IN THIS ISSUE:

• First Use Of Cord Blood To Alter Course Of Type 1 Diabetes
   
• Echinacea 'Can Prevent A Cold'
   
• Drug Warning Prompts Treatment Changes For Those Infected With Hepatitis B And HIV
   
• New Alzheimer's Drug Begins Clinical Trials
   
• New FDA Safety Rules For Dietary Products
   
• FDA Approves First Drug for Treating Fibromyalgia
   
• Omega-3 Fatty Acids Protect Eyes Against Retinopathy, Study Finds

• 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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First Use Of Cord Blood To Alter Course Of Type 1 Diabetes

In a small pilot study, transfusion of stored, autologous, umbilical cord blood into a group of children newly diagnosed with type 1 diabetes appears to have reduced their disease severity, possibly re-setting the immune system and slowing the destruction of their insulin-producing cells, according to a report presented today at the American Diabetes Association's 67th Annual Scientific Sessions.
"After only six months, it is too early to tell how long the children will benefit from this therapy, but early signs indicate that it may have helped enhance blood glucose control and management," said Michael J. Haller, MD, Assistant Professor of Pediatric Endocrinology at the University of Florida College of Medicine and lead author of the study, in a recent interview.
"But more important than the potential benefit in these children, this first use of cord blood in diabetes will help us focus on what it is in the cord blood that yielded the benefit," he said. "We then hope to isolate and grow that cell type to develop therapies for a larger pool of people, not just those who have stored cord blood." He discussed how such a cellular therapy might be one component of a future immune-modulating "cocktail."
Nearly 21 million Americans have diabetes, a group of serious diseases characterized by high blood glucose levels that result from defects in the body's ability to produce and/or use insulin. Diabetes can lead to severely debilitating or fatal complications, such as heart disease, blindness, kidney disease, and amputations. It is the fifth leading cause of death by disease in the U.S.


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Echinacea 'Can Prevent A Cold'

Taking the herbal remedy echinacea can more than halve the risk of catching a common cold, US researchers say.
They found it decreased the odds of developing a cold by 58% and the duration of colds by a day-and-a-half.
The results in The Lancet Infectious Diseases conflict with other studies that show no beneficial effect.
Experts believe echinacea, a collection of nine related plant species indigenous to North America, may work by boosting the body's immune system.

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Drug Warning Prompts Treatment Changes For Those Infected With Hepatitis B And HIV

Cross-resistance alarms raised earlier this year by Johns Hopkins researchers about a widely used antiviral therapy for hepatitis B liver infections have prompted swift treatment revisions by the drug's maker and governmental agencies.
Findings by a team of Johns Hopkins infectious disease specialists, to be published in the latest issue of The New England Journal of Medicine online June 21, showed that entecavir should not be used on its own in patients co-infected with HIV. Use of the drug led to cross-resistance to certain antiviral drugs used to treat the AIDS virus.
As a result of the study's initial presentation in February at the 2007 Conference on Retroviruses and Opportunistic Infections (CROI), Bristol-Myers Squibb, the drug's manufacturer, changed its product labeling to warn of the potential for HIV drug resistance, notified prescribing physicians and informed the U.S. Food and Drug Administration. The U.S. Department of Health and Human Services (HHS) also revised its treatment guidelines. HHS now recommends against using entecavir, better known by its brand name Baraclude, as the first option in treating hepatitis B in co-infected patients who are not already using drugs to suppress HIV.

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New Alzheimer's Drug Begins Clinical Trials

A drug based on the design of a Purdue University researcher to treat Alzheimer's disease just began the first phase of human clinical trials.
"Millions of people suffer from this devastating disease and treatment options are very limited," said Arun Ghosh, the Purdue professor who led the creation of the treatment molecule. "Current drugs manage the symptoms, but this could be the first disease-modifying therapy. It may be able to prevent and reverse the disease."
CoMentis Inc., a biopharmaceutical company based in San Francisco, is initiating the clinical trials of the experimental drug CTS-21166. Ghosh, who has dual appointments in the departments of chemistry and medicinal chemistry, is a scientific co-founder of the company with Jordan Tang, the J.G. Puterbaugh Chair in Medical Research at the Oklahoma Medical Research Foundation.
The collaborative work of Ghosh and Tang led to the development of a treatment that could intercept and disable the disease at an early stage.

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New FDA Safety Rules For Dietary Products

For the first time, makers of vitamins, herbal pills and other dietary supplements will have to test all product ingredients.
The Food and Drug Administration (FDA) said it is phasing in new rules to address concerns that existing regulations allowed supplements onto the market that were contaminated or didn't contain ingredients claimed on the label.
The new rules will govern manufacturing, packaging, storage and labeling and will set testing guidelines for ingredients and final products.
The $22 billion supplement industry has a history of suspect quality and safety. Independent lab tests have found one in four supplements tested to be substandard.

