NCPA Commends Pentagon Decision to Cover Pharmacist-Administered Vaccinations

(BUSINESS WIRE)--The Department of Defense today issued an interim final rule designating pharmacies as providers for H1N1, seasonal flu and pneumonia vaccinations under its TRICARE program. The policy change, effective today and expected to be fully implemented later this month, brings the program in line with other insurers that have covered pharmacist-administered vaccinations for years. TRICARE is also seeking comments on additional vaccines that should be covered through community pharmacies.

In response, National Community Pharmacists Association (NCPA) Executive Vice President and CEO Bruce T. Roberts, RPh, issued the following statement:

“NCPA strongly supports the Pentagon’s decision to cover the provision of these critical vaccines at community pharmacies. This is truly a case where everyone wins. The 9.5 million TRICARE-eligible patients gain a convenient new vaccination option. Taxpayers and plan administrators will save money when vaccines are administered at pharmacies instead of costlier doctors’ offices or hospitals. And community pharmacists can welcome millions of new patients through their doors.

“This is a shining example of how community pharmacists can help produce better health outcomes at lower cost. We commend the Defense Department for taking this step, which NCPA has long advocated. In addition, as these benefits are realized, we’re hopeful Pentagon officials will expand the program to cover additional vaccinations.”

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FDA Approves First Additive Solution for Platelet Storage Up to 5 Days

/PRNewswire/ -- The U.S. Food and Drug Administration today approved InterSol, the first solution approved to replace a portion of plasma used when storing platelets for up to five days, allowing some of the donor plasma to be used for other purposes.

In the United States, platelets, which are blood components that help with blood clotting, have been stored in donor plasma. About 65% of that plasma is replaced with the InterSol platelet additive solution.

Platelets are used to prevent or treat bleeding in individuals undergoing chemotherapy for cancer, after major trauma, during or after surgery, and in individuals who do not produce platelets. InterSol solution does not have a therapeutic effect by itself but acts to provide nutrients and an appropriate environment in which to store platelets.

"The approval of InterSol is a significant step in the development and marketing of novel processes for the storage of platelets," said Karen Midthun, MD, acting director of FDA's Center for Biologics Evaluation and Research.

The InterSol platelet additive solution is an aqueous solution of various salt components. It replaces a proportion of plasma in the storage of platelets collected by an automated instrument.

InterSol solution is manufactured by Fenwal Inc., Lake Zurich, IL.

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PrimaBella™ - First FDA-Cleared Prescription Device for Non-Invasive, Drug-Free Relief of Morning Sickness - Now Available

(BUSINESS WIRE)--PrimaBella™, the only non-invasive prescription therapeutic device cleared by the U.S. Food and Drug Administration (FDA) for the treatment of nausea and vomiting due to pregnancy (NVP), is now available. Providing a non-invasive, drug-free treatment for morning sickness, PrimaBella™ has been proven to be safe for both mother and developing baby and can offer quick relief -- the majority of patients report an immediate improvement in NVP symptoms.1

PrimaBella™ is a Class II neuromodulation device worn on the wrist, helping pregnant women experience relief from morning sickness without the concern of negative side effects from drugs, such as sedation.

“PrimaBella™ gives patients peace of mind while providing relief from potentially debilitating nausea and vomiting during pregnancy,” said Mike Hulse, MD, an OB/GYN and Chief of Staff at Northside Hospital Cherokee, in Atlanta, Georgia. “PrimaBella provides physicians like me with an effective treatment for managing NVP patients. PrimaBella’s adjustable features helps patients feel in control of their symptoms.”

Nausea may be a result of a dysrhythmic output of the central nervous system, resulting in an erratic stomach rhythm. When activated, PrimaBella™ emits gentle pulses through the median nerve on the underside of the wrist, which travel to the nausea center in the brain. These gentle pulses regulate the nausea signaling process between the brain and stomach (via the vagus nerve), restoring normal stomach rhythm and providing relief of nausea and vomiting.

PrimaBella™ is reimbursable by most insurance plans. For more information, visit www.PrimaBellaRx.com.

About Nausea and Vomiting Due To Pregnancy (NVP)

NVP affects approximately 70-85% of pregnant women and can range from mild symptoms, with a short duration, to severe symptoms that last throughout the pregnancy2. The most severe form of morning sickness (hyperemesis gravidarum) affects approximately 0.5–2% of pregnant women.2 The precise cause of NVP remains unknown.3 Nausea can occur at any time of the day although it is most common upon waking thus earning the common term, morning sickness4.

About PrimaBella™

PrimaBella™ neuromodulation device is intended for use in the treatment of nausea and vomiting due to pregnancy (NVP). PrimaBella™ technology is licensed by Alaven® Pharmaceutical LLC from Neurowave Medical Technologies™. The device is sold through prescription distribution channels and promoted to obstetricians and gynecologists by Alaven’s professional sales force.

IMPORTANT SAFETY INFORMATION

INDICATION: The PrimaBella™ Neuromodulation device is available by prescription only for the treatment of nausea and vomiting due to pregnancy (NVP).

WARNINGS: PrimaBella™ should only be used on the designated area. Nausea and vomiting may be signs of a serious health problem, seek medical attention if symptoms continue. PrimaBella™ is not a curative and should always be used under medical supervision. Treatment outcomes may vary depending on patient characteristics and any medications a patient may be taking. PrimaBella™ should be kept out of reach of children. Pacemaker users: Use this device only as directed on the wrist to prevent possible interference with your pacemaker. Avoid placing the electrodes of the device directly on your chest or near pacemaker. Consult with your physician if you have other implanted devices. PrimaBella™ should not be used above an IV line attached to a patient’s arm. If a patient is using an IV line, PrimaBella™ should be placed on the opposite arm.

CAUTION: PrimaBella™ contains natural rubber latex, which many cause allergic reactions, and is not recommended for use in conjunction with electrocautery or MRI equipment.

