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The420Guy
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"The question of whether marijuana has any legitimate medical purpose
should be determined by sound science and medicine." That is the federal
government's official response to the medical marijuana movement, as
expressed in November 2001 by Asa Hutchinson, then head of the Drug
Enforcement Administration (DEA). Since California and Arizona passed the
first medical marijuana initiatives in 1996, both the Clinton and Bush
administrations have insisted that the therapeutic value of cannabis should
be judged by the Food and Drug Administration (FDA) based on careful
research, not by voters or state legislatures based on emotional appeals.
Several years ago, Rick Doblin, president of the Multidisciplinary
Association for Psychedelic Studies (MAPS), decided to take the government
at its word by promoting the kind of research that could ultimately lead
the FDA to approve marijuana as a prescription drug. But along with the
usual obstacles posed by the notoriously arduous FDA approval process, MAPS
encountered problems unique to marijuana. In particular, it found that the
only legal source of marijuana for U.S. research was the National Institute
on Drug Abuse (NIDA).
As its name implies, NIDA focuses on marijuana's dangers rather than its
potential benefits. Hence getting its permission for research on the drug's
medical utility has been tricky. Although a few researchers have managed to
obtain marijuana from NIDA, two studies approved by the FDA have been
rejected by NIDA, and those examples have discouraged other researchers
from bothering to apply. The additional layer of approval, which is not
required for any other Schedule I drug, makes an already daunting process
even more intimidating. Doblin's audacious but sensible solution is to cut
NIDA out of the picture by establishing a private source of cannabis for
research (which already has been done in the U.K.).
To accomplish that goal, MAPS needs permission from the DEA, which it has
been trying to get since June 2001. The history of this effort, described
in detail on the MAPS Web site, demonstrates the disingenuousness of drug
warriors who say their opposition to the medical use of marijuana is based
on scientific concerns. At the same time that they are complaining about
the lack of adequate evidence, they are blocking attempts to obtain it.
MAPS wants to fund a marijuana production facility at the University of
Massachusetts in Amherst that would be overseen by Lyle Craker, a professor
in the school's Department of Plant and Soil Sciences who has extensive
experience with medicinal plants. In addition to eliminating the gratuitous
obstacle created by NIDA's marijuana monopoly, such a facility could
provide better cannabis that would meet researchers' specifications and
eventually be used as a legal medicine.
NIDA's pot, grown under contract at the University of Mississippi for the
last three decades, is of relatively low potency and quality. Its THC
content ranges from 2 percent to 7 percent. "To improve the safety profile
of its product," Doblin writes, "MAPS requires marijuana with a THC content
in the 12-15% range, thereby reducing the amount of particulate matter
inhaled per unit of THC and improving the risk/benefit ratio of the
product." The risks of marijuana use can be further reduced with
vaporizers, which heat cannabis to release THC rather than burning it.
Doblin says these devices, the subject of MAPS-sponsored research, work
especially well with high-potency marijuana.
Dr. Ethan Russo, one of the researchers whose FDA-approved protocols were
rejected by NIDA, interviewed patients who receive NIDA's marijuana under
the government's "compassionate use" investigational new drug program
(closed to new applicants since 1992). "Each of the Compassionate Use IND
patients," he reports, "indicated to me that they would prefer to have
properly manicured, seedless, unfertilized cannabis of a higher grade so
that they might be able to smoke less material to obtain relief of their
medical symptoms." He notes that NIDA's marijuana is not comparable to the
cannabis typically used by patients in Europe, Canada, or the United States.
In addition to producing higher-potency, cleaner marijuana, the University
of Massachusetts operation proposed by MAPS could offer strains with
varying levels of cannabinoids other than THC, some of which may contribute
to marijuana's therapeutic effects. More important, a new supplier would
allow companies trying to get marijuana approved as a medicine to test the
same product they planned to market, as required by the FDA. NIDA's mandate
is to produce marijuana for research, not for medicinal use. "There is no
guarantee that marijuana provided by NIDA for research would be available
for commercial use," Doblin notes. "NIDA-supplied marijuana is therefore
inadequate for use in a privately funded drug development plan... No
rational pharmaceutical company would invest millions of dollars in Phase
III clinical trials of a drug that it cannot be certain it could produce
for commercial sale should safety and efficacy be demonstrated to the
satisfaction of the FDA."
