By: Philip | 11-21-2017 | News
Photo credit: Antonio Gravante | Dreamstime

Family Practitioner Posts Open Letter to FDA Regarding Kratom

The kratom community is on high alert since the FDA issued an advisory claiming some 36 deaths attributable to kratom. A great deal of misinformation exists related to kratom but fortunately for the people who find an improved quality of life using the South East Asian plant, there are several experts who support our case as well. Just earlier today, I wrote about <a href="https://thegoldwater.com/news/12348-Dr-Jane-Babin-Weighs-In-On-Kratom-Safety">my interview with molecular biologist and kratom advocate, Dr. Jane Babin.</a>

The American Kratom Association <a href="https://www.americankratom.org/fda-call-to-action">released a call to action</a> that involved a form letter template, and suggestions for people to contact in regards to kratom. Recently on Reddit, the user hononononoh shared his open letter to FDA Commissioner Dr. Scott Gottlieb. Being an M.D. certainly couldn't hurt as far as establishing an expert opinion. According to the demographic breakdown following the DEA's comment period last Autumn, <a href="https://www.inquisitr.com/4617297/ny-post-spreads-dea-disinfo-regarding-kratom/">48 percent of the respondents</a> was composed of veterans, law enforcement officials, healthcare professionals and scientists.

Dear Dr. Gottlieb:

I am a practicing family physician who is advocating for the continued legality of kratom. I have seen firsthand the positive effects kratom has had on the health and quality of life of patients. Like anything we take into our bodies, kratom carries risk, and is certainly not for everyone. However, recommending a ban on kratom will make it far more difficult to conduct the research necessary for determining its risks and benefits.

I am aware that America's opioid addiction crisis is one of the main issues President Trump's administration selected you to tackle. Having been on the front lines of this crisis, I laud your efforts I support you in this goal. Having examined what evidence there is, including my own patients' outcomes, I deem kratom's continued availability to the public much more a part of the solution, than a part of the problem. I am confident that as a fellow scientist and physician, you and your colleagues will take due consideration of all available unbiased, up to date scientific evidence regarding kratom, before making any recommendations to the DEA and any other government bodies.

Below is my contact information, as I would be happy to discuss this issue further with you and your colleagues. Consider this an open letter to the FDA; I consent to my name and my stance on this issue being shared, and this e-mail forwarded (in full and unaltered) as you see fit.

<a href="https://www.reddit.com/r/kratom/comments/7dmbdp/an_open_letter_to_dr_scott_gottlieb_and_his/">/u/hononononoh also offered some advice</a> for others who would like to help with the letter-writing campaign.

<blockquote>*Hard facts, stated briefly and backed up

*Logical arguments for why our position is in theirs and everyone's best interest

*Unfailingly polite and professional language

The quality, not just the quantity, of communication, is what gets a letter of advocacy taken seriously by people in charge, as opposed to dismissed as the rantings of an internet nutter. Don't feed the stereotype of "druggie".</blockquote>

Credentialed or not, every voice and opinion matters, but it is always best to make sure you know your facts and share them clearly and in a professional and polite manner.

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27 Comment/s
Anonymous No. 12399 2017-11-21 : 18:27

Yes there is a great deal of misinfo floating around. From BOTH Sides.

What is NOT misinformation is the number of Emergency Medical Calls by Metro-city Fire Depts. regarding Kratom Overdoses. Because too many Druggies aren't getting a quick enough BUZZ so they do more, thinking they have not done enough.

MY DATA SOURCE:

My son works for a major southern Metro-City FD. He is a 10 yr EMS vet and a 15 yr Fire Fighter. He is seeing 6++ Kratom OD's (not deaths) a week. He tells me he is pushing as many as 3 Narcan™ (naloxone) counter-acting doses to revive the OD' person.

An yes there has been a few that quit breathing or Cardiac arrested, that likely are the IQ equal now of a fly.

So if we are going to be honest, we need to look at the misuses, and abuses as well as the benefits.

Philip No. 12400 2017-11-21 : 18:57

>>12399

Well, I am in contact with some fairly credentialed medical professionals who would disagree with you. I interviewed Dr. Jane Babin just last week. She and Dr. Karl Ebner (an authority of forensic toxicology) have fully debunked the "15 kratom deaths" claimed to date.

