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Time to Let the FDA Process Go Forward
By Bruce Mirken The reason that marijuana is not presently an FDA-approved medicine is clear: The federal government has systematically blocked the type of research that would be needed for the agency to consider licensing marijuana as a prescription drug. The recorded medicinal use of this remarkably versatile plant goes back thousands of years [1] In recent years, modern clinical trials have found that it stimulates appetite and improves sleep in HIV/AIDS patients[2] and relieves neuropathic pain associated with HIV disease [3], even when the pain is refractory to other medications [4]. It has also been shown effective at treating neuropathic pain from other causes [5]. In all of these trials, toxicities have been mild and serious adverse events have been rare. What we don’t have -- and never will have until federal anti-drug bureaucrats get out of the way -- is the type of research needed to put together an FDA new drug application. The reason for this is that, unlike any other drug – even other Schedule I drugs – the federal government retains absolute control of the supply of marijuana that can be used for research. Researchers are required to obtain marijuana for clinical research from the National Institute on Drug Abuse, which contracts with the University of Mississippi to run the only legal source of research marijuana in the U.S. [6]. But that Mississippi marijuana is only available for research, not for prescription sale, meaning any researcher seeking to develop marijuana as a prescription drug can never test precisely the same product they’d be selling. And if they want to develop particular strains with varying ratios of cannabinoids (the 80+ unique, active components in marijuana) to test for different ailments – well, forget it. Professor Lyle Craker at the University of Massachusetts Amherst has been attempting to set up a production facility to solve these problems. In 2005, 38 members of Congress wrote to the Drug Enforcement Administration [7] to urge the DEA to allow Craker to proceed. They called the NIDA monopoly on marijuana for research “unjustified,” explaining, “The licensing of Prof. Craker’s facility would provide privately-funded sponsors of FDA-approved research the necessary opportunity to conduct studies with a strain of their own choosing, with access to that strain for all FDA-approved studies and for possible prescription use. None of this is possible under NIDA’s monopoly.” Four years later and despite an administrative law judge ruling [8] in Craker’s favor, the DEA is still blocking Craker’s project. It’s time for the drug war bureaucracy to get out of the way and permit medical marijuana research aimed at securing FDA approval. References: 1. http://www3.interscience.wiley.com/journal/115806128/abstract 2. http://journals.lww.com/jaids/Fulltext/2007/08150/Dronabinol_and_Marijuana_in_HIV_Positive_Marijuana.9.aspx 3. http://www.neurology.org/cgi/content/abstract/68/7/515 4. http://www.nature.com/npp/journal/v34/n3/abs/npp2008120a.html 5. http://www.jpain.org/article/S1526-5900(08)00369-6/abstract 6. http://edition.cnn.com/2009/CRIME/05/18/government.marijuana.garden/ 7. http://www.maps.org/mmj/congressletter.pdf 8. http://www.maps.org/ALJfindings.PDF |
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Contact Mr. Mirken of the Marijuana Policy Project at:
Marijuana Policy Project
236 Massachusetts Ave. NE, Suite 400
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202-462-5747
media@mpp.org
get out of the way dea...who made them boss anyway...they are not medical, they are police.
Well said, Mr. Mirken. It’s appalling that anyone would propose jail time for someone using marijuana on the advice of their doctor.
Both the American College of Physicians and the American Medical Association have expressed support for investigation of marijuana for medicinal purposes. Marijuana in various forms, not necessarily smoked, has been used therapeutically for centuries in many parts of the world. Marijuana appears to provide relief from pain, nausea, and other symptoms, with fewer ill effects and a greater margin of safety than the narcotic drugs commonly administered for pain, and safer even than the non-narcotic drugs such as aspirin, ibuprofen and related compounds that are responsible for a few hundred deaths each year (www.acponline.org/journals/annals/15sep97/nsaid.htm).
The American College of Physicians position can be found at (www.acponline.org/advocacy/where_we_stand/other_issues/medmarijuana.pdf)
The American Medical Association position is available at www.ama-assn.org/assets/meeting/mm/i-09-ref-comm-k.pdf (the Medical Marijuana section begins on page 12 of the 27 page document).
I hope that anyone who can benefit from the medical use of marijuana is allowed to do so safely, without having to go to a criminal drug dealer and without fear of prison for himself or herself.
Well, The Federal Government want things done their way or no way at all. If a politician tries to intervene, they are afraid it will disrupt their political career. I am not on any meds except Cannibis. Before my son introduced me to Cannibis, I have gotten off Zoloft, Klonipin, (anxiety and depression) Ambien (for sleep)so it could be the drug companies are paying the feds to keep it illegal. Stupidity is common in Govt issues.
Why is it that one goes to jail for medicinal pot in one town and the other one is doesn't. Hmm. Let me see, do we live in America?
My son quit smoking marijuana so he can get regualar visitations on the weekend with his kids. He never drank until he was told he could not have regular visitation with his kids. But now he is WORSE than ever. He went to the dr. and takes 4 mg Xanex and drinks 2 six packs on top of it, pees clean and I am so pissed I can't see straight. He doesn't drink a lot around the kids. He has high anxiety and marijuana calmed him. I don't smoke but after seeing how the government has forced my son choose a legal vice instead of something way less harmful and dramatic, I am really pissed off. Sometimes he passes out. He won't smoke pot anymore though because he has to pee. Now isn't this just dandy?
Great article. Strictly speaking as a citizen and a parent, I want to see marijuana actually regulated and controlled. The prohibition of marijuana has never controlled it.
Studies have been done regarding marijuana as an effect therapeutic herb(mostly outside of the U.S.). We just need to be allowed to listen and view those studies as scientific evidence... not cherry pick biased studies.
I go further than most. Legalize marijuana, a substance that is far safer than legal alternatives such as tobacco and alcohol. I highly doubt I am just a coincidence in my view... I believe the majority of the American public favors ending marijuana prohibition? 53%?
What is more inhumane and unjust than keeping MEDICINE away from the people? Wall Street is our Federal Government. WE WILL obey and buy their products!! How long do the people allow this to stand? That our "elected" officials must give pause to ponder the "political ramifications" shows just how out of touch and highly corrupt they have become. They ALL need to get voted out. Term limits. Campaign Finance Reform. Audit of the Federal Reserve.
"Why is it that one goes to jail for medicinal pot in one town and the other one is doesn't. Hmm. Let me see, do we live in America?"
YES!!! This is precisely because we live in America. The nation should not have a one-size-fits-all policy towards drug use. This is the core of the "states as laboratories" that was envisioned by our founders.
The fact that marijuana is a criminal justice issue at all is ABSURD! Money & politics, that is what prohibition is about.
Big pharma is laughing all the way to the bank. The FDA/DEA are okay with drugs that cause death or other severe damage so long as Merk or Pfizer are printing their price tags on them. Give me a break, WAKE UP AMERICA, we are being swindled!
the government has no right to control our GOD given right to place whatever we want into our bodies for whatever purpose we see fit. The only reason they get away with aything at all is because most people are mindless cattle who believe in everything they are told by the media that the government controls, and too cowardly to stand up for our rights, not only as americans but as human beings. If all those protesters who marched in D.C. stormed the beaches (if ya know what i mean) we would be done with this absurd nonsense. Idonteven use weed but to me its a matter of principles that our countries government and policies have been perverted beyond political repair. Its time start over and take it back to the constitution. WAKE! UP! SHEEPLE!