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#1 User is offline   Liz 

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  Posted 03 November 2018 - 12:11 AM

Approval Of Powerful Opioid Likely To Put Scrutiny On FDA

Washington Examiner
by Robert King
November 03, 2018 12:00 AM

Excerpt:

Activists and Democrats are livid with the Food and Drug Administration’s decision to approve the most powerful opioid ever, hinting at a possible probe into the way the agency oversees drug approvals.

The FDA on Friday made the controversial decision to approve the powerful opioid Dsuvia, which would be administered only in a medical setting. The approval drew a sharp rebuke from Senate Democrats and activists worried about another powerful version of the opioid fentanyl hitting the streets, and concerned that the agency did not involve a key safety committee in the approval process.

“There was no public health need to approve this formulation of supercharged fentanyl in the face of these questions, opposition from one FDA advisory committee chair, and without the full participation of another advisory committee devoted to drug safety,” said Sen. Ed Markey, D-Mass., in a statement Friday.

Markey and three other Democratic senators had asked Gottlieb Wednesday to delay approval until after convening a new advisory committee hearing.

The senators are worried that the opioid could be diverted or copied and sold to addicts. Illicitly-made fentanyl has become a major contributor to opioid deaths in recent years.

In 2016, of the more than 42,000 opioid overdoses, more than half were linked to fentanyl, according to data from the Centers for Disease Control and Prevention.

Gottlieb said in a statement that there are severe restrictions on the application of the powerful opioid. It will be delivered through a single-dose applicator, and used in only hospitals, surgical centers, or emergency rooms.

He added that the drug was a priority for the Department of Defense as it could be used on the battlefield.

“The involvement and needs of the DoD in treating soldiers on the battlefield were discussed by the advisory committee,” he said.

But the consumer advocacy group Public Citizen raised questions about the advisory committee that recommended approval for Dsuvia, which is made by the drugmaker AcelRx. Public Citizen said that the Oct. 12 meeting at which the application was reviewed should have included the FDA's panel of experts on drug safety issues, which can review the potential for a new opioid to be abused.

Dr. Raeford Brown, who is the chairman of the FDA's anesthetic and analgesic committee, made the unusual move of calling for the FDA to not approve Dsuvia because of the possibility of abuse. Brown could not make it to the meeting on Oct. 12.

“Clearly the issue of the safety of the public is not important to the commissioner, despite his attempts to obfuscate and misdirect,” Brown said in a statement.

“The FDA should never have any discussion about an individual opioid or a problem affecting a group of opioids without having the drug safety committee,” Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group, told the Washington Examiner. “The committee is made up of people who know more about safety and epidemiology.”

From 2016 to 2017, the FDA reviewed 11 drug applications for new opioids. The agency held a joint meeting of both the analgesic committee and the drug safety committee for each of those applications, but did not do the same for Dsuvia.

*snip*

Full Story
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#2 User is offline   Bubbajoebob 

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Posted 03 November 2018 - 07:46 AM

So we "need" this new drug, but cannabis and cannabis-derived drugs are too dangerous?
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#3 User is offline   satellite66 

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Posted 03 November 2018 - 08:10 AM

Activists and democrats livid? This story is another jab at Trump as far as I'm concerned
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#4 User is offline   Dean Adam Smithee 

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Posted 03 November 2018 - 10:00 AM

View PostLiz, on 03 November 2018 - 12:11 AM, said:


The senators are worried that the opioid could be diverted or copied and sold to addicts. Illicitly-made fentanyl has become a major contributor to opioid deaths in recent years.

In 2016, of the more than 42,000 opioid overdoses, more than half were linked to fentanyl, according to data from the Centers for Disease Control and Prevention.



Could it be copied? Undoubtedly. I'd be surprised if it hasn't been copied already... it's been around since '74 and, heck, a molecular model of it is posted on Wikipedia.

Should THAT ALONE prevent approval? No, not if has a legit medical use, and it seems to.
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#5 User is offline   MontyPython 

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Posted 03 November 2018 - 10:07 AM

View PostBubbajoebob, on 03 November 2018 - 07:46 AM, said:

So we "need" this new drug, but cannabis and cannabis-derived drugs are too dangerous?


