Wednesday, September 30, 2009

Where Surgery Was the Standard, Casting May Be the Future

/PRNewswire/ -- When parents are told their babies' scoliosis needs treatment, they often try bracing first. If that fails, their child will need surgery to place metal rods in their backs with spinal fusion later on. These children face the risk of complications from the surgery and their backs and chests may be stiff for life.

New research from the University of Rochester Medical Center (URMC) ( challenges that treatment convention and may lead doctors to choose to tweak an old technology - casting - over using high-tech implantable devices. Casting has fewer, and less serious, potential complications, and it requires no surgery. In fact, with the right training and equipment, the specialized, series of casts can be done as outpatient procedures.

"Best of all, we can cure some children with progressive infantile scoliosis, something we can't do with surgery and devices," said James O. Sanders, M.D., chief of Pediatric Orthopaedics at the URMC's Golisano Children's Hospital and author of the research published in this month's Journal of Pediatric Orthopedics. "If we cast these children before their curvatures become severe and before they turn 2, our chances of avoiding surgery and potentially curing them are much better."

The study followed 55 patients with progressive infantile scoliosis (or early-onset scoliosis) a rare and potentially fatal form of spinal curvature, at Shriners Hospitals for Children in Erie, Pa., Salt Lake City and Chicago. Pediatric orthopaedic specialists used a method of casting, called EDF (for extension, derotation and flexion) that capitalizes on children's rapid growth to untwist and un-curve their spines over time. The method uses a specialized table and casts with strategically placed holes. Sanders and URMC colleague Paul Rubery, M.D., an orthopaedic surgeon, are two of only a handful of surgeons nationwide who use this specialized method with the goal of curing, not just delaying surgery.

Children are given anesthesia and ventilated during the casting because the pressure on the chest during the procedure can make breathing difficult. The cast may extend over the shoulders like a tank-top and down to the pelvis, but large holes are left open between to relieve pressure on the chest and abdomen while preventing the ribs from rotating. The entire procedure can take less than an hour. Depending on the child's age and severity of the curvature, the series of casts (removed and refitted every eight to 12 weeks) could be completed in about two years.

Although the casts can be restrictive and cause some trouble with mobility, initially, Sanders said parents are almost always surprised by how quickly their children adapt and how little having a cast changes their lives. Children can't swim or be immersed in a bath, but they are otherwise unrestricted in their activities.

Current treatments, such as the vertical expandable prosthetic titanium rib (VEPTR), which are attached to the inside of the ribs and adjusted over time, and growing rods, which are inserted near the spine and lengthened over time, are aimed at delaying spinal fusion. They are not meant to be a cure for the disease, and they present a whole host of potential complications, such as infection, pulling loose and causing stiffness in the chest and back.

"Casting remains the only method which can cure some of these curves," Sanders said.

But casting doesn't cure all curvatures and some children may still require growing rods of the VEPTR. Among children in this study a little more than 10 percent saw their curves worsen and they needed surgery. Sanders said his future research will focus on finding the best treatment options for these children, for older children and for those with large curvatures.

Fayette Front Page
Georgia Front Page

Secretary Sebelius Awards $40 Million to States to Find, Enroll Children in CHIP, Medicaid

Georgia grantees are West End Medical Centers Inc and Medical College of Georgia Research Institute.

HHS Secretary Kathleen Sebelius today announced $40 million in grants to 69 grantees in 41 states and the District of Columbia to help them find and enroll children who are uninsured but eligible for either Medicaid or the Children's Health Insurance Program (CHIP).

"Today's awards will help fulfill President Obama's pledge to assure the health and well-being of our nation's children," said Secretary Sebelius. "With millions of Americans either out of work or otherwise struggling to make ends meet during this recession, there is an even greater urgency to bring steady, reliable health care to children in these families who may have lost their coverage."

Recognizing that millions of children are eligible for Medicaid or CHIP, but are therefore needlessly uninsured, the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA) set aside $100 million for fiscal years 2009-2013 expressly to help find and enroll eligible children. Of the total outreach amount, $80 million will be given to states and other organizations, $10 million to Tribal organizations and $10 million for a national outreach effort. Today's awards are for a two year period ending Dec. 31, 2011, which will then be followed by a
second round of $40 million in new grants.

As called for in CHIPRA, grants were awarded to applicants whose outreach, enrollment and retention efforts will target geographic areas with high rates of eligible but uninsured children, particularly those with racial and ethnic minority groups who are uninsured at higher than-average rates. For example, 20 percent of the projects to be funded will target Hispanic children, with an emphasis on Hispanic teens, and 11 percent will focus on homeless children and seven percent will be aimed at Native American/Alaska Native children.

The vast majority of grantees will be using multiple, community-based approaches. One grantee in Missouri, for example, will work with a consortium of 35 churches in low-income, minority communities. Those parishioners will go door-to-door to locate potentially eligible children and then help those families apply for CHIP or Medicaid coverage. Another grantee will place self-service kiosks in community centers and Native American Chapter Houses (community halls) where there will also be staff available to help with applications if needed. One state school system will track children who receive free or reduced cost lunches and, with the families' permission, share that information with state health programs, which will, in turn, mail applications for CHIP and Medicaid to those families. The state will also provide one-on-one-assistance with those applications.

The grant awards require that recipients be able to show actual increases in enrollment and retention of children already in the programs. Both CHIP and Medicaid state agencies are to report to the Centers for Medicare & Medicare Services (CMS) the number of new enrollees and those who retained coverage that are directly attributable to the grant activities. Grantees are also to report activities they believe were the most effective in finding, enrolling and maintaining
children in these benefit programs.

"No child in America should go without decent health care," said Cindy Mann, director of the Center for Medicaid and State Operations -- the group within CMS that will administer the grants. "With the funds we are awarding today we hope to reduce the number of children who do."

Fayette Front Page
Georgia Front Page

Tuesday, September 29, 2009

Secretary Sebelius Releases $27.8 Million in Recovery Act Funds to Expand the Use of Health Information Technology

HHS Secretary Kathleen Sebelius today announced awards totaling $27.8 million to health center-controlled networks and large multi-site health centers to implement electronic health records (EHR) and other health information technology (HIT) innovations. The funds are part of the $2 billion allotted to HHS' Health Resources and Services Administration (HRSA) under the American Recovery and Reinvestment Act of 2009 (ARRA) to expand health care services to low-income and uninsured individuals through its health center program.

"The increased use of health information technology is a key focus of our reform efforts because it will help to improve the safety and quality of health care generally while also cutting waste out of the system," Secretary Sebelius said.

"These funds to expand and upgrade electronic health records systems will make a huge difference for health centers struggling to provide health care to the growing number of people in need," said HRSA Administrator Mary Wakefield, Ph.D., R.N.

"Broad use of health information technology has the potential to improve health care quality, prevent medical errors, and increase the efficiency of care provision," added National Coordinator for Health Information Technology David Blumenthal, M.D., M.P.P. "This program supports the department's overall efforts to assist physicians and hospitals in adopting and becoming meaningful users of health information technology."

Eighteen grants totaling more than $22.6 million will support HER implementation. Grants totaling more than $2.6 million will help four grantees implement a variety of HIT innovations, including the creation of health information exchanges among different providers and the
incorporation of HIT at dental delivery sites. Another five grants totaling over $2.5 million will help health centers devise plans to use existing EHRs to improve patient health outcomes.

HRSA received $2 billion through the Recovery Act to expand health care services to low-income and uninsured individuals through its health center program. To date, more than $1.3 billion of these funds have been awarded to community-based organizations across the country.
HRSA-supported health centers treated 17 million patients in 2008, 40 percent of whom have no health insurance.

In addition, HRSA received $500 million in Recovery Act workforce funds --$300 million to expand the National Health Service Corps (NHSC) and another $200 million for other health care workforce programs. The NHSC funds will pay for student loan repayments for primary care medical, dental, and mental health clinicians who will practice for a minimum of two years in NHSC sites that treat underserved and uninsured people. Recently, awards totaling $33 million -- part of the $200 million total were announced to expand the training of health care professionals.

Fayette Front Page
Georgia Front Page

$120 Million for States Made Available as Part of Recovery Act Community Prevention and Wellness Initiative

The Department of Health and Human Services (HHS) today announced the release of $120 million in American Recovery and Reinvestment Act (ARRA) funds for prevention and wellness programs for U.S. states and territories, building on the recent announcement of the $373 million funding opportunity for communities and tribes around the country. In all, the comprehensive Communities Putting Prevention to Work initiative will make $650 million available for public health efforts to address obesity, increase physical activity, improve nutrition, and decrease smoking.

"Today's announcement is an important step toward a healthier America," said HHS Secretary Kathleen Sebelius. "We know that many chronic diseases are preventable, and the resources now available through the American Recovery and Reinvestment Act will assist states and
territories in the implementation of proven prevention and wellness programs that will save lives and lower health care costs for all Americans."

The $120 million in cooperative agreements will be awarded to states and territories for three components: statewide policy and environmental change, tobacco cessation through quitlines and media campaigns, and special initiatives to create health-promoting policies and environments. For the first two components, dollar amounts awarded to each state and territory will be based on population size and number of smokers. For the third component, states will apply for special funds through a competitive process based on the potential health impact of
the proposed activities. States and territories will have two years to complete their work. They will coordinate their efforts with other Communities Putting Prevention to Work initiatives in large cities, urban areas, small cities, rural areas, and tribal areas.

