FDA orders halt to marketing of unapproved single-ingredient oral colchicine

The U.S. Food and Drug Administration today took action against companies that manufacture, distribute, and/or market unapproved single-ingredient oral colchicine, a medication commonly used for the daily prevention of gout, to treat acute gout flare-ups, and for the treatment of Familial Mediterranean Fever (FMF).

The companies are expected to stop manufacturing single-ingredient oral colchicine within 45 days and must stop shipping this unapproved product in interstate commerce within 90 days. A small amount of unapproved colchicine is expected to be available after these dates until supplies are exhausted.

Many single ingredient oral colchicine products have been used by the medical community for decades. These and a variety of other medications have not received the mandatory modern-day FDA-approval required of all prescription drugs.

Colcrys is the only FDA-approved single-ingredient oral colchicine product available on the U.S. market. Approved by the FDA in 2009, Colcrys’ prescribing information contains important safety data and recommendations on drug interactions and dosing not available with unapproved products.

The manufacturer of Colcrys, Mutual Pharmaceutical/URL Pharma, has established a Patient Assistance Program (PAP) and a Co-Pay Assistance Program (CAP) to ensure that all patients will be able to continue affordable access to colchicine. The company also has informed FDA that it will maintain the programs at a minimum until there is FDA-approved generic competition for Colcrys. The PAP covers three groups of people: those with insurance; those without insurance; and Medicare beneficiaries enrolled in Part D who do not want the cost of Colcrys to contribute toward their true out-of-pocket expenditures under Part D. The CAP helps eligible patients reduce their Colcrys prescription co-pay to no more than $25 per prescription. Specific information on these programs can be found at www.colcrys.com, www.needymeds.org, or by calling 1-888-811-8423.

Today’s action is part of the FDA's broader initiative against marketed unapproved drugs, announced in a June 2006 Compliance Policy Guide describing the agency’s risk-based enforcement approach for marketed unapproved drug products.

“The need for drugs to go through the FDA approval process is clearly demonstrated by our review of oral colchicine tablets,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research (CDER). “Without our safety review and proper drug labeling, the old standard of care would likely have continued, to the detriment of patients.”

Unapproved versions of colchicine are not generic drugs. Generic drugs are approved by the FDA to assure that the approved generic drug products meet the same standards as the innovator drug. All single-ingredient oral colchicine products, other than Colcrys, that are currently being marketed are unapproved drugs and have never been evaluated by the agency.

“It is a priority for the FDA to get unapproved medications, such as older versions of single ingredient oral colchicine, either updated to conform to FDA’s current approval standards or off the market," said Deborah M. Autor, director of CDER’s Office of Compliance. “The FDA remains committed to ensuring that prescription drugs have the necessary FDA approval. We encourage companies to actively pursue approval or face the type of action announced today.”

The FDA previously took action against unapproved colchicine for injection products on Feb. 6, 2008. This ongoing initiative is designed to bring all unapproved medications, including single-ingredient oral colchicine, up to modern-day safety, efficacy, labeling, and quality standards by ensuring that they comply with FDA approval requirements. The FDA is committed to working with companies to ensure that marketed drugs are safe and effective, and meet appropriate standards for manufacturing and labeling.

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FDA issues final rule on safety information during clinical trials

The U.S. Food and Drug Administration today issued a final rule that clarifies what safety information must be reported during clinical trials of investigational drugs and biologics.

“This final rule will expedite FDA’s review of critical safety information and help the agency monitor the safety of investigational drugs and biologics,” said Rachel Behrman, M.D, associate director for medical policy in the FDA’s Center for Drug Evaluation and Research. “These changes will better protect people who are enrolled in clinical trials.”

The new rule requires that certain safety information that previously had not been required to be reported to FDA be reported within 15 days of becoming aware of an occurrence. These reports include:

* findings from clinical or epidemiological studies that suggest a significant risk to study participants
* serious suspected adverse reactions that occur at a rate higher than expected
* serious adverse events from bioavailability studies which determine what percentage and at what rate drug is absorbed by the bloodstream and bioequivalence studies which determine whether a generic drug has the same bioavailability as the brand name drug

The rule also provides examples of evidence that would suggest that an investigational product may be the cause of a safety problem. Under current regulations, drug sponsors often report all serious adverse events, even if there is little reason to believe the product caused the event. Such reporting complicates and delays the FDA’s ability to detect a safety signal. The examples address when a single event should be reported or when there is need to wait for more than one occurrence.

In addition, the rule revises definitions and reporting standards so that they are more consistent with two international organizations, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use and the World Health Organization’s Council for International Organizations of Medical Sciences. The changes are designed to help ensure harmonized reporting of globally conducted clinical trials.

Along with this final rule, the FDA also issued a draft guidance for industry and investigators that provides information and advice about the new requirements and other information.

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HHS announces $30 million in new resources to support the National HIV/AIDS Strategy

U.S. Department of Health and Human Services Secretary Kathleen Sebelius today(September 24) announced that CDC has allocated $30 million of the Affordable Care Act's Prevention and Public Health Fund to expand HIV prevention efforts under the President's National HIV/AIDS Strategy (NHAS). This includes $21.6 million in grants to state and local health departments. The funding will help to further focus HIV prevention on high risk populations and communities, as well as fill critical gaps in data, knowledge and understanding of the epidemic.

"This funding will give a critical boost to our HIV/AIDS prevention efforts across the country," said Secretary Kathleen Sebelius. "By focusing on communities and geographic areas that have been hardest hit by this disease, these critical investments will make a real impact on prevention efforts - a key part of the National HIV/AIDS Strategy."

"The National HIV/AIDS Strategy gives us an opportunity to redefine our nation's approach to HIV prevention, and can help us take our collective efforts to the next level," said Kevin Fenton, M.D., director of CDC's National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. "We are pleased that this funding will allow those of us working in HIV prevention at the federal, state, and local level to support innovative, evidence-based and high-impact prevention efforts in line with recommendations from the strategy."

Grants totaling $11.6 million will support demonstration projects to identify and implement a "combination approach" to enhance effective HIV prevention programming in 12 hard-hit areas across the country. These efforts will both supplement existing programs in these communities and help jurisdictions to better focus efforts on key at-risk populations and fulfill unmet needs.

Under this program, each funded jurisdiction will work with CDC to determine what mix of HIV prevention approaches can have the greatest impact in the local area - at the individual, population, and community level - based on the local profile of the epidemic and by assessing and identifying current gaps in HIV prevention portfolios. While the exact combination of approaches will vary by area, efforts funded under this program will follow a basic approach of: intensifying prevention for individuals at greatest risk, along with testing those individuals to reduce undiagnosed HIV infection; prioritizing prevention and linkage to care for people living with HIV; and directing these intensified efforts to communities with the highest burden of HIV.

The twelve jurisdictions funded in the first year for these efforts include Chicago, the District of Columbia, Florida, Georgia, Houston, Los Angeles, Maryland, New York City, Philadelphia, Puerto Rico, San Francisco, and Texas. The average award is approximately $960,000

Additional funding will allow CDC to expand upon successful existing efforts, as well as fill knowledge gaps to help guide evidence-based policies and approaches as a part of NHAS. Awards to state and local health departments include:

* Increasing HIV testing: $4.4 million from the Affordable Care Act will allow CDC to further expand its successful HIV testing initiative. The initiative began in 2007 to increase knowledge of HIV status primarily among African Americans, and was recently expanded to reach more hard-hit communities and populations at risk, including Latinos, men who have sex with men (MSM), and injection drug users. In the first two years of the program alone, more than 1.4 million Americans were tested, and more than 10,000 individuals were newly diagnosed.

* Filling critical data gaps: $5.6 million from the Affordable Care Act will enhance local area data collection, to provide critical information to better monitor and target future HIV prevention and treatment programs. Specifically, the new funds allow areas to monitor disease indicators among HIV-infected populations to better understand access to care, prevention, and treatment services.

The remainder of the funding is going to support additional activities for HIV prevention:

* Supporting evaluation for new activities: $6.6 million from the Affordable Care Act will support evaluation and monitoring of combination prevention approaches and other activities. Funding will also establish a web-based survey to quickly identify and respond to trends in risk behavior and exposure to HIV prevention services among men who have sex with men (MSM.)

* Prioritizing underserved populations: $1 million from the Affordable Care Act will support work with tribal communities to improve HIV prevention and program integration for American Indians/Alaska Natives.

While the exact eligibility criteria differed for each of the awards, the majority of the funding is directed toward geographic areas hard hit by the epidemic.

