C1 · Advanced
23 min
healthpoliticseconomicsscienceglobalaffairs
Pastillas de oro: innovación farmacéutica y el precio de curar
Golden Pills: Pharmaceutical Innovation and the Price of a Cure
Fletcher breaks down this story in English. Octavio reacts and expands in Spanish. Follow along with the live transcript, tap any word for its translation. Advanced level — perfect for advanced learners pushing toward fluency.
So I want to start with a number.
In 2023, the drug Zolgensma, a gene therapy for a rare childhood disease, cost two point three million dollars per dose.
One dose.
And it works.
It actually cures kids.
That number is either a miracle or a moral catastrophe, depending on where you're standing.
Bueno, y ahí está el núcleo de todo el debate.
Well, and there you have the core of the whole debate.
No se trata solo de ese medicamento, sino de la lógica que lo produce.
It's not just about that drug, it's about the logic that produces it.
La industria farmacéutica dice: invertimos miles de millones en investigación, asumimos riesgos enormes, y necesitamos recuperar esa inversión.
The pharmaceutical industry says: we invest billions in research, we take enormous risks, and we need to recoup that investment.
Y no es mentira, exactamente.
And that's not exactly a lie.
Right, it's not a lie.
But it's also not the whole truth, which is where things get interesting.
The system that makes that drug possible is the same system that makes insulin unaffordable for diabetics in the wealthiest country on earth.
Those two facts coexist, and that's the tension we're going to dig into today.
Mira, para entender dónde estamos hay que mirar atrás, al menos hasta los años noventa.
Look, to understand where we are, you have to look back, at least to the nineties.
En 1995, la Organización Mundial del Comercio adoptó el acuerdo ADPIC, que en inglés se conoce como TRIPS.
In 1995, the World Trade Organization adopted the TRIPS agreement.
Ese acuerdo obligó a todos los países miembros a respetar las patentes farmacéuticas durante al menos veinte años.
That agreement obligated all member countries to respect pharmaceutical patents for at least twenty years.
And the idea was sound in principle.
You protect the patent, you protect the incentive to invest.
I get it.
But the timing was brutal, wasn't it?
Because this lands right in the middle of the AIDS crisis in sub-Saharan Africa.
Exactamente.
Exactly.
A finales de los noventa, los antirretrovirales existían, funcionaban, podían mantener viva a una persona con VIH durante décadas.
By the late nineties, antiretrovirals existed, they worked, they could keep an HIV-positive person alive for decades.
Pero costaban entre diez y quince mil dólares al año por paciente.
But they cost between ten and fifteen thousand dollars a year per patient.
Para Sudáfrica, para Zambia, para Zimbabwe, eso era sencillamente imposible.
For South Africa, for Zambia, for Zimbabwe, that was simply impossible.
La gente moría por razones contables.
People were dying for accounting reasons.
I was in Johannesburg in 1999.
I remember the protests outside the high court when the pharmaceutical companies sued the South African government for trying to import generic versions.
Thirty-nine companies took Nelson Mandela's government to court.
The optics were catastrophic, and eventually they backed down, but the damage was done.
Es que ese episodio fue un punto de inflexión.
That episode was a turning point.
Médicos Sin Fronteras lo convirtió en una campaña global.
Médecins Sans Frontières turned it into a global campaign.
Y en 2001, en Doha, los países del mundo firmaron una declaración que aclaraba algo crucial: los Estados tienen derecho a emitir licencias obligatorias en situaciones de emergencia sanitaria nacional.
And in 2001, in Doha, countries around the world signed a declaration clarifying something crucial: states have the right to issue compulsory licenses in situations of national health emergency.
A compulsory license meaning a government can basically say, we're going to let generic manufacturers copy this patented drug without the patent holder's permission.
The patent still exists, technically, but you're overriding it in the public interest.
Sí, aunque en la práctica esa herramienta se ha usado mucho menos de lo que debería, porque los países que intentan utilizarla suelen enfrentarse a presiones diplomáticas y comerciales enormes por parte de Estados Unidos y la Unión Europea.
Yes, although in practice that tool has been used much less than it should be, because countries that try to use it typically face enormous diplomatic and commercial pressure from the United States and the European Union.
La Declaración de Doha existe, pero el músculo económico de las farmacéuticas también existe.
The Doha Declaration exists, but the economic muscle of the pharmaceutical companies also exists.
Here's the thing that drives me slightly crazy.
Let's talk about insulin.
This is not some exotic gene therapy.
Insulin is over a hundred years old.
Banting and Best discovered it in 1921 and they sold the patent to the University of Toronto for one dollar each, specifically so it could be widely available.
