Author Topic: The ACA/Obamacare Thread  (Read 7456 times)

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Offline Stadler

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Re: The ACA/Obamacare Thread
« Reply #105 on: January 30, 2017, 08:45:13 AM »
???  I have no party.  I am making no assumptions based on party.  I am making no assumptions at all.  YOU are.

No assumptions. Going by what is written on the page, by you and others. If I'm guilty of anything it's lumping you in with the others, but apparently, as others have shown with all the broad brushes about "all Republicans", I'm not the only one guilty of that crime.

Offline Stadler

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Re: The ACA/Obamacare Thread
« Reply #106 on: January 30, 2017, 08:48:31 AM »
Better than the alternative; ramming it through with almost no thought whatsoever -

There's just no evidence at all that the original bill was "rammed through" with almost no thought whatsoever.

This bill was exhaustively debated with industry experts, revised, and debated again.  The only reason it had no "input" from Republicans is because they announced that they would oppose the bill no matter what because Obama.

Well, now they have their chance.  And it appears to me that they have no clue as to how to actually improve it.  Tort reform isn't going to do jack shit...almost every study shows that.  Selling insurance across state lines is going to create chaos and fraud.

I have repeatedly said that I have people close to me who have high positions in healthcare.  Despite the press releases, they were consulted almost not at all, and the few concerns that were noted were almost entirely brushed over.  Coupled with the $80 BILLION back-room profit promise to the pharmaceuticals and the fact that more than half the population didn't want the ACA...   If you've placated the pharmaceuticals, ignored the insurance carriers, and ignored the populace, three of the four biggest interests in U.S. healthcare (the fourth being the providers), it is fair to say it was "pushed through". 

Offline hefdaddy42

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Re: The ACA/Obamacare Thread
« Reply #107 on: January 30, 2017, 09:26:04 AM »
???  I have no party.  I am making no assumptions based on party.  I am making no assumptions at all.  YOU are.

No assumptions. Going by what is written on the page, by you and others. If I'm guilty of anything it's lumping you in with the others, but apparently, as others have shown with all the broad brushes about "all Republicans", I'm not the only one guilty of that crime.
I meant assumptions that the ACA won't be terminated until and unless there is a replacement. 

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Offline Stadler

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Re: The ACA/Obamacare Thread
« Reply #108 on: January 30, 2017, 09:48:29 AM »
???  I have no party.  I am making no assumptions based on party.  I am making no assumptions at all.  YOU are.

No assumptions. Going by what is written on the page, by you and others. If I'm guilty of anything it's lumping you in with the others, but apparently, as others have shown with all the broad brushes about "all Republicans", I'm not the only one guilty of that crime.
I meant assumptions that the ACA won't be terminated until and unless there is a replacement.

I misunderstood; sorry.

But I've already addressed that.  We have them saying "Repeal and replace".  I'm assuming they will do just what they say, in some form or fashion (we may not like the replacement, but there will BE a replacement).  You're assuming they will do something entirely different than what they're saying.  They're both kind of assumptions, but if you're going to call in "evidence", at least I have SOMETHING tangible to fall back on.  "Politicians lie and never do what they say" is opinion, not evidence, especially since, for better or worse, Trump has done everything he said he was going to do (and, apparently, causing "TERROR" in the process). 

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Re: The ACA/Obamacare Thread
« Reply #109 on: January 30, 2017, 09:52:01 AM »
There's just no evidence at all that the original bill was "rammed through" with almost no thought whatsoever.

This is simply not true. Deep in the recesses of this thread or a previous one....I can't remember at this point....I detailed how this 'law' was indeed rammed through by some crafty politicking on obama and pelosi's part. 7/10 Americans at the time did not want the law being proposed passed but they did it anyway in back door sessions. In all sense of the words it was 'rammed through' There is no debating that FACT.

Now, If I truly believed it would make one bit of difference I'd spend the time to either dig up my old post or just compile a new one that essentially proves that assertion. But, given the tone of this thread and every other thread in P/R since the election....it wouldn't matter if I had videotaped confession from obama admitting he rammed it through...the evidence would be ignored and skipped over with some arbitrary 'meh....trump bad....meh' comments.

So...I'm not going to waste my time....just couldn't let that comment slide because of how incredibly false it was.
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Offline XeRocks81

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Re: The ACA/Obamacare Thread
« Reply #110 on: January 30, 2017, 10:02:31 AM »
There's just no evidence at all that the original bill was "rammed through" with almost no thought whatsoever.