Even IF "misused/abused" kratom HAS NEVER been causally linked to death. There is/will be no need for Narcan with a kratom user either as kratom has NEVER been known to create dangerous respiratory depression.

Do you know of Dr. Jack Henningfield's 8 factor analysis? Dr. Henningfield, in addition to being a professor at Johns Hopkins, one of the top medical universities in the nation, is an authority in the field of addiction and drug abuse.

I am going to trust the authorities in the field like Dr. Chris McCurdy, Dr. Heningfield and Dr. Babin on this. Currently, the top researchers do NOT agree with your opinion on kratom's potential for danger.

Below is the link to my interview with Dr. Babin, if you're interested.

https://www.youtube.com/watch?v=7xMcP1MCILE

And below this is the link to the 8 factor analysis by Dr. Henningfield:

http://speciosa.org/8-factor-analysis-of-kratom-performed-by-dr-hennigfield-submitted-the-deafda/

Richard Willsey No. 12401 2017-11-21 : 19:10

Thank you Dr.

Anonymous No. 12403 2017-11-21 : 19:22

The Goldwater sucks Donkey Dick. I mean that in the best way.

John No. 12404 2017-11-21 : 19:30

While not challenging you or the veracity of your son's report, one would need to know more than just an anecdotal report to regard these supposed overdose cases as fact. Considering what is known about the pharmacology of kratom, the story you tell is very difficult to believe. I don't doubt people on the streets are overdosing on something, but I highly doubt it is kratom. Indeed, with such low oral bioavailablity (a little over 3%) for the alkaloids responsible for mu receptor agonism (partial and biased agonism at that) and considering the amount of IV fentanyl would be required to produce a condition where a patient could only be stabilized by 3 naloxone doses, it is impossible to even imagine a situation where kratom could cause such a scenario.

Kendall No. 12405 2017-11-21 : 19:33

In response to the above hysterical claims about purported 'oversdoses,' there is a reason you will see such comments submitted anonymously in various fora. There is a small but dedicated (perhaps a bit rabid) group of individuals who are passionately opposed to kratm despite virtually no credible evidence to support their position (Lance Dyer comes to mind). In the past year or two, they have taken to making absurd claims that are simply not true whatsoever, posing as professionals, posing as people with intimate knowledge, creating fake profiles etc.

The published research is quite clear: kratom has an exceedingly good safety profile. If any individual landed in the hospital, it is overwhelmingly likely that he or she bought readily-available synthetics (eg tramadol) or other junk online. This is in fact one of the problems with a proposed ban: it will simply drive ever more people to seek out easily-obtainable chinese synthetics online rather than being able to obtain safe, tested, and pure kratom leaf. ODs will without any question spike, a new black market will form, a new class of 'criminals' - people merely trying to responsibly manage their health - will be created overnight (as though this has ever improved a drug crisis or curtailed the availability of mind-altering substances, and as though our criminal justice system can bear such a new burden). You cannot stop drug seekers from experimenting with virtually everything, including kratom, but kratom is not a recreational 'drug' and such seekers are inevitably sorely disappointed. the vast majority of kratom consumers are not such people.

Thank you, doctor, for spreading some common sense and truth about this subject.

Thomas Gearman No. 12423 2017-11-22 : 02:05

I appreciate your willingness to risk condemnation by your peers for voicing your position. It speaks to your integrity and passion for the oath you too to your profession. Thank you.

Anonymous No. 12427 2017-11-22 : 03:49

Anonymous No. 12399 claim of having to use Narcan is laughable. Kratom does not cause respiratory depression. This is just another example of false information being spread about this plant.

Michael Soulvie No. 12439 2017-11-22 : 06:31

I use kratom daily.roughly six grams.three in the morning.three at night for pain.if i take more the effects are very unpleasant. Nasty headache and probably vomiting.im obviously no doctor but even i know i couldnt kill myself on it.just basically puke my guts out and learn a lesson about moderation.this fictitious person is ridiculous.