And yet in 2019, Americans were rationing insulin, driving to Canada to buy it.
How does that happen?
Bueno, lo que ocurre con la insulina es un ejemplo perfecto de cómo el sistema puede ser manipulado.
Well, what happens with insulin is a perfect example of how the system can be manipulated.
El compuesto original ya no tiene patente, llevas razón.
The original compound is no longer patented, you're right about that.
Pero las empresas han desarrollado versiones ligeramente modificadas, análogos de insulina, que sí están patentadas y que presentan como mejoras clínicas significativas.
But companies have developed slightly modified versions, insulin analogues, which are patented and which they present as significant clinical improvements.
Es lo que se llama evergreening: alargar artificialmente la protección de un medicamento mediante cambios menores.
It's what's called evergreening: artificially extending the protection of a drug through minor changes.
So you're not inventing a new drug, you're just tweaking the molecule enough to reset the clock on the patent.
And the industry would say those tweaks are real improvements, the new formulations are more stable, easier to dose.
But critics say the improvements are incremental and the price jumps are not.
La verdad es que el argumento de la industria sobre la innovación tiene un problema serio de credibilidad cuando miras los números.
The truth is that the industry's argument about innovation has a serious credibility problem when you look at the numbers.
Los grandes laboratorios farmacéuticos gastan consistentemente más en marketing y publicidad que en investigación y desarrollo.
Big pharmaceutical companies consistently spend more on marketing and advertising than on research and development.
Algunos estudios sugieren que la proporción es de casi dos a uno.
Some studies suggest the ratio is nearly two to one.
Eso no es lo que te cuenta la narrativa oficial.
That's not what the official narrative tells you.
I mean, to be fair, the industry pushes back hard on that comparison.
They say R&D costs aren't just what appears on a balance sheet, that you have to factor in failed trials, the compounds that never make it to market, the years of work that produce nothing.
And that's a legitimate point.
Es un punto legítimo, pero parcial.
It's a legitimate point, but a partial one.
Porque hay otra variable que esa narrativa omite sistemáticamente: el papel de la financiación pública.
Because there's another variable that narrative systematically omits: the role of public funding.
La mayoría de los descubrimientos farmacéuticos fundamentales, los que realmente cambian paradigmas, tienen su origen en investigación universitaria financiada por el Estado.
Most fundamental pharmaceutical discoveries, the ones that truly change paradigms, originate in university research funded by the state.
El contribuyente paga dos veces: primero la investigación básica, y luego el precio de mercado del medicamento resultante.
The taxpayer pays twice: first for the basic research, and then for the market price of the resulting drug.
No, you're absolutely right about that.
The NIH in the United States, the National Institutes of Health, has been involved in the early research behind every single one of the top drugs approved between 2010 and 2019.
Every single one.
That's not a fringe argument, that's the data from a peer-reviewed study in the Proceedings of the National Academy of Sciences.
A ver, y el caso más reciente y más llamativo es el de las vacunas contra el COVID.
Look, and the most recent and most striking case is that of COVID vaccines.
La tecnología de ARN mensajero que hizo posible las vacunas de Pfizer y Moderna no surgió de los laboratorios de esas empresas.
The mRNA technology that made the Pfizer and Moderna vaccines possible did not emerge from those companies' laboratories.
Surgió décadas de investigación pública en universidades como Penn State.
It came from decades of public research at universities like Penn State.
La doctora Katalin Karikó pasó años con financiación muy precaria estudiando ese mecanismo.
Dr.
She was actually demoted at Penn for pursuing it.
Her own institution didn't believe in her research.
And then a pandemic happens, the technology becomes the most important medical intervention of our lifetimes, Moderna becomes a hundred billion dollar company, and Karikó eventually gets a Nobel Prize.
But the profits went to the companies, not to the public institutions that funded the foundational work.
Y entonces llegamos a la gran batalla del COVID.
And then we arrive at the great battle of COVID.
En 2021, India y Sudáfrica propusieron en la OMC suspender temporalmente las patentes de las vacunas para permitir que los países en desarrollo las fabricaran.
In 2021, India and South Africa proposed at the WTO temporarily suspending vaccine patents to allow developing countries to manufacture them.
La propuesta generó un debate absolutamente encendido.
The proposal generated an absolutely fierce debate.
Más de cien países la apoyaban.
More than a hundred countries supported it.
Estados Unidos, la Unión Europea y el Reino Unido la bloquearon durante meses.
The United States, the European Union, and the United Kingdom blocked it for months.
And the counterargument from the industry was that waiving patents wouldn't actually help because the bottleneck wasn't the intellectual property, it was manufacturing capacity.
