Tuesday, June 25, 2013
Friday, June 14, 2013
It's good medicine
Does Granny Need Ganja?
“Marijuana legalization transcends gender, race, class, geography, and age, so it's encouraging to see people from different backgrounds and generations coming together,” Stacia Cosner, SSDP's 26-year-old Associate Director, says. “Young people and seniors don't share a lot of political views and interests, but this is a unique issue that's no longer on the fringe.”
“Marijuana legalization transcends gender, race, class, geography, and age, so it's encouraging to see people from different backgrounds and generations coming together,” Stacia Cosner, SSDP's 26-year-old Associate Director, says. “Young people and seniors don't share a lot of political views and interests, but this is a unique issue that's no longer on the fringe.”
Tuesday, June 11, 2013
Veterans Press Statement -> RE: Senate Bill 281 becomes law:
Who: Veterans For Medical Cannabis Access
www.veteransformedicalcannabis.org
Contact: Sgt. Michael Krawitz USAF Disabled 540-365-2141
What: On 6 June 2013 Gov. John Kitzhaber signed SB-281 into law
Oregon: 10 June 2013
By signing SB-281 into law Governor Kitzhaber, as of 1 Jan 2014, adds PTSD as a qualifying condition to Oregon's well established medical cannabis access laws.
Veterans throughout Oregon and indeed the nation whose eyes have been set on this process express gratitude for the swift and decisive action by Oregon's Legislature and Governor making up for years of agony in the futile attempts to broach the entrenched bureaucracy of the Oregon Department of Human Services whose job it was to add this medical condition to the list of those allowed protection of Oregon's medical cannabis access law.
As retired Lt. Commander Al Byrne said "It's About Time"
An effort that Veterans For Medical Cannabis Access [VMCA] has supported from the beginning, adding PTSD to Oregon's law has been an adventure.
VMCA wants to thank Nurse Ed Glick and Atty. Lee Berger for sticking to it through miserable responses from individuals in positions of authority who should know better. Their requests to Oregon's DHS were not only met with inaction but actual hostility at times despite valiant testimony of disabled United States military Veterans flanked by their respective doctors in absolute majority asking for this addition.
VMCA thanks Todd Dalotto and his constituent Senator Boquist for presenting this request to the state legislature and many thanks to all Veterans, EMS, and Police who spoke to their legislators and presented testimony for this bill as well as those survivors of childhood and/or adult trauma whose testimony helped a unchallenged truth become law. The truth? Cannabis works well for PTSD and those who suffer from this medical condition have real evidence and deserve our respect and compassion.
VMCA thanks Anthony Taylor, Director of Compassionate Oregon and Sam Chapman without whose tireless efforts this bill would have been much slower on the uptake and probably wouldn't have passed this year.
Adding to the growing list of states where cannabis is listed specifically as allowed for treatment of PTSD Oregon joins Delaware, Connecticut and New Mexico as well as Massachusetts and California who, wisely, allows doctors to decide these things as well as Washington and Colorado who, maybe even more wisely have re-legalized all personal use by those over 21.
Considering extreme rates of suicide amongst our disabled Veterans taken together with a host of pharmaceuticals that, in this case, suck and the extraordinarily good results we have seen from Veterans who have been able to integrate cannabis into their PTSD regimens VMCA joins Mr. Byrne in saying "It's about time"!
Who: Veterans For Medical Cannabis Access
www.veteransformedicalcannabis.org
Contact: Sgt. Michael Krawitz USAF Disabled 540-365-2141
What: On 6 June 2013 Gov. John Kitzhaber signed SB-281 into law
Oregon: 10 June 2013
By signing SB-281 into law Governor Kitzhaber, as of 1 Jan 2014, adds PTSD as a qualifying condition to Oregon's well established medical cannabis access laws.
Veterans throughout Oregon and indeed the nation whose eyes have been set on this process express gratitude for the swift and decisive action by Oregon's Legislature and Governor making up for years of agony in the futile attempts to broach the entrenched bureaucracy of the Oregon Department of Human Services whose job it was to add this medical condition to the list of those allowed protection of Oregon's medical cannabis access law.
