Ep65: A New Script for Global Public Health

Ep65: A New Script for Global Public Health
Date:
12 November 2020
Category:

Fellows of the RACP can claim CPD credits via MyCPD for listening to this episode and reading the resources below.

In this episode we present some provocative solutions to problems presented in the previous two stories.We heard about pharmaceutical patents, and how embedded intellectual property law is in global trade relations. There’s this fundamental assumption that innovation occurs thanks only to the vigour of the private sector and the plucky entrepreneur. It’s even been said that financialized capitalism is “the greatest engine of progress ever seen.”

But the reality is that shiny smartphones and targeted drugs wouldn’t exist without massive government spending on research. It’s public money that funds the riskiest stages of development, before private enterprise takes these products to market with the benefit of monopoly pricing. Dr Owain Williams and Associate Professor Peter Hill argue that states can demand more control over the outputs and pricing of drug and vaccine research, and that the current intellectual property regime is not the only way to stimulate innovation.

In the second part Associate Professor Adam Kamradt-Scott talks about the lessons learned and not learned from pandemic modelling in past years. He also makes the case for establishing an Australian Centre for Disease Control with standalone jurisdiction, to cut through some of the conflict we’ve seen in recent months between state and federal leaders.  

Credits

Guests
Dr Owain Williams (University of Leeds)
Associate Professor Peter Hill AFPHM (University of Queensland)
Associate Professor Adam Kamradt-Scott (University of Sydney, United States Studies Centre)

Production
Written and produced by Mic Cavazzini DPhil. Music courtesy of Free Music Archive includes ‘Cherry Blossom’ by Daddy Scrabble, ‘Sunstorm’ by ELFL, ‘Mister S’ by Tortue Super Sonic and ‘Club Crunk for Monkeys’ by Kromatic. Image licenced from Getty Images.

Editorial feedback for this episode was kindly provided by physicians of the RACP’s Podcast Editorial Group; Sern Wei Yeok, Leah Krischock, Saion Chaterjee, Priya Garg, Victoria Langton and Joseph Lee.

References

Podcasts
Can the State Deliver? [Mazzucato lecture, Centre for Policy Development]
The Shiny-Object Psychology of American Capitalist “Innovation” [Citations Needed podcast]
The COVID-19 crisis is a chance to do capitalism differently [Mazzucato, TED]
Government- investor, risk-taker, innovator [Mazzucato, TED]
Australia’s medicine shortage [7am Podcast]

Academic and public literature
Estimating the effect of cooperative versus uncooperative strategies of COVID-19 vaccine allocation: a modeling study [NWU]
Patents Associated with High-Cost Drugs in Australia [PLoS One]
COVID-19 drug and vaccine patents are putting profit before people [The Conversation]
Do large pharma companies provide drug development innovation? Our analysis says no [STAT]
Diagnosing the decline in pharmaceutical R&D efficiency [Nature Reviews Drug Discovery]
The People's Prescription policy report [Mazzucato, UCL]
The global risk of “vaccine nationalism” [Vox media]
Drug Companies Will Make a Killing From Coronavirus [Mazzucato, NYT]
Would We Already Have Had a COVID-19 under socialism?: Debunking the myth that capitalism drives innovation [Bee, In These Times]
An HIV treatment cost taxpayers millions. The government patented it. But a pharma giant is making billions [The Washington Post]
Will the next pandemic be even worse? [Australian Doctor]
The next pandemic is coming – and sooner than we think, thanks to changes to the environment [ABC]
Is Australia prepared for the next pandemic? [MJA 2017]
Diseases have no borders – report on the inquiry into health issues across international borders [Department of Health]
On The Value of Viewing Antimicrobial Resistance as a threat to International Security [Kamradt-Scott, AMR]
Coronavirus pandemic shows it’s time for an Australian Centre for Disease Control – in Darwin [Kamradt-Scott, the Conversation]



Transcript

MIC CAVAZZINI:               Welcome to Pomegranate Health, a podcast about the culture of medicine. I’m Mic Cavazzini for the Royal Australasian College of Physicians. Today I’m going to build in the previous two episodes on what COVID-19 has taught us about global public health strategy.

