Medical Marijuana

DEA Concession Means Marijuana Could Be Approved As a Medicine

With NIDA as the only legal source of cannabis for research, meeting FDA requirements was impossible.

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Reason TV

Rick Doblin, who as head of the Multidisciplinary Association for Psychedelic Studies (MAPS) has been trying for years to jump through the hoops required to get marijuana approved as a medicine, says the Drug Enforcement Administration's new willingness to license more than one producer of cannabis for research will finally make it at least theoretically possible to complete that process.

The National Institute on Drug Abuse (NIDA) has long had exclusive control over the legal supply of marijuana, which is grown by a single contractor at the University of Mississippi. In a legal battle that lasted more than a decade, MAPS tried to break that monopoly, which was a crucial barrier to meeting the Food and Drug Administration's requirements for approving a new medicine. The problem was not just the quality and variety of marijuana available from NIDA, or the agency's lack of enthusiasm for studies aimed at demonstrating the drug's benefits rather than its hazards. It was also the fact that NIDA's marijuana is available only for research, not for sale to patients following FDA approval.

"The FDA requires the Phase III studies be conducted with the exact same drug that the sponsor of the research is trying to market," Doblin explained in a recent interview on the Pacifica drug policy show Century of Lies. "So as long as the NIDA monopoly was in existence, FDA would never accept its marijuana for use in Phase III, and we could never get data that was necessary to reschedule."

MAPS is about to start a Phase II study of marijuana as a treatment for post-traumatic stress disorder in veterans, for example, but it has to use marijuana from NIDA. Since federally approved researchers are not allowed to buy marijuana from state-licensed suppliers in Colorado or Washington, NIDA is the only legal source. One problem with that is MAPS could not get all the strains it wanted: It asked for one with 12 percent THC and 12 percent cannabidiol (CBD), which NIDA did not have. But even if NIDA had a bigger variety, its marijuana would not be suitable for Phase III studies should the Phase II results look promising.

Now that the DEA has agreed to authorize other growers, research sponsors like MAPS can apply for licenses or contract with new licensees, which will make it possible to ensure that the marijuana used in their studies is the same as the marijuana they plan to make available as a medicine. "What's been so frustrating [is] that, on the one hand, the federal government has said there's not enough evidence to reschedule marijuana," Doblin said, "but on the other hand, they've blocked the ability to get the evidence. And so now that DEA has said that they'll end the NIDA monopoly, that evidence can be gathered….It's going to take four to six years, it could be $15 to $25 million, to gather it. But at least it's possible now, whereas before it was not possible."

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  1. This is all such a god damn joke. How gutless are these fucking politicians and bureaucrats?

    1. That rhetorical, right?

  2. Focus on impeaching the prosecutors and DEA executives who violated the Rohrabacher Amendment by illegally dipping into the Treasury to obstruct state medical marijuana laws.

    It’s bad enough for Congress to loot the treasury, but for the executive to loot the treasury in defiance of Congressional funding restrictions touches the Constitution in a vital point of separation of powers. No money may be drawn from the treasury except by appropriations made by law. If that part of the Constitution goes, we’re a Latin American country.

  3. The problem was not just the quality and variety of marijuana available from NIDA, or the agency’s lack of enthusiasm for studies aimed at demonstrating the drug’s benefits rather than its hazards.

    Everyone knows a scientist’s only agenda is science.

    1. I’m using that

  4. “Obama’s gonna legalize weed in his 2nd term”

  5. trying for years to jump through the hoops required to get marijuana approved as a medicine

    Obviously the solution is to label each MJ container with “This product is not intended to diagnose, treat, cure or prevent any disease.”

  6. Treating marijuana as medicine is bad and really muddies the water in my opinion. Getting something approved as a medicine is a huge process with the FDA that involves multiple levels of clinical trials and many opportunities for political wrangling. It must be proven to the feds to be safe and effective.

    I think it’s not something that should be pursued. Treating marijuana as medicine at the federal level is almost the same as prohibition. You can’t get medicines on the federal schedules without prescriptions. I can’t see how the feds can treat something both as a medicine which is tightly controlled while simultaneously allowing for recreational use. Are there any other drugs so treated?

    Marijuana shouldn’t be rescheduled. It should be taken off the schedules completely.

    1. I couldn’t have said it better. Rescheduling is mostly symbolic. Deschedule, not reschedule!

  7. There is no intention of there ever being FDA approved medicines from Mj, except those that purchased licence..
    everrrrrrr.
    Neither will the ONDCP ever change general use laws… unless a Pharma or Cigarette company has control.
    If it happens, legal MJ, it will only be by ballot voting in the States, never by a vote of the people at a federal level/
    How much power does the ONDCP have over MJ? When the DEA was sued about lying on MJ, it was the ONDCP that answered, not the DEA.
    The ONDCP constituents regularly donate, ILLEGALY, with Fed tax derived dollars to State level political candidates election funds. The ONDC has been sued in court and the ONDCP won where no bank records can be used against the ONDCP… for showing proof, they are breaking the law.
    These constituents have for decades donated free POTUS election campaign services to both parties at the same time.

    1. There are THC drugs now for medical MJ, no matter what you may wish for, only FDA approved MJ drugs will be federally approved, when they get to it, to Pharma companies. Never will the Fed make general use legal, never will the State Officials allow a real commodity usage, nor the Presidents, till someone pays then to.
      When finally, some 20+ years from now, a cigarette company is allowed to package MJ, it will require another 30 years, just like alcohol prohibition repeal, for the citizens to be allowed to ‘grow their own’ for a one year supply at on crop.
      Till then, no insurance will be made available interstate for the workplace, no Federally acknowledged ‘safe limit’, or ‘how long since used’, no insurance for safe workplace, no federal or State job will allow employees to have any MJ in their system.

      Now there is a way to blow this up, all people could harangue Politicians continually on whether they take illegal Fed tax dollars for their MJ policy… Politicians are NOT protected like the ONDCP is in the bank records issue.
      Without politicians, Pharmas and cigarette companies haven’t a way to abuse the right of voting citizens.

      What’s the chance of some 30 million users ever actually exposing the corruption… by simply constantly putting it in front of the media… every time a politician is in the public?

  8. Oh dont mind me. I’m just enjoying the libertarian(n?)ess of this moment

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