Streptococci and E. coli Continue to Put Newborns at Risk for Sepsis

Bloodstream infections in newborns can lead to serious complications with substantial morbidity and mortality. What’s more, the pathogens responsible for neonatal infections have changed over time. In recent years, however, antibiotic prophylaxis given to at-risk mothers has reduced the incidence of early-onset group B streptococcal infections among their babies.

A new nationwide, multi-site study aimed at determining current early-onset sepsis rates among newborns, the pathogens involved, and associated morbidity and mortality demonstrates that the most frequent pathogens associated with sepsis are group B streptococci (GBS) in full-term infants and Escherichia coli in preterm infants.

The study, which included nearly 400,000 newborns, also found that infection rates in newborns increased with decreasing gestational age and birth weight. The overall rate of infection was 0.98 per 1,000 live births; 0.41 per 1,000 live births involving GBS and 0.28 per 1,000 live births involving E. coli.

The study appears online April 25 and in the May 2011 issue of Pediatrics.

GBS emerged as the leading cause of early-onset sepsis and meningitis in newborns in the 1970s. In 2002, the Centers for Disease Control and Prevention recommended universal screening of women at 35 to 37 weeks of pregnancy followed by chemoprophylaxis for women with GBS colonization.

Sepsis occurs when pathogenic bacteria enter the blood stream, causing systemic infection. In infants less than 72 hours old, sepsis is considered of early onset.

“Infections occur in almost one case per thousand live births,” says Barbara Stoll, MD, lead investigator for the study. Stoll is the George W. Brumley, Jr., Professor and Chair, Department of Pediatrics in Emory University School of Medicine. “With approximately 4 million births a year in the United States, this equates to a substantial burden of disease. We estimate that approximately 3,000 infants a year develop early-onset sepsis. With current mortality rates, approximately 300 to 350 deaths per year are associated with neonatal sepsis. So, it’s not inconsequential.”

The study also shows that opportunities for prevention of neonatal GBS infections continue to be missed. “Missed opportunities for prevention of GBS include failure to screen all women who deliver at term, failure to provide antibiotics to all colonized women or to those who delivered preterm with unknown colonization status and false negative GBS screens among women who deliver with GBS infection,” says Stoll.

“Our findings suggest that accurate point-of-care diagnostic tests at the time a woman comes in for delivery would enhance our ability to identify at-risk women.”

In addition, the gap in linking electronic medical records between a woman’s obstetrician and the hospital where she delivers can also impede prevention. “A community health record that links the medical record in a physician’s office with the hospital where the woman gets care could enhance identification and therapy for at-risk women,” says Stoll. “If a woman has been screened for GBS and is known to be colonized, that information should be available to the health care team taking care of her at the time she is in labor.”

The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the Centers for Disease Control and Prevention.

By Robin Tricoles

-----

Community News You Can Use
Click to read MORE news:
www.GeorgiaFrontPage.com
Twitter: @gafrontpage & @TheGATable @HookedonHistory
www.ArtsAcrossGeorgia.com
Twitter: @artsacrossga, @softnblue, @RimbomboAAG @FayetteFP

FDA Approves Head Lice Treatment for Children and Adults

The U.S. Food and Drug Administration today approved Natroba (spinosad) Topical Suspension 0.9% for the treatment of head lice infestation in patients ages 4 years and older.

Head lice are parasitic insects found on people’s head, eyebrows, and eyelashes. They feed on human blood several times a day but are not known to cause disease. Head lice are spread mainly by direct head-to-head contact with a person who already has head lice. Lice move by crawling and can easily travel from child to child because children play closely together and often in large groups.

“Natroba provides another option for the topical treatment of head lice infestations, which are especially prevalent in the pediatric population,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. “Head lice is a common problem among school children in the United States.”

Natroba is a topical drug product and should be applied only to the child’s scalp or hair. The product should be used exactly as prescribed by a health care professional.

The safety and effectiveness of Natroba Topical Suspension 0.9 %, has been established in two multicenter, randomized, active-controlled studies. A total of 552 subjects received a 10-minute treatment with Natroba. If live lice were seen a week later, a second treatment was applied. The proportion of subjects who were lice-free fourteen days after the final treatment of Natroba was approximately 86 percent compared to 44 percent of the control group.

Common adverse events reported include redness or irritation of the eyes and skin.