This is simply not true. Deep in the recesses of this thread or a previous one....I can't remember at this point....I detailed how this 'law' was indeed rammed through by some crafty politicking on obama and pelosi's part. 7/10 Americans at the time did not want the law being proposed passed but they did it anyway in back door sessions. In all sense of the words it was 'rammed through' There is no debating that FACT.

Now, If I truly believed it would make one bit of difference I'd spend the time to either dig up my old post or just compile a new one that essentially proves that assertion. But, given the tone of this thread and every other thread in P/R since the election....it wouldn't matter if I had videotaped confession from obama admitting he rammed it through...the evidence would be ignored and skipped over with some arbitrary 'meh....trump bad....meh' comments.

So...I'm not going to waste my time....just couldn't let that comment slide because of how incredibly false it was.

I guess the only thing that matters is if one is for or against the legislation.  The importance of how it's done varies according to bias.  There's just no way aorund this that I can see.

Offline hefdaddy42

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Re: The ACA/Obamacare Thread
« Reply #111 on: January 30, 2017, 10:14:41 AM »
???  I have no party.  I am making no assumptions based on party.  I am making no assumptions at all.  YOU are.

No assumptions. Going by what is written on the page, by you and others. If I'm guilty of anything it's lumping you in with the others, but apparently, as others have shown with all the broad brushes about "all Republicans", I'm not the only one guilty of that crime.
I meant assumptions that the ACA won't be terminated until and unless there is a replacement.

I misunderstood; sorry.

But I've already addressed that.  We have them saying "Repeal and replace".  I'm assuming they will do just what they say, in some form or fashion (we may not like the replacement, but there will BE a replacement).  You're assuming they will do something entirely different than what they're saying.  They're both kind of assumptions, but if you're going to call in "evidence", at least I have SOMETHING tangible to fall back on.  "Politicians lie and never do what they say" is opinion, not evidence, especially since, for better or worse, Trump has done everything he said he was going to do (and, apparently, causing "TERROR" in the process).

They have been trying to repeal without a replacement for 7 years now.  They are still talking about repealing and have no clue how to put together a replacement. 

So, their actual history of deeds AND words is enough for ME to fall back on.

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Offline Stadler

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Re: The ACA/Obamacare Thread
« Reply #112 on: January 30, 2017, 10:21:05 AM »
???  I have no party.  I am making no assumptions based on party.  I am making no assumptions at all.  YOU are.

No assumptions. Going by what is written on the page, by you and others. If I'm guilty of anything it's lumping you in with the others, but apparently, as others have shown with all the broad brushes about "all Republicans", I'm not the only one guilty of that crime.
I meant assumptions that the ACA won't be terminated until and unless there is a replacement.

I misunderstood; sorry.

But I've already addressed that.  We have them saying "Repeal and replace".  I'm assuming they will do just what they say, in some form or fashion (we may not like the replacement, but there will BE a replacement).  You're assuming they will do something entirely different than what they're saying.  They're both kind of assumptions, but if you're going to call in "evidence", at least I have SOMETHING tangible to fall back on.  "Politicians lie and never do what they say" is opinion, not evidence, especially since, for better or worse, Trump has done everything he said he was going to do (and, apparently, causing "TERROR" in the process).

They have been trying to repeal without a replacement for 7 years now.  They are still talking about repealing and have no clue how to put together a replacement. 

So, their actual history of deeds AND words is enough for ME to fall back on.

I've already addressed this; the past seven years are as irrelevant for predicting the future as stock prices.   There was no possibility of getting a replacement in with a President who's NAME was on the law.   They could have come up with the gold standard of healthcare, that solved the problems of every citizen, cured cancer, removed Jar Jar Binks from the Star Wars prequels, and erased the debacle that was the "Sgt. Pepper" movie from the collective consciousness, and Obama would have veto'd it faster than Joe Biden could say "Good one, boss!".    Several representatives - including Rand Paul - DID during that time draft replacements, but no one that solved all the problems adequately.  That's what the debate is now. 

This is the Congressional sausage-making, when done right. 

Offline hefdaddy42

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Re: The ACA/Obamacare Thread
« Reply #113 on: January 30, 2017, 10:30:57 AM »
Obama said, over and over again, show me a better plan.

I still haven't seen one.

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Offline Stadler

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Re: The ACA/Obamacare Thread
« Reply #114 on: January 30, 2017, 10:36:05 AM »
Obama said, over and over again, show me a better plan.

