"This stands in contrast" he points out, "to the good news about drugs which industry manages to get out rapidly in the best quality, highest impact factor journals, apparently authored by the biggest name academics in the field."
There are many other serious adverse side effects associated with SSRIs that never seem to make the headlines. A 1999 study showed a 200% increased risk of upper gastrointestinal bleeding for people exposed to SSRIs within 30 days of the diagnosis of upper gastrointestinal bleeding compared to people not on the drugs, according to the August 31, 2006 Health Sentinel.
In addition, the Sentinel said, 5 other published studies that examined an association between SSRIs and gastrointestinal bleeding all showed and increased risk. "In these studies," it reported, "the increased relative risk of gastrointestinal bleeding between SSRI users and non-users ranged from 50% to 260%."
Overall, critics say efforts to assess the risks and effectiveness of SSRIs have been stymied by the unwillingness of drug makers to make clinical trial available to researchers. However, in recent years documents have surfaced as a result of litigation that show the drug makers have known all the long that SSRIs are dangerous and ineffective.
Experts contend that the value of any drug must be determined by weighing its benefits against its potential risks and its capacity for harm. With SSRIs, Dr. Healy says the treatment effects are modest while the burden and costs of harm have never been defined.
Dr. Breggin notes that a comprehensive review conducted on all studies of SSRIs submitted for approval to the FDA, show that when the studies are taken as a whole, the SSRIs do not work.
A little known secret, he says, is that a drug company may perform twenty studies in attempt to show efficacy and as long as two studies show a positive effective, the FDA will approve the drug.
"If a drug company cannot massage their self-generated data sufficiently to obtain a positive result in two out of twenty clinical trials," Dr. Breggin notes, "the company's paid consultants and employees don't deserve to stay employed."
"And of course, they won't stay employed," he points out, "if they fail to meet the company's needs to promote new products."
This "little known secret" is evidenced by internal FDA documents related to the approval of Celexa. According to a March 26, 1998 Memorandum written by, Thomas Laughren, Team Leader for the FDA's Psychiatric Drug Products, Division of Neuropharmacological Drug Reports, for Celexa (citalopram) there were a total of 17 clinical trials, including 2 uncontrolled trials, 6 active controlled trials showing no difference between treatments, and 2 placebo controlled trials that were too small to be considered studies.
The memo discussed 5 short-term trials (85A, 91206, 86141, 89303, and 89306) and 2 long-term studies (89304 and 89305). "In summary," Dr Laughren wrote, "I consider studies 85A and 91206 positive support for the claim of short-term antidepressant efficacy for citalopram."
"While 3 other placebo-controlled short-term trials (86141, 89303, and 89306) were negative, and not easily interpretable since there were no active control arms," he said, "I feel there were sufficient reasons to speculate about the negative outcomes and, therefore, not count these studies against citalopram."
He also noted support of the effectiveness from 2 positive relapse prevention trials. "Overall," he wrote, "I consider these results sufficient to support claims of both short-term and long-term antidepressant effectiveness of citalopram."
However, a May 4, 1998, memo from Paul Leber, Director of Division of Neuropharmacological Drug Projects, on the subject of "Approvable Action on Forrest Laboratories NDA 20-822 Celexa," was much less enthusiastic and said the pubic had a right to know the truth about all the clinical trials on Celexa submitted to the FDA.
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