Another Pharma Company Recaptures a Generic Medication

Applehu Akbar writes: Daraprim, currently used as a niche AIDS medication, was developed and patented by Glaxo (now GlaxoSmithKlein) decades ago. Though Glaxo's patent has long since expired, a startup called Turing Pharmaceuticals has been the latest pharma company to 'recapture' a generic by using legal trickery to gain exclusive rights to sell it in the US. Though Turing has just marketing rights, not a patent, on Daraprim, it takes advantage of pharma-pushed laws that forbid Americans from shopping around on the world market for prescriptions. Not long ago, Google was fined half a billion dollars by the FDA for allowing perfectly legal Canadian pharmacies to advertise on its site. So now that Turing has a lock on Daraprim, it has raised the price from $13.50 a pill to $750. In 2009 another small pharma company inveigled an exclusive on the longstanding generic gout medication colchicine from the FDA, effectively rebranding the unmodified generic so they could raise its price by a similar percentage.

Comments

Shop elsewhere if you need this drug

[Calibax]

Daraprim (generic name Pyrimethamine) is also used a alternative treatment for maleria where quinine cannot be used, although resistance is now prevalent worldwide. The manufacturing cost is roughly $1 per 25 mg tablet, so even the old price of $13.50 per tablet is a very substantial markup. A typical course of treatment requires around 90 to 120 tablets.

Anyone in the USA needing this drug should fly to the UK where it is still manufactured by GKN and sold for the equivalent of $70 for 90 tablets. Those same 90 tablets would cost $67,500 at the new price in the USA, so the saving would be substantial even allowing for air fare, hotel, etc.

Some enterprising company willing to spend the money to get approval to import the drug from the UK would put this startup out of business. Hopefully.

Re:Shop elsewhere if you need this drug

[Jiro]

Some enterprising company willing to spend the money to get approval to import the drug from the UK would put this startup out of business. Hopefully.

They can't, because of the loophole (which is not explained in this article, but is in other articles like http://blogs.sciencemag.org/pi... ): You are not allowed to sell a generic equivalent unless you can prove it is as effective as the nongeneric version. In order to prove it is as effective as the nongeneric version, you need to do trials that compare it to the nongeneric version. The company that owns the nongeneric version refuses to sell you any, so you can't do trials, so you can't prove it's effective, so you can't sell it.

Re:Shop elsewhere if you need this drug

[ColdWetDog]

Or go to Mexico. Or any other civilized country.

Or perhaps, hammer your hapless elected representative to allow for 'free trade' in pharmaceuticals. Remember that concept? The world is your oyster. It's time that gobalization benefited the majority of the population for a change.

Re:Shop elsewhere if you need this drug

[Intrepid imaginaut]

How did they ever excuse the restrictions in the first place, quality control?

Re:Shop elsewhere if you need this drug

[quantaman]

Daraprim (generic name Pyrimethamine) is also used a alternative treatment for maleria where quinine cannot be used, although resistance is now prevalent worldwide. The manufacturing cost is roughly $1 per 25 mg tablet, so even the old price of $13.50 per tablet is a very substantial markup. A typical course of treatment requires around 90 to 120 tablets.

Anyone in the USA needing this drug should fly to the UK where it is still manufactured by GKN and sold for the equivalent of $70 for 90 tablets. Those same 90 tablets would cost $67,500 at the new price in the USA, so the saving would be substantial even allowing for air fare, hotel, etc.

Some enterprising company willing to spend the money to get approval to import the drug from the UK would put this startup out of business. Hopefully.

Unless the startup just drops the price back down to put the enterprising company out of business.

The whole idea behind drug pricing is really weird. How do you determine a price for something that can literally mean the difference between life and death? What happens when you have things like drug plans, insurance, and regulations to ensure quality. I really don't know how you'd expect a market to properly function.

Re:Shop elsewhere if you need this drug

[gstoddart]

Corporate profits.

In case you haven't noticed, American politicians are more than willing to entrench corporate profits into law.

When pharma buys a law, you can make damned sure it's only pharma who benefits. Likewise, when the copyright cartel buys a law, it's only a good thing for them.

Basically when corporations buy laws, they write it, give themselves exemptions and loopholes so they control the outcomes ... it's a stacked deck, by a corrupt process which says the more money you have the more access to "democracy" you have.

Me, I think shit like this is pretty much demonstrating how the US has sold the farm for a couple of magic beans in the form of "intellectual property". Free markets? Who wants one of those when you can guarantee corporate profits and not have to work for it?

I hope this CEO gets mauled by bears.

Re:Shop elsewhere if you need this drug

[Spy Handler]

Corporate profits.

In case you haven't noticed, American politicians are more than willing to entrench corporate profits into law.

This is why we should all vote for Donald Trump. Bush and Clinton will do whatever Big Pharma tells them to do, but Trump won't.

Re:Shop elsewhere if you need this drug

[Cyberax]

The problem is, you CAN NOT get an approval for an alternative generic. This shitty fucktard invoked an FDA clause allowing this company to use "closed distribution". I.e. this company can pick and choose to which customers it sells the drug in exchange for discounted pricing.

Why does it matter? - To market a generic drug you need to show that it's equivalent to an existing drug. And Turing can block any such clinical study - a classic Catch-22. This loophole should be fixed, but given the dysfunctional state of the Congress any bill fixing this will probably be encumbered with a prohibition on abortions and more NSA spying.

Re:Shop elsewhere if you need this drug

[Calibax]

There are no generic manufacturers for Daraprim because of the low volumes sold. This startup bought the exclusive right to sell the drug in the USA, which is why they can jack up the price.

Other countries still sell it for low prices. The cost of the drug in Canada, or the UK, or Mexico (if you trust their pharmacies) make a trip out of the country worthwhile.

Re:Shop elsewhere if you need this drug

[TsuruchiBrian]

The whole idea behind drug pricing is really weird. How do you determine a price for something that can literally mean the difference between life and death? What happens when you have things like drug plans, insurance, and regulations to ensure quality. I really don't know how you'd expect a market to properly function.

This is a hard question for new drugs. But this drug is old, and I think the answer is really easy. The patent should have expired by now. There should be nothing stopping another company (or maybe a nonprofit) from also producing the same drug and selling it at a more reasonable price. In the meantime, people can apparently buy the drug outside the united states for much less.

There are laws against importing drugs from other countries (even ones approved by the FDA), and that is not in the best interest of the American people and should change.

This is case of a market failure to be certain, but there is no reason there can't be a market correction. All the money that might be spent on $750 pills would be better spent on a non profit organization whose goal is to make this drug available at a reasonable price. This company and it's asshole CEO deserve to die, and I think it is most efficient and only fitting that this death be by the free market.

Re:Shop elsewhere if you need this drug

[countach]

Surely the drug still sold by GSK in the UK would still be considered the "original drug", no? I mean, I would presume that when GSK was selling it in the US, they'd have been free to import it themselves from their UK subsidiary without anybody blinking an eye, right?

Re:Shop elsewhere if you need this drug

[Anonymous Coward]

QC is a big deal, but also sometimes the name brands are simply better. My daughter's asthma is life threatening at times, and generic Albuterol doesn't work nearly as well as the name-brand. We had three expensive ER visits before the doctor suggested the generic as the problem. Also, my wife's name-brand migraine pills work so much better than the generic, I think because of the coating, that her insurance company pays for the name-brand even though the generic is available. When an insurance company recommends a much more expensive name-brand over a generic, you know there are problems with at least certain generics.

Re:Shop elsewhere if you need this drug

[barc0001]

Or alternatively, a company could possibly run "treatment tours" to the UK with complete packages. Not sure if that would fall afoul of the law against Amercians shopping on the world market mentioned in the intro blurb though.

Re:Shop elsewhere if you need this drug

[countach]

Once the enterprising company has spent the money developing it, there wouldn't be much incentive to stop just because another player dropped prices. It would be then just a battle for whoever had deeper pockets.

Re:Shop elsewhere if you need this drug

[PopeRatzo]

Free markets? Who wants one of those when you can guarantee corporate profits and not have to work for it?

Or, it just may be that "free markets" don't exist, have never existed and cannot exist, and this is just a snapshot of what late-stage capitalism looks like.

When it's dog eat dog, the big dog eats and sick dogs die.

LISTEN CAREFULLY: There is no "free market" solution to health care costs. Not drugs, not hospitals, not doctors. How would you feel if you lived in a small town and the doctor came out to your house to see to your sick child and you were told, "You're child won't live the night without this drug. I've got exclusive rights to the drug and even though it costs me $0.25 to make, I'm going to charge you $100,000 because it's a matter of supply and demand and your dying daughter has just increased your demand."

There is no "free market" solution to health care costs because sick people are vulnerable. Their families are vulnerable. And people with the last name, "Inc" will gladly throw a baby off a bridge for a dollar.

Re:Shop elsewhere if you need this drug

[PopeRatzo]

This is why we should all vote for Donald Trump.

Clearly, you have some expertise with pharmaceuticals.

Re:Shop elsewhere if you need this drug

[Zaelath]

Isn't the problem though that the insurance companies are the ones that pay for the drug, so there's no incentive for your European holiday, just a general reaming to the entire US population in the form of more inflation of the health insurance market? (Plus Mexico/Canada is closer...)

Re:Shop elsewhere if you need this drug

[siphonophore]

Your comment is the real meat of this story. All outlets are being lazy and stupid by making the story all about this one unethical businesskid.

Re:Shop elsewhere if you need this drug

[quantaman]

Your comment is the real meat of this story. All outlets are being lazy and stupid by making the story all about this one unethical businesskid.

I'm not sure if I'd call them lazy and stupid.

If you want to rally people to a cause there's nothing better than an unrepentant entitled asshole nominating himself as the villain.

Re:Shop elsewhere if you need this drug

[Anonymous Coward]

Yeah, it's amazing how many free trade agreements you can have and still not end up with.....free trade.

Re: Shop elsewhere if you need this drug

[dell623]

That's ridiculous. It doesn't cost just a dollar to manufacture and sell critical drugs like this.

It costs a few cents. That's how much it retails for in India.

The summary doesn't mention the name of the active ingredient, on slashdot that's pretty inexcusable. Don't give the market name importance.

The real story isn't the egomaniac Ceo, he's doing what's on his job description. The story is the complete absence of checks and balances. Seriously, what the fuck is wrong with your country? They have a nation wide exclusive on a half century old drug with the freedom to set any price they want??? Sanctioned by the Fda?

Sounds like something Obama could do something about. Import vast quantities of the drug, accelerate Fda approval, flood the market? You do have emergency provisions in the law for importing critical medical supplies I hope? You do right? Why isn't this the fucking story, not some idiotic Twitter baiting?

Re:Shop elsewhere if you need this drug

[Anonymous Coward]

Free markets? Who wants one of those when you can guarantee corporate profits and not have to work for it?

Or, it just may be that "free markets" don't exist, have never existed and cannot exist, and this is just a snapshot of what late-stage capitalism looks like.

When it's dog eat dog, the big dog eats and sick dogs die.

LISTEN CAREFULLY: There is no "free market" solution to health care costs. Not drugs, not hospitals, not doctors. How would you feel if you lived in a small town and the doctor came out to your house to see to your sick child and you were told, "You're child won't live the night without this drug. I've got exclusive rights to the drug and even though it costs me $0.25 to make, I'm going to charge you $100,000 because it's a matter of supply and demand and your dying daughter has just increased your demand."

There is no "free market" solution to health care costs because sick people are vulnerable. Their families are vulnerable. And people with the last name, "Inc" will gladly throw a baby off a bridge for a dollar.

