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Marijuana, Inflammation, and CT-3 (DMH-11C)
Cannabis Leads to New Class of Anti-inflammatory Drugs
by John S. James
Rheumatoid arthritis researchers are testing CT-3, a
synthetic derivative of a metabolite of marijuana, as a
potentially new kind of experimental anti-inflammatory
drug-- without the gastric and other side effects of
today's non- steroidal anti-inflammatories, and without
the psychoactive effect or "high" of marijuana. The
natural metabolite has the same anti-inflammatory effect,
but is less powerful. Although CT-3 is far from human
testing, it is interesting for several reasons:
Inflammation is not a single process, but many
different ones. It may be important in the pathogenesis
of HIV disease, and certainly can exacerbating some of
its consequences. Much is still unknown, but a new class
of anti-inflammatory drugs will open new approaches for
research and treatment.
An anti-inflammatory effect separate from the
psychoactive effect may be responsible for most of the
relief which many patients find from medicinal
marijuana. If the only benefit of the drug were in
masking pain or other discomfort, then it would be hard
to design scientific research except to confirm that the
effect is real -- and it is difficult to prove a
subjective effect, especially with a substance like
marijuana where it is probably impossible to use a
placebo effectively. But if the drug is also an
anti-inflammatory, then all kinds of research
opportunities open up, and the subjectivity problem can
usually be avoided.
Obtaining the medical without the psychoactive effects
of cannabis will be important to patients, since the
"high" when it is not wanted is a major drawback, and
can be debilitating.
A recent paper(1) on CT-3 (also called DMH-11C, chemical name dimethylheptyl-THC-11 oic acid) was published in
the January 1998 Arthritis and Rheumatism. The findings
were also presented in November 1997 at the 61st
National Scientific Meeting of the American College of
Rheumatology.
THC (tetrahydrocannabinol) is the major active
ingredient of marijuana; THC is also available legally
in the U.S. as the prescription drug Marinol®. When
the body metabolizes THC, it produces a number of
related chemicals. It was previously known that at least
one of these metabolites has anti-inflammatory and
pain-relieving effects. CT-3 was produced synthetically
by modifying this metabolite so that it is more powerful
and can be given in smaller doses.
The paper also acknowledged much earlier work, citing a
Chinese text from around 2000 BC. "It was claimed that
cannabis 'undoes rheumatism,' suggesting possible
anti-inflammatory effects."(1)
Animal tests found CT-3 effective against both chronic
and acute inflammation; it also prevented destruction of
joint tissue from chronic inflammation. These results
suggest possible usefulness against chronic inflammatory
conditions such as rheumatoid arthritis.
The drug is currently in very early pre-clinical animal
testing. The long safety record of marijuana--no one has
ever died of an overdose -- and the fact that a metabolite
with the desired anti-inflammatory effect is produced in
the body when marijuana is used, strongly suggest that
safe and effective anti-inflammatory drugs in this class
are possible.
CT-3 should not be confused with a different synthetic
marijuana-like drug, WIN 55212, recently reported to
reduce pain in animal tests, by neurologists at the
University of California San Francisco. Several other
university research teams are also studying painkilling
effects of cannabinoids. These studies suggest other
potential uses of marijuana or its derivatives -- for
example, they might reduce the doses of opiates needed
to control pain. But this mechanism is different from
that of the anti-inflammatory effect of CT-3.
CT-3 is being developed by Atlantic Pharmaceuticals in
Raleigh, North Carolina (http://www.atlan.com). The
research was done at the University of Massachusetts
Medical Center in Worcester, Massachusetts.
References
1. Zurier RB, Rossetti RG, Lane JH, Goldberg JM, Hunter
SA, and Burstein SH. Dimethylheptyl-THC-11 Oic Acid: A
Non-psychoactive anti-inflammatory Agent with a
Cannabinoid Template Structure. Arthritis and Rheumatism
January 1998; volume 41, number 1, pages 163-170.
