Sniffles And Sneezes: The AAAAI Offers Tips To Prepare For Ragweed Season

With summer soon coming to an end, allergy sufferers may begin to feel relief from the diminishing tree and grass pollen. Unfortunately, the end of summer also means the start of ragweed season, which unofficially begins in mid-August.

For the nearly 36 million Americans who are affected by seasonal allergic rhinitis, or “hay fever,” this means an increased amount of sneezing and itchy, watery eyes. According to the American Academy of Allergy, Asthma & Immunology (AAAAI), symptoms of allergic rhinitis can have a major impact on a person’s quality of life and, therefore, it is important to properly prepare for ragweed season.

“For most of the country, ragweed starts blooming on August 15,” said Fuad M. Baroody, MD, FAAAAI, Chair of the AAAAI Rhinitis Committee. “Ragweed is a stubborn plant that can grow practically anywhere. It produces one billion grains per average season and, due to their lightweight texture, the grains can travel up to 400 miles. Ragweed is prevalent throughout the Northeast, South and Midwest from mid-August to October, making it a significant cause of fall allergies. Without proper diagnosis and management, your allergies could take a heavy toll on your quality of life.”

Symptoms of allergic rhinitis or “hay fever” include sneezing, runny noses and swollen, itchy, watery eyes. These symptoms can be so severe that they affect a person’s ability to function well at school or work. Nearly 80% of patients with seasonal allergies experience sleep problems, leading to fatigue, loss of concentration and poor performance at work and school. In fact, each year, more than 3.8 million days of work and school are missed due to the abundance of ragweed in the air which, in turn, causes seasonal allergies.

How to avoid exposure to ragweed

The best way to avoid feeling the symptoms of seasonal allergies is to avoid the triggers. To reduce exposure to ragweed, remember the following tips:

– Avoid areas where ragweed plants thrive, including ditches, vacant lots, roadsides, riverbanks and the edges of wooded areas.
– Keep windows closed during ragweed season to prevent pollen from drifting into your home. Use air conditioning, which cools, cleans and dries the air.
– Keep your car windows closed when traveling.
– Minimize outdoor activity when pollen counts are high.
– Take a shower after spending time outside; pollen can collect on your skin and hair.
– Minimize your exposure to other known allergens during ragweed season, since symptoms are the result of a cumulative effect of multiple allergens.
– Get up-to-date pollen information for your area by visiting the National Allergy Bureau (NAB), at aaaai/nab.

To help prepare for the arrival of ragweed, begin your allergy medications 10-14 days prior to your area’s peak ragweed season. By learning about the causes and symptoms of various forms of rhinitis, you will be better able to identify and avoid your triggers. An allergist/immunologist can assist by making an accurate diagnosis and developing an effective treatment plan for you.

When to see an allergy/asthma specialist

According to the AAAAI’s referral guidelines, patients should see an allergist/immunologist if they:

– Have prolonged or severe symptoms of rhinitis
– Have nasal polyps
– Have co-existing conditions such as asthma or recurrent sinusitis
– Have symptoms interfering with quality of life and/or ability to function
– Have limited their diet based upon perceived adverse reactions to foods or additives
– Experience itchy mouth from raw fruits or vegetables
– Have found medications to be ineffective or have had adverse reactions to medications
– Are a child with allergic rhinitis, because immunotherapy may potentially prevent the development of asthma

To find an allergist/immunologist in your area or to learn more about allergies and asthma, visit the AAAAI Web site at aaaai.

The AAAAI represents allergists, asthma specialists, clinical immunologists, allied health professionals and others with a special interest in the research and treatment of allergic disease. Allergy/immunology specialists are pediatric or internal medicine physicians who have elected an additional two years of training to become specialized in the treatment of asthma, allergy and immunologic disease. Established in 1943, the AAAAI has more than 6,500 members in the United States, Canada and 60 other countries. The AAAAI serves as an advocate to the public by providing educational information through its Web site at aaaai.

Perceptive Informatics Introduces Medical Imaging Methodology To Accelerate Development Decisions About Alzheimer’s Treatments

Perceptive Informatics, the industry’s leading eClinical solutions provider and a subsidiary of PAREXEL International Corporation (Nasdaq: PRXL), announced that it has developed a robust medical imaging methodology for Central Nervous System (CNS) clinical trials involving Alzheimer’s disease. The method, based on measuring ventricular size, provides a new approach to monitor brain atrophy in Alzheimer’s disease and potential treatment effects. The technique was presented on April 26, 2009 in Seattle, Washington during an invitation-only meeting of the Alzheimer’s Disease Neuroimaging Initiative (ADNI).

