Hepatitis C is a slow death sentence, and these drugs, based on studies to date, appear to be life saving.
Sorry if this is a little like a stranger at a party asking about how to get rid of their warts :p
I don't understand that statement. I had Hep C and it was cured with interferon/ribavirin. It was a nasty treatment and I guess there are people who don't complete it, hence (probably) its reputation for uncertain effectiveness.
I absolutely would have preferred this new treatment, but if you had been able to tell me five years ago that I could take interferon & ribavirin now, or wait five years for a better treatment, I still would have completed the interferon/ribavirin treatment.
Many people forget how difficult it is to produce a good, generalizable cure to any disease. It requires billions of dollars with a lot of dead ends. Occasionally it pans out. No one wants to spend the money for research that may never produce anything of value but they want the product of persistent and very expensive R&D for next to nothing.
One of the biggest government investors in unpopular diseases is the US military, largely because they have a lot of veterans with them due to blood transfusions, environmental exposure, etc in the backwaters of the world. Organizations like the US Army are willing to put money toward relatively common diseases like multiple sclerosis, because it impacts their people, that the government at large is uninterested in because it is not politically sexy.
(Big Pharma Spends More On Advertising Than Research And Development, Study Finds --- http://www.sciencedaily.com/releases/2008/01/080105140107.ht...)
I can sort of understand why marketing exists. Many people (most?) do not see their doctor on a regular basis, and even if they do, they might not bring up some chronic issue that they've learned to "live with".
For people who do not see their doctor (or who do not have a good relationship with their doctor, or who have a poorly informed doctor) marketing from pharmaceutical companies may very well be the only way that they learn a cure or treatment exists for a problem that they have!
It has been so long since a disease has been cured that the current american system isn't designed to handle it.
I have to say the European state sponsored medicare looks way superior from this point of view.
They are not worried about the high upfront cost since every citizen is paying taxes for that.
Plus they can drive prices down since if the government buys from you you make a lot of money if it doesn't you have to sell it a lot cheaper for regular people to buy it with their own money.
It's not perfect it's open to manipulation however it's better that anything a dynamic corporate sector could offer.
Not only that, but that they can look very clearly at cost vs benefit. With a citizen, who is unlikely to move anywhere else, you can look at lifetime care costs and reduced earning ability (at least in the average case), and say outright that it is sensible to pay $100,000 to save many times that on a lifetime of ineffective care and reduced potential. You can also look at the public health impacts - treating one patient might reduce the risk of wider infection in society, which can also be placed in the cost-benefit analysis.
This is more difficult with American states (because people move between them much more- the payment comes from one state, but the benefit is spread out), and more difficult for insurers (because they are subject to much greater short term pressures, and can't look at wider benefits).
From the article:
“If it is cost-effective from a societal standpoint, it is not necessarily going to be cost-effective from a health plan standpoint,” said Dan Mendelson, chief executive of Avalere Health, a health care consulting company.
But we would need to reward provider networks for keeping people healthy, not just treating them when sick.
Simple: make it federal. Scale it up until you get controlled borders.
As a healthy Veteran, I can say I'm glad I haven't had to dip into my benefits...
Instead of rolling your eyes, work on a solution ;-)
I know we have a broad range of vaccines against once common ailments, and anti-bacterial agents but I don't think we've ever had good viral 'cures' so its not as if cures are being held back. I think the fundamental research just isn't there.
This sword cuts both ways. Implicit in your response is that it's the potential income from American medical spending that's driving the investment in research: even if (or maybe because?) the income from other nations that structure health care expenses is used more wisely, it's not sufficient incentive to induce such research.
..and that pharamceutical companies aren't run by complete monsters.
Pharmaceutical companies have a long history of despicable behavior.
"Pfizer Bribed Nigerian Officials in Fatal Drug Trial, Ex-Employee Claims" (http://www.cbsnews.com/news/pfizer-bribed-nigerian-officials...)
Well, the UK has DEATH PANELS (as some people call them) which is probably the National Institute for Health and Care Excellence (they had a name change which makes the acronym a bit weird, but their still called NICE).
So if a medication can't show efficacy and is very expensive it's not going to get NHS funding.
