Food Allergies Could Be Fought With Friendly Bacteria In Alcoholic Milkshake

Feeding babies alcoholic milk may help to protect against some food allergies. Kefir, a traditional fermented drink, is consumed in Eastern Europe as a health food, and is often used to wean babies, as it is easily digested. Food allergy prevalence is especially high in children under the age of three, with around 5-8% of infants at risk. Currently the only treatment is avoidance of the problematic food.

“Friendly” bacteria in kefir may play a role in blocking the pathway involved in allergic responses, Lisa Richards reports in Chemistry & Industry, SCI’s fortnightly magazine. Research published 16 October 2006(DOI 10.1002/jsfa2469) in the SCI’s Journal of the Science of Food and Agriculture has shown that the milk drink inhibits the allergen specific antibody Immunoglobulin E (IgE). IgE is involved in immune responses to inactivate organisms that might cause disease. However, in the presence of allergens it can also activate cells responsible for the release of histamine, a chemical which stimulates allergic responses, such as inflammation and constriction of airways.

Ji-Ruei Liu’s team of scientists at the National Formosa University, Yunlin, Taiwan, fed mice the milky drink, and found that after 3 weeks, the amount of ovalbumin (OVA) specific IgE was reduced three-fold. Ovalbumin is an allergenic protein found in egg whites, which cause most allergies in young children. Kefir is also reported to prevent food antigens from passing through the intestinal wall.

Liu believes that the milky drink could be a promising tool in the prevention of allergies. “In the future, maybe we can screen out the certain components (bacterial strains or bioactive peptides) from kefir and utilize them in medicine,” he said.

Also in this weeks Chemistry & Industry, UK firm Rigest are looking for backers to develop an air sanitizing system using an enzyme found naturally in human tears. Lactoperoxidase can attack and kill microbes such as ‘flu viruses and the bacteria responsible for MRSA. The system could be used to sanitize the air in airplanes and hospital sick bays.

###

Chemistry & Industrybr> Please acknowledge Chemistry & Industry as the source of these items. If publishing online, please include a hyperlink to http://www.chemind.org/ Please note Chemistry & Industry uses ‘&’ in its title, please do not correct to ‘and’.

About Chemistry & Industry
Chemistry & Industry magazine from SCI delivers news and comment from the interface between science and business. As well as covering industry and science, it focuses on developments that will be of significant commercial interest in five- to ten-years time. Published twice-monthly and free to SCI Members, it also carries authoritative features and reviews. Opinion-formers worldwide respect Chemistry & Industry for its independent insight.

Journal of the Science of Food and Agriculture
About the Journal of the Science of Food and Agriculture The Journal of the Science of Food and Agriculture (JSFA) publishes peer-reviewed original research and critical reviews in these areas, with particular emphasis on interdisciplinary studies at the agriculture/food interface. This international journal covers fundamental and applied research.

JSFA is an SCI journal, published by John Wiley & Sons, on behalf of the Society of Chemical Industry, and is available in print (ISSN: 0022-5142) and online (ISSN: 1097-0010) via Wiley InterScience http://www.interscience.wiley.com/ For further information about the journal go to http://interscience.wiley.com/jsfa

About SCI
SCI is a unique international forum where science meets business on independent, impartial ground. Anyone can join, and the Society offers a chance to share information between sectors as diverse as food and agriculture, pharmaceuticals, biotechnology, environmental science and safety. As well as publishing new research and running events, SCI has a growing database of member specialists who can give background information on a wide range of scientific issues. Originally established in 1881, SCI is a registered charity with members in over 70 countries.

About Wiley
John Wiley & Sons, Ltd., based in Chichester, England, is the largest subsidiary of John Wiley & Sons, Inc. Founded in 1807, John Wiley & Sons, Inc., provides must-have content and services to customers worldwide. Their core businesses include scientific, technical, and medical journals, encyclopedias, books, and online products and services; professional and consumer books and subscription services; and educational materials for undergraduate and graduate students and lifelong learners. Wiley has publishing, marketing, and distribution centres in the United States, Canada, Europe, Asia, and Australia. The company is listed on the New York Stock Exchange under the symbols JWa and JWb. Wiley’s recently re-launched Internet site can be accessed at http://www.wileyeurope.com/

Contact: SCI Press Office
Society of Chemical Industry

Lung Cancer Survival Rates May Be Linked To Access To Care

New research suggests that the lower survival rates of blacks with lung cancer may be explained by access to care. The study, by Wake Forest University Baptist Medical Center researchers and colleagues is reported in the January issue of the Journal of Clinical Oncology.

“The results were intriguing,” said principal investigator A. William Blackstock, M.D., “When offered equivalent therapy, the outcome for black patients was the same as that of non-blacks.”

Historically, studies have shown that, across all stages of the disease, survival for black patients lags behind that of non-blacks. A number of potential explanations have been proposed, including later stage at diagnosis, differences in treatment, and differences in the biologic aggressiveness of the disease. Among the most controversial of these issues is whether race is an independent factor in survival.

