February 24, 2004. The DEA issued
Dr. Mithoefer a Schedule 1 license. The first MDMA-assisted psychotherapy
research project since MDMA was criminalized in 1985 now has the necessary
regulatory approval from the FDA, the IRB and the DEA and can proceed.
February 23, 2004. MAPS donated $11,000 to McLean Hospital,
Harvard Medical School, for Dr. Halpern's work on the protocol design
and approval process for a study of MDMA-assisted psychotherapy
in subjects with anxiety as a result of end-stage cancer, with outcome
measures to evaluate anxiety, pain and quality of life. MAPS has
previously donated $15,000 to McLean for this study on June 2003.
We plan to submit the protocol to the McLean IRB before the end
of Summer 2004.
Ecstasy
Agonistes A retracted study on a controversial substance raises
questions about the reliability of government-sponsored research
on drugs, By Thomas Bartlett, Chronicle of Higher Education
The Chronicle of Higher Education's February 25, 2004 colloquy
live email chat with Rick Doblin is available in the Chronicle
archive.
February 18, 2004. Inching closer! Dr. Mithoefer spoke
with Dr. Belinda Hayes at DEA headquarters. She indicated that DEA
has received a fax of the document they need from FDA but not the
hard copy which they need to issue the license. She says the person
at FDA claimed to have mailed it 2 weeks ago. She said it should
only be a matter of days once they get the document before they
get it "entered into the system" and then issue the license.
January 27, 2004. Dr. Mithoefer received a call from DEA
indicating they have not received the official reply from FDA yet
in response to their request for a consultation. However, they know
that FDA recommended that he be given a Schedule I license and as
soon as DEA receives the official reply, they "will be issuing"
his Schedule I license. This is the first time we have heard from
the DEA that Dr. Mithoefer will receive his license and the study
will be able to move forward.
January 26, 2004. NIDA responds to
MAPS' FOIA request for documents about Dr. Ricaurte's MDMA research.
Three documents were sent:
Read comments
on these documents by Rick Doblin.
January 16, 2004. Rick Doblin has written a
paper discussing how the risks of MDMA neurotoxicity have been exaggerated
by government officials and government-funded scientists in a manner
that has been used to support prohibitionist policies.
Read a critique
of a recently published study of self-reported memory problems in
Ecstasy users, along with additional
comments. You can also view the
full text of the report in PDF format.
January 15, 2004. MAPS received a call from FDA reporting
that DEA's request for a consultation about Dr. Mithoefer's qualifications
to conduct research has finally arrived at FDA. Furthermore, FDA's
recommendation has already been sent back to DEA. We are inching
ever closer.
According to the Code of Federal Regulations [section 304(a) of
the Act (21 U.S.C. 824(a))], DEA must issue Schedule I licenses
to researchers with FDA-approved protocols within 10 days of DEA
receiving a recommendation from FDA that an applicant is qualified
to do the research, unless the applicant can be denied on any of
the grounds specified in section 304 (a) and has either 1) lied
on the application, 2) been convicted of a drug felony, or 3) no
longer has State registration to administer controlled substances.
Since none of these criteria apply, we may be quite close to being
able to start this study.
However, there could be some delays caused by the uncertain amount
of time between when FDA sends its recommendation to DEA and when
DEA acknowledges receiving it, with interagency mail notoriously
slow. MAPS will now work to expedite this process however we are
able.
January 14, 2004. Dr. Michael Mithoefer has been flown
to New York City and is being interviewed today for the upcoming
prime-time Ecstasy documentary being created by Peter Jennings'
documentary team. We're encouraged that a large national audience
will learn of our efforts to conduct MDMA psychotherapy research.
The documentary will probably be aired in late February or March.
January 13, 2004. We're still waiting on DEA to issue Dr.
Mithoefer his Schedule I license. DEA claims it is waiting to hear
from FDA regarding a requested consultation about Dr. Mithoefer's
qualifications to conduct research. We've inquired at FDA to determine
whether DEA's request for consultation has actually arrived yet
and, if so, when FDA will reply. We expect to hear back from FDA
shortly. According to the Code of Federal Regulations, DEA must
issue a Schedule I license for FDA-approved research within 10 days
of receiving favorable recommendation from FDA unless the applicant
has lied on his application, has had a drug-related felony conviction,
or no longer licensed by the State. Since Dr. Mithoefer cannot be
refused his license on any of these grounds, we're cautiously optimistic
we will be able to start the study shortly after FDA responds to
DEA's request for consultation.
January 7, 2004. FDA acknowledges
receiving the FOIA request and says it will respond as soon
as possible.
January 6, 2004. MAPS submits a Freedom of Information
Act (FOIA) request to FDA seeking copies of all correspondence between
FDA and either the DEA, the Office of National Drug Control Policy,
or the Partnership for a Drug-Free America, regarding the MDMA/PTSD
protocol. We'd like to see what, if anything, these organizations
have been communicating to FDA regarding this study.
December 17, 2003. Dr. Mithoefer learned today that on
December 11, 2003, the South Carolina DEA office submitted its recommendation
to DEA headquarters that it give Dr. Mithoefer his Schedule I license
for the MDMA/PTSD study. DEA headquarters told Dr. Mithoefer last
week that it is still waiting to receive a recommendation from FDA's
Controlled Substances Staff but we have no information as to whether
the FDA has actually received DEA's request for a consultation.
Step by step we move closer to starting....
December 7, 2003. A recent media
report appeared, making some unduly alarming claims about MDMA
and "DNA mutations." However, the claims turn out to be false. Read
a
commentary on the research and what it actually meant. You can
also read the full
text (PDF) of the original research report.
December 5, 2003. Newsweek Online publishes
an interview with psychiatrist Julie Holland on the psychotherapeutic
use of MDMA.
December 3, 2003. THE
AGONY OF ECSTASY RESEARCH:
Science Gets Recruited in the Drug War, by Ronald Bailey. Reason
Magazine Online.