Safety in pediatric patients below the age of 4 years has not been established. Although Natroba is not approved for use in children younger than 4 years, it is especially important not to use in infants because the product contains benzyl alcohol. Benzyl alcohol has been associated with serious adverse reactions, including death, when applied topically to the skin of children younger than 6 months.

Natroba is manufactured for ParaPRO LLC of Carmel, Ind.

-----
Community News You Can Use
Click to read MORE news:
www.GeorgiaFrontPage.com
Twitter: @gafrontpage & @TheGATable @HookedonHistory
www.ArtsAcrossGeorgia.com
Twitter: @artsacrossga, @softnblue, @RimbomboAAG @FayetteFP

Infant/Toddler Head-Circumference Charts May Misdiagnose Patients, Children's Hospital Study Finds

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

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

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

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

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

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

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

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

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

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

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

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

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

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

----
Community News You Can Use
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
Follow us on Twitter:  @GAFrontPage

FDA Approves Pediatric Use of Chemical Poisoning Treatment

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

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

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

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

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

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

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

-----
Community News You Can Use
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
Follow us on Twitter:  @GAFrontPage

New Pediatrics Report Urges Medical Community to Address Underlying Pathologies in Patients With Autism

/PRNewswire/ -- An article published today in the journal Pediatrics confirms what parents and advocacy organizations have been saying for years: many individuals with autism suffer from gastrointestinal disease that can contribute to behaviors and symptoms associated with autism.

Evaluation, Diagnosis, and Treatment of Gastrointestinal Disorders in Individuals With ASDs: A Consensus Report is the result of expert panel study and discussion led by Dr. Timothy Buie of the Harvard Medical School Department of Pediatrics. The panel's findings point out not only the existence of underlying GI disturbances that can manifest as behavioral problems, but also notes that such medical issues have often gone undiagnosed or been ignored in the past by physicians treating patients diagnosed with autism.

"We are finally getting mainstream acknowledgement that our kids are physically sick, and not the victims of some mysterious genetic behavioral disorder," commented Lori McIlwain, National Autism Association (NAA) board chair. "With one in 110 children now diagnosed with autism, we are in the midst of a national health emergency. Physicians must address the underlying medical conditions involved in this epidemic if they are to help us find answers and relief for our children."

The panel arrived at several conclusions regarding current clinical practice guidelines and made recommendations for future medical and research priorities. These include:

-- Current treatment guidelines do not routinely consider potential
medical problems
-- Problem behaviors including self-injury, aggression, irritability,
and sleep disturbance may be manifestations of abdominal pain
-- Behavioral treatment should not substitute for medical treatment
-- Gastrointestinal symptoms should be considered an urgent indication
for medical investigation
-- Immunologic dysfunction, inflammation, metabolic dysfunction, and
allergies are all potentially associated with autism
-- Research is needed to determine the role of abnormal GI permeability
in neuropsychiatric manifestations of autism
-- Greater awareness is needed among health care providers of the
atypical manifestations of GI disorders
-- Awareness of unrecognized medical conditions in autism must become a
priority of professional societies including the American Academy of
Pediatrics
-- Diagnostics should be performed to accurately identify co-morbid
allergic disease
-- Research is needed to determine the role of immune dysfunction in
autism


"This is definitely a step in the right direction," said Ms. McIlwain. "Our kids need and deserve clinical investigation and treatment for the underlying medical conditions from which they suffer."

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
Follow us on Twitter: @GAFrontPage

Alert: Two Overdoses of Tamiflu in Pediatric Patients in Pennsylvania

/PRNewswire/ -- Two pediatric patients in Pennsylvania hospitals received overdoses of the drug Tamiflu to treat their flu symptoms because of unawareness among staff as to the concentration of the drug given in an alternative liquid form. Both children were unharmed as a result of the errors, but details of the near misses have been published in a supplementary Pennsylvania Patient Safety Advisory to raise awareness of the issue.

For patients who have trouble swallowing Tamiflu capsules (usually elderly and children), a liquid form of the drug is available. For facilities that have a shortage of Tamiflu in liquid form, the U.S. Food and Drug Administration has approved directions listed in the product labeling for using the powder in the Tamiflu capsule to make a liquid form, which is a different concentration. However, reports show staff are unaware of the differences in the concentrations of these two products.

