The U.S. Food and Drug Administration has approved a new drug to help patients suffering from overactive bladder (OAB). Toviaz (fesoterodine fumarate) works by relaxing the smooth muscle tissue of the bladder, thus reducing the urinary frequency, urge to urinate, and sudden urinary incontinence (leakage of urine), that are characteristic symptoms of OAB.
"Patients who suffer from overactive bladder face quality of life issues that can hamper their ability to enjoy life to its fullest," said George Benson, M.D., deputy director, Division of Reproductive and Urologic Products at the FDA’s Center for Drug Evaluation and Research. "This new drug will provide an additional treatment option to help them manage problems with an overactive bladder."
Toviaz will be available by prescription only, as an extended release tablet in either 4 mg or 8 mg dosage strengths. It is to be administered once daily. The recommended starting dose is 4 mg, which can be increased to 8 mg if needed, based upon individual response and tolerability. Toviaz is only approved for adults.
The safety and effectiveness of Toviaz were studied in two, 12-week, randomized controlled studies of the 4 mg and 8 mg doses. For the combined studies, a total of 554 patients received placebo, 554 patients received Toviaz 4 mg daily, and 566 patients received the drug 8 mg daily. The majority of patients were female with a mean age of 58 years. Toviaz is not approved for pediatric use.
In each of those two studies, the product showed a statistically significant and clinically meaningful improvement in decreasing the number of times patients needed to urinate per day, as well as the number of urine leaking episodes they experienced per day, as compared to placebo.
Common side effects associated with Toviaz included dry mouth and constipation. Less frequently reported side effects included dry eyes and trouble emptying the bladder.
Toviaz is not recommended in doses above 4 mg in those patients with severe reduction in kidney function or in those patients taking medications, such as ketoconazole, that block the metabolism of the drug. It should not be used in patients who suffer from urinary or gastric retention or in patients with uncontrolled, narrow-angle glaucoma. It should also not be used in patients with severe liver impairment. The product should be used with caution in patients who suffer from decreased gastrointestinal motility, such as those with severe constipation.
Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.
--Online: www.fda.gov/MedWatch/report.htm
--Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch,
5600 Fishers Lane, Rockville, MD 20852-9787
--Fax: (800) FDA-0178
--Phone: (800) FDA-1088
Toviaz is manufactured by Schwarz Pharma of Zwickau, Germany and is distributed by Pfizer Inc. of New York, N.Y.
-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
Friday, October 31, 2008
FDA Approves Toviaz, a New Drug to Treat Overactive Bladder
As Diabetes Reaches Epidemic Levels in Georgia and U.S., Thousands Drawn to Diabetes University in Atlanta Nov. 8
PRNewswire/ -- Question: What disease has been diagnosed in more than 600,000 Georgians, could be present in more than 300,000 more, and kills five people every day in Georgia? HIV, cancer, heart disease?
No. The answer is diabetes.
And, new CDC data shows that the rate of diabetes cases in the U.S. has nearly doubled in the past 10 years - with the worst numbers occurring in the South.
Thousands who want to learn how to better manage their diabetes, along with families and loved ones affected by the disease, are expected to take part in a daylong diabetes learning experience at the 15th annual Diabetes University on Saturday, Nov. 8 at the Apparel Mart in downtown Atlanta.
Prevention is essential, but at Diabetes University, participants will learn about managing diabetes to avoid its complications, including blindness and kidney disease.
"For young people born in 2000, the outlook is particularly grim unless they change their lifestyles," said Carol Johnson Davis, Executive Director of the Diabetes Association of Atlanta, key sponsor of Diabetes University Nov. 8. "Statistics show that one third of all Americans born in 2000, and one half of all minorities born in 2000, will develop diabetes in their lifetime if present trends continue. We must address this epidemic now, and Diabetes University is one way we are trying to help."
This November, Diabetes Awareness Month, marks a milestone Georgia should not be proud of, she said. More people than ever before will be suffering from the deadly disease.
At Diabetes University on Nov. 8, participants can experience more than 20 informative and fun workshops, including cooking demonstrations, educational sessions, vendor presentations and other learning events designed to help those affected by diabetes better manage the disease and associated risk factors. The fee for the day full of activities is $10, and includes a healthy lunch and bags full of takeaway materials from the dozens of vendors who will be present.
-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
Emory Eye Center Studying Promising Treatment for Retinopathy of Prematurity
Emory Eye Center will participate in a Phase I research study to establish a safety profile for an anti-VEGF (vascular endothelial growth factor) drug, Avastin (Bevacizumab), for premature babies with retinopathy of prematurity (ROP).
Babies with aggressive posterior ROP who have failed appropriate laser treatment and demonstrate persistent, worsening or recurrent vascular activity can be enrolled. Babies must be at least 30 weeks postmenstrual age (PMA) and no greater than 36 weeks PMA.
Postmenstrual age is the time elapsed between the first day of the last menstrual period and birth (gestational age) plus the time elapsed after birth (chronological age). Postmenstrual age is usually described in number of weeks and is most frequently applied during the perinatal period beginning after the day of birth.
One eye will be randomly selected for anti-VEGF treatment and the fellow eye will serve as the control eye [one that does not receive treatment]. The anti-VEGF drug Avastin will be given as a one-time intravitreal injection. The target enrollment is 22 infants from 11 sites with no more than three infants from any one site.
Emory Eye Center will participate with 10 other sites across the U.S. G. Baker Hubbard III, MD, associate professor of ophthalmology, and director, clinical retina service of Emory Eye Center, will serve as Emory’s physician investigator for the PAN-VEGF Blockade for the Treatment of ROP (Block-ROP).
"Bevacizumab is an exciting new drug that may benefit infants with ROP, and we are pleased to be able to systematically study the drug with other clinical investigators around the country,” says Hubbard. “Safety is our number one concern, however, because we already have an effective treatment for most cases of ROP in laser photocoagulation. That is why, in this first phase of the study, we are investigating the effects of the drug only in the most severe cases that have already failed laser."
Retinopathy of prematurity (ROP) is a leading cause of childhood blindness in the U.S. and the developed world. The condition typically affects children born at less than 32 weeks gestation and weighing less than 1500 grams at birth. Many cases are mild and improve without specific treatment as the child grows and develops. Some cases, however, are severe and result in retinal scarring, retinal detachment, and blindness.
For severe cases, laser treatment can reduce scar tissue formation, reduce retinal detachment risk and reduce the chance of blindness. Despite being the most effective treatment available, however, laser treatment has significant disadvantages and better treatment options are needed. In addition, for the most aggressive form of ROP - aggressive posterior ROP (APROP), laser is often not effective.
The Block-ROP Trial aims to evaluate intravitreal injection of Avastin in infants with ROP. There will be two phases in this study – Phase I will be to establish a safety profile (Block-ROP, Group 1) and Phase II will be to demonstrate/confirm efficacy of Avastin in reducing incidence of retinal detachment (Group 2).
The phase 1, BLOCK-ROP study currently is enrolling patients at the Emory Eye Center/ Children’s Healthcare of Atlanta.
---
www.FayetteFrontPage.com
Fayette Front Page
Community News You Can Use
Fayetteville, Peachtree City, Tyrone
www.GeorgiaFrontPage.com
www.ArtsAcrossGeorgia.com
---
Thursday, October 30, 2008
Breakthrough Mapping of Alzheimer's Genome Helps ID Four New Suspect Genes
PRNewswire-USNewswire/ -- Four novel genes that may significantly increase the risk of the most common form of late-onset Alzheimer's have been identified by researchers at Massachusetts General Hospital and Harvard Medical School, as reported in the November 7th issue of American Journal of Human Genetics. The findings, part of a larger "Alzheimer's Genome Project" (AGP) established three years ago to identify the full set of Alzheimer's disease genetic risk factors, may lead to more aggressive therapeutic interventions to slow, stop or even reverse the effects of the disease. These new therapies would differ from current treatments that only address the symptoms of the disease.
Dr. Rudolph Tanzi, chairman of the Cure Alzheimer's Fund Research Consortium and the Joseph P. and Rose F. Kennedy Professor of Neurology at Harvard Medical School, completed the largest family-based genome-wide association screen conducted to date. More than 400 families affected by Alzheimer's disease were screened to determine genetic variants associated with the inheritance of Alzheimer's. The four genes discovered in the family study are described in the article.
Technological advances are improving the understanding of the genetic mechanism that governs Alzheimer's disease and are making it feasible to identify the complete set of genes influencing risk for Alzheimer's disease, Dr. Tanzi said.
In addition to the genome-wide association screen, Dr. Tanzi and Dr. Lars Bertram of Harvard Medical School have been analyzing Alzheimer's genetics literature to determine which of the hundreds of proposed Alzheimer's candidate genes are genuine disease genetic risk factors. These summarized findings, implicating 30 gene candidates, are updated regularly at http://alzgene.org/ (a public Web site sponsored by the Cure Alzheimer's Fund). Tanzi and Bertram highlighted 10 of the most interesting of these genes in the current issue of Nature Reviews Neuroscience. Ultimately, the goal is to combine the results of the Alzheimer's family-based genome-wide association screen with the bioinformatics results of AlzGene.org.
The combined efforts of the family-based genome-wide association screen and AlzGene.org studies have led to the identification of 70 genes containing variants that either confer risk for, or protect against, Alzheimer's, making up the most comprehensive genetic map of the disease.
"This project is the most complete and comprehensive search for the genes that cause Alzheimer's disease published to date," Tanzi said. "Our hope is to use this new information to not only better diagnose and someday predict risk for Alzheimer's but to also learn from these genes the biological causes of Alzheimer's. The knowledge gained from understanding the Alzheimer's-associated defects in these genes will almost certainly accelerate the development of novel therapeutics and hopefully lead to a potential cure for this devastating disease."
