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.