The advantages of this method include providing higher quality, reproducible, and regulatory compliant assessments with the potential to help clinical trial sponsors make better and faster development decisions about Alzheimer’s treatments in development. To develop this method, the Perceptive Informatics team collected Magnetic Resonance Imaging (MRI) scans from the ADNI database using Perceptive’s medical imaging system and regulatory compliant processes.

“It is more critical than ever that biopharmaceutical companies have the ability to make accurate go/no go decisions as early as possible for new compounds. Medical imaging is increasingly being used as a surrogate endpoint or biomarker of drug efficacy in all phases of CNS trials. With this new methodology, we believe that Perceptive’s therapeutic area experts are able to help sponsors advance neuroimaging and bring important CNS treatments to patients sooner,” said Kenneth G. Faulkner, Ph.D., Vice President of Medical Imaging, Perceptive Informatics.

“Based on ADNI data, measuring ventricular change may be one of the most robust outcomes for imaging progression of Alzheimer’s disease. Perceptive has developed a novel method of ventricular measurement that accurately reflects brain atrophy,” said James Paskavitz, M.D., Medical Director, Perceptive Informatics. “We believe that this method can support sponsors in reducing the time, cost, and risk associated with clinical development of Alzheimer’s treatments by providing medical image data that informs early phase decisions and is reproducible for later phase, multi-center trials.”

The Perceptive Informatics Medical Imaging Group has helped to develop and validate novel surrogate endpoints for a variety of CNS disorders. Perceptive offers a range of capabilities in the application of imaging techniques from early clinical development through late phase studies. The medical imaging team operates globally and services a wide range of therapeutic areas, including oncology, central nervous system, musculoskeletal, cardiovascular, and metabolism/endocrinology imaging.

ADNI is focused on defining the rate of progress of mild cognitive impairment and Alzheimer’s disease, developing improved methods for clinical trials in this area, and providing a large database to improve design of treatment trials. A goal of ADNI is to provide information and methods to help lead to effective treatments for Alzheimer’s disease, leading to effective prevention.

About Perceptive Informatics

Perceptive Informatics, a subsidiary of PAREXEL, is the industry’s leading eClinical solutions provider. Perceptive Informatics offers unprecedented access to innovative eClinical technologies and resources, providing clinical trial sponsors, CROs, and other service providers with the benefits of an extensive line of products and services throughout the entire clinical development lifecycle. In August, 2008 Perceptive was joined with ClinPhone plc, and the newly combined organization offers eClinical software and services that increase the efficiency and productivity of clinical research. Perceptive’s expansive product portfolio includes Interactive Voice and Web Response Systems (IVRS/IWRS), Medical Imaging, Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS) and Electronic Patient Reported Outcomes (ePRO) solutions, as well as eClinical systems integration and implementation services.

About PAREXEL International

PAREXEL International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, medical communications and consulting services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in 69 locations throughout 52 countries around the world, and has over 9,400 employees.

This release contains “forward-looking” statements regarding future results and events. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words “believes,” “anticipates,” “plans,” “expects,” “intends,” “appears,” “estimates,” “projects,” “targets,” and similar expressions are also intended to identify forward-looking statements. The forward-looking statements in this release involve a number of risks and uncertainties. The Company’s actual future results may differ significantly from the results discussed in the forward-looking statements contained in this release. Important factors that might cause such a difference include, but are not limited to, risks associated with: actual operating performance; actual expense savings and other operating improvements resulting from recent restructurings; the loss, modification, or delay of contracts which would, among other things, adversely impact the Company’s recognition of revenue included in backlog; the Company’s dependence on certain industries and clients; the Company’s ability to win new business, manage growth and costs, and attract and retain employees; the Company’s ability to complete additional acquisitions and to integrate newly acquired businesses or enter into new lines of business, including, but not limited to, the successful business integration and anticipated synergy achievements in connection with the ClinPhone acquisition; the impact on the Company’s business of government regulation of the drug, medical device and biotechnology industry; consolidation within the pharmaceutical industry and competition within the biopharmaceutical services industry; the potential for significant liability to clients and third parties; the potential adverse impact of health care reform; and the effects of exchange rate fluctuations and other international economic, political, and other risks. Such factors and others are discussed more fully in the section entitled “Risk Factors” of the Company’s Quarterly Report on Form 10-Q for the quarter ended December 31, 2008 as filed with the SEC on February 9, 2009, which “Risk Factors” discussion is incorporated by reference in this press release. The forward-looking statements included in this press release represent the Company’s estimates as of the date of this release. The Company specifically disclaims any obligation to update these forward-looking statements in the future. These forward-looking statements should not be relied upon as representing the Company’s estimates or views as of any date subsequent to the date of this press release.