"While this funding represents an exciting new investment in HIV prevention, these efforts are just one important part of what is needed to implement the National HIV/AIDS Strategy and address the devastating impact that the epidemic has on many communities in the United States," said Dr. Jonathan Mermin, director of CDC's Division of HIV/AIDS Prevention. "Success will require a shared commitment and responsibility across the board, from CDC and other parts of the federal government and beyond. With far too many new infections occurring here each year - one new infection every nine and a half minutes - we must work together to ensure that the urgent HIV prevention needs in this country are met."

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FDA Approves Combination Contraceptive Containing a Folate

/PRNewswire/ -- The U.S. Food and Drug Administration on Friday approved Beyaz tablets, an estrogen/progestin combined oral contraceptive that also contains a folate (levomefolate calcium 0.451 mg).

Levomefolate calcium is a metabolite of folic acid, a water-soluble B-vitamin that helps produce and maintain new cells in the body. A known association of low folate levels and neural tube defects (e.g., spina bifida) has resulted in recommendations that women of childbearing age supplement their diet with folate.

Beyaz is based on the approved product YAZ, which contains the same doses of estrogen and progestin, and is approved for:

* Prevention of pregnancy
* Treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive for contraception and
* Treatment of moderate acne vulgaris in women at least 14 years of age, only if the patient desires an oral contraceptive for birth control.


In addition to the approved YAZ indications, Beyaz also is approved for the secondary indication in women who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product.

The primary efficacy study for Beyaz was a multicenter, double-blind, randomized, controlled U.S. trial in 379 healthy women age 18 to 40 who were treated with Beyaz or YAZ alone for up to 24 weeks. Beyaz was found to increase folate levels in women. In a German study of Beyaz, folate levels remained elevated for several weeks following discontinuation of Beyaz. Safety and efficacy data for contraception, PMDD, and acne indications were obtained from previous YAZ clinical trials.

The most common side effects reported by users of combined oral contraceptives are irregular uterine bleeding, nausea, breast tenderness, and headaches. Other serious side effects include vascular events (blood clots) and liver disease. Women over age 35 who smoke should not use this product as cigarette smoking increases further the risk of serious cardiovascular events. The common adverse events for Beyaz are expected to be the same as those for YAZ. There were no findings from the clinical trials with Beyaz to suggest a change in the overall safety profile compared to that of YAZ.

Beyaz is manufactured by Bayer HealthCare Pharmaceuticals Inc., the U.S.-based business arm of Bayer HealthCare LLC, a subsidiary of Bayer AG.

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'Improving Access to Clinical Trials Act' Passes U.S. House - Heads to President for Signature

/PRNewswire/ -- Today the U.S. House of Representatives passed the "Improving Access to Clinical Trials Act" (I-ACT), in a victory for the Cystic Fibrosis Foundation, its advocates and 120 other health advocacy organizations.

The bill, which passed the Senate Aug. 5, now goes to President Obama's desk for his signature. He is expected to sign it.

This legislation enables patients with rare diseases to participate in clinical trials without losing eligibility for public health care benefits.

Passage of this legislation is particularly important for people with CF, a rare genetic disease. A limited patient population makes it challenging to find enough people to participate in research studies evaluating the effectiveness of promising new drugs.

"Because of this groundbreaking legislation, people with CF and other rare diseases will no longer be forced to choose between critical health care coverage and participation in research that could lead to the development of a cure for our most serious illnesses," said Robert J. Beall, Ph.D., president and CEO of the Cystic Fibrosis Foundation.

We are grateful to our champions in Congress for approving this bill, which will help move new treatments more swiftly from the lab to the patients who need them most."

Congressional Cystic Fibrosis Caucus Co-Chairs, Reps. Edward Markey, D-Mass., and Cliff Stearns, R-Fla., led the effort to pass the bill in the House. The House version of the legislation, H.R. 2866, has 141 co-sponsors.

"No one should have to choose between participating in a clinical trial and accessing the essential benefits they need. Today's bill will open doors of hope and offer the possibility of better health to those with rare diseases like cystic fibrosis. I am proud to partner with my friend and co-chairman of the Congressional Cystic Fibrosis Caucus, Congressman Cliff Stearns, in the passage of this bi-partisan bill, which now will be signed into law by President Obama. I also want to commend the Cystic Fibrosis Foundation for its incredible work on this vital issue. Today represents an important and hopeful milestone in the battle to beat devastating rare diseases that afflict millions of Americans around the country," Markey said.

Added Stearns: "As co-chair and co-founder of the Congressional Cystic Fibrosis Caucus, I commend my colleagues for approving this legislation allowing people with rare diseases such as cystic fibrosis to participate in life-saving clinical trials that provide nominal compensation without the risk of losing their health care coverage. I also deeply appreciate the work of the Cystic Fibrosis Foundation in supporting my legislation."

The Senate version of the legislation, S. 1674, was introduced by Sen. Ron Wyden, D-Ore., with Sens. Chris Dodd, D-Conn., James Inhofe, R-Okla., Richard Shelby, R-Ala., and Richard Durbin, D-Ill., as original co-sponsors. An additional 17 co-sponsors signed on.

Current law prevents many people who receive Supplemental Security Income (SSI) from accepting research compensation because it makes them ineligible to receive government medical benefits. This penalty has stopped significant numbers of people with rare diseases from participating in clinical studies.

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House Committee Approves Arthritis Bill

/PRNewswir/ -- The Arthritis Foundation announces a major step in passing bi-partisan arthritis legislation in more than 30 years. The Arthritis Prevention, Control and Cure Act (H.R. 1210/S. 984) was approved today by the House Energy and Commerce Committee and will now go to the House of Representatives to vote on passage.

Bill sponsor U.S. Rep Anna Eshoo (D-Calif.) urged the committee leadership to pass the bill in order to address arthritis, a disease that impacts one in five (46 million) Americans and 300,000 children and is the nation's most common cause of disability.

"I'm very proud that my bipartisan legislation has been passed by the Energy and Commerce Committee. The bill will provide states and non-profits the resources they need to tackle this debilitating disorder," Rep. Eshoo said. "It invests in the critical needs of children and adults suffering from arthritis, and in research that will alleviate the costs to future generations of Americans who are diagnosed. I'll continue to fight for this legislation until it's signed into law."

The Arthritis Prevention, Control and Cure Act, when enacted, will better focus federally funded arthritis research, expand and strengthen public health initiatives proven to combat the burden of arthritis, and improve access to pediatric rheumatologists to address the country's severe shortage of these critical health professionals.

"The Arthritis Foundation is comprised of people all across this nation who have worked tirelessly over the past seven years to let Congress know that more needs to be done for people with arthritis," said Dr. John Klippel, president and CEO of the Arthritis Foundation. "Our grassroots advocates deserve to be recognized for reaching and successfully communicating this message to the majority of Congress." To date, 179 Representatives have joined as co-sponsors of the bill.

The Arthritis Foundation urges people to show support for this bill by calling their member of congress and becoming an advocate today.

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FDA significantly restricts access to the diabetes drug Avandia

The U.S. Food and Drug Administration today announced that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.

“The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks,” said FDA Commissioner Margaret A. Hamburg, M.D. “We are seeking to strike the right balance to support clinical care.”

Rosiglitazone also is available in combination with other diabetes medications, metformin under the brand name Avandamet or glimepiride under the brand name Avandaryl.

Avandia, manufactured by GlaxoSmithKline (GSK), is in a class of drugs known as thiazolidinediones, or TZDs. It is intended to be used in conjunction with diet and exercise to improve glucose (blood sugar) control in patients with Type 2 diabetes mellitus.

The FDA will require that GSK develop a restricted access program for Avandia under a risk evaluation and mitigation strategy, or REMS. Under the REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos (pioglitazone), the only other drug in this class. Current users of Avandia who are benefiting from the drug will be able to continue using the medication if they choose to do so.

Doctors will have to attest to and document their patients' eligibility; patients will have to review statements describing the cardiovascular safety concerns associated with this drug and acknowledge they understand the risks. The agency anticipates that the REMS will limit use of Avandia significantly.

“Allowing Avandia to remain on the market, but under restrictions, is an appropriate response, given the significant safety concerns and the scientific uncertainty still remaining about this drug,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

Also today, the FDA ordered GSK to convene an independent group of scientists to review key aspects of the company’s clinical trial known as RECORD, which studied the cardiovascular safety of Avandia compared to standard diabetes drugs. During the course of the FDA’s review of the RECORD study, important questions arose about potential bias in the identification of cardiovascular events. The FDA is requiring this independent review to provide additional clarity about the findings.

In addition, the agency halted the GSK’s clinical trial known as TIDE and rescinded all of the regulatory deadlines for completion of the trial. The TIDE trial compares Avandia to Actos and to standard diabetes drugs.

The FDA may take additional actions after the independent re-analysis of RECORD is completed.

