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Bevo

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7 minutes ago, Chopper said:

But yes of course the pharmaceutical co is going to try to extend their patent. Typically based on a illusory improvement in the medication.

That's not the basis for a patent term extension. https://www.law.cornell.edu/uscode/text/35/156  Such extensions are based on the length of the regulatory review period.

The "illusory improvement" game was effectively ended in 1996.

 

Edited by TwiceHorn
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1 minute ago, TwiceHorn said:

That's not the basis for a patent term extension. https://www.law.cornell.edu/uscode/text/35/156

The "illusory improvement" game was effectively ended in 1996.

 

Certainly. But you may not be aware that patent thickets, mentioned in a post above, have replaced the direct application for an extension - the improvements are still just as illusory and bogus, they're just using a circuitous route to obtain patent extensions. 

I-Mak, an organization that works for patent reform and healthcare equity, put out this report in 2022 (pdf) https://www.i-mak.org/wp-content/uploads/2022/09/Overpatented-Overpriced-2022-FINAL.pdf Each medication will have multiple dozens of patents. The top-sellers in 2022 had an average of 74 patents on it - for just one medication. 2/3 of the patents were filed for AFTER the med was on the market. That's a patent thicket. Those companies are desperate to protect the huge revenue streams that exist because of their monopolies. We're talking $24 million per day of revenue. In Europe, where the laws are much more consumer friendly, patent thickets are not as prevalent and as a result of that, they have more generic medications on the market competing with the most popular medications.   

Also, if you're a company that's about to come out with a generic version of any medication that's been on-patent, especially in the US, get ready to be sued for hundreds of millions of dollars. It's a huge impediment to market and huge cost of doing business, because pharma co's has been stuffing their pockets for years off monopolistic prices, and can pay endless litigation.

 

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2 hours ago, Chopper said:

If there are 10 different people in line at a pharmacy each with a script for the same medication, all 10 will pay a different price depending on their insurer and their particular plan. It's worse than airlines because there's zero transparency. We haven't even touched on the evil-ness of the drug formulary scam.

Doctors have zero ability to quickly determine the cost of any one patients prescription. Out of curiosity I checked my health plan/PBM and Minocycline (whatever that is) 100mg tablet are listed at $22 for 90 days mail order.  Never hurts to research alternative pricing and ask ChatGPT for alternatives if the price is too high. Then send a message to the doctor to switch up if they’re in agreement.

obviously sometimes drugs are time sensitive and then you just need to go with whatever options you have.

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10 minutes ago, Nice Guy Eddie said:

Doctors have zero ability to quickly determine the cost of any one patients prescription. Out of curiosity I checked my health plan/PBM and Minocycline (whatever that is) 100mg tablet are listed at $22 for 90 days mail order.  Never hurts to research alternative pricing and ask ChatGPT for alternatives if the price is too high. Then send a message to the doctor to switch up if they’re in agreement.

obviously sometimes drugs are time sensitive and then you just need to go with whatever options you have.

I don't think I even implied they do, let alone stated it as a truth. In the example you quoted doctors weren't even a part of it. The discussion about price variations came about because of the way health insurers, their PBMs, and pharmaceutical companies conspire to gouge consumers.

edit to add - the example I used of 10 different people at the pharmacy for the same med was specific to illustrate the lack of transparency. Most people won't know how much their medication will cost until after the pharmacy fulfills it. That's why it's good to know about GoodRX but it comes with some negatives to the individual and huge positives to the insurer. Depending on your plan and the med, GoodRX may be lower than your co-pay amount, but Cuban's pharmacy is usually less expensive than GoodRX if a patient has the time to deal with it. 

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59 minutes ago, Chopper said:

the example I used of 10 different people at the pharmacy for the same med was specific to illustrate the lack of transparency. Most people won't know how much their medication will cost until after the pharmacy fulfills it.

This is also the case for basically any medical or doctor or hospital care. They have no idea what it'll cost because it basically just matters what they code it as. And if you disagree with the coding, you can go get bent

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9 hours ago, Bevo said:


Insulin basically comes from three manufacturers who keep prices high. They have switched the market from less expensive human and animal insulins to more expensive insulin analogs.
 

I’m not going to speak for all T1Ds but I’ve been one for 38 years.

The animal and human insulins work reasonably well if you aren’t what I call “brittle”.

Up until I hit 30, I could feel my blood sugar drop before hypoglycemia took hold. I was on human insulin through that time. There’s two categories of insulin: short acting and long acting. The short acting human insulin made low blood sugar episodes happen pretty frequently for me once I hit thirty. I became brittle where I couldn’t fight it off and had severe episodes where I woke up in the hospital a couple of times, other times where the wife had to call paramedics.

The short acting analog I take (lispro) doesn’t have that same effect.