Researchers evaluated, retrospectively, data from 995 patients with advanced small cell lung cancer who participated in one of four Cancer and Leukemia Group B (CALGB) studies. The patients were treated between 1990 and 2002 at 41 centers.

“From our analysis, we concluded that equal treatment in patients with advanced lung cancer yields equal outcome among patients with the same stage of disease regardless of race or ethnicity,” said Blackstock. “Although other factors may be important, perhaps the most relevant is access to standard cancer care.”

Differences in access to care, the quality of care received, and the impact of other health risks may explain the lower survival among African Americans. Continued efforts are needed to encourage disease awareness, promote early detection, implement prompt and appropriate treatment and increase minority participation in clinical trials, the researchers said.

Lung cancer remains the leading cause of cancer death in the United States. Approximately 172,000 Americans were diagnosed with lung cancer in 2005 and 20 percent of those had small-cell lung cancer. Although the incidence of advanced-stage lung cancer has increased in most racial/ethnic groups, the rate of increase has been greatest for African American patients.

###

The study was funded by the National Cancer Institute.

Co-researchers were James Herndon II, Duke University, Electra D. Paskett, Ohio State University, Antonius Miller, Wake Forest University Baptist Medical Center, Christopher Lathan, Dana Farber Cancer Institute, Harvey B. Niell, University of Tennessee Memphis, Mark A. Socinski, UNC Chapel Hill, Everett Vokes, University of Chicago, and Mark R. Green, Medical University of South Carolina.

Contact: Jonnie Rohrer, jrohrer@wfubmc.edu, 336-716-6972, Karen Richardson, krchrdsn@wfubmc.ecu or Shannon Koontz, shkoontz@wfubmc.edu, 336-716-4587.

Wake Forest University Baptist Medical Center is an academic health system comprised of North Carolina Baptist Hospital and Wake Forest University Health Sciences, which operates the university’s School of Medicine. The system comprises 1,187 acute care, psychiatric, rehabilitation and long-term care beds and is consistently ranked as one of “America’s Best Hospitals” by U.S. News & World Report.

Contact: Karen Richardson
krchrdsn@wfubmc.edu
Wake Forest University Baptist Medical Center

Insulin Pump Therapy In Adolescents Investigated By Joslin Diabetes Center

In spite of its many advantages, there are many challenges to using an insulin pump to treat type 1 diabetes. Despite these challenges, however, more and more youngsters are choosing pump therapy, even though important questions remain about the pump’s effectiveness for this age group: With all its risks and demands, is it a method of treatment that children and teens can maintain? What causes adolescents to go off of pump therapy and how often does this occur? Is it possible to identify those youth unable to meet the demands of pump therapy and to find interventions that will help them succeed?

Now, in the first long-term investigation conducted among pediatric patients who chose to go on pump therapy (rather than using it as part of a clinical trial), a new study in the November issue of Diabetes Care by researchers in the Pediatric, Adolescent, and Young Adult Section at Joslin Diabetes Center, is providing answers. Following a group of 161 children and adolescents, ages 4-21, for an average of four years, the researchers have shown that with proper training and follow-up, for the great majority of patients–more than 80 percent of the children in this study–insulin pump therapy provides a lasting and effective mode of treatment. They also identified several factors that put patients at risk for failure in adapting to pump use.

“More than 130 patients were able to use the pump effectively,” says senior author, Lori Laffel, M.D., M.P.H., Chief of Joslin’s Pediatric, Adolescent and Young Adult Section, an Investigator in the Genetics and Epidemiology Section and Associate Professor of Pediatrics at Harvard Medical School. “By looking at differences between the patients who remained on pump therapy and those who returned to injected insulin, we were able to identify factors present even at the start of pump therapy that were predictive of failure. For example, patients who resumed injection therapy checked their blood glucose levels less often from the start. Healthcare providers can use this information to provide more education, more psychosocial support, and more frequent visits directed at increasing blood glucose monitoring from the start of pump therapy to help kids to succeed.”

“The fact that such a high percentage of patients succeeded proves that pump therapy is a viable mode of treatment for children and teens with type 1 diabetes,” says the paper’s lead author, Jamie Wood, M.D., Staff Physician and Research Associate at Joslin and Instructor of Pediatrics at Harvard Medical School. “Our job now is to overcome the barriers to pump therapy, so more patients can benefit from its advantages.”

Starting on an insulin pump requires considerable training. Before beginning pump therapy, patients in the study and their families met with their healthcare team that included a pediatric endocrinologist, a nurse educator and a registered dietitian. The team taught them the mechanics of using and maintaining the pump, how to count carbohydrates, calibrate their insulin requirements and treat risks associated with pump therapy, such as site infections, diabetic ketoacidosis and hypoglycemia (low blood glucose levels). A mental health clinician also met with the children and their families to ensure they were ready to meet any challenges and to help them set up realistic expectations for ongoing diabetes management with the pump.

At three points during the study–the clinical visit just before starting on the pump, one year after initiation, and then at the study’s close in January 2005–researchers gathered data on A1C levels (a measurement that indicates the average blood glucose over the past 2 to 3 months), rate of daily blood glucose monitoring and growth parameters (height, weight and body-mass index). These data also were monitored at the time of discontinuation for patients who stopped using the pump.

