IN THIS ISSUE:

• Use Caution Buying Medical Products Online
   
• In the World of Life-Saving Drugs, a Growing Epidemic of Deadly Fakes
   
• Surgeons Develop Simpler Way To Cure Atrial Fibrillation
   
• Concerns About The HPV Vaccine
   
• In the Stent Era, Heart Bypasses Get a New Look
   
• Breath Test Detects Lung Cancer In Early Stages
   
• FDA Directs ADHD Drug Manufacturers to Notify Patients about Cardiovascular Adverse Events and Psychiatric Adverse Events

• 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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Use Caution Buying Medical Products Online

Get prescription drugs fast--no doctor needed! Cure cancer with herbs! Zap your pain away with an amazing device! Absolutely safe--pull out your credit card NOW, and get rock-bottom prices.
It's not hard to find statements like these floating around in cyberspace. "And if they sound too good to be true, it's because they usually are," says Rich Cleland, assistant director of the Division of Advertising Practices at the Federal Trade Commission (FTC).
Many legitimate Web sites bring customers health products with the benefits of convenience, privacy, and, sometimes, cheaper prices. "But consumers need to be aware that the Internet has also created a marketplace for unapproved medical products, illegal prescribing, and products marketed with fraudulent health claims," says William Hubbard, associate commissioner for policy and planning at the Food and Drug Administration.
"And the unique qualities of the Internet, including its broad reach, relative anonymity, and the ease of creating and removing Web sites, pose challenges for enforcing federal and state laws," Hubbard says. "Many sites are connected to other sites and have multiple links, which makes investigations more complex. And there are jurisdictional challenges because the regulatory and enforcement issues cross state, federal, and international lines."
Government agencies work together to shut down illegal Web sites and prosecute criminals, but enforcement resources are limited. "Consumers need to take some responsibility for recognizing suspicious sites and turning the other way," Hubbard says. So how can you spot the red flags? Here's a guide to help you protect your health and your wallet.

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In the World of Life-Saving Drugs, a Growing Epidemic of Deadly Fakes

Asia is seeing an “epidemic of counterfeits” of life-saving drugs, experts say, and the problem is spreading. Malaria medicines have been particularly hard hit; in a recent sampling in Southeast Asia, 53 percent of the antimalarials bought were fakes.
Bogus antibiotics, tuberculosis drugs, AIDS drugs and even meningitis vaccines have also been found.
Estimates of the deaths caused by fakes run from tens of thousands a year to 200,000 or more. The World Health Organization has estimated that a fifth of the one million annual deaths from malaria would be prevented if all medicines for it were genuine and taken properly.
“The impact on people’s lives behind these figures is devastating,” said Dr. Howard A. Zucker, the organization’s chief of health technology and pharmaceuticals.
Internationally, a prime target of counterfeiters now is artemisinin, the newest miracle cure for malaria, said Dr. Paul N. Newton of Oxford University’s Center for Tropical Medicine in Vientiane, Laos.
His team, which found that more than half the malaria drugs it bought in Southeast Asia were counterfeit, discovered 12 fakes being sold as artesunate pills made by Guilin Pharma of China.
A charity working in Myanmar bought 100,000 tablets and discovered that all were worthless.
“They’re not being produced in somebody’s kitchen,” Dr. Newton said. “They’re produced on an industrial scale.”

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Surgeons Develop Simpler Way To Cure Atrial Fibrillation

Physicians have an effective new option for treating atrial fibrillation, a common irregular heart rhythm that can cause stroke. Heart surgeons at Washington University School of Medicine in St. Louis have developed and tested a device that radically shortens and simplifies a complex surgical procedure that has had the best long-term cure rate for persistent atrial fibrillation.
The simplified procedure is termed Cox-maze IV, and the surgeons believe it can replace the older "cut and sew" Cox-maze III in which ten precisely placed incisions in the heart muscle created a "maze" to redirect errant electrical impulses.
"This technology has made the Cox-maze procedure much easier and quicker to perform," says Ralph Damiano Jr., M.D., the John Shoenberg Professor of Surgery and chief of cardiac surgery at the School of Medicine and a cardiac surgeon at Barnes-Jewish Hospital. "Instead of reserving the Cox-maze procedure for a select group of patients, we would urge use of this device for virtually all patients who have atrial fibrillation and are scheduled for other cardiac surgery."
The device is a clamplike instrument that heats heart tissue using radiofrequency energy. By holding areas of the heart within the jaws of the device, surgeons can create lines of ablation, or scar tissue, on the heart muscle. In the older Cox-maze III procedure, the lines of ablation were made by cutting the heart muscle, sewing the incisions back together and letting a scar form. The ablation lines redirect the abnormal electrical currents responsible for atrial fibrillation, an irregular heart rhythm in which the upper heart chambers or atria wriggle like a bag of worms.

