WFP Resumes Programs Providing Food To People With TB, HIV In Cambodia After Receiving Aid From Spain, U.S.

The World Food Program has resumed its programs providing people living with HIV and tuberculosis in Cambodia with access to food after receiving aid from Spain and the U.S., the agency said on Thursday, the AP/International Herald Tribune reports (AP/International Herald Tribune, 2/8). Thomas Keusters, country director for WFP's Cambodia office, said recently that WFP had been "forced to suspend" the programs because of funding shortages. The programs distribute food rations to 18,000 people with TB and 70,000 people with HIV. They also ensure that HIV-positive people and people with TB needing medicine are connected with food distribution points. "The sick need food first before taking medicines," Haidy Ear-Dupuy -- advocacy manager at the Phnom Penh, Cambodia, office of World Vision -- said, adding, "You cannot take medication on an empty stomach. You must maintain a balance" (Macan-Markar, Inter Press Service, 2/6). WFP in a statement on Thursday said that Spain has provided about $650,000 and that the U.S. has provided 6,100 tons of legumes, as well as 2,370 tons of vegetable oil, for a period of three years. WFP three weeks ago announced that it needed at least $10 million to run its programs in Cambodia through July (AP/International Herald Tribune, 2/8). Keusters said WFP welcomed the donations but added that more "urgent donations" are needed (Agence France-Presse, 2/8). HIV prevalence in Cambodia is 1.6%, the highest in Southeast Asia, according to Inter Press Service (Inter Press Service, 2/6).

"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.

Slow-Release Morphine Reduces Level Of Intractable Cough

Slow-release morphine helped a group of patients with long-term, treatment-resistant chronic cough reduce their daily cough score levels by 40 percent.

The research results appear in the second issue for February 2007 of the American Journal of Respiratory and Critical Care Medicine, published by the American Thoracic Society.

Alyn H. Morice, M.D., of the Department of Academic Medicine at the University of Hull and Castle Hill Hospital in East Yorkshire, United Kingdom, and six associates enrolled 27 patients with intractable cough in an eight-week, randomized, double-blind, placebo-controlled study to test the use of slow-release morphine sulfate versus a placebo on their cough. Each phase lasted four weeks.

Morphine, derived from opium, is used in medicine as an analgesic, light anesthetic or a sedative. Although opiates have been long advocated for the suppression of cough, there are few trial data to support this recommendation. In fact, prior to this research, the use of opiates in intractable chronic cough had never been studied.

"Although acute cough is benign and self-limiting, chronic persistent cough can have a devastating effect on the quality of life of sufferers," said Dr. Morice. "This research provides evidence for the use of opiates in chronic cough."

The investigators found a "rapid and highly significant reduction by 40 percent in daily cough scores was noted by patients on slow-release morphine sulfate."

Patients responded quickly to treatment starting at five milligrams twice daily. The researchers found patients benefited the most by day five of treatment, and that this response was sustained through the remainder of the four-week period. The authors noted that the rapid response to morphine was in contrast to the absence of any effect of placebo.

The 27 participants, 18 of whom were female, were recruited from a hospital cough clinic. All had endured a chronic, persistent cough for more than three months. Their average age was 55.

During each four-week interval, patients made three visits to a clinical trial center, where they filled out a quality-of-life questionnaire on the impact of chronic cough on activities of daily living. A spirometric lung test was performed at the first visit, and lung function was measured on each subsequent visit.

In addition, each participant assessed their cough severity daily, rating it from 0 to 9 on a record card. Participants could not use other cough remedies, including over-the-counter products, during the eight-week study period.

According to the authors, one-third of the participants increased their dose of morphine sulfate from 5 mg to 10 mg twice daily during the first month; 11 percent did so in the second month; and a further 22 percent joined them in the third month. By the end of the study, two-thirds of the patients had increased their dose to 10 milligrams.

"The optimum dose in the suppression of chronic cough lies between 5 and 10 mg twice daily," said Dr. Morice, who added that the most common side effects were constipation (40 percent) and drowsiness (25 percent).

The investigators believe that the risk-benefit ratio makes low-dose morphine sulfate a credible therapeutic option for patients with chronic cough who fail other specific treatments.

Founded in 1905, the American Thoracic Society is the world's leading medical association dedicated to advancing pulmonary, critical care and sleep medicine. The Society has more than 18,000 members who prevent and fight respiratory disease around the globe, through research, education, patient care and advocacy.

American Thoracic Society
61 Broadway, 4th Floor
New York, NY 10006-2755
http://www.thoracic.org
See you at ATS 2007-the 103rd International Conference, May 18-23 San Francisco, CA

Drug Reduces Unscheduled Trips To Doctor For Childhood Asthma Attacks

Young children with attacks of sporadic, recurring asthma who were treated with the prescription drug montelukast by their parents had fewer unscheduled trips to the doctor, missed less days from school or childcare, and caused their parents to take fewer days off work for their care.

Results from this multi-center, randomized, double-blind and placebo-controlled trial appear in the second issue for February 2007 of the American Journal of Respiratory and Critical Care Medicine, published by the American Thoracic Society.

Colin F. Robertson, M.D., of the Department of Respiratory Medicine at Royal Children's Hospital in Melbourne, Australia, and eight associates studied 202 children, ages 2 to 14, who were given either montelukast or placebo by their parents when needed for one year. All of the children had intermittent, doctor-diagnosed asthma.

By the end of the year-long study, the patients treated with montelukast had 163 unscheduled health resource visits for their illness, as compared with 228 in the placebo group.

"Symptoms were reduced by 14 percent, nights awakened by 8.6 percent, days off from school or childcare by 37 percent and parent time off from work by 33 percent," said Dr. Robertson.

In asthma, children's airways become chronically inflamed, with various stimuli causing episodes of airway obstruction and breathing difficulties. The disease is the most common chronic disorder of childhood and affects an estimated 6.2 million children under age 18 in the U.S.

Intermittent asthma is the most common pattern of the disease in children, accounting for attacks in 75 percent of affected youngsters.

Montelukast sodium, a specific leukotriene receptor antagonist that has been shown to be effective in children, is used to prevent mild, persistent asthma. It reduces the swelling and inflammation that tend to close airways, and relaxes the walls of the bronchial tubes, allowing more air to pass through to the lungs.

"Acute episodes of asthma in young children place a significant burden on healthcare resources," said Dr. Robertson. "Admission to the hospital for asthma in children aged 0 to 4 years is five times more common, and for those aged 5 to 14 years, twice as common as for adults who have asthma."

The study was designed to evaluate parent-initiated therapy with montelukast at the onset of each upper respiratory infection or asthma symptom. Treatment continued for a minimum of seven days or until symptoms had resolved for 24 hours.

"A key component of the study was the impact of asthma on the family, as measured by days absent from school or childcare, nights of disturbed sleep, and the number of parent days lost from work," said Dr. Robertson. "Furthermore, the strategy of parent-initiated therapy required children on average to take the study drug only 30 days per year, rather than 365, providing a further cost-benefit for the family."

The authors noted that there was no significant reduction in specialist care, hospitalizations, duration of episodes, or use of beta-agonists and prednisolone as a result of montelukast study.

An analysis of cost showed that the use of montelukast resulted in a savings of $124 Australian dollars - about $96 U.S. dollars - or 29 percent less per treated episode than the placebo controlled arm of the trial.

Founded in 1905, the American Thoracic Society is the world's leading medical association dedicated to advancing pulmonary, critical care and sleep medicine. The Society has more than 18,000 members who prevent and fight respiratory disease around the globe, through research, education, patient care and advocacy.

American Thoracic Society
61 Broadway, 4th Floor
New York, NY 10006-2755
http://www.thoracic.org
See you at ATS 2007-the 103rd International Conference, May 18-23 San Francisco, CA

Animal Testing Reduced By Soft-Cell Approach

The new in-vitro technique pioneered by Dr Amanda Hayes and her UNSW colleagues, Shahnaz Bakand and Chris Winder, directly exposes human cells to airborne toxicants and measures cytotoxic effects. The cells are grown on a porous polyester membrane inside a small diffusion chamber and then exposed to selected toxic air pollutants. After as little as one hour's exposure, they can study cell growth and metabolism, and a range of routine toxicological endpoints.

Importantly, the toxic measurements obtained by the in vitro method, such as the amount of a contaminant needed to inhibit cell growth, mirror well-established lethal values obtained from animal studies - a long-established method in toxicological studies. "In-vitro toxicity tests can improve the scientific, economic, and ethical value of research and play a significant role in the screening of toxic chemicals and the replacement of animals," Dr Hayes says.

This research earned Hayes and her colleagues the 2006 Australian Museum Voiceless Eureka Prize for Research. This prize rewards scientists for work that has reduced the use of animals or animal products in laboratory-based research, education and testing.

Many industrial and environmental air pollutants are already known to have adverse health effects on the respiratory system of workers. Increasingly, new formulations are using tiny nanoparticles and ultrafine particulates in cosmetics, pharmaceuticals and petrochemical products. Little is known about their toxicity and safety to human health but this new category of pollutants poses possible dangers, both medically and environmentally, especially if they get airborne.

Most nanoparticles have a high surface area-to-mass ratio that can make the particles very reactive or catalytic. Being so small, they may also be able to pass through cell walls in organisms, and their reactions inside the body are relatively unknown.

"These tiny new substances are the tip of a huge chemical iceberg," says Hayes, Manager of the Chemical Safety and Applied Toxicology Laboratories at the University of New South Wales.

"Worldwide, there are millions of known chemicals, of which more than 100,000 chemical compounds are in commercial use in an unknown but extremely large number of chemical mixtures.

