Far be it from me to defend the pharma industry, let alone Gilead, but I recently listened to the Acquired episode about Novo Nordisk and they threw an interesting point at me that I hadn't really considered:
Running clinical trials is ridiculously expensive, and most clinical trials don't result in a drug successfully going to market, which means successful drugs need to essentially subsidize the cost of (1) their own clinical trials and (2) all those other unsuccessful trials, to boot. So that hypothetical $40/yr sales price turns a profit if you account for the cost of materials and manufacturing, but not if you also account for the cost of the Very Expensive clinical trials that had to occur to get here.
Now, that said... is $42,000/yr a reasonable price? Fuck no. On a purely humanitarian level, it's unacceptable, and if we're just looking at Gilead's bottom line, I'm sure they could price this drug for a whole lot less and still recoup the cost of clinical trials (and then some). Gilead is certainly not hurting for profit here.
But even if the true "break-even cost" is closer to $4,000/yr, let's say, that's still way too expensive for most people in most parts of the world. Which is where I'd get on my soapbox about single-payer healthcare and how this research should be funded by tax dollars, but my legs are too tired :P
I wonder if it’s useful to consider the $40,000 price tag as the price that’s only practically relevant on an actuarial kind of level, as “0.35% of our pool of insureds who will be very expensive to us whether treated or untreated” rather than “hey sick person, here’s a $40K bill.”
As I understand it Gilead in particular seem to be pretty good about using those cold-hearted, “lifetime cost-effectiveness-ratio” sticker prices to effectively subsidize enormous quantities of affordable or free, high-quality drug in those poorer parts of the world that are bearing the brunt of the HIV epidemic. If the premise of insurance is pooling risk, is it inconsistent for the drug manufacturer to coldly calculate the “fair” price of the drug in proportion to its economic value—that is, the savings it brings over a given patient’s lifetime—then do their humanitarian discounting from that starting point?
They license their HIV patents to the UN Patent Pool so that generic manufacturers can produce them freely for low- and middle-income regions [0], they cover people’s insurance copays if their rich-world insurance bills for access to the drugs [1], and they provide access to the HIV drugs for free to uninsured people in the US [2].
As distasteful as the sticker prices are, I’ve always gotten the sense that you kind of have to play that twisted game if you’re going to get anything shipped at scale and stay in the pharma business. And that Gilead in particular have bent over backward both to focus their research on serious disease that primarily affects marginal and disadvantaged populations, and to make sure that their therapies actually make it out into the lives of the greatest possible number of patients.
The patient assistance program [1] sounds good but it typically runs out at 12 months. At that point the regular copay kicks back in. In a bizarre way it mirrors the pusher giving away some stash to get someone hooked.
I was under the impression that it’s 12 months at a time, you just reapply the next year. Which isn’t to take away from the precariousness of a program that could change on the manufacturer’s whim.
That said, in the US, 12 months also buys you enough time to sort out appropriate insurance if you don’t have it, for example by hitting the Affordable Care Act’s open enrollment window.
I can say with rather higher confidence that the copay coupon program renews annually.
Indeed. It sucks, but developing the quasi-vaccine thing and proving it works seems pretty cool, regardless of what comes next. Sure beats chasing pills for boners and hair loss.
Now things look good for this drug (after decades of false starts on long-acting HIV vaccines and prophylactics). And MSF and the usual (tireless, wonderful, humane) vocal advocates seem to be calling for affected countries to license production compulsively should Gilead attempt to license it on bad-faith terms. Seems like a good sign, though I’m not in a position to understand how serious those kinds of threats might be.
Wish I could access the session about this $40/pppy cost estimate, but the abstract seems to be here:
The way the abstract is phrased, it sounds to me to be in the spirit of “we’re doing this cost analysis because we bet this stuff will soon become available to the worst-affected regions at close to that price, with or without Gilead doing the right thing. So we figure we should see how that fits into our public health planning.”
Could be a total misreading, but a person can hope :)
I used to work for a compounding pharmacy supplier. They also teach you how to make patent-expired drugs.
From what I understand, drugs indeed cost a lot to bring to market. If I remember correctly, new drugs are usually granted a 20-year patent, after which anyone can produce a generic version.
We can debate whether 20 years is too long or too short for a pharmaceutical company to recoup costs and make a profit, but at least drug patents do eventually expire.
> Now, that said... is $42,000/yr a reasonable price? Fuck no. On a purely humanitarian level, it's unacceptable, and if we're just looking at Gilead's bottom line, I'm sure they could price this drug for a whole lot less and still recoup the cost of clinical trials (and then some).
