Five recommendations
to proactively expedite
medical marijuana research.
[Submitted in a 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.]
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.