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Index » Radio Paradise/General » General Discussion » Capitalism and Consumerism... now what? Page: Previous  1, 2, 3, 4, 5, 6, 7  Next
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Lazy8

Lazy8 Avatar

Location: The Gallatin Valley of Montana
Gender: Male


Posted: Aug 29, 2016 - 12:21pm

 NoEnzLefttoSplit wrote:
hmm... there are reasons for those controls.. to stop patients getting killed by new treatments for instance.

There's always a good reason. But there's always a burden imposed by the control. That burden isn't always visible, but it's real. How many people died from AIDS while AZT was in late clinicals? The approval process helped kill them.

We count the cost of releasing a drug too early but we don't count the cost of releasing a drug too late. Just pointing out that that cost is not zero, and we don't let patients and doctors balance and manage the risk/reward ratio of new treatments. The FDA makes that call for them, and it only sees the downside of saying "yes", never the upside.
NoEnzLefttoSplit

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Gender: Male


Posted: Aug 29, 2016 - 12:15pm

 Lazy8 wrote:

Yes, actually, you are railing against capitalism. Scroll down.

I don't mean to imply (and don't think I did) that everything would be perfect if the market in medical devices were free. A free market guarantees no particular outcome, but it does tend toward:
  • Efficiency—inefficient operators are out-competed
  • Variety—if there's money to be made filling a niche someone will try to make that money
  • Innovation—you can't improve your competitive position without improving product, price, or delivery
  • Accountability—when a business treats you poorly you can take your trade elsewhere
The cost of regulatory compliance adds barriers to entry into markets. Got a great idea for a new drug or device? Get started! It will be a decade or more before the company you start can make a dime on your investment. Both large and small companies can innovate but when a small company does it the goal nowadays is to be acquired by a large company. There's no realistic hope for a startup in pharma to make it to the stock exchange on its own, and the business has been consolidating—companies are merging/acquiring to spread that regulatory burden over more volume.

The ACA has accelerated that trend. It had a lot of effects on pharma, some of them easily predictable (the medical device tax raising the cost of medical devices, for instance) and some of them less so (pharma companies rebating directly to consumers to cover increased co-pays on some name-brand drugs).

 
hmm... there are reasons for those controls.. to stop patients getting killed by new treatments for instance.
Lazy8

Lazy8 Avatar

Location: The Gallatin Valley of Montana
Gender: Male


Posted: Aug 29, 2016 - 12:11pm

 black321 wrote:
Now don't go putting words in my mouth.  I'm not railing against capitalism.  It's an economic system and probably the best one we've been able to come up with to date. But it is not perfect.  And neither are regulations.  It's ying/yang, good/bad, every silver lining got's a touch grey...human nature to f#$k it up.  You seem to imply if we had truly "free markets" everything would be peaches and cream and abuse would disappear.  I don't believe that, end of story.  So it's push and pull from both sides to get the best of what we can get. 

p.s., ACA has resulted in increased pressure to reduce Rx reimbursement rates and the only change to the delivery model is that more retailers are using distributors/wholesalers for generics instead of buying direct (looking to share procurement/scale savings)

 
Yes, actually, you are railing against capitalism. Scroll down.

I don't mean to imply (and don't think I did) that everything would be perfect if the market in medical devices were free. A free market guarantees no particular outcome, but it does tend toward:
  • Efficiency—inefficient operators are out-competed
  • Variety—if there's money to be made filling a niche someone will try to make that money
  • Innovation—you can't improve your competitive position without improving product, price, or delivery
  • Accountability—when a business treats you poorly you can take your trade elsewhere
The cost of regulatory compliance adds barriers to entry into markets. Got a great idea for a new drug or device? Get started! It will be a decade or more before the company you start can make a dime on your investment. Both large and small companies can innovate but when a small company does it the goal nowadays is to be acquired by a large company. There's no realistic hope for a startup in pharma to make it to the stock exchange on its own, and the business has been consolidating—companies are merging/acquiring to spread that regulatory burden over more volume.

The ACA has accelerated that trend. It had a lot of effects on pharma, some of them easily predictable (the medical device tax raising the cost of medical devices, for instance) and some of them less so (pharma companies rebating directly to consumers to cover increased co-pays on some name-brand drugs).


black321

black321 Avatar

Location: An earth without maps
Gender: Male


Posted: Aug 29, 2016 - 8:57am

 Lazy8 wrote:

Capitalism didn't fail, a market was constrained from providing a solution to a problem by regulatory intervention. The market didn't provide an outcome you find desirable, but its mechanisms functioned as they were allowed to. Mylan tried to maximize the money it made, and it worked the system. The incentives in that system made that result all but inevitable. And that system is anything but a free market.