I’d likely be dead without the short acting analog. Seriously. I’ve had several episodes where I was entirely alone and fighting as my brain was shutting down to get a candy bar.

I rail on the price of insulin a lot on surly. But I will be the first to thank pharma companies for the advances they’ve made with insulin since those Canadians first extracted it from pigs’ pancreases 100 years ago.

I think pharma companies should get a good return on their R&D and production. I don’t think putting the same insulin in a pen rather than a vile warrants a new patent. Gimme an old fashioned vile and syringe, and I’m good.

Counterpoint: there’s this guy

IMG_2016.thumb.jpeg.53b8405b89af6f9a637b314952101a93.jpeg

 

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3 hours ago, Chopper said:

Certainly. But you may not be aware that patent thickets, mentioned in a post above, have replaced the direct application for an extension - the improvements are still just as illusory and bogus, they're just using a circuitous route to obtain patent extensions. 

I-Mak, an organization that works for patent reform and healthcare equity, put out this report in 2022 (pdf) https://www.i-mak.org/wp-content/uploads/2022/09/Overpatented-Overpriced-2022-FINAL.pdf Each medication will have multiple dozens of patents. The top-sellers in 2022 had an average of 74 patents on it - for just one medication. 2/3 of the patents were filed for AFTER the med was on the market. That's a patent thicket. Those companies are desperate to protect the huge revenue streams that exist because of their monopolies. We're talking $24 million per day of revenue. In Europe, where the laws are much more consumer friendly, patent thickets are not as prevalent and as a result of that, they have more generic medications on the market competing with the most popular medications.   

Also, if you're a company that's about to come out with a generic version of any medication that's been on-patent, especially in the US, get ready to be sued for hundreds of millions of dollars. It's a huge impediment to market and huge cost of doing business, because pharma co's has been stuffing their pockets for years off monopolistic prices, and can pay endless litigation.

 

Of course I'm aware of patent thickets, I do this for a living.   The patents in a thicket all expire on the same day

One of the main things driving the US problem with generics is that filing an ANDA is considered an act of infringement, so a potential generic doesn't have to be made, used or sold in the US (the usual acts of infringement) before a patent owner can sue.  Otherwise, a generic manufacturer could be approved and ready to sell on patent expiration, but not here.

That's not applicable to any other kind of patent.  It's the result of pharma lobbying.

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39 minutes ago, Captainant said:

This is also the case for basically any medical or doctor or hospital care. They have no idea what it'll cost because it basically just matters what they code it as. And if you disagree with the coding, you can go get bent

 

The code is more rules than what you just call guidelines.

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31 minutes ago, GenXer said:

I’m not going to speak for all T1Ds but I’ve been one for 38 years.

The animal and human insulins work reasonably well if you aren’t what I call “brittle”.

Up until I hit 30, I could feel my blood sugar drop before hypoglycemia took hold. I was on human insulin through that time. There’s two categories of insulin: short acting and long acting. The short acting human insulin made low blood sugar episodes happen pretty frequently for me once I hit thirty. I became brittle where I couldn’t fight it off and had severe episodes where I woke up in the hospital a couple of times, other times where the wife had to call paramedics.

The short acting analog I take (lispro) doesn’t have that same effect.

I’d likely be dead without the short acting analog. Seriously. I’ve had several episodes where I was entirely alone and fighting as my brain was shutting down to get a candy bar.

I rail on the price of insulin a lot on surly. But I will be the first to thank pharma companies for the advances they’ve made with insulin since those Canadians first extracted it from pigs’ pancreases 100 years ago.

I think pharma companies should get a good return on their R&D and production. I don’t think putting the same insulin in a pen rather than a vile warrants a new patent. Gimme an old fashioned vile and syringe, and I’m good.

Counterpoint: there’s this guy

IMG_2016.thumb.jpeg.53b8405b89af6f9a637b314952101a93.jpeg

 

That dude is vial.

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39 minutes ago, GenXer said:

I’m not going to speak for all T1Ds but I’ve been one for 38 years.

The animal and human insulins work reasonably well if you aren’t what I call “brittle”.

Up until I hit 30, I could feel my blood sugar drop before hypoglycemia took hold. I was on human insulin through that time. There’s two categories of insulin: short acting and long acting. The short acting human insulin made low blood sugar episodes happen pretty frequently for me once I hit thirty. I became brittle where I couldn’t fight it off and had severe episodes where I woke up in the hospital a couple of times, other times where the wife had to call paramedics.

The short acting analog I take (lispro) doesn’t have that same effect.

I’d likely be dead without the short acting analog. Seriously. I’ve had several episodes where I was entirely alone and fighting as my brain was shutting down to get a candy bar.

I rail on the price of insulin a lot on surly. But I will be the first to thank pharma companies for the advances they’ve made with insulin since those Canadians first extracted it from pigs’ pancreases 100 years ago.

