African Americans Face Higher Risk Of Lung Cancer Than Other Races, Study Says

African Americans who smoke face a higher risk of developing lung cancer than smokers of other races, indicating that genes “might help explain the racial differences long seen in the disease,” according to a study in Thursday’s New England Journal of Medicine, the AP/Detroit Free Press reports (Chang, AP/Detroit Free Press, 1/26). In the largest study on the topic to date, researchers from the University of Southern California and the University of Hawaii followed 183,000 study participants over an eight-year period beginning in 1993. Over the course of the study, 1,979 enrollees developed lung cancer. Among African-American men who smoked, there were 264 cases of lung cancer per 100,000 individuals, compared with 264 cases among native Hawaiian men, 158 cases among white men, 121 cases among Japanese-American men and 79 cases among Latino men. The study, which did not include other ethnic groups, found that women overall had lower incidences of lung cancer, but ethnic disparities generally “followed the same pattern,” the Wall Street Journal reports (Bulkeley, Wall Street Journal, 1/26). Overall, whites who smoked up to one pack of cigarettes daily had a 43% to 55% lower risk of developing lung cancer than blacks who smoked the same amount. Latinos and Japanese Americans were 60% to 80% less likely than blacks to develop lung cancer if they smoked up to a pack a day, according to the study (AP/Detroit Free Press, 1/26). The disparities — which persisted even after researchers considered factors such as diet, socioeconomic status and occupation — disappeared among participants who were the heaviest smokers, likely because the damage caused by smoking at that level overwhelmed other factors, according to lead author Christopher Haiman, an assistant professor at the Keck School of Medicine at USC.

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Haiman said the study could not rule out the possibility that the findings resulted from unidentified environmental factors but noted that there could be “differences in how [African Americans] metabolize nicotine, which would influence smoking behaviors such as the depth and frequency of inhalation of tobacco smoke.” He added, “There could be genetic factors on how they metabolize tobacco smoke” (Stein, Washington Post, 1/26). In an editorial accompanying the study, Neil Risch, director of the Institute for Human Genetics at the University of California-San Francisco, said the results of the study “provide an example of how ethnicity can interact with environmental factors in terms of the risk of disease.” He added that the findings could help doctors diagnose and treat some illnesses (Wall Street Journal, 1/26).

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Esteban Gonzalez Burchard, an assistant professor at the UCSF School of Medicine, said, “If this happens with tobacco, what about other drugs? Tobacco is a drug. What about the drugs we give to patients, such as cancer medications or heart medications or lung medication? There could be important biologic differences that help to explain the differences we see in disease prevalence, severity and mortality, as well as response to therapies.” However, Jeffrey Kahn, a bioethicist at the University of Minnesota, said he is concerned that the findings could lead to discrimination, noting that “[t]he danger would be to sort of view lung cancer as a minority disease, and so something we don’t have to worry as much about.” Troy Duster, a professor of sociology at New York University, said, “This feeds into the 19th-century notion that these categories really separate people in terms of their physical and biological characteristics. The reason why black people may be getting cancer more has to do with a combination of forces, not just their biologic makeup.” M. Gregg Bloche, a health law and policy professor at Georgetown University, said the study should encourage more research into understanding the role of genetics in how different races react to medicines, adding, “The biggest danger here is ideology on both sides getting in the way of trying to understand this phenomenon” (Washington Post, 1/26).

The study is available online. The editorial is available online.

“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.

Adam Morrison "Takes Center Court" For Diabetes Awareness

NBA rookie Adam Morrison is looking forward to an exciting November. Not only does this month mark the official start of his professional career with the Charlotte Bobcats, but November is also American Diabetes Month, and Morrison, who has Type 1 diabetes, has geared up to become an advocate for better diabetes management.

A favorite for Rookie of the Year and compared by some to Larry Bird, Morrison teamed up recently with LifeScan, Inc., makers of the OneTouch® Brand of Blood Glucose Monitors. In fact, Morrison and the company have collaborated on a new Web site, http://www.DiabetesAndFood.com, where visitors can “meet” Adam and learn more about the impact of food on blood sugar levels, a particularly timely topic for people with diabetes, as November also marks the arrival of the holiday food season.

Created to help the nearly 21 million Americans with diabetes eat healthier for better diabetes management, the Web site includes information on testing blood sugar around meals as well as blood sugar targets for before and after meals. Visitors to the Web site can request a free educational DVD and booklet that can help them learn to make simple adjustments so they can still enjoy the foods they love, covering topics like the role of carbohydrates and planning for dessert. The new Web site also addresses topics like why and when to test blood sugar levels and insurance coverage for diabetes supplies.