"Continued conventional animal toxicity testing of this large number of chemicals is simply unachievable from a scientific and economic standpoint," says Dr Hayes. "It's also unethical, given that in Australia alone, more than a million dogs, cats, rabbits, sheep, cattle, pigs and mice are used each year for toxicological testing and research." This is a drop in the ocean, compared with the animal death toll in the rest of the world.

In many inhalation studies, the toxicity of airborne chemicals is tested on laboratory animals by placing them in enclosed chambers and subjecting them to increasing concentrations of the test compounds for specified times until half of the test animals are killed. One type of test commonly used where this occurs is the LD50 test, where LD stands for lethal dose.

This heavy reliance on animal data in toxicology has long been a concern of the scientific community. Predicting the biological activities of toxic chemicals in humans by using animal data always poses uncertainty due to differences between animals and humans.

In a series of published experiments, the UNSW team has demonstrated the feasibility of their in vitro technique for:

* formaldehyde, an industrial contaminant linked to human cancer;

* nitrogen dioxide, a lung irritant that causes inflammation, pulmonary oedema, and pneumonia;

* fire combustion products, including cyanide, hydrogen sulphide, and ammonia; and,

* the volatile organic compounds (VOCs) xylene and toluene, found in solvents used by the printing, painting, and petrochemical industries.

The in vitro method "opens new possibilities for toxicity testing of industrial chemicals, environmental contaminants, workplace airborne contaminants, and fire combustion products", says Dr Hayes.

The technique has several advantages over conventional tests:

* The use of human cells (as opposed to animal cells) generates data representative of direct human chemical exposure.

* A number of human cell types such as lung, skin and liver can be used to represent target organs that are more likely to be significantly exposed or affected by air pollutants. As the respiratory system is both a site of toxicity for pulmonary toxicants, and a pathway for inhaled chemicals to reach other organs, relevant airway cells and lung cells are a major focus for inhalation studies.

* The advantage of using human cell lines and cultures is that the researcher can study toxicity mechanisms at the molecular/cellular level at an earlier stage specifically for individual chemicals, depending on their site of action within the human body without using animals. For example, when assessing the toxicity of formaldehyde, which is known to have a toxic effect on the liver, liver type cells such as hepatocytes can be chosen.

* The in vitro technique is cheap and portable, so scientists can measure immediate toxicity events, rather than waiting for toxicity to be expressed as organ or organism failure many months or even years down the track from initial exposure.

* The application of in vitro methods could open new possibilities for toxicity testing of industrial chemicals, occupational and environmental contaminants, combustion products and respiratory therapeutics and lead to a better understanding of the interactions between chemical exposure and toxic effects of single chemicals and chemical mixtures.

###

Contact: Dr Amanda Hayes
University of New South Wales

Medicsight Plc Receives Canadian Medical Device Licenses For ColonCAD API And LungCAD API

MGT Capital Investments, Inc. (Amex: MGT), an investment company focused on the health care information technology sector, announced today that its subsidiary, Medicsight plc, was granted medical device licenses from the Therapeutic Products Directorate (TPD) of Health Canada to begin marketing and selling Medicsight ColonCAD API and Medicsight LungCAD API.

David Sumner, chief executive officer of Medicsight plc, commented, "We are extremely pleased to receive Canadian medical device licenses for our colon and lung CAD products. These approvals build on Medicsight's recent ColonCAR(TM) market release in the United States and Europe and expands the addressable market of our CAD products for the Company and its distribution partners."

Mr. Sumner continued, "Medicsight's ColonCAD addresses many of the difficulties faced by radiologists and has been designed to help unlock the full potential of virtual colonoscopy. Our LungCAD is designed to allow radiologists to detect and segment lung nodules at early stage, enhancing treatment options and disease management. For these reasons we believe that our products will be well received by the Canadian market and we will continue to work diligently to bring this important software to radiologists around the globe."

Medicsight's CAD products are designed to be seamlessly integrated into either 3D workstations or Picture Archiving Systems (PACS) and assist radiologists in the identification of potentially fatal lesions found in the lung and polyps found in the colon. Medicsight's CAD products are designed to improve radiologist workflow and productivity.

Medicsight ColonCAD API is an image-analysis software tool designed to be used with CT (computed tomography) colonography (virtual colonoscopy) to assist radiologists in detecting and measuring potential colorectal polyps. ColonCAD has been developed using one of the world's largest CT scan databases of verified CT colonography data.

Medicsight LungCAD API is a medical imaging software tool designed to assist radiologists in the evaluation of pulmonary nodules on CT scans of the lung. Developed using one of the world's largest and most population-diverse CT scan databases, the product aims to assist radiologists in detecting lesions in the lung, such as nodules, while providing valuable information to the radiologist to assess patient images more effectively.

About MGT Capital Investments, Inc.

MGT Capital Investments is an investment company with two direct subsidiaries that focus solely on the dynamic and consolidating HCIT sector. The first subsidiary, Medicsight plc, is a leading developer of computer-aided detection (CAD) and computer assisted reader (CAR) software solutions that are validated using one of the world's largest databases of verified CT scan data. Medicsight's CAD and CAR products help clinicians identify, measure, and analyze suspicious pathology, such as colorectal polyps and lung lesions. MGT Capital Investments has invested in and controls a second subsidiary, Medicexchange plc, which operates Medicexchange.com, an online multi-vendor sales channel for diagnostic, treatment and surgery planning solutions for cardiac, thoracic, breast imaging, orthopedic, and gastro intestinal imaging. Medicexchange.com provides these solutions in a low-cost, on-demand and downloadable format, enhancing access to information and products for medical imaging professionals. Additional information can be found at http://www.mgtci.com.

All forward-looking statements are made pursuant to the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. Forward- looking statements are based on current management expectations that involve risks and uncertainties that may result in such expectations not being realized. Potential risks and uncertainties include, but are not limited to, the risks described in company filings with the Securities and Exchange Commission.

MGT Capital Investments, Inc.
http://www.mgtci.com

Intense Cessation Treatment Proves Successful In High-Risk Smokers

Hospitalized patients who undergo structured treatment to quit smoking are significantly more likely to remain smoke-free, says a new study. New research published in the February issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians (ACCP), suggests that high-risk smokers with acute cardiovascular disease are three to four times more likely to quit smoking when treated with an intensive smoking cessation program.

"Smoking is the greatest risk factor for patients with heart disease," said author Syed M. Mohiuddin, MD, FCCP, Creighton University Cardiac Center, Omaha, NE, "and our study showed that intense treatment intervention not only succeeded in getting patients to quit smoking, but it reduced hospitalizations and mortality, as well."

From January 2001 to December 2002, Dr. Mohiuddin and colleagues gathered 209 patients who were admitted to the coronary care unit at the Creighton University Cardiac Center, suffering from unstable angina, heart attack, or severe coronary heart disease. All of the patients were self-identified smokers and agreed to undergo smoking cessation intervention. Patients were then randomized into two groups: the intensive intervention group (109) and the usual care group (100).

Prior to hospital discharge, all patients received approximately 30 minutes of counseling and were given self-help materials. Treatment in the intervention group also included a minimum 12 weeks of behavior modification counseling, coupled with individualized pharmacotherapy. This included nicotine replacement therapy and/or bupropion at no cost to the patient. However, patients in the usual care group did not receive anything beyond the initial inpatient counseling session.

"The intensive component of tobacco cessation therapy was started while patients were hospitalized but continued after release," said Dr. Mohiuddin, "making the outpatient portion of this program the most significant element."

All participants returned at 3, 6, 12, and 24 months, during which follow- up medical histories and expired carbon monoxide levels were obtained. Patients who reported having not smoked during the previous evaluation period and who were confirmed by a negative expired carbon monoxide were classified as "abstinent." Those patients who were confirmed as not smoking by their expired carbon monoxide at every visit were classified as "continuously abstinent."

Compared with the usual care group, patients in the intensive treatment group had significantly higher quit rates at all follow-up time intervals. At the two-year follow-up, 39 percent of the intensive treatment group was continuously abstinent, compared with only 9 percent of the usual care group. Additionally, treatment was shown to reduce the risk of hospitalization by nearly half. Researchers also found that those in the control group were four times as likely to die than were patients in the intervention group.

"Cessation of smoking results in an almost immediate improvement in the risk of heart attack," said Dr. Mohiuddin, "and our study proves that intense smoking cessation treatment in high-risk patients is successful and that it saves lives."

"Smoking clearly links patients with cardiovascular disease to adverse outcomes," said Mark J. Rosen, MD, FCCP, President of the American College of Chest Physicians. "It's never too late to quit smoking and all patients who smoke should work with their doctors to find the quit method that works best for them."

CHEST is a peer-reviewed journal published by the ACCP. It is available online each month at http://www.chestjournal.org. The ACCP represents 16,500 members who provide clinical respiratory, sleep, critical care, and cardiothoracic patient care in the United States and throughout the world. The ACCP's mission is to promote the prevention and treatment of diseases of the chest through leadership, education, research, and communication. For more information about the ACCP, please visit the ACCP Web site at http://www.chestnet.org.

American College of Chest Physicians
http://www.chestnet.org

Sanofi-Aventis Announces Update To U.S. Prescribing Information For Ketek(R) (Telithromycin)

Sanofi-aventis today announced that the U.S. Food and Drug Administration (FDA) has approved revisions to the US Prescribing Information for Ketek(R) (telithromycin).

These revisions follow discussions with the FDA and are based on recommendations of a FDA Joint Advisory Committee meeting of the Drug Safety and Risk Management Advisory Committee and Anti-infective Drug Advisory Committee held in December 2006. The revisions include:

- A boxed warning to alert physicians and patients that the use of the drug is contraindicated in patients with myasthenia gravis (a rare autoimmune disease),

- Updated warnings about possible visual disturbances and loss of consciousness (syncope).