"State health departments are the backbone of the public health system and are uniquely positioned to support and leverage local efforts for chronic disease prevention and control," said Thomas Frieden, M.D., M.P.H., director of the Centers of Disease Control and Prevention (CDC).
"We expect that as a result of this nationwide project, most Americans will live in states with improved obesity-related and tobacco policies, we will make a national shift toward healthy environments, and we will increase significantly the number of people who are able to stop

Funded projects will emphasize state-level policy and environmental changes that will help communities and schools support healthy choices. For example, states will make use of their collective purchasing power to improve the selection and availability of healthy foods in public

"Chronic diseases are the leading cause of premature death in the country, account for spiraling health care costs, and cause disability and suffering for millions of Americans," said Janet Collins, Ph.D., director of CDC's National Center for Chronic Disease Prevention and Health Promotion. "The good news is that we can greatly reduce the toll of chronic disease by reducing just four risk factors -- tobacco use, physical inactivity, poor nutrition, and obesity. With these new funds, states and territories will work to improve the environments where their residents live, work, learn, and play so that healthy choices become the easy choice."

States and territories interested in applying for cooperative agreements can find more information at The application deadline is Nov. 24, 2009. Deadlines for additional projects that are part of the Communities Putting Prevention to Work initiative will be announced soon.

Fayette Front Page
Georgia Front Page

MAG Promoting Both Seasonal Flu and H1N1 Vaccinations

The Medical Association of Georgia (MAG) is reminding Georgians to get their annual flu vaccination, and the leading voice for physicians in the state also says that patients should get vaccinated for the H1N1 flu as soon as the vaccine is available.

“The seasonal flu vaccine is different from the H1N1 swine flu vaccine,” MAG president M. Todd Williamson, M.D., explains. “We’re talking about different viruses, so you need to get both vaccines to be fully protected this year.”

Dr. Williamson is encouraging patients to consult with their primary care physician to determine specifically when they should get vaccinated based on their age and health profile, as well as the availability of the vaccines. He says the seasonal flu and H1N1 vaccines can be administered on the same day, though he adds that it will still be several weeks before the H1N1 vaccine is available. He also points out that the H1N1 vaccination might require two injections for children nine and younger – pending the outcome of some clinical trials that are underway.

Dr. Williamson says the priority groups for the H1N1 vaccination include people six months to 24 years; people who live with or care for children younger than six months; pregnant women; health care and emergency medical services personnel; and people 25 to 64 who have health conditions associated with higher risk of medical complications from influenza.

Dr. Williamson explains that influenza is a contagious respiratory illness that is caused by influenza viruses. Most people who get the flu will recover in a matter of days, but he stresses that more serious complications like pneumonia can occur. Dr. Williamson says that the flu can include a variety of symptoms, including a high fever, headache, extreme tiredness, dry cough, sore throat, muscle aches, and stomach symptoms such as nausea, vomiting, and diarrhea.

Dr. Williamson says the flu shot and the nasal-spray vaccine are effective preventative measures when it comes to the seasonal flu.

In terms of advice, Dr. Williamson says, “The best ways to protect yourself from the flu are to wash your hands on a regular basis and to get your flu vaccinations from your primary care physician as part of your overall health maintenance program.”

Go to for additional information on the flu and flu vaccines. Go to for additional information on MAG.
Community News You Can Use
Follow us on Twitter: @gafrontpage

Friday, September 25, 2009

FDA Approves New Drug to Treat Psoriasis

The U.S. Food and Drug Administration today approved Stelara (ustekinumab), a biologic product for adults who have a moderate to severe form of psoriasis.

Plaque psoriasis is an immune system disorder that results in the rapid overproduction of skin cells. About 6 million people in the United States have plaque psoriasis which is characterized by thickened patches of inflamed, red skin, often covered with silvery scales.

"This approval provides an alternative treatment for people with plaque psoriasis, which can cause significant physical discomfort from pain and itching and result in poor self-image for people who are self-conscious about their appearance," said Julie Beitz, M.D., director, Office of Drug Evaluation III, in the FDA's Center for Drug Evaluation and Research.

Stelara is a monoclonal antibody, a laboratory-produced molecule that mimics the body's own antibodies that are produced as part of the immune system. The biologic treats psoriasis by blocking the action of two proteins which contribute to the overproduction of skin cells and inflammation.

Three studies of 2,266 patients evaluated the biologic's safety and effectiveness.

Since Stelara reduces the immune system's ability to fight infections, the product poses a risk of infection. Serious infections have been reported in patients receiving the product and some of them have lead to hospitalization. These infections were caused by viruses, fungi, or bacteria that have spread throughout the body. There may also be an increased risk of developing cancer.

The FDA is requiring a risk evaluation and mitigation strategy or REMS for Stelara that includes a communication plan targeted to healthcare providers and a medication guide for patients.

Stelara is manufactured by Centocor Ortho Biotech Inc. of Horsham, Pa., a wholly-owned subsidiary of Johnson & Johnson of New Brunswick, N.J.

Fayette Front Page
GeorgiaFront Page

FDA Approves First Drug for Treatment of Peripheral T-cell Lymphoma

The U.S. Food and Drug Administration has approved Folotyn (pralatrexate), the first treatment for a form of cancer known as Peripheral T-cell Lymphoma (PTCL), an often aggressive type of non-Hodgkins lymphoma.

Folotyn was approved under the FDA's accelerated approval process, which allows earlier approval of drugs that meet unmet medical needs. It is approved for patients who have relapsed, or have not responded well to other forms of chemotherapy.

Lymphoma is a cancer of the lymphatic system, which is part of the immune system. There are many types of lymphoma: one type is called Hodgkin's disease, and the rest are called non-Hodgkin's lymphomas. PTCL involves a type of white blood cell called T-cells. It is a relatively rare disease, occurring in less than 9,500 patients each year in the United States.

“Folotyn's approval demonstrates FDA's commitment to the rapid approval of drugs for rare and uncommon diseases,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research.

When studying a new drug, it can take time to learn whether a drug actually provides real improvement for patients – such as living longer or feeling better. This real improvement is known as a “clinical outcome.” In 1992 FDA instituted accelerated approvals which allow earlier approval of drugs based on a surrogate endpoint, a laboratory measurement or physical sign that can serve as an indirect or substitute measurement for clinical outcomes.

In the case of Folotyn, this meant the FDA approved the drug based on evidence that it reduces tumor size, because tumor shrinkage is considered reasonably likely to predict a clinical benefit such as extending the survival of cancer patients. Tumor shrinkage was seen on imaging scans in one study. Of 109 patients with PTCL in the trial, 27% had reduction in tumor size.

To speed the drug's availability, Folotyn was granted priority review, ensuring a review within six months rather than 10 months for a standard review. The drug was also designated as an orphan drug, which provides a variety of financial incentives to manufacturers that develop drugs for a small number of patients with a rare disorder.

The most common adverse reactions seen with Folotyn were irritation or sores of the mucous membranes such as the lips, the mouth, and the digestive tract, low platelet cell counts, low white blood cell counts, fever, nausea, and fatigue.

Folotyn can harm a fetus. Women should avoid becoming pregnant while being treated with this drug and pregnant women should be informed of the potential risk.

Patients treated with Folotyn should take folate and vitamin B12 supplements to reduce mucous membrane irritation.

Folotyn is manufactured by Allos Therapeutics Inc. of Westminster, Colo.

As a condition of accelerated approval, Allos will conduct studies to confirm that tumor shrinkage actually does predict that patients will live longer.

Fayette Front Page
Georgia Front Page

Thursday, September 24, 2009

Mayo Clinic Offers Perspective on Health Care Reform in New England Journal of Medicine

Mayo Clinic's perspective about how to get high-value health care is the focus of a Perspectives article in the New England Journal of Medicine, published online on Sept. 23, 2009, and in the print issue on Oct. 1, 2009.

"We must hold physicians and other providers accountable for providing high-value health care, defined in terms of both quality and cost," say Denis Cortese, M.D., president and CEO of Mayo Clinic and Jeff Korsmo, executive director of the Mayo Clinic Health Policy Center. To help achieve this goal, Cortese and Korsmo recommend basing a portion of Medicare payments to physicians and hospitals on value scores (measurable good outcomes, safety and service delivered at a lower cost), rewarding those providers who deliver high-value care and providing an incentive for others to improve.

In their essay, Dr. Cortese and Korsmo emphasize other key points to achieve true patient-centered health care reform including:

•Coordinating patient care services across people, functions, activities, sites, and time

•Reducing conflict of interest so physicians have less of a personal financial incentive to order unnecessary tests or procedures

"It should also be noted that researchers from the Dartmouth Institute for Health Policy and Clinical Practice have studied regional variation in health care quality and spending," says Korsmo. "They have documented that more care does not necessarily translate into better care. The research suggests that the United States could reduce health care costs by 30 percent or more if all regions practiced to the standard of the best-performing medical centers." The article can be viewed online.