As retired Lt. Commander Al Byrne said "It's About Time"
An effort that Veterans For Medical Cannabis Access [VMCA] has supported from the beginning, adding PTSD to Oregon's law has been an adventure.
VMCA wants to thank Nurse Ed Glick and Atty. Lee Berger for sticking to it through miserable responses from individuals in positions of authority who should know better. Their requests to Oregon's DHS were not only met with inaction but actual hostility at times despite valiant testimony of disabled United States military Veterans flanked by their respective doctors in absolute majority asking for this addition.
VMCA thanks Todd Dalotto and his constituent Senator Boquist for presenting this request to the state legislature and many thanks to all Veterans, EMS, and Police who spoke to their legislators and presented testimony for this bill as well as those survivors of childhood and/or adult trauma whose testimony helped a unchallenged truth become law. The truth? Cannabis works well for PTSD and those who suffer from this medical condition have real evidence and deserve our respect and compassion.
VMCA thanks Anthony Taylor, Director of Compassionate Oregon and Sam Chapman without whose tireless efforts this bill would have been much slower on the uptake and probably wouldn't have passed this year.
Adding to the growing list of states where cannabis is listed specifically as allowed for treatment of PTSD Oregon joins Delaware, Connecticut and New Mexico as well as Massachusetts and California who, wisely, allows doctors to decide these things as well as Washington and Colorado who, maybe even more wisely have re-legalized all personal use by those over 21.
Considering extreme rates of suicide amongst our disabled Veterans taken together with a host of pharmaceuticals that, in this case, suck and the extraordinarily good results we have seen from Veterans who have been able to integrate cannabis into their PTSD regimens VMCA joins Mr. Byrne in saying "It's about time"!
Friday, May 10, 2013
Science Over Ideology? An open letter to President Obama
Science Over Ideology?
And yet the war on pot continues
MAY 9, 2013 - 1:00AM | BY JIM GREIG
An open letter to President Obama:
I am a disabled American worker who uses state approved marijuana for medical reasons. I am offended that you choose to consider me a criminal.
Mr. President, we all know that you smoked a lot of weed as a youth, and that your cannabis consumption did not prevent you from becoming this nation's elected leader. But what seems to be passing over your head, sir, is that had you been arrested for possession of pot, you most certainly would never have become president of the U.S.
You should know that during your first four years in office, while you dodged and dismissed the marijuana issue, some three-quarters of a million people were arrested each year for possession — about three million marijuana arrests just in your first term. I'm curious how that fact fares when we consider your statement at Northwestern University in 2004 that the “war on drugs has been an utter failure."
Mr. President, I'd really like to understand where you're coming from. With 80 percent of U.S. voters supporting medical marijuana legalization and a slim majority favoring adult use, I have a hard time comprehending your reluctance to act properly.
There is no risk to you — and certainly your fellow Democrats in Congress could stand a boost in their popularity.
Mr. Obama, may I remind you that when you were elected, one of your initial points on how your administration would operate revolved around supporting science rather than ideology. You said "promoting science isn’t just about providing resources — it’s about protecting free and open inquiry. It’s about listening to what our scientists have to say, even when it’s inconvenient — especially when it’s inconvenient.”
Well sir, I'm not sure how to break this to you, because it might be "inconvenient" but there is no scientific legitimacy behind the illegality of cannabis in any of its forms. Surely you must agree that the continued prohibition of industrial hemp is absurd. And to deny patients like myself legitimate access to a non-toxic, non-addictive, grow-it-at-home substance that greatly reduces my consumption of toxic pharmaceuticals, is cruel and capricious.
As our commander-in-chief you should know that today 22 veterans will commit suicide. Tomorrow, 22 more. In this country nearly two dozen veterans take their own lives every day. A lot of them suffer from post traumatic stress disorder (PTSD).
When University of Arizona psychiatrist Dr. Sue Sisley put together a study to find how effective cannabis is as a treatment for combat veterans with PTSD she first had to gain FDA and VA approval. Green-lighted from both agencies, her next step was to gain approval from the National Institutes of Drug Abuse. Since NIDA's mission is to find only the harms of drugs, her application was quickly rejected.
