New York Times
by HENRY I. MILLER Op-Ed Contributor
Published: April 28, 2006
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
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
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
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
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.
Henry I. Miller, a doctorand
a fellow at the Hoover Institution, headed the Food and Drug
Administration's Office of Biotechnology from 1989 to 1993.