Sixteen years after Californians approved medical marijuana, the state’s highest court is poised to decide whether cities and counties can ban cannabis dispensaries.

The long-awaited ruling by the California Supreme Court, which hears
arguments on the issue Feb. 5, follows years of contradictory decisions
by the lower courts operating in a void because the state Legislature
has yet to define the law or pass detailed regulations.

If the court upholds bans passed
by more than 200 local governments, as some legal analysts expect, more
such measures are likely to be adopted.

The court also could clarify other parts of the state’s medical
marijuana law, though no one expects its pronouncement to end the
confusion.

"This is a subject matter that requires detailed regulations, and the
California Legislature hasn’t done the job," said Alex Kreit, a law
professor who has advised San Diego on medical marijuana law.

Kreit pointed out that Colorado implemented its medical marijuana law
with hundreds of regulations in a "fairly smooth process." California
legislators have yet to adopt requirements for state licensing and
labeling of marijuana, among other issues.

That has left judges struggling to interpret the law and local
governments uncertain of how to enforce it. Prosecutors also have been
vexed. Atty. Gen. Kamala D. Harris sent letters to legislative leaders in 2011 pleading for action.

"For some reason, the perception in Sacramento has been that this will
go away, that this is radioactive, so there has been a lack of
leadership and commitment on the issue," said Assemblyman Tom Ammiano (D-San Francisco), who last year introduced a bill to regulate medical marijuana. "That is changing."

While such cities as San Francisco and Oakland moved quickly to regulate
medical marijuana, others, such as Los Angeles, failed to act
immediately and were inundated with dispensaries, Kreit said. Once in
place, the medical marijuana providers sued cities that tried to
regulate them.

"Every dot of an ‘i’ and every cross of a ‘t’ is litigated here in Los
Angeles," said Los Angeles Special Assistant City Atty. Jane Usher.
"Nothing has gone unchallenged. Any time you try to regulate, hold on to
your hat because you will spend the next two or three years in
litigation

In the summer of 2007, the owners of Harborside Health Center, then
and now the most prominent medical marijuana dispensary in the U.S.,
were reflecting on their rapid rise. Steve DeAngelo had opened the
center with his business partner in October 2006, on a day when federal
agents raided three other clubs in the San Francisco Bay Area. "We had
to decide in that moment whether or not we were really serious about
this and whether we were willing to risk arrest for it," DeAngelo said.
"And we decided we were going to open our doors. And we did, and we
haven

The Cannabis Committee of the American Herbal Products Association (AHPA) last week delivered draft recommendations on the regulation of distribution (dispensing) of medical marijuana to regulators in three states that allow such practice.

The recommendations seek to ensure best practices at the point of distribution between provider and consumer and cover such issues as product acquisition, physical facilities, security, personnel training, and requirements for purchase. The committee’s recommendations were delivered to regulatory offices in California, Colorado, and Massachusetts and will shortly be sent to the other states that have legalized medical marijuana and to the District of Columbia.

"The AHPA Cannabis Committee includes in its charter a responsibility to develop policy recommendations that support safe use of products derived from Cannabisspecies," said Michael McGuffin, AHPA president. "This initial work should be well-received by state regulators, who share our commitment to ensuring safe access to medical marijuana for their citizens."

The AHPA Cannabis Committee was founded in 2010 to address issues related to the safe use and responsible commerce of legally marketed products derived fromCannabis species. The committee, in cooperation with Americans for Safe Access(ASA), has over the past year coordinated the development of recommendations to state regulators on best practice regulations in several areas, including cultivation; manufacturing, packaging and labeling; laboratory practice; and distribution.

ASA is the largest national, member-based organization of patients, medical professionals, scientists, and concerned citizens promoting safe and legal access to cannabis for therapeutic use and research through legislation, education, litigation, grassroots actions, advocacy, and services for patients and caregivers. "The committee would not have achieved the work completed to date without the support of Americans for Safe Access," added McGuffin. "ASA’s guidance, contacts, and outreach will continue to be essential to completion of the committee’s tasks." The AHPA Cannabis Committee will continue its efforts to develop recommendations to state regulators in each of the other areas where regulations may be implemented and will deliver these as they are completed over the next several months.

Following two years of collaboration with the medical marijuana
industry, the American Herbal Products Association said Thursday that it
was providing recommendations to state officials looking to regulate
medical pot.

The American Herbal Products Association, founded in 1982 to
represent botanical medicine companies, had not previously announced its
alliance with medical marijuana and the trade organization Americans
for Safe Access, which represents pot dispensaries and other elements of
the industry.

The alliance gives medical marijuana a broader presence in Washington
and a less controversial trade group to help it work the corridors of
power. The American Herbal Products Association has reduced its lobbying
and campaign giving in recent years, but has spent nearly $2 million
lobbying since 1998.

A chief argument against marijuana as a medicine centers around its
lack of approval by the Food and Drug Administration. On Wednesday, a
judge rejected an effort to reclassify the drug, citing a lack of
compelling evidence of its medical value.

Millions of people, however, attest to pot’s medical benefits.
Advocates said the association with other herbal and botanical
treatments will help policymakers think of marijuana more rationally.

"The AHPA Cannabis Committee includes in its charter a responsibility
to develop policy recommendations that support safe use of products
derived from cannabis species," Michael McGuffin, American Herbal
Products Association president, said in a statement. "This initial work
should be well received by state regulators, who share our commitment to
ensuring safe access to medical marijuana for their citizens."

Americans for Safe Access said decades of overseeing herbal product
safety makes the the American Herbal Products Association uniquely
qualified to apply that experience to medical marijuana.

The
American Herbal Products Association said it has delivered
recommendations to lawmakers in California, Massachusetts and Colorado.

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.

More than a decade after the Coalition to Reschedule Cannabis first petitioned the U.S. Drug Enforcement Administration
to reschedule marijuana for medicinal purposes, the U.S. Circuit Court
for the District of Columbia ruled Jan. 22 that the DEA was right to
refuse to do so.