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State Approves Piedmont Fayette Hospital CON Applications for NICU Expansion

“Keep Babies in Fayette” Support Made a Difference
The Georgia Department of Community Health announced Monday its approval of Piedmont Fayette Hospital’s Certificate of Need (CON) applications to expand its Level II neonatal intermediate care unit and to establish a Level III neonatal intensive care unit to care for fragile newborns who are born here.

“We are excited about moving forward with these important services and want to extend our heartfelt thanks to the community for its support of our Keep Babies in Fayette initiative,” said W. Darrell Cutts, president and chief executive officer of Piedmont Fayette Hospital. “The numerous individuals who signed our petition and championed this cause have been vital in ensuring that we will now be able to establish the services necessary to provide the highest level of care for our smallest patients and their families.”

The state’s decision to approve the CON applications comes at an important time for the hospital. Since September 2006, when the hospital started offering obstetric services, over 6,700 babies have been born at Piedmont Fayette Hospital, and the need for such services has grown tremendously. The approved expansion of the Level II intermediate care unit will mean that the need for neonatal care close to home can be accommodated within the planned capacity.

The absence of a Level III neonatal intensive care unit has meant that babies who required more specialized care were transferred to other facilities, forcing families to travel for sometimes over an hour to visit and assist in the care of their sick or premature newborn. Some mothers have travelled outside the community to give birth, anticipating the need for Level III care for their baby. Now, Piedmont Fayette Hospital will be able to offer these highly specialized services, keeping babies closer to home and with their families.

Piedmont Fayette Hospital intends to start construction by December 2010 and offer these expanded critical services close to home beginning in the summer of 2011.
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Radiotherapy Centers of Georgia in Partnership with Northside Hospital Present Breast Health & Cancer Awareness Day

Educating the Community on Breast Cancer Awareness October 2, 2010

Have you checked your breasts today? In 2009, the American Cancer Society estimated approximately 40,170 women died from breast cancer. In Georgia, an estimated 5,840 women will be diagnosed with breast cancer and 1,140 women will die from the disease this year. October is Breast Cancer Awareness Month and Radiotherapy Centers of Georgia – Cherokee County, in partnership with Northside Hospital-Cherokee, is presenting the 2nd Annual Breast Health & Cancer Awareness Day on Saturday, Oct. 2, 2010 at the Northside Hospital–Cherokee Conference Center, located at 1130 Bluffs Parkway in Canton, GA 30114.

“Breast Cancer is the leading cause of cancer death in women behind lung cancer,” said Sandra Gregory, M.D., radiation oncologist of Radiotherapy Centers of Georgia – Cherokee County. “It is a disease which is 100 percent treatable if caught early, so it is important to be educated and aware.”

The 2nd Annual Breast Health & Cancer Awareness Day will begin at 10 a.m. and run until 2 p.m., with featured lectures from renowned female physicians and breast specialists -- moderated by Sandra Gregory, M.D. The day’s activities will feature three panels addressing three crucial topics for women: Wellness and Prevention, Latest Treatment and Technology and Recent Developments in Breast Cancer.

Each panel consists of some of the best and brightest in their field. Peahen Gandhi, M.D., OB/GYN, Courtney Sinclair, M.D., GYN and Angela Falany, M.D. will discuss wellness and prevention; Anita Johnson, M.D., Breast Surgeon, Angela Robbins, M.D., Breast Surgeon and Lynn Baxter, M.D., Diagnostic Radiologist will speak towards the latest treatment and technology; and the third panel on recent developments in Breast Cancer will feature Rosa Langella, M.D., Breast Surgeon, Kathleen Long, M.D., Medical Oncologist, Gena Volas-Redd, M.D., Medical Oncologist and Sandra Gregory, M.D., Radiation Oncologist.

This free education event is an opportunity for women of the community to learn about genetic testing, partial breast irradiation, diet and nutrition, changes in surgical management of breast disease and breast cancer prevention. Northside Hospital’s ScreenAtlanta mobile mammography van will be onsite performing mammograms and attendees will also have an opportunity to sign up with StoryCorps Atlanta to go in-studio and record their personal experiences with Breast Cancer.

“Women who have been diagnosed or have loved ones who have been diagnosed are always the most eager to learn every last detail about Breast Cancer. But it is just as important, if not more important for those who are not as aware to be educated and proactive in getting screened,” said Dr. Gregory.

Breakfast, a survivor program and luncheon will be provided with a special butterfly release to honor all those who have fought and won the cancer battle. The 2nd Annual Breast Health and Cancer Awareness Day is free and open to the public. Registration is recommended, but only required for those requesting mammograms. To register, please call 404-845-5555 and press “0,” Monday through Friday from 8:30 a.m. to 4 p.m.

Sponsorship opportunities are still available. For more information on Breast Cancer Symposium 2010 or sponsorship opportunities, contact Toni Karasik at 678-965-4756 x. 115 or e-mail tkarasik@rccancercenters.com.
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FDA approves first oral drug to reduce MS relapses

The U.S. Food and Drug Administration has approved Gilenya capsules (fingolimod) to reduce relapses and delay disability progression in patients with relapsing forms of multiple sclerosis (MS).

“Gilenya is the first oral drug that can slow the progression of disability and reduce the frequency and severity of symptoms in MS, offering patients an alternative to currently available injectable therapies,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research.

Gilenya is the first in a new class of drugs that block some blood cells in lymph nodes, reducing their migration to the brain and spinal cord, which may help with reducing the severity of MS.

MS is a chronic, often disabling, disease that affects the central nervous system—the brain, spinal cord, and optic nerves. According to the National Multiple Sclerosis Society, there are about 400,000 people in the United States and 2.1 million people worldwide with MS.

The progress, severity, and specific symptoms of MS are unpredictable and vary from one person to another. Symptoms can be mild, such as numbness in the limbs, or severe, such as paralysis or loss of vision.

Patients using Gilenya should be monitored for a decrease in heart rate upon starting the drug. Gilenya may also increase the risk of infections. Cases of serious eye problems (macular edema) have occurred in patients taking the drug and an ophthalmologic evaluation is recommended.

The most frequent adverse reactions reported by patients taking Gilenya in clinical trials include headache, influenza, diarrhea, back pain, elevation of certain liver enzymes and cough.

The drug will be available in 0.5 milligram capsules. Gilenya is made by Novartis, Basel, Switzerland.

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Georgia Southern University Researchers to Study Role of Prenatal Exercise and Nutrition in Childhood Obesity

Georgia Southern University researchers are looking for ways to prevent and reduce childhood obesity by connecting pregnant women with an online health education course. The research is geared towards promoting preventative measures in the earliest stages of prenatal development by offering the course and promoting physical activity among pregnant women.

Researchers from Georgia Southern’s College of Health and Human Sciences have been awarded $24,844 by the University System of Georgia to study women in their first trimester of pregnancy. They have teamed up with faculty colleagues from the University of Georgia, the Medical College of Georgia and East Georgia Regional Medical Center for the study.

“The state of Georgia ranks the third highest in the nation for childhood obesity with one in three children who are overweight or obese,” said Bridget Melton, Ed.D., coordinator of the study and director of the University’s Physical Activity Healthful Living Program, “and this study will help people understand the risks of childhood obesity.”

Melton says nationwide studies have revealed a critical link between childhood obesity and a mother’s health behavior and weight gain during pregnancy.

“Some women feel that it is unsafe to start an exercise routine or maintain one during pregnancy, and we are going to dispel the myths of unsafe exercise,” said Melton. “Hopefully, if women understand the benefits and the safety concerns of exercise during pregnancy they will be more likely to continue being physically active throughout their pregnancy,” she said.

Women will receive a nutrition education packet and personal pedometer.  The women will be given a pre and post 30 minute survey and their physical activity patterns will be analyzed during each trimester.  The women will also take part in an online course that will explore the benefits and precautions of exercise during pregnancy. The course will include information about the importance of physical activity, safe exercise programs, nutrition, improving pregnancy outcomes and childhood obesity. Additionally, participants will have the opportunity to join online discussions, complete quizzes and question/answer sessions for reinforcement and feedback. “The discussions and blogs offer a great platform for social networking with peers and the women will develop a strong bond online,” said Melton. Upon successful completion of the study, all participants will receive a total of $50 in gift cards from Wal-Mart.

Recruitment for the 50 participants is now underway for the year-long study. Those who would like to participate must be Bulloch County area residents who are at least 18 years old and in their first trimester of pregnancy. For more information, or to participate in the study, call 912-478-1976 or e-mail jn00964@georgiasouthern.edu.

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HHS Awards $31 million more for prevention and wellness projects‏

$2.35 Million to DeKalb County Board of Health, Georgia for obesity prevention

The U.S. Department of Health and Human Services (HHS) today announced $31 million for awards to ten communities in eight states and one award to a state health department to support public health efforts toreduce obesity and smoking, increase physical activity and improve nutrition.