The profit motive provides the food you eat, the clothes you wear, the roof over your head, the computer you're using to argue against it. I daresay it works on you too: you work for pay.* The profit motive and the markets it engenders provide the vast bounty of things you enjoy. It works everywhere...except healthcare?

Oh, sure, you can buy aspirin for pennies. Competing compounds as well; bandages, toothpaste, antibiotic ointments (ponder for a moment what a miracle Neosporin would have seemed to Karl Marx), sophisticated devices for taking care of your teeth—all sold at a profit by greedy industrialists—but that's not real healthcare! No way could mere grubby businessmen deliver real healthcare! Healthcare should be untainted by commerce, pure, driven only by faceless bureaucrats with no stake in successful outcomes.

Please. Rail against those greedy capitalists all you like but don't imagine for a moment you can do without them and their filthy profit motive.

So the market created an inefficient, burdensome system to inject middlemen into the delivery of drugs, contrary to previous practice. And this only happened in the last few years. Somehow all those greedy businessmen at both ends of the drug delivery system decided to cut someone else in on their trade. I wonder what miracle of capitalism caused that?

Tell me, what else happened in the last few years? Anything ringing a bell?

*Unless you're a trustafarian whose parents took advantage of that filthy incentive to amass a fortune big enough to free their offspring from the drudgery of toil and invested it—with the goal of making a profit!—to keep you in clothes and computers.

 
Now don't go putting words in my mouth.  I'm not railing against capitalism.  It's an economic system and probably the best one we've been able to come up with to date. But it is not perfect.  And neither are regulations.  It's ying/yang, good/bad, every silver lining got's a touch grey...human nature to f#$k it up.  You seem to imply if we had truly "free markets" everything would be peaches and cream and abuse would disappear.  I don't believe that, end of story.  So it's push and pull from both sides to get the best of what we can get. 

p.s., ACA has resulted in increased pressure to reduce Rx reimbursement rates and the only change to the delivery model is that more retailers are using distributors/wholesalers for generics instead of buying direct (looking to share procurement/scale savings)
Lazy8

Lazy8 Avatar

Location: The Gallatin Valley of Montana
Gender: Male


Posted: Aug 26, 2016 - 3:40pm

 black321 wrote:
The profit motive led Mylan and company to raise prices above a reasonable level.  That is the failure of capitalism.  The regulation failure was in the way the FDA deals with injectors...keeping competitors out of the market. the only winner in all this was the high deductible plan...getting the consumer involved in the cost of their healthcare. 
Obviously if we stripped out the regulations completely, there would be no incentive for cos. to invest billions in new drugs if a generic could be released as soon as a competitor was able to find a way to produce a copy.

p.s.there is no regulation that requires a mfg to sell to a wholesaler, or forbids a retailer to acquire direct from mfg (in fact up until about 2 years ago, most retailers did procure most generics direct from mfg).  The market itself set this up.
 
Capitalism didn't fail, a market was constrained from providing a solution to a problem by regulatory intervention. The market didn't provide an outcome you find desirable, but its mechanisms functioned as they were allowed to. Mylan tried to maximize the money it made, and it worked the system. The incentives in that system made that result all but inevitable. And that system is anything but a free market.

The profit motive provides the food you eat, the clothes you wear, the roof over your head, the computer you're using to argue against it. I daresay it works on you too: you work for pay.* The profit motive and the markets it engenders provide the vast bounty of things you enjoy. It works everywhere...except healthcare?

Oh, sure, you can buy aspirin for pennies. Competing compounds as well; bandages, toothpaste, antibiotic ointments (ponder for a moment what a miracle Neosporin would have seemed to Karl Marx), sophisticated devices for taking care of your teeth—all sold at a profit by greedy industrialists—but that's not real healthcare! No way could mere grubby businessmen deliver real healthcare! Healthcare should be untainted by commerce, pure, driven only by faceless bureaucrats with no stake in successful outcomes.

Please. Rail against those greedy capitalists all you like but don't imagine for a moment you can do without them and their filthy profit motive.

So the market created an inefficient, burdensome system to inject middlemen into the delivery of drugs, contrary to previous practice. And this only happened in the last few years. Somehow all those greedy businessmen at both ends of the drug delivery system decided to cut someone else in on their trade. I wonder what miracle of capitalism caused that?

Tell me, what else happened in the last few years? Anything ringing a bell?

