Doctors Tried To Lower $148K Cancer Drug Cost; Makers Tripled Its Price (arstechnica.com) 384
Slashdot reader Applehu Akbar writes: Imbruvica, a compound that treats white blood cell cancers, has until now been a bargain at $148,000 per year. Until now, doctors have been able to optimize dosage for each patient by prescribing up to four small-dose pills of it per day.
But after results from a recent small pilot trial indicated that smaller doses would for most patients work as well as the large ones, its manufacturer, Janssen and Pharmacyclics, has decided on the basis of the doctors' interest in smaller dosages to reprice all sizes of the drug to the price of the largest size. This has the effect of tripling the price for patients, and doctors have now put off any plans for further testing of lower dosages.
The researchers are retaliating by urging clinical investigators to test whether the expensive pill could be safely given every other day -- and by calling on America's public health regulators to investigate the drug's pricing.
But after results from a recent small pilot trial indicated that smaller doses would for most patients work as well as the large ones, its manufacturer, Janssen and Pharmacyclics, has decided on the basis of the doctors' interest in smaller dosages to reprice all sizes of the drug to the price of the largest size. This has the effect of tripling the price for patients, and doctors have now put off any plans for further testing of lower dosages.
The researchers are retaliating by urging clinical investigators to test whether the expensive pill could be safely given every other day -- and by calling on America's public health regulators to investigate the drug's pricing.
Crimes against humanity (Score:5, Insightful)
Hang them
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Big Pharma is JUST LIKE big insurance, folks. They write the laws in their own favor.
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> Martin Shkreli got off scot-free
Give it time. He's going to prison, maybe he bumps into someone there who had a family member die because they couldn't afford treatment and that person will see it as a chance to even the score.
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Unlikely, he's going to rich-people prison where the facilities are nicer than are available to poor people living in an apartment.
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Re:This is what I don't understand. (Score:5, Interesting)
Check the bolded portion below:
Re: This is what I don't understand. (Score:2)
They need to get the generic approved by the FDA by doing expensive studies, even though itâ(TM)s the same chemical formula thatâ(TM)s already been approved. Itâ(TM)s an incredibly stupid law thatâ(TM)s only on the books because of lobbying by large drug companies.
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It's not the only reason. If they use different ratios of delivery/carrier materials, it does need to be proven that they don't interfere with dosing and absorption. And if the patent only covers the active ingredient, can the composition of the tablet itself be kept as a trade secret or is it published with some sort of FDA document? Honest question, I don't know the answer to that.
Re: This is what I don't understand. (Score:5, Interesting)
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The approval process for a new drug is more complex; they have to prove it is safe and that it is effective in rigorous clinical trials. For a generic, they merely have to demonstrate equivalent pharmacological effects (e.g. absorption into the bloodstream in similar quantities and in a similar time, etc.), which is much easier, and requires fewer test subjects, less complex follow-up, etc.
However, to
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Re:Crimes against humanity (Score:4, Insightful)
That's utter horseshit. You've been so brainwashed by the ubiquitous marketing of a late-stage capitalist system that you can't even fathom someone doing research without corporate sponsorship. It's robbed you of imagination.
https://en.wikipedia.org/wiki/... [wikipedia.org]
Re:Crimes against humanity (Score:4, Insightful)
The numbers that get thrown about regarding the cost of conducting clinical trials are inflated by thousands of percent. Profits are disguised as costs. It's a huge scam. Plus, much of the cost of clinical trials in the US is subsidized by the taxpayers.
Re: Crimes against humanity (Score:4, Informative)
OK...I'd think by know you ACs would know better than to challenge me.
This one is to show R&D and clinical trial costs are inflated.
https://www.npr.org/sections/h... [npr.org]
And this one is to show that profit is being reported as costs when a pharma does R&D and clinical trials (this one might be behind a paywall for you).
https://www.nature.com/article... [nature.com]
Forbes did a survey of 100 pharmaceutical companies. The average estimate they gave for the cost of developing a new prescription drug and bringing it to market was $5 billion (with a "b"). It turns out that the average new drug costs $30-40 million for R&D plus clinical trials.
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> Without profits, there is no incentive to do any R&D.
1. /cynical So basically profiting off people's suffering is OK. Got it.
2. ./sarcasm Because money is the ONLY motivation to find a cure. Riiight.