The awards funded by the Prevention and Public Health Fund included in the Affordable Care Act are part of the HHS Communities Putting Prevention to Work (CPPW) program, a comprehensive prevention and wellness initiative administered by the Centers for Disease Control and Prevention.

"As I've seen throughout the year in my work with Let's Move!, prevention works when it comes to improving the health of our families," said First Lady Michelle Obama. "These critical investments will help more communitiesacross America tackle serious health challenges like childhood obesity, wh ile promoting physical activity and healthy eating."

Today's announcement follows the release in February and March 2010 of morethan $491.8 million in Communities Putting Prevention to Work funds to states, U.S territories and communities. Those projects are supporting statewide and community based policy and environmental changes in nutrition, physical activity, tobacco control, expanded tobacco quit lines, and cessation media campaigns.

"To realize our goals of improving the health of Americans and lowering our nation's health care costs, we must address the underlying factors that influence our families' health - factors like the foods we eat and the conditions that exist in our homes, neighborhoods and workplaces," said HHS Secretary Kathleen Sebelius. "With Communities Putting Prevention to Work, we're creating evidence-based models that we can replicate on a large scale to permanently reduce the chronic diseases plaguing so many of our communities."

These Communities Putting Prevention to Work awards will provide communities with the resources to create healthy choices for residents, such as increasing availability of healthy foods and beverages, improving access to safe places for physical activity, discouraging tobacco use, and encouraging smoke-free environments.

Of the 11 new awards, ten are dedicated to obesity prevention efforts and one to tobacco cessation. Currently, seven of ten deaths among Americans each year are caused by chronic diseases such as heart disease, cancer, stroke and diabetes. These same chronic diseases account for more than 75% of our nation's health care spending. HHS also announced $10 million in additional funding for six communities - all of which were part of the original 44 Communities Putting Prevention to Work communities funded by the American Recovery and Reinvestment Act of 2009 (ARRA) - to provide mentoring to less experienced communities based on their previous success in specific policy strategies. Funding for the "Community Mentoring" initiative comes from ARRA.

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Sebelius announces $42.5 million for public health improvement programs through the Affordable Care Act

$399,836 to Georgia State Department of Community Health

U.S. Department of Health and Human Services Secretary Kathleen Sebelius today (September 20) announced that the Centers for Disease Control and Prevention (CDC) has awarded funding for 94 projects totaling $42.5 million to state, tribal, local and territorial health departments to improve their ability to provide public health services. This funding, made possible through the new Prevention and Public Health Fund created by the Affordable Care Act, will be distributed through cooperative agreements to 49 states, eight federally recognized tribes, Washington, D.C., nine large local health departments, five territories, and three Affiliated Pacific Island jurisdictions to maximize public health efforts.

“These funds will help health departments around the country to improve the quality and effectiveness of the critical health services that millions of Americans rely on every day,” said Secretary Sebelius. “Strengthening our public health system through better coordination and collaboration will help to deliver higher quality health care more efficiently.”

This new 5-year cooperative agreement program entitled, Strengthening Public Health Infrastructure for Improved Health Outcomes, will provide health departments with needed resources to make fundamental changes in their organizations and practices, so that they can improve the delivery of public health services including:

- Building and implementing capacity within health departments for evaluating the effectiveness of their organizations, practices, partnerships, programs and use of resources through performance management

- Expansion and training of public health staff and community leaders to conduct policy activities in key areas and to facilitate improvements in system efficiency

-Maximizing the public health system to improve networking, coordination, and cross-jurisdictional cooperation for the delivery of public health services to address resource sharing and improve health indicators

-Disseminating, implementing and evaluating public health’s best and most promising practices

- Building a national network of performance improvement managers that share best practices for improving the public health system.

“Investing in public health builds a foundation for a strong and healthy society and contributes to lowering the cost of health care. Investing in proven preventive services and strong policies helps us to avoid unnecessary costs later,” said CDC Director Thomas R. Frieden, M.D., M.P.H.

“These funds are a down payment on improving public health services across the nation,” said Dr. Judith A. Monroe, CDC’s deputy director for state, tribal, local and territorial support. “With these funds, we will help our nation’s public health departments work more effectively and efficiently to detect and respond to public health problems. This program will strengthen the nation’s public health system and our ability to improve the health and well being of all Americans.”

In response to the CDC’s original funding announcement Public Health Systems and Infrastructure projects in July 2010, CDC received more than 140 applications from health departments seeking funds through this cooperative agreement. For more information, please visit http://www.cdc.gov/ostlts

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Mayo-Led Researchers Discover Genetic Variants Modifying Breast Cancer Risk

Individuals with disrupting mutations in the BRCA1 gene are known to be at substantially increased risk of breast cancer throughout their lives. Now, discoveries from an international research team led by Mayo Clinic researchers show that some of those persons may possess additional genetic variants that modify their risk. These new findings enhancing individualized medicine appear in the current Nature Genetics.

"These findings should be useful in helping determine individual risk for breast cancer in BRCA1 carriers," says Fergus Couch, Ph.D., Mayo investigator and senior author of the study. "It also provides insights into hormone-receptor-negative breast cancer in the general population."

Genetic mutations in the BRCA1 gene give carriers of these mutations an increased risk for developing breast cancer. To determine if any genetic variations would modify or alter this risk among large populations of the mutation carriers, the researchers conducted genome-wide association studies (GWAS) that ultimately spanned 20 research centers in 11 different countries.

They first studied 550,000 genetic alterations from across the human genome in 1,193 carriers of BRCA1 mutations under age 40 who had invasive breast cancer and compared the alterations to those in 1,190 BRCA1 carriers of similar age without breast cancer. The 96 single nucleotide polymorphisms (SNPs) discovered were subsequently studied in a larger sample population of roughly 3,000 BRCA1 carriers with breast cancer and 3,000 carriers without cancer. Researchers found five SNPs associated with breast cancer risk in a region of chromosome 19p13.

Further studies of those SNPs in 6,800 breast cancer patients without BRCA1 mutations showed associations with estrogen-receptor-negative disease, meaning cancer in which tumors don't possess estrogen receptors. In another GWAS involving 2,300 patients, the five SNPs also were associated with triple-negative breast cancer, an aggressive form of the disease accounting for about 12 percent of all breast cancer. Triple-negative tumors don't express genes for estrogen or progesterone receptors or Her2/neu. The researchers also found that these SNPs were not related to risk for ovarian cancer in BRCA1 mutations carriers.

By locating these risk-modifying SNPs, the researchers have provided a target for better understanding the mechanisms behind the development of breast cancer. Furthermore, when combined with other risk-modifying SNPs that remain to be identified in ongoing studies by this group, it may be possible to identify certain BRCA1 carriers who are at lower risk of cancer and, also, carriers at particularly elevated risk of cancer who may decide to change their approach to cancer prevention.

Support for the research came from the Breast Cancer Research Foundation, Susan G. Komen for the Cure, the National Institutes of Health, and Cancer Research UK. In addition to first author Antonis Antoniou, Ph.D., of Cambridge University, over 180 individuals and several consortia contributed to the research and are co-authors.
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Infant/Toddler Head-Circumference Charts May Misdiagnose Patients, Children's Hospital Study Finds

/PRNewswire/ -- The most common charts used by pediatricians to measure head growth in infants and toddlers may be inaccurate, potentially leading to delayed diagnoses, unnecessary tests, and parental worry, according to new research from The Children's Hospital of Philadelphia.

The study, which appears online today in the journal Pediatrics, is the first study to evaluate the validity of these head-circumference curves in the U.S. primary care population.

Head-circumference growth curves are used by pediatricians millions of times annually to identify children who may need extra follow-up or testing because of a large head, also called macrocephaly, or a rapidly growing head. Many children with macrocephaly or a rapidly growing head are healthy, but in some children these findings signify a problem.

"The study was done because primary care doctors were concerned that the curves weren't working well for our patients," said study leader Carrie Daymont, M.D., a pediatric researcher formerly at The Children's Hospital of Philadelphia.

The researchers used the electronic health records of more than 75,000 infants in the Children's Hospital primary care network between August 2001 and January 2008. They compared the most widely used charts with actual measurements and found that the most commonly used chart would lead to a diagnosis of macrocephaly, defined as a head circumference above the 95th percentile for age, in 2.5 times more one-year-olds than expected.

The American Academy of Pediatrics recommends that all children have head-circumference measurements done at each "well child" visit until the age of two. Doctors in the U.S. plot each measurement on the growth chart from The Centers for Disease Control and Prevention (CDC). The World Health Organization (WHO) made charts in 2006 that are used in many countries.