We used to allow people to spend their own money if they wanted to on medication. We still do - IVF has limited provision as one example - but there was a spate of drug companies releasing very expensive and not very efficacious meds. When they got turned down for NHS funding those companies paid money to patient groups to campaign for changes in the decision. (Pretty fucking sleazy - using the desperation of dying people to promote your ineffective medication) The government at the time decided to change the rules around a small number of medications. You would be able to buy those yourself, but you would then have to pay for the rest of your care too. I'm not convinced that was the right decision.
Even though there is a big upfront cost (in the US), isn't the treatment with this drug a lot less expensive than not treating someone with Hep C? So shouldn't the overall costs go down?
Every few years people seem to think we've found all of the significant small molecules for human disease - they keep getting proven wrong.
Different companies do it differently, but the customers I had went through a series of steps. I'll try to summarize them briefly here.
1. Target choice: Typically research focuses on a single "target". In small molecules, this is typically a protein that you want to activate somehow to change a biological pathway. For other sub-fields, such as biologics, "target" can mean other things.
2. Iteration / core choice: You start with a small organic molecule "core" that can be the backbone of your drug. Molecules with similar cores can "fit" into similar places, whereas active groups that branch off of the core affect their efficacy.
3. Screening / lead optimization: Pharma companies have libraries of chemical structures, their properties, and how they fit into certain proteins. The idea is to find a molecule with a core that will fit, and active groups that will make the drug 'plug' the active site of the protein. When doing drug discovery, there are all sorts properties you care about, ranging from pka to toxicity. - For many drugs, there is experimental data that is available. For other drugs, experiments must be performed to obtain data. At this stage it basically becomes a data problem for the chemist. Lots of time looking at pivot tables of raw experiment data, 2d molecule structures, 3d structures, computational predictive results, etc. The idea is to to find holes in the data where potential molecules with the right core and active groups could have matching properties, etc. - A lot of it is data based, but a lot of it is also intuitive. - There are other sources of data other than assays (experiments). One of the most useful is X-Ray crystallography images, which are 3D images of molecules in active sites.
4. Discovery Candidate: At some point (hopefully) you reach the stage where you're pretty sure a drug has good properties. This is when you lock down the IP, not just by patenting that molecule, but all other molecules that are similar. Basically "putting it in a box" to start the more expensive animal / human testing.
5. POST-IND FDA approval process. You can read about this here [1], but basically this is where the expensive / time consuming fun begins. Animal tests, efficacy tests on humans, etc. This is pretty expensive but also well defined by the FDA
Note that I am far from an expert, some of the people I worked with had done this for decades and would probably correct me and / or point out steps I'm missing.
[1] http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534...
Not when you learn that the company that actually created it planned to put the price 2 times lower before being bought out.
Early on in a drug's development, companies will do market research to estimate the value of the drug. That research is pretty quick and dirty and the price you arrive at has a margin of error of +/- 50% easily.
I have acquaintances who worked on the pricing of Gilead's drug. If anything, Gilead priced at the lower end of what they could have. No company, launching that drug today, would have priced it at the price Pharmasset estimated 2-3 years ago.
The incremental cost of actually producing a pill now is probably far, far, lower than $1000, but the pharma companies will want to sell the drug for as much as they think people will pay for it so that they'll have money to produce new drugs.
That argument would be a whole lot more convincing if they didn't spend vastly more money on marketing than on R&D...
"Ask your doctor if somthingodin is right for you."
Just bizarre to me.
Then there's the pure branding ads, where you can say the name of the drug, show pictures of people dancing in forests and playing with puppies, and say "ask your doctor if somethingodin is right for you", without having to spell out the side effects.
So first you learn what the drug does, and all the horrific things it will do to you. Then, when you vaguely remember that the drug helps treat a thing you have, you see the branding ads, and then you talk to your doctor, who, while ethically bound to go over the side effects, is not being monitored by the FDA, and thus will hopefully present a rosier picture than the first ad.
Over the last 10 years, Gilead has spent somewhat more on research than marketing. They still spent a big chunk of change on marketing, though: $9.4 billion.
That being said, presumably they set their marketing budget at a point that maximizes their revenue (i.e. the point at which one more marketing dollar fails to bring in more than one more revenue dollar). Given the fact that the research budget is a fixed cost, obviously it makes sense to spend money on marketing to ensure that there are enough sales to recoup that expenditure and make a profit.
So I guess I don't understand what your point is?
