Barriers to Research
Alexander & Ann Shulgin
Yearbook for Ethnomedicine and the Study of Consciousness,
Issue 2, 1993, pp9-20. ©VWB - Verlag für Wissenschaft und Bildung, 1994.
Text of a presentation made to the American Association for the
Advancement of Science Annual Meeting, Section on Medicine and
Health, San Francisco, California, January 15, 1989. The presentation
itself is preceded by a foreword. The entire text is a working
draft for a chapter in the forthcoming book TIHKAL, [now]
published by Transform Press, Berkeley. (TIHKAL = Tryptamines
I have known and loved)
Foreword
The scientific literature is becoming unmanageable. Every year
there are more and more journals that pop up like mushrooms, dedicated
to the publication of papers of increasingly narrow scope and
appealing to a reading audience with correspondingly narrow interests.
Some of this is a product of the publish-or-perish ethic of the
academic world, where a faculty member will be weighed for his
worth as a tenured faculty member by the number of publications
he has amassed. This push to publish, to get another paper out
there, is a tremendous driving force behind every young scientist
who wishes to create a slot for himself in his university department
or to receive a priority on his pending grant application that
would allow its being funded. This pressure is expressed in a
joke that is told about pharmacologists by those who are not pharmacologists
(and probably told about coroners by those who are not coroners).
What is the definition of a pharmacologist? A laboratory person
who, upon injecting a compound into an animal, produces seven
publications. There is a sad truth to this form of communication
which I have heard referred to as "Salami Science."
Paper after paper is published, each looking at substantially
the same research work, but through an ever-changing lens. Inject
a drug into a pregnant female mouse. Run a maze, and publish a
paper on drug discrimination. Collect a dropping, and publish
on metabolic transformation. Collect a second dropping and report
pharmacodynamic kinetic curves. Let nature take its course and
hatch the young, then put a note into a teratogenicity specialty
journal. And on and on and on. Sometimes the single "injecting
of a compound" is cleverly disguised in the experimental
section; sometimes the authors simply don't bother to hide their
sloth. They assume, and quite rightly, that no one out there has
either the time, the energy, or the interest, to read all of the
literature.
But some of this mushrooming of the scientific literature is the
product of an ego expression of a different sort. As an example
of this type, consider the aging and not-too-widely acknowledged
Dr. Angst, Professor of Botany at Silverdale, who asks himself
how many scientists out there are aware of the seminal work that
I did, some twenty years ago, in defining the Genus Xelorhrobida
in the area of the Euphorbia? Maybe the time is right to start
a research journal, let's call it Xelorhrobida Letters, and
probably we can get Pergamon to publish it if I could guarantee
two hundred subscribers. I will call my buddies and get them to
promise to submit a research paper in the near future. Let's be
sure by making them all associate editors, and giving them free
subscriptions.
The average citizen has no idea how much of his income tax dollar
goes to just this sort of vanity stroking. Every month there are
a half dozen new journals appearing, Volume 1 of this or that,
designed to appear six times a year (the issues may be some 50
pages each) for an outrageous annual subscription rate of $320
a year to institutional libraries and subscribed to by the medical
libraries where Dr. Angst is on the library committee. And so
often the journal predictably fades from sight at the conclusion
of Volume 2. Many of the publication vehicles here can be called
the hyphenated journals, things that require an overlap of normally
separate disciplines, giving rise to names such as: Psychoneuroendocrinology;
or In Vitro Cellular and Developmental Biology; or
Journal of Neurology, Neurosurgery and Psychiatry. Occasionally
one finds an obscure and totally inhouse name such as MacGuires
Comments. They come, they go. But they fill a need for someone,
somewhere. This is the bottom level of published scientific literature.
The middle level consists of journals that offer to publish the
research findings of scientists within a given discipline. And
these are journals that are, generally, each devoted to a separate
discipline. The Journal of Pharmacology, Analytical Chemistry,
Toxicology, Phytochemlstry, Physical Letters. They are, in
many cases, the publications of societies that promote themselves
as being the organizations that define the scientist. Are you
a pharmacologist? Of course. I am a member of the Society of Pharmacology
and Experimental Therapeutics, and I have published in JPET.
