Study Finds Broad Access to Parenting Support Lowers Risk of Child Maltreatment

When parents have access to proven parenting information and support designed to address problems all families face—from tantrums to encouraging good behavior—key measures of child maltreatment fall, according to a study released in the Jan. 26 online edition of the journal Prevention Science.

The study, which was funded by the Centers for Disease Control and Prevention (CDC), found lower rates of confirmed abuse cases, child out–of–home placements, and hospitalizations and emergency room visits for child injuries in counties where parenting support was implemented.

“Previous studies have shown reductions in children′s social, emotional and behavioral problems,” said Ron Prinz, Ph.D., at the University of South Carolina, the study′s lead investigator. “This is the first large–scale study to show that by providing all families, not just families in crisis, with access to parenting information and support, we can reduce the rates of child maltreatment in whole communities.”

Using a multi–level system of parenting support called the Triple P—Positive Parenting Program, nine study counties in South Carolina implemented a wide range of support mechanisms for parents including local media, brief public seminars, and parent consultation by specially trained providers in clinics, schools, churches, and community centers.

Researchers estimate the results of this study could translate annually into 688 fewer cases of child maltreatment, 240 fewer out–of–home placements, and 60 fewer children with injuries requiring hospitalization or emergency room treatment for every 100,000 children under age 8.

“Engaging parents is an important step in our ongoing efforts to prevent child maltreatment and promote safe, stable, nurturing, relationships for children in all communities,” said Rodney Hammond, Ph.D., director of the CDC′s Division of Violence Prevention. Child maltreatment harms people and society, contributing to costly long–term health problems ranging from heart disease and obesity to depression and anxiety, making this type of prevention study critical.”

For more information on the Triple P – Positive Parenting Program, visit www.triplep.net. For information on CDC′s prevention research in child maltreatment, visit www.cdc.gov/injury. For a copy of the study, visit

http://www.springerlink.com/content/a737l8k76218j7k2/?p=587ecf68cf6745058cb3e636889cdf70π=0.

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Parkbrooke Professional Center Attracts Premier Medical Practice

Towne Lake Corridor Experiences Medical Development Growth

North Fulton Family Medicine has leased 8,000 square feet in Parkbrooke Professional Center in Woodstock, according to Tom Kirbo, founder of Kirbo Property Services and developer of the three-story property.

"For North Fulton Family Medicine to choose Parkbrooke Professional Center for their relocation and expansion within this thriving community says a lot about the quality of this project. North Fulton Family Medicine is joining Northside Pediatrics & Adolescent Medicine at Parkbrooke Professional Center," said Kirbo. "This property is the ideal location for a medical office with convenient, covered parking and ample parking for patients, tenants and visitors of the building."

Parkbrooke Professional Center, is a three-story, 23,500 square foot class A medical office building located in Woodstock, Ga., just 2 miles west of I-575. Strategically located in the high-growth Towne Lake corridor, Parkbrooke Professional Center will be completed in March 2009. North Fulton Family Medicine and Northside Pediatrics & Adolescent Medicine both plan to have their offices opened to see patients in June 2009.

Kirbo Property Services, a commercial a real estate development, brokerage and investment firm located in Atlanta, Georgia LLC handles the development, marketing and leasing of Parkbrooke Professional Center.

For more information about Kirbo Property Services or Parkbrooke Professional Center, contact Tom Kirbo at (404) 257-9800.
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New Coalition Created to Help Breast Cancer Survivors Gain Access to Products Designed to Improve Their Quality of Life

A national coalition of patient advocates, physicians, business groups, non-profit organizations and other stakeholders, has been created to help breast cancer survivors gain better access to high quality prostheses and related post-surgical items. Known as Because We CARE (Breast Cancer Survivor Coalition for the Advancement, Reform and Equity), the coalition, a non-profit organization (www.becausewecarecoalition.com) launched this week with the support of U.S. Congressman Phil Gingrey, MD (R-GA). Gingrey spent more than 25 years in a successful OB-GYN practice in Georgia and is an advocate of women's health issues.

"It is time for members of congress to recognize that current Medicare formulas have created a system that deprives many breast cancer survivors and others in need of products and services that can help them move on with their lives. The coalition is a great way to draw attention to this issue," said Gingrey.

Organizations supporting the coalition include Amoena USA Corporation and the National Coalition for Cancer Survivorship. In addition to national support, other organizations include Willie's Specialty Shop in Orange, CA, Late Bloomers in San Mateo, CA, New Day's Dawn in Santee, CA, The Profile Shop in PA, Special Lady Boutique in KY, A Place For Her in FL, Touching You in AL, Enhance by Linda Reib in CA, Barbara Graves Intimate Fashion in AR, and The Pink Petal in South Hadley, MA.

"We joined forces to create this Coalition because we all are extremely dedicated to providing breast cancer survivors with better access to products that will give them the quality of life they deserve," said Bonnie Marshall, patient advocate and breast cancer survivor. "We also understand the issues affecting women's healthcare coverage and the importance of gaining access to breast prostheses, symmetry shapers and other post surgical items. We want to raise awareness of the issues facing women affected by breast cancer and work toward removing barriers that inhibit them from maintaining their dignity and improving their quality of life."

After having surgery to treat breast cancer, many survivors struggle to regain the quality of life they experienced before their diagnosis. Health care research has found that the sooner women can feel whole again, and regain their sense of femininity, the sooner they will be able to move on with their lives.

High quality, doctor-prescribed external breast prostheses can assist a high percentage of the 2.5 million breast cancer survivors living in the United States in achieving this goal. However, due to the formula created by the Centers for Medicare and Medicaid Services (CMS), coverage of breast prostheses differs from state to state. Regardless of health care coverage -- commercial or Medicare -- these disparities effectively limit choice and may deprive women of the best available breast forms and related supplies.

For additional information on Because We Care members and legislative outreach, visit www.becausewecarecoalition.com.

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Governor Perdue Appoints Mental Health Ombudsman Nominating Committee

Governor Sonny Perdue announced today his appointments to the Mental Health Ombudsman Nominating Committee. The nominating committee will recommend at least three candidates to the Governor for the ombudsman position. This committee will provide for the appointment, qualifications and term of the ombudsman and determine the organization of the Office the Ombudsman.

Governor Perdue signed House Bill 535 last year creating a mental health ombudsman position to investigate complaints about state hospitals and community services. Under this bill, the new ombudsman office would be attached to the Governor's Office of Consumer Affairs and operate independently of the Department of Human Resources, which currently operates the public mental health system, including the state psychiatric hospitals. The ombudsmen will serve the crucial role of advocating for system-wide improvements, and providing legislators and other policy makers with independent information. The ombudsman will investigate complaints and make recommendations to agencies and other officials on immunity, mental health, developmental disabilities and addictive disease.

Georgia code requires a nominating committee of at least 5 people to nominate three candidates for ombudsman. The ombudsman shall have knowledge and experience concerning the safety, well-being, and rights of consumers and shall have the skills to perform the duties as provided for in O.C.G.A. 37-3-32.

Brief biographies are provided below:

Mental Health Ombudsman Nominating Committee

Mary Burns, M.D., 46, Atlanta – Burns is engaged in private practice and serves as a clinical assistant professor of psychiatry at Emory University. She is a member of the American Psychiatric Association, Georgia Psychiatric Physicians Association and Atlanta Women’s Medical Alliance. Burns earned a bachelor’s degree from the University of the South and a medical degree from the Mercer University School of Medicine. She completed her residency in psychiatry at Duke University and a fellowship in child psychiatry at Harvard University School of Medicine. She and her husband, Eric, have two children.

Nora Lott Haynes, 58, Atlanta – Haynes is retired from the Department of Education, where she served as an administrator in Ware and Henry County Schools. She is president of the National Alliance on Mental Illness (NAMI) Georgia, member of Daughters of the American Colonists and Colonial Dames of the 17th Century. She is past president of Leadership Waycross and a former member of the Rotary Club of Waycross. Haynes earned a bachelor’s degree from the University of Georgia and both a master’s degree and a specialist degree from Valdosta State University. She is married to Greg Haynes and has two children and two step children.

Thomas “Tommy” D. Hills, 64, Atlanta – Hills is the chief financial officer for the State of Georgia. He had a long and distinguished career with the First National Bank of Atlanta and Wachovia Bank, N.A. from 1965-2001. Most recently, he served as Wachovia Bank’s Atlanta City president. Hills is a member of the board of directors of George West Mental Health Foundation Center/Skyland Trail. His civic and community involvement has included the Atlanta Historical Society, the High Museum of Art, the Atlanta Opera, the Center for Puppetry Arts, the Hospital Authority of Fulton County, the Carter Center Board of Visitors, the Georgia Council on Economic Education, Leadership Atlanta, Metro Atlanta Chamber of Commerce and Atlanta Convention and Visitors Bureau. He is a member of the State Bar of Georgia, American Bankers Association Alumni Council and the Rotary Club of Atlanta. Hills earned a bachelor’s degree and a law degree from Emory University and a master’s degree in southern history from Georgia State University. He and his wife, Wally, have 2 grown children and 5 grandchildren.

Vernon Keenan, 58, Ball Ground – Keenan is director of the Georgia Bureau of Investigation. He is a member of the Executive Board of Atlanta High Intensity Drug Trafficking Area and the Georgia Board of Private Detective and Security Agencies. Keenan served as a member of the State Homeland Security Central Command at the 2004 G-8 Summit in Sea Island, GA. Keenan earned a bachelor’s degree from Valdosta State College and a master’s degree from Columbus State University. He and his wife, Joan, have two children.

Sharon M. McDaniel, 50, Hiram – Following an 18 year career in the overhead door business, McDaniel has taught GED classes at The Church of the Holy Comforter Friendship Academy to consumers of mental health services, as well as working as a Certified Peer Specialist at a Community Service Board. She is on the board of directors of the National Alliance on Mental Illness (NAMI) Georgia, serves as vice president for NAMI’s South Cobb affiliate and is co-founder of MentalHealthRecoveryMinistries.org. She is also a state trainer for NAMI’s Peer to Peer classes, as well as being a peer mentor. McDaniel attended Florida Community College in Jacksonville, where she studied accounting. She and her husband, David, have three children and two grandchildren.