*Unless you're a trustafarian whose parents took advantage of that filthy incentive to amass a fortune big enough to free their offspring from the drudgery of toil and invested it—with the goal of making a profit!—to keep you in clothes and computers.
black321

black321 Avatar

Location: An earth without maps
Gender: Male


Posted: Aug 26, 2016 - 12:14pm

 Lazy8 wrote:
 black321 wrote:
The patent process for the injector is an obstacle that's not really addressed for pharmaceuticals (in terms of easing the speed to market for generics).  Regardless, if there were a dozen companies out there providing epinephrine, i dont think that would have moved the price much.  There have been a few alternatives introduced in the last few years (AuviQ product was recalled) but they all raised the price to similar levels, so so much for capitalism.  To me this is another example of not why regulation doesn't work, but bad/ineffective regulation.

p.s. lets not forget the role of the wholesalers, pharmacy benefit managers and retailers in taking their cuts.  Even if Mylan drops the price it charges wholesalers, that wouldnt help consumers...at least not yet...since the price is set between the payor (insurance, medicare...) and the PBM.  The entire US pharmaceutical industry is guilty of price gouging...to subsidize the much more stringent price controls that the rest of the world's govts. place on drugs.  

There probably are a dozen companies providing epinephrine. They aren't providing the delivery device because the FDA regulates them separately so they aren't used to playing in that space.

Competitors are going to try and make as much as they can while they can (assuming the FDA lets them, which so far it's not) so they introduce at a price similar to the existing product. Which then loses market share and cuts price to compensate, which lowers the price. Maybe not instantly, but the mechanism indisputably works. After all, you're typing your argument that capitalism is a failure (or that it failed in this one instance, or that capitalism always fails eventually, or whatever your argument is) into a device once outrageously expensive made affordable by...capitalism.

That whole chain of middlemen exists because we have an FDA and the byzantine regulation of the insurance and medical industries. If you want to pay them less take the product out of their hands: make it available without prescription. Relax the top-down control that makes them necessary. Let capitalism work.

 
The profit motive led Mylan and company to raise prices above a reasonable level.  That is the failure of capitalism.  The regulation failure was in the way the FDA deals with injectors...keeping competitors out of the market. the only winner in all this was the high deductible plan...getting the consumer involved in the cost of their healthcare. 
Obviously if we stripped out the regulations completely, there would be no incentive for cos. to invest billions in new drugs if a generic could be released as soon as a competitor was able to find a way to produce a copy.

p.s.there is no regulation that requires a mfg to sell to a wholesaler, or forbids a retailer to acquire direct from mfg (in fact up until about 2 years ago, most retailers did procure most generics direct from mfg).  The market itself set this up. 
Lazy8

Lazy8 Avatar

Location: The Gallatin Valley of Montana
Gender: Male


Posted: Aug 26, 2016 - 11:57am

 black321 wrote:
The patent process for the injector is an obstacle that's not really addressed for pharmaceuticals (in terms of easing the speed to market for generics).  Regardless, if there were a dozen companies out there providing epinephrine, i dont think that would have moved the price much.  There have been a few alternatives introduced in the last few years (AuviQ product was recalled) but they all raised the price to similar levels, so so much for capitalism.  To me this is another example of not why regulation doesn't work, but bad/ineffective regulation.

p.s. lets not forget the role of the wholesalers, pharmacy benefit managers and retailers in taking their cuts.  Even if Mylan drops the price it charges wholesalers, that wouldnt help consumers...at least not yet...since the price is set between the payor (insurance, medicare...) and the PBM.  The entire US pharmaceutical industry is guilty of price gouging...to subsidize the much more stringent price controls that the rest of the world's govts. place on drugs.  

There probably are a dozen companies providing epinephrine. They aren't providing the delivery device because the FDA regulates them separately so they aren't used to playing in that space.

Competitors are going to try and make as much as they can while they can (assuming the FDA lets them, which so far it's not) so they introduce at a price similar to the existing product. Which then loses market share and cuts price to compensate, which lowers the price. Maybe not instantly, but the mechanism indisputably works. After all, you're typing your argument that capitalism is a failure (or that it failed in this one instance, or that capitalism always fails eventually, or whatever your argument is) into a device once outrageously expensive made affordable by...capitalism.

That whole chain of middlemen exists because we have an FDA and the byzantine regulation of the insurance and medical industries. If you want to pay them less take the product out of their hands: make it available without prescription. Relax the top-down control that makes them necessary. Let capitalism work.
black321

black321 Avatar

Location: An earth without maps
Gender: Male


Posted: Aug 26, 2016 - 11:49am

Basically, I think this issue boils down to the failure of capitalism/free markets and ineffective regulations in health care.
Personally I believe health care is something that shouldn't or can't be left to the markets to figure out.  You can't deny someone health care, so you shouldn't expect them to be outside of the covered lives/insured pool.  Is it really that difficult to design and regulate an effective health care system? 
ScottFromWyoming

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Location: Powell
Gender: Male


Posted: Aug 26, 2016 - 11:38am

 black321 wrote:

Maybe, but I would think for most plans they wouldn't limit how many times you can get a script filled (you can only get stung by a bee 1x a year!?)  I have a high deductible plan and it does not put any limits on how many times i get an epi script filled ( i think one year had the double dose pens filled 3x). 

