Edmund's Newsletter
June 17, 2008
Issue: #25 Volume 8
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In This Issue
What's Wrong With Selling Kidneys?
Pitt-led Researchers Find Source of Drug-Tolerant Tuberculosis Possibly Behind TB Relapses, Intensity of Treatment
Vitamin D Findings Point to New Treatment for Heart Failure
New-Style Bird Flu Vaccine Shows Promise
Researchers Find Source of Drug-Tolerant Tuberculosis Possibly Behind TB Relapses, Intensity of Treatment
Researchers Find Drugs Being Tested for Alzheimer's Disease Work in Unexpected and Beneficial Ways
"HICY" Drug Regimen Reverses MS Symptoms in Selected Patients
Believe It Or Not
News From MedWatch
Recently Approved Drugs/Indications
FDA Recalls and Safety Alerts in the Past 60 Days
Drug Shortages
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What's Wrong With Selling Kidneys?
Doctors in the British Medical Journal debate the issue of selling kidneys. A regulated system of compensation for living donors may be the solution to the growing shortage of kidneys for transplantation, writes Arthur Matas, Professor of Surgery at the University of Minnesota.

In many areas of the United States the average wait for a transplant from a deceased donor is five years, but in some parts it is as long 10 years. Because of this the annual death rate for suitable transplant candidates has risen from 6.3% in 2001 to 8.1% in 2005.

Current unregulated systems in developing countries only benefit the rich, and provide no long term donor follow-up, or protection for either buyer or seller, he says.

In contrast, Matas argues, a regulated compensation system in the Western world would increase the number of available organs. Such a system would provide strict control and limit harm by allowing every candidate an opportunity for transplant, full donor evaluation, informed consent, long term health follow-up, with payment managed by the government or insurance companies, and the banning of any other commercialisation.

Pitt-led Researchers Find Source of Drug-Tolerant Tuberculosis Possibly Behind TB Relapses, Intensity of Treatment
Growth of TB bacteria as biofilms result in cells genetically and physiologically different from those lab-cultured for antibiotics

University of Pittsburgh-led researchers discovered that the primary bacteria behind tuberculosis can grow on surfaces and that drug-tolerant strains flourish in these bacterial communities, the research team recently reported in "Molecular Microbiology." The findings suggest a possible reason why human tuberculosis (TB) requires months of intensive antibiotic treatment and indicate a potential cause of the relapses that can nonetheless occur.

The researchers are the first to show that "Mycobacterium tuberculosis" can grow in surface-level bacteria clusters known as biofilms that are common in nature but never before shown for TB bacteria, explained the paper's senior author Graham Hatfull, chair and Eberly Family Professor of Biological Sciences in Pitt's School of Arts and Sciences. Hatfull collaborated and coauthored the paper with Professor William Jacobs Jr. of the Department of Microbiology and Immunology at the Albert Einstein College of Medicine in New York.

Hatfull, Jacobs, and their colleagues found that the biofilm bacteria are physiologically and genetically different from TB bacteria harvested in a lab-the type used in developing antibiotics. These variations result in a population of the bacteria that are "drug-tolerant and harbor persistent cells that survive high concentrations of anti-tuberculosis antibiotics," the team reports.

Vitamin D Findings Point to New Treatment for Heart Failure
Strong bones, a healthy immune system, protection against some types of cancer: Recent studies suggest there's yet another item for the expanding list of Vitamin D benefits. Vitamin D, "the sunshine vitamin," keeps the heart, the body's long-distance runner, fit for life's demands.

University of Michigan pharmacologist Robert U. Simpson, Ph.D., thinks it's apt to call vitamin D "the heart tranquilizer."

In studies in rats, Simpson and his team report the first concrete evidence that treatment with activated vitamin D can protect against heart failure. Their results appear in the July issue of the Journal of Cardiovascular Pharmacology.

In the study, treatments with activated vitamin D prevented heart muscle cells from growing bigger - the condition, called hypertrophy, in which the heart becomes enlarged and overworked in people with heart failure. The treatments prevented heart muscle cells from the over-stimulation and increased contractions associated with the progression of heart failure.

New-Style Bird Flu Vaccine Shows Promise
A new-style bird flu vaccine made using monkey cells instead of chicken eggs appears to be safe and effective, corporate researchers reported on Wednesday.

The vaccine against H5N1 avian influenza, made by Baxter International, is the first bird flu vaccine to be made using cells in a lab dish instead of chicken eggs. This is important because the right type of chicken eggs are difficult to obtain -- and because H5N1 kills chickens rapidly.

