IN THIS ISSUE:

• Possible New Cancer Treatment? Antifungal Drug Stops Blood Vessel Growth
   
• How Morphine Breaks the Brain's Brakes May Be Key to Breaking Addiction
   
• Scientists Identify New Genes Linked To Diabetes
   
• Continuous Erythropoiesis Receptor Activator (CERA): An Erythropoiesis-Stimulating Agent For The Treatment Of Anemia In Patients With Chronic Kidney Disease
   
• Many Americans Fall Short on Vitamin D - Elderly at Risk for Muscle Weakness and Poor Physical Performance
   
• Decrease in Breast Cancer Rates Related to Reduction in Use of Hormone Replacement Therapy
   
• New Drug Counteracts Overeating

• Believe It Or Not

• News From MedWatch

• Research Update

• Recently Approved Drugs/Indications

• FDA Recalls and Safety Alerts in the Past 60 Days

• Drug Shortages

• Recommend Edmund's Newsletter

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Possible New Cancer Treatment? Antifungal Drug Stops Blood Vessel Growth

Researchers at Johns Hopkins have discovered to their surprise that a drug commonly used to treat toenail fungus can also block angiogenesis, the growth of new blood vessels commonly seen in cancers. The drug, itraconazole, already is FDA approved for human use, which may fast-track its availability as an antiangiogenesis drug.
In mice induced to have excess blood vessel growth, treatment with itraconazole reduced blood vessel growth by 67 percent compared to placebo. "We were surprised, to say the least, that itraconazole popped up as a potential blocker of angiogenesis," says Jun O. Liu, Ph.D., professor of pharmacology. "We couldn't have predicted that an antifungal drug would have such a role."
In their search for antiangiogenesis drugs, the researchers worked with cells from human umbilical cords, a rich source of blood vessels, and exposed them to 2,400 existing drugs - including FDA- and foreign-approved drugs, as well as nonapproved drugs that had passed safety trials - to see which ones could stop the cells from dividing.
"The best outcome was to find an already approved drug that worked, and the fact that we did was very satisfying," says Liu, whose study appears online in ACS Chemical Biology.

For more information CLICK HERE

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How Morphine Breaks the Brain's Brakes May Be Key to Breaking Addiction

A single dose of morphine can block a process in the brain associated with learning and memory for as long as a full day after being ingested, according to a new study. The disruption causes a neuronal imbalance that researchers say could be the first step in the development of addiction. They add that therapies designed to prevent this from happening during drug use could one day help to thwart chemical dependency.
A team of Brown University scientists found that morphine disrupts an inhibitory mechanism in the ventral tegmental area (VTA), a cluster of neurons in the center of the brain responsible for processing naturally rewarding actions, such as eating and sexual activity. The resulting imbalance between excitation and inhibition allows the levels of the neurotransmitter dopamine, a pleasure chemical, to surge.
Morphine blocks a process called long-term potentiation (LTP), which strengthens the synapses (connections between neurons) to make the transfer of information between cells more efficient. Neuroscientists have identified this mechanism as a cellular process behind memory and learning.
In the current study, scientists focused on synapses between dopamine-containing neurons and those that contain GABA (gamma-aminobutyric acid), an inhibitory chemical. "The ability to have LTP at these synapses is probably a natural mechanism to balance excitation and inhibition," says senior study author Julie Kauer, "so the synapse won't get crazily excited."

For more information CLICK HERE

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Scientists Identify New Genes Linked To Diabetes

The most thorough probe to date of the genetic underpinnings of the most common form of diabetes has identified a new batch of genes that increases risk for a disease affecting 200 million people globally.
The findings by four international teams of researchers, published on Thursday in the journals Science and Nature Genetics, provided great insight into the role played by genes in a disease also tremendously influenced by behavior -- eating too much and exercising too little.
The scientists hope the findings can help guide development of new drugs to treat type 2 diabetes, previously known as adult-onset diabetes, and genetic tests to determine a person's predisposition for developing it.
Despite its growing global prevalence, the disease's underlying causes have been only minimally understood, restricting treatment and prevention efforts.