I think pharma companies should get a good return on their R&D and production. I don’t think putting the same insulin in a pen rather than a vile warrants a new patent. Gimme an old fashioned vile and syringe, and I’m good.

Counterpoint: there’s this guy

IMG_2016.thumb.jpeg.53b8405b89af6f9a637b314952101a93.jpeg

 

Just for the record, it is not the combination of any old syringe with the pharmaceutical composition that makes it patentable.  The syringes have special features that are unique to the composition in question, or to the type of patient or some such.  It's really just a patent on an insulin syringe or applicator.

And infringement is easily avoided by selling the composition/drug in a vial, as you note.  But there are some strange things going on in pharma where it seems only single-use syringes get prescribed and the vial gets left out.

It is interesting to know that the analogs are an actual improvement on straight insulin.  I should say very interesting in that it has improved your outcome.  

In the patent game more broadly, there are patented improvements that aren't really improvements, but various anomalies give them the market reception of a massive improvement.  I'm not actually aware of many of those in blockbuster or important drugs, other than the syringe-type scenario, which I guess is like prescribing the branded over the generic, but dialed to 11.

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Just now, GenXer said:

Lulz. I think I had a freudian slip as I started thinking about shkreli as I was finishing with the vial and syringe thought.

Shkreli didn't even deal in patented drugs.  His gambit was "orphan drugs." https://en.wikipedia.org/wiki/Orphan_drug  The key passage there is this:

Under the ODA orphan drug sponsors qualify for seven-year FDA-administered market Orphan Drug Exclusivity (ODE), "tax credits of up to 50% of R&D costs, R&D grants, waived FDA fees, protocol assistance[10]: 660  and may get clinical trial tax incentives.[13]

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8 minutes ago, TwiceHorn said:

.

It is interesting to know that the analogs are an actual improvement on straight insulin.  I should say very interesting in that it has improved your outcome.  

 

When I first became a T1D, I was told by doctors that there were insulin resistant T1Ds. Meaning their bodies rejected the pork and human insulin. Death was imminent.

The analogs work better for insulin resistant T1Ds. The improvements over my lifetime are significant.

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2 hours ago, Captainant said:

This is also the case for basically any medical or doctor or hospital care. They have no idea what it'll cost because it basically just matters what they code it as. And if you disagree with the coding, you can go get bent

No, you tell them to go get bent. Everything is negotiable. Including your medical expenses. Works best with hospitals and device charges in my experience. You have no leverage at the pharmacy counter. 

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2 hours ago, TwiceHorn said:

Of course I'm aware of patent thickets, I do this for a living.   The patents in a thicket all expire on the same day

Well then you know the point isn't necessarily the date they expire. It's the barrier that having to litigate over potentially 80 or more patents for one medication presents to potential competitors.

Edited by Chopper
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I’m late to this particular party, but when a novel drug costs 100 million dollars to go from early molecule screening to pre-clinical development to regulatory agency submission to phase 1-3 trials to commercial, and say there’s a 100k patient pool annually that need it (a very aggressive number), and they have a patent window to get their money back, how much should be charged per dose?  
understanding that for every drug that gets to market at 100mm price tag there are several that are abandoned at some point during the process for things like lack of clinical signal that have run up a multimillion dollar bill.

what incentivizes these companies to continue researching?

and- if a cheap drug works as well or almost as well as an expensive one, then yes the cheap drug should be prescribed in most cases. 

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54 minutes ago, Anastasis said:

No, you tell them to go get bent. Everything is negotiable. Including your medical expenses. Works best with hospitals and device charges in my experience. You have no leverage at the pharmacy counter. 

there are people and companies that specialize in auditing medical charges for reasonableness.  You do not have to pay for the $10 aspirin or $10 box of Kleenex.   Of course they will try to intentionally fuck you, and while you cannot avoid the fucking, you can slightly affect change in the length and the lube

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10 minutes ago, Pato del Muerto said:

and- if a cheap drug works as well or almost as well as an expensive one, then yes the cheap drug should be prescribed in most cases. 

But this is not how our system works. Drug companies should be required to stand their innovations up against the standard of care during the authorization process. We figure out what works and what doesn't and what the incremental cost effectiveness is. Innovation is good and we should reward it. But you need the model inputs.  

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4 minutes ago, Anastasis said:

But this is not how our system works. Drug companies should be required to stand their innovations up against the standard of care during the authorization process. We figure out what works and what doesn't and what the incremental cost effectiveness is. Innovation is good and we should reward it. But you need the model inputs.  

Clinical results of novel drugs are absolutely compared with those from current standard of care.  Pharma wants those because they want them to show a statistically significant improvement so their move drug becomes the new standard of care. 

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Just now, Pato del Muerto said:

Clinical results of novel drugs are absolutely compared with those from current standard of care.  Pharma wants those because they want them to show a statistically significant improvement so their move drug becomes the new standard of care. 

