Health and Human Services Secretary Kathleen Sebelius announced yesterday that the Federal government will purchase an additional 13 million treatment courses to help fight influenza, including the 2009 H1N1 flu virus. The additional treatment courses will be added to the Strategic National Stockpile. The Secretary also announced that HHS began moving 400,000 treatment courses to Mexico to help slow the spread of the H1N1 virus.
"As this flu virus outbreak expands across the country, we have been taking necessary steps to ensure states have the resources they need," said Sebelius. "The 13 million additional treatment courses that we will purchase will allow us to replenish our national stockpile and further
ensure we are prepared to provide the American people with the treatments they may need to stay healthy."
HHS has stockpiled approximately 50 million courses of antiviral drugs in the Strategic National Stockpile, and state stockpiles across the country include an additional 23 million more treatment courses. Earlier this week, HHS released a total of 11 million treatment courses to help
all 50 states. Today HHS began moving 400,000 treatment courses to Mexico to help stop the spread of the virus. The 400,000 courses represent less than 1 percent of the total American stockpile.
As a result of yesterday's action by the Secretary, HHS will spend an estimated $251 million to refill the Strategic National Stockpile and replace the 11 million treatment courses offered to states and to purchase an additional two million treatment courses. These additional two million treatment courses will be used to replace those that have been provided to Mexico or could also be available to respond to other outbreak needs.
"Flu viruses don't stop at the border, and it is imperative we do whatever we can to slow the spread of the virus and help stop this outbreak," said Sebelius.
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Thursday, April 30, 2009
Sebelius Takes Two Key Actions On Strategic National Stockpile
FDA Requires Boxed Warning for All Botulinum Toxin Products
Prompted by reports of serious adverse events, the U.S. Food and Drug Administration today announced that safety label changes, including a boxed warning, and a Risk Evaluation and Mitigation Strategy (REMS), are necessary for all botulinum toxin products.
The agency said it took the action because of reports that the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism, including unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids.
These symptoms have mostly been reported in children with cerebral palsy being treated with the products for muscle spasticity, an unapproved use of the drugs. Symptoms have also been reported in adults treated both for approved and unapproved uses.
The agency also took the action because of the potential for serious risks associated with the lack of interchangeability among the three licensed botulinum toxin products.
“Updated labels for this class of products will help health care professionals and patients better understand the risks and benefits,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Botulinum toxin products have benefits but can cause serious health problems and it is important that anyone who administers or uses these products understands these risks.”
Product Names
The products required to add the new label and a REMS are Botox and Botox Cosmetic (botulinum toxin type A), marketed by Allergan; Myobloc (botulinum toxin type B), marketed by Solstice Neurosciences; and a new FDA-approved product, Dysport (abobotulinumtoxinA), marketed by Ipsen Biopharm Ltd.
Botox, Myobloc, and Dysport are approved by the FDA for the treatment of a condition marked by repetitive contraction of the neck muscles (cervical dystonia). Botox Cosmetic and Dysport are approved by the FDA for dermatologic use in the temporary improvement in the appearance of frown lines between the eyebrows called glabellar lines. In addition, Botox is approved for the treatment of severe underarm sweating (primary axillary hyperhidrosis), crossed eyes (strabismus), and abnormal tics and twitches of the eyelids (blepharospasm).
Recommendations for Health Care Professionals
The FDA has notified the manufacturers of Botox and Myobloc that label changes and a REMS are necessary to ensure that the benefits of the product outweigh the risks. The FDA approved a REMS for Dysport as part of the product approval. The REMS for each of these products will include a Medication Guide and a Communication Plan. Medication Guides are FDA-approved handouts given to patients, or their families and caregivers, when a medicine is dispensed. The Medication Guides will contain information about the risks associated with botulinum toxin products. The FDA is also requiring the manufacturers to collect safety data in children and adults with muscle spasticity to assess the signal of risk regarding distant spread of toxin effects.
Treatment of muscle spasticity is not an FDA-approved use of botulism toxin products. The doses used in treatment of muscle spasticity are often much higher than the doses for uses described in FDA-approved product label. Symptoms consistent with spread of toxin effects have been reported at doses comparable to or lower than doses used to treat cervical dystonia. For the FDA-approved dermatologic use of temporary improvement in the appearance of glabellar lines, the agency has not identified any definitive serious adverse event reports of a distant spread of toxin effect producing symptoms consistent with botulism when the botulinum toxin products are used in accordance with the approved label.
The companies that make Botox and Myobloc are required to submit the requested safety label changes, including the boxed warning and the Medication Guide, to the FDA within 30 days, or to provide a reason why they do not believe such changes are necessary. If they do not submit new language, or the FDA disagrees with the language the companies propose, the Food, Drug, and Cosmetic Act provides strict timelines for discussions regarding the changes. At the end of these discussions the agency is allowed to issue an order directing the label change as deemed appropriate to address the new safety information.
Health care professionals who use botulinum toxins should do the following:
* Understand that dosage strength (potency) expressed in “Units” is different among the botulinum toxin products; clinical doses expressed in units are not interchangeable from one product to another.
* Be alert to and educate patients and caregivers about the potential for effects following administration of botulinum toxins such as: unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids.
* Understand that these effects have been reported as early as several hours and as late as several weeks after treatment.
* Advise patients to seek immediate medical attention if they develop any of these symptoms.
Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.
--Online: www.fda.gov/MedWatch/report.htm
--Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
--Fax: 800-FDA-0178
--Phone: 800-FDA-1088
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Clayton State Students, Nurses Heading to Guatemala for Maymester
Fourteen Clayton State University nursing students, alongside Drs. Sue Odom, associate dean of the School of Nursing, and Karen Weaver, director RN-BSN program, will head to the jungle of Rio Dulce, Guatemala for their 2009 Maymester trip next month.
The Maymester course will be a total of 14 days and is a three credit hour elective. The group will depart May 15 and return on May 25. Students will stay in a dormitory over looking Lake Izabal in Guatemala. There will also be recreational time to visit the area including trips to museums and parks.
“Students and faculty will work together to provide healthcare to Guatemalan villagers in remote areas of the jungle. These villagers have no access to healthcare and walk many miles to attend the traveling clinic that provides free services for those in need,” Weaver says. “Students will benefit by receiving credits for the Jungle Health course, learning about the people of Guatemala and their healthcare needs, helping those suffering from illness/disease/malnutrition to recover, and teaching the Guatemalan villagers ways to improve their health and prevent these maladies.
“There are other fundamental benefits that will be unique to each individual participating in the program that have to do with personal satisfaction and fulfillment.”
The participants in the Jungle Health Maymester course recently had an orientation session and were honored to have Beatriz Illescas Putzeys, consul general of Ministerio de Relaciones Exteriores, Guatemala, come to Clayton State to speak at the orientation, Weaver explains. Putzeys answered questions related to Guatemala and its people and expressed her appreciation to the students who were going on the trip to help her people who are without healthcare resources.
A unit of the University System of Georgia, Clayton State University is an outstanding comprehensive metropolitan university located 15 miles southeast of downtown Atlanta.
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Positive H1N1 (Swine Flu) Confirmed in Georgia
The Georgia Department of Public Health (GDPH) confirmed today Georgia’s first human case of swine influenza virus Type A (H1N1) disease in Troup County. The person is currently under treatment.
“What we know at this point is this patient recently traveled to Mexico” said GDPH Acting Director Sandra Elizabeth Ford, MD. At this time, we do not know if or how many more cases of H1N1 there are in this area or in the state. We are active participants in the collection of samples based on the CDC case definitions and those samples are being forwarded to the State Public Health Lab for testing.
"Georgia Public Health is actively engaging and addressing this issue with its many community, state and federal partners,” said Michael Brackett, M.D. District 4 Medical Director. “We are already looking for other cases. We have not found any. This case diagnosis is one result of that rapid and highly coordinated effort to protect Georgians from this novel virus. These efforts will continue unabated until this threat is resolved."
Although this is Georgia’s first human case, the total number of US cases has risen to 110 with 7 of the cases resulting in hospitalization.
“I want to stress that there is no need for panic, locally or otherwise. We are further evaluating the situation and will continue to do so. The medical staff and hospital staff have done an excellent job at keeping the community safe,” said Brackett.
The symptoms of swine flu in people are similar to the symptoms of regular human flu and include fever, cough, sore throat, body aches, headache, chills and fatigue. Some people have reported diarrhea and vomiting associated with swine flu. In the past, severe illness (pneumonia and respiratory failure) and deaths have been reported with swine flu infection in people. Like seasonal flu, swine flu may cause a worsening of underlying chronic medical conditions. If you become ill with influenza like symptoms seek medical care. There is medication available that can help.
There is no vaccine available right now to protect against swine flu. There are everyday actions that can help prevent the spread of germs that cause respiratory illnesses like influenza. Take these everyday steps to protect your health:
• Cover your nose and mouth with a tissue when you cough or sneeze. Throw the tissue in the trash after you use it.
• Wash your hands often with soap and water, especially before you eat or after you cough or sneeze. Alcohol-based hand cleaners are also effective, if needed.
• Avoid touching your eyes, nose or mouth. Germs spread this way.
• Try to avoid close contact with people who are sick with flu-like symptoms.