Donald S. Meck, Ph.D., 59, Bonaire – Meck has been in private practice in clinical psychology, neuropsychology, and forensic psychology for over 20 years. He is a member of the Georgia State Board of Examiners of Psychologists, the American Psychological Association, the Association of State and Provincial Psychology Boards, the State Bar of Georgia, and the National Academy of Neuropsychologists. Meck is a fellow of the Georgia Psychological Association and past chairman of the Psychology Professional Standards Committee of Coliseum Psychiatric Hospital. He is the recipient of the 2003 Association of State and Provincial Psychology Boards Roger Smith Award for outstanding contributions to the practice of psychology. Meck earned a bachelor’s degree from Purdue University, a master’s degree from St. Mary’s University, a doctoral degree from Texas A&M University and a law degree from John Marshall Law School. He and his wife, Deborah, have three children, seven grandchildren, and one great grandchild.

Gwendolyn “Gwen” B. Skinner, 52, Villa Rica – Skinner has served as director of the Division of Mental Health, Developmental Disabilities and Addictive Diseases, Department of Human Resources since 2004. She was previously employed by the Georgia Department of Juvenile Justice for more than 25 years, most recently as the deputy commissioner of operations. Skinner is a nationally certified school psychologist, a licensed marriage and family therapist, and a board-approved supervisor of marriage and family therapists in the State of Georgia. In addition, she is a Peace Officer Standards and Training (P.O.S.T.) certified instructor. Skinner earned a bachelor’s degree and a master’s degree from the State University of West Georgia. She earned a second master’s degree and two specialist degrees from Georgia State University. She and her husband, Patrick, have served as foster parents for more than forty youth.
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Governor Perdue Introduces Legislation to Restructure the Department of Human Resources

Governor Sonny Perdue announced today that Rep. Mark Butler has introduced HB 228, the Governor’s legislation to restructure the Department of Human Resources (DHR).

“This legislation reorients our approach to healthcare from inputs to results,” Governor Perdue said. “Georgia spends $3.8 billion within DHR every year – an agency that hasn’t undergone major change since it was formed over three decades ago.”

The legislation would form a new Department of Behavioral Health to oversee the mental health and addictive disease programs currently housed in DHR. The new department would report directly to the Governor and increase fiscal transparency.

The reorganization plan would also merge the Department of Community Health with the public health and health regulation programs of DHR to create the Department of Health. Current DCH Commissioner Dr. Rhonda Medows would lead the new Department of Health. Merging the two departments will streamline the health related activities currently residing in two separate departments and establish a lead agency to focus on improving Georgians’ health.

The remaining social services under DHR would become the Department of Human Services. Programs included in this department include Developmental Disabilities, Aging, Division of Family and Children Services (DFCS) and Child Support. Current DHR Commissioner B.J. Walker would lead the new Department of Human Services.

The legislation is based on recommendations by the Health and Human Service Task Force. Governor Perdue appointed five members of the task force who were joined by Senators Jack Hill and Renee Unterman, and Representatives Ben Harbin and Mark Butler. If the legislation is adopted, the transition to the new agencies would begin on July 1, 2009.

“This is a move in the right direction toward correcting our mental and public health systems,” Rep. Butler said. “It is a huge step for this administration to pull these fragile lives out of this larger mix to get them the help and attention they need and deserve. I truly believe that this reorganization will lead to greater efficiencies and more accountability to the taxpayers of this state.”
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Caring For A Loved One With Cancer?

Join us in 2009 for FREE telephone workshops for Caregiver support and information:

“Coping with Caregiving and Recognizing Depression and Anxiety”
Feb.17 at 10 a.m. OR Feb.19 at 7 p.m.

“Coping with Caregiving: When Treatment Changes from Cure to Care”
March 31 at 10 a.m. OR April 2 at 7 p.m.

“Coping with Caregiving and Pain Relief”
May-TBA

For more information, call the American Cancer Society at 1.800.966.3586 or email meg.garner@cancer.org

Governor Perdue Introduces ‘Access to Flu Vaccines Act’

Governor Sonny Perdue announced today that Rep. Jimmy Pruett, one of the Governor’s floor leaders in the House, has introduced the Governor’s “Access to Flu Vaccines Act” legislation, HB 217, to the General Assembly. The legislation improves Georgians’ ability to receive a flu shot.
“Wide distribution of flu vaccinations is an important component of public health,” said Governor Perdue. “Receiving a vaccination reduces the likelihood of a recipient becoming infected with influenza, and is especially important to vulnerable populations like children and the elderly. The legislation we introduced today will make it easier for Georgians to receive their yearly flu shot.”

The “Access to Flu Vaccines Act” will allow physicians to enter into protocol agreements with pharmacists and registered nurses to allow the ordering and dispensing of flu shots without a physician’s individual prescription. To ensure quality control, physicians may issue no more than 10 standing orders with pharmacists and nurses within the same county or adjacent county to the physician’s primary place of business.

Physicians may also enter into more agreements with corporations with multiple locations such as drug stores and grocery store chains.

“This legislation improves our state’s public health by allowing more Georgians to receive a flu vaccination,” said State Representative Jimmy Pruett. “Pharmacists and registered nurses will be able to administer flu shots through protocol agreements with physicians.”
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Girl Scout Cookies are Safe for Consumers

Girl Scout Cookie season is here! For those of you who are anxiously awaiting the arrival of your favorite variety, Girl Scouts of Greater Atlanta is happy to announce that the peanut butter used in Tagalongs® and Do-Si-Dos®, is not sourced from Peanut Corporation of America, the supplier recently implicated by the FDA in their ongoing investigation of a recent Salmonella outbreak.

All Girl Scout Cookies are baked under stringent guidelines and food safety and quality is of the utmost importance. The Girl Scout Cookie Program is the premier business and economic literacy program for girls. It teaches girls financial responsibility, business proficiency and valuable life skills such as money management, teamwork, decision-making and goal setting. All of the proceeds from the program not only support collective troop activities, but they also help subsidize the cost of providing the Girl Scout Program to approximately 40,000 girls in the metropolitan Atlanta and northwest Georgia area.

Girl Scouts of Greater Atlanta and our partner Little Brownie Bakers are thankful for the public’s response to the importance of the continued support of Girl Scouts and especially the Girl Scout Cookie Program.

The purchase of a box of Girl Scout Cookies is and investment in the leaders of tomorrow! Girl Scouts are currently taking orders. Visit our Web site, www.girlscoutsofgreateratlanta.org, on Monday, Feb.16 to find a Girl Scout Cookie Booth Sale location near you.

About the Girl Scouts of Greater Atlanta, Inc.
Girl Scouts of Greater Atlanta, Inc. serves approximately 40,000 girls and over 16,000 adult members in 34 counties in the Greater Metropolitan Atlanta area, northwest Georgia and Polk County, TN. Girl Scouting’s mission is to build girls of courage, confidence and character, who make the world a better place. For more information on how to join, volunteer or donate to the Girl Scouts of Greater Atlanta, Inc. call 1-800-771-4046, or visit www.girlscoutsofgreateratlanta.org.

Little Brownie Bakers
Little Brownie Bakers has been baking Girl Scout Cookies® since 1973. The bakery is licensed by Girl Scouts of the USA to provide eight varieties of cookies for the annual Cookie Sale activities, including Thin Mints, Samoas®, Tagalongs®, Do-si-dos®, and Trefoils. Little Brownie Bakers’ mission is to provide cookies and support services of the highest quality to Girl Scout councils so that the annual Girl Scout Cookie Program activities will help build a wide range of life skills for girls and generate income for Girl Scout troops and councils.
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Ther-Rx Corporation Issues Nationwide Voluntary Recall of Products

Ther-Rx Corporation, a subsidiary of KV Pharmaceutical (NYSE: KVa/KVb), is issuing, as previously disclosed by KV Pharmaceutical Company on January 26, 2009, a voluntary nationwide recall of the products identified below (all lots within expiration) as a precautionary measure because they may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices (cGMPs).

One of the products, Gynazole-1, was also distributed internationally to Eastern Europe, South America, Asia, and Canada.

Patients who may have these medicines in their possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medication may place patients at risk. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products, or to obtain replacement medications or prescriptions.

Products Recalled to WHOLESALE Level:

Gynazole-1®, NDC 64011-0001-08
Clindesse®, NDC 64011-0124-08
microK® Extencaps® 8mEq 100, NDC 64011-0010-04
microK® Extencaps® 8mEq UD, NDC 64011-0010-11
microK® Extencaps® 8mEq 500, NDC 64011-0010-08
microK® Extencaps® 10mEq 100, NDC 64011-0009-04
microK® Extencaps® 10mEq UD, NDC 64011-0009-11
microK® Extencaps® 10mEq 500, NDC 64011-0009-08

Any customer inquiries related to this action should be addressed to Ther-Rx Customer Service at (877) 567-7676, or faxed to Ther-Rx Customer Service at (314) 646-3701, or e-mailed to info@ther-rx.com. Representatives are available Monday through Friday, 8 am to 5 pm CST.

Ther-Rx Corporation has initiated recall notifications to wholesalers nationwide who received any inventory of the recalled products with instructions for returning the recalled products. Patients with questions about the recall should call the telephone number above, or contact their health care providers.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). At this time, the company is unable to determine when distribution of these products will resume.

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

ETHEX Corporation Issues Nationwide Voluntary Recall of Products

ETHEX Corporation, a subsidiary of KV Pharmaceutical (NYSE: KVa/KVb), is issuing, as previously disclosed by KV Pharmaceutical Company on January 26, 2009, a nationwide voluntary recall of the products identified below (all lots within their expiration dates) at a wholesale or a retail level as a precautionary measure because they may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices (cGMPs). Some of these products have had specific lots recalled earlier due to defects found, including oversized tablets delivering higher than labeled doses. These additional products are being removed to assure that no other defective products remain in the marketplace.