- Deletion of the indications for acute exacerbation of chronic bronchitis (AECB) and acute bacterial sinusitis (ABS).

Ketek(R) remains indicated in patients with mild to moderate community- acquired pneumonia (CAP) caused by susceptible pathogens, including multidrug- resistant Streptococcus pneumoniae (MDRSP).

Ketek(R), when used as directed in its approved indication continues to be an important option in the anti-infective armamentarium and helps to satisfy a medical need.

Ketek(R) is currently approved and marketed in over 50 countries. Since its launch, it is estimated that 28 million patients have been treated with Ketek(R) worldwide.

MORE INFORMATION

In consultation with the FDA, sanofi-aventis has prepared a Medication Guide to be distributed to patients along with every prescription of Ketek. The Medication Guide communicates the rare but potentially serious adverse events associated with the use of Ketek.

In the U.S., sanofi-aventis will inform healthcare professionals about the revisions to the U.S. prescribing information through a "Dear Healthcare Professional" letter, sales force educational communications to healthcare professionals and the posting of the updated prescribing information and Medication Guide on the company and product Web sites (http://www.sanofi- aventis.us and http://www.Ketek.com).

Sanofi-aventis will also be contacting several patient organizations concerned with myasthenia gravis to ensure these parties have the most updated information regarding the label change of Ketek.

Additional information regarding the Medication Guide and update to the Ketek prescribing information can be found on the FDA Web site.

About Ketek

Ketek is contraindicated in patients with myasthenia gravis. There have been reports of fatal and life-threatening respiratory failure in patients with myasthenia gravis associated with the use of Ketek.

KETEK tablets are indicated for the treatment of community-acquired pneumonia (of mild to moderate severity) due to Streptococcus pneumoniae, (including multi-drug resistant isolates [MDRSP*]), Haemophilus influenzae, Moraxella catarrhalis, Chlamydophila pneumoniae, or Mycoplasma pneumoniae, for patients 18 years old and above.

MDRSP, Multi-drug resistant Streptococcus pneumoniae includes isolates known as PRSP (penicillin-resistant Streptococcus pneumoniae), and are isolates resistant to two or more of the following antibiotics: penicillin, 2nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole.

KETEK is contraindicated in patients with myasthenia gravis. Exacerbations of myasthenia gravis have been reported in patients and sometimes occurred within a few hours of the first dose of telithromycin. Reports have included fatal and life-threatening acute respiratory failure with a rapid onset and progression.

KETEK is contraindicated in patients with previous history of hepatitis and/or jaundice associated with the use of KETEK tablets, or any macrolide antibiotic.

KETEK is contraindicated in patients with a history of hypersensitivity to telithromycin and/or any components of KETEK tablets, or any macrolide antibiotic.

Concomitant administration of KETEK with cisapride or pimozide is contraindicated.

Acute hepatic failure and severe liver injury, in some cases fatal, have been reported in patients treated with KETEK. These hepatic reactions included fulminant hepatitis and hepatic necrosis leading to liver transplant, and were observed during or immediately after treatment. In some of these cases, liver injury progressed rapidly and occurred after administration of a few doses of KETEK.

Physicians and patients should monitor for the appearance of signs or symptoms of hepatitis, such as fatigue, malaise, anorexia, nausea, jaundice, bilirubinuria, acholic stools, liver tenderness or hepatomegaly. Patients with signs or symptoms of hepatitis must be advised to discontinue KETEK and immediately seek medical evaluation, which should include liver function tests. If clinical hepatitis or transaminase elevations combined with other systemic symptoms occur, KETEK should be permanently discontinued.

Ketek must not be re-administered to patients with a previous history of hepatitis and/or jaundice associated with the use of KETEK tablets, or any macrolide antibiotic.

In addition, less severe hepatic dysfunction associated with increased liver enzymes, hepatitis and in some cases jaundice was reported with the use of KETEK. These events associated with less severe forms of liver toxicity were reversible.

Telithromycin has the potential to prolong the QTc interval of the electrocardiogram in some patients. QTc prolongation may lead to an increased risk for ventricular arrhythmias, including torsades de pointes. Thus, telithromycin should be avoided in patients with congenital prolongation of the QTc interval, and in patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and in patients receiving Class IA (e.g., quinidine and procainamide) or Class III (e.g., dofetilide) antiarrhythmic agents.

Cases of torsades de pointes have been reported post-marketing with KETEK. In clinical trials, no cardiovascular morbidity or mortality attributable to QTc prolongation occurred with telithromycin treatment in 4780 patients in clinical trials, including 204 patients having a prolonged QTc at baseline.

KETEK may cause visual disturbances particularly in slowing the ability to accommodate and the ability to release accommodation. Visual disturbances included blurred vision, difficulty focusing, and diplopia. Most events were mild to moderate; however, severe cases have been reported.

There have been post-marketing adverse event reports of transient loss of consciousness including some cases associated with vagal syndrome.

Because of potential visual difficulties or loss of consciousness, patients should attempt to minimize activities such as driving a motor vehicle, operating heavy machinery or engaging in other hazardous activities during treatment with KETEK. If patients experience visual disorders or loss of consciousness while taking KETEK, patients should not drive a motor vehicle, operate heavy machinery or engage in other hazardous activities.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including KETEK, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C difficile, and surgical evaluation should be instituted as clinically indicated.

Therapy with simvastatin, lovastatin, or atorvastatin should be suspended during the course of KETEK treatment. Concomitant treatment of KETEK with rifampin, a CYP 3A4 inducer, should be avoided.

Most adverse events were mild to moderate and included diarrhea, nausea, headache, dizziness, and vomiting.

About sanofi-aventis

Sanofi-aventis is one of the world's leading pharmaceutical companies. 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.us

FDA Revises Label Warnings On The Antibiotic Ketek

The US Food and Drug Administration (FDA) has revised the label warnings on the antibiotic Ketek, to improve safe use by patients. Ketek is the brand name of Telithromycin and is manufactured by Sanofi-Aventis.

The FDA has removed approval of the drug for treatment of acute bacterial infections associated with sinusitis and chronic bronchitis. Ketek retains FDA approval for treatment of community acquired pneumonia of "mild to moderate severity" but it will carry a black box label, the most severe level of warning issued by the FDA.

The new label will warn that patients with the muscle weakness autoimmune disease myasthenia gravis should not take the drug. It will also carry a stronger warning about potential side effects such as "visual disturbances" and "loss of consciousness".

This is the second time that Ketek's label has changed in the last 12 months. In June last year the label was strengthened to point out the danger of hepatic toxicity ( a rare but severe symptom of liver disease).

Dr Steven Galson, Director at the Center for Drug Evaluation and Research said the "Action is the result of comprehensive scientific analysis and thoughtful public discussion of the data available for Ketek, and includes important changes in the labeling designed to improve the safe use of Ketek by patients and give healthcare providers the most up-to-date prescribing information."

A new patient information leaflet will also accompany the prescription, explaining the drug's safe use and risks.

These changes reflect the advice given out in December last year by the FDA's Anti-Infective Drugs and Drug Safety and Risk Management Advisory Committees.

The committees pointed out that since the drug was approved in April 2004, new evidence shows that the balance of risks versus benefits has changed. Much of this relates to cases of liver damage, disturbed vision and loss of consciousness.

Dr John Jenkins, Director at the FDA's Center for Drug Evaluation and Research, Office of New Drugs, said that the new benefits versus risk assessment does not support the use of Ketek for self-limited and less serious illnesses such as sinusitis and bronchitis.

But he said the drug will continue to be "approved for community-acquired pneumonia of mild to moderate severity, which is a more serious illness that generally does not resolve without antibiotic therapy."

According to reports by the Associated Press the FDA's handling of Ketek is under Senate investigation. Also, today is the day that the House of Representatives Subcommittee on Oversight and Investigations is hearing witness statements on "The Adequacy of FDA Efforts to Assure the Safety of the Drug Supply", which according to a Bloomberg press report yesterday includes "irregularities in the approval of Ketek".

The drug has a somewhat tortuous pharmacological history. A group of antiobiotics called macrolides was developed to treat people allergic to penicillin. But then some bacteria became macrolide resistant. Enter the Ketolides - developed to defeat the macrolide-resistant bacteria that cause respiratory infections.

Telithromycin (the generic name for Ketek) is a ketolide antibiotic with a similar structure to one of the macrolides - Erythromycin. It works by stopping the bacteria from being able to produce protein which limits the spread of the colony in the respiratory tract.

Telithromycin is metabolized mostly in the liver and has a half life in the body of about 10 hours.

Click here for more information on Telithromycin from the FDA.

Click here for more information on Telithromycin from wikipedia.

Written by: Catharine Paddock
Writer: Medical News Today

Survival In Asbestos-Related Cancer Improved By Chemo Combination

People with mesothelioma - a form of cancer associated with asbestos exposure - have a higher survival rate when treated with a combination of two cancer drugs, a large multicenter study finds.

Mesothelioma, a rare but aggressive form of cancer that occurs in the lining of the lungs, heart and abdomen, is associated with exposure to asbestos. There is no known cure.

In the study, patients receiving pemetrexed and cisplatin - along with the vitamin supplements folic acid and B12 - survived nearly three months longer than patients getting cisplatin alone.

Researchers led by John Green, M.D., at the Clatterbridge Center for Oncology in England, reviewed a study of 448 patients with advanced mesothelioma who were treated with either the single drug or the combination.

"Pemetrexed used in combination with cisplatin significantly increases the length of survival, when compared with cisplatin alone," the researchers say. "Further research is needed into the optimum treatment regimen for pleural mesothelioma."

