The Los Angeles Times is the first to report on the approval of our planned study of marijuana for symptoms of PTSD by the U.S. Department of Health and Human Services. After waiting over four and a half months for a response to our October 24, 2013, protocol resubmission, HHS finally granted approval for MAPS to purchase marijuana from the National Institute on Drug Abuse on March 14, 2014. MAPS has been attempting to purchase marijuana for medical marijuana drug development research for over 22 years. “This is a great day,” said University Arizona researcher Dr. Sue Sisley, who will lead the study. “The merits of a rigorous scientific trial have finally trumped politics.”
Much more news coverage at MAPS in the Media.
Originally appearing here.
WASHINGTON — The Obama administration handed backers of medical marijuana a significant victory Friday, opening the way for a University of Arizona researcher to examine whether pot can help veterans cope with post-traumatic stress, a move that could lead to broader studies into potential benefits of the drug.
For years, scientists who have wanted to study how marijuana might be used to treat illness say they have been stymied by resistance from federal drug officials.
The Arizona study had long ago been sanctioned by the Food and Drug Administration, but under federal rules, such experiments can use marijuana only from a single, government-run farm in Mississippi. Researchers say the agency that oversees the farm, the National Institute on Drug Abuse, has long been hostile to proposals aimed at examining possible benefits of the drug.
“This is a great day,” said the Arizona researcher, Suzanne A. Sisley, clinical assistant professor of psychology at the university’s medical school, who has been trying to get the green light for her study for three years. “The merits of a rigorous scientific trial have finally trumped politics.
“We never relented,” Sisley said. “But most other scientists have chosen not to even apply. The process is so onerous. With the implementation of this study and the data generated, this could lead to other crucial research projects.”
Backers of medical marijuana hailed the news as an indication that the government had started coming to terms with one of the more striking paradoxes of federal drug policy: Even as about 1 million Americans are using marijuana legally to treat ailments, scientists have had difficulty getting approval to study how the drug might be employed more effectively.
“The political dynamics are shifting,” said Rick Doblin, executive director of the Multidisciplinary Assn. for Psychedelic Studies, or MAPS, a group based in Santa Cruz that is raising money to help fund studies such as Sisley’s. The group counts several prominent philanthropists among its backers, including two Pritzkers and a Rockefeller.
Government officials said the approval did not represent a change in underlying policy — just a recognition that Sisley’s proposal meets official standards for research using illegal drugs. The research still requires approval of one more agency, the Drug Enforcement Administration, but Sisley and Doblin expressed confidence that that would prove a lesser hurdle.
In its letter approving the application, a government review panel noted what it called “significant changes” in the study that justified approving it now. Doblin said the changes did not affect the “core design” of the study.
Federal restrictions on pot research have been a source of tension for years. Researchers, marijuana advocates and some members of Congress have accused the National Institute on Drug Abuse of hoarding the nation’s only sanctioned research pot for studies aimed at highlighting the drug’s ill effects. They had pointed to Sisley’s experience as a prime example of what they called an irrational and disjointed federal policy.
“You have impossible burdens,” said Rep. Earl Blumenauer (D-Ore.), who has enlisted other members of Congress to lobby the administration to give researchers more access to the drug.
“These are not people who are going to be involved with some clandestine production of the drug or do something nefarious. They are trying to do scientific research that will add to the body of knowledge and safety,” he said.
Blumenauer likes to recount the story of a doctor who works with children who have violent epileptic seizures. The children’s parents “have found that the use of marijuana has reduced the frequency and intensity of these horrific episodes. But because of our stupid research policies, it is easier for the parent to get medical marijuana than for a researcher,” he said.
Scientists say more research could help determine more precisely which ailments the drug can treat and could eventually lead to regulation by the FDA as a prescription drug. That would allow patients to know what they are consuming. Currently, users of medical marijuana often have little information about the potency and purity of the pot they buy. Physicians who prescribe the drug do so on the basis of evidence that is largely anecdotal.
At the core of the debate is an issue that has implications for both research and the movement to legalize marijuana for recreational use, as Colorado and Washington have done. Currently, federal law classifies pot as more dangerous than cocaine and methamphetamine. As a “Schedule 1” drug, marijuana is designated as having “no currently accepted medical use and a high potential for abuse,” as well as being a drug that puts users at risk of “severe psychological or physical dependence.”
Researchers say that classification needs to change for science to proceed uninhibited. Making the change, though, would be a retreat in the war on drugs. The Obama administration could reschedule the drug without congressional action, but has shown no inclination to wade into that fight.
In the last 10 years, the government had approved just one U.S. research center to conduct clinical trials involving marijuana use for medical purposes — a UC San Diego facility created by the California Legislature.
The scientist who runs that center, Igor Grant, said his success in getting Washington’s sign-off was due in large part to something other scientists do not have: the full force of the state. Blocking his work would have been a direct affront to lawmakers in Sacramento, he noted.
Grant’s studies looked at such questions as whether pot could help ease the nausea and vomiting associated with cancer treatment or the severe appetite suppression experienced by those with HIV, which causes AIDS.
“Every one of those studies showed, in the short term, a beneficial effect,” Grant said. “There is very good evidence cannabis is helpful.”