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FDA Approves First Drug for Treating Fibromyalgia

The U.S. Food and Drug Administration today approved Lyrica (pregabalin), the first drug to treat fibromyalgia, a disorder characterized by pain, fatigue and sleep problems.
Lyrica reduces pain and improves daily functions for some patients with fibromyalgia.
"Today's new approval marks an important advance, and provides a reason for optimism for the many patients who will receive pain relief with Lyrica," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research. "However, consumers should understand that some patients did not experience benefit in clinical trials. We still have more progress to make for treatment of this disorder."
Persons with fibromyalgia typically experience long-lasting or chronic pain, as well as muscle stiffness and tenderness. Fibromyalgia affects about 3 million to 6 million people in the United States each year. The disorder mostly affects women and typically develops in early-to-middle adulthood.
There is no test for the diagnosis of fibromyalgia. Doctors make a diagnosis by conducting physical examinations, evaluating symptoms, and ruling out other conditions.

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Omega-3 Fatty Acids Protect Eyes Against Retinopathy, Study Finds

Omega-3 polyunsaturated fatty acids protect against the development and progression of retinopathy, a deterioration of the retina, in mice. This is the major finding of a study that appears in the July 2007 issue of the journal Nature Medicine. The study was a collaborative effort by researchers at Children’s Hospital Boston, the primary pediatric teaching affiliate of Harvard Medical School, Brigham and Women’s Hospital, Massachusetts General Hospital, the University of Goteborg in Sweden, and the National Eye Institute (NEI) and National Institute on Alcohol Abuse and Alcoholism (NIAAA) of the National Institutes of Health (NIH).
Paul A. Sieving, M.D., Ph.D., director of the NEI, said, “This study explores the potential benefit of dietary omega-3 fatty acids in protecting against the development and progression of retinal disease. The study gives us a better understanding of the biological processes that lead to retinopathy and how to intervene to prevent or slow disease.”
The researchers studied the effect of the omega-3 fatty acids EPA and DHA, derived from fish, and the omega-6 fatty acid arachidonic acid on the loss of blood vessels, the re-growth of healthy vessels, and the growth of destructive abnormal vessels in a mouse model of oxygen-induced retinopathy. The retinopathy in the mouse shares many characteristics with retinopathy of prematurity (ROP) in humans. ROP is a disease of the eyes of prematurely born infants in which the retinal blood vessels increase in number and branch excessively, sometimes leading to bleeding or scarring. Infants who progress to a severe form of ROP are in danger of becoming permanently blind. There are also aspects of the disease process that may apply to diabetic retinopathy, a disease in which blood vessels swell and leak fluid or grow abnormally on the surface of the retina, and age-related macular degeneration (AMD), a disease of the macula, the part of the retina responsible for central vision, and a leading cause of vision loss in Americans 60 years of age and older.

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Believe It Or Not

It's official: Rhythm method off beat

Knowing when a woman is fertile is now officially much trickier with new research showing that a woman's "fertile window" - the six days during a menstrual cycle when intercourse can result in pregnancy - is strikingly unpredictable.
US research published in this week's British Medical Journal shows that even women with very regular periods stand a 10% chance of being fertile at any given day between days 6 and 21 of their cycle. Even on the day their next period is expected, women have a 4-6% chance of being fertile.
"This research is a very scientific way of proving that the rhythm method doesn't work," commented Professor Gab Kovacs, president of FPA and director of Monash IVF.
The research team lead by Allen J. Wilcox of the US National Institutes of Environmental Health Sciences (NIEHS) analysed three menstrual cycles of 213 healthy women who were planning a pregnancy, timing the ovulation using urinary metabolites of oestrogen and progesterone.
They found that only 30% of women had their fertile window entirely within the usual clinical guidelines of days 10 and 17 of the menstrual cycle and that most women reach their fertile window earlier or much later.
The researchers say that the clinical guidelines assumed that ovulation occurred exactly 14 days before the onset of the next menses, and that the fertile window extended before and after ovulation; however, these assumptions were based on outdated information
According to Professor Kovacs the rhythm method relied on using previous cycles to guestimate when ovulation was occurring, however it was more reliable to use a method that tracked what was happening in the current cycle.
"Anyone who wants to use a natural method should use the Billings method which uses cervical mucus observations to assess when ovulation is occurring", Professor Kovacs told ABC Science Online. He has been using this method for the last 20 years to help people get pregnant using donor insemination.
But, he warned, although the Billings method is much more effective, it still doesn't work for everyone.
According to the NIEHS researchers, the timing of the fertile window is even less predictable for women with less regular cycles, such as adolescents.

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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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