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 marijuanainitiatives 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.
Here is a response from a long time activist Rick Doblin:
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 the 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 heros 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.
rick@maps.org
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 marijuanainitiatives 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.
Here is a response from a long time activist Rick Doblin:
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 the 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 heros 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.
rick@maps.org
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