Is it unacceptable if the company decides not to make the drug in the first place? The default alternative isn't that we have the drug for less, it's not having it at all.
Looking at things like food recommendations and the recent false start was it with Alzheimer, I wonder if the private model isn't in any case better. Government funded programs likely would have one or few sources of funding and this funding would be controlled by biases of who ever happen to be in the lead. Even if their decisions on directions to take research was wrong...
Private companies betting their own money might limit options of what is targeted, but on other hand I think end up trying more of different possibilities.
Does not mean we should not also spend money on government funded research programs with those drugs produced at near cost.
It’s pretty obvious - it’s cheaper to fund research than to allow a company to price risk. I think this makes sense as science is at a point where the low hanging fruit is picked and new drugs are more expensive and sometimes less of an improvement than what we saw in the past.
Pharmaceutical firms exist because the US and other governments fund basic research, it’s not an alien concept.
That would be nice, but it isn't happening right now. Until the government starts funding drug development, do you agree it's reasonable for pharma companies to develop drugs and then sell them at high prices to recoup their costs?
The option of doing nothing would be the default since it doesn’t cost them any time, people, or resources. Any other option requires sustained positive actions on their part. There are many versions, alternatives, to what that course would take, but it wouldn’t be the default since they require work.
They are already not making drugs for any number of diseases and illnesses, that’s the default. To change course on those they need a good reason.
Huh. I suppose I meant that if we as a society decide we don’t want them to charge a lot for drugs, an alternative is publicly funded drug research. “Not making drugs” doesn’t strike me as an alternative solution.
But of course this is in itself a choice of governments.
They could say that for drugs, unless the drug is produced and sold at a reasonable price, the company could lose its patent rights, just as trademark rights must be exercised in order to remain in effect.
These situations are not dealing with natural laws and they can be changed.
What incentive would there be for a drug company to undertake a drug program that has a negative expected value? Ultimately, someone has to pay the cost, society just decides if and where.
That’s pretty much common knowledge. Most drugs cost a lot to get to market and next to nothing to manufacture. I’m always amazed by how many people have strong opinions about the industry but don’t even know the 101 stuff.
Corporations don’t exist to recoup costs. They exist to make lots of money. That’s why they spend billions coming up with drugs like this and getting them approved.
It’s easy to take the short view of the system (“we need to force them to not make nearly as much as they can on this patent because people are dying”) rather than the long view (“we want companies to spend billions to cure diseases and that means having them make tens or hundreds of billions even though people unnecessarily die until the patent expires because the alternative is no such medicines at all”).
It may be obvious but rarely is it the focus of public discourse on drug companies. Basically the only thing that gets discussed is the apparent naked greed of drug research companies. Frankly it's a miracle that we have private companies bringing novel and life changing drugs to market, and the ability to make obscene profits off these massively speculative investments is probably the main reason.
That's not to dismiss criticism of them, but to me it's obvious, especially if you take a slightly longer view that these companies are in fact making lives better.
The real estate market is a much better example of the harmful effects of terminal greed. Unfortunately so much of the population is in on it now nobody has the fucking balls to stop the music.
I don't think it's even obvious/common knowledge in public discourse, to be honest. (Case in point: this Guardian article doesn't mention it at all, only mentioning the cost of materials and manufacturing.)
To some extent it may not even matter, since the effects of (negative) public opinion are tangible regardless of whether those opinions are fully informed of all the facts. (And even as someone who's aware of a slightly above-average number of facts, my own opinion skews pretty negative.) God knows these companies aren't in the red, trials or no trials; most consumers are just gonna look at the record profits, then back at their pharmacy bill, and go "Hey, wait a minute..."
> this Guardian article doesn't mention R&D at all
This pisses me off so much. Journalists are supposed to do thorough research so they can accurately inform the public. Instead, we see articles like this. How can we have a thoughtful discussion about serious issues when the general public is so misinformed?
> God knows these companies aren't in the red, trials or no trials
The average profit margin was 20%. On one hand, that's larger than most industries. On the other hand, even if pharma profits were completely eliminated, drugs would only be 20% cheaper...
I always just assumed it’s not part of the discourse because everybody with an interest in the topic already knows. Articles about NVIDIA don’t mention that computers use electricity.
This article is horribly disingenuous and slanted. You could write it about any life saving drug that’s still in patent window. “Pharma company has 99.9% margins while people die unnecessarily” is just business as usual and it sounds maximally evil to phrase it that way and skip the fact that the alternative is no lives saved at all.