We ended the last story with a quote from the Australian Prime Minister telling the United Nations that it was a “moral responsibility” for a successful vaccine “to be shared far and wide.” Australia is a signatory to the COVAX facility, which I described in the last episode like a betting pool. If any one of the 15 vaccine candidates within its portfolio is successful, it distributed to all 172 participating countries.

Both high and low income countries would be permitted to vaccinate 3% of the population in successive rounds until a target of 20% was reached for all. COVAX does then allow for funding nations to bump their vaccination rate up to 50%, but not to jump the queue. 

However, you might recall the concern expressed by Dr Deborah Gleeson of La Trobe Uni, about rich countries signing deals directly with the same vaccine manufacturers. She argued that these bilateral deals would undermine the ability of COVAX to access supplies for more equitable distribution.

As I was putting the final touches on this podcast it was announced that Australia had entered into advance market commitments with Pfizer and Novavax. That’s on top of the arrangement made in August to produce the Oxford/Astrazeneca candidate in Australian laboratories.

The Novavax, Astrazeneca and the home grown Uni of Queensland vaccines all feature in the COVAX stables- but Australia has secured 125 million doses of these up front for our population of 25 million. I contacted the Department of Health to ask whether Australia was expecting priority treatment, or whether we’d allow the objectives of COVAX to be met first. Here is their response;.

“These advance purchase arrangements operate separately from Australia’s participation in the Gavi, COVAX facility.  Australia’s participation in the Gavi, COVAX facility is an important insurance policy to ensure that Australians have access to a wider range of potential vaccine candidates in addition to the doses we have secured through our advance purchase arrangements.”  End quote.

I’ve not come across any formal response to these negotiations from Gavi, or a calculus of their specific impact on global vaccine supply. But in the last podcast it was proposed that a ‘me first’ attitude from rich countries might not be the most pragmatic approach towards SARS-CoV2 in epidemiological terms. In fact there’s a modeling study showing just that from Northeastern University, Massachusetts. In its “cooperative” scenario, researchers distributed a 3 billion doses of a hypothetical vaccine to all countries as a proportion of population. In a second “uncooperative” scenario, only a billion doses were shared out in this way with the remaining 2 billion going to high income countries.

The researchers fed real-life prevalence numbers from March 16th into the model, and compared transmission and mortality through to September 1st. The cooperative scenario averted about 60% of deaths over this period, while the “me first” approach was only half as successful. Later in this podcast we’ll hear some more about lessons learned and not learned from pandemic modelling in past years, and how Australia could benefit from an Independent Centre for Disease Control. But before we do, let’s go back to theme about the intellectual property rules that govern pharmaceutical markets.

The laws on 20 year patents that protect new drug molecules were determined in the 1995 TRIPS agreement of the World Trade Organisation. But these protections present major hurdles to manufacturers of generic pharmaceuticals, and monopoly pricing puts name brand drugs out of reach for many people in low and middle income countries. On top of that, diseases centred in these regions are often neglected by originator firms entirely because there’s just not enough money to be made.

We heard how partnerships like COVAX, The Global Fund and the Coalition for Epidemic Preparedness Innovation are designed to address such market failures. But in an 2012 article for the journal Global Public Health Dr Owain Williams expressed some caveats about such pooled procurement mechanisms. The University of Leeds academic says that they reinforce the existing oligopoly rather than stimulate competition.

OWAIN WILLIAMS:         The thing is, look, the patent system is a systemic – it’s the major system in place globally that provides the conditions for innovation. I don’t think it’s a good system but it’s what we’ve got in place. I mean COVAX is ostensibly a good initiative and I think it would be sensible for most countries to belong to it. All of the different partnerships and approaches – CEPIs and the product development partnerships – what they’re there to do is circumvent the problems, the multiple problems, that are endemic to drug markets and vaccine markets. And they circumvent it, but they’re not systemic – they’re partial interventions. And we’re constant reliant therefore on these rather ad hoc – very good, very well meaning and sometimes very successful – these ad hoc attempts to band-aid the innovation system. It’s a band-aid and there’s a fundamental question, maybe Peter will speak to this, is whether drug innovation should rest within the market, let alone the patent system.