I still haven't seen one.

Oh, okay.  I believe him as much as you believe Paul Ryan.  Obama also said he was going to go after the pharmaceuticals, before he needed to guarantee they didn't scuttle his signature legislation with an $80 BILLION profit guarantee.   Or promised, "you can keep your doctor!".   So let's not put him up as the shining light of integrity when it comes to the ACA. 
« Last Edit: January 30, 2017, 11:31:18 AM by Stadler »

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Re: The ACA/Obamacare Thread
« Reply #115 on: January 30, 2017, 11:21:45 AM »
Obama said, over and over again, show me a better plan.

I still haven't seen one.

Rand Paul has a pretty good replacement plan proposal.
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Re: The ACA/Obamacare Thread
« Reply #116 on: January 30, 2017, 11:44:49 AM »
Rand Paul's plan wasn't a replacement. It was a tweak to the status quo ante.
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Re: The ACA/Obamacare Thread
« Reply #117 on: January 30, 2017, 12:06:21 PM »
I personally wouldn't be opposed to the idea of just fixing the ACA.  If the Republicans in office are struggling to find a good replacement, I would hope (but I doubt) that they would settle for a redo of the ACA and just fix certain things like state lines that may help bring the cost down.  Something to make everyone happy at the expense of the promise of repeal.

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Re: The ACA/Obamacare Thread
« Reply #118 on: January 30, 2017, 12:08:02 PM »
Obama said, over and over again, show me a better plan.

I still haven't seen one.

Oh, okay.  I believe him as much as you believe Paul Ryan.  Obama also said he was going to go after the pharmaceuticals, before he needed to guarantee they didn't scuttle his signature legislation with an $80 BILLION profit guarantee.   Or promised, "you can keep your doctor!".   So let's not put him up as the shining light of integrity when it comes to the ACA.

I still haven't seen one.

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Re: The ACA/Obamacare Thread
« Reply #119 on: January 30, 2017, 12:52:04 PM »
Rand Paul's plan wasn't a replacement. It was a tweak to the status quo ante.

Which what the ACA needs. Some sensible tweaks. But the same 'my way or the highway' partisanship that slammed it through without thought or really caring how it was going to affect people down the road is fueling the desire to repeal it.

None of those people in Washington give two craps about the American citizenry.....any of them claiming to are flat out liars, you know the tree by the fruit it bears and there ain't nothing but thorn bushes and poison ivy growing in DC.
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Re: The ACA/Obamacare Thread
« Reply #120 on: January 30, 2017, 01:04:30 PM »
Rand Paul's plan wasn't a replacement. It was a tweak to the status quo ante.

Which what the ACA needs. Some sensible tweaks. But the same 'my way or the highway' partisanship that slammed it through without thought or really caring how it was going to affect people down the road is fueling the desire to repeal it.

None of those people in Washington give two craps about the American citizenry.....any of them claiming to are flat out liars, you know the tree by the fruit it bears and there ain't nothing but thorn bushes and poison ivy growing in DC.
I think you misunderstood. The ante in this case is pre-ACA. His plan is healthcare circa 2009 with a couple of additions like HSAs and a tax break here or there. It's not a replacement at all as it does not accomplish what the ACA set out to do.
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Re: The ACA/Obamacare Thread
« Reply #121 on: January 31, 2017, 03:22:24 PM »
http://www.cnn.com/2017/01/31/politics/donald-trump-pharma-meeting/index.html

Trump wants to lower prices through deregulation.  I don't know enough to have an opinion on his deregulations, but obviously lower prices is something everyone wants.  I'm curious how this will end up going.

Quote
Merck & Co CEO Kenneth Frazier spoke with reporters by the West Wing of the White House after the meeting concluded.
"The President is very much focused on how we can actually do better for patients, giving them more choice, helping them to deal with the medical bills that they have in a way that also stimulates innovation," he said.
When asked if he's more hopeful for this administration than he was of the last, Frazier said: "I think there is a real opportunity if we actually work on all those things."

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Re: The ACA/Obamacare Thread
« Reply #122 on: January 31, 2017, 03:45:22 PM »
http://www.cnn.com/2017/01/31/politics/donald-trump-pharma-meeting/index.html

Trump wants to lower prices through deregulation.  I don't know enough to have an opinion on his deregulations, but obviously lower prices is something everyone wants.  I'm curious how this will end up going.