Morrison was diagnosed with diabetes when he was 14. He monitors his blood sugar levels regularly – whether he’s playing or not – and has firsthand knowledge of the food/blood sugar connection. He’s learned that – for him – eating the same meal two hours and 15 minutes before every game helps to control his blood sugar levels and enables him to perform well on the court. Because food choices and portions affect everyone differently, Adam encourages people with diabetes to talk to their doctors to see if testing around some meals could help them see how their food and portion choices impact them. This could help them make even healthier food and portion choices in the future.

Morrison hopes that his personal mission – a “full court press” that includes public appearances and other outreach efforts – will help those suffering from diabetes learn how to better manage their disease.

“My goal is to help people with diabetes understand how keeping blood sugar levels in a healthy range can help them avoid complications,” says Morrison. “I’m not perfect by any means, and I find that food can be a challenge. But having diabetes doesn’t mean you have to give up the foods you love – learning about the connection between food and blood glucose levels can make all the difference in the world in better managing the disease.”

For more information, visit http://www.DiabetesAndFood.com.

LifeScan, Inc., a Johnson & Johnson company, is a leading maker of blood glucose monitoring products dedicated to creating a world without limits for people with diabetes.

LifeScan, Inc.
LifeScan, Inc

Allergy Sufferers Offered Longer Relief With Fewer Shots Using Experimental Ragweed Therapy

Americans accustomed to the seasonal misery of sneezing, runny noses and itchy, watery eyes caused by ragweed pollen might one day benefit from an experimental allergy treatment that not only requires fewer injections than standard immunotherapy, but leads to a marked reduction in symptoms that persists for at least a year after therapy has stopped, according to a new study in the October 5 issue of i The New England Journal of Medicine (NEJM). The research was sponsored by the Immune Tolerance Network, which is funded by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), both components of the National Institutes of Health (NIH), and the Juvenile Diabetes Research Foundation International.

“As many as 40 million Americans suffer from seasonal allergies caused by airborne pollens produced by grasses, trees and weeds,” says NIH Director Elias A. Zerhouni, M.D. “Finding new therapies for allergy sufferers is certainly an important research goal.”

“This innovative research holds great promise for helping people with allergies,” says NIAID Director Anthony S. Fauci, M.D. “A short course of immunotherapy that reduces allergic symptoms over an extended period of time will significantly improve the quality of life for many people.”

Ragweed is one of the most common pollens in the United States and is prevalent in the Northeast, Midwest and the South. In Baltimore, where the NEJM study was conducted, the ragweed pollen season lasts from mid-August to October.

Physicians treat people suffering from mild and moderate ragweed allergies with antihistamines or nasal corticosteroids. However, when people with allergies do not respond to these treatments or experience severe symptoms, the next therapeutic option is a course of subcutaneous injections of the allergen, which is called allergen immunotherapy. Although this standard immunotherapy is often effective, it has two major drawbacks. First, it can cause systemic allergic reactions, such as anaphylaxis, a hypersensitivity reaction that can lead to severe and sometimes life-threatening physical symptoms. Second, to provide long-lasting relief, standard immunotherapy may require frequent injections over a 3- to 5-year period. The large number of injections over such an extended period of time often results in many people not completing the treatment.

In the study detailed in NEJM, lead investigator Peter Creticos, M.D., medical director of the Johns Hopkins Asthma and Allergy Center in Baltimore, and his research team found that an investigational therapy based on the major ragweed allergen, Amb a 1, coupled to a unique short, synthetic sequence of DNA that stimulates the immune system, reduced allergy symptoms in adults for at least one year when given just once a week over a 6-week period. The therapeutic agent was provided by Dynavax Technologies Corp., based in Berkeley, CA.

“For almost 100 years, we’ve been using the tedious process of giving allergy sufferers one to two shots a week for up to 4 to 5 years to ensure its success,” Dr. Creticos says. “This study is an important immunotherapy advance in that we’ve shown you can induce long-lasting relief from allergic rhinitis with just a few weeks of injections.”

The study initially involved 25 adult volunteers, ages 23 to 60, with a history of seasonal allergic rhinitis, positive skin test reactions to ragweed pollen, and an immediate reaction when nasally challenged with ragweed. Prior to the start of the 2001 fall ragweed season, the study participants received six injections, each a week apart, of either the investigational therapy in increasingly higher doses or a placebo. They received no other injections throughout the course of the study. Fourteen volunteers received the study drug; 11 were given the placebo. The therapy was well-tolerated and caused only limited local reactions, which required neither medication nor change in treatment dose. No clinically significant, therapy-related adverse events occurred.

