FDA Approves Drug for an Advanced Form of Kidney Cancer

The U.S. Food and Drug Administration today approved Afinitor oral tablets (everolimus) for the treatment of patients with advanced kidney cancer whose disease has progressed after treatment with other cancer therapies.

Renal cell cancer, the most common type of kidney cancer, originates in the lining of the small tubules in the kidney that filter waste products from the blood. The cancer is resistant to such standard treatments as radiation therapy and chemotherapy, and the initial treatment for most patients is surgical removal of the kidney. If the cancer is confined to the kidney, the five-year survival rate is 60 to 70 percent; but the survival rate is considerably lower after the cancer has spread to other parts of the body.

"Afinitor provides an option for patients with advanced renal cell cancer after failure of treatment with the cancer therapies sunitinib or sorafenib," said Robert Justice, M.D., director, Division of Drug Oncology Products in the FDA's Center for Drug Evaluation and Research. "Targeted cancer therapies like Afinitor have increased the number of months patients can live without the tumor progressing."

Afinitor belongs to a class of drugs called kinase inhibitors, which interfere with cell communication, preventing tumor growth. The drug is intended for those patients with advanced renal cell cancer who have already tried another kinase inhibitor, Sutent (sunitinib) or Nexavar (sorafenib).

While Sutent and Nexavar are multiple kinase inhibitors (acting on a number of cellular targets), Afinitor works by blocking a specific protein known as the mammalian target of rapamycin or mTOR. The protein blocking action disrupts the growth, division and metabolism of cancer cells.

A clinical trial studying the safety and effectiveness of Afinitor was discontinued after an interim analysis showed that, in patients receiving the drug, the growth or spread of the tumor was delayed when compared to patients who did not receive the drug. In addition, disease progression was delayed approximately five months in half of the patients who received Afinitor. In contrast, disease progression was delayed two months in patients who did not receive the drug.

The most frequent adverse reactions in the trial (occurring in at least 20 percent of patients) included inflammation in the mouth, loss of strength, diarrhea, poor appetite, fluid buildup in the extremities, shortness of breath, coughing, nausea, vomiting, rash, and fever. Laboratory tests of blood samples determined that at least half of all patients experienced anemia, low white blood counts, high cholesterol and high triglycerides and high blood sugar.

Afinitor is manufactured by Novartis International AG of Basel, Switzerland. Sutent is manufactured by Pfizer Inc. of New York. Nexavar is manufactured by Bayer HealthCare AG, Leverkusen, Germany.

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FDA Approves New Vaccine to Prevent Japanese Encephalitis

The U.S. Food and Drug Administration today approved IXIARO, a vaccine to prevent Japanese encephalitis (JE) which is caused by a mosquito-transmitted virus found mainly in Asia. IXIARO will be the only vaccine for JE available in the United States.

"This vaccine offers protection for individuals who travel to or live in areas where outbreaks are known to occur," said Karen Midthun, M.D., acting director of the FDA's Center for Biologics Evaluation and Research.

In Asia, JE affects about 30,000 to 50,000 people each year, resulting in 10,000 to 15,000 deaths. JE is rarely seen in the United States, with very few cases reported among civilians and military traveling from the United States to Asia.

The virus that causes JE affects membranes around the brain and mild infections can occur without apparent symptoms other than fever and headache. In people who develop severe disease, JE usually starts as a flu-like illness but can worsen, causing high fever, neck stiffness, brain damage, coma, or even death. The disease is transmitted via infected mosquitoes; it is not spread from human to human.

IXIARO is a second-generation JE vaccine,in that itis manufactured using cell culture technology leading to improved manufacturing efficiency as well as more reliable control of the vaccine manufacturing process. This technology utilizes an established bank of cells that can be drawn from at any time contributing to the assurance of consistent vaccine quality.It also enhances the ability to rapidly manufacture a vaccine on a large scale if needed, without compromise to the vaccine's safety or effectiveness.

Clinical studies were conducted in more than 800 healthy men and women in the United States and Europe. Participants received either IXIARO or JE-VAX, another U.S.-licensed vaccine that is no longer being manufactured. The studies found that IXIARO produced sufficient levels of antibodies in the blood to protect against JE. IXIARO requires two doses instead of JE-VAX's three.

The vaccine was well tolerated and the most commonly reported adverse events were headache, muscle pain and pain, swelling, and tenderness at the injection site. Overall, it was more tolerable and had fewer side effects than the comparator, JE-VAX.

IXIARO is manufactured by Intercell Biomedical, Livingston, U.K.

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FDA Acts to Halt Marketing of Certain Unapproved Prescription Narcotic Drugs

The U.S. Food and Drug Administration today warned nine companies to stop manufacturing 14 unapproved narcotic drugs that are marketed in several dosage forms and are widely used to treat pain.

The FDA's warning letters notified the companies they may be subject to enforcement action if they do not stop manufacturing and distributing prescription unapproved products that include high concentrate morphine sulfate oral solutions and immediate release tablets containing morphine sulfate, hydromorphone or oxycodone. This action does not include oxycodone capsules.

Those companies receiving warning letters are Boehringer Ingelheim Roxane, Inc., Columbus, Ohio; Cody Laboratories, Inc., Cody, Wyoming; Glenmark Pharmaceuticals Inc., Mahwah, N.J.; Lannett Company, Inc., Philadelphia; Lehigh Valley Technologies, Inc., Allentown, Pa.; Mallinckrodt Inc. Pharmaceuticals Group, St. Louis; Physicians Total Care Inc., Tulsa, Okla.; Roxane Laboratories Inc., Columbus, Ohio; and Xanodyne Pharmaceuticals Inc., Newport, Ky.

The warning letters are part of the FDA's initiative on marketed unapproved drugs announced in June 2006. At that time, the agency published a compliance policy guide describing its risk-based enforcement approach against illegally marketed unapproved drugs.

"Consumers have a right to expect that their drugs meet the FDA's safety and effectiveness standards," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research (CDER). "Doctors and patients are often unaware that not all drugs on the market are backed by FDA approval. It is a high priority for the FDA to remove these products from the market because they may be unsafe, ineffective, inappropriately labeled, or of poor quality."

Consumers who rely on narcotics for pain relief continue to have access to narcotic products that the agency has evaluated and determined to be safe and effective. The FDA has determined that removal of the unapproved narcotic products will not create a shortage for consumers.

Consumers who may be concerned that they are taking any of these products should refer to the FDA's Unapproved Drugs Web page, which includes a list of manufacturers of these products. These consumers should consult a health care professional for detailed guidance on treatment options.

