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

   Patients in the proposed protocol would receive 1.5-2 mg/kg  MDMA  every two
to four weeks.  MDMA, synthesized and purified at Purdue University, is one
of the hallucinogenic drugs that has been found to be associated with
neurotoxicity (alteration of the serotonin-producing neurons) in rodents and
primates.