Throughout the 2001 and 2002 ragweed seasons, the volunteers were monitored for allergy-related symptoms, including the number of sneezes and the degree of post-nasal drip, allergy medication use and quality-of-life scores. Compared with the placebo recipients, the group that received the therapy experienced dramatically better outcomes that continued throughout the 2002 ragweed season even though therapy ended one year earlier.

Clearly, the regimen of only six injections showed therapeutic promise when compared with the current therapy, the study authors note. However, because the results are based on a small number of volunteers and the long-term safety of the therapy is unknown, they say additional clinical trials with longer-term follow-up to adequately assess the therapy’s safety and effectiveness are necessary.

How the experimental therapy relieves ragweed allergy symptoms is not fully understood at this time. When exposed to ragweed pollen, people who are allergic to ragweed experience an increase in IgE (immunoglobulin) antibodies; immunotherapy blocks this increase in IgE. Researchers believe the experimental therapy tempers the release of immune regulatory proteins called cytokines, which blocks increases in the level of IgE antibodies.

“Using ragweed as a model allergen system with a predictable seasonal pattern of symptoms and pollen counts, it is possible to correlate pollen levels with symptoms and measure treatment effects on symptoms. This enables us to better understand immune response to allergens and serves as an approach to similar therapies to manage other allergic reactions for which there are currently no treatments, such as food allergies,” says Marshall Plaut, M.D., chief of the Allergic Mechanisms Section of NIAID’s Division of Allergy, Immunology and Transplantation.

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NIAID is a component of the National Institutes of Health. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on basic immunology, transplantation and immune-related disorders, including autoimmune diseases, asthma and allergies.

The National Institutes of Health (NIH)–The Nation’s Medical Research Agency–includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov/.

Reference: PS Creticos et al. Immunotherapy with a ragweed-TLR9 agonist vaccine for allergic rhinitis. The New England Journal of Medicine DOI: 10.1056/NEJMoa052196 (2006).

News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov/.

Contact: Kathy Stover
NIH/National Institute of Allergy and Infectious Diseases

IV HYCAMTIN(R) Receives European Marketing Approval As Treatment For Relapsed Small Cell Lung Cancer

GlaxoSmithKline (GSK) announced that the European Commission (EC) has granted Marketing Authorisation for HYCAMTIN(R) (topotecan powder for concentrate for solution for infusion) for the treatment of patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate. HYCAMTIN(R) is the first drug to be approved in Europe that is specifically indicated for the treatment of relapsed SCLC. Data from the HYCAMTIN(R) clinical trials show that treatment with HYCAMTIN(R) is associated with prolonged survival and quality of life compared to best supportive care in patients battling the disease.

The marketing authorisation follows a positive opinion in November 2005 by the European Committee for Human Medicinal Products (CHMP) for HYCAMTIN(R).

HYCAMTIN(R) is a compound already familiar to oncologists as a treatment for relapsed ovarian cancer. The chemotherapeutic agent belongs to a class of drugs known as topoisomerase I (topo-I) inhibitors, and works by inducing DNA damage which results in the death of dividing cells. Because two thirds of patients with SCLC already have extensive disease at the time of diagnosis and nearly all patients with extensive disease eventually relapse, approval of HYCAMTIN(R) is a significant step forward in widening options for patients.

“The oral form of HYCAMTIN(R) has shown promising and unexpected results in improving symptoms and lengthening the life of patients with relapsed SCLC, a disease that is traditionally associated with a grave outlook for patients,” says Dr. Mary O’Brien, Head of the Lung Cancer Unit, The Royal Marsden NHS Foundation Trust, UK. “This approval of intravenous HYCAMTIN(R) will now provide physicians and our patients an important new treatment option in SCLC.”

“HYCAMTIN(R) appears to provide greater symptom improvement than CAV. The regimen has no neurotoxicity and in a randomised study, SCLC patients experienced a significant improvement in breathing difficulties and anorexia,” says Dr J. von Pawel, Head, Department of Oncology, Asklepios Kliniken Munchen-Gaunting, Germany and an investigator in the study. “HYCAMTIN(R) is an important step forward in terms of improving the quality of life for SCLC patients and essentially allows them to make the best use of the time they have left.”

