If you've been following along with us here at the Goldwater as we cover the war on kratom, you won't be surprised to find that the FOIA documents show the FDA has absolutely no documents supporting their wholly unscientific claims regarding the South East Asian plant used safely by thousands. The FDA is not only making false claims about kratom but the people who market it and use it as well. FDA Commissioner Scott Gottlieb recently expressed his fears that kratom could worsen the opiate addiction and cited 36 (supposed) deaths. As is, the data available shows not one single death connected solely to the use of kratom, even in laboratory conditions where doctors were attempting to induce fatal toxicity or respiratory depression on rodents or other small animals weighing only a few ounces.
<blockquote class="twitter-tweet" data-lang="en"><p lang="en" dir="ltr">BREAKING NEWS: Review [email protected]_FDA database shows ZERO kratom-only deaths from 2011-2017. Discovery comes after agency turned down#FOIArequests to show basis for Health Advisory.<a href="https://t.co/WrpXzzsj5I">https://t.co/WrpXzzsj5I</a> …#kratom#keepkratomlegal#iamkratom <a href="https://t.co/IRDe393FKl">pic.twitter.com/IRDe393FKl</a></p>— American Kratom Association (@TheKratomAssn) <a href="https://twitter.com/TheKratomAssn/status/935917263676461059?ref_src=twsrc%5Etfw">November 29, 2017</a></blockquote>
<script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>
Despite the facts at hand, the FDA is making bold claims that kratom is the same sort of deadly killer as the opiates killing 90 people per day. In fact, according to a report from US News last year, the number of people who die from taking FDA approved prescription drugs legally and as prescribed results in some 180,000 deaths per year in the United States. That's <a href="https://health.usnews.com/health-news/patient-advice/articles/2016-09-27/the-danger-in-taking-prescribed-medications">over 350 per day on average</a>. Meanwhile, around 100,000 calls each year for antihistamines, acetaminophen or cosmetics ingestion. Even if there were 36 deaths over a period of ten years, compared to other legal products that don't put kratom anywhere near the supposed "public health hazard" Gottlieb claims. The former head of the National Institute of Drug Abuse thinks the real danger is in banning kratom and referred to the data (and lack of) that the FDA relies on to support their skewed claims as "junk science." For instance, claims that kratom causes psychosis being based on studies of hard drug users who <i>also</i> used kratom.
FDA's advisory made some bold claims based on "clear data" and "evidence" about the supposed dangers of kratom. When a Reuters reporter asked for the data they relied on, they said: "FOIA it." Someone called their bluff and did. Suprise, surprise, they literally made it up.
Though it won't come as much surprise to anyone in the kratom community, it turns out, wonder of wonders, the FDA's advisory was pulled completely out of nowhere. According to FOIA material released by Muckrock. If you're not familiar with the FDA and DEA's years-long unfounded and (according to many pharmacology and addiction researchers) entirely unscientific war on kratom, then you might be unaware of the FDA's recent advisory against kratom marked the plant as some sort of "deadly killer." In addition to making false claims of kratom being linked to 36 deaths, they went as far as to say the plant that has helped thousands kick opiates for chronic pain or beat withdrawal from illicit opiates and opioids would worsen the opiate crisis we are in the midst of.
The FDA made multiple false claims regarding kratom itself, the way it is marketed and who used it. Despite the availability of a wealth of data on kratom (dozens of animal trials and other research in the scientific literature, an 8-factor analysis by a former head of the National Institute for Drug Abuse, hundreds and hundreds of data) the FDA decided to use absolutely no sources to back up the claims in their advisory.
