Why a $158,000 Drug With Unclear Benefits Hurts Whole Health System (wsj.com) 176
Price tag for a recently approved ALS drug illustrates broad industry problems. From a report: Like many patients suffering from amyotrophic lateral sclerosis, or ALS -- also known as Lou Gehrig's disease -- Layne Oliff didn't have any time to waste. Even before the drug Relyvrio was approved late last month by the Food and Drug Administration, he has had his own do-it-yourself method: he gets sodium phenylbutyrate in liquid form from a New Jersey pharmacy and taurursodiol online from Amazon. That costs him over $7,000 a year, but he says it has been well worth it because he feels the combination has helped stabilize a disease that often causes death within a few years. Now that the drug combining those two known compounds has been approved in the U.S., the official list price is going to be $158,000 for a year's supply, or over 20 times more than he was spending.
While that may be excellent news for Amylyx, which makes the drug and whose shares are up 159% over the past 6 months, the exorbitant price tag is bad news for the U.S. healthcare system. Patients won't be footing the entire bill themselves -- insurers pick up most of the tab, which is finalized after rebates are made by pharmaceutical companies to get the drug covered. And of course making the drug available through the proper channels will be a more affordable and more reliable way for patients to take the medication, especially those who can't afford the out-of-pocket costs Mr. Oliff was able to pay for his unorthodox, but doctor-supervised method. But the jarring price difference underscores just how out of whack drug prices have become in the U.S. Each time a drug is priced up in the stratosphere, it sets a precedent for the next manufacturer to do the same, sending drug costs in an upward spiral with no real ceiling except for public outcry.
While that may be excellent news for Amylyx, which makes the drug and whose shares are up 159% over the past 6 months, the exorbitant price tag is bad news for the U.S. healthcare system. Patients won't be footing the entire bill themselves -- insurers pick up most of the tab, which is finalized after rebates are made by pharmaceutical companies to get the drug covered. And of course making the drug available through the proper channels will be a more affordable and more reliable way for patients to take the medication, especially those who can't afford the out-of-pocket costs Mr. Oliff was able to pay for his unorthodox, but doctor-supervised method. But the jarring price difference underscores just how out of whack drug prices have become in the U.S. Each time a drug is priced up in the stratosphere, it sets a precedent for the next manufacturer to do the same, sending drug costs in an upward spiral with no real ceiling except for public outcry.
Now go ahead (Score:5, Insightful)
And tell me the government doesn't need to start regulating drug prices. Oh and make advertising prescriptions illegal. No other country allows this.
Re: Now go ahead (Score:2)
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Everywhere else the drug costs $7k and here we're allowed to price gouge, so the drug companies end up deciding that selling a small quantity at $158k per patient is more profitable than treating everyone at $7k each.
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You don't need to do that. You just need to ban marketing for chemicals.
In other words, you're buying Tylenol-brand acetaminophen, not Tylenol. You could also buy someone else's acetaminophen, This would also prevent lawsuits against people like the individual in TFA for 'patent violation' or some such bullshit, because there should be no patents on chemical formulas.
How they can charge that much for what is effectively an existing drug with a common homeopathic remedy is beyond me. I'm sure they're expecti
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Just to be accurate, New Zealand and the United States are the only countries [consumerhe...atings.com] that allow Direct To Consumer Prescription advertising (DTCA).
Yes, it is crazy and should be prohibited.
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I don't know what the FDA criteria are for approving or denying approval for a given me
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What you just said is the conundrum. Someone has to spend money to develop a drug, even if it doesn't work, and that takes years. Who's paying for all that testing and development and salaris and overhead during that time? Do we want the taxpayers footing bills for drugs that don't work and have to hear, "SOLYNDRA!", or do we want to keep the government out of the free market and let things go as they are? Is there some type of middle ground so companies continue to work on things such as remedies/cures/
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As it happens, we spend quite a bit of tax payer money on drug development. In fact, taxpayers are usually the ones footing the bill for new drug development. You'd have a hard time finding a single one that wasn't at least partially funded with tax dollars.
