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Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s scientific evidence on the presence of opioid compounds in kratom, underscoring its potential for abuse

Kratom-Opioid

For Immediate Release

February 6, 2018

Summary

FDA releases adverse events and scientific analysis providing even stronger evidence of kratom compounds’ opioid properties.

Statement

Over the past several months, there have been many questions raised about the botanical substance known as kratom. Our concerns related to this product, and the actions we’ve taken, are rooted in sound science and are in the interest of protecting public health. However, we recognize that there is still much that is unknown about kratom, which is why we’ve taken some significant steps to advance the scientific understanding of this product and how it works in the body. Today, we’re providing details of some of the important scientific tools, data and research that have contributed to the FDA’s concerns about kratom’s potential for abuse, addiction, and serious health consequences; including death.

Notably, we recently conducted a novel scientific analysis using a computational model developed by agency scientists, which provided even stronger evidence of kratom compounds’ opioid properties. These kinds of models have become an advanced, common and reliable tool for understanding the behavior of drugs in the body. We also have learned more about deaths that involved kratom use, and have identified additional adverse events related to this product. This new data adds to our body of substantial scientific evidence supporting our concerns about the safety and abuse potential of kratom.

We have been especially concerned about the use of kratom to treat opioid withdrawal symptoms, as there is no reliable evidence to support the use of kratom as a treatment for opioid use disorder and significant safety issues exist. We recognize the need and desire for alternative treatments for both the treatment of opioid addiction, as well as the treatment of chronic pain. The FDA stands ready to evaluate evidence that could demonstrate a medicinal purpose for kratom. However, to date, we have received no such submissions and are not aware of any evidence that would meet the agency’s standard for approval.

The FDA’s PHASE model used to assess kratom

Federal agencies need to act quickly to evaluate the abuse potential of newly identified designer street drugs for which limited or no pharmacological data are yet available. This is why the FDA developed the Public Health Assessment via Structural Evaluation (PHASE) methodology – a tool to help us simulate, using 3-D computer technology, how the chemical constituents of a substance (such as the compounds/alkaloids found in kratom) are structured at a molecular level, how they may behave inside the body, and how they can potentially affect the brain. In effect, PHASE uses the molecular structure of a substance to predict its biological function in the body. For example, the modelling platform can simulate how a substance will affect various receptors in the brain based on a product’s chemical structure and its similarity to controlled substances for which data are already available.

Using this computational model, scientists at the FDA first analyzed the chemical structures of the 25 most prevalent compounds in kratom. From this analysis, the agency concluded that all of the compounds share the most structural similarities with controlled opioid analgesics, such as morphine derivatives.

Next, our scientists analyzed the chemical structure of these kratom compounds against the software to determine its likely biologic targets. The model predicted that 22 (including mitragynine) of the 25 compounds in kratom bind to mu-opioid receptors. This model, together with previously available experimental data, confirmed that two of the top five most prevalent compounds (including mitragynine) are known to activate opioid receptors (“opioid agonists”).

The new data provides even stronger evidence of kratom compounds’ opioid properties.

The computational model also predicted that some of the kratom compounds may bind to the receptors in the brain that may contribute to stress responses that impact neurologic and cardiovascular function. The agency has previously warned of the serious side effects associated with kratom including seizures and respiratory depression.

The third aspect of the model is the 3-D image we generate to look at not just where these compounds bind, but how strongly they bind to their biological targets. We found that kratom has a strong bind to mu-opioid receptors, comparable to scheduled opioid drugs.

So what does this body of scientific evidence mean? The FDA relies on this kind of sophisticated model and simulation to supplement its data on how patients react to drugs; often as a way to fully elucidate the biological activity of a new substance. The data from the PHASE model shows us that kratom compounds are predicted to affect the body just like opioids. Based on the scientific information in the literature and further supported by our computational modeling and the reports of its adverse effects in humans, we feel confident in calling compounds found in kratom, opioids.

Furthermore, this highlights the power of our computational model-based approach to rapidly assess any newly identified natural or synthetic opioids to respond to a public health emergency.

Learnings from reports of death associated with kratom

We’ve been carefully monitoring the use of kratom for several years, and have placed kratom products on import alert to prevent them from entering the country illegally. We have also conducted several product seizures. These actions were based, in part, on a body of academic research, as well as reports we have received, suggesting harm associated with its use. And we are not alone in our evaluation and our public health concerns. Numerous countries, states and cities have banned kratom from entering their jurisdictions. We described some of this information in a public health advisory in November 2017, in which we urged consumers not to use kratom or any compounds found in the plant.