Examining the data associated with success and failure, the researchers observed several significant differences between the two groups of patients, one of which was present at the initiation of pump therapy. “We found that patients who were successful measured their blood glucose levels four or more times a day before they began pump therapy, while those who discontinued pump therapy measured them less,” says Dr. Wood.

They also discovered that the patients who stayed on the pump had achieved better glycemic control than the patients who discontinued pump therapy. After the first year on pump therapy, the A1C levels of the group that succeeded dropped significantly. Although these levels subsequently rose to near the levels they were at the start of pump therapy, the group still was able to avoid the deterioration of blood glucose control that happens frequently among adolescents. Caused by such factors as increases in growth and puberty hormones, or the declining adherence to good health practices that occurs as they become more independent from their parents, deteriorating glucose control puts youth at greater risk for developing serious complications later in life. The youth in the group that succeeded also experienced decreased rates of hypoglycemia with pump therapy.

The patients who later resumed injection therapy, however, experienced rising blood glucose levels while they were on the pump. Furthermore, while the rate of severe hypoglycemia before beginning pump therapy was similar between the two groups, in the year following the start of pump therapy the patients who discontinued pump therapy experienced a significantly higher rate of severe hypoglycemic episodes.

“Our research suggests several approaches for improving success rates with pump therapy,” says Dr. Wood. “When you evaluate if a person is ready to begin pump therapy, and you can see he or she is monitoring blood glucose levels only two or three times a day, you can suggest that the patient take some extra time to increase monitoring frequency before starting the pump. Or if you have a patient who doesn’t show improvement in glycemic control in the first six months of pump therapy, you can try to find out what is interfering with success and help overcome any barriers. Our goal is not to determine which patients should be denied pump therapy, but to make it possible for more people to succeed with this remarkable tool.”

###

Also participating in the study were Britta M. Svoren, M.D., Deborah A. Butler, M.S.W., L.I.C.S.W., and Lisa K. Volkening of Joslin, and Elaine C. Moreland, M.D., previously at Joslin and now at the University of Alabama and Children’s Hospital, in Birmingham. The study was funded in part by the Katherine Adler Astrove Youth Education Fund, the Maria Griffin Drury Pediatric Endowment Fund and grants from the National Institutes of Health.

About Joslin Diabetes Center

Joslin Diabetes Center, dedicated to conquering diabetes in all of its forms, is the global leader in diabetes research, care and education. Founded in 1898, Joslin is an independent nonprofit institution affiliated with Harvard Medical School. Joslin research is a team of more than 300 people at the forefront of discovery aimed at preventing and curing diabetes. Joslin Clinic, affiliated with Beth Israel Deaconess Medical Center in Boston, the nationwide network of Joslin Affiliated Programs, and the hundreds of Joslin educational programs offered each year for clinicians, researchers and patients, enable Joslin to develop, implement and share innovations that immeasurably improve the lives of people with diabetes. As a nonprofit, Joslin benefits from the generosity of donors in advancing its mission. For more information on Joslin, call 1-800-JOSLIN-1 or visit http://www.joslin.org/

Contact: Jenny Eriksen
Joslin Diabetes Center

FDA Approves Allegra(R) (fexofenadine Hydrochloride) Oral Suspension For Treatment Of Seasonal Allergy Symptoms And Chronic Idiopathic Urticaria

Sanofi-aventis U.S. (EURONEXT: SAN and NYSE: SNY) announced today that the U.S. Food and Drug Administration (FDA) has approved Allegra(R) (fexofenadine hydrochloride) Oral Suspension for the twice-daily treatment of symptoms associated with seasonal allergies in pediatric patients, 2 to 11 years of age, and for the treatment of chronic idiopathic urticaria in children 6 months to 11 years of age. This approval makes available a safe and effective seasonal allergy treatment option that is non-impairing to pediatric populations as young as 2 years old.

“Until now, parents had few seasonal antihistamine treatment options that were not associated with cognitively impairing adverse side effects,” says Eli Meltzer, M.D., of the Allergy and Asthma Medical Group and Research Center in San Diego. “However, with Allegra Oral Suspension, which does not cause sedation at any dose and is well-established for its antihistamine activity, a medication is now available in a good tasting, easy-to-swallow formulation that can help reduce the seasonal allergy symptoms of children.”

Seasonal allergic rhinitis is a common chronic condition in children. Symptoms of seasonal allergies include nasal drainage, sneezing, watery eyes and itchy nose, eyes and throat. Studies indicate that seasonal allergy inflammation as well as the impairing side effects of older antihistamines can be disruptive to a child and may affect cognitive skills and function.

Allegra Oral Suspension has also been approved for the treatment of chronic idiopathic urticaria (CIU) in twice-daily 30 mg doses for pediatric patients 2 to 11 years of age and twice-daily 15 mg doses for pediatric patients 6 months to 2 years of age. CIU is a rare and bothersome condition characterized by hives lasting more than 6 weeks from an unknown cause. Its symptoms are caused by a reaction to an unknown trigger in the upper layers of the skin. The condition itself may cause severe itching, but is made worse by scratching.