You can hand someone the recipe for a mRNA vaccine, but if they don't have the cold storage infrastructure, the specialized equipment, the trained staff, the recipe is useless.
Es que ese argumento tiene algo de verdad y mucho de conveniente.
That argument has some truth to it and a great deal of convenience.
Es verdad que la cadena de producción de estas vacunas era compleja.
It's true that the production chain for these vaccines was complex.
Pero también es verdad que el Instituto Serum en India, el mayor fabricante de vacunas del mundo, tenía perfectamente la capacidad de producirlas.
But it's also true that the Serum Institute in India, the world's largest vaccine manufacturer, had perfectly adequate capacity to produce them.
Y las restricciones de patentes y de exportación de materias primas por parte de Estados Unidos sí fueron un freno real y documentado.
And restrictions on patents and on the export of raw materials by the United States were a real and documented obstacle.
Look, the Biden administration actually came out in support of the patent waiver in May 2021, which was a significant shift.
But then the EU dug in, largely because BioNTech is a German company and Sanofi is French, and there were obvious political pressures at play.
By the time a limited agreement was reached in 2022, the window had largely passed.
Mira, desde España y desde Europa la perspectiva es peculiar porque tenemos sistemas de salud públicos que negocian los precios de los medicamentos de forma centralizada.
Look, from Spain and from Europe the perspective is peculiar because we have public health systems that negotiate drug prices centrally.
Eso nos protege hasta cierto punto.
That protects us to a certain extent.
La misma pastilla que en Estados Unidos cuesta trescientos dólares, en España puede costar treinta porque el Estado negocia en bloque y establece precios de referencia.
The same pill that costs three hundred dollars in the United States might cost thirty in Spain because the state negotiates in bulk and sets reference prices.
Which is exactly what the American pharmaceutical lobby uses as a talking point domestically, arguing that Americans are essentially subsidizing lower prices elsewhere.
Their argument is that Europe free-rides on American consumer prices to fund global R&D.
And there's a grain of truth in that too, even if the conclusion they draw from it is self-serving.
La verdad es que el modelo americano es una anomalía entre los países desarrollados.
The truth is that the American model is an anomaly among developed countries.
Ningún otro país rico permite que las compañías farmacéuticas fijen precios libremente sin ningún tipo de negociación o regulación estatal.
No other wealthy country allows pharmaceutical companies to set prices freely without any form of state negotiation or regulation.
Hasta hace muy poco, Medicare, el programa público de salud para mayores en Estados Unidos, tenía explícitamente prohibido negociar los precios de los medicamentos.
Until very recently, Medicare, the public health program for the elderly in the United States, was explicitly prohibited from negotiating drug prices.
Eso es una política de Estado diseñada para beneficiar a una industria.
That is a state policy designed to benefit an industry.
The Inflation Reduction Act in 2022 finally changed that, at least partially.
Medicare can now negotiate prices on a limited number of drugs.
The first ten were announced in 2023.
The pharmaceutical industry immediately sued, claiming it was unconstitutional.
I'll let listeners draw their own conclusions about that.
Bueno, y luego está la cuestión de los genéricos, que merece su propio capítulo.
Well, and then there's the question of generics, which deserves its own chapter.
Cuando expira una patente, otros fabricantes pueden producir el mismo compuesto a una fracción del coste.
When a patent expires, other manufacturers can produce the same compound at a fraction of the cost.
India se ha convertido en la farmacia del mundo en desarrollo, precisamente porque desarrolló una industria genérica potentísima.
India has become the pharmacy of the developing world precisely because it developed an enormously powerful generics industry.
El ochenta por ciento de los medicamentos genéricos que se consumen en Estados Unidos vienen de India.
Eighty percent of the generic drugs consumed in the United States come from India.
And India, interestingly, had a very different approach to intellectual property law before it joined the WTO.
Under its old Patents Act, you couldn't patent a molecule itself, only a specific process for making it.
So Indian companies could legally develop different manufacturing processes to produce the same drug.
That's how they built the generics capacity.
TRIPS forced them to change that, but they negotiated carve-outs.
Sí, la famosa sección 3D de la ley de patentes india, que impide patentar nuevas formas de compuestos ya conocidos a menos que demuestres una mejora terapéutica genuina.
Yes, the famous Section 3D of Indian patent law, which prevents the patenting of new forms of already known compounds unless you demonstrate a genuine therapeutic improvement.
Es exactamente lo contrario del evergreening.
It's the exact opposite of evergreening.
Novartis intentó patentar una versión modificada de un medicamento contra la leucemia, el imatinib, y el Tribunal Supremo de India lo rechazó en 2013 basándose precisamente en esa norma.