For more information CLICK HERE

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Continuous Erythropoiesis Receptor Activator (CERA): An Erythropoiesis-Stimulating Agent For The Treatment Of Anemia In Patients With Chronic Kidney Disease

Chronic kidney disease (CKD) affects 20 million Americans, and an additional 20 million are at increased risk for developing CKD. Anemia is a common complication in patients with CKD. The predominant cause of anemia in this patient population is a deficiency in erythropoietin. Continuous erythropoiesis receptor activator (CERA) is a new erythropoietic-stimulating agent (ESA) that is undergoing FDA review for the treatment of anemia in patients with CKD, including in those undergoing dialysis. CERA has an extended half-life and a mechanism of action that promotes increased stimulation of erythropoietin receptors compared with other ESAs. In clinical trials, CERA dosed every 3 to 4 weeks has demonstrated efficacy similar to that of epoetin alfa and darbepoetin alfa in maintaining hemoglobin concentrations within the target hemoglobin range. CERA has generally been well tolerated in clinical trials. Further studies are needed to determine what the role of CERA will be in the hospital and outpatient settings.
The number of patients with chronic kidney disease (CKD) in the United States is increasing. According to the National Kidney Foundation, CKD affects 20 million Americans (1 in 9 adults), and an additional 20 million are at increased risk for developing CKD. The 2 main causes of CKD are diabetes and high blood pressure, which are responsible for up to two-thirds of all CKD cases.
Anemia (defined by the National Kidney Foundation as a hemoglobin concentration less then 12 g/dL in women and less then13.5 g/dL in men) is a common complication in patients with CKD.1 The primary cause of anemia in this population is a deficiency in erythropoietin. Approximately 90% of erythropoietin is produced in the kidneys, and the remainder is produced in the liver. In patients with normal renal function, erythropoietin concentrations can increase up to 100-to 1,000-fold during hypoxia or anemia. However, in patients with impaired renal function, the kidneys are unable to respond with the appropriate physiologic increase in erythropoietin concentration. In addition to erythropoietin deficiency, other factors may contribute to anemia in patients with CKD, including a shortened red blood cell survival time (from approximately 120 days in patients with normal renal function to 40–90 days in patients with impaired renal function); iron and vitamin deficiencies; and blood loss, especially in patients who are undergoing hemodialysis.

For more information CLICK HERE

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Many Americans Fall Short on Vitamin D - Elderly at Risk for Muscle Weakness and Poor Physical Performance

Even though many foods are fortified with vitamin D, a growing number of medical experts say many people do not get enough.
Older men and women who fail to get enough vitamin D -- either from their diets or exposure to the sun -- are at heightened risk for muscle weakness and poor physical performance, a new study shows.
Vitamin D is vital to bone health because it allows the body to use calcium in a way that keeps bones healthy. People who don't have enough vitamin D get rickets, which is essentially damaged bones, though the condition is rare in the developed world.
The National Academy of Sciences says that for people older than 50, 200 international units (iu) of vitamin D per day is adequate. People between 51 and 70 need 400 iu and people older than 70 need 600 iu.
But many experts think that amount is too low, according to ABC News medical editor Dr. Tim Johnson.
"But there is probably no one who can tell you exactly how much do you need. Even the government calls these adequate amounts rather than daily recommended amounts," Johnson said.

For more information CLICK HERE

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Decrease in Breast Cancer Rates Related to Reduction in Use of Hormone Replacement Therapy