Allegra Oral Suspension will have a berry flavor* and is expected to be available to consumers in time for the 2007 spring allergy season.

Artificial raspberry-cream flavoring

Important Safety Information

Side effects in children 6 months to 5 years old were similar to placebo. Side effects varied by age. The most commonly reported side effects were: vomiting, pyrexia, cough, otitis media and diarrhea.

Please see full prescribing information for Allegra Oral Suspension at http://products.sanofi-aventis.us/allegra_oral/allegra.pdf.

About sanofi-aventis

Sanofi-aventis is the world’s third largest pharmaceutical company, ranking number one in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine, and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY)

Forward Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words “expect,” “anticipates,” “believes,” “intends,” “estimates,” “plans” and similar expressions. Although sanofi-aventis’ management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward- Looking Statements” in sanofi-aventis’ annual report on Form 20-F for the year ended December 31, 2005. Other than as required by applicable law, sanofi- aventis does not undertake any obligation to update or revise any forward- looking information or statements.

sanofi-aventis
http://www.sanofi-aventis.com

Early Lung Cancer Diagnosis Facilitated With New Navigation Technology

U.S. hospitals are increasingly embracing the use of a novel imaging technology known as the superDimension(R)/Bronchus System (SDBS) which enables diagnosis of lung cancer at an earlier stage than the conventional technique.

“While flexible bronchoscopy is the preferred method for diagnosing lung cancer, most lesions are located in the peripheral areas of the lung which the standard bronchoscope can’t reach,” Doron Besser, MD, VP Medical Affairs of superDimension, Ltd. In Herzliya, Israel, said. “If a bronchoscopy is non-diagnostic, more invasive interventions such as transthoracic needle aspiration, mediastinoscopy or sometimes thoracotomy are required in order to establish a diagnosis. Such interventions may be associated with significant risks or even be unnecessary as the lesion may still be benign.”

The SDBS machine allows physicians to make a definitive diagnosis of suspicious lesions in the peripheral areas of the lung which are difficult to sample by conventional bronchoscopy, therefore setting the stage for earlier treatment and a better prognosis.

“Lung cancer has a notoriously dismal prognosis,” he noted. “An early diagnosis may boost the patient’s likelihood of survival as about 15 percent of patients diagnosed at stages III or IV are alive at five years versus about 70 percent diagnosed at a an earlier stage.”

The novel imaging system can navigate can be uniquely steered and navigated anywhere in the lungs in real-time and on a three-dimensional roadmap which provides a higher success rates and broadens the applicability of standard diagnostic bronchoscopy, Dr. Besser said.

The SDBS procedure is typically performed in the bronchoscopy suite, and results are usually available within two hours. Notably, clinical studies have demonstrated an 80% success rate in diagnosing lung lesions and a 95% success rate in also performing staging.

The FDA-approved technology is already in use at the Cleveland Clinic, Mayo Clinic, Beth Israel Deaconess Medical Center, Johns Hopkins University Medical Center, and regional hospitals such as Columbus Regional Hospital.

SDBS is manufactured by superDimension Ltd., which has its world headquarters in Herzliya, Israel and its U.S. headquarters in Minneapolis. Lung cancer is the main cause of cancer mortality in the US. and is responsible for more deaths annually breast, colon, and prostate cancers combined. According to the American Cancer Society, the disease accounted for more than 163, 000 deaths in the U.S. last year.

SDBS can also be used for treating lung cancer, and initial clinical trials using internal radiation methodologies have shown promising results.

superDimension, Ltd.
8 Hamenofim St., POB 2045
46120 Herzliya
Israel
Tel. +972-(0)9-971-3700
Fax +972-(0)9-971-3701
info.il@superdimension.com

superDimension, Inc.
14500 Martin Drive
Minneapolis, MN 55344-2040
USA
Tel. +1-952-946-9919
Fax +1-952-946-6145
Toll Free 888-586-4767
info.us@superdimension.com

uperDimension (Europe) GmbH
Grossenbaumer Weg 5
40472 Duesseldorf
Germany
Tel. +49-(0)211-436156-0
Fax +49-(0)211-436156-29
info.de@superdimension.com

www.superdimension.com/contact.html

Written by: Jill Stein

Jill Stein is a Paris-based freelance medical writer.

One In Six Americans Have Pre-Diabetes And Most Don’t Know It

Fifty-four million Americans – that’s one in six of us — have pre-diabetes and most don’t even realize it. Mark Schutta, MD, medical director of the Penn Rodebaugh Diabetes Center, is urging at-risk patients to be proactive and ask your doctor to give you a simple blood test for pre-diabetes – to arm yourself with information before the damage is done. It means you have blood glucose levels that are higher than normal and you could one day reach a high enough level that you would be diagnosed with having diabetes.

Diabetes is a disease that affects the body’s ability to produce or respond properly to insulin and must be managed on a daily basis once diagnosed. If not, it can lead to several health complications including death. November is designated annually as American Diabetes Month.

