Hallucinogens as Therapy, What’s the Hold Up?
Brad Burge, a spokesman for the California-based MAPS, says it took his organization 10 years to get research into MDMA to a phase-3 clinical trial.
Researchers say that getting studies approved can be difficult, as most of these substances are listed as Schedule I drugs by the DEA -- meaning they are presumed to have no accepted medical use and a high potential for abuse.
“You have an entire array of institutions that need to sign off -- the FDA; the DEA; at a university, the institutional review board,” Johnson says. “There are a lot of hoops to jump through.”
DEA spokesman Russ Baer says “We support scientific research. We want to remove any sort of bureaucratic hurdles that may have existed in the past.”
The FDA allows Schedule 1 substances to be studied in clinical research under the Investigation New Drug application. FDA agency spokeswoman Sandy Walsh says substances involved “are subject to the most stringent restrictions.” They are safely stored and tracked through stringent DEA rules.
Bear says researchers studying Schedule 1 drugs must submit their proposed research protocols to the agency. All handlers must be registered with the DEA in an attempt to keep control of the substances.
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“Since we’re not scientists, we’re not evaluating the veracity of the scientific research project,” Baer says -- that’s the job of the FDA and any other research agencies involved. “What we’re required to do is to make sure there are appropriate safeguards in place to ensure security protocols are maintained, to make sure any controlled substance is not subject to theft or diversion from legitimate science on one hand to the black market on the other.”
The DEA is working to streamline the approval process. Currently, there are many hundreds of research projects now underway involving marijuana alone, Baer says, and he doesn’t know of any drug study the agency has rejected or halted.
While the current administration is not as friendly or progressive on controlled substances as it suggested on the campaign trail, some protocols are being implemented that may offer an easier road for researchers to find benefits and to help others avoid problems when using these substances.