Medicine’s Most Infamous Clinical Trial
Study 329 had all the makings of a scandal.
Thousands of North American children and adolescents were seriously harmed by taking SSRIs like Paxil. Many died. Neither doctors nor parents had the information they needed, and the FDA only reluctantly issued the appropriate warnings, as might be expected from a regulator that has “corporate partnership” in its mandate.
End of quote.
In simple terms, a revisit of the study produced the exact opposite conclusions:
Same Data, Opposite Conclusions
| Original Study 329 (2001) Click here |
Restoring Study 329 (2015) Click here |
|
| Conclusion | Paxil was effective. | Paxil was not effective. |
| Paxil was well tolerated. | Paxil caused serious side effects, including hostility, insomnia, and akathisia. | |
| Adverse Events | Did not include all | Included all adverse events, including in taper phase |
| Suicidal behavior | 6 adolescents experienced “emotionally lability” | 13 adolescents became suicidal |
| Implications | Misled doctors into prescribing a drug that is ineffective, unsafe for adolescents | Corrects the record, reveals that the data did not support the conclusion of the original study |
End of quote.
I suspect this phenomenon is far more common than we like to think. We are deluded if we think the FDA and their equivalents elsewhere will act in the best interests of the public. Rather, their purpose is to create the delusion that they are, when they are usually doing the exact opposite; serving Big Pharma.
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