Oh! Then you must be a pharmacologist! It is through publication
at this level that most of the quality research discoveries are
presented to the scientific community.
But what about that highest level of publication, the interdisciplinary
journal which is devoted to any and all fields that are collected
under the broad umbrella of scientific observations and factual
reporting? When I was young, and blossoming forth into this exciting
world, I had been taught that every major country (one with some
self-image of being "first world" in the areas of research)
had its own journal that could serve as a sort of a national emblem.
These were the ne-plus-ultra of class and prestige. To publish
in such a journal was a mark of international recognition and
acceptance by your peers. England had its Nature, the United
States had Science, Switzerland had Experientia, France
had the Comptes Rendu, and Germany had its Naturwissenschaften.
Each of these maintained the principle of multidisciplinary
reporting as a founding heritage, but each of them has found that
such an ideal does not bring in enough subscriptions. And so,
each of them has become more and more specialized, at the cost
of any appeal to a broad interest amongst its readership.
Science, the weekly publication of the American Association for
the Advancement of Science, is an excellent example. Years ago,
articles involving archeology, geology, astronomy, mathematics,
and embryology would compete equally for space on its pages. Recently,
sadly, the editorial staff has chosen to go the genome route,
and almost every page within the reports section deals with genotypes
and DNA sequencing. With a $10,000,000,000 encouragement to be
realized over several years from several governmental agencies
for the unraveling of the human genome, I can't fault their
specialization. That's where the money is. There's where the public
acclaim will come from. The advertising revenue reflects this
specialization. I am sad to say that I believe this is prostitution
at its most blatant, and I have let my membership in the AAAS
lapse.
So, it was with some surprise that I received an invitation to
attend, and address, an AAAS meeting in San Francisco. The topic
of the symposium was the "Designer Drugs" but it was
made known to me that there would be quite a bit of freedom extended,
allowing discussions to involve related topics. I assumed that
there would be much mention of MDMA, since that drug had just
been swept into the Schedule I classification by the invocation
of the Designer Drug Act of 1984. And, as this move would effectively
stop any and all research on its use in clinical practice, I knew
that this would be the area that I would have to address. Since
there had been no medical value acknowledged for MDMA, it was,
by definition, a drug that could not be explored in medical research.
And, as it was untouchable in the research environment, no medical
value could ever be demonstrated. I saw a mindless iron hand removing
some of the freedoms of research, and somehow, this loss had to
be exposed. Why not use the invitation from the AAAS gene cowboys
to the San Francisco Annual meeting, in early 1989, as an opportunity
to discuss this situation. Why not, indeed!
What follows is the text of my presentation. I thought of creating
an exciting title such as "Psychedelics and DNA" but
abandoned the idea. So my presentation was more modestly titled,
was given to an audience of perhaps 400 individuals, and was largely
ignored.
New barriers to research
In a paper that I presented a few years ago to the California
Association of Toxicology, I stated that we were blessed in this
country with what could be considered among the best narcotics
laws in the world. Approximately 250 drugs, and four plants, had
been brought under Federal control and were specifically and explicitly
named. There was rarely any ambiguity in the courts as to whether
a material was or was not an illegal drug.
The procedure for adding new materials was well defined. When
the Federal authorities became aware of a drug which they felt
might present a potential public health hazard if it remained
unregulated, a published announcement was made through the Federal
Register. This action started a sixty day process, and at the
end of that time, the drug would either be placed in a schedule,
in keeping with the degree of its danger and the presence or absence
of medical utility, or hearings would be set up to help decide
these issues.