Patients who may have these medicines in their possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medication may place patients at risk. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products, or to obtain replacement medications or prescriptions.

Products Recalled to WHOLESALE Level:

Amlodipine Besylate Tablets, 10mg (58177-538-26 & 538-11)
Amlodipine Besylate Tablets, 2.5mg (58177-536-26)
Amlodipine Besylate Tablets, 5mg (58177-537-26, 537-07 & 537-11)
Benazepril HCl Tablets, 10mg (58177-342-04 & 342-08)
Benazepril HCl Tablets, 20mg (58177-343-04 & 343-08)
Benazepril HCl Tablets, 40mg, (58177-344-04 & 344-08)
Benazepril HCl Tablets, 5mg (58177-341-04)
Benzonatate Capsules, 100mg (58177-091-04 & 091-08)
Benzonatate Capsules, 200mg (58177-092-04 & 092-08)
Bromfenex ER Capsules (58177-019-04)
Bromfenex PD ER Capsules (58177-020-04)
Buspirone HCl Tablets, 10mg (58177-265-04 & 265-08)
Buspirone HCl Tablets, 15mg (58177-309-04 & 309-08)
Buspirone HCl Tablets, 5mg (58177-264-04 & 264-08)

Codeine Phosphate/Guaifenesin Tablets, 10mg (58177-223-04)
Dextroamphetamine Sulfate Tablets, 10mg (58177-312-04)
Dextroamphetamine Sulfate Tablets, 5mg (58177-311-04)
Dextroamphetamine Tablets, 10mg (58177-312-04)
Diltiazem HC1 Capsules, 120mg (58177-061-11)
Diltiazem HC1 Capsules, 120mg (58177-061-19 & 061-26)
Diltiazem HC1 Capsules, 180mg (58177-062-09 & 062-11)
Diltiazem HC1 Capsules, 180mg (58177-062-19 & 062-26)
Diltiazem HC1 Capsules, 240mg (58177-063-09 & 063-11)
Diltiazem HC1 Capsules, 240mg (58177-063-19 & 063-26)
Diltiazem HC1 Capsules, 300mg (58177-064-19 & 064-26)
Diltiazem HC1 Capsules, 360mg (58177-065-09 & 065-11)
Diltiazem HC1 Capsules, 360mg (58177-065-19 & 065-26)
Diltiazem HC1 Capsules, 420mg (58177-066-09 & 066-11)
Diltiazem HC1 Capsules, 420mg (58177-066-19 & 066-26)
Disopyramide Phosphate ER Capsules, 150mg (58177-002-04)
Doxazosin Mesylate Tablets, 1mg (58177-266-04 & 266-08)
Doxazosin Mesylate Tablets, 2mg (58177-267-04 & 267-08)
Doxazosin Mesylate Tablets, 4mg (58177-268-04 & 268-08)
Doxazosin Mesylate Tablets, 8mg (58177-269-04 & 269-08)
Ethedent Chewable Tablets, .25mg (58177-432-40)
Ethedent Chewable Tablets, .5mg (58177-433-40 & 433-09)
Ethedent Chewable Tablets, 1mg (58177-434-40 & 434-09)
EthexDerm BPW-10, 10% (58177-929-65)
EthexDerm BPW-5, 5% (58177-928-65)
Ethezyme 650 (58177-868-02)
Ethezyme 830 Papain-Urea (58177-816-02)
Ethezyme Papain-Urea (58177-804-02)
ETH-Oxydose Concentrated Solution (58177-914-04 & 914-56)
Guaifenex DM ER Tablets (58177-213-04)
Guaifenex GP ER Tablets (58177-373-04)
Guaifenex PSE 120 ER Tablets (58177-208-04)
Guaifenex PSE 60 ER Tablets (58177-214-04)
Guaifenex PSE 80 Tablets (58177-413-04)
Guaifenex PSE 85 Tablets (58177-478-04)
Hista-Vent DA Tablets (58177-227-04)
Hista-Vent PSE tablets (58177-426-04)
Histinex HC Liquid (58177-877-07 & 877-12)
Histinex PV Liquid (58177-883-07)
Hydrocodone Bitartrate & Acetaminophen Liquid (58177-909-07)
Hydrocodone Bitartrate/Guaifenesin Liquid (58177-881-07)
Hydrocortisone and Iodoquinol Cream, 1% (58177-803-02)
Hydroquinone 4% Cream w/SS, 1oz. (58177-802-02)
Hydroquinone 4% Cream, 1oz. (58177-801-02)
Hydro-Tussin CBX Liquid (58177-924-07)
Hydro-Tussin DHC Syrup (58177-926-07)
Hydro-Tussin DM Liquid (58177-906-07)
Hydro-Tussin EXP Liquid (58177-927-07)
HydroTussin HC Syrup (58177-915-07)
Hydro-Tussin Liquid (58177-890-07)
Hydro-Tussin XP Liquid (58177-916-07)
Hyoscyamine Orally Disintegrating Tablets, .125mg (58177-423-04)
Hyoscyamine Sublingual Tablets, .125mg (58177-255-04)
Hyoscyamine Sulfate ER Tablets, .375mg (58177-237-04)
Hyoscyamine Sulfate ER Capsules, .375mg (58177-017-04)
Hyoscyamine Sulfate Oral Tablets, .125mg (58177-274-04)
Isosorbide Mononitrate ER Tablets, 120mg (58177-201-04)

Isosorbide Mononitrate ER Tablets, 30mg (58177-222-04, 222-08 & 222-11)
Isosorbide Mononitrate ER Tablets, 60mg (58177-238-04, 238-08 & 238-11)
Meperidine/Promethazidne Capsules (58177-027-04)
Morphine InveAmp, 20mg x 1mL (58177-886-56)
Morphine InveAmp, 5mg/.25mL (58177-888-80)
Morphine Sulfate Concentrated Oral Solution 20mg/1ml (58177-886-01, 886-03 &886-05)
Morphine Sulfate Concentrated Oral Solution, 20mg/1ml (58177-886-57)
Morphine Sulfate ER Tablets, 100mg (58177-340-04)
Morphine Sulfate ER Tablets, 15mg (58177-310-04)
Morphine Sulfate ER Tablets, 200mg (58177-380-04)
Morphine Sulfate ER Tablets, 30mg (58177-320-04)
Morphine Sulfate ER Tablets, 60mg (58177-330-04)
Morphine Sulfate IR Tablets, 15mg (58177-313-04)
Morphine Sulfate IR Tablets, 30mg (58177-314-04)
NitroQuick Sublingual Tablets, .3mg (58177-323-04)
NitroQuick Sublingual Tablets, .4mg (58177-324-18 & 324-04)
NitroQuick Sublingual Tablets, .6mg (58177-325-04)
Nystatin Topical Powder, USP 15 grams (58177-839-45)
Nystatin Topical Powder, USP 30 grams (58177-839-46)
Nystatin Topical Powder, USP 60 grams (58177-839-61)
Ondansetron Orally Disintegrating Tablets, 4mg (58177-363-22)
Ondansetron Orally Disintegrating Tablets, 8mg (58177-364-22 & 364-56)
Oxycodone HCl Capsules, 5mg (58177-041-04 & 041-11)
Oxycodone HCl IR Tablets, 10mg (58177-461-04)
Oxycodone HCl IR Tablets, 15mg, (58177-445-04)
Oxycodone HCl IR Tablets, 20mg (58177-462-04)
Oxycodone HCl IR Tablets, 30mg (58177-446-04)
Oxycodone HCl IR Tablets, 5mg (58177-625-04 & 625-11)
Pangestyme CN 20 (58177-030-04)
Pangestyme CN10 (58177-029-04)
Pangestyme EC 100 (58177-031-04)
Pangestyme EC 250 (58177-031-06)
Pangestyme MT16 (58177-028-04)
Pangestyme UL12 (58177-048-04)
Pangestyme UL18 (58177-049-04)
Pangestyme UL20 (58177-050-04)
PhenaVent Capsules (58177-078-19)
PhenaVent D Tablets (58177-444-04)
PhenaVent LA Capsules (58177-095-19)
PhenaVent PED Capsules (58177-079-04)
Plaretase 800 (58177-416-04 & 416-08)
Potassium Chloride ER Capsules, 10mEq (58177-001-04, 001-08, 001-09, & 001-11)
Potassium Chloride ER Capsules, 8mEq (58177-677-04 & 677-08)
Potassium Chloride ER Tablets, 20mEq (58177-202-04, 202-08, 202-09 & 202-11)
Prednisolone Sodium Oral Solution (58177-932-05)
Prednisolone Syrup 15mg/5mL (58177-910-05 & 910-07)
Prednisolone Syrup 5mg/5mL (58177-912-03)
Propafenone HCl Tablets, 150mg (58177-331-04 & 331-11)
Propafenone HCl Tablets, 225mg (58177-332-04)
Propafenone HCl Tablets, 300mg (58177-333-04)
Pseudovent 400 Capsules (58177-096-04)
Pseudovent Capsules (58177-045-04)
Pseudovent PED Capsules (58177-046-04)
Tri-Vent DM Syrup (58177-925-07)
Tri-Vent DPC Liquid (58177-923-07)
Tri-Vent HC Liquid (58177-920-07)

Products Recalled to RETAIL PHARMACY Level:

Hydromorphone HCl Tablets, 2mg (58177-620-04 & 620-11)
Hydromorphone HCl Tablets, 4mg (58177-621-04 & 621-11)
Hydromorphone HCl Tablets, 8mg (58177-449-04)
Metoprolol Succinate ER Tablets, 50mg (58177-369-04, 369-09 & 369-11)
Metoprolol Succinate ER Tablets, 100mg (58177-368-04, 368-09 & 368-11)
Metoprolol Succinate ER Tablets, 25mg (58177-293-04, 293-09 & 293-11)
Metoprolol Succinate ER Tablets, 200mg (58177-358-04, 358-09 & 358-11)

Any wholesale or retail customer inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-748-1472, faxed to ETHEX Customer Service at 314-646-3788, or e-mailed to customer-service@ethex.com. Representatives are available Monday through Friday, 8 am to 5 pm CST.

