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re: Trump to Big Pharma - "We are going to end Global Free-Loading" - BOOM!
Posted on 1/31/17 at 11:14 am to NC_Tigah
Posted on 1/31/17 at 11:14 am to NC_Tigah
quote:
mmcgrath, while technically the FDA may not directly "deny" a patient, in most cases even vis-a-vis "compassionate access", the roadblocks it lays down can be insurmountable.
What roadblocks? There aren't any in these cases. Jeez.
Posted on 1/31/17 at 11:19 am to mmcgrath
quote:mmcgrath, of course there are. The FDA strongly discourages physicians and hospital systems from circumventing protocols. It does so publicly. It does so in ways intimating increased liability.
What roadblocks? There aren't any in these cases.
Posted on 1/31/17 at 11:20 am to AUbagman
quote:
I would imagine they would rather start profiting from the medicine sooner, but that does not mean they have the incentive to kill people. They aren't mutually exclusive.
Correct. But when a drug hasn't been approved, the pricing structure is radically altered. And for life-saving treatments, the pharma companies can charge whatever they want to desperate patients and families without efficacy data or even an idea of efficacy data.
Posted on 1/31/17 at 11:24 am to NC_Tigah
quote:quote:
What roadblocks? There aren't any in these cases.
mmcgrath, of course there are. The FDA strongly discourages physicians and hospital systems from circumventing protocols. It does so publicly. It does so in ways intimating increased liability.
You should just admit you were talking out of your rear. You obviously don't know of any roadblocks.
Posted on 1/31/17 at 11:28 am to NC_Tigah
As of the middle of 2016, 31 states had instituted "Right to Try" legislation. The first one of those was introduced over three years ago.
Zero documented patients have received access to life-saving treatments as a result of the legislation.
It's a solution in search of a problem.
Zero documented patients have received access to life-saving treatments as a result of the legislation.
It's a solution in search of a problem.
Posted on 1/31/17 at 11:28 am to Sleeping Tiger
I will largely agree with your meme.
Posted on 1/31/17 at 11:29 am to Sleeping Tiger
The American lifestyle, particularly our diet, creates customers. If there's a negative to modern pharmaceuticals, it's that they help keep people debilitated by chronic illnesses alive too long who become a financial drain on the system.
Posted on 1/31/17 at 11:39 am to Roger Klarvin
I agree our lifestyles and our diets are a core part of the problem -- which is why I'm huge on altering the medical industry entirely. More focus on holistic and natural approaches, a 1,000% increase in focus on nutrition.
But the industrial complexes that control every aspect of society prevent that while enabling all the bad shite.
But the industrial complexes that control every aspect of society prevent that while enabling all the bad shite.
Posted on 1/31/17 at 11:39 am to mmcgrath
quote:
You should just admit you were talking out of your rear. You obviously don't know of any roadblocks.
There are times when you seem like a knowledgeable guy.
There are other times when you seem to lose your mind.
Since you claim knowledge in this area though, walk us through the unobstructed process by which a patient would gain access to a research pharmaceutical outside of bounds of its research protocol. Be sure to include issues involving FDA position statements, procurement, institutional formularies, local protocols, perceived and actual legal ramifications, and timeframe.
This post was edited on 1/31/17 at 11:40 am
Posted on 1/31/17 at 11:43 am to the808bass
I'm kinda being a shite with those memes.
Working on something at the moment. Decided to do a meme hit-n-run.
Good insight reading some of these posts from you guys in the industry.
Working on something at the moment. Decided to do a meme hit-n-run.
Good insight reading some of these posts from you guys in the industry.
This post was edited on 1/31/17 at 11:43 am
Posted on 1/31/17 at 11:43 am to the808bass
quote:That should speak volumes.
Zero documented patients have received access to life-saving treatments as a result of the legislation.
Is the intimation there are no terminal cases within those 31 states who are in need of such intervention?
If not, why has there been no access?
Posted on 1/31/17 at 11:47 am to NC_Tigah
quote:Should I write a discertation that proves the Lockness Monster doesn't exist too?
There are times when you seem like a knowledgeable guy.
There are other times when you seem to lose your mind.
Since you claim knowledge in this area though, walk us through the unobstructed process by which a patient would gain access to a research pharmaceutical outside of bounds of its research protocol. Be sure to include issues involving FDA position statements, procurement, institutional formularies, local protocols, perceived and actual legal ramifications, and timeframe.
You are the one claiming that the FDA lays down "roadblocks". I am just calling you out on your BS.
Btw, I have experience on both sides of a compassionate care application.
Posted on 1/31/17 at 11:47 am to NC_Tigah
quote:
Since you claim knowledge in this area though, walk us through the unobstructed process by which a patient would gain access to a research pharmaceutical outside of bounds of its research protocol. Be sure to include issues involving FDA position statements, procurement, institutional formularies, local protocols, perceived and actual legal ramifications, and timeframe.
All good questions. None of them outside of the first one is affected by a Federal "right to try" piece of the puzzle.
From 2010 to 2014, 5,995 requests to the FDA out of 6,028 were approved access to experimental meds.
The process of approval from a physician perspective has been cut to 60 minutes.
Posted on 1/31/17 at 11:47 am to Sleeping Tiger
I won't disagree that we are too quick to prescribe medications. I usually give patients with diabetes, hypertension, etc. at least 6 months to make lifestyle changes to improve their health. Starting someone on a statin the second they have high cholesterol is usually unnecessary for instance.
Posted on 1/31/17 at 11:47 am to NC_Tigah
quote:
We're going to be ending global free loading. Foreign price controls reduce the resources of American drug companies to finance drug and R&D innovation. I think you people know that very well. Very unfair to this country.
I agree with this. Americans pay higher prices for drugs bc we don't have the price controls other countries have and someone has to fund R&D.
Hopefully, streamlining the approval process reduces costs to pharma companies to make up some of that cost. I'm wary of too much change in the approval process, though.
Posted on 1/31/17 at 11:48 am to the808bass
quote:Okay.
The process of approval from a physician perspective has been cut to 60 minutes.
Posted on 1/31/17 at 11:48 am to NC_Tigah
quote:
Is the intimation there are no terminal cases within those 31 states who are in need of such intervention? If not, why has there been no access?
Because 1) most drugs for dying patients simply prolong life (at best) and 2) if they haven't been approved through all phases of FDA testing, they usually don't "work" at even doing that.
You're welcome.
Posted on 1/31/17 at 11:49 am to MrLarson
quote:
Let's start with removing Big Pharma from TV ads.
I think we should limit benefits provided to doctors from pharma reps.
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