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| The FDA's Marijuana Problem |
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Posted by CN Staff on August 17, 2006 at 21:40:19 PT By Charles L. Hooper Source: TCS Daily 
Washington, DC -- The U.S. Food and Drug Administration has a marijuana problem. On April 20 of this year, the FDA rejected marijuana for medical uses. The FDA said, "no sound scientific studies supported medical use of marijuana for treatment in the United States, and no animal or human data supported the safety or efficacy of marijuana for general medical use." This conclusion contradicts a lot of other scientific research and expert conclusions, including that of the National Academy of Sciences and the FDA itself. In 1985, the FDA was so convinced of marijuana's medical benefits that it approved Marinol and Cesamet, both synthetic versions of delta-9-tetrahydrocannabinol (THC), the main active ingredient in marijuana. Here's what the FDA has to say about Marinol. "MARINOL® (Dronabinol) Capsules is indicated for the treatment of: (1) anorexia associated with weight loss in patients with AIDS; and (2) nausea and vomiting associated with cancer chemotherapy in patents who have failed to respond adequately to conventional antiemetic treatments." The FDA obviously thinks that Marinol and Cesamet are safe and efficacious drugs or else it wouldn't have approved them. If the synthetic versions are so good, why hasn't the FDA embraced the natural version? After all, in the Marinol statements above, the FDA is basically agreeing with marijuana advocates. Two reasons that might come to mind are dosing and delivery mechanism. Although it may seem that an inability to pin down the ideal dose is a problem, the FDA is fully aware that the gold standard of analgesia in hospitals is patient-controlled analgesia (PCA), in which the patient pushes a button as often as desired to get I.V. doses of morphine. In other words, there is no one-size-fits-all dose with PCA. Empirical evidence shows that PCA produces better pain control with less morphine consumed. Marijuana can be used in much the same way as PCA. The delivery mechanism of marijuana is usually smoke, which can irritate soft tissues and perhaps precipitate cancer. While certainly a problem, I estimate that marijuana smokers consume about one-percent as much per day as do tobacco smokers. Marijuana smokers take a few puffs ("hits") while tobacco smokers may smoke 20 or 40 entire cigarettes per day. Also, many AIDS and chemotherapy patients will be on short-term therapy or won't live long enough to worry about marijuana-induced lung cancer. Many of them would love to live long enough to have such a problem. Look at the FDA's statements critically. The FDA isn't saying that marijuana doesn't have health benefits; it's saying that no good studies exist to prove that conclusion. In 2004, the FDA stated, "FDA will continue to be receptive to sound, scientifically based research into the medicinal uses of botanical marijuana and other cannabinoids." The key term is "sound research." The FDA recognizes only medicines that have gone through its long, expensive, and exhaustive investigational new drug (IND) application process -- its idea of "sound research." The FDA is blind to anything that hasn't been through its process. What's worse, marijuana is highly unlikely ever to clear such hurdles. Why? The FDA requires controlled and consistent production batches and it wants to inspect each manufacturing facility. This would be very difficult for a dried weed that is grown in thousands of different places under thousands of different conditions. The FDA also requires placebo-controlled clinical trials with thousands or tens of thousands of patients. What placebo could possibly be used? I doubt that any other safe and medically inactive plant would smell and taste like smoked marijuana. Last, these clinical trials, I estimate, would cost tens if not hundreds of millions of dollars. Who would pay for them? Not the FDA. Not drug companies. Not self-medicating AIDS and cancer patients. Drugs like marijuana almost certainly do have some health benefits for certain patients. But to put marijuana through the IND process would involve paying for clinical trials, manufacturing facilities, data analysis, legal fees, administrative staff, and FDA face-time, which are all private costs that someone must bear. Marinol's and Cesamet's manufacturers were willing to bear these costs due to the prospect of profits that accrue to the patent holder. For a widespread weed that's been around for millennia, how would anyone garner and enforce such patent protection? Some say this is a weakness of the private enterprise system. The proponents of government spending on medical research use cases like this as an argument for the role of government. They shouldn't be too optimistic about their solution because that's what we have right now and it has failed miserably. Why? Certain parts of the federal government haven't allowed this scientific process to happen. Remember that, above all else, the government is a political organization and the U.S. government is fighting a war against the production, sale, and usage of marijuana. The federal government maintains marijuana's