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Concerns About The HPV Vaccine

Right now, at least 18 states including California are considering legislation to make Gardasil (Merck's HPV vaccine) mandatory.
The governor of Texas signed an executive order February 2 requiring it for girls entering the 6th grade in 2008. But state legislators in Texas are right now working on bills to override the governor's order. And on February 20th, Merck announced it will suspend its lobbying efforts at the state level to make the vaccine mandatory for teen girls.
The drug company had been channeling money through Women in Government, an advocacy group made up of female state legislators across the country. Merck's medical director for vaccines explained the company didn't want its lobbying efforts to distract from its main goal of cervical cancer prevention. In addition to conservative groups that oppose making the vaccine mandatory, some medical groups also voiced concern over Merck's aggressive lobbying.
"I believe that their timing was a little bit premature... before we have any picture of whether there are going to be any untoward side effects," Dr. Anne Francis of the American Academy of Pediatrics said.
The American College of Pediatricians is "opposed to any legislation which would require HPV vaccination for school attendance."

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In the Stent Era, Heart Bypasses Get a New Look

After more than a decade-long decline, is heart bypass surgery poised for a comeback?
Some doctors say it may be time to give bypass operations a second look. They include even some cardiologists who specialize in the far more popular alternative — using stents to keep coronary arteries open.
No one is predicting a sudden surge back to bypass, which is still a far more invasive and initially riskier way to treat plaque-clogged heart arteries, a condition that afflicts millions of Americans.
But in light of new safety concerns over the long-term risks of stents, as well as accumulating data indicating that the sickest heart patients may live longer if they receive bypass surgery instead, some well-known stent specialists say the pendulum may have swung too far away from bypass surgery.
“We as cardiologists have probably pressed forward on stent technology a little faster than we should have,” said Dr. Kirk Garratt, the director of research into stents and related heart therapies at Lenox Hill Hospital in New York, one of the nation’s leading stenting centers.

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Breath Test Detects Lung Cancer In Early Stages

A new breath test has been reported to detect lung cancer in its early stage. Lung cancer is the leading cause of cancer death in the United States, and doctors believe that early detection could offer sufferers their best chance for survival.
Dr. Michael Phillips, CEO of Menssana Research, the company that developed the breath test, said, "We developed a breathalyzer that is one billion times more sensitive than those the police use to measure alcohol in the breath. It detects around 200 different chemicals in a person's breath, and some of these chemicals are markers of cancer. A breath test has great advantages over most other medical tests - it is completely safe, painless and non-invasive. All you have to do is breathe gently into a tube for two minutes. There are no potentially dangerous x-rays to worry about, and it will certainly be a lot less expensive than chest imaging."
In a study funded by the National Institutes of Health that will be published in Cancer Biomarkers, researchers studied 404 smokers and ex-smokers aged over 60. The breath test predicted lung cancer with almost the same accuracy as computerized tomography, or chest CT, the best screening test for lung cancer currently available.
Early detection is essential to save lives. Lung cancer affects over 170,000 Americans annually and more than 95% of them are dead within 5 years if the tumor has metastasized to other organs, versus only 20% if the tumor is found while it is still confined to the lung.

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FDA Directs ADHD Drug Manufacturers to Notify Patients about Cardiovascular Adverse Events and Psychiatric Adverse Events

The U.S. Food and Drug Administration (FDA) today directed the manufacturers of all drug products approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) to develop Patient Medication Guides to alert patients to possible cardiovascular risks and risks of adverse psychiatric symptoms associated with the medicines, and to advise them of precautions that can be taken.
"Medicines approved for the treatment of ADHD have real benefits for many patients but they may have serious risks as well," said Steven Galson, M.D., Director, Center for Drug Evaluation and Research (CDER). "In our ongoing commitment to strengthen drug safety, FDA is working closely with manufacturers of all ADHD medicines to include important information in the product labeling and in developing new Patient Medication Guides to better inform doctors and patients about these concerns."
Patient Medication Guides are handouts given to patients, families and caregivers when a medicine is dispensed. The guides contain FDA-approved patient information that could help prevent serious adverse events. Patients being treated with ADHD products should read the information before taking the medication and talk to their doctors if they have any questions or concerns.

For more information CLICK HERE

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Believe It Or Not

Tip leads police to stolen human kidney

A human kidney stolen from an exhibit of preserved bodies and organs was recovered after two months, thanks to an anonymous tip, police said.
Police interviewed and released a 26-year-old Tacoma man about the case and were waiting for prosecutors to decide whether to bring charges, Officer Jeffery R. Kappel said. Police declined to say why the kidney was taken or where it had been kept.
The organ disappeared Dec. 30 from "Bodies ... The Exhibition," which features 20 cadavers and 260 other parts preserved with a process that replaces human tissue with silicone rubber. Skin is removed, exposing muscles, bones, organs, tendons, blood vessels and brains.
The kidney was part of an interactive area where visitors can touch some body parts.
The exhibit, which runs through April 29, is one of several being shown around the world. The displays have drawn protests in Seattle and elsewhere because the Chinese citizens whose cadavers and body parts were used never agreed to let their remains be displayed.
It was unclear whether anyone would claim a $10,000 reward offered in January by Premier Exhibitions Inc. of Atlanta for the kidney's return. Police were holding the kidney as evidence.
The theft was the first from a "Bodies" display, a Premier Exhibitions spokeswoman said.

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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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