Maybe. But I sympathize with people who recoil at the idea of "Extremely cheap life saving medication sold at unaffordable price".
Must it be sold to the world at a price that is only reasonable for the richest countries to pay?
Is there no possible regulatory system that could avoid 20 years of HIV spread and death in poor countries, while still getting the rich countries to pay their fair share?
> Must it be sold to the world at a price that is only reasonable for the richest countries to pay? Is there no possible regulatory system that could avoid 20 years of HIV spread and death in poor countries, while still getting the rich countries to pay their fair share?
Gilead literally did that! They sold Sovaldi (a treatment for Hepatitis C) for $1000/pill in the USA and $5/pill in India. And people hated them for it.
Only because Americans insist on their self-harm health insurance system. Americans are both collectively wealthy and have a very small number HIV infections per capita
> how this research should be funded by tax dollars
To be fair, some of it is. Conveniently, this rarely seems to be mentioned when they talk about this. The NIH hands out nearly $45 billion in grants annually[0].
Sure however the vast majority of costs come from the government regulation in the first place. Consumers of course bear the cost, however this doesn't necessarily mean we should remove these expensive regulations, one can argue they are beneficial.
If we assume they are beneficial, this also doesn't mean the government should subsidize it less but instead more to continue to allow the production of drugs. If we artificially require a price, many of these drugs would simply not be developed.
I'm under the persuasion that the future of healthcare is a voucher system to allow the competitive bidding of drugs/insurance to remain as well as the maintenance of the quality and quantity of medical research. Many countries purport to have better medical systems however we find that the American payers subsidize the rest of the world––with the USA producing more medical research than the rest of the world combined.
In a single healthcare system, the prices of drugs deemed essential will skyrocket while others will simply be excluded by the bureau. This then creates a cost on the tax payers through the inflation/excess tax required by the national budget to afford it. While at the same time the single healthcare system has little incentive to improve its efficiency of administration until it's fully deteriorated and governmental intervention promises a revamp which may still be ineffective.
The voucher system allows many insurance companies to exist, allowing the quality of insurance provided treatments to remain through that competition on their varied administrative strategies. While at the same time consumers with varying degrees of medicinal concerns can choose the right programme for themselves––opting to even pay beyond the sum provided by the voucher. This way it's no longer only affordable through a corporate benefit and the buyer group is available instead through a national benefit.
Even though I find it hard to defend $42k/year, there must be a reason the US is pretty much the only country that comes up with these breakthrough drugs on a regular basis. It’s basically an adage at this point that the US populace is subsidizing medical breakthroughs for the entire world.
We should also see if we could make clinical trials cheaper. So many people have their hands in the American healthcare cookie jar that costs are as insane as profits. Could better tech help? Or is it just another X industrial complex with with self interest that needs to be worked through?
This is definitely part of the solution. It’s a regulatory problem as much as anything else. I can’t even fathom how many drugs didn’t make it to market because of how hard it is even to get a great one across the finish line.
I think a lot of it comes back to the Hippocratic principle of first do no harm, which sounds lovely, but mathematically speaking is an obvious disaster in instances like this.
R&D isn't as much of the pharma budget as I thought so it's hard to blame high R&D costs as the biggest driver for how expensive drugs are. You mentioned Novo Nordisk and looking at their financials they reported a net profit of $6.8 billion in H1 against an R&D budget of $3.7 billion.
Their "cost of sales" was $3.0 billion, which someone please correct me if I'm wrong, but I think includes manufacturing (but not sales/distribution). But this still means that profit was more than it's total R&D and manufacturing budget.
Novo Nordisk won the lottery by developing Ozempic, an extraordinarily successful drug. (See e.g. https://www.nytimes.com/2023/08/28/business/denmark-ozempic-...) If you cherry-pick the most successful pharma companies, of course they're going to look unreasonably profitable. For a fair comparison, you need to look at the global pharma industry as a whole.
To start the discussion, I found this analysis of global pharma industry profitability: https://www.ispor.org/docs/default-source/euro2023/poster-is... Note that only 55% of the pharma companies even made a profit; the other 45% lost money. And the average profit margin was around 20%. So even if pharma companies voluntarily relinquished all profits, drugs would only be 20% cheaper!
The fundamental issue is that drug development is simply expensive. When people get angry about pharma profits, they're barking up the wrong tree.
I can understand why those numbers are turning heads in isolation. However, the headlines are always something about how a $10k should be priced at $50. I struggle to see how those kinds of pricing gaps disappear even if that profit number drops to 0.
