cannabisnews.com: Crackpot Legislation





Crackpot Legislation
Posted by CN Staff on June 17, 2007 at 06:00:45 PT
By Henry I. Miller
Source: New York Times
Stanford, Calif. -- 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.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.” Source: New York Times (NY)Author: Henry I. MillerPublished: June 17, 2007Copyright: 2007 The New York Times CompanyContact: letters nytimes.comWebsite: http://www.nytimes.com/Related Articles & Web Site:GW Pharmaceuticalhttp://www.gwpharm.com/Prescription for Pain http://cannabisnews.com/news/thread23084.shtmlState Finds Its Compassionhttp://cannabisnews.com/news/thread23080.shtmlMedical Marijuana Bill: Legalize Ithttp://cannabisnews.com/news/thread23078.shtml
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Comment #7 posted by afterburner on June 19, 2007 at 16:43:47 PT
Celaya #5
Excellent!"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?"Cannabis is different because no one has died from it. Opium is a strong sedative which could cause cardiac arrest, especially in combination with alcohol or other sedatives. This overdose potential increases with the "refinement" of "active ingredients," like morphine, codeine, heroin and OxyContin. The illegality of many of these opiates has led to many street deaths of users relying on black market supplies of unknown purity and unknown strength. When the U.S. government and other governments signed the first international treaty outlawing opiates, they created a new class of criminal from the patients that had become addicted to legal opiates.Cannabis is nonaddictive. Opiates and opium are well-known to be extremely addictive.The author would love to subject herbs or as he calls them "plant material" or "crude herbal marijuana plant material" (Note the U.S. government-approved use of the disparaging term 'crude'!) to the machinations of the corrupt FDA with its in-hock pharmaceutical industry researchers and failed approval process that let truly dangerous drugs like Vioxx onto the market.The author's argument about banning smoked or vaporized cannabis because smoked or vaporized opium is banned makes as much sense as banning all cars and trucks because tanks can destroy villages!
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Comment #6 posted by FoM on June 19, 2007 at 06:30:08 PT
Celaya
Good job.
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Comment #5 posted by Celaya on June 19, 2007 at 03:27:51 PT
Please see...
my lengthy refutation here: http://groups.yahoo.com/group/drugpolicyforum/message/452Thanks.
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Comment #4 posted by FoM on June 18, 2007 at 08:56:55 PT
WNYC: New York Eyes Medical Marijuana Laws
By Fred MogulNEW YORK, NY -- June 18, 2007 -- Among the items to be resolved in the waning days of New York's current legislative session is whether to legalize marijuana for medical use. One bill has passed the Assembly, and there is support for some kind of new law from Governor Spitzer and senate leaders. But as WNYC’s Fred Mogul reports, some local doctors caution that medical marijuana can be a mixed bag.REPORTER: Certain types of doctors field a lot of questions about pot – for example, oncologists, from their patients with advanced cancer or pain management specialists who work with sufferers of multiple sclerosis. Dr. Russell Portenoy of Beth Israel Medical Center says he doesn’t discourage people who are using or want to try smoking marijuana, but he doesn’t recommend it, either. He believes it’s potentially effective, but says it’s very difficult to control dose and strength or to know how it interacts with other medications.PORTENOY: I would opt to try many things first because of the uncertainties I have about the safety and effectiveness of medical marijuana.REPORTER: Portenoy consults for a British company seeking FDA approval for a pharmaceutical extract of marijuana. Although he counsels caution, he and others say that if a patient is in severe pain and clearly close to death, they would be more willing to let patients experiment. For WNYC, I’m Fred Mogul.Copyright: 2007 WNYC Radiohttp://www.wnyc.org/news/articles/80766
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Comment #3 posted by Yanxor on June 18, 2007 at 08:02:52 PT
Crackpot article
"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."The only "significant side effect" that he gave was the "high," and the risk of smoking is null and void if it is vaporized, which it often times is in medicinal applications. 
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Comment #2 posted by dongenero on June 17, 2007 at 10:37:42 PT
crackpot article is weak and pandering
"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."Kind of like corn on the cob? Sounds like the vegetables I buy at the grocery store each week.If marijuana has therapeutic potential, it should be required to pass muster with the F.D.A. like any other medicine. How about vitamins and supplements?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. Well, I think the argument here is for pharmaceuticals that can be patented and financially controlled by huge corporations and corporatized government. So, point taken Mr. Miller.And, safe and effective under such control? How's that working these days? Seems to be a lot of news recently about harmful and fatal side effects of all these safe and effective pharmaceuticals.Regarding Sativex the article states:
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. I believe this is just false. Sativex contains THC and CBD and does indeed produce the desirable and therapeutic side effect or "high".
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Comment #1 posted by John Tyler on June 17, 2007 at 07:00:54 PT
medicinal revival
I will assume that the good doctor of this article means well, but he shows a high degree of willful ignorance. In the late 1800’s and early 1900’s (up to 1937) there were a lot of cannabis-based products in all kinds of little bottles on pharmacy shelves all over the country, prescribed by doctors for a many aliments. Cannabis medical products are not a new idea. Despite the excuses of the antis it is time for their revival. In a great social experiment, a huge number people have been, at their own expense mind you, self-testing cannabis products for the past forty plus years with no significant ill effects. The safety and effectiveness has been proven. It is time to make these products legally available. Stop the excuses. 
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