SIDE EFFECTS: Skin irritation can occur beneath or around the electrodes. If irritation occurs, move the device to the other wrist. If irritation does not disappear within 24 hours, stop using the device and consult your doctor or pharmacist. Continued use of the device on irritated skin may cause skin injury.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician or other health care professional licensed in the state in which they practice.

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Medicare Expands List of Covered Preventive Services to Include HIV Screening Tests

The Centers for Medicare & Medicaid Services (CMS) today announced its final decision to cover Human Immunodeficiency Virus (HIV) infection screening for Medicare beneficiaries who are at increased risk for the infection, including women who are pregnant and Medicare beneficiaries
of any age who voluntarily request the service. The decision is effective immediately.

Under the recently passed Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), CMS now has the flexibility of adding to Medicare's list of covered preventive services, if certain requirements are met. Prior to this law, Medicare could only cover additional preventive screening tests when Congress authorized it to do so.

"Today's decision marks an important milestone in the history of the Medicare program," said HHS Secretary Kathleen Sebelius. "Beginning with expanding coverage for HIV screening, we can now work proactively as a program to help keep Medicare beneficiaries healthy and take a more active role in evaluating the evidence for preventive services."

Under MIPPA, CMS can consider whether Medicare should cover preventive services that Congress has not already deemed as covered or non-covered by law. Among other requirements, the new services must have been "strongly recommended" or "recommended" by the U.S. Preventive Services Task Force. For instance, the Task Force graded HIV screening as "strongly recommended" for certain groups. More information about the Task Force is available online at
http://www.ahrq.gov/clinic/uspstfix.htm.

"Every adult should know their HIV status," said Dr. Howard K. Koh, HHS assistant secretary for health. "This decision by Medicare should help promote screening and save lives."

CMS uses the national coverage determination (NCD) process to make decisions on these types of preventive services. This process provides transparency about the evidence that CMS considers when making its decisions and allows opportunity for the public to comment on CMS'
proposals.

"Medicare's coverage of HIV screening tests is an important step forward in protecting beneficiaries from the potentially devastating and life-threatening complications of HIV and Acquired immunodeficiency Syndrome (AIDS)," said CMS Acting Administrator Charlene Frizzera.

AIDS is diagnosed when an HIV-infected person's immune system becomes severely compromised or a person becomes ill with an HIV-related infection. Of the more than one million estimated to have the HIV infection, the Centers for Disease Control and Prevention has estimated that about a quarter of them do not realize they are infected. Without treatment, AIDS develops within 8 to 10 years. While there is presently no cure for HIV, screening can help identify infected patients so that they can receive medical treatment that could help delay the onset of AIDS for years.

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Lung Cancer Alliance-Georgia Hails Senate Leadership on Lung Cancer Mortality Reduction Act of 2009

/PRNewswire/ -- Today, Lung Cancer Alliance-Georgia (LCA-GA) acknowledged Senators Saxby Chambliss (R-GA) and Johnny Isakson (R-GA) for their leadership and support in establishing the first ever multi-agency, comprehensive program targeted at lung cancer.

Entitled Lung Cancer Mortality Reduction Act of 2009, S.332 authorizes a five year program to reduce the mortality rate of lung cancer which continues to be the number one cause of cancer deaths both nationally and in the state of Georgia. Lung cancer causes more deaths each year than breast, prostate, colon, kidney, melanoma and liver cancers combined.

"Lung cancer is the leading cause of cancer deaths among men and women. Anything that can be done to increase the parity in funding for this deadly disease will be a significant advance in reducing cancer morbidity and mortality," commented Senator Chambliss. "This legislation is a strong step in the right direction."

"We must make every effort to address lung cancer comprehensively and not overlook the import of earlier detection and better disease management," said Senator Isakson. "This is how we are going to make a difference in lung cancer mortality,"

In thanking the senators for their support, LCA-GA Chair and lung cancer survivor, Ed Levitt said, "Senators Chambliss and Isakson are looked to as leaders on cancer issues and their co-sponsorships of this breakthrough legislation is very significant. We sincerely thank them and look forward to working to continue to improve lung cancer outcomes in Georgia and beyond."

The bill requires the Secretaries of Health and Human Services, Defense and Veterans Affairs to combine forces on a comprehensive, coordinated plan of action with funding authorized for five years to accomplish the mortality reduction goal.

The National Cancer Institute (NCI) is required to review its funding priorities in order to meet the lung cancer mortality reduction goal and more national institutes are called on directly to take part, including the National Institute of Heart, Lung and Blood, the National Institute of Biomedical Imaging and Bioengineering and the National Institute for Environmental Health

To ensure accountability, the bill requires an annual report to Congress and creates an oversight board composed of the three Cabinet Secretaries and representatives from the fields of lung cancer treatment, research and advocacy.

In addition, the bill directs the Secretaries of Department of Defense (DOD) and Veterans' Affairs (VA) to implement an early detection and disease management program for military personnel who are at high risk for lung cancer because of smoking or exposure to carcinogens during active duty.

The bill also:
-- Authorizes the Food and Drug Administration (FDA) to create a new Lung
Cancer Mortality Reduction drug program with incentives for new
treatments, targeted therapies, vaccines and chemoprevention drugs for
precancerous conditions.
-- Requires the Centers for Disease Control and Prevention to carry out
an early disease research program targeted at the high incidence and
mortality rates among minority and low-income populations.


The bill includes specific authorizations of $75,000,000 for certain NIH agencies in FY10 and authorizes such additional sums as may be necessary for all the cited agencies to accomplish the goal for FY 2010 through FY2014.

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Type 2 Diabetes Gene Predisposes Children to Obesity

/PRNewswire/ -- Pediatric researchers have found that a gene already implicated in the development of type 2 diabetes in adults also raises the risk of being overweight during childhood. The finding sheds light on the genetic origins of diabetes and may present an avenue for developing drugs to counteract the disease, which has been on the upswing in childhood and adolescence.

Researchers from The Children's Hospital of Philadelphia and the University of Pennsylvania School of Medicine published the study Nov. 23 in the online version of the journal Diabetes.

