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The Cancer Drug Market is the Future Pharma Wants for America
Townhall.com ^ | January 14, 2018 | Mytheos Holt

Posted on 01/14/2018 9:55:41 AM PST by Kaslin

2018 has barely finished dawning, and already, the pharmaceutical industry once more has egg on its face from outrageous price hikes. 

This time, the culprit is pharmaceutical startup NextSource, which apparently has taken a 40-year-old cancer drug known as lomustine, and ruthlessly hiked its price from $50/pill in 2013, to $768/pill now. In other words, they’ve raised the price of the drug by over 1400% over the past five years. 

NextSource’s defense for why this has happened has to be read to be believed. CBS News reports that the company’s CEO, Robert DiCrisci, claims that the company set the price based on the costs it incurred in developing the drug, and “the benefits it provides patients.” 

Now, obviously, the drug has been around for 40 years, so the costs of developing it to NextSource, which only acquired the rights to it in 2013, have likely been nonexistent. Which means that the company set the price entirely on the basis of the fact that the drug benefits patients, or to put it more bluntly, the fact that patients need the drug in order to not die. “Nice life you’ve got there, shame if anything happened to it,” is essentially their reasoning. Granted, NextSource is far from the only pharma company to hike its prices with the new year – the practice is still distressingly widespread – but it is the most egregious.

Now, sure, some True Conservatives ™ might read this news and loosen their bowties just enough to nasally intone that that’s how markets work, and what are you, a socialist? And you know what? If this were a price that was set in anything that looked remotely like a free market, they’d have at least a point about the process involved. But, and I will repeat this point until I’m blue in the face, the drug market is not a free market. Rather, it is an assortment of monopolies or near-monopolies that drug companies will move heaven and earth to protect, so that they can go on charging any price they want. In fact, lomustine, which has somehow never been developed into a generic drug in 40 years of existing, is a perfect example of how these practices can lead to de facto monopolies, long after their legal foundations erode. If a generic version of lomustine existed – in other words, if market competition were introduced – it is highly dubious that the drug would fetch even a fraction of its original cost, let alone the gouged nightmare it has become.

And make no mistake, Big Pharma very much wants us to remain at the mercy of their monopolistic practices, and not to be subjected to market forces. The fate of lomustine is what they would impose on every single drug on earth, if they could. You can tell because every legislative or policy-driven attempt to introduce market forces, or to curb price gouging in their absence, is on Pharma’s hit list. 

The US Patent and Trademark Office (USPTO)’s common sense attempt to crack down on unfairly renewed and issued patents through the Inter Partes Review process? Pharma’s against it, even though it has almost never gone against them.

The CREATES Act, which would enable generic drug manufacturers to purchase samples of brand name drugs once they got approval from the FDA, rather than letting pharma go on abusing the Risk Evaluation and Mitigation Strategies (REMS) program? Pharma blatantly lied about what it would do, to try and sink it.

The 340B drug pricing program, which enables safety net hospitals, rural hospitals, children’s hospitals, and any number of other underfunded institutions to purchase drugs at lower prices, as a condition of Pharma’s continued access to taxpayer dollars? Pharma has campaigned against it for years, and cheered its being gutted by friends of theirs at the Department of Health and Human Services (HHS ), though Congress may resolve this particular mistake.

In other words, lomustine’s hike is a powerful and needed reminder of what the future of the US drug market will look like if the pharmaceutical industry is not held to account. Fortunately, bipartisan coalitions exist to challenge them. With any luck, 2018 will prove to be for those coalitions what it should also be for President Trump: a year of action.


TOPICS: Culture/Society; Editorial; Government
KEYWORDS: cancer; drugs; healthcare; italian; mafia; morality; pharmaceutical; protestant
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To: Ouderkirk

*** THE DRUG IS THE PRIVATE PROPERTY OF THE COMPANY ***

While I agree, it’s offensive to charge obscene amounts for drugs, the flawed assumption by all the presumed “conservatives” here is that “the people” somehow have a RIGHT to that drug.