December 2, 2003. Research
on Ecstasy Is Clouded by Errors - The New York Times,
by Donald G. McNeil Jr.
Rick Doblin, President
of MAPS, published
these comments on the NYT article.
The Drug Policy
Alliance have issued this related
press release today.
Mark Kleiman's weblog,
"An
Ouchie for George"
November 28, 2003. The
politics of rEsearch by Harry Shapiro, is published in the Nov/Dec
issue of the British magazine, Druglink.
This article reports that Ricaurte's mislabeling error "came to
light when a student attempted to replicate the study and then made
an official complaint when permission to publish the new findings
was denied." In order to verify if this was accurate, Rick Doblin
called the Johns Hopkins press office and was informed that Dr.
Ricaurte says that there is no substance whatsoever to this allegation.
November 26, 2003. MAPS
sent a letter today to NIDA Director Nora Volkow, Ph.D., responding
to a November 18, 2003 letter
from Dr. Volkow to Rick Doblin. This exchange of letters was
part of a package of material that MAPS sent today to members of
NIDA's National Advisory Council on Drug Abuse (NACDA) requesting
that NACDA recommend to NIDA that it release information about the
MDMA research of Dr. Ricaurte.
Dr. Volkow indicated in her thoughtful but careful letter that
she didn't think it was necessary for NIDA to proactively release
the information about the MDMA research of Dr. Ricaurte that MAPS
requested and noted that MAPS will obtain some information as a
result of its Freedom of Information Act (FOIA) request. In reply,
Rick Doblin noted that, " NIDA should be forthcoming with the information
requested. To do otherwise leaves the impression that NIDA is not
actively and aggressively trying to clear up this disturbing episode
that has damaged the credibility of NIDA's educational efforts regarding
the risks of MDMA and other illegal drugs."
November 24, 2003. The British newspaper The Guardian
published
a positive article today about MAPS' progress towards final
approval of our MDMA/PTSD study. Later today, BBC Scotland will
interview me about the MDMA/PTSD study during its drive-time rush
hour show. BBC World News just called about doing an interview that
it will send out tonight to stations all over the place, and BBC
London called for its Five Live national show. Also, the youth station
in Dublin, Ireland (Spin1038) will conduct an interview. Just the
struggle to obtain permission for the study is presenting us with
some good opportunities to do public education about MDMA.
The BBC published
this news article today on its highly regarded website.
November 21, 2003. Editorial published in Movement Disorders
by Stephen Kish, Ph.D., "What
is the Evidence that Ecstasy (MDMA) Can Cause Parkinson's Disease?"
This strong editorial examines the evidence that ecstasy can cause
Parkinson's and suggests that the evidence is very weak. It also
critiques the flawed McCann/Ricaurte PET evidence that MDMA causes
substantial reductions in serotonin transporter.
Full text of Editorial
in PDF Format
November 18, 2003. Letter
from Dr. Volkow to Rick Doblin.
November 15-17, 2003. MAPS' MDMA/PTSD research team
met in Charleston, South Carolina to review the forms and procedures
that will be used to conduct the study. The meeting went extremely
well. Amy and Todd, the clinical research monitors who are volunteering
to help us implement pharmaceutical-level monitoring and checks
and balances, were impressively professional. This study will be
conducted with a level of formality and oversight that MAPS is implementing
for the first time but that will become standard on all our MDMA
research projects.
November 12, 2003. Dr. Mithoefer receives his Schedule
I research registration (R1) from South Carolina's Department
of Health and Environmental Control (DHEC). Dr. Mithoefer is still
waiting on his DEA Schedule I license, which is all we need to get
started with the study.
November 10, 2003. RTI
denies it made mistake that torpedoed results of a $1.3M
study. Triangle Business Journal, by Leo John.
October 28, 2003. DEA Inspection goes very well.
Several DEA agents inspected Dr. Mithoefer's facility today as part
of DEA's review of his application for a Schedule I license to handle
the 3.5 grams of MDMA needed for the entire study. The inspectors
focused on issues of diversion control and checked out the safe,
the alarm system and the forms and procedures that will be used
to track all of the MDMA and placebo capsules. The DEA agents were
interested in helping Dr. Mithoefer understand and follow their
rules and were quite reasonable. Dr. Mithoefer was told he will
probably receive his license in several weeks to several months.
October 23, 2003. Protocol Improvements Recommended by IRBs.
Though MAPS' long series of interactions with multiple IRBs was
often frustrating, several improvements have been incorporated into
the protocol design as a result of recommendations/requirements
made by various of the IRBs.
MAPS has prepared a document
listing these improvements, with the primary ones consisting
of having patients remain overnight in the treatment facility which
will be staffed by an RN, having data periodically reviewed by an
independent Data Safety Monitoring Board (DSMB), requiring subjects
to take a quiz after reading the informed consent form to make sure
the primary risks were understood, and requiring a minimum score
on the questionnaire assessing the severity of PTSD that reflects
a "moderate" severity.
October 20, 2003 MAPS sends a
letter to all members of the National Institute on Drug
Abuse's National Advisory Council on Drug Abuse, requesting that
it recommend that NIDA release all the information about Dr. Ricaurte's
research that MAPS has requested in its Freedom of Information Act
(FOIA) request. (also in Word
format)
October 17, 2003. Promising news from DEA. DEA has
now scheduled an inspection of Dr. Mithoefer's facility on October
28, by agents from both the regional DEA office and the South Carolina
Bureau of Drug Control. This is a routine step in the processing
of a Schedule I license. It's encouraging to see that DEA is finally
moving forward with its responsibilities, now that IRB approval
for the protocol has been obtained.
October 14, 2003. An article
by Kelly Morris, entitled Concern over research reawakens
ecstasy neurotoxicity debate is published in the journal
Lancet: Neurology Vol 2, November 2003
October 9, 2003. Nature publishes a short news story (PDF
and HTML)
on the MAPS sponsored MDMA/PTSD study. Nature 425, 552 (09 October
2003)
MAPS has a few comments
on the article.