Sure there is, kill the guy with the pills, give them to your kid, and turn yourself in. A knife is cheaper than the pills, and most juries won't convict if someone is that much of an asshole. Sick people aren't the only vulnerable ones in this situation, that's why we pass laws and generally follow them. It's called civilization.

I'm fine with me making 100x what someone else makes and someone else making 100x what I make. I think you need to examine tax policy if you are seeing a situation where Bob makes 10,000x what Bill does though. I don't care if you give aid to Bill or tax Bob to bring it in line, but that delta is not sustainable in w world with guns, knives and rocks.

Re:Shop elsewhere if you need this drug

[phantomfive]

When pharma buys a law, you can make damned sure it's only pharma who benefits

The lawyers benefit, too. They're the ones write the law, after all.

Re:Shop elsewhere if you need this drug

[gijoel]

Chances are your elected representative thinks 'free trade' is an excuse to berate poor countries into enforcing punitive IP agreements. They have to answer to their political masters, political lobbyists.

Re:Shop elsewhere if you need this drug

[tmosley]

To answer your first question, the market sets a price. To answer your second, the price goes up.

You are exactly correct that this market can not function properly. It is simple to see why when you realize that it is neither free market, nor socialist, nor anywhere in between. Instead, it is fascist.

Re:Shop elsewhere if you need this drug

[BradMajors]

Research has shown that the more expensive the drug, the greater the placebo effect.

Re:Shop elsewhere if you need this drug

[the gnat]

This loophole should be fixed, but given the dysfunctional state of the Congress any bill fixing this will probably be encumbered with a prohibition on abortions and more NSA spying.

Eh, I think this case may be outrageous enough to get them to close this particular loophole, and here's why: it's an indefensible perverse incentive, Big Pharma doesn't need it, and the last thing the lobby wants is for politicians to be talking about drug prices in general. Right now their stock prices are falling because of Clinton's comment, and most people working in biotech or pharma think Shkreli is an asshole* and would happily feed him to the wolves anyway. What they need is a very targeted bill that prevents this particular abuse but doesn't touch any other part of the wider industry's business model. I think they could get broad bipartisan support for this - it's the kind of no-brainer that allows politicians to take credit for something without having to address real-world problems.

(* Most of us have scientific backgrounds, and Shkreli is exactly the kind of humanities-major business-weasel we've despised since college. Actually, worse, because most econ majors don't eventually stalk the families of former employees. No one else will cry when his BMW is repossessed.)

Re:Shop elsewhere if you need this drug

[Darinbob]

Now a good trick is to convince doctors to not prescribe this drug if needed, but prescribe other drugs that may be effective, or even recommend a summer vacation to Canada. Part of the problem is that doctors are too far removed from costs, and they'll prescribe a drug without realizing the economic impact; even if patients can afford it because of insurance, it raises costs of drugs overall thus health costs continue to rise.

Re:Shop elsewhere if you need this drug

[sjames]

No. Insurance doesn't help this particular problem at the social level, it just changes things from us paying 4 times more than we should for medical bills to 4 times more than we should for insurance premiums.

Re: Shop elsewhere if you need this drug

[the gnat]

Seriously, what the fuck is wrong with your country? They have a nation wide exclusive on a half century old drug with the freedom to set any price they want??? Sanctioned by the Fda?

I forget the exact background, but there was originally a sensible reason for the "orphan drug" regulations - the FDA are trying to ensure a stable supply of relatively rare drugs like this one, which may not be particularly profitable to make, so they offer limited exclusivity (which effectively means "they allow the company to sell the drug at a higher price than would otherwise be the case"). I think there are valid arguments in favor of the overall concept, but like many regulations, it ended up providing perverse incentives for corporate raiders. In this particular case, I think the fact that it's "closed distribution" is what's really indefensible, since it makes generics testing impossible.

Re:Shop elsewhere if you need this drug

[nobuddy]

This is why we need a sarcasm font.

Re: Shop elsewhere if you need this drug

[s.petry]

Seriously, what the fuck is wrong with your country?

How long of a list do you want? Cronyism, nepotism, and more corruption than you could discuss in a week. Worse than some in certain areas, but not totally unique. Most of us from the US on Slashdot know about it and discuss it. Convincing the masses of the problems and working toward solutions is another story. Again, not unlike other countries where the masses live in extreme poverty and don't revolt, while the bureaucrats live like kings. Our poor just happen to be better off than your poor (I think)

Re:Shop elsewhere if you need this drug

[Pluvius]

Incorrect. If brand-name manufacturers had this sort of power over generic drug approval, then there would be no generic drugs. The people who are saying that they can withhold consent to having their drugs used in bioequivalency trials are doing so based on a court case that never went to trial, about a company (mis)using REMS (a restriction placed by the FDA on certain dangerous drugs) to keep other companies from having their product. Daraprim is not a REMS drug AFAICT.

The real reason why there are no generic versions of Daraprim is because creating one and getting one approved costs a lot of money. When Glaxo was still selling the drug at a relatively low price, there was no incentive to make a generic because said generic couldn't be competitive. Now that Turing has marked the price up, a generic is far more feasible, but it will still take a considerable amount of time before one gets on the market. And even then, it might not be worth the risk that Turing will just lower the price and undercut any would-be competitors.

Rob

Re:Shop elsewhere if you need this drug

[Applehu Akbar]

"You are not allowed to sell a generic equivalent unless you can prove it is as effective as the nongeneric version"

This is why my remedy, if elected, for this situation would be to strip the FDA of all powers to regulate the market for drugs. Let it have proposed new drugs tested for safety and efficacy, as it does now, but let its findings be advisory only. Doctors, patients and insurance companies would generally follow its recommendations as a "gold standard," but absent any power to prevent consumers from shopping around on the world market for cheaper subscription fills and absent any power to enforce sweetheart deals with pharma, the free market would bring the US prices of medications into line with worldwide prices.

given such a reform, abominations like the colchicine deal and the Daraprim deal would a footnote in the "Communism" chapter in our history books.

Re:Shop elsewhere if you need this drug

[Applehu Akbar]

Has Trump, whose wealth comes in part from gaming the federal bankruptcy laws, rendered an opinion on this case?

Re:Shop elsewhere if you need this drug

[Darinbob]

There is no open market is the problem. Rather than sell to pharmacies which then sell to anyone legally allowed to by it, they have a private distribution channel. Several drugs have gone this route, almost certainly for the purpose of keeping control of drugs whose patents have expired.

Re:Shop elsewhere if you need this drug

[Darinbob]

The villain who upset the apple cart though. I can imagine a lot of pharmaceutical CEOs highly annoyed that after years of slowly raising prices, one new asshole raises them suddenly so that the whole world now takes notice.

Re:Shop elsewhere if you need this drug

[publiclurker]

An easier way to make money would be to start some sort of travel agency combined with a doctor that can write the prescription. For significantly less than 67K they set up an apointment with the doctor, book a flight and a nice hotel for awhile. Maybe even throw in a commemorative nick-nak.

Re:Shop elsewhere if you need this drug

[gstoddart]

Or, it just may be that "free markets" don't exist, have never existed and cannot exist, and this is just a snapshot of what late-stage capitalism looks like.

I live in a country with socialized medicine ... I agree with you completely.

I think any system which allows some douchebag corporation to buy the rights to a drug and jack the price up by that much is inherently flawed.

And I believe a government in which industry can buy themselves laws which suit their own purposes is doomed to fail, and is likely in the middle of failing.

America has been coopted by corporate interests. And there are way too many politicians telling us this is the way forward.

Buying a drug so you can make it artificially scarce and jack up the prices by that much? That's not a "free market" ... that's a system which is so utterly broken as to be scary.

The modern form of "capitalism" is pretty much a cancer on the world. It's nothing but greedy douchbags with politicians in their back pocket giving them laws which allow them to manipulate the system as they see fit.

Re:Shop elsewhere if you need this drug

[Anonymous Coward]

So this evil was not perpetrated by Big Pharma, but rather a small startup.

Just sayin'

Re:Shop elsewhere if you need this drug

[publiclurker]

Or they can wait until you have spent all of the money getting approval and then drop their price back down so you can't recoup your expenses. no problem, after awhile, they can buy you our for a song and jack the prices back up again.

Re:Shop elsewhere if you need this drug

[quantaman]

Once the enterprising company has spent the money developing it, there wouldn't be much incentive to stop just because another player dropped prices. It would be then just a battle for whoever had deeper pockets.

Then price drops towards cost of production. The first pharma still gets the windfall from between when they jacked up prices and the enterprising company finally got up an running. The enterprising company might never make a profit since the price drops the moment they enter the market.

The enterprising company knows this will happen which is why they don't enter the market to being with.

Re:Shop elsewhere if you need this drug

[publiclurker]

but not necessarily the legal type.

Re:Shop elsewhere if you need this drug

[Darinbob]

They don't do what big companies ask just because they want some bribes. Bush and Clinton were also rich. Not as much as Trump, but certainly rich enough that they never had to worry about hardships for the rest of their lives. What they wanted was power, and Trump wants that too. Power means a huge spigot of money to fund lots of elections and not even Trump has that much money.

Re:Shop elsewhere if you need this drug

[Applehu Akbar]

That's why we have insurance and other prepayment schemes. Of course a given single payment with a medical crisis has an inflexible demand. So in anticipation of possible future need, you make arrangements with an organization that contracts for medical services, devices and drugs on your behalf so you can be supplied in times of need. Such an organization can be an insurance company or a government agency like the VA. If we had a free market, worldwide, in medicine, it is these organizations who would be able to save on medical costs. Through competition in a free market, these savings are passed down to the customer.

This is the medical system we could have if the ACA and other government medical buyers were allowed to shop the worldwide market, and if insurance companies were allowed to shop around, and if patients were allowed to form buyers clubs to shop around.

Re:Shop elsewhere if you need this drug

[sims 2]

At the doctor the other day I found out they charge less if you don't have insurance. They charge the insurance compaines more because they know they can get it.

Which in the end costs everyone more who is paying for insurance.

W/insurance $237 $75 dedductable
WO/insurance $50

So it looks like you are paying a lot less with that $75 than you really are. Since its a lot of the reason why your premiums are so high.

Its more systemic than anyone wants to admit.

Re:Shop elsewhere if you need this drug

[Darinbob]

And this keeps the prices high. Take some generic $10 pain killer that has some occasional side effects of gastric irritation, add a $5 component that reduces the irritation, now you take that new compound and renew your patent and sell the result for $100. But you can get exactly the same effect for $15 by taking two pills. Except that doctors prescribe the $100 option because they never see the actual price and assume that insurance will cover it all.

How much more is the actual cost of the migraine pill with the coating versus without the coating? Not cost to you, but cost that the insurance company is paying? And what is the cost to health care overall to maintain these inflated prices?

Re:Shop elsewhere if you need this drug

[cascadingstylesheet]

Or, it just may be that "free markets" don't exist, have never existed and cannot exist, and this is just a snapshot of what late-stage capitalism looks like.

In 2009 another small pharma company inveigled an exclusive on the longstanding generic gout medication colchicine from the FDA, effectively rebranding the unmodified generic so they could raise its price by a similar percentage.

Oh dear. It's too bad that no "progressives" have had any power since 2009.

Re:Shop elsewhere if you need this drug

[Zaiff Urgulbunger]

Turing Pharmaceuticals CEO Martin Shkreli defends HIV drugs price hike
What a sack of shit he is.

Re:Shop elsewhere if you need this drug

[sjames]

Sadly, at hospitals, they charge individuals a lot more than they charge insurance companies.

