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OfflineYthanA
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Despite criticism and concerns, FDA approves a new opioid 10 times more powerful than fentanyl
    #25587249 - 11/02/18 04:20 PM (5 years, 4 months ago)

Despite criticism and concerns, FDA approves a new opioid 10 times more powerful than fentanyl
www.statnews.com

In a highly controversial move, the Food and Drug Administration approved an especially powerful opioid painkiller despite criticism that the medicine could be a “danger” to public health. And in doing so, the agency addressed wider regulatory thinking for endorsing such a medicine amid nationwide angst about overdoses and deaths attributed to opioids.

The drug is called Dsuvia, which is a tablet version of an opioid marketed for intravenous delivery, but is administered under the tongue using a specially developed, single-dose applicator. These “unique features” make the medicine well-suited for the military and therefore was a priority for the Pentagon, a point that factored heavily into the decision, according to FDA Commissioner Scott Gottlieb.

Although an FDA advisory committee last month recommended approval, the agency was urged by critics not to endorse the drug because it is 10 times more powerful than fentanyl, a highly addictive opioid. Among those who opposed approval were four U.S. senators and the FDA advisory panel chair, who could not attend the meeting, but took the rare step of later writing a letter to the agency.

The objections included complaints that Dsuvia has no unique medical benefits and might be easily diverted by medical personnel, despite a risk mitigation plan the manufacturer, AcelRx Pharmaceuticals, must maintain. There was also criticism the FDA failed to convene the Drug Safety and Risk Management Advisory Committee, not just the Anesthetic and Analgesic Drug Products Advisory Committee. Last year, the FDA refused to approve the medicine over concerns about usage directions and a need for additional safety data.

“The lack of efficacy data and the (manufacturer’s) inadequate response to safety concerns have not been addressed since the FDA’s complete response letter was sent in 2017. Clearly the issue of the safety of the public is not important to the commissioner, despite his attempts to obfuscate and misdirect,” said Dr. Raeford Brown, the FDA panel chair and a professor of anesthesiology and pediatrics at the College of Medicine at the University of Kentucky. “I will continue to hold the agency accountable for their response to the worst public health problem since the 1918 influenza epidemic.”

In discussing the rationale for the approval, however, Gottlieb argued that the different formulation and battlefield needs made it possible for the FDA to have Dsuvia fit into the “overall drug armamentarium.” And while he acknowledged the criticism, he insisted the risk management program, known as a REMS, will ensure the drug is only used in a medically supervised settings.

“The FDA has made it a high priority to make sure our soldiers have access to treatments that meet the unique needs of the battlefield, including when intravenous administration is not possible for the treatment of acute pain related to battlefield wounds. The military application for this new medicine was carefully considered in this case,” he said in a statement.

In fact, the FDA and the Department of Defense on Friday formalized a collaboration for approving new drugs and devices. AcelRx, by the way, worked with the Defense Department to develop Dsuvia.

“There are very tight restrictions being placed on the distribution and use of this product. We’ve learned much from the harmful impact that other oral opioid products can have in the context of the opioid crisis. We’ve applied those hard lessons as part of the steps we’re taking to address safety concerns for Dsuvia,” he said.

Nonetheless, Gottlieb also acknowledged the episode triggered a broader discussion about FDA policy toward opioid approvals and whether additional opioid painkillers are necessary. In the 12-month period ending in March 2018, the Centers for Disease Control and Prevention reported a decline of 2.8 percent in the number of overdose deaths, to an estimated 71,073 people, which is still a large number.

Toward that end, he mentioned the FDA is undertaking a “comprehensive process” to develop a formal benefit and risk framework for how the agency evaluates the safety and efficacy of opioid medicines. Gottlieb also vowed that the FDA is re-evaluating how it considers individual and public health impacts of new opioids as they are reviewed for approval.

“I recognize that the debate goes beyond the characteristics of this particular product or the actions that we’re taking to mitigate this drug’s risks and preserve its differentiated benefits. We won’t sidestep what I believe is the real underlying source of discontent among the critics of this approval — the question of whether or not America needs another powerful opioid while in the throes of a massive crisis of addiction,” he said.

Among the questions Gottlieb said need to be answered: How does the availability of an additional opioid drug benefit the public health through its ability to, for example, provide therapeutic differentiation, promote more appropriate access, or advance safer use of these medicines? Does the approval of an additional opioid drug create added risks for diversion, accidental overdose, abuse and misuse, or other concerns?

