If Antidepressants Are So Dangerous, How Do They Get Past The FDA?
July 21, 2008
That’s a
major question I often wonder about and after doing
some research, here’s what I’ve found. Many believe
there is an arduous process of getting FDA (Federal
Drug Administration) approval. Therefore, they cannot
understand how the drugs get approval if they are so
dangerous.
The Freedom of Information Act allowed a recent research group to obtain all the studies used by the FDA to approve seven new antidepressants between 1987 and 1997, including Prozac, Zoloft, Paxil, Effexor, Serzone, and Wellbutrin. Nine out of ten studies showed that the drugs were no more effective than placebos. In addition, Prozac has had more adverse side effects submitted to the FDA than any other drug in history.
So how do these drugs get approved? In 1989, Dr. Barry Garfinkel was found guilty on two counts of mail fraud and three counts of filing false statements and spent one year in a halfway house and under house arrest. His fines totaled $210,000. While doing research on antidepressants he instructed lab technicians to invent data on patient visits that had never taken place. In other words, he created patients who took the drugs with no adverse events when in reality these patients did not exist.
In another case, two professors from the Medical College of Georgia were also convicted and each was ordered to $125,000 in fines and serve 5-15 years in prison. These two professors were connected with clinical testing of psychiatric drugs with twenty different companies for more than a decade including Eli Lilly and Pfizer.
The list in these types of cases goes on and on, but by the time the cases go to court the drugs have already been approved and nothing is done to review new evidence. After looking at all the studies done the research group concluded that based on all the published and unpublished data, out of every 1,000 people with depression that were treated with one on the new antidepressants, 4.6 (460 times) more committed suicide each year than would have if they had not received any treatment at all. Something even more alarming is that seriously depressed patients and anyone suicidal were excluded from the studies. Only people with mild to moderate depression were tested at all, yet these drugs are given like candy to children and adults alike.
So research is showing that drugs approved by the FDA should be taken with a grain of salt, right? Keep an eye on how quickly the “next” antidepressant is released and all the hype surrounding it. Scary stuff. I’ll continue to get adjusted and apply the 5 principles to Maximized Living instead.
- J.R.
The Freedom of Information Act allowed a recent research group to obtain all the studies used by the FDA to approve seven new antidepressants between 1987 and 1997, including Prozac, Zoloft, Paxil, Effexor, Serzone, and Wellbutrin. Nine out of ten studies showed that the drugs were no more effective than placebos. In addition, Prozac has had more adverse side effects submitted to the FDA than any other drug in history.
So how do these drugs get approved? In 1989, Dr. Barry Garfinkel was found guilty on two counts of mail fraud and three counts of filing false statements and spent one year in a halfway house and under house arrest. His fines totaled $210,000. While doing research on antidepressants he instructed lab technicians to invent data on patient visits that had never taken place. In other words, he created patients who took the drugs with no adverse events when in reality these patients did not exist.
In another case, two professors from the Medical College of Georgia were also convicted and each was ordered to $125,000 in fines and serve 5-15 years in prison. These two professors were connected with clinical testing of psychiatric drugs with twenty different companies for more than a decade including Eli Lilly and Pfizer.
The list in these types of cases goes on and on, but by the time the cases go to court the drugs have already been approved and nothing is done to review new evidence. After looking at all the studies done the research group concluded that based on all the published and unpublished data, out of every 1,000 people with depression that were treated with one on the new antidepressants, 4.6 (460 times) more committed suicide each year than would have if they had not received any treatment at all. Something even more alarming is that seriously depressed patients and anyone suicidal were excluded from the studies. Only people with mild to moderate depression were tested at all, yet these drugs are given like candy to children and adults alike.
So research is showing that drugs approved by the FDA should be taken with a grain of salt, right? Keep an eye on how quickly the “next” antidepressant is released and all the hype surrounding it. Scary stuff. I’ll continue to get adjusted and apply the 5 principles to Maximized Living instead.
- J.R.