Quote
Merck & Co CEO Kenneth Frazier spoke with reporters by the West Wing of the White House after the meeting concluded.
"The President is very much focused on how we can actually do better for patients, giving them more choice, helping them to deal with the medical bills that they have in a way that also stimulates innovation," he said.
When asked if he's more hopeful for this administration than he was of the last, Frazier said: "I think there is a real opportunity if we actually work on all those things."


Sounds like another attempt at trickle down economics. If I'm a business owner and save 5% a year thanks to less regulatory stuff, odds are at least 3-4% of that is going right into my pocket.

Offline chknptpie

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Re: The ACA/Obamacare Thread
« Reply #123 on: January 31, 2017, 06:13:14 PM »
As someone who works in the pharma/med device industry dealing with regulations - less regulations is not necessary. We need the FDA to actually be able to enforce their regulations. They seem to have a lack of resources to adequately complete inspections and submission reviews.

Offline millahh

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Re: The ACA/Obamacare Thread
« Reply #124 on: January 31, 2017, 06:50:24 PM »
As someone who works in the pharma/med device industry dealing with regulations - less regulations is not necessary. We need the FDA to actually be able to enforce their regulations. They seem to have a lack of resources to adequately complete inspections and submission reviews.

You're not kidding...they seem to be hitting PDUFA dates, but not much else.  FDA being understaffed is creating delays...it's not the burden of the regulations themselves.

I'll answer cramx's question in this thread, since it's a little more relevant.  My understanding is that Trump wants to lower (and roll back) the regulatory hurdles for getting a drug approved, so that the requirements for demonstrating efficacy are greatly reduced (safety requirements would be unchanged in my understanding).  So, the process would go faster, and more drugs would get to market.  More competition means lower process: BUT:

-This means that drugs that may not be effective will make it to market.  However, insurance companies will only want to pay for drugs that work, so companies will still need to run those same studies if they want to get reimbursed for the drug.
-The point above also means that the drugs that are actually demonstrated to work and be worth buying will continue to command a premium in the marketplace
-Most of the mid-and big pharma are global now...and the requirements in Canada, EU, Japan and Latin America won't be loosening.  Companies with global ambitions will run global studies to meet global requirements, so time to approval will still be the same, unless a company wants to run shorter US-only studies, which I don't expect would be cost effective.
-The longest part of the late-stage clinical work is the long-term safety study (needed for anything something that is just a single short course of treatment, like an antibiotic), and these require patient exposure to the drug for 52 weeks.  So unless some company can bend time, this isn't improving.

In short, he's talking out his ass.  Seems mostly like a move to help out investors in smaller biotechs who buy at the IPO, and sell shortly after approval, before people realize that the drug won't sell because it may as well be a placebo.
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Re: The ACA/Obamacare Thread
« Reply #125 on: February 01, 2017, 06:42:47 AM »
Thanks for the good response.  When I saw deregulation on pharm, my first thought was health, like it's probably not worth saving money if you are buying an untested product that you are putting into your body, but figured there must be some other regulations Trump is looking at. 

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Re: The ACA/Obamacare Thread
« Reply #126 on: February 01, 2017, 06:52:44 AM »
I don't know my ass from my elbow when it comes to health care, but generally, when I hear the word "regulations", my mind normally equates it with "protective measures".

If there is a hoop that some company needlessly has to jump through, then fine, but my guess is that a regulation was put into place because there was an issue along the way.
would have thought the same thing but seeing the OP was TAC i immediately thought Maiden or DT related
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Re: The ACA/Obamacare Thread
« Reply #127 on: February 01, 2017, 07:01:53 AM »
I don't know my ass from my elbow when it comes to health care, but generally, when I hear the word "regulations", my mind normally equates it with "protective measures".

If there is a hoop that some company needlessly has to jump through, then fine, but my guess is that a regulation was put into place because there was an issue along the way.

That's not always true. Gas cans are a perfect example. Gas cans were fine. A container with a screw on cap that held the gas in. You ever see a gas can now? Fuck modern gas cans. I bought a new one last year and couldn't figure out how to get it to work for a solid twenty minutes. There are like seven safety measures I need to acknowledge before I can fill my snowblower, a machine that's more than capable of tearing a limb off. I said the hell with it and grabbed the metal can from the 80's that's been sitting in my parent's garage my whole life. Works like a charm.

Those regulations stemmed from the gas canister companies designing uneccessary safety measures, and then lobbying our lawmakers to make using them a requirement. Every store needed to upgrade their inventory, and every contractor under the sun needed to upgrade their gas cans to remain compliant with Osha.

