The Economics of Vaccines

Seth Berkley:  It’s interesting because vaccines used to be thought as not very profitable. The pharmaceutical industry much, much larger-- People when they’re sick of course will have a perception that they’ll pay more because they’re worried about being sick and wanting to get better. There’s nothing that’s more driving than when you feel sick to get treatment. Vaccines used to be seen as public health commodity things, things that were required by the state, relatively inexpensive and that’s beginning to change. There’s been a series of vaccines over the last few years that have come out, that have come out at high price in the west and have created very large markets. But the pharmaceutical markets over the last couple of decades have been looking for blockbusters. They’ve been looking for drugs and vaccines that make billions of dollars and so that hadn’t been the way of working. On top of that, you have a disease that is extremely difficult scientifically. We’ve talked about that. You’ve got a disease that the primary place where it’s spreading, 95% of the infections are in the developing world, and third, you’ve got a disease that’s politically controversial. It’s about sex. It’s about people who are arguing about this. It’s about intellectual property. And so you can rationally see why a company might say this isn’t the best place to invest our shareholders’ resources and so one of our great challenges has been to say this is a global public good. This vaccine will be important not only for the developing but also for the developed world. So how do we create incentives that will engage the best scientists, the best companies, the best groups in the world to focus on this problem? It isn’t going to happen in a natural market mechanism. We’ve got to create them and that’s really part of what we’re trying to do.

Question: How do we incentivize innovation?

Seth Berkley:  In a sense, the mechanisms people usually do for these types of products is people presume there’s a massive market out there that can charge a lot of money and therefore there’s a lot of profit that can occur. And if it’s so profitable that you can make a real killing on a product, what that means is that you can have lots of products that don’t make it along the way and still have it be a profitable business. So in essence, companies and scientists and groups have to think about the probability of success of creating products and factor that into what the potential return on investments going to be, and that’s how the calculations are made. So you have this situation now where you’ve got a product that may be for a place that isn’t going to pay a lot of money, that is scientifically difficult, all these controversies. So if you want to try to get more work done, there are two major mechanisms: push and pull. The push mechanism is you can say all right, we’re not going to expect private companies to pay for the research. We’re going to use public dollars to pay for the research and that’s one way to drive things forward. But there’s also the possibility of creating a pull mechanism. You could say we’re going to put incentives in place whether it be we’ll take the risk out by funding the research, but also we can create an artificial market and that’s what an advanced market commitment is. That’s the idea that you put some money out there and you say we’re going to create a market that says we’ll buy a vaccine at a certain price up to a certain quantity so that the companies know this market is there for the developing world, for the places that they’re discounting. There’s also tax credits. There’s also prizes. There’s a whole range of other incentives one can put in place but the idea is to make sure that you get the best scientists engaged in this. Some of those are going to be in the public sector --  government laboratories, academic laboratories -- but a lot of this type of vaccine development work occurs in private companies, so you want to bring those two together. That’s the idea of a public/private partnership, to make sure you get the best of both sectors engaged in this.

Topic: Public-Private Partnerships

Seth Berkley:  IAVI was the first of these drug type of product development partnerships. There’s now 20-odd ones of these working in the drug and vaccine area and there’s more drugs that are moving forward now but for diseases of poverty than have been moving forward in the last three or four decades. So there’s been in a sense a whole renaissance of movement towards these new types of products. But product development partnerships, in essence, are not just things that are done in the health sector. Some of the most interesting academic product things have been like semi-tech, semiconductor-type work, government industry partnerships like the Airbus Consortia where they’ve taken the public and private sector and put them together to drive things forward. It’s a well-known tool, it just hasn’t been done for drugs and vaccines for diseases of poverty before.

Pharmaceutical companies over the last couple of decades have been looking for blockbusters instead of incremental improvements.

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Yale scientists restore brain function to 32 clinically dead pigs

Researchers hope the technology will further our understanding of the brain, but lawmakers may not be ready for the ethical challenges.

Still from John Stephenson's 1999 rendition of Animal Farm.
Surprising Science
  • Researchers at the Yale School of Medicine successfully restored some functions to pig brains that had been dead for hours.
  • They hope the technology will advance our understanding of the brain, potentially developing new treatments for debilitating diseases and disorders.
  • The research raises many ethical questions and puts to the test our current understanding of death.

The image of an undead brain coming back to live again is the stuff of science fiction. Not just any science fiction, specifically B-grade sci fi. What instantly springs to mind is the black-and-white horrors of films like Fiend Without a Face. Bad acting. Plastic monstrosities. Visible strings. And a spinal cord that, for some reason, is also a tentacle?