There were many in the law enforcement community who felt that
this process was too time consuming. Congress was asked to allow
the hearings process to be deferred, and in 1984 it passed an
emergency scheduling act that allowed the temporary placement
of a drug into Schedule I without hearings and with only a thirty
day notice. This was to apply only to drugs which were felt to
be an imminent hazard to public safety. But please note that the
drugs involved were still explicitly named, and the hearings could
still be held if specifically requested.
Fentanyl is a synthetic narcotic with many years of proven medical
usefulness, and it served as the focal point of the Analogue Enforcement
Act of 1986. A great number of structural modifications of Fentanyl
had been synthesized by Janssen Pharmaceutica in Belgium. Some
of them, compounds such as Alfentanil, Sufentanil, Lofentanil,
and Carfentanil, have been incorporated successfully into medical
and veterinary practice. All of these are morphine-like narcotics
that differ from one-another largely in their potency and duration
of action. A very large number of additional structural modifications
of this parent drug have been explored in the academic community.
Then, a few years ago, one of these synthetic variants of Fentanyl
appeared in the street heroin trade. Almost as soon as it had
been identified, a second and different one appeared, instilling
a legitimate concern within the law enforcement community. The
Drug Enforcement Administration (DEA) expressed its fear that
these new drugs, cleverly named "designer drugs" in
imitation of the "designer jeans" fashion concept, could
continue to appear, one after another, and effective enforcement
would be impossible. Although the Emergency Scheduling Act of
1984 was fully in force, it was stated that a general, rather
than a specific law was needed.
(As an aside, let me ask you to put a moment's thought into the
phrase "designer drugs." How could we, as scientists,
have allowed such an idiotic, pejorative term to be used in our
hearing more than once, without having immediately torn it to
bits and shown it to be completely meaningless! Every one of us
knows perfectly well that when you synthesize a new potential
drug, whether you work for Ciba or for the CIA, what you come
up with is a designer drug. Designed to do something new. Perhaps
designed to avoid patent law. Perhaps designed to allow a new
scientific paper to be published. Almost every new and unknown
drug is a variation on an old, known drug.)
Congress was given carefully worded suggestions by the DEA, through
the offices of the Attorney General. These concerned the need
for a "Designer Drug Law" that could be used as a blanket
control covering any new drug that could be abused, if it lay
outside of the medically approved pharmacopoeia. In other words,
Congress was provided a written outline that would establish legal
control over any "designer drug."
The recommendations of the DEA were followed nearly verbatim,
and Federal law was written and passed to attempt to control anything
and everything that might appear on the illicit drug scene. This
legislation is called "The Controlled Substances Analogue
Enforcement Act of 1986" and is part of Public Law 99-570.
It was signed into law on October 27, 1986, just days before the
national elections, and the news and ramifications of it have
been largely lost in the noise and drama of the political events
of the time. I personally believe that this law presents a shameful
barrier to a very important segment of scientific research.
Let me dissect this law into its two major parts. What is an analogue?
And what is the behavior, involving an analogue, that is criminal?
According to this law, a drug is an analogue if it meets any one
of the following criteria:
First, the chemical structure of the drug is considered. The compound
is an analogue if its structure is substantially similar to the
structure of any listed Schedule I or II drug. Just what are the
structures of the drugs that are contained in these two schedules?
You can find a complete spectrum of functional groups. All four
types of amines are present; primary amines, secondary amines,
tertiary amines, and quarternary ammonium salts. All three types
of alcohols are present; primary alcohols, secondary alcohols
and tertiary alcohols. There are acids, esters, ethers, amides,
ketones, and nitriles.
There are examples of all the most common heterocyclic ring systems,
such as pyridines, piperidines, pyrrolidines, indoles, imidazoles,
morpholines, thiophenes, furans, pyrans, quinazolines, dioxoles,
oxazolines, pyrimidines, and purines. And of course, there are
simple benzene-ring aromatic compounds and there are simple non-benzene-ring
aliphatic compounds including cyclopropyl rings, cyclobutyl rings,
cyclopentyl rings and cyclohexyl rings. One would be hard put
to find a structure of any drug, anywhere, which could not be
argued by some person, somewhere, as being in some way structurally
related to a Schedule I or a Schedule II drug.
