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February 12 – February 19

Feb 13th: New Images Capture Virus injecting its genetic material into a host cell

Fifty years after MIT researchers pioneered the use of electron microscopy to study viruses, MIT scientists have helped produce the most detailed images yet of the tiny infectious agents.

The images show for the first time a virus poised to inject its genetic material into a host cell. The researchers, led by Wen Jiang and Wah Chiu of the National Center for Macromolecular Imaging at Baylor College of Medicine, focused on viruses that infect bacteria, known as bacteriophages. Their paper diagrams the structure of a virus that infects Salmonella bacteria.

The photographs clearly show a long coil of DNA dangling inside the viral shell, waiting to be ejected via a protein channel just inside the shell exterior. To create the detailed images, the researchers photographed about 15,000 virus particles and ran them through a complex computer program that compared the photographs and constructed a 3-D model based on common features shared by the images. Funding for the imaging project was provided by the National Institutes of Health and the Robert Welch Foundation. The electron microscope images were taken at the National Center for Macromolecular Imaging at Baylor College of Medicine.

Feb 15th: Boston Scientific Announces Reimbursement of Taxus™ Liberté™ Stent System by French Government

Boston Scientific Corporation (NYSE: BSX) announced today that it has received reimbursement approval from the French government for its TAXUS™ Liberté™ paclitaxel-eluting coronary stent system - the world's first second-generation drug-eluting stent system. As a result of this announcement, the TAXUS™ Liberté™ Stent system will be available from the 27th of February to patients with coronary artery disease treated in private and public hospitals throughout France.
Until now, French patients suffering from coronary artery disease were being denied the TAXUS Liberté Stent system due to the lack of reimbursement
The TAXUS™ Liberté™ Stent system is the world's first second-generation drug-eluting coronary stent system to incorporate a next-generation stent platform. It is specifically designed for drug delivery and received CE mark approval in September 2005. Boston Scientific has a long heritage of excellence in drug-eluting stents supported by a wealth of clinical trial data proving safety and efficacy of the TAXUS™ Stent system. Recent results from the TAXUS I (four years), TAXUS II (three years), TAXUS IV (three years), and TAXUS VI (two years) studies have demonstrated excellent long-term safety and efficacy with a sustained and robust benefit. First data from the ATLAS clinical trial and OLYMPIA registry confirmed the safety profile of the TAXUS™ Liberté™ Stent system.

Feb 15th: Laser Prevents Diabetes Amputation

Diabetes-associated nerve and circulatory damage is the leading cause of lower limb amputation in the U.S., accounting for more than half of all foot and leg removals each year. According to the American Diabetes Association, 82,000 people lose a foot or leg to diabetes annually.

A laser technique that uses ultraviolet energy to restore blood flow to blocked arteries may help people with advanced diabetes avoid one of the most devastating complications of the disease -- amputation.
The new device, known as the excimer laser, relies on flexible fiber optic catheters to deliver short bursts of ultraviolet energy. The laser is able to precisely target and vaporize blockages without damage to the surrounding artery. This unique feature helps reduce the potential for complications such as clot formations after the surgery. After the laser procedure, balloon angioplasty is performed on almost all patients to help open the once-blocked artery.
In the study, only nine of 119 patients at high risk for amputation ended up losing a limb within six months of having the laser procedure as compare to one in 10 patients ended up having a foot or leg removed within six months of having the conventional laser procedure.

February 16th: Stronger Warnings for Tequin

Today, Bristol-Myers Squibb Co. announced labeling changes for Tequin (gatifloxacin), an antibiotic indicated for the treatment of patients with pneumonia, bronchitis, uncomplicated gonorrhea, and various infections including infections of urinary tract, kidneys, and skin.

The labeling changes, announced by the Tequin manufacturer in a letter to healthcare professionals, update the prescription information as a result of continued reports of serious cases of hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar) in patients receiving Tequin. Since the approval of Tequin in 1999, there have been rare cases of life-threatening events reported globally in patients treated with the drug. Most of these events were reversible when properly managed, but a few had fatal outcomes.

Information about the risks of low blood sugar and high blood sugar was added to the WARNINGS section of the U.S. labeling in 2002. Today's changes strengthen the existing WARNING on hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar), add a CONTRAINDICATION for use in diabetic patients, and include information identifying other risk factors for developing low blood sugar and high blood sugar, including advanced age, renal insufficiency, and concomitant glucose altering medications while taking Tequin.

The FDA will continue to monitor Tequin's safety to ensure that its benefits outweigh the risks to patients.

If you have any comments regarding this update, please email: info@mdiconsultants.com

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