"It has been a bit of a mystery to scientists how or even if these adult diabetes genes function during childhood," said study leader Struan F.A. Grant, Ph.D., a researcher and associate director of the Center for Applied Genomics of The Children's Hospital of Philadelphia. "This finding suggests that there may be genetic activity during childhood that lays the foundation for the later development of type 2 diabetes."

Type 2 diabetes occurs either when the pancreas produces too little insulin, or when the body cannot efficiently use the insulin that is produced because the cells have become resistant. Formerly called adult-onset diabetes and still most common in adults, type 2 diabetes has been increasing sharply among children and teenagers.

Grant and study co-leader Hakon Hakonarson, M.D., Ph.D., director of the Center for Applied Genomics at Children's Hospital, investigated 20 gene variants, known as single nucleotide polymorphisms (SNPs), previously reported to be associated with type 2 diabetes. The researchers drew on a cohort of nearly 7,200 Caucasian children, aged 2 to 18 years, in an ongoing genome-wide association study of childhood obesity at Children's Hospital. Dividing the cohort randomly in half allowed the team to follow their discovery study with a replication study.

Researchers continue to unravel the complicated role of different diabetes-related genes in influencing body weight toward both lower and higher ends of the scale. The risk of developing type 2 diabetes in adulthood is often influenced by factors in the first year of life, including lower birth weight, as well as by higher body mass index (BMI) during childhood. Obesity is a well-known risk factor for type 2 diabetes.

A previous study earlier this year by the same study team found that another type 2 diabetes gene, CDKAL1, affects fetal growth and increases the likelihood that a baby will be underweight at birth.

The current study found that the gene HHEX-IDE does not affect birth weight, but makes it more likely that a child will become obese during childhood. The gene does not appear to predispose to obesity in adults, although by contributing to childhood obesity, it may set the stage for type 2 diabetes in adulthood.

Grant cautioned that HHEX-IDE accounts for only a small proportion of the genetic contribution to the risk of type 2 diabetes, so many other gene variants remain to be discovered. However, he adds, HHEX-IDE may represent an important underpinning of the disease. "Previously we thought that this gene affects insulin production during adulthood, but we now see that it may play an early role in influencing insulin resistance through its impact on body size during childhood," said Grant. "One implication is that if we can develop medicines to target specific biological pathways in childhood, we may be able to prevent diabetes from developing later in life."

The National Institutes of Health, the Cotswold Foundation and The Children's Hospital of Philadelphia supported this study.

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FDA, CDC, and States Investigating Norovirus Illnesses Linked to Oysters

The U.S. Food and Drug Administration is advising consumers to avoid eating oysters harvested from the San Antonio Bay on or after Nov. 16 due to reports of norovirus-associated illnesses in some people who had consumed oysters harvested from this area, which is located on the Gulf of Texas.

The FDA, along with the Centers for Disease Control and Prevention (CDC) and the states of North Carolina, South Carolina and Texas, are investigating about a dozen reports of norovirus-related illnesses from South Carolina and North Carolina consumers who ate oysters recently harvested from the San Antonio Bay.

Consumers who purchased oysters on or after Nov. 16 that have a label showing they came from San Antonio Bay are advised to dispose of the oysters and not eat them. At restaurants, consumers can ask about the source of oysters offered as menu items. Restaurant operators and retailers should not serve or offer for sale oysters subject to this advisory. Restaurant operators and retailers who are unsure of the source of oysters on hand should check with their suppliers to determine where the oysters were harvested. No other seafood is affected by this advisory.

The Texas Department of State Health Services has ordered a recall of all oysters harvested from the San Antonio Bay between Nov. 16 and Nov. 25.

Noroviruses are a group of viruses that cause gastroenteritis. Symptoms of illness associated with norovirus include nausea, vomiting, diarrhea and stomach cramping. Affected individuals often experience low-grade fever, chills, headache, muscle aches and a general sense of tiredness. Most people show symptoms within 48 hours of exposure to the virus. The illness typically lasts one to two days. Norovirus typically is not life-threatening and does not generally cause long-term effects.

Consumers who ate oyster products on or after Nov.16 and have experienced symptoms of norovirus are encouraged to contact their health care provider and local health department.

The implicated oyster beds in the San Antonio Bay were closed by the Texas Department of Health Services on Nov. 26, 2009, and remain closed.

The FDA and CDC will continue working with health officials in the affected states to track any additional cases of norovirus illness.

Persons with weakened immune systems, including those affected by AIDS, and persons with chronic alcohol abuse, liver, stomach or blood disorders, cancer, diabetes or kidney disease should avoid raw oyster consumption altogether, regardless of where the oysters are harvested.

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Studies Investigate Emerging Trends and Treatment Options for Patients With Sickle Cell Disease

/PRNewswire/ -- Sickle cell disease, a condition characterized by deformed and dysfunctional red blood cells, is one of the most common genetic blood disorders affecting millions of people around the world, including more than 70,000 Americans.(1) Research presented today at the 51st Annual Meeting of the American Society of Hematology highlights intriguing studies on the acute danger that the H1N1 pandemic presents for children with this blood disorder, evaluations of both new and standard treatments for common complications of sickle cell disease, and an expansion of the current understanding of hemoglobin expression in red blood cells that may lead to new treatments.

"Treatment for sickle cell disease consists primarily of life-long supportive care, with the only cure being bone marrow transplantation -- a risky procedure that is not readily available for most patients," said Alexis Thompson, MD, PhD, moderator of the press conference and Hematology Section Head at the Children's Memorial Hospital and Associate Professor of Pediatrics, at Northwestern University Feinberg School of Medicine, Chicago. "Therefore, research in this area is particularly important to help ensure that improved therapies continue to be developed and that patients with sickle cell disease have access to the best possible care."

NOTES:

(1) National Heart, Lung, and Blood Institute. Facts About Sickle Cell Anemia. Available at: http://www.nhlbi.nih.gov/health/public/blood/sickle/sca_fact.pdf.