ETHEX Corporation has initiated recall notifications to wholesalers (and to retailers for Hydromorphone HCl and Metoprolol Succinate only) nationwide who received any inventory of the recalled products with instructions for returning the recalled products. Patients with questions about the recall should call the telephone number above, or contact their healthcare providers.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). At this time, the company is unable to determine when distribution of these products will resume.

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

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Taking Control of Your Diabetes Conference Heads to Augusta to Bring Answers, Advocacy and Hope - February 28, 2009

/PRNewswire/ -- Taking Control of Your Diabetes (TCOYD) conference and health fair will be held February 28, 2009 at the Augusta Marriott Hotel, bringing national and local medical experts in diabetes care to people with all types of diabetes, those at risk for diabetes, and their loved ones for a day of highly informative and motivational programs.

Leading specialist will discuss practical advice and developments in the treatment of diabetes, the complications of the disease, psychological barriers to controlling diabetes, prevention, nutritional issues and much more. Health professionals from the Medical College of Georgia, University Primary Care, University Hospital, Augusta Foot and Ankle, Veterans Administration Medical Center, University Medical Associates, and a host of other diabetes specialists have partnered with Taking Control of Your Diabetes to hold this premier conference and health fair.

TCOYD participants can hear lectures, participate in screenings, and speak one-on-one with diabetes specialists including physicians, pharmacists, dieticians, certified diabetes educators and podiatrists.

A health fair with 35 informational exhibits from national and local diabetes-related companies and organizations will be open throughout the day. A banquet lunch is included and will feature special guest speaker All-Star Hawks player Dominique Wilkins who will share his inspiring story, living well with diabetes.

"With the increase in obesity, more and more Georgians are being diagnosed every day with diabetes. This conference and health fair is a great way to learn as much as you possibly can in one day and in one location from a variety of diabetes experts. We want to help individuals and families living with diabetes to be educated, motivated and empowered to take control of their diabetes," says Charles Shaefer, Jr., MD, conference co-director.

Pre-registration is recommended and financial aid is available for those who need assistance. Early registration fees are $15 per person. Registration fees include breakfast, lunch, all conference activities and materials. FINANCIAL ASSISTANCE IS AVAILABLE BY CALLING TCOYD. Onsite registration begins at 9 a.m. and costs $20. The conference is from 10:00 a.m. to 4:00 p.m. To register or get more information, call 800-998-2693 or visit www.tcoyd.org, or www.AugustaDiabetes.org.

TCOYD founder and director Steven Edelman, MD, an internationally recognized leader in diabetes treatment, research and education, who has lived with diabetes for 37 years, says, "Diabetes is demanding and people's daily decisions have an immediate impact on their health. At the same time, information about living with diabetes is complex. Education is critical to staying on top of this disease."

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Governor Perdue Introduces Super Speeder Legislation

Governor Sonny Perdue announced today that State Representative Jim Cole, the Governor’s senior floor leader in the House, has introduced the Governor’s “Super Speeder” legislation, HB 160, to the General Assembly. The legislation will help reduce traumatic automobile accidents and provide funds for trauma care in the state.

“Traffic accidents exact an enormous toll on our state,” said Governor Perdue. “This legislation will save lives by discouraging reckless behavior and by providing critical additional funds for trauma care.”

In 2007, traffic accidents on Georgia’s roadways caused more than 1,600 fatalities. The overall cost of accidents totals $7.8 billion a year. The Super Speeder legislation would generate approximately $23 million that could be spent to improve state’s trauma care network.

“This is extremely important legislation not only to me but to the state of Georgia as a whole,” said Representative Cole. “We must do all we can to help make our roads and highways as safe as possible. The bottom line is this: Super Speeder will both directly and indirectly save the lives of Georgians.”

The principle behind the Super Speeder legislation is that it discourages trauma-causing behavior by increasing fines for dangerous drivers. The legislation would add an additional $200 fine for driving over 85 mph anywhere in the state and for driving 75 mph or more on a two lane road. Super Speeders will also increase driver’s license reinstatement fees for drivers committing a second and third offense for violations that result in a suspended license and for other negligent behaviors.
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Video: Late Winter/Early Spring is Meningitis Peak Season: Is Your Preteen or Teen at Risk?

/PRNewswire/ -- What began for Gerald Pe as a pleasant day at the beach quickly turned into a fight for his life and resulted in him losing portions of his feet and suffering organ failure. Lynn Bozof's son, Evan, called home from college to say he had a terrible headache, and within hours was admitted to the Intensive Care Unit; Evan died 26 days later. Gerald and Evan contracted meningococcal disease, more commonly known as meningitis, and your preteen and teenage children may also be at risk. Meningitis peak season is here, and the National Meningitis Association (NMA) is urging parents to get their children vaccinated now to protect them against this devastating disease.

Meningococcal disease is a serious bacterial infection that can lead to death or permanent disability within hours. The disease can be easily misdiagnosed since early symptoms often mimic those of the flu. Given its quick progression and devastating nature, prevention is the best approach to treating meningococcal disease.

"It wasn't until my son, Evan, died that my family learned about a simple vaccination that could have saved his life," said Lynn Bozof, Executive Director of NMA. "Meningococcal disease can strike anyone at any time, but cases peak in late winter and early spring. With meningitis peak season upon us, I encourage parents to speak with their child's healthcare provider about meningococcal vaccination."

Preteens and teens are at greater risk for meningococcal disease, accounting for nearly 30 percent of the estimated 3,000 cases that occur in the U.S. each year. The good news is the majority of these cases can potentially be prevented through vaccination. This is why the Centers for Disease Control and Prevention recommends meningococcal vaccination for all preteens and teens 11 through 18 years of age and college freshmen living in dormitories.

"I knew the meningococcal vaccine was recommended for teens, but I didn't realize how serious meningococcal disease can be or that I was at increased risk so I never made an appointment to get vaccinated," said Gerald Pe, a meningococcal disease survivor. "I almost lost my life to meningococcal disease. I urge you to have your preteens and teens vaccinated now."

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SCHIP Provides Health Coverage to 7.4 Million Children in 2008

Some 7.4 million children were enrolled in the State Children's Health
Insurance Program (SCHIP) in 2008 -- a four percent increase over the
previous year, the U.S. Department of Health and Human Services
announced today. The announcement comes as Congress is debating
reauthorization of SCHIP, which is projected to expand coverage to an
additional four million children.

"With unemployment numbers rising and the economy struggling to regain
momentum, more and more American families are relying on SCHIP to insure
their children get the health coverage they need," said Acting HHS
Secretary Charles Johnson. "It is no surprise that SCHIP enrollment
went up in 2008 and we expect this trend to continue well into 2009 if
the program is reauthorized."

Created in 1997, SCHIP is a state and federal partnership designed to
help uninsured children. SCHIP received $40 billion in federal funds
over 10 years through 2007. The Medicare, Medicaid and SCHIP Extension
Act of 2007 extended the program until March 31, 2009, with an
appropriation of $5 billion for each of fiscal years 2008 and 2009, with
fiscal year 2009 funding available only through March 31, 2009. The
legislation also provided $1.6 billion in funding for states with SCHIP
budget shortfalls for fiscal year 2008 and $275 million for state
shortfalls through the first two quarters of fiscal year 2009.

Enrollment data, compiled by the Centers for Medicare & Medicaid
Services (CMS), and based on state reports, show that 7.4 million
children were enrolled in SCHIP at some point during federal fiscal year
(FFY) 2008, compared to 7.1 million for fiscal 2007. During FFY 2008,
334,616 adults were covered with SCHIP funds.

"While more children are relying on the program, we know millions more
children need health care coverage and that is why we need a strong
SCHIP to meet the nation's growing need," said Acting Secretary Johnson.
"President Obama believes that healthy children are the key to a healthy
economy and a healthy future for our country. We look forward to
working closely with Congress to reauthorize SCHIP and to working with
the States to do every thing we can to enroll every eligible child in
the program."

The SCHIP targets uninsured children who live in families with incomes
generally around 200 percent of the federal poverty level ($42,000 for a
family of four in 2008), which is too high in most states to qualify for
Medicaid, but in many cases, too low to afford private coverage.

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CDC and National Expert Panel Promote Revised Field Triage Guidelines of Trauma Patients

Guidelines published in last week's MMWR Reports and Recommendations are aimed at ensuring that trauma patients with more severe injuries are taken to trauma centers designed to handle such injuries. The recommendations designed to standardize decision-making at the injury scene also offer guidance on new technologies such as vehicle crash notification systems, which alert emergency services that a crash has occurred and automatically summon assistance.

The guidelines in the publication of the Centers for Disease Control and Prevention were developed by CDC and key experts in trauma care.

The report provides the rationale and development process for the revised 2006 Field Triage Decision Scheme: the National Trauma Triage Protocol for emergency medical service (EMS) providers. It was compiled by key trauma care experts to provide broader access of the information for emergency care services. The goal is to guide the nation′s 800,000 EMS providers in making crucial field triage transport decisions.

Previous CDC-funded research has shown that decisions made at the scene of the injury are vital. The risk of death of a severely injured person is 25 percent lower if the patient receives care at a Level 1 trauma center, which has additional resources specifically designed for care of severe trauma.

“Quality and timely care at an injury scene by EMS providers are integral to determining the severity of injury, initiating medical management, and identifying the most appropriate facility to which the patient should be transported,” said Richard C. Hunt, M.D., director of CDC′s Division of Injury Response, National Center for Injury Prevention and Control and an author of the report. “The Decision Scheme provides a safety net that the public won′t see. But we know it can help improve the chances of survival for severely injured patients.”