The FOIA request was filed by Anthony Roberts who requested "copies of all evidence and all validating documents, plus related proof, that the FDA relied upon when making all of the claims about kratom" that was released in their <a href="https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584970.htm">advisory of November 14, 2017.</a>
<blockquote class="twitter-tweet" data-lang="en"><p lang="en" dir="ltr"><a href="https://twitter.com/RandPaul?ref_src=twsrc%5Etfw">@RandPaul</a> <a href="https://twitter.com/justinamash?ref_src=twsrc%5Etfw">@justinamash</a> <a href="https://twitter.com/RepThomasMassie?ref_src=twsrc%5Etfw">@RepThomasMassie</a> <a href="https://twitter.com/hashtag/kratom?src=hash&ref_src=twsrc%5Etfw">#kratom</a> is used safely and without injury by an estimated 5 million plus Americans every day. Don't let the <a href="https://twitter.com/hashtag/FDA?src=hash&ref_src=twsrc%5Etfw">#FDA</a> turn these law-abiding citizens into criminals overnight. The drug war is a failure and this will be a giant step backwards</p>— Justin Franklin (@DJMF420) <a href="https://twitter.com/DJMF420/status/934125451039031296?ref_src=twsrc%5Etfw">November 24, 2017</a></blockquote>
<script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>
The FDA made numerous medical claims regarding kratom's safety, claiming it was responsible for organ damage. FDA further claimed that it was marketed as a "safe treatment" with "broad healing properties." Mr. Roberts called them on this, asking for specific documentation that factored into their claims. Claims about the "proponents of the plant" also had words placed in their mouth via the FDA press release. "The FDA knows…" the press release read several times. Mr. Roberts calls their hand: "How does the FDA know this? Please provide all documents relied upon as support for this claim." Time and again requesting "validation and documentation" and the supporting evidence for what would, otherwise, be completely baseless claims with no scientific supporting evidence.
<blockquote>What evidence? Please provide said evidence. Again, I am seeking the documents the FDA has relied upon, or experts consulted, to come to these conclusions. Additionally, I am also seeking any emails (whether sent to the FDA or any employee or director of the FDA, by a lobbying group, PAC, or any other outside source, as well as internally composed/generated emails). I additionally seek internal documents, including but not limited to memorandum of interviews and white papers, that offer the opinions or facts used to support the preceding, quoted, claims found in the press release.
Here, I am also seeking to answer, with specificity, which opioids kratom resembles in terms of risk of death. Here, as "similar risk" has been mentioned, I am seeking the documentation and statistical analysis, used by the FDA, that articulates or provides evidence of the "similar risk" of kratom viz other opioids.</blockquote>
Reuters covered the FDA advisory when it was first released November 14. They specifically asked for more information on the supposed "36 deaths" and over what span they had taken place. In a classic stalling tactic, FDA referred the Reuters reporter to FOIA (say that 5 times fast). Kind of the equivalent of saying, "Go fish…"
Well, somebody decided to fish. Mr. Roberts was point blank in his questioning of the FDA. Generally, their position of apparent authority may make them immune to such inquiry, but in the case of kratom there are too many brilliant minds who have shared too many benefits to fool the kratom community into falling for the "kratom scare."
<blockquote>"There’s clear data on the increasing harms associated with kratom. "
Please provide the "clear data" in full.
"Calls to U.S. poison control centers regarding kratom have increased 10-fold from 2010 to 2015, with hundreds of calls made each year."
Please provide details and records of these calls and statistics.
"The FDA is aware of reports of 36 deaths associated with the use of kratom-containing products."
How is the FDA aware of these deaths? Please provide correspondence with any outside agencies or agents, whether governmental, private or otherwise concerning these deaths. Additionally, please provide all evidence and documentation of these deaths, and further that they were associated with kratom.
"There have been reports of kratom being laced with other opioids like hydrocodone."
Provide the reports referenced.
"The use of kratom is also associated with serious side effects like seizures, liver damage, and withdrawal symptoms."
Please provide evidence of kratom being associated with "seizures, liver damage, and withdrawal symptoms."
"…FDA has evidence to show that there are significant safety issues associated with its use. "
Again, please provide the evidence FDA utilized and/or analyzed in the composition of this press announcement to come to this conclusion.</blockquote>
And what was this "clear data" that the FDA didn't want to share with the Reuters reporter? Where was all this "evidence" referred to again and again that the FDA used in order to make their "scientific" conclusion? Turns out they had nothing. Ah well, worked for Paul Newman, didn't it?
<iframe width="854" height="480" src="https://www.youtube.com/embed/zDYyg0QskRo" frameborder="0" gesture="media" allow="encrypted-media" allowfullscreen></iframe>
The Center Food Safety and Applied Nutrition concluded their request as they didn't locate any records responsive to the request. At this point in the process, an appeal can be made, but as is, the FDA lying not only about the plant, those who use it and the way in which it is marketed should be evidence of what kind of case they have at present.