IN THIS ISSUE:

• Pediatricians Voice Anger Over Costs of Vaccines
   
• Low-dose Aspirin Beats High-dose After Cardiac Surgery
   
• Japan Bans Tamiflu for Teenagers
   
• ADHD Drug Use For Youth Obesity Raises Ethical Questions
   
• Mouse Study Shows Blood Pressure Drug Could Treat Lung Cancers
   
• NIH Announces Phase III Clinical Trial of Creatine for Parkinson's Disease
   
• Next Generation of Stents Responds to Problems

• 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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Pediatricians Voice Anger Over Costs of Vaccines

The nation’s pediatricians, the foot soldiers in the campaign to vaccinate America’s children, are starting to revolt.
The soaring cost and rising number of new vaccines, doctors say, make it increasingly difficult for them to buy the shots they give their patients. They also complain that insurers often do not reimburse them enough, so they can lose money on every dose they deliver.
As a result, some pediatricians are not offering the newest and most costly vaccines. And some public health experts say that if the situation worsens, it could lead to a breakdown in the nation’s immunization program, with a rise in otherwise preventable diseases.
“We cannot pay for the vaccination of the American public any longer,” said Dr. Dorothy A. Levine, a pediatrician in Stamford and New Canaan, Conn. “We’re not giving them with as much vigor as we should, and the main reason is financial.”

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Low-dose Aspirin Beats High-dose After Cardiac Surgery

The use of medicines to fight cardiovascular disease has been a primary focus of research in this area for the past several decades, as combinations of interventions and medicinal therapy have gradually begun to increase long-term survival rates. Two studies presented today at the American College of Cardiology's 56th Annual Scientific Session look at the measurable impact of the use of aspirin and other maintenance therapies, and one demonstrates that lower doses of therapies may prove to be just as beneficial while also lowering side effects. ACC.07 is the premier cardiovascular medical meeting, bringing together cardiologists and cardiovascular specialists to further breakthroughs in cardiovascular medicine.
"Cardiovascular disease is the leading cause of death today, and the major focus of research is to find better ways to help these patients through prevention, immediate intervention and long-term treatment regimens," said Douglas P. Zipes, M.D., Distinguished Professor of the Indiana University School of Medicine. "As we continue to discover the benefits of these therapies, we expect to see continued and measurable improvements in overall survival and quality of life."
Effects of Aspirin dose on Ischemic Events and Bleeding after Percutaneous Coronary Intervention (PCI): Insights from the PCI-CURE Study (Presentation Number: 2805-9)

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Japan Bans Tamiflu for Teenagers

Japan officials said the anti-flu drug Tamiflu should not be given to teenagers, after two boys aged 12 and 16 broke their legs jumping from the second floor of their houses.
The ban follows earlier cases of odd behaviour – including some suicides – in Japanese teens taking Tamiflu.
However, a large new study casts doubt over whether the drug is to blame for psychiatric problems.
The company that makes Tamiflu, Roche Holdings in Basel, Switzerland, told New Scientist that new data shows that people with flu are less at risk of psychiatric symptoms if they take the drug. David Reddy, in charge of Tamiflu at Roche, says the company is about to publish data, collected by two large insurance companies in the US, on 226,000 people with flu, of whom 101,500 took Tamiflu.
Between 2% and 5% of patients in both drug and non-drug groups had neuro-psychiatric symptoms including encephalitis (infection of the lining of the brain), delusion, delirium, anxiety and hallucination. But, says Reddy, people on Tamiflu had significantly fewer symptoms.

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ADHD Drug Use For Youth Obesity Raises Ethical Questions

When Alex Veith was 11 years old, he was in a bad spot. He was 30 pounds overweight, and blood tests showed he was headed toward Type 2 diabetes. His parents say Alex was already physically active and eating a healthy diet. They didn't know what to do. Their pediatrician didn't know either, so she referred Lisa and Hank Veith to Dr. Fuad Ziai, a pediatric endocrinologist in nearby Oak Lawn, Illinois. In the summer before Alex entered sixth grade, Ziai prescribed Adderall, an amphetamine used to treat attention deficit and hyperactivity disorder, or ADHD. Alex didn't have ADHD, but one of the drug's common side effects is weight loss. And that's what happened to Alex. "You should have seen everyone when I went back to school the next year. They didn't believe it was me," says Alex. "It was a great feeling to be a thin kid." Ziai's approach to treating obesity -- he says he has prescribed Adderall for weight loss to about 800 children and teens -- raises an important ethical question: Has the obesity epidemic among children become so severe that it's OK to prescribe a drug not approved for weight loss when the drug can have serious, sometimes life-threatening side effects?