As of October 20, 2009, the Pennsylvania Patient Safety Authority has received two reports describing the dosage errors related to the varying Tamiflu concentrations. In each case, physicians prescribed 12 mg of the product to the patient in liquid form. However, due to shortages of the liquid form, which is available in a 12 mg/mL concentration, pharmacists compounded and dispensed a liquid form made from the powder of available capsules as a 15 mg/mL concentration, which was administered without adjusting the dose.

"We believe hospital staff -- prescribers, nurses, and pharmacists -- may be unaware of the potential for dosage errors due to the shortage of the drug in liquid form," Mike Doering, executive director of the Pennsylvania Patient Safety Authority said. "Doctors who are prescribing the Tamiflu in a liquid are unaware that the manufacturer-produced liquid form of the product is not available."

The Authority's subcontractor, the Institute for Safe Medication Practices (ISMP), alerted healthcare professionals on October 15, 2009, about the risk of overdoses and under doses.

"In light of flu season, this is a real-time problem so the Authority and ISMP are working to get the word out as quickly as possible so that healthcare professionals across the board are aware of the potential risks of compounding their own liquid form of the drug," Doering said. "Some strategies previously released by ISMP to help healthcare providers reduce and eliminate the risks are also provided in the Advisory."

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
www.artsacrossgeorgia.com
Arts Across Georgia

FDA Approves Seasonal Influenza Vaccine Fluarix for Pediatric Use

The U.S. Food and Drug Administration today approved use of the seasonal influenza vaccine Fluarix for children ages 3 years to 17 years. Previously, this vaccine, which contains inactivated (killed) influenza A and B viruses, had been approved for use in adults, ages 18 years and older.

The safety and effectiveness of Fluarix for use in children ages 3 years and older is documented by a U.S. study comparing 2,115 children who received Fluarix with 1,210 children who received Fluzone, a different influenza vaccine already licensed by the FDA for use in children ages 6 months and older. Study results showed that children 3 years and older vaccinated with Fluarix and Fluzone produced similar amounts of antibodies in the blood at levels considered likely to be protective against seasonal influenza.

Fluarix is a seasonal influenza vaccine not intended to protect against the 2009 H1N1 influenza virus.

"This approval of an additional seasonal influenza vaccine for children provides help in protecting them against influenza,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research. “Children are very vulnerable to the influenza virus and are more likely to be hospitalized for associated problems.”

With today’s approval, there are now four companies approved by the FDA to manufacture seasonal influenza vaccine for use in children.

Influenza is far more dangerous than the common cold for children, who often require medical care, especially if they are younger than 5 years. It is best to vaccinate children each fall, but vaccination also can occur in the winter months when influenza season often peaks.

Common adverse events experienced after administration of Fluarix are typical of those for flu shots and include pain, redness, and swelling at the injection site as well as irritability, loss of appetite, and drowsiness.

Because Fluarix contains a small amount of egg protein, it should not be administered to anyone allergic to eggs or egg products.

Fluarix is manufactured by GlaxoSmithKline Biologicals of Dresden, Germany.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

Mother's Immune System May Block Fetal Treatments for Blood Diseases

/PRNewswire/ -- Pediatric researchers have resolved an apparent contradiction in the field of prenatal cell transplantation -- a medical approach that holds future promise in correcting sickle cell disease and other serious congenital blood disorders. In a new study in animals, the researchers showed that the mother's immune response interferes with the offspring's earlier ability to tolerate transplanted donor cells.

The study team concludes that focusing on transplant techniques that avoid the maternal immune response may allow scientists to take advantage of fetal tolerance to achieve a long-sought goal of treating blood diseases prenatally.

While cautioning that much work must be done to understand how these animal findings apply to humans, the current findings are "surprising but reassuring," said study leader Alan W. Flake, M.D., of the Children's Center for Clinical Research at The Children's Hospital of Philadelphia.

The study appeared online August 3 in the Journal of Clinical Investigation.

For over 50 years, explained Flake, it has been a fundamental precept of immunology that a fetus tolerates foreign antigens in a window-of-opportunity period before its immune system fully develops the capacity to mount an immune response. Scientists assumed that by carefully introducing donor cells and stimulating a fetus to develop tolerance to those cells, one could set the stage for a later organ or cellular transplant that would not be rejected by a more mature immune system.