In February I was in Washington, D.C., attending the Americas for Safe Access Unity Conference. While there I had the opportunity to meet Dr. John Schwarz, a physicist best known as one of the "fathers of string theory."
In a November 2012 Huffington Post op-ed, Schwarz, who's wife is a medical marijuana patient, criticized your administration for "ignoring scientists' voices on medical marijuana policy ... and severely restricting their ability to conduct new research."
He went on to say the "acceptance of science has come a long way since Galileo was arrested as a heretic for questioning the order of the universe. Yet today, the federal government ignores scientific facts accepted around the globe — not to mention the will of the American people — to cling to outdated ideological policies and restrict marijuana research. This is hardly the 'free and open scientific inquiry' President Obama touted in 2009."
Please, Mr. President. I would like to believe that you are not a hypocrite — that you believe in both science and the will of the American people. You cannot lose, sir, you can only gain.
In the words of Martin Luther King Jr., “Never, never be afraid to do what's right, especially if the well-being of a person or animal is at stake. Society's punishments are small compared to the wounds we inflict on our soul when we look the other way.”
Original article
And yet the war on pot continues
MAY 9, 2013 - 1:00AM | BY JIM GREIG
An open letter to President Obama:
I am a disabled American worker who uses state approved marijuana for medical reasons. I am offended that you choose to consider me a criminal.
Mr. President, we all know that you smoked a lot of weed as a youth, and that your cannabis consumption did not prevent you from becoming this nation's elected leader. But what seems to be passing over your head, sir, is that had you been arrested for possession of pot, you most certainly would never have become president of the U.S.
You should know that during your first four years in office, while you dodged and dismissed the marijuana issue, some three-quarters of a million people were arrested each year for possession — about three million marijuana arrests just in your first term. I'm curious how that fact fares when we consider your statement at Northwestern University in 2004 that the “war on drugs has been an utter failure."
Mr. President, I'd really like to understand where you're coming from. With 80 percent of U.S. voters supporting medical marijuana legalization and a slim majority favoring adult use, I have a hard time comprehending your reluctance to act properly.
There is no risk to you — and certainly your fellow Democrats in Congress could stand a boost in their popularity.
Mr. Obama, may I remind you that when you were elected, one of your initial points on how your administration would operate revolved around supporting science rather than ideology. You said "promoting science isn’t just about providing resources — it’s about protecting free and open inquiry. It’s about listening to what our scientists have to say, even when it’s inconvenient — especially when it’s inconvenient.”
Well sir, I'm not sure how to break this to you, because it might be "inconvenient" but there is no scientific legitimacy behind the illegality of cannabis in any of its forms. Surely you must agree that the continued prohibition of industrial hemp is absurd. And to deny patients like myself legitimate access to a non-toxic, non-addictive, grow-it-at-home substance that greatly reduces my consumption of toxic pharmaceuticals, is cruel and capricious.
As our commander-in-chief you should know that today 22 veterans will commit suicide. Tomorrow, 22 more. In this country nearly two dozen veterans take their own lives every day. A lot of them suffer from post traumatic stress disorder (PTSD).
When University of Arizona psychiatrist Dr. Sue Sisley put together a study to find how effective cannabis is as a treatment for combat veterans with PTSD she first had to gain FDA and VA approval. Green-lighted from both agencies, her next step was to gain approval from the National Institutes of Drug Abuse. Since NIDA's mission is to find only the harms of drugs, her application was quickly rejected.
In February I was in Washington, D.C., attending the Americas for Safe Access Unity Conference. While there I had the opportunity to meet Dr. John Schwarz, a physicist best known as one of the "fathers of string theory."
In a November 2012 Huffington Post op-ed, Schwarz, who's wife is a medical marijuana patient, criticized your administration for "ignoring scientists' voices on medical marijuana policy ... and severely restricting their ability to conduct new research."
He went on to say the "acceptance of science has come a long way since Galileo was arrested as a heretic for questioning the order of the universe. Yet today, the federal government ignores scientific facts accepted around the globe — not to mention the will of the American people — to cling to outdated ideological policies and restrict marijuana research. This is hardly the 'free and open scientific inquiry' President Obama touted in 2009."
