A federal appeals court Tuesday told us all what we already knew about the classification of marijuana as a Schedule 1 illegal drug
on a par with heroin: Any change in national policy, any federal easing
of restrictions upon the use of medical marijuana, must come from
within the executive branch, and specifically from the Drug Enforcement
Administration, which so far has been resolute in its rejection of the
idea that science and medicine have conclusively established that
marijuana helps treat some of the painful illnesses which afflict
millions of us.
In Americans for Safe Access v. DEA, a 45-page mash note to the Administrative Procedures Act,
the D.C. Circuit Court of Appeals offered up a ruling which is both
illuminating and infuriating. It is illuminating because it reminds us
of how much deference Congress requires federal judges to give to
administrative agencies when those agencies reach conclusions about
issues within their areas of expertise. It is infuriating because it
reminds us of how hard it is to change from below, from the people, the
momentum of the vast federal bureaucracy.
At its heart, though, the ruling cements into place the image of the
federal government’s position on pot as something akin to a large
boulder in the middle of a raging stream. It has been 40 years since the
DEA concluded that that marijuana "has no currently accepted medical
use in treatment in the United States." Since then, 18 states and the District of Columbia —
one third of all such jurisdictions — have legalized the use of
medical marijuana while two states, Colorado and Washington, have
legalized the recreational use of marijuana.
And how have the DEA
and the Department of Health and Human Services reacted to all this?
Unmoved and unmoving. Not yet convinced of what they are seeing with
their own eyes, federal regulators insist that marijuana still can’t be
re-classified so that more Americans can more lawfully use it to ward
off their pain or their nausea or whatever other effects of serious
illness they contend it helps with. Here’s the short version of how
these regulators justify their continued inaction. First, from Tuesday’s
ruling, the background:
A drug is placed in
Schedule I if (1) it "has a high potential for abuse," (2) it has "no currently
accepted medical use in treatment in the United States," and (3) "[t]here
is a lack of accepted safety for use of the drug . . . under medical
supervision." (emphasis added). A criterion for Schedule III, IV,
and V drugs is the existence of "a currently accepted medical use in treatment
in the United States."To assess whether there is a "currently
accepted medical use," the DEA looks for five necessary elements: "(1) The drug’s
chemistry must be known and reproducible; (2) There must be adequate safety
studies; (3) There must be adequate and well-controlled studies proving
efficacy; (4) The drug must be accepted by qualified experts; and (5) The
scientific evidence must be widely available." Unlike Schedule I drugs, federal law permits individuals to obtain Schedule
II, III, IV, or V drugs for personal medical use with a valid prescription (citations omitted by me).
The plaintiffs in this case asked the DEA to reclassify marijuana in
2002. The DEA then submitted the request to the DHHS. It took four years
for the DHHS to conclude that such a re-classification was unjustified.
And then it took the DEA five more years to formally deny the
plaintiffs’ request for a re-classification of the drug. To offer some
perspective on the slow march in play here, during the nine-year span
from 2002 to 2011 during which this issue was live before the DEA nine states and the District of Columbia passed medical marijuana laws.
The D.C. circuit now again picks up the trail. Why specifically did
the DHHS reject the request to re-classify marijuana? From the ruling:
In its scientific and
medical evaluation, DHHS concluded that marijuana lacks a currently accepted
medical use in the United States. In reaching this conclusion, DHHS applied the
DEA’s established five-prong test, which requires a known and reproducible drug
chemistry, adequate safety studies, adequate and well-controlled studies demonstrating
efficacy, acceptance of the drug by qualified experts, and widely available
scientific evidence. DHHS stated that there are approximately known components
of the cannabis plant. The components include 66 compounds called cannabinoids,
and marijuana is the only plant in which these compounds are known to exist.DHHS
stated, however, that marijuana’s chemistry was not "known and reproducible" as
there had not been "a complete scientific analysis" of its components. In
addition, although there was ongoing research, there were no studies of
sufficient quality to assess "the efficacy and full safety profile of marijuana
for any medical condition." Further, there was "a material conflict of opinion among
experts" as to medical safety and efficacy, thereby precluding a finding that
qualified experts accepted marijuana as a medicine. Additionally, the raw research data typically were
not available in a format that would allow "adequate scientific scrutiny of
whether the data demonstrate safety or efficacy" (citations omitted by me).
Why did the DEA "adhere" to the DHHS’s recommendation? Again, the
federal appeals court shared with the public the agency’s rationale:
To establish accepted
medical use, the effectiveness of a drug must be established in
well-controlled, well designed, well-conducted, and well-documented
scientific
studies, including studies performed in a large number of patients. To
date, such studies have not been performed. The small clinical
trial studies with limited patients and short duration are not
sufficient to
establish medical utility. Studies of longer duration are needed to
fully
characterize the drug’s efficacy and safety profile. Scientific
reliability
must be established in multiple clinical studies. Furthermore, anecdotal
reports and isolated case reports are not adequate evidence to support
an
accepted medical use of marijuana. The evidence from clinical
research and reviews of earlier clinical research does not meet this
standard (citations omitted by me).
The D.C. circuit then tried again to explain the difference between
how the regulators view "scientific studies" and how the plaintiffs in
the case would like them to view "scientific studies":
[A] limited number of
Phase I investigations have been conducted as approved by the FDA.
Clinical
trials, however, generally proceed in three phases. Phase I trials
encompass initial testing in human subjects, generally
involving 20 to 80 patients. They are designed primarily to assess
initial safety, tolerability, pharmacokinetics, pharmacodynamics, and
preliminary studies of potential therapeutic benefit. Phase II and Phase
III studies involve successively larger groups of patients:
usually no more than several hundred subjects in Phase II and usually
from
several hundred to several thousand in Phase III.
These
studies are designed primarily to explore (Phase II) and to demonstrate
or confirm
(Phase III) therapeutic efficacy and benefit in patients. No Phase II or
Phase III studies of marijuana have been conducted. Even in
2001, DHHS acknowledged that there is "suggestive evidence that
marijuana may
have beneficial therapeutic effects in relieving spasticity associated
with multiple
sclerosis, as an analgesic, as an antiemetic, as an appetite stimulant
and as a
bronchodilator." But there is still no data from adequate
and well-controlled clinical trials that meets the requisite standard to
warrant rescheduling.
I suppose there are two ways in which proponents of medical marijuana
are likely to react to this ruling — and to the scientific
justification for the federal government’s refusal to re-classify the
drug. They are likely to try to put political pressure on the DEA and
the DHHS from above, that is to say politically. And they are likely to
ramp up their efforts on the ground to conduct and conclude the sorts of
"scientific studies" which the regulators say they need to see before
they’ll give medical marijuana clearance to get beyond "Schedule 1."
The first option isn’t encouraging. Even though recent polls show huge public support for legalized medical marijuana,
Congress has ignored the issue and the Obama Administration has been
outright hostile to medical marijuana operations, especially in
California. The second option is going to take more time and, really,
who is to say that the same regulators who today want more than mere
"peer reviews" won’t tomorrow be asking for something more than
"well-controlled, well designed, well-conducted, and well-documented"
studies?
In the meantime, a million or so Americans will continue to use
medical marijuana to blunt their pain — and will continue to do so
under the relative safety of more and more state laws. Nowhere is the
divide between Washington and America more evident than in this one
court ruling on this one topic. The law may not permit the use of this
drug to ease pain. Our government’s tribunes may not yet trust the
science that supports it. But the people have long since rendered their
own judgment. For them, peer review begins at home.
