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FDA Sides with Big Pharma on Bone Drugs
November 16, 2008
FDA management is doing everything in its power to keep the Big Pharma bubble from bursting. Actually, the Big Pharma bubble is more like a balloon that is gradually deflating. Massive layoffs, reduced ad spending, and huge liability from injury suits are occurring as the public is beginning to see that the Big Pharma racket is needlessly killing and injuring hundreds of thousands of Americans every year.
A case in point is that of the bone drugs, one of the great scams of all time. The longer any woman takes these drugs the worse her bones get – as all that is left is old bone that will become more brittle over time. Pictures look better on the bone scans because the bones are actually swollen, something the two-dimensional pictures hide quite nicely. These drugs stay in bone forever, a structural problem in and of itself. And then the finding that serious atrial fibrillation results from taking these drugs, another hot potato landing on the crisis-driven management team at the FDA back in October of 2007.
The FDA said they would review the data and get back in touch with the world in a year. Meanwhile, alarming reports continued to be published. The most recent study1 released last month “showed that 2.5 to 3 percent of patients taking bisphosphonates experienced atrial fibrillation and 1 to 2 percent experienced serious AF, including hospitalization or death. Patients taking bisphosphonates were more likely to experience AF than patients receiving placebo and up to two times more likely to experience serious AF than patients receiving placebo.” Based on the estimated number of American women taking this type of bone drug it means that, conservatively estimating, 100,000 to 200,000 women are seriously injured or killed by bisphosphonate-caused atrial fibrillation every year.
You should also understand that the FDA is looking at the exact same data as this published research. On November 12, 2008 it proclaimed that the atrial fibrillation issue was of no serious concern, although it might consider a study in the future. The FDA told doctors to keep handing out these drugs like candy.
The FDA reached this conclusion by intentionally diluting the data until the risk disappeared. They gladly accepted Big Pharma's version of data, which watered down the meaning of other very clear data. This is a statistical ploy. But why is the FDA doing this?
They are doing it to prevent a crash in public confidence of Western Medicine, especially in the preventive health arena (where they don't belong at all). They are doing it to prop up the sales of drug companies. They are doing it to save face because they have let these horrid bone drugs run wild for 15 years. I would have loved to hear the arguments between the safety scientists at the FDA who obviously understand the risks, and FDA management who controls what will be done and issues the proclamation of false safety. Congress should be all over this with a major investigation. This type of FDA behavior is not tolerable. Of course, with a new administration there will be plenty of FDA management heading out the door to assume their 6 figure salaries in the Big Pharma companies they have helped, to be replaced by the next batch of administrators on the take.
View FDA notice:
Update of Safety Review
Related reading:
The Delusion of Bone Drugs - January 11, 2008
Fosamax Linked to Serious Abnormal Bone Fractures - March 27, 2008
Fosamax Linked to Atrial Fibrillation - May 01, 2008
Is Long Life in Your Bones? - May 08, 2008
Bone Drugs Impair Fracture Recovery - July 19, 2008
Bone Drugs and Jaw Decay – A New Warning - September 29, 2008
By the way:
Fish Oil Reduces Atrial Fibrillation and Sudden Death - February 21, 2008
A case in point is that of the bone drugs, one of the great scams of all time. The longer any woman takes these drugs the worse her bones get – as all that is left is old bone that will become more brittle over time. Pictures look better on the bone scans because the bones are actually swollen, something the two-dimensional pictures hide quite nicely. These drugs stay in bone forever, a structural problem in and of itself. And then the finding that serious atrial fibrillation results from taking these drugs, another hot potato landing on the crisis-driven management team at the FDA back in October of 2007.
The FDA said they would review the data and get back in touch with the world in a year. Meanwhile, alarming reports continued to be published. The most recent study1 released last month “showed that 2.5 to 3 percent of patients taking bisphosphonates experienced atrial fibrillation and 1 to 2 percent experienced serious AF, including hospitalization or death. Patients taking bisphosphonates were more likely to experience AF than patients receiving placebo and up to two times more likely to experience serious AF than patients receiving placebo.” Based on the estimated number of American women taking this type of bone drug it means that, conservatively estimating, 100,000 to 200,000 women are seriously injured or killed by bisphosphonate-caused atrial fibrillation every year.
You should also understand that the FDA is looking at the exact same data as this published research. On November 12, 2008 it proclaimed that the atrial fibrillation issue was of no serious concern, although it might consider a study in the future. The FDA told doctors to keep handing out these drugs like candy.
The FDA reached this conclusion by intentionally diluting the data until the risk disappeared. They gladly accepted Big Pharma's version of data, which watered down the meaning of other very clear data. This is a statistical ploy. But why is the FDA doing this?
They are doing it to prevent a crash in public confidence of Western Medicine, especially in the preventive health arena (where they don't belong at all). They are doing it to prop up the sales of drug companies. They are doing it to save face because they have let these horrid bone drugs run wild for 15 years. I would have loved to hear the arguments between the safety scientists at the FDA who obviously understand the risks, and FDA management who controls what will be done and issues the proclamation of false safety. Congress should be all over this with a major investigation. This type of FDA behavior is not tolerable. Of course, with a new administration there will be plenty of FDA management heading out the door to assume their 6 figure salaries in the Big Pharma companies they have helped, to be replaced by the next batch of administrators on the take.
View FDA notice:
Update of Safety Review
Related reading:
The Delusion of Bone Drugs - January 11, 2008
Fosamax Linked to Serious Abnormal Bone Fractures - March 27, 2008
Fosamax Linked to Atrial Fibrillation - May 01, 2008
Is Long Life in Your Bones? - May 08, 2008
Bone Drugs Impair Fracture Recovery - July 19, 2008
Bone Drugs and Jaw Decay – A New Warning - September 29, 2008
By the way:
Fish Oil Reduces Atrial Fibrillation and Sudden Death - February 21, 2008
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