European approval was principally based on three key Phase III studies. The first study (protocol 090) compared the safety and efficacy of HYCAMTIN(R) to the triple combination cyclophosphomide, doxorubicin and vincristine (CAV) in patients with sensitive SCLC. Median overall survival was comparable between the two arms of the study (25.0 versus 24.7 weeks, p = 0.80).

The second study (protocol 396) compared the safety and efficacy of an oral formulation of topotecan versus IV HYCAMTIN(R) in patients with sensitive SCLC. Median overall survival was comparable between the two arms (33.0 versus 35.0 weeks, Hazard Ratio = 0.98) and both treatments were generally well-tolerated.

The third study (protocol 478) was conducted to prove the survival benefit of second-line chemotherapy for relapsed SCLC patients. The study was conducted using oral HYCAMTIN(R) plus best supportive care and compared safety and efficacy to best supportive care (BSC) alone. Median overall survival for HYCAMTIN(R) plus BSC was 25.9 weeks compared to 13.9 weeks for patients who received BSC alone (p = 0.01).

Mike Unger, Chief Executive, The Roy Castle Lung Cancer Foundation, UK comments, “Small cell lung cancer is a particularly devastating disease, with a very serious outlook for those suffering from it. SCLC comprises 25% of all lung cancers and at the moment there are very few treatment options. The approval of HYCAMTIN(R) by the European Committee for Human Medicinal Products is a very exciting development and will give support and benefits to many patients in the UK and across Europe. The Foundation looks forward to further clinical research and experience concerning HYCAMTIN(R).”

“HYCAMTIN(R) offers an important new therapeutic option for patients in Europe who are faced with managing this devastating disease,” said Andrew Witty, President, Pharmaceuticals Europe, GSK. “This approval is another example of GSK’s continued commitment to researching and developing an industry leading oncology portfolio to address the unmet medical needs of cancer patients around the world.”

About Small Cell Lung Cancer

Lung cancer is the most common cancer in the world attributing to 13.2% of all cancer cases.[i] About 20 out of every 100 cases diagnosed are small cell lung cancer.[ii] Of all those diagnosed with small-cell lung cancer, around one in three have limited disease at the time of diagnosis. Two out of three already have extensive disease at the time of diagnosis. Of those who have limited disease and have chemotherapy, between 35 – 40% will be alive two years later. People with extensive disease are also treated with chemotherapy, but unfortunately the survival rate is even lower. Most only survive another ten to twelve months.[iii]

Globally the highest rates of lung cancer in men are found in Europe, especially eastern Europe, and North America. For women, the highest rates are found in North America and European countries such as Denmark, Hungary, Iceland and the UK.[iv]

About HYCAMTIN(R)

HYCAMTIN(R) (topotecan powder for concentrate for solution for infusion) is a chemotherapeutic agent that belongs to a class of drugs known as topoisomerase I (topo-I) inhibitors. Topo-I is an enzyme essential for the replication of DNA, and therefore cell division, in both normal and cancer cells. Interaction between topo-I and HYCAMTIN(R) results in damage to the cell’s cancerous genetic material and the death of dividing cancer cells.

HYCAMTIN(R) is already registered in the European Union, and 59 other countries around the world for the treatment of relapsed ovarian cancer following platinum-based therapy. More than 230,000 patients have been treated with HYCAMTIN(R) since its launch in 1996. More information on HYCAMTIN(R) can be found at www.emea.eu.int

For further product information please access the Electronic Medicines Compendium at www.medicines.org.uk

Important Safety Information

HYCAMTIN(R) can suppress the body’s ability to produce blood cells, in particular the white blood cells which fight infection. This condition is known as neutropenia. The clotting elements (platelets) can also be decreased, a condition known as thrombocytopenia. HYCAMTIN(R) is contraindicated in patients who have a history of hypersensitivity reactions to topotecan or any of its ingredients. HYCAMTIN(R) should not be used in patients who are pregnant or breast-feeding, or in those with severe bone marrow depression.

About GlaxoSmithKline

GlaxoSmithKline (NYSE: GSK) is one of the world’s leading research-based pharmaceutical and healthcare companies. GlaxoSmithKline is committed to improving the quality of human life by enabling cancer patients to do more, feel better and live longer. For more information, visit http://www.gsk.com.