Medical Marijuana: Federal, State Attacks Against California Cannabis Clubs
by Fred Gardner and John S. James
On January 9 the Clinton Administration filed suits to
close six medical marijuana buyers' clubs in Northern
California; a dozen other clubs operating in the state
were not named. This action came more than a year after
California voters passed Proposition 215 to allow use of
marijuana for medical purposes, and a few days before
the effective date of a California court ruling that
sales by clubs remain illegal.
The six clubs named in the federal suits are the
Cannabis Cultivators Club in San Francisco, Flower
Therapy in San Francisco, Marin Alliance for Medical
Marijuana in Fairfax, Oakland Cannabis Buyers'
Cooperative, Santa Cruz Buyers' Club, and Ukiah Buyers'
Club. Proposition 215 changed the California Health and
Safety code to legalize possession and cultivation by
"seriously ill" Californians using marijuana with the
approval of a physician; but the federal prohibitions
remained in place. The usual federal practice has been
to leave marijuana prosecution to the states unless the
quantities are very large.
Closing the clubs, either by state or federal action,
would mean that persons with a documented need would
still have a legal right to use marijuana for medical
purposes under California law--but not under Federal
law; and there would be no place where they could
legally obtain it. This is a serious problem because
even though most social users can find marijuana
relatively easily, many patients who need it for medical
purposes are not part of that culture, and often have to
seek the drug from strangers on the streets, which
creates anxiety, costs more time and money, and makes
consistent medication virtually impossible.
California Attorney General Lungren has advised local
law enforcement officers to make marijuana arrests
regardless of Proposition 215--meaning that persons who
are seriously ill must still be jailed, and must arrange
and pay for an "affirmative defense" establishing that
their use was legal under Proposition 215 (which was
approved by California voters on November 5, 1996
despite strong opposition from Lungren and Drug Czar
Barry McCaffrey).
Background: Federal Attack against Medical Marijuana in
California
The federal authorities revealed their first plan on
December 30, 1996, at a widely covered press conference.
McCaffrey, flanked by U.S. Attorney General Reno and
U.S. Health and Human Services Secretary Donna Shalala,
warned that a doctor's recommendation of marijuana would
"lead to administrative action by the U.S. Drug
Enforcement Administration to revoke the practitioner's
registration... This isn't medicine," he added, "this is
a Cheech and Chong show." Lungren thanked McCaffrey and
Reno for "quick action."
But the McCaffrey-Reno-Shalala press conference alarmed
many members of the medical community. A January 30
editorial in the New England JOURNAL of
Medicine -- "Federal Foolishness and Marijuana," by Jerome
Kassirer, M.D., the editor-in-chief derided the U.S.
government's policy as "misguided," "hypocritical," "out
of step with the public," and "inhumane," and called for
reclassifying marijuana from Schedule 1 (drugs of abuse
with no therapeutic value) to Schedule 2 (which could
allow prescription use, as with morphine).
In February Conant v. McCaffrey, a class-action lawsuit
on behalf of all California doctors and patients who
discuss marijuana as a treatment option, was filed to
prevent the government from prosecuting or threatening
to punish them. The suit, assigned to U.S. District
Judge Fern Smith, charged that the feds "have intruded
into the physician-patient relationship, an area
traditionally protected from government interference."
In April Judge Smith (a Reagan appointee) granted a
preliminary injunction "limiting the government's
ability to prosecute physicians, revoke their
prescription licenses, or bar their participation in
Medicare and Medicaid because they recommend medical use
of marijuana." In a 43-page opinion she wrote, "The
First Amendment allows physicians to discuss and
advocate medical marijuana, even though use of marijuana
itself is illegal... The government's fear that frank
dialog between physicians and patients about medical
marijuana might foster use does not justify infringing
First Amendment freedoms... Defendants may only
prosecute physicians who recommend medical marijuana to
their patients if the physicians are liable for aiding
and abetting or conspiracy under these statues."
It appears that the feds adopted their current strategy
(close down the clubs) only after the Fern Smith
decision nixed Strategy A (intimidate the doctors).
