'We need to cut red tape and streamline the licensing and regulatory processes so research can move ahead'
Soon after her first birthday, Mallory Minahan began suffering from debilitating seizures. For a decade she suffered these attacks—a symptom of intractable epilepsy—as many as 30 or 40 times a month. Her parents, both medical professionals, were powerless to help.
After years of failed treatments, her parents decided to try cannabidiol oil in October 2013. This product is derived from the marijuana plant, administered orally, and has a very low level of tetrahydrocannabinol, or THC, the component of marijuana that makes users high. According to Tom Minahan, Mallory’s father and an ER doctor in Colton, Calif., it took just 36 hours to see profound changes.
But the process hasn’t been easy. A one-month supply of cannabidiol oil, commonly referred to as CBD oil, can cost up to $2,500. Because CBD oil is not approved by the Food and Drug Administration (FDA), there’s no guarantee that the formulation of each batch will be the same, or that each bottle actually contains CBD oil, rather than some other unknown substance.
In fact, the FDA recently sent warning letters to six companies marketing unapproved products that they claim contain CBD, but don’t. This is why Mallory’s parents are forced to spend up to $100 per bottle of oil if they want to have it tested to verify the contents. And even how much of the oil to administer was a mystery. Dr. Minahan and his wife, Carrin, arrived at the proper dosage for Mallory through trial and error.
This isn’t how modern medicine should work.
For Mallory, who wasn’t responding to any other treatments or medications, the results were spectacular. Her seizures have decreased by 90%. Yet CBD oil hasn’t been effective for everyone. Many questions remain about its long-term effects and how it interacts with other medications.
Simply put, we need to know more about CBD, and the only way to gain that knowledge is to remove barriers to research. Research will shed light on critical safety issues as well as how effective CBD oil is and the proper formulations and dosages for patients.
After hearing from constituents, we asked the Justice Department (DOJ) and the Department of Health and Human Services (HHS) in October 2014 to clarify their positions on CBD research and what it would take to ensure research could move forward. After some back-and-forth with the two departments, we’re pleased to report that both have taken significant steps to ensure that CBD research can proceed. The DOJ agreed to initiate what is known as an “eight-factor analysis” to definitively determine whether CBD has scientific and medical benefits, and if so the proper schedule for it.
Another key step was HHS’s decision that privately-funded researchers are no longer required to submit research proposals for additional review. It is also allowing Epidiolex, a purified form of CBD currently in clinical trials, to be administered to 400 children under a compassionate use program that allows sick patients to access medicines before they are approved by the FDA.
While these are important developments, they’re not enough. That’s why we held a hearing of the Senate Caucus on International Narcotics Control last month to hear from experts on the subject.
We learned that the research process is still overly burdensome. We need to cut red tape and streamline the licensing and regulatory processes so research can move ahead. In addition, we must also find ways to ensure that researchers have access to the quantity and quality of marijuana that they need. Finally, we need to look at expanding compassionate access programs where possible, to benefit as many children as possible.
Patients like Mallory have helped draw attention to this issue. Now, the federal government should step up, continue to reduce research barriers and help the many patients who could benefit from this treatment.
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