in the North Atrium of the state capitol. As part of the March of Dimes 6th annual Prematurity Awareness Month, the agency will issue its first Premature Birth Report Card on the state of babies across the nation. In a presentation called "Solutions are Within Our Grasp," March of Dimes officials will share details on the growing crisis of premature birth, release Georgia’s ranking in the nation and encourage families, public officials and community partners across the State to sign a recently launched Petition for Preemies.

Premature birth, the leading cause of death in newborns, remains a complex and costly national health problem. More than half a million babies are born prematurely each year, with roughly one in eight babies born too soon and too small.

Since 1976 two ANGEL II ambulances have transported an estimated 20,000 premature and ill babies. The vehicles are virtual neonatal intensive care units on wheels that are fully equipped to stabilize the most critical infants. The ANGEL II and its specialized team of caregivers, which average about 600-650 transports a year, can mean the difference between life and death for a critically ill infant. The newest ANGEL II replaces an older ambulance that has logged nearly 400,000 miles.

“This new ANGEL builds on a 30-plus year history of uncompromising, unrelenting and unparalleled commitment to the babies in this state. ANGEL II moves sick babies from 40 counties in north Georgia to NICUs in the metro area,” says William Sexson, MD, a neonatologist at Emory University School of Medicine and Grady Memorial Hospital and chair of the March of Dimes Prematurity Awareness Campaign.

Providing a safe and reliable means for the transport of sick babies aligns with the core mission of the March of Dimes - to improve the health of babies by preventing birth defects, premature birth and infant mortality. To date, millions of babies in the U.S. have been saved from death or disability thanks to advances made by March of Dimes-funded programs.

ANGEL II needs help to continue its mission. "We do so many transports each year we really need two new reliable ANGELs to effectively service the large area covered by the Emory Regional Perinatal Center," says Sexson. "The new ANGEL II is a phenomenal asset; our other transport ambulance has more than 300,000 miles. Another ANGEL is desperately needed so we can minimize breakdowns and avoid the very bumpy ride and potential breakdowns that can endanger these tiny babies during transport.”
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Piedmont Mountainside Hospital Opened Cardiac Imaging Center in Jasper

Piedmont Mountainside Hospital (PMH) recently opened a Cardiac Imaging Center in Jasper! The PMH Cardiac Imaging Center offers cardiac imaging methods such as nuclear medicine and echo services to Jasper and the surrounding communities. Both of these methods allow physicians to take a closer look at the heart and blood vessels with little risk to the patient.

“We are proud to be introducing the latest cardiac technology to the Jasper community,” said Mike Robertson, interim CEO of Piedmont Mountainside Hospital. “The idea is to be able to offer diagnostic services, consultations and interpretations nearby, so patients don’t have to travel too far for their cardiac needs.”

Nuclear medicine is a subspecialty within the field of radiology that uses very small amounts of radioactive material to diagnose or treat disease and other abnormalities within the body. Nuclear medicine imaging procedures are noninvasive and usually painless medical tests that help physicians diagnose medical conditions. These imaging scans use radioactive materials called a radiopharmaceutical or radiotracer.

An echocardiogram is a test in which ultrasound is used to examine the heart. It is noninvasive and entirely safe, and when interpreted by well-trained cardiologists, is very accurate. In addition to providing single-dimension images, known as M-mode echo that allows accurate measurement of the heart chambers, the echocardiogram also offers far more sophisticated and advanced imaging. This is known as two-dimensional (2-D) Echo and is capable of displaying a cross-sectional "slice" of the beating heart, including the chambers, valves and the major blood vessels that exit from the left and right ventricle.

The new Piedmont Mountainside Hospital Cardiac Imaging Center is located on the hospital campus at 220 J.L. White Drive in Jasper. For more information on the Piedmont Mountainside Hospital Cardiac Imaging Center, call 706-301-5401 or visit www.piedmontmountainsidehospital.org.
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Piedmont Hospital First in Georgia to Install Toshiba’s Aquilion One Dynamic Volume CT Scanner

Patients experiencing symptoms associated with heart conditions or stroke frequently undergo multiple tests over the course of several days for physicians to make an accurate diagnosis. Piedmont Hospital in Atlanta is streamlining this process by installing the Aquilion® ONE from Toshiba America Medical Systems, Inc., which can reduce diagnosis time from hours and days to a matter of minutes. With the Aquilion ONE, the world’s first dynamic volume CT system, physicians provide one comprehensive exam; reduce cost and radiation exposure by eliminating multiple tests; and access complete, accurate information to diagnose and treat patients faster.

“Traditionally, we may use three different types of imaging tests to diagnose a cardiac patient, which can take up to five days,” explained Szilard Voros, M.D., chief of the Piedmont Heart Institute’s center for wellness, prevention and women’s heart disease. “The Aquilion ONE provides a more comprehensive exam and diagnosis in a matter of minutes. In just one heartbeat, we are able to see data that is traditionally captured over 500 heartbeats using other imaging systems. This is truly a quantum leap in technology and a great addition to our Piedmont Heart Health Advantage program, designed to predict and prevent heart disease with the help of the new Toshiba scanner.”