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

The researchers examined data from a clinical trial of 20 treatment centers in Europe, the Americas, Australia and Asia. Eighty-one percent of the patients were men, with an average age of 61. Patients who received the combination treatment survived an average 2.8 months longer.

Patients receiving both medications also reported improved quality of life in terms of fatigue, loss of appetite, pain and cough.

During the early stages of the trial, patients receiving pemetrexed had serious symptoms of toxicity, including drug-related death. Other side effects included blood cell abnormalities, nausea and diarrhea, which decreased in both incidence and severity after the vitamins were added to the treatment. People who work trades such as shipbuilding, railway engineering, construction work and asbestos manufacture have higher rates of mesothelioma than the general public. The cancer may take 10 to 60 years to develop, and the risk does not diminish after exposure to asbestos has stopped. Family members of people exposed to asbestos at work also have an increased risk of developing mesothelioma from asbestos fibers carried home on the clothes of the people they live with.

Daniel Baram, M.D., a pulmonologist at the Lung Cancer Evaluation Center at the State University of New York, said, "Most cases [of mesothelioma] are still from pre-OSHA workplace improvements. I suspect that modern asbestos abatement precautions will avoid most, if not all, future cases. The latency is over 30 years, so we are still diagnosing cases with exposure during World War II and the '40s and '50s."

Mesothelioma is difficult to diagnose, Green said, because "there is a lag of many years between exposure and asbestosis, which is a nonmalignant condition, and a greater lag before the development of overt malignancy."

"There is no way of diagnosing the premalignant phase during the latent period of 15 to 20 years," Green added. "Many of these patients smoke and are in economically disadvantaged communities. Many individuals have moved away from heavy industries and may not admit or know they were exposed to asbestos as young men, with similar issues for their partners."

According to the U.S. Environmental Protection Agency, 10 percent to 15 percent of schools and other public buildings in the United States contain asbestos insulation.

Although safety measures for working with asbestos have been in place since the 1970s, mesothelioma is projected to account for 65,000 deaths between 2001 and 2050 worldwide, peaking between 2012 and 2015, according to background information in the review.

It is a personal matter as to whether the survival increase for patients receiving the two drugs is worthwhile, Baram said. "It depends in large part on the patient. A 2.8-month mean survival increase means that some patients may get even more than that, though some people will get less. Many, if not most, patients when faced with a disease with a very bad prognosis are often willing to undergo aggressive therapy, although the toxicity is serious and potentially life-threatening."

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By Lise Millay Stevens, Contributing Writer
Health Behavior News Service

Green J, et al. Pemetrexed disodium in combination with cisplatin versus other cytotoxic agents or supportive care for the treatment of malignant pleural mesothelioma. Cochrane Database of Systematic Reviews 2007, Issue 1.

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

New York Mayor Urges Federal Government To Pay For Sept 11 Health Care

New York Mayor Michael Bloomberg called on the US government to inject 1 billion dollars into a Sept 11 victims' compensation fund that closed in 2004. He said the City cannot afford to foot the bill for the claims that will come forward from people with health problems emerging years after the collapse of the World Trade Centre.

Bloomberg says that the City's bill for dealing with the health problems caused by Sept 11 will cost nearly 400 million dollars a year and it can't afford to do this without federal support.

A recent report commissioned by the mayor says that the city has spent over 2 billion dollars in the last five years on diagnosing and treating citizens with health issues arising out of the trade centre collapse.

He said they could not afford to provide the care that people deserved in the longer term.

He also asked for 150 million dollars a year to support people with physical and mental health problems arising directly from Sept 11.

According to the 80 page report by the World Trade Center Health Panel set up by the Mayor, over 400,000 citizens who were exposed to the toxins in the smoke and dust which lingered for weeks while the twin towers burned qualify for health monitoring. Some 71,000 of them have registered with a scheme that will monitor their health for the next 20 years.

Many of the people who fell ill had mental health and lung problems.

Following the recommendations of the Health Panel, the Mayor held a briefing at a City Hall, where he said that the federal government should as a minimum fund these essential needs and that anything less would be "turning their backs on those who responded with courage and suffering".

US Representative and Manhattan Democrat Jerrold Nadler, and New York Democrat and Senator Hillary Clinton have brought in legislation to give New York funds towards the clean up operation and for treating people with illnesses caused by the dust and toxins arising from the burning aftermath of the towers.

The Mayor said that one of the research programmes the City would establish is to track the progress of cancer and other diseases being diagnosed in uniformed and civilian first responders, including 34,000 police officers and several thousand firefighters.

Another programme would double the diagonostic and treatment capacity to 12,000 patients at Bellevue Hospital for immigrants and residents of Chinatown.

Mayor Bloomberg said if victims aren't compensated for the injuries and illnesses they suffer as a result of helping with the clear up, one might question whether people would be so willing to come forward so selflessly should another disaster occur.

He said the the first responders were "responding to an act of war against this nation," and that meant federal government had a clear responsibility to meet here.

Federal funds amounting to 20 billion dollars in the form of aid and tax concessions have been awarded for the rebuilding of the lower Manhattan area. President Bush has also allocated 25 million in his recent budget to pay for health care for emergency workers.

The World Trade Center Health Panel said the current federal plans for supporting the health care of the people affected by Sept 11 were "modest and short term". They are suggesting the focus needs to be on the longer term too.

The September 11th Fund Home Page.

Written by: Catharine Paddock
Writer: Medical News Today

Why Only Some Cystic Fibrosis Patients Respond To Treatments That Prevent The Generation Of Truncated Proteins

Individuals with the genetic lung disorder cystic fibrosis (CF) lack any functional CFTR protein because their genes that encode this protein carry a mutation. One mutation (the W1282X mutation) that results in CF does so because it causes the cellular machinery that converts the initial product of a gene (mRNA) into a functional protein to prematurely stop making CFTR protein. Agents (such as gentamicin) that enable the protein-generating machinery to ignore such mutations have shown benefit in some, but not all, CF patients with the W1282X mutation. In a study that appears online in advance of publication in the March print issue of the Journal of Clinical Investigation, researchers from The Hebrew University of Jerusalem, Israel, describe a potential molecular explanation for the distinct responsiveness of patients with Cf to treatment with gentamicin.

Batsheva Kerem and colleagues found that CF patients with the W1282X mutation who responded to treatment with gentamicin expressed more nonsense CFTR mRNA than patients who did not respond to treatment. Further analysis showed that different cell lines from CF patients with the W1282X mutation had distinct abilities to destroy nonsense mRNA. Inhibiting the destruction of nonsense mRNA in these cell lines increased the amount of nonsense CFTR mRNA present, making them more susceptible to the ability of gentamicin to induce the production of functional CFTR protein. This study suggests that the ability of an individual's affected cells to destroy nonsense mRNA determines how responsive CF patients with the W1282X mutation are likely to be to treatment with gentamicin. Such observations might also extend to other genetic disorders in which mutations causing the cellular machinery to prematurely stop making protein have been identified, such as Duchenne muscular dystrophy.

TITLE: Nonsense-mediated mRNA decay affects nonsense transcript levels and governs response of cystic fibrosis patients to gentamicin

AUTHOR CONTACT:
Batsheva Kerem
The Hebrew University of Jerusalem, Jerusalem, Israel.

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JCI table of contents -- February 8, 2006

Contact: Karen Honey
Journal of Clinical Investigation

Astrazeneca Launches A Smarter Approach To Asthma Management In Europe

AstraZeneca today announced that 37 countries to date have received approval of Symbicort® Maintenance And Reliever Therapy (Symbicort SMART®), and that a period of world wide launches will now be initiated. This new, smarter approach to asthma is the first to provide patients with both asthma maintenance and reliever therapy together in just one inhaler.

With the Symbicort SMART management approach, patients receive inhaled corticosteroid (ICS) and long acting bronchodilator (LABA) with every inhalation. Thus, with Symbicort SMART it is possible to treat the underlying inflammation with every inhalation, even when used for rapid symptom relief, making it a more effective way to manage asthma. A separate SABA (short acting bronchodilator) inhaler is therefore no longer needed. Symbicort SMART has been proven to reduce exacerbations by 39% compared with salmeterol / fluticasone combination and a separate reliever medication.1

The Symbicort SMART treatment approach is possible only because Symbicort combines two components in one inhaler: budesonide, an ICS to provide an anti-inflammatory effect in the airways, and formoterol, a unique bronchodilator that is both rapid in effect and long lasting (LABA). The other LABA available for maintenance treatment of asthma, salmeterol, does not have the properties that enables it to be used in this way. Consequently, Seretide™ (salmeterol/fluticasone) can not be used in the same way as Symbicort SMART. Patients on Symbicort SMART receive a maintenance dose in line with normal practice to establish asthma control and can then take additional inhalations 'as needed' if symptoms occur, to provide both rapid symptom relief and increased asthma control in the longer term.

"We know that patients tend to over-rely on their symptom relief inhaler when experiencing a worsening of their symptoms," comments Professor Claus Vogelmeier, Professor of Medicine and Head of Pulmonary Division, Marburg University Hospital Germany, and speaker at the official Symbicort SMART launch event in Lund. "Although patients consistently adjust their medication in response to asthma variations, often the adjustment in maintenance therapy is delayed in response to an exacerbation. With Symbicort SMART, physicians can be sure that patients are receiving their anti-inflammatory treatment with every inhalation, ensuring their asthma is better controlled."