Neither the CDC or the WHO charts worked well in the study population, the researchers said. A chart made in 1977 by the National Center for Health Statistics (NCHS) did work well in the study population, classifying 5 percent of children above the 95th percentile. The NCHS growth chart was replaced by the CDC growth chart in 2000.

When using the CDC curves, the percentage of children diagnosed with macrocephaly changes with age. One-fifth of the expected number of one-month olds and 2.5 times the expected number of one-year-olds were classified as having macrocephaly, or being above the 95th percentile. Many of these older infants above the 95th percentile may have received unnecessary follow-up tests and specialty referrals, and their parents may have been unnecessarily worried, the researchers said.

"We were noticing that we had a larger-than-expected number of children labeled as having large and rapidly growing head circumferences," Daymont said.

Using the CDC curves may cause a delay in diagnosis in babies under two months old with diseases causing large heads, and may cause children 6 months to 3 years to be labeled as having large or rapidly growing heads, when in fact they are healthy and have a typical head size, Daymont said. Use of the WHO curves would cause an excess of children to be labeled as having large heads at all ages. The researchers at Children's Hospital used the data from this study to develop a new growth curve.

"More research is also needed to determine how doctors can use head circumference growth curves to identify children with problems without causing unnecessary worry to parents of healthy children," said David Rubin, M.D. , M.S.C.E., a pediatric researcher at Children's Hospital and a senior author on the study. "We are currently working on research related to this question."

The team at Children's Hospital is currently evaluating other sources of data to see if the new head-circumference growth curves work in other populations.

Other study authors are Chris Feudtner, M.D., M.P.H., Ph.D., of Children's Hospital and Wei-Ting Hwang, Ph.D., of the Center for Clinical Epidemiology and Biostatistics at The University of Pennsylvania.

"Head-Circumference Distribution in Large Primary Care Network Differs from CDC and WHO Curves," Pediatrics, published online Sept. 20, 2010. http://www.pediatrics.org.

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HHS awards $130 million to boost health professions workforce

Georgia to receive over $2.6 million in grants

HHS Secretary Kathleen Sebelius today announced $130.8 million in grants to strengthen and expand the health professions workforce. Six areas are targeted: primary care workforce training, oral health workforce training, equipment to enhance training across the health professions, loan repayments for health professionals, health careers opportunity programs for disadvantaged students, and patient navigator outreach and chronic disease prevention in health disparity populations. The grants include $88.7 million in funding from the American Recovery and Reinvestment Act of 2009.

"An adequate health care workforce is the linchpin for reforming our health care system to ensure greater access, improve the quality of health care and cut overall costs in the long term," said Secretary Sebelius. "Today's awards not only will provide more training opportunities for people interested in a health professions career, but also will support equipment purchases and faculty development to expand and enhance the quality of training."

"With an aging and increasingly diverse population, we need to prepare our health professionals to meet the challenges of providing health care in the twenty-first century," noted Mary K. Wakefield, Ph.D., R.N., administrator of HHS' Health Resources and Services Administration (HRSA), which oversees the programs. "This includes ensuring diversity in the workforce, and that well-trained professionals practice in areas of severe need."

Expanding the Primary Care Workforce

Training Programs in Primary Care - $42.1 million ($31.5 million Recovery Act)
Grants will support family medicine, general internal medicine, and general pediatrics programs, including curriculum development, faculty development, didactic and community-based education, and training in underserved areas for primary care residents, pre-doctoral students, interdisciplinary and inter-professional graduate students, and physician assistant students.

Oral Health - $23.9 million ($6.7 million Recovery Act)
Funding will target workforce development programs for pre- and post-doctoral training for dental residents; dental faculty; loan repayment for faculty who teach primary care dentistry; and training for practicing dentists, or other approved dental trainees in general, pediatric, and public health dentistry and dental hygiene programs. Funding also includes $4.3 million to states to provide 9 new grantees the opportunity to address their states' unique oral health workforce needs in underserved urban and rural areas. Grants are designed to strengthen the delivery of multidisciplinary comprehensive oral health care, integral to quality primary care.

Equipment for State-of-the-Art Learning

Equipment to Enhance Training for Health Professionals - $50.5 million (Recovery Act)
Funding from the Recovery Act will provide 208 awards to assist with purchasing equipment for training current and future health professionals across disciplines at the undergraduate, graduate, and post- graduate education levels. Awardees include academic health centers, area health education centers, centers of excellence, and other educational institutions that serve underserved and uninsured patient populations, rural communities, and minorities. Equipment purchases will expand current training capabilities by replacing outdated equipment and technology or purchasing equipment that previously was unaffordable.

Types of equipment to be purchased include e-learning tools such as video, audio and interactive learning systems that provide more distance learning opportunities; human patient simulators that give students the opportunity to improve clinical judgment and critical thinking; and mobile dental vans that provide training in delivering care to diverse segments of the population while bringing basic routine dental treatments to families unable to access care. It is estimated that more than 200,000 individuals will be trained, including health professions students, faculty and clinical practice providers.

Priming the Workforce Pipeline

Loan Repayment ($8.3 million) - 29 grants will be made to states that provide matching funds to assist health professionals in repaying their educational loans. In return, these individuals agree to provide full-time primary health services in federal health professional shortage areas for a minimum of two years. Health professionals eligible to receive funding include physicians, dentists, nurse practitioners, nurse midwives, physician assistants, psychologists, and social workers.

Health Careers Opportunity Program ($2.1 million) - Three grantees will receive funding to increase diversity in the health professions by developing an educational pipeline to enhance the academic performance of economically and educationally disadvantaged students, and prepare them for careers in the health professions. Eligible applicants included schools of medicine, public health, dentistry, pharmacy, allied health, and graduate programs in behavioral or mental health.

Patient Navigator ($3.8 million) - Funding will support 10 grants for patient navigator outreach and chronic disease prevention programs to develop and operate patient navigator services that improve health care outcomes for individuals with cancer or other chronic diseases, with specific emphasis on health disparity populations. Grant recipients recruit, train, and employ patient navigators with direct knowledge of the communities they serve to coordinate care for patients with chronic illnesses. Eligible applicants include federally qualified health centers, health facilities operated through Indian Health Service contracts, hospitals, rural health clinics, and academic health centers.

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FDA approves devices for heart failure patients

The U.S. Food and Drug Administration today approved a new indication for three cardiac resynchronization therapy defibrillators (CRT-D) used to treat certain heart failure patients. The new use is for patients with an abnormality known as left bundle branch block, which occurs when there is delayed activation and contraction of the left ventricle. The three devices, all manufactured by Boston Scientific Corp., are intended to treat patients with left bundle branch block who have either mild heart failure or heart failure with no apparent symptoms.

The CRT-D device combines two functions. As an implantable cardioverter defibrillator (ICD) it senses dangerous abnormal heart rhythms and then attempts to shock the heart back into a normal rhythm. As cardiac resynchronization therapy, it generates small electrical impulses to coordinate the beating of the left and right ventricles so that they work together more effectively to pump blood throughout the body.

CRT-Ds are to be used as an addition to, not a replacement for, heart failure drug therapy.

“This approval allows heart failure patients with left bundle branch block to benefit from this therapy," said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “The FDA is pleased to safely make this new technology available for a greater number of heart failure patients."

The FDA based its approval on the results of the 1,820-patient Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) clinical study. The study which followed 1,820 patients for an average of nearly three years at 110 centers in the United States, Europe, Canada, and Israel. It compared CRT-D therapy to ICD-only therapy in specific heart failure patients to determine whether it reduced the risk of death and heart failure. In patients with left bundle branch block, who represented 70 percent of the study group, CRT-D showed a reduction in the risk of death and heart failure by 57 percent, as compared to ICD alone.

The rate of complications was considered to be acceptable by the FDA for this device, however, physicians should adequately inform patients about potential complications.

As a condition of FDA approval, Boston Scientific must conduct two post-approval studies. One study will evaluate complications and long-term mortality benefits of CRT-D in patients with left bundle branch block identified through the National Cardiovascular Data Registry. The other will follow patients from the original MADIT-CRT clinical study every six months for five years to assess long-term mortality benefits of CRT-D vs. ICD.

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Statement from CHPA on Today's FDA Advisory Committee Meeting on Dextromethorphan

/PRNewswire/ -- The Consumer Healthcare Products Association issued the following statement on the Drug Safety and Risk Management Advisory Committee's recommendation not to schedule over-the-counter (OTC) medicines containing dextromethorphan:

"Today's FDA advisory committee decision not to recommend scheduling OTC cough medicines containing dextromethorphan as a controlled substance reflects a sound balancing of the benefits of over-the-counter medicines containing dextromethorphan.