[i] Boyle P, Ferlay J. Cancer incidence and mortality in Europe 2004. Annals of Oncology, 2005. 16: 481-488
[ii] Onkos Plus Study #5, Small Cell Lung Cancer, December 2004, pg 7
[iii] www.cancerhelp.org.uk/help/default.asp?page=2965#small, accessed January 2006
[iv] GLOBOCAN 2002. Cancer Incidence, Mortality and Prevalence Worldwide (2002 estimates), 2005

http://www.gsk.com

Researchers Report Rapid Non-Invasive Test For Pre-Diabetes

Researchers today reported a new screening device that doesn’t require blood was able to significantly outperform both the fasting plasma glucose (FPG) test and the A1C test for identifying individuals with impaired glucose tolerance (IGT), a condition that often progresses to type 2 diabetes. Presented at the Sixth Annual Diabetes Technology Meeting, held here, results showed a prototype of the device was able to identify 78% more individuals with the IGT form of pre-diabetes than the FPG test, and 47% more than the A1C test. Both the FPG and A1C are blood tests commonly used to screen and evaluate patients at risk for diabetes. An estimated 54 million Americans have pre-diabetes.

Researchers from VeraLight Inc., the developer of the non-invasive diabetes-screening device code-named “Scout,” conducted the study on 322 subjects ranging from 21 to 88 years old with a broad range of skin color. Slated for market introduction in early 2008, the device is able to detect abnormal concentrations of the skin biomarkers known to be associated with diabetes in less than one minute using fluorescent light from an individual’s forearm. Unlike the FPG test, the device does not require a blood draw or an overnight fast prior to testing. Although the A1C test does not require the patient to fast, a blood sample is needed to perform it.

Using Veralight’s proprietary Spectroscopic Advanced Glycation Endproducts detection technology, or SAGE(TM), Scout is seen as a major breakthrough in diabetes and pre-diabetes screening that can lead to early intervention, and a dramatic reduction in the morbidity and $132 billion annual cost to treat the disease and its complications.

Skin Biomarkers Predict Diabetes and Its Complications

According to medical experts, non-invasive skin detection of “advanced glycation endproducts,” or AGE, could replace the FPG test as the medical workhorse for screening people suspected of having diabetes or pre-diabetes. Previous studies have shown AGE are biological markers that correlate well with diabetes and are a predictor of the disease’s serious complications. Analogous to a “diabetes odometer,” AGE are a sensitive metric for the cumulative damage the body has endured due to the effects of abnormally high blood sugar and oxidative stress. They affect the proteins that make up blood vessels, connective tissue and skin, and are thought to be major factors in aging and age-related chronic diseases.

Scout Diabetes Screening System

Scout is a portable, desktop system weighing about 10 pounds. After the subject places the palm side of their forearm onto the system, the device shines various wavelengths of light onto the skin that causes the AGE to emit a fluorescent light signature that indicates diabetes risk. The instrument optically calibrates for skin pigmentation so that performance is not diminished by skin coloration. A specially designed fiber-optic probe couples the excitation light to the subject and relays resulting skin fluorescence to a detection module. The system’s software utilizes multivariate statistical techniques that are applied to the emitted light spectra to obtain a diabetes risk score. Total measurement time is about a minute.

Need for Early and More Accurate Diabetes Screening

According to a study published in the June issue of Diabetes Care, more than 73 million Americans — one third of the adult population — now have diabetes or may be on their way to getting it. Current screening methods for diabetes are grossly inadequate due to their inaccuracy and inconvenience. Consequently, many people with diabetes are not identified until they present 5-to-9 years into the disease, and 50% have one or more often-irreversible complications at the time of diagnosis. A more accurate and convenient screening method could dramatically reduce the costs and morbidity associated with such complications, allowing patients to halt or reverse disease progression.

About VeraLight

VeraLight, based in Albuquerque, N.M., is a privately held medical instrumentation company applying its proprietary SAGE technology to develop the first non-invasive diabetes screening system that provides healthcare professionals with a more accurate and convenient method for detecting type 2 diabetes and pre-diabetes based on the presence of biomarkers found in skin. For more information see http://www.veralight.com/.

VeraLight Inc.
http://www.veralight.com/

EU Health Research Must Prioritise Allergies

European public health experts are concerned because “allergic diseases” in all their different aspects – from hay fever to fatal attacks of asthma or reactions to peanuts – are not included in the health priorities of the EU research programme. While allergies are mentioned among the food research priorities, the absence of wider allergy problem as a top concern in health research agenda threatens to comprise overall progress in the understanding of this complex condition.