Control of Hemoglobin Switching by BCL11A [Abstract #5]

As infants develop in the womb, the gamma-globin gene produces a fetal form of hemoglobin, the protein inside red blood cells that carries oxygen. Shortly after birth, a switch to beta-globin gene expression normally occurs, which leads to the production of adult hemoglobin. Both fetal and adult hemoglobin function similarly, though fetal hemoglobin has a greater affinity for binding with oxygen.

Patients with sickle cell disease have a defective form of adult hemoglobin that causes their red blood cells to become deformed and sickle shaped. As a result, the cells are unable to efficiently carry oxygen to the body's tissues and often stick together and jam vessels, causing blood flow obstruction and episodes of severe pain. If a patient with sickle cell could continue production of the fetal hemoglobin and produce less of their defective adult sickle hemoglobin, many of their complications could possibly be reduced or eliminated. A team of researchers from Harvard Medical School in Boston studied the therapeutic possibility of turning the genetic "switch" back on for the production of fetal hemoglobin to replace the defective adult hemoglobin and alleviate these devastating symptoms.

In previous studies, a gene called BCL11A was found to be involved in blocking the expression of fetal hemoglobin in adults. To test these findings in vivo and investigate the role of BCL11A in hemoglobin regulation at different developmental stages, the researchers performed genetic tests in both embryonic and adult mice that were genetically engineered to carry a complete human beta-globin gene cluster capable of producing adult hemoglobin.

In the embryonic mice, inactivation of the BCL11A gene led to a robust expression of gamma-globin (the fetal form of hemoglobin) during late gestation: more than 90 percent of the globin produced was of this type. Tissue-specific deletion of the BCL11A gene in the adult mice (8-10 weeks old) resulted in an increase of more than 1,000-fold in gamma-globin gene expression in the bone marrow erythroblasts (the precursors to red blood cells) of the experimental mice in comparison to control mice. This increase in the gamma-globin expression after inactivation of BCL11A was rapid and persisted during the course of the experiments (up until the mice were 25 weeks old).

"Currently, there are only a limited number of therapies available for patients with sickle cell disease and thalassemia, another disorder involving abnormal hemoglobin," said senior study author Stuart H. Orkin, MD, David G. Nathan Professor of Pediatrics at Dana-Farber Cancer Institute, Children's Hospital Boston, and Harvard Medical School in Boston. "This research opens up a new avenue for treatment, a way to genetically activate healthy fetal hemoglobin in the red blood cells of patients with these lifelong blood disorders."


Hydroxyurea in Children With Sickle Cell Disease: Practice Patterns and Barriers to Utilization

[Abstract #242]

Sickle cell disease is often marked by episodes of severe and incapacitating pain called vaso-occlusive painful events, which can sometimes require hospitalization. Hydroxyurea, an oral drug that is most commonly taken once daily, was approved by the U.S. Food and Drug Administration for use in sickle cell disease patients in 1998. While hydroxyurea remains the standard of care for reducing these painful events in adults, little is known about its practice patterns in children. Researchers from the Medical College of Wisconsin and Children's Research Institute of the Children's Hospital of Wisconsin in Milwaukee investigated the patterns and barriers to hydroxyurea use in children with sickle cell disease.

In this study, researchers surveyed members of the American Society of Pediatric Hematology/Oncology about their practices and patients. Of the 1,128 surveys disseminated, 31 percent (350 surveys) were returned.

To standardize and increase the quality of care for both adults and children with sickle cell disease, the National Heart, Lung, and Blood Institute (NHLBI) provides clinical practice guidelines for the management of this blood disorder. Most of the survey respondents had heard of (87 percent) and read (78 percent) these guidelines, and provider utilization of hydroxyurea correlated with awareness of the NHLBI recommendations.

The survey found that only 8 percent of providers had half or most (50 to 90 percent) of their pediatric patients with sickle cell disease on hydroxyurea. Another 54 percent of providers had 10 to 30 percent of pediatric patients on the therapy, and 10 percent of providers had fewer than 10 percent of pediatric patients on hydroxyurea. Although a majority of providers (90 percent) felt that hydroxyurea was effective or very effective for the prevention of pain, some still did not prescribe the drug to eligible children because of apprehension about future reproductive issues (birth defects and infertility in males), despite insufficient evidence to support this concern. Low patient compliance was cited by 86 percent of providers as another reason they did not prescribe hydroxyurea. Providers reported that children and their families refused hydroxyurea because of a fear of cancer or other possible side effects, concerns that the drug would not work, compliance with required laboratory monitoring, or because they simply did not want to take medication.

The study also found that many providers prescribed hydroxyurea for reasons other than that for which it was intended, despite insufficient evidence of its efficacy for other complications of the disease.

"Our survey suggests a substantial variation in hydroxyurea utilization in children with sickle cell disease with barriers to its use found on the part of both providers and patients," said lead study author Amanda M. Brandow, DO, MS, Assistant Professor of Pediatrics at the Medical College of Wisconsin and the Children's Research Institute of the Children's Hospital of Wisconsin in Milwaukee. "To alleviate this problem, future research in the following areas may help: continued funding of studies to determine the efficacy of hydroxyurea for complications other than pain, evaluating unconfirmed toxicities of the drug that influence practice, exploring how access to care contributes to noncompliance, and research on methods to promote patient adherence to recommended medical care."

Dr. Brandow will present this study during an oral session on Monday, December 7, at 7:15 a.m. in Room 388-390.

Increased Severity of Pandemic H1N1 Influenza in Children and Young Adults With Sickle Cell Disease [Abstract #264]

Patients with sickle cell disease are more susceptible to infection than the general population. In particular, influenza, a viral disease that affects the respiratory system, is more than 50 times more frequent in children with sickle cell disease than in the general population, according to research conducted by John J. Strouse, MD, PhD, the lead author on this study, and colleagues. As H1N1 influenza, which began circulating in the United States in April 2009, has been reported to cause more severe illness in children and young adults than seasonal flu, researchers from The Johns Hopkins University School of Medicine in Baltimore sought to compare the clinical characteristics and complications associated with these infections in sickle cell disease patients under the age of 21 through a prospective analysis of patient discharge and billing records from September 1993 through July 2009.

