 |
FREE Natural Health Newsletter
Receive natural health product reviews, recommendations and alerts.
Instant download of 20+ free health reports and exclusive interviews.
Join over 1.2 million monthly readers.
|
 |
|
(NaturalNews) Documents on the FDA Web site reveal that pharmaceutical companies Merck and Schering-Plough conducted numerous safety studies on the popular cholesterol drug Zetia but did not publish the results, which suggested that the drug may cause liver damage when mixed with statins.
Zetia is a trade name for the drug ezetimibe, also marketed under the names Ezetrol and Ezemibe. It is a major seller for Merck and Schering, and is estimated to have earned them $5 billion in 2007.
The drug functions by blocking cholesterol absorption in the gut, and is often prescribed in conjunction with another class of cholesterol drugs, called statins. Because statins function in a different fashion by increasing the rate at which LDL cholesterol is cleared from the blood, the combination leads to a greater overall decrease in cholesterol levels. This combination is so popular that Merck and Schering also sell a combination Zetia-Zocor (simvastatin) pill under the brand names Vytorin and Inegy.
But concerns have long existed that the combination of Zetia and statins may lead to liver damage. As early as 2002, an FDA reviewer recommended against allowing the drugs to be mixed, due to liver damage in animal studies. Since the drug's approval, various case studies of liver damage have been published in medical journals.
The trials used to secure Zetia's FDA approval were all short-term studies, in which a total of 3,900 patients had been given Zetia for a maximum of 12 weeks. The time period covered by these studies is generally accepted to be too short for signs of liver damage to emerge in most patients. Yet even in these studies, the rate of health problems was 11 times higher among patients who took Zetia in combination with a statin than among those who took only statins. Nearly all serious health effects were liver-related.
Yet the FDA ruled that these risks were minor, and approved the drug without any request for longer term studies.
Now, careful examination of documents on the FDA web site reveals that the agency also saw the results of longer-term trials that showed more significant liver-related risks. But these studies were never published, leaving doctors and health researchers at large unaware of their results.
The exact results of the studies remain unknown. But allusions to them on the FDA Web site reveal that they were conducted between 2000 and 2003 and looked at several thousand patients who had been given a Zetia-statin combination for a period between one and two years. The statins tested include Lipitor, Crestor and Zocor, and there were signs of liver damage among patients who mixed these drugs with Zetia.
According to Robert J. Spiegel, chief medical officer at the Schering-Plough Research Institute, the results of the studies were not considered scientifically important enough for publication. But many health professionals have disputed this view.
"There is important evidence, but it's not in public view," said Dr. Harlan Krumholz, a Yale cardiologist. "It's hidden from investigators."
The concealment of the studies may also have been a violation of FDA rules that require results of all drug trials completed after October 2002 to be listed on industry Web sites.
The hidden studies' exposure comes at a time when Merck and Schering are already under fire for failing to publish the results of a large-scale trial of Zetia's effectiveness and safety, and questions are increasingly being raised as to whether the drug even provides any benefit to patients.
The companies have been criticized for their delay in releasing the data from a large-scale Zetia study called Enhance, which was completed in early 2006. The companies have acknowledged that several participants were dropped from the study early when tests revealed unusually high levels of liver enzymes in their bodies, which is a sign of liver damage. The results of the Enhance trial are not due for release until March.
In addition, while Zetia definitely lowers cholesterol levels, it has never been shown to have any effect on the heart attack risk or lifespan of patients. Dr. Eric J. Topol, a cardiologist and director of the Scripps Translational Science Institute, says that he asked the company to conduct large, long-term trials on the drug's effectiveness in reducing heart attacks and strokes more than four years ago.
"They looked at me like I was an alien," Topol said.
Merck and Schering have finally begun such a study, with a 10,000-participant pool. But the results are not expected until 2011.
Dr. Beatrice A. Golomb of the University of California at San Diego is critical of doctors who prescribe Zetia along with statins. The point of giving patients cholesterol drugs is not to lower their cholesterol levels, she points out. It is to save lives, and there is no evidence that Zetia does so. Doctors are merely taking this effect as a matter of faith, on the company's say so.
Zetia critics are not mollified by Schering's assurances that the FDA was aware of the concealed long-term studies when it approved the drug, pointing out that the agency has been slow to act on many other popular drugs when evidence of serious health risks emerged. Among these medications are the diabetes drug Avandia, the painkiller Vioxx and the anti-psychotic Zyprexa.
By concealing the results of certain studies, critics say, the companies have misled the public into believing that the drugs are safer than they are.
"You don't want to have data missing," said Dr. Bruce Psaty, a professor of medicine and epidemiology at the University of Washington. "When there have been adverse effects, when the benefits don't look impressive, those are the trials that historically don't make it to press."