  Paul van Cauwenberge, Coordinator of GAІLEN (Global Allergy and Asthma European Network), says that if the European Union does not make it a top concern in health research, researchers and practitioners may fail to contain the allergy epidemic. (1)

  “GAІLEN has helped to demonstrate the magnitude of this public health problem and begun to find the solutions,” says Prof. van Cauwenberge of the University of Ghent, Belgium. “But if allergic diseases are not included as a health priority in the next EU framework programme FP7 (2), we are much less likely to build the overall understanding we need to help control this epidemic through effective prevention and treatment.” (2)

  While allergy experts welcomed the fact that allergy was considered under the food safety programme in the FP6, they point out that only 8% of allergies in Europe are related to food. Allergic diseases represent a “global” problem in the sense that it has multiple presentations and causes, both genetic and environmental. All the different aspects of the condition and its triggers must be addressed to gain a comprehensive understanding of allergic diseases as a whole.

  Prof. van Cauwenberge believes that politicians and different authorities would want to be alerted to the absence of the overall allergy and asthma problem within the research agenda. “If Europe does not continue to make major investments into integrating and co-ordinating research for an overall vision, we are unlikely to get to grips with why the rapid increase in prevalence is occurring, nor to be able to identify and introduce into clinical practice the best ways to prevent and manage the problem,” he says. 

  Allergic diseases are taking lives daily and creating huge financial costs. According to the World Health Organization, asthma kills someone in Europe every hour. (3) One child in three is allergic today and by 2015, half of the European population may be suffering from one or more allergic condition. (4)

  Estimates have put the financial costs of allergic diseases in Europe at up to 100 billion Euros per year. (4) The personal costs fall particularly heavily on families. Parental fears of a serious attack create anxiety, and even with mild allergies family activities may be limited. Children miss days at school and abstain from sport and other recreational activities. Breathing problems and skin rashes can also harm the self-image of young children, adults and especially teenagers. (5)

  The GAІLEN network has successfully brought together 26 “centres of excellence” in allergies spread through different European countries with the aim to advance the diagnosis, prevention and treatment of allergic diseases. European researchers and doctors involved are now using standardised skin-prick allergy tests so that Europe-wide comparative analysis can take place. In the last few months, a huge European database of comparable longitudinal epidemiological studies, known as birth cohorts, has been finalised so that significantly more reliable analysis can now be made of the multiple genetic and environmental factors causing allergies.

  Working with partner organizations representing allergy specialists and patients’ groups (1), GAІLEN is developing evidence-based guidelines for health professionals and the patients to help them preventing and managing the disease. GAІLEN urges policy makers to support the European Parliament proposal to include allergic diseases in the health priorities of the 7th research framework programme.

  1. GAІLEN – the Global Allergy and Asthma European Network is a “Network of Excellence” funded by the European Union 6th Research Framework Programme. It consists of 26 research centres spread throughout Europe, as well as the European Academy of Allergology and Clinical Immunology (EAACI) and the European Federation of Allergy and Airways Diseases Patients Associations (EFA). More than 30 collaborating centres have joined the network since its launch in 2004.

2. The European Union’s next research programme, known as the Seventh Framework Programme Seven (FP7), begins next year and will run for seven years until 2013.  

3. World Health Report 2003, “Shaping the Future”. World Health Organization.

4. “Allergy: An epidemic that must be stopped”, Position Paper, European Academy of Allergology and Clinical Immunology (EAACI). http://www.efanet.org/activities/eu_policy.html

5. “EU 7th Framework Programme for Research”, Position Paper, European Federation of Allergy and Airways Diseases Patients Associations (EFA). http://www.efanet.org/activities/eu_policy.html

GAІLEN – the Global Allergy and Asthma European Network

http://www.ga2len.net

Community Oncology Alliance Gathers In Washington To Address Crisis In Access To Cancer Care

The Board and Officers of The Community Oncology Alliance — representing cancer clinics caring for over 85% of the USA’s cancer patients — will gather with hundreds of oncologists, nurses, and allied health professionals in Washington, DC for the First Annual Community Oncology Conference at the Marriott Wardman Park Hotel February 8- 10, 2006. The three day conference will focus on the crisis in cancer care caused by the Medicare Modernization Act (MMA) which sought to modernize reimbursement for cancer drugs and essential cancer care services by reforming the payment systems for oncology.

