Edmund's Newsletter
January 27, 2009
Issue: #4 Volume 9
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In This Issue
How Chemotherapy Drugs Block Blood Vessel Growth, Slowing Cancer Spread
Children With Inflammatory Bowel Disease Have Surprisingly High Folate Levels
Oral Steroids Ineffective in the Treatment of Preschool Virus-Induced Wheezing
Magnesium Sulphate Protects Babies Against Cerebral Palsy
Clinical Trials: Unfavourable Results Often Go Unpublished
Problems of Prescription Drug Use in Children
Discovery Could Help Scientists Stop The "Death Cascade" Of Neurons After A Stroke
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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How Chemotherapy Drugs Block Blood Vessel Growth, Slowing Cancer Spread
Researchers at the Johns Hopkins University School of Medicine have discovered how a whole class of commonly used chemotherapy drugs can block cancer growth. Their findings, reported online this week at the Proceedings of the National Academy of Sciences Early Edition, suggest that a subgroup of cancer patients might particularly benefit from these drugs.

The anthracycline class of chemotherapeutics - doxorubicin (Adriamycin), daunorubicin, epirubicin, idarubicin - have been used for four decades to treat many types of cancer, including leukemia, lymphoma, sarcomas and carcinomas, The standard method of administration had been to use the highest tolerable dose every few weeks to kill all rapidly growing cells by preventing them from accurately copying their genetic material.

"But the late Judah Folkman discovered in 2000 that so-called metronomic treatment, giving patients lower doses of these drugs more frequently, can keep cancer growth at bay by blocking blood vessel formation, but the exact mechanism by which this occurred wasn't known," says Gregg L. Semenza, M.D., Ph.D., director of the vascular program at the Johns Hopkins Institute for Cell Engineering and a member of the McKusick-Nathans Institute of Genetic Medicine. "Now we've shown how it happens and what players are involved, which could help shape future clinical trials for patients with certain types of cancers."

Children With Inflammatory Bowel Disease Have Surprisingly High Folate Levels
Children with newly diagnosed cases of inflammatory bowel disease have higher concentrations of folate in their blood than individuals without IBD, according to a new study led by researchers at the University of California, San Francisco and UC Berkeley. The findings bring into question the previously held theory that patients with IBD are prone to folate - also known as folic acid - deficiency.

"This is exciting work that opens the door to additional research into the role of folic acid and its genetic basis in the development of IBD, especially in young patients," said first author Melvin Heyman, MD, a professor of pediatrics, chief of pediatric gastroenterology, hepatology and nutrition, and director of the Pediatric IBD Program at UCSF Children's Hospital.

The study appears in the February 2009 issue of the "American Journal of Clinical Nutrition" and is currently available online at http://www.ajcn.org/cgi/content/full/89/2/545.

Oral Steroids Ineffective in the Treatment of Preschool Virus-Induced Wheezing
A new study from Barts and The London School of Medicine and Dentistry has found that a common treatment for wheezing in preschool children is no more effective than a placebo.

The findings, reported in the January edition of The New England Journal of Medicine, call into question national guidelines for the treatment of viral-induced wheezing.

Attacks of wheezing caused by viral infections in the upper respiratory tract are common in preschool children between the ages of ten months and six years. Preschool children who visit hospital with such symptoms are commonly treated with a short course of prednisolone - a steroid which is used to reduce inflammation in the airway and which is very effective in treating attacks of allergic asthma in older children and adults.

Magnesium Sulphate Protects Babies Against Cerebral Palsy
Giving pregnant mothers magnesium sulphate when they are at risk of very preterm birth can help protect their babies from cerebral palsy, according to an international review of research involving the University of Adelaide.

The findings of this review - published today on the international research website The Cochrane Library - could help decrease the incidence of this disabling condition, which affects one in 500 newborn babies overall and one in 10 very premature babies (less than 28 weeks gestation).

Magnesium sulphate therapy involves giving doses of magnesium sulphate to pregnant women via injection.

Clinical Trials: Unfavourable Results Often Go Unpublished
Trials showing a positive treatment effect, or those with important or striking findings, were much more likely to be published in scientific journals than those with negative findings, a new review from The Cochrane Library has found.

"This publication bias has important implications for healthcare. Unless both positive and negative findings from clinical trials are made available, it is impossible to make a fair assessment of a drug's safety and efficacy," says lead researcher, Sally Hopewell of the UK Cochrane Centre in Oxford, UK.

