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Study of marijuana use for symptoms of post-traumatic stress disorder remains frozen

In her Dec. 1 op-ed on AZ Central, Yavapai County Attorney Sheila Polk echoed a misleading statement from the National Institute on Drug Abuse (NIDA) website claiming that the agency “permits or funds studies on therapeutic benefits of marijuana.”

A 1999 guidance issued by the Department of Health and Human Services expressly forbids NIDA from providing marijuana for studies intended to develop the marijuana plant into a prescription medicine approved by the Food and Drug Administration.

The National Cancer Institute study cited by Ms. Polk was on isolated cannabinoids, not the marijuana plant.

NIDA is the sole legal provider of marijuana for research in the U.S. NIDA has denied marijuana to all three FDA-approved studies seeking to develop the whole plant into a prescription medicine, preventing them from taking place.

Our study of smoked or vaporized marijuana for symptoms of PTSD in U.S. veterans was approved by the FDA, but has been frozen for two years due to NIDA’s refusal to sell us marijuana. The study would be sponsored by the nonprofit Multidisciplinary Association for Psychedelic Studies.

We resubmitted the protocol on Oct. 24, 2013, after also receiving approval from the Institutional Review Board at the University of Arizona, where the study would take place.

Unfortunately, unlike the FDA, which must respond to submissions within 30 days of receiving them, NIDA has no such time limit. We have already waited over seven weeks for NIDA’s response, and it could take much longer. Meanwhile, NIDA is successfully preventing FDA and IRB-approved research from taking place.

Dr. Sue Sisley, assistant director of interprofessional education and assistant professor of internal medicine and psychiatry at the University of Arizona, was approved by the Food and Drug Administration two years ago to study the effect of cannabis on veterans who suffer from post traumatic stress disorder.

5 comments

  1. “22 veterans die by suicide every day.” 80% of returning Iraq/Afghanistan war veterans with PTSD symptoms never seek treatment from the Veterans Administration.

    An anonymous online computer therapy program for PTSD at PTSDSTRESS.COM reduces the symptoms of PTSD. Developed in part by a National Institute of
    Health PTSD researcher, the user follows an easy-to-use program on their home computer. There is no registration.

    The cost is $10 per session and accepts credit cards but does not require a cardholder name for further anonymity and confidentiality. Military and non-military men and women users report results on PTSDSTRESS.COM home page.

  2. The federal strategy for a long time has been to provide disinformation, to fail to permit research into benefits of the plant, and to say that no data regarding efficacy exists. Even when marijuana was placed on schedule one of the CSA it was not because of known dangers but rather due to a lack of evidence. When that evidence, from the Schaefer Commission Report was available and suggested that it not be criminalized, that evidence was ignored. Every ten years or so we have continued to support major studies regarding marijuana and they all come to remarkably similar conclusions. Although the FDA, DEA, and NIDA have been able to control research in the US this is not the case worldwide. Evidence continues to emerge of benefits continues to be reported and some countries even provide marijuana to their soldiers because of its benefits for PTSD. It’s time to begin expecting honesty from our federal government rather than the standard line set to economically benefit a few.

  3. The federal strategy for a long time has been to provide disinformation, to fail to permit research into benefits of the plant, and to say that no data regarding efficacy exists. Even when marijuana was placed on schedule one of the CSA it was not because of known dangers but rather due to a lack of evidence. When that evidence, from the Schaefer Commission Report was available and suggested that it not be criminalized, that evidence was ignored. Every ten years or so we have continued to support major studies regarding marijuana and they all come to remarkably similar conclusions. Although the FDA, DEA, and NIDA have been able to control research in the US (because they control the supply available for research) this is not the case worldwide. Evidence continues to emerge of benefits and some countries even provide marijuana to their soldiers because of its positive impact on treatment for PTSD. It’s time to expect honesty from our federal government rather than to accept the standard line that economically benefits a few. It’s also time for Arizona to set reasonable standards to add medical conditions to the Medical Marijuana Act rather than to use a “gold standard” that none could ever meet. The voters rejected use of the FDA standards when the Arizona Medical Marijuana Act was passed.

  4. The federal strategy for a long time has been to provide disinformation, to fail to permit research into benefits of the plant, and to say that no data regarding efficacy exists. Even when marijuana was placed on schedule one of the CSA it was not because of known dangers but rather due to a lack of evidence. When that evidence, from the Schaefer Commission Report was available and suggested that it not be criminalized, that evidence was ignored. Every ten years or so we have another major study regarding marijuana and they all come to remarkably similar conclusions. Although the FDA, DEA, and NIDA have been able to control research in the US (because they control the supply available for research) this is not the case worldwide. Evidence continues to emerge of benefits and some countries even provide marijuana to their soldiers because of its positive impact on treatment for PTSD. It’s time to expect honesty from our federal government rather than to accept the standard line that economically benefits a few. It’s also time for Arizona to set reasonable standards to add medical conditions to the Medical Marijuana Act rather than to use a “gold standard” that none could ever meet. The voters rejected use of the FDA standards when the Arizona Medical Marijuana Act was passed.

  5. Meanwhile, GW Pharma is conducting multiple FDA clinical trials, including expedited phase 3 pediatric epilepsy trials, for whole plant cannabis extract oil medicines Sativex and Epidiolex. Sativex has been in trials for some time, for cancer pain, for MS pain & spasticity and now for cancer treatment. Epidiolex received expedited approval for trials in treating pediatric epilepsy. Amazing that the very same cannabis extracts which are the basis for federal felony charges, and denied patients in many states (such as New Jersey), are perfectly safe when used to conduct trials for corporate products.

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