October 8, 2003. Could MDMA help people with Parkinson's
disease ? A
recently published study in marmosets suggests that MDMA can
reduce side effects of some medicatios used in the treatment of
PD.
October 2, 2003. MAPS responds
to Ricaurte et al.'s retraction letter.
MAPS addresses the evidence that Ricaurte et al. cite in their retraction
letter in which they fail to give up the ghost and make a feeble
attempt to claim that MDMA could, after all, actually cause dopaminergic
neurotoxicity and Parkinson's Disease.
October 1, 2003. MAPS Submits FOIA Request to NIDA.
MAPS receives a confirmation
letter from NIDA's Freedom of Information Act (FOIA) staff that
it has received our request for specific information about the studies
that Drs. Ricaurte et al. conducted with genuine MDMA that failed
to find dopaminergic neurotoxicity, and about the studies that were
conducted with the mislabeled bottles of MDMA and methamphetamine.
The letter seems to indicate that there is a good chance that NIDA
will release most or all of the information we requested, but that
remains to be seen.
September 23, 2003. Triumph. The
Institutional Review Board (IRB) reviewing Dr. Mithoefer's MDMA/PTSD
protocol made its final decision -- and approved the study! This
is a historic moment for MAPS and for MDMA research. The approval
marks the end of a three-month process with this IRB, and a 22-month
IRB process overall. Dr. Mithoefer and MAPS have been struggling
to obtain IRB approval since November 2001, when the FDA approved
the study.
This is the eighth IRB to which we've tried to submit the protocol.
Five refused to accept it for review (after varying periods of consideration),
one approved it then revoked that approval for political reasons,
and another finally tabled the review, after spending months formally
reviewing the study before making it clear, through unreasonable
demands, that the committee did not want to approve it. Along the
way, we also established a MAPS IRB, but fortunately, we didn't
need to use it.
The last remaining step before we can begin the study is for Dr.
Mithoefer to obtain a DEA Schedule I license. DEA received Dr. Mithoefer's
application more than 15 months ago. We hope to receive a license
somewhat quickly now that IRB approval has been obtained, but you
can never tell with DEA. After Dr. Mithoefer does obtain a Schedule
I license, we can finally begin the study of MDMA-assisted psychotherapy
in subjects with chronic Posttraumatic Stress Disorder (PTSD).
September 18, 2003. MAPS sends
a letter
to NIDA Director Nora Volkow noting the many unanswered questions
in the Ricaurte et al. retraction and requesting the release of
additional information. MAPS states that the credibility of NIDA
is at stake. These sentiments are also expressed in a powerful editorial
just released by the scientific journal, Nature.
September 6, 2003. Amazing Retraction! Dr. George Ricaurte
retracted his paper published in Science on Sept. 27, 2002. He originally
claimed that MDMA caused severe dopaminergic neurotoxicity in primates
injected with a common recreational dose regimen of MDMA, and suggested
that Ecstasy users could develop Parkinson's. Dr. Ricaurte now reports
that his research team administered methamphetamine instead of MDMA
to his monkeys, a mistake which came to light after he failed to
replicate his findings after the oral administration of MDMA of
even higher doses of MDMA to additional monkeys. Dr. Ricaurte's
claims were challenged by MAPS in an exchange of letters in Science
in June 6, 2003. Those letters, and a series of media articles about
today's retraction can be found here.
September 5, 2003. George Ricaurte, Ph.D.'s retraction
of his paper "Severe dopaminergic neurotoxicity in primates
after a common recreational dose regimen of methylenedioxymethamphetamine
(MDMA)" is published in Science
August 25, 2003. For the last several months, another independent
Institutional Review Board (IRB) has been reviewing Dr. Michael
Mithoefer's MAPS -sponsored MDMA/PTSD protocol. Today, we submitted
our response to another series of questions and a revised protocol
and informed consent form. We anticipate hearing from the IRB in
several weeks. MAPS had considered forming its own IRB and had written
a set of required standard operating procedures and obtained commitments
from a group of illustrious people to serve on the MAPS IRB. However,
before launching the MAPS IRB, we decided to try one more time with
an Independent IRB. So far, this IRB has restored our faith in the
IRB review process since the review is being based on the scientific
merits of the design.
If MAPS does obtain IRB approval, the final step in the approval
process will be for Dr. Mithoefer, the Principal Investigator, to
obtain a DEA Schedule I license to handle a total of 3 grams of
MDMA for administration to all the subjects in the study (12 subjects
will each receive a dose of 125 mgs on two occasions, three to five
weeks apart, with another 8 subjects will receive placebo on two
occasions, also three to five weeks apart). While DEA has held up
Dr. Mithoefer's application for a Schedule I license for MDMA for
over a year, and has previously indicated that it might refuse to
approve Dr. Mithoefer's license on the grounds that it considered
the study not to be in the public interest, we have more recently
gotten the impression that DEA will indeed approve the license once
IRB approval for the protocol has been obtained. A legal analysis
submitted to DEA by MAPS President Rick Doblin has been helpful
in that it showed that the Controlled Substances Act (CSA) was written
by a Congress that was suspicious the DEA would seek to block medical
research into Schedule I drugs, which has indeed turned out to be
the case. Fortunately, the CSA does not permit the DEA to take the
vague category of public interest into account when it reviews applications
for Schedule I licenses for FDA-approved research but is restricted
to using a much more limited set of criteria relating exclusively
to whether the physician can be trusted to administer the drugs
to the research subjects and not divert any to non-medical uses.
While nothing can be predicted with certainty, it seems that MAPS'
17-year struggle to start MDMA psychotherapy research (MAPS was
founded in 1986) may finally be successful within the next several
months. Time will tell...
June 19, 2003. Drs. Mithoefer, Jerome and Doblin have written
a reply to the Ricaurte
et al. letter published in Science on June 6, 2003. We have submitted
our reply to Drs. Ricaurte and McCann and indicated that we would
be happy to post their response to the MAPS website if they want
to continue this debate. Read more.