Note: The New England Journal of Medicine also published a Mayo Clinic survey on physicians' beliefs and health care reform in the Sept. 14 issue. It can be viewed online.
Community News You Can Use
Follow us on Twitter: @gafrontpage

HIV Vaccine Study First to Show Some Effectiveness in Preventing HIV

/PRNewswire/ -- A Phase III clinical trial involving more than 16,000 adult volunteers in Thailand has demonstrated that an investigational HIV vaccine regimen was safe and modestly effective in preventing HIV infection. According to final results released by the trial sponsor, the U.S. Army Surgeon General, the prime boost combination of ALVAC(R) HIV and AIDSVAX(R) B/E lowered the rate of HIV infection by 31.2% compared with placebo.

"This is the first HIV vaccine candidate to successfully reduce the risk of HIV infection in humans. We are very excited and pleased with the outcome of this trial and congratulate all those who participated in it," said Lieutenant General Eric Schoomaker, Surgeon General, U.S. Army. "In addition, this study is an outstanding example of international and interagency collaboration involving many partners from the Thai and U.S. governments, private companies, non-profit organizations and volunteers."

In the final analysis, 74 placebo recipients became infected with HIV compared to 51 in the vaccine regimen arm. The efficacy result is statistically significant. The vaccine regimen had no effect on the amount of virus in the blood of volunteers who became HIV-infected during the study. More detailed results of this study will be presented next month at the AIDS Vaccine Conference, October 19 through 22 in Paris, France.

This finding has important implications for the design of future HIV vaccines and how they are tested, however additional research is needed to better understand how this vaccine regimen reduced the risk of HIV infection. Given the significant threat of HIV infection worldwide, an efficacious vaccine is urgently needed, as part of a broader prevention effort to help control the epidemic.

Collaborating partners on this study, referred to as RV144, include the U.S. Army, the Thai Ministry of Public Health, the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, sanofi pasteur, and Global Solutions for Infectious Diseases (GSID). The collaborators are already working with external experts to determine the need for additional studies on this vaccine regimen and consider the impact of this study's findings on other HIV vaccine candidates.

"These results show that development of a safe and effective preventive HIV vaccine is possible, " said Colonel Nelson Michael, Director, Division of Retrovirology, Walter Reed Army Institute of Research and Director, U.S. Military HIV Research Program (MHRP). "While these results are very encouraging, we recognize that further study is required to build upon these findings."

Colonel Jerome Kim, Deputy Director, Science, MHRP and the HIV vaccines product manager for the U.S. Army added that, "knowledge gained through this study will be used to accelerate future study design and testing as researchers continue the search for a safe, globally-effective HIV vaccine."

The U.S. Army would like to thank the more than 16,000 Thai men and women who consented to participate in this trial and the efforts of the Thai Ministry of Public Health and all collaborators for their hard work in achieving this important milestone.

RV144 Phase III Trial Background

RV144 tested a prime-boost vaccine strategy that combined two vaccines based on strains (subtypes) of HIV that circulate in Thailand. The first, or "prime" vaccine, known as ALVAC HIV, was developed by sanofi pasteur and the booster vaccine, AIDSVAX B/E, was originally developed by VaxGen and is now licensed to Global Solutions for Infectious Diseases.

The proof-of-concept study, which began in 2003, was designed to evaluate the vaccine strategy's ability to prevent HIV infection, as well as its ability to reduce the amount of HIV in the blood of those who became infected after they enrolled in the study.

More than 16,000 HIV-negative men and women between the ages of 18 to 30 participated in the study; half of these participants received the prime-boost vaccine regimen and half received placebo. Volunteers received vaccinations over the course of six-months and were followed for an additional three-years. Before agreeing to participate, all volunteers were informed of the potential risks associated with receiving the experimental vaccine regimen used in this study and consented to participate in the study. Volunteers continued to receive an HIV test every six-months for three-years following vaccination, in addition to counseling on how to prevent becoming infected with HIV.

For additional information, please visit

Fayette Front Page
Georgia Front Page

GSU researchers explore how pain in infancy can change pain sensitivity in adulthood

Scientists at Georgia State University have uncovered the mechanisms of how pain in infancy alters how the brain processes pain in adulthood.

Research is now indicating that infants who spent time in the neonatal intensive care unit (NICU) show altered pain sensitivity in adolescence. These results have profound implications and highlight the need for pre-emptive and post-operative pain medicine for newborn infants.

The study, published online in the journal Frontiers in Behavioral Neuroscience, sheds light on how the mechanisms of pain are altered after infant injury in a region of the brain called the periaqueductal gray, which is involved in the perception of pain.

Using Sprague-Dawley rats, Jamie LaPrairie, a graduate student in associate professor Anne Murphy’s laboratory, examined why the brief experience of pain at the time of birth permanently decreased pain sensitivity in adulthood.

Endogenous opioid peptides, such as beta-endorphin and enkephalin, function to inhibit pain. They’re also the ‘feel good’ substances that are released following high levels of exercise or love. Since these peptides are released following injury and act like morphine to dampen the experience of pain, LaPrairie and Murphy tested to see if the rats, who were injured at birth, had unusually high levels of endogenous opioids in adulthood.

To test this hypothesis, LaPrairie and Murphy gave adult animals that were injured at the time of birth a drug called naloxone. This drug blocks the actions of endogenous opioids. After animals received an injection of naloxone, they behaved just like an uninjured animal.

The scientists then focused on the periaqueductal gray region to see if inflammation at birth altered the natural opioid protein expression in this brain region. Using a variety of anatomical techniques, the investigators showed that animals that were injured at birth had endogenous opioid levels that were two times higher than normal.

While it’s beneficial to decrease pain sensitivity in some cases, it’s not good to be completely resilient to pain.

“Pain is a warning sign that something is wrong,” Murphy explained. “For example, if your hand is in water that's too hot, pain warns you to remove it before tissue damage occurs.”

Interestingly, while there is an increase in endorphin and enkephalin proteins in adults, there is also a big decrease in the availability of mu and delta opioid receptors. These receptors are necessary in order for pain medications, such as morphine, to work. This means that it takes more pain-relieving medications in order to provide relief as there are fewer available receptors in the brain. Studies in humans are reporting the same phenomenon.

The number of invasive procedures an infant experienced in the NICU is negatively correlated with how responsive the child is to morphine later in life; the more painful procedures an infant experienced, the less effective morphine is in alleviating pain.

The study by LaPrairie and Murphy has major implications for the treatment of infants in neonatal intensive care. On average, a prematurely born infant in a neonatal intensive care unit will experience 14 to 21 invasive procedures a day, including heel lance, insertion of intravenous lines, and intubation. All of these procedures are quite painful and are routinely conducted without prior analgesics or anesthetics.

“It’s imperative that pain be treated,” Murphy said. “We once assumed that a newborn infant is insensitive to pain, and this is clearly not the case. Even at that period of time, the central nervous system is able to respond to pain, and our studies show that the experience of pain completely changes the wiring of the brain in adulthood.”

The next steps in Murphy’s research include the study of how neonatal injury at birth alters stress responses, as well as the affects of infant injury on long-term learning and memory.

LaPrairie’s and Murphy’s work was supported by the National Institutes of Health, the Center for Behavioral neuroscience, a consortium of seven universities at Georgia State, and the Georgia State Brains and Behavior Program.

The article, titled “Neonatal injury alters adult pain sensitivity by increasing opioid tone in the periaqueductal gray,” appears in the September 2009 edition of journal Frontiers in Behavioral Neuroscience, Vol. 3, p. 1-11.

Fayette Front Page
Georgia Front Page

Wednesday, September 23, 2009

Read the Baucus Health Bill On-line

This is the full text of the "Baucus Bill", released on Sept. 16th, 2009. This page on OpenCongress is the only online copy of the bill, which was released as a "mark" from Senate Finance Committee chairman Sen. Max Baucus (D-MD). The original 223-page .pdf version, whose text constitutes the page below, can be downloaded here.

For summary and analysis of the Baucus version, visit our OpenCongress Blog post here. For more info on how Congressional data is Defective By Design and why you should have access to a more fully featured version of this bill text, visit here. To help spread the word, re-tweet from our Twitter page or join our Facebook group. We love feedback: Contact Us with questions or comments.

Tuesday, September 22, 2009

New Reconstruction Method Makes Speaking, Eating Possible After Tonsil Cancer Surgery, U-M Study Shows

/PRNewswire/ -- A new technique for reconstructing the palate after surgery for tonsil cancer maintained patients' ability to speak clearly and eat most foods, a new study shows.

The technique, developed at the University of Michigan Comprehensive Cancer Center, is described in the September Archives of Otolaryngology - Head & Neck Surgery.

"This is the area that triggers swallowing, that separates the mouth from the nasal cavity. It affects speech and eating - typically, patients have difficulty eating when they have this kind of tumor and undergo surgery. We can remove the cancer, but there are major quality of life issues," says study author Douglas Chepeha, M.D., M.S.P.H., associate professor of otolaryngology head and neck surgery and director of the microvascular program at the University of Michigan Health System.

Tonsil cancer develops in the back of the throat, which means surgery could include parts of the palate, the tongue and the jaw. Traditional reconstruction efforts have meant taking a large, round piece of tissue to plug the hole left when the tumor is removed. But this impairs the way the palate and tongue function, and does not restore the complex components of the throat that allow a person to speak and swallow.

