Kids and Cannabis: Why FDA Approval Shouldn’t Matter

Major news networks have been covering the latest cannabis controversy: a treatment for very sick kids. Parents tell moving stories of how their young children, suffering from a rare pediatric epilepsy disease called Dravet’s Syndrome, are finally experiencing their childhood — after years of near-constant seizures had limited their lives to screaming, crying and shaking. Colorado’s laws have even sparked a migration of parents from other states who are willing to do anything to save their children.

Parents attest that their kids aren’t getting “high,” because Colorado cannabis professionals have developed oil so high in CBD (the non-psychoactive cannabinoid) and so low in THC that it could legally be classified as a hemp product rather than marijuana. These parents are replacing conventional drugs — which hadn’t worked, and had been psychoactive, according to mothers interviewed by major news networks — with a safe, non-psychoactive medicine that actually helps their children.

Doctors had told Paige Figi that they were out of options to help her 2-year-old daughter Charlotte, who was suffering from up to 60 seizures a day.

“She wasn’t even human anymore,” Paige told the Gazette in Colorado Springs. “She’d lie in my arms drooling, seizing, screaming and crying.”

Paige and her husband tried absolutely everything doctors suggested. Nothing worked, and the side effects made Charlotte’s suffering worse. At their wits’ end, they signed a Do-Not-Resuscitate order. They silently said their goodbyes. They didn’t want Charlotte to suffer anymore.

But at the last minute, the couple eventually found a doctor to recommend marijuana. Charlotte started taking CBD oil made by a team of six brothers in Colorado Springs. Her monthly seizures dropped from 1,200 to three. The few remaining seizures are much less severe. She has even been able to stop taking the conventional drugs that had given her painful side effects.

Now, Charlotte plays with her sister. She dances. She laughs.

But there are critics.

“The American Academy of Pediatrics is opposed to marijuana because it has not been clinically tested nor approved by the FDA,” according to a NBC Nightly News segment on the new therapy for children.

Children should only take medicines approved by the FDA, the argument says. Those are “safe.”

In October, the FDA approved a new painkiller. So it must be one of these “safe” drugs that doctors can prescribe without fearing criticism.

Zohydro ER is a new opioid painkiller that’s unprecedented in its potential for abuse. It will be the first ever hydrocodone-only opioid, which makes it ideal for snorting or shooting up. It will be available in doses with up to ten times more of the heroin-like narcotic than Vicodin, according to the Milwaukee Journal Sentinel.

In 2010, Vicodin was the most commonly-prescribed drug in the country — and over 16,000 deaths resulted from narcotic painkiller overdoses that year. (That figure was ten times the death toll from painkiller overdoses in 1999.)

Today, the Center for Disease Control is calling the lethal overdoses on narcotic painkillers an “epidemic.”

Because of the dangers, the FDA’s own advisory panel voted 11-2 to NOT approve the new stronger painkiller.

But the FDA approved it anyway.

“Clinical trials” had been conducted. These clinical trials are what CBD oil lacks, its critics point out. Without clinical trials, it’s unsafe for kids.

“We don’t have time to wait for FDA approval,” one mother of an epileptic 7-year-old told reporters in Utah.

But it turns out clinical trials can be done pretty quickly. The clinical trials for Zohydro only lasted 12 weeks.

“During the study’s trial run, 2 of 575 test subjects are believed to have committed suicide,” according to Mother Jones, “one by hoarding the drug and overdosing.”

And the trial only involved subjects who had already indicated their lower-back pain could benefit from the drug. (This convenient pre-screening of trial subjects was OK’d privately at fancy hotels paid for by drug company-funded groups.)

“I don’t see any reason why the FDA should be helping pharma,” says Lewis Nelson, MD, an NYU School of Medicine toxicologist who has served on the FDA advisory panel (reported by The Journal Sentinel).

If only desperate parents of suffering children could afford to host FDA officials in fancy hotels, like drug companies do. Then the clinical trials of CBD oil might have been completed in mere months, too — and these determined parents wouldn’t be stigmatized.

Unfortunately, most of these parents have already exhausted their resources trying to save their children. Their money has already gone to drug companies, because doctors prescribed numerous drugs that didn’t work. In one news clip, a self-professed conservative, Christian mother lamented the lack of cannabis discussion among the many doctors who had seen her son during his nearly ten years of daily seizures.

But marijuana remains a difficult subject for doctors and officials to broach.

“We’re not gonna see the FDA step in and do traditional clinical trials,” NBC’s Dr. Nancy Snyderman predicted in July.

But the FDA recently did approve one company, GW Pharmaceuticals in Britain (the makers of synthetic-cannabinoid drug Sativex), to conduct clinical trials on CBD oil.

Maybe these clinical trials will be as efficient as Zohydro’s.

The company making Zohydro is really maximizing efficiency. They also make a drug for addictions to painkillers. (These addictions are likely to increase due to Zohydro, experts predict.)

Maybe GW Pharmaceuticals should start making a drug for those addicted to cannabis. They could schedule it to hit the market when they release their new cannabis-derived medicine. (Lady Gaga would be a great candidate for its clinical trials, thanks to her highly-publicized, self-diagnosed “marijuana addiction.”)

GW Pharmaceuticals’ clinical trials will be a step towards acceptance of a medicine that is easing child suffering and giving hope to families around the country. But FDA approval shouldn’t be a standard for measuring safe medicine, based on their blatant disregard for public safety. Cannabis’s millennia-long history of safe and effective use is a much better indicator than the approval of an agency that does not have seem to be prioritizing public health.

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