The idea was intoxicating to lawmakers in more than a dozen states where medical marijuana was a political nonstarter: Give patients with certain severe medical problems access to a type of pot that might provide relief without producing the “high” usually associated with the plant.
First of Two Parts
But two years after 17 Midwestern and Southern states began passing a series of what are known as “CBD-only” medical marijuana laws, many people they were intended to help are rising up in protest. The laws, they say, help few patients, exclude others who could benefit and force residents to commit criminal acts in order to get relief for themselves or their loved ones.
“There is no amount of tweaking to a CBD decriminalization law that will make it work,” said Maria La France of Des Moines, Iowa, who gives her 14-year-old son, Quincy Hostager, an oil derived from marijuana to treat his Dravet syndrome, an intractable form of childhood epilepsy. “I don’t want to break the law, but I have to.”
The CBD-only laws allow residents with specified medical conditions to legally use marijuana-derived products that contain cannabidiol (CBD) but are low in tetrahydrocannabinol (THC), which produces marijuana’s “high.” (Both CBD and THC are among the scores of active chemical compounds known as cannabinoids that are present in the marijuana plant.)
For medical purposes, that usually means orally ingesting an oil derived from marijuana or hemp, though there also are numerous other products like body oils containing CBD for topical uses.
Supporters involved in passing the laws portrayed them as compassionate measures that would let patients avail themselves of the potentially therapeutic or pain-relieving properties of pot without risking the possibility of creating a new generation of drug addicts.
But political opposition — often led by some of the families the laws were intended to help — has emerged in many of the states that passed the legislation.
“We’re not lawbreakers and this shouldn’t even be an issue,” said Jennifer Conforti of Fayetteville, Georgia, who gives her 5-year-old autistic daughter, Abby, marijuana-derived oil with higher-than-allowed levels of THC to control dangerous biting episodes. “It should be a medicine that doctors go to when they need it.”
Conforti and others who want to expand the state’s CBD-only law to cover additional medical conditions, allow for higher levels of THC and provide for in-state cultivation and distribution of CBD products have mounted a “civil disobedience” campaign to raise public awareness about the issue.
In Utah, proponents of expanded access to whole-plant medical marijuana say they will conduct a campaign to unseat legislators who opposed a bill to expand the state’s current CBD-only law.
‘Is this what we’re going to do?’
Even some involved in crafting CBD-only laws acknowledge that lawmakers have ventured onto thin ice by intervening in matters that may best be left to patients and their doctors.
“Is this what we’re going to do? Are we going to vote on the next blood pressure medication or chemo treatment because of anecdotal evidence?” said Pat Bird, an executive for a Utah substance abuse prevention program who was involved in the failed effort this year to update the state’s CBD-only law.
The laws also have been harshly criticized by both medical marijuana advocates and prominent members of the medical establishment, albeit for very different reasons.
Paul Armentano, deputy director of the National Organization for the Reform of Marijuana Laws (NORML), which advocates for the decriminalization of both medical and recreational marijuana, said the laws were a transparent attempt by conservatives to avoid appearances of a flip-flop on medical marijuana.
“These same politicians who have opposed legislation for whole-plant cannabis are falling over themselves to support this legislation that has helped very few people,” he said.
Those who believe medical pot should be broadly available have three main objections to what they consider “politically expedient” CBD-only measures:
- They typically are narrower than broad medical marijuana laws passed in other states, often specifying a limited number of medical conditions — in some cases a single malady — that can be treated, excluding many other patients who could potentially benefit from CBD use. In Iowa, for example, only 65 patients had obtained medical marijuana cards as of early April under the state’s law, which allows the use of CBD products only for cases of intractable epilepsy.
- Most of the laws do not regulate or provide for cultivation, processing and distribution of CBD products. So patients or their families are forced to break other federal or state laws by crossing state lines or obtaining the products by mail. (Marijuana remains illegal under federal law, which classifies it as an illegal Schedule I substance, meaning it is considered to have a high potential for dependency and no accepted medical use. That also applies to CBD products, according to most legal experts.)
- By imposing low limits on the amount of THC that products can contain, they penalize patients who obtain relief only from products in which CBD and THC work in concert — a combination that medical marijuana advocates refer to as the “entourage effect.”
La France, the Iowa mom, for example, says that CBD oil with less than 3 percent THC — the limit under the state’s law — didn’t quell Quincy’s violent seizures alone, but combination of CBD oil and another product with higher levels of THCa — another cannabinoid that isn’t authorized under Iowa’s law — significantly reduced them.
That means she’s forced to break the law ostensibly passed to help patients like Quincy — a risk she’s willing to run because of the results she has seen.
“Last year he was not taking cannabis oil and he barely went to school (because of frequent seizures),” La France said. “This year, he’s going to school much more often and for longer parts of the day. His teachers and family have noticed that his eye contact is better, he’s more responsive.”
Many in the medical establishment are equally dismayed by CBD laws — and the broader medical marijuana laws passed by 24 other states — arguing that they were passed based on anecdotal evidence, not hard science.
“That is really not the proper way of practicing medicine,” Nora Volkow, director of the National Institute on Drug Abuse, told NBC News. “That kind of decision-making, based on ‘I think it works,’ can result in very negative outcomes.”