Oh, and a considerable percentage of "research" is really marketing, since its goal is to find minor variations of existing, perfectly effective drugs whose patent protection is about to run out.
Not true at all: Could you sit in an empty, white-walled room and tell us exactly which new drugs will be needed over the next decade and how they will appeal to doctors and different patient groups? Whether they'll be worth developing at all? How existing patients on inferior (or no) treatments will find out about them without you spending a nickel?
Marketing is not just ads.
As a society, marketing more than useless. It manipulates and confuses actual knowledge.
Even if you think DTC is worthless or actively harmful, surely there's some value in marketing to (nominally) informed, expert doctors and insurers, unless you think marketing anything is an essentially fraudulent or worthless activity. Would Ford or their potential customers be better off without marketing? What makes drugs any different?
[1] http://www.cbo.gov/sites/default/files/cbofiles/ftpdocs/105x...
I don't think marketing is either fraudulent nor worthless, but it is a tragedy of the commons these days. People have more than enough tools at their disposal to discover the products they want and need to buy on their own. Marketing by an individual entity is useful and necessary, but the whole field is just pointlessly rearranging the chairs. We'd all be better off if we could somehow all agree to quit it, at least the fluffy parts that convey only emotion and not information.
If people could instantly know about which drugs are relevant to them, or doctors meticulously searched the literature for all available treatments for all patients, then alerting the world about the existence of your new drug would be a complete waste. But we don't live in that world.
If pharmas really are offering identical products, that's a problem of creating unnecessary drugs, not marketing per se, and would be exposed when the relevant people make the cost benefit calculation.
That's a lot easier to do when they can get the government and other insurers to pay $1000 a pill for their wares that they have marketed to the public.
the marketing of many drugs is done to convince consumers to pick a named brand over a generic. frankly the small print warnings they have to carry are more frightening than what is on a pack of smokes.
Take for example PPIs, they where crazy expensive at first, but are now very cheap. I can only imagine the same will be the result with this treatment.
TOBY The pills cost 'em four cents a unit to make.
JOSH You know that's not true. The second pill cost 'em four cents; the first pill cost 'em four hundred million dollars.
If you want to step up and by the first pill I'm sure they won't have a problem bringing down the costs. It cost them 11 billion to buy the company which did the R&D for this drug.
It's pretty tough to evaluate the investments large pharmaceutical companies make in R&D because a lot of the expenditure is through acquisitions and a lot of failed efforts at private companies go uncounted. But do the math on this product: ($84K course of treatment times 3.2 million customers in the US alone) -- or just noting the $55bn total revenue estimate or the $3.5bn they sold last quarter. Compare that to the $2.1bn they spent on R&D last year (less in previous years) or the $11bn they paid for the company that developed the product. It's pretty clear that this is an absolutely monstrous windfall that they can get away with because of the way we've designed our healthcare system.
It's not a bargain.
Also: I don't have data to evaluate your statement that "they often aren't good at sticking to complex drug regimens", but it seems like a gross and extremely callous generalization. Also: it's 2014, we have smart pill bottles, automated alerts, and all sorts of other ways to solve that problem for nearly nothing. I'd refer to some of the other commenters who have noted that companies get richer through treatments than cures.
Much of the article above is essentially about state Medicaid programs freaking out for exactly this reason.
Most European welfare states refuse certain treatments based on costs. This can, obviously, really suck because there are (sometimes) no private options, or they're unrealistic. And of course, every few years an expensive option is made available for a year or so because some politician's daughter happens to have it.
This has been a criticism of Europe. Drugs get developed because Americans will pay for them, then when the cost is mostly recouped (ie. a decade later), it finally becomes available in Europe. This is freeloading, but you can't really blame them.
Does anyone have any reputable cites for this please?
Countries that ensure universal access to approved drugs generally keep costs down by the negotiation power of a government-backed monopsony combined with the threat of compulsory licensing should demands be excessive (rarely exercised, but the fate of BRCA1/BRCA2 tests in France is an example).
[1] https://www.youtube.com/watch?v=_yF69KVbUaQ&t=4m11s
[2] http://blogs.reuters.com/anya-schiffrin/2014/02/12/the-frenc...
> New drug regulations in France: what are the impacts on market access?
"Cost-effectiveness studies will now be part of the market access requirements for all drugs in order to satisfy the selection criteria for medico-economic assessment."