Re:Shop elsewhere if you need this drug

[Darinbob]

But you need a supply of the original drug in order to copy it. Patents as written down do not contain detailed information on how to replicate the product. And this company does not sell its drug on the open market (that is, you don't get this drug at the local pharmacy). Even doctors complain that they can't get this drug (daraprim) just to keep in local supply, so that when they do need to prescribe it there is a delay in getting the drug.

As far as this asshole CEO, he was already well hated before this came out. He was a former hedge fund manager. He was CEO of one bio tech company and later fired; their board sued him for $65 million claiming he was using the bio tech company to help pay back his former hedge fund investors.

Re:Shop elsewhere if you need this drug

[rtb61]

Technically speaking that is quite true, Trump would never do what they tell him to do. Trump would only do what they invited him in to partner with, no bribes, Trump would demand a full piece of the action. No piece of the action and Trump would try to destroy them because competitors must be destroyed. The bigger the corporation the greater the harm, so this would make things even worse (of course his potential competitors will go nuts on spending to block him, if and only if it looks like he is really going to win).

Re: Shop elsewhere if you need this drug

[Darinbob]

Because the pharma companies wrote the laws. I know, we look like a bunch of dumb rubes over here. But don't worry EU will catch up if and become just as corrupt if I read the signs right.

Re:Shop elsewhere if you need this drug

[PopeRatzo]

That's why we have insurance and other prepayment schemes.

"Schemes" is exactly the right word.

If we had a free market, worldwide, in medicine,

There's no such thing as a free market, especially in health care. If a truck hits you, are you going to comparison shop for the best trauma center? If your kid gets leukemia, are you going to look for the cheapest chemotherapy?

You might as well just go straight to the faith healer. Because your faith in a free market is just as evidenced-based.

Re:Shop elsewhere if you need this drug

[TsuruchiBrian]

But you need a supply of the original drug in order to copy it.

Apparently you can buy supply of the drug for $750 a pill. Also there are no doubt lots of people who know how to make the drug, as it's been made for several decades by different groups of people, including the original manufacturer GSK which sells it in the UK for less than $2 per pill.

It seems the real problem is a legal one, where although they do not hold the patent to the drug, they somehow have exclusive legal rights to market the drug in the USA, and it is illegal to buy even FDA approved drugs from pharmacies outside the USA.

So something that seems like it is the result of the greed of the free market is actually something that would be quickly fixed by the free market, if not for our corrupt regulatory capitalist government and the electorate who keep voting for them.

Re:Shop elsewhere if you need this drug

[slew]

AFAIK, the situation is like this. As part of the 2007 update to the Food and Drug Administration Act added the authority for the FDA to require drug manufacturers to implement a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of a drug or biological product outweigh its risks. The theory was that some drugs might have serious enough side effects or complicated treatment plans that the FDA should require drug manufactures to make sure patients weren't harmed needlessly by taking these drugs in a way not supported by safety trials (aka elements to assure safe use or ETASU).

As an example, they could restrict wholesalers to sell the drug only to physicians or patients who attended training seminars, or only allow use for certain purposes and time-limit quantities to prevent certain side effects, make sure medicine is stored correctly and destroyed when expired, and they could require patients to be monitored for certain specific serious side effects, not allow the drug to be administer to otherwise healthy people etc... Seemed like a good idea at the time....

The unintended side effect of this is that Pharma companies have been crafting REMS to make it nearly impossible for generic manufacturers to obtain sufficient quantities of approved drugs for the required safety and equivalence trials. For example, a part of the ETASU might be that all patients must attend a company training seminar, or not allow the drug to be used on healthy people, but if you are doing a blind trial, that won't work.

To make the situation worse, even if the FDA didn't require REMS for a particular drug, the Pharma companies decided to "voluntarily" implement similar restrictions for their drugs on the wholesalers.

Wholesalers that don't comply with the Pharma's ETASUs would be violating both FDA rules and probably licensing restrictions and subject them to direct liability and thus will generally not sell product directly to these generic manufacturers. The only option remaining for generic manufacturers would be to purchase the product directly from the brand-name manufacturer. Under current law they are not required to sell drugs directly to their competitors and under strict interpretation of the FDA act, if a drug has a specific REMS, it is likely not technically legal.

Also even if the generic manufacturer decided to buy some of the drug on the "grey-market", they won't satisfy the requirements of the ANDA (abbreviated new drug application) which would require the same version available in the US market for demonstrating bio-equivalence.

FWIW, in 2012 there was an effort to amend the FDA act to allow the medical trials to bulk purchase of brand-name drugs at market prices and exempt REMS requirements, but it failed due to heavy lobbying...

Re:Shop elsewhere if you need this drug

[sims 2]

Ymmv however hospitals do have a bit of a reason to be money hungry.

We placed a legal requirement that they can not refuse emergency care without any consideration of how it would be funded.

Re:Shop elsewhere if you need this drug

[SylvesterTheCat]

They charge the insurance compaines more because they know they can get it.

No, that's not why they do it... Well, maybe, but it is not the only reason.
It's call "cost-shifting."

They do it because for some procedures / treatments / claims, they get less from some insurance companies than the office normally charges, so to make it up, they charge others more. That's why there are anecdotal stories of $25 aspirin dispensed in a hospital.

Re:Shop elsewhere if you need this drug

[einsteinbutthole]

holy shit! not only is he pure evil, he has the most punchable face i've ever seen. so much hate.

Re: Shop elsewhere if you need this drug

[NormalVisual]

They have a nation wide exclusive on a half century old drug with the freedom to set any price they want??? Sanctioned by the Fda?

You think that's bad? How about a drug that's been around for more than a thousand years?

Re:Shop elsewhere if you need this drug

[TsuruchiBrian]

This particular evil was perpetrated by a small startup and a corrupt politicians who are bribed to pass laws written by big pharma, and exploited by pharma of all sizes.

Re:Shop elsewhere if you need this drug

[TsuruchiBrian]

And there is no drug for "fuckface" either.

Re:Shop elsewhere if you need this drug

[LF11]

Ummm...no. Free market means I kick your sorry ass out of the house and call a real doctor. Someone pulling that game in a small town will find himself run right out of town on a rail.

You also clearly have very little experience in medicine. People don't go into primary care for the money (obviously, because it doesn't pay enough to cover your loans). Small-town doctors are going to be using the free-market economy to help their patients find the cheapest tests and cheapest treatments possible.

That's how it works. Free market does not necessarily mean "predatory." Most people aren't like that, particularly in smaller or more rural communities. Your vague apprehensions about the risk of vulnerable families are given foundation only by systematic distortions of the free market. These distortions limit the supply of both doctors and medicines, forcing families to accept substandard and/or overpriced care. A free market gives these families choices, choices that the current system does not give them.

Re:Shop elsewhere if you need this drug

[sims 2]

EMTALA
https://en.m.wikipedia.org/wik...

We want emergency care to be provided but we don't want to pay for it.

Kind of like how the education board keeps demanding more without providing funding to make it possible.

Re:Shop elsewhere if you need this drug

[TsuruchiBrian]

Or a bigger drug company like GSK (which originally manufactured the drug in the US and still does elsewhere), could get it approved in the US, and undercut Turing until they go out of business. They have so much money they could probably have Martin Shkreli murdered and get away with it.

Small pharma is not that big of a problem. When GSK and other big names pull some shit like this, I don't know what can be done.

Re:Shop elsewhere if you need this drug

[PopeRatzo]

A free market

There is no such thing. A "free market" has never existed in human history and can never exist.

A free market is the unicorn of the economic world. Belief in a free market is religious, not evidence-based.

Re:Shop elsewhere if you need this drug

[TsuruchiBrian]

Trump would make Daraprim free for all Americans, and jack the price up to $7 million a pill for the Mexicans, Chinese and Muslims. That's how you negotiate. Obama won't do that because he's stupid, weak, and a Muslim, and doesn't know how to negotiate.

Trump 2016

Re:Shop elsewhere if you need this drug

[TsuruchiBrian]

He started rich. He would have more money now if he had simply invested it in an index fund. Even by taking advantage of federal bankruptcy laws, his ROI is slightly worse than someone blindly putting money into their 401K.

He's just a regular fucking idiot who has managed not to blow the fortune he inherited.

It turns out having a shit ton of money gives you such a huge advantage that even a fuckface like Trump can't screw up.

Re: Shop elsewhere if you need this drug

[sims 2]

Only two words should have been enough to stop that orphan drug idea.

"World market"

The US is not the only place in the world with drugs. And just because the 300 million people here don't need much of it doesn't mean the other 7 billion people don't either.

Availabillty shouldn't be a problem....

Re: Shop elsewhere if you need this drug

[the gnat]

FDA approval is a huge barrier to market, and any generic drug company wanting to get FDA approval to sell their pills in the USA needs to demonstrate that they are "biosimilar", which actually requires a lot of clinical testing. (I don't think this is a uniquely American thing, but I'm not sure what the Europeans or Japanese do.) It's much less expensive than the Phase I-III trials required for new drug approvals, but for drugs like this one that are low-demand, the testing just isn't worth it. That's a big reason why the orphan drug regulations were put in place, to encourage companies to conduct these trials for old drugs that had been repurposed.

(PS. I'm neutral on whether we have too much regulation; on balance I think the FDA is a good idea but will scale poorly in the future. However, I don't think we're being unreasonable asking generics manufacturers to demonstrate that their pills are a valid substitute for the existing FDA-approved drug.)

Re:Shop elsewhere if you need this drug

[Applehu Akbar]

Autocorrect got creative: "payment" -> "Patient"

Re:Shop elsewhere if you need this drug

[KermodeBear]

The problem is, government regulation and interference is why the company is able to buy exclusive rights to the generic drug in the first place.

The government isn't the solution here. Government is what is causing the problems.

As others have stated, the drug is available very cheaply outside of this country. However, the government will not let us import the drug. If we were able to, the local company would be forced to drop the price or stop production. That is how capitalism works.

Unfortunately, the USA is not capitalist any longer, at least not in the way it pretends to be. The problem is the politicians getting in bed with the corporations so that laws which benefit the corporations - and only the corporations - are rammed through. The problem is not capitalism, because we don't really have it anymore. The problem is corruption.

So you are correct - we don't have a free market. We have a market controlled by the government, with the government controlled by the corporations.

A free market without the government bending to the will of the corporations wouldn't have this problem.

Less government control is the best solution.

Re:Shop elsewhere if you need this drug

[arglebargle_xiv]

or even recommend a summer vacation to Canada

That would be preferable to buying from online "Canadian" pharmacies, which aren't that at all but mostly fronts for Russian organised crime. You'll be shipped generics from India, not Canada. It's not as bad as it sounds because they depend on repeat customers so they work pretty hard to keep customers happy (you generally get the real deal, your credit card won't get ripped off, etc), but it's still taking a bit of a gamble.

Re: Shop elsewhere if you need this drug

[sims 2]

If the patent has expired why can't they make it exactly the same as the original manufactuer? It just seems like trying to reinvent the wheel otherwise. I wouldn't think any additional testing would be needed if nothing other than the name changed.

The FDA is quite necessary as we have seen what they do if left unattended. Its much easier to define the minimums of what they should do than it is to limit it and prevent crap like tfa. Not saying I support them in this case just that it is much better than no regulation at all.

Re:Shop elsewhere if you need this drug

[gl4ss]

sure there is.

that's why when I go to my home country and go to a pharmacy and got a prescription for some medication they will have to offer me a generic cheaper version too and I can just as easily buy that one instead of the so called original brand. they're both just as good anyways.