Other key revisions include:

• Recommendations for the right place and right time to best use crucial emergency care resources
• Vehicle crash damage criteria which can help determine which patients may require care at a trauma center

The Decision Scheme was developed in collaboration with the American College of Surgeons-Committee on Trauma with support from the National Highway Traffic Safety Administration (NHTSA). It was reviewed by the 36-member National Expert Panel on Field Triage, which included representatives from EMS, emergency medicine, trauma surgery, the automotive industry, public health, and several federal agencies.

The Decision Scheme has been endorsed by many professional organizations and associations. It was included in the 2006 versions of the American College of Surgeons′ Resources for the Optimal Care of the Injured Patient, and the National Association of Emergency Medical Technicians′ Prehospital Trauma Care Life Support manual for EMS practitioners.

The revised guidelines are in line with the 2006 Institute of Medicine report on the state of emergency care. The report envisioned a highly coordinated emergency services system that assures that each patient receives the most appropriate care, at the optimal location, with the minimum delay.

With additional funding from NHTSA, CDC is developing a companion educational initiative for local EMS medical directors, state EMS directors, public health officials, and EMS providers. Educational materials will be tailored to meet the needs of their communities and include: a user′s guide, poster and pocket card of the Decision Scheme, a slide presentation for use in trainings, and the MMWR article that includes continuing education opportunities.

FDA Stem Cell Approval Breakthrough Laudable

/PRNewswire/ -- Today the FDA announced approval for the first clinical trials on humans using Embryonic Stem Cells but Adult Stem Cell scientist Christian Drapeau says the experts may not be telling the whole story; Adult Stem Cells have greater potential with less risk.

"While the FDA approval is an exciting step forward toward freeing science from the shackles of politics," said Drapeau. "The expert commentary we're seeing surrounding the FDA's action is misleading."

Christian Drapeau, an early advocate of ASC science, posits that ACS are showing the greatest potential for scientific and medical advances.

Drapeau says that ASC can be a safer alternative to Embryonic Stem Cells because of a lower risk of tumor formation while studies show ASC to have comparable potential or even more in repairing damaged tissues or organs. This contradicts experts on morning talk shows who cast doubt on the efficacy of ACS research.

"The use of ASC requires a different thinking, but they can be as effective as ESC, if not more. ASC do not grow easily in vitro and they are not easy to re-program. But there are ways of using ASC that can be just as effective as methods using ESC, without the risk of tumor formation."

"Adult Stem Cells are showing great promise," notes Drapeau. "This is a very very important area of research right now and people must realize that Embryonic Stem Cells are not the only Stem Cell phenomenon out there."

"The scientific community is rejoicing today as a new age of medicine is ushered in concurrent with the Obama administration but the possibilities of Adult Stem Cell science are so mind boggling in terms of healing physical damage and the elimination of disease that the scientific community must focus on what works best, with the least amount of risk and the greatest scope of application," said Drapeau.

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Stem cell Research could be New Economic Engine

President Obama’s anticipated action on the isolation of new embryonic stem cell lines is welcome news to many, but frankly, it will have little impact on speeding stem cell therapies for the majority of Americans who need them. Those in need of therapies will continue to wait.

The initial outcome of the president’s act is simple: researchers in states such as California and New York that made major investments to fund and create new stem cell lines will have more flexibility. Instead of duplicating laboratories - one for federal funding and one for state funding - labs in these states can combine stem cell lines in one laboratory, freeing resources for additional research.

However, advancing stem cell therapies will require more financial investment from both the public and private sectors.

Little new research will happen in Georgia if only new lines are allowed and dollars aren’t available to turn them into therapies. That isn’t to say we aren’t in the game. Thankfully, despite political setbacks, stem cell researchers in Georgia haven’t sat on the sidelines during the Bush administration. They’ve made major advances.

It’s important to note that although politics put us behind some of the more progressive states, Georgia institutions have a proven, competitive record for being awarded scarce federal stem cell funds. So the notion that Georgia and stem cells don’t mix is wrong.

Significant research funding has been awarded to researchers in the state through several sources, including the National Institutes of Health and National Science Foundation. Even the U.S. Department of Defense is funding regenerative medicine and, indirectly, stem cells. Continued funding is keeping Georgia fiercely competitive in fundamental areas. We are poised and ready to implement advancements in this field.

Progress Report

Georgia researchers are alive and well in the stem cell race. A 2006 study showed that 67 percent of the state is supportive of stem cell research.
The University of Georgia is advancing the basic understanding of stem cells in cancer and drug discovery and is determining the effectiveness of new stem cell therapies. The Medical College of Georgia is advancing nonembryonic stem cell therapies. Emory University recently announced their participation in a cell therapy for amyotrophic lateral sclerosis (ALS) and a few weeks ago hosted a meeting on the use of cellular therapies in the treatment of lung injury.

The Georgia Tech/Emory Center on regenerative medicine is combining stem cells with biomaterials and developing related enabling technologies. GTEC recently brought together industrial and university leaders in a workshop on stem cell biomanufacturing that focused on translating advances in basic stem cell biology into the therapies needed for patients.

So what is the potential impact of future stem cell research in Georgia? Already, through federal research grants, Georgia is training the next generation of stem cell scientists for an ever-expanding commercial market. Economic impact studies suggest that stem cell companies will have sales exceeding $3 billion per year by the end of this year with annual growth between 10 percent and 30 percent.

Brain drain

While some of our trained stem cell graduate students have been recruited to fledgling stem cell companies in Georgia, most of our best students are being snatched up by Ivy League schools and leading stem cell companies in other states as soon as their training is complete. If we don’t create opportunities within our state, we will continue to lose these leaders and fall further behind. We have access to and can train the work force for local stem cell companies. Keeping them in Georgia is the issue.

The stem cell train has left the station, and Georgia’s scientists are on it. We now need the public to get on board. Obama can help stoke the fires on that train with additional funding that will give our state a two-for-one benefit: improving health and improving economic development.

The foundation has been laid in our state and can be leveraged for high-paying stem cell jobs that will help improve the quality of life for Georgians. Georgia’s higher institutions educate students that are going elsewhere for high-paying careers. Our goal should not end at education; rather, we also must attract the companies to the state to keep our best here in rewarding careers. Georgians must actively steer the stem cell economics train toward our state instead of standing on the platform and watching it go elsewhere.

We, as a state, have a competitive set of complementary skills that competes with anyone in the world. To move the momentum forward, researchers across the state have banded together to form the Georgia Stem Cell Initiative. More information about this group, as well as how to get involved, is available at the Web site www.georgiastemcell.org .

By Steven L. Stice
University of Georgia

Robert M. Nerem
Georgia Institute of Technology

Steve L. Stice is a Georgia Research Alliance Scholar and director of the University of Georgia Regenerative Bioscience Center and is the founder of ArunA Biomedical, Inc., a Georgia stem cell company.

Robert M. Nerem is the Parker H. Petit Professor for Engineering in Medicine at the Georgia Institute of Technology and director of the Georgia Tech/Emory Center for the Engineering of Living Tissues, a National Science Foundation-funded engineering research center.

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Surviving Dance Club Music (Noise) with Hearing Intact

By tweaking a system in the ear that limits how much sound is heard, a global team of researchers has discovered one alteration that shows that the ability of the ear to turn itself down contributes to protecting against permanent hearing loss. The report appears this week in PLoS Biology.

“There’s some uncertainty in the field about what this sound-limiting system is used for,” says Paul Fuchs, Ph.D., an author on the paper and professor of otolaryngology-head and neck surgery and co-director of the Center for Sensory Biology at the Institute for Basic Biomedical Sciences at Johns Hopkins. “Now we’ve definitively shown that this system functions in part to prevent acoustic trauma.”

To get a better handle on this sound-limiting system in the ear, the research team built on previous findings in the field and focused their efforts on the nAChR protein found on so-called sensory hair cells in the ear. Nerve cells from the brain release signals that are picked up by nAChR and turn down these sensory hair cells.

The team genetically altered a single building block in the nAChR protein and tested mice for their ability to hear. “This point mutation was designed to produce a so-called gain of function in which the inhibitory effect of ACh should be greater than normal,” says Fuchs.

The altered mice were less able to hear soft sounds than normal mice, showing that the genetic alteration made in the nAChR protein did indeed further “turn down” the ear. The team then asked if the alteration in nAChR, and therefore the improved sound-blocking ability of these altered mice, also could protect from sound damage.

The team blasted 100-decibel sound at mice and again measured their ability to hear. “One hundred decibels, for me, is painfully loud, and conversation is impossible,” says Fuchs. “But sound levels in night clubs or rock concerts can be that high, and extended exposure to sound at that volume can cause hearing loss.”

They found that mice with the altered, gain-of-function nAChR suffered less permanent hearing damage compared to normal mice. “We think this pathway could be a therapeutic target for protecting from sound damage,” says Fuchs. “So far, there is little or no specific pharmacology of hearing. We’re still learning how the inner ear works. The encouraging news is that molecular mechanisms like the hair cell’s nAChR frequently involve unique gene products, so there is a real chance of finding ear-specific drugs in the future.”

Until then, Fuchs suggests limiting time spent at rock concerts, and wearing earplugs, to protect your hearing.

This study was funded by the National Institutes of Deafness and other Communication Disorders, the Howard Hughes Medical Institute, the National Organization for Hearing Research, the Tinnitus Research Initiative, the Agencia Nacional de Promoción Científica y Tecnológica of Argentina, and the University of Buenos Aires.

Authors on the paper are Paul Fuchs of Johns Hopkins; Julian Taranda, Jimena Ballestero, Eleonora Katz, Jessica Savino and A. Belen Elgoyhen of Instituto de Investigaciones en Ingenieria Genetica y Biologia Molecular in Buenos Aires, Argentina; Stephane Maison and M. Charles Liberman of Harvard Medical School; Douglas Vetter of Tufts University School of Medicine; and Jim Boulter of University of California, Los Angeles.

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Kidney Transplant Survival can be Long-Term for People with HIV

A Johns Hopkins study finds that HIV-positive kidney transplant recipients could have the same one-year survival rates for themselves and their donor organs as those without HIV, provided certain risk factors for transplant failure are recognized and tightly managed.

