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CIRCARE – Citizens For Responsible Care and Research
Subject: Testing Ecstasy on Subjects Diagnosed with PTSD and the Use of Internet Recruiting
CIRCARE is concerned about the rights and welfare of 20 men and women soon to be enrolled in a clinical trial testing Ecstasy for the treatment of Post Traumatic Stress Disorder. According to the sponsor, this clinical trial marks the beginning of a multi-year plan to gain FDA approval to market Ecstasy as an anti-depressant medication for the treatment of PTSD.
CIRCARE has serious concerns about testing this drug on vulnerable populations:
1) What is the scientific rationale for giving an hallucinogenic amphetamine to persons diagnosed with PTSD, or in the future, to those with depression? Is the rationale sufficient to justify withdrawing subjects from their current medication?
2) Are there not serious risks in administering an investigational drug like Ecstasy, which can cause rebound depression, neuro-toxicity, and dependency? A recent UN report cites the potential for multiple adverse events including death.
3) Should high-risk research like this be conducted by a principal investigator with no experience conducting clinical trials, and from his office rather than in the hospital?
The sponsor, the Multidisciplinary Association for Psychedelic Studies (MAPS), states that this research was rejected by seven IRBs before gaining approval. While MAPS claims these rejections were
politically motivated, at least two of the IRBs had well-reasoned objections, including:
We are also concerned about the MAPS web site:
FDA approved clinical trial of Ecstasy.Strictly speaking, FDA does not approve clinical trials conducted under an Investigational New Drug (IND) application. Rather, the sponsor may begin research if FDA does not object within 30 days of filing the IND application.
In sum, this study raises CIRCARE's concerns about the approval of research which lacks a clear scientific rationale and carries serious risks, the practice of IRB shopping, and the potential abuse of the internet to recruit research subjects.
Michael A Susko, President, CIRCARE
Elizabeth Woeckner, Board Member, CIRCARE
Adil Shamoo, PhD, CIRCARE Co-Founder
Link: To create an HTML link to this InfoMail, cut and paste the following:
<a href="http://www.circare.org/im/im2Feb2004.htm"> Testing Ecstasy on Subjects Diagnosed with PTSD and the Use of Internet Recruiting </a> , CIRCARE InfoMail (2004-02-02)