THAT is the whole point of "generics", to push down the cost on the patient. USA DOES NOT HAVE A GENERIC REPLACEMENT SYSTEM, if you try to claim otherwise I will point you to this article which proves there really isn't.

Re:Shop elsewhere if you need this drug

[sjames]

The markups they're charging are enough to cover 80% of their patients being indigent.

I do agree that the unfunded mandate is problematic but it doesn't really explain the outrageous costs.

Re: Shop elsewhere if you need this drug

[the gnat]

If the patent has expired why can't they make it exactly the same as the original manufactuer?

Those pills are much more complicated than you think - the basic molecule may be the same, but the packaging can have a huge effect, which is how "extended release" drugs work. It's what makes extremely powerful recreational drugs like opiates and stimulants into milder prescribed pills like Oxycontin and Adderall. (And in both cases, if you crush them and snort the pills, it totally bypasses the packaging that was put there to prevent you getting high as a kite.) It does actually require some trial and error to get it right and occasionally the generics really aren't as good, just because of the way they're absorbed. So the only way to prove that they're the same is to run actual clinical trials.

Re: Shop elsewhere if you need this drug

[sims 2]

Again why can't they use the same packaging? I would assume that their might be a new and valid patent on the current slow release 24hr packaging but when the drug originally came out whatever it was packaged in had to be patented the same time or earlier and should also have also expired.

Is the patent on the packaging longer than on the drug?
Or am I missing something?

Re:Shop elsewhere if you need this drug

[blind biker]

Progressives? Since when did the USA have "progressives" in power? Except for Bernie Sanders and Elizabeth Warren, the whole american political spectrum is far right, corporatist, and corrupt.

And it's going to continue that way: it's going to be Billary, Fiorina or Jeb Bush for president - a corporate sockpuppet once again.

Re:Shop elsewhere if you need this drug

[Tony Isaac]

You are not allowed to sell a generic equivalent unless you can prove it is as effective as the nongeneric version. In order to prove it is as effective as the nongeneric version, you need to do trials that compare it to the nongeneric version.

This is not correct. From the FDA:

The ANDA process does not require the drug sponsor to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness.

The generic drug manufacturer needs only to prove that their version is equivalent to the original (details also spelled out at the above link.)

Re: Shop elsewhere if you need this drug

[the gnat]

Patents on formulations are like any other patent. Again, the issue you're missing is one of testing: a company can claim that it has equivalent packaging, but how do you prove that it really is equivalent? Keep in mind that a large part of FDA approval means "approval to market this drug for specific conditions", or for a generic, "approval to market this formulation as a generic substitute for the previously FDA-approved formulation", and companies get busted (too frequently) when they make claims that aren't FDA-approved. Also, from Wikipedia:

As with new drug substances and dosage forms thereof, novel excipients themselves can be patented; sometimes, however, a particular formulation involving them is kept as a trade secret instead (if not easily reverse-engineered).

And even if the formulation isn't a trade secret, the precise manufacturing processes involved might well be.

Re:Shop elsewhere if you need this drug

[Zontar The Mindless]

This is why my remedy, if elected, for this situation would be to strip the FDA of all powers to regulate the market for drugs. Let it have proposed new drugs tested for safety and efficacy, as it does now, but let its findings be advisory only. Doctors, patients and insurance companies would generally follow its recommendations as a "gold standard," but absent any power to prevent consumers from shopping around on the world market for cheaper subscription fills and absent any power to enforce sweetheart deals with pharma, the free market would bring the US prices of medications into line with worldwide prices.

Right. And when someone takes something that's labelled "aspirin" but actually contains rat poison--because, after all, under your scheme, this would be entirely legal and there'd be no way to prevent it from occurring--and dies as a result, yeah, the market will correct that problem.

You think something like this can't happen? Think again.

Re:Shop elsewhere if you need this drug

[Zontar The Mindless]

I agree with everything with the exception of your conclusion, which is erroneous because you're trying to spin the facts to suit your ideology.

The correct conclusion is that less corporate control over government is the solution.

Re:Shop elsewhere if you need this drug

[Zontar The Mindless]

"Placebo" does not mean or even imply "subtle".

Re:Shop elsewhere if you need this drug

[Zontar The Mindless]

And about 15 minutes after this appeared, he made his Twitter feed private.

Re:Shop elsewhere if you need this drug

[Intrepid imaginaut]

Or, it just may be that "free markets" don't exist, have never existed and cannot exist, and this is just a snapshot of what late-stage capitalism looks like.

Eh you say this as if it were new information, even Adam Smith emphasised the importance of regulation. What you're trying to weasel-word advocate for here is the abolition of capiltalism in its entirety, which not only betrays a fundamental misunderstanding of the economic nature of capitalism, it's never going to happen, mostly because no better alternative exists. "Late stage" capitalism as you call it is mostly doing fine, continuing to improve standards of living, make technology cheaper, and put out of season fresh fruit on the shelves. China's a splendid example of a nation that was foundering until it embraced capitalism, albeit a Japanese-style form of it.

As for healthcare, the Dutch have a competitive system in place which is a passable imitation of semi-free markets in healthcare, hospitals are given a rating by patients and the results are published. That mightn't work everywhere due to their geography, but to say it's impossible is pretty ignorant, and further they show that capitalistic principles can work hand in hand with socialist safety nets (note I say socialist as opposed to Marxist). Their healthcare was rated the best and the best value for money in Europe until relatively recently too.

Re:Shop elsewhere if you need this drug

[RDW]

They have so much money they could probably have Martin Shkreli murdered and get away with it.

No need to spend it. A Kickstarter for this job would probably be funded in 5 minutes at the moment.

Re:Shop elsewhere if you need this drug

[Crowd Computing]

That would be preferable to buying from online "Canadian" pharmacies, which aren't that at all but mostly fronts for Russian organised crime. You'll be shipped generics from India, not Canada.

This looks like another kind of war on drugs. Probably a sign that things are over-regulated like the market for soft recreational drugs.

Re:Shop elsewhere if you need this drug

[Hognoxious]

It was only recently that I found out that this whole "self-made man" thing was a myth. The real estate company was his originally mom's, IIRC. He's about as self-made as Prince Charles.

Why haven't the American people cottoned on yet?

Re:Shop elsewhere if you need this drug

[arglebargle_xiv]

It's a complicated situation. Outside the US, critlcal/life-saving drugs are generally covered by government regulations that keep them affordable. Inside the US, pharma companies get to set whatever price they want. Since this drives buyers to non-US sources, they've got their friends in the US congress to pass laws making it illegal to buy (or at least bring in) drugs from alternative sources. Sure, some people will die because they can't afford the medication they need, but by and large profit margins will be maintained. It's an acceptable loss.

Re:Shop elsewhere if you need this drug

[PopeRatzo]

sure there is.

I'm curious, what country do you live in that has a "free market solution to health care"?

Re:Shop elsewhere if you need this drug

[dywolf]

assume minimum 90 pill treatment.
at 750/pill, that's almost 70k$.

Typical insurance plan: 2k deductible, 25% copay, 6k out of pocket limit.
So for a 70k round of treatment, you max out and are paying 6k between your copay and deductible. and that's with a -decent- plan.
cheaper plans are even worse.

at the previous cost of the drug, 13.50, a round of treatment is only 1,215 in total. Below the deductible, so you pay the full amount without insurance picking any up, but still a far sight better than the 6k alternative caused by the greedy markup.

Or we could be like civilized countries, and simply decide that people shouldn't go broke seeing the doctor.

Re:Shop elsewhere if you need this drug

[dywolf]

words have meanings.
you should try learning them.

Re:Shop elsewhere if you need this drug

[martin-boundary]

It's less of a gamble than buying a few pills for $50k . People who do the latter effectively gamble their house or at least their kids education.

Re:Shop elsewhere if you need this drug

[l0n3s0m3phr34k]

If it's potent enough rat poison, then the headache will soon be gone anyway. But, yes, this would just restart the whole "medicinal potion" with god knows what in it again...a better path would give the FDA the ability to fast-track generics. If a pill is chemically the same as another, and you can prove it, that should be the end of the FDA trials. Especially for a drug like this that has been around for 60+ years, there is no need to go through all the trials and testing on the same substance. Existing pharma companies should already be able to turn up an existing drug line and have something hit the streets in a few weeks if a drug is already off patent.

Re:Shop elsewhere if you need this drug

[l0n3s0m3phr34k]

Sounds like Ayn Rand's utopia. No empathy, all logic.

Re:Shop elsewhere if you need this drug

[martin-boundary]

Sounds almost foolproof, but...

Suppose you by the GSK pills in bulk, importing them NOT for resale. You import them as raw materials for another manufactured product. You stick them into a machine that turns them into powder, you mix the powder with distilled water, and you make new pills. Technically, you've manufactured pills in the USA from imported raw materials.

So can you sell the new pills? You'd have to prove they are equivalent to the originals, which would be expensive using human trials. But another way to prove equivalence would be to prove that the chemical composition of the manufactured pills is literally identical to the original pills. Which would be much cheaper, given the "complicated" manufacturing process.

Re:Shop elsewhere if you need this drug

[Applehu Akbar]

No, we would still have the FDA labeling of the product. If someone else advertised rat poison as "my new and approved aspirin" the lack of FDA approval would keep most of us away. A false claim of FDA approval would be fraud, an entirely different offense under current law.

Re:Shop elsewhere if you need this drug

[bkr1_2k]

AFAIK, the situation is like this. As part of the 2007 update to the Food and Drug Administration Act added the authority for the FDA to require drug manufacturers to implement a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of a drug or biological product outweigh its risks. The theory was that some drugs might have serious enough side effects or complicated treatment plans that the FDA should require drug manufactures to make sure patients weren't harmed needlessly by taking these drugs in a way not supported by safety trials (aka elements to assure safe use or ETASU).

As an example, they could restrict wholesalers to sell the drug only to physicians or patients who attended training seminars, or only allow use for certain purposes and time-limit quantities to prevent certain side effects, make sure medicine is stored correctly and destroyed when expired, and they could require patients to be monitored for certain specific serious side effects, not allow the drug to be administer to otherwise healthy people etc... Seemed like a good idea at the time....

The completely intended result of this is that Pharma companies have been crafting REMS to make it nearly impossible for generic manufacturers to obtain sufficient quantities of approved drugs for the required safety and equivalence trials. For example, a part of the ETASU might be that all patients must attend a company training seminar, or not allow the drug to be used on healthy people, but if you are doing a blind trial, that won't work.

To make the situation worse, even if the FDA didn't require REMS for a particular drug, the Pharma companies decided to "voluntarily" implement similar restrictions for their drugs on the wholesalers.

Wholesalers that don't comply with the Pharma's ETASUs would be violating both FDA rules and probably licensing restrictions and subject them to direct liability and thus will generally not sell product directly to these generic manufacturers. The only option remaining for generic manufacturers would be to purchase the product directly from the brand-name manufacturer. Under current law they are not required to sell drugs directly to their competitors and under strict interpretation of the FDA act, if a drug has a specific REMS, it is likely not technically legal.

Also even if the generic manufacturer decided to buy some of the drug on the "grey-market", they won't satisfy the requirements of the ANDA (abbreviated new drug application) which would require the same version available in the US market for demonstrating bio-equivalence.

FWIW, in 2012 there was an effort to amend the FDA act to allow the medical trials to bulk purchase of brand-name drugs at market prices and exempt REMS requirements, but it failed due to heavy lobbying...

Fixed that for you.

