Subject: Testing Ecstasy on Subjects Diagnosed with PTSD and the Use of Internet Recruiting
Date: 2004-02-02
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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.
URL: http://www.unodc.org/unodc/en/publications/report_ats_2003-09-23_1.html

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:

• The submission of an overly-optimistic safety profile of Ecstasy by MAPS in their Investigator's Brochure, and an inadequate control for bias regarding Ecstasy's therapeutic potential.
• Unclear credentials regarding the persons who wrote the Investigator's Brochure.
• The representation of the study as coming out of the Medical University of South Carolina, and the listing of a faculty member as a co-investigator when there was neither university sponsorship nor IRB approval.

We are also concerned about the MAPS web site:

1. The web site promotes Ecstasy with favorable news articles and testimonials while at the same time recruiting research subjects. This can undermine informed consent, which should be an objective presentation of the potential risks and benefits of research participation.
2. We are particularly concerned by the repeated use of the phrase 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

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<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)