Money needs to be REMOVED from Big Pharma.
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1. /cynical So basically profiting off people's suffering is OK. Got it.
Farmers profit from people's hunger.
2. ./sarcasm Because money is the ONLY motivation to find a cure.
Money is not the only motivation, but it is the most effective motivation.
Money needs to be REMOVED from Big Pharma.
What do you intend to use as a replacement.
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OTOH, the entire electronics industry manages plenty of R&D on far smaller margins.
Consider, at $148K/year/patient, I'd be shocked if they're not pulling in over a billion a year. Quite possible 10 billion a year (the conditions it treats aren't rare).
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Every successful drug has to support the R&D for the 90% that are unsuccessful.
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Also true in other industries.
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More importantly, are 90% of pharma projects unsuccessful?
Way more than 90% fail. But most fail early, before any clinical trials, and don't cost much. Of those that make it to clinical trials, 80-90% fail, depending on how you measure it. But clinical trials are run in phases, so a cancellation after "phase 1" means phases 2 and 3 are never run.
Citations:
The high price of failed clinical trials [clinicalleader.com]
Why too many clinical trials fail [forbes.com]
A new look at clinical success rates [sciencemag.org]
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Every successful drug has to support the R&D for the 90% that are unsuccessful.
True. On the other hand, drug companies have some of the highest profit margins of any industry, and they spend far more on marketing than they do on R&D. So, it seems like R&D isn't a huge part of expenses, which really weakens your point. (A quick bing shows 17% of costs are spend on R&D.)
et tu (Score:4, Insightful)
His abuses of abusive laws are not ok. An "et tu" defense that others do it doesn't make it ok.
Re:Crimes against humanity (Score:4, Interesting)
He absolutely is that bad and he's a total ass besides. He deserved all that he got and more.
Unfortunately and most telling, none of what he got was for his shenanigans with drug prices. He got away scott-free for that.
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The researchers are retaliating by urging clinical investigators to test whether the expensive pill could be safely given every other day
About that 'retaliation' thing....
You remember what happened the last time you tried to give people lower doses to save money?
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The company made all doses the same price. You can buy the four times stronger pills, cut them in four parts and save yourself 75%.
Re:Crimes against humanity (Score:5, Informative)
The company made all doses the same price. You can buy the four times stronger pills, cut them in four parts and save yourself 75%.
That doesn't work with all drugs - for example, some drugs have an enteric coating that prevents it from dissolving in the stomach, others may have a time release coating, etc.
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The company made all doses the same price. You can buy the four times stronger pills, cut them in four parts and save yourself 75%.
That doesn't work with all drugs - for example, some drugs have an enteric coating that prevents it from dissolving in the stomach, others may have a time release coating, etc.
I suspect that a compounding pharmacy could take a bunch of the large pills, powderize them, and make smaller pills with enteric coating. Expensive? Yes, but still peanuts compared with the price of the original pills.
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Are you allowed to remake a medicine? Legally speaking.
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In the Netherlands you are and this is now being used as a loophole. However, insurance companies are hesitant to pay for it, and it is only allowed for the pharmacists registered patients.
The name of this option is "magistrale bereiding" - magisterial preparation.
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In the USA that's a 'compounding pharmacy'. Most pharmacies just dispense pills. Compounding ones mixup custom drug cocktails/dosages. They are, theoretically at least, much better trained and aren't allowed to just 'wing it'.
There have been a few cases of pharmacists dispensing diluted drugs. Mostly addicted pharmacists, but some simple money grubbers.
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Each pharmacy would probably have to go through FDA trials and approvals for their method in doing that.
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The company made all doses the same price.
And... what do you imagine they'll do next time around?
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I'll vote for that.
Re:Crimes against humanity (Score:5, Informative)
We already fund up to 80% of pharmaceutical R&D through our taxes. You forget that the pharmaceutical lobby is the most powerful one in Washington. It's a rigged system and we pay the price. Privatize the profits, socialize the losses.
I live in Japan, where the government is allowed to negotiate prices and can declare certain things (such as MRIs) benefits to the common good and therefore mandate that they be made cheaply available. Finally, drug patents only last for three years. One of the reasons the TPP would be bad news for the other countries: the US wants everyone to extend the patents to 12.
