After more than 50 years, the federal government has lifted the obstacle to cannabis research, which scientists and supporters say are hindering rigorous research and possible drug development in cannabis research.
Since 1968, US researchers have been licensed to use it. Cannabis from the only domestic source: A facility based at the University of Mississippi under a contract with the National Institute of Drug Abuse (NIDA).
That changed when the Drug Enforcement Administration announced earlier this month that it was in the process of: Register some additional American companies Producing cannabis for medical and scientific purposes.
This promises to accelerate the understanding of plant health effects and possible treatments for treating a variety of conditions, including chronic pain, side effects of chemotherapy, multiple sclerosis, and mental illness. It is a movement to do. Not yet fully researched..
“This is a crucial decision,” says Rick Doblin, executive director of the Interdisciplinary Association for Psychedelic Research (MAPS). Schedule 1 medicine — The most restrictive class of controlled substances, defined by the federal government as “drugs not currently approved for medical use”.
“This is the last political impediment to Schedule 1 drug research,” he says.
about One-third of Americans Currently living in a state where recreational marijuana is legal 30 states implement medical marijuana programsHowever, because cannabis is still illegal under federal law, scientists are not yet allowed to use cannabis sold in state-approved dispensing pharmacies for clinical research.
“It’s a big break.” Dr. Igor GrantHe is a professor of psychiatry and director of the Center for Medicinal Cannabis Research at the University of California, San Diego.
The new DEA decision does not resolve the conflict between federal and state law, but it does provide researchers with a new federal-approved pipeline for more products and cannabis stocks.
“We will see more than a decade of explosive cannabis research and potential new therapies.” Glof North AmericaIs one of three companies that have publicly announced that they have received federal pre-approval for research cannabis cultivation.
A long battle to overturn the federal “monopoly”
Despite their efforts, scientists have faced administrative and legal hurdles in growing pharmaceutical-grade cannabis for decades.
In 2001, renowned plant biologist Dr. Lyle Kraker first applied for a license to grow research marijuana — Just encounter years of delay It is the beginning of a lengthy court battle with the DEA and needs to be licensed for research on schedule 1 drugs such as cannabis.
“Everything has its own chemical profile and there are thousands of different cannabis varieties that produce their own clinical benefits, but we didn’t have access to their usual variety,” he said. Dr. Sue SisleyHe is a cannabis researcher, president of the Scottsdale Institute, and has received interim DEA approval to produce cannabis for research.
Only in 2016 will the federal government Notify policy changes That would open the door to new growers, but applications for it had been stagnant for years. Craker and others are over Sue the federal government Beyond the delay.
Sisley has long been concerned about the supply of cannabis from the NIDA facility in Mississippi, especially how it is processed.She used the cannabis produced there Recently published clinical trials About the treatment of PTSD in veterans.
She describes the product as an “anemic” greenish powder.
“When something is diluted, it’s very difficult to overcome the placebo effect,” she says.
A study of 76 people, which took 10 years to complete, concluded that smoked cannabis was generally well tolerated and had no adverse effects on this group. However, there was no statistically significant difference in alleviation of PTSD symptoms when compared to placebo.
For UCSD grants, the issue of long-term cannabis supply is not quality, but the lack of various products such as food and oil, and cannabis strains with different concentrations of CBD and THC, the main psychoactive ingredients of plants. ..
“There isn’t enough research into the types of marijuana products people in the real world are using,” he says.
Due to limited domestic supply, some researchers rely on importing cannabis from outside the United States. Placement It’s “difficult” and prone to hiccups, Sisley says.
Since cannabis at the NIDA facility could only be used for academic research, restrictions on research cannabis are also hampering the path to drug development. Not for prescription drug developmentThe drugs studied in Phase 3 clinical trials (required before applying for approval from the Food and Drug Administration) must be the same as those sold later.
“NIDA’s monopoly is why we own medical marijuana primarily in the United States, but not through the FDA,” said Dobrin of MAPS. “Drug development with domestic supply What we can do is a fundamental change. ”
Some barriers still remain
The few companies that will soon land DEA spots for growing cannabis have an enthusiastic market for researchers who are “seeking” the opportunity to study the scientific properties and medical potential of plants, Groff said. There is also an FDA project to study the antibacterial properties of cannabis to kill dangerous bacteria, such as: MRSA..
By the end of next year, Groff expects his company to produce up to £ 5,000 a year in marijuana and provide researchers with a “full menu of customizable options.”
Biopharmacy research company The third company that grows cannabis under the Drug Enforcement Administration (DEA) license has already signed dozens of contracts with US researchers and has seen more academic institutions, pharmaceutical companies and biotechnology companies following policy changes. CEO George Hodzin said.
“Now there is a very clear and approved legitimate path to legally entering the US cannabis market,” says Hodzin.
Washington State University Cannabis Policy, Research and Outreach Center It’s one of the places where you will eventually procure cannabis from Hodgin’s business.
“This is definitely a big step in the right direction, as the industry is moving much faster than we are studying,” he said. Michael McDonnell, Associate Professor of Medicine and Director of the University Cannabis Center.
But he also finds it never easy to study cannabis as more growers come online, because researchers need a special license to work with Schedule 1 drugs. And it is difficult to get a grant to carry out these studies.
Despite the widespread use of marijuana in the United States, other schedules such as MDMA (Ecstasy) 1 Study of the medical potential of drugs Much more advanced than cannabis..
Grant of UCSD said the biggest step forward in the study was to exclude cannabis from the Schedule 1 drug classification: “If that happens, many of the problems we’ve talked about will be solved. Let’s do it, “he says.
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Fifty years later, the United States opens the door to more cannabis crops for scientists
Source link Fifty years later, the United States opens the door to more cannabis crops for scientists