 
Obviously I have no experience with it, just trying to sort of congeal all the different factors here, and that was one. 
black321

black321 Avatar

Location: An earth without maps
Gender: Male


Posted: Aug 26, 2016 - 11:32am

 ScottFromWyoming wrote:

For a set number per year, usually 2, right? So if you use yours or the ones you got from the pharmacy had already used up half their shelf life and you decided to replace them... the second round in a calendar year might not be covered? 

 
Maybe, but I would think for most plans they wouldn't limit how many times you can get a script filled (you can only get stung by a bee 1x a year!?)  I have a high deductible plan and it does not put any limits on how many times i get an epi script filled ( i think one year had the double dose pens filled 3x). 
ScottFromWyoming

ScottFromWyoming Avatar

Location: Powell
Gender: Male


Posted: Aug 26, 2016 - 11:23am

 black321 wrote:

Even with a high deductible insurance plan, you still pay the lower negotiated price...but you're right, those without insurance pay the highest rate for drugs and doctor care.

 
For a set number per year, usually 2, right? So if you use yours or the ones you got from the pharmacy had already used up half their shelf life and you decided to replace them... the second round in a calendar year might not be covered? 
black321

black321 Avatar

Location: An earth without maps
Gender: Male


Posted: Aug 26, 2016 - 10:45am

 ScottFromWyoming wrote:

 

Somewhere else (maybe here, who knows? ) I read someone saying that pricing for drugs of any stripe are set by pricing it at an astronomical number, then seeing what the insurance will cover. That becomes the sticker price, with the understanding that insurance has already negotiated a rate far below that number so when they say "we'll pay $600" it means "we'll pay $100 and you'll write off the balance" but someone without insurance, or with a $5000 deductible, will pay the full $600. And Mylan just blamed consumers for having those high deductible plans because otherwise they wouldn't even see the cost and there wouldn't be any complaints and they'd have had a carefree August. And they blamed insurance companies for something too I couldn't follow the logic so it's left me.

 
Even with a high deductible insurance plan, you still pay the lower negotiated price...but you're right, those without insurance pay the highest rate for drugs and doctor care. 
The high deductible plans are great way to get costs down, by bringing the consumer back into the pricing decision...and as we see here, it is working.
As I noted below, the insurance company sets the price for drugs with the pharmacy benefit manager...thats what the Mylan CEO was attempting to explain. 
ScottFromWyoming

ScottFromWyoming Avatar

Location: Powell
Gender: Male


Posted: Aug 26, 2016 - 10:38am

 Lazy8 wrote:
SchottFromWyoming wrote:
The EpiPen is a $300 device that delivers $1 worth of medicine; if you're okay with sticking yourself, you can just do that. If you're okay with 1970s tech, there are other autoinjectors available that are still expensive but not nearly as bad as EpiPens. Your Dr. just needs to prescribe "epinephrine .3ml" instead of "EpiPen" and the pharmacist can provide whatever you're most comfortable with. EpiPens are great because I can probably stick you successfully, even though I practice with a dummy device about once every two years. The older ones are more complicated and success on a thrashing patient is less assured. But people who truly have a life-threatening allergy are probably fine with the older generic autoinjector as they're likely to practice with the dummy device at least monthly, about the amount of time experts say is necessary to keep skills up. Others (diabetics?)(pet/animal owners who inject animals routinely) may be just fine with a vial of epinephrine and a standard syringe. Time is of the essence, though, and people aren't likely to carry those everywhere.

But as I understand it, and I'm probably wrong, part of the problem here is patents. This isn't a case of getting a drug thru a lot of trials, it's just a company making hay until their patent expires in 2025. The FDA still has an interest in making sure alternatives/generics are a straight-across equivalent to the brand name product, so new autoinjectors that try to skirt the patent are probably not going to fly. Maybe someone will be able to come up with a better system that doesn't infringe, but they'll just patent that and do the same thing, right?

Kinda.

I used to design medical products. We frequently were given a challenge of getting around a patent to design a competitive product. In ten years of doing it we never failed once.

The patent is an obstacle but it's one that can be overcome. The obstacle you can't overcome without very deep pockets behind you is the FDA. Your new product will need approvals. If it is similar enough to already-approved products (a somewhat subjective call made by the FDA) you get to go thru a much less laborious process called 510(k) where you get to piggyback on the clinical trials of your competitors, otherwise you face years of clinical trials. Very expensive years in which the investment you've made in product R&D is earning you less than nothing.