If you get sick with influenza, CDC recommends that you stay home from work or school; and limit contact with others to keep from infecting them.
GDPH and the LaGrange Public Health District strongly recommend Georgia residents to:
1) Contact your health care provider if you are not feeling well and have recently traveled to areas that have high numbers of confirmed cases of swine flu.
2) Keep up healthy behaviors –such as washing hands, coughing or sneezing in tissue or crook of elbow, staying at home when you are feeling sick, and following your health care provider’s recommendations.
3) Develop or update your Emergency Preparedness plan and Emergency Preparedness kit. Visit www.ready.ga.gov/register to access online tools that will provide step-by-step guidance on how to create a plan and an emergency kit.
Regular updates are also ongoing on the CDC’s website http://www.cdc.gov/swineflu.
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Statement of Governor Sonny Perdue Regarding Confirmed H1N1 Flu Case in Georgia
Governor Sonny Perdue issued the following statement today regarding the first H1N1 flu case in Georgia being confirmed by the Centers for Disease Control:
“Today’s confirmed case of the H1N1 flu in Georgia is a reason for precaution, not panic. I want to stress that it is an isolated case appearing in a woman visiting our state for an event who had also recently traveled to Mexico. The State of Georgia has worked diligently over the past several years to prepare for a situation like this, and we are partnering with local and federal officials to respond appropriately. I encourage Georgians to follow the advice of public health professionals and take the recommended precautions to protect themselves and their families. At this stage, the simplest things – washing hands and using disinfectants – can be the most effective safeguards. I am confident in our planning and preparation and our ability to respond over the coming days.”
The most up-to-date information on H1N1 flu developments in Georgia is available at the Division of Public Health's website at http://health.state.ga.us/swineflu/.
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Number of U.S. Adults Reporting Disabilities is Increasing
The number of U.S. adults reporting a disability increased by 3.4 million between 1999 and 2005, according to a recent report released by the Centers for Disease Control and Prevention.
The study in today's Morbidity and Mortality Weekly Report also finds an estimated 1 in 5 U.S. adults (47.5 million, or 21.8 percent) report a disability. The three most common causes of disability among adults in the United States are arthritis or rheumatism, back or spine problems, and heart disease.
"It is likely we will see more dramatic increases in the number of adults with a disability as the baby boomer population begins to enter higher risk, older age groups over the next 20 years," said Chad Helmick, M.D., CDC medical epidemiologist and coauthor of the study. "CDC is working with state health departments and communities to expand the availability of self-management education programs and interventions, such as appropriate physical activity programs, that can reduce the impact of disability."
The study of data collected from the U.S. Census Bureau's Survey of Income and Program Participation found that women (24.4 percent) have a higher prevalence of disability compared with men (19.9 percent) at all ages. The study also found that disability prevalence doubled for each successive age group - 11.0 percent for ages 18-44, 23.9 percent for ages 45-64, and 51.8 percent for ages 65 or older.
Arthritis encompasses more than 100 diseases and conditions that affect joints and other connective tissue. For more information on arthritis visit www.cdc.gov/arthritis. For information on disabilities visit www.cdc.gov/ncbddd/disabilities.htm. For information on heart disease visit http://www.cdc.gov/heartdisease.
Number of U.S. Adults Reporting Disabilities is Increasing
The number of U.S. adults reporting a disability increased by 3.4 million between 1999 and 2005, according to a recent report released by the Centers for Disease Control and Prevention.
The study in today's Morbidity and Mortality Weekly Report also finds an estimated 1 in 5 U.S. adults (47.5 million, or 21.8 percent) report a disability. The three most common causes of disability among adults in the United States are arthritis or rheumatism, back or spine problems, and heart disease.
"It is likely we will see more dramatic increases in the number of adults with a disability as the baby boomer population begins to enter higher risk, older age groups over the next 20 years," said Chad Helmick, M.D., CDC medical epidemiologist and coauthor of the study. "CDC is working with state health departments and communities to expand the availability of self-management education programs and interventions, such as appropriate physical activity programs, that can reduce the impact of disability."
The study of data collected from the U.S. Census Bureau's Survey of Income and Program Participation found that women (24.4 percent) have a higher prevalence of disability compared with men (19.9 percent) at all ages. The study also found that disability prevalence doubled for each successive age group -- 11.0 percent for ages 18-44, 23.9 percent for ages 45-64, and 51.8 percent for ages 65 or older.
Arthritis encompasses more than 100 diseases and conditions that affect joints and other connective tissue. For more information on arthritis visit www.cdc.gov/arthritis. For information on disabilities visit www.cdc.gov/ncbddd/disabilities.htm. For information on heart disease visit http://www.cdc.gov/heartdisease.
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Emory and HBO Host Alzheimer's Disease Documentary Screening May 2
The Emory University Alzheimer's Disease Research Center in partnership with HBO and the Alzheimer's Association of Georgia will premiere the HBO documentary film, "MOMENTUM IN SCIENCE" on Saturday, May 2, for a gathering of medical professionals and families who have loved ones living with Alzheimer's disease.
"MOMENTUM IN SCIENCE," is part of an HBO Films' Documentary series called THE ALZHEIMER'S PROJECT.
The ALZHEIMER'S PROJECT, executive produced by Maria Shriver, is a multi-part, multi-platform series that brings new understanding and hope for millions of people affected by Alzheimer's disease.
The screening will be held from 9 a.m. to1 p.m. at the Emory Conference
Center located at 1615 Clifton Rd. in Atlanta. It will be followed by a panel
discussion and Q & A with leading Alzheimer's disease researchers, including:
*Allan Levey, MD, PhD – Professor and Chair, Department of Neurology, Emory
University
*James Lah, MD, PhD – Associate Professor and Vice Chair, Department of
Neurology, Emory University
*Felicia Goldstein, PhD – Director of Neuropsychology, Emory University
*Larry Tune, MD – Professor of Psychiatry and Neurology, Emory University
*Angela Ashley, MD – Assistant Professor of Neurology, Emory University
*Ginny Helms – Vice President of Programs and Services, Alzheimer's Association of Georgia
*Monica W. Parker, MD – Assistant Professor of Medicine, Emory University
*Kenneth Hepburn, PhD – Professor and Associate Dean for Research, Nell
Hodgson Woodruff School of Nursing, Emory University
*Carolyn Clevenger, DNP – Assistant Professor of Nursing, Nell Hodgson
Woodruff School of Nursing, Emory University
*Suzette Binford, Executive Director, Alzheimer's Association of Georgia
THE ALZHEIMER'S PROJECT is a presentation of HBO Documentary Films and the National Institute on Aging of the National Institutes of Health in association with the Alzheimer's Association®, Fidelity® Charitable Gift Fund and Geoffrey Beene Gives Back® Alzheimer's Initiative. The series of four films will debut on HBO on May 10, 11 and 12.
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K-State Researcher Finds That the 1918 Spanish Flu Virus Can Infect Swine and Resulted in Current Lineage of H1N1 Swine Influenza Viruses
/PRNewswire / -- In 1918 a human influenza virus known as the Spanish flu spread through the central United States while a swine respiratory disease occurred concurrently. A Kansas State University researcher has found that the virus causing the pandemic was able to infect and replicate in pigs, but did not kill them, unlike in other mammalian hosts like monkeys, mice and ferrets where the infection has been lethal.
Juergen A. Richt, Regents Distinguished Professor of Diagnostic Medicine and Pathobiology at K-State's College of Veterinary Medicine, studied the 1918 Spanish flu pandemic with colleagues from the Canadian Food Inspection Agency, U.S. Department of Agriculture and Mount Sinai School of Medicine.
Their research supports the hypothesis that the 1918 pandemic influenza virus and the virus causing the swine flu were the same. Richt said the virus was able to infect and replicate in swine and cause mild respiratory disease. The 1918 virus spread through the pig population, adapted to the swine and resulted in the current lineage of the H1N1 swine influenza viruses. The researchers' study is published in the May 2009 Journal of Virology.
"This study emphasizes that an influenza virus, which is known to induce a lethal infection in ferrets and macaques, is not highly virulent in pigs, indicating a potential resistance of swine to highly virulent influenza viruses," Richt said. "It also suggests that pigs could have played a role in maintaining and spreading the 1918 human pandemic influenza virus."
Swine flu is a respiratory disease of pigs caused by type A influenza that regularly causes outbreaks of influenza among the animals and can be transmitted to humans. It is a typical zoonotic agent. While swine flu was first recognized as a disease in 1918, there also were reports of the influenza occurring in the Midwest in 1930.
For the study, the researchers used the 1918 pandemic virus and a 1930 H1N1 influenza virus for experimental infections in swine. The 1930 virus was chosen as a virus because it is thought to be a descendent of the 1918 virus, Richt said.
The researchers did not find a significant difference in effects from the 1918 and 1930 viruses in infected pigs. This was surprising, since the 1918 virus killed more than 20 million people and was lethal to ferrets, mice and macaques. Another surprising finding from the study was the rapid antibody response in the animals infected with the 1918 virus, which is not typically reported for the swine influenza virus.
Richt said he plans to conduct a follow-up project that will study what makes a swine flu virus a pandemic flu virus.
