72 lines
3.5 KiB
Plaintext
72 lines
3.5 KiB
Plaintext
Newsgroups: alt.drugs
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From: an13187@anon.penet.fi (H-Man)
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Subject: mdma article #6
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Message-ID: <1993Jul4.031728.24999@fuug.fi>
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Date: Sat, 3 Jul 1993 17:50:56 GMT
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The Pink Sheet 1992; 54(29): T&G-11-T&G-12
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July 20, 1992
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SECTION: TRADE & GOVT. MEMOS
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LENGTH: 483 words
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TEXT:
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HALLUCINOGENS POSE NO GREATER RISK THAN OTHER INVESTIGATIONAL DRUGS, FDA's
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Drug Abuse Advisory Committee agreed at its July 15 meeting. Summarizing the
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committee's discussion, FDA Pilot Drug Staff Medical Officer Curtis Wright, MD,
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said: "I have not heard . . . any discussion of risks involving these compounds
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that we do not routinely face with every new drug we put through the IND
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process."
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The committee was asked to assess problems that might be associated with
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allowing research to be conducted with hallucinogenic drugs. Wright said FDA,
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in the last few years, automatically has put IND applications for
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hallucinogenic drugs on hold, taking from months to years to respond to
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investigators regarding their protocols.
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Wright told the group: "We are coming to the committee because we are going
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to have to deal with the issue of hallucinogens . . . because drugs of this
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class are likely to be explored as potential therapies or modifiers of the
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effects of a variety of agents, including cocaine." FDA's reluctance to approve
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IND requests for hallucinogens stems from several concerns, Wright explained,
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including the potential for diversion of controlled substances by researchers
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and patients, and animal data indicating that selective serotonin agonists,
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such as substituted amphetamines, can permanently alter the serotonin pathways.
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While committee members and consultants agreed that the potential
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long-lasting neurologic changes caused by these drugs are of concern, they
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concurred with Wright's comments that the harm caused by these agents "is
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outweighed in most cases by the knowledge to be obtained or by the therapeutic
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benefit to the patient." Wright said that all neurologic or psychological risks
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"need to be addressed in evaluation of the protocol."
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Synthesizing the comments of the committee and consultants, Wright said: "I
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have heard great concerns by almost every speaker that the usual standards of
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research must be followed: that there must be meticulous attention to questions
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of patient selection, informed consent, [and] monitoring." He remarked: "I
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haven't heard anything that leads me to believe that this is a qualitatively
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different kind of research than the rest of the research we do with other
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agents."
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In closed session, the committee considered an IND protocol submitted by
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University of California at Irvine researcher Charles Grog, MD, for the
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selective serotonin agonist methylenedeoxymethamphetamine ( MDMA, commonly
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known as " Ecstasy" ) for use in psychotherapy and pain relief of terminally-ill
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pancreatic cancer patients.
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Patients in the proposed protocol would receive 1.5-2 mg/kg MDMA every two
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to four weeks. MDMA, synthesized and purified at Purdue University, is one
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of the hallucinogenic drugs that has been found to be associated with
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neurotoxicity (alteration of the serotonin-producing neurons) in rodents and
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primates.
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