And what was the reason for the use of the intentionally vague
phrase "substantially similar?" There is a term in rhetoric
known as a disclaimer, a word introduced as a hedge or qualification,
a word chosen to allow a certain freedom of interpretation. Words
or phrases such as almost, probably, approximately, in a few
days, in two weeks at the latest, are disclaimers. There is
a measured ambiguity in the phrase "similar to" and
there is a measured ambiguity in the phrase "substantially
the same as." But what is to be inferred from "substantially
similar?" Suddenly, the exactness, the precision of the original
Controlled Substances Act, with its explicitly named drug targets,
had been totally compromised.
A second, independent definition of an analogue deals with its
pharmacological action. A drug is to be legally considered as
an analogue if it has a stimulant, depressant, or hallucinogenic
action that is substantially similar to that of a Schedule I or
Schedule II drug. In short, any drug which affects the CNS (central
nervous system) in any of these ways, or in ways that could be
construed as being "substantially similar" to those
evoked by a scheduled drug, becomes an analogue within this legal
definition. Again, the vague double disclaimer "substantially
similar" must be reckoned with as part of the description.
A third definition is an extension of this, and involves the way
a drug is represented. If a material is intentionally represented
as having a stimulant, depressant, or hallucinogenic action substantially
similar to that of a Schedule I or Schedule II drug, it becomes
an analogue.
Not all, but any one of these definitions is sufficient to define
an analogue. Or perhaps the first and either of the other two
definitions are sufficient. The only exceptions—the only conditions
under which such a drug is not considered an analogue—are if
it is already scheduled (a scheduled drug cannot be an analogue),
if the drug has been approved or exempted by the FDA, or if the
drug is not intended for human consumption.
And what is the nature of one's behavior with an analogue that
shall constitute a criminal act? It is the intent to make it available
for human consumption. And if such were to occur, the analogue
would be treated as if it were a Schedule I drug.
This law has given the authority for the decision as to what human
research studies may or may not be performed directly to a governmental
administrative body, where it had never before rested.
The function of the Food and Drug Administration (FDA) has evolved
over the years into one of safeguarding the public from exposure
to medicines that have disproportionate hazard, or that are ineffective,
or that are mislabeled. And the evaluation of protocols for the
determination of actions and risks of medicines is clearly the
FDA's major contribution to the protection of the public from
any inadequate evaluation of these risks. But this role has heretofore
been restricted to the weighing of the virtues of a drug versus
the risk of using it as a medicine. What are the virtues being
claimed? What is the basis for these claims?
The FDA has always carefully avoided any act that could be interpreted
as directing the practice of medicine. That was the province and
the responsibility of the physician. And they have always avoided
any intimate involvement in the structure of academic research,
as this was the province and the responsibility of the individual
researcher. The officials of the FDA have never before been given
the role of judging the merits of research, or been put in a position
of having the power to allow or disallow the pursuit of a research
question. That has classically been a matter involving the relationship
between the researcher, his professional peers, and his experimental
subjects.
We, as the research community, have largely accepted this complete
somersault over the age-old traditions of exploratory research.
We have quietly acceded to a non-scientific authority that can
oversee and, to an increasing degree, influence the direction
of our inquiry. Somewhere along the line in this country, within
the past five years, we have begun to lose that sense of independent
looking, the asking, searching and questioning, and the insistence
upon being personally responsible for what we do in our search
and how we conduct that search.
I am making a heart-felt plea for the changing of these drug laws;
laws which take the research initiative concerning human studies
away from scientists and give it to politicians.
I know that there will be a number of questions and arguments.
Let me try to anticipate them.
There have been remarkable successes in the development of
animal models for human illnesses. Why not use them and avoid
the risks implicit in human experimentation?
Indeed, many of the human illnesses now have superb animal models.