The researchers conducted the study in the biosafety-level 4 laboratory and animal cubicle at the National Centre for Foreign Animal Disease in Canada.
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Public Health Laboratories To Assume Primary Responsibility for Confirmatory Testing of Swine Flu
/PRNewswire / -- Approximately sixty-five state and local public health laboratories around the United States will assume primary responsibility for confirmatory testing of Human Influenza A H1N1 of Swine Origin, or "Swine Flu," within the next week. Previously, all swine flu specimens had to be sent to CDC laboratories in Atlanta for final confirmatory testing, which identifies specimens to the strain level.
The rRT-PCR swine flu panel diagnostic test kits are being shipped this week from the Centers for Disease Control and Prevention (CDC), which developed the assay. Public health laboratories are slated to begin testing late next week following on-site validation of the test.
Deployment of the test was made possible via an emergency use authorization (EUA) issued by the U.S. Food and Drug Administration (FDA) on April 27 in response to a request from CDC.
"Testing will now proceed more rapidly, because we will have sites around the country that can fully characterize the virus, rather than only one at CDC in Atlanta," said Frances Pouch Downes, DrPH, APHL president, and director, Michigan Public Health Laboratory, Michigan Department of Community Health. "Public health labs are receiving considerable attention in connection with the deployment of the swine flu test, but this is really business as usual for us. We're there in the community, ready to protect the public's health as the situation warrants."
Each year state and local public health laboratories conduct routine surveillance to monitor circulating strains of influenza. Their findings are used to develop the influenza vaccine for the following season and to control the spread of the disease in the current year. Additionally, public health laboratories subtype influenza specimens received from clinical and hospital labs. Test results support decisions regarding patient treatment and measures to control the spread of disease.
Yet even though influenza surveillance and diagnostics are routine functions at public health laboratories, this year's outbreak poses particular challenges. "Lab folks are resilient, but even they have limits in how long they can manage to do more with less," said APHL Executive Director Scott Becker. "The economic downturn has really taken a toll on state and local health departments. I am seriously concerned about staff burnout if this outbreak continues more than a couple of months."
Results of a first quarter 2009 APHL survey indicate that the public health laboratory workforce, which numbers only 6500 nationwide, has been reduced by at least 500. These reductions apply to administrative and IT support as well as to laboratory staff. Survey results also show deep cuts to laboratory budgets -- sometimes requiring the elimination of entire public health programs, mandatory furloughs and reductions in funding for essential equipment and supplies. More cuts and staff reductions are anticipated in coming months based on initial responses to APHL's second quarter survey on the impact of the economic downturn.
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Wednesday, April 29, 2009
CDC Guidelines for Screening Swine-Origin Influenza A (H1N1)
Interim Guidance for Screening for Swine-Origin Influenza A (H1N1) by State and Local Health Departments, Hospitals, and Clinicians in Regions with Few or no Reported Cases of Swine Influenza A (H1N1)
This document provides interim guidance for state and local health departments, hospitals, and clinicians in regions with few or no reported cases of swine-origin influenza A (H1N1) (S-OIV) regarding which patients to evaluate for possible infection with swine influenza A (H1N1). As of April 29 1:00 PM, there were 91 laboratory confirmed cases of S-OIV infection identified in 14 states in the United States. Human cases of S-OIV infection also have been identified internationally. Based on the rapid spread of the S-OIV thus far, public health officials believe that more cases will be identified over the next several weeks, including in regions that currently have few or no reported cases.
CDC recommends that state and local health departments, hospitals, and clinicians in regions with few or no reported cases of S-OIV consider the following recommendations for testing of the following persons for S-OIV infection with a nasopharyngeal swab by PCR:
Patients presenting to providers participating in the US Outpatient Influenza-like Illness Surveillance Network (ILINet) who meet the case definition of influenza-like illness (ILI), or
Patients with an ILI who have traveled within 7 days to a community either within the United States or internationally where there are one or more confirmed swine influenza A (H1N1) cases, or
Patients admitted to the hospital with an ILI.
ILI is defined as fever (temperature of 100°F [37.8°C] or greater) and a cough and/or a sore throat in the absence of a KNOWN cause other than influenza.
Specimen Collection and Testing
If swine flu is suspected, clinicians should obtain a respiratory swab for S-OIV testing and place it in a refrigerator (not a freezer). Once collected, the clinician should contact their state or local health department to facilitate transport and timely diagnosis at a state public health laboratory. State public health laboratories should perform subtype testing on all influenza A positive samples identified. State public health laboratories should submit all specimens that cannot be subtyped as human influenza A (H1N1) or (H3N2) to CDC for identification. Please notify CDC of all pending shipments by email at eocsciresource@cdc.gov or if email is not available, by phone at 404-553-7724. Please include shipment tracking information.
Investigation of Cases
Officials should conduct thorough case and contact investigations to determine the source of the swine influenza virus, extent of community illness and the need for timely control measures.
Interim Guidance
Interim Guidance is available, including:
Case definitions to be used for swine influenza A (H1N1) cases
Antiviral recommendations for patients with confirmed or suspected S-OIV infection and close contacts
Infection control for care of persons with confirmed or suspected S-OIV infection in a healthcare setting
S-OIV biosafety guidelines for laboratory workers.
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Flu Vaccine Given in Microneedle Patches Proves Effective in Mice
Flu vaccine delivered through skin patches containing microneedles has proven just as effective at preventing influenza in mice as intramuscular, hypodermic flu immunization. A team of researchers at Emory University and the Georgia Institute of Technology believes the new microneedle skin patch method of delivering flu vaccine could improve overall seasonal vaccination coverage in people because of decreased pain, increased convenience, lower cost and simpler logistics over conventional hypodermic immunization.
The research was published in the early online edition of the journal Proceedings of the National Academy of Sciences (PNAS). Another study by the research team on a different influenza strain was described in the journal Public Library of Science (PLoS) One.
The patches used in the experiments contained an array of stainless steel microneedles coated with inactivated influenza virus. The patches were pressed manually into the skin and after a few minutes, the vaccine coating dissolved off within the skin. The coated microneedle immunizations were compared to conventional intramuscular hypodermic injections at the same dose in another group of mice.
The researchers found that the microneedle vaccinations induced strong immune responses against influenza virus that were comparable to immune responses induced by the intramuscular, hypodermic immunizations. One month after vaccination, the researchers infected both groups of mice with a high dose of influenza virus. While all mice in a control group of unvaccinated mice died of influenza, all mice in both the hypodermic and the microneedle groups survived.
“Our findings show that microneedle patches are just as effective at protecting against influenza as conventional hypodermic immunizations,” says Richard Compans, PhD, Emory professor of microbiology and immunology and one of the paper’s senior authors. “In addition, vaccine delivery into the skin is desirable because of the skin’s rich immune network.”
Even though cutaneous immunization has been shown to induce a broad range of immune responses, and to be especially effective in individuals over age 60, this method has not been widely used because it has not been convenient and has required highly trained personnel.
"Unlike conventional hypodermic injections, microneedles are prepared in a patch for simple administration, possibly by patients themselves, and inserted painlessly onto the skin without specialized training,” says Mark Prausnitz, PhD, professor in the Georgia Tech School of Chemical and Biomolecular Engineering and co-senior author. “These micron-scale needles can be mass produced using low-cost methods for distribution to doctors’ offices, pharmacies and, possibly, people’s homes.”
Other advantages of the microneedle patches could include more convenient storage, easier transportation and lower dosage requirements. Lower doses could be particularly important because flu vaccine production capacity sometimes is limited for seasonal vaccine, and a future influenza pandemic would require much greater production of vaccine.
Replacing a hypodermic needle with a microneedle patch also could significantly impact the way other vaccines are delivered, and could be particularly beneficial in developing countries. A microneedle patch could fit inside an envelope for delivery by the postal service and would occupy much less storage space. Patches also would increase vaccine safety by reducing the dangers of accidental or intentional hypodermic needle re-use.
The project team plans future immunization studies in other animal models, including guinea pigs or ferrets, before initiating studies in humans. Also, more studies are needed to determine the minimum vaccine dose needed for full protection.
The Emory and Georgia Tech research team began developing the new microneedle vaccine patch technology in 2007 using grants from the National Institutes of Health (NIH). The project team has extensive experience in microneedle development, influenza vaccines, vaccine delivery systems, product development and interdisciplinary collaboration.
In 2007 the NIH awarded a $32.8 million, seven-year contract to Emory, along with the University of Georgia, to establish the Emory/UGA Influenza Pathogenesis and Immunology Research Center. The center is working to improve the effectiveness of flu vaccines through a number of different projects studying how influenza viruses attack their hosts, how they are transmitted, and what new immune targets might be identified for antiviral medicines.
Prausnitz and his colleagues have been working since the mid 1990s to develop microneedle technology for painless drug and vaccine delivery through the skin. The Georgia Tech team has also developed manufacturing processes for microneedle patches and tested the ability of the needles to deliver proteins, vaccines, nanoparticles, and other small and large molecules through the skin.
Other authors of the papers are Emory microbiologists Ioanna Skountzou and Chinglai Yang, and first authors Ling Ye, Qiyun Zhu, Dimitrios Koutsonanos, and Maria del Pilar Martin from Emory and Vladimir Zarnitsyn from Georgia Tech. Other authors and contributors were Yulong Gao, Lei Pan, and Zhiyuan Wen from Emory, and Harvinder Gill and Sean Sullivan from Georgia Tech.