Re:Shop elsewhere if you need this drug

[SQLGuru]

My doctor (now retired) would actually offer scripts for multiple drugs if they were cheaper than the single "combined" drug that did the same thing (i.e. a blood pressure + water pill, he'd offer them as single pills to save money).

Re:Shop elsewhere if you need this drug

[Applehu Akbar]

Some patients are allergic to the binders and coatings used in a given generic, and so have to take the branded version. Just as often, it's the other way around.

Make sure you have a doctor who keeps current on all of this. For all of you out there who have no such choice, keep lobbying for a system that allows you to shop around for medicine.

Re:Shop elsewhere if you need this drug

[Applehu Akbar]

IP is not at issue here, because the drug is already generic. Manufacturability is not the issue either, because it is already made and sold cheap all over the world. The issue is that laws the Shkrelis of our pharma business had passed prevent Americans from shopping the world market.

Re:Shop elsewhere if you need this drug

[Nidi62]

Maybe a Change.org petition for an extrajudicial Predator strike?

Re:Shop elsewhere if you need this drug

[Applehu Akbar]

"Or alternatively, a company could possibly run "treatment tours" to the UK with complete packages"

Medical tourism is still legal, and many Americans are indeed going to India for major surgeries. Here in Arizona, bus tours from retirement communities to get prescriptions filled in Mexico are big business. If you drive I-8 between Tucson and San Diego, you will see a small exit called Algodones, leading to a single large hotel. Another casino in the middle of the desert? No, it's a place where you stay overnight, then stroll across the adjacent border to an entire town of dentists, who will do a great job on your teeth for a fraction of the US price.

But the medical tourism model is inapplicable to patients who need a long-term supply of a medication. You can visit another country for gallbladder surgery, but you're not going to live there so you can take one medication for the rest of your life.

Re:Shop elsewhere if you need this drug

[TheGratefulNet]

where is 'anonymous' when you need them? how come this guy has not had his life doxed and ruined? or even worse?

sometimes, you need the hero you deserve. and the US government is not is.

Re:Shop elsewhere if you need this drug

[rch7]

It isn't always the case. You card information may leak (ok, not a big deal, your bank will give you new card), you may get fake medication and never know it, concentration may be lower than required. It is just that, gray market. Sometimes it works, sometimes you get burned. Technically it isn't legal but US Customs allows mailing up to few months medication supply as long as it is not controlled substance. I don't know if they would allow the same when driving/flying.

Re:Shop elsewhere if you need this drug

[3.5 stripes]

Strange thing is, the places where the drug is cheaper, there is sometimes more government control, sometimes less.

It's almost like government control has very little to do with it?

Re:Shop elsewhere if you need this drug

[Reziac]

And a great deal of the branded and generic drugs are manufactured in India anyway, so that makes little difference.

Re:Shop elsewhere if you need this drug

[lsatenstein]

or even recommend a summer vacation to Canada

That would be preferable to buying from online "Canadian" pharmacies, which aren't that at all but mostly fronts for Russian organised crime. You'll be shipped generics from India, not Canada. It's not as bad as it sounds because they depend on repeat customers so they work pretty hard to keep customers happy (you generally get the real deal, your credit card won't get ripped off, etc), but it's still taking a bit of a gamble.

I live in Canada. I refute what you wrote. I have generic medication. It was not manufactured in India or Russia, but in quality controlled labs here in Canada. And since there are about a half dozen major pharmacy chains, these organizations do not want to be sued for providing harmful medication. Ergo, they validate the generics before allowing them in their pharmacies.
The result of having generics is to cause the originators to moderate their selling prices. If my supply of one generic is $10.00, the non-generic might be sold at $12.00 (a max of 20% markup over generics.)

Come to Canada and buy your medication, or find a partner living at the border who will take your prescription to the Canadian pharmacy. Just pay him for the service, which would include the cost of the medication.

Re:Shop elsewhere if you need this drug

[Zontar The Mindless]

And if you look at how dilated his pupils are--even under stage lighting--there are definitely some good drugs happening there.

Re:Shop elsewhere if you need this drug

[david_thornley]

And insurance companies don't pay what they're billed. They assign what they think a reasonable price for a procedure, and don't pay more than that. The medical provider gets to accept what the insurance company pays, have a long expensive court fight, or refuse people with that insurance.

Re:Shop elsewhere if you need this drug

[sims 2]

Thats interesting. So they have a pay what you think its worth policy like ubuntu? If I Only paid my electric/gas/water/dsl/sewer/cellular provider what I thought they were worth they would terminate my service. Not really fair they get to do that.

Re:Shop elsewhere if you need this drug

[sims 2]

Sounds plausible.

Re:Shop elsewhere if you need this drug

[gzuckier]

or even recommend a summer vacation to Canada

That would be preferable to buying from online "Canadian" pharmacies, which aren't that at all but mostly fronts for Russian organised crime. You'll be shipped generics from India, not Canada. It's not as bad as it sounds because they depend on repeat customers so they work pretty hard to keep customers happy (you generally get the real deal, your credit card won't get ripped off, etc), but it's still taking a bit of a gamble.

I live in Canada. I refute what you wrote. I have generic medication. It was not manufactured in India or Russia, but in quality controlled labs here in Canada. And since there are about a half dozen major pharmacy chains, these organizations do not want to be sued for providing harmful medication. Ergo, they validate the generics before allowing them in their pharmacies. The result of having generics is to cause the originators to moderate their selling prices. If my supply of one generic is $10.00, the non-generic might be sold at $12.00 (a max of 20% markup over generics.)

Come to Canada and buy your medication, or find a partner living at the border who will take your prescription to the Canadian pharmacy. Just pay him for the service, which would include the cost of the medication.

i think what he was saying was that actual canadian pharmacies are OK, (i know that for a fact) but that the guys who spam you with "canadian pharmacies" aren't canadian, and probably not pharmacies.

Re:Shop elsewhere if you need this drug

[lucien86]

A system that is completely bent. Goes to show yet again that capitalism has no place in medicine.. When will people realize that the entire US industry has become a giant blood sucking parasite..

Re:Shop elsewhere if you need this drug

[lucien86]

With that mark-up he can afford the best..

Re:Shop elsewhere if you need this drug

[lucien86]

Unfortunately in a Kleptocracy the police always defend the thieves at the top..
That's the trouble with the keepers of the law, if the law gets bent they become the mobsters shills... The only way not to be a bent cop - is to be a bent cop.

Re:Shop elsewhere if you need this drug

[lucien86]

Somalia.. :)

Re:Shop elsewhere if you need this drug

[cwsumner]

The story goes like this:

The US Medicare system said "we only want to pay 80% of the cost. But instead of allowing the patient to pay some, we say the patient can't be billed. And we are the government so you have to!"

So the insurance companies said "They get to only pay 80%, so we should, too!"

So the doctors and hospitals said "We can't live like this, we have to raise our prices 20%!"

So then the private and government lawyers got together and said "You raise your prices on our clients, you better not lower them for anyone else or you get sued!"

So ... the only people -really- paying higher prices are the poor or self-insured!
Because the politicians stuck their fingers into something they didn't understand. 8-(

P.S. If you get caught by this, talk (quietly) to your doctor. They are often quite happy to fudge things in your favor, if you can't pay the "paper" rates. If they can get away with it...

Re:Shop elsewhere if you need this drug

[david_thornley]

Largely, yes, although it has to be pre-negotiated.

Re:Shop elsewhere if you need this drug

[shugah]

Diaprim is now only available through a single specialty distributor rather than the normal wholesale channels. This helps support the high price and allows the distributor to control to whom and how much of the drug is dispensed. This distribution model, and the tiny market for the medication are what prevent generic manufactures from competing. This douchebag specifically targets drugs meet these criteria. After all, he's not a scientist at all, but a hedge fund manager who has made a living out of recognizing opportunities for arbitrage.

Re:Shop elsewhere if you need this drug

[shugah]

Except that I think what GSK sold what exclusive rights to market the drug in the US.

Re:Shop elsewhere if you need this drug

[TsuruchiBrian]

They could market a different drug that is a generic version of the same drug that they already produce.

Re:Shop elsewhere if you need this drug

[KermodeBear]

I mention, twice, that corporate control over the government is the problem. I do end with less government control being the ultimate solution, and it is - because with less government control there is less opportunity for cronyism.

I'm also a touch annoyed that my comment was marked down as "troll" - it was not a troll comment. People can disagree with it, that's fine, but moderation is not a substitution for "I disagree" or "I have another point of view." There's a reply button for that.

Re:Shop elsewhere if you need this drug

[arglebargle_xiv]

I live in Canada. I refute what you wrote

No, you're confirming what I wrote. Bricks-and-mortar Canadian pharmacies are fine. Many/most online "Canadian" pharmacies are fronts for Russian organised crime. For example if you look at CIPA's figures, there are only 68 websites that meet the CIPA standards and are authorized to carry the CIPA certification mark, which makes the other eight million or so sites fakes (at least by CIPA standards).

Come to Canada and buy your medication

Yep, that's the one way to get guaranteed quality. If you buy online you'll probably still be OK, but you are taking a bit of a gamble.

Re:Shop elsewhere if you need this drug

[BalthCat]

Which is why this behaviour makes me wish there was a way to just seize the rights.

Re:Shop elsewhere if you need this drug

[BalthCat]

They support the legal structure that allows this to happen. They say "Oh but we'll do compassionate programs to make it OK!" instead of actually not behaving like assholes in the first place.

Re:Shop elsewhere if you need this drug

[RespekMyAthorati]

the lack of FDA approval would keep most of us away

So it would only kill some people.
You're a sweetheart.

Re:Shop elsewhere if you need this drug

[toddestan]

No, what should happen is that the government should back the R&D to develop the drug (chances are, there is already public money involved as it is now). Once the drug is approved, it goes into the public domain and anyone can manufacture it. The free market would then make sure prices stay low. Everyone wins, except big pharma.

Re:Shop elsewhere if you need this drug

[RockDoctor]

Aside from America's insane health care policy, it's good to see that Derek Lowe is getting more prominence as his excellent, informative and entertaining writing on the chemical industry has long deserved.

armchair activism

[cosm]

this is one of those stories where if everybody on slashdot who fucking hates big pharma posted links on their facebook/twitter/g+/instawhatever, it could probably boil over to one of those flashpoint social media stories that gets the company to own up to being fuckbags.

it seems that's the only way things change these days...voting sure doesn't do shit...

Re:armchair activism

[PopeRatzo]

Turing is not big pharma. It's Martin Shrkeli's new play toy. For those who don't know who he is, he made his money as a tiny hedge fund manager that specialized in shorting crap/scam companies.

He also owns League of Legends and DOTA2 pro teams.

How much you want to bet he posts about ethics in game journalism on 8chan?

Here is an actual photo of Martin Shrkeli:

http://www.slate.com/content/d...

And, if you think I'm being unfair comparing Shrkeli to a certain now-defunct hashtag group beginning with the letter "G", I suggest you read through some of his Tweets. See if you recognize the tone and substance of his arguments. In other words, where have you seen this kind of stuff before?:

http://www.rawstory.com/2015/0...

Re:armchair activism

[Zaiff Urgulbunger]

There's a video of the little prick here defending this shit. Another, more informative video here. He *claims* that this will allow them to invest in developing new treatments... right...

Does anyone know if Turing Pharma actually have research facilities?

Re:armchair activism

[Darinbob]

The price has dropped because it did blow up on social media. And I do not believe with his personality that he had any intention of funelling funds into research.

