Edmund's Newsletter
April 1, 2008
Issue: #14 Volume 8
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In This Issue
Ant Guts Could Pave The Way For Better Drugs
Non-Invasive Imaging Provides Window Into Genetic Properties of Brain Tumors
Spit Tests May Soon Replace Many Blood Tests Easy-Access Body Fluid May Provide Less Invasive Diagnosis Thanks to Proteomics
Increasing Access to Antiretroviral Drugs Would Drastically Cut AIDS Deaths in South Africa
New Chemical Can Kill Latent Tuberculosis Bacteria
Botox for Newborns
Drugs Approved Under Deadline More Likely to Run Into Trouble Later
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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Ant Guts Could Pave The Way For Better Drugs
Scientists have discovered two key proteins that guide one of the two groups of pathogenic bacteria to make ant's hardy outer shells -- their defense against the world.

The work, they said, could allow researchers to create new antibiotics against gram-negative bacteria, like E. coli and salmonella, that would destroy these bacteria by disabling the mechanism that produces their protective coating.

"A long-term goal is to find inhibitors of these proteins we have discovered," said Natividad Ruiz, a research molecular biologist at Princeton University and the lead author on the paper describing the work. "Small molecule inhibitors could become antibiotics that subvert the outer membrane."

The research, conducted by Ruiz, Thomas Silhavy, Princeton's Warner-Lambert Parke-Davis Professor of Molecular Biology, and others from Harvard University, is described in the online edition of the April 8 Proceedings of the National Academy of Sciences.

Non-Invasive Imaging Provides Window Into Genetic Properties of Brain Tumors
 Doctors diagnose and prescribe treatment for brain tumors by studying, under a microscope, tumor tissue and cell samples obtained through invasive biopsy or surgery. Now, researchers at the University of California, San Diego (UCSD) School of Medicine have shown that Magnetic Resonance Imaging (MRI) technology has the potential to non-invasively characterize tumors and determine which of them may be responsive to specific forms of treatment, based on their specific molecular properties.  The study will be published on line by the Proceedings of the National Academy of Science (PNAS) the week of March 24.
 
"This approach reveals that, using existing imaging techniques, we can identify the molecular properties of tumors," said Michael Kuo, M.D., assistant professor of interventional radiology at UCSD School of Medicine.  Kuo and colleagues analyzed more than 2,000 genes that had previously been shown to have altered expression in Glioblastoma multiforme (GBM) tumors. They then mapped the correlations between gene expression and MRI features.

The researchers also identified characteristic imaging features associated with overall survival of patients with GBM, the most common and lethal type of primary brain tumor.

Spit Tests May Soon Replace Many Blood Tests Easy-Access Body Fluid May Provide Less Invasive Diagnosis Thanks to Proteomics
  One day soon patients may spit in a cup, instead of bracing for a needle prick, when being tested for cancer, heart disease or diabetes. A major step in that direction is the cataloguing of the "complete" salivary proteome, a set of proteins in human ductal saliva, identified by a consortium of three research teams, according to an article published today in the Journal of Proteome Research. Replacing blood draws with saliva tests promises to make disease diagnosis, as well as the tracking of treatment efficacy, less invasive and costly.

Saliva proteomics and diagnostics is part of a nationwide effort to create the first map of every human protein and every protein interaction, as they contribute to health and disease and as they act as markers for disease states. Following instructions encoded by genes, protein "machines" make up the body's organs and regulate its cellular processes. Defining exact protein pathways on a comprehensive scale enables the development of early diagnostic testing and precise drug design. In the current study, researchers sought to determine the "complete" set of proteins secreted by the major salivary glands (parotid, submandibular (SM) and sublingual (SL)). Recent, parallel efforts that mapped the blood (plasma) and tear proteomes allows for useful comparisons of how proteins and potential disease markers are common or unique to different body fluids.

"Past studies established that salivary proteins heal the mouth, amplify the voice, develop the taste buds and kill bacteria and viruses," said James E. Melvin, D.D.S., Ph.D., director of the Center for Oral Biology at the University of Rochester Medical Center, and an author on the paper. "Our work, and the work of our partners, has shown that salivary proteins may represent new tools for tracking disease throughout the body-tools that are potentially easier to monitor in saliva than in blood," said Melvin, who collaborates with the research labs of Mark Sullivan, Ph.D., and Fred K. Hagen, Ph.D.

Increasing Access to Antiretroviral Drugs Would Drastically Cut AIDS Deaths in South Africa
More that 1.2 million deaths could be prevented in South Africa over the next five years by accelerating efforts to provide access to antiretroviral therapy (ART), according to a study released online today by the Journal of Infectious Diseases. Using a sophisticated mathematical model of HIV disease and treatment, a team of researchers led by Rochelle Walensky, MD, MPH of Massachusetts General Hospital (MGH) estimated the number of AIDS-related deaths in South Africa through 2012 under alternative ART scale-up assumptions.

The study results underscore the urgent need for Congress to reauthorize the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), which has supported the South African government's effort to increase access to antiretroviral therapy, the researchers note. "If ART is not provided to all who need it, HIV mortality will be enormous," says Walensky. "Deliberate, purposeful, and expedient scale-up will save millions of lives in South Africa alone."

South Africa has one of the largest burdens of HIV infection in the world, with 5 to 6 million individuals and 19 percent of adults aged 15 to 49 infected. While government programs supported by PEPFAR and the Global Fund to Fight AIDS, Tuberculosis and Malaria have steadily increased access to antiretrovirals, at the end of 2006 only a third of individuals eligible for the therapy were receiving it.

