[Gry]

February 6, 2018 Kratom Now an Opioid, FDA Says

A new analysis by scientists at the US Food and Drug Administration (FDA) shows that compounds in kratom act like prescription-strength opioids, the agency said today.
The agency also said kratom has now been linked to 44 deaths, up from 36 reported in November.
The scientific data and adverse event reports have "clearly revealed" that compounds in kratom make it "not just a plant — it's an opioid," FDA Commissioner Scott Gottlieb, MD, said in a statement.
"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," added Dr Gottlieb.

"Claiming that kratom is benign because it's 'just a plant' is shortsighted and dangerous," he added.
FDA scientists analyzed the chemical structures of the 25 most common compounds in kratom and concluded that all of the compounds share structural characteristics with controlled opioid analgesics, such as morphine derivatives. They also found that compounds in kratom bind strongly to mu-opioid receptors, comparable to opioid drugs.
"Based on the data we now have, we feel confident in calling these compounds opioids," Dr Gottlieb said.
Annual Death Rate

To date, the FDA has received 44 reports of deaths associated with the use of kratom. This is an increase since the agency's November 2017 advisory, which noted 36 deaths associated with kratom, as reported by Medscape Medical News.


Megan Brooks wrote this for medscape

[led05]

Originally Posted by Gry

February 6, 2018 View Image Kratom Now an Opioid, FDA Says

A new analysis by scientists at the US Food and Drug Administration (FDA) shows that compounds in kratom act like prescription-strength opioids, the agency said today.
The agency also said kratom has now been linked to 44 deaths, up from 36 reported in November.
The scientific data and adverse event reports have "clearly revealed" that compounds in kratom make it "not just a plant — it's an opioid," FDA Commissioner Scott Gottlieb, MD, said in a statement.
"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," added Dr Gottlieb.

"Claiming that kratom is benign because it's 'just a plant' is shortsighted and dangerous," he added.
FDA scientists analyzed the chemical structures of the 25 most common compounds in kratom and concluded that all of the compounds share structural characteristics with controlled opioid analgesics, such as morphine derivatives. They also found that compounds in kratom bind strongly to mu-opioid receptors, comparable to opioid drugs.
"Based on the data we now have, we feel confident in calling these compounds opioids," Dr Gottlieb said.
Annual Death Rate

To date, the FDA has received 44 reports of deaths associated with the use of kratom. This is an increase since the agency's November 2017 advisory, which noted 36 deaths associated with kratom, as reported by Medscape Medical News.


Megan Brooks wrote this for medscape

Sad... It's interesting these doctors left out the point that Kratom doesn't effect the addictive part(s) of the brain the way opiates do and is exponentially safer than synthetic beefed up opiates prescribe with weekly pill counts into the 100's every day to our brothers, parents, sisters and even our kids across the good ol USA and world...

Reality, a tree that grows naturally and gets huge is hard to make a profit off and eats into "their" monopolistic market of opiates run by their donors or themselves, a lab, synthetics and regulation makes it easy.

Even harder is an annual that grows like a weed that offers way more benefits and relief - so if/when it TRULY gets legalized they'll need decades of time to own the market before we can grow it like tomatoes, hence what we've been watching unfold for the past years and continues to....

Yet again, it's simply about $$$ and power.....

[Jellyfish]

Always follow the money.

[HuffnPufferfish]

outlaw reality haha

[Gry]

It appears to me, the intent is to slam shut any door which people seeking an exit to opiates have traditionally used.

Anti-diarrhea pill abuse on rise; opioid addicts use it for cheap high

https://www.usatoday.com/story/news/...../1087029001/


6 days ago - Opioid addicts looking for a cheap high are turning to an over-the-counter anti-diarrhea medication, prompting a federal agency to ask manufacturers to change the way the drug is packaged in an effort to curb abuse. Some opioid addicts are abusing loperamide, also known by the brand name Imodium ...

[Easy7]

In 2002, there was mainstream talk of scheduling every single medicinal herb.

It's not about dangerous substances and people 'hurting themselves'. They want the power to control your mind and suffering. They hide behind 'oh the children, think of the children'. When every kid can get more drugs than I can (better connected).

I for one will not accept that plants are not for us as adults. They brainwash people to think that if they use a plant that causes a little bit of intoxication, they will be hooked, start hooking and die of aids.

Can't even think of an argument good enough. It's bullshit though!

I'm fine with making extracts illegal. But keep the plants legal!

[Gry]

CMS Pushing 7-Day Limit on Initial Opioid Scripts

Alicia Ault Medscape medical news
The Centers for Medicare & Medicaid Services (CMS) is proposing that beginning in 2019, initial opioid prescriptions for acute pain be limited to 7 days.
The agency is also suggesting in the 2018 Draft Call Letter that Medicare Part D prescription drug plans monitor patients who take medications considered to be "potentiators" of opioid misuse and opioid-related adverse events — specifically, gabapentin and pregabalin.
Noting an alarming increase in gabapentin use to treat pain and concurrent opioid and gabapentin use, CMS is asking for comment on whether it is useful to more closely monitor beneficiaries receiving these prescriptions.
The CMS proposal came as a US House committee took a closer look at Medicare's oversight of opioid use. At the February 6 hearing, members of the Ways and Means Health Subcommittee said there are few data on opioid use among older Americans and that Medicare has done a poor job of encouraging prevention and treatment.

