By Philip  |  12-03-2017   News
Photo credit: Somchai Chusiri | Dreamstime.com

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>&mdash; American Kratom Association (@TheKratomAssn) <a href="https://twitter.com/TheKratomAssn/status/935917263676461059?ref_src=twsrc%5Etfw">November 29, 2017</a></blockquote>

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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&amp;ref_src=twsrc%5Etfw">#kratom</a> is used safely and without injury by an estimated 5 million plus Americans every day. Don&#39;t let the <a href="https://twitter.com/hashtag/FDA?src=hash&amp;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>&mdash; Justin Franklin (@DJMF420) <a href="https://twitter.com/DJMF420/status/934125451039031296?ref_src=twsrc%5Etfw">November 24, 2017</a></blockquote>

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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?

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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.

Source:

https://www.muckrock.com/foi/united-states-of-america-10/fda-evidence-of-claims-in-kratom-press-release-45861/

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14 Comment/s


Anonymous No. 13226 1512308732

FDA database shows ZERO?

Even the CDC has data?

https://www.cdc.gov/mmwr/volumes/65/wr/mm6529a4.htm

National Poison Data System (NPDS) during January 2010–December 2015.

660 calls alone.

CDC - "Kratom use appears to be increasing in the United States (2), and the reported medical outcomes and health effects suggest an emerging public health threat.

Members of the public and health care providers should be aware that the use of kratom can lead to severe adverse effects, especially when consumed in combination with alcohol or other drugs.

As mention before the GA GBI database shows Officially documented cases. What about other states?

It seems the public STILL is not getting the whole unbiased facts.

Jaime litteken No. 13238 1512320294

I have been taking kratom daily for several months now with no adverse effects. I have been diagnosed with a variety of mental disorders including GAD and severe depression. I also have had a back surgury and suffer from near constant pain. Since I started taking kratom I have noticed that I am more social, far less anxious, and the symptoms of my depression are gradually fading away. My back pain has been far more tolerable, which also contributes to my overall better attitude. Kratom has worked far beyond my expectations and, for me, been far more effective than any pharmaceutical drug I have ever been prescribed. If it becomes outlawed I truely fear for my mental and physical wellbeing. There are thousands of us who have had great success with this plant. I urge the opposition to take a step back and really think before they act. We only want to live well.

Pamela Shealy No. 13239 1512320518

This plant has saved many lives. So many lives will be affected in a negative way if this is banned. We should have a choice on what we can take for our health. Years of people taking this plant with no deaths specifically with Kratom.

Ashley No. 13240 1512322081

Thanks for this article! The truth needs to come out about this plant /leaf. It has given me my life back.

Lora Romney No. 13249 1512332790

I am a pain patient who has used opioids for years. My doctor will only give me a very limited amount. Not nearly enough to control my pain. After trying dozens of pharmaceuticals, brain surgery and a stimulator implant in my face, I stumbled upon Kratom. It is the first thing that has helped control my pain outside of opioids. I have been able to drastically cut back on my opioid consumption and it am able to bring my pain to a manageable level most days. The best part is that it works without giving me side effects like opioids do. I feel healthier now. Please don’t take this away from me. Doctors are cutting back opioid prescriptions. Patients are being left with no options. We should be allowed to use this safe plant to help control symptoms.

Lawrence Harrison No. 13255 1512340308

We need to continue to shine the light of truth in this situation. We can win this fight. We are in the right.

This is a very crucial time for the FDA. They have already been proven liars concerning their data. This leads us to extrapolate their motives. To move further in this action would only prove that their are not for Americans right's and the freedom to choose healthy alternatives to the dangers of prescription drugs concerning health and wellness.

Ralph No. 13271 1512378918

The CDC data is for calls to poison control. Not deaths. Not even injuries. Please acknowledge your hyterical failure to comprehend.

Ralph No. 13275 1512379155

You're talking about data from law enforcement. Not health agencies. As I stated before, CDC data for poison control calls are the result of hysteria from mommies with 20 year olds who found kratom in their rooms. That's it. And guess who cause the hysteria… The DEA and FDA!

Ralph No. 13277 1512379578

You know 13226 being anonymous… The DEA sticks people on online propaganda patrol all the time. Post anonymously doesnt matter. You're the only one who doesn't know better. Still misunderstanding data collected. Not understanding that the whole problem is that these deaths ALL involve other drugs in high doses. Kratom simply being present only means that they likely wanted to stop an opiate habit. They all appeared to have died from high doses of hydrocodone and many others.

Anonymous No. 13289 1512382658

BTW: My NON-GOV career for 22+ years has been digging up facts and wading thru personal vs factual statements for evidence.

I have no side in this discussion other that trying to present additional safety facts that seem to be overlooked.

My personal beliefs are "Government should stop at the mailbox".

Either way doesn't the general public have a right to know more facts than just those of happily dosed users?

Its called "An informed decision process".

Grumpy No. 13311 1512402980

The data can make it say whatever you want it to say. Did you know that OTC Benadryl deaths increased 100% between 2010 and 2015 according to poison control data? Nevermind that there was 1 death in 2010 and 2 deaths in 2015.

660 calls in 5 years is NOTHING. It's also highly anecdotal - these aren't researchers calling in with findings, they are every day people calling in who claim something (or a provider via hearsay).

I notice you don't mention the 20,000+ people who responded to the DEA RFC with testimonials about how kratom helped them. I think if you were really unbiased, you might mention that as well.

eGeekiel No. 13385 1512493501

I have been using Kratom DAILY since 2008 with no adverse side effects at all. This FDA is the worst lying, propagandizing government organization I have seen to date,

Their claims are based on NO truth whatsoever and NO facts whatsoever. I know I am getting really tired of every government organization telling me what I can or cannot do and then base all of their cannots or facts as they call them on LIES. Ii thought the DEA was bad enough at this lying game BUT teh FDA has them beat by a mile with teh lies.. not even half truths at all… these "people" at the FDA really need to learn how to call something what it is, and at the very least tell the truth and have documentation, other than some BS docs they pull out of their collective asses.

I am confident that eventually American society as a whole will see what OUR government has become and they will start pushing back at some pint. People are getting sick of all these stupid rules and regulations based on nothing but pure imagination and lies.. you can call it what you want. The FDA are liars…period.

EllieGal No. 13395 1512508442

The FDA and the DEA should be completely transparent with their data and sources. Without transparency, their actions amount to corporate controlled big government and a police state, not a democracy!

Angela No. 13428 1512558791

At least six people die from alcohol abuse each day, families have been torn apart and lives turned upside down yet I can buy booze freely and in whatever quantity I choose without any legal ramifications. This action by the DEA is cruel and senseless. It makes as much sense as outlawing coffee. I suspect corruption and collusion with pharmaceutical companies on the part of the DEA as no other explanation for classifying this substance makes any sense. Please let me know what I can do to help keep this amazing natural supplement available to me and millions of others who have experienced the amazing change in our quality of life because of this great leaf. For more information: www.kratomcrazy.com

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