Agents that relieve pain can be screened for, and evaluated in,
animals which have been given painful stimuli. Agents that can
reduce blood pressure or cholesterol levels can be titrated in
animals that have high blood pressure or high cholesterol levels.
Toxic side-effects can be detected in animals. These are areas
where animal research is indispensable in the discovery of new
medicines, and in the evaluation of their safety and potential
usefulness.
There are numerous areas where animals can be valuable in the
search for drugs that are needed for the treatment of non-animal
illnesses such as depression, anxiety, and psychosis. For these,
the animal models that are used are based on the animal responses
to drugs known to be effective in man in the relief of human symptomatology.
But the animal models that are used are not intrinsically valid,
since these diseases do not exist naturally in the animal.
For example, an antipsychotic drug known to be effective in man
might induce a characteristic behavior pattern or a consistent
biochemical change in an experimental animal. And similar changes
by a completely different drug would imply that it, too, might
possess an antipsychotic action. The screening of drugs with such
animal models can provide leads to new and potentially interesting
families of antipsychotic drugs, but the validation of the action
must take place in the psychotic human subject. The animal model
may even serve research needs by providing an access to receptor
site studies or neurochemical research which can be used to explain
psychosis in man. Yet, intrinsically, the model in animals is
a forced one. There are no spontaneously psychotic rats.
There are, however, many aspects of the human mind for which no
animal model is conceivable.
Consider things such as empathy, imagination, inflation, creativity,
the anticipation of mortality, and the search for meaning, all
of which are unique products of the human mind. Not a single one
of these qualities can be demonstrated believably in a rat. And
I am completely convinced that none of them will be satisfactorily
explained by the study of the distribution of neurotransmitters
in a rat's brain. So, how can one use a rat as an experimental
animal for the discovery of a drug that might influence or touch
upon these aspects of human mental and emotional experience? If
these areas are to be explored, they can only be explored in man.
But the governmental reviewing agencies are composed of respected
scientists with unquestioned standing in the professional community.
How can you object to their evaluations of research projects?
I can object in a simple, straight-forward answer. A person who
has integrity, be he explorer, scientist, or philosopher, cannot
tolerate another person's usurping his right to ask his question
in his own words. If the question is badly asked, or if the answer
is sought in sterile ground, the man of integrity takes full responsibility
for his own errors or his mistakes. And he learns from them. He
will formulate his own questions and he will evolve his own answers,
in his own time and way.
In my opinion, the present reality is that permission to conduct
certain kinds of scientific research—the kinds that must be
done in human beings and cannot be done in any experimental animal—is,
for the most part, now given or withheld according to reasons
of politics, not of science.
Do you advocate discarding laws concerning human experimentation?
Of course not. There must be laws because there are people who
seem unable to empathize with others and who apparently do not
care about other people's fear or pain. We must protect the innocent
from them. We have known of such people in Hitler's Third Reich
and we have known of them in our own CIA. There must be laws that
protect the helpless from those persons who would misuse power
There must be laws to punish the abuse of children or the drunk
driver. I believe that laws must be at hand which insist upon
the three traditional principles of human experimentation: obtaining
informed consent, seeking peer review, and the acceptance by the
researcher himself of personal responsibility. But all other drug
laws must be repealed. Not decriminalized or legalized. These
are merely new laws over old ones. Laws involving drugs must,
in general, be repealed.
But think for a moment on this abuse of children theme. Children
may be of small age or of great innocence. It is within the concept
of informed consent that one can find the best answer to society's
need to protect its innocent against a potentially abusive member
of the research community. When you give informed consent it means
that, first of all, you are a fully responsible adult, not a child.
Second, that you are aware of yourself, your surroundings, and
your social context. And third, that you agree without any kind
of coercion (such as rewards or threats) to whatever activity
it is that you have decided to participate in.
Peer review represents the establishment of a close liaison with
knowledgeable and interested colleagues. It is through the consensus
of a peer group that society is protected against the manipulations
of the crack-pot, the sociopath, or the seductive charmer who
might be able to coerce a naive and unsophisticated individual
into giving his informed consent.