Smith ruled in April. The Justice Department began its
investigation of the clubs -- sending undercover agents in
to make purchases -- in May, according to the court
documents filed January 9, 1998.
All the clubs require documentation of medical need for
marijuana, and they verify its authenticity by calling
the physician. According to Dennis Peron, founder and
maitre 'd of the San Francisco Cannabis Cultivators
Club, the U.S. Drug Enforcement Administration not only
used false documentation, but also set up a special
phone line where a narcotics agent pretended to be in
the medical office, and provided the "verification"
requested.
Attorney Bill Panzer, who represents the Oakland and
Marin clubs, says, "The feds don't want to appear heavy
handed. They are not threatening anyone with jail. They
are seeking an order saying the club has to shut down.
Even if they are successful, and a person violates that
order, under the statute that person is entitled to a
jury trial. Which means that at some point we'll get to
be in front of a jury."
Four of the six federal cases are scheduled to be heard
February 20. Panzer thinks there is a chance that one of
the judges from whom injunctions are being sought will
consider "the real question--the medical efficacy of
marijuana." His goal in the legal arguments that will
now ensue is to somehow promote a trial in which "the
question of whether marijuana is good or bad can be
argued in a district court and the whole history of
marijuana prohibition can be cited to show that the
government has acted arbitrarily and capriciously and
that the Controlled Substances Act, as it relates to
marijuana -- especially medical marijuana -- has no basis in
science, no basis in logic, no basis in rationality."
Reminded that the government has, over the years,
assiduously avoided allowing this history to be reviewed
in open court, Panzer says, "Show me any other time the
government has ever filed for an injunction to close
down a medical marijuana dispensary?"
Background on State Attack
California Attorney General Lungren, who is also running
for governor as a Republican this year, sought to impose
his "narrow interpretation" of Proposition 215 from the
day it passed. At 12:01 a.m. November 6, he announced
(by fax) an "emergency all-zone meeting" of the state's
police chiefs, sheriffs and district attorneys. The
meeting, closed to the press and public, took place in
Sacramento on December 4, 1996. Lungren's interpretation
is that Proposition 215 did not legalize transportation, sales
or buyers' clubs. Doctors should be forced to testify,
he advised, "that the benefits of marijuana use for the
specific patient clearly outweigh the risks to the
patient -- which is believed to be a scientifically
unsupportable finding." Lungren announced he would
travel to Washington December 12 to meet with U.S.
Attorney General Reno "to ascertain the federal
government's detailed prosecution plans."
Lungren's case against the clubs stems from an
investigation by state Bureau of Narcotics Enforcement
agents against one cannabis club, run by Dennis Peron,
in the spring of 1996; this investigation culminated in
a raid August 4, and a civil injunction that halted
operations. The raid, on the eve of the Republican
convention, was widely covered in the media. A
Yes-on-215 headquarters was located in the same building
as the cannabis club, 1444 Market Street in San
Francisco, and Peron protested that the state narcotics
agents violated the election laws by examining campaign
records.
The San Francisco club was allowed to re-open in January
1997 after Superior court Judge David Garcia ruled that
the passage of Proposition 215 entitled Dennis and his
associates to provide marijuana "for the personal
medicinal use of persons who have designated the
defendants as their primary caregiver pursuant to
California Health and Safety Code S11362.5."
Lungren appealed Garcia's ruling, and claimed victory
December 12, 1997, when two of the three judges on a
First District Court panel held that cannabis buyers'
clubs are not caregivers under Proposition 215, and therefore
have no legal right to distribute marijuana. Lungren
immediately sent off a letter (December 15, 1997) to the
district attorneys of California's 58 counties
suggesting that they consider cracking down on clubs
within their jurisdiction. The District Court ruling
became effective on January 12, 1998.
