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Obdicut
May 15, 2012

"What election?"

Ardennes posted:

Universities and non-profits still do all the real R&D work for most pharmaceuticals, that is an ancient excuse. Also, yeah executive salaries themselves have been a red herring for a eon.

Not really accurate. Universities and non-profit research institutions do the R&D work on the basic science that discovers new classes of drugs. However, drug companies both then take these findings and research delivery, spend the enormous amount of money necessary to get it through the FDA, and often provide drug for the researchers to use in the first place to work on the basic science. For example, my wife worked in cancer research at UCSF, and the drug companies provided her lab with all the drug they wanted to use for researching the actual genetic target of the drug, which was unknown.

Universities and non-profits should get far more credit and funding for the basic science research they do, but the pharma companies do a ton as well.



tsa posted:

Eli Lilly pays their execs about 33 million per year, which sounds like an enormous number until you realize they spend over a billion dollars every 3 months on research and development costs alone.





They spend more on marketing.

http://files.shareholder.com/downloads/LLY/292383264x0x817287/495067E5-24AE-4E84-B1F9-7DCF4CD1444B/English.PDF

The pharma industry would be a lot better if they restricted ads and marketing to doctors appropriately.

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Pervis
Jan 12, 2001

YOSPOS

tsa posted:

Eli Lilly pays their execs about 33 million per year, which sounds like an enormous number until you realize they spend over a billion dollars every 3 months on research and development costs alone.

4 billion a year on R&D is not that much, especially since you only point out how much a single exec gets a year, and not all of management/marketing/lobbying in aggregate, rendering the comparison completely useless. The growth of management/marketing expenditures in the drug industry is a well-known thing, and the same is true in most other industries and even public colleges.

The Insect Court
Nov 22, 2012

by FactsAreUseless

Kalman posted:

And "vast rents" my rear end. As I've posted before, pharma profit margins are in line with comparable high tech companies. The bullshit BBC story everyone cites to downplays the fact that 2013 was a huge outlier year for Pfizer due to one-off accounting profits and that their actual margin once you strip out the 10bn they realized in spinning off Zoetis and some litigation revenue from Teva was around 22-23%. Which is comparable to Apple, MS, Intel, or Google.

So your argument that pharma companies aren't rentiers is that they're about as profitable as....tech companies. Who, apparently, don't benefit from restrictive IP laws?


Pervis posted:

4 billion a year on R&D is not that much, especially since you only point out how much a single exec gets a year, and not all of management/marketing/lobbying in aggregate, rendering the comparison completely useless. The growth of management/marketing expenditures in the drug industry is a well-known thing, and the same is true in most other industries and even public colleges.

Not all R&D spending is created equal. A big part of rising drug development costs is the rising cost of phase 3 trials, which are required to show the safety and efficacy of a new drug relative to existing treatments. That can get incredibly expensive if you need to enroll a massive number of study participants that will be needed to show efficacy in some me-too blood pressure drug with relatively negligible benefits.

Ardennes
May 12, 2002

Obdicut posted:

Not really accurate. Universities and non-profit research institutions do the R&D work on the basic science that discovers new classes of drugs. However, drug companies both then take these findings and research delivery, spend the enormous amount of money necessary to get it through the FDA, and often provide drug for the researchers to use in the first place to work on the basic science. For example, my wife worked in cancer research at UCSF, and the drug companies provided her lab with all the drug they wanted to use for researching the actual genetic target of the drug, which was unknown.

Universities and non-profits should get far more credit and funding for the basic science research they do, but the pharma companies do a ton as well.


It sounds like the drug companies simply outsourced the core R&D rather cheaply to the university.

In the context of this thread, the basic science is going to make the basic difference in the grand scheme and while these companies do advance the science to a marketable form, the question is the social utility of the profits they will claim on their patent and if the enforcement in developing states in the TPP of these patents will produce any social good. Ultimately, IP enforcement is going to lock out classes of drugs from the poorer populations of many of those countries, and it is unclear the degree drug companies (at least in their current form) were actually that necessary in the process.

Ardennes fucked around with this message at 21:05 on Jun 15, 2015

Obdicut
May 15, 2012

"What election?"

Ardennes posted:

It sounds like the drug companies simply outsourced the core R&D rather cheaply to the university.


Well, that's a weird way of putting it. Is there anything wrong with saying that the universities and non-profit research groups do the basic science?

quote:

In the context of this thread, the basic science is going to make the basic difference and while these companies do advance the science to a marketable form, the question is the social utility of the profits they will claim on their patent and how enforcement in developing states in the TPP of these patents will produce any social good. Ultimately, IP enforcement is going to lock out classes of drugs from the poorer populations of many of those countries, and it is unclear if the drug companies themselves were actually that necessary in the process.

The basic science doesn't make the basic difference. I'm not sure you're getting what the basic science is. For example, for statins, basic science showed that HMG-CoA reductase is the enzyme involved in cholesterol production, and basic science showed that various organisms attacked that enzyme's precursor's production as a way of defending themselves against stuff. Combining the two of these, various pharma companies played around for a long, long time and a lot of money to produce the first tolerable statin.

