Most Hated Man in America

Skanda_sl said:

You are suppose to keep it on the down low so you don't enrage the peons enough for them to get their pitchforks. Never wave it in their face.

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Yeah obviously. This guy is par for the course. Most these people however are smart enough to turn down a few notches when needed, but his aspy ass just isn't able.

I think he should run for congress.

Big Phoenix_sl said:

So of this drug isn't protected by patents why aren't other companies out they're making it?

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They still have to go through regulatory approval, which is costly and takes a lot of time. What really needs to happen is a reciprocal agreement between the EU and the US, where drugs tested in one market get approved in the other. The requirements for clinical trials follow pretty much the same best practices, so it's just duplicating work. That would immediately increase the number of drugs (including generics) in both markets.

This isn't even about importing drugs (which should also not be a big deal between the US, Canada, and the EU -- but is opposed because the same drugs can be sold at a much higher price in the US), just about the right to sell them.

Big Phoenix_sl said:

So of this drug isn't protected by patents why aren't other companies out they're making it?

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To have a generic approved you need to prove its as effective as the original. The company that owns the original can refuse to sell the drug to any competitors so it's impossible for anyone to conduct tests to prove their generic is as effective.

New FDA Draft Guidance on REMS and Bioequivalence Studies: Does New Procedure Secure ANDA Applicants The Right to Obtain Samples? | FDA Law Updatehas more info on the legal issue and some of the failed attempts to prohibit this behavior.

Kuriin_sl said:

Doesn't Medicare have to deal with the Drug Plan (Plan D)? Donut hole for the lose.

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The bigger problem is after the donut hole (4700 out of pocket spending) people enter catastrophic coverage and only play 5% of the drugs cost. So you hit catastrophic coverage your first month and end up paying 1200 a month for the drug and the plan covers the 21k remainder.

Big Phoenix_sl said:

So of this drug isn't protected by patents why aren't other companies out they're making it?

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Your formulation still has to be approved by the FDA in order to sell it, and nobody else bothered to waste time and money getting one approved because, well, it was only selling for $13.50.

This guy figured out that since AIDS patients need the drug, it could be sold for a lot more. So he bought the rights to that specific formulation and jacked up the price. Other companies can also sell the drug, but it gives him a few years to cash in while they develop their own versions and get them approved.

Sanders and Cummings also wrote to the CEO of Valeant Pharmaceuticals last month to protest dramatic price increases for two heart drugs, Isuprel and Nitropress. Valeant raised the price for Isuprel more than 500% -- from $215.00 to $1,300 a vial -- and boosted the price of Nitropress by more than 200% -- from $257 to $800 a vial -- shortly after buying the drugs from Marathon Pharmaceuticals in February. Valeant is the only company that sells the medications, which can be life saving.

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He isn't the only person doing it in the industry... he just added 1 too many zeroes. If you raised it 500% he would have gotten away with it.

My only solace in this nonsense is that fairly soon AIs will be developing the medications instead of pharma companies. It's to bad the GoogleCancer drug was delayed after the iChemo sales cornered the market.

That's dangerous logic, though.

Big Phoenix_sl said:

So of this drug isn't protected by patents why aren't other companies out they're making it?

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Others have explained, but it is essentially a combination of two things--a regulatory wall, and the issues that stem from "Orphan Drugs" (Note; I only know this from reading the Economist and a few in depth articles on it a couple years ago, its been an issue for a while.) But first, about a decade ago, this drug was made for 1$ a pill, it was sold, and the price jacked up to 13.50. Revenues went up from 600k to 6.6 million--which shows the need in pretty inelastic, most of their customers continued to buy even after the 1300% price hike. His only worry, once he purchased it from the new company, is making sure to set a price that is juuuust low enough so the insurance companies will still suffer from bad PR if they try not to buy it for a dying patient. And as he said, since it is life saving? The key here, actually, is the "image" of it, people tolerate very high prices for "needed" drugs, and he's hoping to shame insurance companies into capitulating for it. Beyond that...

1.) The regulatory wall is severe, as others have said, you need to prove your generic is as good as the original. Even if you know all the ingredients, the actual formulation can be difficult (I don't think that's the case here though, this drug is so old how its made is also well known.)...However, equipment that would pass muster for the FDA? Is extremely expensive, we're easily talking into the millions of dollars for just the manufacturing ability. In addition to that, and here is the important thing--the FDA "Abbreviated New Drug Application" for generics,can take 1-2 years, and that is even with a perfect set up. Just like most things with the government, it is a slow process, even if everything works correctly. (So even if someone does decide to try? This guy gets 1-2 years of gouging, with no chance AT ALL of competition. Even IF someone was crazy enough to try.)

1B.) The Pharmaceutical industry in the U.S. is closed distribution, meaning, from what I understand, there must be a kind of chain of custody from them, to the pharmacy, to your hands. This is to prevent foreign "sub standard" generics from appearing in pharmacies (Which in some cases is good, in others it is thinly veiled protectionism). But this allows this asshole to see exactly who his customers are--and companies like this vigorously check to make sure no company is buying it for research purposes. (And they can deny the sale too, if a company is--because, from what I read, much like the Pharmacy, due to the closed distribution system they can prevent any sale they want.)....So you can't actually get the pills, to test them, to make a generic.

(And companies really are jerk offs in other ways too...Recently companies have begun making very small alterations to old patents, in order to get new ones, then discontinuing their old drugs before their patent expires, thereby not allowing anyone to purchase the old drug to make a generic. One pill currently on the market got a new patent for changing the delivery system, from tablet to capsule, another got one for changing the color of the pill and adding a flavor to it. (I'll have to look this up to make sure, but there have been some ridiculous ones).)

2.) Its an Orphan drug. Which is to say it is only prescribed for a very tiny market. Since the drug has no other approved uses in the U.S. except for the small parasite market? It's only customers are around 2k people. This means a company needs to spend millions to make a generic, wait years, and possibly never achieve it--only to have a market so tiny that they really would have to charge an absorbent amount to turn a profit. And the thing of it is? Since their competition has such an enormous supply chain advantage; they can easily drop the medication price back down to pennies on the dollar, locking the competition who invested out of the market (Which is especially bad, because now the company trying to bring this drug out not only can't sell it, but lost a lot of capital in the process.)

Big Phoenix_sl said:

So government regulation allowing this fuckery to happen?

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Not really. The lack of regulation allows this to happen. An overnight price hike of how many thousand percent? On an old medication. For no better reason than lol I can.

Something like this -should- be the impetus for market oversight. It won't be, but it should be.

Not to be all GA about it, but honestly, you want this kind of shit to be more subtle -- someone needs to shoot this guy in the face.

He'll probably drop it to 70 bucks or something and talk about what a swell guy he is and how his company provides a valuable community service.

Shotgun to the face, only real way to fix it.