Volkow acknowledges that research and clinical trials needed to provide scientific evidence of medical marijuana’s efficacy —and the roles that CBD and THC play — have lagged, burdened by marijuana’s stigma as a recreational drug. But she says that studies currently nearing completion will soon begin to show whether the anecdotal evidence holds up.
Volkow’s concern is shared by Dr. Amy Brooks-Kayal, a pediatric neurologist at Colorado Children’s Hospital. She said an observational study there of young epilepsy patients being treated with medical marijuana found that about a third showed improvement, but 44 percent experienced some type of adverse reaction — some of them life threatening.
That is why the hospital’s physicians do not recommend or administer medical marijuana or CBD products and underlines the need for clinical testing and development of pharmaceutical grade products, said Brooks-Kayal, who also is immediate past president of the American Epilepsy Society.
“If this is a good therapy, we all want to know that, and we want to know how to use it and understand the interaction with other medicines,” she said.
The lack of regulation of CBD products also raises other safety questions.
Sue Rusche, CEO of the Atlanta-based drug prevention group National Families in Action, noted that a quirk in Colorado law, where most CBD oil sold in other states is produced, requires recreational marijuana to be tested for contaminants like pesticides, but not medical marijuana.
“There’s no patient, careful pharmacological work going on,” she said. “It’s very scary.”
Law enforcement also has raised objections to the CBD laws, saying that it can provide cover for drug dealers — a concern cited in April 2015 when Idaho’s Republican Gov. Butch Otter became the first and only state executive to veto CBD-only legislation.
“If you look at CBD or hash oil, there is no way for an officer on the street to tell the difference. It would have to go to a lab for testing,” said Elisha Figueroa, director of the state’s Office of Drug Policy. “That would really cause a big problem for law enforcement.”
While political support for CBD-only laws has shown signs of weakening, they do have their defenders.
Georgia state Rep. Allen Peake, a Republican who introduced the first CBD-only bill there in 2014, said he remains committed to improving the law by making additional medical conditions eligible for treatment and by creating an in-state program to cultivate marijuana and process it into CBD products so that residents can legally acquire them.
“This has become a passionate cause for me,” he said, adding, “From experiences I hear every day, it’s changing lives.”
And Joel Stanley, CEO of CW Botanicals, a Colorado company that he said exploits a “legal gray area” to sell CBD oil to patients in other states, said passage of the laws represented a step “to help some people and get a law on the books in conservative states that were not going to pass a medical marijuana bill for decades.”
“The first thing is to get people to understand that this really does work for a lot of people,” he told NBC News, adding that he supports patients’ rights to access different forms of medical marijuana.
Legal no-man’s land
In the meantime, though, parents like LaFrance and Conforti and patients whose conditions are not eligible to lawfully use CBD products are left in a frustrating legal limbo.
Their risk of prosecution is likely minimal. The Drug Enforcement Agency has not targeted users of CBD products for medicinal use and says it has no plans to do so. The Obama administration also sent a memo to federal prosecutors in 2009 encouraging them not to charge people who distribute marijuana for medical purposes in accordance with state laws.
And state and local law enforcers generally look the other way when it comes to CBD products, even those that exceed the limits prescribed by the law.
But there have been a few cases of parents facing prosecution for giving medical marijuana to their kids.
Angela Brown of Madison, Minnesota, for instance, was charged with child endangerment by local authorities in 2014 for illegally giving her 13-year-old son, Trey, cannabis oil she obtained in Colorado to ease his pain from a traumatic brain injury. A plea deal spared her from spending up to two years behind bars.
Concern over legal liability also is cited as a reason that Missouri — the first state with a CBD-only law to license growers and produce products for residents — had issued only 37 registration cards to patients with intractable epilepsy as of early March.
“The neurologists, many of them are sympathetic, but they’re all associated with hospitals and those hospitals have insurance companies that fear a liability if they recommend it,” said John Payne, executive director of Show-Me Cannabis, a state group advocating for marijuana legalization.
Volkow, the director of National Institute on Drug Abuse, said that studies and clinical trials now under way that will soon begin to provide some clarity for medical professionals and the public at large. And recent moves by the DEA to ease restrictions on clinical trials of CBD also should help speed additional research, she said.
Clinical trial of pharmaceutical-grade CBD under way
Volkow and others who say that legislators got out in front of the science on medical marijuana are closely watching an ongoing clinical trial of a pharmaceutical-grade version of CBD called Epidiolex for treating childhood epilepsy.
If the early promise shown in the trial, which is expected to be completed late this year, is confirmed, that could lead to approval by the FDA and eventually clear the way for insurance companies to start covering CBD products, said Rusche, the executive of the drug abuse prevention group.
Dr. Orrin Devinsky, director of New York University’s Langone Comprehensive Epilepsy Center and leader of the clinical trial of Epidiolex, said he understands the frustration of patients and their family members who believe that some form of marijuana eases their suffering and don’t want to wait out the process.
“I think it puts people in a very difficult position,” he said of the current hodge-podge of medical marijuana laws and the dearth of scientific evidence about the plant’s effects. “If you’ve truly exhausted the major medical options then I think a trial of cannabidiol or other medical marijuana is worth considering, with the understanding that we lack a thorough understanding of its effects.”
But for the longer term, Devinsky said, it’s imperative that gold-standard studies like the one he’s conducting get done to help reveal the science inside the leaves and buds.
“The only way to find out is blindfold myself, and blindfold my patients and see what the results tell us,” he said.
Source: NBC NEWS