At a U.S. Senate Judiciary Committee hearing convened last week to consider "the potential medical benefits of marijuana," lawmakers heard from cannabis advocates and doctors alike. Their testimony overwhelmingly supported marijuana being used for medical purposes; many of the speakers also supported rescheduling cannabis to a Schedule II substance.
Numerous individuals and organizations had been invited to present testimony, including Aaron Smith, co-founder and executive director of the National Cannabis Industry Association. NCIA represents more than 1,000 businesses in forty states, including many in Colorado. Smith told the senators that while the American public has acknowledged the medical benefits of cannabis for decades, the federal government has yet to do so. This reluctance at the federal level has prohibited adequate research into cannabis, which furthers the argument of naysayers. It's a catch-22, he said: Without legitimate research, detractors can continue to claim that marijuana does not have any medical value — but as it stands, scientific research is not possible, so it's hard to prove the medical benefits of the substance.
"The DEA has put up bureaucratic roadblocks to legitimate science and has severely limited, if not completely obstructed, legitimate researchers who would study cannabis's benefits," Smith said. "Americans are denied the opportunity to see the results of FDA-approved, double-blind studies demonstrating the benefits of medical marijuana, while elected officials erroneously point to the lack of these studies as evidence of a lack of therapeutic benefits."
Smith argued that bringing marijuana policy "into alignment" with science would replace the criminal marketplace with tax-paying businesses that are "committed to the compassionate care, health and wellness of its patients."
Several senators from both sides of the aisle also advocated for the medical use of cannabis. In a prepared statement, Senator Chuck Grassley, a Republican from Iowa, discussed constituents who are treating their children's epilepsy with cannabidiol.
"These children are often treated with powerful drugs with strong side effects, which may also further incapacitate them," he said. "But in recent years, evidence has come to light suggesting that a substance called cannabidiol, or CBD, may help these children." In many cases, he added, the seizures had been reduced or completely eliminated.
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While CBD is a compound derived from the marijuana plant, it is used solely for medical purposes, Grassley pointed out. It cannot be smoked and cannot be used to get high. Still, the senator worries that many CBD products parents use to treat their children are "of unknown quality."
Because of the evidence he's seen in his district, Grassley supports medical research of marijuana: "I believe we should be encouraging responsible, FDA-approved research on CBD and other parts of the marijuana plant, to unlock whatever potential medical benefit may lie within them – for children with intractable epilepsy and any other patients who may benefit," he said.
But Grassley made it clear that his support of further medical research does not equate to support of recreational use, "which the science tells us can be harmful and addictive, especially for young people."
Like senators Kirsten Gillibrand and Cory Booker, Grassley has long been an advocate for removing barriers to research.
Last year, Grassley and Senator Dianne Feinstein held a hearing before the Senate Caucus on International Narcotics Control to discuss the changes necessary to allow medical patients access to marijuana. In October 2014 and again in May 2015, the two senators also wrote to the Department of Justice and the Department of Health and Human Services advocating for medical marijuana research.
A CBD-based drug called Epidiolex is currently being reviewed by the FDA in clinical trials to test how it treats rare forms of pediatric epilepsy. "So far, the data emerging from these efforts is promising," Grassley told last week's hearing. "Hundreds of children are being treated with Epidiolex through Expanded Access Investigational New Drug Programs...so even though more research is needed, there is reason to hope that at least one FDA-approved CBD medicine may be more widely available soon."
Dr. Susan Weiss, director of the Division of Extramural Research within the National Institute on Drug Abuse, expanded on Grassley's testimony. In addition to the 25 states and Washington, D.C., that have passed laws permitting marijuana for medical use, another sixteen states have passed laws specifically allowing medicinal use of CBD.
"There is a growing body of research suggesting the potential therapeutic value of cannabinoids in numerous health conditions including pain, nausea, epilepsy, obesity, wasting disease, addiction, autoimmune disorders and other conditions," she said in the statement she presented at the hearing.
Weiss said she supported further research and drug development, focusing on the scientific effects of cannabinoids in the body. Medications derived from cannabis can help patients suffering from pain, pediatric epilepsy and post-traumatic stress disorder, among other pain and psychological issues, she said. But despite growing evidence that the drug aids patients with these afflictions, Weiss also noted that there aren't well-controlled studies to back up this evidence.
"NIH is committed to working with Congress and our federal partners to facilitate more research on the therapeutic potential of marijuana and cannabinoids and to reduce barriers to research," Weiss said. "Patients across the country are using marijuana strains and extracts that have not undergone rigorous clinical trials, are not regulated for consistency or quality, and are used for medical conditions with an insufficient evidence base supporting their effectiveness."
Therefore, she explained, some drugs on the market do not contain the levels of CBD that they claim to.
The Food and Drug Administration issued warning letters to companies marketing these products in 2015 and again in 2016, according to Dr. Douglas Throckmorton, deputy director of the Center for Drug Evaluation and Research at the FDA.
The main concern is that selling these products "does more than simply defraud customers," because "it can create a false hope in a population especially vulnerable: those seeking relief from serious medical conditions for themselves or their loved ones, including their children," Throckmorton said in his testimony. "Moreover, it might divert patients from products with demonstrated safety and effectiveness."
While most marijuana-based drugs being sold in the marketplace have not been tested and approved for use by the FDA, the FDA has approved three medications synthetically derived from cannabinoids: Cesamet, Marinol and Syndros. "The future of marijuana as a potential medicine lies in classical pharmacological drug development," Throckmorton noted.
While most testimony at the hearing supported medical marijuana, there was a notable exception. In his testimony, Dr. Stuart Gitlow, executive director of the Annenberg Physician Training Program in Addictive Disease, said, "There really is no such thing as medical marijuana," and not enough evidence to support marijuana's medical properties.
Corporate interests "wishing to get rich off of legalization" are tipping the scales to capitalize on a drug that's proven to be dangerous and has "no scientific benefit," he added. Other medications on the market treat all of the conditions for which marijuana has been used as a substitute, Gitlow continued, suggesting that patients should focus on using those instead.
Despite his concerns, Gitlow agreed that more research is needed. "It behooves us to research the plant to find out if indeed some component of marijuana is found to have value. If so, we can produce it in a form which is unlikely to have the many risks present with respect to use of the whole plant," he said. "We need robust basic and clinical research to develop more information about marijuana's potential to treat various conditions."
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Gitlow proposed removing marijuana from politics and giving the medical and scientific communities time to research the drug and prove its potential medical benefits. "We must...not engage in medicine by ballot initiative," he concluded.
While there is much talk about rescheduling marijuana so that more research can take place, Linden Barber, a lawyer specializing in DEA Compliance and Litigation Practice, testified that moving marijuana from a Schedule I classification to Schedule II wouldn't help research in the long run. The DEA "considers the same factors and performs the same analysis when establishing aggregate production quotas, regardless of whether the substance is in Schedule I or Schedule II," he said in his testimony.
While marijuana remains a Schedule I drug, many clinical researchers have applied to study the medical benefits of the drug, and Linden says the DEA has shown "flexibility, particularly recently, by easing regulatory requirements involving research with cannabidiol, (and the) DEA has granted nearly forty waivers to this regulatory requirement since late December 2015."
(This statistic was confirmed by Weiss's testimony. "As of July 12, 2016," she said, "the DEA has received and granted all requested  waivers to researchers.")
Linden concluded that there is not an "institutional bias" against marijuana in the DEA. "From the perspective of one who represents registrants before the agency, it appears that the DEA's leadership is working with researchers to reduce barriers to research," he told the hearing.