As prenatal diagnosis has continued to become available for a greater number of congenital diseases, scientists have considered the possibility of correcting blood disorders such as sickle cell disease or thalassemia. After first transplanting a small number of healthy cells in an early-stage fetus to establish tolerance, a second dose of transplanted cells later in gestation would proliferate, and treat the blood disorder before birth. Researchers use hematopoietic cells -- stem cells that that develop into blood cells -- in this technique, in utero hematopoietic cell transplantation (IUHCT).

However, over the years, Flake's team and other research groups found that IUHCT studies in animal models yielded inconsistent results, ranging from no tolerance to transplants to full tolerance and every degree of tolerance in between. Contrary to the concept of fetal tolerance, an immune barrier seemed to be acting against transplanted cells.

The current study, done in mice, solves the puzzle of an apparent immune barrier. Newborn mice (pups) that received cell transplants in utero were divided into two groups. Mice nursed by their biological mothers lost the transplanted donor cells, while mice nursed by foster mothers retained those donor cells.

The mothers whose fetuses received the donor cells transplants had developed antibodies against those cells, and subsequently transmitted those antibodies to their pups through breast milk. "Those antibodies in the breast milk triggered rejection of the transplanted blood cells in the pups," said Flake. "But in the absence of a maternal immune response, we confirmed that immune tolerance does occur in the early-gestation fetus 100 percent of the time."

Of course, mouse biology is not the same as human biology, and Flake added, "Mouse time is not the same as human time." Because mice have such a brief gestational period, the mother's immune response didn't develop until after the birth of her pups, and was therefore transferred by breastfeeding. In large animals and humans, said Flake, the more likely route of maternal-to-fetal transmission would be through the placenta late in pregnancy, and not through postnatal breastfeeding.

However, it remains an open question whether the mouse findings are applicable to larger mammals and especially to humans. Flake's study team is continuing their investigations in larger animal models.

Looking forward to techniques to avoid maternal immune reactions to prenatal cell transplants, Flake proposed two possibilities. One would be use the mother as a source of donor cells, which would not stimulate an unwanted immune response. Another strategy could involve inducing the generation of increased numbers of T regulatory cells; those cells normally act to prevent the fetus from inappropriately reacting against maternal cells.

The ultimate goal, said Flake, is to develop IUHCT as a prenatal treatment for any congenital blood disorder that may currently be treated with postnatal bone marrow transplants. That would include sickle cell disease, thalassemia, and some inherited immunodeficiency diseases. Currently such postnatal transplants are risky and relatively rare.

"Our current finding is not a clinical breakthrough," added Flake. "But it does offer new potential to the field of cellular transplantation."

Funds from the National Institutes of Health, the Ruth and Tristram C. Colket Jr. Chair of Pediatric Surgery at The Children's Hospital of Philadelphia and the Albert M. Greenfield Foundation supported this study.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
www.artsacrossgeorgia.com
Arts Across Georgia

Mutant Genes in High-Risk Childhood Leukemias Identified

/PRNewswire / -- A research team has pinpointed a new class of gene mutations, which identify cases of childhood acute lymphoblastic leukemia (ALL) that have a high risk of relapse and death. The finding suggests specific drugs that could treat this high-risk leukemia subtype in children, particularly because such drugs are already in clinical trials for similar blood diseases in adults.

While the cure rate in pediatric ALL has reached about 85 percent, the remaining high-risk cases have proven especially intractable because they arise from different, unidentified genetic mutations.

Discovery of the mutations was led by scientists from St. Jude Children's Research Hospital, the Children's Oncology Group (COG), the University of New Mexico Cancer Research and Treatment Center, Albuquerque, N.M., and the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). This research was done as part of the NCI Therapeutically Applicable Research to Generate Effective Treatments (TARGET) initiative, which seeks to utilize the study of genomics to identify therapeutic targets in order to develop more effective treatments for childhood cancers. The article appears online May 18 in the early edition of the Proceedings of the National Academy of Sciences.

"We have made such great progress in curing children with ALL that the main challenge is now the remaining high-risk patients," said St. Jude Scientific Director, James Downing, M.D., a co-senior author of the study. "We still do not know how to accurately identify these patients and effectively treat them to provide the highest chance for a cure. The problem is that this high-risk group is likely a heterogeneous mixture of biologic subtypes."

The new study builds on the researchers' previous genetic analysis of the leukemic cells from pediatric ALL patients.