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Re: The ACA/Obamacare Thread
« Reply #128 on: February 01, 2017, 07:05:18 AM »
I don't know my ass from my elbow when it comes to health care, but generally, when I hear the word "regulations", my mind normally equates it with "protective measures".

If there is a hoop that some company needlessly has to jump through, then fine, but my guess is that a regulation was put into place because there was an issue along the way.

That's not always true. Gas cans are a perfect example. Gas cans were fine. A container with a screw on cap that held the gas in. You ever see a gas can now? Fuck modern gas cans. I bought a new one last year and couldn't figure out how to get it to work for a solid twenty minutes. There are like seven safety measures I need to acknowledge before I can fill my snowblower, a machine that's more than capable of tearing a limb off. I said the hell with it and grabbed the metal can from the 80's that's been sitting in my parent's garage my whole life. Works like a charm.

Those regulations stemmed from the gas canister companies designing uneccessary safety measures, and then lobbying our lawmakers to make using them a requirement. Every store needed to upgrade their inventory, and every contractor under the sun needed to upgrade their gas cans to remain compliant with Osha.

So do you think there are similar regulations in healthcare that are unnecessary?  Does anyone know of any? Millah's response didn't appear to think so and I certainly don't know.

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Re: The ACA/Obamacare Thread
« Reply #129 on: February 01, 2017, 07:17:18 AM »
I don't know my ass from my elbow when it comes to health care, but generally, when I hear the word "regulations", my mind normally equates it with "protective measures".

If there is a hoop that some company needlessly has to jump through, then fine, but my guess is that a regulation was put into place because there was an issue along the way.

That's not always true. Gas cans are a perfect example. Gas cans were fine. A container with a screw on cap that held the gas in. You ever see a gas can now? Fuck modern gas cans. I bought a new one last year and couldn't figure out how to get it to work for a solid twenty minutes. There are like seven safety measures I need to acknowledge before I can fill my snowblower, a machine that's more than capable of tearing a limb off. I said the hell with it and grabbed the metal can from the 80's that's been sitting in my parent's garage my whole life. Works like a charm.

Those regulations stemmed from the gas canister companies designing uneccessary safety measures, and then lobbying our lawmakers to make using them a requirement. Every store needed to upgrade their inventory, and every contractor under the sun needed to upgrade their gas cans to remain compliant with Osha.

So do you think there are similar regulations in healthcare that are unnecessary?  Does anyone know of any? Millah's response didn't appear to think so and I certainly don't know.

I'm sure there are many. No clue what they are though.

Offline mikeyd23

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Re: The ACA/Obamacare Thread
« Reply #130 on: February 01, 2017, 07:21:12 AM »
I don't know my ass from my elbow when it comes to health care, but generally, when I hear the word "regulations", my mind normally equates it with "protective measures".

If there is a hoop that some company needlessly has to jump through, then fine, but my guess is that a regulation was put into place because there was an issue along the way.

That's not always true. Gas cans are a perfect example. Gas cans were fine. A container with a screw on cap that held the gas in. You ever see a gas can now? Fuck modern gas cans. I bought a new one last year and couldn't figure out how to get it to work for a solid twenty minutes. There are like seven safety measures I need to acknowledge before I can fill my snowblower, a machine that's more than capable of tearing a limb off. I said the hell with it and grabbed the metal can from the 80's that's been sitting in my parent's garage my whole life. Works like a charm.

Those regulations stemmed from the gas canister companies designing uneccessary safety measures, and then lobbying our lawmakers to make using them a requirement. Every store needed to upgrade their inventory, and every contractor under the sun needed to upgrade their gas cans to remain compliant with Osha.

So do you think there are similar regulations in healthcare that are unnecessary?  Does anyone know of any? Millah's response didn't appear to think so and I certainly don't know.

I don't know if there are in healthcare, but I can tell you in the world Trump came from (development) all those guys think regulation is way out of control. I work for a consulting company (engineering and environmental services) that works for developers trying to develop property and to say there are hoops to jump through is an understatement. I wouldn't say the regulations in place in that industry are bad or unreasonable in most instances, but I can tell you from interacting with developers, they all think they are. That's the world Trump is coming from and it wouldn't surprise me greatly if he took that experience with regulations and applied it (in his mind) to all industries.