The current understanding of the causes and pathological progression of Alzheimer's disease have been made possible by studies of four Alzheimer's genes discovered between 1987 and 1995, three of which were co-discovered by Tanzi. Since these genes account for only 30 percent of the genetic basis of Alzheimer's disease, three years ago Cure Alzheimer's Fund initiated the Alzheimer's Genome Project aimed at determining the remaining 70 percent of the genetic basis of Alzheimer's disease. Taking advantage of major technological and analytical breakthroughs in human genetic studies, the project was able to reach this milestone with a limited budget, led by a contribution of $3 million from Cure Alzheimer's Fund.
"We are on the cusp of a rare 'science moment' that could alter the way we diagnose, treat and prevent Alzheimer's disease," said Tanzi. "Ultimately, the combined results of the family-based genome-wide screen and AlzGene.org will allow for the reliable prediction of Alzheimer's disease while also guiding the development of therapies."
Alzheimer's disease is the most common cause of dementia in the elderly and a burgeoning unmet medical need that only will worsen as individuals continue to live longer. The Alzheimer's Association estimates that as many as 5.2 million Americans are living with Alzheimer's disease, including between 200,000 and 500,000 people under age 65 with young-onset Alzheimer's disease or other dementias. Experts predict that, by 2010, nearly a half million new cases of Alzheimer's disease will occur each year; and by 2050, nearly a million new cases will occur annually.
Cure Alzheimer's Fund has no endowment and passes funds raised directly to selected research as determined by the Cure Alzheimer's Research Consortium. The Foundation has no financial or intellectual property interest in the research funded, and will make known the results of all funded research as soon as possible. At a time when the federal government investment for Alzheimer's research and education is decreasing, Cure Alzheimer's Fund has raised more than $10 million, investing all of it directly into research.
-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
New Cases of Diagnosed Diabetes on the Rise
The rate of new cases of diagnosed diabetes rose by more than 90 percent among adults over the last 10 years, according to a study by the Centers for Disease Control and Prevention (CDC).
The data, published in CDC′s Morbidity and Mortality Weekly Report, show that in the past decade, the incidence (new cases) of diagnosed diabetes has increased from 4.8 per 1,000 people during 1995-1997 to 9.1 per 1,000 in 2005-2007 in 33 states.
“This dramatic increase in the number of people with diabetes highlights the increasing burden of diabetes across the country,” says lead author Karen Kirtland, Ph.D., a data analyst with CDC′s Division of Diabetes Translation. “This study demonstrates that we must continue to promote effective diabetes prevention efforts that include lifestyle interventions for people at risk for diabetes. Changes such as weight loss combined with moderate physical activity are important steps that individuals can take to reduce their risk for developing diabetes.”
The study used data from CDC′s Behavioral Risk Factor Surveillance System, and provides incidence rates of diabetes for 43 states and two U.S. territories. Only 33 states had data for both time periods, but 43 states collected data in 2005-2007.
State-specific, age-adjusted estimates of new cases of diabetes ranged from 5 per 1,000 people in Minnesota to 12.7 per 1,000 in West Virginia. The number of news cases was highest in Puerto Rico at 12.8 per 1,000. States with the highest age-adjusted incidence were predominately Southern states: Alabama, Florida, Georgia, Kentucky, Louisiana, South Carolina, Tennessee, Texas and West Virginia.
“This report documents the geographic distribution of new cases of diabetes and is consistent with previous studies showing an increase in new diabetes cases,” said Kirkland. “We must step up efforts to prevent and control diabetes, particularly in the Southern U.S. region where we see higher rates of diabetes, obesity and physical inactivity.”
CDC, through its Division of Diabetes Translation, funds diabetes prevention and control programs in all 50 states, including the District of Columbia, and seven U.S. territories and island jurisdictions. The National Diabetes Education Program, co-sponsored by CDC and the National Institutes of Health, provides diabetes education to improve treatment for people with diabetes, promote early diagnosis and prevent or delay the onset of diabetes.
For more information about diabetes, visit www.cdc.gov/diabetes. The MMWR report is available at www.cdc.gov/mmwr.
-----
www.fayettefrontpage.com
Fayette Front Page
Community News You Can Use
Fayetteville, Peachtree City, Tyrone
www.georgiafrontpage.com
Georgia Front Page
Wednesday, October 29, 2008
HHS/FDA Grants Tentative Approval for 75th Generic Anti-Retroviral Drug as Part of President's Emergency Plan for AIDS Relief
The Food and Drug Administration within the U.S. Department of Health and Human Services (HHS) has reached the milestone of the 75th anti-retroviral generic drug approved or tentatively approved as part of President Bush’s Emergency Plan for AIDS Relief (PEPFAR).
Marketed by Macleods Pharmaceuticals, Ltd, of Kachigam, Daman, in the Republic of India, the 75th drug is 150 milligram and 300 milligram tablets of generic lamivudine, a nucleoside analog reverse-transcriptase inhibitor (nRTI), which blocks an enzyme called reverse transcriptase, important to HIV production. HIV-infected patients who take lamivudine with other anti-HIV treatments develop less opportunistic infections.
“HHS/FDA has helped save lives by making high quality, anti-retroviral generic drugs available quickly, at a lower cost, for those most in need under the President’s Emergency Plan," said Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. "As we grant tentative approval for the 75th product, our efforts won't stop: we will continue to provide review of applications for safe and effective treatments for AIDS to combat this global concern."
“Tentative approval" means that although existing patents and/or marketing exclusivity prevent the approval of the product in the United States at this time, the product meets all of HHS/FDA's normal requirements for manufacturing quality and clinical safety and efficacy.
HHS/FDA performs all of its reviews of applications received in association with the Emergency Plan on an expedited basis; the agency reviewed this application for lamivudine tablets in less than six months. After receiving approval or tentative approval from HHS/FDA under this expedited process, a generic anti-retroviral passes quickly on to the pre-qualification list maintained by the Secretariat of the World Health Organization (WHO), because of a confidentiality agreement that allows HHS/FDA to share data from its evaluations with the WHO team in Geneva. Generic anti-retrovirals given approval or tentative approval by HHS/FDA are also immediately eligible for procurement by recipients of grants from the Global Fund to Fight AIDS, Tuberculosis and Malaria.
In 2003, President George W. Bush launched his Emergency Plan for AIDS Relief to combat global HIV/AIDS – the largest commitment by any nation to combat a single disease in history. At that time, about 50,000 people in sub-Saharan Africa were receiving anti-retroviral treatment. Today, the Emergency Plan reaches more than 1.7 million worldwide with anti-retroviral treatment, the vast majority of them in sub-Saharan Africa, and supports care for more than 6.6 million people, including 2.7 million orphans and vulnerable children. To date, interventions funded by the Emergency Plan have allowed mothers to give birth to nearly 200,000 HIV-free children.
In 2004, HHS/FDA implemented an expedited process under the Emergency Plan to review individual, generic anti-retroviral (ARV) drug formulations, co-packaged versions of individual ARV drug formulations, and fixed-dose ARV combinations. The expedited process includes a commitment by HHS/FDA and the Office of the U.S. Global AIDS Coordinator to work closely with manufacturers before they submit a marketing application to HHS/FDA, especially those firms that have never previously submitted to the agency, and to conduct a priority assessment of those applications.
On July 30, 2008, President Bush signed into law the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis and Malaria Reauthorization Act of 2008, which reauthorized and expanded the Emergency Plan for five additional years, from 2009 through 2013. The legislation authorizes up to $38 billion over five years for bilateral HIV/AIDS programs under the Emergency Plan, activities under the President’s Malaria Initiative, and bilateral U.S. Government international work against tuberculosis, as well as contributions to the Global Fund.
-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
Drinking Milk to Ease Milk Allergy?
HHH Note: This study is promising. It does, however, come with the warning NOT to try this at home.
Giving children with milk allergies increasingly higher doses of milk over time may ease, and even help them completely overcome, their allergic reactions, according to the results of a study led by the Johns Hopkins Children’s Center and conducted jointly with Duke University.
Despite the small number of patients in the trial – 19 – the findings are illuminating and encouraging, investigators say, because this is the first-ever double-blinded and placebo-controlled study of milk immunotherapy. In the study, the researchers compared a group of children receiving milk powder to a group of children receiving placebo identical in appearance and taste to real milk powder. Neither the patients nor the investigators knew which child received which powder, a rigorous research setup that minimizes the chance for error and bias.
The findings of the study are reported online ahead of print, Oct. 28, in the Journal of Allergy & Clinical Immunology
“Our findings suggest that oral immunotherapy gradually retrains the immune system to completely disregard or to better tolerate the allergens in milk that previously caused allergic reactions,” says Robert Wood, M.D., senior investigator on the study and director of Allergy & Immunology at Hopkins Children’s. “Albeit preliminary and requiring further study, these results suggest that oral immunotherapy may be the closest thing yet to a ‘true’ treatment for food allergy.”
Currently, food allergy management involves complete avoidance of the trigger foods, waiting for the child to outgrow the allergy or treating allergic reactions if and when they occur. The latter could be dangerous, investigators say, because these common foods are difficult to avoid and some reactions can be severe and even life-threatening.
In a report released Oct. 22, the Centers for Disease Control and Prevention estimates that food allergies are on the rise with three million children in the United States now having at least one food allergy, an 18 percent jump from 10 years ago. Milk allergy is the most prevalent type of food allergy.
“Given that the quality of life of a child with a food allergy is comparable to the quality of life of a child with diabetes, we urgently need therapies that go beyond strict food avoidance or waiting for the child to outgrow the allergy,” Wood says.
Researchers followed allergic reactions over four months among 19 children with severe and persistent milk allergy, 6 to 17 years of age. Of the 19 patients, 12 received progressively higher doses of milk protein, and seven received placebo. At the beginning of the study, the children were able to tolerate on average only 40 mg (.04 ounces or a quarter of a teaspoon) of milk.