Peron has asked the state Supreme Court to review the
appeals court ruling. If they take the case, the
District Court ruling is vacated (while we await the
Supreme Court ruling). If the California Supreme Court
denies review--which they usually do--the appeals court
ruling becomes final; but Peron can still return to
Superior Court in San Francisco to argue that the ruling
was based on evidence before Judge Garcia that did not
address the club's authentic caregiver role as a support
group, social scene, provider of wholesome food, etc. He
can introduce new evidence and seek a different ruling
on the club's caregiver status.
Comment
All of the medical marijuana clubs in California will
not necessarily have to close even if the federal and
California governments win the legal disputes currently
before the courts. At this time the federal action does
not name all the clubs. And so far Lungren has urged
local officials to do their own raids, instead of
conducting them all from his office in Sacramento. Most
of the medical marijuana clubs are on good to excellent
terms with their local political and law-enforcement
officials; otherwise they would never have opened their
doors.
It has always been known, however, that Proposition 215
cannot provide a defense against federal marijuana laws,
which do not recognize medical use except for research.
(The federal government does have its own medical
marijuana program, apparently using the research
exception, but only eight patients are currently
enrolled and no new people can be accepted.)
The public has strongly supported legitimate medical use
of marijuana for years, whenever given a chance to vote
or express its opinion in surveys; almost all of the
opposition is from government officials and anti-drug
professionals. Meanwhile, the scientific case for
medical use keeps growing stronger [see "Marijuana,
Inflammation, and CT-3 (DMH-11C): Cannabis Leads to New
Class of anti-inflammatory Drugs
" in this issue]. Far
more dangerous psychoactive drugs, like morphine, are
successfully allowed in medical use. Somehow marijuana
has become a symbolic or political hard line to be
maintained by anti-drug believers regardless of human
cost. The costs will mount until the public can organize
itself to insist that those who urgently need this
medicine can obtain and use it legally.
[Fred Gardner is managing editor of Synapse, the weekly
newspaper at the University of California San Francisco
Medical Center. He is a former editor of Scientific
American.]
Medical Marijuana: The Will Foster Case in Oklahoma
by John S. James
The new information on anti-inflammatory effects of
marijuana [see "Marijuana, Inflammation, and CT-3..." above] is also relevant to the case of Will Foster in
Tulsa, Oklahoma. This case shows the need for legal
recognition of medical marijuana, and other law reform.
In January 1997 Will Foster, who ran a software business
and was formerly a military policeman, was sentenced to
93 years in prison for growing marijuana in his basement
to treat his severe rheumatoid arthritis. He had no
criminal record.
The sentence consisted of 70 years for growing the
plants, 20 years for doing so in the presence of
children (his own, who according to Foster never saw or
knew about the marijuana, which was in a locked room),
and three years for miscellaneous marijuana offenses.
While researching this case we looked for indications of
anything else that could explain the severity of the
sentence, but could find nothing. Foster refused to
plead guilty and accept a 12-year sentence, and instead
had a jury trial -- said to be unheard of in Tulsa in a
marijuana possession or cultivation case, which usually
leads to a plea bargain.
Will Foster's wife Meg had difficulty finding a lawyer
in Tulsa to handle an appeal, but an appeal was filed on
September 6, 1997. Two weeks later Foster was
transferred to a prison in Texas, 400 miles from his
family, where he remains today. He was unable to get his
prescription medications or even minimal medical care
for his arthritis, until public pressure was organized.
The Oklahoma governor rejected requests for clemency.
More information about the case, including updates, a
detailed statement by Will Foster, a 2000-word article
in Reason magazine, and how people can help, can be
found at:
http://www.gnv.fdt.net/~jrdawson/willfoster.htm.
Micronutrients and the HIV Patient, March 23-24 in Boston
"This meeting is designed for physicians, scientists and
other health professionals trained in nutrition and
HIV/AIDS disease management. The overall objective is to
evaluate the scientific data concerning the role of
micronutrients in the treatment of HIV or AIDS. Specific
focus will be placed on the antioxidants (vitamins A, C,
E, and beta carotene), the B-complex vitamins, and
minerals (iron, zinc, and selenium). The discussion will
address:
provisional recommendations on use of
supplemental micronutrients and minerals in HIV/AIDS,
and
development of priorities for intervention
trials to investigate the effects of micronutrient
supplementation on HIV/AIDS progression."
