cations entail extensive testing, which is very expensive, research in certain areas such as the treatment of psychiatric disorders can be conducted only at the corporate industrial level. This is the territory of the pharmaceutical houses who are established and who may be already both capable and committed to financing the promotion of a promising drug through the administrative structure. But research at an earlier stage also needs to be protected, especially when pharmaceutical companies may not be interested because they cannot reliably expect patents and profits. The FDA rules were established to regulate the marketing of drugs, not to shape medical research and practice.

Under the provisions of this law, a chemist who synthesized a new drug might actually be committing a crime by taking that drug. Self-experimentation of this kind is the way in which many, if not most, new drugs with valuable psychoactive properties have been discovered. It is true not only of synthetic drugs but of drugs found naturally in plants. If the Federal Government makes it a crime to work with any new substance thought to have some undefined resemblance to a controlled drug, entire fields of therapeutic psychopharmacology may go undiscovered.

Many of the discoveries of new medicines and therapies have been made by scientists who try one thing and fail and then try something else. The controlled development of analogs, in essence, designer drugs, is essential to the advancement of pharmacology. Many of the antipsychotic and antidepressant drug discoveries of recent years are minor variations on a common molecular theme with similar effects. However, it is precisely the differences that are medically significant-different potencies, different side effects, and most important, different therapeutic utilities.

The same is true of analogs that do not belong to a class of drugs with presently accepted therapeutic uses. One drug that has recently received some publicity is MDMA, or methylenedioximethamphetamine. It is chemically related to several controlled substances. A number of researchers also take seriously its potential as an aid to insight and communication in psychotherapy, and they are interested mainly because its effects are not identical with those of the chemically related controlled drugs.

When MDMA first appeared on the American scene in the early 1970's, it was known only to a few scientific and medical researchers. There was no significant illicit street use. It could not be patented, and no drug company was interested in it. If the proposed legislation had been in effect at that time, all research could have been brought to a halt. Since reputable physicians and scientists would not have been willing to become outlaws to work with MDMA, we would never have learned about this potential, this therapeutic potential. The small illicit market, on the other hand, would have been affected very little. Under the new law, if there are any therapeutically useful analogs of currently controlled drugs, we may never come to know of their existence.

The proposed designer drug legislation needs to be redesigned. Its language must be clarified or the exemption for scientific and medical research rewritten to protect the public against opportunistic illicit drug profiteers without discouraging research on pharmacology in areas where early commercial application is unlikely.

I thank you for your attention.
Mr. HUGHES. Thank you, Dr. Grinspoon.











MAY 1, 1986

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in recent years has been devoted to the study of

psychoactive drugs.

I appreciate the opportunity to appear

before you to address the need for legislation to combat the

serious and growing epidemic of the misuse of so-called

"designer drugs" in this country.

I believe that as Congress studies various approaches

to solving the enormous law enforcement problems posed by

"designer drugs," Congress must also consider the potential

impact of these legislative remedies on legitimate medical

research and treatment, particularly in the field of


That is why I and my other colleagues in the

psychiatric profession appreciate your seeking the views of

representatives of the medical community at today's hearing.

I will be happy to answer your questions after my brief

introductory statement.

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Practitioners and researchers in the field of

psychiatry believe strongly that current efforts by the

House and Senate to deal with the new phenomenon of

"designer drugs" are to be applauded.

Congress should 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 the technical term for

these chemical variations, but they are better known as "designer drugs." Action now has been prompted mainly because of deaths and serious injuries from analogs until

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Parkinson's disease, a disorder of body movement that may

leave the victim nearly paralyzed.

The profiteers who

manufacture and distribute these analogs clearly have no

concern for the public welfare and certainly no ties to

legitimate scientific research.

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