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Tuesday, April 28, 2009
Governor Perdue Signs Student Health and Physical Education Act
Governor Sonny Perdue today signed into law HB 229, the Student Health and Physical Education Act. He signed the bill at Glen Haven Elementary School in Decatur. The Governor was joined by Atlanta Falcons players Matt Ryan, Erik Coleman and Brian Finneran and the Atlanta Dream’s Chantelle Anderson.
“A big part of getting better in anything – a class, your personal fitness, a sport – is knowing how you measure up and what you need to improve on,” said Governor Sonny Perdue. “This legislation will help students live healthier lives.”
With the signing of HB 229 students in a physical education course will receive an annual fitness assessment. Beginning in 2012, each year the State Board of Education will submit a report to the Governor detailing the compliance of each school system and school.
“Instilling the importance of physical fitness at a young age will improve the quality of life for children for years to come,” said Brooks Coleman, House Education Chairman.
“This important piece of legislation will encourage all parents, students, and educators to take a serious look at health education being taught in their school systems.”
"The American Heart Association is very pleased that Governor Perdue and the majority of the state legislature are willing to address the alarming problem of childhood obesity in Georgia,” said Bill Burns, Georgia Advocacy Director for the American Heart Association. “We applaud the enactment of this important legislation. It’s an excellent first step towards allowing the Department of Education to make informed policy and curricula decisions when it comes to our children's physical well-being."
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FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers to Help Consumers Use Products Safely
The Food and Drug Administration issued a final rule today that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling to include warnings about potential safety risks, such as internal bleeding and liver damage, associated with the use of these popular drugs.
Products covered by the FDA action include acetaminophen, and a class of drugs known as the nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs include aspirin, ibuprofen, naproxen, and ketoprofen. Acetaminophen is in a class by itself. The revised labeling applies to all OTC pain relievers and fever reducers, including those that contain one of these ingredients in combination with other ingredients, such as in cold medicines containing pain relievers or fever reducers.
“Acetaminophen and NSAIDs are commonly used drugs for both children and adults because they are effective in reducing fevers and relieving minor aches and pain, such as headaches and muscle aches, “ said Charles Ganley, M.D., director, FDA’s Office of Nonprescription Drugs in the Center for Drug Evaluation and Research. “However, the risks associated with their use, need to be clearly identified on the label so that consumers taking these drugs are fully aware of the potential harm they can cause. It is important that they know how to take these medications safely to reduce their risk.”
Under the final rule, manufacturers must ensure that the active ingredients of these drugs are prominently displayed on the drug labels on both the packages and bottles. The labeling also must warn of the risks of stomach bleeding for NSAIDs and severe liver damage for acetaminophen.
Since 2006, some manufacturers have voluntarily revised their product labeling to identify these potential safety concerns. However, the voluntary changes to labeling do not address all of the labeling requirements in the new rule. For example, the new rule includes a warning on products containing acetaminophen that instructs consumers to ask a doctor before they are taking the blood thinning drug warfarin. The new rule requires all manufacturers to relabel their products within one year of today’s date.
Safety data reported in medical literature indicate that people sometimes take more acetaminophen than the labeling recommends. Others unknowingly take multiple products containing acetaminophen at the same time. Exceeding the recommended dosage of acetaminophen may increase the risks for severe liver damage. Alcohol use can also increase the risk of liver damage with acetaminophen.
The risk for stomach bleeding may increase in people who use NSAIDs and who are taking blood-thinning drugs (anticoagulants) or steroids. Stomach bleeding risks also increase for people who take multiple NSAIDs at the same time, or in people who take them longer than directed. Alcohol use can increase the risk for stomach bleeding with NSAIDs use.
An FDA Advisory Committee meeting will be convened on June 29 & 30, 2009, to discuss further steps the FDA could take to reduce the risk of liver damage associated with acetaminophen overdoses.
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SAMHSA and FDA Join to Educate the Public on the Safe Use of Methadone
The U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) and the U.S. Food and Drug Administration (FDA) today launched an initiative to help ensure the safe use of methadone. A prescription drug best known as a treatment for addiction and dependence on heroin and other narcotic pain medicines, methadone is also prescribed to treat moderate-to-severe chronic pain patients. The campaign responds to concerns about an escalating number of poisoning deaths linked to the improper use of this medication.
The public outreach effort, Follow Directions: How to Use Methadone Safely, is designed to inform consumers, health care professionals and treatment clinics about the safe use and misuse of the drug for both pain relief and drug addiction treatment.
Methadone is a synthetic opioid that has been used for decades to reduce drug withdrawal symptoms. Recently, it has been increasingly prescribed as a pain reliever for patients whose moderate-to-severe chronic pain does not respond to non-narcotic pain medications.
The percentage of all poisoning deaths linked to methadone has tripled in recent years, increasing from 4 percent in 1999 to 14 percent in 2004, according to the Centers for Disease Control and Prevention. Moreover, the number of poisoning deaths linked to methadone is rising faster than the number of poisoning deaths from any other narcotic drug.
Methadone may be best known for use as an addiction treatment medication, but the bigger problem and concern has been with the more recent use as an analgesic. The risk of methadone overdose is partly due to the way the drug metabolizes in the body. People who take methadone normally feel relief within four to eight hours. However, unlike other narcotic pain relievers a single dose of methadone can remain in the body anywhere from eight to 59 hours. As a result, the drug builds up to toxic levels if it is taken too often, in too high an amount, or with other medications.
“The methadone safety campaign materials provide simple instructions on how to use the medication correctly to either manage pain or treat drug addiction,” said H. Westley Clark, M.D., J.D., M.P.H., C.A.S., F.A.S.A.M., Director of SAMHSA’s Center for Substance Abuse Treatment. “Our goal for this training is to support the safe use of methadone by all patients and prescribing healthcare professionals.”
Methadone, when used for the treatment of narcotic addiction, must be dispensed by a program/clinic that is certified by SAMHSA and registered with the Drug Enforcement Administration (DEA). But when used as an analgesic, methadone may be prescribed by any healthcare professional registered to prescribe Schedule II controlled substances, and can be dispensed by any licensed and DEA-registered pharmacy.
“Methadone is an important and beneficial drug when prescribed and used properly,” said Douglas Throckmorton, M.D., Deputy Director of the FDA’s Center for Drug Evaluation and Research. “Educational efforts like the one we are announcing today can help prevent the tragedies that occur when methadone is used improperly.”
Outreach materials about methadone for the public and health care professionals include a brochure, a poster and a fact sheet, in English and Spanish. In addition, a point-of-sale information sheet will be distributed in pharmacies where methadone is dispensed to pain management patients.
SAMHSA and the FDA will continue to work collaboratively with other federal agencies, states, health professional societies, patient advocacy groups, and other interested parties to develop and implement practical steps to reduce avoidable methadone-associated deaths.
To learn more information about the campaign, visit www.dpt.samhsa.gov/methadonesafety.
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Mayo Clinic Researchers Formulate Treatment Combination Lethal To Pancreatic Cancer Cells
A combination of two targeted therapies packs a powerful punch to kill pancreatic cancer cells in the laboratory, Mayo Clinic cancer researchers report. With further testing of these drugs that are from classes of pharmaceuticals already used in patients, the Mayo research may lead to new treatment opportunities for patients with pancreatic cancer, which is extremely difficult to treat.
In a study being presented at the annual meeting of the American Association for Cancer Research, Mayo Clinic Cancer Center investigators found that rapamycin and panobinostat (also known as LBH589) act synergistically when used in combination, destroying up to 65 percent of cultured pancreatic tumor cells.
The finding is particularly significant, says the study's first author, Mamta Gupta, Ph.D., because the three cell lines studied were all resistant to the effects of chemotherapy - as are many pancreatic tumors - and because the drugs studied are already available for treatment of patients. Panobinostat is approved as therapy for cutaneous T cell lymphoma (CTCL), and rapamycin is best known as an immunosuppressant to help prevent rejection of transplanted organs.
"We need new therapies and strategies for the treatment of pancreatic cancer because these tumors are resistant to almost all known treatments," says Dr. Gupta, a research associate in the Division of Hematology. "No targeted treatment has shown much value to date."
Dr. Gupta studied the combination of agents in pancreatic cancer cells because her previous research at Mayo Clinic had shown that this combination worked well in laboratory tests of non-Hodgkin's lymphoma. A phase one clinical trial to test this combination in patients with lymphoma will open soon at Mayo Clinic under the direction of Thomas Witzig, M.D.
"While our pancreatic cancer cell line results look very promising, these are laboratory, not clinical, studies," she says. "We are preparing to take this combination of drugs to clinical trial to evaluate whether they can be safely given to patients."
While clinical studies will ultimately determine the benefits of panobinostat and rapamycin, Dr. Gupta and her colleagues remain focused on trying to understand the mechanism for how these agents together are so powerful.
Rapamycin and a closely related drug, everolimus (RAD001), have both been tested in pancreatic cancer cells, but by themselves have shown minimal activity, Dr. Gupta says. They belong to a class of agents known as mTOR inhibitors. The mTOR pathway is a major cellular survival mechanism that is persistently activated in pancreatic cancer cells.