“If you have pre-diabetes, there’s a 75% probability that you will develop diabetes within 30 years,” comments Schutta. “Our country is in the middle of a type 2 diabetes epidemic. Right now, if you’re born in the U.S., your risk of developing diabetes is one in three.”

Schutta says the reason for the high numbers is that diabetes is a “silent killer” and in the early stages of the disease, patients often have no symptoms. Schutta urges anyone at risk for diabetes to be screened. He adds, “If you knew you had pre-diabetes, you could still prevent getting diabetes through changes in diet and exercise. There are many health benefits to knowing you have pre-diabetes and ‘heading it off.’ If you wait until you have diabetes, the vascular damage to your body may already be done.”

You should be screened for pre-diabetes if:

• You have a known family history of diabetes.
• You are African American, Latino, Native American, Asian American or Pacific Islander.
• While pregnant, you developed gestational diabetes.
• You delivered a baby who weighed more than nine pounds.
• You have high blood pressure, high blood cholesterol, are overweight.

Schutta explains there are two kinds of blood tests you can request, “The first is a fasting plasma glucose test, in which your glucose levels measured when you have not been eating. The other is an oral glucose tolerance test which introduces glucose into your system, challenging your beta cells to make insulin by testing your body’s acute insulin response to glucose.”

Schutta says the numbers are clear. If your blood glucose level, two hours after receiving oral glucose, is over 200 milligrams per deciliter, you are considered to be diabetic. Anything between 141-199 is considered to be pre-diabetic. Again, Schutta stresses that if you have pre-diabetes, it doesn’t necessarily mean you’re going to develop diabetes – if you take the proper steps now to avoid getting the fifth deadliest disease in America.

###

For more information on the Penn Rodebaugh Diabetes Center, please click here
Mark Schutta, MD — on-line bio

Diabetes is a chronic disease affecting more than six percent of the U.S. population or 21 million people. Diabetes is linked to heart and kidney disease, strokes and other serious health problems. Diabetes results when the body either does not produce insulin or cannot use it properly. Insulin is a hormone that your body needs to convert sugar, starches, and other food into energy for living. Although there is no cure for diabetes, it can be controlled.

PENN Medicine is a $2.9 billion enterprise dedicated to the related missions of medical education, biomedical research, and high-quality patient care. PENN Medicine consists of the University of Pennsylvania School of Medicine (founded in 1765 as the nation’s first medical school) and the University of Pennsylvania Health System.

Penn’s School of Medicine is ranked #2 in the nation for receipt of NIH research funds; and ranked #3 in the nation in U.S. News & World Report’s most recent ranking of top research-oriented medical schools. Supporting 1,400 fulltime faculty and 700 students, the School of Medicine is recognized worldwide for its superior education and training of the next generation of physician-scientists and leaders of academic medicine.

The University of Pennsylvania Health System includes three hospitals, all of which have received numerous national patient-care honors [Hospital of the University of Pennsylvania; Pennsylvania Hospital, the nation's first hospital; and Penn Presbyterian Medical Center]; a faculty practice plan; a primary-care provider network.

For further information please visit:
University of Pennsylvania Health System

About 700,000 People Each Year Seek Care In Emergency Departments For Adverse Supplement And Drug Reactions, Study Says

Adverse reactions to some of the most commonly prescribed medications result in more than 700,000 emergency department visits annually, according to a study published on Wednesday in the Journal of the American Medical Association, the AP/Washington Times reports. For the study, led by CDC epidemiologist Daniel Budnitz, researchers examined data from the first two years — 2004 to 2005 — of a national surveillance project on outpatient medication safety developed by CDC, FDA and the Consumer Product Safety Commission. The data included information from 63 nationally representative hospitals that reported 21,298 adverse reactions to medications among ED patients. According to the study, the data, when extrapolated nationwide, indicated that adverse reactions to medications accounted for at least 701,547 ED visits (Tanner, AP/Washington Times, 10/18). The study found that the most common adverse reactions among ED patients involved accidental overdoses and allergic reactions (Ricks, Long Island Newsday, 10/18). About 17% of ED patients who experienced adverse reactions to medications required hospitalization, the study found (AP/Washington Times, 10/18). In addition, the study found:

• The medications most commonly involved in adverse reactions among ED patients were insulins used to treat diabetes; pain medications that contain opiates, such as OxyContin; and blood thinners, such as Coumadin;

• The medications most commonly involved in allergic reactions among ED patients were antibiotics that contain amoxicillin and antihistamines and other over-the-counter cold treatments (McVicar, South Florida Sun-Sentinel, 10/18); and
• Patients ages 65 and older who experienced adverse reactions to medications were twice as likely to visit EDs and seven times as likely to require hospitalization as younger patients (AP/Washington Times, 10/18).

“These are estimates just of the patients who make it” to the ED, Budnitz said, adding, “We don’t even attempt to estimate the number of patients who never make it to treatment” (Long Island Newsday, 10/18).

An abstract of the study is available online.

CBS’ “Evening News” on Tuesday reported on the report. The segment includes comments from Paul Watkins, professor of medicine and pharmacotherapy at the University of North Carolina-Chapel Hill, and a U.S. patient who experienced an adverse reaction to a medication (LaPook, “Evening News,” CBS, 10/17).