The Symbicort SMART approach is recognised by the Global Initiative for Asthma (GINA) who recently announced revised international treatment guidelines on best practice in the prevention and treatment of asthma. The guidelines support the need for a new management approach - Symbicort SMART.2

"Previous editions of the GINA Guidelines have perhaps led to an impression that mild asthma could be equated to mild symptoms and severe asthma to severe symptoms, which we know is not the case," comments Dr Paul O'Byrne, McMaster University, Ontario, Canada and Chair of the GINA Executive Committee. "Asthma is a variable disease and the GINA Committee felt that a treatment approach based upon effective control of symptoms and exacerbations would better reflect the natural course of the disease. The result will be improved outcomes by allowing treatment to be rapidly increased when symptoms first appear and then brought back down again when control is achieved, and thus let the dosing respond quickly to the patients' asthma control status."

Symbicort SMART has been tested extensively in a wide clinical trial program involving over 14,000 patients with persistent asthma. These studies consistently show that Symbicort SMART, irrespective of asthma severity, reduces the risk of patients developing potentially life-threatening asthma attacks compared with traditional treatment approaches such as fixed dosing with either higher doses of ICS plus a short-acting bronchodilator (SABA) or with an ICS/LABA combination therapy plus a SABA. 1, 3-7

In the EU, Symbicort SMART is licensed for use in adults with a need for ICS / LABA combination treatment. National launches are expected throughout the EU over the coming months.

"We are delighted to announce the launch of Symbicort SMART in Europe," said Dr John Patterson, Executive Director, Development for AstraZeneca. "This new treatment approach will simplify asthma management and has the potential to improve the lives of a great many asthma patients. We now have a management approach that provides the reassurance of instant relief when needed and in the same breath treats the underlying disease for the long term. This is a significant step forward for asthma patients."

To date, Symbicort has been effectively and widely used as a traditional maintenance treatment for asthmatics across the world. With the advent of today's launch of Symbicort SMART, Symbicort is the first maintenance therapy to als

o be proven effective and licensed for maintenance and reliever therapy in one inhaler. AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

For further updates, news and information on Symbicort, please visit
http://www.astrazenecapressoffice.com

References

1. Kuna P, Peters MJ, Buhl R. Budesonide/formoterol as maintenance and reliever therapy reduces asthma exacerbations versus a higher maintenance dose of budesonide/formoterol or salmeterol/fluticasone. Abstract presented at the ERS Congress 2006.

2. The Global Initiative for Asthma (GINA). GINA Report, Global Strategy for Asthma Management and Prevention, published November 2006. www.ginasthma.com

3. Rabe K, Atienza T, Magyar P et al. Reduction in asthma exacerbations with budesonide in combination with formoterol for reliever therapy: a randomised, controlled, double-blind study. Lancet 2006;368: 744-53.

4. Vogelmeier C, D'Urzo A, Pauwels R, Merino JM, Jaspal M, Boutet S, Naya I, Price D. Budesonide/formoterol maintenance and reliever therapy: an effective asthma treatment option? Eur Respir J 2005; 26(5): 819-828.

5. O'Byrne P, Bisgaard H, Godard P, Pistolesi M, Palmqvist M, Zhu Y, Ekström T, Bateman E. Budesonide/Formoterol Combination Therapy as Both Maintenance and Reliever Medication in Asthma. American Journal of Respiratory and Critical Care Medicine 2005; 171(2): 129-136.

6. Scicchitano R, Aalbers R, Ukena D, Manjra A, Fouquert L, Centanni S, Boulet L-P, Naya IP, Hultquist C. Efficacy and safety of budesonide/formoterol single inhaler therapy versus a higher dose of budesonide in moderate to severe asthma. Current Medical Research and Opinion 2004;20(9):1403-18.

7. Klaus F. Rabe, Emilio Pizzichini, Björn Ställberg, Santiago Romero, Ana M. Balanzat, Tito Atienza, Per Arve Lier, and Carin Jorup, Budesonide/Formoterol in a Single Inhaler for Maintenance and Relief in Mild-to-Moderate Asthma: A Randomized, Double-Blind Trial, Chest, Feb 2006; 129: 246 - 256

Symbicort SMART -- Symbicort SMART improves daily symptom control and reduces asthma attacks while patients only need one inhaler*. A separate short-acting bronchodilator is no longer needed. Patients prescribed Symbicort SMART, take a maintenance dose of Symbicort every day in line with normal practice to establish asthma control and take additional inhalations 'as needed' of Symbicort if symptoms occur, to provide both rapid symptom relief and improved asthma control. *not indicated for prophylactic use before exercise

-- Symbicort SMART successfully completed the European Union Mutual Recognition Procedure (MRP) in October 2006

-- Symbicort SMART is currently approved in 37 countries worldwide

-- Symbicort is currently approved in more than 90 countries; sales were $585 million in the first half 2006 (up 24 percent on 2005 figures) and have now reached more than five million treatment years

-- Symbicort received FDA approval in the US in July 2006 for maintenance treatment of asthma (in patients from 12 years of age)

Asthma -- Asthma is a chronic inflammatory condition of the airways characterised by reversible airway obstruction. It is a variable condition that can change both daily and seasonally

-- Most asthma patients require maintenance treatment with an inhaled corticosteroid (ICS), which suppresses the underlying airway inflammation, and a bronchodilator, which relaxes the smooth muscle of the airways.

High Rates Of Latent TB Infection Found In Russian Health Workers

Testing for tuberculosis has revealed that nearly 40% of the doctors in one Russian city have latent infection, with even higher levels in those who work in TB clinics. The research has been published in PLoS Medicine.

TB disease is a growing problem worldwide. Russia is one country where it is particularly common. Although up to a third of the world's population are infected with the bacterium that causes the disease, in most people the infection remains 'latent'. It is important to detect latent infection in order to reduce the spread of the infection and to hold back the rise in the number of active cases. Working in Samara City in the Russian Federation, researchers from Queen Mary College, UK and colleagues in Samara, tested both health workers and students for latent TB. All the health staff, including students, were found to have higher rates of infection than other people in Samara. The 47% infection rate found in staff in TB clinics was ten times higher than that in the population at large.

The study authors say that, although more research is first needed, it may be necessary to conduct regular occupational health screening for latent infection followed by treatment where appropriate. However, even this may not be effective in controlling rates of active infection, as resistance to TB drugs is so common.

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Everything published by PLoS Medicine is Open Access: freely available for anyone to read, download, redistribute and otherwise use, as long as the authorship is properly attributed.

Note: The test used by the researchers was not the 'traditional' tuberculin skin test, as this is not reliable when used with people who were given the 'BCG' vaccination for TB early in life, which is common in Russia as in many other countries. The new 'IFN-gamma' test gave good results and the researchers recommend that it be used in further research of this kind.

Citation: Drobniewski F, Balabanova Y, Zakamova E, Nikolayevskyy V, Fedorin I (2007) Rates of latent tuberculosis in health care staff in Russia. PLoS Med 4(2): e55.

PLEASE ADD THE LINK TO THE PUBLISHED ARTICLE IN ONLINE VERSIONS OF YOUR REPORT

CONTACT:

Francis Drobniewski
Barts and the London School of Medicine and Dentistry
Queen Mary College
University of London
2 Newark Street
London, E1 2AT United Kingdom

Contact: Andrew Hyde
Public Library of Science

Ethiopians With TB Must Overcome Barriers To Complete Treatment

One in five Ethiopians treated for tuberculosis fails to complete the length course of drugs required, according to a study by Ethiopian and Norwegian researchers, published in PLoS Medicine. The research has made clear some of the difficulties that patients must overcome in order to succeed in completing a course of treatment. People who cannot easily travel to a treatment centre are the most likely to 'default'.

Tuberculosis is one of the world's leading causes of death and the number of cases is increasing. Ethiopia is one of the worst affected countries. The treatment recommended by the World Health Organization (WHO) can be very effective for most patients but it does involve taking drugs for at least six months. Patients may find it difficult to complete the full treatment, although it helps to have a system where trained observers help make sure that each patient takes all the necessary pills. WHO promotes this approach - known as DOTS (directly observed treatment short course) - and says national programs should aim for a treatment completion rate of at least 85%. Ethiopia was already known to have made good progress towards this goal during the 1990s. However, the researchers wanted to know why those people still not completing treatment were failing to do so.

They studied over 400 patients diagnosed and registered for treatment in a hospital in Hossana Hospital in southern Ethiopia over a two-year period. Using questionnaires they recorded information about the patients' circumstances. They recorded who completed or failed to complete treatment and analysed their data to determine which factors were most closely associated with failure to complete.

The overall completion rate was 80% (i.e. 20% failed to complete), still some way short of the WHO target. The patients who needed to use public transport, which is expensive for many Ethiopians, in order to reach a treatment centre were the most likely to fail to complete. This was despite the fact most of the patients in the study lived in less remote areas than the majority of southern Ethiopians. Other factors were also noted; for example people aged over 25 were less likely to finish their treatment.

The researchers concluded that it will be necessary for the Ethiopian government to continue to expand its efforts to improve access to treatment centres for patients with TB.

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Everything published by PLoS Medicine is Open Access: freely available for anyone to read, download, redistribute and otherwise use, as long as the authorship is properly attributed.

Citation: Shargie EB, LindtjГёrn B (2007) Determinants of treatment adherence among smear-positive pulmonary tuberculosis patients in southern Ethiopia. PLoS Med 4(2): e37.

PLEASE ADD THE LINK TO THE PUBLISHED ARTICLE IN ONLINE VERSIONS OF YOUR REPORT

CONTACT:

Estifanos Shargie
Centre for International Health,
University of Bergen
Bergen, Norway

About PLoS Medicine

PLoS Medicine is an open access, freely available international medical journal. It publishes original research that enhances our understanding of human health and disease, together with commentary and analysis of important global health issues. For more information, visit http://www.plosmedicine.org/

About the Public Library of Science

The Public Library of Science (PLoS) is a non-profit organization of scientists and physicians committed to making the world's scientific and medical literature a freely available public resource. For more information, visit http://www.plos.org/

Contact: Andrew Hyde
Public Library of Science

Spray Drying Technique Created For TB Vaccine

Bioengineers and public health researchers have developed a novel spray drying method for preserving and delivering the most common tuberculosis (TB) vaccine. The low-cost and scaleable technique offers several potential advantages over conventional freezing procedures, such as greater stability at room temperature and use in needle-free delivery. The spray drying process could one day provide a better approach for vaccination against TB and help prevent the related spread of HIV/AIDS in the developing world.