During the study period, 99 patients who were seen at The Johns Hopkins Hospital in Baltimore were identified as having both sickle cell disease and influenza (89 with seasonal influenza and 10 with H1N1 influenza). Clinical symptoms, such as fever, cough, and runny nose, were similar between the two groups, although those with H1N1 influenza were at an estimated three-fold increased risk for life-threatening complications, such as acute chest syndrome (a severe lung illness), and nine times more likely to require intensive care, such as ventilator support.

"Our findings underscore that receiving a vaccination against H1N1 influenza, in addition to seasonal influenza, is extremely important for the health and safety of children and young adults with sickle cell disease," said lead author John J. Strouse, MD, PhD, Assistant Professor of Pediatrics and Medicine at The Johns Hopkins University School of Medicine in Baltimore.

Dr. Strouse will present this study in an oral session on Monday, December 7, at 8:15 a.m. in Room 220-222.

Safety and Efficacy of Sildenafil Therapy for Doppler-Defined Pulmonary Hypertension in Patients With Sickle Cell Disease: Preliminary Results of the Walk-PHaSST Clinical Trial [Abstract #571]

As patients with sickle cell disease have a high rate of hemolysis (red blood cell destruction), excessive amounts of hemoglobin are released into the blood stream that react with and destroy nitric oxide, a critical regulator that dilates blood vessels and inhibits clotting. This can lead to pulmonary hypertension, or abnormally high blood pressure in the arteries of lungs that also affects the heart. Approximately 10 to 30 percent of patients with sickle cell disease are suspected to have this life-threatening condition.

While the oral drug sildenafil (known as Revatio®) is approved to treat pulmonary arterial hypertension, it is unknown whether it is a safe and effective treatment for pulmonary hypertension in those with sickle cell disease. Therefore, a 16-week, double-blind clinical trial, known as the Walk-PHaSST study (treatment of Pulmonary Hypertension and Sickle cell disease with Sildenafil Therapy) was conducted in 10 medical centers in the United States and United Kingdom to test this application in adults and children over 12 years of age with sickle cell disease.

Before starting treatment, potential study participants were given baseline tests, including a Doppler echocardiogram and a six-minute walk test to measure heart and lung function. Seventy-four patients who had a tricuspid regurgitant jet velocity (TRV) of greater than or equal to 2.7 m/s (a sign of suspected high pulmonary blood pressure) and a six-minute walking distance of only 150-500 meters (reflecting decreased exercise capacity) were included in the study. The researchers then randomly assigned the study participants into two groups of 37 patients each. Half of the patients were treated with sildenafil at escalating doses from 20, 40, and 80 mg three times per day, and the other half received a placebo three times per day. In previous studies of patients with primary pulmonary hypertension, the highest dose of sildenafil (80 mg) had the greatest effect on blood circulation; however, to monitor for possible adverse effects associated with escalating doses, the sildenafil doses in this study were increased slowly, with dose increases made every four weeks.

The study was prematurely stopped when a significant number of the patients in the sildenafil treatment arm (46 percent) began experiencing serious side effects (primarily sickle cell pain crises requiring hospitalization), compared with only 22 percent of those in the placebo arm. Headache and blurred vision, which were expected side effects of sildenafil, were also experienced. The patients in the sildenafil group had more headaches (27 percent versus 14 percent) and more blurred vision (11 percent versus 3 percent) than the placebo group.

Prior to stopping the study, 33 patients had completed the 16-week assessment and were found to have no change in TRV value or in the walking distance test. On pain questionnaires, patients on the sildenafil treatment also reported worsening pain during walking and less enjoyment of life when compared to the patients on placebo.

"Although sildenafil is approved by the U.S. Food and Drug Administration and by the European Medicines Agency for patients with pulmonary arterial hypertension, the Walk-PHaSST study was prematurely stopped for safety concerns. However, these preliminary data should not be interpreted as implying that sildenafil may not be efficacious and safe in select sickle cell patients with documented pulmonary hypertension who are at low risk for vaso-occlusive events," said lead study author Mark Gladwin, MD, Chief of the Division of Pulmonary, Allergy, and Critical Care Medicine and Director of the Vascular Medicine Institute at the University of Pittsburgh Medical Center. "Further investigations are critically needed to find a safe and effective treatment for this patient population at high risk for death from this debilitating condition."

Dr. Gladwin will present this study in an oral session on Monday, December 7, at 2:45 p.m. in Room 220-222.

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VELCADE® (Bortezomib) for Injection Based Regimens Result in Lower Costs and Less Patient Burden Than Other Commonly Used Multiple Myeloma Treatment

(BUSINESS WIRE)--Millennium: The Takeda Oncology Company today announced that two studies presented at the 51st American Society of Hematology (ASH) Annual Meeting found that VELCADE based regimens are more cost-effective for payers and reduced out-of-pocket costs for patients than other commonly used multiple myeloma treatments. The study found that VELCADE-melphalan-prednisone (VMP), a commonly used treatment in multiple myeloma, was more cost-effective compared to MP and delivered more cost-savings compared to melphalan-prednisone-thalidomide (MPT), another commonly used treatment regimen, based on a health economic model.

A second study based on claims data found patients with multiple myeloma treated with VELCADE:

* Incurred fewer out-of-pocket costs than patients treated with the oral drugs thalidomide and lenalidomide
* Did not require significantly more healthcare visits than patients prescribed thalidomide and lenalidomide.

“These studies support VELCADE’s overall cost-effectiveness and reduced out-of-pocket costs. As measured by the number of healthcare visits, VELCADE appears to be as convenient as oral multiple myeloma treatments,” said Dixie-Lee Esseltine, M.D., Vice President, Global Medical Affairs, Millennium. “This is valuable information for healthcare providers, patients and payers.”