"We will continue to take aggressive action against those firms that do not have the required FDA approval for their drugs," said Deborah M. Autor, J.D., director of CDER's Office of Compliance. "Today's warning letters are another demonstration of our commitment to remove illegal, unapproved drugs from the market."

Manufacturers have 60 days to stop manufacturing these products. Distributors have 90 days to stop shipping existing products. Previously manufactured products may still be found on pharmacy shelves for a short time.

To view copies of the Warning Letters, the names of the companies and their affected products, see the FDA's Unapproved Drugs Web page at:
http://www.fda.gov/cder/drug/unapproved_drugs/enforcement.htm#narcotics

Information on FDA-approved drugs: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/

Drugs Marketed in the United States That Do Not Have Required FDA Approval:
http://www.fda.gov/cder/drug/unapproved_drugs

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UGA to Host Stem Cell Therapies for Spinal Cord Injuries Workshop April 4

Following President Barack Obama's decision to lift the ban on federal funding for embryonic stem cell research, medical and scientific experts will converge at the University of Georgia to discuss how recent advances in stem cell research can be turned into cures for spinal cord injuries.

The second Spinal Cord Workshop, a program of the Bedford Stem Cell Research Foundation, will be held on Saturday, April 4 from 8:30 a.m. to 5:30 p.m. at the Paul D. Coverdell Center for Biomedical and Health Sciences in Athens, Ga.

Every year close to 11,000 people sustain spinal cord injuries in the United States, while more than 200,000 Americans live each day with a disability caused by them.

“Because spinal cord injury usually occurs in otherwise healthy, young adults, it is an especially attractive candidate for a cure for stem cell therapy,” said Ann Kiessling, director of the Bedford Stem Cell Research Foundation. “The big question is whether a ‘moon shot’ approach will produce a cure, or if there is still too much basic science yet unknown.”

The workshop is hosted by UGA’s Regenerative Bioscience Center. Additional support is provided by the UGA Biomedical and Health Sciences Institute, the Shepherd Center in Atlanta and Millipore, Inc.

“The University of Georgia is fortunate to team up with the Bedford Foundation to host these leading experts in spinal cord therapies to discuss and develop new paths forward for spinal cord injuries,” said Steven Stice, director of the Regenerative Bioscience Center and a UGA College of Agricultural and Environmental Sciences professor. “In addition, Georgia’s recent legislation aimed at restricting stem cell research makes this workshop an especially timely one.”

Created in 1996, the Bedford Stem Cell Research Foundation is a Massachusetts-based public charity and biomedical institute conducts stem cell and related research for diseases and conditions that currently have no cure.

The Regenerative Bioscience Center brings UGA’s expertise, resources and accomplishments in human embryonic stem cell research under one umbrella, while contributing to the university’s educational and outreach missions with student research experiences and public lectures, symposia and workshops.

The event serves as a follow-up to the inaugural Spinal Cord Workshop held at UGA in March 2008. For more information, go to the Web site www.spinalcordworkshop.org.

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Closing Open Heart Surgery: Saint Joseph's Performs Georgia's First Totally-Closed, Beating Heart Bypass Surgery

/PRNewswire/ -- Patients facing open heart surgery for coronary artery bypass or valve repairs just got some great news: open heart surgery doesn't have to be open anymore.

Sudhir P. Srivastava, MD, a cardiothoracic surgeon at Saint Joseph's Hospital in Atlanta and the world leader in performing beating heart, totally-endoscopic, coronary artery bypass surgery, has started performing the procedures in Georgia.

"Dr. Srivastava performed the first-in-Georgia procedure on Friday, March 20 and the patient was released on Sunday, March 22," says Kirk Wilson, president and CEO of Saint Joseph's Hospital.

"With robotic assistance, Dr. Srivastava performed the single coronary artery bypass through four small, dime-sized incisions reducing the patient's recovery time, trauma to the body and risk of infection."

Dr. Srivastava is one of the world's most experienced cardiac robotic surgeons and has performed nearly 1000 robotic cardiothoracic surgical procedures since 2002. Three hundred and fifty have been singe and multi-vessel (two, three and four vessel), beating heart, totally-endoscopic coronary bypass procedures (TECAB). TECAB is done through four or five fingertip-size incisions and associated with functional recovery in days rather than months compared to the other traditional approaches. Dr. Srivastava has numerous world's firsts in robotic and minimally-invasive cardiac surgery and has unmatched expertise in obtaining bilateral internal mammary arteries using the robotic surgical system.

"This TECAB procedure for obtaining the mammary arteries is the gold standard of treatment for patients," says Dr. Srivastava. "The benefits are proven: faster recovery, less scarring, reduced risk of infection and a faster return to normal living."

With the addition of Dr. Srivastava to Saint Joseph's robotics program, cardiac patients have a choice of 'closing' open heart surgery for most procedures.

Dr. Srivastava performed a double bypass procedure on Monday, March 23 and that patient also was able to be discharged two days later on March 25, much sooner than the typical five - seven day hospital stay required for traditional open procedures.

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Georgia State Researcher Investigates Link Between Folic Acid and Heart Health, Anemia

A Georgia State University researcher and his colleague are investigating the effects of a decade-long requirement to fortify all cereals in the United States with folic acid, and its link with a chemical believed to play a role in cardiovascular disease.

Vijay Ganji, associate professor of nutrition in Georgia State’s College of Health and Human Sciences, and Mohammad R. Kafai, of San Francisco State University, investigated multiple factors involved in the levels of the nutrient folic acid and homocysteine — for which studies suggest a link to increased risk for cardiovascular disease.

The report is one of the first examining factors such as gender, race, blood pressure, and levels of certain chemicals in the blood during the post-fortification period. Ganji and Kafai examined the data from the National Center for Health Statistics’ National Health and Nutrition Examination Survey from 1999 to 2004.

Since 1998, all processed cereals in the United States have been fortified with folic acid in an effort to help prevent neural tube defects — a type of birth defect that can lead to neurological diseases such as spina bifida, a defect resulting in an incomplete spinal cord.

Folic acid fortification has reduced the risk of neural tube defects by up to 20 percent in the United States, and by higher levels in Canada, which started fortification at about at the same time, Ganji explained.

But an unintended effect of fortification is the reduction of homocysteine — a chemical which studies suggest increases the risk of cardiovascular disease, decreased cognitive function and bone mineral density. Fortification has helped reduce homocysteine levels in the population.
Not everyone needs high levels of folic acid. The intended target for fortification is women who are pregnant or are of child-bearing age, and not necessarily men, children or the elderly.

In the study, Ganji and Kafai found an association between homocysteine levels and serum methylmalonic acid, or MMA — which can indicate vitamin B12 deficiency, a factor in certain types of anemia.

