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

[two sheds]

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

Ok I'll bite

This article Why Hedge Funder's Price-Gouging Pill Scandal Is Even Worse Than You Might Think

says that the drug is now "closed distribution" - by raising prices that much the company has prevented other companies from producing generic versions because it's now too expensive for companies to get their hands on enough supplies to do clinical trials with.

So there’s already been one round of price-jacking with this old drug, and now Turing is here to take it to unheard-of levels. In any functioning market, someone else would jump in and offer this compound for less – but Turing’s business plan includes “closed distribution”, that loophole mentioned above to try to keep any other generic companies from getting enough of the drug to run a clinic trial proving equivalence. (What to do about this will be the subject of the next post, going up immediately after this one).

 

[not-bono-ever]

naughty.by exploiting the shitty pro pharma legislation he had gerrymandered the market for this.thats againt the rules of capitalism innit.

 

[Manter]

naughty.by exploiting the shitty pro pharma legislation he had gerrymandered the market for this.thats againt the rules of capitalism innit.

As I think I said to diamond, the pharma market is such a pickle that the 'simple rules' of economics he throws around often don't apply. I have no idea what the answer is on drug pricing, but it's definitely not the current mess....

 

[SpookyFrank]

I don't care if this kid is just a symptom of a fundamentally crooked system that rewards unconscionable behaviour, he still needs his throat cut.

 

[ViolentPanda]

he's apprantly going to cut the price but I'll wait to see by how much
for a dollar to $13.50 was steep but this is just taking the piss.

sniper elite V the cunt cull anyone want to help crowd fund it.
dick cheney is obviously going to be an end of level boss as he gets secret service protection and is armed with shotguns

TBF though, you're more at risk from Cheney if you're a friend of his.

 

[gosub]

Ok I'll bite

This article Why Hedge Funder's Price-Gouging Pill Scandal Is Even Worse Than You Might Think

says that the drug is now "closed distribution" - by raising prices that much the company has prevented other companies from producing generic versions because it's now too expensive for companies to get their hands on enough supplies to do clinical trials with.

so how according to the BBC does it cost the NHS 47p?

 

[two sheds]

Different rules US/UK I presume - specific make has to be licenced by FDA?

I did see in one of those articles that the active ingredient is known so presumably generic version produced over here.

 

[gosub]

Different rules US/UK I presume - specific make has to be licenced by FDA?

I did see in one of those articles that the active ingredient is known so presumably generic version produced over here.

but that makes the article you linked to a load of bollocks

 

[two sheds]

but that makes the article you linked to a load of bollocks

? It's talking about the US position, and why they can't have a generic version of the drug that's been bumped up in price.

Eta: I don't really know, though - Diamond knows about all this so he'll tell us when he gets here.

 

[gosub]

? It's talking about the US position, and why they can't have a generic version of the drug that's been bumped up in price.

Eta: I don't really know, though - Diamond knows about all this so he'll tell us when he gets here.

article reckons they can't make the generic coz its too expensive to get hold of the orginals to make the copies. return flight to uk where they buy a thousand < buying 3pills in states. i think your own idea, that its down to legislative differences on licensing is closer to the truth.
Fucking over the generics is supposed to be one of the things the yanks want in the trade deal. Mr Shkreli clearly doesn't give fuck about the common man, be funny as fuck if his efforts help galvanise the support needed to spike the trade deal. Billionaires (whose love I'm sure Shkreli does crave,) would be lining up to kick him in the bollocks.

 

[two sheds]

Yes I presume that they actually need the actual US-approved drug to use in the trials so bussing in a UK approved one wouldn't do.

 

[Manter]

so how according to the BBC does it cost the NHS 47p?

UK prices are set differently- the NHS negotiates prices on the basis of need, efficacy, alternatives, volume etc. a massive price hike means it may cost more in the next negotiation round, but it avoids some of the U.S. Madness

Edit to add- don't think there are other generic makers of this drug

Edit again to add I don't have access to the NHS lists but the internet suggests just over 50p per dose

 

[gosub]

UK prices are set differently- the NHS negotiates prices on the basis of need, efficacy, alternatives, volume etc. a massive price hike means it may cost more in the next negotiation round, but it avoids some of the U.S. Madness

Edit to add- don't think there are other generic makers of this drug

so we've been getting it at half the $1 pill production price (sans marketing/distribution blah blah) off this blokes company

 

[Manter]

so we've been getting it at half the $1 pill production price (sans marketing/distribution blah blah) off this blokes company

His published production price will be bullshit, tbf. But yes, odd isn't it?

There are better drugs out there, wouldn't be surprised if it is just dumped....

 

[two sheds]

Unless someone else not in the US is making it with the active ingredient for over here?

 

[gosub]

His published production price will be bullshit, tbf. But yes, odd isn't it?

There are better drugs out there, wouldn't be surprised if it is just dumped....

the people who come up with British Rail ticket prices have transferable skills, who knew!

 

[Spymaster]

Otherwise known as the patent system.

Jesus - you have no idea what you are talking about in a legal perspective, do you?

Oh fucking hell. Not again.

 

[Manter]

Unless someone else not in the US is making it with the active ingredient for over here?

The active ingredient- pyrimethamine- is listed here Pyrimethamine: Brands, Medical Use, Clinical Data

Interestingly, it has had a series of brand names- tindurin for example- but only one licence, for daraprim, is active.

There are a few places you can buy it on the internet all from India and unlicensed- this is one of the other issues with the fuck up, people get desperate and buy stuff that isn't 'real' and tested.

 

[Manter]

the people who come up with British Rail ticket prices have transferable skills, who knew!

This made me snort

 

[ViolentPanda]

the people who come up with British Rail ticket prices have transferable skills, who knew!