The meeting will be chaired by Sherwood Gorbach, M.D.,
Ronenn Roubenoff, M.D., and Margo Woods, Ph.D. It is
sponsored by Serono Symposia USA and Tufts University
School of Medicine. Since it was only recently
announced, this meeting has not yet been widely
publicized.
For more information contact: David Pherson, Ph.D.,
Serono Symposia USA, Inc., 800-283-8088x2372, or
781-982-9000x2372, or fax 781-982-9481.
Scholarships Available for Geneva Conference
Application Deadline March 8
On January 8 the National AIDS Fund announced
scholarships of up to $3,500 for persons involved in
community-based service organizations to attend the 12th
World AIDS Conference, June 28 - July 3, in Geneva,
Switzerland.
"Applicants must be actively involved in community-based
HIV/AIDS organizations. Preference will be to those
applicants who do not have the resources -- or who would
not normally have the opportunity -- to participate in
educational opportunities of this scope. Applicants will
be selected by a panel of representatives from the
nation's major HIV/AIDS organizations and institutions."
Major funding this year for the Community Advocates
Scholarship Program is from Merck & Co., Glaxo Wellcome,
Roche Laboratories, Pfizer, Agouron Pharmaceuticals, and
Gilead Sciences.
Applications are due at the National AIDS Fund on March
8; they must include a letter of support, and cannot be
submitted by fax.
For more information, or to obtain the application form,
contact Ken Aldrich, Scholarship Liaison, National AIDS
Fund, 202-408-4848, 9:00 a.m. to 6:00 p.m. Eastern time.
Or call any time and leave your fax number.
More Attention to HIV Reporting As GMHC Changes Policy
by John S. James
On January 14 the Gay Men's Health Crisis, the nation's
largest AIDS service organization, announced that it had
changed its position and now supported a new monitoring
system to report cases of HIV infection in New York
State, through a system of "unique identifiers" for
patients (instead of patients names) to provide the
best privacy protection (see "AIDS Group Urges New York
to start reporting of HIV," The New York Times January
13, page 1). Many other large and small AIDS
organizations remain strongly opposed. The push for
reporting cases of HIV infection to government agencies
has developed great momentum in the last few years, and
it is now widely believed that HIV reporting will
eventually become required in all states, probably by
name. Therefore the AIDS community needs to analyze the
considerable concerns about and objections to names
reporting, to be able to propose ways to reduce the harm
which is feared.
Today all states require doctors and clinics to report
cases of AIDS. About half the states also require them
to report HIV infection; however, the states where most
people with AIDS live, including New York and
California, do not. Only a handful of states have
outlawed anonymous testing clinics. But everywhere in
the U.S. it is possible to test oneself privately, by
using the FAD-approved HIV test kit from Home Access
Health Corporation, the only approved HIV home test kit
currently available in the U.S. The retail price is
about $40.
The GMHC's main arguments for HIV reporting are to use
the data collected to help provide treatment for people
infected, and to design better prevention programs to
reduce new infections. Another prominent argument -- from
others -- is to end "AIDS exceptionalism" so that HIV is
not treated differently from other reportable diseases
such as syphilis -- even though there seems to be little
evidence that such "traditional public health measures"
ever were effective.
GMHC proposes a number of safeguards, including
involving affected communities in developing a new
surveillance system, assuring strong privacy safeguards,
not linking HIV surveillance to non-surveillance
activities like mandatory partner notification or the
criminal justice system, and preserving free, publicly
funded anonymous testing. It also calls for federal and
state confidentially protection for medical records
[which today are far more accessible and open to abuse
than the surveillance records kept by state government
health agencies, as there is no comprehensive federal
statute giving individuals privacy rights concerning
their medical records]. On January 16 GMHC, several
other AIDS organizations, and the American Civil
Liberties Union held a press conference to urge that
coded identifiers, instead of names, be used in any HIV
reporting system in New York State.
