FDA Warnings Update | FDA statements in media misleading
The position taken by the FDA (and broadly disseminated in the national media) about its request that antidepressant drug makers warn of a suicide risk in adults and children, has been that, even though it has requested this warning, such a risk might not actually exist. These public statements are contrary to the findings of the FDA’s own scientists who have concluded otherwise. Indeed, the FDA has suppressed these findings and engaged a group from Columbia University to second-guess the clinical judgment of the original clinical trial researchers and even the FDA’s own scientists.
Two separate congressional investigations are currently underway to look
into the FDA’s failure to protect the public health on this issue
as well as its suppression of evidence related thereto.
- Grassley Questions FDA’s Handling of Research on Antidepressants, Suicide
- Barton, Greenwood Seek Info From FDA On Antidepressants
of importance is that the FDA and media reports since the March 22, 2004
warnings announcement have largely failed to discuss the drugs’
lack of efficacy (see page 3 of DOH Memo re Zoloft and An Analysis of Antidepressant Medication Data Submitted to the U.S. Food and Drug Administration). Thus, statements by the FDA and others to the media about fears that people will not seek and/or receive the medical treatment they need (i.e., antidepressants) and that this lack of treatment will increase the risk of suicide, is a misleading and hollow argument in the face of the drugs’ lack of efficacy. In fact, there is a grotesque over-prescription of these drugs for common-place life situations that cannot be considered a “disease” necessitating medication.
Moreover, there is no evidence that these drugs reduce suicide.
Antisuicidal Effect Of Psychotropics Remains Uncertain ‘We have to ask if medication is the only way’ to approach the prevention of suicide.’
Statements by the FDA and others (such as the ACNP) in the media that the suicide rate has gone down in countries where antidepressant use is prevalent are disingenuous at best. In fact, it is very well known that economic factors are the most prominent signal to increased or reduced suicide rates in any given geographical location.
Member of the UK panel investigating antidepressants for the MHRA (UK FDA) resigns, citing Government Cover-up
Drug companies and regulators knew that higher doses of antidepressants were ineffective, but they significantly increase side effects, including suicide risk, yet allowed the misconception to continue for more than 10 years, that increasing the dose was okay.
By Richard Brook, Chief Executive of Mind re Seroxat/Paxil
Member of UK Parliament speaks out, calling the “Seroxat [Paxil] scandal one of gigantic proportions.”