Who's paying for all that testing and development and salaris and overhead during that time?
Taxpayes.
do we want to keep the government out of the free market
LOL!
usa pays for the rest of the countrys to have low (Score:2)
usa pays for the rest of the country's to have low prices.
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The government should NEVER regulate the actual prices, as that will destroy the free market.
Part of the reason we have this problem is exactly that! Messed up laws that allow loop holes out the wazoo.
Ideally what they should/can do is regulate how the price is determined — a fine line and very semantically different. Basically, cap how much profit a company is allowed to add onto their prices, using some logic that scales as the market changes.
But even that is ripe for abuse.
The real problem is the h
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The government is regulating the prices: they are granting egregious monopolies via the FDA approval system.
They are also regulating by requiring health insurance where the premiums of the many are used to buy the regulatory-captured care for the few. This inevitably results in high prices.
Contrast to home and car insurance: while you still have "premiums of the many paying for the losses of the few", there is no monopoly power for car repair or home construction, so the prices can't escalate. Health insu
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All other countries regulate the prices of drugs. Only the US permits "your money or your life" pricing.
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Oh and make advertising prescriptions illegal. No other country allows this.
We get to see the American ones here in Canada all the time. Some of them are hilarious.
Tell your doctor if you have had an organ transplant before starting xxx. Nah, why would my doctor need to know that?
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This whole situation is precisely because of government intervention.
You have the regulatory burden driving up costs known as the FDA.
Then you have George Bush's Medicare Part D where Big Pharma wrote the law and said the largest purchaser won't negotiate drug prices - so pharmaceutical companies are then free to raise prices because the largest purchaser will pay whatever.
Then Barak Obama's ACA implemented the same language from Medicare Part D in the commercial space and drug inflation really took off.
And
Re: Now go ahead (Score:3, Insightful)
Re: Now go ahead (Score:4, Interesting)
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The problem with that is that the $7K is just the cost to produce the product. It doesn't include the costs to develop the drug in the first place, which can run into the billions of dollars (a large percentage of which is the cost to get it approved). If you can't recoup that development /approval cost there is no reason to even develop the drug in the first place. So you must divide that billion dollars by the expected number of doses you can sell before either the drug is off patent, or is replaced by
Re: Now go ahead (Score:2)
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Apparently you live in some alternate world where every experiment leads to success. Under your simplistic idea, a company would calculate that they could spend $x developing a drug. They spend that money, but the trials fail (which happens far more often than success). Now what? The company (and investors) are barred from ever recouping that money? All that will do is stop anyone from investing in drug development.
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They spend that money, but the trials fail (which happens far more often than success). Now what? The company (and investors) are barred from ever recouping that money? All that will do is stop anyone from investing in drug development.
If you fail so often that you need to charge orders of magnitude over your costs for the ones that succeed maybe the drug development business is not for you. The free market should deal with that easily, but if you can milk the insurance companies (which really means their customers) to pay for your failure rate then that is a workaround.
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They spend that money, but the trials fail (which happens far more often than success). Now what? The company (and investors) are barred from ever recouping that money? All that will do is stop anyone from investing in drug development.
If you fail so often that you need to charge orders of magnitude over your costs for the ones that succeed maybe the drug development business is not for you.
So you're saying companies shouldn't try to work on developing a drug unless they can guarantee greater than 10% chance that drug will be successful.
In other words, only invest in sure things.
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So you're saying companies shouldn't try to work on developing a drug unless they can guarantee greater than 10% chance that drug will be successful. In other words, only invest in sure things.
Well there is a huge difference between 10% and a sure thing, but yeah, structure your operations so that you don't need to game the system to cover your losses. It is not on the insurance company's premium payers to bail you out of an unsustainable business plan.