“MMA and vitamin B12 are both coming out to be a strong predictor of homocysteine,” Ganji said. “What might be happening is the worsening of B12 deficiency symptoms.”

The paradox is that folic acid fortification has had the unintended effect of reducing the risk for anemia. It is possible that certain B12 deficiency symptoms may be masked.

“When you give folic acid to someone with B12 deficiency, the anemia coming from the lack of B12 might be cured and patient does not feel tired due to lack of anemia, hence less likely to see the physician, but the neurological symptoms of the deficiency may be worsened,” Ganji explained.

Still, the enormous benefits of folic acid fortification cannot be discounted.

“It has been positive so far, and has resulted in significant reductions in neural tube defects, as well as homocysteine,” Ganji said. "We must have an ongoing public policy evaluation, though, to see if there are any trends or changes among the population.

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FDA: Insulin Pens and Insulin Cartridges Must Not Be Shared

The U.S. Food and Drug Administration today issued an alert to health care professionals reminding them that single-patient insulin pens and insulin cartridges should not be used to administer medication to multiple patients due to the potential risk of transmitting blood-borne pathogens such as HIV and the hepatitis viruses.

Insulin pens are pen-shaped injector devices that contain a disposable needle and either an insulin reservoir or an insulin cartridge. The devices typically contain enough insulin for a patient to self-administer several doses of insulin before the reservoir or cartridge is empty. All insulin pens are approved only for single-patient use (one device for only one patient).

The FDA is aware of incidents at two undisclosed hospitals involving more than 2,000 people in which the cartridge component of the insulin pens were used to administer insulin to multiple patients, although the disposable needles were reportedly changed among patients.

“Insulin pens are designed to be safe for one patient to use one pen multiple times with a new, fresh needle for each injection,” said Amy Egan, M.D., deputy director of safety at the FDA’s Division of Metabolism and Endocrinology Products in the Center for Drug Evaluation and Research. “Insulin pens are not designed, and are not safe, for one pen to be used by more than one patient, even if needles are changed between patients due to the risk of transmitting blood-borne pathogens.”

Patients exposed to shared insulin pens are being contacted by the two hospitals and are being offered testing for hepatitis and HIV. Some of the potentially exposed patients have reportedly tested positive for the hepatitis C virus, although it is not known if the virus was spread as a result of insulin pen sharing.

The FDA is working with the Centers for Disease Control and Prevention and professional organizations to address infection control issues related to insulin pens.

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Heart Disease: An Epidemic For Firefighters

/PRNewswire/ -- H. Robert Superko, MD, principal investigator in the landmark FEMA-sponsored study of firefighters aged 40 and over conducted at Saint Joseph's Hospital in Atlanta, released preliminary findings in the world's first study of first responders at risk of suffering sudden death or other significant cardiac events. Firefighters are known to have a three hundred percent increased risk for cardiac disease as compared to other segments of the population.

"Preliminary findings show that one third of firefighters had heart disease that is unrelated to traditional risk factors, such as high cholesterol," says Dr. Superko. "Those results are astounding and point at job duties and environment as the primary determinants for early death in our country's first responders."

Dr. Superko, recognized as a leading expert on lipids, cholesterol and advanced metabolic markets and their contribution to heart disease, and his team performed a comprehensive, scientific battery of sophisticated blood and imaging tests on three hundred firefighters in Gwinnett County, Georgia. Gwinnett County first responders were identified for the study following an emotional report by Fire Chief Steve Rolader, following the sudden death of one of his firefighters from cardiac arrest while fighting a house fire.

"This wasn't the first firefighter in my department to die but I wanted to do something to make it among the last," says Chief Rolader. "This man was 53 years old, in great physical shape and he had no known symptoms of heart disease. We also had lost several newly-retired firefighters to sudden cardiac death. There had to be a way to stop it."

Study volunteers underwent a comprehensive genetic screen of more than a million genes including newly identified KIF6 (statin responsiveness gene) and 9p21 (myocardial infarction gene), advanced phenotype (blood) and imaging analyses, diet and exercise review over the year-long study. Results and explanations were presented to the groups followed by individual consultations. Complete statistical and comprehensive genetics results are expected this year.

According to Dr. Superko, stress and psychological pressures related to the job, as well as diet, exercise issues and inherent personality, interacting with a genetic predisposition to heart disease, probably have tremendous impact on the risk of heart attack in these first responders.

"Imagine being awakened from a dead sleep by a loud, shrieking siren several times during the night, responding through the rush of adrenaline, carrying a hundred pounds of equipment on your back, and meeting people at the very worst possible moments in their lives every day and you can begin to understand the toll it takes on the first responders," says Superko. "And, consider the emotional and psychological stress they encounter each day as they respond to society's most brutal moments from murders to car wrecks and death. Finally, those who serve as first responders have a mind-set and a desire to help people. They certainly bring a competitive nature to the job but also a profound desire to help and to do the best for others. All these elements create an environment that puts them at an increased risk for cardiac disease."

In response to the growing awareness to issues of diet and exercise, Gwinnett Fire Department has instituted exercise programs within local firehouses and the county now re-reimburses for fitness club memberships. The department also educates firefighters on proper diet and nutrition with one-on-one opportunities as well as "lunch and learn' programs in the station houses. And, over the years, the traditional firehouse alarm in Gwinnett stations has been replaced with softer alarms and even-voiced prompts to awaken sleeping first responders.

As a result of the study, Saint Joseph's Hospital and Dr. Superko's team implemented a two month screening program for all Atlanta first responders (firefighters, Police and EMS) regardless of age in order to provide them with some basic and advanced diagnostic tests at prices affordable to firefighters.. Several physicians are providing their services free of charge.

"There are tremendous costs associated with early deaths of our first responders in every community as we lose men and women in their 30s, 40s and 50s who are our first line of defense but who don't live to perform their jobs for very long," says Chief Rolader. "With the results of this study, we can implement programs across the country that will save lives."

Final results are expected to be submitted for presentation consideration at the annual American Heart Association meeting.

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Is Your Home Poison-Proof?

National Poison Prevention Week: March 15-21, 2009

Children’s bodies are still in the developing stages, and even a brief encounter with a poison in the home can have devastating consequences.

“The short amount of time it takes to answer a phone call or see who’s at the door is all that’s needed for a curious toddler to find his or her way to the cabinets where kitchen cleaners are kept, or the medicine cabinet,” said Don Keenan, founder of the non-profit child advocacy organization Keenan’s Kids Foundation.

Each year, more than two million poisonings are reported to Poison Control Centers nationwide, and more than 90 percent of all incidents happen inside the home.

