The DEA is looking for candidates to grow marijuana for research – but will it find any takers?

Wanted: Someone to grow marijuana for the federal government. Benefits: A contract likely worth millions and the chance to enable medical research. Requirements: Ability to deal with the costs and regulations that come with growing an illegal drug for the federal government.

For more than four decades, the University of Mississippi has had an exclusive license with the government to grow marijuana for federally sanctioned research. But this month, the Drug Enforcement Administration announced it would grant permission to other growers — an effort, it said, to expand the supply and variety of marijuana available for research.

So has the change set off a gold rush to grow the green? Not exactly.

STAT contacted almost a dozen agricultural schools, including those with industrial hemp programs, to gauge their eagerness to grow marijuana for the government.

Not interested, said Cornell University, the University of Kentucky, and Virginia Tech. Ditto, said Michigan State University, the University of Vermont, and Western Kentucky University.

No plans, said University of California, Davis, and University of Nebraska, Lincoln. Same with Colorado State University, Oregon State University, and Purdue University.

“We are very boring that way,” Janna Beckerman, a plant pathologist who researches hemp at Purdue, wrote in an email.

Some interested groups could be keeping their plans under wraps. And other possible candidates may be trying to get a better sense of what the DEA wants. But any reluctance might stem from more than being boring.

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To register with the agency, applicants will need to show that they will have security measures in place to protect the marijuana and be willing to comply with a host of other requirements. And depending on the scale of the operation, prospective growers will likely have to make significant investments to get it up and running.

Bob Morgan, an attorney at Much Shelist who formerly led the Illinois medical marijuana program, said that facilities in states that have strict regulations on medical marijuana growers are probably looking at multimillion-dollar expenditures for construction alone.

“I think everybody is just thinking about how to approach this,” said Dr. Igor Grant, director of the Center for Medicinal Cannabis Research at the University of California, San Diego. “What will it really take to get one of these DEA licenses?”

Grant said he would consider talking with other universities and agencies in California to see if it was worth the effort to get a cultivation operation in the state, but beyond that had not heard of groups intending to apply.

One researcher in the running is Lyle Craker, who studies medicinal plants at the University of Massachusetts, Amherst, and has tried in the past to get approval to grow marijuana. He did not reply to an email requesting comment, but a spokesman for a group called the Multidisciplinary Association for Psychedelic Studies — which sponsors related research — said it is supporting Craker’s efforts to get a license, as it has in the past.

Other possible applicants include independent growers who operate in states where medical and recreational marijuana is legal. Some cultivators have an expertise in running a large-scale marijuana facility — with state-of-the-art practices and security measures and experience dealing with state regulators — that in theory might appeal to federal authorities.

But the fact is, their existence contravenes federal law.

In a memo announcing the policy change, acting DEA Administrator Chuck Rosenberg said that it would consider whether applicants have “engaged in illegal activity involving controlled substances … regardless of whether such activity is permissible under state law.” While that doesn’t disqualify current cultivators, policy experts and people in the industry say the DEA won’t look highly upon them.

“They made it very clear that if you have been in violation of the [Controlled Substances Act], that would be weighted heavily against you,” said Rachel Gillette, an attorney at Greenspoon Marder in Colorado who represents marijuana businesses.

That might not stop people from trying, though.

Charlie Bachtell is the CEO and founder of Cresco Labs, which grows medical marijuana at three sites in Illinois. Bachtell said he is considering applying to the DEA because he wants to support research that could show marijuana has medical benefits.

“The future of this industry definitely starts with research,” Bachtell said. “The opportunity to help progress the acceptance, the elevation, and the professionalism of the medical cannabis industry really starts with research.”

The DEA’s policy change also opened the door to a new group of candidates: drug makers. While the Mississippi marijuana is funneled to academic research, Rosenberg wrote that marijuana can now be grown “for strictly commercial endeavors … aimed at drug product development.”

GW Pharmaceuticals, a company that is developing a drug for epilepsy from a component of marijuana called cannabidiol, said it has not made a decision about a growing facility in the United States, but remained vague enough to suggest possible interest. The company makes the drug, Epidiolex, in the United Kingdom, where it is based.