"Today, 40 million American households turn to dextromethorphan-containing OTC medicines each year to relieve their cough symptoms. More common than heartburn and severe headaches, cough burdens the sufferer, families, and society (as a very rapid way to spread virus). Because of cough's widespread prevalence and effects, it's vital for people to have OTC access to safe and effective self-treatment. Dextromethorphan is in nearly 90 percent of OTC cough suppressants sold today. We agree that dextromethorphan should not be scheduled as a controlled substance.

"We do, however, recognize the need for continued education to keep any abuse levels low. We also have long called for federal legislation that would limit purchases of bulk quantities of dextromethorphan to manufacturers who are registered with FDA. We believe that a statutory ban on sales of dextromethorphan medicines to those under 18 would limit abuse. We also believe legislation must be matched with targeted research-based education, which has been shown to be effective in reducing substance abuse.

"Research over the past 35 years clearly shows that targeted educational interventions focusing on increased parental awareness and increased perceptions of the risks and social disapproval are the most effective abuse-reduction strategies. Since 2003, we have had educational programs focusing on the dangers of misuse of over-the-counter medicines, including those containing dextromethorphan. We will continue to expand upon these programs through our comprehensive Abuse Mitigation Plan that targets the key risk factors leading to abuse, along with limiting the various points where teens are accessing these medicines.

"It is our hope that FDA will follow the advisory committee's guidance and weigh the important public benefit of continued over-the-counter access to these medicines in making its final recommendation."

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FDA Approves New Drug for Gout

/PRNewswire/ -- The U.S. Food and Drug Administration today approved Krystexxa (pegloticase) to treat the painful condition known as gout in adults who do not respond to or who cannot tolerate conventional therapy.

Gout occurs due to an excess of the bodily waste uric acid, which is eventually deposited as needle-like crystals in the joints or in soft tissue. These crystals can cause intermittent swelling, redness, heat, pain and stiffness in the joints.

Gout is strongly associated with obesity, high blood pressure, high cholesterol and diabetes, and occurs more often in men, in women after menopause, and in people with kidney disease.

"About 3 percent of the three million adults who suffer from gout are not helped by conventional therapy. This new drug offers an important new option for them," said Badrul Chowdhury, M.D., director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA's Center for Drug Evaluation and Research.

For patients with gout, the conventional therapy is to receive drugs that lower the amount of uric acid in the blood, as, for example, the xanthine oxidase inhibitors Zyloprim (allopurinol) and Uloric (febuxostat). Krystexxa is an enzyme that lowers uric acid levels by metabolizing it into a harmless chemical that is excreted in the urine. The drug is administered to patients every two weeks as an intravenous infusion.

Two six-month clinical trials of 212 total patients demonstrated that the drug lowered uric acid levels and reduced deposits of uric acid crystals in joints and soft tissue.

Since one out of every four patients in the clinical trials experienced a severe allergic reaction when receiving an infusion of Krystexxa, health care providers should dispense a corticosteroid and an antihistamine to their patients beforehand to minimize the risk of such a reaction. Other reactions during the clinical trials included gout flare, nausea, injection site bruising, irritation of the nasal passages, constipation, chest pain and vomiting.

Physicians are also being warned to be cautious about administering Krystexxa to patients with congestive heart failure because the drug was not studied in this patient population.

Krystexxa is being approved with a Risk Evaluation and Mitigation Strategy that includes a medication guide for patients and materials for healthcare providers to communicate the risk of severe infusion and allergic reactions.

Krystexxa is manufactured by Savient Pharmaceuticals Inc. of East Brunswick, N.J.

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New Study Finds Positive Return on Investment for States That Invest in Quit Smoking Treatments

/PRNewswire/ -- A new study released today by the American Lung Association, and conducted by researchers at Penn State University, finds that helping smokers quit not only saves lives but also offers favorable economic benefits to states. The study, titled Smoking Cessation: the Economic Benefits, provides a nationwide cost-benefit analysis that compares the costs to society of smoking with the economic benefits of states providing cessation (quit-smoking) coverage. The study comes at an important time, as important cessation benefit provisions are being implemented at the federal and state levels as a result of healthcare reform legislation.

Each year, tobacco use kills 393,000 people in America, and this new study identifies significant and staggering costs directly attributable to death and disease caused by smoking. For example, the study finds that smoking results in costs to the U.S. economy of more than $301 billion. This includes workplace productivity losses of $67.5 billion, costs of premature death at $117 billion, and direct medical expenditures of $116 billion.

The study also calculates the combined medical and premature death costs and workplace productivity losses per pack of cigarettes. The nationwide average retail pack of cigarettes is $5.51. The costs and workplace productivity losses nationwide equal $18.05--more than 300 percent the average retail price of a cigarette pack.

"This study spells out in dollars and cents the great potential economic benefits to states of helping smokers quit. We urge the District of Columbia and all states to offer full coverage of clinically proven cessation treatments for smokers, which will not only save lives but also money," Charles D. Connor, President and CEO of the American Lung Association.

Smoking is the number one preventable cause of illness and death in the United States and surveys show that 70 percent of tobacco users want to quit. Quitting can often take several attempts before a smoker is successful. Using evidence-based treatments increases smokers' chances of quitting - but many smokers don't have access to or don't know about what kind of treatments are available to them.

In addition to identifying the staggering costs of smoking to the U.S. economy, this new study now provides state governments with compelling economic reasons to help smokers quit. For example, the study finds that if states were to invest in comprehensive smoking cessation benefits, each would receive, on average, a 26 percent return on investment. In other words, for every dollar spent on helping smokers quit, states will see on average a return of $1.26.

Some states (and the District of Columbia) would see a higher return than others. For example, the study finds that the District of Columbia would receive the highest return on its investment. For every dollar spent on smoking cessation treatments, it would see a return of $1.94. Other states with higher than average returns include the following: Louisiana ($1.47), Massachusetts ($1.43), Maine ($1.41), Ohio ($1.41) and North Dakota ($1.41). State specific data can be found at www.lungusa.org/cessationbenefits.

The study derives these economic benefits by considering lower medical costs due to fewer people smoking, increased productivity in the workplace and reduced absenteeism and premature death due to smoking.

Some of the highest rates of smoking are found among people enrolled in Medicaid, the joint federal and state health program for low-income people. The American Lung Association urges every state to provide all Medicaid recipients and state employees with comprehensive, easily accessible tobacco cessation benefits. A comprehensive cessation benefit includes all seven medications and three types of counseling recommended by the U.S. Public Health Service for tobacco cessation. Only six states now provide comprehensive coverage for Medicaid recipients: Indiana, Massachusetts, Minnesota, Nevada, Oregon and Pennsylvania.

The Lung Association also recommends that private insurance plans and employers offer comprehensive cessation coverage and encourages states to require them to cover these treatments. Only seven states have such requirements now: Colorado, Maryland, New Jersey, New Mexico, North Dakota, Oregon and Rhode Island.

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HHS Awards $31 million more for prevention and wellness projects

Funded by the Affordable Care Act of 2010

The U.S. Department of Health and Human Services (HHS) today announced $31 million for awards to ten communities in eight states and one award to a state health department to support public health efforts to reduce obesity and smoking, increase physical activity and improve nutrition.
The awards funded by the Prevention and Public Health Fund included in the Affordable Care Act are part of the HHS Communities Putting Prevention to Work (CPPW) program, a comprehensive prevention and wellness initiative administered by the Centers for Disease Control and Prevention.

"As I've seen throughout the year in my work with Let's Move!, prevention works when it comes to improving the health of our families," said First Lady Michelle Obama. "These critical investments will help more communities across America tackle serious health challenges like childhood obesity, while promoting physical activity and healthy eating."

Today's announcement follows the release in February and March 2010 of more than $491.8 million in Communities Putting Prevention to Work funds to states, U.S territories and communities. Those projects are supporting statewide and community based policy and environmental changes in nutrition, physical activity, tobacco control, expanded tobacco quit lines, and cessation media campaigns.

"To realize our goals of improving the health of Americans and lowering our nation's health care costs, we must address the underlying factors that influence our families' health - factors like the foods we eat and the conditions that exist in our homes, neighborhoods and workplaces," said HHS Secretary Kathleen Sebelius. "With Communities Putting Prevention to Work, we're creating evidence-based models that we can replicate on a large scale to permanently reduce the chronic diseases plaguing so many of our communities."

These Communities Putting Prevention to Work awards will provide communities with the resources to create healthy choices for residents, such as increasing availability of healthy foods and beverages, improving access to safe places for physical activity, discouraging tobacco use, and encouraging smoke-free environments. Of the 11 new awards, ten are dedicated to obesity prevention efforts and one to tobacco cessation.