...
"Conclusion: In light of these changes, it clearly appears that the access to the French drug market will be increasingly driven by data pertaining to comparative-effectiveness and cost-effectiveness, and an increased role of postmarketing studies in the years to come."
http://www.jmahp.net/index.php/jmahp/article/download/20891/...
> Countries that ensure universal access to approved drugs generally keep costs down by the negotiation power of a government-backed monopsony combined with the threat of compulsory licensing should demands be excessive
Putting compulsory licensing aside, which does not happen in many countries, I don't think this contradicts the poster above - a government agency makes a judgement about the cost-effectiveness of a particular drug, and they either decide to buy or not to buy depending on whether the price is above or below that limit.
As your source notes, that does not affect "irreplaceable and expensive drugs". Cost-effectiveness concerns are typically about cases such as reimbursement for a generic vs. an equally-effective non-generic medicine.
> Putting compulsory licensing aside, which does not happen in many countries, I don't think this contradicts the poster above - a government agency makes a judgement about the cost-effectiveness of a particular drug, and they either decide to buy or not to buy depending on whether the price is above or below that limit.
Regarding compulsory licensing: contrary to what some people think, Europe isn't actually all that socialist; compulsory licensing exists as an ultima ratio in cases where the greed of a pharmaceutic corporation would endanger access to an important new drug or procedure (which was exactly the case in the BRCA case). It's a Sword of Damocles, not a weapon that's being wielded routinely. Whether the option actually exists is irrelevant: with a government-backed negotiator, it can always be legislated into practice (again, which is what happened in the BRCA case after a firestorm of criticism).
Regarding government agencies making a cost-effectiveness judgement about the purchase of a drug, that's again an inaccurate generalization.
First of all, recall that private insurance companies make such decisions all the time (see the article I referenced above), with the difference that they are interested only in their own bottom line, and that the health of their customers only enters into that calculation insofar as it affects profit or regulations force them to (the latter of which is the exact same situation as government backed-negotiation, except for the lack of the bargaining power of a monopsony).
Second, a minority of drugs are actually monopolies; price a drug for which there is competition out of the market, and you simply put money in your competitor's pocket. Likewise, drug companies don't just want to sell one single drug. Ask for too much for their one new irreplaceable drug, and they may see the income from their other ones go down (there is, after all, only so much money to be had in total).
Third, this is not necessarily how it happens. For example, it may not be a government agency (as in Germany, for example), and the agency may not have the power to make a decision whether to buy or not to buy a drug, but only whether the drug is effective (including relative effectiveness compared to other drugs), especially for life-saving drugs.
There is still a cost-effectiveness judgment even for irreplacable drugs (that's the SMR/ASMR category I):
"Two criteria must be met: 1) The ASMR of the drug claimed by the company is major, important, or moderate (ASMR I, II, or III, respectively); and 2) the drug is likely to have a significant impact on the health insurance budget regarding its impact on care organization, professional practices, or patient care and, when applicable, its price. This decree also specifies the medico-economic assessment procedure. The pharmaceutical company, together with its request for inclusion (or renewal of inclusion) of a medicine on the reimbursable drugs formulary, transmits all medico-economic data related to the drug to CEESP and CEPS. CEESP will provide an opinion [reported as a ‘flash opinion’ (14)] (Fig. 1) on the predictable or established efficiency of the drug and its coverage by health insurance. This opinion is based on comparative analysis, between the different therapeutic alternatives, of the ratio of the cost compared to the expected or observed benefit for patient health and quality of life."
I think here in the UK it's slightly more accurate to say that the NHS limits treatments on a balance of costs and expected benefits.
Has this ever actually happened? This reads like a caricature. The decisions about cost-effectiveness in Britain are made by the National Institute for Clinical Excellence, which has a very strong reputation for rigor and independence.
Alas not necessarily. PPACA (aka Obamacare) was supposed to ensure exactly that, but the Supreme Court struck down those provisions. So in 24 states Medicaid does not necessarily cover poor, non-senior, non-disabled adults without dependent minor children.
That's leaving aside the entire category of aliens which even in the other 26 states have only spotty coverage.
There is very little true price discovery going on when the largest payer for healthcare services has absolutely no choice to purchase the product at a given price. All they have to do is get a new treatment approved (i.e. show that it works and is safe), and then the government has no choice but to buy it.