MIC CAVAZZINI:               They’re market solutions to market failures, but beneath it there is a moral failure that isn’t being addressed.

OWAIN WILLIAMS:         Yeah, there’s a moral failure that lurks within it. But they’re not market – they are market solutions, they’re political economic solutions, because they involve states and government money.

MIC CAVAZZINI:               As an illustration of these tensions, just look at the COVID Technology Access Pool which was launched alongside COVAX in May. It was put forward by Costa Rica and the WHO as place to share patents, technology, and research findings to speed up collaborative efforts against the coronavirus.

But Big Pharma was not impressed. The CEO of Pfizer described this patent pool as “nonsense” given that, “the risks that we are taking is billions of dollars.” And the chief executive of AstraZeneca, had this response: “I think IP is a fundamental part of our industry and if you don't protect IP, then essentially there is no incentive for anybody to innovate.”

There’s this embedded assumption, not just in pharma but in every industry, that innovation occurs thanks only to the vim and vigour of the private sector. We lionise the plucky “entrepreneur”- the big fish like Elon Musk and Richard Branson who succeed in the competitive waters of the free market.

“The New York Times is in favor of capitalism because it has been …  the greatest anti-poverty program and engine of progress that we’ve seen” said opinion editor David Bennett to his staff. Columnist Thomas Loren Friedman went even further to describe; America as “the greatest engine of innovation that has ever existed”  thanks to “a noncorrupt bureaucracy, and financial markets and a venture capital system that are unrivaled at taking new ideas and turning them into global products.”

I suppose I didn’t question this maxim too much until attended a lecture last year where Mariana Mazzucato presented her book titled, “the Entrepreneurial State.” She’s a Professor in the Economics of Innovation & Public Value at University College London, and one of those rock star academics asked to give TED lectures and advise the EU. I’ll link to some of her writing in the show notes, including “the People’s Prescription policy report and another article titled “Drug Companies Will Make a Killing From Coronavirus.”

Mazzucato says that brilliant as Steve Jobs might have been, the iPhone didn’t have an immaculate conception. The internet that makes it a smartphone began as a network of computers at the US Department of Defence. They also came up with GPS while research into the touchscreen was funded by the National Science Foundation and the CIA. And Wi-Fi, now used on 5 billion devices globally? That was conceived by two Australian electrical engineers working at the CSIRO and Macquarie University.

In all these technologies the state has been the “early investor”- putting public money in when there is the least guarantee of a successful outcome. And the same of course is true of drug research. In the USA, the National Institutes of Health pours $40 billion a year into fundamental research. Of the 210 new drugs approved by the FDA between 2010 and 2016, every single one can be linked to public funding. Here’s Owain Williams to carry this idea further- and after a few minutes you’ll also hear Associate Professor and RACP Fellow Peter Hill from the University of Queensland. 

OWAIN WILLIAMS:         The role of core states, core western states in terms of financing both basic research but also applied research is enormous – is enormous. Life’s answers broadly are basically the product of state investment – government labs, universities, NIH funding, European framework program in Australian universities. It’s the same picture. So all our tax dollars are busily generating these systems, these R&D systems, these technologies, and then along come the firm and they patent them or they run the phase III trials and phase IV and so on and so forth, they clear the regulatory hurdles. They’re very good at doing these things, they have the knowhow and the expertise to do these things in pharmaceuticals especially. And we then pay twice, because then we have to buy them.

MIC CAVAZZINI:               There was a figure in Mazzucato’s article in New York Times that since the 2003 SARS outbreak the NIH has spent nearly $700 million of taxpayer money on coronavirus research.

OWAIN WILLIAMS:         Yeah.

MIC CAVAZZINI:               And even the antiviral remdesivir, which as we said at the beginning improves recovery times for people with COVID, that was developed from research on MERS – for the MERS coronavirus at the University of Alabama.