There are two things at work here that make pharma companies with a for-profit motive actually worthwhile, and I say this as someone who is basically a huge socialist for most stuff: how interesting a scientific question is is divorced from how useful answering that question is or how many people will benefit from making a practical use of that answer. A biologist can make a hugely scientific discovery about a disease that affects one in ten million people--it still adds to our knowledge of basic science and has potential further outflows, but there isn't any motivator other than grant funding to research stuff that affects certain areas, and in general grants go for the really fundamental science where it's hardest to show that there will be a useable output, though people writing grants almost routinely claim that it will have a large effect. Pharma companies, on the other hand, have a huge vested interest in making a drug that deals with problems that affect large numbers of people.

Where you are right is that drug companies have a lot of incentive, therefore, to make Viagra for white middle class westerners, and much less incentive to make drugs that combat diseases only found in tropical areas--but that is a by-product of the poverty in those areas. It is somewhat reinforcing--harder to make money when you're loaded down with parasites--but it's mostly not. Absent global wealth equality, it'd probably be more efficacious to mandate pharma companies research drugs that do target those populations--but as has been noted, they do actually make some stuff for those populations because making $1 a pill on a million pills every year is better than making $1000 a pill a hundred pills a year. Those diseases are underserved, not ignored. Given the donor base of universities, we wouldn't see a huge change in the targets of research if removed the pharma companies from the equation and massively funded universities so that they could research, produce, and distribute drugs--what you'd get instead is the universities having pressure on them to put more brains on the drug-producing side and fewer on the basic science side. When non-profits get involved directly in the market, they tend to resemble for-profits in their behavior. Universities would then be very protective of IP rights (as, in fact, they are now--see MIT for example) because it'd represent a huge amount of their income.

Ardennes
May 12, 2002

Obdicut posted:

Well, that's a weird way of putting it. Is there anything wrong with saying that the universities and non-profit research groups do the basic science?


The basic science doesn't make the basic difference. I'm not sure you're getting what the basic science is. For example, for statins, basic science showed that HMG-CoA reductase is the enzyme involved in cholesterol production, and basic science showed that various organisms attacked that enzyme's precursor's production as a way of defending themselves against stuff. Combining the two of these, various pharma companies played around for a long, long time and a lot of money to produce the first tolerable statin.

There are two things at work here that make pharma companies with a for-profit motive actually worthwhile, and I say this as someone who is basically a huge socialist for most stuff: how interesting a scientific question is is divorced from how useful answering that question is or how many people will benefit from making a practical use of that answer. A biologist can make a hugely scientific discovery about a disease that affects one in ten million people--it still adds to our knowledge of basic science and has potential further outflows, but there isn't any motivator other than grant funding to research stuff that affects certain areas, and in general grants go for the really fundamental science where it's hardest to show that there will be a useable output, though people writing grants almost routinely claim that it will have a large effect. Pharma companies, on the other hand, have a huge vested interest in making a drug that deals with problems that affect large numbers of people.

Where you are right is that drug companies have a lot of incentive, therefore, to make Viagra for white middle class westerners, and much less incentive to make drugs that combat diseases only found in tropical areas--but that is a by-product of the poverty in those areas. It is somewhat reinforcing--harder to make money when you're loaded down with parasites--but it's mostly not. Absent global wealth equality, it'd probably be more efficacious to mandate pharma companies research drugs that do target those populations--but as has been noted, they do actually make some stuff for those populations because making $1 a pill on a million pills every year is better than making $1000 a pill a hundred pills a year. Those diseases are underserved, not ignored. Given the donor base of universities, we wouldn't see a huge change in the targets of research if removed the pharma companies from the equation and massively funded universities so that they could research, produce, and distribute drugs--what you'd get instead is the universities having pressure on them to put more brains on the drug-producing side and fewer on the basic science side. When non-profits get involved directly in the market, they tend to resemble for-profits in their behavior. Universities would then be very protective of IP rights (as, in fact, they are now--see MIT for example) because it'd represent a huge amount of their income.


Let's be honest here and say it could be done differently even if we are locked into the system we have now. The old argument is that because pharmaceutical companies are the key part of the process (if not the only part of the process) that then in turn we can't infringe their profit-taking in any manner, in reality it probably doesn't necessary mean millions of people will then die. They occupy a spot in the chain no doubt but at the same time, but if those universities researchers disappeared those drugs would as well. So yeah what they are doing right now what needs to be done, but the question is how much are they really the sacred cow here.

Moreover I got what you said the first time but I don't think your engaging my point that the issue is about the net social good that is going to come from the TPP itself. These companies in general are making profits the way they are and the question is if their profit share grows how will the benefits some how eventually trickle down to Vietnamese peasants who now can't afford heart medicine?

As for the universities/non-profits themselves, they are a problem as well, but at the same time, there has to be some reflection on the social utility of these for-profit companies considering their costs and the effect this will have on people who will simply not be able to afford medication. At the core here is the argument we have to clear a path of for engorged rents to these companies or else there will be disaster but there is a reason to be skeptical.

Ardennes fucked around with this message at 23:01 on Jun 15, 2015

Obdicut
May 15, 2012

"What election?"