June 9, 2003. MAPS donated $15,046.25 to McLean Hospital,
affiliated with Harvard Medical School. The donation is to enable
Dr. John Halpern to develop a protocol for the use of MDMA-assisted
psychotherapy in the treatment of anxiety and depression in end-stage
cancer patients, and for work related to obtaining approval for
the study from the McLean Institutional Review Board (IRB) and the
FDA. The donation will support a portion of Dr. Halpern's time from
now until the end of December 2003.
If this project is approved, it will represent the first psychedelic
research at Harvard since 1965 and will signal the beginning of
the post-Leary era.
June 6, 2003. Letters in Science. An exchange of letters
about MDMA dopaminergic neurotoxicity between the MAPS MDMA/PTSD
team and the NIDA-funded research team of Ricaurte et al. appeared
in the journal Science, June 6, 2003, Vol. 300, p. 1503-4. MAPS
has already submitted to Science a request for a correction to a
misleading statement in the Ricaurte et al. letter, in which only
one of the primates was claimed to have died from the doses of MDMA
administered, as compared to two primates reported to have died
in the initial paper. For details, see MAPS' discussion
of the Ricaurte et al. study.
MAPS is in the process of preparing a response to the Ricaurte
et al. letter for the MAPS website and Forum. In brief, Ricaurte
et al. state that dopaminergic deficits will only be found in binge
users, but then discount all the studies in heavy MDMA users that
found no dopaminergic changes by saying that they contained no or
only a few binge users. This raises the obvious question of just
how "common" is this binge use pattern, since they allege in the
title of their paper that the doses they administered to the primates
represented a "common recreational dose regimen." Ricaurte conclude
their letter by saying that "we remain of the opinion that there
are not sufficient data to conclude that clinical MDMA research
can be conducted without running the risk of monoaminergic brain
neural injury." First, it's impossible to ever prove that there
is no risk. Nevertheless, by Ricaurte et al.'s own admission that
binge use isn't even the same as heavy use, it is possible to conclude
that there is no evidence that the clinical use of MDMA will in
any way cause dopaminergic neurotoxicity or lead to Parkinson's.
Note also that Ricaurte et al. conclude with a general statement
about both serotonergic and dopaminergic risk, and dismiss as being
unpublished evidence from Dr. Franz Vollenweider's PET scan study
that showed no evidence of serotonin changes in MDMA-naive subjects
administered doses of MDMA in the therapeutic range.
April 11, 2003. Yet Another Dead End. The new IRB informed
MAPS today that it has decided not to accept the protocol for review.
MAPS was clearly told in writing a month ago that this IRB would
accept the protocol for review. Now, after we spent all the staff
time to prepare and submit the necessary documents and yet another
month has gone by, that decision is reversed. We were told that
the IRB believes that "the local IRB has to take responsibility."
However, there is no local IRB, since the project is not affiliated
with any local institution. A fear of liability was also mentioned.
This is also rather puzzling since MAPS has been able to arrange
for an insurance policy for several million dollars that would indemnify
the IRB from lawsuits, in the extremely unlikely event that a subject
in the study would choose to sue the IRB.
Proposing to research a potentially beneficial use of one of the
most demonized drugs in America, and around the world, could be
considered a fool's mission. But it's not, it's just extraordinarily
difficult and extraordinarily important. After all, MDMA-assisted
psychotherapy really can promote healing in a unique manner unlike
any other prescription medicine. A moment of despair is now in order,
after which MAPS will select a new strategy for moving forward with
this project.
March 7, 2003. Yet Another New Start. A new IRB has reviewed
the documents from the first two IRBs that led to dead-ends and
agreed to review the protocol. Documents were submitted, with feedback
expected in a month or so.
March 6, 2003. A Decision to Let the Review Stay Tabled.
Two weeks have passed without MAPS receiving an estimate for the
costs of consultants from the IRC-IRB. In any case, MAPS has decided
to let the review remain tabled, not to pay for consultants, and
start over with another IRB. We didn't immediately inform the IRC-IRB
since we expected to hear any day about the costs of the consultants,
at which time we planned to explain our decision. The proverbial
straw that broke the camels back was that the IRB indicated that
even though a majority of its members agreed that MAPS has offered
persuasive arguments against the use of a CRO and the multi-site
design, the panel will not withdraw those suggestions unless and
until an unanimous decision is reached after a report from consultants
on seemingly unrelated matters. After waiting until March 25 without
being informed of the costs of the consultants, over a month after
MAPS requested in writing that these costs be provided, MAPS sent
a letter to the IRC-IRB saying that we were withdrawing the application.
MAPS then learned that the staff person at the IRC-IRB with whom
MAPS has primarily interacted has left the IRC-IRB for reasons unrelated
to our protocol.
March 3, 2003. No Decision Unless Unanimous, and After Consultation.
The IRC-IRB sends a letter indicating
that it needs to receive the advice of consultants before making
a decision on the issues of the CRO and the multi-site study. While
the IRC-IRB does indicate that a majority of the members of the
panel find MAPS' arguments that a CRO is not needed to be "compelling"
and that a majority are willing to consider abandoning the request
for a multi-site study, we are told that no decision will be made
unless it is unanimous, which MAPS is claimed to have previously
agreed to though this was never mentioned before and is not standard
practice.
February 25, 2003. A Request for A Decision. MAPS phones
the IRC-IRB and requests that the panel make a definite decision
on whether it would require MAPS to hire a CRO and/or move to a
multi-site design, neither of which MAPS is willing to do, before
MAPS decides whether to pay for consultants which the letter from
the IRC-IRB seems to indicate would be focused on issues unrelated
to the need for a CRO and a multi-site study.
February 21, 2003. IRB Review Tabled.The IRB informed
MAPS that it cannot proceed with its review until it obtains the
advice of two "qualified, objective psychiatric consultants," with
fees for the consultants required to be paid by MAPS. An estimate
of costs will be submitted to MAPS for approval prior to the IRB's
engaging the services of these consultants.
