Edmund's Newsletter
September 25, 2007
Issue: #39 Volume 7
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In This Issue
Testosterone Deficiency Relatively Rare In Men
Stem Cells in Adult Testes Provide Alternative to Embryonic Stem Cells for Organ Regeneration
The jury is in: When it comes fighting to C. difficile, the Palme d'Or goes to soap and warm water
CDC Touts Ample Supply of Flu Vaccine
Congress Passes FDA Legislation that Focuses on Antibiotic Pipeline and other Infectious Diseases Issues; President Expected to Sign into Law
New Antibiotic Drug Combo to Speed Up Treatment of Tuberculosis
WHO Stresses Need to Ensure the Safety of Children's Medicines
Believe It Or Not
News From MedWatch
Recently Approved Drugs/Indications
FDA Recalls and Safety Alerts in the Past 60 Days
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Testosterone Deficiency Relatively Rare In Men
A new study reveals that relatively few men, only 5.6 percent of the male population, actually suffer from low testosterone accompanied by clinical symptoms. That percentage, however, rises substantially with age.

Low testosterone levels are typically defined as less than 300 ng/dL (nanograms per deciliter) of total testosterone and less than 5 ng/dL of free testosterone. Free testosterone is the amount of the hormone unbound to other proteins and is "free" to work inside the body. "Low levels of testosterone impact many aspects of male physiology," said Andre B. Araujo, Ph.D., a research scientist at the New England Research Institutes in Watertown, Mass., and lead author of the study. "This is particularly significant because the ongoing aging of the U.S. male population is likely to cause the number of men suffering from androgen deficiency to increase appreciably."

Consistent with a recently issued Clinical Practice Guideline from the Endocrine Society, symptomatic androgen deficiency in the study by Araujo and colleagues is defined as low total and free testosterone plus the presence of low libido, erectile dysfunction, osteoporosis or facture, or two or more of the following symptoms: sleep disturbance, depressed mood, lethargy, or diminished physical performance.

Stem Cells in Adult Testes Provide Alternative to Embryonic Stem Cells for Organ Regeneration
Easily accessed and plentiful, adult stem cells found in a male patient's testicles might someday be used to create a wide range of tissue types to help him fight disease-getting around the need for more controversial embryonic stem cells.

That's the promise of a breakthrough study in mice led by a team from Weill Cornell Medical College in New York City, who report their findings in the September 20 issue of Nature.

Using spermatogonial progenitor stem cells (SPCs) obtained from the mouse's testes, the researchers were able to redirect the cells' development in the lab to form so-called "multi-potent adult spermatogonial-derived stem cells" (MASCs).

It was these cells that went on to develop into working blood vessel (endothelial) cells and tissue, as well as cardiac cells, brain cells and a host of other cell types.

Prior research conducted elsewhere has used genetic manipulation to reprogram adult cells derived from connective tissue to acquire stem-cell potential, differentiating into various organ-specific tissues. However, this reprogramming method-called "induced pluripotency"-resulted in generation of multi-potent stem cells that carried an increased risk of transforming into malignant cells.


The jury is in: When it comes fighting to C. difficile, the Palme d'Or goes to soap and warm water
Hospitals world-wide battle nosocomial infections on a daily basis. One of the most difficult bacteria to combat is Clostridium.difficile. To help ensure the best control methods possible, Dr. Michael Libman, Director of the Division of Infectious Diseases at the McGill University Health Centre (MUHC), studied the most effective ways to eliminate C.difficile bacteria from the hands of health care workers, with the highest honour going to soap and warm water!

The results from this study were presented yesterday by Dr. Matthew Oughton, a researcher in Dr Libman's team, at the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy in Chicago.

Dr. Libman's team, which included Dr. Oughton, Dr. Vivian Loo, director of the MUHC Department of Microbiology, and Susan Fenn, MUHC assistant Chief Technologist, tested five separate hand washing protocols that emulated hospital conditions as closely as possible. After the hands of the ten volunteers were contaminated with C.difficile, they washed successively with: regular soap and warm or cold water, antiseptic soap and warm water, an alcohol-based solution, and eventually with a disinfectant towel. "The results were striking: the protocols that involved washing with water eliminated more than 98% of the bacteria, while washing with an alcohol-based solution eliminated almost none! The protocol involving a disinfectant towel eliminated around 95% of bacteria." stated Dr. Oughton.
CDC Touts Ample Supply of Flu Vaccine
Come one, come all: After years of shortages and confusion, this fall promises plenty of flu vaccine to go around - up to 132 million doses, more than the nation has ever produced.

The ample supplies have the government urging vaccinations not just for people at highest risk of dying from influenza, but for anyone who wants to avoid a week of aching misery.