That is like looking at a lottery winner and say "clearly gambling on the lottery is profitable”. You have too look at the industry as a whole and not the outliers.
I'd love to see drug trials funded by tax dollars, ideally informed by a legal prediction market on which trials are likely to succeed or fail. The people betting on pharma stocks would likely prefer betting directly on trials, since stock prices move for all kinds of unrelated reasons -- it'd be a new asset class. I'm skeptical about single payer healthcare though :p
To me it seems obvious that the correct solution to this dilemma is to publicly fund all medical research. All other approaches feel like band aids we are forced to implement because we’re simply doing it the wrong way, expecting private companies to pay for public benefit research.
Insurance providers can negotiate on drug prices, and they can certainly negotiate based on many factors.
In many countries, either the government is the provider or the government works with providers to set a price for drugs, and in doing so, both sides are heavily motivated.
> how this research should be funded by tax dollars
Tax dollars of which country? No country would want to pay for research requiring 100s of billions of dollars, that would benefit everyone else equally.
You'd be surprised! Humira, the best-selling drug of all time, partly owes its existence to taxpayer-funded researchers in the UK.
And then of course the irony is that AbbVie made a killing selling it in the US (and milking their US-specific patents for as long as humanly possible while patients in the UK were using cheaper generics...)
The phage display technology that opened the door to Humira manufacturing was independently developed by three organizations, including the MRC Laboratory in the UK. The MRC went on to partner with some for-profit biotech/pharma companies to bring Humira to market.
The other two organizations that made their own phage display breakthroughs were the Scripps Research Institute (US nonprofit that gets a lot of government funding/grants) and the DKFZ (German national research organization, not sure about their funding but definitely not a typical pharma joint).
The big deal with Humira is that it's the first fully human monoclonal antibody to hit the shelves, and phage display is what made that possible.
Isn’t the huge price to offset their upfront fixed cost?
Similar to the old days when software was sold and delivered to you on a physical cdrom, and then saying “[your cdrom software] could be made for just $0.25 … why do you pay $1,000 for AutoCAD” because it took a lot of time and money for the company to create AutoCAD - and selling AutoCAD for $0.40 won’t recoup that investment cost.
Well, it is already developed why not give it to everyone who needs it? In these cases it is much better for the government to force buy the medicine for a few billions to give the company good profits for it, and then give it to everyone, instead of letting many die just because the company wants more profits.
I don't think companies shouldn't be allowed to make profits, but I don't see why people can't get the drug after the company made profits.
> Similar to the old days when software was sold and delivered to you on a physical cdrom
Unlike software many people will die due to not being able to afford this, that makes things a bit different.
The other comments have made the point that this is the marginal cost and ignores the fixed cost of the trials, so I’ll leave that aside (and all of the tricky morals).
I just want to point out that most people on this site work in the software industry. And industry famous for having marginal costs approaching zero. We too could give away most of what we make for free or for very little money (marginal hosting costs). But few of us do. Something to think about.
> In a trial, the drug offered 100% protection to more than 5,000 women in South Africa and Uganda, according to results announced by Gilead last month.
Is anyone familiar with what happens at the end of trials like these? I assume this was a very late stage of trial - do the participants get a lifetime of treatment? I'm doubtful 43k/yr is anywhere near affordable, amd stopping after a successful trial seems so cruel.
In this particular trial it wasn't used for treatment but for prevention, the patients don't have HIV (and none had it at the end of the trial either because it was so successful!)
That said: generally there's no guarantee of continued treatment.
There are two issues - patents, and US clinical trial exclusivity. The latter is only good for five years and expires in 2027. Some of the patents have narrow claims. The one that expires in 2041 applies only to the use of this drug in patients with extensive previous treatment, not for use for prevention. It really is a new drug, so some of the other patents from 2022 will hold up.
Software is essentially free to reproduce? Why isn't normal costs of software a few cents? After all it doesn't cost too much more than that to produce the copy and send it over internet? Why are all of these companies so greedy that they charge these margins of insane percentages for their software?
I'm pretty sure one of the reasons clinical trials are so expensive is regulatory capture. If the trials are expensive only the biggest of the biggest can afford them.
I mean, the methods employed remain the same for years and years but the costs balloon. It doesn't have to be this way.
So, I don't really swallow this "oh, but we have to have high prices because it's costly to research drugs!". If the cost of developing drugs is so high, then in my opinion we should be looking at a state-effort. But I highly doubt anyone in the pharmaceutical industry would be okay with the government setting up a program for research and development that produced open drugs.