February 14, 2003. More Documents. MAPS submitted a document
detailing our standardized procedures for responding to "agitated
subjects, or those with suicidal ideation associated with study
procedures." We also submitted a document
discussing the $175,000 bid that we received from a Contract Research
Organization (CRO) for monitoring the study, along with information
about the volunteer who would monitor the study for MAPS who had
the exact same credentials as the person who would be assigned by
the CRO.
February 10, 2003. An Exhaustive and Exhausting Reply.
MAPS submitted a twelve page basic
reply (which included in a bit of comic relief a required menu
of the snack foods and drinks that we would offer to subjects on
the MDMA therapy days and our plans for handling the issue of food-related
allergies), and assorted other documents including
- a letter from the researcher
conducting the screening and outcome measures explaining that
he had never met Dr. Mithoefer in person and had no particular
interest in MDMA
- an eight page informed consent
form for the friend/partner who would pick up the subject
after the MDMA session
- a release form for sharing
of subject's personal medical information
- a wallet card for subjects showing
there had participated in a legal MDMA research project in case
they were drug tested for any reason in the several days after
the experimental sessions during which time they might test positive
for MDMA or amphetamines, and
- a confidentiality agreement
for any physicians or therapists who referred subjects to the
study.
February 6, 2003. A Rapid Response. MAPS submitted a six
page response focusing just on
the issues of the Contract Research Organization and the multi-site
study requirements, to be following up within a week or so with
a more detailed discussion of these and other issues raised by the
IRC-IRB.
February 4, 2003. An Astonishingly Depressing Response.
After the extensive discussions and good feelings of the January
28, 2003 in-person meeting, at which we seemingly discussed all
the outstanding issues, the totally surprising reply
sent by the IRC-IRB came with several scientifically misguided new
demands. One of these (hiring a Contract Research Organization to
take over the conduct of the study to avoid "unconscious bias")
was unusual, exorbitantly expensive and unnecessary since the study
was already a placebo-controlled, double-blind pilot study, with
blinded, independent raters. Another (redesigning the study into
a multi-site study with two different therapeutic teams) would probably
not even be approved by the FDA since single-site studies to standardize
the intervention precede multi-site studies. The IRC-IRB response,
which included quite a few other requirements, indicated a profound
misunderstanding by the IRC-IRB of the generally-accepted scientific
research process and communicated that the IRC-IRB was deeply fearful
of approving this protocol.
Though I (Rick Doblin) am by nature happy and optimistic (which
some friends of mine have teasingly referred to as evidence of MDMA
brain damage), the IRC-IRB response resulted in two days of a dark
depressive funk, the likes of which I haven't felt for almost 30
years, back when I was working through early difficult LSD experiences.
The resolution of the depression came with the decision to throw
myself into responding in detail to the IRC-IRB letter, in the hopes
that a clearer presentation on our part of the qualifications of
our research team members, the logic behind our protocol design
choices, and a willingness to give the IRC-IRB whatever information
it asked for, would result in a return to generally-accepted scientific
research principles.
January 31, 2003. A Productive Dialogue. The January 28
meeting with the new IRB, at which Dr. Michael Mithoefer and Rick
Doblin, Ph.D. appeared in person, involved a series of thoughtful
questions about protocol design, risk assessment, confidentiality
procedures and the nature of PTSD and currently available treatments.
The meeting was characterized by mutual respect. We expect to receive
a written report outlining the IRB's decisions within the next several
weeks.
January 21, 2003. A Substantive Reply to IRB. MAPS submitted
a series of documents today to the IRC-IRB, in response to their
initial comments about the protocol which MAPS received on January
6. These documents represent a very substantial amount of staff
time on MAPS' part and include a twenty page primary response letter, a five page protocol
summary, a two page plan for external
evaluation, a two page phone script
for the initial screening calls from potential volunteers, and a
sixty page updated review of
the MDMA literature published since our initial review was completed.
Dr. Michael Mithoefer and Rick Doblin will meet in person with
the IRB review panel on January 28 to discuss the issues under consideration.
January 21, 2003. History Lesson for the DEA. MAPS submitted
a letter to DEA from Rick Doblin concerning Dr. Michael Mithoefer's
July 2002 application for a Schedule I license to possess the MDMA
that will be used in the MDMA/PTSD study. DEA has indicated that
it has safety concerns that need to be addressed before it will
issue the license. However, DEA is only legally charged with diversion
control (preventing drugs approved for medical use to be diverted
to non-medical uses) and has no legal mandate to review safety concerns,
which are the responsibility of the FDA. In 1994, DEA tried to use
similar arguments to justify its delay in issuing a Schedule I license
to Dr. Donald Abrams for his FDA-approved marijuana/AIDS wasting
study. Fortunately, FDA Commissioner Dr. David Kessler protested
to Dr. Lee Brown, Director, Office of National Drug Control Policy
(the Drug Czar), who wrote a letter to DEA Administrator Tom Constantine
reminding him that DEA has no authority to review scientific matters.
Dr. Brown told DEA that established lines of responsibility and
authority should be respected and that national policy was to permit
research with Schedule I drugs. MAPS' letter reminds DEA of this
history and urges it to respect the national interest in facilitating,
and not obstructing, important research into new treatments for
PTSD.
January 6, 2003. Renewed hope. Today, MAPS received the
initial set of comments of the
IRC-IRB. My initial impression is that we will eventually be able
to get some protocol approved, but that we might need to limit enrollment
to more severe PTSD patients who have failed on psychotherapeutic
treatments as well as an SSRI, and are 21 or older.
We have been requested by the new IRB to provide a substantial
amount of additional information. We hope to submit our response
within several weeks for the next review, which Dr. Michael Mithoefer
and I will probably attend on either January 28 or February 4. Despite
the additional work that is ahead of us, it's a profound relief
that the new IRB is willing to approach this issue based on the
science.