With the new technique, surgeons first create a tube from the remaining palate by attaching the palate to the back part of the throat, next to where the tumor was removed. This tube separates the mouth from the nasal cavity and closes during swallowing, allowing patients to eat and speak.

Then the surgeons sew up the defect in the base of the tongue to separate the tongue from the rest of the reconstruction. This ensures that the tongue can move, which improves swallowing and speech. The shape of the remaining defect is irregular, so a template is designed for using transplanted tissue to fill in any other holes left by the surgery.

The tissue used in the reconstruction is a transplant from the arm or another part of the patient's own body. L-shaped patterns, similar to dress patterns, help the surgeon determine the size and shape of the skin tissue they'll remove for transplant.

The study followed 25 patients with tonsil cancer. Patients were grouped based on how much of their palate was removed during surgery: less than half or more than half. The patients were followed for an average of five years after the surgery.

Both groups reported few problems with speech. Patients who had more than half their palate removed were more limited in what they could eat and reported some restrictions to eating out in public. Emotional scores were high for both groups, suggesting overall satisfaction with their lives.

"In particular, patients who have less than half their palate removed do very well with this reconstruction. We're trying to make sure the remaining tongue and palate they have really work. Our goal is to get patients eating in public and back to work," Chepeha says.

The number of tonsil cancers diagnosed has increased in recent years due to HPV, or human papillomavirus, the virus that is also linked to cervical cancer.

Cancer statistics: 12,610 Americans will be diagnosed with throat cancer this year and 2,230 will die from the disease, according to the National Cancer Institute. The tonsils are one of three locations in which throat cancer occurs.

Additional authors: Assuntina Sacco; Vanessa Erickson, M.D.; Teresa Lyden; Marc Haxer; Jeffrey Moyer, M.D.; Theodoros Teknos, M.D.; Mark Prince, M.D.; Avraham Eisbruch, M.D.; Carol Bradford, M.D.; and Gregory Wolf, M.D.

Funding: No financial disclosures

Reference: Archives of Otolaryngology - Head & Neck Surgery, Vol. 135, No. 9, Sept. 2009

Fayette Front Page
Georgia Front Page

Sunday, September 20, 2009

Risky Behavior in Adolescents May Signal Mature Brain

A new study using brain imaging to study teen behavior indicates that adolescents who engage in dangerous activities have frontal white matter tracts that are more adult in form than their more conservative peers.

The brain goes through a course of maturation during adolescence and does not reach its adult form until the mid-twenties. A long-standing theory of adolescent behavior has assumed that this delayed brain maturation is the cause of impulsive and dangerous decisions in adolescence. The new study, using a new form of brain imaging, calls into question this theory.

In order to better understand the relationship between high risk-taking and the brain’s development, Emory University and Emory School of Medicine neuroscientists used a form of magnetic resonance imaging (MRI) called diffusion tensor imaging (DTI) to measure structural changes in white matter in the brain. The study’s findings are published in the Aug. 26, 2009 PLoS ONE.

“In the past, studies have focused on the pattern of gray matter density from childhood to early adulthood, says Gregory Berns, MD, PhD, principal investigator and professor of Psychiatry and Neuroeconomics at Emory University and director of the Center for Neuropolicy. “With new technology, we were able to develop the first study looking at how development of white matter relates to activities in the real world.”

Gray matter is the part of the brain made up of neurons, while white matter connects neurons to each other. As the brain matures, white matter becomes denser and more organized. Gray matter and white matter follow different trajectories. Both are important for understanding brain function.

The study enrolled 91adolescents ages 12 through 18 over a three-year period. Levels of engagement in dangerous behaviors were measured by a survey that included questions about the teens’ thrill seeking behaviors, reckless behaviors, rebellious behaviors and antisocial behaviors. DTI was used to measure corresponding structural changes in white matter.

“We were surprised to discover that risk-taking was associated with more highly-developed white matter – a more mature brain,” says Berns. “We were also surprised to learn that except for slightly higher scores in risk-taking, there was no significant difference in the maturity of the white matter between males and females.”

Berns suggests that doing adult-like activities requires sophisticated skills.

“Society is a lot different now than it was 100 years ago when teens were expected to go to work and raise a family,” says Berns. “Now, adolescents aren’t expected to act like adults until they are in their twenties, when they have finished their education and found a career.

“You could make the case that in this country, biological capacity shows up long before the wisdom that comes with time is fully developed,” notes Berns.

Berns says more studies need to be done to determine if early brain development predisposes someone to engage in risky behaviors, or if the risky behavior drives the maturation of the brain.

The CDC reports that, 27,000 people between the ages of 10 and 24 die from bad decisions in the United States per year. Additionally, it has been shown that the period of mid-adolescence (ages 15 through 19) is the time when teens are more likely to begin high-risk behaviors such as drinking, abusing drugs or driving recklessly.

Other researchers who contributed to this study include, Sara Moore, BS, Department of Psychiatry and Behavioral Sciences at Emory University School of Medicine and C. Monica Capra, PhD, the Department of Economics and the Center for Neuropolicy, Emory University.

This study was funded by grants from the National Institute on Drug Abuse.

“Adolescent Engagement in Dangerous Behaviors Is Associated with Increased White Matter Maturing of Frontal Cortex”, PLoS ONE, 8/26/09, 10.1371
Community News You Can Use
Follow us on Twitter: @gafrontpage

Mayo Clinic Proceedings: Common Blood Disorder May Not be Linked to as Many Serious Diseases, as Previously Thought

A symptomless blood disorder, monoclonal gammopathy of undetermined significance, known as MGUS, is not linked to as many serious diseases as previously thought. This finding may save patients from undergoing unnecessary workup and treatment according to a study published in the August 2009 issue of Mayo Clinic Proceedings.

MGUS has long been thought to be a precursor of serious disease, such as multiple myeloma, primary amyloidosis and Waldenström macroglobulinemia. However, for years physicians have reported possible association of MGUS with many more diseases. As a result, some patients with MGUS who had these disorders were subjected to investigations and sometimes additional treatments as a precaution.

MGUS is a fairly common disorder, affecting roughly 3 percent of the U.S. population. This study was supported in part by grants from the National Institutes of Health and the U.S. Public Health Service.

In this study, researchers looked at the records of 17,398 patients, all of whom were uniformly tested for the presence or absence of MGUS. Among the 17,398 samples tested, 605 cases of MGUS were identified. The researchers then looked at the incidence of over 16,000 different diagnosis codes in those with MGUS and those without. They identified 14 real disease associations, while 61 disease associations with MGUS were determined to be likely coincidental.

In addition to multiple myeloma, the associations deemed real include vertebral and hip fractures and osteoporosis. "In addition to the article, we have made available on the journal Web site an appendix that has the raw data on all 16,062 hospital diagnosis codes which we think will be valuable to other researchers in the field," says S. Vincent Rajkumar, M.D., of Mayo Clinic's Department of Hematology and senior author on the study.

A peer-review journal, Mayo Clinic Proceedings publishes original articles and reviews dealing with clinical and laboratory medicine, clinical research, basic science research and clinical epidemiology. Mayo Clinic Proceedings is published monthly by Mayo Foundation for Medical Education and Research as part of its commitment to the medical education of physicians. The journal has been published for more than 80 years and has a circulation of 130,000 nationally and internationally. Articles are available online at
Community News You Can Use
Follow us on Twitter: @gafrontpage

Friday, September 18, 2009

FDA Approves Donor Screening Test for Antibodies to HIV

/PRNewswire/ -- The U.S. Food and Drug Administration today announced approval of the Abbott Prism HIV O Plus assay, as a screening tool designed to detect the presence of certain antibodies to HIV. The assay is one of five assays that run on the fully automated Abbott Prism System.

There are two types of HIV. HIV type 1 consists of various subgroups, including group M, the most common subgroup of the virus in the United States, and group O, found primarily in Cameroon and other areas of West Africa.

HIV type 2 is found mostly in West Africa. Both types have been detected in the United States and Europe.

The Abbott Prism HIV O Plus assay detects antibodies to HIV type 1, groups M and O, and HIV type 2. It is the second donor screening test licensed for the detection of antibodies to HIV type 1, group O.

The Abbott Prism HIV O Plus assay is licensed to screen donated blood and blood specimens from other living donors for these specific types of HIV and subgroups of HIV type 1. The assay is also licensed to screen specimens from organ donors when specimens are obtained while the donor's heart is still beating and from cadavers. Positive results from the screening test require confirmation from supplemental tests.

Fayette Front Page
Georgia Front Page

FDA Warns Consumers Not to Use Stolen Albuterol Sulfate Inhalation Solution and Ipratropium Bromide Inhalation Solution

The U.S. Food and Drug Administration today advised consumers not to use certain respiratory medications purchased after Sept. 8, 2009 and manufactured by Dey L.P., a subsidiary of Mylan Inc., because the medications might have been part of a shipment being transported on a tractor-trailer stolen in Tampa, Fla., on Sept. 8, 2009.

The respiratory medications, Ipratropium Bromide Inhalation Solution, 0.02%, and Albuterol Sulfate Inhalation Solution, 0.083%, unit-dose vials, have not been recovered and may be dangerous to use because the drugs may not have been stored and handled properly.