Ardennes posted:

Let's be honest here and say it could be done differently even if we are locked into the system we have now.

I am being honest. For gently caress's sake. And nothing I said implied it couldn't be done differently--I mentioned multiple ways it could be done differently.

quote:

The old argument is that because pharmaceutical companies are the key part of the process if not the only part of the process that then in turn we can't infringe their profit-taking in any manner, in reality it doesn't necessary mean millions of people will then die. They occupy a spot in the chain no doubt but at the same time, but if those universities researchers disappeared those drugs would as well. So yeah what they are doing right now what needs to be done, but the question is how much are they really the sacred cow here.

I didn't say that we can't infringe their profit-taking in any manner. Why do you need to get hyperbolic and make up poo poo I didn't say?

quote:

I got what you said the first time but I don't think your engaging my point that the issue is about the net social good that is going to come from the TPP itself. These companies in general are making profits the way they are and the question is if their profit share grows how will the benefits some how eventually trickle down to Vietnamese peasants who now can't afford heart medicine?

Analyzing the net social good of something that isn't finished and is incredibly complex is beyond my capacity. I'm addressing the idea that the pharma companies don't add to the process; the profit motive, for pharma companies, actually is useful, unlike many other areas of health. "Protecting profits" is also protecting innovation for pharma research, and you can't just discount that. However, there are problems in the ways that TPP approaches patents in terms of innovation, which to me is the most crucial part--the way that they protect reformulations> Companies are more likely to innovate when they have smaller patent windows and can't just reformulate because they know they're going to lose that market share to generics anyway, so they innovate on a different drug. If there's any part of the TPP to severely criticism in terms of pharma, it's that one. Though again: TPP doesn't actually exist yet.

quote:

As for the universities/non-profits themselves, they are a problem as well, but at the same time, there has to be some reflection on the social utility of these for-profit companies considering their costs and the effect this will have on people who will simply not be able to afford medication. At the core here is the argument we have to clear a path of for engorged rents to these companies or else there will be disaster but the question is what actually gets lost in that process.

I have no idea what you mean by 'rents', which is generally a term applied to companies that don't do anything except to charge that 'rent'. The drug companies do actually spend a shitload--again, I think they should be prevented from engaging in direct marketing and severely limited in how they could market to doctors, which would actually have the effect of increased R&D dollars. If you reduce the profits of the pharma company significantly by reducing patent time and allowing more generics without the rigorous testing that the pharma companies have to go through, you'll have multiple effects: You'll reduce drug prices, reduce innovation, cause more drug companies to go bankrupt, and lower the number of new drug companies started, and reduce the testing of the basic science done by the universities and non-profits. It is not as simple as turning a dial and making the profits of the pharma companies go down and the price of drugs go down.

In addition, there are legitimate and severe concerns about allowing companies in other countries to produce generics, since they often are far more corrupt than the US and have less robust overwatch of drug quality.

Ardennes
May 12, 2002

Obdicut posted:

I am being honest. For gently caress's sake. And nothing I said implied it couldn't be done differently--I mentioned multiple ways it could be done differently.

I didn't say that we can't infringe their profit-taking in any manner. Why do you need to get hyperbolic and make up poo poo I didn't say?


Analyzing the net social good of something that isn't finished and is incredibly complex is beyond my capacity. I'm addressing the idea that the pharma companies don't add to the process; the profit motive, for pharma companies, actually is useful, unlike many other areas of health. "Protecting profits" is also protecting innovation for pharma research, and you can't just discount that. However, there are problems in the ways that TPP approaches patents in terms of innovation, which to me is the most crucial part--the way that they protect reformulations> Companies are more likely to innovate when they have smaller patent windows and can't just reformulate because they know they're going to lose that market share to generics anyway, so they innovate on a different drug. If there's any part of the TPP to severely criticism in terms of pharma, it's that one. Though again: TPP doesn't actually exist yet.


I have no idea what you mean by 'rents', which is generally a term applied to companies that don't do anything except to charge that 'rent'. The drug companies do actually spend a shitload--again, I think they should be prevented from engaging in direct marketing and severely limited in how they could market to doctors, which would actually have the effect of increased R&D dollars. If you reduce the profits of the pharma company significantly by reducing patent time and allowing more generics without the rigorous testing that the pharma companies have to go through, you'll have multiple effects: You'll reduce drug prices, reduce innovation, cause more drug companies to go bankrupt, and lower the number of new drug companies started, and reduce the testing of the basic science done by the universities and non-profits. It is not as simple as turning a dial and making the profits of the pharma companies go down and the price of drugs go down.

In addition, there are legitimate and severe concerns about allowing companies in other countries to produce generics, since they often are far more corrupt than the US and have less robust overwatch of drug quality.

I am sorry but some of this sounds like pretty much the boilerplate you would get out of lobbyist to be fair: everything from foreign generics to being unsafe to the necessity of profit-taking for innovation. I simply have a hard time seeing your argument that really any real infringement on profit taking of these companies will actually cause a domino reaction (and to be fair the TPP is increasing their profit taking above the baseline in all likelihood), especially since pharmaceuticals as a sector has done amazingly well for years. The S&P's pharmaceutical index post -2008 was a very good investment if you got into it.