:2up: :yes: :thumbsup:
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#6 User is offline   Ladybird 

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Posted 03 November 2018 - 10:39 AM

Those of us who don't abuse drugs are being punished because of those that do.
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#7 User is offline   kestrel 

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Posted 03 November 2018 - 11:06 AM

View PostLadybird, on 03 November 2018 - 10:39 AM, said:

Those of us who don't abuse drugs are being punished because of those that do.


Unfortunately this is one of the inevitable consequences when the govt is involved in "Doing something for the people" Sometimes it turns out ok but there are times when the innocent pay the price. Check out the guy in the FDA who led the charge to make "Oxycontin" legal..the drug company that made the drug marketed it as having less than a 1% chance of creating an addiction was approved in record time and...well the results are not too stellar, but hey the good news is that the FDA guy in charge at the time went on to leave the FDA and began a VERY lucrative career with???..You guessed it! the pharmaceutical company that invented the drug in the first place.
Take away is this: Be very careful with the words "The govt should do something about...whatever" Read the 10th amendment and consider what it really says.

Kestrel...

This post has been edited by kestrel: 03 November 2018 - 11:37 AM

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#8 User is offline   Junto 

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Posted 03 November 2018 - 11:07 AM

View PostBubbajoebob, on 03 November 2018 - 07:46 AM, said:

So we "need" this new drug, but cannabis and cannabis-derived drugs are too dangerous?

Ritalin is basically synthesized cocaine. Adderall is amphetamines mixed with methamphetamines. We dose up our kids with it like it's candy. I had friends whose 10 year old kids were given scripts of vicodin for routine dentist procedures. Opioids (heroin in pill form)were passed out to anyone and everyone for the past 25 years+ until they finally starting scrutinizing how it is prescribed, offloading countless Americans onto real heroin - whose prevalence went up dramatically once we went into Afghanistan (CIA). But they have had a problem all along with people buying CBD oil. Insanity...




*Edited because I cannot spell.

This post has been edited by Junto: 03 November 2018 - 10:28 PM

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#9 User is offline   Severian 

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Posted 03 November 2018 - 11:14 AM

View PostLadybird, on 03 November 2018 - 10:39 AM, said:

Those of us who don't abuse drugs are being punished because of those that do.

It has always been so. And I'd add:

Those of us who don't abuse or misuse guns are being punished because of those that do. :hunter:
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#10 User is offline   Junto 

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Posted 03 November 2018 - 02:31 PM

Inside the Story of America’s 19th-Century Opiate Addiction

By Erick Trickey
smithsonian.com
January 4, 2018

.....


By 1895, morphine and opium powders, like OxyContin and other prescription opioids today, had led to an addiction epidemic that affected roughly 1 in 200 Americans. Before 1900, the typical opiate addict in America was an upper-class or middle-class white woman. Today, doctors are re-learning lessons their predecessors learned more than a lifetime ago.

Opiates made up 15 percent of all prescriptions dispensed in Boston in 1888, according to a survey of the city’s drug stores. “In 1890, opiates were sold in an unregulated medical marketplace,” wrote Caroline Jean Acker in her 2002 book, Creating the American Junkie: Addiction Research in the Classic Era of Narcotic Control. “Physicians prescribed them for a wide range of indications, and pharmacists sold them to individuals medicating themselves for physical and mental discomforts.”

Male doctors turned to morphine to relieve many female patients’ menstrual cramps, “diseases of a nervous character,” and even morning sickness. Overuse led to addiction. By the late 1800s, women made up more than 60 percent of opium addicts. “Uterine and ovarian complications cause more ladies to fall into the [opium] habit, than all other diseases combined,” wrote Dr. Frederick Heman Hubbard in his 1881 book, The Opium Habit and Alcoholism.

....