“The majority of non-fatal poisonings occur in children ages six or younger,” said Keenan, author of child safety book 365 Ways to Keep Kids Safe. “Take this week as the perfect opportunity to talk with your kids about hazardous substances; let them know they should never eat or drink anything they cannot identify.”

National Poison Prevention Week is held the third week in March every year, highlighting the dangers of poisonings and how to prevent them. Here are some tips for parents to help “poison-proof” the home, based off the 365 Ways to Keep Kids Safe checklist for poison safety:

1. Store medicine, household cleaners, paints/varnishes and all pesticides in their original packaging in locked cabinets or containers out of a child’s reach; also install safety latches on child-accessible cabinets containing any harmful products.

2. Only purchase medicine with safety caps and discard unused and expired medication; never refer to medicine as “candy” or something desirable for eating; and always check labels when providing a child with medicine to ensure proper dosage.

3. Keep coal, wood and kerosene stoves in safe working order; and maintain working smoke and carbon monoxide detectors near all bedrooms (hardwiring when feasible).

If your child appears to have been poisoned, call the Poison Control Center national hotline at 1-800-222-1222. For more information about National Poison Prevention Week and other tips and information, visit www.poisonprevention.org.
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Clayton State to Hold Love Your Body Community Health Fair March 26

Clayton State University’s University Health Services, in conjunction with Gamma Beta Mu Leadership Society, Inc, and the University’s Office of Counseling and Psychological Services, will host the “Love Your Body” Community Health Fair on Thursday, Mar. 26, from 10 a.m. to 2 p.m. in the James M. Baker University Center. The health fair will be held on the Baker Center’s “Main Street” and is open to students, faculty, staff and the community.

This year’s fair will observe Women’s Health Month as well as focus on every aspect of taking care of your body for men and women. Some featured vendors are Life South Blood Mobile, the City of Morrow, Acupuncture and the Health and Fitness Team from the Clayton State Fitness Center. Also included are prizes and giveaways, plus blood pressure checks and cholesterol screening.

For more information, contact Latrice Barlow, University Health Services office manager at (678) 466-4940.

A unit of the University System of Georgia, Clayton State University is an outstanding comprehensive metropolitan university located 15 miles southeast of downtown Atlanta.
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FDA Approved First DNA Test for Two Types of Human Papillomavirus

The U.S. Food and Drug Administration yesterday approved the first DNA test that identifies the two types of human papillomavirus (HPV) that cause the majority of cervical cancers among women in the United States.

The test, called Cervista HPV 16/18, detects the DNA sequences for HPV type 16 and HPV type 18 in cervical cells. Differentiating these HPV types gives health care professionals more information on a patient’s risk of subsequently developing cervical cancer.

A positive Cervista 16/18 test result indicates whether HPV type 16, 18 or both types are present in the cervical sample.

The FDA also approved yesterday the Cervista HPV HR test, which is the second DNA test that detects essentially all of the high-risk HPV types in cervical cell samples. The Cervista HPV HR test uses a method similar to the Cervista HPV 16/18 test to detect the DNA sequences of these HPV types.

In women age 30 and older or women with borderline cytology, the Cervista HPV 16/18 test can be used together with cytology and the Cervista HPV HR test to assess risk of cervical disease.

“Results from these two tests, when considered with a physician’s assessment of the patient’s history, other risk factors, and professional guidelines, can help physicians better determine risk and could lead to better patient management,” said Daniel G. Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health.

HPV is the most common sexually transmitted infection in the United States. The U.S. Centers for Disease Control and Prevention estimates that more than 6 million Americans become infected with genital HPV each year and that more than half of all sexually active women and men become infected at some time in their lives.

For most women, the body's own defense system clears the virus and infected women do not develop related health problems. However, some HPV types can cause cell abnormalities on the lining of the cervix that later can become malignant. While there are many different types of HPV, types 16 and 18 cause about 70 percent of all cervical cancers.

Cervista HPV 16/18 and Cervista HPV HR are manufactured by Madison, Wis.-based Third Wave Technologies.

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Not enough vitamin D in the diet could mean too much fat on adolescents

Too little vitamin D could be bad for more than your bones; it may also lead to fatter adolescents, researchers say.

A Medical College of Georgia study of more than 650 teens age 14-19 has found that those who reported higher vitamin D intakes had lower overall body fat and lower amounts of the fat in the abdomen, a type of fat known as visceral fat, which has been associated with health risks such as heart disease, stroke, diabetes and hypertension.

The group with the lowest vitamin D intake, black females, had higher percentages of both body fat and visceral fat, while black males had the lowest percentages of body and visceral fat, even though their vitamin D intake was below the recommended levels. Only one group – white males – was getting the recommended minimum intake of vitamin D.

“This study was a cross-section so, while it cannot prove that higher intake of vitamin D caused the lower body fat, we know there is a relationship that needs to be explored further," says Dr. Yanbin Dong, a molecular geneticist and cardiologist at the MCG Gerogia Prevention Institute.

Dr. Dong, who also co-directs the MCG Diabetes & Obesity Discovery Institute, and Inger Stallman-Jorgensen, a research dietician at the GPI, present their findings this week at the American Heart Association’s Joint 49th Conference on Cardiovascular Disease Epidemiology and Prevention and Nutrition, Physical Activity and Metabolism in Palm Harbor, Fla.

The pair will next study whether it is feasible for teens to take a daily vitamin D supplement in pill form. Those results will help them design a larger study to explore the relationship between vitamin D intake and body fat levels in teens.

“We already know that encouraging teens to get an adequate amount of vitamin D in their diets will help promote a healthy body as they grow and develop,” Ms. Stallman-Jorgensen says. “Now we need to do intervention studies where we give teens vitamin D supplements to determine if there is a cause and effect relationship between vitamin D intake and fat.”

The American Academy of Pediatrics recommends adolescents get at least 400 units of vitamin D per day – either from milk or sun exposure. There are typically 100 units in one 8-ounce glass of whole milk. The recommended daily dose from the sun would require at least 30 minutes of adequate exposure to direct sunlight two or three times a week at peak hours, between noon and 3 p.m.

Ms. Stallman-Jorgensen said there are many reasons teens don't get enough vitamin D, which has been linked to the prevention of diabetes, cancer and cardiovascular disease.

“As humans, our largest source of vitamin D should be the sun. But we don’t spend enough time outdoors to get enough sun exposure and when we do, we’re often covered up and wearing sunscreen," she said. "We can get vitamin D from certain foods, like fatty fish and liver, but it’s not in a lot of foods that we commonly consume. In this country, our milk is fortified with vitamin D. Unfortunately, teens just don’t drink enough milk to get their daily requirements.”

