cannabisnews.com: Reefer Medicine Reefer Medicine Posted by CN Staff on April 28, 2006 at 09:23:45 PT By Henry I. Miller Source: New York Times Stanford, Calif. -- 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 doctor. 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 serious problems.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 same standards. 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 remain.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.Source: New York Times (NY)Author: Henry I. MillerPublished: April 28, 2006Copyright: 2006 The New York Times CompanyContact: letters nytimes.comWebsite: http://www.nytimes.com/ Related Articles & Web Sites:GW Pharmaceuticalhttp://www.gwpharm.com/IOM Reporthttp://newton.nap.edu/html/marimed/Medical Marijuana: Reefer Madnesshttp://cannabisnews.com/news/thread21784.shtmlMMJ Advocates Slam Politicized FDA Reporthttp://cannabisnews.com/news/thread21774.shtmlFDA Loses Credibility With Jab at Medical Pothttp://cannabisnews.com/news/thread21772.shtml Home Comment Email Register Recent Comments Help Comment #10 posted by kaptinemo on April 29, 2006 at 15:31:38 PT: Almost instant karma So, just a few days after he insults the world-wide assembly of cannabis consumers, Ol' Rush gets nailed again. What is it with these people? Don't they believe that 'what comes around, goes around'? Evidently not, but it makes little difference, as in his case, as far as I am concerned, it's been proven.It would be sweet indeed if a new boycott took place, and this time stuck. It might be a good time to call ClearChannel Communications (Clear Channel 200 Basse Road San Antonio, TX 78209 Phone 1-210-822-2828) and let them know how displeased you are that 'my hero Rush' is showing himself to be no better than the 'druggies' he rails against. Tell 'em you want somebody else to represent 'wholesome middle-class American values' than a pill-popping hypocrite. Tell 'em your pastor said to call. That would really get their knickers in a wad; they're deathly afraid of offending the American Taliban. He had his chance, and with typical arrogance, blew it. Let him roast... [ Post Comment ] Comment #9 posted by mayan on April 28, 2006 at 16:09:02 PT Smoked Marijuana Smoked marijuana,smoked marijuana,smoked marijuana, smoked marijuana,smoked marijuana,smoked marijuana, smoked marijuana,smoked marijuana,smoked marijuana, smoked marijuana,smoked marijuana,smoked marijuana, smoked marijuana,smoked marijuana,smoked marijuana, smoked marijuana,smoked marijuana,smoked marijuana, smoked marijuana,smoked marijuana,smoked marijuana...WHAT ABOUT VAPORIZED CANNABIS??? [ Post Comment ] Comment #8 posted by Max Flowers on April 28, 2006 at 15:40:59 PT Rush He had better shut his damn mouth now and forever about drug use by anyone else. [ Post Comment ] Comment #7 posted by Max Flowers on April 28, 2006 at 15:40:03 PT Rush Limbaugh busted for prescription fraud http://www.wptv.com/News/042806_RushLimbaugh.cfm [ Post Comment ] Comment #6 posted by Taylor121 on April 28, 2006 at 14:52:33 PT Wrong "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."I agree, at the University of Mississippi they do not have a supply that would allow FDA testing. They are blocking efforts to have someone that could grow a consistent supply.Now, what gets me more than anything is he mentions Sativex. Sativex is a whole plant extract meaning what? It means that they found a way to grow cannabis in a manner that you will get the same potency everytime. The same could be done with herbal cannabis, but they won't allow a grower to do so to undergo FDA trials. [ Post Comment ] Comment #5 posted by runderwo on April 28, 2006 at 13:46:03 PT article This article is wrong in a number of its assumptions. First of all, the IOM did not "flatly reject" smoked cannabis, it said that the harms due to smoking are the only drawback. However, they were ASSUMING harms because the research wasn't there yet. In 2005, Tashkin refuted harm due to smoking and even hypothesized a protective effect. And smoking is NOT the only delivery system for whole cannabis, has he ever set foot in a dispensary or is this fellow just another ivory tower expert? He even acknowledges this by saying "usually smoked", but then goes on to base the rest of his argument on this assumption. It is usually smoked not because that gives you an empirically consistent dose, but because the person smoking can very easily assess their level of relief versus their level of intoxication and stop at the appropriate point. You can't make such adjustments with a pill or a metered inhaler."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."Author is sadly mistaken. THC and CBD = high. There is no way around it. Dr. Grinspoon has pointed this out many a time when this argument is made (usually by GW themselves trying to cover their ass) What would the author presume causes the high from smoked marijuana then, if not THC and CBD?"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."That's right. In essence, the FDA cannot effectively regulate herbal medicine is all he is saying. But, as an example, what is wrong with tincture of cannabis as marketed pre-1937? It hardly gets more pure than that."Different strains of cannabis vary radically in their cannabinoid composition and in the contaminants fungi, bacteria, pesticides, heavy metals and other substances they contain."Pesticides? Heavy metals? Home-grown cannabis is not commercial tobacco."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."If this guy thinks there is anything dangerous about marijuana, he's got his head in the sand. Oh, but it might do this and that horrible things! Show me the bodies, or STFU. I don't suppose he ever heard of the FDA grandfathering in pre-FDA medicines that are OBVIOUSLY safe and effective."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."NO COMMENT. About the only thing the FDA did was to get rid of patent medicine marketing. It should NOT be preventing people from making an informed decision on their own about what gives them a best quality of life."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 same standards."Yes there is, because those drugs come from a raw source that is known to be dangerous and of unknown purity. And I believe cannabis by now has met with quite enough irrational obstruction to justify simply saying, screw the FDA, people are hurting and dying, they WANT cannabis because it helps them and there have been NO demonstrated permanent harm from it only the wildest of speculation, and you have no business trying to regulate what plants they choose to grow and consume anyway. [ Post Comment ] Comment #4 posted by runderwo on April 28, 2006 at 13:21:38 PT whig I added the parts about drug testing and medical marijuana to the Barthwell page. The page was "vandalized" a while back, in that someone deleted the contents of the page and replaced it with a PR-style bio. [ Post Comment ] Comment #3 posted by sam adams on April 28, 2006 at 10:16:19 PT what is the issue? This is great example of what has gone terribly wrong with our form of government. The issue is NOT whether or not smoked cannabis is an effective, safe medicine. I see the issue as being whether or not men and women have a right to decide what medicine is safe. We don't. No one in the United States is allowed to decide what to take for medicine, or how much of it to take. One we ceded this right to the government, it was only a matter of time before people started dropping dead from Seldane and Vioxx, and people starting vomiting to death from being deprived of cannabis.To me it's a terrible, terrible mistake and moral wrongdoing to take away a person's right to eat and drink whatever plants and foods and beverages they want. This issue right here, medical marijuana, is the best argument for individual rights that I've ever seen. If you think about it long and hard, I think you'll realize that the biggest problem here is not the lies of the government, or Big Pharm. The problem here is a lack of personal freedom. Men will always lie and be greedy, that is a constant that will hold true to the end of time. So the only way to protect yourself is to protect your civil rights. And we lost ours a long time ago. [ Post Comment ] Comment #2 posted by whig on April 28, 2006 at 09:42:37 PT GWP http://en.wikipedia.org/wiki/Andrea_Barthwell [ Post Comment ] Comment #1 posted by FoM on April 28, 2006 at 09:26:00 PT Interesting It really is interesting to watch how it all works. [ Post Comment ] Post Comment