So why would the FDA crack down on a substance that may help save lives?
Some say the agency has actually been involved in a massive disinformation campaign against a substance called kratom. What is kratom, and why is the FDA fighting so hard against it?
This is a Reality Check you won’t get anywhere else.
Another White House administration is making fighting the opioid epidemic a top priority. And again, the focus is on the wrong thing.
What if, while ignoring the root causes of the opioid epidemic, the FDA is also fighting a substance that is saving people’s lives who suffer from opioid addiction?
Before we can answer that question, let’s talk about the substance the FDA is looking to ban. It’s called kratom.
So what is kratom?
Kratom is a tropical tree in the coffee family. It is commonly used in raw plant form, with the dried leaves used to make tea or crushed and mixed with food. Indigenous to Southeast Asia, the plant has become popular in the U.S. as a natural medicine.
So how popular is kratom?
Actually, millions of people around the world take it for chronic pain, alcohol addiction, weaning off opiates, depression, anxiety, PTSD and more.
But the FDA says kratom is actually just as dangerous as opioids. In fact, in November, the FDA Commissioner Scott Gottlieb recommended that kratom be scheduled as a Schedule 1 drug, meaning it is highly addictive and has no proven medical value.
In addition, the FDA claims that kratom is responsible for 36 deaths.
But here’s the problem: just days ago, nine leading scientists in substance addiction and safety wrote to the White House Opioid Crisis Team Leader Kellyann Conway and acting-DEA Administrator Robert Patterson.
They encouraged both to disregard the FDA’s claims about kratom, pointing out serious flaws in the agency’s claims.
“The scientists warned that ‘four surveys indicate that kratom is presently serving as a lifeline away from strong, often dangerous opioids for many of the several million Americans who use kratom. A ban on kratom that would be imposed by CSA Scheduling would put them at risk of relapse to opioid use with the potential consequence of overdose death. Similar unintended consequences are to be expected in some who would be forced to use opioids to manage acute or chronic pain.’”
These scientists went on to challenge the claims by the FDA by pointing out that, “available science is clear that kratom, although having effects on opioid receptors in the brain, is distinct from classical opioids (e.g. morphine, heroin, oxycodone, etc.) in its chemistry, biological effects, and origin.”
Kratom is not poppy based. it is a tree in the coffee family, and therefore has a reportedly milder euphoric effect than traditional opioids and opiates.
The other important rebuttal these scientists made was to point out that the FDA used significantly flawed information when it claimed kratom was responsible for 36 deaths.
“…the fatalities that the FDA lists as having been associated with kratom include deaths with a wide variety of apparent causes in people suffering from various diseases and/or taking other substances that also likely contributed to their deaths. For example, it includes 9 fatalities in Sweden that resulted from an adulterated product that included the active substance of the prescription opioid tramadol…”
In response, the FDA commissioner released more information on those who have died, the agency says, from kratom. And that information is even more stunning.
According to HuffPo:
“Almost all of the FDA’s cases involve subjects who were found to be on multiple substances at the time of their death, with the vast majority including either illicit or prescription drugs that carry well-known fatal risks.
“FDA’s list of kratom-related deaths includes a 43-year-old man determined to have died from complications due to deep vein thrombosis.
“He had a long list of medical problems… At the time of his death, he’d recently been prescribed five different medicines.
“His toxicology test came back positive for opioids, Xanax, antidepressants and a medication apparently used to treat his Tourette’s syndrome. He also tested positive for kratom.
“One case involves a man who had fallen out a window, broken his arm and refused treatment before dying.
“He was ultimately found to have had nine different substances in his bloodstream, among them, the primary psychoactive substance in kratom.
“One case the FDA listed as a kratom-related death, which has been completely redacted in the document, appears elsewhere in an agency database as a death by homicide due to a gunshot wound to the chest.”
So why is the FDA doing this? We don’t know the motives of the FDA but as I have shown you in the past, the FDA suffers from severe conflicts of interest, especially when it comes to the revolving door between the agency and Big Pharma.
With the government spending more than $500 billion per year to fight the opioid epidemic, one could assume there are lines of pharmaceutical companies looking for product alternatives.
But remember, any naturally occurring substance like kratom cannot be privately patented. So there is no real profit incentive for Big Pharma in kratom.
So what you need to know is that while I won’t speculate about what the FDA is ultimately trying to do, I can tell you what the FDA wants done.
The agency wants kratom to become subject to an FDA new drug application. To be clear, they say a naturally occurring plant taken in its raw form, that is helping millions of people right now, needs to be banned and become subject to a study that would take no less than 10 years and cost up to $2.5 billion dollars.
More importantly, what the FDA is recommending is exactly the opposite of the agency’s charge. There is no evidence that kratom, on its own, is harming anyone.
And so the question remains. If the FDA is successful, will the agency actually push millions of people toward more dangerous alternatives, including harmful opioids? If so, how is that making the fight against opioid abuse a priority?