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| The Straight Dope on 'Medical Marijuana' |
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Posted by CN Staff on August 31, 2006 at 21:44:11 PT By Dr. Henry I. Miller Source: TCS Daily 
Washington, DC -- The medical marijuana controversy rages on. Is it a "medicine?" Does it work? Is it safe? Are claims of medical benefits merely a ploy for legalization?The FDA weighed in several months ago by endorsing a multi-agency study that found "no animal or human data supported the safety or efficacy of marijuana for general medical use." This enraged those who claim that cannabis is an appropriate treatment for ailments from nausea and vomiting to muscle spasticity and intractable pain. They accused the FDA of elevating politics over science -- more specifically, over the conclusions of a 1999 report from the Institute of Medicine (IOM), a branch of the prestigious National Academy of Sciences. It also rubbed Charley Hooper ("The FDA's Marijuana Problem," TCS Daily, 18 August) the wrong way. However, his arguments are typical of the specious arguments in favor of using smoked marijuana -- as opposed to purified, standardized drug preparations -- for medicinal purposes. For example, he asserts that the FDA's statement, "no sound scientific studies supported medical use of marijuana . . . for general medical use," conflicts with the IOM report and other findings. The operative phrase here is for general medical use. No reputable group has made that claim. In fact, the FDA's position both makes sense and is consistent with the requirements of the Federal Food Drug and Cosmetic Act. And in spite of claims to the contrary by cannabis supporters and much of the media, it is also consistent with the 1999 IOM report. The IOM's experts rejected the idea that crude herbal (usually smoked) cannabis had been shown to be a safe and effective medication for various medical conditions, concluded that there is "little future in smoked cannabis as a medically approved medication," and emphasized that smoked plant material is a crude drug delivery system that exposes patients to a significant number of harmful substances. They recommended smoked cannabis only for short term use (less than 6 months), and only for patients who suffer from debilitating conditions like intractable pain or vomiting, who have failed on all other therapies, and who are under the close supervision of a physician and an institutional review board-type process. Finally, they predicted that "if there is any future of marijuana as a medicine, it lies in its isolated components, the cannabinoids and their synthetic derivatives," and called for clinical trials to develop "rapid-onset, reliable and safe delivery systems." The IOM's analysis is far from an endorsement of crude cannabis, in whatever form, as a safe and efficacious medicine that should be made available to patients for a wide variety of medical conditions, as is permitted in eleven states. In the context of the IOM report and federal law, the FDA's position was perhaps inevitable. First, federal law requires that to be marketed, a drug must have been judged safe and effective by experts who have evaluated evidence obtained from well-controlled clinical trials. Second, there is the question of what constitutes "evidence". Contrary to the implications of the news reports, it is not an amorphous collection of anecdotal reports and patient testimonials, but rather hard data arising out of carefully designed preclinical and clinical trials. Although there are some recent data from small safety and efficacy trials using smoked cannabis, as the IOM pointed out such trials are merely a first step towards the development of a suitably defined and tested pharmaceutical. That brings us to a critical third point: What is a "medicine?" In order for a company to sell a drug, and a physician to prescribe it, it must be standardized by composition, formulation, and dose, have been tested for a particular medical condition in rigorous trials, and be administered by means of an appropriate delivery system. From these, as it were, first principles, it is clear that smoked marijuana will have great difficulty in meeting the required scientific and legal standards. There is insufficient evidence that smoked cannabis is a safe and effective medicine (leaving aside the question of whether the federal soldiers in "the war on drugs" have obstructed clinical testing). Different cannabis strains vary radically in cannabinoid composition and contaminants; plant materials may be contaminated with fungi, bacteria, pesticides, heavy metals and other substances; and there is no safe and reliable delivery system for crude cannabis products. Such provides an answer to the question posed by Hooper in his article, "If the synthetic versions are so good, why hasn't the FDA embraced the natural version?" It's not standardizable, so it's not a medicine. Moreover, the synthetic versions are not, in fact, all that good. Both smoked marijuana and the synthetic versions of delta-9-tetrahydrocannabinol (THC) mentioned by Hooper are poorly tolerated by many patients for chronic use. But, as discussed below, there seems to be a better alternative on the horizon. Finally, there is no justification for treating cannabis differently from other pharmaceutical raw materials. Other plant-derived drugs -- morphine, codeine, and taxol, among many others -- became available only after successfully passing through the FDA review process. The FDA recently issued a guidance document setting forth the path that botanically-based products must take in order to gain regulatory approval, and cannabis must meet those requirements. If physicians and patients are ever to have meaningful access to cannabis' therapeutic potential, crude plant material should serve only as a substrate, the first step in the development of a modern medicine. The FDA's position on medical marijuana does not forsake science in favor of politics, nor do regulators appear to be negatively disposed toward cannabis as the source of medicines. In January, they approved an Investigative New Drug submission for a product called Sativex, a cannabis-derived drug that has been approved in Canada for the treatment of neuropathic pain in multiple sclerosis and that, although not yet fully licensed, is available by prescription in both Spain and the United Kingdom. More than 1,500 patients are currently using it for a variety of serious conditions under the supervision of their physicians. After reviewing the data, the FDA agreed to pivotal late-stage (Phase III) clinical trials of Sativex in the United States. The product has been standardized and tested in accordance with modern pharmaceutical standards. It is composed of a fixed ratio of cannabinoids (tetrahydrocannabinol and cannabidiol, a non-psychoactive cannabinoid, in a 1:1 ratio) and is administered by means of an oral spray that delivers the drug through the mucosa of the mouth. These elements appear to enlarge the "therapeutic window," better enabling patients to seek symptomatic relief without experiencing the kind of "high" that many view as an undesirable side effect. Although it may be the presence of cannabidiol in Sativex that improves the risk/benefit profile, that compound is almost entirely absent from most herbal cannabis in the United States, which has been selected and bred to enhance the levels of tetrahydrocannabinol, THC, for recreational use. Another possible explanation for the minimal psychoactive effects is the spray delivery method, which prevents THC blood levels from rising too rapidly. The availability of 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. Meanwhile, FDA 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 FDA., the "war on drugs" components of the government and other interested parties should strive to agree. Henry I. Miller, a physician and fellow at the Hoover Institution, headed the FDA's Office of Biotechnology from 1989 to 1993. Barron's selected his most recent book, "The Frankenfood Myth..." one of the 25 Best Books of 2004. Source: TCS Daily (DC) Related Articles & Web Site: IOM Report The FDA's Marijuana Problem The FDA's Reefer Madness Follow The Drug War Money Home Comment Email Register Recent Comments Help |
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| Comment #13 posted by dongenero on September 01, 2006 at 07:35:42 PT |
| Please delete #11 if you can. Thanks [ Post Comment ] |
| Comment #12 posted by dongenero on September 01, 2006 at 07:29:02 PT |
| With this article you have to understand where this guy is coming from. He's a big proponent of genetically modified food and......well, I guess everything. Oh , and by the way loosen all the restictions on GMOs and certainly don't label anything as such. I also found a petty article where he attacks Al Gore with a pseudo-psychiatric analysis....not that Miller's a psychiatrist but he's more than willing to play one in print, and after all, Al was attacking genetically modified foods. Of course he's opposed to natural cannanbis...he's opposed to pretty much natural everything. The guy's a shill. http://www.hoover.org/bios/miller_h http://www.nationalreview.com/comment/miller200406010833.asp http://www.organicconsumers.org/ge/biotechapologists.cfm [ Post Comment ] |
| Comment #11 posted by dongenero on September 01, 2006 at 07:28:45 PT |
| With this article you have to understand where this guy is coming from. He's a big proponent of genetically modified food and......well, I guess everything. Oh , and by the way loosen all the restictions on GMOs and certainly don't label anything as such. I also found a petty article where he attacks Al Gore with a pseudo-psychiatric analysis....not that Miller's a psychiatrist but he's more than willing to play one in print, and after all, Al was attacking genetically modified foods. Of course he's opposed to natural cannanbis...he's opposed to pretty much natural everything. The guy's a shill. http://www.hoover.org/bios/miller_h http://www.nationalreview.com/comment/miller200406010833.asp http://www.organicconsumers.org/ge/biotechapologists.cfm [ Post Comment ] |