Re:Crimes against humanity (Score:4, Insightful)
Our Minuteman and nuclear sub force is enough to deter invasion.
Right, keep the nuclear deterrents but get rid of any and all defensive weapons. Boats? Bullets? Rifles, tanks, attack aircraft? "We don't need 'em anymore; we've got nukes."
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Because that worked so well in the 1930s?
You're not completely wrong. We should cut back, but let's stay real. Can the Europeans really be trusted to run their business without adult supervision?
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Given Europe's history. No. That's how WW2 happened. WW1 finished and we went back to being isolationist. The next thing you know, Europe is back at it. We haven't left since then because we're afraid they'll start WW3. There are countries that have hated each other for hundreds of years and still haven't gotten over it. You can't prove who started it, but they're pretty sure it was those other fuckers (probably over some cow grazing in the wrong field).
Most European countries couldn't stop the next
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You can't prove who started it, but they're pretty sure it was those other fuckers (probably over some cow grazing in the wrong field).
That actually would make a great premise for a Monty Python-style comedy about a war that's gone on for years.
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When we're coming out of a century where we needed bailing out _twice_, you can talk.
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Just because you can doesn't mean you should. (Score:4, Insightful)
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If profit can be had and they don't do it, then shareholders will come after them with lawyers.
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Some markets should not be driven by shareholders. This is one area where government spending would benefit everyone.
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The problem is that governments can't seem to balance a budget.
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Then the shareholders and investors own the shame, too. Not that many would care, I agree. But take a look at this example [macrumors.com], where investors urge Apple to do more to protect children from smartphone addiction. Such things could have potential impact to "profit", but one could reasonably state that it's the right thing to do.
I doubt the investors think there's any real risk to their bottom lines. The moment there's money to be made it's easy to rationalize an action. In this case it's actually pretty easy, the drug was priced based not on raw materials but to recoup R&D + profit. So if people suddenly discover the correct dosage is only 1/3rd as much as before then the correct action is to triple the price of the product. Heck, it means your product was 3x as effective as people thought!
People hold up Shkreli as the poster
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That's patently untrue. Counterexample 1: Amazon leaves a lot of cash on the table.
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If profit can be had and they don't do it, then shareholders will come after them with lawyers.
And... If there's any poetic justice, some of them will get cancer and then not be able to afford the drug. (fingers crossed)
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I get it.. recovery of R&D costs, profit, all of that.
Or do you?
1. How many years of labor by a huge team of specialists did it take to develop this drug?
2. How much does it cost to make each dose?
3. How big is the pool of patients who take the drugs?
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If you chop the "sale price" by cutting the dosage, then you chop the company's income, thus extending the time that it takes to recoup the R&D costs (which wasn't free money).
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I figure those things were calculated in the original price. Where do those three items fit in with tripling the price of the drug?
Corporate economics. Patients are using less so they jack up the price to maintain revenues. It's not based on need, but want - aka: greed.
For example, look at the grass/weed killer RoundUp. A 32oz bottle of regular concentrate costs about $19. The same size bottle of "Extended Control" (prevents growth "up to" 4 months) concentrate is about $33 and the same size bottle of "Max Control 365" (prevents growth "up to" 1 year) is about $45. (from experience, the "up to" parts are generous on their part) The
Re: Just because you can doesn't mean you should. (Score:2)
They could just stop making the drug all together then no one gets it.
I wouldn't want to get into any medical industry because it's like a gun pointed at your head with a bunch of people demanding you manufacture for free, work basically for free and give it to them for free.
I really don't know the full story here about why the drug costs so much, but there has to be some reason for it. I like to get away with high margins too, but perhaps they're not getting high margins or they're getting 10000% margins,
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and we'll happily fund the countless failures in the hopes of an eventual win
Do you? Really? I thought big pharma were the ones putting the money.
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Often, they only come in after grant funded research finds a promising drug. The grant funded failures are on the public dime.
That's not to say that there is no risk to the company. Not all promising drugs pan out, but it's not as if they take all of the burden on.
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I betcha that nobody would be willing to take the grants. Here's why: The grants don't pay 100% for the research. The IP pays for the rest.