New Chemical Can Kill Latent Tuberculosis Bacteria
Success in the laboratory suggests that a new compound can point the way to preventing active tuberculosis in people infected with the latent form of the bacterium, says a team led by researchers at Weill Cornell Medical College in New York City. A drug with such properties could also be useful in treating people who already have tuberculosis by shortening the lengthy treatment period. The discovery also points to new ways of thinking about fighting bacterial infection, which is becoming increasingly resistant to traditional antibiotics.

"With each new case of antibiotic resistance, doctors are losing ground against Mycobacterium tuberculosis and other infectious diseases," explains the study's senior author Dr. Carl Nathan, chairman of Microbiology and Immunology and the R.A. Rees Pritchett Professor of Microbiology at Weill Cornell Medical College. "This new approach fights the pathogen in a way that's different from conventional antibiotics. For what may be the first time, we have found compounds that only kill M. tuberculosis when they are not dividing. This lack of replication is a characteristic of latent bacteria, which are tough to eradicate with existing antibiotics and ultimately play a huge role in the epidemic's spread."

The new findings are published in the March 12 online issue of the journal Cell Host & Microbe.

Botox for Newborns
Using a common cosmetic drug to treat hypersalivation at the Montreal Children's Hospital of the MUHC.

Botulinum toxin, also called Botox, is best known as one of the most commonly used molecules to reduce wrinkles. It is also known as one of the most poisonous naturally occurring substances.

Now, thanks to Dr. Sam Daniel, Associate Director of Research of the Otorhinolaryngology Division at the Montreal Children's Hospital of the McGill University Health Centre, this protein has become an effective method to save newborns suffering from CHARGE Syndrome from having to undergo devastating tracheotomies. Dr. Daniel describes the case of the first infant patient treated with the toxin in an article from the Archives of Otolaryngology dated March 17th.

CHARGE Syndrome is rare, but it can become life-threatening in its most severe form. The syndrome includes a variety of birth defects in different organs, such as the heart, eyes or ears, but it also affects the salivary glands. They are hyper-stimulated and secrete excessive fluids that are discarded into the lungs, causing asphyxia. This was the case for the patient that Dr. Daniel discusses in his article: at the age of two and a half months, little Franck (not his real name) was still unable to breathe without assistance and a tracheotomy seemed inevitable in order to relieve his respiratory system.

Drugs Approved Under Deadline More Likely to Run Into Trouble Later
New research shows that drugs that are approved quickly to meet mandated deadlines are more likely to run into trouble down the line, after they are in millions of Americans' medicine cabinets, than drugs that receive more deliberation before approval.

"It's not necessarily the case that these drugs should not have been approved, but it may have helped to have a black box warning in the first place rather than adding one three years later," said study author Daniel Carpenter, a professor of government at Harvard University. "It's not just the fact of approval. It's approval or regulatory processes assisting clinicians and patients with optimal use down the road. That's a big part of the approval process. It's not just saying yes and no, but saying with conditions and information that help us use drugs well."

The Prescription Drug User Fee Act (PDUFA), enacted in 1992, mandated that the U.S. Food and Drug Administration must act on 90 percent of all drug applications within 12 months of submission of the application or face funding cuts. That deadline was narrowed to 10 months in 1997.

"This study actually puts quantitative information around the question of whether the PDUFA user fee laws have resulted in a rush to approve things or to make decisions too quickly and many people, myself included, have worried about this," said Dr. Steven Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic Foundation.

Believe it or not
Man declared dead feels 'pretty good'

Four months after he was declared brain dead and doctors were about to remove his organs for transplant, Zach Dunlap says he feels "pretty good."
 
Dunlap was pronounced dead Nov. 19 at United Regional Healthcare System in Wichita Falls, Texas, after he was injured in an all-terrain vehicle accident. His family approved having his organs harvested.

As family members were paying their last respects, he moved his foot and hand. He reacted to a pocketknife scraped across his foot and to pressure applied under a fingernail. After 48 days in the hospital, he was allowed to return home, where he continues to work on his recovery.

On Monday, he and his family were in New York, appearing on NBC's "Today."

"I feel pretty good. but it's just hard ... just ain't got the patience," Dunlap told NBC.

Dunlap, 21, of Frederick, said he has no recollection of the crash.

"I remember a little bit that was about an hour before the accident happened. But then about six hours before that, I remember," he said.

Dunlap said one thing he does remember is hearing the doctors pronounce him dead.

"I'm glad I couldn't get up and do what I wanted to do," he said.

Asked if he would have wanted to get up and shake them and say he's alive, Dunlap responded: "Probably would have been a broken window that went out."

His father, Doug, said he saw the results of the brain scan.

"There was no activity at all, no blood flow at all."

Zach's mother, Pam, said that when she discovered he was still alive, "That was the most miraculous feeling."

"We had gone, like I said, from the lowest possible emotion that a parent could feel to the top of the mountains again," she said.

She said her son is doing "amazingly well," but still has problems with his memory as his brain heals from the traumatic injury.

"It may take a year or more ... before he completely recovers," she said. "But that's OK. It doesn't matter how long it takes. We're just all so thankful and blessed that we have him here."

Dunlap now has the pocketknife that was scraped across his foot, causing the first reaction.

"Just makes me thankful, makes me thankful that they didn't give up," he said. "Only the good die young, so I didn't go."
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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