Please, Mr. President. I would like to believe that you are not a hypocrite — that you believe in both science and the will of the American people. You cannot lose, sir, you can only gain.
In the words of Martin Luther King Jr., “Never, never be afraid to do what's right, especially if the well-being of a person or animal is at stake. Society's punishments are small compared to the wounds we inflict on our soul when we look the other way.”
Original article
Sunday, April 28, 2013
Medical Cannabis - Healing with an herbal medicine
We are raising funds for a project that will produce educational videos about how marijuana is used in the treatment of various medical conditions. We need to raise at least $20,000 to get this project started. We will produce professional quality videos with medical cannabis experts and patients describing how they use marijuana to treat their condition.
Click here to donate
Thank you for your support!
Click here to donate
Thank you for your support!
Saturday, February 2, 2013
Rick Doblin reply to Bonner
Subject: Rick Doblin reply to Bonner - LA Times: Ex-DEA Head Bonner claims no studies support mj efficacy and that the DEA/NIDA has never blocked a single study
From: Rick Doblin
Date: February 1, 2013
What follows below is a reply I wrote to Bonner's article in the LA Times. I tried to post it below the article but I'm not sure if my text will actually be posted. There was a word limit and I had to post it in five segments. The posts are moderated which adds another layer of review. You can circulate this however you wish.
Dear Mr. Robert Bonner,
Hello from Rick Doblin, Ph.D., (Public Policy, Kennedy School of Government, Harvard University, with my dissertation on the regulation of the medical uses of psychedelics and marijuana). I'm currently Executive Director of the non-profit research and educational organization, the Multidisciplinary Association for Psychedelic Studies (MAPS, www.maps.org), which I founded in 1986. You may be surprised to learn that for the last 20+ years, I have been inspired by, and frequently quote, your 1992 statement that you mention in your article above in which you encouraged advocates of medical marijuana to conduct more research.
In 1992, you wrote, “Those who insist that marijuana has medical uses would serve society better by promoting or sponsoring more legitimate scientific research, rather than throwing their time, money and rhetoric into lobbying public relations campaigns and perennial litigation."
I have put my full energies for the last 20+ years into trying to conduct FDA-approved medical marijuana drug development research. Unfortunately, my experience, to which I hope you will give some credence, is exactly opposite of the open door to research that you claim exists. MAPS has obtained FDA and IRB approval for three different protocols to which NIDA refused to sell any marijuana, preventing the studies from taking place. In addition, NIDA refused for 7 years to sell MAPS 10 grams (!!) of marijuana for laboratory research investigating the vapors that come out of the Volcano vaporizer, compared to smoke from combusted marijuana.
Furthermore, MAPS has been involved for the last decade in litigation against DEA for refusing to license Prof. Craker, UMass Amherst, to grow marijuana exclusively for use in federally regulated research. In 2007, DEA Administrative Law Judge Bittner recommended, after extensive hearings with witness testimony, that it would be in the public interest for DEA to license Prof. Craker to grow marijuana under contract to MAPS, ending the NIDA monopoly on the supply of marijuana legal for use in FDA-regulated studies. DEA waited for almost two years and then rejected the ALJ recommendation just six days before the inauguration of Pres. Obama.
On May 11, 2012, oral arguments took place before the 1st Circuit Court of Appeals in a lawsuit by Prof. Craker challenging DEA's rationale for rejecting the DEA ALJ recommendation. A ruling is currently pending from the 1st Circuit. From my perspective, DEA's rationale for rejecting the DEA ALJ recommendation is arbitrary and capricious, but of course what matters is what the 1st Circuit will eventually decide.
In your article above, you claimed, “To the contrary, not a single scientifically valid study by a qualified researcher has ever been denied by the DEA or, for that matter, by the National Institute of Drug Abuse.” The wiggle room in your statement above is the definition of "scientifically valid study". One would think that for a privately funded study being conducted without a penny of government money, with the aim of developing marijuana into an FDA-approved prescription medicine, that the FDA would be the regulatory agency to determine whether the study was "scientifically valid” and that Institutional Review Board (IRB) approval would be sufficient to protect the safety of the human volunteers to the study.