Universities often pool multiple grants together to pay for research. Some of those grants are public, some are private. The research school may then license or sell the IP to a corporation. So the research universities would not be willing to take a grant if it required the IP to be made public. Perhaps they would, but only if the grant paid a lot lot more. The g
And when true drug price controls... (Score:5, Interesting)
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this drug does in fact cost $100,000 per year for treatment then demanding the company sell it for $50,000 just means the government demanded the company into bankruptcy
If the cost of the drug is more down to recovering R&D costs, then it's better to sell it at any price than not at all.
Public interest (Score:5, Insightful)
Lots of folks here are allergic to the idea of the public interest having any role in public policy. I understand where you're coming from - "if it isn't helping me now..."
But here's the thing - properly funding public research is WAY cheaper than these ruthless extortion tactics we've turned healthcare into for the past few decades.
I mean, it's crazy cheaper to prioritize a working public healthcare, and yes, research programs.
As in, most of the rest of the world would consider how we run things a complete joke.
But somehow, because it involves some sort of public interest at play... it's somehow seen as a threat(?)
But somehow, these stories after stories of business people deciding to extort folks, with such calculated corporate smiles on their faces are seen as not a threat.
Which is rather odd - those same folks would see Andy Griffith as a misty memory ideal don't see how basically that's exactly the kind of cruel selfishness personified that he ranted at in half of the episodes of his show.
It's just so bizarre to see what passes for debate and morality in discussions on Slashdot these days.
Ryan Fenton
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As a Canadian I have to say that most of us *do* consider how you guys run things a complete joke and we have been thinking that for quite a few decades now.
Your two biggest problems are as follow:
1. You all seem to fear common good for some reason. The word "communism" doesn't mean "Russian" or "poor" or "dictator". Communism is "the philosophical, social, political, and economic ideology and movement whose ultimate goal
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That's only true if you compare public and and private funding for research of the exact same thing - you use 20/20 hindsight to filter out failed research. Without some sort of profit motive to indicate which research has greater benefit to society, public research ends up going off the rails and wasting resources investigating silly things wit
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properly funding public research is WAY cheaper than these ruthless extortion tactics we've turned healthcare into for the past few decades.
We all want that to be true, unfortunately that isn't the case, and US keeps leading the world pharma innovation [quora.com]
I hate ruthless capitalism as much as the next guy, but reality is that it keeps outperforming any other system on most serious metrics.
This is the economic system... (Score:5, Insightful)
Re:This is the economic system... (Score:4, Interesting)
Except it's not the free market, because this only happens due to a government granted monopoly on the drug formulation (i.e. the patents).
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Free? It looks bloody expensive tome!
Re:This is the economic system... (Score:4, Insightful)
...that so many Americans identify with and defend patriotically and decry anything else as Socialism/Communism/government overreach. This is the free market and minimal regulation at work, doing what it's supposed to do, regardless of anything except profits and share prices, and you vote for it like true patriots every few years.
"'Money before people', Ted, it's the company motto, written right on the lobby floor. It just looks more heroic in Latin."
-- Veronica Palmer, Better Off Ted [wikipedia.org], Season 1, Episode 4.
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We don't know what is the drug company's return on investment it "demanded' for developing the drug or what they need to recoup investment. We do know that most companies (especially those with monopolies) tend to price whatever the market will bear. The cost of developing this drug is a sunk cost and, in isolation, according to simplistic economics should have no bearing on its present price. The present cost has a floor of only what it takes to manufacture the drug and a ceiling which is in principle u
Fixed cost vs incremental cost. (Score:2)
I'm assuming this is because they are trying to get back the fixed R&D cost. Maybe the solution should be an incremental cost for the medicine and the fixed cost divided by the number of users. That way the more people who sign up, the lower the cost is to all. Or maybe the government should buy out the fixed cost and let the company collect the incremental cost.
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I'm assuming this is because they are trying to get back the fixed R&D cost.
Nope, it's because they're trying to screw people with cancer out of every last cent they possibly can. The entire family will be in debt for the rest of their lives just because they thought they were doing the right thing buy buying grandpa four or five extra months.
(when really, they aren't... people need to accept that grandpa's time has come)
Re: Fixed cost vs incremental cost. (Score:2)
How many users are of this drug? What's the demand for this product? Why aren't there any alternatives or competition? What's the actual costs of production of this drug? Are they really making huge margins or are they recouping costs like huge debt? We don't have any clear answers from this article.
