We write to express our support for increasing scientific research on the therapeutic risks and benefits of marijuana. We ask that you take measures to ensure that any non-National Institutes of Health (NIH) funded researcher who has acquired necessary Food and Drug Administration (FDA), Institutional Review Board (IRB), Drug Enforcement Administration (DEA) and appropriate state and local authority approval be able to access marijuana for research at-cost without further review.
Twenty-one states and the District of Columbia have passed laws allowing for the use of medical marijuana. Over one million Americans currently use medical marijuana at the recommendation of their physician. There is overwhelming anecdotal evidence from patients, their family members, and their doctors of the therapeutic benefits of marijuana for those suffering from cancer, epilepsy, seizures, Post-Traumatic Stress Disorder, glaucoma, anxiety, chronic pain, and more.
We believe the widespread use of medical marijuana should necessitate research into what specific relief it offers and how it can best be delivered for different people and different conditions. Yet, the scientific research clearly documenting these benefits has often been hampered by federal barriers.
Researchers seeking to develop prescription drugs in the United States must go through FDA and IRB approval processes. To conduct research using Schedule I substances such as marijuana, LSD, psilocybin and MDMA, researchers must also seek a DEA registration, as well as any required state and local licenses. The review process required to gain these approvals is robust and ensures that researchers are weighing the risks as well as the possible benefits of their potential medications.
Only with marijuana, and no other Schedule I substances, is there an additional Public Health Service review for non NIH-funded protocols, established in the May 21, 1999, Department of Health and Human Services (HHS) “Guidance on Procedures for the Provision of Marijuana for Medical Research.” This review process grants access to the only source of marijuana that can be legally used for research – grown by the University of Mississippi under contract with the National Institute on Drug Abuse (NIDA).
In light of the fact that substances like opioids and barbiturates have been researched and developed for human use, it would seem that we should investigate the legitimate medical uses of marijuana. We request that you review and revise the HHS 1999 Guidance to eliminate what we believe to be an unnecessary additional review process. NIDA should provide marijuana at-cost to all non-NIH funded marijuana research protocols that have successfully obtained necessary FDA, DEA, IRB and appropriate state and local authority approval.
Considering the number of states with medical marijuana laws and the number of patients who use marijuana medicinally in the United States, it is clear that we need more scientific information about the therapeutic risks and benefits of marijuana.
Thank you for your attention to this request, and we look forward to your response.
Sincerely,Guidance on Procedures for the Provision of Marijuana for Medical Research: http://grants.nih.gov/grants/