“If the approval of an additional opioid will create such added risks, will the new drug provide sufficient clinical differentiation that can benefit certain groups of patients, or offer other important clinical benefit, such that the benefits to patients of introducing the additional opioid outweigh the risks? And can the implementation of REMS help mitigate some of these risks?”

Critics were not appeased.

“More than a year ago Commissioner Gottlieb endorsed a National Academy of Sciences report that called on FDA to overhaul its opioid policies. In particular, NAS urged FDA to utilize a new risk vs benefit analysis for opioid approval AND removal decisions,” said Dr. Andrew Kolodny, who heads the Opioid Policy Research Collaborative at Brandeis University and is executive director of Physicians for Responsible Opioid Prescribing, an education and advocacy group.

“If Gottlieb meant business when he endorsed the report — if he was speaking truthfully when he promised Congress that he would fix FDA’s past mistakes — then he would not have allowed this product on the market. Rather than approving new exceptionally dangerous opioid formulations, he would be pulling the most dangerous opioids off the market.”

“There is absolutely no need for this product,” Kolodny concluded. “Claiming we need it on the market to help soldiers on the battlefield is ridiculous. We already have sublingual fentanyl product available for use on the battlefield.”

“It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly,” said Dr. Sidney Wolfe, senior adviser at Public Citizen Health Research Group. “It will be taken by medical personnel and others for whom it has not been prescribed. And many of those will overdose and die.”

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Offlinetacodude
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Re: Despite criticism and concerns, FDA approves a new opioid 10 times more powerful than fentanyl [Re: Ythan]
    #25587513 - 11/02/18 06:05 PM (5 years, 4 months ago)

It's a sufentinal sublingual tablet if anyone's wondering. They say it will only be used in hospital settings, but I call bullshit. That stuff will get diverted fast as it's in a dissolvable formula that would be easy to make into an injectable solution. I bet not even a month after it becomes available someone will OD

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Offlinecorrosionsteady
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Re: Despite criticism and concerns, FDA approves a new opioid 10 times more powerful than fentanyl [Re: tacodude] * 3
    #25587551 - 11/02/18 06:24 PM (5 years, 4 months ago)

Quote:

tacodude said:
It's a sufentinal sublingual tablet if anyone's wondering. They say it will only be used in hospital settings, but I call bullshit. That stuff will get diverted fast as it's in a dissolvable formula that would be easy to make into an injectable solution. I bet not even a month after it becomes available someone will OD




People are not ODing and dying on their prescribed pain medication.... due to this "epidemic" doctors are being forced to cut back prescribing opiates so people with chronic pain are left to find street drugs which are not controlled or dosed exactly, leading to more overdoses

Heroin is very rarely heroin anymore, almost all street dope is now being cut with fentanyl or fentalogues, and instead of it being manufactured in a lab by educated licensed scientists/doctors, it's being done in homeboys kitchen. The people that are dying are not chronic pain patients who have been on pain management for years, although cutting those people off from there medicine does put them in an extremely dangerous position of either seeking out street drugs, or living in pain/suicide.

But lets keep living in fear of legit medicine that can help people, while illicit and uncontrolled heroin kills off a whole generation of americans.

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Invisibletrvptamine
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Re: Despite criticism and concerns, FDA approves a new opioid 10 times more powerful than fentanyl [Re: Ythan] * 2
    #25587589 - 11/02/18 06:46 PM (5 years, 4 months ago)

I dont see anything wrong with this drug being approved. Its unlikely that it will be as available on the streets as hydrocodone, oxy, and fent/heroin.
This is certainly a great drug for the battlefield as well. It kicks in quicker than having to take a pill, and can be used in unsterile conditions where IV opioids would be unsafe.
Pharmaceutical fentanyl isnt even a huge problem anyways. People dont use pharmaceutical fentanyl to lace heroin  or make fake pills with. They use fentanyl made on the black market.


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Offlineparadoxlost
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Re: Despite criticism and concerns, FDA approves a new opioid 10 times more powerful than fentanyl [Re: trvptamine]
    #25587909 - 11/02/18 09:30 PM (5 years, 4 months ago)

What happens when on the battlefield you use this and than the patient over doses?