“The reform was woefully short,” states Steve Coplon, Co-Executive Director of COA. “The Medicare Modernization Act overcorrected drug reimbursement to below cost and under corrected service reimbursement to below cost. Essentially, cancer clinics are now subsidizing cancer care for Medicare patients. A typical example occurred yesterday,” Coplon adds. “Our clinic is currently treating a patient with Non-Hodgkin’s Lymphoma. Current reimbursement for that care is $1,607 below our cost. The patient’s co-insurance is over $3,000. If the patient can’t afford the co-insurance, we will subsidize the treatment though the clinic will be reimbursed $4,600 below cost. In either case clinics cannot afford to subsidize this care.”

Similar situations are being reported by cancer clinics throughout the country, and as a result many patients are being shifted to hospital in-patient and/or outpatient settings which can result in more cost to Medicare, unnecessary treatment delays, long waits, and lower quality care. In some communities hospitals are not accepting these patients because cost greatly exceeds reimbursement. A number of oncology groups are further reporting that they can no longer treat Medicare patients — including a group in New Orleans, one group in Iowa, and another in Panama City, Florida. Many other similar reports have emerged from dozens of states.

“MMA was supposed to fix a broken payment system for oncology,” said Leonard Kalman, MD, a Miami based oncologist and President of COA. “Instead oncology reimbursement has been cut by $15.7 billion over 10 years — adversely impacting quality and access to care. This overcorrection needs to be fixed before the crisis gets out of hand any further.”

Representatives from COA are encouraged that their message is being heard in Washington. “COA has a voice at the table,” affirms Chief Administrative Officer, Dianne Kube. “We regularly meet with Congressional leadership, The White House, CMS, MedPAC, and other agencies addressing reimbursement for cancer care. In addition, we have legislation, HR 4098 — The Community Cancer Care Preservation Act, introduced by Congressman Jim Ramstad, Republican of Minnesota. This legislation addresses many of the deficiencies of MMA. Unfortunately, policy issues do not move as quickly as we would like.”

“For cancer clinics like ours in Memphis this means that patients are experiencing a regression in ‘The War on Cancer,’” declares Coplon. “Oncologists, nurses, and patients from around the country are deeply concerned that much of the progress in early diagnosis and treatment and much of the cost savings resulting from care in the office setting is now going to be lost as care shifts to hospitals or does not occur at all. Some patients have indicated that they will not go to the hospital for care. The real tragedy is that we have come so far in this fight and now MMA is forcing us to retreat rather than advance.”

The three day gathering in Washington will lay out strategies for policy change before the crisis exacerbates.

For additional information contact Dianne Kube, Community Oncology Alliance, 202-756-2258.

The Community Oncology Alliance (COA) is committed to fostering and protecting high quality, affordable and accessible cancer care for all Americans battling cancer. COA’s vision is to strongly promote initiatives that further enhance the quality and affordability of cancer care, which along with accessibility have been hallmarks of cancer treatment delivered in the community setting where over 80% of Americans with cancer are treated.

Community Oncology Alliance
www.communityoncology.org

Patients With Type 2 Diabetes Helped By Periodontal Therapy

Patients with Type 2 diabetes and periodontal disease who receive periodontal therapy see levels of oxidative stress, a condition in which antioxidant levels are lower than normal, reduced to the same levels as nondiabetic patients, according to a new study that appeared in the November issue of the Journal of Periodontology (JOP).

Researchers from Kyushu Dental College in Kitakyushu, Japan investigated the impact of periodontal therapy on patients with Type 2 diabetes, as compared to nondiabetic patients. They found that periodontal therapy decreased lipid peroxide (LPO), an oxidative stress index, in diabetic patients.

“Our research emphasized one of the benefits of having periodontal therapy for patients with diabetes,” said Dr. Kazuo Sonoki, M.D. PhD at Kyushu Dental College, one of the study authors. “However, this was just a preliminary study and more research should be conducted to evaluate how periodontal disease affects both people with and without diabetes.”

It has been found that diabetes and periodontal disease can lead to atherosclerosis, which occurs when deposits of fatty substances, cholesterol, and other substances build up in the inner lining of an artery. This buildup is called plaque. It has been thought that oxidative stress is linked to heart disease because oxidation of LDL (low-density lipoprotein) in the endothelium is a precursor to plaque formation. Recently, oxidative stress has emerged as an important factor for atherosclerosis in patients with diabetes.

“We hear every day about how more and more people are being diagnosed with diabetes,” said Preston D. Miller, DDS and AAP President. “This research confirms that patients with diabetes should be especially conscious of their periodontal health. While more research needs to be done to evaluate the relationship between periodontal disease and diabetes, we do know that treating periodontal diseases can save teeth, and can promote overall health.”