You still aren't engaging me on what it may actually mean for the populations of these countries if the TPP (very likely) greatly increasing IP enforcement. The TPP isn't finished fine, but we have an idea of what it is going to mean and almost certainly these countries won't be in the same ambiguous position as far as IP rights as they are in now.

Ardennes fucked around with this message at 23:50 on Jun 15, 2015

Nintendo Kid
Aug 4, 2011

by Smythe

Ardennes posted:

I mean to be honest a lot of this sounds like pretty much boilerplate you would get out of lobbyist to be fair: everything from foreign generics to being unsafe to the necessity of profit-taking for innovation. I simply have a hard time seeing your argument that really any infringement on these companies will actually cause this collapse (and to be fair the TPP is increasing their profit taking above the baseline in all likelihood), especially since pharmaceuticals as a sector has done amazingly well for years. The S&P's pharmaceutical index was a very good investment if you got into it.

You still aren't engaging me on what it may actually mean for the populations of these countries if the TPP (very likely) greatly increasing IP enforcement.

IP enforcement in general? Most of the countries involved enforce IP law a ton.

icantfindaname
Jul 1, 2008


Isn't Japanese IP law even stricter than American?

WhiskeyJuvenile
Feb 15, 2002

by Nyc_Tattoo
I don't understand reformulation issues

Why would this prevent generics of the now-lapsed original formulation?

Ardennes
May 12, 2002

Nintendo Kid posted:

IP enforcement in general? Most of the countries involved enforce IP law a ton.

Not in the way the US does it though. There is the issue of costs here, I am especially thinking of Peru, Vietnam and possibly the Philippines ie developing countries where increased costs will hit the population harder. That said, developed countries like New Zealand are probably going to be effected by higher drug prices as well.

WhiskeyJuvenile posted:

I don't understand reformulation issues

Why would this prevent generics of the now-lapsed original formulation?

Under the TPP they would likely take longer to lapse in the first place?

icantfindaname posted:

Isn't Japanese IP law even stricter than American?

Supposedly there are some unique concerns on Japanese side as well.

quote:

A group of artists, archivists, academics, and activists, have joined forces in Japan to call on their negotiators to oppose requirements in the TPP that would require their country to expand their copyright scope and length to match the United States' of copyright.[177] Ken Akamatsu, creator of Japanese manga series Love Hina and Mahou Sensei Negima!, expressed concern the agreement could decimate the derivative dōjinshi (self-published) works prevalent in Japan. Akamatsu argues that the TPP "would destroy derivative dōjinshi. And as a result, the power of the entire manga industry would also diminish." Kensaku Fukui, a lawyer and a Nihon University professor, expressed concerns that the TPP could allow companies to restrict or stop imports and exports of intellectual property, such as licensed merchandise. For example, IP holders could restrict or stop importers from shipping merchandise such as DVDs and other related goods related to an anime or manga property into one country to protect local distribution of licensed merchandise already in the country via local licensors.[178] At a NicoNico live seminar called How Would TPP Change the Net and Copyrights? An In-Depth Examination: From Extending Copyright Terms to Changing the Law to Allow Unilateral Enforcement and Statutory Damages, artist Kazuhiko Hachiya warned that cosplay could also fall under the TPP, and such an agreement could give law enforcement officials broad interpretive authority in dictating how people could dress up. Critics also have derided the agreement could also harm Japanese culture, where some segments have developed through parody works.[179] Both the copyright term expansion and the non-complaint provision previously failed to pass in Japan because they were so controversial.[177]

Ardennes fucked around with this message at 00:07 on Jun 16, 2015

Obdicut
May 15, 2012

"What election?"

Ardennes posted:

I am sorry but some of this sounds like pretty much the boilerplate you would get out of lobbyist to be fair:

Then you don't know poo poo about lobbyists, if you think they want to have marketing banned and that I cited the reformulary patents as a problem. I can go on at length about how the marketing-driven aspect of pharma companies is much more harmful than profit-taking from efficacious drugs, because it guides innovation to what they think is marketable rather than what fits medical need, but you don't genuinely seem interested. The risk isn't restricted to generics for overseas drug companies, however, so that was a weak point of mine; i'm not sure if TPP does anything to strengthen inspections, but brand-name drugs in foreign areas have a lot of the same risk. Where the difference lies is that if a drug company or a generics company is only going to sell domestically abroad, and not send their drug to the US, they only have to worry about local inspection and standards. This isn't that prevalent because the US market is so profitable, but it is growing and will grow more.

Can you explain what you didn't understand about how I laid out how profit-taking and innovation are tied together?

it's really annoying to make a long effort-post and have you say it sounds like what a lobbyist would say when it really, really doesn't. Unless you're saying that everyone saying the profit motive has utility for the industry sounds like a lobbyist, in which case I'd like you to actually engage with what I said about the profit motive rather than just smearing me.

quote:

You still aren't engaging me on what it may actually mean for the populations of these countries if the TPP (very likely) greatly increasing IP enforcement. The TPP isn't finished fine, but we have an idea of what it is going to mean and almost certainly these countries won't be in the same ambiguous position as far as IP rights as they are in now.

