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," caught the attention of media over the past year and a half as a new trend in America's illicit drug scene. As you are aware the term does not refer to a particular pharmaceutical classification but rather to a method of making new products. for the illicit market. Drugs which may carry few, if any legal risks and offer greater profits than selling controlled

substances.

The problem of clandestine, synthetic drugs is not a topic. Up Front Drug Information Center has warned about dangerous drugs in the street market for the past thirteen 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. The profits were higher and the legal risks fewer than dealing in authentic drugs. 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. The problem of the sythetic heroin designer drugs, including analogs of fentanyl and meperidine, have already created mass public poisoning incidents 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 manufactured 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 Drug Enforcement Administration (DEA) lab to be MPTP. Over fifty 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 has been diagnosed as having Parkinson's disease induced by MPTP sold as heroin.

Other recent occurrences with Designer Drugs have been reported by members of the Community Epidemiology Work Group, a National Institute on Drug Abuse (NIDA) panel. In San Diego, at least fourteen deaths were attributed to fentanyl

like compounds in the past two years. Law enforcement. agencies in Los Angeles reported confiscating 704 grams of fentanyl in 1985. From Detroit we have reports of confirmed Parkinson's disease caused by taking MPTP alleged 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 have not been previously encountered is complicated by the lack of drug standards, reference spectra and analytical methodologies. The substance may be hundreds of time 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 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 counter offensive that has escalated the War on Drugs. Dr. Sidney Cohen has compared illicit drug contamination to the "bad booze" of Alcohol Prohibition (1920-33) which caused

encephalitis, polyneuritis, and blindness in some imbibers.

In closing, I wish to share some findings from a paper I recently presented to the International Institute on the Prevention and Treatment of Drug Dependence based on the cocaine situation in Miami. 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 that judges find the cure for cancer or 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% of all illicit substances. Yet, there are health, medical, educational, social, family and religious solutions to our drug abuse problems. These represent the "90% Solution" and demand far more attention than they have been previously given.

Mr. HUGHES. Mr. Grinspoon.

Mr. Grinspoon, like the other statements your statement is a part of the record. We have read your statement and if you could summarize for us, we would appreciate it.

Dr. GRINSPOON. Thank you, Chairman Hughes. Let me say, first of all, I appreciate the opportunity to appear before you to address the need for legislation to combat this serious and growing misuse of so-called designer drugs. But the gist of my statement is that I am concerned that as Congress studies various approaches to solving the enormous problems posed by designer drugs that it must consider the potential impact of these legislative remedies on legitimate medical research and treatment, particularly in the field of psychiatry. That is why I, and my colleagues, are concerned about this bill, or this proposed law as it is presently written.

There is no question that Congress must take action to stop underground chemists who try to stay one step ahead of the law by altering the molecular structure of a drug listed as a controlled substance, and thus create a product that is entirely legal but produces effects similar to an illegal substance. "Analog" is a technical term for these chemical variations, but they are better known as "designer drugs." Action now has been prompted mainly because of the deaths and serious injuries from analogs, as you have heard and seen tape ofs, particularly with analogs of heroin.

The Senate has passed a new amendment to the Controlled Substances Act, and you and your colleagues are now considering several similar bills. The Controlled Substances Analog Enforcement Act makes it a crime knowingly to manufacture, possess, or distribute for human consumption any substance that is chemically "substantially similar" to a controlled drug in schedule I or schedule II, or "specifically designed to produce a substantially similar effect. Schedule I includes heroin, marijuana, and other drugs with no accepted medical uses. Schedule II includes such medically important drugs as morphine, dextroamphetamine, and methylphenidate.

Now, although the aim of the Senate bill and related House measures is a worthy one, I believe in its present form the legislation is seriously deficient in several ways that may be easily overlooked but are bound to have unfortunate effects on medical research. First of all, criminal penalties are imposed without a requirement for evidence that anyone has been injured by a new analog or even that anyone has abused it. Instead, the law relies on the Justice Department officials and the courts to evaluate the molecular structure of a chemical or read the mind of its manufacturer. Even if the Justice Department and the courts were scientific authorities, they could not properly do that. No one can know in advance the specific effects of a substance that has not yet been created, and the term "substantially similar" as used in the proposed law is both vague and unscientific. What may seem to be a small change in the chemical structure of a drug sometimes leads to a large difference in pharmacological effect.

Secondly, the Senate bill permits an exception only for persons who have a new drug application or exemption for investigational use, IND, approved by the Food and Drug Administration. Otherwise, it does not distinguish between illicit sale and legitimate medical research. Since the current requirements for these FDA appli