Drug Goes From $13.50 a Tablet to $750 overnight after buy out by hedge fund start up

[Jon-of-arc]

Another link to this
WATCH: Ex-hedge funder who hiked AIDS pill cost by 5,500 percent says drug ‘still underpriced’

Cannot believe anyone lacks basic human compassion to this level, is the world actually sliding back to pre-victorian values? Is the price of less destructive wars in the West a flowering of utter and total cunts without the belief in equality and fairness that we saw reach its peak post WW2?

He looks really creepy in the picture in that link...

He looked much less intense and megalomaniac-ish when he was playing Oswald Cobblepot/The Penguin in Gotham...

 

[Manter]

some interesting stats on cases of price gouging. This particular example may be flagrant, but it is not unique....

 

[trashpony]

some interesting stats on cases of price gouging. This particular example may be flagrant, but it is not unique....

What a bunch of cunts

 

[Manter]

What a bunch of cunts

Yes. But American cunts- this is a U.S. Issue. And systemic. So hedgie is a useful bogeyman as he is repellent and desperately needs someone to remove his social media access and stop him talking to the press, but the real issue is an american systemic issue about how drugs are priced and sold. Interesting, but in the EU drugs are priced differently.

This is a good simple explanation of what price gouging is and why 'oh, it's a generic competition will bring the price down' (as said above repeatedly, not by you!) doesn't work What The Daraprim Price Hike Actually Does To Health Care

 

[trashpony]

Yes. But American cunts- this is a U.S. Issue. And systemic. So hedgie is a useful bogeyman as he is repellent and desperately needs someone to remove his social media access and stop him talking to the press, but the real issue is an american systemic issue about how drugs are priced and sold. Interesting, but in the EU drugs are priced differently.

This is a good simple explanation of what price gouging is and why 'oh, it's a generic competition will bring the price down' (as said above repeatedly, not by you!) doesn't work What The Daraprim Price Hike Actually Does To Health Care

I guess it's good it's being discussed openly - foolish man got too greedy and has blown the whole scam wide open

 

[Manter]

I guess it's good it's being discussed openly - foolish man got too greedy and has blown the whole scam wide open

Yes. And seems to have missed charm school, he really has made himself look bad! Idiot. I just think it'd be a shame if everyone focuses on him, and backs off now he has climbed down- it's a much bigger issue

 

[Diamond]

Nope.

Not even sure where to start tbh.

Patents are based on active ingredient and formulation, plus usage. That may or may not be molecular. Cf Norovir which has three formulations patented and usages that come off patent at different times.

Generic manufacturers don't just leap in and make drugs on a whim- they still have to complete the abbreviated new drug application process (anda) that takes up to 2 years. It tests bio equivalence, efficacy, manufacturing conditions, strength, dosage, method of administration etc. generics are usually tee-ed up long in advance- see the fda website for a list of what generics are approved but not yet available- they are basically waiting for patents to expire.

This drug is used on less than 200,000 people a year. It isn't a prime target.

There is no agreed cost for r&d for a new drug. The Tufts estimate- $2.6bn is hotly debated, with numbers between $1.15 and $5bn tossed around depending on who you talk to. There are so many variables- large or small molecule, innovator compound or patent extension, codification of off label use. Do you include regulatory costs, failure costs? And these days when so many discoveries are initiated outside the big pharma firms and then bought as incubators, how much of that cost do you include?

Pfizer and GSK are not brilliant at R&D at the moment. They are outstanding at refining and then nursing drugs through the regulatory process- so much so that they are slashing r&d spending and instead setting up their own hedge funds that basically buy ideas from universities, biotech, start up etc

The pharma industry doesn't work on the normal rules of competition bringing down price- it's one of the conundrums and issues with it.

Sure - medicines may be protected by patent thickets but this one is decades old. The idea that it still benefits from any meaningful patent protection is absurd.

And sure - it's not a prime target but that is because its price point was so low before, it being off patent, that there was most likely very little profit to be made. If these guys start raking it in as a result of their current price point, generics will make every effort possible to get their ANDAs/MAs as quickly as possible so they can enter this market. It's not difficult - just simple economics.

Not sure what your point is on R&D - do you really think this guy is going to protect his price point for long enough to protect generics from entering his sector while he rakes in huge profits and also invest in new projects? That's quite frankly a ridiculous position to take.

 

[scifisam]

Yes. But American cunts- this is a U.S. Issue. And systemic. So hedgie is a useful bogeyman as he is repellent and desperately needs someone to remove his social media access and stop him talking to the press, but the real issue is an american systemic issue about how drugs are priced and sold. Interesting, but in the EU drugs are priced differently.

This is a good simple explanation of what price gouging is and why 'oh, it's a generic competition will bring the price down' (as said above repeatedly, not by you!) doesn't work What The Daraprim Price Hike Actually Does To Health Care

The US also makes using generics very difficult, I've heard. They don't allow imports from other countries - even, say the UK, where our testing guidelines are in line with the US - and are extremely strict about which drugs can be licensed for Medicare, which affects whether they can be licensed for private healthcare too.