She points out that low sunlight during the winter months reduces the amount of vitamin D the skin produces, and that darker-skinned people obtain less vitamin D from the sun because the extra melanin in their skin filters out more sunlight.

Some people can't tolerate milk because they lack the enzyme that processes lactose, the natural sugar in milk, though "most people can handle it in small amounts,” Ms. Stallman says.

Cultural issues may also be at play, Ms. Stallman-Jorgensen says.

“Most teens want to drink sodas and sugary drinks. It’s not cool to drink milk – they think of it as more of a food for babies,” she said.

Potential study participants had their weekday and weekend diets tracked by researchers seven times during a three-month period. Those who provided at least four diet reports were included in the final group of 659.

Body fat percentages were measured by dual energy X-ray absorptiometry scans, which can measure total body composition. Visceral fat was measured in a subset of 432 teens.

Jennifer Hilliard
Medical College of Georgia

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Study Suggests Blood Test for Alzheimer’s Possible

Researchers have revealed a direct relationship between two specific antibodies and the severity of Alzheimer’s disease symptoms, raising hopes that a diagnostic blood test for the devastating disorder is within reach.

Researchers from the University of Georgia, the Charlie Norwood VA Medical Center in Augusta and the Medical College of Georgia compared antibody levels in blood samples from 118 older adults with the participant’s level of dementia. The team, whose results appear in the current edition of Journal of Gerontology: Medical Sciences, found that the concentration of two specific proteins that are involved in the immune response increases as the severity of dementia increases.

“We found a strong and consistent relationship between two particular antibodies and the level of impairment,” said study co-author L. Stephen Miller, professor and director of clinical psychology training in the UGA Franklin College of Arts and Sciences. “The finding brings us closer to our ultimate goal of developing a blood test that can diagnose Alzheimer’s disease or potentially identify if someone is at higher risk for the disease.”

Miller’s co-authors include Jennifer S. Wilson, a former undergraduate student in the UGA Honors program who is now pursing graduate studies at Emory University; Shyamala Mruthinti, research pharmacologist at the VA Medical Center and adjunct professor at MCG; and Jerry Buccafusco, director of the MCG Alzheimer’s Research Center. The team focused on antibodies that the body creates in response to two proteins that are associated with Alzheimer’s disease. One protein, known as amyloid-beta, forms the plaques that are evident in the brains of people with Alzheimer’s upon autopsy. The other protein, known as RAGE, is involved in the normal aging process but is expressed at higher levels in the brains of people with Alzheimer’s.

In a previous study that compared a group of people with Alzheimer’s disease to a healthy control group, Mruthinti and her colleagues found that anti-amyloid beta and anti-RAGE antibodies are significantly higher in the group with Alzheimer’s. The team’s latest study expands on that finding to reveal a direct relationship between severity of Alzheimer’s disease and levels of the two antibodies in the blood.

“Alzheimer’s is an inflammatory disease of the brain, and these two antibodies give us a way to measure that inflammation,” Mruthinti said. “Using them as an early diagnostic marker may allow us to start drug treatment early, when it’s most effective, to increase the patient’s quality of life.”

While optimistic about their findings, the researchers caution that it could still be years before a diagnostic test based on their work is clinically available. The study found that the relationship between the two antibodies and Alzheimer’s severity persists even after controlling for patient age and total antibody levels. To further test the strength of the relationship, the researchers are now working with a sample that controls for other factors that have the potential to influence levels of the two antibodies, such as diabetes and heart disease. Buccafusco and his colleagues are also working to decrease the cost and time involved in the test.

“We’re in the process of trying to reduce the test to a one-day procedure, whereas right now it takes three to four days,” Buccafusco said. “But even now, our test is orders of magnitude cheaper than having people come in every few months to get a functional MRI or PET scan to try to discern brain plaques.”

The team is targeting the two proteins themselves as a possible treatment for Alzheimer’s disease. Mruthinti explains that, individually, amyloid-beta and RAGE proteins don’t provoke an immune response. The trouble begins when the two bind and the immune system attacks, resulting in constant state of inflammation that damages the brain. The researchers recently developed a way to measure levels of amyloid beta-RAGE complex, and preliminary data using transgenic mice that express Alzheimer’s symptoms suggest that an antigen they created to boost the body’s natural immune response to the complex can reduce the formation of the brain plaques.

“The amyloid beta-RAGE complex cuts off the connections between neurons,” Mruthinti explained, “but our hope is that we can protect those connections by preventing those plaques from forming.”

The research was funded by a Merit Review Award from the Veterans Administration to principal investigator Mruthinti and by the Medical College of Georgia Alzheimer’s Research Center.

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Investigators at the Atlanta Institute of Medicine & Research Are Seeking Adults Who Stutter for Clinical Research Study

(BUSINESS WIRE)--Men and women who stutter often have so much to say but they may not always say it the way they want. As part of a new clinical study at the Atlanta Institute of Medicine & Research in the Atlanta area, researchers led by Dr. Angelo Sambunaris will test whether pagoclone, an investigational medication for stuttering, may offer a way to achieve more fluent speech. To determine whether you or someone you know may qualify for the study, please visit www.StutteringStudy.com or call 866-469-0444.

Stuttering is a speaking disorder affecting an estimated three million Americans – approximately one percent of the population. It can cause high levels of social anxiety in individuals, particularly in speaking situations, and affects four times as many men as women. Stuttering is often characterized by interruptions in the flow of speech by repetition of syllables, prolongation of sounds or unplanned stoppages. The cause is not clearly understood and varies among individuals. Some research in the last decade suggests that stuttering may result from disruption to the brain’s speech pathway during earlier developmental years.

“Stuttering can have a tremendous impact on a person’s life: their social functioning, their occupational achievement,” said Dr. Gerald A. Maguire, a lead investigator of the pagoclone stuttering study and Associate Professor of Clinical Psychiatry at the University of California, Irvine School of Medicine. “The treatment challenge for the future is not only to improve fluency, but to reduce the individual’s anxiety and avoidances of certain feared speaking situations.”

Pagoclone was originally developed and investigated as a potential treatment for generalized anxiety disorder and panic disorder. During the clinical study, it was observed that a few participants with a history of stuttering experienced less stuttering while taking the investigational drug.

Safety and efficacy data from a previous pagoclone clinical trial for people who stutter were presented at the 2008 National Stuttering Association meeting as well as to the Oxford Dysfluency meeting in England. This new research study is designed to determine whether adults treated with the investigational medication, pagoclone, experience a reduction in the number of stuttered syllables compared to those administered a placebo (an inactive medication or “sugar pill”).