"Flu is a formidable foe," Dr. Julie Gerberding, head of the Centers for Disease Control and Prevention, said Wednesday. "It is not an illness we should be complacent about."

But new CDC data show only a fraction of people who need flu shots the most get them, including just one in five babies and toddlers. And there's wide geographic variation, with Rhode Island reporting the most high-risk adults vaccinated and Nevada the fewest.

Shots aren't the only option. Wednesday, the government ruled that it's safe for younger kids than ever before to try a nasal-spray vaccine called FluMist. Once only an option for people ages 5 to 49, FluMist now can be used by children as young as 2.

Congress Passes FDA Legislation that Focuses on Antibiotic Pipeline and other Infectious Diseases Issues; President Expected to Sign into Law
This week, the House and Senate passed new legislation, the FDA Prescription Drug User Fee Act Reauthorization (PDUFA).  The PDUFA legislation contains several provisions the Infectious Diseases Society of America (IDSA) prompted and promoted to strengthen the antibiotic pipeline and to address other infectious diseases issues.

The antibiotic pipeline provisions entitled: "Antibiotic Access and Innovation" include:

New Antibiotic Drug Combo to Speed Up Treatment of Tuberculosis
A team of tuberculosis experts at Johns Hopkins and in Brazil have evidence that substituting the antibiotic moxifloxacin in the regimen of drugs used to treat the highly contagious form of lung disease could dramatically shorten the time needed to cure the illness from six months to four.

Adding moxifloxacin to a standard combination of other antibiotics increased by 17 percent the number of patients who cleared active infections from their lungs (raising cure rates from 68 percent to 85 percent), after just two months of therapy, and when compared to  patients taking the standard combination with another, older antibiotic, ethambutol.

"This is the most compelling evidence in nearly 25 years that a novel antibiotic drug combination works better than the current gold standard at curing active TB infection," says study senior author Richard E. Chaisson, M.D., a professor of medicine, epidemiology and international health at the Johns Hopkins University School of Medicine and founding director of its Center for Tuberculosis Research.  Chaisson will present his team's findings Sept. 18 in Chicago at the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).

"Beyond the obvious value of healing patients more quickly, a shorter treatment time could also cut down on transmission of the disease to others and make it easier for health care workers worldwide, who are overwhelmed by large numbers of patients, to treat more people and to treat them faster," says Chaisson, who started the study in 2003.

WHO Stresses Need to Ensure the Safety of Children's Medicines
The lack of thorough and reliable clinical data on the way medicines affect children requires strengthened safety monitoring and vigilance of medicinal products. This is the fundamental message of Promoting safety of medicines for children, released today by the World Health Organization (WHO).

The publication gives an overview of the problem and offers solutions on how best to address side effects from medicines in children; namely, through improved reporting systems and collaboration between governments, regulatory authorities, research institutions and the pharmaceutical industry. The publication is part of a broad effort WHO is initiating to expand children's access to quality-assured, safe and effective medicines.

"We need to learn more about the way children's bodies react to medicines so we can improve global child health. That's why it's extremely important to keep track of potential side effects in child populations. Ultimately, this will save lives and build up a knowledge base for the future," said Dr Howard Zucker, WHO Assistant Director-General for Health Technology and Pharmaceuticals.

Believe it or not

Dead" man wakes up under autopsy knife


A Venezuelan man who had been declared dead woke up in the morgue in excruciating pain after medical examiners began their autopsy.

Carlos Camejo, 33, was declared dead after a highway accident and taken to the morgue, where examiners began an autopsy only to realize something was amiss when he started bleeding. They quickly sought to stitch up the incision on his face.



"I woke up because the pain was unbearable," Camejo said, according to a report on Friday in leading local newspaper El Universal.

His grieving wife turned up at the morgue to identify her husband's body only to find him moved into a corridor -- and alive.

Reuters could not immediately reach hospital officials to confirm the events. But Camejo showed the newspaper his facial scar and a document ordering the autopsy.



News From MedWatch
Keep up-to-date on all of the recent MedWatch reports that gives you timely safety information on the drugs and other medical products regulated by the U.S. Food and Drug Administration by  CLICKING HERE
 
Recently Approved Drugs/Indications
Keep up-to-date on all of the recently approved drugs and/or approved new indications on already FDA approved drugs by CLICKING HERE
 
FDA Recalls and Safety Alerts in the Past 60 Days:
To see a list of all FDA Recalls and product safety alerts for the last 60 days CLICK HERE
 
Drug Shortages:
As many of you are aware, many drugs in the US are either unavailable or in short supply.  To view a list of these drugs CLICK HERE
 
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