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dangers of clandestinely produced drugs, they also provided researchers investigating Parkinson's disease with a long-needed animal model of the disease's process. Since 1982, numerous PHS sponsored research studies have begun to examine the process by which brain cells are selectively attacked and destroyed by MPTP and other substances. Last year, the Public Health Service sponsored a two-day symposium on MPTP in Bethesda, Maryland where scientists from several countries presented findings on the toxicity, clinical pathology, and epidemiology of MPTP. Other research into MPTP, and synthetic analogs in general, has been initiated.

Investigations of the nature and extent of MPTP first used in California were conducted through an interagency agreement between NIDA and CDC. In January 1985, NIDA and CDC began to interview and locate persons who may have used MPPP and MPTP. Preliminary results from the study, conducted at the request of the State of California, suggest several hundred persons may been exposed to meperidine in California based on reported symptoms similar to those reported by known users of the drug.

NIDA continues to support research projects seeking to understand basic mechanisms of action of these new synthetic analogs. In order to provide controlled substances analogs to researchers for this purpose, NIDA is synthesizing these compounds and distributing them to research laboratories for chemical and pharmacologic evaluation. In 1985, NIDA produced large quantities of MDMA and MDE in order to study its abuse liability in animal models. The production of 3-methylfentanyl was carried out in June 1985 to provide DEA with an authentic sample of this recently controlled substance. Since October 1985, NIDA has prepared 15 fentanyl and meperidine analogs including MPPP and PEPAP, and the synthesis of an additional five are either in process or have been planned for the next few months. Five of the 15 have already been tested by NIDA for abuse liability and the remaining compounds will be tested by November. These tests indicate that the potency of some of these compounds is up to 600 times that of morphine. Additionally, NIDA has been actively soliciting, through the regular and small business grant programs, analytical methods for the detection of these drugs in human biological fluids.

PHS activities have not been limited to research. NIDA notified the drug abuse treatment and prevention community nationwide of the dangers of MPTP. Together with the National Institute on Mental Health (NIMH), NIDA prepared a report on MPTP for publication in the Morbidity and Mortality Weekly Report (MMWR). This CDC published report, which reaches a national audience of physicians, served as the basis for an article later published in the Journal of the American Medical Association, where the information reached an even wider audience. NIDA has engaged in extensive networking with State treatment programs, community-based drug abuse prevention and treatment programs, parents groups, including the National Federation of Parents for Drug Free Youth, interdisciplinary conferences involving education, law enforcement, parents, and health profession groups, and other national prevention networks.

In carrying out this responsibility, the Institute shared information with regard to the dangers associated with designer drugs through publication of

materials in the NIDA Notes, the ADAMHA News, and the publication and dissemination of a NIDA News Capsule. The Notes are mailed to all drug abuse treatment programs, prevention programs, State agency directors, and State prevention coordinators; while the News Capsules are shared with the press and policymaking officials in the drug abuse area.

Data on the extent of abuse and the adverse health consequences of drugs are needed to schedule substances under the CSA. The controlled substances analogs, however, are extremely difficult to track through existing drug abuse data systems operated by NIDA. Not only are the substances so closely related chemically to a parent compound thus creating identification problems but, as in the case of the fentanyl analogs, toxic doses are often so small that they are easily overlooked by routine laboratory analysis. As a result, data collected from hospital emergency rooms and medical examiners across the nation and reported to NIDA's Drug Abuse Warning Network do not provide a valid measure of the designer drug problem in this country. Data also can be gathered through special epidemiologic studies such as the collaborative project with CDC and through NIDA's Community Epidemiology Work Group (CEWG). In its most recent semi-annual meeting held in December 1985, CEWG members reported that the fentanyl compounds continue to be a severe problem in southern California, and that some 704 grams of Fentanyl were confiscated by law enforcement agencies in 1985. In San Diego, 24 fentanyl-related deaths have been reported since mid-1982, with 10 deaths occurring during 1984 and 4 more deaths in 1985. Fentanyl-like compounds are being sold as heroin in the street, but only from select dealers. Indications that fentanyl analogs are available in other areas of the country, including New York and Atlanta, were also noted by CEWG members. Several preliminary reports from the CEWG also suggest that meperidine analogs may have become available in other parts of the country outside California, including Detroit and Florida. Efforts of PHS agencies to further understand the health implications of the synthetic analog problem will continue to include epidemiologic studies, research investigations, synthesis and distribution of compounds, and knowledge dissemination activities.

Before closing my remarks, I would like to stress that synthetic analogs do present a serious hazard to those who use them, but that the use of these substances has so far been confined to relatively few areas of the country. Certainly, as of now, the synthetic analogs I have discussed today have not begun to present problems as widespread as those posed by marijuana, cocaine, or heroin. Yet, as we have seen, many of these drugs lack any known health benefit and are indeed causing very severe adverse health consequences.

We must exercise our options for controlling these substances, including the emergency scheduling authority which can be used to place them under the CSA. Because current laws are not adequate for addressing the unique problems of designer drug manufacture and distribution, PHS staff has worked with the DEA to formulate the legislation which is now under consideration in the House. In developing this proposal, we were careful to avoid inhibiting research or interfering with the legitimate manufacture of drugs by focusing upon the intent of manufacturing the drug. If the intent of manufacture is for legitimate scientific purposes and not for sale to humans, it is not prohibited. Protection is provided where the intent of manufacture is for

legitimate sale to humans by exempting individuals or companies which apply for and receive appropriate FDA approval to develop a new drug. Thus legitimate scientific research is sufficiently protected. We believe this legislation will tackle the synthetic drug problem at its source, and it is my hope that Congress will enact this needed control so that we can be more successful in stopping the abuse of these dangerous drugs.

