Edmund's Newsletter
December 16, 2008
Issue: #50 Volume 8


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In This Issue
Popular Class of Diabetes Drugs Doubles Risk of Fractures in Women
Broccoli Compound Targets Key Enzyme In Late-Stage Cancer
Death Rates In Hospital Highest For Infants, And Uninsured Children
Breast Cancer: Research On Tamoxifen Leads To Recommendation For CYP2D6 Gene Test
Keeping The Weight Off: Which Obesity Treatment Is Most Successful?
Harm-reduction Cigarettes Are More Toxic Than Traditional Cigarettes, UCR Study Finds
Precious Metal Could Lead To Next Generation Of Cancer Treatments
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News From MedWatch
Recently Approved Drugs/Indications
FDA Recalls and Safety Alerts in the Past 60 Days
Drug Shortages
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Popular Class of Diabetes Drugs Doubles Risk of Fractures in Women 
New findings out of Wake Forest University School of Medicine and the University of East Anglia show that long-term use of a popular class of oral diabetic drugs doubles the risk of fractures in women with type 2 diabetes.

The findings appear online today on the Web site for the Canadian Medical Association Journal and will appear in the January 6 issue.

"We knew going into this study that there was an association between thiazolidinediones and fracture risk, however the magnitude of risk had not been evaluated," said Sonal Singh, M.D., M.P.H., an assistant professor of internal medicine and a co-researcher for the study. "This study shows that these agents double the risk of fractures in women with type 2 diabetes, who are already at higher risk before taking the therapy."

Broccoli Compound Targets Key Enzyme In Late-Stage Cancer
An anti-cancer compound found in broccoli and cabbage works by lowering the activity of an enzyme associated with rapidly advancing breast cancer, according to a University of California, Berkeley, study appearing this week in the online early edition of the journal Proceedings of the National Academy of Sciences.

Indole-3-carbinol, or I3C, is a chemical compound found in broccoli and other cruciferous vegetables and which is known to stop the growth of breast cancer cells. UC Berkeley researchers' discovery of how I3C works will help them modify the compound to improve its anti-cancer effects. (Firestone & Bjeldanes labs/UC Berkeley)The compound, indole-3-carbinol, is already undergoing clinical trials in humans because it was found to stop the growth of breast and prostate cancer cells in mice.

The new findings are the first to explain how indole-3-carbinol (I3C) stops cell growth, and thus provides the basis for designing improved versions of the chemical that would be more effective as a drug and could work against a broader range of breast as well as prostate tumors.

"I think one of the real uses of this compound and its derivatives is combining it with other kinds of therapies, such as tamoxifen for breast cancer and anti-androgens for prostate cancer," said coauthor Gary Firestone, UC Berkeley professor of molecular and cell biology. "Humans have co-evolved with cruciferous vegetables like broccoli and Brussels sprouts, so this natural source has a lot fewer side effects."

Death Rates In Hospital Highest For Infants, And Uninsured Children
The vast majority of children who die while hospitalized are newborns, according to a new nationwide study. Additionally, death rates are higher for hospitalized children without insurance compared to those with insurance, the researchers found.

Children who were transferred between hospitals also had significantly higher mortality rates, according to the study, which was co-authored by Matthew M. Davis, M.D., M.A.P.P., associate professor of general pediatrics and internal medicine at the Child Health Evaluation and Research (CHEAR) Unit of the U-M Medical School; and Rachel N. Caskey, M.D., M.A.P.P., of the University of Chicago Pritzker School of Medicine. The study appeared recently in the Journal of Hospital Medicine.
 
"As health care providers and institutions expand their efforts to meet the needs of severely ill children and their families, they need to be aware of the higher mortality rates among the youngest children, those without insurance coverage and those who are transferred from one hospital to another," notes Davis, who also is the director of the C.S. Mott Children's Hospital National Poll on Children's Health and associate professor of public policy at the Gerald R. Ford School of Public Policy at U-M.

Breast Cancer: Research On Tamoxifen Leads To Recommendation For CYP2D6 Gene Test
Findings from a new study have prompted Mayo Clinic researchers to recommend CYP2D6 gene testing for postmenopausal women about to begin tamoxifen therapy. This data confirms that women with an inherited deficiency in the CYP2D6 gene, which is important for the metabolism of tamoxifen, have a nearly fourfold higher risk of early breast cancer recurrence compared to women who have not inherited the deficiency.

The research findings, announced jointly by investigators from Mayo Clinic and the Austrian Breast and Colorectal Cancer Study Group (ABCSG) confirmed results from a previous study conducted by Mayo Clinic. The latest findings will be presented December 13 at the Cancer Therapy & Research Center-American Association for Cancer Research (CTRC-AACR) 31st annual San Antonio Breast Cancer Symposium.