Novartis tried to patent a modified version of a leukemia drug, imatinib, and India's Supreme Court rejected it in 2013 based precisely on that rule.
Fue una decisión histórica.
It was a historic decision.
So what does a better system actually look like?
Because I think we've established pretty clearly that the current one has serious problems.
But the alternative isn't obvious.
You can't just abolish patents because then you genuinely do destroy the incentive to invest in drug development.
A ver, hay varias propuestas sobre la mesa que van más allá del debate binario entre patentes sí o patentes no.
Look, there are several proposals on the table that go beyond the binary debate between patents yes or patents no.
Una de las más interesantes es el modelo de premios o prize funds: en lugar de darle a una empresa el monopolio de mercado durante veinte años, el Estado paga un premio global por el descubrimiento, el compuesto pasa a ser de dominio público de inmediato, y cualquiera puede fabricarlo.
One of the most interesting is the prize fund model: instead of giving a company a twenty-year market monopoly, the state pays a global prize for the discovery, the compound immediately enters the public domain, and anyone can manufacture it.
El economista Joseph Stiglitz lleva años defendiendo esta idea.
The economist Joseph Stiglitz has been advocating this idea for years.
The prize model is elegant in theory.
The problem is calibration.
How do you set the prize?
Too low and you don't incentivize the research.
Too high and you've just recreated the same problem with public money instead of private.
And who decides what counts as a sufficiently important discovery to merit a big prize versus a small one?
Es un problema real de diseño institucional, de acuerdo.
That's a real problem of institutional design, agreed.
Pero también hay modelos híbridos que ya existen y funcionan con matices.
But there are also hybrid models that already exist and work, with nuances.
El modelo de la tuberculosis, por ejemplo, o el de ciertas enfermedades tropicales olvidadas, donde la financiación pública y filantrópica cubre la investigación básica y se exige que los resultados sean accesibles.
The tuberculosis model, for example, or that of certain neglected tropical diseases, where public and philanthropic funding covers basic research and the results are required to be accessible.
La Iniciativa de Medicamentos para Enfermedades Olvidadas, la DNDi, opera exactamente así.
The Drugs for Neglected Diseases Initiative, DNDi, operates exactly like this.
And that brings us to what I think is one of the most revealing failures of the current market logic, which is the problem of orphan diseases.
Rare diseases affecting small populations.
The market incentive just isn't there because you can't make the money back on a small patient population, regardless of what you charge per dose.
Bueno, aunque ahí la historia se complica de una manera bastante irónica.
Well, although there the story becomes quite ironic.
Los incentivos fiscales creados para estimular la investigación de enfermedades raras, los orphan drug designations en Estados Unidos y Europa, han sido masivamente explotados por las farmacéuticas para obtener ventajas regulatorias y de mercado.
The tax incentives created to stimulate research into rare diseases, the orphan drug designations in the United States and Europe, have been massively exploited by pharmaceutical companies to obtain regulatory and market advantages.
Algunos de los medicamentos más rentables de la historia tienen esa designación, incluyendo tratamientos para el cáncer que en realidad afectan a millones de personas.
Some of the most profitable drugs in history carry that designation, including cancer treatments that actually affect millions of people.
So even the corrective mechanisms get gamed.
You design a policy to fix a market failure and the industry finds a way to route around it.
This is part of why I find the purely libertarian argument for pharmaceutical deregulation so baffling.
The market, left to its own devices, has consistently failed to produce affordable treatments for the most vulnerable populations.
That's not a bug in the current system.
It's a feature.
La verdad es que yo comparto esa frustración, pero también creo que hay que ser honesto sobre las limitaciones del Estado como motor de innovación.
The truth is I share that frustration, but I also think we have to be honest about the limitations of the state as an engine of innovation.
Los grandes avances contra el VIH, que mencionabas antes, los inhibidores de la proteasa, las combinaciones antirretrovirales, fueron impulsados en parte por la presión tremenda de los activistas y también por la competencia feroz entre laboratorios privados.
The great advances against HIV that you mentioned earlier, the protease inhibitors, the antiretroviral combinations, were driven in part by the tremendous pressure from activists and also by fierce competition between private laboratories.
Eso generó una velocidad de innovación que probablemente ningún programa público hubiera igualado.
That generated a speed of innovation that probably no public program would have matched.
So we're back to the central paradox.
The system produces extraordinary science driven by profit motives, and the profit motive is also the reason millions of people can't access what that science produces.
I don't think there's a clean resolution to that.
But I do think we can design a system that manages the tension better than the current one does.
