One could think of words such as establishing credentials for people who might not yet have an IND and who have been doing research on certain kinds of compounds or for certain kinds of purposes, but you very quickly get into the kinds of things that people would bring up if they were taken to court to prove their innocence, or from the other side, to provide their lack of innocence. It almost seems like those kinds of subtleties are going to have to be worked out when this bill starts being used for enforcement and from interpretations from the courts and in the policy that results from that. I don't have any immediate suggestions for changes in the wording. I think Dr. Tocus has a comment to make on that, if he would. Mr. HUGHES. When an analog is being investigated pursuant to an investigative process, they still are required to apply for registry with the Food and Drug Administration? Dr. HAWKS. If it is not intended for human use, there is no reason to. I mean, if there is not going to be human experimentation. Mr. HUGHES. If it is not intended for human use. Dr. Tocus. Mr. Chairman. Mr. HUGHES. Is that the only exception? Dr. Tocus. An application can be made to the Food and Drug Administration at any time along the development of the drug. They don't have to wait until they intend to give it to humans. Someone interested in developing a drug can make an application at the time they first synthesize it and carry that along. It is our belief that the Food, Drug, and Cosmetic Act is the best and quickest way to see a drug that has useful therapeutic uses gets to the market. We see that studies have proper controls. One of the things that we look at is the design of the studies to make sure that there is useful scientific information that is going to come out, that people aren't put at risk with the drugs that have no basis in scientific fact. Actually, the Food, Drug, and Cosmetic Act is the mechanism by which drugs can quickly come to market. One of the greatest rewards of working at the Food and Drug Administration is seeing a good drug get through and get out to the American people. That is what we want. If it has useful activity, we work with the scientists. But we make sure that it is on a scientific basis. Mr. HUGHES. OK. I don't have any further questions. The gentleman from California. Mr. LUNGREN. No, I have no questions. Mr. HUGHES. Well, thank you very much, Doctors. We appreciate your testimony. You have been very helpful to us today, and we appreciate that very much. Mr. HUGHES. Our last witnesses will appear as a panel. Our panel consists of: Mr. James N. Hall, the executive director of the Up Front Drug Information Center, Miami, FL, a member of the Florida cocaine task force set up by Governor Bob Graham and a member of NIDA's community epidemiology work group. Robert T. Angarola, a lawyer with the firm of Hyman, Phelps & McNamara, a professional corporation, here in Washington. Mr. Angarola served in the Office of General Counsel in the White House Special Action Office for Drug Abuse Prevention in 1972. In 1973 he became the legal adviser to the International Narcotics Control Board in Geneva, Switzerland. In 1977 he was asked to serve as general counsel of the White House Office of Drug Abuse Policy, and later served as the Assistant Director of the White House Domestic Policy Staff dealing with health and drug issues. Dr. Lester Grinspoon is associate professor of psychiatry at the Harvard Medical School in Cambridge, MA. As a distinguished physician and teacher for over 30 years, he has been a member or officer of numerous professional boards and associations. He has testified before numerous government, legislative and research panels. He is the author or co-author of over 100 academic papers, and the author, co-author or editor of some 14 books. On behalf of the American Psychiatric Association is Dr. Everett Ellinwood, professor of psychiatry and Pharmacology at Duke University Medical Center. Among Dr. Ellinwood's many credits, he is a fellow of the American College of Neuropsychopharmacology and a member of the research council of the American Psychiatric Association. Gentlemen, we welcome you here today on behalf of the committee. We have your statements, which will be made a part of the record without objection, and you may proceed as you see fit. We will begin with you, Mr. Hall. Welcome. STATEMENTS OF JAMES N. HALL, DIRECTOR, UP FRONT DRUG INFORMATION CENTER, MIAMI, FL; ROBERT T. ANGAROLA, ESQUIRE, HYMAN, PHELPS & MCNAMARA, WASHINGTON, DC; LESTER GRINSPOON, M.D., ASSOCIATE PROFESSOR OF PSYCHIATRY, HARVARD MEDICAL SCHOOL, CAMBRIDGE, MA.; EVERETT H. ELLINWOOD, JR., M.D., PROFESSOR OF PSYCHIATRY AND PHARMACOLOGY, DUKE UNIVERSITY MEDICAL CENTER, ON BEHALF OF THE AMERICAN PSYCHIATRIC ASSOCIATION Mr. HALL. Mr. Chairman, and members of the committee, thank you for addressing one of this decade's more complex issues in the drug abuse field. The name "designer drugs," has caught the attention of the media over the past year and a half as a new trend in America's illicit drug scene. As you aware, the term does not refer to a particular