I occasionally get weird clients asking me for some products to make, demand a free sample and get shocked at my pricing, without realizing I have to bare the large cost of retooling just to accommodate them, an
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Sounds like you lose that business. Maybe you need better salesstaff.
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Why would R&D costs matter? First, R&D is not the biggest cost. Second, they're trying to maximize their profit, not recoup costs.
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Here's an idea.
You may charge $10 per month's dose as patent licensing - and reasonable manufacturing costs (which will be in competition with everyone else licensing the same medicine) - for 10 years upon discovery.
Now what you'll do is hope to sell enough diagnosis equipment that more people will go on your pill, separate R&D and manufacturing, and research the treatment to hundreds of different ailments rather than just pour all your money into one.
For what it's worth... (Score:2)
Second, as far as I know, every pharmaceutical marketer has a drug affordability of some kind. In fact I think it might be a little known requirement under US FDA regulations. Here is the official drug affordability site for the drug: Imbruvica cost support [imbruvica.com] Any one who needs this drug (or any other l
Health Care Evolved (Score:3)
1. Kidnap a pharmaceutical company CEO.
2. Lock him up with a rabid raccoon until they become properly acquainted.
3. Offer the exec access to the anti-rabies vaccine for $30 million deposited in an untraceable numbered bank account.
4. Profit!
Where are all of the free market supporters? (Score:2)
It always blows my mind when I see users who constantly post pro-Trump free market posts on slashdot calling for the death and hanging of someone or some organization who is doing just that!
Geez. Either you want free market or you don't! At least be consistent.
I have suspected MOST Republicans actually want socialized healthcare, they've just been bamboozled by their party to think otherwise.
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It's quite possible they are different people.
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It's quite possible they are different people.
You can't have the same username and be different people on slashdot.
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Re:Where are all of the free market supporters? (Score:5, Informative)
It always blows my mind when I see users who constantly post pro-Trump free market posts on slashdot calling for the death and hanging of someone or some organization who is doing just that!
Except last year the con artist said he'd lower drug prices [cnn.com]. Then he picked a guy who is a former pharmaceutical executive who raised drug prices [washingtonpost.com].
Even in February's State of the Union address he said he'd lower drug prices [latimes.com].
What has he done so far? Reduce regulations on oil and gas drillers [washingtonpost.com], put a guy in charge of the EPA who is vowed and determined to let polluters off the hook [nytimes.com], and started a trade war with China which is already costing Midwest farmers [thehill.com].
This was predicted (Score:3)
Johnathan Pie sums medical care in the USA & (Score:2)
https://www.youtube.com/watch?... [youtube.com]
Can't anyone here do math? Read? (Score:2)
Here is the horrible action the pharmaceutical company took:
But after results from a recent small pilot trial indicated that smaller doses would for most patients work as well as the large ones, its manufacturer, Janssen and Pharmacyclics, has decided on the basis of the doctors' interest in smaller dosages to reprice all sizes of the drug to the price of the largest size. This has the effect of tripling the price for patients,
So, previously there was a pricing anomaly in that 4x smaller pills were as effective as 1x large pill, so when they repriced the drug, each of the smaller doses cost as much as the larger dosages. Why would a patient keep taking several of the smaller dosage pills after the price change? Just take the 1x larger dose pill and it costs as much as the 4x smaller pils used to.
I would expect highly specialized medicines to retail at a price based on th
In Europe drugs are 1/10-1/20th of USA price (Score:5, Insightful)
It's the prices, stupid! (Score:5, Insightful)
The entire US health care system is a scam run by doctors, hospitals, pharma, insurance companies. Prices for health care in the US are four to ten times that of the rest of the world. Other developed countries have universal care and better health indicators than the US and they spend less than half what the US spends to cover just part of the population.
We have the most expensive, least effective health care in the world.
No other civilized country would let pharma get away with these obscene prices for drugs. Other countries control prices. However, the US is run by a crony capitalist system where corporations, etc. buy congress to protect their profits.
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But that is true of many other things as well. The US pays for all the medical research that the rest of the world uses for free or next to it.
That is like comparing America's expenditures on its military to France's or Japan's. France and Japan only spend so little and yet manage to not be enslaved because America has acted as their military for the last generation or two, them and half of the rest of the world besides.