This is not the guidance from the FDA. And drug companies absolutely do not want their novel drugs compared to standard of care on an equal footing. 

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11 hours ago, Chopper said:

Well then you know the point isn't necessarily the date they expire. It's the barrier that having to litigate over potentially 80 or more patents for one medication presents to potential competitors.

Well, that's not usually the reality.  It is true that pharma milks the living shit out of the patent system and every other legal/regulatory regime applicable to them.

But, in almost every patent thicket, it boils down to a relatively small handful of patents that have competitive value, and those tend to be focused on the actual technological merit of the invention, rather than some peripheral, possibly trivial bullshit.

If you drill down on any of the alleged patent thickets, you'll find that there are usually fewer than 10 patents, in one country, at least, that are enforcing the monopoly.

And, expiration dates matter.  Tremendously.  It doesn't matter how many patents cover something if they all expire on the same day:  they're off-patent on that day.

And, generic manufacturers aren't helpless.  They're as sophisticated as the "innovators," but lack the leg up that innovation confers.  They are frequently in pari delicto with the innovators in taking ANDA infringement settlements that pay them to hold off pursuing valid claims until patent expiration or some other event.  In many cases, a "generic" on one drug will be "brand" or innovator on another.  

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36 minutes ago, TwiceHorn said:

Well, that's not usually the reality.  It is true that pharma milks the living shit out of the patent system and every other legal/regulatory regime applicable to them.

But, in almost every patent thicket, it boils down to a relatively small handful of patents that have competitive value, and those tend to be focused on the actual technological merit of the invention, rather than some peripheral, possibly trivial bullshit.

If you drill down on any of the alleged patent thickets, you'll find that there are usually fewer than 10 patents, in one country, at least, that are enforcing the monopoly.

And, expiration dates matter.  Tremendously.  It doesn't matter how many patents cover something if they all expire on the same day:  they're off-patent on that day.

And, generic manufacturers aren't helpless.  They're as sophisticated as the "innovators," but lack the leg up that innovation confers.  They are frequently in pari delicto with the innovators in taking ANDA infringement settlements that pay them to hold off pursuing valid claims until patent expiration or some other event.  In many cases, a "generic" on one drug will be "brand" or innovator on another.  

So there's little or no patent abuse by pharma and their monopolies shouldn't really bother us...do I correctly understand what you're saying?

Here's an NIH study. It's a few years old and the data is only through 2018, but pharma profitability has only increased since then. https://pmc.ncbi.nlm.nih.gov/articles/PMC7054843/

image.thumb.png.8e4da86597f1bcce89dc4d856903286f.png

Here's another NIH study, this one's from 2020

image.thumb.png.7d03cc1141931871a93e2faeea24786f.png

image.thumb.png.0d4b95ed4e683bdab4fe0db4aba1210e.png

and here's their recommendations for reform from 4 years ago

image.thumb.png.4e64d078c6b74885bc5b46b27323fcd0.png

https://pmc.ncbi.nlm.nih.gov/articles/PMC7311400/

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1 hour ago, Chopper said:

So there's little or no patent abuse by pharma and their monopolies shouldn't really bother us...do I correctly understand what you're saying?

Here's an NIH study. It's a few years old and the data is only through 2018, but pharma profitability has only increased since then. https://pmc.ncbi.nlm.nih.gov/articles/PMC7054843/

image.thumb.png.8e4da86597f1bcce89dc4d856903286f.png

Here's another NIH study, this one's from 2020

image.thumb.png.7d03cc1141931871a93e2faeea24786f.png

image.thumb.png.0d4b95ed4e683bdab4fe0db4aba1210e.png

and here's their recommendations for reform from 4 years ago

image.thumb.png.4e64d078c6b74885bc5b46b27323fcd0.png

https://pmc.ncbi.nlm.nih.gov/articles/PMC7311400/

I never said any of that.  I find the patent analyses of outfits like I-Mak to be rather facile, however.

The patent system as applied to pharma has some peculiarities that are not generic to the patent system as a whole.  Some are specific to drugs, as in patent term extensions and the treatment of generics under Hatch-Waxman.  Other problems are more directly tied to the FDA, which grants exclusivity by name and de facto in ways unrelated to the patent system.

Any efforts at patent reform aimed at restraining pharma need to carefully do just that, so as not to fuck it up for the other thousands of users of the patent system.  But with interested parties whipping up uninformed outrage, I'm not confident that's going to happen.

Also, note that the proposed solutions above are mostly all outside of the patent system.

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More to the point, the major complaint about patents is extension of a patent monopoly beyond the initial 20-years-from-filing term.  Since the 1995 changes to the patent laws, that has become less of an issue, because all patents in a family of related patents expire on the same day.

