Selective Serotonin Reuptake Inhibitor (SSRI) Drugs: More Risks Than Benefits? Joel M. Kauffman, Ph.D.
excerpts:
"Kirsch et al. concluded that the updated findings from 35 carefully vetted trials suggest that, compared with placebo, the four new-generation antidepressants (fluoxetine, venlafaxine, nefazodone, and paroxetine) do not produce clinically significant improvements in depression in patients who initially have moderate or even severe depression. They show statistically significant but clinically minor effects only in the most severely depressed patients. Moreover, the significance of the effect probably is based on a decreased responsiveness to placebo, rather than increased responsiveness to medication. Given these results, the researchers conclude that there is little reason to prescribe new generation antidepressant medications to any but the most severely depressed patients unless alternative treatments have been ineffective."
"Typical dropout rates in recent trials are claimed to be 5% (see below), but these must be short trials, or trials with a run-in period. In a meta-analysis of 62 earlier trials with a total of 6,000 subjects, the
mean total dropout rate and the proportion of dropouts due to side effects appear comparable to results in general practice: total dropout rates of between 30% and 70% have been reported by 6 weeks, of which some 30%–40% are attributed to side effects and the rest to failure of treatment."
"Early findings of severe adverse effects by SSRI makers came to light only after the class was established. Of 53 healthy volunteer studies on fluoxetine, the results of only 12 were openly reported. From 35 healthy volunteer studies on paroxetine, pre-launch, the results of only 14 appeared. Among the unpublished trials, there was one in which all volunteers dropped out because of agitation (akathisia). In published work on sertraline, data excluded material on behavioral toxicity, including at least one suicide of a healthy volunteer, and in a different trial, 2 of 20 volunteers became
intensely suicidal. This last is consistent with the dropout rate of 5% for agitation alone in actual trials. It is also consistent with Lilly’s animal studies, in which previously friendly cats treated with fluoxetine started growling and hissing—an unheeded warning."
Now why do you suppose so few of the trials results are published? 12 out of 53 that is less that a quarter, and 12 out of 35 is less than half---the drug companies are obviously trying to bury trial results which show "unfavorable results." The FDA is allowing drug companies to bury trial data relevant to a drug's safety and efficacy; it continues to be done...
more excerpts:
"Adverse effects, mostly dose-dependent, will appear in up to 75% of patients on normal doses. Of these, studies suggest that suicidality will be observed in an additional 2%–13% (1 in 50 to 1 in 8) of patients on normal doses, beyond what is seen on placebo or many non-SSRI antidepressant drugs. This is sufficiently frequent that a typical prescribing physician should observe examples in routine practice."
"The actual suicide rate could be about 123/100,000 (1 in 813) higher in patients on SSRIs than in those on tricyclics or placebo. Studies show that many more suicides are attempted on normal doses of SSRIs beyond what is seen on placebo or many non-SSRI antidepressant drugs."
"Available data suggest that actual murders may be committed at about the rate of 250/100,000 (1 in 400) SSRI-treated patients beyond what is seen on placebo or many non-SSRI antidepressant drugs, and that many more murders will be attempted on normal doses as well. While correlation does not prove causation, and results of court trials are not medical science, the data for suicide are solid, and the association of murder with simultaneous suicide is very suggestive."
WARNING:
It is extremely dangerous to abruptly stop or to quickly taper off of SSRI antidepressants. No one should never stop taking these or any psychotropic drug without medical supervision. The entire article is in the read more section below.
excerpts:
"Kirsch et al. concluded that the updated findings from 35 carefully vetted trials suggest that, compared with placebo, the four new-generation antidepressants (fluoxetine, venlafaxine, nefazodone, and paroxetine) do not produce clinically significant improvements in depression in patients who initially have moderate or even severe depression. They show statistically significant but clinically minor effects only in the most severely depressed patients. Moreover, the significance of the effect probably is based on a decreased responsiveness to placebo, rather than increased responsiveness to medication. Given these results, the researchers conclude that there is little reason to prescribe new generation antidepressant medications to any but the most severely depressed patients unless alternative treatments have been ineffective."
"Typical dropout rates in recent trials are claimed to be 5% (see below), but these must be short trials, or trials with a run-in period. In a meta-analysis of 62 earlier trials with a total of 6,000 subjects, the
mean total dropout rate and the proportion of dropouts due to side effects appear comparable to results in general practice: total dropout rates of between 30% and 70% have been reported by 6 weeks, of which some 30%–40% are attributed to side effects and the rest to failure of treatment."
"Early findings of severe adverse effects by SSRI makers came to light only after the class was established. Of 53 healthy volunteer studies on fluoxetine, the results of only 12 were openly reported. From 35 healthy volunteer studies on paroxetine, pre-launch, the results of only 14 appeared. Among the unpublished trials, there was one in which all volunteers dropped out because of agitation (akathisia). In published work on sertraline, data excluded material on behavioral toxicity, including at least one suicide of a healthy volunteer, and in a different trial, 2 of 20 volunteers became
intensely suicidal. This last is consistent with the dropout rate of 5% for agitation alone in actual trials. It is also consistent with Lilly’s animal studies, in which previously friendly cats treated with fluoxetine started growling and hissing—an unheeded warning."
Now why do you suppose so few of the trials results are published? 12 out of 53 that is less that a quarter, and 12 out of 35 is less than half---the drug companies are obviously trying to bury trial results which show "unfavorable results." The FDA is allowing drug companies to bury trial data relevant to a drug's safety and efficacy; it continues to be done...
more excerpts:
"Adverse effects, mostly dose-dependent, will appear in up to 75% of patients on normal doses. Of these, studies suggest that suicidality will be observed in an additional 2%–13% (1 in 50 to 1 in 8) of patients on normal doses, beyond what is seen on placebo or many non-SSRI antidepressant drugs. This is sufficiently frequent that a typical prescribing physician should observe examples in routine practice."
"The actual suicide rate could be about 123/100,000 (1 in 813) higher in patients on SSRIs than in those on tricyclics or placebo. Studies show that many more suicides are attempted on normal doses of SSRIs beyond what is seen on placebo or many non-SSRI antidepressant drugs."
"Available data suggest that actual murders may be committed at about the rate of 250/100,000 (1 in 400) SSRI-treated patients beyond what is seen on placebo or many non-SSRI antidepressant drugs, and that many more murders will be attempted on normal doses as well. While correlation does not prove causation, and results of court trials are not medical science, the data for suicide are solid, and the association of murder with simultaneous suicide is very suggestive."
WARNING:
It is extremely dangerous to abruptly stop or to quickly taper off of SSRI antidepressants. No one should never stop taking these or any psychotropic drug without medical supervision. The entire article is in the read more section below.
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