“As the largest support organization for people who stutter, the National Stuttering Association advocates research into effective treatment for stuttering,” said Jim McClure, media relations director for the association. “While we do not endorse specific treatments, we are excited about the prospect of a future medication that may help some people who stutter improve their fluency which in turn may help the individual to gain self-confidence.”

Dr. Maguire said, “If this study is successful, future investigations may combine study medication with speech therapy to determine whether that will lead to better results.”

Approximately 330 people who stutter will be enrolled to receive either pagoclone or a placebo. The research study will require six office visits and four telephone check-ins over an eight-month period. At the end of the eight-month treatment period, participants have an option to choose to continue in an extension of the study in which all participants will receive the investigational medication, pagoclone, for approximately 12 months. All study-related doctor’s visits, procedures and study medication will be provided at no cost. The participants may receive compensation for travel-related expenses.

To be eligible for the current pagoclone clinical study, participants must be between the ages of 18 and 80 and have a history of stuttering prior to the age of eight. All adults must be English speaking with an eighth grade education level and meet additional eligibility requirements. Details are available at www.StutteringStudy.com or by phoning 866-469-0444.

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Benign Brain Tumors Removed through Small Openings at Emory University Hospital Midtown

Neurosurgeons at Emory University Hospital Midtown are now removing benign tumors from deep within the brain though tiny incisions and openings in the skull no larger than a pea. This novel treatment alleviates the need to fully open the skull to remove tumors, meaning fewer risks, less operating time and shorter hospital stays for the patient.

Emory University Hospital Midtown is the only hospital in Georgia removing these tumors endoscopically through small openings in the skull.

The most common brain tumors removed by this method are called colloid cysts. They are benign cystic tumors found deep in the brain, which can cause obstructive hydrocephalus, an increased build-up of cerebrospinal fluid (CSF) within the ventricles of the brain.

Blockage of the normal flow of CSF can lead to increased intracranial pressure, resulting in headache, vertigo, memory impairment, weakness of limbs and behavioral changes. In some cases, the tumors can even cause sudden death.

“In most medical centers, colloid cysts are removed with a craniotomy, resulting in a large incision and complete opening of the skull,” says Costas Hadjipanayis, MD, PhD, assistant professor of neurosurgery, Emory University School of Medicine. “Now, we are able to remove these tumors through small incisions and openings in the skull with the use of a 6 millimeter endoscope (fiberoptic camera). Visualization by the endoscope allows for identification of the colloid cyst in the third ventricle, and small instruments (2 millimeters) are passed through openings at the end of endoscope for removal of the tumor.”

In addition to removing the tumor, surgeons are able to create new pathways for the cerebrospinal fluid to flow freely again, so no shunts to drain excess fluid are needed.

A skilled neurosurgeon, Hadjipanayis reports he is seeing excellent outcomes in patients who have these tumors removed using this minimally invasive technique. Patients have a much shorter recovery time and can return to normal activities several days after surgery.

Colloid cysts account for approximately one percent of all intracranial tumors.

For more information on this procedure, call Emory HealthConnection at 404-778-2000.
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Mayo Clinic Research Shows That Improving Brain Processing Speed Helps Memory

Mayo Clinic researchers found that healthy, older adults who participated in a computer-based training program to improve the speed and accuracy of brain processing showed twice the improvement in certain aspects of memory, compared to a control group.

"What's unique in this study is that brain-processing activities seemed to help aspects of memory that were not directly exercised by the program — a new finding in memory research," says Glenn Smith, Ph.D., Mayo Clinic neuropsychologist and lead researcher on the study.

The research, a controlled, multisite, double-blind study, will be published in the April issue of the Journal of the American Geriatrics Society. A copy is available online Feb. 9, 2009.

For an hour a day, five days a week for eight weeks, study participants worked on computer-based activities in their homes. The participants, from Minnesota and California, were age 65 or older. No one had a diagnosis of cognitive impairment, such as early Alzheimer's disease.

The control group, with 245 adults, watched educational videos on art, history and literature topics. They completed quizzes on the content.

The experimental therapy group, with 242 adults, completed six auditory exercises designed to help the brain improve the speed and accuracy of processing. For example, participants were asked to distinguish between high- and low-pitched sounds. To start, the sounds were slow and distinct. Gradually, the speed increased and separation disappeared.

"The sounds go faster and faster, until it ends up sounding almost like a click," says Dr. Smith. The difficulty increases only as participants master each step with 85 percent accuracy. Other exercises, such as matching or distinguishing between similar-sounding words, for example, pop and pot, also were part of the skill building.

The commercially available program was developed by Posit Science, San Francisco company that financed the research. Mayo Clinic researchers do not have financial ties to this business.

At the end of eight weeks, researchers used a standardized tool to measure participants' memory changes. Called the Repeatable Battery for the Assessment of Neuropsychological Status, it includes tasks such as repeating words or numbers after hearing them once.

"We found that the improvement in these skills was significantly greater in the experimental group — about double," says Dr. Smith. The improvement was 3.9 points for the experimental group and 1.8 points for the control group.

Participants in the experimental group self-reported memory improvement, too, indicating the change was noticeable in day-to-day tasks.

While the study results are statistically significant, Dr. Smith says it is important to understand the extent of the memory boost. Collectively, the experimental group's memory function increased about 4 percent over the baseline measured at the study's onset. The control group's overall memory gain was about 2 percent.

But, Dr. Smith says, because participants were in generally good health, the results don't offer insights on preventing Alzheimer's or other forms of dementia.

Results indicate that aging adults may be able to make better-informed decisions about ways to improve memory. "Brain processing speed slows as we age," says Dr. Smith. "The study indicates that choosing a memory-enhancing approach that focuses on improving brain processing speed and accuracy, rather than memory retention, may be helpful."

There's no harm in trying other approaches — mnemonics, workshops or even doing crosswords or playing piano, he says, but there's little evidence these methods sustain benefits in memory.

Other researchers involved in this study include: Patricia Housen, Ph.D., and Elizabeth Zelinski, Ph.D., both with Leonard Davis School of Gerontology, University of Southern California, Los Angeles; Kristine Yaffe, M.D., University of California, San Francisco; Ronald Ruff, Ph.D., Stanford University, Stanford, Calif.; Robert Kennison, Ph.D., California State University, Los Angeles; and Henry Mahncke, Ph.D., Posit Science Corporation, San Francisco. His affiliation with this company is noted in the journal article.
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FDA Approves Cardiac Adhesion Barrier for Pediatric Use

The U.S. Food and Drug Administration today announced its approval of a device that reduces the severity of adhesions in children undergoing open-heart surgery.

