President Obama’s Department of Health and Human Services administration recently announced that research on the medical effects of marijuana using non-federal grant money no longer need to pass a Public Health Service (PHS) review. This represents a big step forward for companies and other researchers who want to investigate the possible health effects of marijuana.
David Goldstein, the CEO of a start-up called PotBotics looks forward to regulations easing. His company is trying to create a reference database matching neurological illnesses with their appropriate medicinal cannabanoids at the molecular level. He says the new ruling will open the doors to much more research in the United States. “We won’t need to go to Israel or Canada to find the all data we need,” Goldstein said.
Medical marijuana drug development research, which aims to bring the whole plant through the FDA approval process so it can be prescribed, has been so tightly restricted that it has barely existed, said Brad Burge, Director of Communications and Marketing of MAPS, the Multidisciplinary Association for Psychedelic Studies.
That is starting to change. Since 1999, The PHS committee has reviewed non-federally-funded marijuana study research proposals including clinical and laboratory practices and appropriate interaction with human subjects. Working with the National Institutes of Health and the Food and Drug Administration, The Office of the Assistant Secretary for Health, found the process overlapped enough with the FDA procedures that studies already go through, that it was not necessary and has been eliminated.
Krystal Kitahara, CEO of Yummi Karma (not to be confused with Yummy Karma, an Indian food company) would like to see research opportunities expanded for marijuana products even more. “Businesses are hungry for this information so we can make the best products for people,” she said. Kitahara’s company created a cannabis tincture to help relieve menstrual symptoms called Mood Magic and is working on a female libido enhancer to be released soon called Love Potion Number 420.
To create her products, Kitahara teams up with an herbalist and a doctor to create test versions and then sends samples out to a group who will try them and give her feedback via survey. As a small business she does not have the resources or scientific training to include a control group or manage other aspects of the study the way a pharmaceutical company or university researcher would. “We are careful not to claim too much because this isn’t medical-grade research.” She said, “If we had reliable sources of information, it would be a game changer in the industry.”
While streamlining the approval process represents the removal of a major roadblock to new research, another daunting hurdle stands between companies, researchers and their ability to work – the one single supplier of all cannabis for government-approved testing. All marijuana used in FDA-approved research has to be supplied by NIDA the National Institute on Drug Abuse.
NIDA wasn’t set up to provide marijuana for medicinal research and so far hasn’t been able to supply everything researchers need, according to Burge. In an attempt to increase marijuana availability, his organization will soon be applying to the Drug Enforcement Agency to open an alternative farm for privately funded researchers. “We’ve been turned down before, but hope this signal from President Obama will change things,” he said.
A greater supply would help researchers like Dr. Sue Sisely who wants study the use of marijuana for symptoms associated with post-traumatic stress disorder among veterans. She says she has been waiting 15 months for special marijuana strains she designed and then requested from NIDA. “A private grower could have created them in three months,” she said.
Allowing made-to-order marijuana that could be sold for medical testing could launch a whole new area of the industry because there are many different forms of it that could be supplied by the private sector. Along with different strains of the plant in its flower form, Potbotic’s Goldstein says he would like to see concentrates available that could be more specialized at the chemical level, for more precise testing.
Once roadblocks are cleared, medical marijuana research companies can grow quite quickly. Tikun Olam in Israel was established in 2005 and was licensed to produce and supply medical cannabis to approved patients in 2007. Now the company employs about 100 workers including scientists, doctors, nurses, biochemists, and agronomists. Maayan Weisberg says the company has provided cannabis treatments for 10,000 patients. As regulation ease, she is looking forward to collaborating with partners in the United States.
By Julie Weed - Forbes/June 28, 2015
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