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[quote]koods said:
Asante, I don’t think we should have any sympathy and should celebrate the deaths of antivax/antimask activists. They are responsible for far more American deaths than al Qaeda ever was. Every time one of them dies ther movement of death is weakened.ut[/quote]

[quote]koods said:
Chasing variants with vaccines is a dumb idea[/quote]

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OfflineCrispy224
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Re: Despite criticism and concerns, FDA approves a new opioid 10 times more powerful than fentanyl [Re: paradoxlost]
    #25587943 - 11/02/18 10:01 PM (5 years, 4 months ago)

I dont think they are just giving this to anyone on the battlefield. I think only those with medical training will be able to administer it. So I don't imagine many will overdose unless you army Doctor is an idiot.


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Invisibletyrannicalrex
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Re: Despite criticism and concerns, FDA approves a new opioid 10 times more powerful than fentanyl [Re: corrosionsteady]
    #25587961 - 11/02/18 10:10 PM (5 years, 4 months ago)

Quote:

corrosionsteady said:
Quote:

tacodude said:
It's a sufentinal sublingual tablet if anyone's wondering. They say it will only be used in hospital settings, but I call bullshit. That stuff will get diverted fast as it's in a dissolvable formula that would be easy to make into an injectable solution. I bet not even a month after it becomes available someone will OD




People are not ODing and dying on their prescribed pain medication.... due to this "epidemic" doctors are being forced to cut back prescribing opiates so people with chronic pain are left to find street drugs which are not controlled or dosed exactly, leading to more overdoses

Heroin is very rarely heroin anymore, almost all street dope is now being cut with fentanyl or fentalogues, and instead of it being manufactured in a lab by educated licensed scientists/doctors, it's being done in homeboys kitchen. The people that are dying are not chronic pain patients who have been on pain management for years, although cutting those people off from there medicine does put them in an extremely dangerous position of either seeking out street drugs, or living in pain/suicide.

But lets keep living in fear of legit medicine that can help people, while illicit and uncontrolled heroin kills off a whole generation of americans.



Well said, great points! I work in the pain management part of healthcare as a nurse and I am seeing the effect on people who are compliant and really need opioids to just maintain a somewhat "normal" life. They have chronic pain that will last the rest of their lives. I do Prior auth's at least once a week for people that have been on some of these meds for 10 plus years.:sad:


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Offlinesk8fast
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Re: Despite criticism and concerns, FDA approves a new opioid 10 times more powerful than fentanyl [Re: tyrannicalrex]
    #25588006 - 11/02/18 10:49 PM (5 years, 4 months ago)

I wish pharma companies would put out mitragynine tablets and analogues instead of these powerful opioids. Even ampakine agonists mixed with morphine would be much better

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Offlineolson
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Re: Despite criticism and concerns, FDA approves a new opioid 10 times more powerful than fentanyl [Re: corrosionsteady]
    #25588069 - 11/02/18 11:43 PM (5 years, 4 months ago)

Quote:

corrosionsteady said:
Quote:

tacodude said:
It's a sufentinal sublingual tablet if anyone's wondering. They say it will only be used in hospital settings, but I call bullshit. That stuff will get diverted fast as it's in a dissolvable formula that would be easy to make into an injectable solution. I bet not even a month after it becomes available someone will OD




People are not ODing and dying on their prescribed pain medication.... due to this "epidemic" doctors are being forced to cut back prescribing opiates so people with chronic pain are left to find street drugs which are not controlled or dosed exactly, leading to more overdoses

Heroin is very rarely heroin anymore, almost all street dope is now being cut with fentanyl or fentalogues, and instead of it being manufactured in a lab by educated licensed scientists/doctors, it's being done in homeboys kitchen. The people that are dying are not chronic pain patients who have been on pain management for years, although cutting those people off from there medicine does put them in an extremely dangerous position of either seeking out street drugs, or living in pain/suicide.

But lets keep living in fear of legit medicine that can help people, while illicit and uncontrolled heroin kills off a whole generation of americans.




Precisely.
Fentanyl and it's approved analogues are extremely useful drugs for doctors and anesthesiologists. When prescribed/adminstered correctly, they are actually much safer and arguably less abuse prone than morphine,heroin, oxy etc. In general, the therapeutic index (i.e. the ratio the dose producing OD vs the dose required for analgesia) is FAR higher for fentanyl et al than traditional opiates and semisynthetic opiates.