At the end of the four-month study, both groups were given milk powder as a “challenge” to see what dose would cause reaction after the treatment. The children who had been receiving increasingly higher doses of milk protein over a few months were able to tolerate a median dose of 5, 140 mg (over 5 ounces) of milk without having any allergic reaction or with mild symptoms, such as mouth itching and minor abdominal discomfort. Those who had been getting the placebo remained unable to tolerate doses higher than the 40 mg of milk powder without having an allergic reaction. In the group receiving milk protein, the lowest tolerance dose was 2, 540 mg (2.5 ounces) and the highest was 8,140 mg (8 ounces). Lab tests showed the children who regularly drank or ate milk had more antibodies to milk in their blood, yet were able to better tolerate milk than those who took the placebo. Researchers say, tolerance in children treated with milk continued to build over time, and recommend that these children continue to consume milk daily to maintain their resistance. The researchers caution that it remains unclear whether the children would maintain their tolerance once they stop consuming milk regularly. “It may very well be that this tolerance is lost once the immune system is no longer exposed to the allergen daily,” Wood says.
The Hopkins group is currently studying oral immunotherapy in children with egg allergy to determine whether increasingly higher doses of egg protein can help resolve their allergy, and have recently started another study of milk immunotherapy.
Wood emphasizes the findings require further research and advises parents and caregivers not to try oral immunotherapy without medical supervision.
Other Hopkins investigators in the study: Justin Skripak, M.D., Hannah Rowley, R.D., Nga Brereton, R.D., Susan Oh, R.D., Robert Hamilton, M.D., Elizabeth Matsui, M.D. M.H.S.
Duke University co-investigators: Scott Nash, M.D., and A. Wesley Burks, M.D.
The research was funded by the National Institutes of Health and The Eudowood Foundation.
-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
FDA Statement on Release of Bisphenol A (BPA) Subcommittee Report
We appreciate the hard work and long hours the subcommittee has invested in scientific peer review of the FDA’s draft safety assessment of the use of BPA in food contact applications. The FDA requested this peer review to provide additional insight into this complex issue. This group of distinguished scientists has devoted their considerable knowledge and experience to this effort.
The subcommittee report to the Science Board raises important questions regarding the draft safety assessment, and the FDA looks forward to the review of the subcommittee's report by the Science Board on Oct 31.
The FDA agrees that, due to the uncertainties raised in some studies relating to the potential effects of low dose exposure to bisphenol A, additional research would be valuable. The FDA is already moving forward with planned research to address the potential low dose effects of bisphenol A, and we will carefully evaluate the findings of these studies.
Consumers should know that, based on all available evidence, the present consensus among regulatory agencies in the United States, Canada, Europe, and Japan is that current levels of exposure to BPA through food packaging do not pose an immediate health risk to the general population, including infants and babies.
Regarding Canada, the FDA notes that Health Canada’s assessment of bisphenol A on newborns and infants up to 18 months of age concludes that exposure levels are below the levels that could cause health effects. Out of an abundance of caution, the Government of Canada has taken steps to restrict the use of BPA.
Parents who, as a precaution, wish to use alternatives for their bottle-fed babies can use glass and other substitutes for polycarbonate plastic bottles; avoid heating formula in polycarbonate plastic bottles; and consult their pediatrician about switching to powdered infant formula.
For a copy of the Subcommittee Report, go to:
http://www.fda.gov/oc/advisory/scienceboard/meeting103108.html.
Statement of the Acting Surgeon General, Rear Admiral Steven K. Galson, M.D., M.P.H.
"The most important thing parents can do for their babies is ensure that they receive adequate nutrition. While the best source of nutrition for babies is the mother's breast milk, infant formula remains the recommended alternative when breast milk is not an option."
-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
Tuesday, October 28, 2008
FDA Issues Warning Letters to Bayer HealthCare for Illegally Marketing Two Unapproved Drugs
The U.S. Food and Drug Administration today sent Warning Letters to Bayer HealthCare concerning two unlawful, over-the-counter (OTC) aspirin products — Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's) and Bayer Aspirin with Heart Advantage (Bayer Heart Advantage).
The products, which contain aspirin with either phytosterols or calcium, are unapproved new drugs that require an approved new drug application in order to be legally marketed. In addition to being labeled for use as a pain reliever, both products are labeled for use in reducing the risks of heart disease. Bayer Women's is also labeled for use in "fighting" osteoporosis. Neither product has been approved by the FDA for such uses. These drug uses require a health care professional's diagnosis and supervision, and therefore these products cannot be labeled for use by consumers and sold over-the-counter (OTC).
"The FDA considers these products new drugs and thus they must undergo the FDA's drug approval process," said Mike Chappell, the FDA's acting associate commissioner for regulatory affairs. "The FDA will take enforcement action against manufacturers found to be violating the law or attempting to circumvent the drug approval process."
Bayer Heart Advantage combines aspirin and phytosterols in a single tablet. Bayer Women's combines aspirin and calcium carbonate in a single tablet. The products are labeled as being a combination of a drug and a dietary supplement, but when a drug and a dietary supplement are combined in a single tablet, the product is regulated by FDA as a drug. According to the labeling, the phytosterols in Bayer Heart Advantage are intended to lower blood cholesterol and the calcium in Bayer Women's is intended to strengthen bones to fight osteoporosis. Although certain calcium-containing dietary supplements may bear claims to reduce the risk of osteoporosis, products that are labeled to "fight" or otherwise treat osteoporosis are drugs that require FDA approval. Similarly, although certain phytosterol-containing dietary supplements may bear claims to reduce the risk of coronary heart disease, and may note that the mechanism by which phytosterols achieve this effect is through lowering blood cholesterol, direct claims to lower cholesterol are claims to prevent or treat coronary heart disease and hypercholesterolemia, which is also a disease. Products bearing such claims require an approved new drug application from FDA in order to be legally marketed, and cannot be legally marketed for OTC use.
Under its OTC drug monograph system, FDA allows some drugs to be marketed without first obtaining agency approval. These drugs must comply with applicable monographs, that is, regulations that set requirements for the drugs' labeling and formulation, as well as the indications (uses) for which the drugs can be marketed. OTC drugs that do not meet these requirements and that lack FDA approval are considered illegal, unapproved drugs. Bayer Heart Advantage and Bayer Women's do not meet the conditions in any applicable OTC monograph, and do not have FDA approval. Therefore, Bayer Heart Advantage and Bayer Women's are unapproved new drugs.
In addition, Bayer Heart Advantage and Bayer Women's are misbranded because their labeling lacks adequate directions for use by consumers. In order for a drug to have adequate directions for use, the directions must be written so that consumers can use the product safely for its intended purpose, without the supervision of a health care professional. The use of these products for treatment of heart disease and osteoporosis requires diagnosis and supervision by a health care professional to ensure safe use. Therefore, it is not possible, in OTC drug product labeling, for these products to have adequate directions for their intended uses. The products also are misbranded because their labeling do not have adequate warnings and are misleading. Among other things, the labeling for the aspirin in the products includes directions and warnings regarding short term use, but these directions and warnings are contradicted by other directions for the phytosterols and calcium that promote the products' daily use without any time limits. The result is a mixed message about the products' purposes and the length of time for which the products can be safely used.
"The marketing of these unapproved drugs is troubling," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "Because OTC drugs are widely used by consumers, without supervision by a doctor or other health care professional, the overuse or misuse of these aspirin-containing products can put consumers at risk for internal bleeding and other adverse events. It is essential that companies obtain FDA approval and fully comply with FDA regulations."
Although the FDA is not aware of significant adverse events associated with these products, the agency is concerned because neither product has been approved by FDA for its marketed uses.
Today's actions reaffirm the position taken by FDA in two previously issued Warning Letters - one sent to B.F. Ascher & Co., Inc., Lenexa, KS, regarding Melagesic PM, and the other to Omni Nutraceuticals, Inc., Los Angeles, CA regarding Inholtra Joint Pain products. In those letters, the FDA stated that drug ingredients combined with dietary ingredients in a single dosage form require agency approval to be legally marketed in the United States.
Companies that do not resolve violations in FDA Warning Letters risk enforcement action, such as injunctions and/or seizure of illegal products.
-----
www.fayettefrontpage.comFayette Front Page
www.georgiafrontpage.com
Georgia Front Page
New Trauma Center Locator Map Shows If Georgia Counties Are Within the “Golden Hour”
A new interactive trauma center locator map shows whether you, your family and your friends can get to a Georgia trauma center within the “golden hour.”
A trauma patient's chances of survival increase dramatically if he or she receives care within the "golden hour" immediately following injury. Rapid response by emergency medical technicians in ground and air ambulances is critical. So is the distance to the nearest trauma center - a special hospital facility with the resources and medical specialists to handle the most severe injuries.
The trauma center locator map, which is part of the http://www.georgiaitsabouttime.com/ trauma awareness Web site, shows how far each county is from the nearest Georgia trauma center. You simply click on a county to see if it is within an hour of a trauma center.
The map shows that all or parts of more than 50 counties in South Georgia are not within the golden hour.
The golden hour is defined as within 50 miles of a trauma center. Distances are estimates and do not account for traffic delays.
Georgia is served by only 15 trauma centers – about half the number needed, according to state health officials – and many areas of the state currently lack access to adequate emergency transportation. As a result, trauma death rates are significantly higher than the national average. If Georgia’s death rate improved to the national average, it would mean a difference of as many as 700 more lives saved every year.
The trauma center locator map is part of the Georgia It’s About Time trauma awareness campaign which is funded through a grant from Healthcare Georgia Foundation. The campaign is aimed at helping to establish a statewide trauma system that will serve all Georgians, including many in rural areas of the state that are currently lacking access to adequate emergency transportation and trauma care.