You don’t realize it, but you’re using socialist arguments. Now you say you want the deep state to restrict this company’s freedom to charge what they want for their products (at gunpoint, no less).

Do you all realize that the company also has the right to cease selling their drug?

What would happen if they decided to cease to sell their drug?

And if their drug isn’t generic, they could also sue to prevent competitors from using their formula to make/sell a generic.

The company no doubt spent millions of dollars developing the drug. The company did the research for the drug.

So the drug is their PRIVATE PROPERTY. We, the people, have no “rights” to that drug at certain prices.


21 posted on 01/14/2018 11:50:08 AM PST by AlanGreenSpam (Obama: The First 'American IDOL' President - sponsored by Chicago NeoCom Thugs)
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To: AlanGreenSpam
They did not develop the drug. The company did not even exist when the drug was developed.

They got the right to the patient which is not the same thing and they were not the first company under Obama and Co who somehow managed to get a patient on a very old drug with limited market that they did not develop.

You are defending socialism yourself when you think that this is ok. The government should not be able to sell the patient rights to a drug.

22 posted on 01/14/2018 12:10:13 PM PST by Harmless Teddy Bear (Not a Romantic, not a hero worshiper and stop trying to tug my heartstrings. It tickles! (pink bow))
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To: Harmless Teddy Bear
"Why a 40 year old drug is under patent is a good question. "

I don't claim to be an expert on this issue.

The patent on the drug I take ran out 18 months ago. The generic maker was already making the drug in India despite American patents.

The Indian company wanted to incorporate improvements in the formulation that had been made after the original patent and which were protected by a newer patent. They made a non-compete deal lasting six months in exchange for being licensed to use the improvements.

For reasons I don't know, the generic is not approved by the FDA for my ailment. As long as my drug insurance company covers the brand name, I don't care. I prefer to stick with what I already know and not risk some unexpected side-effects from the generic. (Surprisingly, this generic costs about 85% of the cost of the brand name.)

I think the same people who harp about high drug prices also want to levy substantial penalties and damage payments on these same companies when things don't work perfectly. An example of this is Xarelto. I think this was responsible for my bout of unexplained bleeding years ago and additional medical risk and procedures. Despite that, the drug is still on the market and helps many. It's just not for me.

In my opinion too many people just don't appreciate how great we have it and want to change what works well into what won't work much at all. I can't prove it conclusively, but I would bet that I wouldn't be alive today if one removed any one of a dozen medical developments of the last fifty years. This includes intubation equipment and procedures, cat scans, modern antibiotics, blood testing, anesthetics, cancer drugs, and genetic testing.

We're all gonna die. Some will die because there isn't time to get them medical help. Some will die because the help doesn't work. And some will die because the help they need is too expensive. This will never change. If expense were no object, there would be a fully staffed ambulance with its engine running parked outside my front door.

23 posted on 01/14/2018 12:14:24 PM PST by William Tell
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To: Kaslin
"...the company’s CEO, Robert DiCrisci..."

One of the costs of allowing foreign cultures to invade western business.


24 posted on 01/14/2018 12:15:19 PM PST by familyop ("Welcome to Costco. I love you." --Costco greeter in the movie, "Idiocracy")
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To: Harmless Teddy Bear
"They did not develop the drug."..." They got the right to the patent which is not the same thing ..."

It most certainly is the same thing. Patent rights are private property.

Let's use Merck as an example. If every stockholder in Merck sold his stock tomorrow and new buyers were found, then the company would be owned by entirely new owners. Would that invalidate their patents? Of course not.

It's no different if Merck decides to sell some of its property to a different company, no matter how new such a company might be.

Forty years of protection for a patent is unusual. Typical might be under twenty years. That means that patients today benefit from every medical development made up until 1998. That's an incredible benefit. In twenty years, EVERYONE will benefit from most of what is available today. Why destroy a system of development with such a brilliant outcome in order to benefit the few who fall in the cracks? It doesn't make sense; it just feels good.