| Comment #10 posted by Storm Crow on September 01, 2006 at 07:28:19 PT |
| I did get one thing out of this stinking pile of BS. The article says that most cannabis is bred for THC, not CBD. In my rambling around several medical sites, I noticed that CBD is an effective medicine according to some studies (diabetes and arthritis are two conditions that respond to CBD). Someone should be breeding a high CBD (low THC?) cannabis for medical use in conditions that respond to it. In fact, remember that Aussie doctor who got busted with thousands of "low quality" plants a few weeks ago? I wonder if that is exactly what he was doing? Breeding a high CBD cannabis to treat his patients. I'd love to tear this article apart, but I have to go to work and others are happily doing it for me! [ Post Comment ] |
| Comment #9 posted by Sinsemilla Jones on September 01, 2006 at 06:23:59 PT |
| What the female pharmacist said when the big Avadart shipment arrived. Why did the man quit taking Avadart? Answer 1 - He saw palmetto. Answer 2 - His wife thought the same rules that apply to the drug, should apply to the penis passing the drug. Well, even though they've got a huge ass advertising budget, I think the makers of Avadart better try to make saw palmetto illegal. Maybe associate it with interracial sex, pacifism, and murder. Or call it crude plant material, that'll do it. [ Post Comment ] |
| Comment #8 posted by mayan on September 01, 2006 at 06:22:44 PT |
| Strict guidelines needed for medical pot:
http://www.times-standard.com/opinion/ci_4272216 Officials doubt marijuana policy will be loosened: http://www.diamondbackonline.com/vnews/display.v/ART/2006/09/01/44f81848dd4fb Wayne, I don't believe any cannabis laws will change at the federal level until the two-party system is history. Dismantling the mainstream media would be a good start, and how better to totally destroy the credibility and power of the mainstream media than with 9/11 truth? Here is a link that I've already posted on a previous thread but I strongly recommend everyone check it out. It is the transcript of an interview of Barrie Zwicker, author of Towers of Deception: The Media Cover-up of 9/11. Zwicker's final response in the interview tells our situation in a nutshell. Either we quickly expose the 9/11 inside job or we lose our freedom. Searching for truth in the rubble: http://www.vcreporter.com/article.php?id=3396&IssueNum=87 [ Post Comment ] |
| Comment #7 posted by Wayne on September 01, 2006 at 05:57:41 PT |
| You know, it really doesn't matter how many times we argue for cannabis on its medical merits. Because the other side is ALWAYS going to have nimrods like this coming out of the woodwork. There are so many policies and procedures that Big Pharma and the FDA use, they'll keep throwing them back in our faces until the end of time. I ask, why aren't there more groups that are devoted to promoting recreational usage? We've got plenty of groups who support medical usage, we've got plenty of groups who support decriminalization and legalization. But I'm talking SPECIFICALLY about the positives of recreational usage. Why don't we ever hear about those types of groups? Why do people in general seem so afraid to take that stance? The majority of cannabis users do so for recreational purposes. It's a well-known fact. Let's stop avoiding it and get it out into the open for real debate. It would serve us well. When it comes to medical usage and decrim/legalization, there are too many studies, laws, and precedents for them to fight us with. But when it comes to recreational usage...there aren't nearly so many negative arguments. And the laws are faulty and baseless, and there aren't as many precedents because it's never really been debated. It would bemore successful for us to have more advocates to start attacking the establishment on THAT front. "Millions of Americans smoke cannabis for fun, they love it, and it is not a real danger to society. Prove us wrong." Then you might start to see some more dominoes fall. [ Post Comment ] |
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Comment #6 posted by kaptinemo on September 01, 2006 at 05:35:27 PT:
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| There it is, the new prohib mantra. The latest bureaucratic boogeyman: 'smoked marijuana'. With that, they have given away the game in the first play. They also do something else: they tacitly admit that cannabis does indeed have medicinal uses...they just don't want the great unwashed, the hoi polloi, to avail themselves of the opportunity to NOT fill their Big Pharma buddies' coffers by growing their own meds. About as transparent as cellophane wrap. Keep it up, guys, keep it up. You're playing right into our hands... [ Post Comment ] |
| Comment #5 posted by mayan on September 01, 2006 at 05:32:27 PT |