status as a Schedule I controlled substance, keeping company with infamous drugs like heroin and PCP. A Schedule I drug is defined as having a very high potential for abuse, no accepted medical use in the United States, and a lack of accepted safety data for use under medical supervision. Interestingly, Marinol is rated as only Schedule III (less dangerous), just like, for example, Tylenol with Codeine. Just recently, the FDA has landed in more hot water over its marijuana ruling. In 2000, Congress passed what is known as the Data Quality Act to help ensure that regulations are based on solid science. The two-paragraph Data Quality Act wasn't written by a member of Congress, but by James J. Tozzi, and included in a longer appropriations bill. Now Tozzi, who is founder of the Center for Regulatory Effectiveness, is suing the government because the FDA's marijuana ruling has ignored data showing that marijuana is helpful to some patients. Should we pity the FDA? In some ways, yes, we should. The FDA behaves as a bureaucratic scientist. The FDA will always to be too slow and conservative and require too much data. I am happy that there are such careful and plodding people in the world. I am not happy that they have the power to prohibit drugs like marijuana. In some cases, like this one, the FDA is the wrong tool for the job. Americans shouldn't rely on the FDA to control widely used and naturally occurring botanicals such as marijuana. The FDA is simply unable to effectively assess the medical value of natural plants like marijuana in any reasonable timeframe. AIDS and cancer are deadly serious diseases and the FDA's approach is fatally flawed. AIDS and cancer patients deserve a better path to useful medicines and than through the FDA's benediction. Charles L. Hooper is president of Objective Insights, a company that consults for pharmaceutical and biotech companies. He is a visiting fellow with the Hoover Institution and coauthor of Making Great Decisions in Business and Life (Chicago Park Press, 2006). Related Articles & Web Site: IOM Report FDA Issues Report for Political Purposes The FDA's Reefer Madness Follow The Drug War Money Home Comment Email Register Recent Comments Help |
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| Comment #19 posted by FoM on August 18, 2006 at 17:03:15 PT |
| That is very nice to read. I guess I'm a liberal but I also am conservative. That is really hard to define for me. Let's see if I can do it. I am conservative in that I don't believe in big government and what government I could get behind would be medical care for everyone. Helping people get into a starter home is a real benefit. I feel the the two contractors who are working here everyday are more like family now. I wake up in the morning and they are already here working. One is from the south, loves country music is in his mid 50s and has a son in the Marine Corp. The other one is your age and his father is a building contractor and he has been taught well by his father. He is big into eco-housing. He and his wife just had a little girl. His wife picked her first name and he picked the middle name. The middle name is Rain and that was picked because that was what his Father did. I asked him was or is his father a hippie. He smiled and say yes he was. His father named the middle names of the children and he gave them names like Sky and Autumn. We all get along very well and share common concerns. Ending the war and fixing our social structure so the future has some hope. Freedom is very important to them too. Everyday good working people feel much the same desires and worries. I want to be in the middle of that way of thinking somehow. [ Post Comment ] |
| Comment #18 posted by mayan on August 18, 2006 at 16:43:39 PT |
| The more people that know about the inside job the less chance there is of the governmente staging another one. I doubt if they want a full-scale revolution on their hands. The neo-cons are now in major damge control mode and trying to keep the cat in the bag. They must keep folks in the dark until the next attack, which would probably occur before the mid-terms. If there is another,bigger,deadlier attack then 9/11 becomes overswhadowed and irrelevant. They could temporarily take down the internet and round up all who questioned 9/11 and put them in the halliburton detention camps which are now empty but fully operational. Any hope for a better future would be forever lost. THAT IS WHY IT IS IMPERATIVE THAT WE EXPOSE THE INSIDE JOB NOW!!! [ Post Comment ] |
| Comment #17 posted by whig on August 18, 2006 at 16:27:50 PT |
| I decided I'm a liberal. http://cannablog.wordpress.com/2006/08/18/on-changing-sides/ [ Post Comment ] |
| Comment #16 posted by FoM on August 18, 2006 at 14:52:09 PT |