I don't see anything wrong with Gilead charging $84,000 for curing a disease. I just see something wrong with the stats not being able to take it or leave it.
This is, of course, for reasons nobody can adequately respond to with reason instead of feelings, unpopular.
But it's certainly 1. fair and 2. a large cost savings, given the sheer number of Hep C patients who brought it on themselves.
This will not be an issue when the masses that have Hep-C now are cured. This is mostly a short term financing problem. Would you rather solve the issue for $1X now or pay $3-5X over time to deal with it. I would rather cure the masses now and lower the long term medical costs.
The basis is that these people choose, of their own agency, to shoot up with used needles. This isn't some poor guy getting the cancerous genetic bit flipped by a cosmic ray or an uninsured single mom getting disabled by a drunk driver. These are consequences brought on by the patients themselves. By what moral basis should society be paying for the consequences of willful degeneracy?
They certainly chose to shoot up right until the point they achieved chemical addiction, but after that there is much less free will than people presume.
>By what moral basis should society be paying for the consequences of willful degeneracy?
I don't know about you but I hate seeing people self destruct. I certainly feel an obligation to assist them when possible. You might not, but please don't act like your moral compass is the only one that matter.
Personally, I do. Helping other people is never going to be friendly with a free market. I accept that it may have a cost, but I reject the idea that people's health is something that should be traded on the free market. While it's great that this cure was developed, it was developed because there was a profit to it. That's the worst reason to develop a cure—how about working on diseases that aren't likely to return a profit? Curing the cold may not make you rich, but it would yield substantial productivity benefits for our society. Same with basic dietary habits. In fact, I'd be willing to bet that the US (not familiar with other countries) is worse off, mental-health wise, since the invention of Prozac, compared to basic research into public awareness of exercise, diet, and basic emotional well-being.
That sounds similar to Medicare (Australia), although I haven't had to use Medicare to pay for medications.
That certainly does make it seem like they're attempting to price gouge the government, because "they can afford to pay".
http://www.advisory.com/~/media/Advisory-com/Daily-Briefing/...
If you live in any of the grey areas and don't make enough to get Obamacare, you cannot afford this drug, you will die.
That is 50+ million people. Hopefully only a tiny fraction of those people have Hep C because I feel horrible for them.
They didn't price it $5000, $10K, $20K or even $30k. They priced it $80k. Every 12 people is a million dollars for them.
Then they turn around and will sell it overseas for $8000.
The only hope for people in those states will be to buy a plane ticket to where it will be $8000 for the whole treatment, live there until cured and hopefully come back alive and not arrested for not giving the corporation $80k
Then you cannot get medicaid unless you make below a certain amount, in some states it is like $3000 a year, which I imagine you'd have to be homeless or living under someone else's roof for free.
All states were supposed to do medicaid "expansion" (raise the $3k minimum) to cover that big gap. Instead the supreme court ruled it was okay to let people be sick and/or die if they couldn't afford it.
So either get two jobs (with hep c, good luck) to make enough to get obamacare, or become homeless to get under the $3000 mark in half the country. Yay America and million dollar profit for every 12 people dying.
You mischaracterize the ruling. What the ruling said was the the federal government isn't allowed to coerce the states as it was trying to do.
Moreover, you're making the mistake of working backwards. You're starting from what you want the outcome to be. With that baseline, you then determine what the court should rule.
But surely you took enough classes in school about American history and civics to understand that this isn't how the American government works. There's a system of laws that determines what the government is allowed to do; if what it wants to do isn't permitted in that framework, then it's not allowed to do that.
Your desire to see a particular outcome - even if that outcome is agreed on by all to be a morally superior one - does not enable our government to take actions it isn't given the authority to execute.
(and apologies for wandering a bit astray into more concrete politics...)
A belief that we ought to ignore the legal framework and instead focus on what is sold to us as "a practical view" is the way that we get to such governmental actions as Guantanamo Bay and prisoner torture.
At the very least, it was a ballsy move that has generated about 6 billion in revenue in just the 1st 6 months on market in the U.S.
Note that Bristol Myers Squibb paid about 2.5Billion to acquire a competing company (Inhibitex) and that drug had to be junked for safety issues shortly after the acquisition.