The ultimate responsibility for any inquiry must be assumed by
the researcher himself. He should be able to speak from personal
experience when he states that his new and experimental drug is
not life-threatening. He should be able to say with confidence
that it is free from disturbing side effects, since he himself
has tried it at or above the intended dosages. In the area of
psychopharmacology, especially in research with exploratory drugs
which may affect the state of mind, I hold that it is irresponsible
to give to another person any drug which you have invented or
discovered, unless you have personally experienced that drug's
effects.
This is a form of ethics that is gradually but steadily disappearing
from the research scene. We call upon the government authorities
for permission to perform our experiments, as if their blessing
somehow assured us of safety, and freedom from risk. There has
always been risk in using drugs to probe the machinery of the
human mind, just as there has always been risk in using drugs
to affect the physical body. There always will be.
If one looks at the basis of this entire business of laws, regulations,
and losses of scientific courage, one is confronted with some
profound questions. How afraid are we of truly looking at and
into the mind? Are we all so distrustful of what we suspect we
might find in exploring the human mind and spirit that we must
pass laws against certain kinds of investigation?
What is the inevitable future of research into the mind, as opposed
to simply the chemistry of the brain, if the laws now on the books
are allowed to remain unchanged? The investigation into the nature
of mind started with the appearance of man, and it will continue
in its many ways as long as man is curious. The tools will basically
remain the same as they have always been. These include the use
of meditation, the study of dreams and sleepwalking states, exploration
by means of hypnotic trance, and the use of psychoactive substances
that bring about alterations in perceptions and states of consciousness.
It would be a tragic development if we were to see the dissemination
of knowledge accumulated by such investigations revert to the
old system of word-of-mouth, or perhaps underground pamphlets—shades
of the Dark Ages. The information which should, in this day and
age, be published openly by reputable and responsible scholars
in good, respected journals will instead be lost to the scientific
community at large. It will again become a new form of arcane,
occult knowledge. This reorientation is already happening, as
a matter of fact. We are becoming a society of respectable establishment
journals, increasingly separated from an underground of mystical-psychological-alchemical
knowledge that is being transmitted, not from laboratory to laboratory,
but from bookstore to bookstore.
What is there to be lost by working within the framework of
these new regulations?
There is everything to be lost. Regarding present-day experimentation
with drugs that might have the changing of a person's state of
mind or state of consciousness as the primary expectation, the
official framework that is in place is clear. We are told that,
as there is no virtue to be gotten from any such experiment, and
since no answer to any valid question can be expected, there can
be no risk tolerated. Thus, no experiment can be approved.
I believe that it is more important today than ever before in
human history that we begin to try to understand the human mind.
The human brain is now very popular, and it is surrounded on all
sides by questioners and probers, by makers of positron-emitting
ligands that will locate receptor sites that are begging to be
named, by analysts with exquisitely sensitive spectrographs who
can measure the slightest hints of metabolites in body fluids.
The human mind, on the other hand, has always been surprisingly
unpopular. It is to many scientists an object of distrust, awe,
and apprehension. In many parts of the scientific community, there
is an absolute refusal to acknowledge that it exists at all. The
only people who seem to be making a living out of trying to understand
any part of the mind are psychotherapists, terrorists, and the
makers of horror movies.
I am deeply committed to the concept that the art of chemistry
can provide superb tools for use in this area of research. Over
the last thirty years I have devoted a major part of my efforts
to the task of making sense of the human mental processes by the
designing of research probes that in some way influence them.
The techniques I have used can be summarized as follows.
First, there is the conceptualization of a potential probe that
can be argued as having some possible constructive or disruptive
effect on a person's psyche or sensorium. It is synthesized, then
gradually brought up through graded dosages in self-experimentation
until there is some indication of biological activity noted or
until the assay is deemed—for whatever reason—to be no longer
worth the time and risk.