OWAIN WILLIAMS:         $70 million, that’s what the NIH put into that drug.

MIC CAVAZZINI:               And now it’s patented exclusively by Gilead Sciences.

OWAIN WILLIAMS:         Gilead are great at doing this. The other thing that they’re really good at doing is buying up companies, smaller companies, that have like the DAC for hepatitis C. They didn’t generate that, Gilead – they brought the company that had done it. Very quickly in 2012, as soon as the results were in they brought the company. Just from the top of my head it’s around $8 billion. They’re now on $50 billion profits. That’s good business without any R&D effort whatsoever.

MIC CAVAZZINI:               Well in fact the trend in recent years has actually been for large pharmaceutical companies to move away from the lab bench and as you say just buy licences or companies altogether. In a 2019 study, researchers at Harvard Medical School found that Johnson & Johnson had only discovered two of its 18 top-selling drugs in house, and for Pfizer it was ten from 44.

OWAIN WILLIAMS:         Yeah.

MIC CAVAZZINI:               So this really debunks the idea that all the existing patent protections are stimulating great innovation from these big companies.

OWAIN WILLIAMS:         Yeah, they sit on top of a pyramid, and it’s not just a pyramid of firms. It’s a pyramid of government labs, of university labs – they’re apex predators. I mean this is the absurdity now – you’ve got the NIH and Moderna arguing about their proprietary rights – their respective proprietary rights to the Moderna candidate. The governments funded that development so the NIH wants a stake in the profits. So you’ve got a government agency starting to talk about intellectual property. The upshot is it doesn’t matter what arrangements those two entities come to, the fact is that both the US government and Moderna will continue to support the patent system. And the UK will do exactly the same thing with the Oxford candidate and AstraZeneca.

MIC CAVAZZINI:               And as in the example of the COVID Technology Access Pool, their threats to walk away from research if intellectual property is wound back, that’s a hollow threat given how conversative they already are in terms of basic research.

PETER HILL:        I think you’re right, and yet is there an appetite within government to actually make up that gap? And part of it I think is how we conceptualise the risk of investment in the latter part of pharmaceutical development. The funding of the pure science is in a sense more abstract. The successful outcomes are the beginning of the phase II, phase III trials. And there’s a sense in which that can be justified relatively easy to a public. But to take punts on returns that may give you a 5% return on your investment- for governments there is a great disincentive if the negative risk, if the risk of loss are high for where we concentrate our funds.

I mean what would be interesting is to look at countries like China where those latter stages of development are now linked intrinsically to the state where the divides – I’m not suggesting that there’s not a degree of capitalisation functioning within that, but where there is a complicity. Because that’s the one place where a different kind of model might be currently operating.

OWAIN WILLIAMS:         Yeah, I think Peter’s right. But the other thing, there’s this holy cow syndrome as well with patents. Everybody thinks that somehow COVID’s going to prove exceptional and just because we – we need to produce this to huge volumes. We need six or seven billion doses, maybe times two, every year. So it’s going to have to be licensed – yes, that’s all true – but are they going to give up those patent claims and proprietary rights? Now my cynical answer is no, that’s not going to happen. You know, there’s a sense of the liminal and the tipping point about COVID, and if you give your backing to the Costa Rica plan, how do you get out of that in the future? How do you justify when the next pandemic or the next killer disease occurs? How do you say, “We’re not doing that again”? There’s no going back. And I think there’s so much invested in this patent system and in this oligopoly that to defect from it is almost unthinkable.

MIC CAVAZZINI:               This trope of the plucky and innovative private sector is always paired with the idea that government spending is by contrast boring and wasteful and stifling. A good example is British Prime Minister David Cameron announcing in 2001 that he was "taking on the enemies of enterprise”, and pointing his finger at civil servants and so on.  But it’s funny that actually – again research from Professor Mazzucato and her collaborator William Lazonick showed that between 2007 and 2016 the top listed 19 pharmaceutical companies spent almost $300 billion USD buying back their own shares, just to boost stock prices. Pfizer alone dropped $139 billion down this well in 2011. So what it spent on paying out dividends and share buybacks was almost equivalent to its total R&D expenditure. So that sort of reframes who the enemies of enterprise are or the motivation – the perverse motivation of the financialised system that they work in.