The complete transcript of the segment is available online. The complete segment is available online in RealPlayer.

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

FDA Approves Prescription Zaditor(R) For Over-The-Counter Relief From Itchy Eyes

Novartis Pharmaceuticals Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved prescription Zaditor(R) (ketotifen fumarate ophthalmic solution 0.025%), indicated for the temporary prevention of itchy eyes due to allergic conjunctivitis, for OTC use. An estimated 40 million Americans suffer from eye allergies. Whether in reaction to seasonal allergens including pollen and ragweed, or perennial allergens such as animal hair or pet dander, itchy eyes are a main complaint.

While most OTC products provide only 3-4 hours of short-term relief, Zaditor’s full prescription strength formula offers eye itch relief that works in minutes and lasts up to 12 hours with just one drop. This significantly reduces the number of doses required per day to keep affected eyes itch-free. In addition, Zaditor is the first OTC eye itch medication safe for use in children as young as three.

“Now for the first time, people who suffer from itchy eyes caused by allergens such as pollen or pet dander can get fast, long-acting relief over- the-counter with Zaditor,” says Marion Morton, Head of the US Novartis Ophthalmics Business Unit. “Because Zaditor is now available at full prescription strength without a prescription, consumers can save time and money without sacrificing long-lasting symptom relief.”

Zaditor is the only OTC drop to treat eye itch associated with pollen, ragweed, grass, animal hair and dander without the potentially negative effects of a decongestant. Many OTC eye drops contain topical decongestants, which constrict the blood vessels to reduce the appearance of redness in the eye. With regular use, these products can interfere with the eye’s natural ability to regulate the blood vessels, resulting in a continued redness for a period of time after discontinuation (rebound effect). Zaditor does not contain a decongestant and may be used without risk of rebound redness.

“The availability of Zaditor without a prescription greatly improves treatment options for eye itch sufferers,” said Jane MacEnroe, MD, Associate Director, Medical Information and Communication, Novartis Ophthalmics. “For the first time, patients can get lasting relief over-the-counter without worrying about potential side-effects associated with long-term use of topical decongestants found in other OTC eye itch drops.”

Triple Mechanism of Action

Zaditor is the only OTC eye itch drop with a triple-action formula to provide fast, durable efficacy at the source. It includes a:

— Potent antihistamine that rapidly relieves itchy eyes within minutes

— Mast cell stabilizer that provides extended relief for up to 12 hours

— Prevents the release of chemical mediators to stop the late phase allergic reaction

Histamines, a chemical made by the body during an allergic reaction, are a primary cause of itchy eyes. Unlike most OTC drops, Zaditor blocks the histamines that cause itchy eyes and prevents the release of additional histamines, treating the source of the itch, not just the symptoms.

Approved in 1999 for prescription use, Zaditor has become a leading treatment for the temporary prevention of itchy eyes due to allergic conjunctivitis. Zaditor will be available over-the-counter in drug and chain stores nationwide beginning January 2007. It has a suggested retail price of $14.99 for a 30-day supply. In clinical studies, Zaditor was well tolerated and any side effects are generally mild.

About Novartis Ophthalmics

Novartis Ophthalmics, a business unit of Novartis Pharmaceuticals Corporation, is a leader in research, development and manufacturing of leading ophthalmic pharmaceuticals that assist in the treatment of age-related macular degeneration, eye inflammation, glaucoma, ocular allergies and other disorders of the eye. Novartis Ophthalmics products are available in more than 110 different countries. Novartis products are made in Switzerland, France, the United States and Canada.

About Novartis Pharmaceuticals Corporation

Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG (NYSE: NVS), a world leader in offering medicines to protect health, treat disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. Novartis is the only company with leadership positions in both patented and generic pharmaceuticals. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. In 2005, the Group’s businesses achieved net sales of USD 32.2 billion and net income of USD 6.1 billion. Approximately USD 4.8 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 97,000 people and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com/.

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as “will,” or similar expressions, or by express or implied discussions regarding potential future sales of Zaditor. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Zaditor to be materially different from any future results, performance or achievements expressed or implied by such statements. Management’s expectations regarding Zaditor could be affected by, among other things, competition in general; increased government, industry, and general public pricing pressures; unexpected clinical trial results, including additional analysis of Zaditor clinical data, or new clinical data; unexpected regulatory actions or delays or government regulation generally; the company’s ability to obtain or maintain patent or other proprietary intellectual property protection; and other risks and factors referred to in the Company’s current Form 20-F on file with the U.S. Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

Novartis Ophthalmics
http://www.novartis.com/

Allergy Drugs More Harmful Than Helpful For Chronic Ear Inflammation

Children who have persistent fluid in the middle ear, a condition called otitis media with effusion, are more likely to be harmed than helped by antihistamines and decongestants, a new review of studies has found.

The drugs are no better than placebo in alleviating symptoms or avoiding complications of OME and expose children to a significant risk of drug-related side effects.