Tamoxifen, approved by the Food and Drug Administration (FDA) to both prevent development of estrogen-receptor-positive (ER+) breast cancer and as a therapy to stop ER+ breast cancer from coming back, is a "pro-drug"; it must be metabolized in the liver to become active. Mayo researchers had previously discovered that the drug is less effective in postmenopausal breast cancer patients who had a deficiency in the CYP2D6 gene, which is key for activating tamoxifen and many other drugs. However, until now, testing for the gene has not been done routinely at most medical centers.

Keeping The Weight Off: Which Obesity Treatment Is Most Successful?
Severely obese patients who have lost significant amounts of weight by changing their diet and exercise habits may be as successful in keeping the weight off long-term as those individuals who lost weight after bariatric surgery, according to a new study published online by the International Journal of Obesity.

While weight loss and maintenance were comparable between the two treatments, patients who relied on non-surgical methods had to work harder over a longer duration to maintain their weight losses, say researchers from The Miriam Hospital's Centers for Behavioral and Preventive Medicine.

"Our findings suggest that its possible to maintain large weight losses through intensive behavioral efforts, such as changing your approach to eating and exercise, regardless of whether you lost weight with bariatric surgery or through non-surgical methods," says lead author Dale Bond, PhD, of The Miriam Hospital's Centers for Behavioral and Preventive Medicine. "Behavioral modifications and lifestyle changes are critical components to long-term weight loss maintenance."

Harm-reduction Cigarettes Are More Toxic Than Traditional Cigarettes, UCR Study Finds
Typically, tobacco companies market harm-reduction cigarettes as being safer than traditional "full-flavored" brands, leading many smokers to conclude that the use of harm-reduction brands lowers their exposure to toxicants.

But a UC Riverside study now shows that smoke from these "light" or "low-yield" harm-reduction cigarettes retains toxicity and that this toxicity can affect prenatal development.

"Many chemicals found in harm-reduction cigarette smoke have not been tested, and some are listed by manufacturers as safe," said Prue Talbot, a professor of cell biology who led the study. "But our tests on mice clearly show that these chemicals adversely affect reproduction and associated development processes. The effects are likely to be the same in humans, in which case pregnant women would be particularly vulnerable to the effect of smoke from these cigarettes."

Precious Metal Could Lead To Next Generation Of Cancer Treatments
A precious metal which has never before been used in a clinical setting is being developed as an anti-cancer agent by University of Warwick researchers. The metal, osmium, is closely related to platinum, which is widely used to treat cancers in the form of the drug cisplatin. Most famously, the cyclist Lance Armstrong was treated with cisplatin for testicular cancer.

Now the researchers, based in the Department of Chemistry, at the University of Warwick, are working closely with Warwick Ventures, the university's technology transfer office, to seek partners to help develop the potential of osmium through more extensive biological tests. The team will be presenting their work on 9 December at the national university technology showcase event, Bioversity.

Professor Peter Sadler, of the Department of Chemistry, explained: "Although cisplatin has been proven to be a very successful treatment; it is not useful for all kinds of cancer. It is also quite a toxic therapy, which can produce side effects and, from a clinical point of view, cells can also become resistant to platinum."

Believe it or not
Country faces Santa shortage

Wanted: Cheerful, chubby men, preferably with fluffy white beards and no criminal record, ready to work hard for one month.

Germany is running out of qualified Santa Clauses and needs to recruit and train them fast, a leading job agency says.

Germans are trying to shut out the financial crisis by taking comfort in traditional festivities, and there is an acute shortage of Santas to entertain children at shopping centers, Christmas markets and private parties.

"Being Santa is not an easy job," Jens Wittenberger, in charge of Santa Claus recruitment at the Jobcafe Munich, told Reuters Monday. "To be honest, not many people have what it takes to be a good Father Christmas."

The job center wants its Santas to be child-friendly, good organizers, reliable and have acting skills. They also need a clean police record.

"You can't have your Santa drive up in a car," said Wittenberger. "Every child knows that Santa travels in a sleigh pulled by reindeer so we don't want to disappoint anybody." Santas are told to park their car a few streets away and walk.

"People are turning to traditions to protect their children from the 'evils of the real world', especially in the wake of this financial turmoil," Wittenberger said.

Recruitment sessions are being held in cities across the country, and while the job may be stressful, it's better than being jobless, Wittenberger said.

"Santas can make up to 60 euros ($75) an hour," he said. "That's not bad, is it?"
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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