It's also frozen—no changes until you get approval. Which means new manufacturing technology or better detail design has to wait until the FDA clears your first shot at it. And oy have I seen some horrible design frozen in amber like that. But I digress.

As a teenager I used to carry a two-shot epinephrine syringe with me for a beesting allergy decades before the EpiPen. Never had to use it but I'm sure I could have. The EpiPen is a great advance, but it should be a $25 product. It isn't—when CD players and cars and cell phones (vastly more complex products) are cheaper every day—because the FDA has the manufacturer's back. Once you get past the hoops they make you jump thru you're in the club and big brother will keep the public safe from your competition.

 
 

Somewhere else (maybe here, who knows? ) I read someone saying that pricing for drugs of any stripe are set by pricing it at an astronomical number, then seeing what the insurance will cover. That becomes the sticker price, with the understanding that insurance has already negotiated a rate far below that number so when they say "we'll pay $600" it means "we'll pay $100 and you'll write off the balance" but someone without insurance, or with a $5000 deductible, will pay the full $600. And Mylan just blamed consumers for having those high deductible plans because otherwise they wouldn't even see the cost and there wouldn't be any complaints and they'd have had a carefree August. And they blamed insurance companies for something too I couldn't follow the logic so it's left me.
black321

black321 Avatar

Location: An earth without maps
Gender: Male


Posted: Aug 26, 2016 - 10:12am

 Lazy8 wrote:
SchottFromWyoming wrote:
The EpiPen is a $300 device that delivers $1 worth of medicine; if you're okay with sticking yourself, you can just do that. If you're okay with 1970s tech, there are other autoinjectors available that are still expensive but not nearly as bad as EpiPens. Your Dr. just needs to prescribe "epinephrine .3ml" instead of "EpiPen" and the pharmacist can provide whatever you're most comfortable with. EpiPens are great because I can probably stick you successfully, even though I practice with a dummy device about once every two years. The older ones are more complicated and success on a thrashing patient is less assured. But people who truly have a life-threatening allergy are probably fine with the older generic autoinjector as they're likely to practice with the dummy device at least monthly, about the amount of time experts say is necessary to keep skills up. Others (diabetics?)(pet/animal owners who inject animals routinely) may be just fine with a vial of epinephrine and a standard syringe. Time is of the essence, though, and people aren't likely to carry those everywhere.

But as I understand it, and I'm probably wrong, part of the problem here is patents. This isn't a case of getting a drug thru a lot of trials, it's just a company making hay until their patent expires in 2025. The FDA still has an interest in making sure alternatives/generics are a straight-across equivalent to the brand name product, so new autoinjectors that try to skirt the patent are probably not going to fly. Maybe someone will be able to come up with a better system that doesn't infringe, but they'll just patent that and do the same thing, right?

Kinda.

I used to design medical products. We frequently were given a challenge of getting around a patent to design a competitive product. In ten years of doing it we never failed once.

The patent is an obstacle but it's one that can be overcome. The obstacle you can't overcome without very deep pockets behind you is the FDA. Your new product will need approvals. If it is similar enough to already-approved products (a somewhat subjective call made by the FDA) you get to go thru a much less laborious process called 510(k) where you get to piggyback on the clinical trials of your competitors, otherwise you face years of clinical trials. Very expensive years in which the investment you've made in product R&D is earning you less than nothing.

It's also frozen—no changes until you get approval. Which means new manufacturing technology or better detail design has to wait until the FDA clears your first shot at it. And oy have I seen some horrible design frozen in amber like that. But I digress.

As a teenager I used to carry a two-shot epinephrine syringe with me for a beesting allergy decades before the EpiPen. Never had to use it but I'm sure I could have. The EpiPen is a great advance, but it should be a $25 product. It isn't—when CD players and cars and cell phones (vastly more complex products) are cheaper every day—because the FDA has the manufacturer's back. Once you get past the hoops they make you jump thru you're in the club and big brother will keep the public safe from your competition.

 
The patent process for the injector is an obstacle that's not really addressed for pharmaceuticals (in terms of easing the speed to market for generics).  Regardless, if there were a dozen companies out there providing epinephrine, i dont think that would have moved the price much.  There have been a few alternatives introduced in the last few years (AuviQ product was recalled) but they all raised the price to similar levels, so so much for capitalism.  To me this is another example of not why regulation doesn't work, but bad/ineffective regulation.

p.s. lets not forget the role of the wholesalers, pharmacy benefit managers and retailers in taking their cuts.  Even if Mylan drops the price it charges wholesalers, that wouldnt help consumers...at least not yet...since the price is set between the payor (insurance, medicare...) and the PBM.  The entire US pharmaceutical industry is guilty of price gouging...to subsidize the much more stringent price controls that the rest of the world's govts. place on drugs. 