PAREXEL is a registered trademark of PAREXEL International Corporation, and Perceptive Informatics is a trademark of Perceptive Informatics, Inc. All other names or marks may be registered trademarks or trademarks of PAREXEL International Corporation, Perceptive Informatics, Inc. or their respective owners and are hereby acknowledged.

Source: PAREXEL International Corporation

Significant Improvement In Asthma And Osteoarthritis After Bariatric Surgery – Most No Longer Require Steroids Within 18 Months

Most patients with asthma and osteoarthritis were able to stop taking steroids within 18 months of bariatric surgery, according to a new study presented here at the 25th Annual Meeting of the American Society for Metabolic & Bariatric Surgery (ASMBS).

Researchers from The Western Pennsylvania Hospital, a teaching hospital of Temple University School of Medicine in Pittsburgh, studied 49 morbidly obese patients who were taking steroids and other immunosuppressive medications to treat chronic inflammatory diseases including asthma and osteoarthritis, and autoimmune diseases such as rheumatoid arthritis and myasthenia gravis. These patients, with an average body mass index (BMI) of 47, had bariatric surgery sometime between 1999and 2008.

Eighteen months after bariatric surgery more than half of the patients had so much improvement in their inflammatory or autoimmune disease, they were able to stop taking or significantly reduce the use of oral steroids or immunosuppressive medications, powerful treatments that manage disease but also produce numerous adverse effects, particularly after prolonged use. Patients had an average excess weight loss of 65.2 percent and other obesity-related diseases including type 2 diabetes and obstructive sleep apnea were resolved or improved in more than 80 percent of patients. There were 8 early complications and no deaths.

“Patients with compromised immune systems or taking steroids for chronic inflammatory diseases may have been excluded from bariatric surgery because they are at higher risk for complications related to their disease or immunosuppressant medications,” said Daniel J. Gagn?©, MD, the study’s lead author and Director of Bariatric Surgery and Laparoscopic and Minimally Invasive Surgery at The Western Pennsylvania Hospital. “However, this study shows not only can these patients safely have bariatric surgery, but they can achieve significant improvements or elimination of many diseases.”

Study Results – Highlights

All nine patients with asthma or chronic obstructive pulmonary disease (COPD) were able to discontinue use of oral steroids after surgery. Seven more were able to discontinue use of inhaled steroids, one had reduced frequency and one was unchanged after 18 months. Five patients with osteoarthritis were able to discontinue use of oral steroids and one was able to decrease dosage and two of the four patients with rheumatoid arthritis were able to stop taking oral steroids and two others required lower doses of other medications. Of the six patients with psoriasis, two were able to discontinue the use of topical steroid cream and one discontinued the use of cyclosporine. Two others decreased dosages of other psoriasis medications and one remained unchanged.The four patients with Myasthenia Gravis had improvement in their condition after bariatric surgery and were able to decrease the frequency of treatment or immunosuppressant dosage. Researchers found that not all patients with immunosuppressive diseases saw changes. The patients with Lupus or Multiple Sclerosis had no change in their immunosuppressive diseases or medications. Resolution or improvement of other obesity-related diseases was consistent with previous studies. Type 2 diabetes was improved or resolved in 95 percent of patients; high blood pressure in 80 percent; obstructive sleep apnea in 96 percent; and GERD in 85 percent.

Dr. Gagn?© says immunocompromised patients can present special challenges and surgeons must carefully evaluate individual patient risk factors, disease severity, and type of medication before surgery.

In 2007, the ASMBS reported that an estimated 205,000 people in the U.S. had bariatric surgery. According to guidelines issued by the National Institutes of Health (NIH), bariatric surgery is indicated for people with a body mass index (BMI) of 35 or more with an obesity-related condition or a BMI of 40 or more. People who are morbidly obese are generally 100 or more pounds overweight.

The most common methods of bariatric surgery are laparoscopic gastric bypass and laparoscopic adjustable gastric banding (LAGB). In gastric bypass, the stomach is reduced from the size of a football to the size of a golf ball and food is made to bypass part of the small intestine. In LAGB, a silicone band is wrapped around the upper part of the stomach to restrict the amount of food the stomach can hold. The amount of restriction is adjusted by adding or removing saline from the band.

Two landmark studies, published in the New England Journal of Medicine in August 2007, showed patients with morbid obesity who had bariatric surgery lost significant weight and are significantly less likely to die from heart disease, diabetes and cancer seven to 10 years following the procedure than those who did not have surgery. [1], [2]

A 2004 study in the Journal of the American Medical Association showed that bariatric surgery resolved or improved type 2 diabetes in 86 percent of patients and resolved sleep apnea in more than 85 percent of patients [3].