Jason Callahan, MPH No. 12468 2017-11-22 : 17:12

Anonymous' (12399) post regarding narcan can't be dismissed entirely but there is zero evidence that those people who overdosed did so because of kratom. If kratom was the sole culp it would be medically negligent to administer narcan. What is more likely probable is the OD cases are from heroin or another potent opioid. Kratom does not cause any deadly side effects. If those people overdosed on heroin or another illicitly obtained opiate isn't it convenient for them to blame kratom in an attempt to avoid legal problems? How many people are trying to avoid illegal drug use charges by claiming the substance the ingested was legal [kratom]? I suspect this kind of lying is more prevalent than we may know. Those who would lie to medical professionals don't care about the negative press being pushed on to kratom when in fact it is a safe plant.

Anonymous No. 12482 2017-11-22 : 21:28

Anonymous' (12399) Chiming in again.

Look I know I am like Trump as a Guest speaker at an ANIT-FA rally on this issue. But BOTH sides need to be more honest about the pro's and con's. Because as we know even Aspirin if misused can be deadly.

In my case what I am relying comes from a seasoned EMS son who runs 100's of OD's a year. Yes "some" are KRATOM. But a vast majority are the very drugs (legal and Illegal) it could replace. He nor I, has no Iron in the fire of either side, but he does have Ground Zero experience that Kratom OD's do happen.

I will also restate Kratom related calls are far and in between.

Do I hope it gets to open market in safe and FDA approved manner like any other over the counter med? YES.

Do I hope it is safe enough to be sold w/o a prescription, like Aspirin? YES.

But I like things to be a lot less loosey goosey. Because too many Folk remedies in the past have had serious side effects and Birth defects.

Ralph No. 12541 2017-11-23 : 20:18

I di have to point out to yoy that your son EMT fails to mention what other drugs were being taken with kratom when they supposedly stopped breathing.

Kratom clinically DOES NOT CAUSE SIGNIFICANT RESPIRATORY DEPRESSION. What you're talking about is mixing of drugs. If what you're saying is true then we should be seeing many more apnea events with 3 millions daily users of kratom.

Ralph No. 12542 2017-11-23 : 20:27

Anon. 12399: I keep asking you for details. None provided. 3 million users of kratom. And somehow so far the only confirmed issues occur when taken with other drugs.

You also misunderstand kratom. Kratom contains corynantheideine, which is a fairly potent mu ANTAGONIST. So if kratom were the main component of a case of apnea in dispute, your misinformed EMT son would not be administering naloxone.

Please leave the science to scientists. The subtleties of thebbiochemistry of opioids requires more than simply "common sense" to comprehend. Your common sense will fail you. That's why we actually use scientific methods to understand things and we don't understand. We dont just have and EMT's mother take the stand and tell a jury that their "common sense" says whatever.

Ralph No. 12544 2017-11-23 : 20:45

The irony is that mixing kratom (with its antagonist component) will actually dampens any "high" from pure mu agonist drugs like morphine. It literally saves lives from respiratory depression. But you can't save people from continuing to take more and more hydrocodone or oxycodone to regain the high they wanted. They'll overdo it and kill themselves. Kratom did not and would not cause apnea at all. There's a large body of peer-reviewed evidence in vitro and in vivo proving this.

So… response?

Ralph No. 12546 2017-11-23 : 21:01

"My son is an EMT" is not a reference. If your son knew anything about kratom and the scientific method of isolating the effects of different variables, i.e. separating the simultaneous effects of e.g. oxycodone and kratom then he would have published material you could point to.

Dont get me wrong. If it's something genuinely simple like observing that getting punched in the face results in pain then conclusions from common sense can be made. But biochemistry isn't simple. Biochemical science is tremendous in complexity.

Ralph No. 12548 2017-11-23 : 22:44

This is typical of interactions I've had with opponents to rational ideas. They post anonymously and then vanish when challenged. They usually cite their own sad lives as references or some gossip rag periodical or tabloid media.

They never give citations from people or organizations who have dedicated their lives to understanding phenomena like the biological activity of kratom in humans. They fail miserably at understanding that a MIXTURE of drugs automatically discredits their attempt to blame kratom for death or injury. The FDA is banking on this working (at least Scott Gottlieb is, since it is his cash cow connection to pharmaceuticals that drives his desire to ban kratom through whatever means).

Of course 'Anonymous 12399' may simply be a typical American who has no appreciation for the technology they use everyday because they think medicine, CPUs/GPUs, home security equipment, food science, genetics, etc., all just somehow popped into existence. Never mind the thousand years of progress in science that has brought us here.

Anonymous No. 12639 2017-11-25 : 12:32

Experts vs. Users.