Those countries aren't in an ambiguous position now with IP rights. What medicine sans frontiers is objecting to is the new extension of patents and restrictions on generics, not that IP will be enforced. But assuming you just misspoke: the effect will be to make generic companies in those countries less profitable, to potentially raise the price of drugs in those countries--though just because you can find a drug sold at price X in that country doesn't mean that is the average price the actual consumer pays for it in the end.

WhiskeyJuvenile posted:

I don't understand reformulation issues

Why would this prevent generics of the now-lapsed original formulation?

We're stepping outside my area of knowledge but I think one of the main ways is that it means the data about the original formulation remains entirely proprietary property of the original company, so the generics companies are prevented from using that in the formulation--they have to start from scratch on the process, and the FDA approval is about process as well as final molecule. I may be wrong on this though.

Obdicut fucked around with this message at 00:12 on Jun 16, 2015

Ardennes
May 12, 2002

Obdicut posted:

Then you don't know poo poo about lobbyists, if you think they want to have marketing banned and that I cited the reformulary patents as a problem. I can go on at length about how the marketing-driven aspect of pharma companies is much more harmful than profit-taking from efficacious drugs, because it guides innovation to what they think is marketable rather than what fits medical need, but you don't genuinely seem interested. The risk isn't restricted to generics for overseas drug companies, however, so that was a weak point of mine; i'm not sure if TPP does anything to strengthen inspections, but brand-name drugs in foreign areas have a lot of the same risk. Where the difference lies is that if a drug company or a generics company is only going to sell domestically abroad, and not send their drug to the US, they only have to worry about local inspection and standards. This isn't that prevalent because the US market is so profitable, but it is growing and will grow more.

Can you explain what you didn't understand about how I laid out how profit-taking and innovation are tied together?

it's really annoying to make a long effort-post and have you say it sounds like what a lobbyist would say when it really, really doesn't. Unless you're saying that everyone saying the profit motive has utility for the industry sounds like a lobbyist, in which case I'd like you to actually engage with what I said about the profit motive rather than just smearing me.

Marketing is an easy criticism and it isn't at the heart of the issue here. I said some of your post sounded boilerplate because it honestly did even if it was overall a mixed bag.

The core issue here is the profit taking in the first place, so yes, that is something to be critical of and I saw how you laid it out and I don't buy it. Drug companies,as a sector, are very profitable and equity in them is a valuable investment, and yet we have a crisis over drug costs. Your analysis of this is to ignore it because it is for the best in the name of innovation, when there is every reason to be skeptical of the "flow" of profits toward innovation versus the broad and heavy social cost this process is having on the population. As for safety risks, I haven't seen good evidence of this, especially considering the make up of the TPP's members.

quote:

Those countries aren't in an ambiguous position now with IP rights. What medicine sans frontiers is objecting to is the new extension of patents and restrictions on generics, not that IP will be enforced. But assuming you just misspoke: the effect will be to make generic companies in those countries less profitable, to potentially raise the price of drugs in those countries--though just because you can find a drug sold at price X in that country doesn't mean that is the average price the actual consumer pays for it in the end.

Does that include Vietnam and other potential developing ratifiers? But yes, it is mostly about the form of the IP, but the core of that point is at the same time it is about the ultimate increased to cost to governments or consumers. That said, your last point was unclear.

Ardennes fucked around with this message at 00:30 on Jun 16, 2015

Obdicut
May 15, 2012

"What election?"

Ardennes posted:

Marketing is an easy criticism and it isn't at the heart of the issue here. I said some of your post sounded boilerplate because it honestly did even if it was overall a mixed bag.


Did you consider that being a lovely and insulting thing to say? Do you think that lobbyists don't use things that are true in their criticisms, and so you might hear them from other sources?


quote:

The core issue here is the profit taking in the first place, so yes, that is something to be critical of and I saw how you laid it out and I don't buy it. Drug companies,as a sector, are very profitable and equity in them is a valuable investment, and yet we have a crisis over drug costs.

Saying "I don't buy it" doesn't tell me what you don't buy. Saying that they're profitable isn't an answer to what I said. I laid out the reason why the profit motive actually serves a useful function in directing production of drugs towards real health issues. You haven't talked towards that at all, except to apparently dismiss it.

quote:

Your analysis of this is to ignore it because it is for the best in the name of innovation, when there is every reason to be skeptical of the "flow" of profits toward innovation versus the broad and heavy social cost this process is having on the population. As for safety risks, I haven't seen good evidence of this, especially considering the make up of the TPP's members.

My analysis is not to ignore it. I'm going to stop talking to you now, because you just make up poo poo I didn't say and there's no point in making sincere, effortful posts when you just respond in this totally facile way.

quote:

Does that include Vietnam and other potential developing ratifiers? But yes, it is mostly about the form of the IP, but the core of that point is at the same time it is about the ultimate increased to cost to governments or consumers. That said, your last point was unclear.

Just as in the US, the price point is often offset by group buying, discounts, etc.

Ardennes
May 12, 2002

Obdicut posted:

Did you consider that being a lovely and insulting thing to say? Do you think that lobbyists don't use things that are true in their criticisms, and so you might hear them from other sources?

