My Correspondence With FDA

Dear JP,



(part omitted, about how it worked for me because I've already written about this on my blog)

...There is something wrong when most of the U.S. and European doctors are supporting the medicinal use of marijuana, and it is proving effective for some, and yet it's listed as Schedule I. It's very strange that cocaine is Schedule II and I should be getting in less trouble for using IT than marijuana. Maybe cocaine is good for numbing the eye in surgery and for pain relief or something, but marijuana is good for glaucoma and could perhaps prevent the need for cocaine and a major surgery if marijuana was being prescribed to defeat blindness. I quit taking marijuana (maybe tried it 6-8 times total) after 2 months. I want to experiment more and want to do it legally. How must researchers and good doctors feel as well! I'm supposed to say, "Okay, well I'll just go ahead and suffer the rest of my life because this plant I could grow in my backyard is a big Schedule I no-no?" I don't want state approval, I want federal government approval. I am as honest as it gets, and I wouldn't spend time writing about this, to try to find a legal way to use a drug recreationally. It's beginning to look like the federal government cares more about the loss of revenue from pharmaceutical companies that push Topamax and triptans, than the loss of it's citizen's lives. How much money would be lost, to the makers of triptans (ALL forms!), Migranol, muscle relaxants, narcotics/Demerol, and anti-seizure meds, if marijuana eliminated the need for acute treatment because it prevented them to begin with? Now combine that loss with revenues from anti-seizure meds (because marijuana is supposed to help with these too). Those drug companies do a lot of business with big government, especially Republicans. And of course the DEA doesn't want it legalized, because how many of them would lose funding and jobs? What are THEY going to do? Go out and become pot farmers themselves instead? It is morally wrong to withhold the potential for good medicine by placing something on a list which prohibits scientific research. For that matter, I am going to look at the other things on the Schedule I list, because it seems to me that most drugs have at some point in history, been found to have a positive effect on the body or they wouldn't be used. It's not like Arsenic and pesticides are on the list. Everything on the list should be open to research. Banning something from even having scientific studies done on it, is going to hinder progress in America, not help it. If the main concern is that putting something on Schedule II opens the drug up to being legally prescribed by a doctor, before it's been tested long enough, and Schedule I means no testing can be done, period, someone needs to think outside of the Schedule box and change the structure of the Schedules. Schedule I-A could mean something has been tested for decades and has no use and is harmful to humans, Schedule I-B could mean research is allowed and supported, but doctors cannot legally prescribe yet. I believe marijuana should be placed on Schedule II and then someone needs to go over structuring of the whole schedule business and open the doors to science. Again, if you ever need my testimony or would like to review my medical records in addition, let me know. Thank you for your clear answer in the meantime, and for your concern in protecting the public from harm. I don't think only potheads want to legalize marijuana anymore--I tend to think, rather, that those opposing it have no personal experience with severe pain and disability. Sincerely, Cameo>



Subject: RE: FDA comment> Date: Tue, 1 Apr 2008 09:35:06 -0400> From: DRUGINFO@fda.hhs.gov> To: cameocares@live.com> > > Ms. Garrett:> > Thank you for writing the Division of Drug Information, in the FDA's> Center for Drug Evaluation and Research. > > Thank you for your comments regarding smoked marijuana as a medicine.> Marijuana is listed in schedule I of the Controlled Substances Act> (CSA), the most restrictive schedule. The Drug Enforcement> Administration (DEA), which administers the CSA, continues to support> that placement of marijuana in Schedule I under 21 U.S.C. 812(b)(1)> (e.g., marijuana has a high potential for abuse, has no currently> accepted medical use in treatment in the United States, and has a lack> of accepted safety for use under medical supervision). FDA concurs with> this position. A growing number of states have passed voter referenda> (or legislative actions) making smoked marijuana available for a variety> of medical conditions upon a doctor's recommendation. These measures are> inconsistent with efforts to ensure that medications undergo the> rigorous scientific scrutiny of the FDA approval process and are proven> safe and effective under the standards of the FD&C Act. Accordingly,> FDA, as the federal agency responsible for reviewing the safety and> efficacy of drugs, DEA as the federal agency charged with enforcing the> CSA, and the Office of National Drug Control Policy, as the federal> coordinator of drug control policy, do not support the use of smoked> marijuana for medical purposes.> > You can read FDA's entire statement on this issue at> http://www.fda.gov/bbs/topics/NEWS/2006/NEW01362.html > > > Best regards, > > JP> > Division of Drug Information > > Center for Drug Evaluation and Research > > Food and Drug Administration > > This communication is consistent with 21CFR10.85(k) and constitutes and> informal communication that represents our best judgment at this time> but does not constitute and advisory opinion, does not necessarily> represent the formal position of the FDA, and does not bind or otherwise> obligate or commit the agency to the views expressed. > > > > > -----Original Message-----> From: OC Webmail > Sent: Monday, March 31, 2008 4:16 PM> To: CDER DRUG INFO> Subject: FW: FDA comment> > > -----



Original Message-----> From: ] > Sent: Sunday, March 30, 2008 11:58 PM> To: OC Webmail> Subject: FDA comment> > > E-Mail: > > URL: > > Comments: Please refer to Advisory Committee:> > Dear Committee,> > I want to thank you for the research you've approved, for study of> marijuana for medicinal use. I have recently discovered marijuana, at> 33 years of age, to be effective in prevention of extremely severe> migraines I've had for over 10 years. I have documentation of trying> every available remedy and preventative medicine, and nothing worked.> The best thing for aborting my migraines was DHE (ergotamine), but the> only thing which has worked to drastically reduce or lessen the severity> of my migraines is marijuana, smoked in extremely small amounts. It was> mild and had no noticeable side effects. I had tried Topamax (lowest> dose possible) and that stuff made it impossible for me to even think at> all. I had to quit after a few days. They don't call it "Dopamax" for> nothing. I hope you will allow further research of marijuana for> prevention of migraine and also, to study WHY it works and what is being> targeted exactly, in order to one day find a possible cure. I tried it> for 2 months on personal trial and then quit, because I didn't have a> legal permit. I am now awaiting a permit from my state (WA) and yet my> heart goes out to others who suffer with migraines. I've lost so much> because of them and had to go to ER so often it was an economic stress> to the state as well. The problem is that this treatment is not yet> approved by the federal government and moved to Schedule II. Please> consider this as my testimony in support of moving marijuana to Schedule> II. I would be more than happy to provide anyone with full copies of my> medical diagnostics for migraine (menstrual migraine with some> musculoskeletal probs too) and records of all the treatments and> medications I tried before marijuana. You may contact me at any time.> If I may be of any help, please email: . Thank you.> Sincerely,> Cameo L. Garrett