December 17, 2002. A New Start. MAPS submitted the MDMA/PTSD
protocol for review to the Independent Review Consulting Institutional
Review Board (IRC-IRB), with the protocol to be discussed by the
review board on January 2, 2003. Officials at the IRC-IRB have read
the entire correspondence between MAPS and the Western IRB and have
indicated that they will carefully review the protocol on its merits
without bias due to the controversial nature of MDMA-assisted psychotherapy
research. This IRB has a reputation for being rigorous but fair,
a set of characteristics that inspires confidence.
December 10, 2002. A Shameful Conclusion. On November 20,
after the Western IRB decided not to review MAPS' MDMA/PTSD protocol,
Rick Doblin spoke to James Baldwin, Ph.D., Executive Director of
the Western IRB. Dr. Baldwin informed Rick that he was not authorized
to speak about what motivated the Western IRB to decide not to engage
in a dialogue about the rationale for WIRB's decision to revoke
approval, to refuse to continue to review the protocol, and to refund
MAPS' fee. Instead, Dr. Baldwin suggested that for more information,
Rick should contact Mr. Ron Warren, Senior Vice President of the
Western IRB. After Rick Doblin made repeated attempts over several
weeks to speak with Mr. Warren, his secretary finally informed Rick
Doblin on December 10 that he was unwilling to speak and had nothing
to add to the letter. So it ends, with a shameful silence.
November 27, 2002. MDMA/PTSD Research in Israel. MAPS sent
a draft of the MDMA/PTSD pilot study that MAPS is seeking to sponsor
in Israel to Dr. Moshe Kotler and Dr. Jorge Gleser, Israeli Ministry
of Health, for their review. MAPS' conference on MDMA/PTSD research,
held at Beer Yakov Mental Health Center near Tel Aviv on November
14 for members of the Israeli Ministry of Health, the Israeli Society
of Addiction Medicine, and the Israeli Anti-Drug Authority, was
very well received. The conference and the proposed pilot study
were discussed in a positive article mentioned on the front page
of Maariv, Israel's second largest newspaper. The protocol design
meeting, held at Beer Yakov on Nov. 17, was also productive, with
the draft protocol submitted today reflecting design choices made
at that meeting.
November 20, 2002. Pathetic News. Ron Warren, Senior Vice
President of the Western IRB, wrote a letter to Dr. Michael Mithoefer,
reporting the outcome of the November 19 meeting of the WIRB's Executive
Policy Committee. The WIRB letter was two short sentences, "The
Western Institutional Review Board, Inc. (WIRB) has made the decision
not to provide institutional review board services for the Multidisciplinary
Association for Psychedelic Studies (MAPS). Please find enclosed
a refund of your previously paid fees, along with the material you
submitted for IRB review."
The WIRB retreated from its supposed
scientific rationale for revoking approval for MAPS' MDMA/PTSD study,
as described in its September 6, 2002 letter and critiqued in MAPS'
October 10 letter, and fell back on no rationale whatsoever. The
WIRB has shown itself to be scientifically out of its depth and
lacking of sufficient integrity to acknowledge its mistakes and
refocus on a rational, data-based, risk/benefit analysis of MAPS'
MDMA/PTSD protocol.
Most importantly, MAPS will very soon
start the process of submitting the protocol to another IRB for
review.
November 18, 2002. MAPS submitted a short
letter to the Western IRB's Executive Policy Committee, in advance
of its November 19 meeting at which it will discuss its review of
MAPS' MDMA/PTSD protocol. The letter discussed MAPS' Israeli MDMA/PTSD
project, briefly reviewed US government and international treaty
policies regarding research with Schedule I drugs, and reported
that MAPS had submitted unpublished data to FDA about MDMA and heart
valve tissue, data which the WIRB cited as partial justification
for revoking approval which neither MAPS nor FDA had seen.
October 17, 2002. A Surprising New Issue. After reviewing
MAPS' letter, Dr. James Baldwin of the WIRB informed RIck Doblin
that the October 30 meeting was canceled, but not for the reasons
MAPS had hoped. Dr. James Baldwin said that the meeting was "premature"
because the WIRB now needed to convene its Executive Policy Committee
(EPC) to discuss whether the WIRB should be involved with research
with Schedule I drugs. The next EPC meeting is scheduled for November
19. The WIRB is no longer reviewing the protocol based on the science
but on non-scientific, internal policy issues, not a very encouraging
development.
October 11, 2002. A Comprehensive, Strong Response. MAPS
submitted a lengthy written response
to the WIRB letter, along with 14 letters of information and support
from MDMA scientists around the world. MAPS' letter addressed every
point raised in the WIRB letter and was so solid that we thought
perhaps the WIRB would conclude that the October 30 meeting was
not necessary.
October 3, 2002. A Glimmer of Hope. Rick Doblin speaks
with James Baldwin, Ph.D., Executive Director of the WIRB. Dr. Baldwin
apologized for the tone of the WIRB letter and seemed to view favorably
MAPS' arguments. He was informed that the one scientist whom the
WIRB letter claimed was against the study was actually in favor
of the study (subject to two conditions that MAPS could easily agree
with), that the second scientist cited in the WIRB letter was strongly
in favor of the study, and that the third scientist was probably
not fully informed about the details of the protocol and was neither
opposed to or in favor of the study. Dr. Baldwin tentatively scheduled
a meeting between Rick Doblin and Michael Mithoefer and the WIRB
for October 30, in Olympia, Washington.
September 27, 2002. Outrageous News. Dr. George Ricaurte
publishes an
article in Science reporting on primate data that he claims
suggests that even one night's recreational use of Ecstasy can lead
to Parkinson's. This government-funded research, which ignored the
high mortality rate of the test animals and directly contradictory
human data, is a classic example of risk amplification and the demonization
of illegal drugs. MAPS obtained a copy of this article before publication
and responded by sending out our first
press release ever. MAPS' critique was favorably
reported in articles in the New York Times and Washington Post
and elsewhere. MAPS has also written a letter
to the editor of Science.
