possible or by allowing the placement of less abusable 3. Re-evaluate the possibility of using the Federal Food, Drug, and Cosmetic Act to address the problem of designer drugs. It is a federal crime to violate the "new drug" provision of that Act. Designer drug manufacture and distribution appears to be such a violation. Perhaps the administration should direct the FDA, working in conjunction with DEA, to be more active enforcing this provision. 4. See if greater protections could be afforded legitimate pre-IND research activities. The Senate-passed bill attempts to do this but still leaves open several questions of interpretation. You Thank you for permitting me to appear before you today. and the dedicated staff at DEA have a difficult problem to resolve. I know that I can speak for all controlled substances' manufacturers and researchers when I wish you success in identifying and prosecuting the individuals who make and sell designer drugs. But I again urge caution. We should not let fears of drug abuse prevent the discovery of therapeutically useful psychoactive substances, particularly when active enforcement of existing legislation may be sufficient to deal with the problem. I would be happy to answer any questions you might have. Mr. HUGHES. Our next witness is Dr. Everett Ellinwood. Welcome. We have your statement, which likewise will be made a part of the record. We hope you can summarize for us. Dr. ELLINWOOD. Thank you, Mr. Chairman. I am a member of the Research Council of the American Psychiatric Association. My remarks have been drawn from consultation with many knowledgeable scientists, and particularly members of the APA Research Council, but it does not reflect a scientific consensus of that group. In general, we are aware of the present and future danger of maverick chemists who eschew the principles of medical science for the incredibly extensive illegal gains to be reaped from the synthesis of novel drugs. The capacity of these individuals to design drugs in a time frame that consistently anticipates the current law is clearly evident. The APA unequivocally endorses any legislation that would facilitate prosecution and prevention of the disastrous consequences as noted in the scenario with the meperidine analogs, MPPP Furthermore, we are aware of the difficulty in steering legislation in order to avoid after-the-fact legal action directed only piecemeal at a series of new compounds and at the same time avert an overinclusive, presumptive scheduling based on no facts other than the intent to distribute to humans. In more parabolic language, we understand your desire to avoid closing the barn door after the horses are out, yet hesistant to count your chicks before they hatch. I would like to skip down and go over some points that we think we would like to have considered in the law and its interpretation. We think there should be included in the law a means of avoiding retardation of innovative research due to the scheduling or anticipated scheduling of a drug. We need to avoid the perception that the law will involve further unnecessary legal entanglement for legitimate researchers. When we talk about not enacting barriers to scientific inquiry we are referring to high quality research designs proposed by respected and experienced investigators with appropriate scholarly oversight and environment. We are not talking about more informal studies. We think that you should avoid imprecise language in the law that would facilitate inappropriate liability suits or capricious legal action against medical researchers. We think that within the FDA and NIDA that we should establish positive advocate procedures for facilitating appropriate legitimate human research with these drugs in order to balance the effects of needed restrictive legislation. These advocate procedures might include establihment of a separate independent science-legalethics panel to expeditiously review procedures and to process proposal requests for research addressed in the schedule I and under the new law. We also are concerned about certain kinds of research that are practically non-existent at this time. We think that the law should allow leeway for expediting significant rigorous investigations on psychedelic drugs, especially their therapeutic utility in certain mental disorders and the nature of their potential for adverse mind-altering effects. Research in this area has been so severely constricted that we have only limited knowledge of the parameters mediating the balance between a therapeutic and adverse outcome. I would like now to address a few principles and procedures that we endorse but only partially pertain to the new law. We feel that appropriate animal toxicity screens should be performed before human experimentation in accordance with the ethics put forth in the Nuremberg code and the Helsinki agreement. For example, there is evidence accumulating that both MDA and MDMA have neurotoxic consequences. If the therapeutic toxic ratio as has been indicated may be as narrow as some individuals are reporting for these drugs, then they may be of considerable danger if they become a popular recreational drug. In any systematic project research should be of sufficient significance and proper experimental design to warrant that human experimentation. Where therapeutic intent for individual patients is involved the rationale underlying that therapeutic potential should be clearly documented, including the alternatives that are available. The law needs to be narrowly and precisely written to preclude encroachment on legitimate research laboratories involved in (a) synthesis of radio-labelled analogs for experimental work; for example, in the new Positron emission tomography; (b) possession or distribution to human research subjects or patients in research endeavors with the legitimate approval by a qualified institutional review board for human research and/or an exemption of investigational use. Six. Precise language is needed to define the "substantially similar" aspect of the law to include several pharmacological effects as well as molecular design. It must be kept in mind that very similar molecules can either be active or inert, as the case may be, with many isomers and many drugs that are very, very similar can be actually antagonists to the original drug effect. Some drugs may be dissimilar but produce similarly active metabolites. Finally, we realize that we have iterated a series of problems with few solutions. The American Psychiatric Association through many contacts with scientists in this area would welcome an active role in consultation on this legislation if requested. Thank you. Mr. HUGHES. Thank you very much, Doctor. [The statement of Dr. Ellinwood follows:] Mr. Chairman: My name is Dr. Everett H. Ellinwood, Jr., Professor of Psychiatry and Pharmacology, Director of Behavioral Neuropharmacology at Duke University Medical Center, and a member of the American Psychiatric Association's Council on Research. The American Psychiatric Association, a medical specialty society representing over 32,000 psychiatrists nationwide, appreciates the opportunity to testify before the Crime Subcommittee of the House Judiciary Committee on the issues of concern to us in the designer drug legislation you are considering today. My remarks have been drawn from consultation with many knowledgeable scientists and particularly members of the APA's Research Council. At this time it does not reflect a scientific consensus of the APA. In general, we are well aware of the present and future danger of maverick chemists who eschew the principles of medical science for the incredibly extensive illegal gains to be reaped from the synthesis of novel drugs of abuse. The capacity of these individuals to design drugs in a timeframe that consistently anticipates the current law is clearly evident. The APA unequivocally endorses any legislation that would facilitate prosecution and prevention of the disastrous consdquences as noted in the scenario with the meperidine analogs, MPPP and MPTP. Furthermore, we are aware of the difficulty in steering legislation in order to avoid "after the fact" legal action directed only piecemeal at a series of new compounds and at the same time avert an overinclusive, presumptive scheduling based on no facts other than intent to distribute to human. In more parabolic language, we understand your desire to avoid closing the barn door after the horses are out; yet, be hesitant to count the chicks before they hatch. The APA perspective is grounded on two premises: 1) The encouragement of high quality scientific investigation in significant health problems. |