About the Trauma Awareness Campaign and the Georgia Statewide Trauma Action Team
(GSTAT): The trauma awareness campaign is designed to educate Georgians about the need for a statewide trauma system. It is funded through a grant by Healthcare Georgia Foundation (www.healthcaregeorgia.org.) The Georgia Statewide Trauma Action Team (GSTAT) is a coalition of hospitals, EMS providers, physicians, nurses, local government officials, business leaders and others interested in creating a statewide trauma system. For more information, please visit www.georgiaitsabouttime.com.
---
www.FayetteFrontPage.com
Fayette Front Page
Community News You Can Use
Fayetteville, Peachtree City, Tyrone
www.GeorgiaFrontPage.com
www.ArtsAcrossGeorgia.com
---
Blue Cross and Blue Shield of Georgia Expands Breast Cancer Care Program
PRNewswire/ -- As October, Breast Cancer Awareness Month, draws to a close, Blue Cross and Blue Shield of Georgia (BCBSGa) understands that it is truly a year-round effort, and is taking additional steps to further improve breast cancer care and awareness for its members. The BCBSGa Breast Cancer Care Program, designed for patients with breast cancer and their physicians, has helped more than 16,000 Georgians navigate through the emotional hardship experienced when undergoing treatment/care for breast cancer.
The goals of this quality improvement program are:
-- To improve breast cancer care and to provide awareness and targeted interventions that will promote informed decision making through meaningful discussions between the patient and the health care team
-- To improve appropriate treatment selections consistent with accepted standards of care and best practice guidelines
-- To provide frontline support to patients with breast cancer.
"It is a wonderful surprise, and a great feeling, to know my insurance company cares," noted Jenifer Hinkemeyer, BCBSGa member. "The program includes useful resources that helped me understand and cope with my diagnosis and treatment."
"When we developed the program, we formed two advisory panels, one of physicians and one of survivors and support organization leaders, to ensure we would provide the most beneficial program for all audiences," said Sandra White, M.D., medical director, BCBSGa. "We identified the most salient messages for each audience in order to ensure the information provided would be well-received and informative. Materials were developed and the program rollout began. We are thrilled with the response thus far and are continuing to expand materials and outreach."
With feedback from the advisory panels, BCBSGa created four new collateral pieces. The materials address the various needs of breast cancer patients at different stages of their cancer journey. "These pieces are designed to provide comprehensive information to support informed decision-making, delivered in a simple, clearly stated manner -- suitable for a diverse audience," said Dr. White.
The program materials include:
-- BCBSGa Resource List - offers support and additional helpful resources to breast cancer patients and their caregivers.
-- BCBSGa Patient Educational Book - contains information on many topics related to breast cancer. This booklet is designed to help patients with breast cancer understand and cope with their disease.
-- BCBSGa Patient Checklist of Questions to Ask the Doctor -- suggests questions for the patient to ask their doctors at each stage of treatment, helping patients arrive at the treatment decisions they are most comfortable with.
-- BCBSGa General Treatment Guidelines for Breast Cancer -- provides information on diagnosis staging of breast cancer and the related treatment decisions or options. This quick reference tool is designed for physicians who are not oncology specialists, to discuss breast cancer treatment options with their patients in general terms.
"We have received a great deal of positive feedback from our members and medical providers. We understand what a difficult and confusing time it can be when being diagnosed with or diagnosing breast cancer," noted Dr. White. "Our goal is to ease the confusion and increase communications between the caregiver and the patient. We believe we are succeeding through this program."
The program reaches all BCBSGa products -- HMO/POS, PPO, and Indemnity. To date, educational materials have been distributed to more than 16,000 patients nationally, and more than 5,200 physicians at more than 7,800 office locations throughout Georgia. The program is expected to reach more than 3,500 patients annually.
In addition to individual requests for the materials, BCBSGa has collaborated with community and clinical organizations to distribute the program materials to their constituents, providing nearly 20,000 component pieces. Among others, the National Black Leadership Initiative on Cancer (NBLIC) partners and the Breast Health Connection of Georgia are including the BCBSGa tools within their community-based distribution networks throughout Georgia (reaching more than 600 breast cancer advocates annually). In addition, the Winship Cancer Institute at Emory University has selected the BCBSGa Patient Education Book as part of their patient support program and the staff of the Grady Health Clinic at the Atlanta Hartsfield-Jackson International Airport is making program materials available for use in their health clinic activities.
BCBSGa is currently involved in a research project that will help BCBSGa identify additional educational needs and address possible disparities. BCBSGa is also researching how to achieve an effective transition of care from the cancer specialist back to the primary care physician for long-term follow-up with breast cancer survivors.
In addition to direct distribution, program materials are available for viewing and download on the BCBSGa Web site, www.bcbsga.com. For more information, please contact Nancy A. Rodriguez at 404-848-2334 or nancy.rodriguez@bcbsga.com.
-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
Researchers Discover Hydrogen Sulfide Is a Major Regulator of Blood Pressure
Anyone with a nose knows the rotten-egg odor of hydrogen sulfide, a gas generated by bacteria living in the human colon. Now an international team of scientists has discovered that cells inside the blood vessels of mice — as well as in people, no doubt — naturally make the gassy stuff, and that it controls blood pressure.
Having discovered that hydrogen sulfide, or H2S, is produced in the thin, endothelial lining of blood vessels, the researchers, including scientists from Johns Hopkins, report today in Science that H2S regulates blood pressure by relaxing blood vessels. As the newest member of a family of so-called gasotransmitters, this messenger molecule is akin in function, if not form, to chemical signals like nitric oxide, dopamine and acetylcholine that relay signals between nerve cells and excite or put the brakes on mind-brain activities.
“Now that we know hydrogen sulfide’s role in regulating blood pressure, it may be possible to design drug therapies that enhance its formation as an alternative to the current methods of treatment for hypertension,” says Johns Hopkins neuroscientist Solomon H. Snyder, M.D., a co-author of the paper.
Conducting their investigations using mice missing a gene for an enzyme known as CSE, long suspected as responsible for making H2S, the researchers first measured hydrogen sulfide levels in a variety of tissues in the CSE-deficient mice and compared them to normal mice. They found that the gas was largely depleted in the cardiovascular systems of the altered mice, engineered by Rui Wang, M.D., Ph.D., of Lakehead University in Ontario, and Lingyun Wu, M.D., Ph.D., of the University of Saskatchewan, Canada. By contrast, normal mice had higher levels — clear evidence that hydrogen sulfide is normally made by mammalian tissues using CSE.
Next, the scientists applied tiny cuffs to the tails of the mice and measured their blood pressure, noting spikes of about 20 percent, comparable to serious hypertension in humans.
Finally, the team tested how blood vessels of CSE-deficient mice responded to the chemical neurotransmitter methacholine, known to relax normal blood vessels. The blood vessels of the altered mice relaxed hardly at all, indicating that hydrogen sulfide was largely responsible for relaxation.
Because gasotransmitters are highly conserved in mammals, the findings of the research are believed to have broad applications to human physiology and disease.
“In terms of relaxing blood vessels, it looks like hydrogen sulfide might be as important as nitric oxide,” Snyder says, referring to the first gasotransmitter that two decades ago was discovered to regulate blood pressure.
Just because these two gas molecules perform similar functions, doesn’t mean they’re redundant, says Wang, the paper’s principal author. “Nature has added on layer upon layer of complexity to provide a better and tighter control of body function — in this case, of blood pressure.”
Studying gaseous messengers can be tricky, explains Snyder, an authority on nitric oxide (NO) whose lab in 1990 discovered that the enzyme triggering NO production is activated by a protein mechanism known as calcium-calmodulin.
“When a nerve fires, it releases a bit of neurotransmitter. Then it fires again, very quickly, and releases more of the neurotransmitter, which is always in reserve and at the ready in large storage pools called vesicles. However, gasses can’t be stored; they diffuse. So every time there’s a nerve impulse, an enzyme must be activated to make it,” he says.”
Although CSE, the enzyme that activates hydrogen sulfide, was characterized more than half a century ago, the new work is the first to reveal that it is activated in the same way as the nitric oxide-forming enzyme, thus establishing how hydrogen sulfide regulates blood pressure by relaxing blood vessels.
“It’s difficult to overestimate the biological importance of hydrogen sulfide or its implications in hypertension as well as diabetes and neurodegenerative diseases,” Wang says. “In fact, most human diseases probably have something to do with gasotransmitters.”
The research was supported by grants from the U.S. Public Health Service and the Canadian Institutes of Health Research as well as a Research Scientist Award.
Authors on the paper are Guangdong Yang, Lingyun Wu, Bo Jiang, Wei Yang, Jiansong Qi, Kun Cao, Qinghe Meng, all of the University of Saskatchewan, Canada; Wang of the University of Saskatchewan and Lakehead University, Canada; Shengming Zhang of Lakehead University, Canada; and Asif K. Mustafa, Weitong Mu and Snyder, all of Hopkins.
-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
Monday, October 27, 2008
Green Tea May Delay Onset of Type 1 Diabetes
A powerful antioxidant in green tea may prevent or delay the onset of type 1 diabetes, Medical College of Georgia researchers say.
Researchers were testing EGCG, green tea's predominant antioxidant, in a laboratory mouse with type 1 diabetes and primary Sjogren's syndrome, which damages moisture-producing glands, causing dry mouth and eyes.
"Our study focused on Sjogren's syndrome, so learning that EGCG also can prevent and delay insulin-dependent type 1 diabetes was a big surprise," says Dr. Stephen Hsu, molecular/cell biologist in the School of Dentistry.
They found it also worked well in their original disease focus.
In the mouse, EGCG reduced the severity and delayed onset of salivary gland damage associated with Sjogren's syndrome, which has no known cure.
