IN THIS ISSUE:

• Bacteria Suggest New Approach To Alzheimer's Therapy
   
• Connecting Diabetes and Inflammation
   
• Study Finds COPD Patients Taking Inhaled Steroids Are At Risk Of Severe Pneumonia
   
• Would You Like Fries With That?
   
• Accounting for Proteins’ Internal Motion May Have Implications for Drug Design
   
• Adverse Reactions of Natural Health Products/Drugs Under-Reported, Study Shows
   
• Osteoporosis Therapies: Novel Agents Coming

• 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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Bacteria Suggest New Approach To Alzheimer's Therapy

New insights into how bacteria form fibers called curli offer intriguing clues to the formation of harmful protein tangles in diseases such as Alzheimer's, Huntington's and Parkinson's, University of Michigan researchers report.
The research builds on a chance discovery that U-M microbiologist Matthew Chapman and co-workers made five years ago. In research initially aimed at understanding urinary tract infections, they discovered that the common bacterium Escherichia coli makes and employs amyloid fibers, the same types of fibers that are the calling cards of many neurodegenerative diseases. Until then, amyloids were considered "biological blunders" that occurred only when proteins misfolded into deviant forms that aggregate into harmful clumps, Chapman said. But his work showed that bacteria produce amyloid fibers "by design" and use them to adhere to surfaces and to interact with other bacteria.
Since making the discovery, Chapman and his lab group have been exploring bacterial amyloids, using an approach that blends microscopy, biochemistry and genetics. In the current work, the researchers reveal details of how curli—functional amyloid fibers assembled by E. coli and certain other bacteria—are assembled.
In both bacteria and humans, amyloids form through a process known as nucleation, in which protein subunits link together in a coordinated fashion. Just as a snowflake begins as a speck of dust around which water freezes, an amyloid fiber also requires a template or nucleus to begin forming.


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Connecting Diabetes and Inflammation

It has long been known that type 1 diabetes is an autoimmune disease. The body attacks the islet cells in the pancreas that produce insulin. In recent years, the immune system has also been implicated in type 2 diabetes — in particular imbalances in cytokines, an immune system component that causes inflammation. These imbalances become especially marked as people become obese. Dr. Jerry Nadler and his colleagues are investigating the role of a key gene — 12/15-LO (12/15-lipoxygenase ) — that has been implicated in the immune-system induced inflammatory effects linked to both forms of diabetes and their complications.
It is not obesity in and of itself that causes type 2 diabetes. Research done with knockout mice — mice that are genetically engineered to have inoperative genes — has demonstrated that the 12/15-LO gene is the culprit. Knockout mice that lack the 12/15-LO gene do not develop diabetes, even when fed an extremely high-fat diet. This gene is present in the insulin-producing cells of the pancreas, and when activated causes the cells to malfunction. It is also expressed by macrophages, a type of white blood cell. “Under normal conditions, this gene is probably involved in cell development,” Nadler says. “It’s only in pathologic conditions that the gene is activated in adults.”
Macrophages appear in high concentrations in fatty tissue. With funding from the National Institutes of Health, Nadler has traced the mechanism by which the presence of large numbers of fat cells stimulate the macrophages to activate the 12/15-LO gene, and has documented the cascade of inflammatory reactions that results. He has found that the 12/15-LO gene produces two proteins that convert fatty acids into cytokines.

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Study Finds COPD Patients Taking Inhaled Steroids Are At Risk Of Severe Pneumonia

Patients with COPD (chronic obstructive pulmonary disease) are increasingly being prescribed inhaled corticosteroids to control exacerbations of the disease, but a new study finds that the anti-inflammatory drugs increase the chances that these patients will be hospitalized for pneumonia.
“In a large cohort of patients with COPD, we found that current inhaled corticosteroid use was associated with a significant 70 percent increase in the risk of being hospitalized for pneumonia,” said the researchers. “Furthermore, for the severest pneumonias leading to death within 30 days of hospitalization, the risk with current inhaled corticosteroid use was also significantly increased.”
These and other findings of the population-based study were reported in the second issue of the July American Journal of Respiratory and Critical Care Medicine, published by the American Thoracic Society.
Pierre Ernst, M.D., a clinical epidemiologist at McGill University, Canada, along with three other researchers from the university’s department of medicine, analyzed the hospitalization and drug prescription information from 1988 to 2003 of 175,906 patients with COPD living in Quebec, Canada. During that time, 23,942 of the patients were hospitalized for pneumonia.
In their report, the researchers noted that the admission rate for pneumonia increased with higher doses of inhaled steroids and that reduction in risk was observed once the medications were stopped. Among all patients taking inhaled steroids, there was a 53 percent increase in pneumonia deaths within 30 days of being admitted to the hospital.

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Would You Like Fries With That?