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Since well over 90% of drugs investigated don't turn out to work, don't work as well as existing drugs, or have other reasons not to be approved, you basically just said "don't invest in developing new drugs."
Or maybe just find a more transparent and effective way to finance them. There is risk in developing anything, there should be both wins and losses just like with anything else. Pretending you can make everything a sure thing is not realistic or healthy.
I'm not even opposed to spending tax dollars, so long as the resulting intellectual property belongs to taxpayers, but we all know that never happens. They OTOH only get risks, never rewards.
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Re: Now go ahead (Score:3)
I don't know where you live, but our government schools are ranked close to MIT, Oxford and similar institutions. At a fraction of the tuition fees.
Most of Northern Europe has a similar experience.
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I have mod points but I hate modding down because it doesn't give an explanation.
The problem with that is that the $7K is just the cost to produce the product. It doesn't include the costs to develop the drug in the first place, which can run into the billions of dollars
He buys the drugs legally one from a pharmacy and the other from Amazon, so he pays more than the cost of the product. He is actually paying someone profit as well. In many cases public money is used to develop some drugs and seldom is this taken into consideration.
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He is doing some homebrew drug compounding. That compound did not go through any required drug trials. These trials are very expensive. So no, he has not in any way paid more than the cost of this drug.
Re: Now go ahead (Score:4)
Just buy the patents out.
Or better still, pay for the R&D out of taxation. The global R&D budget for pharmaceuticals is only about $200bn. The EU or US or China could do that on its own, or club together and split the cost. All developed drugs available at cost to everyone.
We could even double it and do a few moonshots on cancer, long COVID, obesity and dementia.
$200bn a year is less than some European countries spend on healthcare.
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Side effects include...
https://www.youtube.com/watch?... [youtube.com]
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https://www.youtube.com/watch?... [youtube.com]
Re:Now go ahead (Score:5, Insightful)
As for price fixing/regulation, community funded medical care should have a ceiling somewhere or everyone suffers both from over paying, and less of that funding to go around.
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My wife was prescribed a medication by her doctor. She had awful side effects. Told the doctor, and the doctor said 'well you need the medicine'. She said she saw an ad for a different drug for the same issue. Doctor says 'yes, but it likely has the same side effects' so you should just stay with what you have. She asks if she can at least try it. Problem gone!
I get it, most countries think their citizens are unable to help in their own healthcare and must simply trust the (government paid) doctor. No
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As we've recently discovered, a not insignificant portion of the population is far too stupid to make even basic healthcare decisions. This is a problem that you'd think would solve itself except that their stupidity harms people other than themselves.
She said she saw an ad for a different drug for the same issue.
And you somehow think she's qualified to make that decision? Get real. It's absolutely criminal that we allow marketing of prescription drugs to consumers.
and must simply trust the (government paid) doctor.
I'll trust the "government paid" doctor over one with a profit motive any day of the week.
I'm going to
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No, moron, I don't think she's qualified to make the decision, and I didn't say otherwise. But she certainly IS qualified to press her doctor about it.
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I get it, most countries think their citizens are unable to help in their own healthcare and must simply trust the (government paid) doctor. No thanks.
I'll trust the "government paid" doctor over one with a profit motive any day of the week.
The funny thing is it was probably a "profit motivated" doctor pushing his wife onto a particular med and he did not even recognize it, because it must be government that is bad LOL.
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Americans think that government is intrinsically bad because most interactions with the government in the so-called "Land of the Free" are negative ... after all, it has the one of the highest rates of incarceration in the world and a high rate of killings by police.
The problem isn't that public services are inherently bad ... it's that the US governments (fed/state/local) are often good at brutalizing people (both its own people and in wars abroad) while not being particularly adept at providing public ser
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Fuck right off with your insane right-wing anti-Semitic propaganda.
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Re:Now go ahead (Score:5, Insightful)
I get it, most countries think their citizens are unable to help in their own healthcare and must simply trust the (government paid) doctor. No thanks.