“This review finds no benefit for any of the short- or long-term outcomes, including resolution of the fluid, hearing problems or the necessity of additional referral to specialists,” concluded review authors led by Glenn Griffin, M.D., of Quinte West Medical Centre in Ontario, Canada. “However, treated study subjects experienced 11 percent more side effects than untreated subjects.”

The review appears in the current issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates research in all aspects of health care. Systematic reviews draw evidence-based conclusions about medical practice after considering both the content and quality of existing trials on a topic.

Otitis media with effusion is one of the most common conditions affecting young children, and about nine of 10 children will have OME at least once before school age. While OME usually is not painful, the presence of fluid in the middle ear can cause problems with hearing and balance.

Antihistamines and decongestants, commonly used to treat symptoms of allergies and colds, are sometimes prescribed for OME. According to the review authors, these drugs theoretically could alleviate congestion and decrease obstruction of the Eustachian tube, allowing drainage of fluid.

The reviewers pooled the results of 15 randomized controlled trials involving 1,516 children that compared antihistamines, decongestants or the combination to a placebo for otitis media with effusion.

The findings were consistently negative. Children who received decongestants alone or in combination with antihistamines were no more likely to be cured within one month than children who received a placebo. The same results were seen when children were evaluated at one to three months or after more than three months.

Likewise, for each of the other major outcomes the reviewers examined — hearing loss, risk of recurrent OME, development of acute otitis media and the need for surgery to drain fluid from the middle ear — the drugs performed no better than placebo. In fact, for hearing loss, there was a trend toward worse outcomes among the children who received medication.

In parallel with the consistent lack of benefit, the reviewers also found a significant risk of harm. In the six studies that evaluated side effects, 17 percent of children who received medication suffered side effects, compared with 6 percent of children who received a placebo.

The 11 percent difference in side effects means that for every nine children treated with these drugs, one would be harmed while none would benefit.

The results of this review came as no surprise to Richard Rosenfeld, M.D., director of pediatric otolaryngology at Long Island College Hospital in Brooklyn, N.Y. The real surprise, he said, is that physicians continue to prescribe these medications for a condition that in the vast majority of cases resolves on its own.

The 2004 American Academy of Pediatrics guideline for OME, for which Rosenfeld was co-chairman, recommended against the use of antihistamines and decongestants for OME based on the preponderance of harm over benefit. A 1994 guideline also found no data supporting the use of these drugs.

“There is absolutely no question that these products don’t work,” said Rosenfeld. “We have a very old, very consistent body of knowledge, all of which says the same thing, and yet these products are still commonly used by practicing clinicians.”

According to Rosenfeld, the continuing use of these drugs despite no evidence of benefit is a classic example of the way in which mental images can trump the best research.

“Parents will say, ‘My doctor gave me these medications to dry up the fluid,’ or, ‘If I use this, it’s going to open the Eustachian tube.’ Apparently that mental image is so powerful that it completely overwhelms common sense regarding the management of this disorder.”

The best-documented side effects of antihistamines and decongestants are insomnia, hyperactivity, drowsiness, behavioral changes and variability in blood pressure.

“These are pretty ubiquitous and nontrivial effects that can impair a child’s functioning at home and at school,” said Rosenfeld. “If you’re going to subject your child to any medication that has the potential for harm, there needs to be some assurance of benefit. Don’t use ineffective medications just because you have nice visual images. You’re better off doing nothing.”

###

By Kelly Griffin, Contributing Writer Health Behavior News Service

Griffin GH, et al. Antihistamines and/or decongestants for otitis media with effusion (OME) in children. Cochrane Database of Systematic Reviews 2006, Issue 4.

The Cochrane Collaboration is an international nonprofit, independent organization that produces and disseminates systematic reviews of health care interventions and promotes the search for evidence in the form of clinical trials and other studies of interventions. Visit http://www.cochrane.org/ for more information.

Contact: Lisa Esposito
Center for the Advancement of Health

Growing Evidence Of Sex-based Differences In Lung Cancer Highlighted At Roundtable Meeting

Women’s health and lung cancer advocacy groups, led by the Society for Women’s Health Research, vowed today to make lung cancer education and advocacy, especially among women, a top priority for their organizations in 2006 and beyond. The roundtable meeting took place at the National Press Club, where health experts and advocacy leaders discussed sex-based research advances in lung cancer and the challenges in elevating public dialogue about the deadly disease. Lung cancer is the number one cancer killer of women and women are approximately 1.5 times more likely to develop lung cancer than men.

“A growing number of women, including non-smokers, are diagnosed with lung cancer each year” said Phyllis Greenberger, president and CEO of the Society for Women’s Health Research. “We need to improve women’s awareness of this disease and we need more research to understand the impact of sex and gender on the development and treatment of lung cancer. The federal government can play an important role in this process by increasing funding for research and education targeted at the underserved population of women.”

Lung cancer claims the lives of more American women and men than the three most common cancers combined (colon, breast, and prostate) yet it receives a disproportionately low amount of media attention and government research funding. Approximately 350,000 people in the United States have lung cancer, and an estimated 173,000 were diagnosed in 2005. Non-small cell lung cancer is the most common form of lung cancer, accounting for approximately 87 percent of cases. While lung cancer incidence and mortality have been declining among men, there has been an alarming four-fold increase in lung cancer in women over the last 30 years.