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Re: The ACA/Obamacare Thread
« Reply #131 on: February 01, 2017, 08:15:08 AM »
As someone who works in the pharma/med device industry dealing with regulations - less regulations is not necessary. We need the FDA to actually be able to enforce their regulations. They seem to have a lack of resources to adequately complete inspections and submission reviews.

You're not kidding...they seem to be hitting PDUFA dates, but not much else.  FDA being understaffed is creating delays...it's not the burden of the regulations themselves.

I'll answer cramx's question in this thread, since it's a little more relevant.  My understanding is that Trump wants to lower (and roll back) the regulatory hurdles for getting a drug approved, so that the requirements for demonstrating efficacy are greatly reduced (safety requirements would be unchanged in my understanding).  So, the process would go faster, and more drugs would get to market.  More competition means lower process: BUT:

-This means that drugs that may not be effective will make it to market.  However, insurance companies will only want to pay for drugs that work, so companies will still need to run those same studies if they want to get reimbursed for the drug.
-The point above also means that the drugs that are actually demonstrated to work and be worth buying will continue to command a premium in the marketplace
-Most of the mid-and big pharma are global now...and the requirements in Canada, EU, Japan and Latin America won't be loosening.  Companies with global ambitions will run global studies to meet global requirements, so time to approval will still be the same, unless a company wants to run shorter US-only studies, which I don't expect would be cost effective.
-The longest part of the late-stage clinical work is the long-term safety study (needed for anything something that is just a single short course of treatment, like an antibiotic), and these require patient exposure to the drug for 52 weeks.  So unless some company can bend time, this isn't improving.

In short, he's talking out his ass.  Seems mostly like a move to help out investors in smaller biotechs who buy at the IPO, and sell shortly after approval, before people realize that the drug won't sell because it may as well be a placebo.
That makes sense because I can't see any of my doctors prescribing me something because it's shiny and new. Given a choice between something with proven efficacy and something untested, they're not rolling the dice on me.
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Re: The ACA/Obamacare Thread
« Reply #132 on: February 01, 2017, 08:22:31 AM »
As someone who works in the pharma/med device industry dealing with regulations - less regulations is not necessary. We need the FDA to actually be able to enforce their regulations. They seem to have a lack of resources to adequately complete inspections and submission reviews.

You're not kidding...they seem to be hitting PDUFA dates, but not much else.  FDA being understaffed is creating delays...it's not the burden of the regulations themselves.

I'll answer cramx's question in this thread, since it's a little more relevant.  My understanding is that Trump wants to lower (and roll back) the regulatory hurdles for getting a drug approved, so that the requirements for demonstrating efficacy are greatly reduced (safety requirements would be unchanged in my understanding).  So, the process would go faster, and more drugs would get to market.  More competition means lower process: BUT:

-This means that drugs that may not be effective will make it to market.  However, insurance companies will only want to pay for drugs that work, so companies will still need to run those same studies if they want to get reimbursed for the drug.
-The point above also means that the drugs that are actually demonstrated to work and be worth buying will continue to command a premium in the marketplace
-Most of the mid-and big pharma are global now...and the requirements in Canada, EU, Japan and Latin America won't be loosening.  Companies with global ambitions will run global studies to meet global requirements, so time to approval will still be the same, unless a company wants to run shorter US-only studies, which I don't expect would be cost effective.
-The longest part of the late-stage clinical work is the long-term safety study (needed for anything something that is just a single short course of treatment, like an antibiotic), and these require patient exposure to the drug for 52 weeks.  So unless some company can bend time, this isn't improving.

In short, he's talking out his ass.  Seems mostly like a move to help out investors in smaller biotechs who buy at the IPO, and sell shortly after approval, before people realize that the drug won't sell because it may as well be a placebo.
That makes sense because I can't see any of my doctors prescribing me something because it's shiny and new. Given a choice between something with proven efficacy and something untested, they're not rolling the dice on me.

Maybe not on you (and I wouldn't be going that route either), what about people who are dying and would like to use an experimental drug?  I follow someone on social media that I played golf with at PSU who he was a linebacker and got drafted by the Titans.  Had to retire early because he was diagnosed with ALS.  He just went to Isreal for some sort of treatment that he can't get in the US.  I've seen this same type of story featured on HBO's Vice.  I find it interesting.  It seemed Trump was also talking about this type of scenario.  Which I'd imagine is a small amount of people overall, but on some level I feel like this goes against our personal freedoms (well and I think that with all drugs really I guess).