However, in 1999, HHS created a policy (which could be reversed by Pres. Obama at any time without Congressional action) stating that PHS/NIDA reviewers would have to conduct an additional review of protocols from privately-funded sponsors seeking to purchase marijuana from NIDA. This additional PHS/NIDA protocol review process exists only for marijuana, not for research with any other controlled substance. MAPS has been able to make substantial progress with our research exploring the use of MDMA-assisted psychotherapy in subjects with chronic, treatment-resistant PTSD, including a current study in 24 US veterans, firefighters and perhaps even police officers with work-related PTSD.
It is these PHS/NIDA reviewers who have rejected all three of MAPS' FDA and IRB approved medical marijuana drug development protocols, preventing them from taking place. You can claim that the rejection of these protocols was because they were not "scientifically valid". However, to make that claim, you would be saying that FDA and IRBs have approved studies that are not "scientifically valid", an accusation against the FDA that I doubt you really want to make.
MAPS currently has obtained FDA and IRB approval for a study of marijuana in 50 US veterans with chronic, treatment-resistant PTSD. Dr. Sue Sisley of UArizona is the PI and approval has been obtained from the UArizona IRB as well as the FDA. Research into a potentially beneficial treatment for US veterans is being blocked by PHS/NIDA reviewers who rejected this protocol. These PHS/NIDA reviewers approached the protocol review as if we were asking for a government grant for a basic science study. Instead, we were seeking to purchase marijuana from NIDA for a privately-funded drug development study. The PHS/NIDA reviewers made numerous incorrect and uninformed comments and clearly didn't understand drug development research. One reviewer objected to our outcome measures when we are using the FDA-required measure of PTSD symptoms, the CAPS. If you or any readers want to review our protocol along with the PHS/NIDA reviewers' comments and my annotated response, the documents are posted at: http://www.maps.org/research/mmj/marijuana_for_ptsd_study/
The compete record of Prof. Craker's DEA lawsuit is posted at: http://www.maps.org/research/mmj/dea_timeline/
MAPS will soon be resubmitting our marijuana/PTSD protocol for another round of PHS/NIDA review, even though we think this review should be eliminated from the process. All FDA/IRB and DEA approved protocols should automatically be allowed to purchase marijuana from NIDA.
To summarize, you have been an inspiration to me and have motivated me to devote several decades of my life to seek approval for medical marijuana drug development research. My failure to make progress in overcoming the obstruction of medical marijuana research by DEA/NIDA/PHS provides one of the clearest reasons for state level medical marijuana policy reform.
My conclusion is opposite of yours, when you said, "One can only conclude the marijuana proponents did not go this route because doing so would have shown that cannabis is not an effective and safe medicine."
Rather, one can only conclude that privately-funded medical marijuana drug development research is being aggressively and actively obstructed by DEA/NIDA/PHS because they know it can be scientifically proven that marijuana, smoked or vaporized, is both safe and effective.
The heroes in all of this in my eyes are the FDA. It's not because FDA is pro-medical marijuana, or pro-psychedelic psychotherapy. Rather, FDA is pro science over politics. In other words, FDA are heroes simply for doing their jobs. If only DEA/NIDA/PHS considered the public interest over their increasingly out of touch passion for blocking FDA-regulated medical marijuana drug development research.
I urge you to reread your 1992 statement and join MAPS in asking for the end of the PHS protocol review process and for a new policy in which all FDA/IRB/DEA approved protocols automatically obtain approval to purchase NIDA marijuana. In addition, I sincerely hope you will also support DEA licensing of Prof. Craker. It's time to “serve society better by promoting or sponsoring more legitimate scientific research."
Sincerely,
Rick Doblin, Ph.D.
Executive Director, MAPS
3 Francis Street
Belmont, MA 02478 USA
617-484-8711
www.maps.org
Date: February 1, 2013
Subject: LA Times: Ex-DEA Head Bonner claims no studies support mj efficacy and that the DEA/NIDA has never blocked a single study
http://www.latimes.com/news/opinion/opinion-la/la-ol-dea-marijuana-blowbac-20130201,0,5287678.story
BLOWBACK
The DEA's pot defense [Blowback]
By Robert Bonner
February 1, 2013, 8:23 a.m.