Dey issued an advisory on Sept. 11, 2009 regarding the theft. Although the FDA is not aware of any reports of adverse events, the agency is advising patients who use these respiratory medications to check to see if products received or purchased after Sept. 8, 2009 are from one of the following lots:

Albuterol Sulfate Inhalation Solution (892,000 doses; all lots contain 3.0 ml vials and display the brand name “Dey”)

* Lot number 9G04, NDC # 49502-697-29
* Lot number 9FD8, NDC # 49502-697-61
* Lot number 9FD9, NDC # 49502-697-61
* Lot number 9FE1, NDC # 49502-697-61

Ipratropium Bromide Inhalation Solution (432,000 doses; all lots contain 2.5 ml vials and display the brand name “Dey”)

* Lot number F09089, NDC # 49502-685-31
* Lot number C09119, NDC # 49502-685-62
* Lot number C09120, NDC # 49502-685-62

Do not use Albuterol Sulfate Inhalation Solution or Ipratropium Bromide Inhalation Solution if it is from one of these lots and was purchased or received after Sept. 8, 2009. Replace it with the same product from another lot.

Notify your health care professional of any adverse effects you may have experienced as a result of taking these medications.

Bring products from these lots back to the pharmacy where you received the medicine to exchange for products from a different lot or call Dey customer service at 800-527-4278. Contact your health care professional if you must switch to another product for any reason for possible dose adjustments.

The FDA is asking for the public's help in reporting any information regarding the stolen Dey products to the FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site (

Fayette Front Page
Georgia Front Page

Thursday, September 17, 2009

HHS Secretary Sebelius Announces Cornerstone Funding of the $650 Million Recovery Act Community Prevention and Wellness Initiative

Creating ways for healthful lifestyle habits to be the natural first choice for Americans is the goal of a $650 million initiative of the U.S. Department of Health and Human Services (HHS). The funds from the American Recovery and Reinvestment Act will be used to increase physical
activity, improve nutrition, decrease obesity, and decrease smoking in U.S. communities.

HHS Secretary Kathleen Sebelius today announced a funding opportunity for communities and tribes to apply for $373 million in cooperative agreements for the comprehensive public health initiative, Communities Putting Prevention to Work, to be led by the Centers for Disease Control
and Prevention (CDC).

"This initiative will make disease prevention and health promotion top priorities in states and communities across the country," Secretary Sebelius said. "Preventing disease is vital as a strategy to improve our nation's health and reduce health care costs."

Communities Putting Prevention to Work will change systems and environments-for example, improving access to healthy foods and opportunities for physical activity-and putting into place policies, such as clean-indoor-air laws, that will promote the health of populations. Funded entities will have two years to complete their work.

The $373 million in cooperative agreements will be awarded to communities through a competitive selection process. The cooperative agreements will support evidence-based prevention strategies for youth and adults and will promote partnerships across communities and sectors.

The remainder of the funds for this initiative will be made available in the coming weeks to states, territories, and organizations to support, extend and evaluate the reach and impact of the community projects.

Funded projects will emphasize high-impact, broad-reaching policy, environmental, and systems changes in schools (K-12) and communities. For example, communities will work to make high-fat snack foods and sugar-sweetened beverages less available in schools and other community sites and to use media to promote healthy choices. In addition, funded communities will be encouraged to provide quality physical education in the nation's schools and enact comprehensive smoking bans.

"The CDC is excited to have this opportunity to help states and communities do more to deliver proven prevention strategies, in ways that reach whole communities and populations," said CDC Director, Thomas Frieden, M.D., M.P.H. "Chronic diseases linked to obesity, poor nutrition, physical inactivity, and tobacco use are the leading causes of death and disability in our nation. These additional resources will improve the quality of life for millions of Americans."

Communities interested in applying for Communities Putting Prevention to Work grants can find more information at The application deadline for the community projects is Dec. 1, 2009. Deadlines for state, territory, and other prevention projects that are part of the
Communities Putting Prevention to Work initiative will be announced soon.

Fayette Front Page
Georgia Front Page

Wednesday, September 16, 2009

Operating Cells Via Joystick

Moving cells around by joystick without causing any damage helps doctors study live samples.

Biomedical research could someday look a lot like playing video games thanks to a new device that allows users to manipulate cells with the swerve of a joystick.

A team of physicists and engineers at Ohio State University in Columbus, Ohio developed the device from a tiny piece of square-centimeter silicon inlaid with rows of zigzagging magnetic wires. At each corner, the wire behaves like two magnets pointed north to north or south to south. The fields of the two magnets create a point of strong attraction just above them. A nearby magnetic object, such as a magnetically-tagged cell is attracted to the corner and gets stuck there

To get the particles moving, the researchers then place two magnetic fields around the chip one in the plane of the chip and the other perpendicular to it. By flipping the direction of these fields, the researchers can guide tagged cells along the zigzagging wire and even make them jump from one wire to the next. The researchers computerized the magnetic field switching so that a user steered the cells by simply handling a joystick.

The team at OSU put the device through its paces with magnetically-tagged T-cells, the body's guardians against infection. They snapped the cells to attention at one end of the chip, marched them down to the other end, and made them hop from one wire to another, reaching speeds of about 20 micron, or about a one-fifth the width of a human hair, per second.

Jeffrey Chalmers, the chemical engineer who tagged the T-cells for the experiment, said that the device would be ideal for examining tumor cells. To study biopsied tumors, researchers often treat them with enzymes, which break them down into their constituent cells. Researchers then separate cancerous cells they want to study from healthy cells like fat and blood.

By Lauren Schenkman
Inside Science News Service
Community News You Can Use
Follow us on Twitter: @gafrontpage

Senate Introduces Bill to Boost Participation in Clinical Trials for Rare Diseases

/PRNewswire-/ -- Four members of the United States Senate introduced legislation today to allow patients with rare diseases to participate in clinical drug studies without losing their eligibility for public healthcare coverage, echoing a move by the House of Representatives last month.

The "Improving Access to Clinical Trials Act" is co-sponsored by Senators Ron Wyden (D-OR), Chris Dodd (D-CT), James Inhofe (R-OK) and Richard Shelby (R-AL).

Researchers who develop drugs to treat rare diseases such as cystic fibrosis often struggle to recruit participants for clinical trials because of limited patient populations. To compound the problem, current law prevents many people who receive Supplemental Security Income (SSI) from accepting research compensation because it would make them ineligible to continue receiving government medical benefits. This financial penalty prevents significant numbers of people with rare diseases from participating in clinical studies.

"For many suffering from rare diseases, access to clinical trials is their best hope for treatment," said Senator Wyden. "This legislation will make sure the small financial incentives these people receive will not be counted against them if they are on SSI or Medicaid. Patients suffering from rare diseases should not have to choose between their best hope for treatment or losing benefits, nor be denied the access more financially fortunate patients receive."

"For those living with a rare disease, clinical drug studies can offer a ray of hope: access to cutting-edge medical technologies that may help treat or even cure a serious illness," Senator Dodd said. "Currently, individuals who receive public assistance often do not participate in compensated clinical trials for fear of losing their Medicaid or Supplemental Security Income. This legislation will remedy this inequity by ensuring that more Americans, including those who receive public assistance, have access to these potentially life-saving clinical drug studies."

"This bill allows patients with a rare disease to disregard up to $2,000 of compensation received for participation in a clinical trial in their SSI and Medicaid income calculations," said Senator Inhofe. "Though it will have a negligible impact on the federal budget, it will make a dramatic difference in the lives of those who will gain access to potentially life-saving treatments by enrolling in clinical trials as well as all those in the future whose lives will be improved by the medical advances that arise from this research.

"Scientists and researchers across our nation continually produce new therapies that have the potential to save the lives of countless Americans who suffer from life-threatening rare illnesses," said Senator Shelby. "These patients should not be forced to choose between the health benefits they desperately need and the opportunity to participate in a clinical trial that could improve their medical condition. I am confident that this legislation will open a pathway for more patients to receive life-saving treatments."

Fifty years ago, there were no drugs for people with CF and those with the disease rarely lived to attend elementary school. Today, because of the Cystic Fibrosis Foundation's focus on innovative and aggressive research, there are more than 30 potential therapies in development, and the median life expectancy is higher than 37 years.

Fayette Front Page
Georgia Front Page

Secretary Sebelius Announces Medicare to Join State-Based Healthcare Delivery System Reform Initiatives

Health and Human Services Secretary Kathleen Sebelius, along with Vermont Governor Jim Douglas and Director of the White House Office of Health Reform Nancy-Ann DeParle today announced an initiative that will allow Medicare to join Medicaid, and private insurers in state-based efforts to improve the way health care is delivered. Innovative models of delivering primary care around the country are examples of the types of programs that will be part of the President's health reform plan. These are models that improve care for patients, give primary care providers better information about their patients and achieve greater value for the health dollars spent.

The new demonstration will build on a model being tested in Vermont. Under the Vermont model, private insurers work in cooperation with Medicaid to set uniform standards for "Advanced Primary Care (APC) models" also known as medical homes. These models provide incentives for doctors to spend more time with their patients and offer better coordinated higher-quality medical care.

