Summary
"We were wrong about Vioxx, but you can trust us on all those other meds," the FDA seems to be saying.
Original source:
http://seattlepi.nwsource.com/national/apscience_story.asp?category=1500&slug=FDA%20Drug%20Safety
Details
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On Thursday, Merck announced it was withdrawing its drug, Vioxx, because of health concerns.
- Americans should feel reasonably safe taking government-approved prescription drugs - with a few caveats - even after a popular arthritis medication was pulled from the market, medical experts say.
- But the problems with Vioxx raise questions about the Food and Drug Administration's safety review process and the length of time it took Merck to pull the drug, observers say.
- Vioxx was the first prescription drug since 2001 to be taken off the market for safety reasons.
- Its maker, Merck & Co., cited an increased risk of heart attack and stroke in people who used the medication.
- The withdrawal on Thursday came just weeks after the company defended the safety of the drug, which accounted for $2.5 billion in worldwide sales in 2003, and the FDA approved the use of Vioxx in children as young as 2 years old.
- The FDA has come under intense pressure from the industry and elsewhere to approve drugs more quickly, despite clinical trials that some say enroll too few patients and for too short a time for worrisome side effects to surface.
- "I fear that FDA has gotten a little bit too cowed by industry demands to function as a good regulator," said Avorn, an associate professor of medicine at Harvard Medical School who is affiliated with Brigham and Women's Hospital in Boston.
- "The FDA is not going to hold up a medication for a generation to make sure it's safe.
- And similarly, they're not going to require you to study half a million people," Ray said.
- "There is no provision for systematically assessing and reviewing the safety of the many, many medications that are out there," Ray said.
About the author: Mike Adams is a consumer health advocate and award-winning journalist with a strong interest in personal health, the environment and the power of nature to help us all heal He has authored more than 1,800 articles and dozens of reports, guides and interviews on natural health topics, and he is well known as the creator of popular downloadable preparedness programs on financial collapse, emergency food storage, wilderness survival and home defense skills. Adams is an independent journalist with strong ethics who does not get paid to write articles about any product or company. In mid 2010, Adams produced TV.NaturalNews.com, a natural health video sharing website offering user-generated videos on nutrition, green living, fitness and more. He's also a noted pioneer in the email marketing software industry, having been the first to launch an HTML email newsletter technology that has grown to become a standard in the industry. Adams volunteers his time to serve as the executive director of the Consumer Wellness Center, a 501(c)3 non-profit organization, and regularly pursues cycling, nature photography, Capoeira and Pilates. He's also author of numerous health books published by Truth Publishing and is the creator of several consumer-oriented grassroots campaigns, including the Spam. Don't Buy It! campaign, and the free downloadable Honest Food Guide. He also created the free reference sites HerbReference.com and HealingFoodReference.com. Adams believes in free speech, free access to nutritional supplements and the ending of corporate control over medicines, genes and seeds.
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Monday, October 04, 2004
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