Reacting to a federal appellate court decision upholding the U.S. Drug Enforcement Administration's denial of reclassification of marijuana, The Times states in its Jan. 25 editorial that whether marijuana should be reclassified under federal law to permit its prescription as a medicine should be based on science and an evaluation of the facts, rather than on myths. I fully agree.
And yet the editorial is based on the myth that the DEA has made it "nearly impossible" for researchers to obtain marijuana for such scientific studies. To the contrary, not a single scientifically valid study by a qualified researcher has ever been denied by the DEA or, for that matter, by the National Institute of Drug Abuse. And there is ample government-grown marijuana, specifically for research, available at the marijuana farm run by the University of Mississippi. More surprising, as your editorial points out, is that there is still no scientifically valid study that proves that marijuana is effective, much less safe, as a medicine.
As the DEA administrator 20 years ago, I denied the reclassification of marijuana from a Schedule I controlled drug because there were no valid scientific studies showing that smoking marijuana was an effective medicine.
In my decision, published in the Federal Register, I interpreted federal law and set forth a five-part test that included whether there were valid scientific studies demonstrating that marijuana was safe and effective for treating any medical condition. I noted that at that time there were none of the kind of controlled, double-blind studies that the Food and Drug Administration would require before approving a new drug application, and I clearly spelled out that this would be necessary before marijuana would be reclassified to a lower schedule that would permit its use as a physician-prescribed medicine.
Essentially, I invited those who advocate marijuana use as a medicine to conduct research and then present it to the DEA. I laid out a road map for what they needed to do. If scientifically valid studies demonstrated that marijuana was ‘effective’ and ‘safe’, as the FDA defines those terms, the agency would reclassify marijuana into one of the other schedules. It is amazing that 20 years later there is still no such scientific study establishing that marijuana is effective as a medicine. And yet in the interim, the well-funded marijuana lobby, including the National Assn. for the Reform of Marijuana Laws and others, have spent tens of millions of dollars on convincing voters to pass medical marijuana initiatives based on anecdotes but not science.
The reason the FDA and the DEA have scientific standards is because snake-oil salesmen are able to sell just about anything to sick people without any scientific proof that it has a truly helpful therapeutic effect. If proponents of medical marijuana had invested even a small fragment of their money in scientifically valid studies, we would know one way or the other whether it works.
One can only conclude the marijuana proponents did not go this route because doing so would have shown that cannabis is not an effective and safe medicine. Alternatively, we are left to conclude that their agenda was not about marijuana to help sick people, but rather was getting voters to pass medical marijuana initiatives as a wedge to legalize the drug for “recreational" use.
From: Rick Doblin
Date: February 1, 2013
What follows below is a reply I wrote to Bonner's article in the LA Times. I tried to post it below the article but I'm not sure if my text will actually be posted. There was a word limit and I had to post it in five segments. The posts are moderated which adds another layer of review. You can circulate this however you wish.
Dear Mr. Robert Bonner,
Hello from Rick Doblin, Ph.D., (Public Policy, Kennedy School of Government, Harvard University, with my dissertation on the regulation of the medical uses of psychedelics and marijuana). I'm currently Executive Director of the non-profit research and educational organization, the Multidisciplinary Association for Psychedelic Studies (MAPS, www.maps.org), which I founded in 1986. You may be surprised to learn that for the last 20+ years, I have been inspired by, and frequently quote, your 1992 statement that you mention in your article above in which you encouraged advocates of medical marijuana to conduct more research.
In 1992, you wrote, “Those who insist that marijuana has medical uses would serve society better by promoting or sponsoring more legitimate scientific research, rather than throwing their time, money and rhetoric into lobbying public relations campaigns and perennial litigation."
I have put my full energies for the last 20+ years into trying to conduct FDA-approved medical marijuana drug development research. Unfortunately, my experience, to which I hope you will give some credence, is exactly opposite of the open door to research that you claim exists. MAPS has obtained FDA and IRB approval for three different protocols to which NIDA refused to sell any marijuana, preventing the studies from taking place. In addition, NIDA refused for 7 years to sell MAPS 10 grams (!!) of marijuana for laboratory research investigating the vapors that come out of the Volcano vaporizer, compared to smoke from combusted marijuana.