Seeing Americans go through contortions to defend their pharmaceutical and healthcare industries helps a little in understanding how Russians can possibly defend their invasion of other countries (until they think they might get conscripted). Blind nationalism.
Last I checked, healthcare was approaching 20% of GDP in the US! $12,000 per man, woman and child, double the average in other developed countries. Second highest was $7000 in Germany and Switzerland. But better outcomes, partly because nobody is going broke or avoiding medicine because of costs.
Singapore beats us all at us$2600 per capita, only 4% of GDP! (And yes it is developed. Similar per-capita GDP to the US now.) Insurance and savings is compulsory, mixed public/private hospital system, choice of provider... The world needs to learn from that before we follow the US down an endless spiral.
Re:Now go ahead (Score:5, Informative)
most countries think their citizens are unable to help in their own healthcare and must simply trust the (government paid) doctor.
You misunderstand how it works. Government-paid doctors is just one you can get for free or nearly-free. You always can can see a private doctor or try several (their price is affordable, and will be covered by any insurance you have).
Re: Now go ahead (Score:5, Informative)
I'm an anesthesiologist. We have... maybe three drugs I can think of that are on patent. One is absolutely amazing and deserves to make the company a whole lot of money; even though you can usually get by with the older, cheaper alternative, this works in a completely different way and is vastly more effective. One is a pretty good way out of a tight spot, but maybe 80-90% of its use cases can be covered by something cheaper. One is a they're-allergic-to-everything-else-can-we-try-this drug.
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Look, if that's the case, I've missed out on almost twenty years of free strip club visits.
You have. Talk to your medical supplier representative about it.
Re: Now go ahead (Score:4, Informative)
Nonsense. Your insurance company would have a conniption fit if your doctors did that. Instead they have rules that say you must first try at least so many drugs from a preferred list of generics. Only then can you try the non-preferred genetics. Only after all that can you try a non-generic drug. I know this because I read my insurance policy and asked my doctor if this was normal practice and was told that literally all insurance companies do this, although what drug is on what list can vary a bit.
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We did used to ban drug ads. When they were allowed it prompted the whole crapload of useless ads ("ask your doctor if WhataBoutVirium is right for you!" while showing a happy family in a park).
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We did used to ban drug ads. When they were allowed it prompted the whole crapload of useless ads ("ask your doctor if WhataBoutVirium is right for you!" while showing a happy family in a park).
Or Cialis ads that end with a man and woman in separate bathtubs, on a cliff-side, overlooking the ocean, at sunset. "Ask your doctor is Cialis is right for you." Right for what, solo sunset cliff bathing?
Re: Now go ahead (Score:2)
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Price should be what the people are willing and able to pay without insurance-pharma fuckery driving up prices. Invisible hand and all that.
At this point the actual patients and their ability to pay means next to nothing when it comes to pricing drugs. The entire industry is a big grift between pharma and insurance. If you cant see obvious truth here after countless examples and injustices, you're either a fool, or a shill.
There is a reckoning coming. Every one of these stories is another step towards the e
inmates pay $0 for daily Insulin if needed (Score:2)
inmates pay $0 for daily Insulin if needed
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Pricing things based on what people are willing to pay, when one company has a monopoly and the alternative to not paying it is dying, is a difficult problem. When you can double the price and only 10% will decide to die instead, prices can only go up.
That can only work when "No, that's too expensive, I won't buy it' is a reasonable decision, or, sometimes, when there are multiple suppliers to choose from, but then only if they are all competing on price, which doesn't always happen. Competitors often decid
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Lots of states set the price of lots of things.
Cigarettes. Alcohol.
Heck, in Michigan, the state literally is the sole wholesaler of liquor.
We can do the same for drugs.
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Bad examples. The state sets the minimum price on those things.
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OK, so what should the price be? Also, 'other countries carefully control what information is provided to citizens' seems like a pretty dumb excuse to do it here.
Well unless their manufacturing costs went up 20x certainly not $158,000.
