CRACKPOT LEGISLATION

MANY states nationwide are considering legislation to legalize the
medical use of marijuana. Last week, one such bill cleared both
houses in Connecticut (but at press time had not yet been signed by
the governor), New York appears likely to follow suit and New Jersey
has two bills with bipartisan support. Indeed, a number of states
have had similar measures in play over the last year, in addition to
the 12 that have already passed such laws.

The picture is very different at the federal level, where marijuana
is branded as an illegal drug. An amendment to a recent drug safety
bill would require all purveyors of state-authorized medical
marijuana to be subject to Food and Drug Administration regulation.
The senator who introduced this amendment said that making any drug
available without F.D.A. review or proof of safety and effectiveness
would set a dangerous precedent that would threaten patient safety.
Marijuana advocates have opposed the bill, because it would close
medical marijuana cooperatives and create barriers to the use of the drug.

Should state laws permit marijuana dispensaries -- which charge high
prices for marijuana products, including tinctures, baked goods and
candies, and offer medical advice -- to flourish without any kind of
federal supervision or other assurance of quality? After all,
marijuana is not a uniform, well-defined material. Different plant
strains vary radically in their cannabinoid composition and in the
contaminants -- fungi, bacteria, pesticides, heavy metals and other
substances -- they contain. Products made without any proof of
quality control may be ineffective or harmful.

If marijuana has therapeutic potential, it should be required to pass
muster with the F.D.A. like any other medicine. We have considerable
experience with making drugs from plant material, including the opium
poppy. We don't authorize patients to smoke (or vaporize) opium for
medical purposes; rather, we require that opiate products, including
morphine for pain relief and paregoric for diarrhea, be standardized,
controlled for quality, fully tested, delivered in an appropriate
manner and shown to be safe and effective. Why should marijuana be
any different?

That question is often ignored by marijuana advocates as they tout
recent research findings. For example, they note that researchers
like Dr. Donald Abrams of the University of California, San
Francisco, have demonstrated that marijuana has a modest ability to
relieve pain, but play down its significant side effects, not to
mention the risks of smoking.

It is difficult to see how inhaled herbal cannabis can ever become a
federally approved medication. Indeed, the California Medical
Association recently questioned the appropriateness of continued
research into crude herbal marijuana plant material. So why does
controversy continue?

Medical marijuana proponents claim that it is only for political
reasons that the F.D.A. and the Drug Enforcement Agency will never
license a marijuana-based product or even permit legitimate research.
But they are being disingenuous at best and deceptive at worst. These
marijuana advocates fail to acknowledge that although smoking is an
imprecise way to deliver any substance to the bloodstream (and from
there to the brain), there is substantial evidence that herbal
marijuana material can be extracted, formulated, standardized and
delivered by means of an appropriate delivery system, and that such
research is at an advanced stage in the United States and elsewhere.
When presented with a cannabinoid development program that comports
with modern scientific principles, both the F.D.A. and the D.E.A.
have demonstrated their willingness to allow it to proceed.

Last year, the F.D.A. approved advanced clinical trials of a
marijuana-derived drug called Sativex, formulated as 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.
The scientific community has shown interest in the future of
cannabinoid products, and this year, two major organizations of pain
specialists held a symposium that presented data on Sativex. Numerous
cancer pain researchers have agreed to join the study, which is
scheduled to begin soon.

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 allow its active ingredients to be medically effective
without causing the kind of "high" that many patients view as an
undesirable side effect. Like other products ranging from the cancer
drug taxol (derived from the bark of the yew tree) to codeine (from
the opium poppy), Sativex offers a model for making a genuine
pharmaceutical out of crude plant material.

Drugs like Sativex should -- but won't -- end the rancorous debate
over medical marijuana in a way that would both benefit patients and
satisfy the legal requirement that marketed medicines must be proven
safe and effective. Even if it did, the issue of whether marijuana
should be legalized as a recreational drug would remain. In fact, one
cannot escape the suspicion that the real agenda of many medical
marijuana enthusiasts is legalization, and that they are using state
legislative initiatives as a way to circumvent rigorous testing and
federal oversight.

Patients who are genuinely in need deserve safe and effective
medicines, and rigorous testing and oversight are the best ways to
provide them.