"EGCG modulates several important genes, so it suppresses the abnormality at the molecular level in the salivary gland. It also significantly lowered the serum autoantibodies, reducing the severity of Sjogren's syndrome-like symptoms," Dr. Hsu says. Autoantibodies are antibodies the body makes against itself.
Both type 1 diabetes and Sjogren's syndrome are autoimmune diseases, which cause the body to attack itself. Autoimmune disorders are the third most common group of diseases in the United States and affect about 8 percent of the population, says Dr. Hsu. Sjogren's syndrome can occur alone or secondary to another autoimmune disease, such as lupus, rheumatoid arthritis or type 1 diabetes.
The study, published in the Oct. 24 issue of Life Sciences, supports earlier research showing EGCG's impact on helping prevent autoimmune disease.
Researchers treated a control group of mice with water and a test group with a purified form of EGCG dissolved in the drinking water. At 16 weeks, the EGCG-fed mice were 6.1 times more likely to be diabetes-free than the water-fed group, and 4.2 times more likely at 22 weeks.
"Previous studies used another animal model that developed type 1 diabetes only after an injected chemical killed the insulin-producing cells. That may not accurately resemble disease development in humans, because type 1 diabetes is a genetic disease," says Dr. Hsu, the study's corresponding author.
"Our study is significant because we used a mouse model with the genetic defects that cause symptoms similar to human type 1 diabetes and Sjogren's syndrome, so the immune cells attack the pancreas and salivary glands until they are no longer functional."
Another related finding was that even when salivary cells were under attack, they seemed to be rapidly reproducing in the control group. The proliferation was suppressed in the EGCG-fed group.
"It's kind of counterintuitive – why would there be proliferation of the glandular cells occurring when the present cells are not secreting saliva?" says Dr. Kevin Gillespie, first author of the study he conducted for his master's research project at MCG.
The proliferation phenomenon also can be observed in psoriasis, an autoimmune disease affecting the skin and joints, says Dr. Hsu. "Normal skin cells turn over every 30 days or so, but skin cells with psoriasis turn over every two or three days." Dr. Hsu's group previously found that green tea polyphenols, including EGCG, inhibited rapid proliferation in an animal model for human psoriasis.
"We never thought proliferation was going on to this extent in the salivary gland, but we now believe it is tightly associated with Sjogren's syndrome," he says.
The next step is to observe Sjogren's syndrome in human salivary gland samples to determine whether the study findings hold up in humans.
"If the abnormal expression of these genes is the same in humans as in the animal model, then the second stage will be intervention and treatment with a pure form of EGCG," says Dr. Hsu.
"The benefit of using green tea in preventing or slowing these autoimmune diseases is that it's natural and not known to harm the body," says Dr. Gillespie, periodontics chief resident at Fort Gordon's Tingay Dental Clinic. "EGCG doesn't have the negative side-effects that can be associated with steroids or other medications that could otherwise be prescribed."
By Paula Hinely
Medical College of Georgia
-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
Sunday, October 26, 2008
Thoratec Corporation Issues Worldwide Medical Device Correction of HeartMate II® Left Ventricular Assist System
Thoratec Corporation is initiating a worldwide medical device correction of all serial numbers of the HeartMate II Left Ventricular Assist Systems (HM II LVAS) having Catalogue No. 1355 or 102139, which have been distributed since the beginning of clinical studies in November 2003. Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump and potentially result in serious injury or death. The estimated probability of the need for pump replacement due to percutaneous lead damage is 1.3% at 12 months, 6.5% at 24 months and 11.4% at 36 months.
Patients who are currently being supported by a HeartMate II LVAS should contact their doctors, who can assess the wear and fatigue of the percutaneous lead as well as provide proper instruction on management and care of the lead.
Thoratec is voluntarily issuing an Urgent Medical Device Correction notice after confirming 27 reports where wear and fatigue to the percutaneous lead necessitated pump replacement. These reports occurred over five years of clinical experience with 1,972 implants. All patients who have undergone a replacement of the HeartMate II pump survived the operation and were alive at least 30 days postoperatively. In five cases, pump replacement was not feasible and the patients expired.
The affected systems were distributed to 153 hospitals and distributors throughout the United States, Europe, Canada and other countries. The HM II LVAS can be identified by the catalogue number located on the label of the package.
Hospitals are being sent an Urgent Medical Device Correction letter identifying the probability and symptoms of the problem, and recommending that the pump be replaced as soon as possible if damage to the percutaneous lead is confirmed. Hospitals are also requested to review the instructions for care of the percutaneous lead with their ongoing HeartMate II LVAS patients. Hospitals with ongoing HeartMate II LVAS patients should contact Thoratec for further instructions if they do not receive the Medical Device Correction letter. The labeling for the HeartMate II LVAS will be revised with the updated risk information related to percutaneous lead damage. Copies of this press release may be found on Thoratec’s website, www.thoratec.com, under Investor Relations/Press Releases.
Clinicians and patients with questions may contact the company at 1-800-528-2577, or if calling from outside the USA, 1-925-847-8600 (7 days a week, 8-5 Pacific Time).
FDA has been informed of this action.
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:
www.fda.gov/MedWatch/getforms.htm. Mail to MedWatch 5600 Fishers Lane, Rockville, MD
20852-9787
• Fax: 1-800-FDA-0178
-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
Friday, October 24, 2008
FDA Approves Lung Valve to Control Some Air Leaks after Surgery
The U.S. Food and Drug Administration today approved an implantable and removable valve system designed to control some air leaks in the lungs that persist after certain kinds of lung surgery.
While air leaks are generally common after lung surgery, prolonged air leaks, which are leaks present seven days after surgery, occur less frequently and make it difficult for patients to breathe. Prolonged leaks also can increase the length of hospital stays and require additional surgeries to close.
The IBV Valve System consists of an implantable valve, a catheter for valve insertion, and a sizing kit, which can be used to measure the target area for valve implantation. The FDA approved this system under the Humanitarian Device Exemption (HDE) program, which supports the development of medical devices intended to benefit patients in the treatment of diagnosis of diseases or conditions affecting fewer than 4,000 people in the United States per year.
This device is approved for use in patients who have undergone partial or total removal of a lung lobe or lung volume reduction surgery and who experience prolonged air leaks or significant air leaks that may become prolonged.
Most air leaks heal themselves. An air leak still present on the seventh day after surgery is considered prolonged, unless it is only noticed during forced exhalation or cough.
An air leak present on the fifth day after surgery is considered a significant air leak that may become prolonged if the leak is always present, present during normal inhalation, or present during normal exhalation and accompanied by emphysema or other respiratory problem.
"This valve may ease post-operative recovery of patients undergoing certain kinds of lung surgery," said Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health. "This approval is an example of the agency's commitment to addressing unmet medical needs through the HDE program."
The IBV valve is inserted through a bronchoscope, and placed in the airway of the lung area affected by the air leak. Once inserted, the valve allows air to flow in only one direction, preventing air from entering the affected area but allowing air and mucus to escape.
Potential adverse events include collapsed lung, bleeding, bronchitis and damage to the airway in which the valve is placed. The valve should not remain implanted for longer than six weeks. Patients who cannot tolerate bronchoscopy should not be treated with the device.
The IBV Valve System helped heal air leaks in a small number of patients undergoing lung surgery. A pivotal trial, where the valve system was used to treat emphysema, provided additional safety information as did other studies, such as animal studies, biocompatibility tests, sterilization validation, and packaging and shelf life studies.
The IBV Valve System is manufactured by Spiration, Inc., located in Redmond, Wash. The company will conduct a post-approval study to collect additional safety and benefit information that may be used to enhance labeling for the device.
-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
Memories Selectively, Safely Erased in Mice
New and old memories have been selectively and safely removed from mice by scientists.
"While memories are great teachers and obviously crucial for survival and adaptation, selectively removing incapacitating memories, such as traumatic war memories or an unwanted fear, could help many people live better lives," says Dr. Joe Z. Tsien, brain scientist and co-director of the Brain & Behavior Discovery Institute at the Medical College of Georgia School of Medicine.
"Our work reveals a molecular mechanism of how that can be done quickly and without doing damage to brain cells," says the Georgia Research Alliance Eminent Scholar in Cognitive and Systems Neurobiology.
Dr. Tsien's research team, in collaboration with scientists at East China Normal University in Shanghai, were able to eliminate new and old memories alike by over-expressing a protein critical to brain cell communication just as the memory was recalled, according to research featured on the cover of the Oct. 23 issue of Neuron.
Dr. Tsien had already created a mouse that couldn't form memories by eliminating the NMDA receptor, which receives messages from other neurons. He then garnered international acclaim by making "Doogie," a smart mouse in which a subunit of the NMDA receptor is over-expressed. Younger brains have higher amounts of this NR2B subunit which leaves communication channels between brain cells open longer. That is why young people can learn faster than older adults.
This time he was examining downstream cascades of the NMDA receptor to learn more about memory formation. An abundant protein found only in the brain, called αCaMKII, was a logical place to look because it's a major signaling molecule for the NMDA receptor. He found that when he over-expressed αCaMKII while a memory was being recalled, that single memory was eliminated.
Receptors such as the NMDA receptor are like front doors to cells, providing an opening for signaling molecules such as calcium. Synapses are the point of communication between two cells, and NMDA receptors are on the receiving end of the message. Like people, neurons change with the signals they receive. "Learning changes the way cells connect to each other," says Dr. Tsien. To form a memory, the NMDA receptor is activated, which results in the insertion of AMPA receptors into those synapses and subsequent strengthening of the synaptic connections among hundreds of thousands of neurons. Scientists believe that αCaMKII plays an important role in the insertion of AMPA receptors into synapses during learning and subsequent strengthening of connections between neurons to create a memory.