The research team led by Yun-Ling Wong, a graduate researcher in bioengineering, and David Edwards, Gordon McKay Professor of the Practice of Biomedical Engineering, both at the Harvard School of Engineering and Applied Sciences, and Barry R. Bloom, Dean of the Harvard School of Public Health and Joan L. and Julius H. Jacobson Professor of Public Health, was sponsored in part by the Bill and Melinda Gates Foundation. The work appeared in the February 13 edition of the Proceedings of the National Academy of Sciences.

"With the increasing incidence of tuberculosis and drug resistant disease in developing countries due to HIV/AIDS, there is a need for vaccines that are more effective than the present Bacillus Calmette-GuГ©rin (BCG) vaccine," said Wong. "An optimal new vaccine would obviate needle injection, not require refrigerated storage, and provide a safe and more consistent degree of protection."

BCG, while the most widely administered childhood vaccine in the world, with 100 million infant administrations annually, is presently dried by freezing - or lyophilization - and delivered by needle injection. The commercial formulation requires refrigerated storage and has shown variable degrees of protection against tuberculosis in different parts of the world. Because of such limitations, public health experts and physicians have long seen a need for alternatives to the traditional BCG vaccine and current treatment strategies.

"The breakthrough for developing the spray drying process involved removing salts and cryoprotectants like glycerol from bacterial suspensions," explains Edwards. "This is counter to conventional thinking: that bacteria be dried in the presence of salts and cryoprotectants. While these substances are generally required for normal storage and freezing protocols, in the case of evaporative drying as occurs in spray drying, salt and cryoprotectants act like knives that press on the bacterial membrane with great force and inactivate the bacteria. By removing these, we managed to save the bacteria and achieve better stability."

The spray drying process developed for the BCG vaccine is similar to the way manufacturers prepare powdered milk. In fact, Edwards' first exposure to the spray drying process occurred when he was working with a spray dryer to produce highly respirable drug aerosols in a food science lab. While spray drying of small and large molecules is common in the food, cosmetic and pharmaceutical industries, the method has not been commonly used for drying cellular material. Most important, the new technique enables the BCG vaccine, and potentially other bacterial and viral based vaccines, to be dried without the traditional problems associated with standard freezing.

"Unlike traditional freezing techniques, spray drying is lower cost, easily scaleable for manufacturing, and ideal for use in aerosol (needle free) formulations, such as inhalation," says Wong. "Its greater stability at room temperature and viability ultimately could provide a more practical approach for creating and delivering a vaccine throughout the world."

Edwards, an international leader in aerosol drug and vaccine delivery, sees great promise for the advance, which he and his colleagues hope to develop in the next few years for better vaccination approaches for diseases of poverty through the international not-for-profit Medicine in Need (Mend), based in Cambridge, Paris, and Cape Town, South Africa.

"With the emergence of multidrug and extremely drug resistant TB, we hope this breakthrough is one more step to help us develop a stable vaccine to stem the tide of disease," says Bloom. "Better vaccination against TB can go a long way to addressing the current developing world health care crisis, with TB alone presently taking the lives of more than 2 million people a year. And we believe this method could also be used to improve delivery of many other vaccines."

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Wong, Edwards, and Bloom's co-authors included Samantha Sampson and Sunali Goonesekera (Harvard School of Public Health); Willem Andreas Germishuizen (Harvard School of Engineering and Applied Sciences); Giovanni Caponetti (Eratech), Jerry Sadoff (Aeras Global TB Vaccine Foundation). The work was supported by a Grand Challenge Grant from the Bill and Melinda Gates Foundation and with a grant from the National Institutes of Health.

Contact: Michael Patrick Rutter
Harvard University

Statement On The Passing Of Congressman Charlie Norwood (R-GA), By John Kirkwood, American Lung Association President & CEO

The American Lung Association's volunteers and staff wish to express our deepest condolences to family of U.S. Congressman Charlie Norwood, DDS (R-GA), who died today after a long battle with idiopathic pulmonary fibrosis and lung cancer. A long-time champion for all patients, Representative Norwood inspired lung disease patients across the country when he returned to Congress following his lung transplant in 2004. American Lung Association staff and volunteers fondly remember Representative Norwood's keynote speech to our national conference in May 2002.

Idiopathic pulmonary fibrosis is a form of interstitial lung disease. When a person has idiopathic pulmonary fibrosis, the lung is affected in three ways. First, the lung tissue is damaged in some known or unknown way. Second, the walls of the air sacs in the lung become inflamed. Finally, scarring (or fibrosis) begins in the interstitium (or tissue between the air sacs), and the lung becomes stiff. The American Lung Association supports an array of research into the basic cellular and molecular processes that underlie the inflammatory response in the lungs that precedes pulmonary fibrosis. Our researchers are also examining new ways to prevent the lung scarring that follows this type of inflammation and are looking for new treatments for lungs damaged excess scar tissue formation.

Lung cancer is the number one cancer killer in the U.S., and the American Lung Association is committed to funding vital research to help fight this devastating disease including our Lung Cancer Discovery Award which is specifically directed at developing improved treatments. Lung cancer may also be the most tragic cancer because in most cases, it might have been prevented. Nearly 90 percent of lung cancer cases are caused by smoking. The more time and amount you smoke, the greater your risk of lung cancer. But if you stop smoking, the risk of lung cancer decreases each year as normal cells replace abnormal cells.

About the American Lung Association

Beginning our second century, the American Lung Association is the leading organization working to prevent lung disease and promote lung health. Lung disease death rates continue to increase while other leading causes of death have declined. The American Lung Association funds vital research on the causes of and treatments for lung disease. With the generous support of the public, the American Lung Association is "Improving life, one breath at a time." For more information about the American Lung Association or to support the work it does, call 1-800-LUNG-USA ( 1-800-586-4872) or log on to http://www.lungusa.org.

EPA Rule Slashes Toxics From Gasoline, Vehicles, And Portable Fuel Containers - USA

Toxic fumes from gasoline, vehicles and fuel containers will decrease significantly, further reducing health risks under tough new standards signed today by EPA Administrator Stephen L. Johnson. By 2030, EPA's new Mobile Source Air Toxic (MSAT) regulations and fuel and vehicle standards already in place will reduce toxic emissions from cars to 80 percent below 1999 emissions.

"Americans love their cars. By clearing the air from tons of fuel and exhaust pollution, President Bush and EPA are paving the road toward healthier drivers and a cleaner environment," said EPA Administrator Stephen L. Johnson.

The MSAT rule toughens benzene standards for gasoline, sets hydrocarbon emissions standards for cars at cold temperatures and tightens fuel containers to prevent the evaporation of harmful fumes.

Once the new standards are fully implemented in 2030, they are expected to reduce emissions of mobile source air toxics annually by 330,000 tons, including 61,000 tons of benzene. EPA estimates annual health benefits from the particulate matter reductions of the vehicle standards to total $6 billion in 2030. The estimated annual cost for the entire rule is about $400 million in 2030.

The new MSAT standards will take effect in 2011 for gasoline, 2010 for cars, and 2009 for fuel containers.

Click here for a copy of this final rule

http://yosemite.epa.gov

Respiratory Research About To Experience Influx Of Talented Young Scientists, UK

The field of respiratory research is about to experience an influx of talented young scientists. Twenty-one PhD students will soon begin research projects that address the role of factors as diverse as fungi, viral infection, immune system reactions and the influence of maternal diet on the serious respiratory disorders asthma, chronic obstructive pulmonary disease (COPD) and other conditions.

The research awards have been made in response to the growing number of people in the UK who suffer from respiratory disease. The medical research charities Asthma UK, the British Lung Foundation and the British Thoracic Society (with the Morriston Davies Trust) have joined together with the Medical Research Council to fund the studentships.

They hope that by encouraging young scientists to study conditions that affect the respiratory system, there will be a greater capacity to develop treatments and knowledge of these illnesses in the future.

The funding collaboration was prompted by the report of a workshop attended by clinicians, scientists, research charities and other research funders in October 2005. The report reviewed the current standing and future of respiratory medicine research in the UK.

Professor Stephen Holgate, Chair of the UK Respiratory Research Strategy Committee, said: "More and more people in the UK are becoming ill as a result of respiratory conditions. Two major disease areas, lung cancer and lung fibrosis, were still under-represented in the research applications but this simply highlights why it is so important that we encourage young scientists to begin their careers in respiratory research, build their knowledge and find out more about how and why these conditions are on the rise so that we can offer effective treatments in the future. All of the funding partners believe the collaboration is a fantastic opportunity to strengthen respiratory research."

Twelve awards will be available in 2007 and a further nine in 2008. Students all over the UK will carry out a three or four year research project and receive training in research methods and key personal skills. The first awards have been made to scientists in Aberdeen, Edinburgh, Southampton, Manchester, Nottingham, Leicester, Glasgow, Leeds, Sheffield and London.

http://www.asthma.org.uk

Hospital Performance Measures May Not Accurately Reflect Quality Of Care Or Predict Patient Outcomes

A comparison of hospitals with high and low Medicare performance measures found little difference in the rate of death for three common conditions at the hospitals, indicating that the measures may not accurately reflect patient outcomes, according to a study in the December 13 issue of JAMA.