Toshiba’s Aquilion ONE dynamic volume CT system builds one 3D image of an entire organ in a single gantry rotation by using 320, half-millimeter, detector rows so physicians can see everything inside the organ. That makes the Aquilion ONE CT technology dramatically different from multi-slice CT technology that creates multiple images – or slices – and pieces them back together.

Unparalleled in diagnostic imaging today, the Aquilion ONE can also produce a 4D clinical video showing up to 16 cm of anatomical coverage, enough to capture the entire brain or heart, and show its movement and its blood flow.

“In addition to streamlining the diagnosis process, the Aquilion ONE significantly reduces the amount of radiation the patient is exposed to by replacing several exams with this single comprehensive test,” added Dr. Voros. “With Aquilion ONE, patients are exposed to less than 15 mSv of radiation versus an accumulated 40 mSv of radiation through the traditional multiple tests. If the only clinical question is the status of the arteries supplying the heart, the radiation dose can be as low as 3 to 5 mSv. As a reference, the annual background radiation we all experience in the United States is about 3 mSv. The Aquilion ONE allows us to provide one safe and accurate exam with significantly less radiation to the patient.”

As a leading provider of cardiac services in Atlanta, the Piedmont Heart Institute will use the Aquilion ONE primarily for cardiac patients but can expand its use into other areas, including neurology.

“Toshiba’s Aquilion ONE is designed for today’s healthcare environment and the installation at Piedmont will serve thousands of patients a year,” said Doug Ryan, senior director, CT Business Unit, Toshiba. “By replacing several tests with a single exam, the Aquilion ONE has the potential to change physicians’ approach to treat at-risk patients immediately – saving resources and time for both the healthcare facility and the patient.”
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Hydrogen Sulfide Gas Shows Promise for Treating Heart Failure

At low concentrations, the toxic gas hydrogen sulfide protects the hearts of mice from heart failure, scientists at Emory University School of Medicine have found.

Their findings, presented Nov. 11 at the American Heart Association (AHA) Scientific Sessions conference in New Orleans, suggest that doctors could use hydrogen sulfide to treat humans with heart failure.

Best known for its rotten-egg smell, hydrogen sulfide can pose a deadly threat to miners or sewer workers. However, scientists have recently found that enzymes within the body produce the gas in small, physiological amounts, with multiple beneficial effects such as regulating blood pressure and attenuating inflammation.

David Lefer, PhD, professor of surgery at Emory University School of Medicine, and his team created a model of heart failure in mice by blocking their left coronary arteries either temporarily for an hour or permanently, causing part of their heart muscles to die. Hydrogen sulfide was administered intravenously once a day for a week.

John Calvert, PhD, assistant professor of surgery working with Lefer, will present the findings at the AHA Meeting. “Our results show that hydrogen sulfide can blunt the impact of heart failure on heart function and mortality in a mouse model of heart failure,” Calvert says.

Four weeks after artery blockage, mice treated with hydrogen sulfide had an ejection fraction, a measure of heart function, about a third larger than controls (36 compared to 27 percent). He and his colleagues also found similar effects in mice engineered to make more of an enzyme that generates hydrogen sulfide.

Heart failure, a leading cause of hospitalization for the elderly, describes a situation when the heart muscle cannot pump enough blood to meet the body’s needs. Previous injury to the heart muscle from a heart attack, obesity, diabetes or high blood pressure all are contributing factors.

In a separate presentation, Calvert presented experimental data on how hydrogen sulfide works in the heart. The gas appears to stimulate heart muscle cells to produce their own antioxidants and molecules that stave off programmed cell death, a response to the loss of blood flow.

Both Calvert and Lefer are based at Carlyle Fraser Heart Center at Emory Crawford Long Hospital in Atlanta. Some of the research was performed at Albert Einstein College of Medicine in New York, with Susheel Gundewar, Saurabh Jha and John Elrod.

The research was funded by the National Institutes of Health, the American Diabetes Association and by 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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Study Focuses on Teens at Risk for Psychosis

Emory University in Atlanta is playing a key role in the largest, most comprehensive study ever funded by the National Institute of Mental Health (NIMH) of adolescents and young adults at risk for developing a psychotic disorder. The five-year, $25-million study joins the resources of Emory and seven other major research universities, with the goal of identifying more precise predictors for psychosis, and a better understanding of the neural mechanisms involved.

"This is a critical, watershed study," said Elaine Walker, Samuel Candler Dobbs Professor of Psychology and Neuroscience at Emory. "To date, no one has systematically studied brain development, patterns of electrical brain activity and changes in gene expression in youth at risk for psychosis."

Schizophrenia, the most extreme psychosis, affects about 1 percent of the population and can have devastating consequences. Most people diagnosed with schizophrenia are unable to hold a job or live independently for most of their lives. They often suffer from homelessness, major depression and anxiety disorders.

"Because schizophrenia is severely debilitating, usually chronic and very costly, preventing its onset has become a major area of emphasis of the NIMH," said Walker, who has studied the origins and precursors of psychosis for 30 years.