With so many kratom users on this forum it should be clear to us that these drugs have their uses and demonizing a whole family of drugs just makes them harder to access for people who really need them.


--------------------

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such as glucose or even neurotransmitters across a cell.
This little guy struts along the microtubule using ATP as fuel.

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OfflineFractal420
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Re: Despite criticism and concerns, FDA approves a new opioid 10 times more powerful than fentanyl [Re: olson]
    #25588353 - 11/03/18 05:21 AM (5 years, 4 months ago)

And then they say carfentanil is criminal, theyre making the same kind of analogs

Also, its not manufactured in homeboys kitchens, its mixed up there from some ready made chinese fent analog along with some real dope. Its basically a potential hotshot. Since the potency is so high and "homeboy" usually doesnt have a nanogram scale and doesnt mix evenly

Btw ironically the drug theyre releasing is Sufentanil.

Which has already been on the market from china lol. making it legal and schedule 2 then saying the opioid crisis is so bad is very contradictory. Well i guess sufentanil pushers luck out because of this, since its not a schedule 1 substance at least

I find it so fucked that many of these articles about the "new potent opioid" dont name it. I wonder why

Also luckily its true that people dont usually OD from clearly dosed 100ug rx patches or whatever. Its the unknown street shit thats killing people. But theyre gonna make the rx version of this very hard to get anyway


--------------------
Dreaming of That face again.
It's bright and blue and shimmering.
Grinning wide
And comforting me with it's three warm and wild eyes.

Prying open MY third eye


Edited by Fractal420 (11/03/18 05:30 AM)

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Offlinecorrosionsteady
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Re: Despite criticism and concerns, FDA approves a new opioid 10 times more powerful than fentanyl [Re: tyrannicalrex]
    #25588532 - 11/03/18 08:14 AM (5 years, 4 months ago)

Quote:

tyrannicalrex said:
Quote:

corrosionsteady said:
Quote:

tacodude said:
It's a sufentinal sublingual tablet if anyone's wondering. They say it will only be used in hospital settings, but I call bullshit. That stuff will get diverted fast as it's in a dissolvable formula that would be easy to make into an injectable solution. I bet not even a month after it becomes available someone will OD




People are not ODing and dying on their prescribed pain medication.... due to this "epidemic" doctors are being forced to cut back prescribing opiates so people with chronic pain are left to find street drugs which are not controlled or dosed exactly, leading to more overdoses

Heroin is very rarely heroin anymore, almost all street dope is now being cut with fentanyl or fentalogues, and instead of it being manufactured in a lab by educated licensed scientists/doctors, it's being done in homeboys kitchen. The people that are dying are not chronic pain patients who have been on pain management for years, although cutting those people off from there medicine does put them in an extremely dangerous position of either seeking out street drugs, or living in pain/suicide.

But lets keep living in fear of legit medicine that can help people, while illicit and uncontrolled heroin kills off a whole generation of americans.



Well said, great points! I work in the pain management part of healthcare as a nurse and I am seeing the effect on people who are compliant and really need opioids to just maintain a somewhat "normal" life. They have chronic pain that will last the rest of their lives. I do Prior auth's at least once a week for people that have been on some of these meds for 10 plus years.:sad:




I'm one of them, I have floating shoulders from gymnastics and something torn in my left knee that doctors havent been able to figure out exactly what's wrong, last week i had dental surgery to remove 2 wisdom teeth, i wasn't even given general aneasthetic, i was told to take ibprofuen before and after and that's it.

it's fucking archaic and it makes me so angry, i'm going to cop dope today because the pain is bad enough it's affecting my quality of life. I wish i could just take some tylenol and tough it out but real pain doesn't work that way, Thank you for your service as a nurse! I myself was a CNA in hospice before it just became to much for me.

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Offlinecorrosionsteady
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Re: Despite criticism and concerns, FDA approves a new opioid 10 times more powerful than fentanyl [Re: Fractal420]
    #25588542 - 11/03/18 08:25 AM (5 years, 4 months ago)

Quote:

Fractal420 said:
And then they say carfentanil is criminal, theyre making the same kind of analogs

Also, its not manufactured in homeboys kitchens, its mixed up there from some ready made chinese fent analog along with some real dope. Its basically a potential hotshot. Since the potency is so high and "homeboy" usually doesnt have a nanogram scale and doesnt mix evenly

Btw ironically the drug theyre releasing is Sufentanil.