After an 18-month delay, the DEA responded to Lyle Craker's application for
a license to produce marijuana with a series of specious objections. First
it said licensing the University of Massachusetts facility would violate
international drug treaties, an argument demolished in an analysis prepared
by Graham Boyd, director of the American Civil Liberties Union's Drug
Policy Litigation Project, and two Washington attorneys. Then the DEA said
there's no evidence the current marijuana supply is inadequate.
Dismissing Ethan Russo's points out of hand, the DEA insisted on seeing
complaints from researchers who are currently using NIDA's marijuana.
"While I recognize that the primary researchers now receiving plant
material may openly state to you that they are satisfied with the current
source," Craker replied, "I am sure you appreciate that in private
conversations these same researchers indicate a fear of having the current
supply eliminated if they complain about the available source material."
The DEA's official record also does not reflect the researchers who would
be interested in studying marijuana if a better supply were available and
the approval process were less cumbersome.
In short, the odds of breaking NIDA's marijuana monopoly do not look good.
But the attempt has at least demonstrated that the drug warriors are not
really interested in the thorough scientific investigation they claim to
favor. "As long as NIDA is the sole source of supply" for cannabis, Doblin
observes, "the FDA process will rightly be perceived by the public as
obstructed, further fueling efforts by states to circumvent federal
authority over the medical uses of marijuana through ballot initiatives or
state legislation." The DEA's intransigence thus will validate state
attempts to make marijuana available as a medicine regardless of what the
federal government says.
Jacob Sullum, a senior editor at Reason, is the author of Saying Yes: In
Defense of Drug Use, forthcoming in May from Tarcher/Putnam.
Pubdate: Mon, 14 Jul 2003
Source: Reason Online (US)
Copyright: 2003 The Reason Foundation
Contact: letters@reason.com
Website: Reason.com
should be determined by sound science and medicine." That is the federal
government's official response to the medical marijuana movement, as
expressed in November 2001 by Asa Hutchinson, then head of the Drug
Enforcement Administration (DEA). Since California and Arizona passed the
first medical marijuana initiatives in 1996, both the Clinton and Bush
administrations have insisted that the therapeutic value of cannabis should
be judged by the Food and Drug Administration (FDA) based on careful
research, not by voters or state legislatures based on emotional appeals.
Several years ago, Rick Doblin, president of the Multidisciplinary
Association for Psychedelic Studies (MAPS), decided to take the government
at its word by promoting the kind of research that could ultimately lead
the FDA to approve marijuana as a prescription drug. But along with the
usual obstacles posed by the notoriously arduous FDA approval process, MAPS
encountered problems unique to marijuana. In particular, it found that the
only legal source of marijuana for U.S. research was the National Institute
on Drug Abuse (NIDA).
As its name implies, NIDA focuses on marijuana's dangers rather than its
potential benefits. Hence getting its permission for research on the drug's
medical utility has been tricky. Although a few researchers have managed to
obtain marijuana from NIDA, two studies approved by the FDA have been
rejected by NIDA, and those examples have discouraged other researchers
from bothering to apply. The additional layer of approval, which is not
required for any other Schedule I drug, makes an already daunting process
even more intimidating. Doblin's audacious but sensible solution is to cut
NIDA out of the picture by establishing a private source of cannabis for
research (which already has been done in the U.K.).
To accomplish that goal, MAPS needs permission from the DEA, which it has
been trying to get since June 2001. The history of this effort, described
in detail on the MAPS Web site, demonstrates the disingenuousness of drug
warriors who say their opposition to the medical use of marijuana is based
on scientific concerns. At the same time that they are complaining about
the lack of adequate evidence, they are blocking attempts to obtain it.