In the United States, quality of care delivered in hospitals is often variable. Because it is assumed that measuring quality of care is a key component in improving care, quality measurement has an increasingly prominent role in quality improvement, according to background information in the article. These measures can provide an incentive to improve the quality of the care delivered and to influence consumer choice of hospitals and health care plans. While some research has documented an association between higher adherence to care guidelines and better outcomes of patients who receive that care, to date there has been limited evidence demonstrating that hospitals that perform better on process measures also have better overall quality.

Rachel M. Werner, M.D., Ph.D., of the Philadelphia Veterans Affairs Medical Center, Philadelphia, and Eric T. Bradlow, Ph.D., of the University of Pennsylvania, Philadelphia, conducted a study to determine whether certain quality measures are correlated with and predictive of hospitals' risk-adjusted death rates. The researchers analyzed data from Hospital Compare, a website of the Centers for Medicare & Medicaid Services (CMS) that reports results of hospital performance measures. This study included data on hospital care between Jan. 1 and Dec. 31, 2004, for heart attack, heart failure, and pneumonia at acute care hospitals included on the Hospital Compare website. Ten process performance measures were compared with hospital risk-adjusted death rates, which were measured using Medicare Part A claims data. A total of 3,657 acute care hospitals were included in the study based on their performance reported in Hospital Compare.

Across all heart attack performance measures, the absolute reduction in risk-adjusted death rates between hospitals performing in the 25th percentile vs. those performing in the 75th percentile was 0.005 for inpatient death, 0.006 for 30-day death, and 0.012 for death at 1-year. For the heart failure performance measures, the absolute death reduction was smaller, ranging from 0.001 for inpatient death to 0.002 for 1-year death. For the pneumonia performance measures, the absolute reduction in death ranged from 0.001 for 30-day death to 0.005 for inpatient death.

"Our study suggests that in the case of hospital performance, the CMS's current set of performance measures are not tightly linked to patient outcomes. These findings should not undermine current efforts to improve health care quality through performance measurement and reporting. However, attention should be focused on finding measures of health care quality that are more tightly linked to patient outcomes. Only then will performance measurement live up to expectations for improving health care quality," the authors conclude.

(JAMA. 2006;296:2694-2702.)

Dr. Werner was supported by a career development award from the Department of Veterans Affairs. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Commentary: Performance Measures and Clinical Outcomes

In an accompanying commentary, Susan D. Horn, Ph.D., of the Institute for Clinical Outcomes Research, Salt Lake City, discusses the findings concerning hospital performance measures.

Dr. Horn notes, "The results of this study raise questions about the appropriateness of using Hospital Compare performance measures as the basis either for pay-for-performance systems or for consumers to identify better-quality hospitals. If performance measures are not strongly associated with better outcomes, why should clinicians and health care centers be required to collect and submit the data, and why would payers and consumers want to act on them""

"As the study by Werner and Bradlow illustrates, current simplistic process measures based on randomized controlled trials (RCTs) do not necessarily provide a meaningful basis for consumers to choose one clinician or hospital over another, or for clinicians or hospitals to improve their outcomes. In the real world where multiple clinical variables and patient factors affect outcomes, RCTs and comprehensive observational studies both have a role to play in improving patient care: the effects of RCTs in clinical practice can be examined in observational studies and observational studies can be progenitors [originators] for new RCTs. Patients, physicians, and policymakers will all benefit from efforts to evaluate rigorously and further understand the relationship between performance measures and clinical outcomes."

(JAMA. 2006;296:2731-2732.)

Dr. Horn reports that she in an employee, officer, shareholder, and founder of International Severity Information Systems Inc., which provides products and services to facilitate studies on practice-based evidence for clinical improvement.

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Contact: Judi Cheary
JAMA and Archives Journals

FDA Approves Cyanokit(R) For Treatment Of Cyanide Poisoning

EMD Pharmaceuticals and Dey, LP, U.S. Affiliates of Merck KGaA of Darmstadt, Germany, jointly announced today that the U.S. Food and Drug Administration (FDA) has approved Cyanokit(R) (hydroxocobalamin for injection), for the treatment of known or suspected cyanide poisoning.

EMD Pharmaceuticals completed the submission of a New Drug Application (NDA) for Cyanokit(R) (hydroxocobalamin for injection) to the FDA in June of 2006. Dey, LP is located in Napa, CA and will market Cyanokit in the US market. Dey, LP expects Cyanokit to be available early in 2007.

Cyanokit's unique mechanism of action makes possible its use in a pre- hospital or hospital setting. It is the first cyanide antidote to be approved in the United States in several decades.

In the U.S., cyanide poisoning is primarily caused by smoke inhalation during closed space structural fires. Additional causes may include accidental or intentional ingestion or exposure during industrial accidents or a terrorist attack involving cyanide.

"We are very pleased with the FDA's decision to approve Cyanokit," said Christy Taylor, Senior Vice President of Marketing, Sales and Business Development for Dey, LP. "Treating cyanide poisoning as soon as possible after exposure is critical to survival. Emergency responders will now have a way to treat people for cyanide poisoning immediately at the scene of a fire, accident or other emergency as well as in the emergency department of a hospital. We anticipate that the availability of Cyanokit will have a significant impact on the survival of those who are affected by cyanide poisoning."

Cyanokit Exhibited Positive Safety, Efficacy Profiles

The FDA approval is supported by efficacy studies in animals and safety studies in healthy adults. These studies demonstrated that Cyanokit is safe and effective in treating cyanide poisoning from smoke inhalation and other causes.

At the American College of Emergency Physicians 2005 Research Forum, investigators Frederic Baud, MD, Medical and Toxicological Critical Care Department, Lariboisiere Hospital, Paris, France and Stephen W. Borron, MD, FACEP of The University of Texas Health Science Center at San Antonio presented the results of several studies including a prospective open-label study(1) carried out in 69 subjects who had been exposed to smoke inhalation from fires. Subjects were over 15 years of age, presented with soot in the mouth or nose and expectoration, and had altered neurological status. The median Cyanokit dose was 5.0 g with a range from 4.0 to 15.0 g.

Fifty of 69 patients, or 73 percent of subjects, survived following treatment with Cyanokit and supportive care. Of the 19 subjects who did not survive, 13 subjects were in initial cardiac arrest at the scene.

Of the 42 subjects with pretreatment cyanide levels considered to be potentially toxic, 28 (67 percent) survived. Of the 19 subjects whose pretreatment cyanide levels were considered potentially lethal, 11 (58 percent) survived. Of the 50 subjects who survived, 9 subjects (18 percent) experienced long-term neurologic effects from cyanide poisoning at hospital discharge.

A study of 136 healthy adult subjects(2) also was conducted to assess the safety, tolerability, and pharmacokinetics of Cyanokit. Side effects observed with Cyanokit were generally transient and self-limiting. The most frequently occurring adverse reactions were injection site reactions; skin rash; chromaturia (urine discoloration), which was reported in all subjects receiving 5.0 g Cyanokit or greater; and erythema (skin redness), which occurred in most subjects receiving 5.0 g Cyanokit or greater. Elevations in blood pressure were observed in some subjects, generally returning to normal within a few hours after administration. People with known hypersensitivity to hydroxocobalamin and /or Vitamin B12 should not be administered Cyanokit.

"These results show that Cyanokit is safe and effective in treating cyanide poisoning, even in patients with potentially lethal concentrations of cyanide in the blood," says Dr. Stephen W. Borron, one of medical advisors to the safety study. "In addition, the side effects experienced by patients were modest and temporary; no severe adverse events related to Cyanokit treatment were observed. These characteristics of a cyanide antidote are very important in an emergent situation requiring rapid, life-saving treatment."

Smoke Inhalation and Cyanide Poisoning

Fire smoke is a common source of cyanide exposure. Cyanide may be produced by the pyrolysis (incomplete burning) of common synthetic or plastic materials as well as from natural materials such as wood, paper and silk. Cyanide is increasingly recognized as a common and dangerous component of fire smoke, adding to the effects of carbon monoxide as a fire smoke toxicant. In fact, cyanide poisoning and carbon monoxide poisoning most often occur together during a fire. Prompt recognition and treatment of cyanide poisoning with an antidote can save lives.

Cyanokit has been used in France for over 10 years in both pre-hospital and hospital settings to treat cyanide poisoning resulting from smoke inhalation, ingestion and other causes. Although recognized in Europe for many years, only recently has the risk of cyanide exposure in fire smoke gained recognition in the U.S. The U.S. maintains one of the highest fire- related death rates of industrialized countries even though the number of fires has steadily decreased over the past two decades. Smoke inhalation is responsible for up to 80 percent of U.S. fire-related injuries and deaths. According to the United States Fire Administration (USFA), in 2004, the most recent year for which statistics are available:

-- 3,900 civilians and 117 firefighters lost their lives in fires, with an additional 17,785 civilians injured as the result of fire

-- Of all civilian fire-related deaths, 83 percent of them occurred in residences

-- An estimated 20,800 residential structure fires are attributed to mattresses, pillows, and bedding materials, all of which are highly likely to contain synthetic materials that release hydrogen cyanide when they smolder

Cyanide is highly toxic by all routes of exposure and may result in rapid onset of serious effects on the nervous, cardiovascular, and respiratory systems, leading to death within minutes to hours. Exposure to lower concentrations of cyanide may produce headache, confusion, nausea, and vomiting followed in some cases by coma and death. The presence and extent of cyanide poisoning are often initially unknown.

There is no widely available, rapid, confirmatory cyanide blood test. Treatment decisions must be made on the basis of clinical history and/or signs and symptoms of cyanide intoxication. If clinical suspicion of cyanide poisoning is high, Cyanokit should be administered without delay.