Early Diagnosis Critical for Teens

The typical onset of schizophrenia and other psychotic disorders is about 21 years of age, with warning signs beginning, on average, around age 17. Studies have shown that about 30 to 40 percent of prodromal teenagers – those showing warning signs – will develop schizophrenia or another psychotic disorder. About 25 percent of the prodromal teens continue to experience mild symptoms without getting worse, while the remaining 35 percent get better as they enter adulthood.

"We are hoping to get to the point where we can identify people who will cross the threshold into psychosis with 85 to 95 percent accuracy, instead of 30 to 40 percent," Walker said. "Evidence has been accumulating that, not only are there brain abnormalities in people with psychotic disorders, the brain abnormalities get worse the longer the patient goes untreated."

While anti-psychotic drugs can be effective, they also have serious side effects, so physicians are hesitant to recommend them until someone enters the clinical stages of psychosis.

Stress Hormones May Hold Key for Treatment

Walker recently completed a study that tracked changes in the stress hormone cortisol over several years in prodromal teenagers. The results found much sharper increases in cortisol levels in the participants who were eventually diagnosed with a psychosis. "This suggests that youth who are vulnerable to psychosis may be especially sensitive to elevations in cortisol selection," Walker said.

One hypothesis of the NIMH study is that changes in stress hormones that occur in at-risk adolescents are influencing gene expression in the brain. "All neurons in the brain have receptors for hormones and research on animals has shown that cortisol can change how these neurons function," Walker said. "If our theory is right, and we can identify what's going on with this process, it's possible that we could eventually modify cortisol secretion in a way that buffers teenagers against its effects, and gets them through this critical risk period."

Each of the eight institutions involved in the NIMH study will recruit 100 prodomal teenagers and 50 controls to participate in the project. Participants will undergo regular diagnostic interviews, measurements of their cortisol levels, magnetic resonance imaging (MRI) to observe physical development of their brains, and electroencephalography (EEG) to measure neural electrical activity. In addition, the researchers will regularly collect and compare genetic data of the participants.

Researchers are now undergoing training in the study protocol, to ensure data standardization. In January, recruitment for participants will begin. In addition to Emory, the institutions involved are: Harvard, Yale, UCLA, UC-San Diego, Einstein Medical College and the University of Calgary.

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Johnson & Johnson-Merck Consumer Pharmaceuticals Company Announces Urgent Voluntary Nationwide Recall of Infants' MYLICON(R) GAS RELIEF DYE FREE Drops

Johnson & Johnson-Merck Consumer Pharmaceuticals Company Announces Urgent Voluntary Nationwide Recall of Infants' MYLICON(R) GAS RELIEF DYE FREE Drops (Simethicone-Antigas) Non-Staining Due to Possible Metal Fragments

PRNewswire/ -- Johnson & Johnson-Merck Consumer Pharmaceuticals Company (JJMCP) is voluntarily recalling approximately 12,000 units of Infants' MYLICON(R) GAS RELIEF DYE FREE drops (simethicone-antigas) non-staining sold in 1 oz. plastic bottles that were distributed after October 5, 2008 nationwide. The company is taking this action in consultation with the U.S. Food and Drug Administration (FDA). Although the potential for serious medical events is low, the company is implementing this recall to the consumer level as a precaution after determining that some bottles could include metal fragments that were generated during the manufacturing process. If any medical events were to occur, most are expected to be temporary and resolve without medical treatment. Parents who have given the product to their infant and are concerned should contact their health care provider immediately.

The two lots of Infants' MYLICON(R) GAS RELIEF DYE FREE drops non-staining 1 oz. bottles included in the recall are:

Product
Code # Lot # Exp Product
71683791111-1 SMF007 09/10 Infants' Mylicon(R) Gas Relief Dye Free
Non-Staining Drops 1 oz.

71683791111-1 SMF008 09/10 Infants' Mylicon(R) Gas Relief Dye Free
Non-Staining Drops 1 oz.

Consumers can find the lot numbers on the bottom of the box containing the product and also on the lower left side of the sticker on the product bottle.

Consumers who purchased Infants' MYLICON(R) GAS RELIEF DYE FREE drops non-staining included in this recall should immediately stop using the product and contact the company at 1-800-222-9435 (Monday -- Friday, 8:00 a.m. -- 8:00 p.m. EST) or via the internet at http://www.mylicon.com/ for instructions regarding how to dispose of the product and request a replacement or refund.

Infants' MYLICON(R) drops are sold over-the counter, in retail stores and pharmacies, as an anti-gas medicine to relieve the discomfort of infant gas frequently caused by air swallowing or by certain formulas or foods.

The recall does not affect any Original Infants' MYLICON(R) GAS RELIEF products (1/2 oz. or 1 oz. size) or Infants' MYLICON(R) GAS RELIEF DYE FREE drops non-staining (1/2 oz. size).

The manufacturer has instructed retailers and wholesalers to return their inventories.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online: www.fda.gov/medwatch/report.htm

Regular Mail: Use postage-paid FDA form 3500 available at:
http://www.fda.gov/MedWatch/getforms.htm.
Mail to MedWatch 5600 Fishers Lane, Rockville, MD
20852-9787

Fax: 1-800-FDA-0178

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