Dude, British Rail ticket pricers are mostly retired on in the grave by now!
Do you mean the ticket pricers for the privatised ATOCs?

 

[ViolentPanda]

Oh fucking hell. Not again.

Respect his AUTHORITAH!!!

 

[Diamond]

Ok I'll bite

This article Why Hedge Funder's Price-Gouging Pill Scandal Is Even Worse Than You Might Think

says that the drug is now "closed distribution" - by raising prices that much the company has prevented other companies from producing generic versions because it's now too expensive for companies to get their hands on enough supplies to do clinical trials with.

But all you would need to prove is bio-equivalence - there is no need for proper clinical trials because they will have been satisfactorily completed by the originator long ago otherwise the drug would not be on the market.

I have no idea what "closed distribution" is supposed to be but it sounds very close to an exclusive supply agreement either upstream or downstream, both of which are often illegal depending on the market power of the relevant participants and the term of the agreement.

 

[two sheds]

But all you would need to prove is bio-equivalence - there is no need for proper clinical trials because they will have been satisfactorily completed by the originator long ago otherwise the drug would not be on the market.

I have no idea what "closed distribution" is supposed to be but it sounds very close to an exclusive supply agreement either upstream or downstream, both of which are often illegal depending on the market power of the relevant participants and the term of the agreement.

But the guy on that site - who seems to know the precise situation over there - is saying that closed distribution is the precise reason why they can't easily produce a generic version of the drug in the US. He seems to be saying that bio-equivalence is not enough - could you point to the legislation that says it is? We ought to let him know if he's putting out such inaccurate information.

You don't know what 'closed distribution' is despite having worked on this sort of stuff for several months? It's clearly not illegal because it seems to be a common way in which drug companies in exactly this situation - where the patent has run out and the prices are ramped up - stop people from producing generic versions.

I presume that the FDA demands that any generic drug is compared in clinical trials against the precise, labelled original version. But I'm sure you can confirm or refute this with references, since you've worked on this sort of stuff for several months.

 

[Dowie]

Sad thing is, given his past form for short selling other pharma companies then (allegedly) spreading rumours about them, lobbying the FDA to not approve their new drugs etc.. basically trying to actively harm those companies... I wonder if the recent drop in share prices triggered by Clinton's response to his price rise have actually made him a bunch of money?

Hopefully he's caused enough of a shit storm that some prosecutors over there might try to get something on him - it seems from what has been posted that he's already potentially committed crimes by hacking his former employee's e-mail and social media accounts, perhaps some of his previous short selling antics could be reviewed too.... There must be something to get him on and given the size of the shit storm he has created there must surely be some prosecutors/regulators in the US actively trying to nail him.

 

[Manter]

But the guy on that site - who seems to know the precise situation over there - is saying that closed distribution is the precise reason why they can't easily produce a generic version of the drug in the US. He seems to be saying that bio-equivalence is not enough - could you point to the legislation that says it is? We ought to let him know if he's putting out such inaccurate information.

You don't know what 'closed distribution' is despite having worked on this sort of stuff for several months? It's clearly not illegal because it seems to be a common way in which drug companies in exactly this situation - where the patent has run out and the prices are ramped up - stop people from producing generic versions.

I presume that the FDA demands that any generic drug is compared in clinical trials against the precise, labelled original version. But I'm sure you can confirm or refute this with references, since you've worked on this sort of stuff for several months.

It's much more than bio equivalence- see here Abbreviated New Drug Application (ANDA): Generics it's less full on than a new drug, obv, but it's still pretty harsh, and takes 18 months- 2 years

 

[Manter]

Oh- and closed distribution is an anti tampering/counterfeiting measure. V simply, it is manufacturer>distributor>pharmacy with every step tracked and recorded. Highly regulated but ultimately means that a pill you as a patient take can be traced back through every step of its life, right back to ingredients. its where some of the really interesting work on RFiDs is going on too. There are lots of regs about re-importation etc that as well as cutting out counterfeiting cuts out the grey market and the ability for rivals, research labs etc to get large volumes of the drug.

 

[two sheds]

ta

 

[ViolentPanda]

But the guy on that site - who seems to know the precise situation over there - is saying that closed distribution is the precise reason why they can't easily produce a generic version of the drug in the US. He seems to be saying that bio-equivalence is not enough - could you point to the legislation that says it is? We ought to let him know if he's putting out such inaccurate information.

"Closed distribution" is what happens with some haz-chems. It usually means that the distribution chain goes "manufacturer - courier - end-user". In terms of pharmaceuticals that may or may not include a pharmacy - I'm aware of some companies having done deliveries direct-to-patient for non-volatile novel HIV medications in the past.

E2A: The obvious reason here for use of closed distribution is to make infiltration and substitution by rivals harder, and to make tracking/tracing any material leakage of the pharmaceuticals much simpler.

 

[ViolentPanda]

Sad thing is, given his past form for short selling other pharma companies then (allegedly) spreading rumours about them, lobbying the FDA to not approve their new drugs etc.. basically trying to actively harm those companies... I wonder if the recent drop in share prices triggered by Clinton's response to his price rise have actually made him a bunch of money?

Hopefully he's caused enough of a shit storm that some prosecutors over there might try to get something on him - it seems from what has been posted that he's already potentially committed crimes by hacking his former employee's e-mail and social media accounts, perhaps some of his previous short selling antics could be reviewed too.... There must be something to get him on and given the size of the shit storm he has created there must surely be some prosecutors/regulators in the US actively trying to nail him.

Be a shame if they have to Capone him, though.

 

[trashpony]

. I wonder if the recent drop in share prices triggered by Clinton's response to his price rise have actually made him a bunch of money?

Funny you should say that ... The Master Plan of Martin Shkreli