The Agency for Healthcare Research and Quality (AHRQ) recently reported that bariatric surgery is safer than ever. The risk of death from bariatric surgery has declined from 0.89 percent in 1998, to 0.19 percent in 2004. [4]

About 64 million or 32 percent of adults in the U.S. are considered obese, which is associated with many other diseases and conditions including type 2 diabetes, heart disease, sleep apnea, hypertension, asthma, cancer, joint problems and infertility. The direct and indirect costs to the healthcare system associated with obesity are about $117 billion annually.

The ASMBS is the largest organization for bariatric surgeons in the world. It is a non-profit organization that works to advance the art and science of bariatric surgery and is committed to educating medical professionals and the lay public about bariatric surgery as an option for the treatment of morbid obesity, as well as the associated risks and benefits. It encourages its members to investigate and discover new advances in bariatric surgery, while maintaining a steady exchange of experiences and ideas that may lead to improved surgical outcomes for morbidly obese patients. For more information on the ASMBS, visit asmbs.


1. Sj?¶str?¶m L, Narbro K, Sj?¶str?¶m CD, et al. Effects of bariatric surgery on mortality in Swedish obese subjects. N Engl J Med 2007; 357:741-52.

2. Adams TD, Gress RE, Smith SC, et al. Long-term mortality after gastric bypass surgery. N Engl J Med 2007:357:753-61.

3. Buchwald Henry, et al. Bariatric Surgery: A Systematic Review and Meta-Analysis. JAMA. 2004; 292: 1724-1737.

4. Zhao, Y. (Social and Scientific Systems, Inc.), and Encinosa, W. (AHRQ). Bariatric Surgery Utilization and Outcomes in 1998 and 2004. Statistical Brief #23. January 2007. Agency for Healthcare and Research Quality, Rockville, Md.hcup-us.ahrq/reports/statbriefs.sb23.pdf.

American Society for Metabolic & Bariatric Surgery

Spouse Caregivers of Alzheimer’s Patients Show Higher Risk of Gingivitis

Caregiver spouses of patients with Alzheimer’s disease develop gum disease at twice the rate of their non-caregiver counterparts, researchers report in the latest issue of Psychosomatic Medicine.

Because there was little difference in oral hygiene between the two groups in the study, the researchers say the difference may be related to stress.

Gingivitis is a mild form of gum disease that causes swelling and bleeding. It can progress to more serious disease leading to bone destruction and tooth loss.

Lead investigator Peter Vitaliano, Ph.D., of the University of Washington School of Medicine in Seattle, said of the results: “On a practical level, they speak to relationships between chronic stress and oral health in the general population and suggest that these are independent of oral care. They show that caregivers are at risk for oral health problems and not just physical health problems.”

The investigators enrolled 240 subjects, 123 caregivers of spouses with Alzheimer’s disease and 117 demographically similar non-caregiver spouses. The percentage of caregivers (17 percent) reporting gum disease was twice that of the non-caregivers (8.5 percent), although there was no significant difference in oral healthcare behaviors between the groups.

In addition to evaluating participants’ gum disease, self-reports and medical records, investigators measured blood insulin levels, obesity and intra-abdominal fat. All these are components of metabolic syndrome, the group of symptoms that put people at higher risk for type 2 diabetes. The caregiver spouses scored higher on these measures.

“The implication of this study is considerable,” says Neil Schneiderman, Ph.D., director of the University of Miami Behavioral Medicine Research Center. “The study shows that the relationship between caregiver stress and oral health can be explained by psychosocial factors such as depression and hassles, constitutional factors such as obesity and physiological factors such as insulin metabolism.”

“The links among psychosocial factors, obesity, insulin metabolism and inflammation are particularly intriguing,” Schneiderman added, “because inflammation can have important consequences in terms of the progression of atherosclerosis and coronary heart disease.”

The authors note that the link between chronic stress and gingivitis was first observed in World War I when oral infections among soldiers fighting in the trenches was so high that their teeth became loose and the tips between their teeth eroded away. Since then, studies have continued to show a correlation between various forms of stress and oral disease.

According to the authors, this is the first study to specifically examine oral health in caregivers.

Psychosomatic Medicine is the official bimonthly peer-reviewed journal of the American Psychosomatic Society – psychosomaticmedicine.

Vitaliano P, et al. Caregiving and gingival symptom reports: psychological mediators. Psychosomatic Medicine 67(6), 2005.