It's not just cost stopping generics, but regulations. And that is something the US govt can potentially do something, if they have the will. A big story with a perfect bad guy like this might provide that will.

 

[Manter]

Sure - medicines may be protected by patent thickets but this one is decades old. The idea that it still benefits from any meaningful patent protection is absurd.

And sure - it's not a prime target but that is because its price point was so low before, it being off patent, that there was most likely very little profit to be made. If these guys start raking it in as a result of their current price point, generics will make every effort possible to get their ANDAs/MAs as quickly as possible so they can enter this market. It's not difficult - just simple economics.

Not sure what your point is on R&D - do you really think this guy is going to protect his price point for long enough to protect generics from entering his sector while he rakes in huge profits and also invest in new projects? That's quite frankly a ridiculous position to take.

Patents don't work on the basis of time alone. They are usually 20 years but can be extended. If you are the only manufacturer for a generic you essentially get treated like a patent holder, too.

This drug (checked this morning) is prescribed to less than 2000 Americans per year, for a week each. Developing a generic and getting regulatory approval will take c 2 years. There isn't one in the pipeline currently. Simple economics gets a bit less simple when you are dealing with the hugely complex and regulated pharma industry.

I was correcting some of your misconceptions about R&D. His case is that toxoplasmosis is second largest cause of death from food related bacterial infections in the U.S., so he wants to leverage this existing drug to treat those infections. If he could prove new/extended use he'd get a new patent. I have no idea where you got your argument above from.

Incidentally all hypothetical on this drug now, as he has backed down. But the issues of pharma pricing, price gouging, r&D pipeline stand across the industry, even if this case was v US specific

 

[Manter]

The US also makes using generics very difficult, I've heard. They don't allow imports from other countries - even, say the UK, where our testing guidelines are in line with the US - and are extremely strict about which drugs can be licensed for Medicare, which affects whether they can be licensed for private healthcare too.

It's not just cost stopping generics, but regulations. And that is something the US govt can potentially do something, if they have the will. A big story with a perfect bad guy like this might provide that will.

Interestingly, agreements on things like alignment of safe manufacturing protocols- so exactly what you suggest- are in TTIP!

 

[scifisam]

Interestingly, agreements on things like alignment of safe manufacturing protocols- so exactly what you suggest- are in TTIP!

There has to be something good in there!

 

[Diamond]

The irony in the US is that the Hatch-Waxman Act, which was designed to make it easier for generics to come to market (not all US legislators are bastards!), has actually allowed a mechanism to develop that makes it easier for originators to prevent generics coming on to their market. It's been one of the major antitrust issues for a number of years now - pay for delay/reverse patent settlement stuff.

 

[Manter]

There has to be something good in there!

Well, quite.... It's why it won't just die tbh- there are a couple of industries who are desperate for some of the things in there to be implemented.....

 

[Diamond]

Patents don't work on the basis of time alone. They are usually 20 years but can be extended. If you are the only manufacturer for a generic you essentially get treated like a patent holder, too.

This drug (checked this morning) is prescribed to less than 2000 Americans per year, for a week each. Developing a generic and getting regulatory approval will take c 2 years. There isn't one in the pipeline currently. Simple economics gets a bit less simple when you are dealing with the hugely complex and regulated pharma industry.

I was correcting some of your misconceptions about R&D. His case is that toxoplasmosis is second largest cause of death from food related bacterial infections in the U.S., so he wants to leverage this existing drug to treat those infections. If he could prove new/extended use he'd get a new patent. I have no idea where you got your argument above from.

Incidentally all hypothetical on this drug now, as he has backed down. But the issues of pharma pricing, price gouging, r&D pipeline stand across the industry, even if this case was v US specific

Yes patents can be extended - here by using a Supplementary Protection Certificate (SPC) and potentially a paediatric extension (where applicable - but neither of those will be relevant here. I haven't done the relevant patent searches because I don't have access to the relevant databases at present but I would be extremely surprised if the medicine benefits from any meaningful patent protection whatsoever.

And to state that you are treated as a patent holder when you are simply the only guy on the market who doesn't hold any patents is completely wrong. You simply don't have any IP in that situation - fundamentally, you cannot seek an injunction against market entrants.

 

[Manter]

scifisam worth saying too that you can import drugs to the U.S., provided they meet US regulations. Which isn't a bad thing . In the EU we can't even agree between all of us what testing etc standards we want, so the fact we don't agree with the U.S. Shouldn't be a surprise. And the FDA has teeth and isn't afraid to use them. Their standards are in some ways higher than ours, eg on testing in target populations.

Global centres of manufacture for a couple of things are in Ireland and NL, and then shipped to multiple markets including the U.S.- but the manufacturing sites have to prove they meet US standards, there are inspections by the FDA etc. stuff is usually shipped un-packaged as the most Byzantine legislation is around what the boxes say. There are even rules on font size and how much white space there has to be on the box....

 

[Manter]

Yes patents can be extended - here by using a Supplementary Protection Certificate (SPC) and potentially a paediatric extension (where applicable - but neither of those will be relevant here. I haven't done the relevant patent searches because I don't have access to the relevant databases at present but I would be extremely surprised if the medicine benefits from any meaningful patent protection whatsoever.