"These demonstrations will strengthen our health care system and allow public and private providers to better work together," said Sebelius. "When Medicare, Medicaid and private insurance companies coordinate their efforts, we can improve the quality of care for Medicare
beneficiaries. As we have seen in Vermont, improved efficiencies in the system mean doctors can spend more time with their patients, provide high quality care and better coordinate that care with other medical professionals."

"The Medicare pilot program announced today will help states like Vermont achieve our vision of high quality, affordable health care for all our residents," said Douglas. "This is something we had been pushing for in Vermont for quite some time and I'm thrilled that Secretary Sebelius and her team have made it happen."

In Advanced Primary Care models, physicians are given supplemental payments for achieving nationally-recognized quality standards, coordinating care across a multidisciplinary team and monitoring patients' care outside the physician's office or hospital using health information technology.

This demonstration will mark the first time Medicare will be a full partner in these experiments and the practice model would, for the first time, align compensation offered by all insurers to primary care physicians. Instead of each third party payer and public program adopting different approaches, using different ways of measuring performance and creating different payment incentives, multi-payer programs will join together to work toward common goals to improve the delivery of care.

States wishing to participate in the new demonstration must:
* certify they have already established similar cooperative agreements
between private payers and their Medicaid program;
* demonstrate a commitment from a majority of their primary care doctors
to join the program;
* meet a stringent set of qualifications for doctors who participate;
* integrate public health services to emphasize wellness and prevention

The demonstration's design will include mechanisms to assure it generates savings for the Medicare trust funds and the federal government overall.

The Centers for Medicare & Medicaid Services will develop application materials later this fall with the expectation that the demonstration programs begin next year.

"This is a jump start on health insurance reform," said DeParle. "These demonstration projects will foster innovation, support change at the local level and help us build a better 21st century health care system."

Fayette Front Page
Georgia Front Page

MHA Director McIlwain Prepared for the Challenges of the Health Care System

As health care remains on the front burner of political debate, the Master of Health Administration (MHA) program at Clayton State University is prepared to continue its mission of developing well-rounded competent individuals for administrative positions in varying types of health care organizations. The new director of the MHA program, Dr. Thomas F. McIlwain, is prepared for the challenges in a changing health care system.

“Change is inevitable, and the health care system is no exception,” he says. “In my 25 or so years of working and teaching in health services administration, I have seen the problems, issues, health policies, and health policy outcomes debated. Each new policy change is a tweak of the existing system, but each has been designed to make it better. I have no doubt of the outcome of the current debate. The system will get a little better.”

McIlwain comes to Clayton State with a wealth of prior industry and teaching experience. In the 80s, he served as an administrative associate at University Hospitals of Alabama while teaching in the MSHA program at the University of Alabama at Birmingham, where he received his Ph.D. in Health Services Administration. His administrative residency was with a for-profit system, American Medical International, which eventually merged with National Medical Enterprises to form what is now know as Tenet Health Care.

His immediate teaching position after UAB was at Appalachian State University in the Walker College of Business’ Department of Management. He served as director of the undergraduate health care management program for eight of the 10 years he was in Boone, N.C. He then moved to Mount Pleasant, S.C., where he served as MHA program director for three of the 10 years he was on faculty at the Medical University of South Carolina.

For the past four years he was associate professor of Public Health and vice-chair in the Department of Community Health Sciences in the College of Health at the University of Southern Mississippi in Hattiesburg. While there, he developed the graduate emphasis in health administration in the CEPH-accredited Master of Public Health program. He was also involved in the development of the cohort-based Executive Master of Public Health in Health Services Administration program.

McIlwain has consulted with health care organizations in the area of strategic planning including medical group practices, nursing homes, and hospitals. His research interests are in health care marketing, including direct-to-the-consumer pharmaceutical advertising, and health care strategic management.

“The main goal of the MHA program at Clayton State is to become CAHME (the Commission on Accreditation of Health Management Education) accredited. CAHME is dedicated to promoting, evaluating, and improving graduate healthcare management education. I was responsible for the re-accreditation of the MHA program at MUSC where the program received the highest awarded number for seven years,” McIlwain says. “My goal is to move this program to that level of quality education. This process will involve making sure that we have quality admissions, support, and outcomes in teaching, service, and research. We are moving the program to competency based outcome measurement also.

“I was attracted to Clayton State because of its proximity to the health care industrial complex of the Metro Atlanta area. This program is poised to become a premier provider of graduate health care management education in the Atlanta and Georgia region. My experience with accreditation and program management provides me with a perspective of what this University can accomplish in this type of program”McIlwain is looking forward to accomplishing many goals within MHA program.

“The goals of the program are to prepare students for positions of increased responsibility within healthcare organizations. It also provides individuals with clinical backgrounds the management skills needed to assume leadership positions,” he says. “We are also interested in attracting individuals who have experience in other industries but want to begin careers in health care management.

“Of course the goal of all health administration programs is to improve the quality of care and resource use in health organizations by graduating individuals with the skills and competencies to achieve this goal.”
McIlwain is married to Margaret, a family nurse practitioner, and is the father of two sons.

A unit of the University System of Georgia, Clayton State University is an outstanding comprehensive metropolitan university located 15 miles southeast of downtown Atlanta.
Community News You Can Use
Follow us on Twitter: @gafrontpage

Tuesday, September 15, 2009

FDA Approves Vaccines for 2009 H1N1 Influenza Virus

The U.S. Food and Drug Administration announced today that it has approved four vaccines against the 2009 H1N1 influenza virus. The vaccines will be distributed nationally after the initial lots become available, which is expected within the next four weeks.

“Today's approval is good news for our nation's response to the 2009 H1N1 influenza virus,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “This vaccine will help protect individuals from serious illness and death from influenza.”

The vaccines are made by CSL Limited, MedImmune LLC, Novartis Vaccines and Diagnostics Limited, and sanofi pasteur Inc. All four firms manufacture the H1N1 vaccines using the same processes, which have a long record of producing safe seasonal influenza vaccines.

”The H1N1 vaccines approved today undergo the same rigorous FDA manufacturing oversight, product quality testing and lot release procedures that apply to seasonal influenza vaccines,” said Jesse Goodman, M.D., FDA acting chief scientist.

Based on preliminary data from adults participating in multiple clinical studies, the 2009 H1N1 vaccines induce a robust immune response in most healthy adults eight to 10 days after a single dose, as occurs with the seasonal influenza vaccine.

Clinical studies under way will provide additional information about the optimal dose in children. The recommendations for dosing will be updated if indicated by findings from those studies. The findings are expected in the near future.

As with the seasonal influenza vaccines, the 2009 H1N1 vaccines are being produced in formulations that contain thimerosal, a mercury-containing preservative, and in formulations that do not contain thimerosal.

People with severe or life-threatening allergies to chicken eggs, or to any other substance in the vaccine, should not be vaccinated.

In the ongoing clinical studies, the vaccines have been well tolerated. Potential side effects of the H1N1 vaccines are expected to be similar to those of seasonal flu vaccines.

For the injected vaccine, the most common side effect is soreness at the injection site. Other side effects may include mild fever, body aches, and fatigue for a few days after the inoculation. For the nasal spray vaccine, the most common side effects include runny nose or nasal congestion for all ages, sore throats in adults, and -- in children 2 to 6 years old -- fever.

As with any medical product, unexpected or rare serious adverse events may occur. The FDA is working closely with governmental and nongovernmental organizations to enhance the capacity for adverse event monitoring, information sharing and analysis during and after the 2009 H1N1 vaccination program. In the U.S. Department of Health and Human Services, these agencies include the Centers for Disease Control and Prevention.

Vaccines against three seasonal virus strains are already available and should be used (see information on the seasonal flu). However, they do not protect against the 2009 H1N1 virus (see information on H1N1 flu).

Fayette Front Page
Georgia Front Page

Piedmont Fayette Hospital Hosts Prostate Cancer “Ask the Doc” Session in Recognition of Prostate Cancer Awareness Month

PFH is Proud to Now Offer Brachytherapy for Prostate Cancer Patients

According to the American Cancer Society, prostate cancer is the most common form of cancer found in American men. September is Prostate Cancer Awareness Month, and Piedmont Fayette Hospital (PFH) and the American Cancer Society want to help educate men about this disease which will affect one in six men in their lifetime.

Man to Man, the prostate cancer support group held monthly at PFH, will hold a special “Ask the Doc” session at its next meeting on Tuesday, Sept. 22, at 7 p.m. at Piedmont Fayette Hospital’s 1279 Building, in the 3rd floor conference rooms. Medical oncologist Jonathan Bender, M.D., and urologist Scott Shelfo, M.D., will lead the discussion and answer questions concerning prostate cancer.

This free and informative session will feature a variety of topics including risk factors, diagnosis, treatment options, and ways to control recurrent cancer. Participants will also learn more about the plans for the new cancer center at Piedmont Fayette Hospital, as well as new cancer treatments available at PFH, including brachytherapy, a cutting-edge treatment for prostate cancer.

Brachytherapy allows radiation to concentrate more on cancerous cells, therefore inflicting less damage on normal cells. This unique type of radiation therapy allows higher doses of radiation to be administered as close to the cancer as possible over a shorter period of time.