Now, I’d like to share more information about the tragic reports we have received of additional deaths involving the use of kratom. Looking at the information we have received – including academic research, poison control data, medical examiner reports, social science research and adverse event reports – we now have 44 reported deaths associated with the use of kratom. This is an increase since our November advisory, which noted 36 deaths associated with these products. We’re continuing to review the newly received reports and will release those soon. But it’s important to note that these new reports include information consistent with the previous reports.

Today, we’re releasing the reports of the 36 deaths we referenced in November. These reports underscore the serious and sometimes deadly risks of using kratom and the potential interactions associated with this drug. Overall, many of the cases received could not be fully assessed because of limited information provided; however, one new report of death was of particular concern. This individual had no known historical or toxicologic evidence of opioid use, except for kratom. We’re continuing to investigate this report, but the information we have so far reinforces our concerns about the use of kratom. In addition, a few assessable cases with fatal outcomes raise concern that kratom is being used in combination with other drugs that affect the brain, including illicit drugs, prescription opioids, benzodiazepines and over-the-counter medications, like the anti-diarrheal medicine, loperamide. Cases of mixing kratom, other opioids, and other types of medication is extremely troubling because the activity of kratom at opioid receptors indicates there may be similar risks of combining kratom with certain drugs, just as there are with FDA-approved opioids.

However, unlike kratom, FDA-approved drugs have undergone extensive review for safety and efficacy, and the agency continuously tracks safety data for emerging safety risks that were previously unknown. So we have better information about the risks associated with these products; and can better inform the public of new safety concerns. For example, in August 2016, the FDA required a class-wide change to drug labeling to help inform health care providers and patients of the serious risks (including respiratory depression, coma and death) associated with the combined use of certain opioid medications and benzodiazepines. In June 2016, the agency also issued a warning that taking significantly high doses of loperamide, including through abuse or misuse of the product to achieve euphoria or self-treat opioid withdrawal, can cause serious heart problems that can lead to death. We also recently took steps to help reduce abuse of loperamide by requesting packaging restrictions for these products sold “over-the-counter.”

Taken in total, the scientific evidence we’ve evaluated about kratom provides a clear picture of the biologic effect of this substance. Kratom should not be used to treat medical conditions, nor should it be used as an alternative to prescription opioids. There is no evidence to indicate that kratom is safe or effective for any medical use. And claiming that kratom is benign because it’s “just a plant” is shortsighted and dangerous. After all, heroin is an illegal, dangerous, and highly-addictive substance containing the opioid morphine, derived from the seed pod of the various opium poppy plants.

Further, as the scientific data and adverse event reports have clearly revealed, compounds in kratom make it so it isn’t just a plant – it’s an opioid. And it’s an opioid that’s associated with novel risks because of the variability in how it’s being formulated, sold and used recreationally and by those who are seeking to self-medicate for pain or who use kratom to treat opioid withdrawal symptoms. We recognize that many people have unmet needs when it comes to treating pain or addiction disorders. For individuals seeking treatment for opioid addiction who are being told that kratom can be an effective treatment, I urge you to seek help from a health care provider. There are safe and effective, FDA-approved medical therapies available for the treatment of opioid addiction. Combined with psychosocial support, these treatments are effective. Importantly, there are three drugs (buprenorphine, methadone, and naltrexone) approved by the FDA for the treatment of opioid addiction, and the agency is committed to promoting more widespread innovation and access to these treatments to help those suffering from an opioid use disorder transition to lives of sobriety. There are also safer, non-opioid options to treat pain. We recognize that some patients have tried available therapies, and still have unmet medical needs. We’re deeply committed to these patients, and to advancing new, safe and effective options for those suffering from these conditions.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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The Children Left Behind…

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I hope someone is listening!

It has  been a month now since my daughter was killed in a one car accident on I65 outside of Nashville, TN, on her way home to her children.  She had been out of town for a few days with her fiancé attending his Sons’ Graduation from Military School.They had driven for ten hours and it was about 4 a.m. when it happened.  It is an old story, and it happens everyday to someone’s child.  I am not special and so on that fateful day I lost my baby girl.  I won’t bore you with the details.  That story is posted HERE.

My Daughter had serious depression and anxiety problems and was never able to get the right doctor to treat her illness…moreover, she was tired of trying to.  She had been self medicating for years with street drugs.  The problem was that the drugs that she ended up using only exasperated the problem.  It was not feasible that her drug use would help the problem…it only made it worse.What started as a “pain pill” problem after being prescribed opiates by a doctor for chronic pain, which she indeed had, ended up being a cocaine, meth and possibly a heroin addiction for which she then decided to self medicate with  buprenorphine which she also obtained “off the street”. 