Ultimately, pharmaceuticals are not losing money. Like, at all. These are some of the most profitable businesses there are and due to the costs it's a market that's been completely captured by a few players. It's impossible for people to even think they could start a pharmaceutical company today. And I believe this is simply because they themselves benefit of this lack of access/high costs of research.
I don't know, this topic makes me a bit angry and frustrated at the state of the world.
The high R&D costs justify the high profits, the high exec salaries, and the high prices. And every company can point at the others and say "see, this is what it costs to hire the best in this industry. Sorry!" It's almost as bad in Big Tech, which doesn't even have pharma's level of regulatory capture.
Maybe this is all textbook supply and demand. But it sure feels broken.
Time and time again people are reminded that prices are not set based on some function of what it costs to produce the good or service, but by price discovery of the maximum amount a group of people would pay that would max out the profit. Obviously because medicine for certain diseases makes the goods and service price inelastic, depending on the disease, pricing can be set pretty high.
Is it right? Nope. It is what makes the shareholders billions of dollars? Yep.
Pharma companies also make and study dozens of drugs that don't make it. We need the successful drugs to fund the unsuccessful ones. Given that I believe there are still many more amazing drugs and medical interventions to be discovered, I don't think we should be reducing the profit to be earned in this space (because that's what induces people to continue to invest in research).
When you look at cost per life saved, pharmaceuticals are a bargain compared to hospitals or other parts of our medical system (esp. in the US).
We could do that. But generally businesses are better at allocating capital than government, and less and less research is funded by government these days so I don't think the government has a strong track record.
Seems like eradicating disease and illness worldwide is a pretty strategic concern for humanity.
I guess it’s like climate change. We can’t beat our neighbors by solving it so who cares, but these feel like things our species is really gonna have to start solving. But maybe we won’t and we will just make life unnecessarily hard for most human beings, when we could be stopping climate change and eradicating AIDS.
As a human being, I totally get you. We should be doing much better than this. But, realistically, governments are responsible to their electorates only. As for the global humanity, first question is who's going to foot the bill and imagine global powers today coming to a consensus on that?!
To that point, there's no way this drug is going to cost $40,000 in Uganda, because the Ugandan market will not bear that price.
Usually the way it works is there is some wildly high sticker price for individual Americans, which is what that $40K probably is here, and almost everyone pays less than that. E.g. American insurance companies pay something that's still very high but lower than that. Europeans pay something lower than the American insurance companies. And lower income countries get the cheapest price of all.
The article does refer to this btw, Gilead is already talking about some voluntary licensing program that'll be available so somebody can manufacture cheap generics in countries like Uganda. This is quite common with this sort of drug but people generally don't read past the headline.
What's going on is simply that the pharmas have American regulators in their pockets so they can charge anything they want in the US.
Perhaps considering stakeholders might be a better, but harder to calculate, method.
Systems don’t have to treat people for AIDs. People get less sick so they can work more and pay more taxes. Parents are around to raise their children, leading to better outcomes for everyone.
Also, we can subsidize R&D (or subsidize it more).
To be specific, that’s only true in the case of a monopoly (which patents are meant to grant). Competition is the means by which products get priced closer to their production cost.
I would not say that this only applies to monopolies. You could add in companies that have strong moats, companies and industries that are able to collude(real estate brokers). Essentially there is more room for profit as competition decreases, but it is a sliding scale and not only monopolies apply. Even in spaces where there is lots of competition, it takes time for companies to reduce prices closer to production costs, aka a race to the bottom.
Running clinical trials is ridiculously expensive, and most clinical trials don't result in a drug successfully going to market, which means successful drugs need to essentially subsidize the cost of (1) their own clinical trials and (2) all those other unsuccessful trials, to boot. So that hypothetical $40/yr sales price turns a profit if you account for the cost of materials and manufacturing, but not if you also account for the cost of the Very Expensive clinical trials that had to occur to get here.
Now, that said... is $42,000/yr a reasonable price? Fuck no. On a purely humanitarian level, it's unacceptable, and if we're just looking at Gilead's bottom line, I'm sure they could price this drug for a whole lot less and still recoup the cost of clinical trials (and then some). Gilead is certainly not hurting for profit here.
But even if the true "break-even cost" is closer to $4,000/yr, let's say, that's still way too expensive for most people in most parts of the world. Which is where I'd get on my soapbox about single-payer healthcare and how this research should be funded by tax dollars, but my legs are too tired :P