The Cost-Effectiveness of Bortezomib for the Initial Treatment of Multiple Myeloma in the United States (Abstract #1379)

Based on a direct comparison of patient-level data, researchers projected that VMP would be cost-effective over a patient’s lifetime compared with MP in the United States. A second indirect comparison across different trials projected the combination of VMP would cost payers 17.7 percent less over a patient’s lifetime and generate better quality-adjusted life expectancy than MPT. Quality-adjusted life years are a measure of disease burden that take into account both the length and quality of life.

The incremental cost-effectiveness of VMP versus MP was found to be within the generally accepted cost-effectiveness range of $50,000-$100,000 per quality-adjusted life year. The projected overall survival years were greatest for patients treated with VMP versus those treated with MPT or MP (4.19, 4.14, and 2.86 years, respectively).

“Cancer can be a costly disease for both payers and patients, and this is certainly true in multiple myeloma,” said Professor Lou Garrison, a study co-author and Associate Director in the Pharmaceutical Outcomes Research and Policy Program, Department of Pharmacy, University of Washington, Seattle. “It is therefore important to identify cost-effective therapies. This trial-based modeling study demonstrates that the first-line regimen using VELCADE is cost-effective compared to other commonly used regimens.”

To assess the relative costs and outcomes of different treatment combinations, study methodology generated modeling projections based on a direct comparison from the Phase III VISTA1 trial, which demonstrated superiority in overall survival of VMP versus MP (San Miguel et al, New England Journal of Medicine 2008) for treatment of multiple myeloma, as well as an indirect comparison of this trial with data published from the IFM 99-06 clinical trial for MPT (Facon et al, Lancet 2007). Costs included per-protocol drug and medical costs, treatment-related adverse events, second-line treatment, and resource utilization during treatment-free interval and progressive disease. Unit costs of medications were obtained from published literature.

Multiple Myeloma: Patient Out-Of-Pocket Costs and Health Care Utilization (Abstract #1366)

In the second study, researchers used data from one of the largest U.S. commercial healthcare plans to evaluate the number of healthcare visits and out-of-pocket costs for multiple myeloma patients being treated with various therapies. After adjusting for patient characteristics, line of treatment, and co-morbidities by multivariate analysis, data showed that patients receiving VELCADE did not have a significantly different number of healthcare visits than those receiving lenalidomide or thalidomide, two oral therapies. Additionally, direct out-of-pocket costs were found to be significantly lower for patients treated with VELCADE than patients treated with thalidomide or lenalidomide.

“There is a common perception that oral drugs are more convenient for patients, but these data show that, in terms of healthcare visits, that perception of convenience is false,” said study author Brett W. Pinsky, i3 Innovus researcher. “These data are consistent with the fact that patients with multiple myeloma typically require a great deal of care and resource utilization; therefore, most patients will not see a major difference in the number of healthcare visits regardless of whether their treatment is oral or infusion – but they may face a significantly higher out-of-pocket cost with oral medications.”

The total patient out-of-pocket costs for the year after treatment initiation were significantly less for patients treated with VELCADE ($3,504) than for those treated with either of the oral drugs thalidomide ($4,443, p<0.05) or lenalidomide ($4,766, p<0.05), after adjusting for patient characteristics, line of treatment, and co-morbidities by multivariate analysis. These differences were greatest for Medicare patients, with the adjusted patient costs nearly two and three times greater for thalidomide ($8,824) and lenalidomide ($12,568), respectively, compared with VELCADE ($4,395).

The study is a retrospective cohort study, which used claims data from a large national U.S. commercial health plan representing approximately 14 million members, and included a total of 2,642 treatment episodes for the 1,900 multiple myeloma patients.

Both studies were supported by Millennium Pharmaceuticals, Inc. The Wang study was also supported by Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

About Multiple Myeloma

Multiple myeloma is the second most common hematologic malignancy and although the disease is predominantly a cancer of the elderly (the median age of onset is 70 years), recent statistics indicate both increasing incidence and younger age of onset. In the U.S., more than 50,000 individuals have MM and 20,000 new cases are diagnosed each year. Worldwide there are approximately 74,000 new cases and over 45,000 deaths annually.

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FDA Approves Kalbitor for Treating Potentially Life-Threatening Attacks of Hereditary Angioedema

The U.S. Food and Drug Administration approved Kalbitor (ecallantide) on Dec. 1 to treat sudden and potentially life-threatening fluid buildup that can occur in people with a rare genetic condition known as hereditary angioedema (HAE).

HAE is caused by a defect in the blood protein C1 esterase-inhibitor, which plays a role in regulating how certain immune system and blood clotting pathways function. Decreased function of this protein can lead to rapid and serious swelling of the face or other parts of the body, which may result in permanent disfigurement, disability or death. Swelling of the digestive tract may cause excruciating abdominal pain, nausea, and vomiting, while airway swelling puts patients at risk of suffocation. About 10,000 people in the United States have HAE.

“Kalbitor offers another potentially life-saving option for those people with HAE,” said John Jenkins, M.D., director, Office of New Drugs, in the FDA’s Center for Drug Evaluation and Research. “FDA is committed to facilitating the development and approval of safe and effective therapies for patients with rare conditions.”

This is the second drug marketed in the United States to treat HAE attacks. In October 2009 the FDA approved Berinert, a C1-inhibitor derived from blood plasma to treat facial and abdominal attacks of HAE.

Kalbitor is a liquid that is intended to be injected under the skin for patients age 16 and older who experience HAE attacks.

The medication’s most serious side effect is anaphylaxis, a severe allergic reaction that can close a person’s airways and stop them from breathing. Other side effects include headache, nausea, diarrhea, swelling in the nose and throat, fever, and skin irritations.

Kalbitor should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis.

The drug is marketed by Dyax Corp., Cambridge, Mass. The second HAE drug, Berinert, is marketed by CSL Behring Inc., Marburg, Germany.