I begged her a number of times to get help but there was no real help.  She refused to use Cannabis because of drug testing – first she was scared of CPS drug testing, then she needed to test clean for a job (which she could never hold onto).  She was scared of losing her children because of a positive THC test.  The “other stuff” you can get out of your system quicker, she had told me.  Well, that’s just fucking great.  Now she is dead.

Her medical history is about as difficult as mine is.  It suffices to say that chronic debilitating pain especially when you throw that on top of a mental illness such as we have, Chronic Major Depression and chronic anxiety, that is enough to cause you to look anywhere for some kind of relief.  It is only human nature that if you are in pain, mental or physical,  to try and find some way to get out of it!  In this World you do not have time to sit down and be ill or in pain.  There are bills to pay and kids to feed and nobody cares if you are sick. We are slaves to the system.

I had begged her to come home a number of times.  But at 34 years old I suppose that she needed her own space.  She worked hard at anything she could do to make a little money to keep going.  The drugs kept her going physically, until they took her down.  And when it finally did take her down that last time as she was driving down I65, she left behind three Son’s and a family who loved her so much words can do no justice.

The buprenorphine was the beginning of the end for her.  I watched while she slowly disintegrated….and that was what it was like…watching something disintegrate before your eyes and not being able to stop it.  Because she was so good at hiding what she was doing, I never really knew what drugs she was on at what time, with the exception of the Buprenorphine which she told me about.. The past few years the boys had been with me a lot of the time.  She just could not handle the stress of “trying to find money to live on” and taking care of kids at the same time.  She was totally dysfunctional.  Totally depressed and anxietized.  The only thing I could think of was to get her off the drugs which was impossible to do especially when she wouldn’t use Cannabis. 

She was scared.  She also had some idea that she was going to die young.  The past 6-8 months she spent getting all her paperwork in order and labeled accordingly so that when the time came we could find what we needed.  God Bless Her.I’ve never seen so much OCD in organization before.  She had spent hours labeling folders and had everything neatly packed in boxes.  Everything since 1999 when she lost her first child as a stillborn – back before she EVER thought about using any kind of drugs.  She was completely drug free for the pregnancy and  births of all of her children.

She got caught up in the drug war.  And it ended up killing her.If she had used Cannabis instead of all of the other drugs she did, she may very well be alive today. She fell asleep while driving and went off the road – while taking buprenorphine – because she was afraid to use Cannabis.

Drug testing is the single most deadly weapon used by Government and law enforcement to trap people.  It is the cause of many death’s via drug use, which it was intended to prevent.  “Spice” is a good example of this as many people have died from using it because it was a Cannabis “substitute” and it normally does not show up on drug testing.  It is called “probation weed” down here in Kentucky.

Drug testing only invades our privacy and sets us up for failure.  Drug testing does not prevent nor treat drug abuse.  Drug testing is just another way to to seize money via commerce.  Just think of all of the money that is involved in drug testing. Manfred Donike would be proud – I suppose.

The regulation and legalities surrounding the use of drugs and plants have been the trap that has incarcerated so many innocent people, ruined so many people’s lives and is responsible for many, many death’s in this war.  It IS a war.

Legalize, Tax and Regulate Cannabis is not an option if you want to regain your freedom.  It is just another avenue for the Government to grow their control over the people.  A way to give some of us what we want while still maintaining their “complexes” of control via the Controlled Substance Act, These controls keep the medical/pharmaceutical industrial complex, the military/police force industrial complex, the agricultural industrial complex, the private prison industry, the “child protection” industry and more running at high speed, and commerce and taxation flows appropriately, under Government control, to keep it going in the right direction to feed the very industries that control our every move – including the use of Cannabis both medically and recreationally. 

If you think that the prison population was high (no pun intended) before “legalization”, just wait until it is “legalized, taxed and regulated”. 

The only way to lift this burden is to REPEAL all statutes, regulations and control of the personal use of plants…period, from the United Nation’s Treaties and Agenda 21/30, on down through each Country’s own Constitution.  The only “drugs” which need regulation are those which are created by the pharmaceutical industry itself.  This would include Cannabis based medicines when they are created and sold by pharmaceutical industries or in dispensaries.  The plants in your yard for your own personal use should never be subjected to any kind of “legislation”.

It suffices to say that in this war a lot of us, including myself, will be raising our Grandchildren.  And a lot of us are unable to do so, which leaves many children to the claws of the Government.  My daughter was a good Mother – just ask her children.  They are the ones that have lost the most – their Mother.  She loved her boys to no end. She did the best that she could do.  It is up to us to continue on and try to rectify the evil that she succumb to.

https://www.minds.com/blog/view/735675763440754701

https://thinkprogress.org/states-spend-millions-to-drug-test-the-poor-turn-up-few-positive-results-81f826a4afb7

https://en.wikipedia.org/wiki/Manfred_Donike

http://web.archive.org/web/20041208084352/kentucky.usmjparty.com/policy_elkhorn.htm

https://www.thenewamerican.com/tech/environment/item/22267-un-agenda-2030-a-recipe-for-global-socialism

Why Are So Many Veterans on Death Row?