Health Behavior News Service
Center for the Advancement of Health
2000 Florida Ave. NW, Ste 210
Washington, DC 20009
United States

Affymetrix 500K Array Used To Identify Memory Gene

Affymetrix Inc. (Nasdaq: AFFX) announced 19 Oct. 2006 that researchers at the Translational Genomics Research Institute (TGen) in Phoenix, Arizona have used the Affymetrix 500K Array to discover a gene–called Kibra–associated with memory performance in humans. The team’s findings may be used to develop new medicines for memory-based diseases such as Alzheimer’s and Parkinson’s by providing scientists with a better understanding of how memory works at the molecular level.

The study entitled, “Common KIBRA alleles are associated with human memory performance,” will be published in the Oct. 20, 2006 issue of Science. The research team was led by Dietrich Stephan, Ph.D., director of TGen’s Neurogenomics Division. It included colleagues at the University of Zurich in Switzerland, Banner Alzheimer’s Institute and Mayo Clinic Scottsdale.

“Using the latest Affymetrix 500K Array, we have shed light on the fundamental biological process of human memory performance,” said Dr. Stephan. “We can use this new understanding to develop drugs that will improve memory function.”

Until now, researchers did not have access to the high-density technology needed to examine the genetic components associated with memory performance. The team at TGen used Affymetrix Human Mapping 500K Arrays to analyze 500,000 DNA markers simultaneously, providing a genetic blueprint for the memory-study participants. The researchers discovered the Kibra gene by comparing the genetic blueprints of people with good memory vs. poor memory and looking for the genetic variations consistently present in one group, but not the other. They then validated their discovery by replicating the Kibra gene finding in two separate and distinct groups of subjects.

“This memory study is a perfect example of how the use of advanced technologies in human genetics yields fundamental discoveries,” said Stephen P.A. Fodor, Ph.D., chairman and CEO at Affymetrix.

To learn more about this breakthrough:

Register for the upcoming Affymetrix Microarray Bulletin (AMB) teleconference/online symposium with Dr. Stephan on November 1, by visiting: microarraybulletin/memory_symposium

* Watch a full AMB interview featuring Dr. Stephan at microarraybulletin/memory

* Read an AMB interview with co-authors Dr. Stephan and Dr. David Craig, associate investigator and faculty member within the TGen Neurogenomics Program, at microarraybulletin/memory

* View the AMB graphic workflow (poster print-out) of the memory study at microarraybulletin/memory

About Translational Genomics Research Institute

The Translational Genomics Research Institute (TGen), a non-profit 501(c)(3) organization, is focused on developing earlier diagnostics and smarter treatments. Translational genomics research is a relatively new field employing innovative advances arising from the Human Genome Project and applying them to the development of diagnostics, prognostics and therapies for cancer, neurological disorders, diabetes and other complex diseases. TGen’s research is based on personalized medicine and the institute plans to accomplish its goals through robust and disease-focused research.

About Affymetrix

Affymetrix scientists invented the world’s first high-density microarray in 1989 and began selling the first commercial microarray in 1994. Since then, Affymetrix GeneChip® technology has become the industry standard in molecular biology research. Affymetrix technology is used by the world’s top pharmaceutical, diagnostic and biotechnology companies as well as leading academic, government and not-for-profit research institutes. More than 1,400 systems have been installed around the world and more than 7,000 peer-reviewed papers have been published using the technology. Affymetrix’ patented photolithographic manufacturing process provides the most information capacity available today on an array, enabling researchers to use a whole-genome approach to analyzing the relationship between genetics and health. Affymetrix is headquartered in Santa Clara, Calif., with manufacturing facilities in Sacramento, Calif., and Bedford, Mass. The company maintains important sales and marketing operations in Europe and Asia, and has about 1,100 employees worldwide. For more information about Affymetrix, please visit the company’s website at affymetrix/.

All statements in this press release that are not historical are “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act as amended, including statements regarding Affymetrix’ “expectations,” “beliefs,” “hopes,” “intentions,” “strategies,” or the like. Such statements are subject to risks and uncertainties that could cause actual results to differ materially for Affymetrix from those projected, including, but not limited to: risks and uncertainties associated with the use of the Affymetrix 500K Array discussed in this press release; risks of the Company’s ability to achieve and sustain higher levels of revenue, higher gross margins, reduced operating expenses; uncertainties relating to technological approaches, manufacturing, product development; personnel retention; uncertainties related to cost and pricing of Affymetrix products; dependence on collaborative partners; uncertainties relating to sole source suppliers; uncertainties relating to FDA and other regulatory approvals; competition; risks relating to intellectual property of others and the uncertainties of patent protection and litigation. These and other risk factors are discussed in Affymetrix’ Form 10-K/A for the year ended December 31, 2005, and other SEC reports, including its Quarterly Reports on Form 10-Q for subsequent quarterly periods. Affymetrix expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Affymetrix’ expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

NOTE: Affymetrix, the Affymetrix logo and GeneChip are registered trademarks owned or used by Affymetrix Inc.

