IN THIS ISSUE:

• Immunization Against Type 1 Diabetes: Mice Successfully Treated
   
• Man's Best Friend Joins the Fight Against Cancer
   
• Antidepressant Use May Boost Fracture Risk
   
• New Hope For Severe Heart Disease Patients
   
• Vitamin D and Calcium May Lower Breast Cancer Risk
   
• FDA Approves New Drug for Advanced Kidney Cancer
   
• Spoonful of Medicine, and Risk?

• 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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Immunization Against Type 1 Diabetes: Mice Successfully Treated

Researchers in France and Germany have successfully treated type 1 diabetic mice with a vaccination. The vaccine they designed in this model included structures that the immune system mistakenly attacks in type 1 diabetes.
The researchers showed that, in principle, it is possible to treat autoimmune diseases (diseases, in which the immune system attacks the own body) by inducing “active tolerance”. That means activating the immune system so that it no longer attacks the body’s own structures, but instead protects them from the immune attack.
Autoimmune diseases develop when the immune system can no longer distinguish between “non-self” and “self” and attacks the body’s own structures as is the case in type 1 diabetes. In this severe metabolic disorder, misguided T cells of the immune system destroy the cells of the pancreas that produce insulin, a hormone essential for life. The affected persons, who often develop the disease already during childhood, are subjected to insulin injections throughout their entire lives.
Previously in an experiment with mice, Drs. Falk and Rötzschke proved that it is possible to block the misdirected immune system. They vaccinated mice with modified structures of the same organ against which the immune system runs amok.

For more information CLICK HERE

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Man's Best Friend Joins the Fight Against Cancer

Alex doesn't know it, but the 12-year-old golden retriever is actually a hero of cancer research.
"When she was about 10, we noticed that she started to limp," said her owner, Kevin Darling, an IT professional living near Columbus, Ohio. "She had the beginning stages of osteosarcoma -- bone cancer."
Because the tumor was confined to Alex's left front leg, veterinarians recommended amputating the limb and then giving the dog chemo. "They said she probably had a 50 percent chance of living one year," said Darling, 45.
He took that chance, and nearly three years later, Alex, minus one front leg, is still "full-tilt running, keeping up with my other dogs," Darling said.
And the bone cancer? A tiny piece of it, along with blood samples from a number of Alex's littermates and other relatives, is slated to become part of the first U.S. canine tumor tissue bank in Frederick, Md. The bank -- formally called a "biospecimen repository" -- began accepting the first of a projected 3,000 canine biopsy samples on May 1.
The new facility lies adjacent to the U.S. National Cancer Institute's own library of human cancer samples. That's no accident -- the canine tissue bank is the dream of a group of researchers who know that malignancies that occur spontaneously in dogs hold vital clues to human cancer.

For more information CLICK HERE

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Antidepressant Use May Boost Fracture Risk

Evidence is accumulating that depression is a risk factor for osteoporosis, reports the June 2007 issue of Harvard Women's Health Watch. A recent study found that people ages 50 and over who regularly took antidepressants called selective serotonin reuptake inhibitors (SSRIs) had double the rate of fractures as people not using such medications. Other research points to depression itself as a source of endocrine changes that can damage bone.
Whether the danger comes from depression, the drugs used to treat it, or something else, doctors are paying more attention to this association. During the 1990s, depression began to emerge as a possible cause of bone loss, rather than a result.
Scientists studied women who didn't have osteoporosis symptoms or even know they had the condition. They found lower bone mineral density in those who were depressed. Moreover, the link was found in both younger women and women past menopause. Other studies have found a similar relationship, so investigators have been looking at hormones and brain chemicals potentially involved in both depression and bone loss.
Researchers working with an animal model found that depression triggers the release of noradrenaline, which interferes with bone-building cells. Moreover, they found that imipramine-a member of an older class of drugs called tricyclic antidepressants-reversed both depression and depression- induced bone loss.

For more information CLICK HERE

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New Hope For Severe Heart Disease Patients

Patients with severe heart disease may soon have access to a simple injection to help manage their symptoms and reduce their need for large amounts of pain relief medication if a new study is successful.
Funded by the MBF Foundation, the second phase of the project will test whether using the G-SCF hormone to stimulate the release of blood vessel-forming stem cells can alleviate the condition, improve heart function and increase quality of life for people with severe heart disease.
Executive Director of the Victor Chang Cardiac Research Institute, Professor Bob Graham, said evidence from the first phase of the study into the safety of the G-SCF treatment gave hope to the patients taking part. Many of these patients currently rely on numerous medications to relieve the pain caused by the lack of blood supply to the heart.
"The 20 patients trialling the innovative treatment responded extremely positively, with most experiencing a reduction in angina and finding that they were able to reduce their intake of pain relief with marked improvements in some patients," Professor Graham said.