MAPS wants to fund a marijuana production facility at the University of
Massachusetts in Amherst that would be overseen by Lyle Craker, a professor
in the school's Department of Plant and Soil Sciences who has extensive
experience with medicinal plants. In addition to eliminating the gratuitous
obstacle created by NIDA's marijuana monopoly, such a facility could
provide better cannabis that would meet researchers' specifications and
eventually be used as a legal medicine.
NIDA's pot, grown under contract at the University of Mississippi for the
last three decades, is of relatively low potency and quality. Its THC
content ranges from 2 percent to 7 percent. "To improve the safety profile
of its product," Doblin writes, "MAPS requires marijuana with a THC content
in the 12-15% range, thereby reducing the amount of particulate matter
inhaled per unit of THC and improving the risk/benefit ratio of the
product." The risks of marijuana use can be further reduced with
vaporizers, which heat cannabis to release THC rather than burning it.
Doblin says these devices, the subject of MAPS-sponsored research, work
especially well with high-potency marijuana.
Dr. Ethan Russo, one of the researchers whose FDA-approved protocols were
rejected by NIDA, interviewed patients who receive NIDA's marijuana under
the government's "compassionate use" investigational new drug program
(closed to new applicants since 1992). "Each of the Compassionate Use IND
patients," he reports, "indicated to me that they would prefer to have
properly manicured, seedless, unfertilized cannabis of a higher grade so
that they might be able to smoke less material to obtain relief of their
medical symptoms." He notes that NIDA's marijuana is not comparable to the
cannabis typically used by patients in Europe, Canada, or the United States.
In addition to producing higher-potency, cleaner marijuana, the University
of Massachusetts operation proposed by MAPS could offer strains with
varying levels of cannabinoids other than THC, some of which may contribute
to marijuana's therapeutic effects. More important, a new supplier would
allow companies trying to get marijuana approved as a medicine to test the
same product they planned to market, as required by the FDA. NIDA's mandate
is to produce marijuana for research, not for medicinal use. "There is no
guarantee that marijuana provided by NIDA for research would be available
for commercial use," Doblin notes. "NIDA-supplied marijuana is therefore
inadequate for use in a privately funded drug development plan... No
rational pharmaceutical company would invest millions of dollars in Phase
III clinical trials of a drug that it cannot be certain it could produce
for commercial sale should safety and efficacy be demonstrated to the
satisfaction of the FDA."
After an 18-month delay, the DEA responded to Lyle Craker's application for
a license to produce marijuana with a series of specious objections. First
it said licensing the University of Massachusetts facility would violate
international drug treaties, an argument demolished in an analysis prepared
by Graham Boyd, director of the American Civil Liberties Union's Drug
Policy Litigation Project, and two Washington attorneys. Then the DEA said
there's no evidence the current marijuana supply is inadequate.
Dismissing Ethan Russo's points out of hand, the DEA insisted on seeing
complaints from researchers who are currently using NIDA's marijuana.
"While I recognize that the primary researchers now receiving plant
material may openly state to you that they are satisfied with the current
source," Craker replied, "I am sure you appreciate that in private
conversations these same researchers indicate a fear of having the current
supply eliminated if they complain about the available source material."
The DEA's official record also does not reflect the researchers who would
be interested in studying marijuana if a better supply were available and
the approval process were less cumbersome.
In short, the odds of breaking NIDA's marijuana monopoly do not look good.
But the attempt has at least demonstrated that the drug warriors are not
really interested in the thorough scientific investigation they claim to
favor. "As long as NIDA is the sole source of supply" for cannabis, Doblin
observes, "the FDA process will rightly be perceived by the public as
obstructed, further fueling efforts by states to circumvent federal
authority over the medical uses of marijuana through ballot initiatives or
state legislation." The DEA's intransigence thus will validate state
attempts to make marijuana available as a medicine regardless of what the
federal government says.
Jacob Sullum, a senior editor at Reason, is the author of Saying Yes: In
Defense of Drug Use, forthcoming in May from Tarcher/Putnam.
Pubdate: Mon, 14 Jul 2003
Source: Reason Online (US)
Copyright: 2003 The Reason Foundation
Contact: letters@reason.com
Website: Reason.com