September 6, 2002. Terrible News. The Western IRB, which
approved the MDMA/PTSD protocol on July 10, informed us by letter
that approval was withdrawn. The revocation was based on secondhand
reports of conversations (not on data!) that a WIRB staff person
had with three MDMA researchers. The WIRB letter was written in
a surprisingly insulting manner and contained numerous mistakes.
MAPS was not informed that the protocol was being reevaluated and
did not have an opportunity to respond to the reports by the WIRB
staff person, who didn't like the fact that the WIRB had approved
the protocol.
July 17, 2002. Tremendous news. On July 10, we received
word that the Institutional Review Board (IRB) had approved MAPS'
MDMA/PTSD study! We can now definitely say that the US study will
take place. Dr. Michael Mithoefer still needs to obtain his DEA
Schedule 1 license, which should take about 4-6 weeks, but this
is just a matter of time
There is now an excellent chance that the Israeli Ministry of
Health will approve an Israeli MDMA/PTSD study. Michael and I are
tentatively planning to go there in late Sept. or early Oct. for
a one-day seminar organized by the Ministry to discuss the latest
findings in MDMA research, and protocol design options for the Israeli
study.
Here are the financial implications:
We still need to raise an additional $60,000 for the US MDMA/PTSD
study and another $60,000 for the Israeli study. MAPS is also seeking
$10,000 for our National Institute of Mental Health (NIMH) grant
application for support for the development of a treatment manual
that describes in detail hw MDMA-assisted psychotherapy for PTSD
should be conducted and provides specific ways to evaluate whether
the therapy technique itself is being delivered appropriately. We
are also seeking $20,000 for our ongoing MDMA literature review.
Any help or suggestions would be greatly appreciated.
June 19, 2002. MDMA/PTSD protocol submitted to the Western
Institutional Review Board (WIRB). Review expected to take 3-5 weeks.
June 14, 2002. FDA gives final approval to conduct the
treatment sessions in Dr. Michael Mithoefer's office, with a "crash
cart" and an Emergency Room doctor and nurse in the next room in
case they are needed.
May 14, 2002. Conference call with Dr. Mithoefer, Rick
Doblin and FDA o fficials, in which we come to tentative agreement
to conduct the study in Dr. Mithoefer's office, as long as we hire
both an ER doctor and nurse to sit in the room.
May 10, 2002. FDA rejects our request, primarily saying
that they would like a larger emergency response team.
March 14, 2002. Request submitted to FDA to change the
location of the treatment sessions from the Medical University of
South Carolina (MUSC) to Dr. Mithoefer's office. We propose renting
a "crash cart" and hiring an emergency room nurse to be on site
in the room next to the treatment room for the first five hours
of each session, in case Dr. Michael Mithoefer and Annie Mithoefer,
R.N. need help responding to an adverse event.
November 28, 2001. The fourth patient in the Spain MDMA/PTSD
dose-response study was treated on November 28, 2001. We have now
completed the 50 mgs dose group (3 patients received 50 mgs and
1 received a placebo). The next dose level is 75 mgs (5 patients
will receive 75 mgs and 2 will receive a placebo).
November 2, 2001. It's my pleasure
to report some excellent news. About 10 AM, Friday, November 2,
FDA contacted me to say that MAPS' MDMA/PTSD protocol was approved.
This approval marks the culmination of 16 years of efforts to obtain
permission from FDA for MDMA-assisted psychotherapy research, since
MDMA was criminalized in 1985. This approval also marks the beginning
of what I hope will be a $5 million, 5-year project to develop MDMA
into a prescription medicine.
On Wednesday, Dr. Michael Mithoefer,
the principal investigator, and I had a conference call with FDA
during which we discussed various design issues. The conference
call was calm, serious and respectful. We agreed to make several
design changes, mainly closer monitoring of blood pressure and omitting
the opportunity for placebo subjects who still met inclusion criteria
for PTSD at the final evaluation to enroll in an open label extension
study during which they would receive MDMA. We argued against several
other possible changes, mainly the idea that patients should be
required to have had prior experience with MDMA. On Thursday, I
faxed an addendum specifying the changes we had agreed upon and
the places where the protocol needed to be changed. Last night,
I saw on CNN that anthrax was discovered in the FDA mailroom at
Rockville, where the FDA officials reviewing the protocol work.
Today, FDA officials were still at work and informed me that the
protocol was approved without the need for any additional changes.
Of course, we still need to obtain
Institutional Review Board approval from the Medical University
of South Carolina. This should take several additional months.
I've already let the Israeli Ministry
of Health know that the FDA approved the study. According to Dr.
Moshe Kotler, the principal investigator of the proposed Israeli
MDMA/PTSD protocol, FDA approval was need for an MDMA/PTSD study
before he would feel comfortable submitting a protocol to the Ministry.
The subjects in the ongoing Spain MDMA/PTSD study are women survivors
of sexual assault with chronic PTSD. The subjects in the FDA-approved
study are women and men survivors of criminal assault with chronic
PTSD. The Israeli study will hopefully include subjects whose PTSD
was the result of war and terrorism.
The formal approval letter from FDA
will arrive next week. -- Rick Doblin, Ph.D.
October 1, 2001. MAPS submitted
to the FDA today the protocol for Dr. Michael Mithoefer and Dr.
Mark Wagner's MAPS-supported pilot study into the use of MDMA-assisted
psychotherapy in the treatment of patients who have experienced
criminal victimization and as a result have suffered from chronic,
treatment-resistance posttraumatic stress disorder (PTSD). The submission
of this protocol to FDA marks a major milestone in the history of
MAPS, and hopefully in the history of MDMA research. FDA has 30
days to respond to the protocol. We fully expect FDA eventually
to approve the study in some form.