“We are exploring additional growing facilities in places around the world,” the company said in a statement.

The DEA’s application process is open, but the agency has set no deadline to select growers. The agency has indicated it wants just enough marijuana to be produced so research demands are met, but not more than that.

“It could be that two years from now, we still only have one registrant,” said Alex Kreit, an expert on marijuana law at Thomas Jefferson School of Law.

Even if cultivators gets licenses, they will confront a chicken-and-egg quandary: If they get special approval to grow marijuana, where do they get the supply they need to start it?

They could obtain marijuana from the University of Mississippi, but that would defeat the purpose of trying to expand the genetic variety of plan
ts available. Or they could get seeds and plants from another country, such as Canada or Israel, with the proper permits.

An existing grower could also surrender some marijuana to law enforcement, which could then hand it over to a newly registered grower.

For its part, a spokesman wrote in an email that that the DEA “would require manufacturers to obtain their seeds from a lawful source, and the DEA would assist the new manufacturers in this regard.”

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Marijuana studies

Craker is known for proposing that medical grade marijuana be available for scientific studies into its possible health benefits. Since the marijuana available for studies is too weak for any kind of medical study, he proposed that medical grade marijuanna be made available for research purposes. He has been named in many newspapers on this subject. The federal government refuses to give him a license to grow medical grade marijuana. On April 29, 2009, Senators Edward M. Kennedy and John F. Kerry wrote a letter to the Honorable David W. Ogden urging the Deputy Attorney General to delay a final decision on the application by Lyle E. Craker of the University of Massachusetts Amherst to produce research-grade marijuana for use in federally approved clinical trials[3][2][4][5]

Medical Marijuana Research Hits Wall of U.S. Law

By SERGE F. KOVALESKIAUG. 9, 2014

    Above: Suman Chandra checking marijuana plants at a federal marijuana facility at the University of Mississippi in Oxford. Credit Lance Murphey for The New York Times

    Nearly four years ago, Dr. Sue Sisley, a psychiatrist at the University of Arizona, sought federal approval to study marijuana’s effectiveness in treating military veterans with post-traumatic stress disorder. She had no idea how difficult it would be.

    The proposal, which has the support of veterans groups, was hung up at several regulatory stages, requiring the research’s private sponsor to resubmit multiple times. After the proposed study received final approval in March from federal health officials, the lone federal supplier of research marijuana said it did not have the strains the study needed and would have to grow more — potentially delaying the project until at least early next year.

    Then, in June, the university fired Dr. Sisley, later citing funding and reorganization issues. But Dr. Sisley is convinced the real reason was her outspoken support for marijuana research.

    “They could never get comfortable with the idea of this controversial, high-profile research happening on campus,” she said.

    Dr. Sue Sisley said the University of Arizona had fired her because of her outspoken support for marijuana research. Credit Laura Segall for The New York Times

    Dr. Sisley’s case is an extreme example of the obstacles and frustrations scientists face in trying to study the medical uses of marijuana. Dating back to 1999, the Department of Health and Human Services has indicated it does not see much potential for developing marijuana in smoked form into an approved prescription drug. In guidelines issued that year for research on medical marijuana, the agency quoted from an accompanying report that stated, “If there is any future for marijuana as a medicine, it lies in its isolated components, the cannabinoids and their synthetic derivatives.”

    Scientists say this position has had a chilling effect on marijuana research.

    Though more than one million people are thought to use the drug to treat ailments ranging from cancer to seizures to hepatitis C and chronic pain, there are few rigorous studies showing whether the drug is a fruitful treatment for those or any other conditions.

    A major reason is this: The federal government categorizes marijuana as a Schedule 1 drug, the most restrictive of five groups established by the Controlled Substances Act of 1970. Drugs in this category — including heroin, LSD, peyote and Ecstasy — are considered to have no accepted medical use in the United States and a high potential for abuse, and are subject to tight restrictions on scientific study.