And to state that you are treated as a patent holder when you are simply the only guy on the market who doesn't hold any patents is completely wrong. You simply don't have any IP in that situation - fundamentally, you cannot seek an injunction against market entrants.

Dreary me. Have you not read my posts?
I have said over and over again that this drug is a generic, but there is only one manufacturer. I have
1. Corrected your terminology/ understanding about pharma patents, which are not necessarily molecular and are not defined by time but by a much more complex assessment.
2. Tried to explain why a drug being a generic won't suddenly mean loads of other versions. 3. Tried to explain why price gouging happens in the U.S.- why the simple laws of capitalist economics- more competition=lower price- don't apply. If you are the sole manufacturer of an off patent orphan drug in the U.S. you get additional protections which means from a day to day perspective you are treated as if you were the patent holder. Sure, if someone turned up and applied for an ANDA and after 2 years was successful and they wanted to undercut you on price that is their prerogative. But it won't happen.

 

[N_igma]

They don't allow imports from other countries - even, say the UK, where our testing guidelines are in line with the US

Not strictly true I work for a veterinary pharmaceutical company and we export to the US all the time although that is for animals not humans.

 

[Manter]

Er, google also tells me SPCs are EU. You do know we are discussing the U.S.?

 

[Manter]

Not strictly true I work for a veterinary pharmaceutical company and we export to the US all the time although that is for animals not humans.

V similar regs

Edit to add- I don't know huge amounts about animal health but one of my employers accidentally bought an AH operation they couldn't sell while I worked for them! Two years of frantically scrambling to try and figure them out

 

[Diamond]

Dreary me. Have you not read my posts?
I have said over and over again that this drug is a generic, but there is only one manufacturer. I have
1. Corrected your terminology/ understanding about pharma patents, which are not necessarily molecular and are not defined by time but by a much more complex assessment.
2. Tried to explain why a drug being a generic won't suddenly mean loads of other versions. 3. Tried to explain why price gouging happens in the U.S.- why the simple laws of capitalist economics- more competition=lower price- don't apply. If you are the sole manufacturer of an off patent orphan drug in the U.S. you get additional protections which means from a day to day perspective you are treated as if you were the patent holder. Sure, if someone turned up and applied for an ANDA and after 2 years was successful and they wanted to undercut you on price that is their prerogative. But it won't happen.

I have read your posts and they are singularly uninformed about the law.

Clearly you know a bit about the sector but to state that a monopolist on a generic market is treated in the same way as a patent holder is ridiculously ignorant.

 

[Diamond]

And I'm not sure where you got the idea that I stated that a molecule patent is the only IPR that can protect a treatment...

 

[Diamond]

Er, google also tells me SPCs are EU. You do know we are discussing the U.S.?

Yes, I said "here" - this jurisdiction.

Do you know anything about generic entry because it sounds as if you categorically do not.

Can you explain Hatch-Waxman, for instance?

 

[Bahnhof Strasse]

I have read your posts and they are singularly uninformed about the law.

'ere we go again.

Fuck off Diamond you tedious cunt.

 

[Bahnhof Strasse]

Manter if you've not come across this cretin before, just stick the prick on ignore. He thinks he's a lawyer, but has trouble understanding Mr Man books.

 

[two sheds]

The irony in the US is that the Hatch-Waxman Act, which was designed to make it easier for generics to come to market (not all US legislators are bastards!), has actually allowed a mechanism to develop that makes it easier for originators to prevent generics coming on to their market. It's been one of the major antitrust issues for a number of years now - pay for delay/reverse patent settlement stuff.

Errrrrrm doesn't that back up what Manter is saying and contradict your argument that it will be easy for other manufacturers to produce generic versions?

 

[trashpony]

Errrrrrm doesn't that back up what Manter is saying and contradict your argument that it will be easy for other manufacturers to produce generic versions?

Are you trying to reason with him?

 

[not-bono-ever]

Errrrrrm doesn't that back up what Manter is saying and contradict your argument that it will be easy for other manufacturers to produce generic versions?

Yup. The premise of the act was unlikely to be anything that would restrict the pharmaceutical lobby would it ?

 

[Diamond]

Errrrrrm doesn't that back up what Manter is saying and contradict your argument that it will be easy for other manufacturers to produce generic versions?

No it doesn't - what we are dealing with here is a drug that has already gone generic.

Hatch-Waxman is supposed to be about facilitating generic entry into an originator market but because of its mechanism, and this is very disputed, has allowed originators to restrict generic entry where there is patent protection of dubious validity.

This is the most recent relevant decision from the SCOTUS if you fancy a bit of a long read:

http://www.supremecourt.gov/opinions/12pdf/12-416_m5n0.pdf

 

[Diamond]

I spent two years working on one of these cases so I'm fairly sure that I'm on pretty firm ground here.

 

[Manter]

Then you'll know it's one of two objectives of the act- the other being to protect innovator firms and allow them to get the benefit of their research.