IN THIS ISSUE:

• Cinnamon Does Not Aid Type 1 Diabetes Control
   
• Novel Antigen-cloning Technique May Boost Efforts To Develop A Melanoma Vaccine
   
• Blood Pressure 'Is In The Brain'
   
• Pain Medication and Antipsychotics May Stop Brain Tumor Growth
   
• Drugs Losing Efficacy Against Gonorrhea
   
• Gleevec Decreases Cancer Recurrence for Patients with Primary Gastrointestinal Stromal Tumor
   
• Debate Builds Over Drug Companies' Fees to FDA

• 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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Cinnamon Does Not Aid Type 1 Diabetes Control

Despite earlier promising findings, it seems unlikely that cinnamon can improve blood sugar levels in people with type 1, or insulin-dependent, diabetes, researchers report.
Previous research has shown that cinnamon appears to help fat cells recognize and respond to insulin. In test tube experiments and in animal studies, the spice led to a noteworthy increase in the processing of glucose.
Moreover, in a previous study of people with type 2, or non-insulin dependent, diabetes, those who incorporated a small amount of cinnamon each day for 40 days into their normal diets experienced a healthy drop in blood sugar levels.
Against this backdrop, Dr. Kevin M. Curtis from Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire and colleagues had 72 adolescents with type 1 diabetes take 1 gram of cinnamon per day or a matching placebo while they continued with their existing medication, diet and exercise routines.

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Novel Antigen-cloning Technique May Boost Efforts To Develop A Melanoma Vaccine

In recent years, researchers have worked to develop a number of vaccines to help the immune system fight tumors. Cancer vaccines are not intended to prevent cancer; rather, they are used to boost immune responses to preexisting tumors. Unlike traditional chemotherapy, vaccines have relatively low toxicity and, potentially, a high degree of efficacy.
To date, these vaccines have rarely been designed to directly stimulate one of the body's most critical immune responders, the helper T cells. Though helper T cells contain receptors on their cell surfaces that are capable of recognizing and binding to tumor-related antigens, scientists have been stymied by the complex and time-consuming process required to isolate and clone the antigens for vaccine development.
In working to identify a key tumor antigen in melanoma and other cancers, scientists at The Wistar Institute have now developed a novel way to clone an antigen recognized by a helper T cell. Already, Herlyn's group has used the new cloning technique to identify a new tumor antigen called ribosomal protein L8, or RPL8. Findings on the new cloning method and the newly identified tumor antigen will be published as a Priority Report in the April 15 issue of Cancer Research.
The new antigen-cloning approach may allow scientists to design vaccines capable of directly stimulating helper T cells, aiding the development of vaccines not only for cancer but also for infectious diseases, says Dorothee Herlyn, D.V.M., senior author on the study and a professor in the Molecular and Cellular Oncogenesis and Immunology programs at Wistar.

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Blood Pressure 'Is In The Brain'

The cause of high blood pressure may lie within the brain, rather than with problems relating to the heart, kidneys or blood vessels, research suggests.
Scientists at Bristol University say the findings could lead to new ways of treating the condition, which affects about one in five Britons.
The scientists isolated a protein, JAM-1, which appeared to trap white blood cells, obstructing blood flow.
This can cause inflammation and result in poor oxygen supply to the brain.
Professor Julian Paton and colleagues believe these, in turn, trigger events that raise blood pressure, the journal Hypertension reports.
The future challenge will be to understand the type of inflammation within the vessels in the brain Lead researcher Professor Julian Paton
Their studies in rats show JAM-1 is linked to raised blood pressure, but the exact mechanisms behind this are still unclear. They are now looking at the human brain to understand more.
Professor Paton explained: "The future challenge will be to understand the type of inflammation within the vessels in the brain, so that we know what drug to use, and how to target them.
"JAM-1 could provide us with new clues as to how to deal with this disease.
"We are looking at the possibility of treating those patients that fail to respond to conventional therapy for hypertension with drugs that reduce blood vessel inflammation and increase blood flow within the brain."

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Pain Medication and Antipsychotics May Stop Brain Tumor Growth

After screening nearly 1,300 chemical compounds, scientists have identified a number of drugs in use today that may in stop the growth of neural stem cells, including cancerous populations. The finding, reported in this week's issue of Nature Chemical Biology, opens up the possibility of using drugs already available to battle brain tumors, which kill an estimated 13,000 people in the U.S. yearly.
"A lot of the receptors for those drugs were thought to be exclusively expressed in mature cells in the central nervous system," says study co-author Peter Dirks, a neurosurgeon and researcher at The Hospital for Sick Children's Brain Tumor Research Center in Toronto, "They may have the same function on stem cells as they do on the mature cells," which makes them candidates for treating brain cancer. Dirks and his team found 160 compounds that interfered with the development and proliferation of neurospheres—clusters of cells in different stages of differentiation, ranging from stem cells to cells well on their way to becoming neurons or glia (cells that support and insulate neurons). The researchers then tested the drugs both in vitro, with cells derived from an embryonic mouse brain, human brain tumor cells and with cancer cells from knockout mice, which were genetically predisposed to develop brain tumors.
Several of the prescreened drugs seemed to inhibit tumor growth in the human and mouse cancer cells as well as in the knockout mice. "Some of the drugs were quite selective for the human cancer cells versus the normal human cells," Dirks says, "suggesting there may be some window of therapeutic opportunity." The drugs are already being used to treat other disorders.

