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CIRCARE – Citizens For Responsible Care and Research
We objected to continual advertising, promotion, and subject recruitment that asserted this trial was
FDA approved because it's misleading and incorrect, especially while the trial was on clinical hold.
This is FDA's position on approval claims:
FDA approval of studies — Investigational drug and biologic studies are not officially approved by FDA. When a sponsor submits a study to FDA as part of the initial application for an investigational new drug (IND), FDA has thirty days to review the application and place the study onholdif there are any obvious reasons why the proposed study should not be conducted. Therefore, subjects are likely to impute a greater involvement by the Agency in a research study than actually exists if phrases such as,FDA has given permission …orFDA has approved …are used in consent documents. If FDA does not place the study on hold within the thirty day period, the study may begin (with IRB approval).
Accessed 2004-03-09 at: FDA IRB Information Sheets,
Guide to Informed Consent, p. 5.
FDA also believes an explicit statement that an IRB has approved solicitation of subjects to participate in research could mislead or unduly induce subjects. Subjects might think that, because the IRB had approved the research, there is no need to evaluate the study for themselves to determine whether or not they should participate.
Yet the sponsor promoted the trial as
IRB approved, and so increased the likelihood that subjects might have misunderstood the purpose of the research, and so may have been coerced into enrolling by an unwarranted expectation of therapeutic benefit.
Message to reporters: while it's true that an Investigational New Drug (IND) application is proprietary, it's also true that if the IND sponsor publicly discloses the filing of the IND application with the Food and Drug Administration, the agency will confirm, or be unable to confirm, this. Reporters can telephone the the FDA Press Office at 301-827-6242. Of the dozens of stories on MAPS' clinical trial testing ecstacy in subjects diagnosed with post-traumatic stress disorder, in only one did a reporter attempt to confirm the sponsor's claim of an
FDA-approved IND; the reporter wrote that
FDA was unable to confirm the sponsor's assertion. Because there were no other attempts to confirm the IND, and not realizing that FDA doesn't approve INDs to begin with, media coverage prior to September 23, 2003 unwittingly circulated the sponsor's inaccurate information.
Media scrutiny of unethical research has been one of the most powerful catalysts for improvement in the protection of human subjects, and it's not inaccurate to say that, in the absence of law and effective regulation in this area, media scrutiny has saved lives and prevented harm. To whatever extent possible, especially in research conducted outside academic institutions or hospitals, please attempt to confirm IND filings with FDA.
Western Institutional Review Board (WIRB) to MAPS, Withdrawal of Approval (2002-09-06)
MAPS (sponsor) reply to Western Institutional Review Board (WIRB)
FDA form 1572, submitted by Dr Mithoefer MD, MAPS principal investigator for clinical trial of Ecstasy in subjects diagnosed with PTSD
Dr Michael Mithoefer MD, MAPS Bulletin Vol. 12, No.2 (description of attempts to submit research to MUSC IRB, Summer 2002)
MAPS Research Subject Recruitment
http://web.archive.org/web/20030722141350/http://maps.org/volunteer.html (July 2003)
http://web.archive.org/web/20020803094928/http://www.maps.org/volunteer.html (August 2002)
IRC-IRB to MAPS (2003-01-03)
MAPS to IRC-IRB (2003-01-20)
IRC-IRB to MAPS (2003-02-03)
MAPS to IRC-IRB (2003-02-06)
MAPS to IRC-IRB (2003-02-10)
MAPS to IRC-IRB (2003-02-13)
MAPS to IRC-IRB (2003-02-14)
MAPS (Wagner) to IRC-IRB (2003-02-07)
IRC-IRB to Maps (2003-02-21)
IRC-IRB to MAPS (2003-03-03)
Conditional IRB approval (2003-09-23)
Informed Consent (2003-09-25)
Dr Michael Mithoefer MD, MAPS Bulletin Vol. 13, No.1 (Summer 2003)
Full story from MAPS web site:
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