Nothing new under the sun.
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#11 User is offline   Ladybird 

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Posted 03 November 2018 - 02:36 PM

View PostJunto, on 03 November 2018 - 02:31 PM, said:

Inside the Story of America’s 19th-Century Opiate Addiction

By Erick Trickey
smithsonian.com
January 4, 2018

.....


By 1895, morphine and opium powders, like OxyContin and other prescription opioids today, had led to an addiction epidemic that affected roughly 1 in 200 Americans. Before 1900, the typical opiate addict in America was an upper-class or middle-class white woman. Today, doctors are re-learning lessons their predecessors learned more than a lifetime ago.

Opiates made up 15 percent of all prescriptions dispensed in Boston in 1888, according to a survey of the city’s drug stores. “In 1890, opiates were sold in an unregulated medical marketplace,” wrote Caroline Jean Acker in her 2002 book, Creating the American Junkie: Addiction Research in the Classic Era of Narcotic Control. “Physicians prescribed them for a wide range of indications, and pharmacists sold them to individuals medicating themselves for physical and mental discomforts.”

Male doctors turned to morphine to relieve many female patients’ menstrual cramps, “diseases of a nervous character,” and even morning sickness. Overuse led to addiction. By the late 1800s, women made up more than 60 percent of opium addicts. “Uterine and ovarian complications cause more ladies to fall into the [opium] habit, than all other diseases combined,” wrote Dr. Frederick Heman Hubbard in his 1881 book, The Opium Habit and Alcoholism.

....


Nothing new under the sun.



I've had two wisdom teeth removed. Morphine would be welcome right about now.
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#12 User is offline   Junto 

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Posted 03 November 2018 - 02:46 PM

View PostLadybird, on 03 November 2018 - 02:36 PM, said:

I've had two wisdom teeth removed. Morphine would be welcome right about now.

I bet! You are right that now it's the rest of us hurt by this opioid epidemic in that doctors either can't or are extremely hesitant to prescribe narcotics even for people in clear need of them.
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#13 User is offline   MontyPython 

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Posted 03 November 2018 - 03:08 PM

View PostLadybird, on 03 November 2018 - 02:36 PM, said:

I've had two wisdom teeth removed. Morphine would be welcome right about now.


I had 14 teeth pulled in one afternoon with nothing but novocaine. Preparation for dentures.

B)
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#14 User is offline   Dean Adam Smithee 

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Posted 03 November 2018 - 04:38 PM

View PostLadybird, on 03 November 2018 - 02:36 PM, said:

I've had two wisdom teeth removed. Morphine would be welcome right about now.


One wisdom tooth removed in the Navy circa '80 or '81. Not sure what they gave me, but let's just say I was feeling no pain. I treated myself to a milkshake from the on-base Baskin-Robbins. Oh, lord, spent the night puking my guts out.

Fast forward a bit, late '90s. Other upper wisdom tooth out. Well, I'm not going to make THAT mistake again. "No Dairy Products". But I have this bottle of Jim Beam on hand "for medicinal purposes", and, Oh, lord, spent the night puking my guts out.

I need to have a word with US Navy dentists; there's something THEY (not ME) have gotten wrong in this whole situation.
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#15 User is offline   Ladybird 

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Posted 03 November 2018 - 05:49 PM

View PostDean Adam Smithee, on 03 November 2018 - 04:38 PM, said:

One wisdom tooth removed in the Navy circa '80 or '81. Not sure what they gave me, but let's just say I was feeling no pain. I treated myself to a milkshake from the on-base Baskin-Robbins. Oh, lord, spent the night puking my guts out.

Fast forward a bit, late '90s. Other upper wisdom tooth out. Well, I'm not going to make THAT mistake again. "No Dairy Products". But I have this bottle of Jim Beam on hand "for medicinal purposes", and, Oh, lord, spent the night puking my guts out.

I need to have a word with US Navy dentists; there's something THEY (not ME) have gotten wrong in this whole situation.


When I got teeth removed for braces, they gave me Tylenol 4, which is with codeine. I was only fourteen at the time. This time they gave me ibuprofen and an ice pack. Luckily I had a couple left overs from my knee surgery.
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