Lazy8

Lazy8 Avatar

Location: The Gallatin Valley of Montana
Gender: Male


Posted: Aug 26, 2016 - 9:42am

SchottFromWyoming wrote:
The EpiPen is a $300 device that delivers $1 worth of medicine; if you're okay with sticking yourself, you can just do that. If you're okay with 1970s tech, there are other autoinjectors available that are still expensive but not nearly as bad as EpiPens. Your Dr. just needs to prescribe "epinephrine .3ml" instead of "EpiPen" and the pharmacist can provide whatever you're most comfortable with. EpiPens are great because I can probably stick you successfully, even though I practice with a dummy device about once every two years. The older ones are more complicated and success on a thrashing patient is less assured. But people who truly have a life-threatening allergy are probably fine with the older generic autoinjector as they're likely to practice with the dummy device at least monthly, about the amount of time experts say is necessary to keep skills up. Others (diabetics?)(pet/animal owners who inject animals routinely) may be just fine with a vial of epinephrine and a standard syringe. Time is of the essence, though, and people aren't likely to carry those everywhere.

But as I understand it, and I'm probably wrong, part of the problem here is patents. This isn't a case of getting a drug thru a lot of trials, it's just a company making hay until their patent expires in 2025. The FDA still has an interest in making sure alternatives/generics are a straight-across equivalent to the brand name product, so new autoinjectors that try to skirt the patent are probably not going to fly. Maybe someone will be able to come up with a better system that doesn't infringe, but they'll just patent that and do the same thing, right?

Kinda.

I used to design medical products. We frequently were given a challenge of getting around a patent to design a competitive product. In ten years of doing it we never failed once.

The patent is an obstacle but it's one that can be overcome. The obstacle you can't overcome without very deep pockets behind you is the FDA. Your new product will need approvals. If it is similar enough to already-approved products (a somewhat subjective call made by the FDA) you get to go thru a much less laborious process called 510(k) where you get to piggyback on the clinical trials of your competitors, otherwise you face years of clinical trials. Very expensive years in which the investment you've made in product R&D is earning you less than nothing.

It's also frozen—no changes until you get approval. Which means new manufacturing technology or better detail design has to wait until the FDA clears your first shot at it. And oy have I seen some horrible design frozen in amber like that. But I digress.

As a teenager I used to carry a two-shot epinephrine syringe with me for a beesting allergy decades before the EpiPen. Never had to use it but I'm sure I could have. The EpiPen is a great advance, but it should be a $25 product. It isn't—when CD players and cars and cell phones (vastly more complex products) are cheaper every day—because the FDA has the manufacturer's back. Once you get past the hoops they make you jump thru you're in the club and big brother will keep the public safe from your competition.
ScottFromWyoming

ScottFromWyoming Avatar

Location: Powell
Gender: Male


Posted: Aug 26, 2016 - 8:36am

 miamizsun wrote:
looks like we've got another Shkreli moment

but why?

does evidence take precedence over politically induced conditioning, ignorance and stupidity?

Don’t Blame Capitalism for Your Pricey EpiPen

 

In South Park: Bigger, Longer, and Uncut, offensive television characters Terrance and Phillip inspire moral indignation within a small Colorado town, sparking a movement of outraged parents who actively organize to censor the actors. Rather than focusing their energy on the individuals in question, the parents launch into an over-the-top campaign (complete with song and dance) targeting the entire country of Canada, where Terrance and Phillip live. Their crusade to “Blame Canada” drives the plotline to equally comedic and ridiculous lengths.

We have a similar short fuse in the United States. Though we don’t launch into full-scale invasions of our quiet northerly neighbors (at least, not yet), many Americans tend to miss the mark when attributing blame for our largest problems and woes. This propensity of impugning ideological strawmen usually places capitalism in the crosshairs of America’s most outraged.

On This Episode of “Blame Capitalism”: The EpiPen

One doesn’t have to look far from today’s headlines to see this pattern. The latest controversy: the price of the EpiPen – Mylan’s famous medical auto-injector that delivers an immediate and measured dose of epinephrine – recently skyrocketed 400%, causing an uproar amongst 3.6 million people who depend upon the prescribed product. For those who live in fear of anaphylactic shock, the cost of living quite literally went up.

 

But surely a new business will take advantage of this public relations debacle, enter the market, and offer a more affordable option, right?

From the time this bill was introduced to the date it was signed by Obama, Mylan’s stock was up nearly 20%.