Which has already been on the market from china lol. making it legal and schedule 2 then saying the opioid crisis is so bad is very contradictory. Well i guess sufentanil pushers luck out because of this, since its not a schedule 1 substance at least

I find it so fucked that many of these articles about the "new potent opioid" dont name it. I wonder why

Also luckily its true that people dont usually OD from clearly dosed 100ug rx patches or whatever. Its the unknown street shit thats killing people. But theyre gonna make the rx version of this very hard to get anyway





that's what i meant, but also the manufacturers of black market fentalogues are not making them in a lab, they are truely clandestine operations, sometimes in very rural parts of mexico, these are not professionals and very easily could put out a dangerous analogue and not really give a shit, which all comes back around to control and regulation, decriminalization of a humans basic right to alter their own brain chemistry to better their lives, as long as it hurts no one but themselves.

Btw i love your posts fractal, long time lurker and you remind me of the older heads, keep up the good shrooming my friend.

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OfflineJacksonMetaller
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Re: Despite criticism and concerns, FDA approves a new opioid 10 times more powerful than fentanyl [Re: corrosionsteady]
    #25588567 - 11/03/18 08:49 AM (5 years, 4 months ago)

Quote:

corrosionsteady said:
Quote:

tacodude said:
It's a sufentinal sublingual tablet if anyone's wondering. They say it will only be used in hospital settings, but I call bullshit. That stuff will get diverted fast as it's in a dissolvable formula that would be easy to make into an injectable solution. I bet not even a month after it becomes available someone will OD




People are not ODing and dying on their prescribed pain medication.... due to this "epidemic" doctors are being forced to cut back prescribing opiates so people with chronic pain are left to find street drugs which are not controlled or dosed exactly, leading to more overdoses

Heroin is very rarely heroin anymore, almost all street dope is now being cut with fentanyl or fentalogues, and instead of it being manufactured in a lab by educated licensed scientists/doctors, it's being done in homeboys kitchen. The people that are dying are not chronic pain patients who have been on pain management for years, although cutting those people off from there medicine does put them in an extremely dangerous position of either seeking out street drugs, or living in pain/suicide.

But lets keep living in fear of legit medicine that can help people, while illicit and uncontrolled heroin kills off a whole generation of americans.




That wasn't his point. People ARE dying from prescribed pain medication. Not AS prescribed, but none the less it is being diverted to illegal use. I agree with you in regards to not depriving people of pain medicine, but the hypocrisy here is unreal. The FDA wants to ban kratom because it's too dangerous but approve a very risky oral fentanyl formulation? Yeah this is not in the patients interest... hate to say it. I don't want the patients who need it to be deprived, but I also don't want business interests to be the determinant of legality.

As for heroin, the best thing they could do with that is put it back in the doctors hands and treat addiction like a disease. Give people the "cure" to their dope sickness in a controlled manner until they are ready to quit. Also think about how much damned money our healthcare system would be generating if it took the difference in current drug price inflation as tax money.

Btw pain sufferer myself. Demyelinating polyneuropathy, carditis, myalgia since age 22. I get it

Edited by JacksonMetaller (11/03/18 08:53 AM)

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Offlineolson
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Re: Despite criticism and concerns, FDA approves a new opioid 10 times more powerful than fentanyl [Re: JacksonMetaller]
    #25588682 - 11/03/18 09:52 AM (5 years, 4 months ago)

The FDA don't just approve drugs for the hell of it. Safety and efficacy with regard to the intended use must be shown in repeated trials.
The point is it's counterproductive and a bit hypocritical to staunchly advocate kratom legalization while denouncing other seemingly "less savory" opioid medications.
There many pain conditions for which kratom just doesn't cut it, not to mention variations in body chemistry among patients. We should have access to all the available pharmacolgical tools that can help us, should we need them.


--------------------

Kinesin, a motor protein, shuttling a vesicle full of cargo
such as glucose or even neurotransmitters across a cell.
This little guy struts along the microtubule using ATP as fuel.