Currently, seven of ten deaths among Americans each year are caused by chronic diseases such as heart disease, cancer, stroke and diabetes. These same chronic diseases account for more than 75% of our nation's health care spending.

HHS also announced $10 million in additional funding for six communities - all of which were part of the original 44 Communities Putting Prevention to Work communities funded by the American Recovery and Reinvestment Act of 2009 (ARRA) - to provide mentoring to less experienced communities based on their previous success in specific policy strategies. Funding for the "Community Mentoring" initiative comes from ARRA.

Awards:

Communities Putting Prevention to Work Community Initiative

. $3.0 Million to Alabama Department of Health: Mobile County, Alabama for tobacco prevention
. $2.3 Million to Arkansas Department of Health: City of North Little Rock, Arkansas for obesity prevention; and Independence County, Arkansas for obesity prevention
. $5.8 Million to Children's Memorial Hospital / City of Chicago, Illinois for obesity prevention
. $2.35 Million to DeKalb County Board of Health, Georgia for obesity prevention
. $3.7 Million to North Carolina Division of Public Health: Appalachian District Health Department, North Carolina for obesity prevention; and Pitt County, North Carolina for obesity prevention
. $4.85 Million to Pinellas County Health Department, Florida for obesity prevention
. $3.6 Million to Santa Clara County Public Health Department, California for obesity prevention
. $3.8 Million to Southern Nevada Health District, Nevada for obesity prevention

Note: The five small city/rural awards are administered through three state departments of health (Alabama, Arkansas, and North Carolina).

Communities Putting Prevention to Work States and Territories Competitive Special Policy and Environmental Change Initiative

. $1.6 Million to South Carolina Department of Health and Environmental Control for obesity prevention

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Gene Therapy Proves Effective in Treating Severe Heart Failure; Holds Potential to Drastically Reduce Healthcare Costs for Heart Failure Patients

/PRNewswire/ -- The 14th Annual Scientific Meeting of the Heart Failure Society of America (HFSA) will feature a discussion titled "Latest Developments in Stem Cell and Gene Therapy in Heart Failure" which includes a presentation by Dr. Roger Hajjar, Director of the Cardiovascular Research Institute, one of the 12 translational science institutes at The Mount Sinai Medical Center in New York. Dr. Hajjar's discussion will focus on the injection of a gene into patients with advanced heart failure to reverse the debilitating and life-threatening condition.

Over ten years, Dr. Hajjar and his team have validated the cardiac sarcoplasmic reticulum calcium ATPase pump, SERCA2a, as a target in heart failure and developed methodologies for cardiac-directed gene transfer. This work has led to the initiation and recent completion of phase 1 and phase 2 First-in-Man clinical trials of SERCA2a gene transfer in patients with advanced heart failure.

Patients treated with high dose therapy have shown 90 percent risk reduction for heart failure-related cardiovascular events such as significantly worsening health, the need for a transplant or cardiovascular device support, intravenous treatment or death.

"The patients receiving this gene therapy have shown marked improvements," said Dr. Hajjar. "Through our tests we've observed heart failure patients' quality of life improves greatly for significantly less cost than traditional therapies."

Patients treated with the gene therapy treatment may result in a large decrease in personal health care costs across their trial period. In nine months, individuals treated with the trial's placebo spent an average of $27,118 on health care, paying for expenses such as hospital stays, emergency medicine, and home care. Comparatively, in the same period of time, individuals treated with gene therapy spent an average of $329 on health care.

"Gene Therapy is a breakthrough in the treatment of heart failure patients that holds the potential to reverse the disease while also making treatment and recovery more affordable than ever," said Dr. Douglas Mann, HFSA President. "It is critical for the medical community to continue to integrate science and clinical medicine so biomedical research can improve patient care."

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AHIMA Files Response to HHS Privacy Rules

/PRNewswire/ -- The following statement was released today by Rita K. Bowen, President, AHIMA Board of Directors:

"While AHIMA (American Health Information Management Association ) continues to applaud federal government support for the ideal of protecting patients' health information rights, the proposed rule-making for HIPAA privacy, security and enforcement by HHS has a number of requirements that we do not believe the industry is ready to undertake; especially as it gears up for Meaningful Use. Today AHIMA is releasing its recommendations to the HHS Office of Civil Rights (OCR) that speak to the issues we believe are most critical to the patients of America, the healthcare industry and the best practice of health information management.

"As staunch supporters of patients' health information rights, AHIMA agrees the single most contentious issue in the proposed regulation is the ability of individuals to restrict the information held by their healthcare providers from being shared with their health plan. While AHIMA believes an individual's control over this data flow is valid, data flow restrictions in the HHS proposal creates unintended repercussions for data integrity, data processing and other elements within the current US reimbursement system.

"Many AHIMA members are engaged in providing patients' individual and aggregate data for a variety of approved uses. There is a continued discussion within the profession on how to best cover the costs of the retrieval, analysis and release of information within the context of the privacy and security regulations, patient restrictions; and the need to verify the requesting individual as a means of keeping released information available to a necessary minimum. Additionally, we remain concerned the charges permitted by states or HIPAA do not cover all costs and ultimately raise the cost of health care.

"AHIMA also questions the sale of patient health information when an organization is being absorbed by a second organization. The OCR's approach, while practical, raises the issue of whether consumers have the right to determine if their health information should be transferred with the ownership of a health organization.

"Finally, AHIMA feels strongly that the OCR needs to provide greater clarification regarding the definition of 'agents' as it relates to covered entities and who should be covered by HIPAA, including its hybrid organizations."

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ViiV Healthcare Awards Southern Initiative Grants to Reduce HIV Disparities Among African Americans and Latinos

/PRNewswire/ -- ViiV Healthcare today announced the grant awardees of the Positive Action Southern Initiative, focused on supporting African American and Latino populations in Alabama, Georgia, Louisiana, and Mississippi to help high-risk HIV/AIDS individuals and provide linkages to HIV/AIDS care and treatment adherence.

"The Positive Action Southern Initiative awards are being made at a critical time in the national fight against HIV. These funds are nothing short of life-saving. Community organizations are facing tremendous pressure to do more with less in this economic climate and the demands continue to grow, especially among African American and Latino communities in Southern states," stated A. Cornelius Baker, Senior Policy Advisor of the National Black Gay Men's Advocacy Coalition. "I am excited that ViiV is supporting such important initiatives that address disparities in HIV and support the goals of the National HIV/AIDS Strategy."

In the U.S., 1.1 million people are living with HIV/AIDS(i) and African Americans and Latinos account for a disproportionate share of new HIV infections (62 percent). In 2007, the Southern United States accounted for almost half (46 percent) of new AIDS cases and has the greatest number of people estimated to be living with AIDS(i).

The Southern Initiative is part of ViiV Healthcare's Positive Action, a collaborative, community-focused program designed to address gaps in services or programs that support care and treatment adherence among individuals living with HIV/AIDS. ViiV Healthcare has committed $850,000 this year to support Positive Action Community Grants in the U.S. and $500,000 over the next two years to support the Southern Initiative grantees. ViiV Healthcare is hosting the grant recipients at this week's United States Conference on AIDS, where they will enable the development of a Regional HIV Network to share best practices and resources to advance the fight against HIV.

ViiV Healthcare has selected a total of seven organizations to receive grants over the next two years to support their programs specifically focused on reducing disparities in HIV/AIDS linkages to care and treatment among African American and Latinos in Alabama, Georgia, Louisiana, and Mississippi. The following organizations were selected as grant awardees:

-- Aid to Inmate Moms, based in Montgomery, AL, will continue its
collaboration with local AIDS Service Organizations to support
HIV-positive incarcerated women with critical counseling services.
-- Atlanta Harm Reduction Coalition, based in Atlanta, GA, will provide
additional case management services for HIV-positive individuals who
are re-entering the community from the state's jails and prisons.
-- Family Service of Greater Baton Rouge, based in Baton Rouge, LA, will
expand its Corrections Referral and Case Management program to serve
more HIV-positive individuals exiting the corrections system and to
successfully connect them with quality care.
-- Grace House in Jackson, MS, will expand its CLEAR (Choosing Life:
Empowerment, Action, Results) program to serve more HIV-positive
clients and provide services aimed at improving treatment adherence,
cognitive behavior, and prevention activities.
-- Positive Impact, based in Atlanta, GA, will provide additional
intensive case management services for HIV-positive Latino individuals
and HIV-positive African American women.
-- Southwest Louisiana AIDS Council based in Lake Charles, LA, will
expand its medical systems navigation program, FAST (Find, Assess,
Stabilize, and Treat), to serve additional newly-diagnosed persons,
previously incarcerated persons, and those who have not successfully
remained in care.
-- Union Mission's J.C. Lewis Primary Health Care Center, based in
Savannah, GA, will enhance its Healthy Living education and adherence
program for homeless and low-income persons living with HIV/AIDS.