Memory has four distinct stages: learning, consolidation, storage and recall. It has been difficult to dissect the molecular mechanisms of these stages because researchers lacked techniques to manipulate proteins quickly. For example, when researchers disable a gene suspected to play a role in the memory process, the deletion typically occurred throughout the entire period so it was impossible to tell which parts of processes were impaired. Previous technology would take several days to switch off a protein, which is the product of a gene.
So Dr. Tsien’s team developed a powerful chemical-genetic method that allows him to use a pharmacologic inhibitor to instantly turn αCaMKII off and on in a mouse that he genetically engineered to over express this signaling molecule. That enabled him to study exactly what happened if he threw off the natural balance during the retrieval stage.
Much as a war veteran remembers a fateful patrol when he was fired upon, mice can establish a very long-lasting emotional memory about a place if, for example, they receive a mild shock to the paws while there. The researchers showed if they over-expressed αCaMKII, this powerful memory was rapidly erased as the animals tried to retrieve them while other memories remained intact.
A similar approach was taken with object recognition memory, giving mice a couple of toys to play with then erasing their memory of one of them. "You will feel like every time, it's a new toy," says Dr. Tsien.
While the ability to rapidly erase a selective memory is exciting, he cautions that its translation to humans would be difficult at this stage. “We are barely at the foot of a huge mountain,” says Dr. Tsien. A possible strategy for humans would be a drug that mimics the αCaMKII over expression that researchers accomplished through genetic manipulation. Or, further downstream substrates that αCaMKII acts upon could become possible drug targets.
The research was funded by the National Institute of Mental Health, the National Institute on Aging and the Georgia Research Alliance.
By Toni Baker
-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
Thursday, October 23, 2008
Men With Intracranial Hypertension Experience Vision Loss More Often Than Women
Men who suffer from idiopathic intracranial hypertension (IIH), a cause of increased pressure around the brain, are more likely to have vision loss than women with the same disease, says Beau Bruce, MD, assistant professor, Emory Eye Center and Emory University School of Medicine.
The cause of IIH is not known. Symptoms include headache, ringing in the ears and vision problems (due to swelling of the optic nerves) such as blurriness and double vision. It is most common in young, obese women. If untreated vision loss is possible.
According to research published in the Oct. 15, 2008 issue of Neurology, the medical journal of the American Academy of Neurology, Bruce and his colleagues at Emory, University of Mississippi and Wayne State University retrospectively reviewed the medical records of more than 700 people with the disease. Nine percent of the group was male.
The participants had visual acuity exams, visual field exams and brain scans as part of their evaluations. At both initial and final evaluations men’s vision was worse than the women’s.
The study found that men with IIH were more likely to have visual loss symptoms, while women had headache symptoms more frequently. It was also noted that men had a diagnosis of sleep apnea more frequently (24 percent vs. 4 percent for the women). It is not known how much that condition contributed to the vision problems.
“This study highlights the importance of following men with IIH carefully because they may not have the typical symptoms of raised intracranial pressure to alert the physician to be more aggressive,” says Bruce. “In addition, it emphasizes the importance of screening patients with IIH for sleep apnea when appropriate.”
The study was supported in part by grants from Research to Prevent Blindness, Inc., and the National Institutes of Health.
Reference:
Bruce, BB et al, “Idiopathic intracranial hypertension in men” Neurology 2008.
---
www.FayetteFrontPage.com
Fayette Front Page
Community News You Can Use
Fayetteville, Peachtree City, Tyrone
www.GeorgiaFrontPage.com
www.ArtsAcrossGeorgia.com
---
Emory Lecture to Address Improving Patient Safety
WHAT:
2008 David Jowers Lecture, Emory University Nell Hodgson Woodruff School of Nursing
"Getting Everyone Involved in Improving Quality and Safety in Health Care"
WHEN:
Thursday, Nov. 6, 2008. 4 p.m.
LECTURER:
Marjorie M. Godfrey, MS, RN
Marjorie Godfrey serves as instructor for The Dartmouth Institute for Health Policy and Clinical Practice. She is also quality advisor for the Cystic Fibrosis Foundation and Vermont Oxford Network. Godfrey is a visiting professor at Fairfield University School of Nursing and a clinical effectiveness coordinator at Cooley Dickinson Hospital.
Godfrey is a doctoral student at Jonkoping University School of Nursing. Her dissertation focus is coaching health care improvement. She received a Master of Science at the Center for Evaluative Clinical Sciences, Dartmouth Medical School at Dartmouth College in 1995, a Bachelor of Science in nursing at Vermont College of Norwich University in 1989, and a Diploma in nursing at Concord Hospital School of Nursing in 1977.
Godfrey’s work in healthcare has focused on systems of care, patient safety and improving health outcomes of patients nationally and globally for more than a decade. Her first book "Quality By Design" (2007 Jossey-Bass) provides the foundational theory and practical education to improving system performance, patient and family satisfaction, and staff morale. Godfrey has presented at a number of conferences including "Quality and Safety in Nursing Education: A Clinical Microsystem Approach" sponsored by the Joint Commission in 2008.
WHERE:
Emory University Nell Hodgson Woodruff School of Nursing
1520 Clifton Rd., Atlanta, Plaza Auditorium
Link to map and directions:
http://emap.fmd.emory.edu/website/campus/index.htm?queryzoom=Yes&Query=(bldg='1515')
The lecture is free and open to the community. To RSVP, call 404-712-963.
---
www.FayetteFrontPage.com
Fayette Front Page
Community News You Can Use
Fayetteville, Peachtree City, Tyrone
www.GeorgiaFrontPage.com
www.ArtsAcrossGeorgia.com
---
U.S. Suicide Rate Increases
The rate of suicide in the United States is increased for the first time in a decade, according to a new report from the Johns Hopkins Bloomberg School of Public Health’s Center for Injury Research and Policy. The increase in the overall suicide rate between 1999 and 2005 was due primarily to an increase in suicides among whites aged 40-64, with white middle-aged women experiencing the largest annual increase.
Whereas the overall suicide rate rose 0.7 percent during this time period, the rate among middle-aged white men rose 2.7 percent annually and 3.9 percent among middle-aged women. By contrast, suicide in blacks decreased significantly over the study’s time period, and remained stable among Asian and Native Americans. The results are published online at the website of the American Journal of Preventive Medicine and will be published in the December print edition of the journal.
The researchers also conducted a detailed analysis of suicide methods across specific population groups. While firearms remain the predominant method, the rate of firearm suicides decreased during the study period. Suicide by hanging or suffocation increased markedly with a 6.3 percent annual increase among men, and a 2.3 percent annual increase among women.
Hanging/suffocation accounted for 22 percent of all suicides by 2005, surpassing poisoning at 18 percent.
“The results underscore a change in the epidemiology of suicide, with middle-aged whites emerging as a new high-risk group,” said study co-author Susan P. Baker, MPH, a professor with the Bloomberg School’s Center for Injury Research and Policy. “Historically, suicide prevention programs have focused on groups considered to be at highest risk—teens and young adults of both genders as well as elderly white men. This research tells us we need to refocus our resources to develop prevention programs for men and women in their middle years.”
Baker along with colleagues Guoqing Hu, PhD, Holly Wilcox, PhD, Lawrence Wissow, MD, MPH, analyzed data from the Web-based Injury Statistics Query and Reporting System (WISQARS) mortality reports, which provides data on deaths according to cause and intent of injury by age, race, gender and state. WISQARS mortality data are based on annual data files of the National Center for Health Statistics (NCHS) of the Centers for Disease Control and Prevention (CDC).
The reasons for the increase in the suicide rate are not fully understood. “While it would be straightforward to attribute the results to a rise in so-called mid-life crises, recent studies find that middle age is mostly a time of relative security and emotional wellbeing,” said Baker. “Further research is warranted to explore societal changes that may be disproportionably affecting the middle-aged in this country.”
The research was funded by the Center for Injury Research and Policy.
-----
www.georgiafrontpage.com
Georgia Front Page
www.fayettefrontpage.com
Fayette Front Page
Wednesday, October 22, 2008
Emory Researchers Study Test to Better Detect High-Risk HPVs and Cervical Cancer
Researchers at Emory University are participating in a large national study to evaluate an investigational test used to detect high-risk human papillomavirus (HPV), which in some cases can lead to a woman developing cervical cancer.
The investigational test would be performed in conjunction with a woman’s annual Pap test in an effort to find a better method of detecting cervical disease, either pre-cancerous or cancerous.
“This is a second generation of testing for cervical cancer and cervical cancer precursors,” says Kevin Ault, MD, associate professor in the Department of Gynecology and Obstetrics, Emory University School of Medicine and principal investigator of the study at Emory. “We’ve been using the standard Pap test since the mid-1950’s, and while this test has drastically reduced the number of deaths from cervical cancer, it does report false negatives.” (A false negative means there is actually a disease or other condition, but the results come back as negative).
"A newer, approved HPV test on the market tends to yield false positives and is more expensive than Pap testing,” says Ault. “So, we need a better standard in testing for HPV and cervical cancer.
Human papillomaviruses are a group of more than 100 related viruses. They are called papillomaviruses because certain types may cause warts, or papillomas, which are benign (non-cancerous) tumors. Some types of HPV are associated with certain types of cancer. These are called high-risk or carcinogenic HPVs.
The new automated APTIMA HPV Assay test studied at Emory is designed to detect 14 high-risk HPV types that are associated with or progress towards cervical cancer.
Diagnosing HPV is useful in two situations that women commonly face. HPV testing may be useful in women with mildly abnormal Pap smears. Also, HPV testing may be a useful test in detecting a precancerous problem in women older than 30. Both of these problems will be studied in this clinical trial.
“We hope this research study will help us find a better and more effective test for detecting high-risk HPV infections,” says Ault. “We’ve previously identified a vaccine to protect young women against two major strains of HPV. Now we must work to find a better detection device.”