The issue is accepting much of the core of their argument is that the safety of foreign drug importation is suspect and infringement on their profit-taking ability is endangering lives. I mean on one hand you are saying it is insulting, but on the other hand you are saying "but what if they are right?"

quote:

Saying "I don't buy it" doesn't tell me what you don't buy. Saying that they're profitable isn't an answer to what I said. I laid out the reason why the profit motive actually serves a useful function in directing production of drugs towards real health issues. You haven't talked towards that at all, except to apparently dismiss it.

My point is that engorging the already massive profitability of the drug industry is almost certainly going to cause more damage to due to higher costs, especially since the expenses you were describing were in fact only a portion of the far larger puzzle of of these companies. Basically, you tip the scale completely on the side of the company but leave the consumer high and dry except for the issue of marketing. Sure there is a balance there because the stranglehold these companies have, but at the same time you have to be skeptical about the social efficiency of the entire enterprise. The TPP only enhances this by comforting more countries to US IP law.

quote:

My analysis is not to ignore it. I'm going to stop talking to you now, because you just make up poo poo I didn't say and there's no point in making sincere, effortful posts when you just respond in this totally facile way.

If you want, but yeah you still aren't engaging my main point so better just to save the time.

Ardennes fucked around with this message at 00:52 on Jun 16, 2015

WhiskeyJuvenile
Feb 15, 2002

by Nyc_Tattoo

Obdicut posted:


We're stepping outside my area of knowledge but I think one of the main ways is that it means the data about the original formulation remains entirely proprietary property of the original company, so the generics companies are prevented from using that in the formulation--they have to start from scratch on the process, and the FDA approval is about process as well as final molecule. I may be wrong on this though.

That hasn't been the case for over 30 years, domestically, since the Hatch-Waxman Act.

quote:

Hatch-Waxman amended the Federal Food, Drug, and Cosmetic Act. Section 505(j) of the Act, codified as 21 U.S.C. § 355(j), outlines the process for pharmaceutical manufacturers to file an Abbreviated New Drug Application (ANDA) for approval of a generic drug by the Food and Drug Administration (FDA).

Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical (animal and in vitro) and clinical (human) trial data to establish safety and effectiveness. Instead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner as the innovator drug). One way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream in 24 to 36 healthy volunteers. This gives them the rate of absorption, or bioavailability, of the generic drug, which they can then compare to that of the innovator drug. The generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the innovator drug.

The trade-off was that under the old system, generic manufacturers couldn't start clinical trials until the patent expired, but if generics don't have to go through clinical trials while pioneers do, then the patent term is effectively lessened. Hatch-Waxman dictated a tradeoff where generics wouldn't have to bear the cost of repeating clinical trials, but the pioneer would still benefit from market exclusivity for the time of the trial.

quote:

In terms of patent term restoration, the bill provides that a pioneer drug can receive an extension term equal to one-half of the time of the investigational new drug (IND) period, which runs from the time human clinical trials begin to the time the NDA is submitted. In addition to getting credit for the IND period the complete period of NDA review is added as the second part of the extension. This is so long as half of the IND period plus the NDA review period is less than or equal to 5 years. Furthermore, the time after the drug has been approved and is on the market cannot exceed fourteen years.

Kalman
Jan 17, 2010

WhiskeyJuvenile posted:

That hasn't been the case for over 30 years, domestically, since the Hatch-Waxman Act.


The trade-off was that under the old system, generic manufacturers couldn't start clinical trials until the patent expired, but if generics don't have to go through clinical trials while pioneers do, then the patent term is effectively lessened. Hatch-Waxman dictated a tradeoff where generics wouldn't have to bear the cost of repeating clinical trials, but the pioneer would still benefit from market exclusivity for the time of the trial.

There's a secondary system called data exclusivity that deals with the fact that WJ's coworkers (meaning the PTO) are faster than clinical trials, so pharma patents are often near expiry when the NDA gets approved. Data exclusivity provisions (which are related to but different from reformulation issues, which are what Obdicut was talking about) are essentially a secondary patent-like system which bars ANDAs on drugs for a period of time after the drug is first approved for use. In the U.S. you get 5 years for new drugs, 3 years for new uses, and 12 years for biologics. During that period (assuming the patent is expired) a generic maker can apply via a NDA, but not via an ANDA (or the biosimilars equivalent), so they have to produce their own test data. For followons (ie ever greening), once the original drug comes out of exclusivity, you can ANDA the original drug even if there's exclusivity on the new indication.

Of course, the EU offers 8 years for data exclusivity with an additional 2 years of market exclusivity (so you can start your trials after 8 years but you still can't sell for 10 after approval) and a 1 year new use exclusivity, while Japan is 6 years for new drugs. So it's not like data exclusivity is the sole driver in the U.S. (or even a primary driver).

Lastly, shorter patent periods probably would not produce cheaper drugs - they would produce more expensive drugs during the patent period since the recoupment math changes.

Thunder Moose
Mar 7, 2015

S.J.C.

Kalman posted:


Lastly, shorter patent periods probably would not produce cheaper drugs - they would produce more expensive drugs during the patent period since the recoupment math changes.