"ViiV Healthcare received a great response from grassroots organizations in the South demonstrating the need is great. The awardees' proposed programs are unique and provide promise towards alleviating HIV in the United States among communities most impacted by the disease. ViiV Healthcare puts the interests of those affected by HIV at the center of everything we do. We are honored to support communities through these grants. It is our hope the initiatives will positively impact those areas in critical need of HIV/AIDS resources," said Bill Collier, Head of North America, ViiV Healthcare.

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FDA Approves Pediatric Use of Chemical Poisoning Treatment

/PRNewswire/ -- The U.S. Food and Drug Administration has approved the pediatric use of Protopam Chloride (pralidoxime chloride), a drug used to treat poisoning by organophosphate pesticides and chemicals (e.g., nerve agents). The drug is approved to be administered either by intravenous (IV) or intramuscular (IM) injections.

"We know this drug has been widely used for many years to treat poisoning in pediatric patients in emergency situations," said Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "Improving the drug's label with new dosing information for children will give health care professionals better guidance on how to use this drug safely and effectively."

"It can be difficult to use IV drugs in children, particularly in emergency situations, so having the new option of IM injection may help health care professionals use this medicine quickly and accurately," said Dianne Murphy, M.D., director of the FDA's Office of Pediatric Therapeutics.

Organophosphate pesticides are typically used in the farm setting and by professional exterminators. A person poisoned with organophosphate pesticides or chemicals (e.g., nerve agents) can have mild symptoms, such as a runny nose, teary eyes, or vomiting, to more serious symptoms such as difficulty breathing, weakness and convulsions. When chemical poisoning is suspected, medical attention should be sought immediately and the local poison control center should be contacted by dialing 800-222-1222, nationwide.

Protopam Chloride was approved by the FDA in 1964 to treat various types of pesticide and chemical poisoning in adults. The drug works as an antidote to pesticides and chemicals of the organophosphate class by slowing the attachment of the chemical to nerve endings.

Adverse reactions that have been reported in pediatric and adult use of the drug include: blurred vision, double vision, dizziness, headache, drowsiness, nausea, difficulty breathing, increased heart rate and increased blood pressure.

Protopam Chloride is made by Baxter Healthcare Corp., Deerfield, Ill.

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Flu Shots Available from University Health Services at Clayton State, Starting Sept. 8

Starting on Wednesday, Sept. 8, from 10 a.m. to 4:15 p.m., Clayton State University’s University Health Services (UHS) will be offering flu shots to students, faculty, staff and the community on a first-come, first-serve basis.

“With more than 300 shots available, there is plenty to go around,” says UHS Director Dr. Julia Spinolo.

The 2010/11 seasonal vaccine includes H1N1 and is being offered to anyone six months and older. Only the inactivated vaccine will be offered. The vaccinations will be given in UHS, room 211 of the Clayton State Student Center, during the following hours: Monday, 10 a.m. to 6:15 p.m.; Tuesday through Thursday, 10 a.m. to 4:15 p.m.; and Friday, 10 a.m. to 1 p.m. Types of payment accepted are cash, debit/credit cards and Laker Cards.

UHS typically serves only the Clayton State campus -- except during flu season when the flu vaccine is available. Costs for vaccinations are $20 for the general public and $15 for Clayton State students, faculty, and staff with a valid Laker Card. Please call University Health Services at (678) 466-4940 to make an appointment for a flu shot, although appointments are not necessary.

UHS will have the 2010 Flu Information Sheets and Consent Forms on the UHS website; http://nursing.clayton.edu/uhs/default.htm, so that individuals wishing to get a flu shot can print them out and fill then out beforehand to reduce their waiting time.

University Health Services, under the direction of Spinolo, offers a wide array of services for the Clayton State community including assessments and treatment for acute primary care health care issues, immunizations, minor illness and injury management, laboratory tests, and health education. UHS also maintains all student health records. Dr. D. Ann Travis Honeycutt, family practice physician, is on site to provide professional medical assessments and services.

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

Natural system for eliminating salt may point to new antihypertensives

A study of the body system that deals with Americans’ love affair with salt may yield more insight into why so many end up hypertensive and how to better treat them.

A team of scientists from the Medical College of Georgia, the University of Utah and the University of Texas at San Antonio is looking at how the kidneys know you’ve eaten too much salt and what they do to eliminate it. The work is funded by a $11.2 million National Institutes of Health Program Project grant.

Their focus, endothelin, ironically has a bad rep as a “death peptide” because of its shared ancestry with the Israeli burrowing asp that can shut down coronary arteries with one bite.

But the powerful protein produced by the kidney takes direction – good or bad – from its receptors, according to Dr. David Pollock, renal physiologist at MCG’s Vascular Biology Center and director of the program project.

“It’s like politics: all things are local,” said Pollock.  In this case the upright guy tends to be the B receptor, which aids sodium excretion while its roguish sibling A receptor – the same one that shuts down the coronary arteries of asp victims – blocks it. When all goes well, the balancing act regulates the sodium level with the kidneys producing more endothelin and B receptors to eliminate the excess.

However in hypertension models, the B receptor doesn’t work so well, although exactly why is still unclear. “It’s this balance between A’s and B’s that is critical,” Pollock said. “If your balance becomes unbalanced you will have salt-sensitive hypertension.”  That’s why he is looking at the pathways that become activated on a high-salt diet and just what the A receptor is up to.

He and his colleagues are studying rats deficient in B receptors; they are a slightly hypertensive on a regular diet and very hypertensive on a high-salt diet.  More circuitously, the researchers also infused angiotensin, a powerful blood vessel constrictor, into rats causing similar dysfunction of the B receptors.

“We also think without the B receptor function, your A’s go a little bit crazy,” Pollock said. Not only do the A’s constrict, they promote inflammation, which can further damage blood vessels. In fact, a high-salt diet can cause even B receptors to behave badly, said Dr. Jennifer Pollock, MCG biochemist and a project leader.

Across the country, Dr. Donald Kohan, nephrologist and physiologist at the University of Utah, wants to figure out what prompts the kidneys to make more endothelin in the face of a high-salt diet. He is studying kidney cells to examine how endothelin production changes and ideally learn why. The goal, again, is drug therapies to inspire this natural phenomenon.

The results when A receptors go unchecked include stiff, tortuous blood vessels; a thick boggy pumping chamber in the heart; and other major organ damage that includes the kidney.

“The consequences are measurable targets,” said Dr. Edward Inscho, MCG physiologist and a project leader, noting that treatments are available but “preventing it from occurring is something we are not very good at yet.”

To help put the pieces together, Inscho is focusing on how blood vessels that feed directly into kidney filters react to a high-salt diet. Blood, containing salt, continuously flows through the kidneys. The researchers have seen that excess salt increases B receptor expression, which should help the kidneys filter more sodium then get rid of it.

“If you filter more, you have more salt available for excretion,” Inscho said. He wants to know what’s happening with A and B receptors inside the tiny vasculature of the kidneys. He’s using B-deficient rats and drugs that block either receptor to get a better idea about both. The idea is to figure out not just how they normally work but how the system becomes dysfunctional in hypertension.  “I think we are beginning to understand how the B receptor may factor into some other regulatory systems the kidney may use to control filtration,” he said.

Noted Jennifer Pollock, “Your kidneys in theory should be able to lower your blood pressure but because people do remain hypertensive, that means there must a problem with your kidneys as well.” She suspects that endothelin activates production of nitric oxide when it hits the B receptor. Nitric oxide, which dilates blood vessels, prompts the sodium channels in kidney tubules to fold inward.

“The salt can’t get in and so it gets excreted,” Jennifer Pollock said. “We are connecting the dots now.” If they are correct, they have found a new mechanism for controlling salt excretion that is a natural drug target. Since it’s difficult to enhance nitric oxide, it likely will be necessary to find another cue to prompt sodium channels to fold up their tents. She developed a mouse lacking nitric oxide synthase, which prompts nitric oxide production, to help pursue the theory.

Co-investigator Dr. James Stockand in Texas is investigating mechanisms for how endothelin affects transport of sodium in and out of the cell, focusing on proteins known as ion channels. Dr. Jennifer Sullivan, pharmacologist/physiologist at MCG’s Vascular Biology Center, is providing support and expertise with the numerous animal models needed for the grant.

“The future of pharmaceutical therapies is going to be the right balance of different drugs,” said David Pollock.  “Most people with high blood pressure are also taking cholesterol medicine and possibly other drugs. So the future has to be what is the right formula for you and your situation.”

The scientists hope their studies will point the way to these new, targeted options.

By Toni Baker
Medical College of GA

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