25 posted on 01/14/2018 12:29:35 PM PST by William Tell
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To: William Tell
"If expense were no object, there would be a fully staffed ambulance with its engine running parked outside my front door."

If each ambulance was a hot rod station wagon with two thin, healthy, young, wide awake, drug-free former Army combat medics in white, we wouldn't need it outside our front door. Same with the hospitals and drug companies, if they were managed and staffed by real Americans instead of people so recently descended from s***hole commie/fascist countries.

Immigration has been all about money for too long. Get a degree, take all of the Yankees' money and land.


26 posted on 01/14/2018 12:29:52 PM PST by familyop ("Welcome to Costco. I love you." --Costco greeter in the movie, "Idiocracy")
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To: amihow
True conservatism takes into account human greed and cruelty and establishment of REASONABLE LAWS AND REGULATIONS to prevent it!

Ah, finally, a new definition of "Conservatism". And what exactly are "Reasonable Laws and Regulations" and just who makes that determination......?

27 posted on 01/14/2018 12:31:42 PM PST by Hot Tabasco (My cat is not fat, she is just big boned........)
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To: Angels27

Who exactly are these powers that be? I see stuff like this on Facebook all the time. “So and so has a cure for cancer but big pharma won’t let anyone know”.

There are cures for a lot of diseases - why just deny cancer?


28 posted on 01/14/2018 12:46:29 PM PST by ilovesarah2012
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To: Ouderkirk
"If you’ve got one foot on a banana peel and the other in a grave, then they’re worth the world to you if they are what’s keeping you out of that grave."

Sometimes, yes. Sometimes, no.

A relative of mine was taking OpDivo. I don't know what it cost, but it didn't help him and he stopped taking it. He couldn't tolerate the side-effects. Apparently the average overall survival benefit of this treatment is about 90 days.

I think that is a point that a lot of people miss. Most drugs are not miracle pills. They extend survival for sick people but they don't necessarily make everyone whole again. It's tragic when an eight-year-old dies from cancer. We would all be willing to make sacrifices to prevent such a tragedy.

It's also tragic when a 69-year-old Freeper dies for whatever reason. But there are limits on what society should be compelled to sacrifice to buy more days for such a person. Today if an unfortunate person is denied a benefit because a drug company charges a lot, we read all about it in detail. Tomorrow, if the government mandates certain behaviors from drug companies we may never know how many lives might be lost from such bad policies. We can certainly see how bad government policies affect places like Venezuela.

29 posted on 01/14/2018 1:13:24 PM PST by William Tell
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To: Kaslin
According to FDA's standard reference for marketed products which also includes patent and exclusivity information, commonly know as the "Orange Book," there are no patents and no market exclusivities that would prevent an enterprising generic manufacturer from identifying a suitable FDA-compliant manufacturer for the active lomustine ingredient, formulating it into the same kind of dosage form as is the currently marketed product (the "Reference Standard" drug), performing a bioequivalence study as specified by FDA against that Reference Standard, preparing and filing an Abbreviated New Drug Application with FDA, and obtaining FDA's approval to market.

Currently, there are two Drug Master File ("DMF") holders who have DMFs on file at FDA who make the chemical substance, and who a generic firm might approach to contractually make the substance (also known as the "API" = Active Pharmaceutical Ingredient) for the product.

Given the price this drug is commanding presently, one expects there might be such an enterprising generic firm willing to pursue their market share for this product.

For all we know, there might be such a filing at FDA going through review right now.

It would be interesting to learn why GSK got out of the business, since it was originally their product.

FReegards!

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30 posted on 01/14/2018 1:13:33 PM PST by Agamemnon (Darwinism is the glue that holds liberalism together)
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To: Ouderkirk
Obviously, these drugs are worth only what one is willing to pay for it. If you’ve got one foot on a banana peel and the other in a grave, then they’re worth the world to you if they are what’s keeping you out of that grave.

I'll probably get grief for saying this, but if my choices are to spend every penny I have for medicine, or die, I'll die and leave my money to someone young and healthy who can enjoy it.