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Re: The ACA/Obamacare Thread
« Reply #133 on: February 01, 2017, 08:40:41 AM »
For regular product development, I wouldn't want any shortening of any safety regulations/trials.

But the layman in me DOES wish there were some kind of shortcut/waiver for terminal patients here in the US to get access to drugs not yet through the pipeline.  What's the worst that can happen in that instance?

I say this keeping in mind that I am a layman, and there probably is a good reason they don't normally do this.

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Re: The ACA/Obamacare Thread
« Reply #134 on: February 01, 2017, 08:45:02 AM »
As someone who works in the pharma/med device industry dealing with regulations - less regulations is not necessary. We need the FDA to actually be able to enforce their regulations. They seem to have a lack of resources to adequately complete inspections and submission reviews.

You're not kidding...they seem to be hitting PDUFA dates, but not much else.  FDA being understaffed is creating delays...it's not the burden of the regulations themselves.

I'll answer cramx's question in this thread, since it's a little more relevant.  My understanding is that Trump wants to lower (and roll back) the regulatory hurdles for getting a drug approved, so that the requirements for demonstrating efficacy are greatly reduced (safety requirements would be unchanged in my understanding).  So, the process would go faster, and more drugs would get to market.  More competition means lower process: BUT:

-This means that drugs that may not be effective will make it to market.  However, insurance companies will only want to pay for drugs that work, so companies will still need to run those same studies if they want to get reimbursed for the drug.
-The point above also means that the drugs that are actually demonstrated to work and be worth buying will continue to command a premium in the marketplace
-Most of the mid-and big pharma are global now...and the requirements in Canada, EU, Japan and Latin America won't be loosening.  Companies with global ambitions will run global studies to meet global requirements, so time to approval will still be the same, unless a company wants to run shorter US-only studies, which I don't expect would be cost effective.
-The longest part of the late-stage clinical work is the long-term safety study (needed for anything something that is just a single short course of treatment, like an antibiotic), and these require patient exposure to the drug for 52 weeks.  So unless some company can bend time, this isn't improving.

In short, he's talking out his ass.  Seems mostly like a move to help out investors in smaller biotechs who buy at the IPO, and sell shortly after approval, before people realize that the drug won't sell because it may as well be a placebo.
That makes sense because I can't see any of my doctors prescribing me something because it's shiny and new. Given a choice between something with proven efficacy and something untested, they're not rolling the dice on me.

Maybe not on you (and I wouldn't be going that route either), what about people who are dying and would like to use an experimental drug?  I follow someone on social media that I played golf with at PSU who he was a linebacker and got drafted by the Titans.  Had to retire early because he was diagnosed with ALS.  He just went to Isreal for some sort of treatment that he can't get in the US.  I've seen this same type of story featured on HBO's Vice.  I find it interesting.  It seemed Trump was also talking about this type of scenario.  Which I'd imagine is a small amount of people overall, but on some level I feel like this goes against our personal freedoms (well and I think that with all drugs really I guess).
This is a reasonable approach. Of course it has no appeal to the market so it's not what Grabby wants to do. What he did, if I understand Doc Millahh correctly, simply sounded better as a soundbite while requiring no real forethought.
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Re: The ACA/Obamacare Thread
« Reply #135 on: February 01, 2017, 08:46:40 AM »
I don't know my ass from my elbow when it comes to health care, but generally, when I hear the word "regulations", my mind normally equates it with "protective measures".

If there is a hoop that some company needlessly has to jump through, then fine, but my guess is that a regulation was put into place because there was an issue along the way.

That's not always true. Gas cans are a perfect example. Gas cans were fine. A container with a screw on cap that held the gas in. You ever see a gas can now? Fuck modern gas cans. I bought a new one last year and couldn't figure out how to get it to work for a solid twenty minutes. There are like seven safety measures I need to acknowledge before I can fill my snowblower, a machine that's more than capable of tearing a limb off. I said the hell with it and grabbed the metal can from the 80's that's been sitting in my parent's garage my whole life. Works like a charm.

Those regulations stemmed from the gas canister companies designing uneccessary safety measures, and then lobbying our lawmakers to make using them a requirement. Every store needed to upgrade their inventory, and every contractor under the sun needed to upgrade their gas cans to remain compliant with Osha.

I agree with the bolded part, but I'm speaking in general terms.