Or course their exist many other countries with better and cheaper options, as their gov
The company's position might be reasonable. (Score:2)
Low volume of patients. High cost to invent the drug and pass the regulatory hurdles. And it has to subsidize all the drugs they researched that didn't work out. They need to make this money back over the lifetime of the patent or they go out of business.
A couple of researchers try to game that system and the company responds: Nope, prescribe the medicine the patient needs based on the medical evaluation only. We're going to make it cost exactly the same per patient regardless of the dosage you pick.
There a
Re:The company's position might be reasonable. (Score:4, Informative)
This 2017 article from the New York Times [nytimes.com] has some of those answers.
Summary: According to SEC filings, Imbruvica cost Pharmacyclics $388 million to develop, which included the development cost of three other drugs that were not successful. Not mentioned in the article is that Pharmacyclics actually paid $2 million in cash and $1 million in stock for the compound from its actual inventor, Celera Genomics, and their expense was mostly related to developing the compound into an salable drug. After the Phase II clinical trials, J&J paid Pharmacyclics $975 million to jointly continue development of the drug. The drug was approved for CLL in 2014, and just over a year after that, Abbvie bought Pharmacyclics for $21 billion (a 5400% return on investment for Pharmacyclics's shareholders), and the drug is now being sold under the "Janssen and Pharmacyclics" name. In 2016, J&P projected Imbruvica sales of $1 billion for that year, increasing to $5 billion by 2020.
In my opinion, the developers of the drug have already been very well paid for their efforts, certainly well enough "to promote the progress of science and useful arts". I haven't been able to find any other information that would lead me to believe that this isn't a simple money grab, and/or that Abbvie simply paid too much for the drug and is extracting the cost of their mistake from patients. If there are other concrete facts that would argue for other legitimate development costs that need to be recouped, I genuinely would be interested to see them.
Let's toss in some numbers... (Score:5, Informative)
A New York Times article stated that this drug was developed with three other non-viable drugs for a total cost of $388,000,000. Dividing by the stated cost of $143,000 dollars, 2,713 patients have to be treated with this drug for 1 year to recover development costs.
This drug treats Chronic Lymphocytic Leukemia (CLL). Approximately 20,000 people are diagnosed with CLL each year, and those people have an average age of 71 years. Approximately 4,500 people die each year from CLL. Your lifetime risk of developing CLL is 1 in 175.
Cancer.org lists 5 other treatments (Obliersenn, Lumiliximab, HA22, Lenalidomide, 'standard' chemotherapy) for CLL [cancer.org], and mentions dozens of drugs are in testing for CLL treatment.
You now have more information to discuss alternative treatments, their costs, and why folks would choose one over the other, as well as a greater ability to evaluate the potential profitability of this drug (Imbruvica) at any price point.
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What Other Solution Did they Have? (Score:2)
The drug was priced that way with a very simple formula.
Number of Patients X Dosage X Cost = Development Cost + Marketing + L. Insurance + Profit
The Dev and Marketing costs are already spent, or at least mostly, and kept at an absolute minimum anyways. The Insurance is probably not going to be negotiable, and the profits are almost certainly a set industry standard. So if the dosage goes down the company either has to increase the number of patients, the cost, or quit selling the drug and just try and take
I'd rather die. (Score:2, Interesting)
Pure monopoly pricing (Score:2)
This is why monopolies used to be broken up - they could price like this. In addition, in this case, it's a life and death product. "How much is your life worth to you? That's how much it costs." Shkreli was was honest and transparent about the reprehensible actions he was taking. The people you need to worry about are the ones who are smiling and empathizing as they knife you. They don't slip out of character either. And they're still leading the industry.
Additionally, the government prohibited itself fr [thehill.com]
When is a cancer patient going to shoot them? (Score:3, Interesting)
I mean seriously- shooters kill over their youtube account being demonetized.
What about you dying?
What about your parent dying?
What about your child dying?
When is someone going to track down the people or corporation increasing the price?
It seems inevitable.
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Dear America,
Fix your fucking healthcare system.
Sincerely,
The civilised world.
Dear Europe (and much of the rest of the "civilized" West),
Please start paying for your own national defense, the nuclear arsenals, standing armies, air forces, navies, etc to match Russia and China.
Then we can talk about us spending that money we currently spend to protect YOUR asses on healthcare instead.
The US is bankrolling your 'free' healthcare.
Just say "thank you" and STFU, 'mkay?
Strat