pharmaceutical classification but rather to a method of making new products for the illicit market. Such drugs may carry few, if any, legal risks, yet offer greater profits than selling controlled substances. The problem of clandestine, synthetic drugs is not a new topic. Up Front Drug Information Center in Florida has warned about dangerous drugs in the street market for the past 13 years. Our telephone hotline, recorded drug warning messages, laboratory analysis program and publications have exposed deadly deceptions associated with illicit drug sales. We have witnessed fake, toxic street drugs before, bootleg Quaalude tablets, phoney cocaine, and fake heroin. Yet some of the designer drugs we discuss today have escalated the human risk of drug use to potentially catastrophic levels. Perhaps it was a loophole in our criminal justice statutes that encouraged the development of designer drugs. Hopefully, we may identify the remedies needed in the law to remove those incentives. Yet the issue of toxic drugs needs to be viewed first as a public health problem and then secondly as a criminal problem. Synthetic heroin designer drugs, including analogs of fentanyl and meperidine, have already created mass public poisoning incidences in several States. The public health threat is not only to drug abusers but to anyone, including police and laboratory technicians, who may merely be in the same room where these drugs are manufac tured or stored. During the past several months Up Front Drug Information Center has worked with physicians from the Federal Centers for Disease Control in monitoring the presence of the meperidine analog, MPTP, in the South Florida illicit drug market. A street sample from Ft. Lauderdale was confirmed by a DEA lab to be MPTP. Over 50 individuals have been identified as having been exposed to MPTP by taking a drug that was reported to be heroin or cocaine. At least one subject in South Florida has been diagnosed as having Parkinson's disease induced by MPTP sold as heroin. And, Mr. Chairman, if we might pause at this moment I have a very brief, 2-minute, video tape of a news broadcast from Station WCIX in Miami reporting on the MPTP episode in our area. [Film.] Mr. HALL. Other recent occrrences with designer drugs have been reported by members of the community epidemiology work group, a National Institute on Drug Abuse panel. In San Diego, at least 14 deaths were attributed to fentanyl-like compounds in the past 2 years. Law enforcement agencies in Los Angeles reported confiscating over 700 grams of fentanyl in 1985. From Detroit we have reports of confirmed Parkinson's disease caused by taking MPTP alleged to be heroin. Identification of and monitoring for new analogs of controlled substances is extremely difficult, and consequently, many such drugs may go undetected. Laboratory analysis of substances which may have not been previously encountered is complicated by the lack of drug standards, reference spectra and analytical methodologies. The substances may be hundreds of times more potent than known drugs and thus may appear in minute quantities or mixed with other drugs. Medical examiner's offices and hospital laboratories are not likely to find certain designer drugs in body fluids of overdose victims and patients. Thus it be probable that numerous injuries and deaths caused by these drugs have gone undetected. In Florida our surveillance activities this year have included public health warnings, interviews with street drug users, a special telephone hotline service, a laboratory analysis program, coordination of medical assistance for identified victims, and expanded intervention and treatment opportunities to free those imprisoned by addiction. Warnings, which have included a physical description of suspected drugs and specific signs and symptoms of their use, have proven to be the most effective. When viewed as a crime issue designer drugs become a counteroffensive that has escalated the war on drugs. Dr. Sidney Cohen has compared illicit drug contamination to the "bad booze" of alcohol prohibition which caused encephalitis, polyneuritis, and blindness in some imbibers. In closing, I wish to share some findings from a paper I recently presented to an International Institute on the Prevention and Treatment of Drug Dependency based on Miami's cocaine situation. The conclusion was that there are very limited criminal justice solutions to society's drug abuse problems. Expecting the criminal justice system to solve drug abuse is akin to demanding of judges that they find the cure for cancer or expecting that Interpol halt the spread of alcoholism. The most optimistic view is that the entire criminal justice approach to drugs is able to stop only 10 percent of all illicit substances. That is the most optimistic view. Yet there are health, medical, educational, social, family, and religious solutions to our drug abuse problems. These represent the 90percent solution and demand far more attention than they have previously been given. I thank you for this opportunity. Mr. HUGHES. Thank you very much, Mr. Hall. [Statement of Mr. Hall follows:] |