Contact: Andrew Noble

Affymetrix, Inc.

New Approach To Treatment Benefits Teens Who Think They Have Asthma Under Control

Two studies that offer new insights to help adolescents and younger children improve their asthma control were presented by researchers from Cincinnati Children’s Hospital Medical Center at this year’s annual meeting of the Pediatric Academic Society (PAS) in Honolulu, Hawaii.

One study found that teens with asthma dramatically overestimate their ability to control the condition, according to Maria Britto, M.D., MPH, a physician in the Division of Adolescent Medicine at Cincinnati Children’s and study co-author.

“We’ve known that adolescent asthma patients tend to have poorer outcomes than younger children with the condition, and this study shows that teens tend to think they’re in control when they may be having difficulty,” Dr. Britto said.

The researchers reported that 74 percent of adolescents dramatically overestimated their ability to control asthma, especially compared to the teens’ own reports of symptoms, use of rescue medications and limitations they placed on their activities. The study included 201 adolescents with an average age of 16.2 years who were observed during clinical visits. The findings suggest that adolescents’ perception of being in control may impact whether or not they follow treatment regimens and avoid situations that trigger their condition.

“For those of us who treat teens with asthma, these findings will help us address with patients their perceived control versus what is actually going on,” Dr. Britto said. “As we have this dialogue with them, our hope is that it will improve their ability to manage their asthma and improve their health.”

Improved care for asthma patients was also the subject of a second study at Cincinnati Children’s, presented at PAS. This study found that a creative approach referred to as “unplanned planned asthma visits” resulted in young patients having fewer emergency room and hospital visits. The approach involves physicians discussing asthma with patients every time they come for an office visit, even if those visits are scheduled for totally unrelated reasons.

“Having regular, planned physician appointments to manage a child’s asthma is an integral part of the chronic care model,” said Greg Szumlas, M.D., a physician in the Division of General Pediatrics at Cincinnati Children’s and study co-author. “Unfortunately, many patients don’t always keep these appointments, so the planned opportunity for education of patient and parent is lost. We also know patients see their physicians for other acute problems, so we developed a system to capture these opportunities and turn them into what we call the ‘unplanned planned’ asthma visits.”

During these visit, patients undergo asthma control screening, condition assessment and receive education on asthma self-management. The visit is turned into an opportunity to assess and manage the patient’s asthma. Correct medications and effective self management result in an overall improvement in asthma quality measures and patient outcomes. In a study group of 230 asthma patients followed during the program, the researchers noted a 30-percent increase in patients with established asthma treatment action plans. The program also led to a 50-percent reduction in asthma hospitalizations and a 47 percent decrease in asthma related emergency room visits over a one-year period.

Cincinnati Children’s Hospital Medical Center, one of the leading pediatric research institutions in the nation, is dedicated to changing the outcome for children throughout the world. Cincinnati Children’s ranks second among all pediatric institutions in the United States in grants from the National Institutes of Health. It has an established tradition of research excellence, with discoveries including the Sabin oral polio vaccine, the surfactant preparation that saves the lives of thousands of premature infants each year, and a rotavirus vaccine that saves the lives of hundreds of thousands of infants around the world each year. Current strategic directions include the translation of basic laboratory research into the development of novel therapeutics for the treatment of disease, and furthering the development of personalized and predictive medicine. Additional information can be found at cincinnatichildrens/.

Source: Nick Miller

Cincinnati Children’s Hospital Medical Center

Early Hurricane Preparations Can Save Lives And Property

The hurricane season is upon us again. The U.S. Environmental Protection Agency urges people and businesses to start planning before hurricane force winds or storm flooding may occur. Early preparations can help minimize injury and property damage.

EPA’s hurricanes Web site includes information for business operators on preventing and reporting chemical releases due to severe weather, which can be required by law. Local governments and community agencies can find suggestions for preparing and protecting water and wastewater facilities. There is also detailed information for debris planning, since storm debris can occur in enormous amounts that overwhelm local landfills, and can also present serious dangers to human health and the environment.

This information is currently available in English and Spanish. Hurricane preparedness information in Chinese and Vietnamese will be posted on the EPA Web site early next week.

