U.S.: Obama Administration Removes Crucial Barrier To Marijuana Research

MarijuanaResearchCartoon[TheColumbian]

Big Win for Marijuana Reform Advocates but More Has to Be Done

Senate Hearing on Medical Marijuana Scheduled for Wednesday

By Steve Elliott
Hemp News

In a long-sought move anticipated by many marijuana reform advocates, the White House on Monday announced that it was removing a major obstacle to marijuana research – the Public Health Service (PHS) Review.

Rep. Earl Blumenauer (D-Oregon) welcomed the decision of the U.S. Department of Health and Human Services (HHS) to eliminate its Public Health Service (PHS) Review Committee for non-federally funded medical marijuana research – an additional review process not applied to other Schedule I substances. Last year, Rep. Blumenauer led a letter, signed by 29 other members of Congress, to the Secretary of HHS Sylvia Mathews Burwell requesting that this PHS process be eliminated.

“Today’s decision by HHS is a significant step toward improving an antiquated system that unfairly targets marijuana above and beyond other substances in research," Congressman Bluemanuer said. "I applaud the Administration in heeding our request and the request of many to eliminate this barrier.

"I hope this action will facilitate easier access to marijuana for medical researchers,” Rep. Blumenauer said. “Considering the widespread use of medical marijuana, it is absolutely essential that we allow doctors and scientists to research the therapeutic benefits and risks of its use.

"There is still more to be done to ensure this happens," Rep. Blumenauer said. "I am working on legislation to address these issues, and I look forward to working with the Administration and my colleagues in Congress to further increase research.

“The president has often said that drug policy should be dictated by unimpeded science instead of ideology, and it’s great to see the Obama Administration finally starting to take some real action to back that up," said Tom Angell, chairman of Marijuana Majority. "But there’s more to be done.

"The next step should be moving marijuana out of Schedule I to a more appropriate category, which the administration can do without any further Congressional action," Angell said. "Given what the president and surgeon general have already said publicly about marijuana’s relative harms and medical uses, it’s completely inappropriate for it to remain in a schedule that’s supposed to be reserved for substances with a high potential for abuse and no therapeutic value. Hopefully today’s action is a sign of more to come."

“This announcement shows that the White House is ready to move away from the war on medical marijuana, and enable the performance of legitimate and necessary research,” said Bill Piper, director of Drug Policy Alliance’s Office of National Affairs. “This is progress, but the White House should also end the NIDA’s unique monopoly on marijuana production, and allow private entities to grow marijuana, thus facilitating even more important research.”

"The U.S. government has systematically impeded marijuana efficacy research, and the PHS review has played a large role in that stonewalling," said Dr. Sue Sisley. "It was a shameful tactic used by opponents of marijuana research who never wanted the public to see objective data about the efficacy of marijuana.

"To see the government finally eliminate this waste of taxpayer dollars is a triumph and hopefully represents another historic shift in drug policy reform," Dr. Sisley said.

“The elimination of the PHS review of privately-funded medical marijuana protocols is an important step forward that's taken 16 years to achieve,” said Rick Doblin, founder and executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS). “The next and even more crucial reform is ending the monopoly on DEA-licensed marijuana that can be used in FDA-regulated research, a monopoly that is currently held by the National Institute on Drug Abuse (NIDA).

"Once there are privately-funded, DEA-licensed medical marijuana producers, then the question of the medical use of marijuana will be evaluated by the FDA based on scientific data, the same as with all other drugs," Doblin said.

Since 2009 Dr. Doblin and Dr. Sisley have been attempting to conduct a major research study on using marijuana to treat post traumatic stress disorder. On March 12th, 2014 the Department of Health and Human Services approved the research study.

Later that year, the state of Colorado awarded a $2 million grant for the study. Despite these developments the study still continues to wait for NIDA to deliver the marijuana necessary to begin.

The DEA has refused to issue additional licenses to grow marijuana for research purposes citing international treaties as the reason for not doing so, despite other treaty parties such as the United Kingdom issuing multiple licenses.

The PHS Review was introduced by the Clinton Administration. At the time, the Institute for Medicine was one of the first major entities to call for more research on marijuana. But they urged the Clinton Administration to ensure the process was as controlled as possible.

The Clinton Administration response was to make the Department of Health and Human Services conduct an individual review of all applications for all marijuana research. This bureaucratic hurdle meant that research for marijuana was heavily slowed, and also meant that it became more difficult to study marijuana than to study cocaine and heroin. Today’s announcement was published in the federal register.

Marijuana advocates have called for years for the elimination of the PHS review, and its elimination was included in the CARERS Act, the groundbreaking medical marijuana bill introduced in the Senate this year by Senators Booker, Paul and Gillibrand. The research section of the bill also calls for an end to NIDA’s monopoly on marijuana production.

This move by the Obama Administration comes just days before a June 24 Senate hearing on medical marijuana. On Friday, the Senate Caucus on International Narcotics, chaired by Chuck Grassley (R-IA) announced a hearing entitled “Cannabidiol: Barriers to Research and Potential Medical Benefits”.

“There’s huge momentum surrounding marijuana reform, and this is just the latest example. This year we have seen the introduction of the CARERS ACT, passage of amendments in the House and Senate to stop federal interference in medical marijuana, a hearing on medical marijuana and this positive step from the White House, said Bill Piper. “Our objective of moving the CARERS Act piece by piece is bearing fruit, and there will be more to come this year.”

Largely out of public view, for more than four decades DEA and NIDA/PHS have blocked drug development research by maintaining a government monopoly on the supply of marijuana that can legally be used in research. This frustrating reality belies the recent pronouncements of pundits and policymakers implying that the FDA has already dismissed the medical benefits of marijuana or that proponents have simply failed to explore FDA approval.

While there is a plethora of scientific research establishing marijuana's safety and efficacy, the specific FDA clinical trials necessary to bring the marijuana plant to market as a prescription medicine have been obstructed.

Marijuana remains the only Schedule I drug that DEA prohibits from being produced by private laboratories for scientific research. Although DEA has licensed multiple privately-funded manufacturers of all other Schedule I drugs, it permits just one facility, located at the University of Mississippi, to produce marijuana for research purposes.

This facility, under contract with NIDA, holds a literal monopoly on the supply of marijuana available to scientists, including researchers seeking to conduct FDA-approved studies of the plant's medical properties -- studies that, of course, squarely conflict with NIDA's mission to study drug abuse. Unlike research with any other drugs, until now all protocols had to be approved by PHS and NIDA.

Currently, 23 states, the District of Columbia and Guam have legalized marijuana for a variety of medicinal purposes – and an additional 16 states have passed laws to allow access to CBD oils, a non-psychotropic component of marijuana that has proven uniquely effective in managing epileptic seizures that afflict children. Four states – Alaska, Colorado, Oregon and Washington – have legalized marijuana like alcohol.

In 2016, voters in Arizona, California, Maine, Massachusetts, and Nevada are expected to decide ballot initiatives on the question of legalizing marijuana for adult use. A slew of recent polls show that significant majorities of both Democrats and Republicans strongly believe that the decision of whether and how to regulate marijuana should be left up to the states.

Graphic: The Columbian