Some 7,000 women are expected to enroll in the study nationwide. Gen-Probe, Incorporated, the maker of the assay test, is funding this study.
To enroll in this HPV investigational test clinical trial or to find out more about participation, please call Shara Karlebach, study coordinator, at 404-778-4169.
---
www.FayetteFrontPage.com
Fayette Front Page
Community News You Can Use
Fayetteville, Peachtree City, Tyrone
www.GeorgiaFrontPage.com
www.ArtsAcrossGeorgia.com
---
Emory Scientist Earns American Cancer Society Grant to Fight Multiple Myeloma
Emory cancer researcher Jing Chen, PhD, has earned a $720,000 award from the American Cancer Society to support his work on new drug targets in multiple myeloma. Multiple myeloma is one of the most common blood cancers found in patients over 65 with more than 15,000 new cases diagnosed each year.
“Current chemotherapy and even newer reagents are inadequate in treating this disease,” says Chen. “This award will help us to extend our work finding and validating critical signaling effectors that could be therapeutic targets in the future.”
Chen is an assistant professor of hematology and medical oncology at Emory University School of Medicine and Emory Winship Cancer Institute.
He and his colleagues recently identified ribosomal S6 kinase 2 (RSK2) as one of the key growth circuits in multiple myeloma cells. Abnormalities in the fibroblast growth factor receptor 3 (FGFR3) gene are present in around 15 percent of multiple myeloma tumors, and the overproduction of FGFR3 activates RSK2.
Chen says he plans to study RSK2’s role in driving out-of-control growth and to test inhibitors of RSK2 for their ability to block multiple myeloma. The award is $180,000 per year for four years.
---
www.FayetteFrontPage.com
Fayette Front Page
Community News You Can Use
Fayetteville, Peachtree City, Tyrone
www.GeorgiaFrontPage.com
www.ArtsAcrossGeorgia.com
---
Physical Therapy Helps Fayette Resident Get Back on Her Feet
Billie Burnett of Fayetteville is one of millions of individuals who has undergone physical therapy after an injury or surgical procedure. Burnett suffered from arthritis and a torn meniscus and had to have knee replacement. If you break an arm, suffer a stroke or have a total joint replacement, chances are your physician will refer you to a physical therapist.
October is National Physical Therapy Month, and Piedmont Fayette Hospital is recognizing the hospital’s physical therapy department and their efforts to help individuals recover from surgery or an injury.
“Following my knee replacement I underwent physical therapy at Piedmont Fayette,” said Burnett. “Upon starting therapy, I had been limping for two years, but Kesha, my therapist was very understanding and helped build me up at a pace I was comfortable with.”
Therapeutic exercise and functional training are the cornerstones of physical therapist treatment. Depending on the particular needs of a patient, physical therapists can “manipulate” a joint, or perform certain types of passive movements at the end of the patient's range of motion, and massage a muscle to promote proper movement and function. Physical therapists may even use other techniques such as electrotherapy, ultrasound, hot packs and ice when appropriate.
“Physical therapists aim to help patients overcome physical challenges they might face due to an injury or illness,” said Jill Fenimore, director of rehabilitation and fitness at Piedmont Fayette Hospital. “Physical therapists will also work with individuals to prevent loss of mobility by developing fitness and wellness programs for healthier and more active lifestyles.”
Today, patients and physicians are demanding the talents of physical therapists for conservative management of a wide variety of conditions. In many cases, patients are being sent to physical therapy instead of surgery. Physical therapists help people with orthopedic conditions such as low back pain or osteoporosis; joint and soft tissue injuries such as fractures and dislocations; neurologic conditions such as stroke, traumatic brain injury, or Parkinson’s disease; and workplace injuries including repetitive stress disorders and sports injuries.
“Everyone is just so friendly at Piedmont Fayette from the minute you walk in the door to the minute you leave,” said Burnett. “There were a few days when I was not looking forward to the exertion of therapy, but everyone’s positive attitude is just so infectious that it made therapy enjoyable.”
Physical therapy has its origins in ancient history, but made significant strides when massage and remedial gymnastics became a vital service in both world wars. Much was learned through the rehabilitation of injured servicemen from these events. Physical therapy grew rapidly after the Second World War with spinal injury units, orthopaedic hospitals and chest clinics providing new challenges to the profession. Today, physical therapists practice in a variety of settings and provide services that help restore function, improve mobility, relieve pain, and prevent or limit permanent physical disabilities of patients suffering from injuries or disease.
There are more than 150,000 physical therapists in the United States, according to the U.S. Department of Labor. About 1,640 physical therapists practice in the metro Atlanta area.
Physical therapy services offered at Piedmont Fayette Hospital include orthopedic, neurological, and obstetric physical therapy, pelvic pain and incontinence therapy. Other services available include cardiac rehab, occupational therapy, lymphedema therapy, speech-language pathology, a wound care clinic and a Fitness Center, which offers a variety of exercise classes such as Moms in Motion. The Rehabilitation and Fitness Department also offers free Healthy Heart and Total Joint Replacement classes.
The Rehabilitation and Fitness Center focuses on disease prevention, rehabilitation of injuries and maintenance of optimal health, and educates members on fitness and nutrition. It also features state‑of‑the‑art cardiovascular equipment and strength training programs. The Piedmont Fayette Hospital Fitness Center is open to individuals 14 years and older. The Rehabilitation and Fitness Center is located across from the main hospital in the Fayette Professional Center. For more information about PFH's physical therapy services, call 770-719-7290. To learn more about Piedmont Fayette Hospital, visit www.fayettehospital.org
---
www.FayetteFrontPage.com
Fayette Front Page
Community News You Can Use
Fayetteville, Peachtree City, Tyrone
www.GeorgiaFrontPage.com
www.ArtsAcrossGeorgia.com
---
CDC Study Finds 3 Million U.S. Children have Food or Digestive Allergies
The number of young people who had a food or digestive allergy increased 18 percent between 1997 and 2007, according to a new report by the Centers for Disease Control and Prevention. In 2007, approximately 3 million U.S. children and teenagers under age 18 – or nearly 4 percent of that age group – were reported to have a food or digestive allergy in the previous 12 months, compared to just over 2.3 million (3.3 percent) in 1997.
The findings are published in a new data brief, “Food Allergy Among U.S. Children: Trends in Prevalence and Hospitalizations.” The data are from the National Health Interview Survey and the National Hospital Discharge Survey, both conducted by CDC′s National Center for Health Statistics.
The report found that eight types of food account for 90 percent of all food allergies: milk, eggs, peanuts, tree nuts, fish, shellfish, soy, and wheat. Reactions to these foods by an allergic person can range from a tingling sensation around the mouth and lips, to hives and even death, depending on the severity of the reaction.
Children with food allergy are two to four times more likely to have other related conditions such as asthma and other allergies, compared to children without food allergies, the report said.
Other highlights:
* Boys and girls had similar rates of food allergy – 3.8 percent for boys and 4.1 percent for girls.
* Approximately 4.7 percent of children younger than 5 years had a reported food allergy compared to 3.7 percent of children and teens aged 5 to 17 years.
* Hispanic children had lower rates of reported food allergy (3.1 percent) than non-Hispanic white (4.1 percent) or non-Hispanic black children (4 percent.)
* In 2007, 29 percent of children with food allergy also had reported asthma compared to 12 percent of children without food allergy.
* Approximately 27 percent of children with food allergy had reported eczema or skin allergy, compared to 8 percent of children without food allergy.
* Over 30 percent of children with food allergy also had reported respiratory allergy, compared with 9 percent of children with no food allergy.
* From 2004 to 2006, there were approximately 9,537 hospital discharges per year with a diagnosis related to food allergy among children from birth to 17 years. Hospital discharges with a diagnosis related to food allergy increased significantly over time between 1998-2000 through 2004-2006.
The mechanisms by which a person develops an allergy to specific foods are largely unknown. Food allergy is more prevalent in children than adults. Most affected children will outgrow food allergies, although food allergy can be a lifelong concern.
The full report is available at www.cdc.gov/nchs.
-----
www.fayettefrontpage.com
Fayette Front Page
Community News You Can Use
Fayetteville, Peachtree City, Tyrone
www.georgiafrontpage.com
Georgia Front Page
Poor Perioperative Blood Pressure Control Linked to 30-Day Morbidity and Mortality in Cardiac Surgery Patients
Business Wire - The Medicines Company (NASDAQ: MDCO) announced October 21, 2008, that poor blood pressure control during cardiac surgery is associated with a higher risk of 30-day death, stroke, myocardial infarction and renal dysfunction, compared to patients with tight blood pressure control, according to a post-hoc analysis of the ECLIPSE trial. The data were presented at the American Society of Anesthesiologists (ASA) 2008 Annual Meeting.
“In this analysis, what we found was clear: the worse the blood pressure control, the poorer the outcome in these cardiac surgery patients,” said Solomon Aronson, M.D., Professor of Anesthesiology, Duke University School of Medicine. “These data support the need to more effectively manage blood pressure in the surgical and critical care settings.”
The ECLIPSE trial enrolled 1,964 cardiac surgery patients in one of three randomized, open-label trials comparing Cleviprex™ (clevidipine butyrate) injectable emulsion to nitroglycerin, sodium nitroprusside or nicardipine. In this post-hoc analysis, 1507 ECLIPSE patients were stratified by precision of blood pressure control measured as excursions and time out of a pre-specified range. Adverse outcomes, assessed as death, myocardial infarction, stroke and renal dysfunction at 30 days post-discharge, were significantly higher in patients with poor blood pressure control (14.4%) than in patients with tight blood pressure control (8.8%).