"The findings from our previous studies have hinted that some high-risk ALL cases might arise from mutations in genes that produce enzymes called kinases, which function as biological on-off switches in cells," said Charles Mullighan, M.D., Ph.D., assistant member in the St. Jude Department of Pathology and a co-first author of the study. "Such mutations would cause those kinases to be stuck in the on position, triggering the uncontrolled proliferation of white blood cells that is seen in leukemia."

Thus, the researchers began to analyze the genetic sequences of many kinases known to be components of the proliferation machinery of white blood cells. The team analyzed the leukemic cells from 187 patients with high-risk ALL. That analysis revealed mutations in about 10 percent of the cases in a family of protein kinases called JAK, whose members were also known to be mutated in other types of leukemias and related diseases.

"Further studies of these mutant JAK proteins revealed that the changes in their molecular structures could switch them on to drive the blood cell proliferation that is characteristic of ALL," said Stephen Hunger, M.D., chairman of the COG ALL committee and a co-senior author of the study. "What's more, in test tube studies, we found that drugs blocking the activation of the mutant JAK kinases prevented uncontrolled growth suggesting that drugs that target JAK proteins might be effective in this subtype of ALL."

The researchers discovered, in some high-risk ALL patients, that mutations in JAK appeared to work in concert with another mutation -- in the gene IKZF1 -- which they had earlier found to underlie such cases.

"Our studies of these leukemia subtypes indicate that leukemia is not necessarily a single-cause disease," said Cheryl Willman, M.D., director and CEO of the University of New Mexico Cancer Research and Treatment Center and a co-senior author of the study. "A patient may have multiple different genetic lesions that target different cellular pathways to induce leukemia. Thus, it is very important to develop new therapies that target these specific mutations, and our discovery of JAK as target now allows us to begin to develop clinical trials with JAK inhibitors for children and adults with this form of disease."

In further studies, the researchers plan to identify mutations in kinase genes and other enzymes that underlie high-risk ALL, as well as explore how these abnormalities might work together to drive the cancers.

The discovery that mutations in JAK underlie some cases of high-risk ALL is enough to warrant clinical trials of inhibitory drugs to treat such cancers.

"JAK-inhibiting drugs are now moving into clinical trials for treatment of such adult myeloproliferative diseases as polycthemia vera, essential thrombocytosis and primary myelofibrosis," Downing said. "We expect that there will soon be initial clinical studies to assess the safety and effectiveness of these drugs in children with relapsed ALL in which JAK mutations have been identified within their leukemic cells."

Such studies would be coordinated by the COG, an international clinical trial cooperative group supported by the NCI.

Other authors of the paper are Racquel Collins-Underwood, Letha A. Phillips, Xiaoping Su, Wei Liu and Brenda Schulman (St. Jude); Sarah Tasian and Mignon Loh (University of California San Francisco); Meenakshi Devidas (Children's Oncology Group); Susan Atlas, I-Ming Chen and Richard C. Harvey (University of New Mexico Cancer Research and Treatment Center, Albuquerque); Robert J. Clifford, Daniela Gerhard, Malcolm Smith and Jinghui Zhang (National Cancer Institute); William Carroll (New York University Cancer Institute); and Gregory H. Reaman (The George Washington University).

This research was supported in part by a supplement to the Children's Oncology Group Chair's award; a National Cancer Institute Strategic Partnering to Evaluate Cancer Signatures Program award; the National Institutes of Health/National Institute of General Medical Sciences Pharmacogenetics Research Network and Database; National Institutes of Health Cancer Center Core Grants; the Children's Oncology Group and Statistical Center; the Leukemia and Lymphoma Society Specialized Center of Research grant supporting University of New Mexico Cancer Center; CureSearch; St. Baldrick's Foundation; a National Health and Medical Research Council (Australia) CJ Martin Traveling Fellowship; and ALSAC.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page
www.artsacrossgeorgia.com
Arts Across Georgia

Terumo Cardiovascular Systems Issues Urgent, Nationwide/Worldwide Recall of Pediatric Arterial Cannulae

Terumo Cardiovascular Systems (Terumo CVS) is issuing an urgent, nationwide/worldwide recall of its Tenderflow™ Pediatric Arterial Cannulae involving 21 lot codes (see information below). Terumo received five reports of difficulty retracting the introducer from the cannula. When the introducer cannot be retracted from the cannula, the cannula must be removed and replaced, a process that may lead to aortic damage, blood loss and/or death.