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OK, so what should the price be? Also, 'other countries carefully control what information is provided to citizens' seems like a pretty dumb excuse to do it here.
How about setting the ceiling at the average price paid by other nations? You could limit the calculation to developed countries to allow manufacturers to provide lo cost drugs to developing nations. Or simply allow reimportation.
Re:Now go ahead (Score:5, Insightful)
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Re:Now go ahead (Score:4, Informative)
Excelsior scholarship - tuition is free with family income under $120k, provided the student resides and works (or goes to grad school) in NY state for 4 years after graduation (otherwise, it may convert to a loan).
In-state tuition for SUNY/CUNY is still reasonable - $7-9k/yr with fees -- but no one really pays that much (see above). The real money-maker is housing, probably makes more sense to live off campus or with family if possible.
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Change the government guarantee and watch the prices drop overnight
That's a good one. Oh wait you're serious? A company is going to pass savings onto me and not pocket the difference. What fantasy world are you living in?
Ceiling (Score:3)
with no real ceiling except for public outcry.
The ceiling is you don't use it.
There is an expensive allergy medicine that works very well for me. I use a cheaper generic medicine instead, because it's cheaper and works almost as well.
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There are also no other treatments for the disease.
But there is an alternative to this compound drug and it's described in the TFS; buy the two components at 1/20th the price. Drug pricing may have problems, but this particular story is more about investors getting rooked by a company setting a price that makes projected income very high with some assumed sales figures, despite a much lower price alternative.
ALS is not your allergies. (Score:3)
with no real ceiling except for public outcry.
The ceiling is you don't use it.
There is an expensive allergy medicine that works very well for me. I use a cheaper generic medicine instead, because it's cheaper and works almost as well.
ALS is not your allergies!! We're talking life or death, not a little sniffly vs slightly less sniffly. Your comment may be the most offensively dumb ever uttered by a sentient being. "Oh, I don't like the price, so I'm going to just go die now?"...but hey, those pharma bros have a really cool house, though!
When it is life or death, you really have no choice. All organisms are wired to survive. And it's rarely your choice. If my son had this illness, can I let him die?...so martin shkreli can go live
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Actually it probably is. What's important is the number of copies of latent viruses, like cytomegalovirus. At lower copy numbers, it causes allergies. At higher copy numbers, disease.
One main route latent viruses cause disease is via binding p300/cbp to the virus nbox. This prevents the cell from having p300 bind to it, genes that p300 supresses increase, and genes that p300 increases, decrease. Androgen receptor is one such gene that p300 suppresses. This is why a high copy number of latent viruses can cau
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When it is life or death, you really have no choice.
The choice is to do what the ALS sufferer in the original article does and buys the two compounds independently at a fraction of the price of the combined medicine.
Drug companies have been doing this for decades. You combine ibuprofen with a muscle relaxer and sell it for $300 a tab, when you can buy them separately for $1. It's stupid and capricious, but, with a tiny bit of due diligence, easily avoidable.
Re:Ceiling (Score:4, Insightful)
The problem with that is the mandated medical insurance industry. Once you have already been forced to buy insurance, why would you care how much they are paying for drugs?
Re:Ceiling (Score:5, Insightful)
with no real ceiling except for public outcry.
The ceiling is you don't use it.
There is an expensive allergy medicine that works very well for me. I use a cheaper generic medicine instead, because it's cheaper and works almost as well.
Which is a model that completely breaks down the moment you change from treating allergies to treating life and death medical conditions.
Riluzole (Score:2)
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Here they still prescribe riluzole. It was invented in the early 80s and about as effective as holding a plastic shopping bag out the window going down a steep mountain in a car with no brakes
I agree. It also costs about the same amount. My sister was on it and about the only effect I could discover was that she got to talk with the visiting nurse that gave her the infusions.
Link is broken (Score:2)
The link to the article is broken.