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Offlinecorrosionsteady
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Registered: 07/31/17
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Re: Despite criticism and concerns, FDA approves a new opioid 10 times more powerful than fentanyl [Re: JacksonMetaller]
    #25588706 - 11/03/18 09:59 AM (5 years, 4 months ago)

Quote:

JacksonMetaller said:
Quote:

corrosionsteady said:
Quote:

tacodude said:
It's a sufentinal sublingual tablet if anyone's wondering. They say it will only be used in hospital settings, but I call bullshit. That stuff will get diverted fast as it's in a dissolvable formula that would be easy to make into an injectable solution. I bet not even a month after it becomes available someone will OD




People are not ODing and dying on their prescribed pain medication.... due to this "epidemic" doctors are being forced to cut back prescribing opiates so people with chronic pain are left to find street drugs which are not controlled or dosed exactly, leading to more overdoses

Heroin is very rarely heroin anymore, almost all street dope is now being cut with fentanyl or fentalogues, and instead of it being manufactured in a lab by educated licensed scientists/doctors, it's being done in homeboys kitchen. The people that are dying are not chronic pain patients who have been on pain management for years, although cutting those people off from there medicine does put them in an extremely dangerous position of either seeking out street drugs, or living in pain/suicide.

But lets keep living in fear of legit medicine that can help people, while illicit and uncontrolled heroin kills off a whole generation of americans.




That wasn't his point. People ARE dying from prescribed pain medication. Not AS prescribed, but none the less it is being diverted to illegal use. I agree with you in regards to not depriving people of pain medicine, but the hypocrisy here is unreal. The FDA wants to ban kratom because it's too dangerous but approve a very risky oral fentanyl formulation? Yeah this is not in the patients interest... hate to say it. I don't want the patients who need it to be deprived, but I also don't want business interests to be the determinant of legality.

As for heroin, the best thing they could do with that is put it back in the doctors hands and treat addiction like a disease. Give people the "cure" to their dope sickness in a controlled manner until they are ready to quit.




It's being implemented in the military for battlefield emergency situations, read the article. Also with a little research you will learn only a small percentage of overdoses are patients on prescription opioid regiment, the "epidemic" is black market fentanyl from china and mexico killing our heroin addicts, many of whom were forced to the street due to doctors no longer prescribing opioid medications. you don't see the circle? I think you would be surprised how many end of life pain patients are not diverting their only means to a quality of life to make a few extra bucks, it's usually the doctors and the pharmaceutical companies themselves that flood the markets. Don't blame addicts/pain patients for turning the pharmaceutical and medical industry into a capitalistic business.

I agree with you that maintenance programs are the answer, and to treat addiction any different from any other mental illness/disease is just sad and only sets us back.

EDIT: And kratom saved my life a few years back, i was crippled with anxiety and i'm allergic to benzos. It really helped me finish culinary school and work 2 kitchen jobs up to 16 hours a day. If the US FDA bans kratom so that pharmacuetical companies can monopolize it (which appears to be happening) I really will lose a huge amount of the nonexistent faith i had in this country...if that makes any sense, lol. Anyway this really hits close to home to me, i'm glad we can have a civil discussion, i love this forum.

Edited by corrosionsteady (11/03/18 10:03 AM)

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Offlinecorrosionsteady
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Re: Despite criticism and concerns, FDA approves a new opioid 10 times more powerful than fentanyl [Re: olson]
    #25588721 - 11/03/18 10:05 AM (5 years, 4 months ago)

Quote:

olson said:
The FDA don't just approve drugs for the hell of it. Safety and efficacy with regard to the intended use must be shown in repeated trials.
The point is it's counterproductive and a bit hypocritical to staunchly advocate kratom legalization while denouncing other seemingly "less savory" opioid medications.
There many pain conditions for which kratom just doesn't cut it, not to mention variations in body chemistry among patients. We should have access to all the available pharmacolgical tools that can help us, should we need them.





^Right on.

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Invisibletrvptamine
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Re: Despite criticism and concerns, FDA approves a new opioid 10 times more powerful than fentanyl [Re: paradoxlost]
    #25588787 - 11/03/18 10:31 AM (5 years, 4 months ago)

Quote:

paradoxlost said:
What happens when on the battlefield you use this and than the patient over doses?



Why would they be overdosing in the first place? They should only be administered one dose. One tablet of a pharmaceutical drug shouldnt be strong enough to make someone overdose. Seems like you dont realize how accurately they can dose these substances.