The other major complaint seems to be "broadening" the monopoly beyond the basic drug composition.  Yes, pharma files a shitload of patents, often on things beyond or peripheral to the original composition and dosage and method of manufacturing, creating an alleged "patent thickpolet."  But the reality is that the thicket boils down to a few basic patents and the broadened monopoly is more a theoretical construct and not a real impediment.

The rest of the problems, and I'd submit the bigger problems are external to the patent system or very specific to drug-related patent legislation, that maybe should be repealed or refined.

For example, in that I-Mak paper you cited, one of the more alarming stats is that Enbrel seems to go off-patent in the US in 2029 versus 2016 in the EU.   What happened there is Amgen's predecessor licensed the composition from UT and applied for a series of patents on top of UTs that expired in 2016.   It was one of the first biologics invented and approved for a therapeutic use.

But where things went different is that Roche applied for a patent on manufacturing such drugs that proved to be hugely important to the industry.  Amgen bought that technology and patent family, extending the monopoly, not on Enbrel, but on the method of manufacturing TNF inhibitors and similar drugs that seems to be indispensable to the technology. That set of patents expires in 2029 in the US, through a quirk relating to the 1995 patent law changes.  Europe, on the other hand, has always had 20-year-from-filing terms, so the Roche/Amgen patents expired at approximately the same time.

So, like shit software patents filed in the 80s and early 90s that fueled the "troll problem." it will take some time for pre-1995 patents to shake out of the system so that everything expires at the same time.  Like the "troll problem," there are some anomalies in the system that will work themselves out and probably shouldn't be "reacted to" at this late date.

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2 hours ago, Chopper said:

So there's little or no patent abuse by pharma and their monopolies shouldn't really bother us...do I correctly understand what you're saying?

Here's an NIH study. It's a few years old and the data is only through 2018, but pharma profitability has only increased since then. https://pmc.ncbi.nlm.nih.gov/articles/PMC7054843/

image.thumb.png.8e4da86597f1bcce89dc4d856903286f.png

Here's another NIH study, this one's from 2020

image.thumb.png.7d03cc1141931871a93e2faeea24786f.png

image.thumb.png.0d4b95ed4e683bdab4fe0db4aba1210e.png

and here's their recommendations for reform from 4 years ago

image.thumb.png.4e64d078c6b74885bc5b46b27323fcd0.png

https://pmc.ncbi.nlm.nih.gov/articles/PMC7311400/

 

That is a really, really dumb intro to an article. Of course the P/E ratios of pharmaceutical companies is higher than commodity companies. Look at the numbers though and tell me what's out of line?

 

https://pages.stern.nyu.edu/~adamodar/New_Home_Page/datafile/pedata.html

image.thumb.png.f5f3d89678ce459bf7005e2e641eea10.png

 

 

 

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37 minutes ago, Blotto said:

How the fuck does a group of companies with 572 constituents have a current PE of 3263 when the trailing PE is ~30 and the future PE is ~73?

and why would they divide pharmaceuticals into 2 categories? That just alters the overall numbers for the sector.

fwiw here's a study published in JAMA that found no link between high drug prices and R&D expenses https://jamanetwork.com/article.aspx?doi=10.1001/jamanetworkopen.2022.18623

Quote

 

In the first known study of its type, an international team of researchers evaluated whether high research and development (R&D) costs explain high drug prices in the United States.

“There is a presumption that high R&D costs justify high drug prices. If that were true, then we’d see a positive association between the two measures,” said first author Olivier Wouters, PhD, assistant professor at the London School of Economics and Political Sciences.

But in a paper published September 26, 2022, in JAMA Network Open, Wouters, in collaboration with colleagues at Skaggs School of Pharmacy and Pharmaceutical Sciences at University of California San Diego, found no such association for 60 new drugs approved by the U.S. Food and Drug Administration from 2009 to 2018.

The researchers compared data on R&D costs with drug prices. They found no relationship between what pharmaceutical companies spend on R&D and what they charge for new medicines. The authors also assessed whether the therapeutic value of a product was associated with its price, but found no association there either.

“Our findings provide evidence that drug companies do not set prices based on how much they spent on R&D or how good a drug is. Instead, they charge what the market will bear,” said senior author Inmaculada Hernandez, PharmD, PhD, associate professor at Skaggs School of Pharmacy and Pharmaceutical Sciences.

 

 

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1 hour ago, Bevo said:

 

That is a really, really dumb intro to an article. Of course the P/E ratios of pharmaceutical companies is higher than commodity companies. Look at the numbers though and tell me what's out of line?