About Cyanokit

The active ingredient in Cyanokit, hydroxocobalamin, is a precursor of vitamin B12. Hydroxocobalamin works by binding directly to the cyanide ions, creating cyanocobalamin, a natural form of vitamin B12, which is excreted in the urine. Advantages of this approach are that methemoglobin is not produced and the oxygen-carrying capacity of the victim's blood is not lowered. Therefore, Cyanokit is suitable for use in smoke inhalation victims. The most common side effects seen in clinical trials of hydroxocobalamin are: injection site redness; temporary discoloration of the skin, urine and mucous membranes; and transient elevations in blood pressure.

The initial dose of Cyanokit for adults is 5.0 g, (2 vials) administered by intravenous infusion. Depending upon the severity of the poisoning and the clinical response, a second dose of 5.0 g may be administered up to a total dose of 10.0 g.

Cyanokit has been approved for marketing in France (marketed under the same name by Merck Sante s.a.s.) since 1996 for the treatment of cyanide poisoning.

For full prescribing information, please contact 1-800-429-7751 or visit http://www.dey.com.

About EMD Pharmaceuticals, Inc.

A U.S. Affiliate of Merck KGaA of Darmstadt, Germany, EMD Pharmaceuticals is a specialty pharmaceutical company with a focus on clinical development, regulatory affairs, and business development in support of providing targeted therapies for cancer treatment and other specialty areas, including central nervous system disorders and cyanide poisoning. EMD is headquartered in Durham, N.C. Additional information about EMD is available at http://www.emdpharmaceuticals.com.

About Dey, LP.

A U.S. Affiliate of Merck KGaA of Darmstadt, Germany, DEY, L.P. develops, manufactures, and markets innovative airway, allergy and emergency medications that save and improve lives. The Company puts "patients first" through integrated healthcare delivery solutions, and facilitates efficient, cost- effective partnerships with its customers. DEY is committed to investing in its employees and the communities in which they live. Additional information about Dey, LP is available at http://www.dey.com.

(1) Borron SW et al. "Hydroxocobalamin for Empiric Treatment of Smoke Inhalation-Associated Cyanide Poisoning: Results of a Prospective Study in the Prehosptial Setting" poster presentation presented at the American College of Emergency Physicians 2005 Research Forum.

(2) Uhl W. "Hemodynamic Effects of Hydroxocobalamin in Healthy Volunteers" poster presentation presented at the American College of Emergency Physicians 2006 Research Forum.

EMD Pharmaceuticals; Dey, LP
http://www.emdpharmaceuticals.com

DNA Damage Might Be Caused By Underground Air

Our everyday environments are full of airborne particles that are harmful to varying degrees when inhaled. Particularly damaging to our cellular DNA are the particles from the underground system in Stockholm, Sweden, according to a new doctoral thesis from Karolinska Institutet.

"Luckily, most of them do not remain in the underground for any length of time," says scientist Hanna Karlsson. "However, particle levels are often very high. My results show that there is every reason to speed up the work being done to clean the air in the underground."

Every year, some 5,300 Swedes die premature deaths from inhaling the microscopic particles of coal, asphalt, iron and other materials that pollute the city’s air. These particles, which are the result of incomplete combustion, road surface attrition, etc. could be reduced if the right steps were taken; the problem is that it is not known which particle sources pose the greatest threat to human health.

To build up a picture of which particles are the most harmful, Dr Karlsson has compared how particles from a variety of sources affect cultured lung cells. The results, which are presented in her thesis Particularly harmful particles show that particles from the Stockholm underground are much more damaging to cellular DNA than the other sources tested (e.g. wood smoke and cars).

The airborne particles in the underground system largely comprise iron, and are formed by the abrasion of the train wheels against the rails. The damage is caused when these particles enter the body and form free radicals in the body’s cells. Free radicals are highly reactive molecules that can prove harmful to the cell’s DNA; although such damage can often be repaired by the cell, it can sometime remains untreated, and this increases the risk of cancer.

Another type of particle that stood out in the studies was that caused by the friction between car tyres and the road surface. The report shows that these particles trigger a powerful inflammatory response (i.e. a general defence reaction in the body). Levels of these particles are particularly high in the spring, when road surfaces dry out and cars are still fitted with studded winter tyres.

"It’s a serious problem, as these particles exist in large concentrations in environments that people remain in for long periods," says Dr Karlsson.

Apart from particles from the underground and the roads, the study also examined those released by the combustion of wood, pellets and diesel. None of the other types of particle tested were totally harmless. Modern wood- and pellet-burning boilers gave off much fewer emissions than old ones, but the particles produced were no less harmful.

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Thesis: "Particularly harmful particles" - A study of airborne particles with a focus on genotoxicity and oxidative stress" by Hanna Karlsson, Department of Bioscience and Nutrition, KI.

For further information, please contact:
PhD Hanna Karlsson

Contact: Katarina Sternudd
Karolinska Institutet

Researchers Barcode DNA Of Vast Fungi Collection

In the storerooms of a Venice, Italy, museum, a University of California, Berkeley, scholar and Italian experts are at work on a rare collection, but the objects aren't Renaissance paintings or the art of ancient glassblowers. Instead, the team is collecting samples from the largest and best preserved collection of fungi in Italy to create an unprecedented DNA database.

These 28,000 samples of fungi that represent 6,000 species - many of which are quite rare - are housed at the Venice Museum of Natural History, a partner with UC Berkeley for this ambitious project. The collection also is one of the largest in Europe.

The project was publicly announced in Italy at the prestigious Venetian Institute of Sciences, Letters and Arts.

"We are building up a huge molecular database that will be available to the entire scientific community," said Matteo Garbelotto, UC Berkeley adjunct associate professor of ecosystem sciences and principal investigator of the project. "In addition to aiding research on the productivity of forests and agricultural ecosystems, this database will greatly aid the diagnosis of plant diseases."

Fungi are a kingdom of organisms that include yeasts, mushrooms and mold. They are essential to most terrestrial ecosystems, channeling nutrients in the soil and making them available for the growth of plants, including trees and agricultural crops. "Without fungi, there would be no forests," Garbelotto pointed out.

A large number of fungi are also plant pathogens and cause serious diseases of crops and trees, especially when transported to new areas of the world through the global trade of goods and movement of people. In addition, some species of fungi can lead to human illness, including pneumonia, skin infections, allergies and asthma.

Garbelotto is perhaps best known for his work in the identification of Phytophthora ramorum, the fungus-like plant pathogen that made its way from Europe to the United States. The pathogen is responsible for sudden oak death, the disease that has caused widespread dieback of tanoaks and coast live oaks in California and southwest Oregon.

"In the case of exotic plant diseases, DNA information may be used, as it is in criminal forensics, to identify possible culprits and to understand how they were introduced," said Garbelotto. "This provides governments with pivotal information needed to avoid repeated introductions of pathogens."

Garbelotto is working with Italian mycologist Giovanni Robich and Luca Mizzan, curator of Marine Biology at the Venice Museum of Natural History, to sort through the samples in the museum, which are being sent to Garbelotto's lab at UC Berkeley for DNA sequencing and analysis.

The Venice Natural History Museum is part of the Musei Civici Veneziani, a network of 11 museums in Venice. It is housed in the Fontego dei Turchi, a Byzantine-style palace on the Grand Canal that dates back to the 12th century. Before it was established as a museum in 1923, it had served as a trading depot for Turkish merchants.

"Often museums are seen as places where people just go and see things," said Garbelotto, who is doing this work during a sabbatical leave from UC Berkeley. "This shows that museums are actually involved in cutting-edge research. Providing a database of this scope is pretty novel."

Museum curator Mizzan said the museum's vast collection of fungi got a kick start when the Venice Society of Mycology formed in the late 1980s to monitor the mycological flora in the Lagoon of Venice and surrounding areas. The collected samples represented over 1,200 species of fungi and formed the foundation of the museum's present collection.

Garbelotto noted that the relatively young age of the samples has been critical to obtaining good quality tissue for DNA analysis. The samples come from throughout Europe, with a significant number representing species found elsewhere in the world.

Rather than sequencing the entire genome of each species, the researchers are focusing on a non-coding region of the ribosomal DNA that is known to be unique in each species. The length of the region varies from around 450 base pairs to 900 base pairs, depending upon the taxa from which it is sampled.

"If you're going to cross-compare species, you've got to amplify the same region," said Sarah Bergemann, the post-doctoral researcher in ecosystem science who is heading the lab analysis work at UC Berkeley. Bergemann is working with Amy Smith, staff research associate at Garbelotto's lab, to process the samples Garbelotto sends from Italy.

"This will be important for people who study the evolutionary characteristics of fungi," said Bergemann. "They'll be able to use our database for cross comparisons. It's also useful for people who study species distribution. For example, if you want to figure out how some species are related to one another, and you know something about their taxonomy, you can go back to their DNA to see if the morphological characteristics match their molecular code."

Without the DNA fingerprint, researchers traditionally need to wait for fungi to fruit or mushroom to identify them. "This can be very limiting because mushrooms are only produced seasonally, with some species only fruiting once every several years," said Garbelotto. "The database we are creating will allow people to identify the fungi present in plants, in the soil and in the air at any time."

The project, which began in April, is expected to be completed by the end of 2007. "We do not know of any similar project in Europe, at least of this dimension," said Enrico Ratti, the museum's scientific director.

"The importance of this project is in the cooperation between different subjects, namely private collectors, a private association, a public municipal museum and a foreign university," said Giandomenico Romanelli, director of the Musei Civici Veneziani. "We think that this is an exemplar model, to be followed in subsequent projects. Furthermore, in our philosophy, natural science collections are public goods that everybody belonging to the scientific community should be able to take advantage of."

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Contact: Sarah Yang
University of California - Berkeley