Unfortunately – and as no surprise to libertarians and free market advocates – federal regulators continue to buffer the padding that surrounds Mylan’s monopoly. Shortly after the Auvi-Q recall, Teva Pharmaceutical Industries pitched a generic version of the EpiPen. However, the Food and Drug Administration (FDA) squashed their efforts, citing “major deficiencies” in their application. Teva plans to appeal the decision, but won’t be able to effectively move forward until 2017 at the earliest.

Teva isn’t alone in this struggle. Windgap Medical, a Boston startup, and Adamis, a small biotech firm based in San Diego, have both struggled to bypass FDA’s barriers of entry in the marketplace as well.

If you need further convincing that the FDA impedes the market, consider the following:

  • The average time it takes for a drug to go from the lab to the medicine cabinet is 12 years
  • Only 1 in 5,000 new drugs will make it through the FDA approval
  • Based on the regulatory burden of creating new medicine, the average price tag for research and development for a new compound is $2.6 billion

So, no, Bernie – it isn’t always just a “few dollars” to produce a pharmaceutical product. The price tag of producing that “first pill” is often steep.

An Unironic “Thanks Obama”

Those companies who “paid to play” are providing a textbook example of crony capitalism, not free market capitalism.

Mylan’s monopoly was also bolstered by the White House. In 2013, President Obama signed into law the School Access to Emergency Epinephrine Act. The program incentivizes the school system to stockpile EpiPens by dangling the carrot of federal grant monies in front of financially beleaguered school districts. From the time this bill was introduced to the date it was signed by Obama, Mylan’s stock was up nearly 20%.

But this little piece of legislation pales in comparison to the benefit doled out by the Affordable Care Act. Following Obamacare’s codification, net spending on prescription drugs increased nearly 20%. Meanwhile, the pharmaceutical industry experienced a renaissance era of whirlwind profits: estimates of profits over the next decade range from $10 billion to $35 billion – a hefty door prize for the industry lobbyists who crafted the ACA legislation.

The EpiPen is not a microcosm; the cost of other prescription drugs are also on the rise. A House of Representatives report found that ten different drugs experienced even larger price hikes, starting as low as 420% and as high as 8,000%.

Considering the scope of government intervention in this specific marketplace, rather than blaming the free market for this controversy, a more appropriate response would be “what free market?” And now, lawmakers are ironically “demanding answers” from Mylan. If forced to speak in front of a Congressional panel and asked what inspired this price hike, Bresch and company should be encouraged to hold up a mirror to lawmakers’ faces.

 

 

more



 
The EpiPen is a $300 device that delivers $1 worth of medicine; if you're okay with sticking yourself, you can just do that. If you're okay with 1970s tech, there are other autoinjectors available that are still expensive but not nearly as bad as EpiPens. Your Dr. just needs to prescribe "epinephrine .3ml" instead of "EpiPen" and the pharmacist can provide whatever you're most comfortable with. EpiPens are great because I can probably stick you successfully, even though I practice with a dummy device about once every two years. The older ones are more complicated and success on a thrashing patient is less assured. But people who truly have a life-threatening allergy are probably fine with the older generic autoinjector as they're likely to practice with the dummy device at least monthly, about the amount of time experts say is necessary to keep skills up. Others (diabetics?)(pet/animal owners who inject animals routinely) may be just fine with a vial of epinephrine and a standard syringe. Time is of the essence, though, and people aren't likely to carry those everywhere.

But as I understand it, and I'm probably wrong, part of the problem here is patents. This isn't a case of getting a drug thru a lot of trials, it's just a company making hay until their patent expires in 2025. The FDA still has an interest in making sure alternatives/generics are a straight-across equivalent to the brand name product, so new autoinjectors that try to skirt the patent are probably not going to fly. Maybe someone will be able to come up with a better system that doesn't infringe, but they'll just patent that and do the same thing, right? 
miamizsun

miamizsun Avatar

Location: (3261.3 Miles SE of RP)
Gender: Male


Posted: Aug 26, 2016 - 7:17am

looks like we've got another Shkreli moment

but why?

does evidence take precedence over politically induced conditioning, ignorance and stupidity?

Don’t Blame Capitalism for Your Pricey EpiPen

 

In South Park: Bigger, Longer, and Uncut, offensive television characters Terrance and Phillip inspire moral indignation within a small Colorado town, sparking a movement of outraged parents who actively organize to censor the actors. Rather than focusing their energy on the individuals in question, the parents launch into an over-the-top campaign (complete with song and dance) targeting the entire country of Canada, where Terrance and Phillip live. Their crusade to “Blame Canada” drives the plotline to equally comedic and ridiculous lengths.