There have been no reports of patient injury or death associated with the product.

Tenderflow™ Pediatric Arterial Cannula Catalog and Lot Numbers Affected

Catalog Number Lot Number

813568 0501639, 0512002

813567 0501557, 0512008

813570 0502200, 0513069

813569 0502199, 0513068, 0517852

813572 0507121, 0512918

813571 0507120, 0512919, 0518680

813574 0509240

813573 0509238, 0517874

813576 0509241

813575 0500759, 0513331

813578 0500760

813577 0502878

An arterial cannula is a disposable tube inserted in the aorta during many cardiac bypass surgery procedures and is used to perfuse the ascending aorta. The cannula is inserted using an introducer, which stabilizes the cannula during insertion and is then removed.

Terumo CVS distributed this product directly to 68 U.S. hospitals, and has notified all of the hospitals of the voluntary recall in a letter dated Oct. 16, 2008. The product was also distributed from distribution centers in Australia, Canada and Europe. The notification letter recommended that customers not use the product unless medically necessary. In those cases, the cannula should be used without the introducer. Clinicians with questions may contact the company at 800-521-2818, or if calling from outside the U.S., 734-663-4145. Contact can be made Monday-Friday from 8:00 a.m. to 5:00 p.m. EST.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

* Online: www.fda.gov/medwatch/report.htm
* Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
* Fax: 1-800-FDA-0178

Terumo informed the U.S. Food and Drug Administration of this recall. Terumo Cardiovascular Systems Corporation is a global manufacturer and marketer of medical devices for cardiac and vascular surgery. The company is headquartered in Ann Arbor, Michigan with manufacturing operations in Ann Arbor; Elkton, Maryland; Ashland, Massachusetts; and Tustin, California. For more information, visit www.terumo-cvs.com.

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

FDA Approves Bayer HealthCare's Kogenate(R) FS Treatment for Routine Prophylaxis in Children with Hemophilia A

PRNewswire/ -- Bayer HealthCare LLC announced today that the U.S. Food and Drug Administration (FDA) has approved routine prophylaxis with Kogenate(R) FS Antihemophilic Factor (Recombinant) to reduce the frequency of bleeding episodes and the risk of joint damage in patients aged 0-16 years with severe hemophilia A with no pre-existing joint damage. This important approval provides these patients with the only factor VIII treatment that the FDA has determined safe and effective for routine prophylaxis -- a treatment regimen recommended by the National Hemophilia Foundation's Medical and Scientific Advisory Council (MASAC).(1)

"The FDA approval of Kogenate FS as the first factor VIII treatment product in the U.S. to be used to replenish factor VIII levels in a prophylactic manner marks a significant milestone in the care of patients, especially young children, with hemophilia A," said Craig Kessler, M.D., Georgetown University Hospital and Chair, MASAC. "The results from the pivotal clinical study confirmed that the administration of Kogenate FS to prevent bleeding into the joints was more beneficial to joint health and function than 'on-demand' treatment of acute episodes of joint bleeds."

Dr. Kessler added, "The data justify the consideration of prophylaxis treatment for children with severe and moderate severity hemophilia A, uncomplicated by pre-existing joint damage, to be the medical standard of care. The FDA's recognition that Kogenate FS is an effective prophylactic FVIII replacement product has 'jump started' the standard of hemophilia care in the United States so that it is now on par with other developed countries, especially those in Western and Northern Europe."

The FDA approval of Kogenate(R) FS for routine prophylaxis in children without pre-existing joint damage is based on the clinical data from a multicenter trial in the U.S. that included 65 boys with severe hemophilia A less than 30 months of age at study entry. Study participants were followed for up to 5.5 years. This Joint Outcomes Study (JOS), conducted over a 10-year period, was led by Marilyn J. Manco-Johnson, M.D., Professor of Pediatrics and Associate Professor of Pathology in the Department of Pediatrics, University of Colorado at Denver and Health Science Center, and Director of the Mountain States Regional Hemophilia & Thrombosis Center at the University of Colorado. Key findings from the JOS study, published in the August 9, 2007 issue of The New England Journal of Medicine(2), include:

-- 93 percent of the participants in the routine prophylaxis group showed
normal joint function, in contrast to 55 percent in the episodic
group.
-- Kogenate FS prophylaxis treatment was able to preserve the joint even
if the child had less than or equal to two bleeds per index joint.
-- Patients from the prophylaxis group were eight times more likely to
have damage-free joints than those from the episodic group.
-- The prophylaxis group had an 81.5 percent reduction in annual bleeding
frequency compared to the episodic group.
-- Overall, there was an 83 percent reduction in the risk for joint
damage in patients receiving prophylaxis from an early age.
-- Ten percent of the patients treated episodically experienced
life-threatening bleeds compared to zero patients treated
prophylactically.
-- The most common adverse events were related to central venous access,
such as catheterization and catheter removal, central line infection
and pyrexia.