But like any good science fiction, it's only a matter of time before some manner of it seeps into our reality. This week's Nature published the findings of researchers who managed to restore function to pigs' brains that were clinically dead. At least, what we once thought of as dead.

What's dead may never die, it seems

The researchers did not hail from House Greyjoy — "What is dead may never die" — but came largely from the Yale School of Medicine. They connected 32 pig brains to a system called BrainEx. BrainEx is an artificial perfusion system — that is, a system that takes over the functions normally regulated by the organ. The pigs had been killed four hours earlier at a U.S. Department of Agriculture slaughterhouse; their brains completely removed from the skulls.

BrainEx pumped an experiment solution into the brain that essentially mimic blood flow. It brought oxygen and nutrients to the tissues, giving brain cells the resources to begin many normal functions. The cells began consuming and metabolizing sugars. The brains' immune systems kicked in. Neuron samples could carry an electrical signal. Some brain cells even responded to drugs.

The researchers have managed to keep some brains alive for up to 36 hours, and currently do not know if BrainEx can have sustained the brains longer. "It is conceivable we are just preventing the inevitable, and the brain won't be able to recover," said Nenad Sestan, Yale neuroscientist and the lead researcher.

As a control, other brains received either a fake solution or no solution at all. None revived brain activity and deteriorated as normal.

The researchers hope the technology can enhance our ability to study the brain and its cellular functions. One of the main avenues of such studies would be brain disorders and diseases. This could point the way to developing new of treatments for the likes of brain injuries, Alzheimer's, Huntington's, and neurodegenerative conditions.

"This is an extraordinary and very promising breakthrough for neuroscience. It immediately offers a much better model for studying the human brain, which is extraordinarily important, given the vast amount of human suffering from diseases of the mind [and] brain," Nita Farahany, the bioethicists at the Duke University School of Law who wrote the study's commentary, told National Geographic.

An ethical gray matter

Before anyone gets an Island of Dr. Moreau vibe, it's worth noting that the brains did not approach neural activity anywhere near consciousness.

The BrainEx solution contained chemicals that prevented neurons from firing. To be extra cautious, the researchers also monitored the brains for any such activity and were prepared to administer an anesthetic should they have seen signs of consciousness.

Even so, the research signals a massive debate to come regarding medical ethics and our definition of death.

Most countries define death, clinically speaking, as the irreversible loss of brain or circulatory function. This definition was already at odds with some folk- and value-centric understandings, but where do we go if it becomes possible to reverse clinical death with artificial perfusion?

"This is wild," Jonathan Moreno, a bioethicist at the University of Pennsylvania, told the New York Times. "If ever there was an issue that merited big public deliberation on the ethics of science and medicine, this is one."

One possible consequence involves organ donations. Some European countries require emergency responders to use a process that preserves organs when they cannot resuscitate a person. They continue to pump blood throughout the body, but use a "thoracic aortic occlusion balloon" to prevent that blood from reaching the brain.

The system is already controversial because it raises concerns about what caused the patient's death. But what happens when brain death becomes readily reversible? Stuart Younger, a bioethicist at Case Western Reserve University, told Nature that if BrainEx were to become widely available, it could shrink the pool of eligible donors.

"There's a potential conflict here between the interests of potential donors — who might not even be donors — and people who are waiting for organs," he said.

It will be a while before such experiments go anywhere near human subjects. A more immediate ethical question relates to how such experiments harm animal subjects.

Ethical review boards evaluate research protocols and can reject any that causes undue pain, suffering, or distress. Since dead animals feel no pain, suffer no trauma, they are typically approved as subjects. But how do such boards make a judgement regarding the suffering of a "cellularly active" brain? The distress of a partially alive brain?

The dilemma is unprecedented.

Setting new boundaries

Another science fiction story that comes to mind when discussing this story is, of course, Frankenstein. As Farahany told National Geographic: "It is definitely has [sic] a good science-fiction element to it, and it is restoring cellular function where we previously thought impossible. But to have Frankenstein, you need some degree of consciousness, some 'there' there. [The researchers] did not recover any form of consciousness in this study, and it is still unclear if we ever could. But we are one step closer to that possibility."

She's right. The researchers undertook their research for the betterment of humanity, and we may one day reap some unimaginable medical benefits from it. The ethical questions, however, remain as unsettling as the stories they remind us of.

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