In brachytherapy, small radioactive isotopes are placed in seeds, wires and rods called implants and then placed in the body. There are two types of brachytherapy placement: temporary and permanent. Temporary brachytherapy uses higher doses of radiation in the implants, which are removed after treatment. Permanent therapy uses small implants, which are inserted directly into the tumor, with smaller doses of radiation that remain in place after radiation is complete.

Man to Man support group is held on the 4th Tuesday of each month from 7 to 9 p.m., and provides a forum for men and their partners to discuss diagnosis, treatment options, and quality-of-life issues surrounding prostate cancer. This program will be followed by a period of questions as well as a time for sharing experiences.

The presentation is open to the public. For more information on the event, please call Man to Man coordinator Jim O'Hara at 770-632-2898, or Lisa Cockerham of the American Cancer Society in Peachtree City at 770-631-0625. For more information on cancer services at Piedmont Fayette Hospital, visit

About Piedmont Fayette Hospital
Named one of the nation’s Most Wired hospitals for five consecutive years in the 100 Most Wired Survey and Benchmarking Study, Piedmont Fayette Hospital (PFH), ranked third in patient satisfaction among metro Atlanta hospitals according to the HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) survey released in March 2009. One of the nation’s 100 Top Hospitals® four years in a row (2004-2007) according to Thomson Reuters (formerly Solucient), Piedmont Fayette Hospital is a 143-bed, acute-care community hospital located on Highway 54 in Fayetteville, offering 24-hour emergency services, medical and surgical services, as well as obstetrics, diagnostic cardiac catheterization and rehabilitation services. With over1,100 employees and a medical staff of over 500 physicians, PFH is a member of Piedmont Healthcare (PHC), a not-for-profit organization that also includes Piedmont Hospital, a 481-bed acute tertiary care facility offering all major medical, surgical and diagnostic services located on 26 acres in the north Atlanta community of Buckhead; Piedmont Mountainside Hospital, a 42-bed community hospital in Jasper; and Piedmont Newnan Hospital, a 143-bed, acute-care community hospital in Newnan. Piedmont Healthcare also is the parent company of the Piedmont Heart Institute (PHI), which combines over 60 renowned cardiologists in the Piedmont Heart Institute Physicians with over 30 offices across north Georgia, and the 162-bed Fuqua Heart Center of Atlanta; Piedmont Philanthropy, the philanthropic entity for private fundraising initiatives; the Piedmont Physicians Group, with over 100 primary care physicians in 30 offices throughout metro Atlanta; and the Piedmont Clinic, a 600-member physician network. For more information, visit
Community News You Can Use
Follow us on Twitter: @gafrontpage

Monday, September 14, 2009

Piedmont Fayette Hospital Celebrates Its Neonatal Nurses

September 15 is National Neonatal Nurses Day

In recognition of National Neonatal Nurses Day on Tuesday, Sept. 15, Piedmont Fayette Hospital would like to shine the spotlight on its neonatal nurses for the outstanding care they provide to patients.

“Sometimes we don’t say ‘thank you’ enough to our employees,” said Darrell Cutts, president and CEO of Piedmont Fayette Hospital. “This day is a chance for us to tell them how much we appreciate the top service they give to some of the smallest patients in our community.”

The Neonatal nursing team at Piedmont Fayette Hospital specialize in comprehensive care for premature and compromised infants from gestation of 28 weeks and greater. These nurses are charged with monitoring ventilators and incubators, making sure the baby is responding and checking for complications. Often nurses must be available to check on an infant every 15 minutes to record health parameters.

“Neonatal nurses are the ones we trust to take care of our most sensitive newborns and help prepare them to go home,” said Cutts. “Piedmont Fayette Hospital is proud to celebrate these nurses who so carefully and professionally look after our precious new loved ones.”

Take the time on Tuesday, Sept. 15, to thank and honor any neonatal nurses you know. For more information on Piedmont Fayette Hospital’s neonatal services, visit
Community News You Can Use
Follow us on Twitter: @gafrontpage

Center for AIDS Research at Emory University to Serve as Local Host of AIDS Vaccine 2010

/PRNewswire/ -- The Global HIV Vaccine Enterprise (the Enterprise) today announced that the Center for AIDS Research at Emory University (CFAR) in Atlanta, Georgia will serve as Local Host of AIDS Vaccine 2010, the largest and most important global scientific conference focused on AIDS vaccine research. AIDS 2010 is to be held September 28 to October 1, 2010. This annual international conference brings together scientists, community advocates, funders, and policy makers from around the world to hear cutting edge scientific results, exchange new ideas, educate future leaders, and engage a diverse community of scientists in the quest for an HIV vaccine.

"The Global HIV Vaccine Enterprise is committed to accelerating the search for a safe and effective vaccine through scientific collaboration and global initiatives that bring together the world's best researchers, scientific organizations, advocates, funders, and policy makers for common purpose," said Alan Bernstein, Ph.D., executive director, Global HIV Vaccine Enterprise. "Our annual AIDS Vaccine conference is one such initiative and we look forward to collaborating with the Center for AIDS Research at Emory University to plan and implement the premier conference dedicated to HIV vaccine research."

AIDS Vaccine 2010 will feature daily plenary presentations by leading researchers, clinicians, and community advocates, and oral and poster presentations of hundreds of research papers addressing every aspect of HIV vaccine development and testing. The conference is expected to attract more than 1,000 researchers, clinicians, and community advocates from around the world to Atlanta.

Eric Hunter, Ph.D., Georgia Research Alliance eminent scholar and co-director, Center for AIDS Research at Emory University will chair AIDS Vaccine 2010 with support from the following co-chairs: James Curran, M.D., MPH, dean, Rollins School of Public Health and co-director, Center for AIDS Research, Emory University; Carlos del Rio, M.D., Hubert chair, department of Global Health, Rollins School of Public Health and co-director, Center for AIDS Research, Emory University; and Harriet Robinson, Ph.D., senior vice president of research and development, GeoVax, former director, division of Microbiology and Immunology, Yerkes National Primate Research Center, Emory University.

"The Center for AIDS Research at Emory University is pleased to host the AIDS Vaccine 2010 conference in Atlanta. Because Atlanta is the epicenter for the HIV/AIDS pandemic in the Southeast, the development of a viable vaccine is a very relevant objective for our community," said Eric Hunter, Ph.D., whose research is conducted at the Emory Vaccine Center. "The devastation of HIV/AIDS is well known, and the need for continued scientific inquiry and global awareness of the disease remains critical in the quest for an effective HIV vaccine."

AIDS Vaccine 2010 aims to help cultivate a global network of scientific talent to carry the field of HIV vaccine research into the future. AIDS Vaccine 2010 will welcome a large cohort of promising early career scientists both nationally and internationally through conference scholarships and travel support.

AIDS Vaccine 2009, with the French National Agency for Research on AIDS and Viral Hepatitis (ANRS) serving as Local Host, will be held in Paris, France from October 19 to 22, 2009. AIDS Vaccine 2008 was held in Cape Town, South Africa.

Fayette Front Page
Georgia Front Page

Saturday, September 12, 2009

Mayo Clinic Identifies Two Genes as Potential Therapeutic Targets for Multiple Sclerosis

Early research holds promise for new therapies and better prediction of patient outcomes

A Mayo Clinic study has found that two genes in mice were associated with good central nervous system repair in multiple sclerosis (MS). These findings give researchers new hope for developing more effective therapies for patients with MS and for predicting MS patients' outcomes. This study will be presented at the Congress of the European Committee for Treatment and Research in Multiple Sclerosis in Dusseldorf, Germany, on Sept. 11, 2009.

"Most MS genetic studies have looked at disease susceptibility — or why some people get MS and others do not," says Allan Bieber, Ph.D., a Mayo Clinic neuroscientist and author of this study. "This study asked, among those who have MS, why do some do well with the disease while others do poorly, and what might be the genetic determinants of this difference in outcome."

Mayo Clinic provides care for nearly 2,500 patients with MS each year. MS is a disease of the central nervous system that includes the brain, spinal cord and nerves. MS is called a demyelinating disease because it results from damage to myelin, the insulating covering of nerves. It occurs most commonly in those between the ages of 20 and 40, and is the most frequent neurological disorder in young adults in North America and Europe. Approximately 330,000 people in the United States have MS. Symptoms include loss of muscle coordination, strength, vision, balance and cognition.

Dr. Bieber and a team of Mayo Clinic researchers used two different strains of mice with a chronic, progressive MS-like disease. One strain progressed to paralysis and death. The other underwent the initial damage induction phase of the disease and then spontaneously repaired the damage to the central nervous system and retained most neurologic function. Using the powerful genetic mapping techniques that are available for mice, the team mapped two strong genetic determinants of good disease outcome.

"It's possible that the identification of these genes may provide the first important clue as to why some patients with MS do well, while others do not," says Dr. Bieber. "The genetic data indicates that good central nervous system repair results from stimulation of one genetic pathway and inhibition of another genetic pathway. While we're still in the early stages of this research, it could eventually lead to the development of useful therapies that stimulate or inhibit these genetic pathways in patients with MS."

According to Dr. Bieber, the research suggests that there may be a small number of strong genetic determinants for central nervous system repair following demyelinating disease, rather than a larger number of weak determinants.