The study was designed with special emphasis on the "index joints," including the elbow, knee and ankle joints, which are most prone to bleeding in severe hemophilia patients. Joint structural outcomes and functioning were measured at 6 years of age by radiography, magnetic resonance imaging (MRI) and physical exams.

"The value for prophylaxis for hemophilia A patients has been understood for many years, but until today we have not had the combination of clinical evidence, pharmaceutical indication and the alignment of healthcare professionals, patients and regulators needed to ensure this treatment option is available," said Val Bias, CEO, National Hemophilia Foundation. "Bayer HealthCare's pursuit of this approval shows leadership and commitment to providing the scientific evidence that proves the benefits of prophylactic use for joint health in pediatric hemophilia patients."

This U.S. FDA approval may positively affect the prophylactic use of Kogenate FS in certain developing markets, including countries in Asia and South and Central America, where the product is approved based on the U.S. label.

"Today's announcement is a milestone in Bayer HealthCare's continuing commitment to advancing the science and treatment for the hemophilia community," said Paul Bedard, Vice President, General Manager, Hematology Business Unit, Bayer HealthCare. "From the beginning, our goal in pursuing this indication was to provide treatment options that would reduce bleeding episodes and protect the joint health of children with hemophilia A, which are the everyday concerns of patients."

-----
www.fayettefrontpage.com
Fayette Front Page
www.georgiafrontpage.com
Georgia Front Page

Researchers at Children's Healthcare of Atlanta and Emory University School of Medicine Make New Discovery in Pediatric Heart Disease Diagnosis

PRNewswire-USNewswire/ -- Erin Strickland had been sick for months when she was admitted to Children's Healthcare of Atlanta at Egleston in January 2008. The Douglasville teen had been treated for practically everything, from strep throat to scarlet fever to allergic reactions. Erin's quality of life had been limited by an unidentified illness, preventing her from participating in her normal athletic activities. Erin's mother, Lynda, was deeply concerned and spent endless hours taking Erin to specialist after specialist seeking an explanation for her numerous symptoms, which included rash, eye swelling, vomiting and headache.

Finally, at Children's, Lynda received the explanation for which she'd been searching so desperately. Erin was diagnosed, by cardiac biopsy, with giant cell myocarditis, an extremely rare cause of heart disease in children. Erin's diagnosis was aided by research led by Kevin Maher, M.D., Pediatric Cardiologist at the Children's Sibley Heart Center, and Assistant Professor at Emory University School of Medicine. Erin's B-type natriuretic peptide (BNP) level was elevated -- more than 50 times its normal level -- on admission to Children's, which led to further evaluation and biopsy.

Dr. Maher recently concluded research--diagnosing and evaluating 33 patients who presented in the Emergency department--regarding the use of (BNP) testing to help diagnose heart disease in infants and children. BNP testing is already being used effectively in adult emergency rooms to determine if patient symptoms are heart-related or not. Though BNP tests are not currently being used in pediatric emergency rooms, Dr. Maher's research indicates they should be. Use of such tests could dramatically increase the chances of diagnosing heart problems early, before more serious complications arise. Dr. Maher and his team concluded that BNP level can be used as a marker to aid in the recognition of pediatric heart disease. This means that the same test physicians use to diagnose heart disease in a 75-year-old can now be used to diagnose heart disease in an infant. This discovery will aid Emergency physicians in the recognition of pediatric heart disease and has great life-saving potential.

Fortunately for Erin, Dr. Maher and the other cardiologists at Children's diagnosed her quickly enough to avoid heart transplantation. Erin is currently being treated for her condition with medication, and she celebrated her 15th birthday in March. Though she is unable to resume her normal athletic pursuits immediately, physicians are pleased with her progress and believe she has a bright future.