However, this is not just about the one company. The one company did bring to light the problem with overpriced drugs, the increase in drug prices, and the problems of why generics aren't readily available. The earlier BBC article about the problems of drug prices used Turing as one example among other similar drugs where prices were raised even though the patents had expired.

Re:armchair activism

[Zontar The Mindless]

And, if you think I'm being unfair comparing Shrkeli to a certain now-defunct hashtag group beginning with the letter "G"

Why don't you also mention he's a "J"?

Because, according to his old OKCupid profile (what, deleted? I don't think so...), he's a Christian.

Re:armchair activism

[scourfish]

Aren't you SJW types supposed to be against tone policing?

Re:armchair activism

[thegarbz]

it could probably boil over to one of those flashpoint social media stories that gets the company to own up to being fuckbags.

What do you mean it could? The guy has been attempting corporate suicide via his own twitter feed for the past week. Unfortunately while everyone hates him that's not enough.

Now I'm not American but I kind of hope an all American solution comes to this problem in the form of a bullet fired by a late stage AIDS patient.

Re:armchair activism

[sims 2]

Twitter has done it again!

"Turing Will Roll Back Massive Drug Price Hike After Backlash"

http://www.huffingtonpost.com/...

Wow that was quick!

Not an exclusive lock

[Etherwalk]

The post is saying they're the only manufacturer selling in the US. The patent has expired. Another company can make it and sell it here if they want.

Re:Not an exclusive lock

[Qzukk]

Sure, and after you spend hundreds of thousands of dollars buying the equipment and the chemicals and hiring people to do it, Turing Pharmaceuticals "sees the light" and drops the price to 50 cents using the profit they've collected up to that point to stay afloat. Then they buy you out of bankruptcy with the rest of their profit and burn your facility to the ground as a message to any other investors who think they can stand up to them.

Then they raise the price to $751/pill, just to make a point.

Re:Not an exclusive lock

[Blrfl]

Getting an existing medication to market is still very expensive even if the IP costs you nothing.

Re:Not an exclusive lock

[TsuruchiBrian]

Because there are no pharmaceutical companies with more money than Turing?

Furthermore, even if the new company does go bankrupt, Turing doesn't get to just buy out whoever they want. Another drug company can offer more money than Turing. Turing can't undercut everyone (especially much larger companies) forever.

This is just regular price gouging. You can try to sell flashlights during as power outage for $100 for only so long. Furthermore, wasting your time and profit potential undercutting competitors is probably a bad idea considering that now everyone realizes how demand heavy this market actually is.

Re:Not an exclusive lock

[Etherwalk]

Wrong; they have also secured rights to be the only producer in the united states.

Patents work on a simple premise: you disclose to the public enough about your invention so they can replicate it, in exchange for which you get a monopoly for X period of time.

When X period of time is done, you *no longer have a monopoly*.

So anyone who wants to sink the money into replicating the drug can replicate it. They may have some hurdles that make it more expensive, but it's legally possible.

Re:Not an exclusive lock

[BradMajors]

It is perfectly legal for patients to import this drug from overseas for their own use for a little over a dollar per pill. There is no problem.

Re:Not an exclusive lock

[countach]

No they can't. There are a million hoops to jump through to prove your generic is as good as the original. And if Turing won't sell you the original to test, then you are out of luck.

Re:Not an exclusive lock

[LunaticTippy]

The problem is deceptively simple. This is a drug with a small market. No pharma company, large or small, is willing to invest many tens of millions to get approval when it will take decades to make the investment back.

Also, if some company took this route Turing would simply match or beat their price until they stopped. Since Turing didn't need to spend money on approval they can beat anyone else's price indefinitely.

This is a case where the markets don't work.

Re:Not an exclusive lock

[TsuruchiBrian]

Are you saying that they don't have to pay for approval, because they already paid for approval?

Re:Not an exclusive lock

[tsotha]

No, the summary is worded to be misleading inflammatory. There's no such thing as "exclusive rights" on a drug that's off patent. They bought the brand name, and any company can produce this drug as a generic.

The problem is the market is too small to support two producers. It's a textbook case of a company abusing a monopoly. It has nothing to do with IP.

Re:Not an exclusive lock

[sjames]

Actually, it is not. In practice, there is an unofficial policy of looking the other way. That tells you something when a law is so unconscionable that even a government bureaucracy doesn't have the stomach to enforce it.

Re:Not an exclusive lock

[Headw1nd]

This has nothing to do with patents, and everything to do with FDA regulations. You can make it by the truckload, fine, but the minute you sell one as a drug (i.e. for its intended purpose) you are risking jail. The patent on meth ran out a long time ago too, doesn't mean you can make it.

Re:Not an exclusive lock

[Darinbob]

You can get approval for a generic copy of it. But you must prove that it compares the same or better than the original drug. That requires having plenty of the original drug to compare with, and Turing is not selling. The drug is not available on the open market or from any pharmacy. Several companies are doing the same thing to prevent drugs whose patents have expired from being replicated.

Re:Not an exclusive lock

[Darinbob]

Even when you replicate the drug, the FDA requires you to prove the drugs is as effective as the original. The problem is that you can't get enough of the original drug in order to do the comparisons and get approval. The company is not making the drug generally available and is sold through direct channels only.

Re:Not an exclusive lock

[Darinbob]

Not quite true. There are additional hurdles. You can't just use the patent to replicate the drug, it is not a complete recipe of all steps and procedures. Next you have to get FDA approval of the drug, and prove that as a generic that it's as effective as the original. And you can't get that approval without having a supply of the original drug to test against. And they're not going to sell any samples of the drugs to competitors, which can not be purchased at a pharmacy. So instead of merely being expensive to replicate, it's expensive, time consuming, and impractical.

Re:Not an exclusive lock

[Darinbob]

It is not legal in many cases. http://www.fda.gov/AboutFDA/Tr...
Though I suspect this particular drug would fall under the exceptions.

The snag though is that there is a relatively short period during which this drug is used (100 pills or so?). Importing drugs is difficult and so is more practical if you have an ongoing use of the drug such as for a chronic condition.

Re:Not an exclusive lock

[TsuruchiBrian]

The drug is available very cheaply outside the USA. So this is not a technical problem, it's a legal one.

Re:Not an exclusive lock

[NormalVisual]

There's no such thing as "exclusive rights" on a drug that's off patent.

Yeah, there is, in the U.S. at least. The FDA's Unapproved Drug Initiative, among other things, grants pharmaceutical manufacturers the exclusive right to sell the drugs they test under the program. It's the reason that colchicine, which had been around for hundreds of years and was cheap and common prior to the program, is no longer available as a generic. Another screwed-up situation is that of albuterol, which was also cheap and widely available. In that case, mandated changes to the drug's delivery system to remove CFCs (even though using CFCs was otherwise legal in this application) allowed manufacturers to patent new delivery systems, and albuterol is no longer available as a generic even though the drug itself is not patented.

In both cases, it was administrative action by the FDA that was solely responsible for forcing drastically increased drug prices on people.

Re:Not an exclusive lock

[bearded_yak]

Thanks to all the mentions of colchicine in all these discussions, I got to Googling around to see if anything has changed since I quit getting my refills of the brand-name colchicine, which for a long time was the only option.

I have just discovered that there is now apparently a generic available:

http://www.medpagetoday.com/Rh...

Re:Not an exclusive lock

[tsotha]

That's all true and irrelevant to the IP discussion. Off-patent drugs that are used widely generally have generics. Sometimes more than one.

As I said, the market is too small to support two producers. This is classic monopoly behavior - raise the price because you're the only producer. Other companies would make tons of money at this price, but they know damn well by the time they actually got to market the price would be too low for them to make money.

Charge them with murder

[Anonymous Coward]

Because that's what they're doing: Killing people by taking their medication away from them.

Scum of the Earth

[JustAnotherOldGuy]

People and companies that do this sort of predatory business are truly Scum of the Earth.

I don't care how legal it is, this is just pure scumbaggery at its absolute worst.

"I don't care if you die, I need to make a profit!"

Re: Scum of the Earth

[Red Flayer]

"general corporate purposes"

Like executive compensation?

Re: Scum of the Earth

[BlackPignouf]

The CEO totally looks like a guy who would invest the extra revenue in R&D, not coke and hookers.
http://www.iflscience.com/heal...

Re:Scum of the Earth

[no-body]

Will this catch fire as the story of the dentist shooting this famous lion? Hardly, but it's much worse and the folks doing this are in good company protecting them - crooks altogether, shame them publicly!

Re: Scum of the Earth

[TsuruchiBrian]

I think he explained that the extra revenue could be used for R&D (so raising drug prices is not evil per se), but I think they are just going to spend it on houses and cars and stuff for themselves.

Re:Scum of the Earth

[countach]

The problem is there is no clear line between legitimate pricing and "scum of the earth". The truth is, all pills cost pennies to make, and the difference between that price and the selling price is to support a particular business model and share price. This is the same for Turing as for Big Pharma. Turing needs the money to expand his company. Big Pharma need the money for the same reason. Anytime you grant a monopoly on a product, capitalism is no longer capitalism, with all the assumptions about competition that are normally implied by capitalism.

Re:Scum of the Earth

[fnj]

"I don't care if you die, I need to make an OBSCENE profit!".

FTFY.

Re: Scum of the Earth

[Anonymous Coward]

Why not both?

Re:Scum of the Earth

[PopeRatzo]

Today, during the first day of his visit to the US, someone asked Pope Francis I what he thought of Martin Shrkeli. His response (and I'm quoting here), was, "I'd like to snap this little fucker's back like a piece of celery."

Re:Scum of the Earth

[tmosley]

I, personally, would be more angry at the government that crafted this horrible system of thievery unto death.

Re: Scum of the Earth

[Darinbob]

The CEO uses the word "moron" a lot. Is that you? Also I do not think the CEO even remotely plans to use any of the profits for new research, especially given his history with other companies.

Re:Scum of the Earth

[Darinbob]

He's in his mid thirties and with too much money too spend already. It would be an awful shame if he had to lower the price and not be able to retire before forty.

Re:Scum of the Earth

[Darinbob]

Amen.

Re:Scum of the Earth

[kheldan]

Calling these fucking assholes 'scum of the Earth' is giving an unnecessarily bad rep to actual scum of the Earth, who comparatively speaking are saints compared to these motherfucking piece of shit assholes; Islamic State assholes, running around cutting of peoples' goddamned heads are not as bad as these fuckers. If there is an actual Hell, they need to make a new, special Plane of it just for dickheads that do shit like this. Back in the Real World, this sort of bullshit needs to be made illegal; close the gods-be-damned 'loophole', already!

Re: Scum of the Earth

[Zontar The Mindless]

Hi Martin! So you do read Slashdot, after all!

Re: Scum of the Earth

[JustAnotherOldGuy]

Moron. The CEO has explained that they're using the extra revenue to fund R&D for new drug development, marketing to expand the market for this drug, and general corporate purposes.

Oh yeah, totally believable. That guy would never lie to anyone, especially in light of the immense outpouring of outrage and hate against him.

Re:Or just use homeopathy?

[JustAnotherOldGuy]

What about just using homeopathic treatments instead?

Yeah, but if you forgot to take your homeopathic meds, you'd overdose.

Re:We Pharmaceutical companies protest!

[sims 2]

No sir "Just ship it."
I don't care if all three tests say its contaminated with salmonella.
We "desperately at least need to turn the raw peanuts on our floor into money."

Money above all!

"My chemists and I deeply regret the fatal results, but there was no error in the manufacture of the product. We have been supplying a legitimate professional demand and not once could have foreseen the unlooked-for results. I do not feel that there was any responsibility on our part."