Exploiting interactions between food and drugs could dramatically lower the rapidly rising costs of several anticancer drugs, and perhaps many other medications, two cancer-pharmacology specialists suggest in a commentary in the July 16, 2007, issue of the Journal of Clinical Oncology.
University of Chicago oncologists Mark Ratain, MD, and Ezra Cohen, MD, call attention to the flip side of recent studies showing how certain foods can alter absorption or delay breakdown of precisely targeted anti-cancer drugs.
Instead of seeing such studies as highlighting a dosing problem, Ratain and Cohen argue that results like this one should point researchers toward a partial solution, a novel way to decrease medication costs while increasing benefits from these effective but expensive drugs.
The commentary was inspired by a study presented in March at the at the 2007 annual meeting of the American Society for Clinical Pharmacology and Therapeutics. Researchers from Dartmouth showed that taking the breast cancer drug lapatinib (TYKERB) with food--instead of on an empty stomach as suggested on the label--resulted in more of the drug being absorbed and available to treat the cancer.

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Accounting for Proteins’ Internal Motion May Have Implications for Drug Design

Researchers at the University of Pennsylvania School of Medicine are the first to observe and measure the internal motion inside proteins, or its “dark energy.”
This research has revealed how the internal motion of proteins affects their function and overturns the standard view of protein structure-function relationships, suggesting why rational drug design has been so difficult.
Using nuclear magnetic resonance spectroscopy, the investigators were able to look at the changes in the internal motion of calmodulin itself in each of the six different protein binding situations. They found a direct correlation between a change in calmodulin’s entropy – a component of its stored energy – and the total entropy change leading to the formation of the calmodulin-protein complex.
The findings were published in the current issue of Nature.

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Adverse Reactions of Natural Health Products/Drugs Under-Reported, Study Shows

The adverse effects of using prescription drugs side by side with natural health products (NHP) are being under-reported, so the potential risks may be underestimated by health-care professionals and the public, a study from the University of Alberta in Edmonton, Canada shows.
A literature review and survey of 132 pharmacists revealed that while 47 per cent reported that they had encountered a patient with a suspected adverse event, only 1.5 per cent reported this to Health Canada. In contrast, 19 per cent of the pharmacists had reported adverse reactions to prescription or non-prescription drugs.
The study, co-authored by the U of A, the University of Toronto and Health Canada, is published in this month’s issue of The Annals of Pharmacotherapy. “The data show that adverse events are not being reported or are being under-reported at a dramatic rate,” said Dr. Sunita Vohra, one of the study authors and an associate professor of pediatrics at the University of Alberta. “Natural health products should be treated with due respect.” While the number of potential adverse events is low relative to the rates of NHP use in Canada, such products may be effective, but they may also have side effects, Vohra said. Natural health products include such products vitamins, minerals probiotics, St. John’s wort, echinacea and garlic. There are 50,000 such products for sale in Canada.

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Osteoporosis Therapies: Novel Agents Coming

People with osteoporosis are benefiting from several new drugs that have reached the market in recent years, but the fight against the bone-thinning disorder is yet to be won. The National Osteoporosis Foundation estimates that one in every two women over the age of 50 will experience an osteoporosis-related fracture in her lifetime. Osteoporosis, a disease characterized by low bone mass and structural deterioration of bone tissue and an increased susceptibility to fractures, is the nation's most common bone disease, affecting more than 10 million people.
Another 34 million Americans are at increased risk for osteoporosis and fractures because of low bone mass. With 1.5 million osteoporotic fractures occurring in the United States every year, the direct medical costs are about $14 billion, which is estimated to swell to $50 billion by 2040.
With an aging population and increasing medical costs, osteoporosis research has experienced renewed attention from the medical community. Scientists are investing countless resources to better understand the disease at the cellular level. There are some 20 agents in all stages of development for the treatment of osteoporosis, according to the Pharmaceutical Research & Manufacturers of America in Washington, D.C.
"Osteoporosis is a silent disease that doesn't get as much attention as other conditions such as heart disease and diabetes. But it's an important women's health issue, and pharmacists can do so much to both prevent and treat it," said Amy Stump, Pharm.D., clinical assistant professor at the University of Wyoming School of Pharmacy.

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Believe It Or Not

11-year-old charged with driving drunk

An 11-year-old girl was charged with drunken driving after leading police on a chase at speeds of up to 100 mph that ended when she flipped the car in an Alabama beach town.
A video camera in the police car captured the look of surprise on the officer's face when he approached the wrecked car and got a look at the motorist.
The Mobile Press-Register newspaper said the patrolman saw the Chevrolet Monte Carlo speeding and flashed his lights to signal the driver to stop. Instead, the car sped faster, traveling at up to 100 mph (160 kph) before sideswiping another vehicle and flipping over in the Gulf Coast town of Orange Beach, Alabama, on Tuesday night.
The young driver, who lived nearby in Perdido Key, Florida, was treated at a hospital for scrapes and bruises and released to relatives. Police also charged her with speeding, leaving the scene of an accident and reckless endangerment.
The car belonged to a relative and police were still trying to find out where she got the alcohol. There was none in the vehicle but her blood alcohol level was over the limit for adult motorists, police told the newspaper.

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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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