In this study, rapamycin killed less than 5 percent of pancreatic cancer cells, and previous tests with RAD001 showed the same minimal effect, Dr. Gupta says. Panobinostat is a histone deacetylase (HDAC) inhibitor. In cancer, HDAC proteins "silence" tumor suppressor genes, so an HADC inhibitor restores expression of these beneficial genes. The agent is also believed to block angiogenesis - the growth of new blood vessels needed for tumors to grow," Dr. Gupta says.
Panobinostat killed about half of pancreatic cancer cells studied, she says. But both agents combined inhibited growth of pancreatic cancer cell lines and induced apoptosis (cell death) in up to 65 percent of the cells, Dr. Gupta says.
Dr. Gupta noted that panobinostat is effective at extremely low concentrations that are consistent with optimal pharmacological doses. "Our aim is always to use as little of a drug as possible in order to reduce potential side effects in patients," she says.
Although the researchers say they don't yet know the synergistic mechanism responsible for the combined drugs' effectiveness, they hypothesize that the agents are primarily interfering with the mTOR pathway, which is involved in growth and angiogenesis.
"Overall, these results indicate that rapamycin and panobinostat disrupts essential survival and proliferating pathways in pancreatic cancer cells, and this is a good start toward a novel treatment of this cancer," Dr. Gupta says.
The study was funded by the National Cancer Institute.
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Mayo Clinic-Led Researchers Confirm Gene Variants Associated With The Most Common Adult Leukemia
A national team of researchers led by Mayo Clinic has found that patients with chronic lymphocytic leukemia (CLL) are more likely to have similar DNA changes or variants in up to six genes, compared to people who do not have the cancer.
The findings, being presented at the annual meeting of the American Association for Cancer Research, are an independent validation of an earlier European study that found a link to seven different gene variants. Six were replicated in the Mayo Clinic study.
Together, the two studies demonstrate a genetic basis for the development of CLL, the most common adult leukemia in the United States, says the study's lead investigator, statistical geneticist Susan Slager, Ph.D., an associate professor of biostatistics at Mayo Clinic.
"In our study of American patients, we replicated six out of seven gene associations that were linked to this white blood cell cancer in Europeans, and in my field this level of replication is not common," Dr. Slager says. "This is a very exciting finding, and our job now is to investigate these genes to understand how they biologically affect the development of the cancer."
"These findings could potentially lead to new treatments or even prevention of CLL, but we have a lot more work to do before we can reach that ultimate goal."
Dr. Slager estimates the risk of developing the cancer doubles if a person has any of these gene variants, but overall, that absolute risk is still very small. Four out of every 100,000 people develop CLL, so having the variant genes could increase risk to eight out of every 100,000 people, she says.
Although CLL can be generally controlled, it is considered an incurable cancer, she says. Researchers from across the country collaborated with Dr. Slager and her team to collect genetic information on 399 CLL patients and 632 participants who did not have the cancer. Within the group of CLL patients, 99 were from high-risk CLL families - defined as two or more relatives diagnosed with CLL.
Using blood samples, investigators performed a genome-wide association study. They combined patients into one group and controls into another and then compared the two groups, looking for differences in genetic variants across the chromosomes. The first analysis of this data focused on the seven single nucleotide polymorphisms (SNPs) that European researchers had found. An SNP is a variation that occurs within a single nucleotide - the structural units of DNA - within a gene, and in most studies like this, the genes in which SNP changes occur are largely known. Analyses of the other genetic variants are under way.
They found that for six of the seven variants examined, CLL patients tended to have the variant more often than patients without the disease. Dr. Slager says these variants are associated with risk of developing the disease, not with prognosis - the outcome of a patient once disease has developed. "We do know that some patients have lost regions of certain genes due to the cancer and this is associated with a poorer outcome. However, we are looking for changes in the genome that potentially determine who will get the disease in the first place," she says.
"Our general theory is that these changes, which a person inherits, combined with environmental risk factors, can predispose a person to developing CLL," she says. "The more you understand about these gene variants and how they affect risk, it becomes possible to think about ways to treat or even prevent CLL."
The researchers have identified some candidate genes that correspond to the identified SNPs, while other SNPs seem to be located near genes or in regions with no genes, i.e., what scientists call gene deserts.
The study was funded by the National Cancer Institute. Co-authors include researchers from the National Cancer Institute; The University of Texas M.D. Anderson Cancer Center; Duke University Medical Center; the University of California, San Diego, Moores Cancer Center; the University of Minnesota; The University of Utah School of Medicine; and the Center for Biologics Evaluation and Research at the Food and Drug Administration.
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AUA Guideline: Full Kidney Removal Not Necessary for All Kidney Tumors
/PRNewswire/ -- Radical nephrectomy (complete removal of the affected kidney) is not the best treatment for most small kidney tumors because it puts patients at risk for chronic kidney disease and cardiovascular disease. Nephron-sparing treatments, such as partial nephrectomy, thermal ablation and active surveillance, minimize these risks and are viable options for patients with early-stage kidney tumors, according to a new clinical guideline issued by the American Urological Association (AUA). The guideline was released on Tuesday, April 28, 2009 during the Association's Annual Scientific Meeting in Chicago.
This is the first time that the AUA has released official guidelines for the management of patients with kidney cancer. This guideline is focused on the management of patients with early-stage renal masses, which has become controversial in the past few years. Guideline Panel Co-Chair Steven C. Campbell, MD, PhD, will present the guideline to the media on April 28, 2009 at 12:30 p.m. in the AUA Press Suite, located at the Hyatt Regency McCormick in Chicago.
Detection of clinical stage 1 (<7.0>3 to 4 cm) should be managed in a proactive manner, if possible.
Radical Nephrectomy: Radical nephrectomy is still occasionally required. A laparoscopic approach should be considered because it is associated with a more rapid recovery profile.
The Guideline Panel also addressed the following novel treatment modalities: high-intensity focused ultrasound, radiosurgery, microwave thermotherapy; laser interstitial thermal therapy; and pulsed cavitational ultrasound.
The "Guideline for Management of the Clinical Stage 1 Renal Mass" will be published in The Journal of Urology(R) later this year. A press conference on the Guideline will be held on April 28, 2009 at 12:30 p.m. at the Hyatt Regency McCormick Place during the AUA Annual Meeting in Chicago, IL. For more information on covering the press conference or to schedule an interview, please contact Lacey Dean at LDean@AUAnet.org.
Panel Members included: Steven C. Campbell, MD, PhD, Co-Chair; Arie Belldegrun, MD; Michael L. Blute, MD; George Kuoche Chow, MD; Ithaar H. Derweesh, MD; Jihad H. Kaouk, MD; Raymond J. Leveille, MD; Surena F. Matin, MD; Paul Russo, MD; Robert Guy Uzzo, MD; and the late Andrew C. Novick, MD.
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Monday, April 27, 2009
Mayo Clinic Study Suggests Those Who Have Chronic Pain May Need to Assess Vitamin D Status
Mayo Clinic research shows a correlation between inadequate vitamin D levels and the amount of narcotic medication taken by patients who have chronic pain. This correlation is an important finding as researchers discover new ways to treat chronic pain. According to the Centers for Disease Control and Prevention, chronic pain is the leading cause of disability in the United States. These patients often end up taking narcotic-type pain medication such as morphine, fentanyl or oxycodone.
This study found that patients who required narcotic pain medication, and who also had inadequate levels of vitamin D, were taking much higher doses of pain medication — nearly twice as much — as those who had adequate levels. Similarly, these patients self-reported worse physical functioning and worse overall health perception. In addition, a correlation was noted between increasing body mass index (a measure of obesity) and decreasing levels of vitamin D. Study results were published in a recent edition of Pain Medicine.
"This is an important finding as we continue to investigate the causes of chronic pain," says Michael Turner, M.D., a physical medicine and rehabilitation physician at Mayo Clinic and lead author of the study. "Vitamin D is known to promote both bone and muscle strength. Conversely, deficiency is an under-recognized source of diffuse pain and impaired neuromuscular functioning. By recognizing it, physicians can significantly improve their patients' pain, function and quality of life."
Researchers retrospectively studied 267 chronic pain patients admitted to the Mayo Comprehensive Pain Rehabilitation Center in Rochester from February to December 2006. Vitamin D levels at the time of admission were compared to other parameters such as the amount and duration of narcotic pain medication usage; self-reported levels of pain, emotional distress, physical functioning and health perception; and demographic information such as gender, age, diagnosis and body mass index.
Further research should document the effects of correcting deficient levels among these patients, researchers recommend.
This study has important implications for both chronic pain patients and physicians. "Though preliminary, these results suggest that patients who suffer from chronic, diffuse pain and are on narcotics should consider getting their vitamin D levels checked. Inadequate levels may play a role in creating or sustaining their pain," says Dr. Turner. "Physicians who care for patients with chronic, diffuse pain that seems musculoskeletal — and involves many areas of tenderness to palpation — should strongly consider checking a vitamin D level," he says. "For example, many patients who have been labeled with fibromyalgia are, in fact, suffering from symptomatic vitamin D inadequacy. Vigilance is especially required when risk factors are present such as obesity, darker pigmented skin or limited exposure to sunlight."