"If that's true, it may be possible to map the most important genetic determinants of central nervous system repair in patients with MS and define a reparative genotype that could predict patients' outcomes," says Moses Rodriguez, M.D., a Mayo Clinic neurologist and director of Mayo Clinic's Center for Multiple Sclerosis and Central Nervous System Demyelinating Diseases Research and Therapeutics. "Such a diagnostic tool would be a great benefit to patients with MS and is consistent with the concepts of 'individualized medicine.'"

Also on the Mayo Clinic research team was Kanitta Suwansrinon, M.D.
Community News You Can Use
Follow us on Twitter: @gafrontpage

Friday, September 11, 2009

FDA Clears a Test for Ovarian Cancer

/PRNewswire/ -- The U.S. Food and Drug Administration today cleared a test that can help detect ovarian cancer in a pelvic mass that is already known to require surgery. The test, called OVA1, helps patients and health care professionals decide what type of surgery should be done and by whom.

OVA1 identifies some women who will benefit from referral to a gynecological oncologist for their surgery, despite negative results from other clinical and radiographic tests for ovarian cancer. If other test results suggest cancer, referral to an oncologist is appropriate even with a negative OVA1 result.

OVA1 should be used by primary care physicians or gynecologists as an adjunctive test to complement, not replace, other diagnostic and clinical procedures.

OVA1 uses a blood sample to test for levels of five proteins that change due to ovarian cancer. The test combines the five separate results into a single numerical score between 0 and 10 to indicate the likelihood that the pelvic mass is benign or malignant.

OVA1 is intended only for women, 18 years and older, who are already selected for surgery because of their pelvic mass. It is not intended for ovarian cancer screening or for a definitive diagnosis of ovarian cancer. Interpreting the test result requires knowledge of whether the woman is pre- or post-menopausal.

The American College of Obstetricians and Gynecologists and the Society of Gynecologic Oncologists published recommendations in 2002 for the role of generalist obstetrician-gynecologists in the early detection of ovarian cancer, which included a recommendation of patient referral to a gynecological oncologist when specific indicators of malignancy are present.

These recommendations and later reports indicate that patients with ovarian cancer have improved survival when the surgery is performed by gynecologic oncologists as opposed to general gynecologists or surgeons.

"Tests such as OVA1 personalize and improve public health by providing patients and health care providers with more information to support medical decisions that impact survival rates and reduce surgical complications," said Jeffrey Shuren, M.D., J.D., acting director of the FDA's Center for Devices and Radiological Health.

The FDA reviewed a study of 516 patients, including 269 evaluated by non-gynecological oncologists, which compared OVA1 results with biopsy results. When combined with pre-surgical information, such as radiography and other laboratory tests, results from the OVA1 tests identified additional patients who might benefit from oncology referral who were not identified using pre-surgical information alone.

OVA1 is developed by Vermillion Inc., headquartered in Fremont, Calif., in conjunction with researchers at The Johns Hopkins University in Baltimore.

Fayette Front Page
Georgia Front Page
Arts Across Georgia

Secretary Sebelius Releases $33 Million in ARRA Funds to Train Health Professionals

HHS Secretary Kathleen Sebelius today announced awards totaling $33 million to expand the training of health care professionals. The funds are part of the $500 million allotted to HHS' Health Resources and Services Administration (HRSA) to address workforce shortages under the American Recovery and Reinvestment Act (ARRA).

"President Obama is committed to passing health insurance reform and we're closer to reform than ever before," said Secretary Sebelius. "The Recovery Act will help ensure we grow our health care workforce and give our aspiring doctors, nurses and health professionals the tools and training they need to provide top-quality care to more Americans."

"As we mark 200 days since President Obama signed ARRA, HRSA has moved quickly to distribute most of the $2.5 billion assigned to us," said HRSA Administrator Mary Wakefield, Ph.D., R.N. "These funds are helping us rebuild the infrastructure needed to produce more skilled health professionals, and they are expanding essential primary care services to hundreds of thousands of additional Americans through our health center system."

The grants announced today, with funding totals, are distributed through six HRSA programs:

* Scholarships for Disadvantaged Students, $19.3 million. This
program funds health professions schools and training programs which, in
turn, provide scholarships to full-time health professions students,
with priority given to those with financial need.

* Centers of Excellence, $4.9 million. This program funds health
professions schools to establish or expand programs for minority
individuals. Funds may be used to improve student academic performance,
recruit and retain minority faculty, and expand opportunities to train
at off-campus, community-based health care sites.

* Public Health Traineeships, $3 million. This program funds
schools of public health to support traineeships that pay tuition, fees,
and stipends for students in biostatistics, epidemiology, environmental
health, toxicology, nutrition, or maternal and child health.

* Nursing Workforce Diversity, $2.6 million. This program
increases nursing education opportunities for individuals from
disadvantaged backgrounds through student scholarships or stipends,
pre-entry preparation, and retention activities.

* Health Careers Opportunities, $2.5 million. This program funds
schools and health professions training sites to establish or expand
programs that help individuals from disadvantaged backgrounds enter and
graduate from a health professions program.

* Dental Public Health Residency Training, $810,925. This program
funds residency programs in dental public health, including financial
aid to residents.

Today's grants follow an Aug. 12 announcement by HHS Deputy Secretary Bill Corr of $13.4 million in ARRA funds for loan repayments to nurses who agree to practice in facilities with critical shortages and for schools of nursing to provide loans to students who will become nurse

To date, HHS has announced the availability of nearly $200 million in ARRA workforce funds, of a total $300 million, to expand HRSA's National Health Service Corps. The funds will pay for student loan repayments for primary care medical dental and mental health clinicians who wish to practice, for a minimum of two years, in NHSC sites that treat underserved and uninsured people.

In addition, HRSA received $2 billion through ARRA to expand health care services to low-income and uninsured individuals through its health center program. To date, more than $1.3 billion of these funds have been awarded to community-based organizations across the country. HRSA-supported health centers treated 17 million patients in 2008, 40 percent of whom have no health insurance.

Fayette Front Page
Georgia Front Page

Statement by Dr. Anthony Fauci, NIH Regarding Early Results from Clinical Trials of 2009 H1N1 Influenza Vaccines in Healthy Adults

Statement by Dr. Anthony Fauci
Director, National Institute of Allergy and Infections Diseases, NIH
Regarding Early Results from Clinical Trials of 2009 H1N1 Influenza
Vaccines in Healthy Adults

We are encouraged by reports that are now emerging from various clinical trials of 2009 H1N1 influenza vaccines, conducted by various vaccine manufacturers. We expect additional companies to announce their preliminary trial results shortly. The early data from these trials
indicate that 2009 H1N1 influenza vaccines are well tolerated and induce a strong immune response in most healthy adults when administered in a single unadjuvanted 15-microgram dose. We congratulate the companies on these trials, which are an important part of the ongoing worldwide effort to develop vaccines to protect the public from 2009 H1N1 influenza.

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, also is conducting clinical trials of 2009 H1N1 influenza vaccines, produced by Sanofi Pasteur and CSL Limited. The NIAID trials are testing two different dosages (15 micrograms versus 30 micrograms) and evaluating the immune response to one and two doses of these vaccines. More than 2,800 people are participating in ongoing NIAID trials of these vaccines.

We are pleased to note that preliminary analyses of early data from the NIAID trials align with the recently announced findings and those to be announced imminently by other companies in that both vaccines studied induced what is likely to be a protective immune response in most adults following a single dose in the same amount (15 micrograms) used in seasonal flu vaccines. Specifically, in blood samples obtained 8 to 10 days after vaccination:

* Among healthy adults who received a single 15-microgram dose of
the Sanofi Pasteur vaccine, a robust immune response was measured in 96
percent of adults aged 18 to 64 and in 56 percent of adults aged 65 and
* Similarly, among healthy adults who received a single
15-microgram dose of the CSL Limited vaccine, a robust immune response
was measured in 80 percent of adults aged 18 to 64 and in 60 percent of
adults aged 65 and older.

Additional data from the NIAID trials are forthcoming. However, on the basis of these strong early data, our results are consonant with other reports that a single 15-microgram dose of unadjuvanted 2009 H1N1 influenza vaccine is well tolerated and induces a robust immune response in healthy adults between the ages of 18 and 64. For adults aged 65 and over, the immune response to 2009 H1N1 influenza vaccine is somewhat less robust, as is the case with seasonal influenza vaccines.

We note that the slight discrepancies seen in our trials between the Sanofi Pasteur and CSL Limited vaccines may be due to technical differences in the preliminary measurement of the amounts of antigen in the doses used in the clinical trial lots and the relatively limited numbers of samples studied to date, as well as the fact that our data are drawn from a very early time point after immunization.

NIAID will continue to provide timely updates on these trials as well as those in children and in pregnant women, which began later.

Information from the NIAID studies will help inform the development of recommendations for immunization schedules, including the optimal dosage and number of doses for different age groups.

NIAID is conducting these clinical trials through its longstanding vaccine clinical trials infrastructure: the Vaccine and Treatment Evaluation Units, a network of medical centers that offers rapid response capability to test vaccines for emerging public health concerns. Detailed information is available from the NIAID Web site ( and from

Fayette Front Page
Georgia Front Page