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The Kenneth Rainin Foundation Announces $100,000 Innovator Awards Program for Inflammatory Bowel Disease (IBD) Research

/PRNewswire/ -- The Kenneth Rainin Foundation announced today its new Innovator Awards Program for Inflammatory Bowel Disease. The Program is designed to accelerate the pace of discovery in IBD research. Approximately four million people worldwide suffer from some form of IBD and most are diagnosed between the ages of 20 and 40.

"Launching the Kenneth Rainin Foundation's Innovator Awards Program for IBD research is very exciting for all of us," said Jen Rainin, president of the Kenneth Rainin Foundation. "Our Program is unique in that it encourages investigators from all scientific disciplines and from any non-profit research institution to collaborate to explore bold and innovative ideas that can expand our understanding of IBD, which, in turn, will have a major impact in finding a cure for IBD."

Jen Rainin is the daughter of the late founder, Kenneth Rainin, who suffered greatly from IBD. To further his memory and accomplish the Foundation's mission of no one suffering from IBD, the Innovator Awards Program is focused on finding applicants with diverse backgrounds who can help build a creative, conceptual paradigm for IBD with emphasis on the importance of nurturing interdisciplinary collaboration between fields. Alternative approaches that are nutrition-based or holistic in nature may also play an important role in our research.

Initial one-year grants of $100,000 will be awarded once annually. The first round of applications will be accepted February 15 - March 15, 2010. Applications must be submitted online, and selected applicants will be notified in July, 2010. Applications will be initially reviewed by our Scientific Advisory Board. Based on their recommendations, final selections will be made by the Foundation's Board. Successful projects will be eligible for significant multi-year funding based on the initial year's proof of principle work.

About Inflammatory Bowel Disease

Inflammatory bowel disease (IBD) is a group of inflammatory conditions of the gastrointestinal tract. The main forms of IBD are Crohn's Disease and ulcerative colitis. Symptoms include pain, bleeding and debilitation. Current therapeutic options for patients are largely limited to the use of anti-inflammatory steroids applied either systemically or locally for the treatment of the symptoms. Removal of the colon is the only cure at this time.

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FDA Approves Agriflu Seasonal Influenza Vaccine

The U.S. Food and Drug Administration today approved Agriflu for people ages 18 years and older to prevent disease caused by influenza virus subtypes A and B.

Agriflu, manufactured by Novartis Vaccines and Diagnostics in Siena, Italy, was approved using the FDA’s accelerated approval pathway, which helps safe and effective medical products for serious or life-threatening diseases become available sooner. In this case, Novartis demonstrated that the vaccine induced levels of antibodies in the blood likely to be effective in preventing seasonal influenza.

Agriflu is administered as a single injection in the upper arm and is available in single dose, pre-filled syringes that do not contain preservatives.

“The approval of the new seasonal influenza vaccine, Agriflu, is an important step in adding to the production capacity to enhance the supply of vaccine for the United States for future influenza seasons,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research.

Common side effects in clinical studies included pain, swelling and redness at the injection site, headache, muscle aches and malaise. People with severe or life-threatening allergies to chicken eggs, or to any other substance in the vaccine, should not be vaccinated.

As part of the accelerated approval process, Novartis is required to conduct further studies to verify that the vaccine induces levels of antibodies in the blood that are effective in preventing seasonal influenza. The company also manufactures another licensed seasonal influenza vaccine, Fluvirin, for use in the United States. Fluvirinis approved for people ages 4 years and older. Agriflu is not intended to protect against the 2009 H1N1 influenza.

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Highest Rates of Obesity, Diabetes in the South, Appalachia, and Some Tribal Lands

Wide sections of the Southeast, Appalachia, and some tribal lands in the West and Northern Plains have the nation's highest rates of obesity and diabetes, according to estimates released today by the Centers for Disease Control and Prevention. In many counties in those regions, rates of diagnosed diabetes exceed 10 percent and obesity prevalence is more than 30 percent.

The estimates, in this week's Morbidity and Mortality Weekly Report, are the first to provide county-level snapshots of obesity across the United States. They also update diabetes county-level estimates released in 2008.

Eighty-one percent of counties in the Appalachian region that includes Kentucky, Tennessee, and West Virginia have high rates of diabetes and obesity. So do three-quarters of counties in the southern region that includes Alabama, Georgia, Louisiana, Mississippi, and South Carolina.

"Diabetes is costly in human and economic terms, and it's urgent that we take action to prevent and control this serious disease," said Dr. Ann Albright, director of CDC's Division of Diabetes Translation. "The study shows strong regional patterns of diabetes and can help focus prevention efforts where they are most needed."

The estimates come from the agency's Behavioral Risk Factor Surveillance System (BRFSS), which uses self-reported data from state-based adult telephone surveys, and 2007 census information. The information may help public health workers, health care providers, community organizations, and policymakers focus on high-risk regions to prevent type 2 diabetes and its complications as well as other chronic diseases linked to obesity, including heart disease, stroke, and some cancers.

The proportion of U.S. adults who are obese was 26.1 percent in 2008, according to BRFSS data. CDC estimates that nearly 8 percent of the population, or about 24 million people, have diabetes. Of these, 5.7 million are undiagnosed.

"The small-area estimates for obesity will be an important tool to help communities better understand and battle this serious public health problem. Communities are in the best position to prevent and reduce obesity among their citizens through innovative programs," said Dr. William H. Dietz, director of CDC's Division of Nutrition, Physical Activity and Obesity.

The medical costs of obesity reached an estimated $147 billion in 2008, and the medical costs of diabetes were $116 billion. People with diagnosed diabetes have medical costs that are 2.3 times higher than those without the disease.

Obesity is one of several factors linked to type 2 diabetes. Where people live, how much money they earn, their culture and their family history also play a role. An unhealthy diet, lack of physical activity, and socioeconomic factors contribute to both obesity and type 2 diabetes as well as to complications of diabetes. Some population groups also are at higher risk, including a number of racial and ethnic minorities.