 

https://pages.stern.nyu.edu/~adamodar/New_Home_Page/datafile/pedata.html

image.thumb.png.f5f3d89678ce459bf7005e2e641eea10.png

 

 

 

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19 minutes ago, Chopper said:

fwiw here's a study published in JAMA that found no link between high drug prices and R&D expenses https://jamanetwork.com/article.aspx?doi=10.1001/jamanetworkopen.2022.18623

I absolutely believe the point about charging what the market will bear, but based on my interpretation of reading the key points section, they couldn’t establish a correlation between specific drug r&d costs and their eventual pricing.  Buy you can’t look at it this set way because so much money is spent on new drugs that don’t make it to approval and commercial, so the ones that do need to be able to cover costs for all of those other programs that were terminated.  Or do we want government subsidizing for such things, such that innovation is still pursued?  
 

or- if there is a cancer that affects 10,000 people a year why would a company spend tens of millions on research for that cancer if they can’t make that money back, or if it would take 50 years to make it back?  Maybe hundreds of millions if several drugs for that target end up failing due to lack of efficacy or high adverse reactions at efficacious doses, when it gets to the human trials?

 

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23 hours ago, Chopper said:

But you may not be aware that patent thickets, mentioned in a post above, have replaced the direct application for an extensio

 

19 hours ago, TwiceHorn said:

Of course I'm aware of patent thickets, I do this for a living.

Legit LOL. Next, Chopper will introduce the concept of BBWs to Vic Mackey. 

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13 minutes ago, Pato del Muerto said:

I absolutely believe the point about charging what the market will bear, but based on my interpretation of reading the key points section, they couldn’t establish a correlation between specific drug r&d costs and their eventual pricing.  Buy you can’t look at it this set way because so much money is spent on new drugs that don’t make it to approval and commercial, so the ones that do need to be able to cover costs for all of those other programs that were terminated.  Or do we want government subsidizing for such things, such that innovation is still pursued?

or- if there is a cancer that affects 10,000 people a year why would a company spend tens of millions on research for that cancer if they can’t make that money back, or if it would take 50 years to make it back?  Maybe hundreds of millions if several drugs for that target end up failing due to lack of efficacy or high adverse reactions at efficacious doses, when it gets to the human trials?

 

 

One thing that is kind of interesting is that drug company research cost is pretty low. They would rather focus on development than pure research if given the opportunity. Research is a huge expense so they let research find targets, let biotech establish the target as a legitimate drug opportunity, and then partner with biotech to get it to market. However, biotech usually only has a biologic solution like a monoclonal antibody. That's great because it gets to the market quickly, but it isn't a great solution because the COGS are extremely high for monoclonal antibodies, and patients would rather take a pill than get an infusion. So, while the monoclonal is on the market, pharma will use its huge bank of chemical libraries and see if it can find a hit. Then, it will optimize any hit through combinatorial libraries which are similar in structure to the hit.

So, pharma doesn't waste much money on basic research but it pours a shit-ton of money into development (which includes clinical trials). Still, pharma spends a ton of money on marketing. As a consultant (20yrs ago), I saw that the best correlation to sales was the number of papers on a drug. Sales force size, advertising budgets, medical science liaisons, etc. weren't well correlated. So, I worked to get pharma on board with getting papers out there. It is interesting though, how much pharma still focuses on sales. I have a buddy who is heavily involved with Dupixent (a monoclonal antibody with high COGS) and sales on such a drug is more about helping get patient insurance to pay for the product. Cost without insurance and discount cards is about $5000/mo or $60,000/yr. so it makes since to get a sales rep to help individual patients get the drug. So, the sales rep is helping the doctor write the letters to insurance and he is helping patients get a drug which they need and spending less time convincing the doctor to prescribe it.

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I work in the antibody-drug conjugate space currently.  And it is a morale killer personally when so many all company meetings have data that lead with financials instead of human impact to our work. But it is a business in the end.  And announcements of insurer acceptance of a therapy are celebrated just as much as agency approvals. 

Edited by Pato del Muerto
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53 minutes ago, Pato del Muerto said:

I absolutely believe the point about charging what the market will bear, but based on my interpretation of reading the key points section, they couldn’t establish a correlation between specific drug r&d costs and their eventual pricing.  Buy you can’t look at it this set way because so much money is spent on new drugs that don’t make it to approval and commercial, so the ones that do need to be able to cover costs for all of those other programs that were terminated.  Or do we want government subsidizing for such things, such that innovation is still pursued?  

The thing is - a traditional market model is an extremely poor model for healthcare. If you're sick and at a hospital, you're probably not going to be price shopping between facilities for the cheapest care and least dickish medical coders. People have no choice but to pony up or die. 

And wouldn't ya know it, THAT """market""" will bear a shitload of price increases. Because it's life and death. Wow, what a free market lol

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14 minutes ago, Captainant said:

The thing is - a traditional market model is an extremely poor model for healthcare. If you're sick and at a hospital, you're probably not going to be price shopping between facilities for the cheapest care and least dickish medical coders. People have no choice but to pony up or die. 

