The Obama administration lifted a significant roadblock to medical research on marijuana Monday, but many obstructions and complications remain for anyone looking to do clinical trials or research with cannabis and the compounds it contains.
The Department of Health and Human Services announced Monday that non-federally funded researchers looking into the potential therapeutic benefits of marijuana would no longer need to undergo a Public Health Service (PHS) review, an onerous process implemented in 1999 with the stated intention of facilitating research. That means that researchers with access to state or private funding who are looking to evaluate the medical potential of cannabis have one fewer major bureaucratic hoop to jump through.
"Oh my gosh, it's a miracle," said Sue Sisley, a physician and psychiatrist who believes her research into veterans and medical marijuana led to her firing from the University of Arizona last year. Sisley explained that the PHS review had held up her PTSD study for three years but ultimately asked her to make no changes. "To see the government finally eliminate this waste of taxpayer dollars is a triumph and hopefully represents another historic shift in drug policy reform."
Marijuana is currently classified as a Schedule I narcotic, a category reserved for the most dangerous drugs with the least medical potential—other Schedule I drugs include ecstasy and heroin. No other Schedule I drug was subject to the extra layer of regulation involved in the PHS review process, and many aspects of the PHS review process are identical to the review process already necessary under the Federal Drug Administration's Investigational New Drug (IND) process, which makes much of the PHS review process redundant. As a bipartisan group of Congressmen pointed out in a letter to Secretary of Health and Human Services Sylvia Mathews Burwell last month, the PHS review "has actually prevented medical marijuana research from taking place in the United States."
The policy change follows growing calls for better regulation and more reliable information about the medical benefits of cannabis, especially as mounting anecdotal evidence suggests that cannabis has enormous potential for helping forms of epilepsy that do not respond to existing pharmaceuticals. Although 23 states have legalized medical marijuana and an additional 16 states have legalized the use of the compound cannabidiol (CBD), which is not psychoactive but has been shown to stop seizures, the drug remains federally illegal.
As a result, reliable and objective research on the medical benefits of cannabis is still difficult to find. Since there are so few trusted sources, weed-oriented companies and publications find it easy to make absurd claims about the benefits of marijuana use, such as the oft-repeated notion that cannabis can cure cancer.
Furthermore, all of the marijuana available for research in the United States comes from a single farm in Mississippi, where the cannabis is far weaker than anything available at medical and recreational dispensaries from California to Massachusetts.
"The White House is right to lift a major barrier to conducting essential medical marijuana research," said Senator Kirsten Gillibrand in a statement. "However, other barriers remain. With the anticipated boost in research, we'll need an adequate supply of marijuana samples that are only available through one provider."
The strongest weed available for research from the Mississippi farm is about 6% tetrahydrocannabinol (THC), the cannabinoid that gets you high, while the pot available at dispensaries is typically 15-20% THC. With some recent research showing that consuming high amounts of THC may be associated with psychosis, some experts say the weed being used for research should better reflect what's currently on the market.
Even though the PHS review process is now gone, getting approval and funding for medical marijuana research will still be difficult. Lester Grinspoon, the retired Harvard Medical School professor of psychiatry and longtime proponent of medical marijuana, pointed out that it is still difficult for researchers to find money outside of the federally funded National Institute of Health.
"This [new policy] is not going to solve the problem. There are not that many people with enough money that we can put into answering questions like, is this stuff safe? And is it a good medicine? For me, those are already answered, but for people who demand large, double-blind studies, this isn't going to do much to make that research more allowable," Grinspoon told BuzzFeed News. "A lot of the money for drug research comes from pharmaceutical companies, and the last thing they want is to support using cannabis as a medicine."
Anyone looking to administer the drug to patients must still gain approval from both the FDA and the Drug Enforcement Administration, which can take several years.
Ashley Durval, whose three-year-old daughter Harper Grace suffers from a form of epilepsy known as Dravet's syndrome, helped lead the fight to legalize cannabidiol in her home state of Mississippi last year. Though the law passed last summer, the FDA has yet to approve clinical trials at the Pediatric Epilepsy College at the University of Mississippi, leaving doctors, patients and parents anxiously waiting for access to a potentially life-changing medicine.
"We feel helpless. She takes medicine through a feeding tube twice a day, and the side effects are awful. We honestly have no idea what the hold up is, if it's the FDA or the DEA," Durval told BuzzFeed News. "If they were to run a blood test and find CBD in her system, they would take her away from us, but we've thought about happily sitting in jail."
So even though the new policy will make marijuana research easier, it's unlikely to help families like Durval's, who are waiting on the bureaucratic process of federal agencies like the FDA and the DEA.
Bill Piper, Director of Drug Policy Alliance's Office of National Affairs, heralded the victory in a statement but acknowledged that the elimination of PHS was only one small step in the right direction.
"This is progress," Piper said, "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."