Assessment and treatment are relatively simple and inexpensive. Levels can be assessed by a simple blood test (25-hydroxyvitamin D [25(OH)D]). Under the guidance of a physician, an appropriate repletion regimen can then be devised. Because it is a natural substance and not a drug, vitamin D is readily available and inexpensive.
In addition to the benefits of strong muscles and bones, emerging research demonstrates that vitamin D plays important roles in the immune system, helps fight inflammation and helps fights certain types of cancer.
Other study authors from Mayo Clinic include W. Michael Hooten, M.D., Department of Anesthesiology; John Schmidt, Ph.D., Department of Anesthesiology Research; and Jennifer Kerkvliet, Cynthia O. Townsend, Ph.D., and Barbara Bruce, Ph.D., all from the Pain Rehabilitation Center.
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Heart Attack Victim Survives the Unsurvivable
Luck, Skill and Piedmont Hospital’s New Technology Save Peachtree City Man
Tom Dix, 50, had just returned from an afternoon walk with his wife, Dana, when he went into cardiac arrest at their Peachtree City home. Two hours later, he was in the cardiac catheterization lab at Piedmont Hospital being treated with a CardiacAssist TandemHeart. His wife’s nursing background, the skills of emergency responders, Piedmont Fayette Hospital, Piedmont Heart Institute Physicians, the Fuqua Heart Center of Atlanta at Piedmont Hospital and more than a little luck saved his life.
At 4 p.m. on January 13, 2009, Dana Dix, a registered nurse, began performing CPR on her husband until the Peachtree City emergency responders arrived. After arresting in route to Piedmont Fayette Hospital, Dix was stabilized and flown via LifeFlight to Piedmont Hospital, where Victor Corrigan, M.D., opened Dix’s blocked artery with a stent in the cath lab. But Dix remained in cardiac shock. By chance, interventional cardiologist Vivek Rajagopal, M.D., who was scheduled to be in the lab to treat another patient, was on hand to propose the use of the TandemHeart, giving Dix’s left ventricle heart chamber a chance to rest and recover.
The unusual circumstances—the continuum of care that began with CPR, rapid onset of cardiac shock and the availability of the TandemHeart, which Dr. Rajagopal introduced at Piedmont in February 2008—all aligned perfectly to make Dix’s survival possible.
“It was just chance that I happened to be there to suggest using the TandemHeart. But without all of those particulars coming together as they did, all indications are that Mr. Dix would not have survived,” said Dr. Rajagopal, who joined Piedmont Heart Institute Physicians last year after practicing at the Cleveland Clinic. He estimates that the TandemHeart increases survival for patients in Dix’s condition from well below 50 percent to more than 70 percent.
Tom Dix is well aware of just how lucky he is and, thinking of his son and two stepchildren, finds it difficult to talk about the experience without becoming emotional. “I’m inordinately blessed to have my wife who immediately knew how to take care of me and a physician as skilled and extraordinarily caring as Dr Rajagopal,” he said.
His wife, Dana, agreed, adding high praise for Gregg Steahr, physician assistant and chief of Piedmont’s critical care medicine program. “They gave us more than just medical treatment and information. On many days they gave us hope when we felt like there wasn’t any,” she said.
Dix was discharged from Piedmont Hospital on February 11. He continues to recover at home in the Peachtree City Centennial subdivision.
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FDA Authorizes Emergency Use of Influenza Medicines, Diagnostic Test in Response to Swine Flu Outbreak in Humans
The U.S. Food and Drug Administration, in response to requests from the U.S. Centers for Disease Control and Prevention, has issued Emergency Use Authorizations (EUAs) to make available to public health and medical personnel important diagnostic and therapeutic tools to identify and respond to the swine flu virus under certain circumstances. The agency issued these EUAs for the use of certain Relenza and Tamiflu antiviral products, and for the rRT-PCR Swine Flu Panel diagnostic test.
The EUA authority allows the FDA, based on the evaluation of available data, to authorize the use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products following a determination and declaration of emergency, provided certain criteria are met. The authorization will end when the declaration of emergency is terminated or the authorization revoked by the agency.
Currently, Relenza is approved to treat acute uncomplicated illnesses due to influenza in adults and children 7 years and older who have been symptomatic for less than two days, and for the prevention of influenza in adults and children 5 years and older. Tamiflu is approved for the treatment and prevention of influenza in patients 1 year and older.
The EUAs allow for Tamiflu also to be used to treat and prevent influenza in children under 1 year, and to provide alternate dosing recommendations for children older than 1 year. In addition, under the EUAs, both medications may be distributed to large segments of the population without complying with the label requirements otherwise applicable to dispensed drugs, and accompanied by written information pertaining to the emergency use. They may also be distributed by a broader range of health care workers, including some public health officials and volunteers, in accordance with applicable state and local laws and/or public health emergency responses.
In authorizing an EUA for the rRT-PCR Swine Flu Panel diagnostic test, the FDA has determined that it may be effective in testing samples from individuals diagnosed with influenza A infections, whose virus subtypes cannot be identified by currently available tests. This EUA allows the CDC to distribute the swine flu test to public health and other qualified laboratories that have the needed equipment and the personnel who are trained to perform and interpret the results.
The test amplifies the viral genetic material from a nasal or nasopharyngeal swab. A positive result indicates that the patient is presumptively infected with swine flu virus but not the stage of infection. However, a negative result does not, by itself, exclude the possibility of swine flu virus infection.
The EUA authority is part of Project BioShield, which became law in July 2004.
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Georgia: Swine Flu Update
In response to positive Swine Flu cases in California, Texas, Kansas, New York City, Michigan and Ohio; District Four is initiating active surveillance for this novel H1N1 Influenza in conjunction with the District Health Emergency Assessment and Response Team (DHEART) and County Health Emergency Assessment Response Teams (CHEART). Our goals this week are to rapidly identify initial cases and initiate epidemiologic evaluations/surveillance, inform and activate our Public Health staff and coordinate with our community partners as they activate and respond.
U.S. Centers for Disease Control and Prevention officials said Sunday afternoon that tests of the seasonal vaccine and the new virus show no cross-reaction, suggesting that people who got the vaccine have no added protection against the new bug.
CDC has determined that this swine influenza A (H1N1) virus is contagious and is spreading from human to human. However, at this time, it not known how easily the virus spreads between people.
The symptoms of swine flu in people are similar to the symptoms of regular human flu and include fever, cough, sore throat, body aches, headache, chills and fatigue. Some people have reported diarrhea and vomiting associated with swine flu. In the past, severe illness (pneumonia and respiratory failure) and deaths have been reported with swine flu infection in people. Like seasonal flu, swine flu may cause a worsening of underlying chronic medical conditions. If you become ill with influenza like symptoms and experience any of the following warning signs, seek medical care.
In children emergency warning signs that need urgent medical attention include:
· Fast breathing or trouble breathing
· Bluish skin color
· Not drinking enough fluids
· Not waking up or not interacting
· Being so irritable that the child does not want to be held
· Flu-like symptoms improve but then return with fever and worse
cough
· Fever with a rash
In adults, emergency warning signs that need urgent medical attention include:
· Difficulty breathing or shortness of breath
· Pain or pressure in the chest or abdomen
· Sudden dizziness
· Confusion
· Severe or persistent vomiting
There is no vaccine available right now to protect against swine flu. There are everyday actions that can help prevent the spread of germs that cause respiratory illnesses like influenza. Take these everyday steps to protect your health:
· Cover your nose and mouth with a tissue when you cough or sneeze. Throw the tissue in the trash after you use it.
· Wash your hands often with soap and water, especially after you cough or sneeze. Alcohol-based hand cleaners are also effective.
· Avoid touching your eyes, nose or mouth. Germs spread this way.
· Try to avoid close contact with sick people.
· If you get sick with influenza, CDC recommends that you stay home from work or school and limit contact with others to keep from infecting them.
We know that some viruses and bacteria can live 2 hours or longer on surfaces like cafeteria tables, doorknobs, and desks. Frequent handwashing will help you reduce the chance of getting contamination from these common surfaces. It is also important to disinfect commonly used surfaces.
District 4 Health Services
More info on the CDC’s website http://www.cdc.gov/swineflu
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Piedmont Hospital Offers Stroke Screening and Education on Stroke Outreach Day
Joins with Other Atlanta Hospitals in Challenge to Conduct 100,000 Free Screenings
The local American Stroke Association issued a challenge to metro Atlanta hospitals for them to conduct a combined total of 100,000 free stroke screenings as part of efforts to focus consumer attention on National Stroke Awareness Month in May.
Piedmont Hospital is rising to the challenge and will offer free stroke screenings and education on Saturday, May 2 from 10 a.m. to 2 p.m. in the 77 Building, Level M. Participants will complete a stroke risk assessment, receive a blood pressure check and speak with a stroke educator as well as experts in rehabilitation, fitness and nutrition. A pharmacist also will be available to discuss blood-thinning medications such as Coumadin as well as those for high blood pressure, cholesterol and diabetes -- all related to risk factors for stroke. The first 50 participants will receive a T-shirt.