“Kidney transplantation is a viable and necessary option for HIV-positive patients with chronic kidney disease, especially since kidney disease is taking such a large toll on this group,” says Jayme Locke, M.D., a resident in the Department of Surgery at Johns Hopkins University School of Medicine, and lead researcher of the study described in the January issue of the Archives of Surgery.

Traditionally, HIV patients were not considered transplant candidates because survival rates after transplantation were thought to be greatly compromised by the disease, which cripples the body’s immune system. Transplant patients also take drugs that suppress their immune systems in order to prevent organ rejection, a regimen thought to further threaten their already fragile immune systems.

Locke says their study results are in part a reflection of newer antiretroviral therapies that have reduced HIV death rates by 80 percent. Indeed, people with HIV now die like most other people, of chronic diseases, rather than from the opportunistic infections that once took a grave toll. Kidney disease, for example, accounts for more than 10 percent of HIV-related deaths.

For the study, Locke and her team looked at the one-year kidney survival rates and one-year patient survival rates of 36,492 HIV-negative and 100 HIV-positive kidney transplant recipients listed on the United Organ Sharing Network (UNOS) list who received transplants between January 2004 and June 2006. They excluded those under 18 and anyone who had multi-organ transplantation.

The chances of survival were the same in both groups. However, kidney survival rates in these two groups showed that HIV-negative recipients had a 94.6 percent survival rate, compared to 87.9 percent in people with HIV. (People can survive on dialysis even if their transplanted kidney fails.)

However, when the investigators broke down the results into subgroups, they learned that some of the kidneys transplanted into HIV-positive recipients were relatively late getting to full function. This so-called delayed graft function (DGF) reduced kidney survival by 30 percent. When this group was removed from the rate comparison, both HIV-positive and HIV-negative groups had equal kidney and patient survival rates, says Locke.

According to Locke, this is significant because DGF can be avoided by controlling certain negative risk factors such as advanced organ donor age, deceased-donor kidneys (vs. live-donor kidneys) and long cold ischemic times (the time the kidney is without blood flow before transplant).

Other researchers who contributed to this study from Johns Hopkins University School of Medicine include Robert Montgomery, M.D., Ph.D.; Daniel S. Warren, Ph.D.; and Dorry Segev, M.D., of the Department of Surgery; and Aruna Subramanian, M.D., of the Department of Medicine.

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Stents Can Treat - Not Just Prevent - Strokes, Suggests Early Research

/PRNewswire/ -- Stents can be placed in the brain to treat a stroke as it's occurring, suggests preliminary data being presented at the 21st Annual International Symposium on Endovascular Therapy (ISET).

Stents have long been used to open up blocked blood vessels in the heart to prevent heart attacks and in the neck to prevent strokes. More recently stents have been used in the heart to treat occurring heart attacks by opening up the blocked arteries. This early research suggests stents also can be used to treat occurring strokes, by opening up blocked arteries in the brain.

Treatments for ischemic stroke currently include delivering clot-busting drugs to the blockage through the veins or directly into the clot through an artery, or by removing the clot with a tiny corkscrew-like device or vacuuming it out. But early research suggests stents may work better than those treatments.

"Most patients had significant improvement; for instance, they could go home rather than having to be placed in a nursing home, which is pretty dramatic," said L. Nelson Hopkins, M.D., professor and chairman of neurosurgery and professor of radiology at the State University of New York at Buffalo, who is presenting the data at ISET. "Stents seem to work when clot-busters or other mechanical devices can't."

The third-leading cause of death in the U.S., stroke is called a brain attack because blood flow and oxygen to part of the brain is cut off. About 85 percent of strokes are ischemic, meaning they're caused by a blocked blood vessel. About 700,000 people suffer an ischemic stroke every year. The remaining 15 percent of strokes are hemorrhagic and are caused by a broken blood vessel. The lack of blood flow and oxygen to the site of the stroke causes the brain tissue to die. About a quarter of people who suffer a stroke die. Another third are severely disabled and may be paralyzed or lose the ability to speak or remember.

SUNY Buffalo researchers are reporting preliminary results on 16 patients who received stents to treat their strokes as part of a single center Investigational Device Exemption (IDE) from the FDA, with Elad Levy, M.D., as the principal investigator. Stents were placed and opened blocked arteries in the brain in all patients (100 percent) and 11 patients (69 percent) had significant improvement in their stroke symptoms.

Clot-busting drugs only work about half of the time because the blockage can be sticky and adhere to the wall of the artery, making it difficult to break up, said Dr. Hopkins.

Researchers used computed tomography (CT) perfusion to determine if the use of a stent would be beneficial. "With CT perfusion we can tell if the brain is dead or alive," said Dr. Hopkins. "Some patients experience brain death within an hour; others can have a viable brain 24 hours after the stroke starts." In those cases, it may still be possible to place a stent.

Tiny cage-like cylinders, stents are placed minimally invasively by threading a small tube, or catheter, through the arteries to the site of the blockage. A tiny balloon is inflated to open up the blockage. A collapsed stent is then placed at the site, where it expands and acts like scaffolding to keep the artery open.

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Emory Healthcare Garners Quality and Patient Safety Initiative Awards

Emory Healthcare received four awards, including the prestigious Overall Circle of Excellence Award, from the Partnership for Health and Accountability (PHA) during its annual Patient Safety Summit in Greensboro, Ga.

The PHA Quality and Patient Safety Awards recognize health care organizations for achievement in implementing evidence-based processes and best practices in reducing the risk of adverse outcomes and improving patient safety and quality.

The PHA was formed in January 2000 and is sponsored by the Georgia Hospital Association. It is a unique statewide collaborative that brings together health care providers with community agencies and individuals to achieve healthy communities. The organization includes representation from groups including hospitals, physicians, state health officials, legislators and businesses.

Emory received the following awards for 2008:

* Reduction of Sternal Wound Infections
* Reduction of Ventilator Associated Pneumonia Rates
* Flu Vaccine Compliance
* Overall Circle of Excellence Award

Emory Healthcare Chief Quality Officer William A. Bornstein, MD, PhD, who has led the charge for improving quality and safety at Emory since 2002, says Emory's commitment to being a national leader on quality and safety initiatives makes these awards even more special for the entire organization. Under his leadership, Emory Healthcare has been recognized with Quality and Patient Safety Awards from the PHA every year since 2002.

"Our quality promise to our patients is impeccable clinical outcomes, safety and outstanding service,” Bornstein says. “We are committed to enhancing our national leadership in clinical quality through our many educational, cultural and process-driven initiatives. This recognition certainly validates our continuing efforts, and it inspires us to continue challenging ourselves to improve each day.

"By maintaining a constant focus on our quality promise to our patients, we recognize that clinical outcomes improve, care is safer, and patients and families experience better service," says Bornstein.

According to Emory Healthcare Chief Nursing Officer Susan Grant, MS, RN, the Circle of Excellence Award is presented only to hospitals that have demonstrated a sustained commitment to quality and patient safety as evidenced by not only winning a patient safety award in 2007, but also by earning at least three PHA Patient Safety Awards within the past five years. The overall program, however, is something Emory looks to each year as a way to continually improve its quality and safety goals.

"This awards program is an important part of our overall commitment to patient safety and quality, as it allows us to measure our own progress and compare ourselves against state and national benchmarks," says Grant. "For each project we enter, information is submitted that describes specific measures for improvement initiatives; barriers and obstacles encountered, the process and data used to prioritize improvement needs; and even the level of involvement from the front-line staff and physicians to the board of trustees to patient or community partners.

“So while these awards are certainly a wonderful testament to our nursing staff, physicians and employees at Emory Healthcare, they also serve as milestones in our overall journey to continuously improve and provide the very best care possible for our patients in terms of quality and safety," says Grant.

For more information about Partnership for Health and Accountability or this year's award winners, please visit www.gha.org/pha.
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Think you know about dental health? your teetch?

Take this quiz:

http://www.tomsofmaine.com:80/dentalhealth/oral_health/quiz.asp

It doesn't take long and it's rather interesting.

Tom's of Maine Invites Everyone to Start the New Year by Helping Families in Need

The new year brings a challenging economy but Tom’s of Maine is keeping its steadfast commitment to community programs. This month, the company launches Dental Health for Allä, an initiative that brings everyday Americans and local communities together with Tom’s of Maine to help create greater access to dental care for families in need.

Over the past four years, the program has contributed to nearly 60,000 new annual dental visits and awarded significant grants to 25 school and community-based dental clinics to increase and improve patient capacity and help support facility expansion projects.

“It’s hard for a parent to imagine not being able to take their child for a routine dental check-up, but for the nearly half of American families without dental insurance or access to dental care this is an unfortunate reality,” said Kerry Maguire, D.D.S., M.S.P.H. and Tom’s Director of Professional of Advocacy. “It may seem like an overwhelming problem but Tom’s of Maine truly believes we can work together to make a difference, one small step at a time.”

In January, Tom’s of Maine will donate a portion of its sales for all products towards Dental Health for All and will award dental clinics across the country grants for oral health projects in February. With each purchase, families can enjoy their same favorite products or try natural oral care for the first time and have it benefit not only their family but a family in need of dental health.

For additional information, please visit www.tomsofmaine.com.

About Tom's of Maine
Tom’s of Maine is a leader in natural personal care with a longstanding passion for responsible and sustainable business solutions. The company shares the belief of its consumers that small steps everyday can make the community, the environment and the world a better place. For more than 40 years, the company has maintained a steadfast commitment to donate 10% of its profits to charity and to allow employees 5% paid time off to volunteer. Each day, Tom’s of Maine employees contribute to high sustainability standards and their ideas from wind power to recycled and recyclable packaging have fueled the company’s sensitive way of doing business. Tom’s of Maine enjoys partnering with its consumers, vendors and community groups to help improve the earth. For more information, visit www.tomsofmaine.com
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Piedmont Fayette Hospital offering Phase III Cardiac Rehab Program

Piedmont Fayette Hospital (PFH) is now offering a Phase III Cardiac Rehabilitation Program which helps patients manage or reduce risk factors for cardiovascular disease. The participants in these classes will be monitored by exercise physiologists and registered nurses on staff. It is a $79 self-pay program which includes 12 sessions, twice a week on Tuesdays and Fridays for six weeks. Each patient will also be offered a nutrition consultation with a PFH dietician. A physician referral is required.

