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Spielmans, G. I. & Kirsch I, 2014 Drug Approval and Drug Effectiveness

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#1 dalsaan



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Posted 05 January 2015 - 07:12 PM

Annu Rev Clin Psychol. 2014;10:741-66. doi: 10.1146/annurev-clinpsy-050212-185533. Epub 2013 Dec 9.
Drug approval and drug effectiveness.
Spielmans GI1, Kirsch I.
Abstract at http://www.ncbi.nlm....pubmed/24329178
Data on the efficacy and safety of psychiatric medicines should form the foundation of evidence-based treatment practices.
The US Food and Drug Administration (FDA) reviews such data in determining whether to approve new treatments, and the published literature serves as a repository for evidence on treatment benefits and harms.
We describe the FDA review of clinical trials, examining the underlying logic and legal guidelines. Several FDA reviews provide evidence that the agency requires only minimal efficacy for psychiatric drugs. Further, in some instances, the FDA has relied on secondary rather than primary outcomes and has discounted the findings of negative studies in its review of antidepressant and antipsychotic medications.
The published literature provides another lens into the safety and efficacy of treatments. We describe how treatment efficacy is systematically overstated and treatment-related harms are understated in the scientific literature. Suggestions are provided to improve public access to underlying safety and efficacy data and for the FDA to potentially improve its review process.
From the paper

In sum, there is much evidence that the randomized withdrawal method of examining antidepressant maintenance efficacy conflates short-term and protracted antidepressant withdrawal with long-term antidepressant efficacy. As noted in a thorough review of such studies, “researchers must be aware that additional research is required to clarify whether antidepressants are actually preventing future depressive episodes or simply preventing antidepressant withdrawal phenomena” (El-Mallakh & Briscoe 2012, p. 106).


Edited by Altostrata, 23 February 2015 - 11:35 AM.
formatted for Journals

Please note - I am not a medical practitioner and I do not give medical advice. I offer an opinion based on my own experiences, reading and discussion with others.On Effexor for 2 months at the start of 2005. Had extreme insomnia as an adverse reaction. Changed to mirtazapine. Have been trying to get off since mid 2008 with numerous failures including CTs and slow (but not slow enough tapers)Have slow tapered at 10 per cent or less for years. I have liquid mirtazapine made at a compounding chemist.
Was on 1.6 ml as at 19 March 2014.
Dropped to 1.5 ml 7 June 2014. Dropped to 1.4 in about September.
Dropped to 1.3 on 20 December 2014. Dropped to 1.2 in mid Jan 2015.
Dropped to 1 ml in late Feb 2015. I think my old medication had run out of puff so I tried 1ml when I got the new stuff and it seems to be going ok. Sleep has been good over the last week (as of 13/3/15).
Dropped to 1/2 ml 14/11/15 Fatigue still there as are memory and cognition problems. Sleep is patchy but liveable compared to what it has been in the past.

>My intro post is here - http://survivinganti...ic/2250-dalsaan

#2 Altostrata



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Posted 23 February 2015 - 11:35 AM


This is not medical advice. Discuss any decisions about your medical care with a knowledgeable medical practitioner.

"It has become appallingly obvious that our technology has surpassed our humanity." -- Albert Einstein

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#3 bubbles


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Posted 21 April 2016 - 06:00 PM

Was anyone able to get a full copy of this paper?

My thread here at AS: http://survivinganti...-bubbles/page-3

2001 Hashimotos diagnosis

2005 St John's Wort

2006 Lexapro 20mg

2 unsuccessful attempts to discontinue

Discontinued successfully over 5 or so months in early 2012

January 2013 started sertraline, over time worked way up to 100mg

July 2014 dropped from 100mg to 75mg, held for several months

January 2015 started to taper to 50mg over several months, held for several months

February 2016 at 35mg

6 March 2016 at 33 mg

(also takes Armour Thyroid plus a small dose T4)