“These critical new findings underscore the risk posed by uncontrolled blood pressure during cardiac surgery and emphasize the need for tight blood pressure control in these patients,” said James Ferguson, M.D., Vice President, Global Medical, Surgical and Critical Care, The Medicines Company. “Cleviprex, recently approved by the FDA, provides physicians with an important, new clinical tool for achieving rapid and predictable blood pressure control.”
Additional post-hoc data from the pivotal ECLIPSE program, involving patients undergoing cardiac valve surgery, will be presented at the American College of Chest Physicians (ACCP) annual meeting in Philadelphia on Tuesday, October 28, 2008.
-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
Monday, October 20, 2008
Early Exposure To Drugs, Alcohol Creates Lifetime Of Health Risk
People who began drinking and using marijuana regularly prior to their 15th birthday face a higher risk of early pregnancy, as well as a pattern of school failure, substance dependence, sexually-transmitted disease and criminal convictions that lasts into their 30s.
A study published online by the journal Psychological Science has been able to sort out for the first time the difficult question of whether it's bad kids who do drugs, or doing drugs that makes kids bad.
The answer is both, said Duke University psychologist Avshalom Caspi, who co-authored the report with his wife and colleague Terrie Moffitt. They are part of a team of researchers from the U.S., Britain and New Zealand that analyzed data tracking the health of nearly 1,000 New Zealand residents from birth through age 32.
Half of the study subjects who were using alcohol and marijuana regularly before age 15 were indeed the so-called "bad kids" who came from an abusive, criminal or substance-abusing household and had behavior problems as children.
But the other half were the "good kids" from more stable backgrounds, and they also ended up in poorer health in their 30s.
Caspi said it is clear from these data that adolescent exposure to drugs and alcohol can make a good kid veer off on a bad trajectory. "The good kids who do drugs end up looking like the bad kids who didn't do drugs," Caspi said.
The "good kids," who were without behavior problems as children and didn't have any of the family risk factors, but who began using drugs and alcohol before 15, ended up being 3.6 times more likely to be dependent on substances at age 32. They were also more likely than the other good kids to wind up with a criminal conviction and a herpes infection.
Good and bad, the adolescents who regularly used drugs and alcohol "all had poorer health as adults," Caspi said. "This is consistent with a growing body of evidence that early adolescence may be a sensitive time for exposure to alcohol and other drugs."
He noted however, that the study is not concerned with a kid who tries alcohol a couple of times or who takes a toke at a party. "These are kids who, by the age of 15, are invested in it, purchasing drugs and alcohol and using regularly."
A third of the girls from the "good kids" group were pregnant before age 21 if they had been using drugs and alcohol regularly. That's the same number of pregnancies as the "bad kids" who didn't use drugs. Two-thirds of the "bad kids" who used before 15 were pregnant before age 21. By comparison, only 12 percent of "good" girls who were non-users had early pregnancies.
“Even adolescents with no prior history of behavioral problems or family history of substance use problems were at risk for poor health outcomes if they used substances prior to age 15," said first author Candice Odgers of the University of California-Irvine, who did a post-doctoral fellowship with Caspi and Moffitt. "Universal interventions are required to ensure that all children -- not just those entering early adolescence on an at-risk trajectory -- receive an adequate dose of prevention.”
Because the study has tracked these people from birth, "we know pretty much everything about them and we can sort out these things," Caspi said. "We have rich data on these kids' lives and their family situation before they started to do drugs."
The study was funded by the National Institute of Mental Health, the U.K. Medical Research Council, the William T. Grant Foundation, the Health Research Council of New Zealand, and a National Institute on Drug Abuse grant to the Duke University Transdisciplinary Prevention Research Center.
Other authors of the Psychological Science paper include Daniel Nagin of Carnegie Mellon University; Barry Milne of King's College, London; Alex Piquero of the University of Maryland, College Park; Wendy Slutske of the University of Missouri-Columbia; and Nigel Dickson and Richie Poulton of the University of Otago in New Zealand.
By Karl Leif Bates
-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
Saturday, October 18, 2008
Clayton State Nursing Students Working With BB&T on Health Fair
Clayton State University senior nursing students are working with a local BB&T bank branch to hold a community health fair on Saturday, Oct. 25 from 10 a.m. until 2 p.m. The event will take place at the new BB&T bank branch in Morrow, Ga., located at 1860 Mt. Zion Rd.
“Many common health issues are education centered. At the health fair we plan to educate our community on the leading public concern, heart disease,” says nursing student Tracy Towery of Griffin, Ga.
“We will be passing out information that we have obtained from the American Heart Association as well as teaching from a poster that we have created. We will also be doing blood pressure screenings and teaching on how to take your own blood pressure,” says Angel Abdullah, a nursing student from McDonough, Ga.
The nursing students will be teaching the signs and symptoms of hypertension and how to control and prevent this disease.
“We will also discuss diet because this can be a major factor in hypertension. People do not realize how sodium affects the blood and how much sodium is in their daily diet,” says Towery.
The health fair will have several local businesses and health related vendors. BB&T will even be providing financial health check-ups.
A unit of the University System of Georgia, Clayton State University is an outstanding comprehensive metropolitan university located 15 miles southeast of downtown Atlanta.
---
www.FayetteFrontPage.com
Fayette Front Page
Community News You Can Use
Fayetteville, Peachtree City, Tyrone
www.GeorgiaFrontPage.com
www.ArtsAcrossGeorgia.com
---
Friday, October 17, 2008
Medicaid Spending Projected to Rise Much Faster Than the Economy
Cumulative Spending on Medicaid Benefits Projected to Reach $4.9
Trillion Over 10 Years
Under current law, spending on Medicaid is expected to substantially
outpace the rate of growth in the U.S. economy over the next decade,
according to a new annual report released today by the Centers for
Medicare & Medicaid Services (CMS).
The report projects that Medicaid benefits spending will increase 7.3
percent from 2007 to 2008, reaching $339 billion and will grow at an
annual average rate of 7.9 percent over the next 10 years, reaching $674
billion by 2017. That compares to a projected rate of growth of 4.8
percent in the general economy.
HHS Secretary Mike Leavitt presented the report today at the fall
meeting of the National Association of State Budget Officers (NASBO).
"This report should serve as an urgent reminder that the current path of
Medicaid spending is unsustainable for both federal and state
governments. We must act quickly to keep state Medicaid programs
fiscally sound," Secretary Leavitt said. "If nothing is done to rein in
these costs, access to health care for the nation's most vulnerable
citizens could be threatened."
Although the CMS Office of the Actuary regularly produces 75-year
projections of Medicare expenditures for the annual report of the
Medicare Board of Trustees, the report released today is the first
annual fiscal report on Medicaid.
The Medicare Trustees Report provides detailed information on the past
and estimated future financial operations of the Hospital Insurance and
Supplementary Medical Insurance Trust Funds. This new annual report on
Medicaid contains analysis of past program trends and projections of
Medicaid expenditures and enrollment for the next 10 years only. Future
reports will expand on content to include longer-range projections and
more extensive analysis.
Medicaid is a federal/state partnership program that provides health
care to certain low-income people and is one of the largest payers for
health care in the United States. For both federal and state
governments, Medicaid is the largest source of general revenue spending
on health services. Notably, Medicaid is the largest source of general
revenue spending for health care for both the Federal government and the
states.
This growth rate compares to spending projections for Medicare of 7.4
percent per year through 2017. Medicaid benefits spending over the next
10 years is projected to be $4.9 trillion. These amounts are in
addition to that spent by federal and state governments on the State
Children's Health Insurance Program (SCHIP).
At this rate, Medicaid growth is projected to slightly exceed growth in
overall health care expenditures, which is projected by CMS actuaries
and economists to increase by 6.7 percent per year over the next 10
years, or over twice the rate of general inflation. Additionally,
Medicaid's share of the Gross Domestic Product (GDP) is projected to
reach about three percent in 2017. The combined share of GDP spending
for Medicare and Medicaid is projected to be 6.9 percent by 2017.
As a partnership program, both states and the federal government pay for
services to Medicaid beneficiaries. The federal government matches
state expenditures based on a formula that yields subsidies ranging from
50 percent to as high as 83 percent. The average federal medical
assistance percentage is 57 percent.
However, even with federal support, states report they are struggling to
meet their share of expanding Medicaid costs. State spending on
Medicaid has remained relatively stable as a share of states' budgets,
averaging about 20 percent from 1995-2007. However, some states such
as Maine are already spending as much as 31 percent of their budgets on
Medicaid, according to NASBO.
NASBO is projecting that state spending on Medicaid will increase by 4.4
percent from 2008 to 2009. NASBO says such an increase would be more
than four times the rate of growth in the average state general fund.
"High and increasing Medicaid spending clearly leaves states less able
to fund other state priorities," said Acting CMS Administrator Kerry
Weems. "This new financial report confirms that America's health care
system faces significant fiscal challenges.
"As a nation we must tackle the difficult job of bringing health care
costs under control and assuring that our health care dollars are buying
the highest quality, most efficient health care services."
Other findings from the report include:
* Average Medicaid enrollment is projected to increase 1.8 percent
to 50 million people in 2008.
* During the next 10 years, average enrollment is projected to
increase at an average annual rate of 1.2 percent and to reach 55.1
million by 2017.
* The estimated average cost of a person covered by Medicaid in
2007 is $6,120; however, per-enrollee spending for non-disabled children
($2,435) and adults ($3,586) was much lower than that for aged ($14,058)
and disabled beneficiaries ($14,858), reflecting the differing health
status of these groups.
* Medicaid represented 14.8 percent of all health care spending in
the United States in 2006.
* Medicaid is projected to grow as a share of the federal budget
from 7.0 percent in 2007 to 8.4 percent by 2013.
-----
www.fayettefrontpage.com
Fayette Front Page
Community News You Can Use
Fayetteville, Peachtree City, Tyrone
www.georgiafrontpage.com
Georgia Front Page