It would herald the generic cheaper brand sooner at the cost of making the designer drug more expensive if I get what you are saying? (Honest question, I am pretty bad at comprehending this sort of thing)

Nintendo Kid
Aug 4, 2011

by Smythe

Thunder Moose posted:

It would herald the generic cheaper brand sooner at the cost of making the designer drug more expensive if I get what you are saying? (Honest question, I am pretty bad at comprehending this sort of thing)

That's certainly one of the more likely outcomes, yes. Again, the impact of that higher cost depends on who has leverage and how big they can make their buys, just as now.

Kalman
Jan 17, 2010

Thunder Moose posted:

It would herald the generic cheaper brand sooner at the cost of making the designer drug more expensive if I get what you are saying? (Honest question, I am pretty bad at comprehending this sort of thing)

Basically, yeah. It's not a 1:1 thing - you might wind up saving money overall, since pricing isn't purely based on recoupment cost, but you also might end up losing money overall, since it's not an exact science by any means. It's hard to say that a 100k/wk drug is suddenly going to become even more expensive, although if it did, that drug is only ever getting covered by insurance anyway. On the other hand, it's probably not a safe assumption that the $4000/wk drug won't go to $5000/wk while it's still protected if you cut the term of protection.

Basically, earlier generics are likely to result in attempts to extract even higher prices during the protected period. Attempts may or may not succeed, depending on external factors, but it's not like it's all patient benefit.

Hal_2005
Feb 23, 2007
Seriously good thread.

All I got to bring to the chat tonight is Jeff Immelt and Charlie Rose. Which is on par with bringing 10 year old boxed red wine. Sorry

http://charlierose.com/watch/60576659

Not sure if Jeff brings any fresh insight but he tries to argue the pro-TPP at his paygrade.

http://www.reuters.com/article/2015/05/19/us-general-electric-exim-exclusive-idUSKBN0O42ER20150519

Direct all threadnaughts and hate to NBC.

Thunder Moose
Mar 7, 2015

S.J.C.

Hal_2005 posted:

Seriously good thread.

All I got to bring to the chat tonight is Jeff Immelt and Charlie Rose. Which is on par with bringing 10 year old boxed red wine. Sorry

http://charlierose.com/watch/60576659

Not sure if Jeff brings any fresh insight but he tries to argue the pro-TPP at his paygrade.

http://www.reuters.com/article/2015/05/19/us-general-electric-exim-exclusive-idUSKBN0O42ER20150519

Direct all threadnaughts and hate to NBC.

Charlie Rose is always welcome viewing material, thanks.

rscott
Dec 10, 2009
TPP is just capital's latest effort to bake neoliberal principles into the way international trade is conducted, which is an increasingly large portion of every counrty's economy with globalization. Those same principles are facing increasing resistance from the domestic populations of nearly every developed country that is a party to the agreement. Why should states cede their sovereignty to multinational corporations that have no loyalties to the states they're nominally headquartered in the first place? Their only loyalty is to accumulation, they have no reason to give a poo poo about the social welfare of their markets. For many products that really isn't a huge deal except in regards to abuse of the commons but when it comes to healthcare, which everyone seems to agree is a right afforded to everyone these days, the moral hazard becomes immense. Simple market actions like raising the price of your generics in response to reduced supply by your competitors suddenly have human costs. We should be regulating these companies more wrt to their ability to monopolize production of life saving treatments, not less.

More broadly, international treaties should be signed to increase the social wellbeing of the party nations, not to increase the profit margins of multinational corporations that are largely prospering while the rest of the world finds themselves in an increasingly precarious posistion.

Kalman
Jan 17, 2010

rscott posted:

More broadly, international treaties should be signed to increase the social wellbeing of the party nations, not to increase the profit margins of multinational corporations that are largely prospering while the rest of the world finds themselves in an increasingly precarious posistion.

The TPP may lower drug prices for US consumers, since actual patent protection in other markets will increase the ability of a U.S. drug company to recoup out of that market, allowing them to lower U.S. prices in order to capture portions of the U.S. market they didn't previously serve.

Should the U.S. government sign this treaty, based on the benefits to US citizens, even though it will harm people in (eg) India?

Mc Do Well
Aug 2, 2008

by FactsAreUseless
There do need to be market equilibrations as a consequence of economic interdependence - and this affects everyone and everything - labor costs, living standards, costs of medicine - going up and down all over. The great strength of the US has been the 50 states with a central system requiring open borders and trade. This is a guiding example of internationalism/globalization. Shouldn't the borders to our north and south begin to vanish as well? A continental economic shift allowing individuals to have free commerce should occur before we expand the zone of corporate border-jumping.

Mc Do Well fucked around with this message at 01:32 on Jun 19, 2015

rscott
Dec 10, 2009
Call me a skeptic if I don't believe that drug companies in this country would lower their prices when there is no regulatory pressure to do so, but even if we take your hypothetical to be true it would still be unethical for India to be party to such a treaty. It really isn't in any of these countries interest to sign this thing in my opinion though. Why give handouts to companies that do everything in their power to avoid paying taxes on their revenue and seek to supplant you at every turn?

