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IN THIS ISSUE:

Should Smokers Be Refused Surgery?
FDA Approves the First Drug for Obese Dogs
New HIV Test May Predict Drug Resistance
American Heart Association Year-End Report -- Cardiovascular Disease Kills One In Three
New Source of Stem Cells Discovered
FTC Fines Weight Loss Pill Firms 25 Million Dollars
FDA Updates Health Claim for Calcium and Osteoporosis
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
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Should Smokers Be Refused Surgery?

Last year a primary care trust announced it would take smokers off waiting lists for surgery in an attempt to contain costs. In this week's British Medical Journal, two experts go head to head over whether smokers should be refused surgery.
Denying operations is justified for specific conditions, argues Professor Matthew Peters from the Concord Repatriation General Hospital in Australia.
Professor Peters says that smoking up to the time of any surgery increases cardiac and pulmonary complications, impairs tissue healing, and is associated with more infections.
These effects increase the costs of care and also mean less opportunity to treat other patients, he writes. In healthcare systems with finite resources, preferring non-smokers over smokers for a limited number of procedures will therefore deliver greater clinical benefit to individuals and the community.

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FDA Approves the First Drug for Obese Dogs

The Food and Drug Administration (FDA) today is announcing the approval of Slentrol (dirlotapide), a prescription drug for the management of obesity in dogs. Slentrol reduces appetite and fat absorption to produce weight loss. A veterinarian will determine whether the dog should be treated, based on the dog's weight and general health.
"This is a welcome addition to animal therapies, because dog obesity appears to be increasing," said Stephen Sundlof, D.V.M., Ph.D., director of FDA's Center for Veterinary Medicine. "Veterinarians are well aware that overweight pets are at a higher risk of developing various health problems, from cardiovascular conditions to diabetes to joint problems."
Veterinarians generally define a dog that weighs 20 percent more than its ideal weight as obese. Surveys have found that approximately 5 percent of dogs in the United States are obese, and another 20-30 percent are overweight.
Slentrol is a new chemical entity, called a selective microsomal triglyceride transfer protein inhibitor, which blocks the assembly and release of lipoproteins into the bloodstream. The mechanism for producing weight loss is not completely understood, but seems to result from reduced fat absorption and a satiety signal from lipid-filled cells lining the intestine.

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New HIV Test May Predict Drug Resistance

Researchers at Duke University Medical Center have developed a highly sensitive test for identifying which drug-resistant strains of HIV are harbored in a patient's bloodstream.
The test may provide physicians with a tool to guide patient treatment by predicting if a patient is likely to become resistant to a particular HIV drug, said one of its developers, Feng Gao, M.D., associate professor of medicine. Drug resistance is one of the most common reasons why therapy for HIV, the virus that causes AIDS, fails.
The test, which detects genetic changes, or mutations, in HIV, also may help scientists understand how the constantly evolving virus develops drug resistance, Gao said. He said such knowledge ultimately may result in the development of new treatments designed to evade resistance.
The findings will appear online on Sunday, Jan. 7, 2007, in the journal Nature Methods, as well as in the journal's February 2007 print edition. The work was supported by the National Institutes of Health and the Duke Center for AIDS Research.
Duke has filed for a provisional patent on the technology, and the Duke Office of Licensing & Ventures is considering various options to commercialize this technology.

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American Heart Association Year-End Report -- Cardiovascular Disease Kills One In Three

Cardiovascular disease (CVD) as an underlying cause of death accounted for more than one-third (36.3 percent) of all deaths in the United States in 2004, according to the most recent data from the American Heart Association’s Heart Disease and Stroke Statistics – 2007 Update. The Update will be available in the Dec. 29 online issue of Circulation: Journal of the American Heart Association at http://www.americanheart.org/statistics.
The Update provides the most recent statistics about cardiovascular diseases, risk factors, treatments, quality of care and costs of care. The American Heart Association does not generate the data, but synthesizes it from many sources and provides it online without charge for government policymakers, physicians, researchers, educators and the public to use, making the Update a unique national – and even international – resource.
Cardiovascular diseases (CVD) include heart disease, stroke, high blood pressure, heart failure and congenital cardiovascular defects. Counting only heart disease, this has been the leading cause of death in the United States every year since 1900 except during the 1918 flu epidemic.

