REEFER MEDICINE

Stanford, Calif.

LAST week, the Food and Drug Administration staked out its position
on the long-standing controversy over the medical use of marijuana --
and made a lot of people smoking mad. The F.D.A. endorsed a
multi-agency study that found that "no animal or human data supported
the safety or efficacy of marijuana for general medical use." This
came as an affront to those who claim that cannabis is an appropriate
treatment for ailments from nausea and vomiting to muscle spasticity
and intractable pain.

Many news reports and commentaries accused the F.D.A. of
contradicting a 1999 report by the Institute of Medicine that
recommended further research on marijuana's medical potential. The
regulators were denounced as elevating politics over science.

But the F.D.A. did no such thing. To be sure, its one-page statement
was far shorter and less detailed than the institute's book-length
report, but its conclusions were essentially the same. The F.D.A.
also recently gave the go-ahead for clinical trials of a new drug
derived from marijuana -- further demonstrating that its position is
both sensible and proper.

In their 1999 report, the Institute of Medicine's panel of experts
flatly rejected the idea that herbal (usually smoked) cannabis would
ever be considered a safe and effective medicine for widespread use.
They noted that marijuana appears to be modestly effective in
treating the nausea and vomiting induced by chemotherapy and the
wasting caused by AIDS -- though not as effective as some approved
medicines are. But they also said that because smoked marijuana can
increase the risk of lung damage, cancer and complications during
pregnancy, it is appropriate only for short-term use (less than six
months) by acutely suffering patients who have failed to find relief
with other therapies and who are under the close supervision of a doctor.

It is not the F.D.A. but the 11 states that have passed laws allowing
the use of smoked marijuana for various medical problems that are at
odds with the Institute of Medicine's position.

More promising than smoked marijuana, the institute said, is the
potential of drugs made with cannabinoids -- the bioactive substances
found in marijuana. It called for clinical trials of such medicines
and the development of safe ways to deliver them.

In January, the F.D.A. approved advanced clinical trials of a
marijuana-derived drug called Sativex, which comes in the form of a
mouth spray. Sativex has been approved in Canada for the treatment of
neuropathic pain associated with multiple sclerosis, and it is
available by prescription (though not yet fully licensed) in Spain
and Britain. According to GW Pharmaceuticals, the British company
that makes the drug, more than 1,500 patients in those three
countries are using Sativex to alleviate pain, muscle spasticity and
other serious problems.

Federal law requires that before any drug is marketed, it must first
be judged safe and effective by qualified experts. And that judgment
requires the review of scientific evidence -- not anecdotal reports
and patient testimonials but hard data from carefully designed animal
testing and clinical trials. While far from perfect in practice, this
approach goes a long way toward ensuring that patients are protected
from exposure to unsafe or ineffective products. Even for terminally
ill patients, this commitment to safety and effectiveness is
important, because the suffering of a dying patient can be aggravated
by an imprudent medical intervention.

Smoked marijuana cannot be subjected to careful, well-controlled
trials, because it does not come in a standard, reproducible formula
or dose, and cannot meet the accepted standards for drug purity,
potency and quality. Different strains of cannabis vary radically in
their cannabinoid composition and in the contaminants -- fungi,
bacteria, pesticides, heavy metals and other substances -- they
contain. And smoking is not a precise way of delivering any substance
to the bloodstream.

Other plant-derived drugs -- morphine, codeine and Taxol, to name a
few -- have made it through the F.D.A.'s review process, and there is
no reason drugs made from cannabis should not be required to meet the
same standards.

Sativex contains an equal ratio of two cannabinoids:
tetrahydrocannabinol, which is psychoactive, and cannabidiol, which
is not. Its spray dispenser delivers a precise dose of the drug,
which is absorbed through the mucous membranes of the mouth. The
composition of the drug and the manner in which it is delivered
together ensure that its active ingredients can be medically
effective without causing the kind of "high" that many patients view
as an undesirable side effect.

THE availability of drugs like Sativex should (but won't) end the
rancorous debate over medical marijuana. Even if it did, the issue of
whether marijuana should be legalized as a recreational drug would remain.

Meanwhile, F.D.A. officials must ensure that the testing and
potential approval of cannabinoid-containing drugs are not hindered
by political agendas or other nonscientific considerations, inside or
outside the agency. For the benefit of patients in need, this is
something about which the F.D.A., the parts of our government waging
the "war on drugs" and other interested parties should be able to agree.