Mira, lo que está claro es que el debate no puede seguir siendo rehén del lobby farmacéutico.
Look, what is clear is that the debate cannot continue being held hostage by the pharmaceutical lobby.
Cuando las empresas gastan más en cabildeo político en Washington que cualquier otro sector de la economía, cuando financian la formación médica y los congresos científicos, cuando colocan a sus ejecutivos en los organismos reguladores, la pregunta de quién diseña las reglas del juego deja de ser abstracta.
When companies spend more on political lobbying in Washington than any other sector of the economy, when they fund medical education and scientific conferences, when they place their executives in regulatory bodies, the question of who designs the rules of the game stops being abstract.
The extraordinary thing is that this is one of those issues where the polling is remarkably consistent across party lines in the United States.
Republican voters, Democratic voters, they both want the government to be able to negotiate drug prices.
Both.
By very large majorities.
And yet for decades Congress couldn't get there.
That tells you something about whose interests the system is actually serving.
Es que hay una dimensión filosófica más profunda aquí que no podemos ignorar.
There is a deeper philosophical dimension here that we can't ignore.
La pregunta es si la salud es una mercancía o un derecho.
The question is whether health is a commodity or a right.
Y la respuesta que da un sistema a esa pregunta, de manera implícita, a través de sus leyes y sus políticas, define qué tipo de sociedad quiere ser.
And the answer a system gives to that question, implicitly, through its laws and policies, defines what kind of society it wants to be.
Europa mayoritariamente ha respondido que es un derecho, aunque con muchas contradicciones.
Europe has mostly answered that it's a right, albeit with many contradictions.
Estados Unidos todavía no ha terminado de responder.
The United States still hasn't finished answering.
And that framing, health as a right versus health as a commodity, that's not just a philosophical abstraction.
It has real consequences for how you structure patent law, how you fund basic research, whether you allow price gouging, how you respond to a pandemic.
The philosophy is actually the policy.
Y a mí lo que me parece más preocupante mirando hacia adelante es la combinación de inteligencia artificial y farmacéutica.
And what worries me most looking ahead is the combination of artificial intelligence and pharmaceuticals.
Las herramientas de IA están acelerando de forma dramática el descubrimiento de nuevos compuestos.
AI tools are dramatically accelerating the discovery of new compounds.
Lo que antes tardaba décadas puede tardar años.
What used to take decades can now take years.
Eso es fantástico.
That is fantastic.
Pero si esa capacidad queda exclusivamente en manos de cuatro o cinco megacorporaciones, la brecha de acceso no va a mejorar, va a empeorar.
But if that capacity remains exclusively in the hands of four or five mega-corporations, the access gap is not going to improve, it's going to get worse.
Right, so the same technology that could make drug discovery cheaper and faster could also just entrench the existing players more deeply.
Because the AI systems, the data infrastructure, the regulatory expertise, all of that is enormously expensive to build and gives huge advantages to whoever gets there first.
Bueno, aunque también hay una corriente opuesta y genuinamente esperanzadora.
Well, although there is also an opposing and genuinely hopeful current.
Iniciativas como la del Wellcome Trust, o algunos proyectos financiados por la Unión Europea, están intentando construir infraestructuras abiertas de datos biomédicos y herramientas de IA de acceso público para la investigación.
Initiatives like the Wellcome Trust's, or some projects funded by the European Union, are trying to build open biomedical data infrastructures and publicly accessible AI tools for research.
La batalla sobre si esas plataformas serán abiertas o cerradas va a ser tan importante como cualquier negociación sobre patentes.
The battle over whether those platforms will be open or closed will be just as important as any patent negotiation.
I want to end where we started, with that two million dollar dose.
Because I think the question it raises isn't whether the science is real or the investment is real.
It clearly is.
The question is who gets to benefit from it.
And right now the answer is: whoever can pay.
And that might be the most important political question in medicine for the next generation.
Mira, la industria farmacéutica ha producido algunos de los logros más extraordinarios de la civilización humana.
Look, the pharmaceutical industry has produced some of the most extraordinary achievements of human civilization.
La erradicación de la viruela, el control del VIH, las vacunas que salvaron a generaciones enteras.
The eradication of smallpox, the control of HIV, the vaccines that saved entire generations.
Seria deshonesto no reconocerlo.
It would be dishonest not to acknowledge that.
Pero el hecho de que pueda hacer todo eso y aun así dejar a millones de personas sin acceso a tratamientos básicos no es inevitable, es una elección política.
But the fact that it can do all of that and still leave millions of people without access to basic treatments is not inevitable, it is a political choice.
Y las elecciones políticas se pueden cambiar.
And political choices can be changed.