| I believe that people need to turn over every stone. If we at all hope for accurate history to be recorded it has to happen. I want the laws on cannabis reformed. That is primary to me. Coming in a close second is getting Democrats in power so they can maybe be able to impeach Bush. I also feel that no change will come until Democrats regain power. So my issues are looking way into the future. I have been seriously kicking around becoming a Democrat. That would be the first time in my life I will have ever decided such a thing. Neil last night was good. I feel very much like he does. They said on Hardball a little bit ago that we are losing a battalion a month with death and injuries. I love children. I see our young men and women as children that are serving our country. I have seen amputees at the VA hospital in northern Ohio. I have seen dieing Veterans from Vietnam there to from cancer. I want to cry when I see twisted bodies because of war and these young people are fighting a major civil war where the soldiers have no idea who the enemy is. I hate it and I really don't hate much. [ Post Comment ] |
| Comment #15 posted by Toker00 on August 18, 2006 at 14:26:06 PT |
| It's just that when a "conspiracy theory" sounds more logical, reasonable and believable, given the legally documented articles that seem to support it, than the official government issued, hap-hazard account, somebody needs to be digging to find out why. I thank God for those who do this. They have saved many lives in the past, will save many in the future, and have brought closure, vindication, and even reparations to those done wrong at the hands of those who practice to deceive, and they do it at great personal risk. Without these Truth Hawks, many more would, and could be wronged. It is your right to project ahead and look for better paths than the one behind you. But you will need those Hawks no matter which path you take. And they do this without being asked. Is there a better example of sincerity? They are like you, in a way. By operating this site, you are providing a truly revolutionary tool. A place where Truth can be examined, recognized, shared, and passed about. From here, it goes global. But you are merely looking for the Truth of the matter. And Truth is so very inspirational. Toke. [ Post Comment ] |
| Comment #14 posted by FoM on August 18, 2006 at 13:18:28 PT |
| I did my math again and it isn't six years but five years. There I feel better. It seems more like an eternity though. [ Post Comment ] |
| Comment #13 posted by FoM on August 18, 2006 at 11:24:51 PT |
| Excerpt: Americans shouldn't rely on the FDA to control widely used and naturally occurring botanicals such as marijuana. Hi Rainbow! [ Post Comment ] |
| Comment #12 posted by Rainbow on August 18, 2006 at 11:03:55 PT |
| What placebo could possibly be used? I doubt that any other safe and medically inactive plant would smell and taste like smoked marijuana. Not true, I was in a U of Wash experiment with smoked herb. They processed the non-psychoactive joints (placebos) in an alcohol solution I believe. The placebos and the real stuff smelled, tasted and looked the same. As well we all "smoked" in the same room so we could not tell whose smoke we were smelling. So I believe this gentleman does not know that it can be done. [ Post Comment ] |
| Comment #11 posted by FoM on August 18, 2006 at 10:39:51 PT |
| I went and tried to read the Popular Mechanics article but I stopped. I look at it this way. I believe no matter what we think or do we could very well have a worse attack on the USA. I don't believe it would be stoppable if they decided to do it again. I look at the issue of 9/11 as a discovery that someone has cancer. At first they would wonder how they got cancer and hash it out over and over again and then they would try to figure out how to live with cancer and get it to go into remission. 6 years later wondering how someone got cancer won't save their life but trying to find a cure for the cancer might just save their life. I look at it all this way. I don't look back but right here and now and how can we stop the war. [ Post Comment ] |
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Comment #10 posted by bdimebag on August 18, 2006 at 10:33:31 PT:
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| i read an article in the Baltimore Sun recently that exposed the bias and extent of just how political the FDA. Senator Mikulski says the FDA is not what it used to be and is now a government tool and, according to employees at the FDA, can and does "leave out"or even falsify conclusions from studies. Mikulski stated she is furious with the FDA as it is today and that many scientists who work for the FDA were told by superiors to ignore or throw away certain findings. Certain medications that are without a doubt unsafe have been approved by the FDA and some conclusions by the FDA are supposedly flat out government lies. It is in my opinion that the modern day, political FDA has skewed its studies on marijuana and possibly made up or exaggerated its effects and health hazards as well as left out findings pointing to its health benefits. I wish someone could expose this more and bring these bastards who are politically swaying the FDA down. What is this country coming to? we can't even trust our food and drug admin? the FDA has approved medications 10 times more dangerous than marijauna. how can our government ever be taken seriously, trusted, even perhaps on issues they may be correct on, if their so corrupt and tell so many lies? if we cant trust our own governemt, then who do we trust? how is it that the people supposed to protect and serve have become our enemy? we need someone to protect us and serve us from our own government.