Female smokers appear to be two to three times as susceptible to lung cancer as male smokers. Biological differences between the sexes may partially explain why women are more vulnerable to the cancer-causing effects of tobacco and other lung carcinogens. For example, the cells and DNA in women’s lungs may be more easily damaged by tobacco smoke.

At the meeting, advocacy group representatives listened to presentations by top cancer researchers detailing the rising risks of lung cancer among women as well as inroads that have been made in sex-based research. Roundtable discussion prompted the groups to make lung cancer awareness in women a top national health priority, including a drive to urge the government to increase funding for sex-based lung cancer research.

Among the advocacy groups joining the Society for Women’s Health Research to talk about ways to increase awareness of sex differences in lung cancer risk and treatment approaches were the American Society for Clinical Oncology, CancerCare, Intercultural Cancer Council, Joan’s Legacy, Lung Cancer Alliance, LUNGevity, National WomenЎ¦s Health Resource Center, Women Against Lung Cancer, and the Women’s Health Policy and Advocacy Program at Brigham and Women’s Hospital.

Individuals participating in the Roundtable committed to working together around the following lung cancer advocacy needs:

* Greater attention by the public, policy makers, and researchers in order to reduce lung cancer risks and rates of occurrence, improve diagnosis, and expand treatment options through research ЎV particularly for women of all cultures, races, ethnicities, and socioeconomic strata.

* Significant increases in public and private funding to support sex- and gender-based research and education.

* Health care provider education to reduce nihilism, pessimism, and stigma in the treatment of lung cancer patients.

A major goal is to significantly increase survivorship and reduce death from lung cancer by 2015.

Sex-Based Differences in Lung Cancer
Between 85 and 90 percent of men and women diagnosed with lung cancer are current or former tobacco users. Since tobacco smoke is the leading risk factor for developing lung cancer, it is important to understand how the various components of tobacco smoke, including nicotine and many carcinogens, are metabolized or chemically modified in the body in ways that contributed to lung cancer development.

The reproductive hormone estrogen may increase women’s susceptibility to developing lung cancer, but its exact role in this process is currently unknown. Estrogen binds to estrogen receptors in many tissues of the body, including lung tissue, which results in production of proteins involved in normal tissue growth. It has been postulated that the estrogenic environment in women and the differential expression of various forms of estrogen receptors in the lung tissue of women and men may contribute to sex differences in lung cancer susceptibility. Through the actions of these various forms of the estrogen receptor, estrogen may influence lung tumor growth in women by causing the synthesis of tumor-promoting proteins.

Also, estrogen may act directly on the DNA in lung cells to disrupt its normal function, resulting in uncontrolled growth of lung tissue. Some studies indicate that women who take menopausal hormone therapy have an increased risk for lung cancer.

“There is some exciting, emerging evidence of the role of estrogen in measuring the risk of and treating lung cancer,” said Joan H. Schiller, M.D., University of Wisconsin Comprehensive Cancer Center, and a presenter at the Advocacy Roundtable. “We are optimistic that this breakthrough science will translate into targeted lung cancer treatments for women and we can give this patient group the medical attention they need.” In addition to researching and treating lung cancer, Schiller is president of the board of directors for the advocacy group Women Against Lung Cancer.

Schiller is currently researching a novel approach to targeting lung cancer in women that relies on a chemotherapy agent that exploits the presence of estrogen in women and its effect on the metabolism of proteins in the cancer cell. Schiller is one of a team of investigators directing the international trial to evaluate the efficacy of a novel chemotherapy agent that appears to be more effective in the presence of estrogen-regulated proteins.

Research suggests that estrogen may facilitate lung cancer growth and metastasis, making the disease more aggressive in pre-menopausal women. However, the same estrogen-induced proteins that promote lung cancer may also facilitate delivery of a highly active therapeutic agent to tumor tissue, thus converting a negative risk factor (higher estrogen levels) into one that may benefit the patient.

###

The Society for Women’s Health Research
The Society for Women’s Health Research is the nation’s only non-profit organization whose mission is to improve the health of all women through research, education, and advocacy. Founded in 1990, the Society brought to national attention the need for the appropriate inclusion of women in major medical research studies and the need for more information about conditions affecting women disproportionately, predominately, or differently than men. The Society advocates increased funding for research on women’s health; encourages the study of sex differences that may affect the prevention, diagnosis and treatment of disease; promotes the inclusion of women in medical research studies; and informs women, providers, policy makers and media about contemporary women’s health issues. Visit the Society’s Web site at http://www.womenshealthresearch.org/ for more information.

The Talk and Take Action: Women & Lung Cancer Advocacy Roundtable was supported by an educational grant from Cell Therapeutics, Inc. (CTI). Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. The company recently launched a trial, known as PIONEER, for women with advanced lung cancer. For additional information, please visit http://www.cticseattle.com/.

Contact: Leslie Wheeler
Weber Shandwick Worldwide