We can regulate ourselves the government doesn't need to check anything!

It should sell for =$2.51, like it does in Canada

[Anonymous Coward]

You can also find it at Canadian pharmacies for $2.51 per tablet. I hope nobody is foolish enough to buy any Daraprim from Turing Phama.

Abuse of dominance

[Timmy D Programmer]

There are many other laws that prevent abuse of dominance in a market. Hopefully all of this noise will attract the attention of those who enforce those laws.

Pharma-pushed laws

[PPH]

Lets see if this is enough to get those laws overturned and let Americans shop around for a generic equivalent.

Nope. Because Congress has its lips firmly wrapped around industry lobbyists private parts in exchange for campaign contributions.

Re:Pharma-pushed laws

[OhPlz]

I'd like to see a list of names of the people responsible for this FDA provision that enables this asswipe to control distribution. It's interesting that none of the linked articles mention how that got passed.

Re:Pharma-pushed laws

[siphonophore]

So many times this.

The story is NOT that some jerk is doing business unethically. The story is that the FDA is preventing the market from establishing pricing. We let it slide when USPTO prevents competition because it's expensive to innovate. But exclusivity via FDA? That is not something we want.

Re:Pharma-pushed laws

[PPH]

the FDA is preventing the market from establishing pricing

My understanding (please correct me if I'm wrong) is that this is a matter of legislation. So the FDA is only carrying out the letter of the law.

Re:Pharma-pushed laws

[Darinbob]

The industry typically gets to write the laws. Not just the pharmaceutical industry, but all industries.

Re:Pharma-pushed laws

[OhPlz]

That would be a first for a federal three letter agency.

Regardless, this thing stinks. If it's the legislature, they need to fix this and be held to account. If it's a misinterpretation by the FDA, same.

Re:Or just use homeopathy?

[TsuruchiBrian]

Or praying. Has anyone tried praying? Or Magic?

If I received a terminal diagnosis...

[hyades1]

...I know how I'd spend my last time on Earth.

Re:If I received a terminal diagnosis...

[sexconker]

Stabbing the fucks who bankrupted you and your family on your way to the grave?

Re:If I received a terminal diagnosis...

[hyades1]

When you eventually get this guy's cock out of your ass, maybe you'll read what I wrote and understand I wasn't saying I'd do anything to him. As it happens, I live in a civilized country, and wouldn't have to worry about getting this drug at a reasonable cost that would have nothing to do with the little creep.

But thanks for your opinion. The next time I want more of your lip, I'll rattle my zipper.

Re:If I received a terminal diagnosis...

[hyades1]

I'm very glad I don't live in the US of A.

Come back DPR, all is forgiven

[Tokolosh]

What is needed / what will result, is a marketplace on the dark web, allowing frictionless free enterprise as our Founding Fathers intended, using units of exchange which have real intrinsic value.

http://techcrunch.com/2015/09/...

Re:Come back DPR, all is forgiven

[TapeCutter]

The problem with the US health "system" is that it even relatively wealthy patients are at risk of bankruptcy paying for it. Just bite the 'socialist" bullet and introduce a sane UHC system like most other western nations did 30-40yrs ago. Also "the invisible hand" == "government regulation", by that I mean even your "frictionless free enterprise" cannot exist without some form of property law.

Re: We Pharmaceutical companies protest!

[bill_mcgonigle]

the FDA are a bunch of retards, responsible for 25 million American deaths and counting.

When I buy a toaster, I make sure it says 'UL' on the bottom. Insurance is quite sufficient a mechanism.

Re:Or just use homeopathy?

[Anonymous Coward]

I've heard that the upcoming block will return to Zendikar, so I'd go back to Magic if I could.

But I can't.

Re:Or just use homeopathy?

[taustin]

Suicide is illegal in the US.

Re:What we need...

[OhPlz]

This has nothing to do with patents.

Re:What we need...

[MountainLogic]

Patent reform is not strictly the issue. It is the willingness of Wall Street to invest in very high risk research. Parma has given up on real research and as a result we are see almost no new classes of drugs. Most of what we are seeing come on the market are incremental improvements of existing classes of drugs. If you want a radical solution, for a decade invest equal to say half of what we spend on drugs per year and put that into universities and NIH to do the breakthrough research that pharma refuses to perform. Then have NIH manage the trials. After approval let the generic industry sell the stuff without patent restrictions. On a straight out of pocket basis we'd pay less for drugs after an initial investment as new drugs would be at generic cost. The biggest return on investment for society would be the advances in real breakthrough drugs. Big investment up front, but massive long term payback in health and dollars.

Re:which is not explained in this article

[hackwrench]

Which is why I voted this summary down, but it got through anyways.

Re:Or just use homeopathy?

[The Rizz]

Suicide is illegal in the US.

False. Attempted suicide is illegal. It's not illegal if you're successful.

Re:Or just use homeopathy?

[Lunix Nutcase]

I hear that power crystals are amazing treatments.

Re:Or just use homeopathy?

[wavedeform]

I prefer my placebos to have more flavor. Like chocolate, or beer, or vindaloo. In fact, I think I'm going to try a nice chicken vindaloo with some beer tonight, to cure my cold.

Evidently, the CEO is a sociopath?

[AdamThor]

I guess their CEO (Turing Pharmaceuticals CEO Martin Shkreli) harasses people on the internet as well.

See:
http://gawker.com/lawsuit-scum...

Re:It should sell for =$2.51, like it does in Cana

[AaronW]

Sadly the crooks in congress made it illegal to import foreign drugs which often are a fraction of the price compared to the local supply that more than likely comes off of the same production line.

How much does it cost?

[timrod]

What I'm wondering is, how much does it cost to get sole marketing rights to a generic drug? This seems like the kind of thing where a nonprofit or NGO should form to buy the rights to all the generics, and then sell the drugs at or very close to cost - until, that is, the loophole that allowed Turing to do what they did is closed.

Re:Or just use homeopathy?

[U2xhc2hkb3QgU3Vja3M]

As long as you don't use homeophatic treatments at the same time as Placebo(TM) medication.

Re:Or just use homeopathy?

[U2xhc2hkb3QgU3Vja3M]

If you get caught after an attempted suicide, they send you to the electric chair.

Re:It should sell for =$2.51, like it does in Cana

[U2xhc2hkb3QgU3Vja3M]

At which point will the majority of Americans stand up and revolt against these immoral and corrupted laws?

Hmmm

[feufeu]

After all, communism isn't perhaps that bad compared to sick capitalism like this ?

Re:What we need...

[MountainLogic]

"Never doubt that a small group of thoughtful, committed citizens can change the world; indeed, it's the only thing that ever has. - Margaret Mead

You mean go to Jail?

[s.petry]

Not only do the laws allow abuse, but they ensure that the public has no other legal option.

Re:FDA

[rock_climbing_guy]

That will happen around the same time that the Social Security Administration becomes an advisory panel with no authority to dictate how your retirement is funded.

Nope

[s.petry]

If you are successful, you can not be prosecuted for the suicide but that does not make it legal. The legal question is answered by the Insurance, or should I say lack of insurance coverage after a suicide.

Re:Nope

[Radtastic]

Insurance doesn't have anything to do with the legality of suicide. And suicide does not invalidate a life insurance policy if the policy has been in place for a while (commonly two years.)

Re:Nope

[s.petry]

Fine points vary from State to State, but the insurance drop is allowed mostly because of the legality. While the felony classification of suicide was removed from all States within the last 20-30 years or so, many places still consider suicide illegal under common law. Source

For what it's worth

[rsilvergun]

Hilary just called them out (and their stock dropped as a result). Still, I'll believe it when I see it. She's pretty pro-business and anti-consumer. Hell, she was a republican until her husband decided to run as a Democrat.

Re:For what it's worth

[TsuruchiBrian]

Hillary is like a a broken weather vane that works like 40% of the time. She supports Ahmed and his clock by tweeting "Assumptions and fear don't keep us safe—they hold us back.", but she was the one playing up assumptions and fear of Muslims back in the 2008 democratic primary when she circulated pictures of Obama in "Muslim" (i.e. actually African) clothing in a pathetic attempt to win by playing into people's fears and racism.

I don't think there is anything to hide about Benghazigate, but if there were, I'm sure she would have done whatever to cover her own ass.

Re:For what it's worth

[lucien86]

That's why she's the Republicans dream Dem ticket for the nomination. Just like Trump is the Democrats dream choice for the Republicans..

Re:For what it's worth

[TsuruchiBrian]

And if both parties get their dream choice in the primaries, it's America that's fucked.

Mod Parent Up

[rsilvergun]

There's another good reason why there's no free market in health care: It's too hard to comparison shop.

Ever get a bad Twinkie? You know, one of the Generic brands that just isn't very good? Maybe you tried two or three brands before you found one you like better than Twinkies. Me, I like the Safeway brand better than the Hostess one.

Now, try doing that for a heart transplant. See, you don't have enough information. It takes one taste to know a bad Twinkie and you're out $3 bucks for a pack of 'em. It takes 8 years to know what goes into a heart transplant and you're probably only gonna ever have the one.

Re:Mod Parent Up

[Anonymous Coward]

It's hard to comparison shop hotels in foreign countries, too. I mean, what are you going to do, try three hotels on your once in a lifetime trip to Japan to find the on that's right for you? No way, chances are at least two won't suit!

It really sucks there's no advisor for your trip. Makes you want to yelp! Why a private laboratory can't underwrite standards to let you know if the places are safe, I don't know!

I wish I could rate MDs... .com. Sucks that nobody invented the internet yet. :(

Re:Mod Parent Up

[ThatsNotPudding]

It takes 8 years to know what goes into a heart transplant and you're probably only gonna ever have the one.

Unless you're Dick Cheney, then you can do whatever the fuck you want.

If everyone on /. did that

[rsilvergun]

it'd mean fuck all. Maybe less. It's childs play for a large pharma company to manipulate social media. And besides people will loss interest when your post gets pushed down in favor of cat videos and pictures of what they just ate.

Votes on the other hand get attention, but you need to vote left. Vote for the most left leaning candidate you can get.

It's not personal, it's just business

[rsilvergun]

that's what scares me the most. At least Hitler _hated_ the Jews. It was irrational. He was nuts. I can comfort myself with that. Tell myself we can watch out for that kinda crazy in the future. With business men there's no end to the horrible things they can do and just write it off as "Just Business". It's like a religion with a false air of science...

You honestly thing you'd get near anyone

[rsilvergun]

that mattered? At these kind of profits they've got armed security and the police more or less in their employ. You'd show up in their neighborhood and stick out like a sore thumb because you'd _look_ poor. The best you could hope for is suicide by cop.

You're not going to get anywhere going after the 1% with violence. Take a look into what a Mr Bernie Sanders is doing these days. It's a good start. He's a good kid.

Re:You honestly thing you'd get near anyone

[hyades1]

I think somebody later on in life would very likely possess a level of sophistication to blend in well enough to do what they wanted to do.

Re:Or just use homeopathy?

[onkelonkel]

You win the internet. And coffee came out my nose. Well done indeed.

for allowing perfectly legal Canadian pharmacies

[frovingslosh]

Adding insult to injury, most of the drugs in question were developed, at least in part, at public universities in the USA with taxpayer money. And then the drug companies are allowed to sell them to Canada cheaper than they sell then in the USA and use legal abuse like in the summary to keep the lower cost same product from coming back into the USA.