CDC and its partners are working on a variety of initiatives to prevent type 2 diabetes and to reduce obesity. CDC has recommended 24 community strategies to prevent obesity, from providing greater access to healthy foods to redesigning communities to encourage more physical activity. The agency is also in a new partnership with state, federal, and nonprofit agencies targeting health disparities in Mississippi, which has the nation's highest obesity rate and one of the highest rates of diabetes. CDC's national diabetes prevention and control program provides resources and technical assistance to state health departments, national organizations, and communities.

To see county-level estimates of obesity and diagnosed diabetes, go to www.cdc.gov/diabetes/statistics. For more information on diabetes and preventing the disease, visit www.cdc.gov/diabetes. To learn more about CDC s efforts in the fight against obesity or for more information about nutrition, physical activity, and maintaining a healthy weight, go to www.cdc.gov/obesity/index.html.

/PRNewswire-USNewswire

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American College of Surgeons Voices Strong Support for American Cancer Society Screening Mammography Guidelines

/PRNewswire/ -- The American College of Surgeons (ACoS) today released comments strongly supporting current American Cancer Society (ACS) screening mammography guidelines that recommend women get a mammogram every year, starting at age 40. The College is supporting the ACS guidelines despite the recommendations from the U.S. Preventive Services Task Force stating the women should have regular mammograms once every two years beginning at the age of 50. The College believes the ACS guidelines have resulted in an effective approach toward dealing with the possibility of breast cancer and that women should continue to follow them in consultation with their physicians.

The federal panel's position that regular mammography screening in women under the age of 50 may do more harm than good was dismissed by David P. Winchester, MD, FACS, Medical Director of ACoS Cancer Programs, and Chair of the National Accreditation Program of Breast Centers. Dr. Winchester was particularly concerned about the panel's belief that mammography may cause an increased risk of false-positive results in younger women who have denser breast tissue, observing that "the term unnecessary biopsy is misleading. In most cases," he said, "biopsy -- done by either surgeons or radiologists -- is the reliable way to rule out cancer at any age."

The College notes that the American Cancer Society has long recognized mammography "as the gold standard for early detection of breast cancer,"* and ACoS encourages women to take an active role in partnering with their physicians to determine at what age, and what interval, they should undergo screening mammography. The College agrees with the ACS that factors such as a woman's family history of the disease and her overall medical condition are some of the issues that should be addressed, particularly for women who are known to be at an increased risk for developing the disease.

"Many surgeons in this country have the tremendous responsibility and privilege of caring for breast cancer patients each day. While recognizing that mammography is not perfect and supporting continuing research for improved methods, the surgical community believes that the American Cancer Society's screening mammography guidelines offer an optimal approach to detecting breast cancer early, when it can be most successfully treated," Lamar S. McGinnis, Jr., MD, FACS, President of the American College of Surgeons and former president of the American Cancer Society, said. "Mammography is a good and safe tool, which we will continue to improve. In the meantime," he added, "let's save lives as best we can. The lives of women, mothers, and grandmothers are invaluable. Our progress has been significant, and it will continue. Let us not confuse our patients and the public with mixed messages."

About the American College of SurgeonsThe American College of Surgeons is a scientific and educational organization of surgeons that was founded in 1913 to raise the standards of surgical practice and to improve the care of the surgical patient. The College is dedicated to the ethical and competent practice of surgery. Its achievements have significantly influenced the course of scientific surgery in America and have established it as an important advocate for all surgical patients. The College has more than 77,000 members and is the largest organization of surgeons in the world. For more information, visit www.facs.org.

In the field of cancer care, the American College of Surgeons Commission on Cancer (CoC) is a pioneer in measuring performance. All hospitals and freestanding cancer treatment facilities approved by the CoC report clinical data through the National Cancer Data Base and receive evidence-based benchmark comparison reports based on accepted standards of care for breast and colorectal cancers. These measures are endorsed by the National Quality Forum. In addition, the College administers the National Accreditation Program for Breast Centers (NAPBC), a consortium of national, professional organizations dedicated to the improvement of the quality of care and the monitoring of outcomes for patients with diseases of the breast.

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$10 Million in Grants Aimed at Enrolling American Indian, Alaska Native Kids in Health Care to be Awarded

HHS Secretary Kathleen Sebelius today announced the availability of up to $10 million in grants to help reach American Indian and Alaska Native (AI/AN) children who qualify for, but are not yet enrolled, in Medicaid and the Children's Health Insurance Program (CHIP).

These new grants are part of a broader effort to find and enroll uninsured children who are eligible for Medicaid or CHIP but not enrolled. 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 uninsured children, including $10 million specifically for Indian health providers.

As called for in CHIPRA, grants will be awarded by the Centers for Medicare & Medicaid Services (CMS) to applicants whose outreach, enrollment and retention efforts will target geographic areas with high rates of eligible but uninsured American Indian and Alaska Native
children, who often live in isolated areas and are uninsured at higher-than-average rates.

"American Indian children are often uninsured, although many are eligible for Medicaid and CHIP," Secretary Sebelius said. "These grants will help Tribes and Indian health providers reach out to children and families to ensure more children get the health care they need."

Grants will be awarded to applicants that will be able to demonstrate increases in enrollment and improved retention of children already in Medicaid and CHIP. Grantees will report to CMS the number of new enrollees and those who retained coverage that are directly attributable
to the grant activities. Grantees will also report activities they believe were the most effective in finding, enrolling and maintaining coverage for eligible children.

"States have been effective in enrolling over 28 million children in Medicaid and more than 7 million children in CHIP, but there are still millions of uninsured, low-income children who are not enrolled in these programs even though they are eligible" said Cindy Mann, the director of
the CMS Center for Medicaid and State Operations. "We are looking forward to innovative grant proposals that will put new outreach, enrollment and renewal systems in place to ensure that uninsured Indian children get enrolled and stay enrolled for as long as they are eligible."

Applications are due by Jan. 15, 2010, and the grants will be awarded on April 15. Grants will be available to:

* The Indian Health Service;
* Tribes and Tribal organizations operating a health program; and,
* Urban Indian organizations operating a health program.

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