Most of the concerns about HIV names reporting focus
either on loss of confidentiality and resulting
discrimination, or on deterring people from being tested
for HIV. Some of the dangers are:
Protection from discrimination through the Americans
with Disabilities Act (ADA) is not assured for persons
with HIV. While the ADA certainly covers persons with
AIDS, a federal appeals court in Virginia ruled in
August 1996 that it did not cover discrimination due to
asymptomatic HIV infection. That ruling applies to only
a few states, and has been appealed to the Supreme
Court, but as of today it is the highest court ruling on
the matter. Apparently it means that people can be
fired, evicted from their apartment, denied a mortgage,
etc. simply because they have HIV (unless they also have
AIDS-related symptoms and would therefore be protected
by the ADA). This result undermines the common argument
that mandatory reporting should be more acceptable, now
that discrimination protection is in place.
Many people will avoid being tested if they cannot do
so anonymously. Both legal and undocumented immigrants
reasonably fear deportation, unless they are sure that
the HIV surveillance data will not be used for such
purposes -- and how can such assurance be reliable? Anyone
may be concerned that, if the ADA is ruled not to apply
to asymptomatic HIV, there may come a time when they
have to say they are HIV negative to avoid losing a job,
mortgage, or something else for which they are otherwise
qualified; therefore they might think twice about
creating even a confidential official record that could
prove they had lied. The central problem is the
uncertainty -- that without either anonymous testing or
discrimination protection, persons deciding to be tested
must weigh all possible futures if they want to protect
their interests, before making what could be an
irrevocable decision to put their names on the list.
Mandatory names reporting of HIV test status could
make it harder to recruit HIV-negative volunteers for
vaccine trials -- since most vaccines will cause people
to test positive, even though they are not infected.
Supporters of HIV surveillance have not adequately
explained to the community the hoped-for benefits; most
of the AIDS community has little concrete picture of how
HIV reporting could contribute to anyone's health. It is
hard to see how better data will result in more people
getting treatment, since it will not increase the number
who know they are HIV positive (and may even do the
opposite, as some people will be deterred from being
tested). Better data might or might not result in more
access to care, through more or better targeted care
dollars. The new surveillance data may well improve
prevention efforts, but just how has not been well
explained to non-professionals.
The GMHC policy change came as a surprise to many other
AIDS activists in New York -- suggesting lack of broad
community dialog and education. Given the lack of
consensus, it is not surprising that many grassroots
activists believe that the real organizational incentive
for HIV surveillance is money -- to improve the funding
stream by making sure that cases which could justify
additional payment are not missed.
A related concern is that government agencies may want
the data in order to avoid paying multiple organizations
for different services to the same client. Ultimately
this might force consolidation of many small AIDS
organizations into a few large ones, reducing
participation and increasing the remoteness of "AIDS
Inc." from those it serves.
It also does not help that outside of the AIDS
community, much of the case for surveillance has been
fueled by hostility, not pragmatism -- for example,
right-wing calls for an end to "AIDS exceptionalism" as
if the issue is special privileges or favors that should
be taken away on principle, by imposing a far-reaching
policy change for "moral" reasons with no need to show
any actual benefit.
The larger issue is that most AIDS policy so far has
been built on a fundamental premise of involvement and
voluntary cooperation of those infected, instead of on
coercion. This voluntary approach has worked well. HIV
reporting does not necessarily threaten the policy of
cooperation. But it will be a threat if imposed without
the meaningful consultation and discussion which could
bring unintended consequences to light.
ISSN # 1052-4207
Copyright 1998 by John S. James. Permission granted for noncommercial reproduction, provided that our address
and phone number are included if more than short quotations are used.
This article was provided by AIDS Treatment News. It is a part of the publication AIDS Treatment News.