– Information on hurricane preparedness

– Information on hurricane preparedness in Spanish


Global Fund Aims To Raise $12B By 2012, Chair Says

The Global Fund To Fight AIDS, Tuberculosis and Malaria aims to raise more than $12 billion by 2012, Global Fund Chair Rajat Gupta said Monday during a visit to Zambia, Reuters reports. Gupta said he is confident that the Global Fund can reach the target after having secured $100 million during the past 18 months. “The money we are mobilizing will help us mitigate the effects of AIDS, tuberculosis and malaria, especially in the worst affected countries,” Gupta said.

Government figures show that about one million of Zambia’s 12 million residents are HIV-positive and that about 300,000 need access to antiretroviral drugs, Reuters reports. Gupta told Zambian President Levy Mwanawasa that the country is making progress in the fight against HIV/AIDS. “The HIV prevalence in Zambia is unacceptably high and continues to be a source of grave concern,” Mwanawasa said, adding that the country’s HIV/AIDS situation is “further compounded by co-epidemics of tuberculosis and malaria” (Chilabi, Reuters, 3/10).

Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Expert: Parents Can Help Alleviate Children’s Fears About Flu Outbreak

Parents should assess their personal feelings about the current flu situation as they begin talking to children, and then they can determine what messages they want to communicate, says a Purdue University child development expert.

“Don’t assume children don’t know anything about it, but don’t assume they understand everything either,” says Judith Myers-Walls, an associate professor, Extension specialist and certified family life educator. “Recognize that children may be afraid, but they also may be sad about other people who are facing the illness.”

The spread of H1N1 (swine flu) may spark fear and questions among children of all ages, especially with reports of the first American fatality, which was a child, and schools closing in some areas.

“We’ve never had this fast of a response while watching a health outbreak like this develop, so we are probably more on top of it than ever before, but we are also more scared than ever before,” she says.

Parents should be ready to have multiple discussions with their children and encourage them to ask questions. Children may be confused by unfamiliar words such as “pandemic” or “influenza.” Myers-Walls says parents don’t need to try to explain everything, but they should answer questions as they come up. They also should watch for signs that might indicate a child is struggling with the issues. Some physical indicators could include not sleeping or eating well.

“This also is an opportunity to teach children about preventive measures such as washing hands and not sharing drinking glasses with other children,” she says. “Parents can approach these lessons by reminding their children these are good habits for any time. Caution is good, but it’s important to keep children from getting so cautious that they are afraid to explore and learn during childhood.”

– Amy Patterson Neubert

Purdue University

See our Map Of H1N1 Outbreaks
See our Mexico Swine Flu Blog

FDA Approves Cymbalta® For The Management Of Chronic Musculoskeletal Pain

Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved Cymbalta® (duloxetine HCl) for the management of chronic musculoskeletal pain. This has been established in studies in patients with chronic low back pain and chronic pain due to osteoarthritis. This is the fifth indication the FDA has approved for Cymbalta.

Cymbalta, which has been shown to significantly reduce chronic low back pain and chronic pain due to osteoarthritis, is a non-narcotic pain reliever that is meant to be taken once a day, every day by people with these pain conditions.

“People with chronic musculoskeletal pain often struggle to find a medication that works for them. The approval of Cymbalta for chronic musculoskeletal pain by the FDA gives doctors another option to help an underserved and suffering group of patients,” said Michael Clark, M.D., MPH, director, Chronic Pain Treatment Program, Department of Psychiatry and Behavioral Sciences, The Johns Hopkins Medical Institutions.

Although the exact way that Cymbalta works to reduce chronic musculoskeletal pain is unknown, it is believed that Cymbalta helps lessen pain by enhancing the body’s natural pain suppressing system by increasing the activity of serotonin and norepinephrine in the brain and spinal cord.

In chronic musculoskeletal pain clinical studies, the most commonly observed adverse events (those occurring in at least 5 percent of study participants taking Cymbalta and at least twice the rate of placebo) in Cymbalta-treated patients with chronic low back pain were nausea, dry mouth, insomnia, sleepiness, constipation, dizziness and fatigue. The most commonly observed adverse events in Cymbalta-treated patients with chronic pain due to osteoarthritis were nausea, fatigue and constipation.

“It’s important that people with chronic musculoskeletal pain have different treatments available to them because responses to medications can be highly individualized,” said Robert Baker, M.D., global development leader for psychiatry and pain disorders at Lilly. “This is why we are happy to be able to provide doctors and patients with a new option.”

Osteoarthritis affects an estimated 27 million adults in the U.S.(i) An estimated 70 to 85 percent of adults experience low back pain at some time,(ii) with some reports estimating that 2 to 10 percent of these people go on to experience chronic low back pain.(iii) (iv) (v) (vi)

“Having a medication that is approved specifically for people with chronic musculoskeletal pain is a great step in helping these individuals live with less chronic low back pain or chronic pain due to osteoarthritis. Good medical care from a health care professional and involvement by the person with the condition is important,” said Penney Cowan, executive director, American Chronic Pain Association.

