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
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
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
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.