Furthermore, MAPS has been involved for the last decade in litigation against DEA for refusing to license Prof. Craker, UMass Amherst, to grow marijuana exclusively for use in federally regulated research. In 2007, DEA Administrative Law Judge Bittner recommended, after extensive hearings with witness testimony, that it would be in the public interest for DEA to license Prof. Craker to grow marijuana under contract to MAPS, ending the NIDA monopoly on the supply of marijuana legal for use in FDA-regulated studies. DEA waited for almost two years and then rejected the ALJ recommendation just six days before the inauguration of Pres. Obama.
On May 11, 2012, oral arguments took place before the 1st Circuit Court of Appeals in a lawsuit by Prof. Craker challenging DEA's rationale for rejecting the DEA ALJ recommendation. A ruling is currently pending from the 1st Circuit. From my perspective, DEA's rationale for rejecting the DEA ALJ recommendation is arbitrary and capricious, but of course what matters is what the 1st Circuit will eventually decide.
In your article above, you claimed, “To the contrary, not a single scientifically valid study by a qualified researcher has ever been denied by the DEA or, for that matter, by the National Institute of Drug Abuse.” The wiggle room in your statement above is the definition of "scientifically valid study". One would think that for a privately funded study being conducted without a penny of government money, with the aim of developing marijuana into an FDA-approved prescription medicine, that the FDA would be the regulatory agency to determine whether the study was "scientifically valid” and that Institutional Review Board (IRB) approval would be sufficient to protect the safety of the human volunteers to the study.
However, in 1999, HHS created a policy (which could be reversed by Pres. Obama at any time without Congressional action) stating that PHS/NIDA reviewers would have to conduct an additional review of protocols from privately-funded sponsors seeking to purchase marijuana from NIDA. This additional PHS/NIDA protocol review process exists only for marijuana, not for research with any other controlled substance. MAPS has been able to make substantial progress with our research exploring the use of MDMA-assisted psychotherapy in subjects with chronic, treatment-resistant PTSD, including a current study in 24 US veterans, firefighters and perhaps even police officers with work-related PTSD.
It is these PHS/NIDA reviewers who have rejected all three of MAPS' FDA and IRB approved medical marijuana drug development protocols, preventing them from taking place. You can claim that the rejection of these protocols was because they were not "scientifically valid". However, to make that claim, you would be saying that FDA and IRBs have approved studies that are not "scientifically valid", an accusation against the FDA that I doubt you really want to make.
MAPS currently has obtained FDA and IRB approval for a study of marijuana in 50 US veterans with chronic, treatment-resistant PTSD. Dr. Sue Sisley of UArizona is the PI and approval has been obtained from the UArizona IRB as well as the FDA. Research into a potentially beneficial treatment for US veterans is being blocked by PHS/NIDA reviewers who rejected this protocol. These PHS/NIDA reviewers approached the protocol review as if we were asking for a government grant for a basic science study. Instead, we were seeking to purchase marijuana from NIDA for a privately-funded drug development study. The PHS/NIDA reviewers made numerous incorrect and uninformed comments and clearly didn't understand drug development research. One reviewer objected to our outcome measures when we are using the FDA-required measure of PTSD symptoms, the CAPS. If you or any readers want to review our protocol along with the PHS/NIDA reviewers' comments and my annotated response, the documents are posted at: http://www.maps.org/research/mmj/marijuana_for_ptsd_study/
The compete record of Prof. Craker's DEA lawsuit is posted at: http://www.maps.org/research/mmj/dea_timeline/
MAPS will soon be resubmitting our marijuana/PTSD protocol for another round of PHS/NIDA review, even though we think this review should be eliminated from the process. All FDA/IRB and DEA approved protocols should automatically be allowed to purchase marijuana from NIDA.
To summarize, you have been an inspiration to me and have motivated me to devote several decades of my life to seek approval for medical marijuana drug development research. My failure to make progress in overcoming the obstruction of medical marijuana research by DEA/NIDA/PHS provides one of the clearest reasons for state level medical marijuana policy reform.
My conclusion is opposite of yours, when you said, "One can only conclude the marijuana proponents did not go this route because doing so would have shown that cannabis is not an effective and safe medicine."