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New Source of Stem Cells Discovered

Scientists on Sunday reported the discovery of a new source of human stem cells that have the capability to develop into many different types of cells, including muscle, bone, fat, blood vessel, nerve and liver cells.
These stem cells, found in amniotic fluid, could one day lead to a readily available supply of stem cells that don't come with the ethical problems surrounding embryonic stem cells.
"These cells are easier to get, and from acceptable medical procedures [for example, amniocentesis] that are done on a routine basis," said study senior author Dr. Anthony Atala, director of the Institute for Regenerative Medicine at Wake Forest University School of Medicine.
"This is another source of multi-potential cells," added Paul Sanberg, director of the University of South Florida Center for Aging and Brain Repair, in Tampa. "Because the cells can be accessed either post-birth or through amniocentesis, it's possible that people could store those cells. If the cell lines that are created were available, then people could do some research on a non-embryonic source, which eliminates all the ethical and political issues."
The discovery of the cells, known as amniotic fluid-derived stem (AFS) cells, is reported in the Jan. 7 issue of Nature Biotechnology.

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FTC Fines Weight Loss Pill Firms 25 Million Dollars

The Federal Trade Commission on Thursday fined the marketers of four weight loss pills $25 million for making false advertising claims ranging from rapid weight loss to reducing the risk of cancer.
FTC Chairman Deborah Platt Majoras said the products would remain on store shelves, but that the companies would have to stop making the false claims.
"What we challenge is the marketing of the claims," she said. "The marketers are required to back up the claims with the science and if they can't do that they can't make the claim. But we don't ban the products from the shelves."
The FTC investigated a variety of claims made -- including rapid weight loss and reduction in the risk of osteoporosis, Alzheimer's and even cancer, Majoras noted.

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FDA Updates Health Claim for Calcium and Osteoporosis

The Food and Drug Administration (FDA) is proposing to allow new claims on foods and dietary supplements containing calcium and Vitamin D to show their potential to reduce the risk of osteoporosis. The proposed rule would allow manufacturers to include new information on their food and supplement labeling and to eliminate certain other information, described below.
“This is important information for all citizens,” said Robert E. Brackett, Ph.D., director of FDA’s Center for Food Safety and Nutrition. “All persons lose bone with age, and the loss can influence an individual's risk of developing osteoporosis. Maintenance of an adequate intake of calcium and vitamin D in all stages of life can help lower one’s risk.”
Today’s action is part of FDA’s continued commitment to helping consumers make informed and healthy food choices, and responds to a health claim petition submitted by the Beverage Institute for Health and Wellness, The Coca-Cola Company.

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Believe It Or Not

Robot Mother Helps South Koreans Prepare For Birth

With South Korea's birth rate at its lowest ever, medical students are resorting to robots to practice bringing babies into the world.
Kyunghee University Medical Center in Seoul is the first institution in South Korea to use Noelle, a life-sized robot, and her "newborn" to give obstetric students experience.
"With this simulator training tool, we can conduct not only normal deliveries, but also complicated deliveries such as breech births, Caesarean deliveries," Professor Jung Eui told Reuters Television. "Students can practice in a very realistic situation with this mannequin."
Students regularly crowd around Noelle as she gives "birth." They take turns at monitoring her vital signs and at pulling the "baby" out of her body.
The newborn, also a robot, is equipped with lights on its hands and cheeks to indicate its health -- blue lights mean problems while pink lights signal all is ok.
Students say using Noelle is more useful than sitting in a classroom and taking notes.
"I think it's more helpful to have delivery training on a life-like mannequin than studying with books or lectures before treating my first live patient," said student Woon Jin-kwang.
Professor Jung said South Korea's consistently decreasing birth-rate gave her students fewer chances to watch and practice delivering babies, making Noelle's presence necessary.
South Korea currently has a population of just over 48 million and one of the lowest birth rates in the world -- an average of 1.08 children per woman.
Noelle was purchased for $20,000 from Miami-based Gaumard Scientific Co. Inc. in the United States. She was manufactured in 2000 and over 400 units have been sold in the United States.

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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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