The Phase III Cardiac Rehab Program is for individuals with any single or combination of the following cardiovascular risk factors:

• Hypertension
• Smoking
• Sedentary lifestyle
• Stress
• High body mass index
• Diabetes
• Hypercholesterolemia

If you have any of these risk factors you may want to discuss this program with your physician as a physician referral is required.

Piedmont Fayette Hospital offers numerous advanced, comprehensive diagnostic and rehabilitative cardiology services including electrocardiograms (EKG), holter and event monitoring, cardiac monitoring, stress-testing, diagnostic cardiac catheterization and cardiac rehabilitation. For more information about the Phase III Cardiac Rehab Program, please call 770-719-7095 or for more information about Piedmont Fayette Hospital’s cardiology services, visit www.fayettehospital.org.
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Salmonella recovered from King Nut peanut butter by MDA lab found to be a genetic match to cases in national Salmonella outbreak

The Minnesota Departments of Agriculture and Health announced January 12 that laboratory analyses have confirmed a genetic match between the strains of Salmonella bacteria found in a container of King Nut brand creamy peanut butter and the strains of bacteria associated with 30 illnesses in Minnesota and nearly 400 illnesses around the country.

MDA lab tests conducted last week discovered Salmonella bacteria in a 5-pound package of King Nut peanut butter collected from a long-term care facility associated with one of the reported illnesses. The Minnesota Department of Agriculture (MDA) and the Minnesota Department of Health (MDH) issued a product advisory on Friday alerting institutions that may have received the product. MDA and MDH scientists performed additional testing this weekend to verify the connection between the contaminated product and the illnesses.

State officials initially discovered the contaminated product through product testing conducted after MDH epidemiological evidence and an investigation by MDA’s Rapid Response Team implicated King Nut creamy peanut butter as a likely source of Salmonella infections in Minnesota residents. In the product advisory issued Friday, state officials urged establishments who may have the product on hand to avoid serving it, pending further instructions as the investigation progresses.

Eating food contaminated with Salmonella can result in abdominal cramping, diarrhea, and fever. Anyone who believes they may have become ill as a result of eating this product or foods made with this product should contact their health care provider.

King Nut peanut butter is produced by Peanut Corporation of America, of Lynchburg, Va., and is distributed in seven states by Ohio-based King Nut Companies. The product was distributed in Minnesota to establishments such as long-term care facilities, hospitals, schools, universities, restaurants, delis, cafeterias and bakeries. King Nut Companies reports that the product is not distributed for retail sale to consumers, and has voluntarily withdrawn the product from distribution.

Minnesota officials continue to coordinate their investigation with the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration and other states.

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FDA Approves RiaSTAP for Treatment of Bleeding in Patients with Rare Genetic Defect

The U.S. Food and Drug Administration today licensed RiaSTAP, an orphan drug for the treatment of bleeding in patients with a rare genetic defect known as congenital fibrinogen deficiency. Without treatment, these patients are at risk of potentially life-threatening bleeding.

People with congenital fibrinogen deficiency are unable to make sufficient amounts of fibrinogen, which plays an important role in blood coagulation by helping to form blood clots and prevent bleeding. Fibrinogen is manufactured in the liver and circulates in the blood plasma in a normal concentration of 250-400 mg/dL.

"This product offers much-needed treatment for the small number of patients with congenital fibrinogen deficiency," said Jesse Goodman, M.D., M.P.H., director of the FDA’s Center for Biologics Evaluation and Research. "If bleeding occurs in the brain or other organs and is left untreated, it may lead to blood loss, organ damage and death.”

Fibrinogen deficiency affects only 150 to 300 people in the United States and is usually diagnosed at birth when newborns bleed from their umbilical cord site. Children with the defect need to curtail activities because of risk of bleeding from minor trauma.

RiaSTAP is an intravenous fibrinogen concentrate made from the plasma of healthy human blood donors. The product is indicated for patients who have no fibrinogen or low levels of the substance, an abnormality known as afibrinogenemia, or for those patients whose fibrinogen levels are below 50 mg/dL, an abnormality known as hypofibrinogememia. The product is not indicated for patients with dysfibrinogenemia, who may have normal fibrinogen levels but defective fibrinogen function. Patients such as these are at risk for both bleeding and clotting complications.

The licensing of RiaSTAP was supported by a study of 15 patients with afibrinogenemia who achieved the target level of fibrinogen expected to prevent bleeding after they received 70 mg/kg of the drug. In addition, plasma from 14 of the 15 patients showed increased maximum clot firmness, a surrogate marker likely to predict clinical benefit. Fever and headache were the most common adverse reactions.

Clinical benefit will be further verified in a postmarketing study which will include both afibrinogenemic and hypofibrinogenemic patients.

Orphan drugs are drugs or biologics intended for use in a rare disease or condition. Manufacturers are qualified to receive certain government benefits in exchange for developing such products. RiaSTAP [Fibrinogen Concentrate (Human)] was developed under the FDA’s accelerated approval regulations.

The drug is manufactured by CSL Behring, Marburg, Germany.

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FDA Alerts Public about Danger of Skin Numbing Products

The U.S. Food and Drug Administration today issued a Public Health Advisory to alert consumers, patients, health care professionals, and caregivers about potentially serious and life-threatening side effects from the improper use of skin numbing products. The products, also known as topical anesthetics, are available in over-the-counter (OTC) and prescription forms.

Skin numbing products are used to desensitize nerve endings that lie near the surface of the skin, causing a numbness of the skin. These topical anesthetics contain anesthetic drugs such as lidocaine, tetracaine, benzocaine, and prilocaine in a cream, ointment, or gel. When applied to the skin surface, they can be absorbed into the blood stream and, if used improperly, may cause life-threatening side effects, such as irregular heartbeat, seizures, breathing difficulties, coma, or even death. FDA has received reports of adverse events and deaths of two women who used topical anesthetics before laser hair removal. In February 2007, the FDA issued a Public Health Advisory - “Life-Threatening Side Effects with the Use of Skin Products containing Numbing Ingredients for Cosmetic Procedures,” to warn consumers about these products.

Patients for whom an over-the-counter or prescription topical anesthetic is recommended should consider using a topical anesthetic that contains the lowest amount possible of medication that will relieve your pain. Also, health care professionals should determine whether adequate pain relief can be safely achieved with a topical anesthetic, or whether a different treatment would be more appropriate.

The FDA strongly advises consumers not to:

* make heavy application of topical anesthetic products over large areas of skin;
* use formulations that are stronger or more concentrated than necessary;
* apply these products to irritated or broken skin;
* wrap the treated skin with plastic wrap or other dressings; and
* apply heat from a heating pad to skin treated with these products.

When skin temperature increases, the amount of anesthetic reaching the blood stream is unpredictable and the risk of life-threatening side effects increases with greater amounts of lidocaine in the blood.

A recently published study in Radiology looked at women taking acetaminophen and ibuprofen by mouth versus applying lidocaine gel, a topical anesthetic, to the skin to decrease discomfort during mammography. The lidocaine gel was applied to a wide skin surface area and then covered with plastic wrap. There were no serious or life-threatening side effects reported in the study, nor were any reported when FDA discussed the results with the doctor who performed the study. The study results favored the use of lidocaine as there was significantly less discomfort than with the plain gel or oral acetaminophen or ibuprofen. However, given the life-threatening side effects associated with the use of topical anesthetics during laser hair removal, FDA is concerned that similar side effects could occur when topical anesthetics are used during mammography. Further, the study was small and it is possible that a larger study might show different findings.
Patients should talk with their health care professional if they are considering using a topical anesthetic before a mammogram. The following summarizes advice for patients if a topical anesthetic is recommended for their use:

* use a topical anesthetic that contains the lowest strength, and amount, of medication that will relieve the pain;
* apply the topical anesthetic sparingly and only to the area where pain exists or is expected to occur;
* do not apply the topical anesthetic to broken or irritated skin;
* ask their healthcare professional what side effects are possible and how to lower their chance of having life-threatening side effects from anesthetic drugs; and
* be aware that wrapping or covering the skin treated with topical anesthetics with any type of material or dressing can increase the chance of serious side effects, as can applying heat to the treated area while the medication is still present.

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UGA Research Shows Need for Vitamin Supplements among Georgia's Elderly

A new study by University of Georgia researchers shows that despite the availability of fortified foods, many older adults suffer from deficiencies of vitamin D, calcium and B12, which are critical for optimal bone, blood and nervous system health.

The research grew out of the authors' interest in providing scientifically sound health promotion programs at more than 200 senior centers across Georgia that help prevent malnutrition and provide nutritionally balanced meals to low-income elderly. Published in the Journal of Nutrition for the Elderly, the study notes that nutrient deficiencies make the elderly more vulnerable to chronic health problems such as osteoporosis, anemia and cognitive impairment.

"We always say 'food first' because eating a wide variety of foods provides the best source of minerals, vitamins and other nutrients," said Mary Ann Johnson, professor of foods and nutrition in the UGA College of Family and Consumer Sciences and coauthor of the study. "But people don't always eat a balanced diet, and vitamin supplements are convenient, relatively inexpensive and some have shown definite benefits in preventing or reducing the risks of chronic disease."

Johnson and study coauthors Joan Fischer, associate professor of nutrition, and research assistant Sohyun Park, said that among those surveyed, more than 60 percent of adults aged 60 or older take some type of dietary supplement; 40 percent take multivitamin and mineral supplements. Yet many were also confused about which vitamin supplements are beneficial.

That's understandable, they said, given conflicting research studies. While the use of multi-vitamin and mineral supplements do increase the blood concentration of nutrients, researchers often can't demonstrate specific health benefits from their use.