"With 10,000 baby boomers joining Medicare each day, we must harness innovation, technology and data to get ahead of this problem," said Subcommittee Chairman Peter Roskam (R-IL). "Unfortunately, there is a lack of available data regarding the Medicare population and the extent to which opioid abuse, overprescribing, and diversion is an issue for seniors and the disabled," he said.
That echoed an October 2017 Government Accountability Office (GAO) report, which found that Part D plans are not sufficiently identifying and helping beneficiaries at high risk for opioid misuse. CMS established its overutilization monitoring system (OMS) in 2013, but opioid misuse continues, and thousands of baby boomers are being added to the Medicare rolls daily.
Drugs of Concern

The agency said in its latest announcement that the system has reduced "very high risk overutilization of prescription opioids in the Part D program," but "given the urgency and scope of the continuing national prescription opioid epidemic, we will propose new strategies to more effectively address this issue for patients in Part D."
CMS proposes the following:

• To have the OMS identify high-risk beneficiaries who use "potentiator" drugs (such as gabapentin and pregabalin) in combination with prescription opioids to ensure that plans provide appropriate case management. The agency noted in its proposal that in just 2 years (2015 to 2017), the rate of gabapentin users in Part D plans increased by 14%: from 93 to 108 users per 1000 enrollees. Opioid users had even higher gabapentin use.
• To create a new quality measure that would track how well Part D plans flag concurrent use of opioids and benzodiazepines. The OMS already flags concurrent benzodiazepine use, but there is no follow-up mechanism. According to CMS, in late 2016, when the OMS began tracking concurrent use, 64% of beneficiaries flagged as potential opioid overusers had a benzodiazepine prescription. In 2017, after monitoring, the number had dropped to 62%.
• That Part D plans to have a pharmacy point-of-sale edit that prohibits dispensing of any prescription that is more than a 90 morphine milligram equivalent, or a 7-day supply.
• That all sponsors implement soft point-of-sale edits that alert when there is duplicative therapy of multiple long-acting opioids.

CMS is taking comments on the proposal until March 5 and will publish the final requirements on April 2.
The Part D proposal builds on another CMS proposed rule, issued in December 2017. The agency was required by the Comprehensive Addiction and Recovery Act of 2016 to beef up opioid oversight.

As with that previous regulation, the newest proposal would exempt patients with cancer, in hospice, or in long-term care facilities from much of the strict oversight.
Methadone Treatment Not Covered

Even as enrollees who misuse opioids are flagged, Medicare is not fully prepared to help. The federal health program does not pay for outpatient methadone treatment, for instance.
"We know there are significant gaps in access and coverage under Medicare," said the top Democrat on the Ways and Means Health Subcommittee, Richard Neal (MA), at the hearing.
Neal introduced a bill in October 2017 — the Medicare Beneficiary Opioid Addiction Treatment Act — that would require Medicare to pay for outpatient methadone therapy.
Neal and Democratic colleague Frank Pallone (NJ) also have written to 14 Medicare Advantage and Part D drug plans asking them to share their evidence-based best practices.
"The growth of Medicare Part D spending on opioids far outpaces the growth in enrollment, having increased 165 percent from 2006 to 2015," said Neal and Pallone. They said that among the 12 million Medicare enrollees who were prescribed opioids in 2015, "the average beneficiary received five prescriptions for commonly abused opioids."

[mowood3479]

...

[Easy7]

It's just bullshit that a non-lethal remedy would be scheduled because it causes a slight good feeling. That's what it is too.

Laws only make prisoners.

It's actually very hard to overdose on opium. It takes a gram orally, with no tolerance. Easy for a dog but not a human. They just make things sound far worse than they really are.

Exploiting peoples suffering is not freedom for the sufferers. Then we have the long ass battle of proving safety and effectivness and legalizing state by state.

It's a backwards country

[Anne_Fetamine]

I'm glad you guys are on the right side of this issue. I've seen a lot of cannabis/CBD users dogging kratom & saying it SHOULD be banned. My thing is, you don't have to use a substance to be against a ban. I happen to use kratom daily but even if I didn't, I'd still oppose a ban. It's helped thousands of people get off opioids, alcohol & other drugs as well as being a great pain reliever. Locking people up for possessing it is not the answer. So what if kratom is an opioid? It doesn't cause respiratory depression like true opioids, which is the biggest takeaway. And their claim of "36 deaths" is bunk too. Every last person who died with kratom in their system had other drugs or health conditions present that contributed to their deaths. One was a murder & another a suicide, yet they're counting those as kratom deaths. This is why you shouldn't ever take what the media tells you at face value.



I hope the cannabis community will stand by the kratom community in speaking out against this abuse of power. Scott Gottlieb was a fentanyl-pusher for Cephalon before being appointed head of the FDA, which makes his motives even shadier.