Needless to say, most materials have proven to be of no great
value, but some few have made the search worthwhile. With them,
a careful clinical trial amongst a small and experienced group
of subjects serves to define the action with considerable exactness,
and the findings are then published in an appropriate medical
or pharmacological journal so that the compound can be explored
by other researchers in the area.
Through just this form of research, several tools and potential
pharmaceuticals have come into the hands of researchers. The prototype
hallucinogen DOM (STP), the serotonin receptor ligands DOI and
DOB, the auditory distortant DIPT were all discovered by these
techniques. There would have been no other way to have discovered
them.
I am making an appeal here, very simply, for a resumption of this
kind of courage. I am speaking for the removal of artificial restraints
that are, if not completely prohibitory of such research, at least
casting a heavy chill on it. In the present social and political
climate, such a chill is enough to discourage many researchers
from these avenues of exploration, avenues which I strongly feel
must be traveled. Let me consider a single example, one which
was the focus of intense interest at the American College of Neuropsychopharmacology
(ACNP) meetings not long ago in Puerto Rico. This is the remarkable
and controversial drug MDMA.
Here is a drug that has the unusual property of, more often than
not, freeing a patient in psychotherapy from the anxiety and lack
of trust that often prevents the emotionally fragile person from
expressing his feelings to another. And, as has been attested
to by many therapists and patients, MDMA allows a personal perspective,
which is called "insight," with a minimum amount of
fear and self-censoring. All of this without any loss of self-control
or rationality.
The recent flood of primate research with MDMA has shown that
there are long-term changes in the serotonin systems in the brains
of some animal species although there is as yet no clinical study
which has shown that such changes occur in man.
I am completely convinced that this is the type of tool that must
be developed and explored as a possible adjunct to psychotherapy.
The official line is, at the moment, that MDMA has a large risk
factor, and no medical utility. That is, in my opinion, totally
incorrect. The extent of risk to humans can only be extrapolated
from animal experiments, and MDMA has been shown to have less
toxicity than the FDA-approved appetite suppressant fenfluoramine.
But there is a real medical utility and an immense medical promise.
The FDA has not allowed any IND (Investigation of New Drug) application
to be effective and so, to the extent that the term "currently
accepted medical use" means FDA approval for medical use,
there can be no medical use. The fact remains that MDMA has proven
extraordinarily effective in many clinical applications and therapeutic
interventions.
However, since it came to administrative attention at the same
time that the Fentanyl analogs became notorious, it was labeled
a designer drug, and condemned as an abuse drug that had no virtue.
The DEA holds that it is a hallucinogen, which is simply untrue.
MDMA is not a hallucinogen.
How might a compound with similar action be discovered and developed
for potential medical utilization? By definition, thanks to the
present Analogue Amendments currently in force, such a drug would
be an analogue (it would have an action substantially similar
to a Schedule I or II drug) and it would be a felony to explore
it in man without prior FDA approval. And I know of no animal
screening, from behavioral screening to drug discrimination studies,
which could demonstrate those subtle properties that separate
MDMA from any of the structurally related stimulants which do
not share those properties.
This is simply one example of the many paths through the unknown
territory of the human mind that must be pursued and which are
currently very difficult to explore in light of our present scientific
and political attitudes.
In an effort to facilitate law enforcement, and in the pursuit
of an ideal of rational social behavior, we have allowed laws
to be passed which have robbed us of our freedom to inquire. To
accept these laws without argument and without protest means not
only a further loss of our integrity but also—as I said earlier—a
continuing loss of essential information to the scientific community
and society at large.
Discoveries about the functioning of the human mind and psyche
must be made in the open—not in hiding. The effort to develop
a working vocabulary for various levels of mental experience and
the sharing of information and theories about what is discovered—all
this must be done out loud, not in conspiratorial whispers and
anonymous underground publications.
The continuation of the human species itself obviously requires
that we get to work very quickly indeed to understand as much
as we can about how the human mind functions. We must use all
possible tools toward that end, and we must use them with care,
with love, and with respect.