The sharp decline in the rate of new breast cancer cases in 2003 may be related to a national decline in the use of hormone replacement therapy (HRT), according to a new report in the April 19, 2007, issue of the New England Journal of Medicine. The report used data from the Surveillance, Epidemiology and End Results (SEER) program of the National Cancer Institute (NCI), part of the National Institutes of Health.
Age-adjusted breast cancer incidence rates in women in the United States fell 6.7 percent in 2003. During this same period, prescriptions for HRT declined rapidly, following highly-publicized reports from the Women’s Health Initiative (WHI) study that showed an increased risk of breast cancer, heart disease, stroke, blood clots, and urinary incontinence among postmenopausal women who were using hormone replacement therapy that included both estrogen and progestin. The two most commonly prescribed forms of HRT in the United States, Premarin® and Prempro™, had their steepest declines starting in 2002-2003 — from 61 million prescriptions written in 2001 to 21 million in 2004.
Led by senior investigator, Donald Berry, Ph.D., of the University of Texas M.D. Anderson Cancer Center, Houston, Texas, the research team showed that the decrease in breast cancer incidence began in mid-2002 and leveled off after 2003. Comparing rates from 2001 and 2004 showed a decrease in annual age-adjusted incidence of 8.6 percent. The decrease occurred only in women over the age of 50 and was more evident in women with cancers that were estrogen receptor (ER) positive — tumors that need estrogen in order to grow and multiply. The speed at which breast cancer rates declined after the WHI announcements may indicate that extremely small ER-positive breast cancers may have stopped progressing, or even regressed, after HRT was stopped.
“Breast cancer is the most frequently diagnosed cancer among women in the United States, and we have made great strides in its treatment,” said NCI Director John E. Niederhuber, M.D. “Still, we don’t know all the causes of breast cancer, and breast cancer rates had been increasing for two decades up to 2002. Finding the simple ways, such as limiting HRT use to decrease breast cancer risk, is a step forward.”

For more information CLICK HERE

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New Drug Counteracts Overeating

A pill might one day achieve the same calorie-burning effects of vigorous exercise.
It's possible, according to a scientist who's developed a potential weight-loss drug that revs up cellular metabolism, much like what happens during heavy physical activity.
In mice, the drug does "result in protection against weight gain on high-fat and high-caloric diets," said Ronald M. Evans, an investigator at The Salk Institute in San Diego. "We're very excited by the potential extension to people."
Of course, there's one big caveat: mice aren't people, and no one knows if the drug will allow ordinary folks to eat to their heart's content without gaining weight.
At stake is a medical solution for people who want to lose weight but either will not diet and exercise properly or can't lose enough weight that way. Diet pills have existed for decades, but they have significant side effects and aren't always effective.
One possible solution is to rev up the body's metabolism, the process whereby it turns food into energy. That's where Evans enters the picture.

For more information CLICK HERE

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Believe It Or Not

Lilly gets U.S. approval for Prozac for pooches

Man's best friend may have a new best friend after Eli Lilly and Co. won U.S. approval to sell its former blockbuster antidepressant Prozac to treat misbehaving mutts.
The drug, repackaged into a chewable, beef-flavoured tablet to be called Reconcile, was officially approved by the Food and Drug Administration for the treatment of separation anxiety in dogs in conjunction with behaviour modification training, the drugmaker said on Wednesday.
The product gives new life to a drug that was once Lilly's most lucrative medicine before it lost patent protection several years ago and sales evaporated in the face of generic competition.
"Lilly research shows that 10.7 million, or up to 17 percent of U.S. dogs suffer from separation anxiety," Steve Connell, manager of technical, academic and consumer services for companion animal health at Lilly, said in a statement.
Canine separation anxiety can occur when dogs are left alone and manifests itself in a range of undesirable behaviours, such as destruction, excess barking, eating disorders or urinating or defecating in the house.
The drug, known chemically as fluoxetine hydrochloride, can minimise a pet's distress from being left alone, Lilly said. It belongs to a class of drugs known as selective serotonin reuptake inhibitors, or SSRIs, which are used to treat human depression.
Lilly said veterinarians may recommend tests before diagnosing separation anxiety to rule out physiological rather than emotional causes of inappropriate behaviour.
Reconcile will compete with Clomicalm from Swiss drugmaker Novartis, a repackaged form of another older antidepressant from a different class of drugs that is also approved for separation anxiety in dogs.

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A political cartoon that has nothing to do with the content of this publication. (but I think it is funny and maybe accurate)

What Would Georg W. Bush Do?

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 CLICK HERE

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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 CLICK HERE

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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

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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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Edmund M. Hayes, R.Ph., M.S., Pharm.D.
Departments of Pharmacy and Medicine
Stony Brook University Hospital
State University of New York at Stony Brook
Stony Brook, New York, 11794
631 444-2668

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