Kalman
Jan 17, 2010

rscott posted:

Call me a skeptic if I don't believe that drug companies in this country would lower their prices when there is no regulatory pressure to do so, but even if we take your hypothetical to be true it would still be unethical for India to be party to such a treaty. It really isn't in any of these countries interest to sign this thing in my opinion though. Why give handouts to companies that do everything in their power to avoid paying taxes on their revenue and seek to supplant you at every turn?

Pretend I'm India. I currently have a weak patent system. As a result of this, my major pharmaceutical companies (Ranbaxy and Dr Reddy's) make most of their money from reverse engineering and perfecting production techniques for drugs researched by western companies. Drugs for primarily local diseases aren't being researched by western companies to the extent I would prefer, and my local companies won't put money into researching it because they can't protect them from secondary reverse engineering companies (the bottom ~2000 Indian pharma generic makers). If I sign TPP and strengthen my patent laws, then my local pharma companies can transition from being generic makers over to doing original research - for example, on dengue or antimalarial drugs. In addition, I can recognize trade benefits and make it so that my current generic (soon to be brand) makers aren't being discriminated against because we don't recognize IP laws and that frequently triggers non-reciprocation clauses in other agreements.

Is it unethical for India to sign TPP and strengthen their patent laws, in order to improve their local pharma industry which might solve local problems instead of relying on Western medicine?

rscott
Dec 10, 2009
Why rely on the private sector to fulfill a need when they won't step up to the plate? Maybe, just maybe the Free Market is not the best way to solve a problem. Shocking idea I know.

VitalSigns
Sep 3, 2011

The money to do that research isn't going to come from gouging Indian peasants on antibiotics lmao.

If India wants local scientists to research cures for ignored diseases that mainly hurt the poor, they're going to need to levy taxes on the rich and fund that research nationally, not sign treaties quadrupling the price of existing medicines and destroying their local pharmaceutical industry's ability to compete on price.

Nintendo Kid
Aug 4, 2011

by Smythe
I sure am glad it was conclusively proved that the non-existent treaty will definitely quadruple prices on antibiotics.

VitalSigns
Sep 3, 2011

Nintendo Kid posted:

I sure am glad it was conclusively proved that the non-existent treaty will definitely quadruple prices on antibiotics.

So the price increases will simultaneously not be a big deal, and also so madly profitable that Western companies will rush to create new dengue fever treatments. Okays.

Series DD Funding
Nov 25, 2014

by exmarx
They hypothetical price increases wouldn't be for existing drugs, they'd be for hypothetical new drugs that wouldn't exist at all without IP protection.

VitalSigns
Sep 3, 2011

Really? The treaty has a grandfather clause that says "oh hey any patent violations you're already doing are totally cool and you don't have to pay any license fees"?

Well that's surprisingly generous.

Although it still doesn't change the fact that there's no profit in developing new drugs for people who can't afford to buy them.

Nintendo Kid
Aug 4, 2011

by Smythe

VitalSigns posted:

So the price increases will simultaneously not be a big deal, and also so madly profitable that Western companies will rush to create new dengue fever treatments. Okays.

There is no guarantee companies will profit either, genius. Because there is no agreement!

This entire thread is nearly pointless because there won't be anything meaningful to discuss at all for months if not years. Ranting about how this will definitely hurt people in countries that aren't even party to the agreement is negatively meaningful.

India is only potentially a member but so is China, and neither is likely to actually sign it.

Nintendo Kid fucked around with this message at 03:12 on Jun 19, 2015

VitalSigns
Sep 3, 2011

Nintendo Kid posted:

There is no guarantee companies will profit either, genius. Because there is no agreement!

I was responding to a scenario Kalman illustrated about the possible effect of such an agreement to protect IP, einstein.

Nintendo Kid
Aug 4, 2011

by Smythe

VitalSigns posted:

I was responding to a scenario Kalman illustrated about the possible effect of such an agreement, einstein.

Good for you, it's still bullshit, because nothing in his argument leads to "quadrupled prices".

VitalSigns
Sep 3, 2011

Yes, that was an arbitrary number I selected obviously, but the smaller the price increase the less tenable his argument is that the golden profit potential will spur development of neglected drugs. You can't have it both ways: either the price increases over bootleg generics are negligible in which case there's no sudden rush of profits to fund new research, or they're large in which case how are people who can't afford them going to provide a profit motive.

Nintendo Kid
Aug 4, 2011

by Smythe

VitalSigns posted:

Yes, that was an arbitrary number I selected obviously, but the smaller the price increase the less tenable his argument is that the golden profit potential will spur development of neglected drugs.

Not at all. Small increases per unit on a very large volume is an assload of money. While having double would be super great if you're the owner, as little as 4% can mean hundreds of millions of dollars.

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VitalSigns
Sep 3, 2011

So you are telling me that all this hypothetical R&D on malaria and dengue fever that Kalman was touting that is unprofitable now because of the thieving poor only requires a 4% markup to be a sure-thing money-maker?

Gee, I guess that's why prescriptions in the USA only ever cost 4% more than they do everywhere else. What is everyone complaining about.

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