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