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Mouse Study Shows Blood Pressure Drug Could Treat Lung Cancers

A hormone similar to commonly used medicines to lower high blood pressure in humans has been found to also shrink lung cancer tumors in mice, a new study shows.
Reporting in the journal Cancer Research, the scientists led by Drs. Patricia E. Gallagher and Dr. E. Ann Tallant at Wake Forest University School of Medicine said that in mice treated with the hormone, angiotensin-(1-7), tumor volume decreased by 30 percent. In mice that did not receive the treatment, the tumor size more than doubled.
"The current study is the first demonstration of the effect in animals," said Tallant. "Taken together, the two studies suggest a novel treatment for lung cancer, a disease that kills an estimated 170,000 Americans each year."
Gallagher and Tallant had previously reported a similar effect in lung cancer cells grown in the laboratory. In this mouse study, human cancer cells were obtained from the American Tissue Culture Collection. Mice were inoculated with the cells and 32 days later were randomly selected to receive either an intravenous treatment of angiotensin-(1-7) or saline for 28 days. The blood levels of angiotensin-(1-7) achieved through treatment were similar to levels in humans being treated with an ACE inhibitor.
"The study may explain the molecular mechanism for a decreased risk of lung cancers in patients with high blood pressure taking ACE inhibitors," said Tallant.

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NIH Announces Phase III Clinical Trial of Creatine for Parkinson's Disease

The NIH National Institute of Neurological Disorders and Stroke (NINDS) today is launching a large-scale clinical trial to learn if the nutritional supplement creatine can slow the progression of Parkinson's disease (PD). While creatine is not an approved therapy for PD or any other condition, it is widely thought to improve exercise performance. The potential benefit of creatine for PD was identified by Parkinson’s researchers through a new rapid method for screening potential compounds.
The double-blind, placebo-controlled, phase III study is one of the largest PD clinical trials to date. It will enroll 1720 people with early-stage PD at 52 medical centers in the United States and Canada.
"This study is an important step toward developing a therapy that could change the course of this devastating disease," says Elias A. Zerhouni, M.D., director of the NIH. "The goal is to improve the quality of life for people with Parkinson's for a longer period of time than is possible with existing therapies." Currently there is no treatment that has been shown to slow the progression of PD.
The trial is the first large study in a series of NINDS-sponsored clinical trials called NET-PD (NIH Exploratory Trials in Parkinson's Disease). NINDS has organized this large network of sites to allow researchers to work with PD patients over a long period of time, with a goal of finding effective and lasting treatments. NET-PD builds on a developmental research process — from laboratory research to pilot studies in a select group of patients, to the definitive phase III trial of effectiveness in people with Parkinson’s disease.

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Next Generation of Stents Responds to Problems

A new generation of stents, created largely to address problems associated with the current artery-opening devices, made their debut during the American College of Cardiology meeting in New Orleans Saturday.
These new stents attempt to ward off restenosis, the reclosing of a stented vessel, and thrombosis, the dangerous clotting that has been seen mostly in drug-eluting stents. The innovations ranged from coating stents with different and better drugs to building biodegradable stents that dissolve over time.
In one study, researchers compared the standard paclitaxel-eluting stent with a new drug-eluting stent called Xience V. Dr. Gregg W. Stone, director of Cardiovascular Research and Education at Columbia University Medical Center, and his colleagues randomly assigned 1,002 patients to receive stents with either Xience V or the standard drug-eluting stent.
"This is a second-generation drug-eluting stent," Stone said. "This trial was designed to get approval for this stent in the United States."

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Believe It Or Not

Bhagat: had his twin brother on his stomach

Sanju Bhagat's stomach was once so swollen he looked nine months pregnant and could barely breathe. iving in the city of Nagpur, India, Bhagat said he'd felt self-conscious his whole life about his big belly. But one night in June 1999, his problem erupted into something much larger than cosmetic worry. Mehta said that he can usually spot a tumor just after he begins an operation. But while operating on Bhagat, Mehta saw something he had never encountered. As he cut deeper into Bhagat's stomach, gallons of fluid spilled out — and then something extraordinary happened. "First, one limb came out, then another limb came out. Then some part of genitalia, then some part of hair, some limbs, jaws, limbs, hair."
At first glance, it may look as if Bhagat had given birth. Actually, Mehta had removed the mutated body of Bhagat's twin brother from his stomach. Bhagat, they discovered, had one of the world's most bizarre medical conditions — fetus in fetu. It is an extremely rare abnormality that occurs when a fetus gets trapped inside its twin. The trapped fetus can survive as a parasite even past birth by forming an umbilical cordlike structure that leaches its twin's blood supply until it grows so large that it starts to harm the host, at which point doctors usually intervene.

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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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