Repel-CV is a synthetic film barrier inserted over the heart just before a surgeon closes the chest following an open-heart procedure. During the early healing stages, the temporary, absorbable barrier helps reduce the severity of post-surgical adhesions.

Adhesions are bands of scar tissue that develop after surgery, infection, or other trauma. The bands can develop in any part of the body but are most commonly found in the abdomen, pelvis, or chest. Cardiac adhesions bind the outer membrane of the heart to surrounding tissue, which may restrict heart activity and complicate any additional surgical treatment. While scar tissue is part of the body’s natural healing response, adhesions can become densely fibrous and difficult to surgically navigate, which can pose problems for patients who require repeat surgeries.

In the United States, there are 350,000 to 400,000 children with congenital cardiac abnormalities. Many neonatal and infant patients must undergo multiple surgeries before their defect is corrected while other children require additional operations as they grow. This product gives physicians another tool to help decrease this type of complication that may occur.

Repel-CV is intended for children who are likely to require additional heart surgery. In a clinical study, patients who received Repel-CV were found to have less area of severe adhesions—21 percent of the surgical site. Patients who did not receive Repel-CV were found to have severe adhesions occupying 47 percent of the surgical site.

“Designing and testing medical devices for children is challenging because they are still growing,” said Daniel G. Schultz, director of FDA’s Center for Devices and Radiological Health. “Approval of Repel-CV is an example of FDA’s commitment to work with regulated industry to make more safe and effective pediatric medical devices available.”

Repel-CV is manufactured by SyntheMed Inc. in Iselin, N.J.

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Study Finds Family History, Higher Incidence of Sunburns Associated With Rosacea

/PRNewswire-USNewswire/ -- Rosacea is a chronic skin condition that causes redness, swelling and vascular abnormalities, most commonly on the face, with varying degrees of severity. While the exact cause of rosacea is unknown, dermatologists are examining several characteristics shared by rosacea patients. This research could improve the general understanding of this complex disease which affects an estimated 14 million Americans.

Speaking today at the 67th Annual Meeting of the American Academy of Dermatology (Academy), dermatologist Alexa Boer Kimball, MD, MPH, FAAD, associate professor of dermatology at Harvard Medical School in Boston, presented findings from a case-controlled study of rosacea subjects compared to control subjects and the implications of her research.

"This study was building on previous photo database work that we had done in which we looked at photos of 3,000 people with and without rosacea to try to determine the prevalence of rosacea in certain populations and some of the factors that seemed to be associated with it," said Dr. Kimball. "We wanted to see whether we could validate some of these initial findings, as well as explore whether rosacea was predictive of other systemic conditions that might be related -- similar to the link between severe cases of psoriasis and other medical conditions such as diabetes and heart disease."

In this case-controlled study that built on the photo study conducted at Massachusetts General Hospital and Brigham and Women's Hospital, both in Boston, 65 rosacea subjects (age 24 to 86) and 65 controls without rosacea (age 18 to 78) underwent a facial skin exam, completed a questionnaire and had their height, weight and blood pressure measured. Blood pressure measurements, body mass indexes and questionnaire results of the two groups were compared. In general, the rosacea subjects had a moderate to severe form of the skin condition.

Comparing the data for the two study groups, Dr. Kimball found that rosacea subjects were three times more likely to have a family member with rosacea compared to the control group. Specifically, 34 percent of rosacea subjects reported a family member with rosacea vs. 10.5 percent of control subjects. When answering questions about their dermatological and medical conditions, rosacea subjects had significantly higher rates of blistering sunburns than control subjects (44 percent vs. 5.2 percent, respectively).

"Even when we did a more sophisticated analysis of the data controlling for age and gender, we found these findings were statistically significant and confirmed our previous findings," said Dr. Kimball. "Although these results are quite preliminary, they are important for future research as we start to explore these positive associations and their implications in controlling this condition."

In families with a history of rosacea, Dr. Kimball advised parents to consistently protect children from sun exposure with a broad-spectrum sunscreen with a Sun Protection Factor (SPF) of 15 or higher and to practice other sun-safe behaviors in order to minimize the risk of sunburns. From her research, it could not be determined if sunburns were a contributing factor to rosacea or if patients with rosacea were more likely to sunburn due to the nature of their skin condition. In either case, she noted that these preventative measures could help lessen the severity of rosacea.

One potential association with rosacea that Dr. Kimball noticed in her previous photo database analysis that was not found to be significant in her case-controlled study was a higher body mass index (BMI) in rosacea patients. While a BMI in the range of 18.5 to 24.9 is considered normal, the rosacea subjects in the previous photo analysis had a mean BMI of 27.6 (which is considered overweight) vs. a 24.3 mean BMI in the subjects without rosacea.

However, in the case-controlled study, the rosacea subjects had a slightly lower mean BMI of 26.6 vs. a comparable 26.1 mean BMI in the control subjects -- both of which were considered overweight.

"Future studies should explore the possible connection between a higher BMI and rosacea, as excess weight could be found to be a contributing factor to the condition," said Dr. Kimball.

Dr. Kimball advised rosacea patients to see their dermatologist to discuss the most appropriate treatment options available and factors that may be contributing to the severity of their condition.

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HHS Issues Special Report on Health Reform and Launches New healthreform.gov Web Site

Americans expressed serious concerns regarding health care in a new
report released today by the Department of Health and Human Services.
The report, Americans Speak on Health Reform: Report on Health Care
Community Discussions, summarizes comments from the thousands of
Americans who hosted and participated in Health Care Community
Discussions across the country and highlights the need for immediate
action to reform health care.

The report is available on a new Web site dedicated to health reform:
www.healthreform.gov. Unveiled today, the Web site will allow Americans
to view today's White House Health Forum, share their thoughts about
health reform with the Obama Administration and sign a statement in
support of President Obama's commitment to enacting comprehensive health
reform this year.

"This new Web site, www.healthreform.gov and report ensure that when we
discuss health reform, the American people will have an equal stake in
the health reform efforts," said HHS Spokeswoman Jenny Backus.
"Sky-rocketing health care costs are creating enormous pressure on
families, on businesses and our fiscal future. The Obama Administration
is committed to taking action this year on health reform and is calling
on government, business, health care stakeholders and everyday Americans
to come together to make it happen."

In December, then President-elect Obama called on the American people to
host Health Care Community Discussions to assess the seriousness of the
problems and identify solutions. In the last eight years, health
insurance premiums have grown four times faster than wages and one
million more Americans have lost their health insurance each year.
Health care costs have forced small businesses to close their doors and
compelled corporations to ship jobs overseas.