For more information CLICK HERE

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Vitamin D and Calcium May Lower Breast Cancer Risk

Young women who consume higher amounts of calcium and vitamin D may have a lower risk of developing breast cancer, a new study shows.
Led by Dr. Jennifer Lin of Brigham and Women's Hospital and Harvard Medical School, the research team assessed 10,578 premenopausal and 20,909 postmenopausal women age 45 and older who were part of the Women's Health Study. They reported their findings in today's issue of Archives of Internal Medicine.
"A possible explanation for the evident difference by menopause status may be related to the joint relationship among calcium, vitamin D and insulin-like growth factors (IGFs)," the authors wrote. "In vitro (laboratory) studies have suggested that calcium and vitamin D exert anticarcinogenic effects on breast cancer cells expressing high levels of IGF-1 and IGF binding protein 3. Calcium, vitamin D and IGF binding protein 3 have been shown in vitro to interact with each other in promoting growth inhibition in breast cancer cells."

For more information CLICK HERE

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FDA Approves New Drug for Advanced Kidney Cancer

The U.S. Food and Drug Administration (FDA) today approved Torisel (temsirolimus) for the treatment of a certain type of advanced kidney cancer known as renal cell carcinoma. Torisel was approved based on a study that showed use of the drug prolonged survival of patients with renal cell carcinoma. The drug is an enzyme inhibitor, a protein that regulates cell production, cell growth and cell survival.
"We have made significant advances in the battle against kidney cancer,” said Steven Galson, M.D., M.P.H., director of the FDA’s Center for Drug Evaluation and Research. "Torisel is the third drug approved for this indication in the past 18 months, and one that shows an increased time in survival for some patients."
The approval of Torisel follows the December 2005 approval of Nexavar (sorafenib), which was based on a delay in progression of disease. In January 2006, Sutent (sunitinib) received accelerated approval based on durable response rate, or tumor size reduction, and was later demonstrated to delay tumor progression.
The safety and effectiveness of Torisel were shown in a clinical trial of 626 patients divided into three groups. One group received Torisel alone, another received a comparison drug called Interferon alfa, and a third received a combination of Torisel and interferon.

For more information CLICK HERE

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Spoonful of Medicine, and Risk?

It's been a week since the release of a controversial study suggesting the popular diabetes drug Avandia increases the risk of heart attacks and heart deaths.
The Food and Drug Administration is convening a panel of experts to investigate, but there is at least one point on which most doctors appear to agree: The whole process of ensuring drug safety in this country is seriously flawed.
In an exclusive interview with ABC News, Dr. Janet Woodcock, deputy commissioner of the FDA, conceded: "We are finding more problems with marketed medications, but not just with recently marketed medications, but drugs approved long ago."
A report from the Government Accounting Office found that, after approval, 51 percent of drugs were later discovered to have major safety problems requiring label changes. And in 3 percent to 4 percent of drugs, the safety issues were so serious the drugs were pulled off the market.
Dr. Jerry Avorn, author of "Powerful Medicines: The Benefits, Risks and Costs of Prescription Drugs," called that "unacceptable."

For more information CLICK HERE

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Believe It Or Not

Bullet removal ends Chinese woman's 64-year headache

A Chinese woman's 64-year-old headache has ended after doctors removed a bullet that relatives said lodged in her skull when Japanese soldiers shot her during World War Two, state media reported on Monday.
Jin Guangying, now 77, lost consciousness after a Japanese patrol in Jiangsu province fired on her in 1943 as she went to meet her grandfather, a guerrilla fighter, the Beijing News said.
"When she came to, her head was wrapped in a bandage and she never realised there was a bullet lodged deep in her head," the paper said.
Later, she would regularly have headaches, foam at the mouth and "talk nonsense... like she had gone mad", the paper said.
Jin's family had thought her symptoms were due to a tumour, the paper said, quoting Wang Zhengping, the woman's daughter.
"Because our family was poor, we were never able to have her taken for a thorough check-up," Wang said.
A military expert in Nanjing, the Jiangsu capital, had identified the bullet as one used by Japanese soldiers at that time, the newspaper said.
Jin's relatives planned to seek redress for her more than 60 years of suffering.
"As her children, we will soon go to Nanjing to consult with relevant experts as to how to seek compensation from the Japanese government, and will definitely be seeking a public apology," the paper quoted Wang as saying.

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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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