The international team of researchers carried out a systematic review of all the existing research in this area. In addition to showing that negative results were published less often, they found that if these results were eventually published, they would take between one and four more years to appear in journals than studies showing positive results.

Results from one of the five studies in the review indicated that investigators and not editors might be to blame. The reasons most commonly given for not publishing were that investigators thought their findings were not interesting enough or did not have time. "The registration of all clinical trial protocols before they start should make it easier to identify where we are missing results," says Kay Dickersin from Johns Hopkins University in Baltimore, USA, another of the researchers on this project.

Problems of Prescription Drug Use in Children
Accompanying the article "Off-Label Use of Prescription Drugs in Childhood and Adolescence-an Analysis of Prescription Patterns in Germany" by Mühlbauer, Janhsen, Pichler, and Schoeller in this issue of Deutsches Ärzteblatt International

The pediatric health care study by Mühlbauer et al. that appears in this issue deserves our close attention: It reminds us once again of a longstanding public health problem, namely, the inadequate safety of prescription drug use in children (1). Pediatricians often give medicines in ways that do not conform with the product licence. The literature generally calls this practice "off-label use." Arising from the treating physicians' inadequate knowledge of the medicines that they prescribe, in both ambulatory and inpatient settings, off-label use doubles the frequency of adverse drug reactions, which are sometimes life-threatening (2, 3). As early as 1963, an American pharmacist and pediatrician, Harry C. Shirkey, complained that children risked becoming "therapeutic or pharmaceutical orphans" because many pediatric drugs had not been licensed (4). He felt it was unacceptable that safe and effective medicines should be withheld from this vulnerable group of patients. Yet it is only now, at the beginning of the 21st century, that laws and regulations are being put into effect at the national level and in the European Union as a whole to improve prescription in pediatrics (Directive 2001/20/EC of the European Parliament and Council relating to good clinical practice; 12th Amendment to the German Pharmaceuticals Act [Arzneimittelgesetz]; Regulation EC/1901/2006). Thus, the data from the year 2002 that Professor Mühlbauer and his colleagues have analyzed can still be considered an accurate reflection of the situation as it exists in 2008.

Discovery Could Help Scientists Stop The "Death Cascade" Of Neurons After A Stroke
Discovery could help scientists stop the "death cascade" of neurons after a stroke

Distressed swimmers often panic, sapping the strength they need to keep their heads above water until help arrives. When desperate for oxygen, neurons behave in a similar way. They freak out, stupidly discharging energy until they drown in a sea of their own extruded salts. Every year, millions of victims of stroke or brain trauma suffer permanent brain damage because of this mad rush to oblivion that

Saving neurons. When normal neurons (top) are subjected to stroke-like damage, they quickly deteriorate and die (center). New research shows that a small portion of the cell's glutamate receptors, the KA1 subunit, is responsible for this damage. Cells treated with an antibody that blocks this subunit are largely protected (bottom).
begins once a part of the brain is deprived of blood.

It is well known that a ubiquitous cell receptor drives these oxygen-starved neurons' lemming-like behavior. But this particular receptor, for the neurotransmitter glutamate, is also responsible for the rapid transmission of information between neurons required for all cognition, among other things. Shutting it off has serious consequences, like coma. Now, a team of scientists at The Rockefeller University has identified a single subunit of this receptor that drives neuronal death. This new discovery suggests that drugs targeting a specific subunit of the complex glutamate receptor might be able to slow brain damage without disrupting other crucial brain functions.

"We have found that you can make mice resistant to this kind of cell death by blocking one piece of the receptor without the terrible side effects you get by blocking the whole thing," says Sidney Strickland, head of the Laboratory of Neurobiology and Genetics, who directed the research. "Now we can start exploring potential drugs to do that in humans."

Believe it or not
Newspaper claims car thief transformed into a goat

One of Nigeria's biggest daily newspapers reported that police implicated a goat in an attempted automobile theft. In a front-page article on Friday, the Vanguard newspaper said that two men tried to steal a Mazda car two days earlier in Kwara State, with one suspect transforming himself into a goat as vigilantes cornered him.

The paper quoted police spokesman Tunde Mohammed as saying that while one suspect escaped, the other transformed into a goat as he was about to be apprehended.

The newspaper reported that police paraded the goat before journalists, and published a picture of the animal.

Police in the state couldn't immediately be reached for comment.

Belief in black magic is widespread in Nigeria, particularly in far-flung rural areas
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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