By Pat Anson, Editor
The Food and Drug Administration may have gotten more than it bargained for when it asked for public comments about the medical value and abuse potential of 17 different drugs.
The agency wound up getting over 6,400 comments in the Federal Register, the vast majority of them from people advocating for cannabidiol (CBD) -- one of the active ingredients in medical marijuana.
Unlike tetrahydrocannabinol (THC), the substance in marijuana that makes people high, CBD-based oils and medications relieve pain, and are increasingly being used to treat a variety of medical conditions.
“CBD's are not a way to get high as THC is. These oils have so many beneficial uses for anxiety, stress, pain, joint issues, muscular issues, arthritis, seizures, Parkinson's, cancer,” wrote Tami Camp in her public comment. “We need natural herbs, not man-made poisons!”
“CBD helps me with my chronic nerve pain, in a way that prescription medications can't match,” wrote Jason Turgeon.
“I've been consistently using CBD oil now for three months and have noticed an uptick in my moods, a reduction of joint pain, and my sleeping cycles at night have improved as my sleep is deeper and I wake up feeling refreshed,” wrote Kerry Meier.
Public opinion polls show that these are not isolated comments or marijuana supporters trying to game the system by flooding the Federal Register with comments. A recent poll by CBS News found 85% of Americans favor medical marijuana use.
But while medical cannabis may be legal in 29 states and the District of Columbia, marijuana is still classified as an illegal Schedule I controlled substance by the Drug Enforcement Administration, right alongside heroin and LSD.
The FDA opened the cannabis can of worms at the behest of the World Health Organization (WHO), which is not only reviewing the safety and effectiveness of CBD, but 16 other drugs -- including pregabalin, tramadol, ketamine, and several chemical cousins of fentanyl, a synthetic opioid blamed for thousands of overdose deaths.
WHO is seeking input from the FDA on whether international restrictions should be placed on any of the drugs. Under the Controlled Substances Act, the FDA was required to seek public comment in the Federal Register before responding to WHO -- perhaps not anticipating the overwhelmingly positive response that CBD would get.
“Cannabidiol should not be restricted because CBD is not addictive, nor does it have the potential for abuse nor should it be tied to hallucinogenic drugs. Therefore, no international restrictions should be placed on CBD,” wrote Steve Easterly.
“For cannabis to be scheduled as a class I drug is ludicrous especially when the entire prohibition of cannabis was based on lies,” wrote Mike Copple. “What a shameful spectacle that we the people still have to argue about the usefulness of the cannabis plant. Cannabis has and continues to help me in many ways both physically and mentally.”
“I want cannabis to be legalized and available for over the counter sale. I have known several people who have benefited for various conditions from anxiety, depressions, MS, arthritis and epilepsy,” wrote Nancy Scott-Puopolo.
The public comment period ended on Wednesday. You can look at other responses in the Federal Register by clicking here.
Mixed Reviews of Lyrica
There were only a few dozen comments about pregabalin (Lyrica), a prescription medication that millions of Americans take for fibromyalgia, neuropathy and other chronic pain conditions. As PNN has reported, WHO is investigating reports that pregabalin is being abused by addicts.
“Patients are self-administering higher than recommended doses (of pregabalin) to achieve euphoria, especially patients who have a history of substance abuse, particularly opioids, and psychiatric illness,” WHO told the FDA..
The public comments about pregabalin were mixed at best.
“I have been on several medications prior to being switched to Lyrica about six months ago. I actually feel nothing while taking the drug, and assume you would indeed have to take lots to maybe feel high,” wrote Mary. “Not sure if it helps my fibromyalgia or not since I still have lots of pain.”
“I take pregabalin in Lyrica form twice a day currently for nerve pain and fibromyalgia. I cannot accurately express the relief this has brought me,” wrote Renee.
“I have tried many, many medications. When I tried Lyrica, the side effects were horrible. I couldn't even lift my head without severe dizziness and the room spinning,” said Lora Berry.
“I take Lyrica and all I got from it was fatter,” said Debra Winegar. “CBD oil is wonderful. Take a few drops under the tongue and I'm good to go. Narcotics are needed when my pain is out of control. I'm tired of waiting to be pain free. Legalize pot now!”
Will the FDA now report to WHO that thousands of American citizens want CBD-based medications fully legalized? The FDA notice in the Federal Register only notes that public comments “will be considered” when the FDA prepares its scientific and medical evaluation. The FDA report to WHO is due September 30.