By Jeffrey Toobin

A new study shows that at least ten per cent of death-row inmates are military veterans.

The death penalty has always provided a window into the darkest corners of American life. Every pathology that infects the nation as a whole—racism, most notably—also affects our decisions about whom to execute. A new report from the Death Penalty Information Center adds a new twist to this venerable pattern.

The subject of the report, just in time for Veterans Day, is the impact of the death penalty on veterans. The author, Richard C. Dieter, the longtime executive director of the invaluable D.P.I.C., estimates that “at least 10% of the current death row—that is, over 300 inmates—are military veterans. Many others have already been executed.” In a nation where roughly seven per cent of the population have served in the military, this number alone indicates disproportionate representation. But in a nation where military service has traditionally been seen as a route into the middle class—and where being a vet has been seen as more of a benefit than a burden—the military numbers are especially disturbing.

Why are so many veterans on death row? Dieter asserts that many veterans “have experienced trauma that few others in society have ever encountered—trauma that may have played a role in their committing serious crimes.” Although this is hardly the case with every veteran, or even the overwhelming majority of them, Dieter goes on to relate several harrowing stories that follow this model. Because of such traumas, many veterans suffer from post-traumatic stress disorder, for which they have too often received poor treatment, or none at all.

Veterans who kill are not, by and large, hit men or members of organized crime or gangs. They very often lash out at those around them. Dieter notes that a third of the homicide victims killed by veterans returning from Iraq and Afghanistan were family members or girlfriends. Another quarter were fellow service members. This record suggests that, if these veterans had received adequate mental-health care, at least some of them and their victims might have had a different fate.

But it’s possible to see, in the D.P.I.C. study, an echo of another recent high-profile study. Anne Case and Angus Deaton, of Princeton, found that the death rates for middle-aged white men have increased significantly in the past decade or so. This was largely due, according to the authors, to “increasing death rates from drug and alcohol poisonings, suicide, and chronic liver diseases and cirrhosis.” The Princeton study fits into a larger pattern in American life, which is the declining health and fortunes of poorly educated American whites.

That cohort has gravitated to military service for generations. And while, again, most veterans never commit any crime, much less crimes that carry the death penalty, the sour legacies of our most recent wars certainly play into the despair of many veterans. Earlier generations of veterans came home from war to ticker-tape parades, a generous G.I. Bill, and a growing economy that offered them a chance at upward mobility. Younger veterans returned to P.T.S.D., a relatively stagnant economy, especially in rural and semi-rural areas, and an epidemic of drug abuse. And they came home to a society where widening income inequality suggested the futility of their engagement with the contemporary world.

In an interview with Vox, Deaton said that the death rate for members of this cohort had increased, in part, because they had “lost the narrative of their lives.” This elegant, almost poetic phrase can be read to include the lost promise of military service—the vanished understanding that veterans earned more than a paycheck, that they also gained a step up in status, both economic and social. The reality has been that many veterans returned to lives that were materially and spiritually worse than the ones they left, and far worse than the ones they expected.

According to the Princeton study, a shocking number of poorly educated whites turned their rage inward, in the form of drug abuse and suicide. But a small handful inflicted their rage on others, and an even smaller number wound up on death row. They are different groups of people, and their individual stories are even more variegated, but it’s possible to see across them the symptoms of a broader anguish.

CONTINUE READING…

RE: Erin Grossman Vu

ERIN 3

 

Ms. Erin Grossman Vu, a popular activist for medical marijuana in Kentucky passed from this life on April 10th, 2015.

She was born May 30th, 1974.  She was 40 years old.

She suffered from “congenital heart disease”.

She passed at home where she was staying with Henry and Debbie Fox since December 2014.

Kentucky Activist’s  lost a great partner in the fight for freedom from prohibition of Cannabis.

I first met Erin in 2010 when she and her Sister visited me in Louisville when I lived there.

Her funeral arrangements are being made at this time and the details so far are as follows:  (please

watch Henry Fox on Facebook for any updates).

 

Mike Whosoever Miller will be holding the services.

The services will be held at Newcomer Funeral Home at 7 pm Wednesday.

The address is:

235 Juneau drive, Louisville KY 40243.

If you need info or anything at all please call Henry Fox at 502-640-5609.

 

Your presence will be appreciated.

Donations to “Kentucky Cannabis Freedom Coalition”.