“A stroke is preventable, but not if you don’t take the time to learn your level of risk,” said neurologist Doug Stuart, M.D. “We encourage everyone to take part in this 100,000 stroke screening challenge. The screening is free, but the education you will receive about stroke is priceless.”
Stroke is the third leading cause of death in the United States. According to a 2008 Georgia Department of Human Resources report, Georgia’s stroke death rate is 16 percent higher than the national rate, accounting for 6 percent (3,826) of all deaths.
A stroke occurs when blood vessels carrying oxygen and other nutrients to the brain become blocked by a clot or burst, impeding oxygen and blood flow. Without oxygen, the brain’s ability to function is hindered. The part of the brain that is affected, in turn, impairs other bodily functions resulting in paralysis, speech and vision problems.
Controllable risk factors include high blood pressure and cholesterol, poor diet, lack of exercise, smoking and other lifestyle choices. Working with a doctor to make gradual changes to your daily routine can greatly reduce the risk of stroke. Unfortunately, not all risk factors can be controlled. Age, gender, family medical history, previous strokes and current heart conditions all play a role in determining risk. Race is also a factor. African-Americans are twice as likely to have a stroke due to a high prevalence of high blood pressure, tobacco use and obesity.
Being able to recognize the warning signs of the onset of stroke can make the difference between life, death and disability. If you experience any of the following symptoms you should immediately seek emergency care:
Sudden numbness or weakness of the face, arm or leg, especially on one side of the body
Confusion or trouble speaking
Sudden complications in vision in one or both eyes
Trouble walking, dizziness or loss of balance and coordination
Sudden severe headache with no known cause
For more information on Piedmont Hospital, visit piedmonthospital.org.
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CDC: Swine Flu Update April 27, 2009
Human cases of swine influenza A (H1N1) virus infection have been identified in the United States. Human cases of swine influenza A (H1N1) virus infection also have been identified internationally. The current U.S. case count is provided below.
| State | # of laboratory confirmed cases | |
|---|---|---|
| California | 7 cases | |
| Kansas | 2 cases | |
| New York City | 28 cases | |
| Ohio | 1 case | |
| Texas | 2 cases | |
| TOTAL COUNT | 40 cases | |
An investigation and response effort surrounding the outbreak of swine flu is ongoing.
CDC is working very closely with officials in states where human cases of swine influenza A (H1N1) have been identified, as well as with health officials in Mexico, Canada and the World Health Organization. This includes deploying staff domestically and internationally to provide guidance and technical support.
CDC activated its Emergency Operations Center to coordinate the agency's response to this emerging health threat and yesterday the Secretary of the Department Homeland Security, Janet Napolitano, declared a public health emergency in the United States.
This will allow funds to be released to support the public health response. CDC's goals during this public health emergency are to reduce transmission and illness severity, and provide information to assist health care providers, public health officials and the public in addressing the challenges posed by this newly identified influenza virus. To this end, CDC has issued a number of interim guidance documents in the past 24 hours. In addition, CDC's Division of the Strategic National Stockpile (SNS) is releasing one-quarter of its antiviral drugs, personal protective equipment, and respiratory protection devices to help states respond to the outbreak. Laboratory testing has found the swine influenza A (H1N1) virus susceptible to the prescription antiviral drugs oseltamivir and zanamivir. This is a rapidly evolving situation and CDC will provide updated guidance and new information as it becomes available.
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Swine Flu: Infection Control in Hospitals Will Be Critical
/PRNewswire / -- In response to confirmed cases of swine flu in Mexico, Canada, and the United States, European Union health officials are advising against travel to North America. At airports in Japan and several other Asian countries, thermal scanners are being used to identify fever among passengers from North America.
But in the U.S. the disease is already among us. The severity and extent are unknown. The SARS outbreak (severe acute respiratory syndrome) in 2003 teaches that rigorous infection control in hospitals may be key to limiting deaths from swine flu in the U.S. Much will depend on what hospitals do when the first seriously ill victims arrive." If hospitals have effective infection controls in place, the disease can be prevented from spreading to visitors, healthcare workers and their families," warns Betsy McCaughey, Ph.D., and Chairman of the Committee to Reduce Infection Deaths (RID), a national organization that educates the public and medical community about preventing infection. McCaughey explains that "77% of the people who contracted SARS in the Canadian outbreak were patients, visitors or workers in hospitals. SARS was almost entirely a hospital infection epidemic."
SARS -- four letters that filled the headlines in the spring of 2003, and then disappeared. "A report issued after the fact by the government of Ontario (The SARS Commission, Spring of Fear, December 2006) shows how hospitals in one city thwarted an epidemic while hospitals in another city made deadly mistakes" says McCaughey, an expert on preventing infection.
Many hospitals in the U.S. are under-prepared for a similar challenge. As many as ten percent of patients contract infections in the hospital, according to the Centers for Disease Control and Prevention. Bacteria such as MRSA (methicillin-resistant Staphylococcus aureus) and Clostridium difficile race through hospitals, spread by unwashed hands and unclean equipment. How can hospitals that are failing to prevent ordinary infections spread by touch contain a new, unknown virus that can spread whenever someone coughs or sneezes?
"The best defense against swine flu and other unknown pathogens is rigorous hospital hygiene and routine infection prevention. That is the lesson of SARS," says McCaughey.
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HHS Declares Public Health Emergency for Swine Flu
The Department of Health and Human Services yesterday issued a nationwide public health emergency declaration in response to recent human infections with a newly discovered swine influenza A (swine flu) virus.
The formal declaration of a Public Health Emergency (PHE) is a tool that facilitates HHS’ preparation and mobilization for disasters and emergencies. For example, PHEs were recently declared for flooding in North Dakota, the Inauguration, and several 2008 hurricanes.
Yesterday’s declaration, made under section 319 of the Public Health Service Act, will help HHS prepare for prevention and mitigation activities by enabling Food and Drug Administration (FDA) emergency use authorizations of drugs, devices, or medical tests under certain circumstances.
Specifically, the PHE will enable the FDA to review and issue emergency use authorizations (EUAs) for the use of certain laboratory tests to help detect the newly discovered strain of influenza and for the emergency use of certain antivirals.
“HHS is taking these steps today to be proactive in responding to this new influenza virus by offering national tools in support of community-led preparedness and response efforts,” Acting HHS Secretary Charles Johnson said. “The declaration allows us the flexibility, while we learn more about the virus and its impact in the United States, to take additional steps to fully mobilize our prevention, treatment and mitigation capabilities should those actions become necessary.”
In addition to the declaration, HHS leaders are working together across operating divisions to coordinate response to the swine flu outbreak. For example, the FDA, the National Institutes of Health, and the Centers for Disease Control and Prevention are working together to develop a vaccine precursor that could be used to develop a vaccine for this swine flu virus.
To date, there have been 20 confirmed cases of swine Influenza A (swH1N1) in California, Texas, Kansas, New York, and Ohio. No deaths in the U.S. have been reported due to the illness. Additional cases of the virus have been confirmed in Mexico and Canada.
Swine flu is a respiratory disease of pigs caused by type A influenza that regularly causes outbreaks of influenza among pigs. Swine flu viruses do not normally infect humans; however, human infections with swine flu do occur, and cases of human-to-human spread of swine flu viruses have been documented.
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Friday, April 24, 2009
Piedmont Hospital Offers FREE Skin Cancer Screenings May 16
May is National Skin Cancer Awareness Month
Each hour, one person dies from skin cancer. More than 90 percent of skin cancers are caused by sun exposure and with summer just around the corner, everyone needs to take precautions to protect their skin.
Piedmont Hospital invites you to drop in for a convenient and free screening: Saturday, May 16, from 8 a.m. until noon on the 5th floor of building 77 at Piedmont Hospital, 1968 Peachtree Road, Atlanta, GA 30309.
Dermatologists and physician assistants will be screening “exposed skin” only, so please prepare by wearing comfortable appropriate attire, such as shorts and sleeveless shirts. Come by and pick-up free sun screen samples and register to win goodies and a complimentary beauty service package.
Parking is available in the North Parking Deck behind the hospital. Registration is required for this free event, so please call 1-866-900-4321 for more information or to register.
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Emory University Hospital to Host Stroke Awareness Event
In conjunction with the Metro Atlanta American Stroke Association’s Stroke Outreach Day, and in recognition of National Stroke Awareness Month, Emory University Hospital will host "The Mind is a Terrible Thing to Waste -- How to Prevent Stroke" on Saturday, May, 2, from 9 a.m.-3 p.m.
The day-long event will be held in the Emory University Hospital auditorium, featuring educational lectures by Emory physicians and clinical staff, as well as health screenings including:
• Body Mass Index/Nutrition Counseling
• Blood Glucose (sugar) screening
• Blood Pressure screenings
• Individual consultation with Nurse Practitioners to discuss a plan to reduce personal modifiable risk factors
Stroke lectures will include:
• "Understanding Stroke: It's a State of Mind"
• "Blood Pressure and Cholesterol: What’s So Important?"
• "Diabetes and Stroke"
• "Healthy Eating"
The first lecture will begin at 10 a.m. Health screenings will begin at 9 a.m. and end at 3 p.m. The screenings will continue throughout the lecture series in order to accommodate more participants.
The event is free and open to the public. However, participants are encouraged to contact Emory’s Health Connection line at 404-778-7777 in order to guarantee seating and individual health screening.