Source [Re:Link is broken] (Score:4, Informative)
Seems to be an article from the Wall Street Journal. The link (paywalled) is here: https://www.wsj.com/articles/w... [wsj.com]
Another article is here: https://www.biopharmadive.com/... [biopharmadive.com]
An article about the controversy whether the drug even works is here: https://www.npr.org/sections/h... [npr.org]
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It's not broken, their website is simply shitty. Try the archive version.
https://archive.ph/20221010205... [archive.ph]
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It's not broken, their website is simply shitty.
??
The link in the summary I see is "https://slashdot.org/PricetagforarecentlyapprovedALSdrugillustratesbroadindustryproblems", which only link back in a circle.
You're seeing a different link?
Worst of all worlds (Score:5, Interesting)
I have lived and worked in several countries. A free market health system, with minor regulation? Been there, done that, it works. A nearly "socialist" system - dictated by government? Been there, done that, it works.
Obama-care in the US? You have managed to achieve the worst of both systems, with the advantages of neither. Why does the US put up with this? Either drop the mandates and let the free market do its job - including getting rid of the tie to an employer. Or else eliminate the insurance companies, dictate prices to the doctors and hospitals and drug companies - run everything under the government.
The current US system? You couldn't design a more horrible mess if you tried.
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Why does the US put up with this?
That's the ACA [wikipedia.org] your legislature gave you. Don't blame Obama. He signed what was placed on his desk. I guess he could have vetoed it*. But he was on the hook to sign something or take the political heat. And the healthcare and insurance industries paid Congress a lot of good money to get it written their way. It's doubtful they would have allowed anything different through.
*The perfect is the enemy of the good.
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Re:Worst of all worlds (Score:5, Insightful)
Before ACA, the free market was certainly not doing its job. As I recall from the early 2000s, my premiums tripled over the course of two years while the deductible doubled. If you had a pre-existing condition and were not covered by an employer's plan you were doomed to bankruptcy. The more affordable individual plans would reject anyone with even a hint of actually needing coverage. It is true that ObamaCare stinks but the right wing would not and still won't accept single-payer and an unregulated system was and is known to not work.
I'm curious where and when you found a "free market health system, with minor regulation" that worked.
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That may be many things, but minor regulation ain't one of them.
It's also the second most expensive healthcare in the world.
Re: Worst of all worlds (Score:2)
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Why does the US put up with this?
When Clinton or Obama offered a single-payer system, US propaganda screamed "evil socialism" and thus politicians were 'forced' to protect US-style fascism. In addition, rich people want health-care and pensions to be a perk of full-time employment. It makes employment a necessity even when the job doesn't pay a living wage and forces employees to abandon insurance.
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For context, Obamacare enrolls https://www.kff.org/other/stat...
1- Employer-sponsored (158M/ 49.%) /14.2%
2- Medicaid (63M/ 19.%)
3 - Medicare (45.2M
4 - Uninsured 29.3M (/9.2%)
5 - ACA/Obamacare (18.7M/ 5.9%)
6 - Military (4.3M/1.4%)
The bulk of cost problem comes from employer-sponsored insurance, which typically pays 2-3x the prices that Medicare pays. Additionally, ~50% of Medicare beneficiaries are actually covered by private plans, which are notorious for overbilling:
https://www.nytimes.com/2022/1... [nytimes.com]
Note as
Is the brand-name combo needed? (Score:4, Interesting)
If the two ingredients are separately available, why can't a physician prescribe both of them at their appropriate dosesEven if it's off-label, it should still be valid to write a scrip for it. When I had a prescription for an alergy med written for a certain brand-name product, my insurance company wouldn't even cover it unless my doctor would allow them to swap in a generic equivalent. Or are they not available either OTC or by prescription, but only through less-formal channels?
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Compounding pharmacy [wikipedia.org]
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The combo of OTC ingredients will soon be off the market. Do you think the patent holder, Amylyx, will allow this competition? It will be easier to buy heroin.