Mr. HUGHES. Gentlemen, we are just delighted to have you with us this morning. We have your statements, which will be made a part of the record in full, and you may proceed as you see fit.

Dr. Hawks, why don't we begin with your statement?

STATEMENT OF RICHARD HAWKS, PH.D., CHIEF, RESEARCH

TECHNOLOGY BRANCH, DIVISION OF PRECLINICAL RESEARCH, NATIONAL INSTITUTE ON DRUG ABUSE, PUBLIC HEALTH SERV. ICE, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, ACCOMPANIED BY VERNON HOUK, M.D., DIRECTOR, CENTER ENVIRONMENTAL HEALTH, CENTERS FOR DISEASE CONTROL, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES; EDWARD C. TOCUS, PH.D., DIRECTOR, DRUG ABUSE STAFF, CENTER FOR DRUGS AND BIOLOGICS, FOOD AND DRUG ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Dr. HAWKS. Thank you, Mr. Chairman, members of the subcommittee.

We have already covered much of the background description of the problem and the kinds of drugs we are dealing with, with a lot of nice statements from yourselves. As indicated in previous testimony, we are dealing with underground chemists who have been active in producing compounds designed simply to circumvent legal liability under the Controlled Substances Act without much regard to the toxic danger of these compounds themselves or the possible impurities of side products in those preparations.

While the actual numbers of persons affected so far have not been great, at least in comparison to the people affected by cocaine, marijuana, PCP, in this country, these particular kinds of synthetic analogs, or designer drugs, do present special problems and have great potential for adverse and large-scale effect on the public health.

The super potent narcotic compounds such as 3-methyl fentanyl, which was used as an example here already, and was manufactured by the chemist at DuPont, is several hundred times more potent than morphine, as recent studies that NIDA has done indicate. An ounce of this material can produce 5 million doses. And an ounce of material doesn't take up much space if one wants to move it around clandestinely. This has implications not only for health of individuals who might use this drug in terms of the potential for overdose, but also for law enforcement. It is very hard to keep up with such small amounts of material that will go so far.

Another synthetic narcotic which has been the subject of a number of the comments made in the video tapes that we have seen so far is MPTP, which is a side product that results in the synthesis of MPPP. I won't give you the whole chemical name, but MPPP is a narcotic. It is a synthetic heroin made to be sold on the street. But just about any street synthesis of this material produces smaller or larger amounts of MPTP as a side product. And this one side product, a very simple chemical molecule, is very unusual in that it causes such a tremendous amount of neurotoxicity. It produces the devastating effect as we have seen on these videos.

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All syntheses of street drugs produce side products. There is no attempt to make good, pure products when people set out to make the drugs. When you are dealing with something that is hundreds of times more potent than currently available drugs on the street, there is no need to worry if your compound, or formulation happens to be only 50 percent pure, or even 10 percent pure; there is enough activity there for you to sell it easily. And the rest of that material is potentially toxic. MPTP is a little bit unusual in that it is so toxic and so specifically toxic.

This particular compound is also rather insidious because of the neuronal damage that can occur from one injection, as we have heard. It can also cause damage which will not show up until years later because the normal effects of neuronal destruction that are associated with the normal aging process eventually will lead to the point where the cumulative effect of the drug use many years before and the aging process add up to a premature Parkinson's situation later in life.

Another class of drugs that we are particularly concerned about which we haven't mentioned today, believe, contains the drug called Ectasy, or MDMA, which has become quite prevalent throughout the country in the young adult population and has been used by some physicians as an adjunct to psychotherapy. We have become particularly concerned about this popular analog because research in animals strongly suggest that it contributes to the cumulative destruction of certain brain neurons associated in humans with sleep function, mood, sexual activity, and other factors, which can have profound effects on personality.

Doses of MDMA producing neurotoxicity in rats are very close to the doses that produce subjective effects in those same animals. This implies that humans may well be exposing themselves to neurotoxic doses of these compounds in attempting to get the desired psychological effects. This is one example of an amphetamine analog. I understand since, in talking to the DEA recently, that two other similar analogs of amphetamine have recently been identified from street sources. There is no information at all yet on what their potential chronic toxicity might be.

In response to this concern about the synthetic analogs the Public Health Service, NIDA and CDC, primarily, have launched a fairly extensive informational campaign through State treatment programs, parent groups, and various community-based drug abuse prevention and treatment programs, including physicians groups. We have had some clinical referrals coming through a hotline at NIDA—which includes information on designer drugs—and we have made clinical referrals from physicians around the country who suspect they may have someone who has been exposed to these compounds.

In basic research, NIDA has established initiatives to develop pure standards of some of these compounds. This is done, in part, through an interagency agreement with DEA. We have synthesized over a dozen of these analogs and have put them into animal testing. Some of that testing is completed. The remainder will be finished by November. These standards are also being supplied to DEA labs and through other mechanisms to forensic laboratories so

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