Emory University Hospital is located at 1364 Clifton Road, NE. Atlanta, GA 30322.
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Metro Atlanta Hospitals Challenged to Conduct 100,000 Stroke Screenings in One Day
American Stroke Association Urges Local Participation in Stroke Awareness Day
Hospitals throughout metro Atlanta are being challenged to administer a combined 100,000 free stroke screenings on Saturday, May 2, 2009 as part of the Metro Atlanta American Stroke Association’s Stroke Awareness Day.
The local American Stroke Association has issued the challenge as part of efforts to focus consumer attention on National Stroke Awareness Month in May, which was created in order to make Americans aware that stroke is the third leading cause of death in the United States. According to a 2008 Georgia Department of Human Resources report, Georgia’s stroke death rate is 16% higher than the national rate, accounting for 6% (3,826) of all deaths.
A stroke occurs when blood vessels carrying oxygen and other nutrients to the brain become blocked by a clot and burst, impeding oxygen and blood flow. Without oxygen, the brain’s ability to function is hindered. The part of the brain that is affected, in turn, impairs other bodily functions resulting in paralysis, speech and vision problems.
“Knowing your risk is the first step in preventing a possible stroke,” said Mary Robichaux, the American Stroke Association’s vice president of quality initiatives and improvements. “While some factors are not controllable, many are. With proper diagnosis it’s possible to help decrease your personal risk.”
Controllable risk factors include high blood pressure and cholesterol, poor diet, lack of exercise, smoking and other lifestyle choices. Working with a doctor to make gradual changes to your daily routine can greatly reduce the risk of stroke. Unfortunately, not all risk factors can be controlled. Age, gender, family medical history, previous strokes and current heart conditions all play a role in determining risk. Race is also a factor. African-Americans are twice as likely to have a stroke due to a high prevalence of high blood pressure, tobacco use and obesity.
Being able to recognize the warning signs of the onset of stroke can make the difference between life, death and disability. If you experience any of the following symptoms you should immediately seek emergency care:
· Sudden numbness or weakness of the face, arm or leg, especially on one side of the body
· Confusion or trouble speaking
· Sudden complications in vision in one or both eyes
· Trouble walking, dizziness or loss of balance and coordination
· Sudden severe headache with no known cause
“We believe this challenge is an excellent step in educating the community about stroke,” said Robichaux.
The free stroke screenings will take place at Atlanta Medical Center and Emory University, Grady, North Fulton Regional, Saint Joseph’s, Piedmont and Wellstar Hospitals.
For more information on stroke or to find the nearest hospital participating in Stroke Awareness Day on May 2nd, visit www.strokeassociation.org. For more information on African-Americans and stroke, visit www.PowertoEndStroke.org. Power to End Stroke is a national campaign dedicated to making African-Americans aware of their stroke risk
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FDA Approves Monthly Injectable Drug for Treating Three Types of Immune-Related Arthritis
The U.S. Food and Drug Administration today approved Simponi (golimumab), a monthly treatment for adults with moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis.
All three conditions are chronic disorders in which the immune system attacks multiple joints, causing stiffness, pain, and restricted motion.
“Today’s approval provides another treatment option for patients with these three debilitating disorders,” said Bob Rappaport, M.D., director of the Division of Anesthesia, Analgesia, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research. “And the steps we’re taking to minimize the risks will give patients the same level of safety protection required for other drugs in its class."
Simponi is injected under the skin. It is intended for use in combination with the immunosuppressant drug methotrexate in patients with rheumatoid arthritis. It also may be used with or without methotrexate for psoriatic arthritis and alone in patients with ankylosing spondylitis, a chronic inflammatory arthritis of the spine.
In clinical trials, patients who received Simponi for one of the three conditions showed improvements in the signs and symptoms common to their form of arthritis.
Simponi is in a class of drugs that target and neutralize tumor necrosis factor-alpha (TNF-α), a protein that, when overproduced in the body due to chronic inflammatory diseases, can cause inflammation and damage to bones, cartilage and tissue. Like other TNF- α blockers, Simponi labeling includes a boxed warning alerting patients and health care professionals to the risk of tuberculosis and invasive fungal infections with use of the drug. The FDA also required a risk evaluation mitigation strategy (REMS) for Simponi, as it required for other TNF-α blockers. The REMS for Simponi includes a Medication Guide for patients and a communication plan to help prescriber’s understand the drug’s risks.
The most common adverse reactions to Simponi include upper respiratory tract infection, sore throat and nasal congestion.
Simponi is marketed by Centocor Ortho Biotech Inc., Malvern, Pa.
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Thursday, April 23, 2009
TeamSTEPPS™ comes to Piedmont Fayette Hospital’s Maternity Center
Piedmont Fayette Hospital, recently ranked third in patient satisfaction among metro Atlanta hospitals, according to the recently-released HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) survey, is taking yet another “Stepp” towards improving their quality of care and patient safety. They are partnering with Healthcare Team Training, LLC (an Atlanta based company) to implement TeamSTEPPS (Strategies and Tools to Enhance Performance and Patient Safety) within their Maternity Center.
TeamSTEPPS is an innovative medical teamwork program that was co-developed by the US Department of Defense and Agency for Healthcare Research and Quality. 25 years of research and evidence shows that implementing this program will reduce medical errors and improve patient safety. Healthcare Team Training is a world-class provider of teamwork consulting and training services. Their professional staff includes practicing physicians, surgeons, nurses and anesthetists.
For the first time, Healthcare Team Training brings medical teamwork expertise to Piedmont Fayette Hospital. They will conduct physician and staff teamwork training using the latest techniques in simulation for improving teamwork in PFH’s maternity center.
Piedmont Fayette Hospital and Healthcare Team Training, LLC
TeamSTEPPS Physician-Training Workshop
Friday, April 24, 2009
1:00 until 2:00 pm
Physicians Conference Room
Piedmont Fayette Hospital
1255 Highway 54 West
Fayetteville, GA 30214
Patient safety is a critical issue to all healthcare systems and a top priority for communities. Piedmont Fayette prides itself in providing the highest caliber of effective medical teams who can optimize their environment, information and resources to achieve the best clinical outcomes with utmost care. Healthcare Team Training, with its extensive TeamSTEPPS work in both military health systems as well as civilian organizations, will bring this innovative model to Piedmont Fayette’s Maternity Center physicians and staff.
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Piedmont Fayette Hospital Patient Regains Full Use of Hands
April is Occupational Therapy Month
While out with her family at the local skating rink, Fayetteville resident Jennifer Smith, tripped over another skater and landed backwards on the edge of her palms. The result: bilateral fractures in both wrists, and shattered bones beneath her thumb and pinky. She was rushed to the emergency room at Piedmont Fayette Hospital (PFH). After X-rays, splints, surgery and a 2-day hospital stay, Smith was sent for occupational therapy.
“When I showed up for therapy at Piedmont Fayette Hospital, my hand was straight up and down, I could only move it a quarter of an inch at the very most,” said Smith. “I couldn’t tie my shoes or get dressed, let alone do my job.”
Smith underwent 6 weeks of therapy at PFH, with two sessions every week. She participated in flexion, extension and strength building exercises, which included lifting small weights, pushing and pulling objects, circular movements of the wrist to regain rotation, and massages.
“The occupational therapy program is designed to help our patients perform day-to-day tasks for themselves, whether that is at home, school, work or play,” said Lisa Caphe, an occupational therapist at Piedmont Fayette Hospital. “But more than boosting motor skills and improving mental acumen, we want them to know they can overcome their injuries or disabilities and lead normal lives.”
April is Occupational Therapy (OT) Month and Piedmont Fayette Hospital is recognizing the hospital’s occupational therapy department for its efforts to help individuals, like Smith, lead fulfilling lives.
Occupational therapy (OT) is the use of treatments to develop, recover, or maintain the daily living and work skills of patients such as Smith. The therapists help clients not only to improve their basic motor functions and reasoning abilities, but also to compensate for permanent loss of function. The goal is to help clients have independent, productive, and satisfying lives.
“Lisa explained everything to my husband so he would know what to do after my sessions were over,” said Smith. “She suggested using things around the house for weights – like canned goods or a hammer to simulate the same exercises.”
With continued exercises at home, as suggested by her OT, Smith returned to work and has regained almost full mobility in her left wrist and hand and is 85-90 percent recovered in her right.
“You get so much more out of the therapy with a specialist than you can do it at home. Having someone there to tell you when you’re doing it right or wrong, and what exercises to do really helped,” said Smith. “It was a wonderful experience, -- without them I don’t think I’d be back where I am today.”
PFH Rehabilitation and Fitness Center offers cardiac rehab, pulmonary rehab, diabetes education, physical therapy, occupational therapy and speech-language pathology. There are also specialty programs including pelvic pain and incontinence therapy, lymphedema therapy, wound care and ostomy management, joint replacement pre-op classes, and Healthy Heart Classes. The fitness center is open to the community and offers a full line of state of the art equipment. Physician referral is required for most rehabilitation services. For more information about PFH's occupational therapy department and other rehabilitation and fitness services, call 770-719-7290. To learn more about Piedmont Fayette Hospital, visit www.fayettehospital.org.
