MEDICAL MARIJUANA, MYTH OR MIRACLE?

Medical marijuana's history began thousands of years ago in China and
India. In India, marijuana has had a solid position in Ayruvedic medicine
and is still prescribed today.

The world's first encyclopedia of medicines, compiled in 1 A.D. by Chinese
authors, suggests marijuana for over 100 conditions such as malaria and
absentmindedness. Even in the United States, pharmaceutical companies
produced marijuana-based drugs until 1937, when high taxes and extensive
paperwork discouraged doctors from treating patients with marijuana.

Today's medical marijuana advocates are seeking the right to use marijuana
for a relatively short list of ailments. California's Compassionate Use
Act, approved by voters in 1996, supports the possession and cultivation of
marijuana for the "treatment of cancer, anorexia, AIDS, chronic pain,
spasticity, glaucoma, arthritis, migraine, or any other illness for which
marijuana provides relief."

The majority of Americans approve of legal medical marijuana use. In the
past six years, citizens of Alaska, California, Colorado, the District of
Columbia, Maine, Nevada, Oregon and Washington have voted in favor of this
position. Supportive articles have appeared in the New England Journal of
Medicine and even in Consumer Reports. Meanwhile, President Bush's drug
czar, John P. Walters, targets medical marijuana in his war against
recreational drugs.

His Washington Post editorial warns Americans about the "cynical campaign"
for medical marijuana that is based on "psuedo-science." He aims for the
weak point in the argument for medical marijuana: lack of documented
scientific evidence.

Yet, the US government has prevented nearly all medical marijuana research
for two decades.

The handful who have chosen to challenge this system have faced barriers to
even the most basic studies.

Scientists lack adequate funding to study medical marijuana.

Also, many regulations limit marijuana research. Researchers must seek
permission from a long chain of agencies: the Department of Health and
Human Services, the Drug Enforcement Agency and the Food and Drug
Administration. The federal Controlled Substances Act of 1970 classifies
marijuana as a Schedule I drug with a "high potential for abuse" and "no
currently accepted medical use" in the US. The law imposes stringent rules
on the registration, security, labeling and distribution of marijuana.

Researchers also must navigate a maze of varying state laws that apply to
marijuana regulation.

Yes, No, Maybe

Dr. Donald Abrams, a professor at the University of California at San
Francisco, is the best-known example of a scientist whose research has been
restricted by the government. Abrams' ordeal began in 1992. Partially
funded by the Multidisciplinary Association for Psychedelic Studies (MAPS),
his project would study the use of smoked marijuana to treat AIDS Wasting
Syndrome. Some people with HIV believe that smoking marijuana has helped
them decrease the amount of extreme weight loss associated with the
disease, but there had never been a controlled study to measure how this
treatment actually affects body composition, appetite or weight gain.

After the FDA approved his study design, Abrams requested marijuana from
the only legal supplier of marijuana in the United States, the National
Institute on Drug Abuse (NIDA). Nine months later, the NIDA rejected his
application, saying that the study's "design, scientific merit and
rationale" were inherently faulty.

According to the NIDA, Abrams did not have a way of ensuring that the
patients had consistent dosages of marijuana. Therefore, the study could
not examine whether how much marijuana the patient took affected the amount
of weight gain. Also, the study did not record daily calorie intake or the
types of foods eaten.

NIDA did not suggest that any revisions in Abrams' design would change
their stance.

Abrams fired back with his response. "You and your Institute failed,"
Abrams wrote in a letter posted on the MAPS website. "In the words of the
AIDS activist community: SHAME!" He scolded NIDA for waiting so long to
reply and not allowing any discussion on the study design.

He listed a variety of advisors who had assisted him with the study design
to disprove the claim that the study did not have scientific merit.

More importantly, he offered specific changes in the design that would
satisfy NIDA's demands. He explains that their concerns are somewhat
irrelevant because the study was meant to assess marijuana's impact on
heart health, immune system and severity of HIV. If the pilot study did not
cause any intolerable side effects, further research would address AIDS
Wasting Syndrome.

The exchange of proposals and letters continued.

Finally, just as the government was reevaluating its position on medical
marijuana research, Abrams' third proposal was approved.

NIDA gave Abrams a $978,000 grant in September 1997. Abrams conducted the
first legal medical marijuana research on humans in fifteen years.

In his preliminary study, he found that patients who smoked marijuana for
21 days did not have any increase in HIV severity. Today, Dr. Abrams
continues his research at the Center for Medicinal Cannabis Research in
California.

Hometown Help?

Massachusetts' own quest to conduct medical marijuana research began in
1991. The State Legislature and Governor William Weld established a statute
that allowed the Department of Public Health to head a "therapeutic
research program," which would study how well marijuana could treat
glaucoma, asthma and cancer treatment side effects.

The federal government denied Massachusetts' request to begin the study.

In 1996, the governor intensified state efforts to gain federal approval.

He added two amendments to the law that put the commissioner of public
health in charge of the program and gave legal protections to certified
patients.

The federal government still stalled research, implying that it would only
approve a legal marijuana supply for a well-designed study but not defining
any specific requirements.

The following year, the Department of Public Health sent a letter to Donna
Shalala, Clinton's Secretary of Health and Human Services, asking for
detailed information on how to begin an approved study and receive federal
marijuana. The letter clearly states the Department of Public Health's
intent to research whether "marijuana improves the quality of life" for
patients. "Considering the urgency of our desire to establish a
compassionate, humane program," wrote David H. Mulligan, Massachusetts
Commissioner of Public Health, "we seek your earliest possible response."
The Massachusetts Department of Public Health tried to increase awareness
by sending copies of the letter to Attorney General Janet Reno, Senator
Edward M. Kennedy, Senator John F. Kerry, the Massachusetts Congressional
Delegation and Barry McCaffrey, Clinton's Director of National Drug Control
Policy.