Over 9,000 people signed up in all 50 states and the District of
Columbia to host a discussion, and thousands more participated in these
gatherings. After each Health Care Community Discussion, guests and
hosts were asked to fill out a Participant Survey and submit a group
report to the Presidential Transition Team's Web site summarizing the
group's concerns and suggestions. Group reports from 3,276 Health Care
Community Discussions as well as Participant Surveys from 30,603
participants were collected, analyzed, and are summarized in the report.

The cost of health care services and health insurance was the top
concern about the health care system for 55 percent of discussion
participants. Participants also cited lack of emphasis on prevention,
pre-existing conditions limiting insurance access, and the quality of
care as key concerns. A qualitative analysis found that the Health Care
Community Discussions focused on concerns about a "broken" health
system, access to health insurance and services, rising premiums and
drug costs, medical mistakes and the system not being "for them."

Health Care Community Discussion group participants agreed on the values
and direction that should guide reform. They called for a system that
is fair, patient-centered and choice-oriented, simple and efficient, and
comprehensive. Participants also offered a wide range of specific
solutions, including making health insurance more accessible through an
insurance "exchange" or a public plan option, creating scorecards on
quality and cost, improving the nutritional content of school lunches,
implementing electronic medical records and creating an AmeriCorps for
health workers.

Today's report also includes a series of personal testimonials from
Health Care Community Discussion participants who expressed their
concern about the state of health care in America. A farmer from Enid,
Okla., explained, "I have spent my life's savings on [health care], and
now I am refused care at our local hospital because I cannot pay. I may
have to file bankruptcy due to this." A report from Missoula, Mont.,
commenting on policies that allow insurers to deny coverage to Americans
with pre-existing conditions said, "No mother should have to say her
daughter is 'uninsurable.'"

President Obama has committed to reforming health care this year and has
already acted to make health care more affordable and accessible.
President Obama signed a law to provide and protect health insurance for
11 million American children through the Children's Health Insurance
Program. The President also signed into law the American Recovery and
Reinvestment Act which includes investments in electronic health
records, prevention, comparative effectiveness research, and health
workforce training -- foundations for a 21st century health care system.
Additionally, the President's Budget Blueprint also includes an historic
commitment to comprehensive health care reform.

A copy of Americans Speak on Health Reform: Report on Health Care
Community Discussions, group reports filed by participants and hundreds
of submitted photos are available at www.HealthReform.gov.

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FDA Warns About Risk of Wearing Medicated Patches During MRIs

Certain adhesive patches that deliver medication through the skin have been found to be a risk to patient safety. The patches, if worn while undergoing magnetic resonance imaging scans or MRIs, can cause skin burns, says the U.S. Food and Drug Administration today.

The patches of concern include both brand name and generic products and patches purchased over the counter without a prescription.

The FDA issued the Public Health Advisory on transdermal drug patches after learning that a warning was missing on some patches that contain aluminum or other metals in their non-adhesive backing. The backing is the portion of the patch not in direct contact with the skin.

While not attracted to the magnetic field of the MRI, the metal can conduct electricity, generating heat which can cause burns. Users of the patches reported receiving skin burns at their patch site when wearing the patch during an MRI scan.

"The risk of using a metallic patch during an MRI has been well-established, but the FDA recently discovered that not all manufacturers include a safety warning with their patches," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "Because the metal in these patches may not be visible and the product labeling may not disclose the presence of metal, patients should tell both their health care professional and their MRI facility that they wear a medicated adhesive patch."

The FDA was alerted to the missing MRI warning on Teva Pharmaceutical's fentanyl transdermal system in January. The FDA investigated and found that a similar warning was also missing on a variety of skin, or transdermal, patches delivering medications.

The FDA is reviewing the labeling and composition of all medicated patches to ensure that those made with materials containing metal provide a warning to patients undergoing an MRI and will alert the public when this information has been added. Until then, the agency recommends that people wearing medicated skin patches, including nicotine patches, talk to a health care professional about their patch at the time they receive their MRI referral. The professional will advise the patient about when to remove the patch before the procedure and about replacing it after the procedure.

Patients should also tell their MRI facility that they are using a patch when they call to schedule their appointment and should repeat this information when filling out their health history questionnaire after arriving for their appointment.

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Harvard Study Shows Folic Acid, B Vitamins in Animi-3(R) May Prevent Vision Loss

/PRNewswire/ -- A new study by researchers at Harvard Medical School has found that combining essential B vitamins, including B6, B12, and folic acid, lower risk of developing age-related macular degeneration (AMD), one of the leading causes of vision loss among older Americans. These ingredients, which are formulated in combination with key omega-3 fatty acids and phytosterols, are also contained in the prescription supplement Animi-3, which is actively being prescribed by physicians to address deficiencies in these nutrients.

In the randomized, double-blind clinical trial, more than 5,000 women with heart disease, and at least three risk factors for cardiovascular disease, were given vitamins B6, B12, and folic acid over a seven-year time period. At the end of the trial, approximately 34 percent of the women had a lower risk of developing any type of AMD, while 41 percent had a lower risk of more severe forms of AMD.

"What's interesting here is the study authors note the correlation between age-related macular degeneration and cardiovascular disease," said nutritional expert Dr. Barbara Levine, Weill Cornell Medical College. "I recommend patients with nutritional deficiencies speak to their physicians about Animi-3, which is formulated with these essential B vitamins and DHA, the most important omega-3 fat, to address various conditions, including heart disease, arthritis, eye health, and depression."

"DHA is highly concentrated in the retina of the eye, which is one of the reasons why a DHA deficiency may be important to vision," added President Jack Schramm, PBM Pharmaceuticals, Inc., the makers of Animi-3. "Animi-3 delivers DHA as well as B6, B12, and folic acid. Studies continue to suggest that DHA, along with a combination of vitamins B6, B12, and folic acid, can address deficiencies in these nutrients associated with eye problems, including dry eye and macular health."

Each capsule of Animi-3 contains 500 mg of omega-3, (350 mg of DHA), 200 mg of phytosterols, 1 mg of folic acid, 12.5 mg of B6, and 12 mcg of B12.

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Brooks UMC Hosting Blood Drive

Brooks United Methodist Church will be hosting a blood drive on Tuesday, March 31st, from 3:00 – 8:00 pm. Schedule an appointment in advance by calling Lynn Quinnell at 770-719-1506 or just drop by the church at 119 Morgan Mill Road, Brooks. The church is just 3 miles east of Starrs Mill at the corner of 85 Connector and Morgan Mill Road. More info: www.brooksumc.com.