    CONTINUE READING ON NYT…

    Medical Marijuana Research Hits Wall of U.S. Law

    By SERGE F. KOVALESKIAUG. 9, 2014

      Above: Suman Chandra checking marijuana plants at a federal marijuana facility at the University of Mississippi in Oxford. Credit Lance Murphey for The New York Times

      Nearly four years ago, Dr. Sue Sisley, a psychiatrist at the University of Arizona, sought federal approval to study marijuana’s effectiveness in treating military veterans with post-traumatic stress disorder. She had no idea how difficult it would be.

      The proposal, which has the support of veterans groups, was hung up at several regulatory stages, requiring the research’s private sponsor to resubmit multiple times. After the proposed study received final approval in March from federal health officials, the lone federal supplier of research marijuana said it did not have the strains the study needed and would have to grow more — potentially delaying the project until at least early next year.

      Then, in June, the university fired Dr. Sisley, later citing funding and reorganization issues. But Dr. Sisley is convinced the real reason was her outspoken support for marijuana research.

      “They could never get comfortable with the idea of this controversial, high-profile research happening on campus,” she said.

      Dr. Sue Sisley said the University of Arizona had fired her because of her outspoken support for marijuana research. Credit Laura Segall for The New York Times

      Dr. Sisley’s case is an extreme example of the obstacles and frustrations scientists face in trying to study the medical uses of marijuana. Dating back to 1999, the Department of Health and Human Services has indicated it does not see much potential for developing marijuana in smoked form into an approved prescription drug. In guidelines issued that year for research on medical marijuana, the agency quoted from an accompanying report that stated, “If there is any future for marijuana as a medicine, it lies in its isolated components, the cannabinoids and their synthetic derivatives.”

      Scientists say this position has had a chilling effect on marijuana research.

      Though more than one million people are thought to use the drug to treat ailments ranging from cancer to seizures to hepatitis C and chronic pain, there are few rigorous studies showing whether the drug is a fruitful treatment for those or any other conditions.

      A major reason is this: The federal government categorizes marijuana as a Schedule 1 drug, the most restrictive of five groups established by the Controlled Substances Act of 1970. Drugs in this category — including heroin, LSD, peyote and Ecstasy — are considered to have no accepted medical use in the United States and a high potential for abuse, and are subject to tight restrictions on scientific study.

      CONTINUE READING ON NYT…

      Medical marijuana backers ask judges for looser regulation

       

       

      October 17, 2012

      By BLOOMBERG NEWS

      mmj3

      The U.S. Drug Enforcement Administration ignored research showing marijuana had legitimate medical uses when it rejected efforts to reclassify the drug as a less harmful substance last year, a lawyer for medical marijuana backers told a federal appeals court.

      Joseph Elford, a lawyer for Americans for Safe Access, asked a three-judge panel in Washington today to order the DEA to reconsider its decision to keep marijuana a Schedule I narcotic, saying the agency’s ruling that there are no scientific studies finding an acceptable medical use was arbitrary and capricious.

      “There are over 200 studies that are adequate and well-controlled studies,” Elford told the judges.


      MORE: Editorial: Why not pot for medical use in NY?
      VIDEO: Learning the marijuana trade | Seniors using medical marijuana | Should federal prosecutors ease up on states where medical marijuana is legal?


      The case involves an 10-year-old petition from medical marijuana advocates who asked the DEA to reclassify marijuana as a Schedule III, IV or V drug, which would allow for looser regulation. On June 21, 2011, the DEA rejected the request, stating that existing clinical evidence wasn’t adequate to warrant reclassification.

      The judges questioned whether the medical marijuana patients and the advocacy group had the authority to challenge the DEA’s decision. U.S. Circuit Judge Merrick Garland said the court has limited authority to review it as long as the agency made a proper showing of support for it.

      “I’m trying to figure out what our standard of review is,” Garland asked a lawyer for the Justice Department. “Is there evidence to support the administration’s position that there is no substantial evidence? That sounds funny.” Lena Watkins, a lawyer for the Justice Department, said the studies cited by the marijuana proponents were rejected because the research didn’t meet government standards. She said about 15 studies meet the standards, though the government doesn’t have the final results yet.

      The case is Americans for Safe Access v. Drug Enforcement Administration, 11-1265, U.S. Court of Appeals for the District of Columbia (Washington).

      CONTINUE READING…