(Faster download - without
individual case reports from Phase 1 study; longer
version - with individual case reports from Phase 1 study)
July 18, 2001. As part of its submission to FDA of a protocol
designed to study the use of MDMA in the treatment of PTSD, MAPS'
commissioned an extensive review
of the scientific literature on MDMA. This literature review was
developed under the direction of Matt Baggott with Ilsa Jerome,
Ph.D., and is now being made available to regulatory agencies, other
researchers and the public. The literature review will be updated
on a regular basis as new research is published.
July 16, 2001. A draft of the MDMA/PTSD
protocol that MAPS has been working for 2 years to develop, with
Dr. Michael Mithoefer and Mark Wagner, Ph.D., at the Medical University
of South Carolina, has now been posted to the web. The protocol
will submitted to FDA shortly after NIDA's scientific meeting on
MDMA, held at the National Institutes of Health campus in Bethesda,
MD, on July 19-20. If and when it becomes approved in some form,
this protocol will be the first FDA-approved study of the therapeutic
use of MDMA since MDMA was placed in Schedule 1 in 1985.
March 19, 2001. The US Sentencing Commission held an open
hearing concerning its proposal to increase penalties on MDMA. Testimony
about MDMA opposing the increase was presented by Rick
Doblin, Ph.D., David Nichols,
Ph.D., Charles Grob, M.D.,
Julie Holland, M.D. and
Richard Glen Boire, Esq.
Testimony about legal issues by opponents of the increase was presented
by Ed Mallet, Executive Director of the National Association of
Criminal Defense Lawyers (NACDL), Julie Stewart, Executive Director
of Families Against Mandatory Minimums (FAMM), and Bill McColl,
Legislative Director of The Lindesmith Center/ Drug Policy Foundation
(TLC/DPF). The testimony had little effect and the Sentencing Commission
recommended substantial increases in penalties. MDMA is now, dose
for dose, punished more heavily than heroin.
Judge Diane Murphy, Chair of the
U.S. Sentencing Commission, explained the rationale
behind the Commission's recommendation during a hearing of the Senate
Caucus on International Drug Control on March 21, 2001. (See also
visual presentation)
February 3, 2001. MAPS convened a protocol design meeting
in San Francisco to discuss the details of a protocol evaluating
the use of MDMA-assisted psychotherapy in the treatment of Post-Traumatic
Stress Disorder (PTSD). The meeting included. among others, the
principle investigator and therapists of the South Carolina team
(Dr. Michael Mithoefer and Annie Mithoefer, RN), the MAPS team that
has for the last year and a half been reviewing the MDMA literature
for submission to FDA (Matt Baggott, Ilsa Jerome), the team that
has been creating the MDMA bibliography of all scientific papers
on MDMA published in peer-reviewed journals (from erowid.org), and
scientific consultants including Dr. Charles Grob, Dr. George Greer,
and Dr. Dave Nichols. The meeting was quite productive, with the
protocol expected to be submitted to FDA in April 2001.
February 2, 2001. Rick
Doblin outlines MAPS' strategy for the development of the therapeutic
use of MDMA into an FDA-approved prescription medicine, at the State
of Ecstasy conference in San Francisco, sponsored by the Lindesmith
Center- Drug Policy Foundation. Additional
transcripts of other speakers have been helpfully archived by
an anti-drug group.
November 9, 2000. The first patient was treated in the
MAPS-supported MDMA/PTSD study being conducted in Madrid, Spain,
under the director of José Carlos Bouso, Ph.D. candidate. José
Carlos and Marcela Ot'alora were the co-therapists. The four hour
session went very well and the patient seemed to have gotten to
a deeper, more therapeutic level. Of course, we won't know for some
time whether the patient received a dose of 50 mgs or a placebo!
What we do know is that study is off to a great start. Read
more about this study, including the protocol
and informed consent form.
November 1, 2000.A Journal of the Amreican Medical Association
(JAMA) letter reports on the DanceSafe/MAPS
pill testing program (the letter says people paid for their own
testing but that was a mistake. MAPS paid for most of the testing
of these pills).
August 15, 2000. A discussion about "Raves, Ecstasy and
Youth" was held at the Shadow Convention 2000 in Los Angeles. A
celebrity panel of MDMA researchers, experts and psychonauts was
assembled by the Lindesmith Center/Drug Policy Foundation; video
and audio coverage of this unique event can be found at the Shadow
Conventions 2000 website.
May 5-6, 2000. The California Association of Toxicologists
held a conference in North Hollywood, California, the first day
of which was devoted to drugs that are commonly found at raves.
Read summary and comments by Earth
and Richard
G. Boire.
March 2000 - New York Lindesmith Center. Hear
in RealAudio MDMA ('Ecstasy') Research: When Science and
Politics Collide. Sound quality is excellent except for the
first few minutes, so be patient. Speakers: Julie Holland, MD, attending
psychiatrist, Bellevue Hospital Psychiatric Emergency Room and faculty,
NYU School of Medicine; John P. Morgan, MD, professor of pharmacology,
City College of New York; and Rick Doblin, president, MAPS) and
Ph.D. candidate, Kennedy School of Government, Harvard University,
assessed scientific and political efforts to conduct MDMA research
in the US and abroad. See also the transcript
of Holland's talk.
February 2000 - Spain. A pilot study of MDMA therapy in
the treatment of PTSD has been approved and will be the first formal
therapy study with MDMA ever conducted. (Read
current update. MAPS has pledged $54,000 for this study; we
have raised $23,000 and are seeking additional contributions.
Autumn 1999 - MAPS Israel MDMA Conference. MAPS organized
an international symposium
on the medical utility of MDMA. Talks from this event, held August
31 to September 1, 1999, are posted on this site (talks by George
Greer, Juraj and
Sonja Styk and Mark
Kleiman). See also video
clips of some of the talks.
July 24, 1999 In a teleconference
with the FDA concerning MDMA psychotherapy research to treat anxiety,
depression and pain in cancer patients, the FDA indicates a willingness
to approve a "proof of principle" study.