Rather, one can only conclude that privately-funded medical marijuana drug development research is being aggressively and actively obstructed by DEA/NIDA/PHS because they know it can be scientifically proven that marijuana, smoked or vaporized, is both safe and effective.
The heroes in all of this in my eyes are the FDA. It's not because FDA is pro-medical marijuana, or pro-psychedelic psychotherapy. Rather, FDA is pro science over politics. In other words, FDA are heroes simply for doing their jobs. If only DEA/NIDA/PHS considered the public interest over their increasingly out of touch passion for blocking FDA-regulated medical marijuana drug development research.
I urge you to reread your 1992 statement and join MAPS in asking for the end of the PHS protocol review process and for a new policy in which all FDA/IRB/DEA approved protocols automatically obtain approval to purchase NIDA marijuana. In addition, I sincerely hope you will also support DEA licensing of Prof. Craker. It's time to “serve society better by promoting or sponsoring more legitimate scientific research."
Sincerely,
Rick Doblin, Ph.D.
Executive Director, MAPS
3 Francis Street
Belmont, MA 02478 USA
617-484-8711
www.maps.org
Date: February 1, 2013
Subject: LA Times: Ex-DEA Head Bonner claims no studies support mj efficacy and that the DEA/NIDA has never blocked a single study
http://www.latimes.com/news/opinion/opinion-la/la-ol-dea-marijuana-blowbac-20130201,0,5287678.story
BLOWBACK
The DEA's pot defense [Blowback]
By Robert Bonner
February 1, 2013, 8:23 a.m.
Reacting to a federal appellate court decision upholding the U.S. Drug Enforcement Administration's denial of reclassification of marijuana, The Times states in its Jan. 25 editorial that whether marijuana should be reclassified under federal law to permit its prescription as a medicine should be based on science and an evaluation of the facts, rather than on myths. I fully agree.
And yet the editorial is based on the myth that the DEA has made it "nearly impossible" for researchers to obtain marijuana for such scientific studies. To the contrary, not a single scientifically valid study by a qualified researcher has ever been denied by the DEA or, for that matter, by the National Institute of Drug Abuse. And there is ample government-grown marijuana, specifically for research, available at the marijuana farm run by the University of Mississippi. More surprising, as your editorial points out, is that there is still no scientifically valid study that proves that marijuana is effective, much less safe, as a medicine.
As the DEA administrator 20 years ago, I denied the reclassification of marijuana from a Schedule I controlled drug because there were no valid scientific studies showing that smoking marijuana was an effective medicine.
In my decision, published in the Federal Register, I interpreted federal law and set forth a five-part test that included whether there were valid scientific studies demonstrating that marijuana was safe and effective for treating any medical condition. I noted that at that time there were none of the kind of controlled, double-blind studies that the Food and Drug Administration would require before approving a new drug application, and I clearly spelled out that this would be necessary before marijuana would be reclassified to a lower schedule that would permit its use as a physician-prescribed medicine.
Essentially, I invited those who advocate marijuana use as a medicine to conduct research and then present it to the DEA. I laid out a road map for what they needed to do. If scientifically valid studies demonstrated that marijuana was ‘effective’ and ‘safe’, as the FDA defines those terms, the agency would reclassify marijuana into one of the other schedules. It is amazing that 20 years later there is still no such scientific study establishing that marijuana is effective as a medicine. And yet in the interim, the well-funded marijuana lobby, including the National Assn. for the Reform of Marijuana Laws and others, have spent tens of millions of dollars on convincing voters to pass medical marijuana initiatives based on anecdotes but not science.
The reason the FDA and the DEA have scientific standards is because snake-oil salesmen are able to sell just about anything to sick people without any scientific proof that it has a truly helpful therapeutic effect. If proponents of medical marijuana had invested even a small fragment of their money in scientifically valid studies, we would know one way or the other whether it works.
One can only conclude the marijuana proponents did not go this route because doing so would have shown that cannabis is not an effective and safe medicine. Alternatively, we are left to conclude that their agenda was not about marijuana to help sick people, but rather was getting voters to pass medical marijuana initiatives as a wedge to legalize the drug for “recreational" use.
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