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Drugs Losing Efficacy Against Gonorrhea

Antibiotic-resistant gonorrhea is spreading rapidly across the United States, federal health officials reported yesterday, raising alarm about doctors' ability to treat the common sexually transmitted infection.
New data from 26 U.S. cities show the number of resistant gonorrhea cases is rising dramatically, jumping from less than 1 percent of all gonorrhea cases to more than 13 percent in less than five years, the Atlanta-based Centers for Disease Control and Prevention reported.
In response, the CDC advised doctors treating gonorrhea to immediately stop using ciprofloxacin, marketed as Cipro, and other antibiotics in its class, which have been the first line of defense against the disease, and resort to an older class of drugs to ensure patients are cured and do not spread the stubborn infection.
"We've lost the ability to use what had been the most reliable class of antibiotics," said John M. Douglas Jr., who heads the CDC's division of sexually transmitted disease prevention. "This is necessary to protect both public and private health."

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Gleevec Decreases Cancer Recurrence for Patients with Primary Gastrointestinal Stromal Tumor

Preliminary results from a large, randomized, placebo-controlled clinical trial for patients with primary gastrointestinal stromal tumor (GIST), a type of tumor usually found in the stomach or small intestine, showed that patients who received imatinib mesylate (Gleevec ®) after complete removal of their tumor were significantly less likely to have a recurrence of their cancer compared to those who did not receive imatinib. The clinical trial was sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), and conducted by a network of researchers led by the American College of Surgeons Oncology Group (ACOSOG).
The data monitoring committee overseeing the trial (known as ACOSOG Z9001) recommended that the results from a recent interim analysis be made public because the study had met is primary endpoint of increasing recurrence-free survival.
“The standard treatment for primary GIST is complete surgical removal of the tumor without additional therapy,” said Elias A. Zerhouni, M.D., NIH Director. “It is excellent news that addition of this well-tolerated cancer pill to the treatment regimen can have such a positive impact on decreasing the risk of recurrence.”
Researchers found that approximately 97 per cent of patients in the study who received one year of imatinib after surgery did not have a recurrence of their cancer compared to 83 percent of patients who received one year of placebo. In addition, imatinib therapy was well tolerated by most patients enrolled in the study. The types of side effects observed in this trial were similar to those observed in other clinical trials with imatinib, and included nausea, diarrhea, and swelling. Presentation of detailed results from this trial is planned for a future scientific meeting.

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Debate Builds Over Drug Companies' Fees to FDA

Controversy continues to engulf renewal of the Prescription Drug User Fee Act (PDUFA), with the key issue being whether the law does enough to protect U.S. consumers from potentially harmful drugs.
The act was passed by Congress in 1992 to establish "user fees" that are paid by drug companies to the U.S. Food and Drug Administration to review and vote on new drug applications. In 2008, these user fees are expected to total $438 million and account for more than 42 percent of all the money the FDA receives for regulating drugs.
Now, several sides of the debate are expressed in a trio of opinions that will be published in the April 26 issue of The New England Journal of Medicine; the articles were released Friday to coincide with public debate on the issue.
Opinions about PDUFA, which has to be renewed every five years and is set to expire Sept. 30, vary. They range from those who think the user fees make the FDA too cozy with the drug companies, leading to compromised drug safety, to those who believe the funds are essential to the FDA. Still others think that more of these funds should be spent on drug safety than is currently planned by the FDA.
One of the NEJM articles, co-authored by Sean Hennessy, an assistant professor of pharmacology and epidemiology at the University of Pennsylvania School of Medicine, argues that more of the PDUFA money should go to FDA-funded drug safety studies once medications have been approved, to monitor their safety in the marketplace.

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Believe It Or Not

Bomb squad is asked to help clean up a pharmacy

It's not often that a bomb squad is asked to help clean up a pharmacy. But experts say a 2-ounce sample of picric acid in the basement of Sharrow Drug Store packed the punch of nearly half a stick of dynamite.
Store employees found the sample Thursday as they were cleaning out old chemicals. Store owner Nick Sharrow is relieved that the local bomb squad safely destroyed the sample Friday, saying its explosive capability was stunning.
"This is very similar to TNT," Sharrow said.
Picric acid isn't volatile as a liquid. But as it ages, it can form highly explosive crystals, Sharrow said. The sample discovered on the basement shelf dated back to around World War I.
The sample was probably overlooked when employees disposed of the rest of its picric acid supply in 1984, a process that also required the assistance of a bomb squad.
Picric acid was used as an antiseptic and in medical formulations to treat such afflictions as malaria, herpes and smallpox.
Authorities decided to remove the acid Friday around 8:15 a.m. because traffic would be light and school buses would have already passed.
The drug store and its second-story apartments were evacuated, as were neighboring businesses. The street was also closed to traffic during the removal.

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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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