Despite the initial impetus of Massachusetts' demands, the therapeutic
research program has mysteriously disappeared. The Department of Public
Health issued a memorandum summarizing the proposed program in April 1997.
By August 1997, according to the Boston Globe, the federal government still
had not responded to the proposal.

No written record exists after that point. The Department of Public Health
declined to comment on exactly how research was blocked or why
Massachusetts no longer seems to be pursuing the issue.

The Government Moves So Slow - Perhaps They're Stoned?

Although Abrams and the Massachusetts Department of Public Health faced
obstacles, the federal government appears to be gradually relaxing its
prohibitive stance on medical marijuana research.

Two major developments influenced this mood change.

First, the state referenda passed in California and Arizona gave legitimacy
to the medical claims made about marijuana. Second, scientists began to
understand that the human body produces its own supply of cannabinoids, the
class of chemical compounds such as THC that exist in marijuana.

These chemicals act as keys that either open or block protein "locks" on
the surfaces of our bodies' cells. These proteins send signals within the
cell or to neighboring cells.

The body's natural cannabinoids are believed to affect memory, pain and
movement. When a person smokes marijuana, the plant's cannabinoids enter
the body and act in a similar way. So far, scientists have identified 66
cannabinoids in the marijuana plant.

In 1997, at around the same time that Abrams first successfully obtained
government approval for his work, the NIH held a meeting to discuss
possibilities for future medical marijuana research.

The NIH nominated the panel of eight experts, each chosen because of their
lack of strong opinions on the issue.

It was, however, the first well-publicized crack in the government's solid
refusal to acknowledge the potential merits of medical marijuana.

The panel recommended that future clinical trials, studies involving human
beings, were justifiable.

At the request of the Office of National Drug Control Policy, an Institute
of Medicine (IOM) study team completed a two-year report on issues related
to medical marijuana in 1999. The IOM team investigated marijuana's safety,
potential for addiction, effectiveness and future marketability. The report
emphasizes the benefits of biotechnology, praising the pharmaceutical
industry's ability to isolate chemical compounds in a plant and to create
medicines rather than discover them. It states that the marijuana plant
would not have "known composition or quality." While very positive about
marijuana's potential to help patients, it favors the mainstream route of
drug development that is expensive and difficult.

The IOM team believes that the future of medical marijuana lies in the
creation of synthetic cannabinoids that can be profitable enough to entice
drug companies to pursue further research.

Currently, the Center for Medicinal Cannabis Research (CMCR) at the
University of California offers the most hope for scientists who wish to
research medical marijuana in a non-hostile, stable environment. The State
Legislature of California and Governor Gray Davis established the CMCR in
order to "enhance understanding of the efficacy and adverse effects of
marijuana as a pharmacological agent" during a three-year period.

The 1997 NIH report and the 1999 IOM report will both guide the direction
of research topics.

The CMCR will also help investigators secure funding sources and comply
with state and federal regulations. Seven studies are now in progress at
the center.

Medical marijuana researchers ask several questions.

Scientists want to document exactly how much marijuana helps ease the
symptoms of different diseases. They also wish to compare whole-plant
marijuana with Marinol, the THC pill. Patients report many difficulties
with the synthetic pill. Marinol takes a long time to affect the body, and
patients find the pill difficult to swallow when nauseated.

Many doctors, however, express concerns that burning marijuana creates
chemicals that may cause cancer or weaken the immune system.

Therefore, researchers are looking for ways to ingest marijuana that do not
involve smoking or taking pills, such as inhalers or skin patches, but
still contain the complex web of chemicals present in marijuana.

In the meantime, researchers hope to establish consistent ways of smoking
marijuana so that patients can ingest a standard amount of the drug. They
are also seeking methods of using medical marijuana that provide relief
without producing a high. Some patients, especially the elderly, do not
want to deal with psychoactive effects on a daily basis.

If medical marijuana follows the conventional path towards drug
development, patients could be in for a long wait. The typical process
takes five to ten years.

For medical marijuana advocates, being able to begin experiments involving
human patients is a major accomplishment, but only one in five drugs given
permission to carry out human trials will ever secure final FDA approval.

For now, patients and their doctors have to weigh the risk of arrest versus
the ability to treat health problems.

Marinol's history shows the limitations of the established path. Since
appearing on the US market in 1985, Marinol has been the only legal
cannabinoid medicine.

Unimed, a pharmaceutical company, developed the THC pill with the financial
support of the NIH. The US government partially funded the research
necessary for FDA approval.

Despite its adverse effects and inconvenient pill form, Marinol still has
$20 million in annual sales. Individual patients pay approximately $200 a
month to combat AIDS Wasting Syndrome, the most common condition treated
with the drug. Many patients cannot afford the financial burden and are
forced to look elsewhere for relief. Marinol's manufacturers are not concerned.

According to the IOM report, "Unimed perceives only a small percentage of
its market to be lost to 'competition' from marijuana itself."

When the government and pharmaceutical companies join together for both
research and profit, our health care suffers.

If this partnership continues, medical decisions will increasingly be based
on profit instead of patient need. The 1997 IOM report bluntly illustrates
this connection. "The outcomes of preclinical and clinical research
determine whether a drug is sufficiently safe and effective to warrant FDA
approval for marketing," explains the government-funded report. "But the
decisions to launch preclinical research and to proceed to clinical trials
if early results are promising are dictated largely by economic factors ...
For any given drug, the question is, will there be an adequate return on
investment?"

If money is the primary factor, medical researchers may be forced to
abandon creative solutions to human suffering.

The pursuit of profit creates an environment of unasked scientific questions.

Patients seeking their own answers find closed paths.

The question is, do Americans have access to the medicines that they need?