In fact, several recent vitamin studies only muddy the waters about the benefits of supplements. In November 2008, scientists released findings of a large clinical trial of nearly 15,000 male doctors who took vitamins C and E for a decade, showing no benefits in reducing cancer rates. Another recent study found that vitamins C and E don't lower heart disease rates. And last October, a third major clinical trial--looking at whether vitamin E and selenium protect men against prostate cancer-- ended early when it was clear that neither nutrient would reduce cancer risks.

But the UGA researchers say the benefits of taking certain supplements, especially calcium and vitamin D, are well-documented. Vitamin D, a fat-soluble vitamin, helps the body absorb calcium. It is present in significant amounts in fish and fortified milk, but very few other foods. Vitamin D is also known as the "sunshine vitamin" because it can be manufactured by the body when exposed to sunshine. However, as people age their skin starts to lose this ability to make vitamin D.

"We found that milk consumption varies widely in older adults," said Fischer, "and some elderly people avoid dairy products altogether because of the fat in whole fat products--or because they have trouble digesting milk products. But there is strong evidence that vitamin D and calcium supplements improve overall bone health and prevent bone fractures."

Calcium, essential for strong bones, is also important for normal heart and muscle function--and it helps the blood clot normally. The body uses and loses calcium every day through sweat, urine, feces, hair, nails and skin. It's replaced by calcium-rich foods in the diet, including milk and dairy products, kale, collard greens and foods fortified with calcium, such as some brands of orange juice. But when the body doesn't get enough, it pulls calcium from skeletal bones to carry out the more critical demands of the heart, nerves and major muscles.

B12, a water soluble vitamin, promotes the normal functioning of the brain and nervous system--and facilitates the formation of blood and new cells throughout the body. Good dietary sources include milk products, meat, poultry, fish and fortified breakfast cereals. After age 50, people don't absorb vitamin B12 as efficiently and must guard against a deficiency.

"By the time people reach their elder years, the cumulative effects of lifestyle really start to show, good or bad," said Johnson. "Part of the problem is that we need research that demonstrates the costs of poor nutrition and poor lifestyle. For example, many cases of diabetes and its complications are preventable. Nutrition is a science, but it doesn't get the attention it deserves. We're making progress, but we have a long way to go."

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Forest and Cypress Announce FDA Approval of Savella(TM) for the Management of Fibromyalgia

/PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE:FRX) and Cypress Bioscience, Inc. (NASDAQ:CYPB) today announced that Savella(TM) (milnacipran HCl), a selective serotonin and norepinephrine dual reuptake inhibitor, was approved by the U.S. Food and Drug Administration (FDA) for the management of fibromyalgia. Fibromyalgia is a chronic condition characterized by widespread pain and decreased physical function, afflicting as many as six million people in the United States. The safety and efficacy of Savella was established in two US pivotal phase III clinical trials involving over 2,000 patients with fibromyalgia. The studies showed that Savella doses of 100 mg/day and 200 mg/day demonstrated statistically significant and clinically meaningful concurrent improvements in pain, patient global assessment, and physical function. The companies expect Savella to be available in pharmacies by March 2009.

"Fibromyalgia is a complicated chronic pain condition, so it is important that physicians and patients have access to treatments that have been shown to help manage the symptoms that define the experience of fibromyalgia," said Dr. Daniel Clauw, Professor of Anesthesiology and Medicine (Rheumatology) at the University of Michigan. "The introduction of Savella is important because it is the first drug approved to treat the symptoms of fibromyalgia using a composite responder analysis.".

"Savella is the product of a unique clinical development program, one that considered a patient to be a responder to therapy only if they demonstrated concurrent clinically significant changes in multiple aspects of their fibromyalgia, including pain, patient global assessment and physical function. Savella is the only product approved for the management of fibromyalgia that used this complete responder analysis as its primary endpoint," said Jay D. Kranzler, MD, PhD, Chairman and CEO of Cypress Bioscience.

Howard Solomon, Chairman and Chief Executive Officer of Forest said, "We and our partner Cypress Bioscience are very pleased to receive marketing approval for Savella, following a first-cycle review, from the FDA. Fibromyalgia is a chronic and often debilitating condition with a significant need for new therapies. Savella is a valuable new treatment for patients afflicted with fibromyalgia. Its effectiveness was evaluated based upon the multiple symptoms included in the responder analysis."

"This approval is crucial for Pierre Fabre Laboratories as milnacipran is one of the flagship products of our portfolio and represents another product of Pierre Fabre research registered in the United States," said Jean-Pierre Garnier, Chief Executive Officer of Pierre Fabre SA.

Although the exact mechanism by which Savella improves the symptoms of fibromyalgia is unknown, some researchers believe that abnormalities in certain brain neurotransmitters may be central to fibromyalgia. Savella blocks the reuptake of both norepinephrine and serotonin, with greater selectivity for the inhibition of norepinephrine reuptake in vitro. This may be the mechanism by which Savella acts to improve the symptoms of fibromyalgia.

Data Highlights

The clinical development program for Savella was unique in its use of a composite responder analysis as the primary endpoint. This endpoint required individual patients to demonstrate concurrent improvement to multiple validated measures, including pain (visual analog scale), patient global assessment (patient global impression of change), and physical function (Short Form-36 Physical Component Summary).

The efficacy of Savella was established in two US pivotal Phase III clinical trials involving 2,084 treated patients (1,460 Savella; 624 placebo), which showed that Savella demonstrated clinically significant improvements compared to placebo in treating fibromyalgia. The first study was 6 months in duration and the second study was 3 months in duration.

In both studies, a greater proportion of patients in the Savella treatment arms (100 mg/day and 200 mg/day) as compared with placebo treatment, at 3 months, experienced at least a 30% reduction in pain from baseline and also rated themselves as "very much improved" or "much improved" based on the patient global assessment. In addition, a greater proportion of patients treated with Savella as compared with placebo treatment met the criteria for a treatment response as measured by concurrent improvements in pain, physical function, and patient global assessment. In both studies, some patients who rated themselves as globally "much" or "very much" improved experienced a decrease in pain as early as week 1 of treatment with a stable dose of Savella that persisted throughout these studies.

The clinical development program demonstrated that Savella was safe and generally well tolerated. The most frequently occurring adverse reaction was nausea. Other common adverse reactions reported in these clinical trials were constipation, hot flush, hyperhidrosis, vomiting, palpitations, heart rate increased, dry mouth and hypertension. The majority of adverse reactions reported were mild to moderate in nature.

About Savella

Savella is a dual-reuptake inhibitor that preferentially blocks the reuptake of norepinephrine with higher potency than serotonin (in-vitro), two neurotransmitters thought to a play a central role in the symptoms of fibromyalgia. Savella will be marketed by Forest and its licensor, Cypress Bioscience. Pierre Fabre, who originally developed and sells milnacipran outside the U.S., licensed the rights for North America to Cypress Bioscience.

About Fibromyalgia

Fibromyalgia is a chronic and debilitating condition characterized by widespread pain and decreased physical functioning. According to the American College of Rheumatology fibromyalgia is estimated to affect over 6 million Americans. It is most often diagnosed in the primary care setting and is the second most commonly diagnosed condition in rheumatology clinics in the United States after osteoarthritis. Despite the high prevalence and severity of this condition, there are limited treatment options specifically approved for fibromyalgia in the United States.

Important Safety Information

Savella is a selective serotonin and norepinephrine inhibitor (SNRI), similar to some drugs used for the treatment of depression and other psychiatric disorders. Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of such drugs in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on Savella should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Savella is not approved for use in the treatment of major depressive disorder. Savella is not approved for use in pediatric patients.

Savella is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs) concomitantly or within 14 days of discontinuing treatment of an MAOI or in patients with uncontrolled narrow-angle glaucoma.

Development of a potentially life-threatening serotonin syndrome may occur with agents that inhibit serotonin reuptake, including Savella, particularly with concomitant use of serotonergic drugs (including triptans and tramadol) and with drugs which impair metabolism of serotonin (including MAOIs). The concomitant use of Savella with serotonin precursors is not recommended.

Blood pressure and heart rate should be monitored prior to initiating treatment with Savella and periodically throughout treatment. SNRIs, including Savella, have been associated with reports of increases in blood pressure and heart rate. Pre-existing hypertension, tachyarrhythmias and other cardiac diseases should be treated before starting therapy with Savella. Savella should be used with caution in patients with significant hypertension or cardiac disease. For patients who experience a sustained increase in blood pressure or heart rate while receiving Savella, either dose reduction or discontinuation should be considered.

Savella should be prescribed with caution in patients with a history of a seizure disorder, mania or controlled narrow-angle glaucoma.

Savella has been associated with mild elevations of ALT and AST. Rarely, fulminant hepatitis has been reported in patients treated with milnacipran. Savella should be discontinued in patients who develop jaundice or other evidence of liver dysfunction and should not be resumed unless another cause can be established.

Savella should ordinarily not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease.

As with other SNRIs and SSRIs withdrawal symptoms have been observed following discontinuation of milnacipran. A gradual dose reduction is recommended.

Hyponatremia may occur as a result of treatment with SSRIs and SNRIs, including Savella. Discontinuation should be considered for patients with symptomatic hyponatremia.

SSRIs and SNRIs, including Savella, may increase the risk of bleeding events. Patients should be cautioned regarding the risk of bleeding associated with concomitant use of Savella and NSAIDs, aspirin, warfarin or other drugs that affect coagulation.

Male patients with a history of obstructive uropathies may experience higher rates of genitourinary adverse events.

Savella is unlikely to be involved in clinically significant pharmacokinetic drug interactions. Pharmacodynamic interactions of Savella with other drugs can occur.

Savella contains FD&C Yellow No. 5, which may cause allergic-type reactions in susceptible persons.

In clinical trials, the most frequently occurring adverse reaction was nausea. The most commonly occurring adverse reactions (greater than or equal to 5% and twice that of placebo) were constipation, hot flush, hyperhidrosis, vomiting, palpitations, heart rate increased, dry mouth, and hypertension.

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