Friday, March 17, 2017

Big Pharma Shows No Responsibility About Opioids But FDA Slaps Endo Down on Opana

Opana is another medication for relief of chronic pain and the manufacturer, in a fit of overt human sensitivity, reformulated the strength of the medication and the number of addicts who were injecting it more than doubled.  The FDA considered the risk of Opana to be too high and denied approval for commercial distribution.  (RT:  New opioid painkiller considered too high a risk of abuse – FDA panel)

Opana ER, an opioid painkiller redesigned in 2012, still carries too high a risk of abuse despite its potential health benefits, said a joint Food and Drug Administration advisory panel. Despite its reformulation, drug users began using it intravenously.

The 27 voting members from the Drug Safety and Risk Management (DSaRM) and Anesthetic and Analgesic Drug Products (AADP) advisory committees had to evaluate Opana ER’s safety compared to other products, its risk-benefit profile, and possible consequences to patients if the FDA imposed regulatory action on the drug.

In an 18-8 vote, the joint panel concluded the benefits of Opana ER did not outweigh the risks. One member abstained from voting.

- RT

While the immediate reaction might be lividity at the release or attempt at it for yet another opioid medication into a system which is swamped with them but it would be acceptable if there were evidence this mitigates the larger problem in any way.  In fact, it appears highly likely to make it even worse.


Among the materials the FDA panel considered was survey data that showed that, among people who reported abusing Opana, the percentage who injected it roughly doubled after the reformulation, from 17 percent to 38 percent.

The panel’s vote is nonbinding, but the FDA gives deference to its advisory committees.

Endo’s shares closed down about 4 percent and were down about 1.7 percent in extended trading.
On its website, Endo said it believes that “Opana ER remains an important clinical choice for appropriate patients and will evaluate the range of available options for maintain access for legitimate use.”

- RT

You know, don't you worry about those junkies.  That problem will take care of itself (wink, wink).

Those bastards are absolutely shameless.


Here's how it really goes:

Injected Opana ER, manufactured by Endo Pharmaceuticals, was linked to an HIV outbreak in rural Scott County, Indiana in 2015, due to shared needles.

Indiana’s state health commissioner, Dr. Jerome Adams, spoke to the advisory panel on Monday. He said there are now 215 cases of HIV in the area, and nearly all of those people had injected Opana.

“I would respectfully suggest that we’re here today not so much to look back at what happened,” Adams, according to NPR. “But to make sure it doesn’t happen in another community.”

The drug was being overprescribed in the area, Adams said, telling the committee: “You need to ask yourself, ‘Are you helping more people than you’re hurting?’”

- RT

Endo insists the drug is fine if it goes to the right population.  The real world experience shows it doesn't and you knew that already either intuitively or, in some cases, from direct experience.

14 comments:

Anonymous said...

Tennessee has introduced legislation to allow schools to have Narcan at each school.
Scary how this even has to be considered. The law is a little disturbing as I haven't seen where parental notification is required. This is not surprising in a society that does not require notification of a juvenile receiving an abortion.
These same schools are required parental approval to administer aspirin.
Warped Logic

Peas InOurThyme said...

It really does anger me to hear that and not because they do it but, as you say, because it is necessary.

I'm not sure how parental notification could work. If I've got some kid convulsing or whatever effect from O.D., then I've got to get him some help and pronto. Maybe he croaks if I wait to make a phone call.

I'm not going to bite on extending this to abortion since I don't see the same thing although the point of notification is the same.

As to aspirin, I'm become progressively more enamored of the idea of simply eliminating Washington altogether. That's not to push states rights since those statehouses are hanging by a thread too (larfs).

Anonymous said...

Of course the notification for Narcan would have to be post use.
The abortion piece is just another part of government believing parents are not smart enough to be involved in raising children. i.e. It Takes a Village to Raise a Child

Peas InOurThyme said...

I do believe it takes a village to raise a child but that doesn't necessarily mean anyone can be interfering in anyone else's business when it's not wanted.

Anonymous said...

A new twist for Big Pharma Vivitrol can be used to block the effects of opioids and dramatically increase the success rate of recovery.
Yes the but is it costs $1500 per injection and it is a monthly dose
Which is cheaper than the addiction but most insurances do not cover it

Anonymous said...

Which is ridiculous since most cover rehab which runs $12k to $60k for a 60 to 90 day program with a 10-15% success rate
Vivitrol is said to run at least 36% to a Russian test of 750 addicts with a 90% success rate. The Russian test does not say if that is while the subject were still on Vivitrol or after leaving get the program

Peas InOurThyme said...

Man, I don't get how this stuff can cost $1500 per injection unless it's injecting gold dust along with the medicine.

Even so, I see repeatedly from your comments just now that 'insurance won't cover it' and that's the time to put my head in my hands ... now what.

All of us see the problem with heroin going so crazily out of control but ... insurance won't cover it.

I'm sure you'll understand this is endearing me to commercial insurance in no way whatsoever.

Anonymous said...

Latest study
1 in 11 teens reportedly have abused opioids. Most of which were originally prescribed by a DR
80% of the world's opioids are consumed by the US.
I selected my latest PCP because the practice does not prescribe opioids. They say only a specialist treating major pain needs to prescribe them

Anonymous said...

Latest study
1 in 11 teens reportedly have abused opioids. Most of which were originally prescribed by a DR
80% of the world's opioids are consumed by the US.
I selected my latest PCP because the practice does not prescribe opioids. They say only a specialist treating major pain needs to prescribe them

Peas InOurThyme said...

I was starting to get drawn into that Vicodin and that was just from visits to the dentist. Mystery Lady saw it before I did as that stuff is as sneaky as it is evil. Every bit of it was legal too.

Anonymous said...

I will give a Vivitrol update in the near future. Several people will be trying it as they move into unsupervised living. Each are scared that even after two years they need something to assist their willpower.
I believe in each case a placebo would be just as effective as their commitment seems to be very solid.
But I am an outsider and will help them as I can

Peas InOurThyme said...

I'm most interested to know what comes from a personal and general knowledge interest and best wishes to anyone anywhere who is taking the step you describe.

Anonymous said...

Mostly street kids society kicked to the curb as worthless. Some crazy stories from these people
Like the one we picked up walking along the road with a tire and rim tied to his back with rope walking to get the flat fixed.
End of story he has air is his tire.
All we asked was pay it forward.
The amazement in his face that people would help a complete strangers will last a long long time.
That look of amazement was also in terms faces of the people in the car we were driving to an appointment.
So I ask your readers one favor one day.
You do the math Yes if it carried forward by the end of 1 year over 6B favors

Peas InOurThyme said...

That's the Theory of Propagated Goodness in living color. I'm in with some good deeds in the background and it's unknown how those will percolate but no chance of anything bad.

Like you said, there's that look when someone looks at you and wonders, 'you would really do that?'

Yah, I want to do that.

I bet the regulars do things like that when they can. People are usually reticent about talking about such things since it may be perceived as bragging but I don't see any brag in doing something a good person would do if the chance to do it were there. The strange part but also the cool part is it surprises the hell out of people when you do.