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Offlinetacodude
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Re: Despite criticism and concerns, FDA approves a new opioid 10 times more powerful than fentanyl [Re: corrosionsteady]
    #25588941 - 11/03/18 11:59 AM (5 years, 4 months ago)

Quote:

corrosionsteady said:
Quote:

tacodude said:
It's a sufentinal sublingual tablet if anyone's wondering. They say it will only be used in hospital settings, but I call bullshit. That stuff will get diverted fast as it's in a dissolvable formula that would be easy to make into an injectable solution. I bet not even a month after it becomes available someone will OD




People are not ODing and dying on their prescribed pain medication.... due to this "epidemic" doctors are being forced to cut back prescribing opiates so people with chronic pain are left to find street drugs which are not controlled or dosed exactly, leading to more overdoses


I never said anything insinuating the opposite of what you said... Hell I posted the last article about pain patients being victims of excess regulations. Think twice before you put words in my mouth as I'm a suffering pain patient myself.

The fact is it's bullshit they approved a sublingual sufentinal pill yet are restricting basic morphine type compounds. Simple as that

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OfflineJacksonMetaller
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Registered: 03/13/11
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Re: Despite criticism and concerns, FDA approves a new opioid 10 times more powerful than fentanyl [Re: olson]
    #25588944 - 11/03/18 12:00 PM (5 years, 4 months ago)

Quote:

olson said:
The FDA don't just approve drugs for the hell of it. Safety and efficacy with regard to the intended use must be shown in repeated trials.
The point is it's counterproductive and a bit hypocritical to staunchly advocate kratom legalization while denouncing other seemingly "less savory" opioid medications.
There many pain conditions for which kratom just doesn't cut it, not to mention variations in body chemistry among patients. We should have access to all the available pharmacolgical tools that can help us, should we need them.




I don't know if Im being clear this morning but I don't think either of you are hearing me. I advocate BOTH. My criticism is not in green-lighting sulfentanil. It's in green-lighting it amidst concerns while simultaneously driving sensationalist bullshit around kratom. My criticism is the double standard in this "war on opioids". The fact is taco is right, it WILL be diverted. In effort to avoid overprescribing and diversion there needs to be alternatives for those who don't need real opioids to manage their pain as well as better access to real opioids for those who do. Gottlieb has flat our said "we are interested in pain management alternatives... but not kratom..." Why not kratom? Approval is smoke and mirrors in this case. Pharma companies have billions to show their drug can be used safely and lobby but they can not eliminate addiction risks. Kratom addiction risk is comparatively small but vendors don't have billions lying around for R and D and lobbying. I'm sure there are plenty of good people in the FDA, but it is being run as a business not a public health measure. Now please don't take my words out of context and say that I think everyone should just switch to kratom. "We should have access to all the available pharmacolgical tools that can help us" - this is exactly what I'm talking about and exactly what the FDA is threatening by encouraging drug monopolies

"you don't see the circle? I think you would be surprised how many end of life pain patients are not diverting their only means to a quality of life to make a few extra bucks, it's usually the doctors and the pharmaceutical companies themselves that flood the markets. Don't blame addicts/pain patients for turning the pharmaceutical and medical industry into a capitalistic business.
"
Why do you think I don't see the circle? I just advocated physician access to heroin because I know that most opioid addictions/dependencies start at the doctors office and feel they should end there. Blaming patients? Read again the part where I am a sufferer of demylinating polyneuropathy, carditis, and myalgia. Before I got it under control I lived for months feeling like my nerves had been lit on fire. I never caved, but I had my heroin addict friend on practically on speed dial because I was afraid I would

Edited by JacksonMetaller (11/03/18 12:04 PM)

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OfflineJacksonMetaller
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Registered: 03/13/11
Posts: 13,361
Last seen: 1 year, 3 months
Re: Despite criticism and concerns, FDA approves a new opioid 10 times more powerful than fentanyl [Re: tacodude]
    #25588946 - 11/03/18 12:01 PM (5 years, 4 months ago)

Quote:

tacodude said:


The fact is it's bullshit they approved a sublingual sufentinal pill yet are restricting basic morphine type compounds. Simple as that




Exactly what I was defending in the first place. The hypocrisy and lack of patient-centered regulation is absurd

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