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Current Question:

Illegal Research?

Dear Dr. Shulgin:

As I understand it, current laws make it impossible to publish a study on the effects of a psychedelic drug in humans. How general are these laws? To what extent are they prosecuted? For instance, is there anything that would prevent someone from publishing a study on a potential antidepressant if the study revealed that it actually had psychedelic qualities? What does someone interested in eventually doing this kind of research have to fear?

-- Andrew

Dear Andrew:

Thank you for a fascinating and important group of questions. Since I am not a lawyer, the answers here simply reflect my own experiences and my non-professional understanding of the federal laws in the area of psychedelic drugs.

Is it illegal to publish human studies describing the effects of psychedelic drugs? Not at all. The act of publication is still (in principle) protected by the First Amendment to our Constitution wherein Congress has been informed that it shall make no law abridging the freedom of speech or of the press. If you have performed an illegal act, you are certainly allowed to give a talk about it publicly, or publish a letter to the editor of a newspaper or journal.

But remember that you are going on record as having done something against the law, and you are in essence providing a prosecutor with a confession. The way to avoid this vulnerability is to not do anything that is illegal.

If you wish to run a legal clinical study with, say, psilocybin, all you need to do in advance is to get a Schedule I research license from the DEA, an investigating new drug (IND) approval from the FDA, a licensed commercial laboratory who will provide you with the drug, and obtain approval of your detailed research protocol from the DEA, the FDA and the Institutional Review Board (IRB) of the academic location where the study will take place.

So if you can weather a couple or three years of very foot-dragging bureaucracy, your work has become legal and you can publish it where you wish.

How general are these laws? They exist at both the Federal and the State level. I should have added a bit more weight to the bureaucracy delay above, in that most States have similar approval requirements. In California, approval has to be obtained for your submitted research protocol from the group called the California Research Advisory Panel which, a few years ago, noticed what the initials stood for. The State's name was quickly dropped from their letterhead.

To what extent are they prosecuted? Probably not at all, and there is virtually no one who has the patience and money to go through this approval process. Very little research is being done legally on psychedelic drugs today, and so few papers are being published.

In certain other countries, yes. But in the United States, no.

Can you publish a clinical study on, say, antidepressants if some psychedelic properties have been observed? My feeling here is that the answer is yes. By definition, the drug you are looking at is not a Schedule I drug, and the only way that the Controlled Substance Analogue Law can be invoked is if you are representing it as having the action of a Schedule I drug. And there are no Schedule I antidepressants. Your intent was innocent, and I believe you are also innocent. I go even further, and urge you to publish this side-effect. This would alert anyone who is exploring this medical area that there may be side-effects with your compound that might be unacceptable in any final prescription drug.

What is one to fear if he wishes to eventually do this kind of work? Aside from the medical risks of exploring new drugs in humans, the only certain risk is the law. Work with a competent physician, and also with a competent lawyer. Or work in a country such as Switzerland where research of this nature is considered a medical matter, not a legal one.

--Dr. Shulgin
 

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