There are many ways to make this happen. The FDA (Food & Drug Admin.) has long been known to cater to wealthy patent holders, just as any bureaucrat loves donors. You may wonder how this drug got a patent when people were already using the same natural ingredients for the same purpose. Many patented drugs were derived from existing natural ingredi
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They could, but insurance will not cover a non approved drug, and you would not be able to sue the manufacturer if something went wrong because you are using it off label. In most cases you also probably cannot find medical grad chemicals verified not to contain things hazardous to human health.
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If the two ingredients are separately available, why can't a physician prescribe both of them at their appropriate doses
Apparently, the ingredients are less expensive than the compounded drug... but still expensive.
Insurance will pay for the drug, but not for the ingredients.
This is just legal Medicine Shows (Score:2)
Completely misses the point (Score:4, Interesting)
The cost to develop a drug is between $1B to $2B" [cbo.gov] per drug. The time is roughly 10 years between drug discovery start and clinical marketing. There are 5,000 drug programs started for every 1 that makes it to the clinic. The clinical trials are exceedingly rigorous to show some efficacy and understand safety concerns. 90% of drugs that make it to Phase 1 trials [sciencedirect.com] fail (never recouping the discovery cost). Ever heard the phrase "It's the Dose that makes the poison" [chemicalsafetyfacts.org]? Virtually any material is potentially beneficial or harmful; knowing what a given formulation and it's dosage is going to do to minimize problems or how to correct for them when something goes wrong is a big part of drug manufacturing.
I get someone is desperate with a horrible disease like ALS, but self medicating by buying the chemicals on Amazon and mixing them yourself sounds awful. Even just suggesting people can do this means other ALS folks might become desperate and try to self medicate and I guarantee you that a lot of people will get seriously hurt by trying this approach. The much higher price tag pays for the R&D (that Mr. Oliff just read about and started copying, but that knowledge took hundreds of millions of dollars to produce), the clinical trials to prove to the FDA true clinical utility and safety, etc.
It's completely backwards to suggest that incremental cost of a drug should be the only input with regards to price. Since most on Slashdot are software people, then let's apply the same logic. Software costs nothing to make incrementally, so I shouldn't have to pay for any software at all. Yet the development of said software cost money; who pays for that? Drug development is far more complex, laborious, and risky to develop; who pays for that?
And yes, there's the tired old trope that other countries control drug prices. So what? That's not a drug pricing issue, that's a monopolized buyer issue. Single payer systems can do that because the US system pays for the drug development cost. That's why for example countries with controlled drug prices like Canada ban exporting prescription drugs; the argument is they'd lose their supply but that's ludicrous; they could just order more and make money. The reality is they're buying them from American companies, then exporting them to American citizens thus undercutting those countries? Then those companies wouldn't sell any drugs to Canada and their health system would have ZERO drugs. If you don't like that, then the problem is trade agreements, not drug pricing.
I get people hate the price of drugs in the US. It's fine to hate it. But at the same time, there's a reason that cost exists. More new drugs are available in the US than are available in any other country [phrma.org]. Most drugs are discovered in the US. Taxpayer grants are the biggest source of innovation, to US universities, in drug discovery. The tapestry of drug pricing is just a difficult road, and it's way more complex than "inputs = outputs" when it comes to pricing.
Re:Completely misses the point (Score:4, Informative)
That's not at all the case here. Most drugs cost virtually nothing to manufacture; $7,000 for the material cost is in fact kind of exorbitant. But you're not paying for the chemicals when you buy a drug.
The cost to develop a drug is between $1B to $2B" [cbo.gov] per drug. The time is roughly 10 years between drug discovery start and clinical marketing. There are 5,000 drug programs started for every 1 that makes it to the clinic. The clinical trials are exceedingly rigorous to show some efficacy and understand safety concerns. 90% of drugs that make it to Phase 1 trials [sciencedirect.com] fail (never recouping the discovery cost).