About Cymbalta

Serotonin and norepinephrine in the brain and spinal cord are believed to both mediate core mood symptoms and help regulate the perception of pain. Although the exact way that Cymbalta works in people is unknown, it is believed to be related to an increase in the activity of serotonin and norepinephrine, two naturally occurring substances in the brain and spinal cord.

Cymbalta is approved in the United States for the treatment of major depressive disorder, the treatment of generalized anxiety disorder, the management of diabetic peripheral neuropathic pain, fibromyalgia and chronic musculoskeletal pain, which has been established in studies in patients with chronic low back pain and chronic pain due to osteoarthritis, all in adults (18+). Cymbalta is not approved for use in pediatric patients.

Indications and Important Safety Information About Cymbalta


Cymbalta is approved to treat major depressive disorder and generalized anxiety disorder, and to manage diabetic peripheral neuropathic pain and fibromyalgia. Cymbalta is also approved for the management of chronic musculoskeletal pain including chronic osteoarthritis pain and chronic low back pain.


Important Safety Information About Cymbalta

Antidepressants can increase suicidal thoughts and behaviors in children, adolescents, and young adults. Suicide is a known risk of depression and some other psychiatric disorders. Patients should call their doctor right away if they experience new or worsening depression symptoms, unusual changes in behavior, or thoughts of suicide. Be especially observant within the first few months of treatment or after a change in dose. Cymbalta is approved only for adults 18 and over.

Cymbalta is not for everyone. Patients should not take Cymbalta if they have recently taken a type of antidepressant called a Monoamine Oxidase Inhibitor (MAOI), are taking Mellaril® (thioridazine), or have uncontrolled narrow-angle glaucoma (increased eye pressure).

Patients should speak with their doctor about all their medical conditions including kidney or liver problems, glaucoma, diabetes, seizures, or if they have bipolar disorder. Cymbalta may worsen a type of glaucoma or diabetes. Patients should talk to their doctor if they have itching, right upper belly pain, dark urine, yellow skin or eyes, or unexplained flu-like symptoms, which may be signs of liver problems. Severe liver problems, sometimes fatal, have been reported. They should also talk to their doctor about alcohol consumption. Patients should tell their doctor about all their medicines, including those for migraine, to avoid a potentially life-threatening condition. Symptoms may include high fever, confusion, and stiff muscles. Taking Cymbalta with NSAID pain relievers, aspirin, or blood thinners may increase bleeding risk. Patients should consult with their doctor before stopping Cymbalta or changing the dose. If patients experience dizziness or fainting upon standing while taking Cymbalta, they should contact their doctor. This is likely to occur in the first week or when increasing the dose, but may occur at any time during treatment. Cymbalta can increase blood pressure. Healthcare providers should check patients’ blood pressure prior to and while taking Cymbalta. Patients should tell their doctor if they experience headache, weakness, confusion, problems concentrating, memory problems, or feel unsteady while taking Cymbalta as this may be signs of low sodium levels. Patients should consult their doctor if they develop problems with urine flow while taking Cymbalta. Female patients should tell their doctor if they are pregnant or plan to become pregnant during therapy or are breastfeeding.

The most common side effects of Cymbalta include nausea, dry mouth, sleepiness, fatigue, constipation, dizziness, decreased appetite, and increased sweating. This is not a complete list of side effects. Cymbalta may cause sleepiness and dizziness. Until patients know how Cymbalta affects them, they should not drive a car or operate hazardous machinery.

Take Cymbalta exactly as directed by your healthcare provider. Cymbalta should be taken by mouth. Do not open, break or chew capsule, it must be swallowed whole. Cymbalta can be taken with or without food.

This press release contains forward-looking statements about the potential of Cymbalta for the management of chronic musculoskeletal pain, and reflects Lilly’s current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. There is no guarantee that the product will continue to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly’s filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.




(i) Lawrence RC, et al. Arthr Rheum. 2008.58(1):26-35.

(ii) Andersson GBJ. Lancet. 1999;354:581-585.

(iii) Burton AK et al. European Guidelines for Prevention of Low Back Pain.

(iv) Freburger JK, et al. Arch Int Med. 2009; 169(3):251-258.

(v) Klenerman L, et al. Spine. 1995; 20(4):478-484.

(vi) Van Den Hoogen HJM, et al. Ann Rheum Dis. 1998; 57:13-19.

Source: Eli Lilly and Company

View drug information on Cymbalta.