And this isn't just rare drugs like mentioned in the article that are being gouged, last year the supply of a long generic drug allopurinol dried up and when it reappeared it was 5 to 10 times the previous price. Allopurinol is also used for prevention of gout and is listed by the the World Health Organization as one of the ten most important drugs in the world.

Re:Or just use homeopathy?

[Austerity Empowers]

Someone uttered the magic phrase "AbracaSCAM", and voila, he has regionally exclusive rights to print money.

Re:It should sell for =$2.51, like it does in Cana

[Austerity Empowers]

This same issue also has had a terrible impact on the price of insulin, which has doubled in the past 5 years or so.

Re: We Pharmaceutical companies protest!

[sims 2]

The FDA is paradoxical It simultaneously over and under regulates.

Over regulation: see TFA
Under regulation: Why is airborne on the shelves again?

Re:It should sell for =$2.51, like it does in Cana

[Applehu Akbar]

"You can also find it at Canadian pharmacies for $2.51 per tablet"

Were you aware that in 2011 the FDA fined Google half a billion dollars - billion with a B - for the crime of pointing this out. We need to make the FDA give Google every stolen dime back, and then slash its budget until it can't hurt us any more.

http://www.justice.gov/opa/pr/...

Re:Or just use homeopathy?

[Anonymous Coward]

I think i got a molecule of your coffee up my nose. im buzzed as hell. i need a quantum of valium now

Re:It should sell for =$2.51, like it does in Cana

[Darinbob]

Some of this was debated in Congress at times. A 2004 bill allowing importation was not approved, a later bill to allow Medicare to negotiate drug prices was rejected, and Obamacare dropped the idea of it as well in order to get support of the pharma industry.

But Maine allows importing of drugs from Canada (or at least did in 2013). Maybe a few other states. The pharmaceutical industry, of course, is highly opposed to it.

Re:Oh yes he will

[NormalVisual]

Yeah, we get the idea, but the problem is that they need a lot more Daraprim for testing than a dozen patients could provide. Also, finding a doctor willing to risk his license and potential jail time to write the replacement scripts might be problematic.

Big Pharma says...

[Zhe Mappel]

"Psssst. Hey, sick person. Try this. The first one's on us!*"

*Free as in Daraprim, not free beer.

get from other countries

[bmorency]

I see other people commenting that it would be cheaper to just go to another country to get your pills because it is cheaper but how is this possible? You can just go to another country with your prescription and get your pills? A pharmacy will just take your prescription from a doctor that is not even from the same country? A doctor doesn't need to be licensed in that country to fill the prescription? Can anyone answer this?

Re:get from other countries

[Zontar The Mindless]

I know from personal experience that at least some US pharmacies (the 7 or 8 of them I tried, last time I was over there) won't honour foreign prescriptions, even when I've offered them contact details so they could verify that it was legitimate. That's right--Customs allowed me to waltz into the country carrying enough codeine to keep someone stoned out of their mind for at least 2 weeks straight, but I couldn't buy Diklofenac (aka Voltaren). Not even with a prescription for it, which my doctor in Sweden gave me precisely because he knew it wasn't available OTC in the US.

Re:get from other countries

[Applehu Akbar]

This is a great example of why we need to make FDA approvals advisory, rather than mandatory. Your Voltaren went through the European approval system, which is just as good as the US system. Japan has another perfectly good approval regime. Patients should have the option of trusting any of these foreign systems as an alternative to our own.

Re:Or just use homeopathy?

[Anonymous Coward]

What about just using homeopathic treatments instead?

That sounds like something A.P.K. would suggest.

Unlike homeopathic treatments, hostfiles actually exist, so APK has that going for him.

Look, the scumbag responds to pressure

[DanDD]

So, the scumbag CEO Martin Shkreli responds to pressure.

Perhaps it's time to start pressuring this scumbag to stop wasting oxygen that someone else, certainly anyone else, deserve more.

combo tablets under 4 cents in India...

[harvey the nerd]

The two drug combo tablet, Pyrimethamine 25mg + Sulfadoxine 500mg, has many generic suppliers in India, for under 4 cents a tablet, with a lot more sulfa drug added in. The aseptic pilling and blister packaging probably cost more than the pyrimethamine at 1 cent.

$13.50 per tablet of 25 mg pyrimethamine was a joke and an utter ripoff. The $750 makes the French Revolution more understandable when they started shortening corrupt financiers and government royalists after a short trial...Sort of a closer shave with that super sized Gillete thing.

but?

[SuperDre]

But if there isn't a patent anymore (which means anyone can create the drug without having to license it), how can Turing get an exclusively produce and sell the drug, how is it other companies can't?
Also it seems Turing has come back on the decission to sell it for that much profit, and said it will lower te price (ofcourse it won't be 13,50 I guess))

Fuck this Guy

[ze_jua]

Like the person who posted the first message I saw on this topic (2 days ago):

"I'm not advocating violence but if you see him choking in a restaurant don't intervene. If you see him on fire, don't spit on him."

And another top comment :

"Oh no, immigrants, jobless people and the poors are ruining the country !"

A cynical strategy

[sugar and acid]

The issue here is actually the FDA rules on generics and how it doesn't work for "orphan drugs". The FDA demands that a generics manufacturer do some basic clinical trials to prove the drug is as effective as the original. Simply showing it is the same chemical entity is not enough.

This creates a problem, as the generics company has to buy the drug on the open market to compare to. An often expensive and difficult endeavour. It also advertises to the original manufacturer exactly what they are doing, so it is hard to keep generics development quiet.

In this particular case the medication is given in controlled clinical environments, so it can essentially have it's distribution controlled by the original manufacturer to prevent a generics company comparing to it.

It should be noted that the big companies pull similar tricks to delay launching of competing generics.

A generics company could create the same drug, and go through full approval for the FDA. It will end up not being "interchangeable" though, which means one prescription for the original drugs can not be used for the generic.

The simple solution is to enact a law that forces all marketed drugs to also be sold for reference use at the current marketed price, for exactly this type of comparison.

Re:Thank you, President Obama!

[Zontar The Mindless]

Obama's got fuck-all to do with this. Thanks for playing, though.

Re:Oh yes he will

[PortHaven]

The problem is, you go to jail for drug dealing....because YOU are not an authorized prescriber of drugs. Then all research said company did, is voided because the said acquisition of the drug was illegal.

This is how it works...

Re:Thank you, President Obama!

[NostalgiaForInfinity]

Obama's got fuck-all to do with this. Thanks for playing, though.

You're completely wrong. These are regulatory matters decided by the FDA and other government agencies, and it's the president who has ultimate authority. That authority actually got strengthened with the ACA. Obama could end this tomorrow if he wanted to.

Re:Now, now, now...

[PortHaven]

THIS IS BEING ENABLED BY THE FDA

In a capitalist society, anyone could make and sell this drug. This is NOT capitalism, but neo-fascist economics. Fascism is an economic structure in which industry and government are tightly knit. It is a two class system, oligarchy and workers. Neo-fascism is simply a reversal where the corporations have the more dominant influence than the government.

Fascism not equal Nazi death camps. There were many fascist nations that did NOT murder their people. And many democracies that have. FDRs policies were very fascist. Government control of industry, two class system, control of wealth (gold/silver), etc. The fact that FDR had hundreds of thousands of innocent Americans put into concentration camps merely he acts of a tyrant. The fact that the most famous fascist regime, was led by a homicidal tyrant has blurred the understanding and shifted the term.

Google fascism and you get: "an authoritarian and nationalistic right-wing system of government and social organization."

But this is adamantly not the truth historically. Fascist government were not right-wing. They weren't die-hard capitalist-anarchists. They were almost ALL socialist democratic regimes. Most of the crap of right-wing, totalitarian, dictatorships was all added after World War II. Prior to that, many fascist nations were viewed as progressive. An alternative to communism. One of the fundamentals being a mixed-economic

Hmm...sounds like the U.S. economy, doesn't it? How many Americans realize we live in a fascist nation?
"In general the mixed economy is characterised by the private ownership of the means of production, the dominance of markets for economic coordination, with profit-seeking enterprise and the accumulation of capital remaining the fundamental driving force behind economic activity. But unlike a free-market economy, the government would wield indirect macroeconomic influence over the economy through fiscal and monetary policies designed to counteract economic downturns and capitalism's tendency toward financial crises and unemployment, along with playing a role in interventions that promote social welfare.[2] "
https://en.wikipedia.org/wiki/...

The Italian term fascismo derives from fascio meaning a bundle of hay, ultimately from the Latin word fasces.[15] This was the name given to political organizations in Italy known as fasci, groups similar to guilds or syndicates and at first applied mainly to organisations on the Left.
https://en.wikipedia.org/wiki/...

The other big aspect of fascism was nationalism and a protection mindset. This too is extremely common in America btw.In truth, fascism is less left or right, and very much so dogmatic center.

Benito Mussolini in 1919 described fascism as a movement that would strike "against the backwardness of the right and the destructiveness of the left".[43][44]

Fascism in many ways "sought an authoritarian corporatist state"

there are only two classes in society, "the governing" (the organized minority) and "the governed" - hmm also sounds like America, doesn't it?

A really good way to consider fascism, is that Marxism (socialism as purported a century ago) advocated for the elimination of nationalism, elimination of states. Fascism share a very large portion of common views. However, fascist held to the state and nationalism.

This is the two class system, relegated by the oligarchy. Does this sound eerily familiar to any of my fellow U.S. citizens?
"in which the Italian employers' association Confindustria and Fascist trade unions agreed to recognize each other as the sole representatives of Italy's employers and employees, excluding non-Fascist trade unions"

Life imitates art?

[Nidi62]

Well, at least now we know who Max Brooks based the character who invented Phalanx off of.

I don't trust Yelp with a Sandwich

[rsilvergun]

you think I want to trust the equivalent service to pick my doctor?

Re:I don't trust Yelp with a Sandwich

[bkr1_2k]

As opposed to letting your insurance company pick one for you? Seriously, I use customer reviews to pick doctors, dentists, and just about every other thing. At least I get some insight as to how they actually treat patients that way. The "old way" you just accepted whatever doctor your primary doctor recommended without much else to go on... who knows why they pick each other but I can guarantee one thing, it isn't because "they're the best". There's only 1 "best" and it's very unlikely that person lives and works near you.

His company is named after Alan Turing!

[l0n3s0m3phr34k]

Which is even more of an insult to the LGBT community. Not only is he basically holding a gun to the head of people with AIDS complications, he named the company after the famous gay mathematician who was basically tortured by the British for being gay. So it's doubly insulting, and is pretty much the opposite of what Alan Turing would actually do. This is a very rare level of douchebaggery, both very subtle (with the name) and in-your-face with the price rise. Reading about his other current financial antics, he might end up in jail soon anyway.

How is this even legal?

[wardrich86]

I assume the mentality is that insurance will throw him all the money, and people won't run into much trouble because of insurance. How is this any different from insurance fraud?

On that note - why are there no laws in place that require studies and solid reasoning for ridiculous price-hikes like this? Is there no laws in place to prevent price gouging?

Legalize the import of generic foreign drugs...

[gestalt_n_pepper]

...and this problem stops. Immediately. The pharmaceutical grifters wouldn't have a clue as to how to operate in an unprotected, global, competitive environment.

Re:Or just use homeopathy?

[Coren22]

Is that what computer power supplies contain?

Re:Or just use homeopathy?

[Coren22]

Even if they are less effective and more insecure than the alternatives.

Re:Or just use homeopathy?

[Salgak1]

I have a buddy who tried using homeopathy to develop resistance to bullets, starting with bb's and working up. It went bad, as soon as he moved up to .22's (grin)