I think you are also missing the point.
No one is talking about manufacture cost as the primary determinant for retail cost, it's just a really weird exception in this story that the patient was actually able to "home brew" the meds.
The standard scenario is the med is a patented molecule that must be manufactured. Sometimes there's a not quite as good out-of-patent generic, and sometimes there's nothing (and sometimes there's an out-of-patent with only a single manufacturer [wikipedia.org]).
Patients are left with a very nasty decision, spend a ton of money (enough to jeopardize their families future) or sacrifice their health. That's not the foundation of a functional market.
That's why drug prices keep hitting the news, the thing keeping prices in check isn't market forces, it's public shame. The drug companies aren't worried that people will stop buying their products, they're worried that public outrage will cause legislative action.
Not to mention, the weird secondary industries where insurance companies also like the high prices since they can look good negotiating massive rebates (and making sure people need insurance). Patients are even in on the game where rebates can cancel out co-pays and make it cheaper for the patient to get the expensive version than the generic.
There's not an easy fix... but there's a decent fix.
Establish a drug pricing board. Set out some rules and when a company has a new drug the price is set by the board set on various criteria related to proven medical benefit.
It's not a perfect system, but it's better than what you have now.
Labeling (Score:3)
The FDA was established as a labeling agency.
Ensure that what's on the label is what's in the bottle. That is fine.
Now it's just a captured agency driving the prices of drugs into the stratosphere and lying to the public to enrich the pharmaceutical industry. The delay of drug time to market has caused an estimated 20M more deaths than it prevented. That's almost a quarter of what Mao killed.
The answer is simple: make it a labeling agency again.
My fear is the entire system has to crash before people will accept this. And, no, Thalidomide never made it to market in the US.
Re: (Score:3)
I'm not sure how you think this supports your position. Thalidomide was not approved in the US because the FDA had approval powers and didn't approve it. Things would have been much better if the FDA just said "yup, that's totally thalidomide, enjoy!" right?
Re: (Score:3)
The answer is simple: make it a labeling agency again.
My fear is the entire system has to crash before people will accept this. And, no, Thalidomide never made it to market in the US.
Frances Oldham Kelsey had "concerns about the lack of evidence regarding the drug's safety". It sounds like the FDA was acting as more than a labeling agency when it stopped Thalidomide. wikipedia link [wikipedia.org]
Re: (Score:3)
Interesting isn't it, that Frances was actually given the President's Award for Distinguished Federal Civilian Service and FDA started to give out an award named after her (Kelsey award)?
All cos she withstood the pressure from Richardson-Merrell Pharmaceuticals Co, the company which was pushing thalidomide.
Why the hell is it ok for companies to pressure federal agencies and staff? So much so that someone was given awards and such for withstanding pressure, and yet applying pressure in such manner is not ill
Hurts everybody on Medicare (Score:3)
This is why premiums go up for everybody. In order to pay this exhorbitant price for the relatively few people who need this drug, premiums are raised across the board. Thus, the drug company takes a little bit out of everybody's pocket, whether they need the drug or not.
The Id Roars, "Only My Meds Are Valid!" (Score:2)
Cost of R&D (Score:2)
But the jarring price difference underscores just how out of whack drug prices have become in the U.S.
The jarring price difference come from the cost of R&D. The drug company is trying to recover all the money it spent developing the drug, getting it through human trials, and covering it's ass in case they get sued for missing a side effect. Mr. Oliff is just play for the cost of the raw materials. Pharmaceuticals are like software. Getting a high quality product without bugs / side-effects is hard. Making copies of the finished product is easy.
Re:Cost of R&D (Score:4, Insightful)
not true. it shouldn't take you long to find out that it is a scam; they don't actually need to charge that much! It's similar to Hollywood "accounting" in that it's BS but it's not for tax purposes and it kills people.
The fact their stock and profits rise with these things is like them admitting they are making way more profit than normal. That alone should make you distrust anything they say.