Pubdate: Sun, 17 Jun 2007
Source: New York Times (NY)
Copyright: 2007 The New York Times Company
Author: Henry I. Miller, Stanford, Calif.
Note: Henry I. Miller, a doctor and fellow at the Hoover Institution, 
headed the Food and Drug Administration's Office of Biotechnology 
from 1989 to 1993. He is the co-author, most recently, of "The 
Frankenfood Myth."
Bookmark: (Opinion)
Bookmark: (Marijuana - Medicinal)


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.
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MAP posted-by: Richard Lake