And wouldn't ya know it, THAT """market""" will bear a shitload of price increases. Because it's life and death. Wow, what a free market lol

The older I get the more I believe that free market capitalism should ONLY ever be applied to situations with low barriers to market entry (lots of competition) and highly elastic demand (price gouging kills the market itself).

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15 minutes ago, Pato del Muerto said:

I work in the antibody-drug conjugate space currently.  And it is a morale booster personally when so many all company meetings have data that lead with financials instead of human impact to our work. But it is a business in the end.  And announcements of insurer acceptance of a therapy are celebrated just as much as agency approvals. 

For what disease? Early on, the cancer antibodies coupled to cytotoxic agents didn't work as well as anticipated. There are a few on the market such as ado-trastuzumab emtansine and brentuximab vedotin, but I thought that modifying the monoclonal subtype and isoform were now the preferred way to go. Is your company using complete antibodies or just Fabs?

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24 minutes ago, Captainant said:

The thing is - a traditional market model is an extremely poor model for healthcare. If you're sick and at a hospital, you're probably not going to be price shopping between facilities for the cheapest care and least dickish medical coders. People have no choice but to pony up or die. 

And wouldn't ya know it, THAT """market""" will bear a shitload of price increases. Because it's life and death. Wow, what a free market lol

 

Didn't you say earlier that airline surge pricing was better? I don't think so.

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1 hour ago, Pato del Muerto said:

I absolutely believe the point about charging what the market will bear, but based on my interpretation of reading the key points section, they couldn’t establish a correlation between specific drug r&d costs and their eventual pricing.  Buy you can’t look at it this set way because so much money is spent on new drugs that don’t make it to approval and commercial, so the ones that do need to be able to cover costs for all of those other programs that were terminated.  Or do we want government subsidizing for such things, such that innovation is still pursued?  
 

or- if there is a cancer that affects 10,000 people a year why would a company spend tens of millions on research for that cancer if they can’t make that money back, or if it would take 50 years to make it back?  Maybe hundreds of millions if several drugs for that target end up failing due to lack of efficacy or high adverse reactions at efficacious doses, when it gets to the human trials?

 

The EBITDA in the pharma industry is 32% higher than the average of the S&P 500, and their profit margin (both gross and operating) is nearly double that of the S&P 500, thanks to the monopolization advantages to which they're gifted. Clearly they're doing alright without government subsidies (not counting their COVID subsidies). What society needs from them is to serve a public purpose but given their significant profit margins, they're gouging the fuck out of us. 

From one of the NIH studies I believe I linked above.  https://pmc.ncbi.nlm.nih.gov/articles/PMC7054843/

Gross Profit Margin: Pharmaceutical companies have a significantly higher gross profit margin (70.3%) compared to the S&P 500 companies (37.4%) 

EBITDA Margin: Pharmaceutical companies have a higher EBITDA margin (25.2%) compared to the S&P 500 companies (19.0%) 

Net Income Margin: Pharmaceutical companies have a higher net income margin (10.2%) compared to the S&P 500 companies (7.7%) (Table 3).

Research and Development (R&D) Expenses: Pharmaceutical companies dedicate a larger percentage of their revenue to R&D expenses (17%) compared to other industries (average R&D expenses as a percentage of revenue range from 2% to 10% for various industries) (Table 4).

Marketing and Sales Expenses: Pharmaceutical companies spend more on marketing and sales expenses (18-22 billion USD) compared to R&D expenses (8-12 billion USD) for some of the largest pharmaceutical companies (e.g., Bayer, Johnson & Johnson) (AHIP analysis).

Operating Expenses: Pharmaceutical companies have higher operating expenses (selling, general, and administrative expenses) compared to other industries, with some companies allocating over 30% of their revenue to these expenses (AHIP analysis).

Profitability: Pharmaceutical companies are generally more profitable than other industries, with an average operating profit margin of 23.1% compared to 12.1% for the S&P 500 companies (Table 4).

 

1 hour ago, BrickHorn said:

Legit LOL. Next, Chopper will introduce the concept of BBWs to Vic Mackey. 

My recollection is that I asked him the question you quoted because patent thickets were a key part of a topic in 2 prior posts of mine to which he responded but didn't address the topic of patent thickets. Also how the fuck am I to be expected to know what he does for a living?

Logically it makes zero sense to me that multiple studies by the federal government and higher education over the past several years including by USCPB, the NIH, HHS, GAO and UCSD have pointed to the same problems with pharma patents, including a high rate of patent abuse. But hey a poster on Surly who apparently works for pharma is convinced about the correctness of his own arguments, which (unless I'm reading between the lines incorrectly which is certainly more than possible) seem quite likely to benefit him financially.   

Edited by Chopper
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19 minutes ago, Bevo said:

For what disease? Early on, the cancer antibodies coupled to cytotoxic agents didn't work as well as anticipated. There are a few on the market such as ado-trastuzumab emtansine and brentuximab vedotin, but I thought that modifying the monoclonal subtype and isoform were now the preferred way to go. Is your company using complete antibodies or just Fabs?