The trial of more than 250 people was a phase I/II safety trial, but the report, published in the New England Journal of Medicine, showed the vaccine produced a strong immune response in people who received two doses.

Researchers Find Source of Drug-Tolerant Tuberculosis Possibly Behind TB Relapses, Intensity of Treatment
Researchers at University of Pittsburgh and Albert Einstein College of Medicine of Yeshiva University have discovered that the bacteria behind tuberculosis can grow on surfaces and that drug-tolerant strains flourish in these bacterial communities, the research team recently reported in Molecular Microbiology. The findings suggest a possible reason why human tuberculosis (TB) requires months of intensive antibiotic treatment and indicate a potential cause of the relapses that can nonetheless occur.

The researchers are the first to show that Mycobacterium tuberculosis can grow in surface-level bacteria clusters known as biofilms that are common in nature but never before shown for TB bacteria, explained the paper's senior author Graham Hatfull, chair and Eberly Family Professor of Biological Sciences in Pitt's School of Arts and Sciences. Hatfull collaborated and coauthored the paper with William Jacobs Jr., a Howard Hughes Medical Institute investigator and professor of microbiology and immunology at Einstein.

Hatfull, Jacobs, and their colleagues found that the biofilm bacteria are physiologically and genetically different from TB bacteria harvested in a lab-the type used in developing antibiotics. These variations result in a population of the bacteria that are "drug-tolerant and harbor persistent cells that survive high concentrations of anti-tuberculosis antibiotics," the team reports.

Researchers Find Drugs Being Tested for Alzheimer's Disease Work in Unexpected and Beneficial Ways
Researchers at Mayo Clinic, with their national and international collaborators, have discovered how a class of agents now in testing to treat Alzheimer's disease work, and say they may open up an avenue of drug discovery for this disease and others.

In the June 12 issue of Nature, they report that agents known as gamma-secretase modulators (GSM) work to reduce production of long pieces of the amyloid beta protein (Abeta) that readily stick together and form clumps, and increase production of shorter Abeta that can inhibit the longer forms from sticking together.

This is critical because only when Abeta aggregates and accumulates is it harmful and can trigger Alzheimer's disease, the researchers say.

"So, as these compounds lower the amount of the bad, longer sticky Abeta peptides in the brain, they increase the quantity of shorter Abeta peptides that may protect against development of Alzheimer's disease," says senior author Todd Golde, M.D., Ph.D., Chair of the Department of Neuroscience at Mayo Clinic in Jacksonville.

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"HICY" Drug Regimen Reverses MS Symptoms in Selected Patients
A short-term, very-high dose regimen of the immune-suppressing drug cyclophosphamide seems to slow progression of multiple sclerosis (MS) in most of a small group of patients studied and may even restore neurological function lost to the disease, Johns Hopkins researchers report. The findings in nine people, most of whom had failed all other treatments, suggest new ways to treat a disease that tends to progress relentlessly.
 
"We didn't expect such a dramatic return of function," says Douglas Kerr, M.D., Ph.D, associate professor of neurology at the Johns Hopkins University School of Medicine. "Although we're very early in the game, we think this approach could be the linchpin of a significant advance for MS treatment."
 
Researchers have used the so called HiCy treatments with some success at Johns Hopkins for a variety of other immune system disorders, including aplastic anemia, lupus and myasthenia gravis.
 
Cyclophosphamide kills immune-system cells but spares the bone marrow stem cells that make them. The usual method of delivering it in pulsed, small doses, however, can cause the drug to build up to toxic concentrations in patients' bodies, causing a variety of side effects, including a greatly increased risk of infection.

Believe it or not
Nail-in-skull survivor: 'It never really hurt'

George Chandler says he didn't know a 2 1/2-inch nail was driven into his skull until his buddy spotted it stuck through his cap.

Chandler said he felt only a sting.

"It never did really what you call hurt," the Shawnee man said Wednesday on NBC's "Today."

Chandler said his friend Phil Kern was using a nail gun to mount lattice on Chandler's deck when a hose on the powerful tool became caught.

Chandler said he stood up just as Kern tried to free the gun and it discharged. At first, they couldn't locate the nail. But then Kern saw it, he ordered Chandler to sit down while he called 911.

An emergency room doctor tried unsuccessfully to remove the nail with a pair of pliers.

"He looked at me and said, 'I need a claw hammer,'" Chandler recalled. "I thought, 'Ah, he's just teasing.'"

So the doctor borrowed a claw hammer from a worker to finish the job and sent Chandler home with a few stitches.

"He got a screwdriver at the same time, and he took the screwdriver and pried the nail up a little bit and got the claw hammer," Chandler said.
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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