It's funny you mention gas containers. I bought a new one a few years ago because there's hole in the top of my old one. I got it home, and I was like WTF?? How does it f'n work? :facepalm:
So anyway, I fill that one up at the gas station and transport it, but then I pour it into my old one to actually pour into my equipment.
would have thought the same thing but seeing the OP was TAC i immediately thought Maiden or DT related
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Re: The ACA/Obamacare Thread
« Reply #136 on: February 01, 2017, 08:49:18 AM »
I've also struggled with using my new gas container for awhile  :lol

This is a reasonable approach. Of course it has no appeal to the market so it's not what Grabby wants to do. What he did, if I understand Doc Millahh correctly, simply sounded better as a soundbite while requiring no real forethought.

Grabby mentioned it so that's why i brought it up as well, but we all know Trump is known for his soundbites.

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Re: The ACA/Obamacare Thread
« Reply #137 on: February 01, 2017, 09:48:58 AM »
http://www.cnn.com/2017/01/31/politics/donald-trump-pharma-meeting/index.html

Trump wants to lower prices through deregulation.  I don't know enough to have an opinion on his deregulations, but obviously lower prices is something everyone wants.  I'm curious how this will end up going.

Quote
Merck & Co CEO Kenneth Frazier spoke with reporters by the West Wing of the White House after the meeting concluded.
"The President is very much focused on how we can actually do better for patients, giving them more choice, helping them to deal with the medical bills that they have in a way that also stimulates innovation," he said.
When asked if he's more hopeful for this administration than he was of the last, Frazier said: "I think there is a real opportunity if we actually work on all those things."


Sounds like another attempt at trickle down economics. If I'm a business owner and save 5% a year thanks to less regulatory stuff, odds are at least 3-4% of that is going right into my pocket.

It's case by case, of course, but that sounds about right.  The higher prices are often a measure of risk.  The company has to charge more to cover the risks that higher regulations often impose.  So if you remove the risk, not ALL that should go to the consumer, though some should.   If the removal of a regulation reduces an owner's cost/risk by 5%, and the consumer gets a 2% or 3% price cut, it's still a price cut.   

This is exactly the same mechanism - in reverse - why the ACA doesn't work.  It never addressed that there are five or six layers of that going on, each one taking their cut, and/or protecting their risk.   

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Re: The ACA/Obamacare Thread
« Reply #138 on: February 01, 2017, 09:51:52 AM »
As someone who works in the pharma/med device industry dealing with regulations - less regulations is not necessary. We need the FDA to actually be able to enforce their regulations. They seem to have a lack of resources to adequately complete inspections and submission reviews.

You're not kidding...they seem to be hitting PDUFA dates, but not much else.  FDA being understaffed is creating delays...it's not the burden of the regulations themselves.

I'll answer cramx's question in this thread, since it's a little more relevant.  My understanding is that Trump wants to lower (and roll back) the regulatory hurdles for getting a drug approved, so that the requirements for demonstrating efficacy are greatly reduced (safety requirements would be unchanged in my understanding).  So, the process would go faster, and more drugs would get to market.  More competition means lower process: BUT:

-This means that drugs that may not be effective will make it to market.  However, insurance companies will only want to pay for drugs that work, so companies will still need to run those same studies if they want to get reimbursed for the drug.
-The point above also means that the drugs that are actually demonstrated to work and be worth buying will continue to command a premium in the marketplace
-Most of the mid-and big pharma are global now...and the requirements in Canada, EU, Japan and Latin America won't be loosening.  Companies with global ambitions will run global studies to meet global requirements, so time to approval will still be the same, unless a company wants to run shorter US-only studies, which I don't expect would be cost effective.
-The longest part of the late-stage clinical work is the long-term safety study (needed for anything something that is just a single short course of treatment, like an antibiotic), and these require patient exposure to the drug for 52 weeks.  So unless some company can bend time, this isn't improving.

In short, he's talking out his ass.  Seems mostly like a move to help out investors in smaller biotechs who buy at the IPO, and sell shortly after approval, before people realize that the drug won't sell because it may as well be a placebo.

Millahh, if what you said is true, particularly the bullet about U.S.-only trials (and let me say, I have absolutely no reason to think what you've said ISN'T true), why then is Drug A x dollars here and only a fraction of that in, say, Canada?  It's not ALL R&D and/or patent protections, since those countries have those too.  If it's not FDA regulations, what is it? 

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Re: The ACA/Obamacare Thread
« Reply #139 on: February 01, 2017, 09:54:24 AM »
I'm curious to hear the good doctor's answer, but I'm going to speculate that it's because we're capable and willing to pay more and our slow talking neighbors to the North are not.
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