| That brings us to a critical third point: What is a "medicine?" In order for a company to sell a drug, and a physician to prescribe it, it must be standardized by composition, formulation, and dose, have been tested for a particular medical condition in rigorous trials, and be administered by means of an appropriate delivery system. In other words, "medicine" can't be grown in someone's back yard because it might cut into the Pharmaceutical industry's profits! Who cares if it helps sick and dying folks who are on a shoe-string budget!?! Garbage! The FDA's position on medical marijuana does not forsake science in favor of politics, nor do regulators appear to be negatively disposed toward cannabis as the source of medicines.BWAHAAHAAAHA!!! What a huge pile of garbage!!! The availability of 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."Safe and effective" like the FDA approved drugs that kill over 100,000 Americans each and every year? The author knows that the feds will NEVER recognize medical cannabis and tries to appear rational and balanced while spewing complete nonsense at the same time. The garbage can is overflowing! The TCS Daily runs articles that tend to obfuscate issues very well. It's no wonder, considering who butters their bread... TCS is supported by a small group of sponsors: ExxonMobil, Freddie Mac, General Motors Corporation, Gilead Sciences, McDonalds, Merck and PhRMA.[ Post Comment ] |
| Comment #4 posted by Sinsemilla Jones on September 01, 2006 at 05:21:02 PT |
| "...there is the question of what constitutes 'evidence'. Contrary to the implications of the news reports, it is not an amorphous collection of anecdotal reports and patient testimonials, but rather hard data arising out of carefully designed preclinical and clinical trials." "...there is no justification for treating cannabis differently from other pharmaceutical raw materials." ...sound like good arguments for why the PLANT cannabis and the HERBAL supplement marijuana should be legal. The "evidence" that made cannabis illegal was an amorphous collection of anecdotal reports, the lies of W.R. Hearst, and the testimony of Harry Anslinger, rather than hard data arising out of carefully designed preclinical and clinical trials. And, certainly, there is no justification for treating cannabis differently from other pharmaceutical raw materials. Those plants are LEGAL to grow. Those plants aren't hunted down and eradicated in the wild. Even the opium poppy is legal till the opium is harvested, and the FDA and DEA both seem unconcerned that folks might try to make their own taxol from Pacific yews. "If physicians and patients are ever to have meaningful access to cannabis' therapeutic potential, crude plant material should serve only as a substrate, the first step in the development of a modern medicine." Yeah, why let people eat crude tomatoes when we have modern ketchup. (Although, I have heard that some of the lower races are eating a dangerous new condiment called catsup!) "...smoked marijuana..." "...appropriate delivery system..." Yeah, don't confuse things with the options of eating or vaporizing. "...standardized by composition, formulation, and dose..." "...Different cannabis strains vary radically in cannabinoid composition and contaminants; plant materials may be contaminated with fungi, bacteria, pesticides, heavy metals and other substances; and there is no safe and reliable delivery system for crude cannabis products." "...It's not standardizable, so it's not a medicine. You know, even though ALL plant strains can vary radically in composition and contaminants, it's amazing how you can find safe canned, bottled, and otherwise packaged plant material of all sorts on supermarket shelves that is so standardised, the same label listing the exact composition and nutritional percentages can be put on thousands of different packages of the same raw plant product. [ Post Comment ] |
| Comment #3 posted by whig on September 01, 2006 at 02:14:21 PT |
| http://marshianchronicles.com/?p=703 [ Post Comment ] |
| Comment #2 posted by whig on September 01, 2006 at 02:12:43 PT |
| Then it is an herb, and it shouldn't even be called a drug. You cannot have it both ways. You cannot call cannabis a drug and simultaneously say it is not a medicine. The only difference between the words is the inflection, people often use drugs in a negative sense, and medicine in a positive. But they both refer to the same thing. One person's medicine is another person's drug. One person's drug is another person's medicine. [ Post Comment ] |
| Comment #1 posted by Had Enough on September 01, 2006 at 02:02:34 PT |
| Village People Cop To Check Into Drug Rehab Aug 31, 2006 9:24 am US/Pacific (AP) San Diego The original policeman in the 1970s disco band The Village People will check himself into the Betty Ford Center after pleading no contest to drug possession charges. Victor Willis was arrested in March in South San Francisco, after police stopped his car and found cocaine and drug paraphernalia. and… The judge will decide whether Willis should serve prison time before entering drug rehab. Willis, who co-wrote the hits "Macho Man," "Y-M-C-A" and "In the Navy," left The Village People in 1980. and the rest of the story… http://cbs5.com/topstories/local_story_243122750.html [ Post Comment ] |
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