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This week's FDA advisory committee meeting on rosiglitazone (Avandia) drew back the curtain on the agency's internal politics but left its final decision shrouded in uncertainty.
GlaxoSmithKlines Rosiglitazone (Avandia) Hearing Reveals Not-So-Rosy Rifts at FDA
Seeded on Sun Jul 18, 2010 12:08 PM EDT
Article Source: Medpage Today- Enjoy this article? Help vote it up the 'Vine.
- Public Discussion (9)
Fraud and corruption between the FDA and Big Pharma is hitting the fan. Go ahead FDA...keep on supporting medical fraud and abuse like you have for the last decade...stay in your complicit position that assures death, misery, and murder. My father is dead because of you!!!!!
- 2 votes
#1 - Sun Jul 18, 2010 12:21 PM EDTGood article Gozo. FDA needs a thorough investigation.
The doctor's give out sample's of new med's without knowing the first thing about them. Many drugs people are taking now need to be gradually reduced before quitting them. Doctor's don't know enough to tell you about that. Doctor's are supposed to monitor most new drugs for side effects, by ordering regular blood tests for a period of time. Most doctor's do not do that.
I have often found that I am on medications that counteract each other. I too have had young family members die because of a medication.
- 1 vote
#2 - Sun Jul 18, 2010 1:33 PM EDTI can't go to the doctor...when I do they either refuse to treat me (with pharmaceuticals) or almost kill me with them. With Multiple Chemical Sensitivity...it's a crap shoot. They have no clue how to treat someone like me. No big deal...as I have learned how to stay healthy and treat myself...naturally and successfully. I'm still alive.
- 2 votes
Even though our system of pharmaceutical review and approval is regarded as the most effective in the world, there exists an incredible -- and potentially deadly -- loophole: unapproved drugs.
Recent news stories regarding the recall of 1,500 lots of Johnson & Johnson's children's and infants' Tylenol, Motrin, Zyrtec and Benadryl due to bacterial contamination, and the subsequent suspension of the their manufacture, reinforce the importance of the US Food and Drug Administration's (FDA) regulatory oversight over drug products--even years after they have been approved for sale. But due in large part to grandfather provisions going back 50 years, unapproved drugs - those that have been marketed prior to the establishment of today's FDA - are actively promoted, prescribed and taken by millions of patients in the U.S. These drugs escape FDA scrutiny otherwise imposed for all approved prescription and over-the-counter medications.
Most alarming is the fact that unapproved drugs account for nearly 72 million prescriptions per year. Unapproved drugs lack the specific quality controls of an FDA-approved drug, including manufacturing oversight that ensures the appropriate amount of active drug in each tablet, the purity of ingredients and consistency from dose-to-dose. And perhaps equally troubling is the fact that - unlike every other medication available for human consumption in the United States - unapproved drugs are not required to be accompanied by dosing information supported by human clinical studies.
The consequences of this approval gap can be tragic. Hundreds of deaths have been linked to the more than 500 unapproved drugs that FDA eventually banned. Yet to this day dozens of unapproved drugs are marketed under the regulatory radar. As recently as this past March, FDA took action against manufacturers of unapproved sublingual nitroglycerin tablets for treating certain heart conditions. FDA stated that it had seen "significant quality and efficacy problems" with unapproved nitroglycerin products and, as a result, recalled them from the market. Meanwhile, an FDA approved version had been available for years right alongside the unapproved, unregulated, and we now know, unsafe versions.
- 2 votes
Colchicine, for example, is a toxin. It reduces the inflamation, and consequently pain in acute gout episodes. It's exact mechanism of action, is unknown. That's right, they don't know how, or why it works, but it has been approved. There are many drugs like this. If they work, they approve them. No drug should be administered, as approved by the FDA, if they have no idea how it acts in the body.
- 2 votes
#3 - Sun Jul 18, 2010 7:43 PM EDTPineapple...sweet anti-inflammatory...kissed a pineapple lately?
- 1 vote
No, I have not kissed a pineapple lately. What's with all this sex imagery regarding food? If you can get Victoria's Secret girls to bring me granola bars, you might be onto something.
- 1 vote
Is Food the New Sex?
"The desires for sex and for food are joined at the root."
http://www.hoover.org/publications/policy-review/article/5542
- 1 vote
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