on another note: i need some advice: i was arrested for possesion a few months ago and in ocean city md which is a very conservative place, and do you know what i must do? supervised probation for a year and random drug tests. for a year because i had like .5 on me. i have no idea what the hell i'm going to do. I'm 18 and starting my freshman year in college and these a##swipes think they are so much better than me and know more than me that they can say, hey, if i find out that you are putting a specific plant in YOUR body i'm going to lock you up. but anyway should i go with terminator or zydot or somthing? it does work but i was wonderin if anybody heard of an instance when it didnt thanks guys i love this website o and tomorrow i'm smokinng an ounce with just one other person becuase he's leaving for college. awesome [ Post Comment ] |
| Comment #9 posted by Toker00 on August 18, 2006 at 08:59:08 PT |
| "However, Popular Mechanics magazine and HEARST Communications have provided a handy antidote to the conspiracy theorists' more noxious rhetorical poisons." More yellow journalism. Toke. [ Post Comment ] |
| Comment #8 posted by mayan on August 18, 2006 at 06:03:33 PT |
| I just checked out your new blog and it's pretty hip! If I can find any spare time I'll stop by and comment. [ Post Comment ] |
| Comment #7 posted by mayan on August 18, 2006 at 05:23:39 PT |
| I overlooked that connection! Gilead,Rumsfeld,bird flu,tami-flu,etc. - Of course! Here is a very alarming piece from last year. I just don't trust these crooks... Bird Flu: A Corporate Bonanza for the Biotech Industry Tamiflu, Vistide and the Pentagon Agenda: http://www.globalresearch.ca/index.php?context=viewArticle&code=ENG20051106&articleId=1190 Now I am VERY skeptical of anything on TCS Daily!!! [ Post Comment ] |
| Comment #6 posted by The GCW on August 18, 2006 at 04:51:14 PT |
| mandatory minimum education? Mandatory minimum health care? US PA: Reefer Gladness http://www.mapinc.org/drugnews/v06/n1092/a03.html?397 Pubdate: Thu, 17 Aug 2006 Source: Philadelphia City Paper (PA) [ Post Comment ] |
| Comment #5 posted by whig on August 18, 2006 at 04:26:12 PT |
| Remember, "Gilead" is always pronounced, "Rumsfeld." http://answers.google.com/answers/threadview?id=447040 [ Post Comment ] |
| Comment #4 posted by mayan on August 18, 2006 at 04:18:16 PT |
| I was just checking out the 'TCS Daily' site and I found this... 9/11 Myths, Debunked: http://www.tcsdaily.com/article.aspx?id=081806C Now I am very suspect of anything on that site. I also found this... "TCS is supported by a small group of sponsors: ExxonMobil, Freddie Mac, General Motors Corporation, Gilead Sciences, McDonalds, Merck and PhRMA. We are proud to have them as sponsors; however, the opinions expressed on these pages are solely those of the writers and not necessarily of any corporation or other organization." No wonder they push the government's absurd account of 9/11! THE WAY OUT... Popular Mechanics' Deceptive Smear Against 9/11 Truth: http://www.911review.com/pm/markup/index.html Popular Mechanics Attacks Its "9/11 LIES" Straw Man: http://911research.wtc7.net/essays/pm/ Popular Mechanics Cites Hoaxes To Discredit 911 Truth: http://rense.com/general62/popp.htm [ Post Comment ] |
| Comment #3 posted by billos on August 18, 2006 at 03:36:34 PT |
| Mr. Hooper's company refuses to hire people who test positive for THC? [ Post Comment ] |
| Comment #2 posted by whig on August 17, 2006 at 22:37:56 PT |
| I think the explanation that marijuana possession and use would still be illegal under federal law would actually increase the chances of the ballot measure's passage. Think about it this way, the more liberal voters will support the state regulation as a better alternative to prohibition, while the more conservative voters will be more likely to accept the regulation because the federal government would still be enforcing prohibition. [ Post Comment ] |
| Comment #1 posted by FoM on August 17, 2006 at 21:55:03 PT |
| August 17, 2006 PIERRE, S.D. (AP) -- A judge was asked today to order the attorney general to change the wording on his explanation of a ballot measure that seeks to legalize marijuana for medical use in South Dakota. A lawyer for sponsors of the measure says Attorney General Larry Long submitted an explanation that is not objective and argues against passage of the measure. But an assistant attorney general said the ballot explanation is fair and correct. Circuit Judge Max Gors of Pierre says he will rule in the case by tomorrow or Monday at the latest. Secretary of State Chris Nelson says he needs to know right away what language will go on the ballot so ballots can be ready for early voting starting September 26th. One of the complaints about Long's explanation is that it says marijuana possession and use would still be illegal under federal law, even if South Dakota legalized it for medical purposes. Copyright: 2006 The Associated Press http://www.ktiv.com/News/index.php?ID=3460 [ Post Comment ] |
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