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For more information including referral to a periodontist or a free brochure entitled Diabetes & Periodontal Diseases, visit the AAP Web site at http://www.perio.org/.

The American Academy of Periodontology is an 8,000-member association of dental professionals specializing in the prevention, diagnosis and treatment of diseases affecting the gums and supporting structures of the teeth and in the placement and maintenance of dental implants. Periodontics is one of nine dental specialties recognized by the American Dental Association.

CONTACT INFORMATION:

Kerry Gutshall
The American Academy of Periodontology
http://www.perio.org/

A copy of the JOP article “Decreased lipid peroxidation following periodontal therapy in type 2 diabetic patients” is available to the media by contacting the AAP Public Affairs Department at 312/573-3243. The public and/or non-AAP members can view a study abstract online, and the full-text of the study may be accessed online for $20.00 at http://www.joponline.org/

Contact: Kerry Gutshall
American Academy of Periodontology

Children Of Allergy Sufferers Prone To Same Problem

Infants whose parents have allergies that produce symptoms like wheezing, asthma, hay fever or hives risk developing allergic sensitization much earlier in life than previously reported, according to a study by Cincinnati researchers.

The study suggests that the current practice of avoiding skin testing for airborne allergens before age 4 or 5 should be reconsidered, so children in this high-risk group can be detected early and monitored for the possibility of later allergic respiratory disease.

Produced by scientists in UC’s departments of environmental health and internal medicine and at Cincinnati Children’s Hospital Medical Center, the study is reported in the October 2006 edition of The Journal of Pediatrics.

The Cincinnati researchers collected data on 680 children being evaluated for enrollment in the Cincinnati Childhood Allergy and Air Pollution Study (CCAAPS), sponsored by the National Institute of Environmental Health Sciences (NIEHS), and compared their results with findings in a 2004 Swedish study.

Using the skin-prick allergy test, the Swedish group found that in their general population – which included children whose parents did not suffer from allergies – 7 percent had allergic sensitivity at age 1. The Swedes tested five allergens, two of which were food allergens.

The Cincinnati results, however, showed that 28.4 percent of infants born to “atopic” parents, defined as those with allergies, were sensitized to one or more airborne or food allergens. Eighteen percent were positive to one or more airborne allergens, and 13.7 percent were positive only to an airborne allergen.

According to UC epidemiologist Grace LeMasters, PhD, principal investigator for CCAAPS and the lead author of the report, the Cincinnati findings suggest that the potential for allergic disorders in infancy is underemphasized, “even though sensitization to allergens at younger ages has been shown to be more important than sensitization in late childhood for the development of wheezing symptoms and asthma.”

Working with LeMasters on the study were David Bernstein, MD, Jocelyn Biagini, James Lockey, MD, Patrick Ryan, Manuel Villareal, MD, all UC, and Gurjit Khurana Hershey, MD, PhD, Cincinnati Children’s.

Contact: Amanda Harper
University of Cincinnati

Serum Testosterone Associated With The Metabolic Syndrome

UroToday.com – At the recent annual meeting of the American Urological Association, Dr. Steven Kaplan of New York added to the accumulating evidence that serum testosterone (T) is associated with the Metabolic Syndrome (METS).

He reviewed 864 men (mean age 52 years) participating in 2 lipid treatment studies and observed that aging men with obesity and METS (including diabetes) have a clinically significant decrease in total T levels. The median T for obese aging men with METS was 150 ng/dl less than lean aging men who do not have METS. Further almost 70% of obese aging males with METS have serum T levels less than 400 ng/dl. Dr. Kaplan concluded that ED in diabetic obese men probably involved a hypoandrogenic component.

Editor’s note: Urologist assessing and treating ED patients need to become familiar with metabolic syndrome (central obesity, hypertension, hyperlipidemia, diabetes); these patients are not only at risk for erectile dysfunction but have significantly higher risk of symptomatic coronary heart disease. Patients presenting to our practices with metabolic syndrome should be referred to internists, endocrinologists or diabetologists. There is the very real probability that these men will suffer symptomatic coronary artery disease and the presentation with ED may be a life saver if it leads to a thorough cardiovascular evaluation and subsequent risk reduction through exercise, diet and medical management. What remains to be determined is the role of testosterone in pathogenesis of metabolic syndrome and its potential efficacy in treatment.

AUA 2006 – Abstract #692

Reviewed by UroToday.com Contributing Editor Joel Kaufman, MD

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