About the author: Mike Adams is a holistic nutritionist with a mission to teach personal and planetary health to the public He has authored and published thousands of articles, interviews, consumers guides, and books on topics like health and the environment, reaching millions of readers with information that is saving lives and improving personal health around the world. Adams is an independent journalist with strong ethics who does not get paid to write articles about any product or company. In 2007, Adams launched EcoLEDs, a maker of energy efficient LED lights that greatly reduce CO2 emissions. He also founded an environmentally-friendly online retailer called BetterLifeGoods.com that uses retail profits to help support consumer advocacy programs. He's also a noted technology pioneer and founded a software company in 1993 that developed the HTML email newsletter software currently powering the NaturalNews subscriptions. Adams is currently the executive director of the Consumer Wellness Center, a 501(c)3 non-profit, and pursues hobbies such as Pilates, Capoeira, nature macrophotography and organic gardening. Known by his callsign, the 'Health Ranger,' Adams posts his missions statements, health statistics and health photos at www.HealthRanger.org
 Get articles like this delivered to you FREE in our popular email newsletter
|
 |
This new Omega-3 oil makes fish oil obsoleteThe Health Ranger has replaced fish oil and krill oil with THIS. What is THIS? Full details revealed...
Click here to find out more
This is the revolutionary omega-3 oil you've been hearing about. Click the link above to find out more.
|
The Health Ranger reveals financial protection strategies for tough timesThis eight-CD audio seminar by the Health Ranger reveals hard-core financial protection strategies for surviving the next wave of the global financial crisis.
Click here to protect yourself now
"Guaranteed to deliver the most powerful financial protection advice you've ever seen or your money back!" - Mike Adams, the Health Ranger
|
Additional Products of Interest to AllBreville Juice Fountain Elite 800JEXL☯
Simply the best juicer in the world
for fast, easy juicing
Paraliminal Audio Courses☯
Powerful mind-enhancing audio therapy
for reprogramming your mind for a new future
How to Halt Diabetes in 25 Days☯
Health Ranger guide to reversing diabetes
for reversing type-2 diabetes
Boku Superfood
High-potency superfood powder
for preventing numerous diseases
Preparedness Tools Natural News Bundle☯
For preparedness and safety: 60% off
for preparing for natural disasters
Katadyn Exstream XR Water Purifier☯
#1 personal water purifier
for clean, pristine water in seconds
Healing Cancer From the Inside Out (DVD)
Amazing, eye-opening cancer documentary
for anyone wanting to know the truth on cancer
Zeitgeist: Addendum - Must-See Movie
A shocking documentary about money
for people who wan to know the real truth
The Genie In Your Genes by Dawson Church
A free, downloadable summary of this book
for learning about the biology of intention
Spirulina Pacifica
Pure, pristine spirulina superfood
for cancer prevention, alkalizing, immune func
The Biology of Belief by Bruce Lipton
A free download of Biology of Belief
for learning about the mind-biology connection
Living Fuel SuperBerry Ultimate
Delicious superfood meal powder
for disease prevention, antioxidant boost
The Weiss Method for Heart Disease☯
How to reverse heart disease naturally
for heart disease, high cholesterol
Appetite for Profit (free download)
Free download summary of this top book
for discovering the truth about food companies
Hair Soap
A pure, simple and chemical-free shampoo
for washing hair without chemicals
Exposed! The Toxic Chemistry of Products
Free summary of this shocking book
for learning the truth about toxic products
Aloe Vera 100
Pure, dried 100% aloe vera gel flakes
for sludge blood, IBS, Crohn's disease
Free download: Selling Sickness (summary)
Read the best book on disease mongering
for learning the truth about Big Pharma
Revealed: Natural Health Solutions (free)
Free summary of book by Mike Adams
for learning censored natural health remedies
Katadyn MicroPur Water Purifier Tablets☯
The best water purification tablets
for purifying almost any water source
Vitamineral Green from Healthforce
Nutrient-dense superfood powder
for disease prevention, body alkalizing & more
Fucoxanthin with PinnoThin
Natural appetite suppressant
for obesity, overweight, overeating
Zyflamend
Powerful anti-inflammatory herbal formula
for arthritis, joint pain, inflammation
Nascent Iodine
Miraculous nascent iodine solution
for thyroid function, Alzheimer's, brain func.
Blood Support
Halts growth of cancer tumors
for breast cancer and all cancers
Amaz-a-Power
Amazing wild berry tincture from Peru
for eye & brain protection, cancer prevention
P-73 Oreganol
Potent source of wildcrafted oregano oil
for parasites, heart disease, immune func.
Ocean Minerals Pure Magnesium Oil
#1 product for magnesium therapy
for back pain, heart health, muscle health
MGC-5 Mushroom Extracts
Potent extracts of medicinal mushrooms
for reversing cancer, boosting immune function
Better Than Roasted - Macadamia Nuts☯
The most delicious raw nut spread ever
for heart health, circulatory health
* Products do NOT pay to be listed here. These are genuine, independent recommendations by the Health Ranger
☯ Products with this symbol are sold by NaturalNews or its affiliates and earn revenues for NaturalNews
|
|
Printable Version
Email this article to a friend
Share this article on: 
