FDA statements in media misleading
Congressional Investigations Underway re FDA’s Failure to Protect Public Health
April
5, 2004
FOR IMMEDIATE RELEASE
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.
See:
- FDA
under fire over barred antidepressant report
- FDA Mum On Suicidal Side Effects?
- Los Angeles Times, FDA sat on report linking
suicide, drugs; Officials ordered more studies after their own expert
found children on antidepressants were twice as likely to show suicidal
behavior.
- http://www.baumhedlundlaw.com/media/ssri/paxil/FDAHearing/TierneyLetter.htm
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.
See:
- Barton,
Greenwood Seek Info From FDA On Antidepressants
- Grassley Questions FDA's Handling of Research on Antidepressants, Suicide
Also 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.
See, e.g.
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."