31 posted on 01/14/2018 1:14:53 PM PST by A_perfect_lady
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To: Kaslin

Why do you that no marijuana is still a class one drug and they try to suppress medical marijuana which is currently in Cavinoid oil form curing cancer?


32 posted on 01/14/2018 1:28:20 PM PST by Georgia Girl 2 (The only purpose of a pistol is to fight your way back to the rifle you should never have dropped)
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To: William Tell
It most certainly is the same thing.

No.

Patent rights are private property.

Yes and no.

When you have developed a drug you receive a patent on it. This allows you to make the drug exclusively for a certain amount of time. The key here is A CERTAIN AMOUNT OF TIME.

A patent is not forever.

This drug was not under patent and then suddenly the US government decided to award the patent to a company who had nothing to do with the drug.

Sorry, but that is not the way it works.

You are correct that 40 years of protection is unusual. In fact it does not exist. Except for some reason for a few years under Obama these orphan drugs were somehow placed back under patent and awarded to companies that had nothing to do with them.

That is not capitalism.

33 posted on 01/14/2018 3:55:37 PM PST by Harmless Teddy Bear (Not a Romantic, not a hero worshiper and stop trying to tug my heartstrings. It tickles! (pink bow))
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To: Harmless Teddy Bear; William Tell
This drug was not under patent and then suddenly the US government decided to award the patent to a company who had nothing to do with the drug.

Your statement is completely false.

Except for some reason for a few years under Obama these orphan drugs were somehow placed back under patent and awarded to companies that had nothing to do with them.

I don't like Obama any more than anyone else does on this board, but again your statement is false.

GSK decided to get out of the product or sold it off for their own business reasons. A small company picked up the asset where no competition is currently present. They have a window of market uniqueness because there is not competition -- not that a patent is standing on the way of anything.

A generic firm or firms may choose or may have already chosen to file a generic version of this drug with FDA in search of marketing approval.

It is entirely a business decision for a generic firm to file a product with FDA to enter this market, but FDA is not standing in the way of anything here either. In fact it is FDA's policy to put generic approvals on a prioritized review track for an eligible drug product like this one is when there are fewer than 3 generics on the market. Once generic entrants are approved the price for the med will collapse almost overnight.

You need to research things more thoroughly before you post.

FReegards!

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34 posted on 01/14/2018 5:10:40 PM PST by Agamemnon (Darwinism is the glue that holds liberalism together)
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To: Hot Tabasco
The Government composed of true conservatives duly elected by the People makes said determination.

Are you familiar with the history of trust busting laws and why they were passed?

Think good to familiarize your self if not. Do not think you want to be at mercy of a corporation like the one in the article.

35 posted on 01/14/2018 6:30:38 PM PST by amihow
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To: Angels27

‘The powers that be want no cure for cancer.’

this truth cannot be stated too baldly; way too much money would be lost...


36 posted on 01/14/2018 6:47:29 PM PST by IrishBrigade
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To: Harmless Teddy Bear

‘Why a 40 year old drug is under patent is a good question.’

seems like there’s something more to this whole story...a drug on the market cannot under normal circumstances be price protected by patent...


37 posted on 01/14/2018 6:52:05 PM PST by IrishBrigade
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To: ilovesarah2012

‘why just deny cancer?’

have you had experience that shows first hand how lucrative treatment of cancers is...especially in this country?

Curing would obviate the treatment, and a lot of medical people would be out of jobs...


38 posted on 01/14/2018 6:55:13 PM PST by IrishBrigade
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To: IrishBrigade

What about other countries? No one in the world wants to cure cancer?


39 posted on 01/14/2018 6:57:04 PM PST by ilovesarah2012
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To: IrishBrigade

‘a drug on the market cannot under normal circumstances be price protected by patent...’

and this is why IrishBrigade needs to proofread his statements...he (I) meant to add ‘for a period of forty years...’


40 posted on 01/14/2018 7:07:31 PM PST by IrishBrigade
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