Report to NIDA's Expert Panel on Medical Marijuana
Research
submitted February 25, 1997
following the
February 19-20, 1997
NIH Workshop on the Medical Utility of
Marijuana
held at the NIH Campus in Bethesda, MD.
Turning Protests into Protocols: Dr. Harter's Legacy
Dr. John Harter was director of the FDA's Pilot Drug Evaluation Staff
from 1989 to 1993.
During his tenure, clinical research with a variety
of psychedelic drugs was permitted to resume
after such research had
been almost totally prohibited for two decades in the United States
and
abroad. To its credit, NIDA financially supported the resumption
of this field of research.
In 1991, I asked Dr. Harter what had motivated him to place the
interests of science over the
ideological resistance to psychedelic
research. He responded by telling me of the impact that the
famous
October 1988 ACT-UP demonstration at FDA headquarters had on his
views. His primary
reaction to the demonstration was that it
represented a tremendous waste of resources from a social
perspective. He pointed out that thousands of government employees were
unable to work that day,
at a substantial cost to the treasury, and
that large sums of money had been spent planning the
protest,
transporting all the protesters from around the country to the FDA
building and housing and
feeding them. Dr. Harter realized that all of
those resources would have been put to much better use
if they had
gone directly into research instead of into protests. Dr. Harter reported
that the
demonstration had convinced him that he should do all he
could to foster research into the drugs
under the control of his
division, regardless of political or ideological pressure to block
studies.
Though Dr. Harter passed on before seeing the passage of Proposition
215 in California, I feel
pretty certain that he would have been
appalled at the waste of resources represented by the $1.2
million
political campaign on behalf of the medical use of marijuana. That sum
of money could
have funded several large clinical studies into a
variety of potential medical uses of marijuana.
When FDA-
approved research into the medical use marijuana is blocked or delayed,
protests from
patients and physicians who face arrest and
imprisonment are inevitable.
The public mandate to your panel is to build on Dr. Harter's legacy.
Please work to turn
protests into protocols. A few suggestions follow
as to how you can help proactively expedite
medical marijuana
research.
Rick Doblin, M.P.P.
February 25, 1997
Synopsis:
1. Make available a list of the inventory of NIDA
marijuana currently in stock.
NIDA currently has a monopoly on the supply of marijuana available to
researchers who have
obtained FDA approval for their proposed
protocols. In light of this, research protocols could be
designed to use
marijuana which is currently in stock rather than being blindly designed
for
marijuana that may be need to be planted and grown before the
studies can begin. This simple
request is my litmus test to determine
whether NIDA is serious about proactively supporting medical
marijuana research or whether expressions of support for the need for
research are purely cosmetic.
An October 30, 1996 Los Angeles
Times article by Eric Bailey reported that NIDA had about
one ton
of marijuana already in stock. Is this true? What are the amounts and
potencies of NIDA
marijuana currently in stock? How much of this
marijuana is needed for purposes other than medical
marijuana
research?
Developing such an estimate should guide NIDA in determining how
much additional marijuana,
if any, needs to be grown for medical
marijuana research. This estimate should be linked to a Clinical
Plan
for the study of the medical uses of marijuana. I developed such a Clinical
Plan at the request of
the FDA and with its consultation. The final
draft of this Clinical Plan(see enclosure)was submitted
to the
FDA in March 1994 as an adjunct to Dr. Donald Abrams's IND (#43,542) to
study the use of
marijuana in the treatment of AIDS wasting.
By
my estimate, NIDA would need to supply roughly 25 kilograms of
marijuana per year for
each of the following three years to all the studies investigating the medical use of marijuana.
The cost to NIDA of its marijuana has been cited as a main
justification for the need for extensive
NIH peer-review of all new
medical marijuana protocols. Just how expensive is NIDA marijuana?
Dr. ElSohly, director of NIDA's marijuana farm at the University of
Mississippi, estimates that the
production cost is $1,120 per
kilogram. This is a relatively minor cost compared to NIDA's
estimated $487 million budget. Dr. Leshner says that Dr. ElSohly's
estimates are low and that the
entire marijuana production program
costs about $600,000 per year in total.
The Panel should obtain and
provide to the public the marginal costof supplying 25
kilograms
per year for the next three years to studies investigating
the medical use of marijuana in several
patient populations. The true
cost of supplying marijuana for a new use is the additional cost over
and above the costs already assumed by NIDA as part of its current and
regular production program.
The Panel should also obtain and provide
to the public NIDA's average production costs.
The NIH peer-review process is very lengthy. There are only three
application deadlines per year
and it takes about eight months or so
from the application deadline to the availability of funding.
NIDA's
requirement that it will only provide marijuana to NIH-approved
protocols, regardless of
funding needs, has so far prevented the
initiation of FDA-approved medical marijuana research and
will
definitely slow the pace of any research that does manage to secure NIH
approval.
The Panel should propose other peer review processes that
can respond to state and privately
funded projects, that will act more
rapidly than the NIH process, and that will still satisfy NIDA's
concerns that the protocols be well designed.The specification of
alternative routes to NIDA
marijuana is the most difficult litmus test
to determine if the Panel, and NIDA, are really serious
about
expediting medical marijuana research.
Marijuana smoke contains compounds that are neither therapeutic nor
without health risks. From
1994-1995, research into the
effectiveness of water pipes and vaporizers in filtering marijuana
smoke
was conducted at the American Health Foundation (AHF), a
leading center for research into the
constituents of tobacco and
marijuana smoke. The study was funded by MAPS and California
NORML
and used marijuana donated by NIDA outside of any NIH peer-review
process. This
research determined that water pipes were counterproductive and
selectively filtered out more
cannabinoids than particulate matter
but that vaporizers did improve the ratio of cannabinoids to
particulate matter.
Vaporizers are existing technology that can be
rapidly tested and improved. Their political
downside is that they are
designed to improve the safety profile of smoked marijuana. Aerosol
technology is also important to support but will take more time and cost
more money to develop.
Its political advantage, and medical advantage
as well, is that it can utilize only the therapeutic
cannabinoids and
need not involve the delivery of any extraneous substances.
Unfortunately, AHF has decided not to continue with the water
pipe/vaporizer research project,
citing the controversial nature of
researching marijuana smoke. MAPS has tried to continue this
research, but a research proposal that I submitted to RTI has not been
accepted. I think that a
recommendation to RTI from the Panel that
encourages it to conduct research specifically on
vaporizer
technology would be a sign to RTI that such research is acceptable to
NIDA.*