We have a similar short fuse in the United States. Though we don’t launch into full-scale invasions of our quiet northerly neighbors (at least, not yet), many Americans tend to miss the mark when attributing blame for our largest problems and woes. This propensity of impugning ideological strawmen usually places capitalism in the crosshairs of America’s most outraged.

On This Episode of “Blame Capitalism”: The EpiPen

One doesn’t have to look far from today’s headlines to see this pattern. The latest controversy: the price of the EpiPen – Mylan’s famous medical auto-injector that delivers an immediate and measured dose of epinephrine – recently skyrocketed 400%, causing an uproar amongst 3.6 million people who depend upon the prescribed product. For those who live in fear of anaphylactic shock, the cost of living quite literally went up.

 

But surely a new business will take advantage of this public relations debacle, enter the market, and offer a more affordable option, right?

From the time this bill was introduced to the date it was signed by Obama, Mylan’s stock was up nearly 20%.

Unfortunately – and as no surprise to libertarians and free market advocates – federal regulators continue to buffer the padding that surrounds Mylan’s monopoly. Shortly after the Auvi-Q recall, Teva Pharmaceutical Industries pitched a generic version of the EpiPen. However, the Food and Drug Administration (FDA) squashed their efforts, citing “major deficiencies” in their application. Teva plans to appeal the decision, but won’t be able to effectively move forward until 2017 at the earliest.

Teva isn’t alone in this struggle. Windgap Medical, a Boston startup, and Adamis, a small biotech firm based in San Diego, have both struggled to bypass FDA’s barriers of entry in the marketplace as well.

If you need further convincing that the FDA impedes the market, consider the following:

  • The average time it takes for a drug to go from the lab to the medicine cabinet is 12 years
  • Only 1 in 5,000 new drugs will make it through the FDA approval
  • Based on the regulatory burden of creating new medicine, the average price tag for research and development for a new compound is $2.6 billion

So, no, Bernie – it isn’t always just a “few dollars” to produce a pharmaceutical product. The price tag of producing that “first pill” is often steep.

An Unironic “Thanks Obama”

Those companies who “paid to play” are providing a textbook example of crony capitalism, not free market capitalism.

Mylan’s monopoly was also bolstered by the White House. In 2013, President Obama signed into law the School Access to Emergency Epinephrine Act. The program incentivizes the school system to stockpile EpiPens by dangling the carrot of federal grant monies in front of financially beleaguered school districts. From the time this bill was introduced to the date it was signed by Obama, Mylan’s stock was up nearly 20%.

But this little piece of legislation pales in comparison to the benefit doled out by the Affordable Care Act. Following Obamacare’s codification, net spending on prescription drugs increased nearly 20%. Meanwhile, the pharmaceutical industry experienced a renaissance era of whirlwind profits: estimates of profits over the next decade range from $10 billion to $35 billion – a hefty door prize for the industry lobbyists who crafted the ACA legislation.

The EpiPen is not a microcosm; the cost of other prescription drugs are also on the rise. A House of Representatives report found that ten different drugs experienced even larger price hikes, starting as low as 420% and as high as 8,000%.

Considering the scope of government intervention in this specific marketplace, rather than blaming the free market for this controversy, a more appropriate response would be “what free market?” And now, lawmakers are ironically “demanding answers” from Mylan. If forced to speak in front of a Congressional panel and asked what inspired this price hike, Bresch and company should be encouraged to hold up a mirror to lawmakers’ faces.

 

 

more


Lazy8

Lazy8 Avatar

Location: The Gallatin Valley of Montana
Gender: Male


Posted: Dec 22, 2015 - 11:37am

 aflanigan wrote:
An interesting admission from a self-proclaimed libertarian.{#Wink}

More of an accusation.

Whenever interventions in an economy create perverse incentives the economy itself seems to get the blame rather than the interventions.
aflanigan

aflanigan Avatar

Location: At Sea
Gender: Male


Posted: Dec 22, 2015 - 9:07am

 Lazy8 wrote:
 Steely_D wrote:
Folks are upset with Shkreli, but what he was did with drug prices was merely capitalism: supply/demand/profit.

Would people prefer a different model? Government controlled price limits or other interventions?

This isn't what I've been reading on the hyper conservative pages. It's mostly "free market" this or that. Well, this is what free market looks like.

An anything-but-free market.

 
An interesting admission from a self-proclaimed libertarian.{#Wink}
black321

black321 Avatar

Location: An earth without maps
Gender: Male


Posted: Dec 22, 2015 - 6:50am

 miamizsun wrote:
this may help...


 
re. free markets...like many other effective strategies that could alleviate our ills, we are likely beyond the point of no return...that is, unless there is new technology that can disrupt the current infrastructure. 
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