Who is right?

GA. Bureau Investigations (GBI)

Dr. Jonathan Eisenstat, the GBI's chief state medical examiner, said Kratom contributed to 5 deaths in 2016 and 11 deaths so far in 2017.

The GBI Medical Examiner said Kratom is showing up in GBI Lab tests done for drug related autopsies.

It should be noted Dr. Eisenstat added a caveat and said of the 11 Kratom related deaths so far in 2017, Kratom was the sole drug used that caused 2 deaths. Given Kratom is now widely being used as a recreational drug, it is more frequently found mixed with other Illegal drugs.

The same Doctor said of the 5 Kratom related deaths in 2016, it was the only drug used in 1 case.

So it is clear that it does kill at some level of intake.

Also the director at the Extension Addiction Treatment Center in Marietta Ga, who has middle level research clearly agrees. Having treated and detoxed a few Kratom taking patients.

Warning Kratom is already Illegal in some states.

The question now is:

Who will win this War of Words?

Brian Hunsinger No. 12648 2017-11-25 : 14:56

Been using Kratom for 18 months and honestly don't find it possible to cause an overdose. If i use to much my stomach will churn and sometimes I will throw it back up. Normally I use 3 to 4 grams twice a day and it helps with pain and allows me to function. Kratom changed my life for the better.

Anonymous No. 12701 2017-11-26 : 10:45

Official Criminal Reports.

Please explain the fact that Dr. Jonathan Eisenstat, the GBI's chief state medical examiner in Georgia , has officially said Kratom has contributed to five deaths in 2016 and 11 deaths so far in 2017?

http://www.wsbtv.com/news/local/controversial-herb-supplement-is-killing-people-in-georgia-medical-examiner-says/648796946

Bob No. 13124 2017-12-01 : 22:00

Did some looking and those few anon comments saying narcan was used on kratom etc–all came from one person.

Lance is that you?

Bob No. 13125 2017-12-01 : 22:04

Every single comment "against" kratom all came from one person. He tried. We should give him a little credit but I would think everyone knew by now that this isnt 1997.

Just because it says they let you post anonymously, doesnt mean nobody can find shit out.

Anonymous No. 13141 2017-12-02 : 11:49

I see everybody avoid answering the GBI findings Kratom death related question.

Note: those are just GA GBI numbers

(just 1 state) there are states not mentioned.

Personally, I could careless what a person does in the privacy of their home. Because, I believe that Government should stop at the Mail Box.

But we are discussing something that has been proven fatal in certain specific situations. What is needed here are FACTS why that happened.

Something that has been totally avoided or ridiculed here. So obviously in the interest of public safety, a whole and factual picture needs to be debated. DEA & AKA neither are doing, this due to eaches own agenda.

Melissa Marshall No. 13189 2017-12-03 : 01:19

I am a resposibale kratom consumer for 7 months! I am a wife and mother of 3 kids! I now live a life full of joy! Thanks to kratom !! I am more focus, have more energy and sleep great now! Kratom is not a public health crisis in any way shape or forme ! Foucus on the real issues which is drugs! Kratom is an all natural tea! It only helps people! Does not hurt and defanitly does not kill!!

Anonymous No. 13228 2017-12-03 : 13:59

Please explain 660 Calls to Poison Control Centers in the US.

CDC- Published numerous case reports have associated Kratom exposure with psychosis, seizures, and deaths .

Note: See the following for greater FACTS.

https://www.drugabuse.gov/publications/drugfacts/kratom

Any use of Kratom should ONLY be made after learning ALL the FACTS.

Currently I do not see either side (DEA-FDA or AKA ) publishing all the facts.

So educate and exercise good adult judgement.

Anonymous No. 13605 2017-12-08 : 20:40

All you have to do is tohave somw common sense and to look at statistics to know that kratom is not the huge danger that some people would make it out to be…millions use kratom yet we only have 36 supposed deaths? OnLY 600 calks in to poison control

J mason No. 13606 2017-12-08 : 20:47

If something doesnt make sense its generally because its not true. If you look at this statistically..we have millions of users of kratom but only 36 alleged deaths and only 600 poison control calls? IF kratom is dangerous, this doesnt make sense.

Anonymous No. 14019 2017-12-15 : 03:17

J mason, do you have a source for those 600 poison control calls?

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