I think I’ll stop there on my employment, but clinical trials are ongoing on the industry for whole antibodies, fragments, altered antibodies, multivalent antibodies, etc along with different types of payload other than cytotoxic agents like vedotin. T-cell engagers for one example, immune response triggers for another.  

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1 minute ago, Pato del Muerto said:

I think I’ll stop there on my employment, but clinical trials are ongoing on the industry for whole antibodies, fragments, altered antibodies, multivalent antibodies, etc along with different types of payload other than cytotoxic agents like vedotin. T-cell engagers for one example, immune response triggers for another.  

If you need contacts in different area, let me know. It has been 20 years and the scientists and business people l I worked with may be retired but they were at the forefront when the company was purchased by Amgen.

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6 minutes ago, Bevo said:

If you need contacts in different area, let me know. It has been 20 years and the scientists and business people l I worked with may be retired but they were at the forefront when the company was purchased by Amgen.

I know a couple of people that had a nice windfall from the Amgen purchase. 

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2 hours ago, Chopper said:

The EBITDA in the pharma industry is 32% higher than the average of the S&P 500, and their profit margin (both gross and operating) is nearly double that of the S&P 500,

 

That's the stuff I was just complaining about. Compare those numbers to High Tech, Finance rather than Aluminum and Oil and Gas and Paper Products. If you need to know why that matters, I'll go into more detail.

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1 hour ago, Bevo said:

That's the stuff I was just complaining about. Compare those numbers to High Tech, Finance rather than Aluminum and Oil and Gas and Paper Products. If you need to know why that matters, I'll go into more detail.

If you're familiar with what a hyperbaric oxygen chamber can do to a person's eyesight, hopefully temporarily, you'll understand when I tell you I cannot get the essentials of that full chart on my computer screen in a way that it's readable to me. It's too wide. 

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6 hours ago, Chopper said:

 

The EBITDA in the pharma industry is 32% higher than the average of the S&P 500, and their profit margin (both gross and operating) is nearly double that of the S&P 500, thanks to the monopolization advantages to which they're gifted. Clearly they're doing alright without government subsidies (not counting their COVID subsidies). What society needs from them is to serve a public purpose but given their significant profit margins, they're gouging the fuck out of us. 

From one of the NIH studies I believe I linked above.  https://pmc.ncbi.nlm.nih.gov/articles/PMC7054843/

Gross Profit Margin: Pharmaceutical companies have a significantly higher gross profit margin (70.3%) compared to the S&P 500 companies (37.4%) 

EBITDA Margin: Pharmaceutical companies have a higher EBITDA margin (25.2%) compared to the S&P 500 companies (19.0%) 

Net Income Margin: Pharmaceutical companies have a higher net income margin (10.2%) compared to the S&P 500 companies (7.7%) (Table 3).

Research and Development (R&D) Expenses: Pharmaceutical companies dedicate a larger percentage of their revenue to R&D expenses (17%) compared to other industries (average R&D expenses as a percentage of revenue range from 2% to 10% for various industries) (Table 4).

Marketing and Sales Expenses: Pharmaceutical companies spend more on marketing and sales expenses (18-22 billion USD) compared to R&D expenses (8-12 billion USD) for some of the largest pharmaceutical companies (e.g., Bayer, Johnson & Johnson) (AHIP analysis).

Operating Expenses: Pharmaceutical companies have higher operating expenses (selling, general, and administrative expenses) compared to other industries, with some companies allocating over 30% of their revenue to these expenses (AHIP analysis).

Profitability: Pharmaceutical companies are generally more profitable than other industries, with an average operating profit margin of 23.1% compared to 12.1% for the S&P 500 companies (Table 4).

 

My recollection is that I asked him the question you quoted because patent thickets were a key part of a topic in 2 prior posts of mine to which he responded but didn't address the topic of patent thickets. Also how the fuck am I to be expected to know what he does for a living?

Logically it makes zero sense to me that multiple studies by the federal government and higher education over the past several years including by USCPB, the NIH, HHS, GAO and UCSD have pointed to the same problems with pharma patents, including a high rate of patent abuse. But hey a poster on Surly who apparently works for pharma is convinced about the correctness of his own arguments, which (unless I'm reading between the lines incorrectly which is certainly more than possible) seem quite likely to benefit him financially.   

I don't work for pharma, that's not my area.  I am, however, a patent lawyer.

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If you're familiar with what a hyperbaric oxygen chamber can do to a person's eyesight, hopefully temporarily, you'll understand when I tell you I cannot get the essentials of that full chart on my computer screen in a way that it's readable to me. It's too wide. 

What does a hyperbaric chamber do to your eyesight?
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