OWAIN WILLIAMS:         Quite. And then there’s also research out there about their marketing spend especially in the US. Some projections by admittedly very hostile critics of pharma is the marketing spends bigger than the R&D spend. Now I don’t think that’s true, but you add a substantial marketing budget and a routine kind of glad handing of the medical professional – you know, golfing holidays, conferences, mugs and so on, and all of that circus. And all of this is peripheral to R&D and science. It’s clear that there’s a hugely, in scientific terms, wasteful kind of circus surrounding pharmaceutical companies and markets.

MIC CAVAZZINI:               So what’s the solution? In your recent editorial with Susan Sell you described intellectual property as a “fictitious commodity” conjured up by a financialised capitalism. What do you mean by that and what’s the alternative to it?

OWAIN WILLIAMS:         Fictitious commodities is something that the political economist Polanyi came up with to describe how capitalism, late capitalism makes money out of commodities that aren’t really real. So derivatives and patents are part of that, they’re a legal and state construct and they guarantee profits from monopoly rights, legally. Now we can choose politically and legally to dilute them or we can choose to widen the basis of exceptions, or we can just get rid of them. Now my preference here in terms of being a bit more philosophical and radical is this is a failing innovation system, clearly, in terms of health.

MIC CAVAZZINI:               But TRIPS doesn’t just protect pharmaceutical patents, it also protects copyright on books and music and –

OWAIN WILLIAMS:         That’s correct.

MIC CAVAZZINI:               – without being facetious here, do you make a distinction though between the intellectual property on drug research and the copyright that an artist has on their work. We’re rightly outraged when big fashion labels copy designs from independent designers, so here it’s –

OWAIN WILLIAMS:         Well I’m not really. But I think of all the family of intellectual property, I think copyright is probably the most defensible.

MIC CAVAZZINI:               So there is a distinction. There’s a –

OWAIN WILLIAMS:         Yeah, I mean you don’t want to write your book for ten years, write your first novel, and then somebody is pumping it out on a press in Brisbane and you get nothing back from that effort. Now that’s clearly a different case than Pfizer buying up a firm which has a promising ovarian cancer treatment.

MIC CAVAZZINI:               But intellectually what’s the difference? I mean you could – intellectually the difference is that the drug is a public good but –

OWAIN WILLIAMS:         I think the question you were asking, really underlying this, is if we don’t have patents how do we innovate?

MIC CAVAZZINI:               Essentially.

OWAIN WILLIAMS:         But you know, that’s a different set of circumstances from generating a system that is skewing drug production. So patent thickets, neglected and missing markets in health – they’re all skewing the innovation system. So it’s not working – if you’ve got a neglected disease or rare or orphan disease the patent system and the current innovation system is not working for you. If you’re in a country where Ebola is endemic the patent system’s not working for you, and hasn’t worked for you. Historically, if you had a coronavirus it hasn’t worked for you, which is why we’re in the hole that we’re in.

MIC CAVAZZINI:               There was a similar article by a journalist Vanessa Bee and I guess she wears her heart on her sleeve because the essay is titled, “Would we already have a COVID-19 vaccine under socialism?”

OWAIN WILLIAMS:         Yeah, I’ve read it.

MIC CAVAZZINI:               She points – yeah, she interviews this guy from the Texas Children’s Hospital’s Center for Vaccine Development that had been working on a SARS vaccine for years and just needed another $3 million to take it to clinical trials. In February, so after COVID had already broken out, he approached a number of investors telling them that it could provide a head start on COVID-19 but the response was, “We’re waiting to see if this will be a seasonal thing that will keep …”.

OWAIN WILLIAMS:         It’s the same at the University of Queensland. They had worked on a SARS vaccine, a coronavirus vaccine, only to have the money pulled.

MIC CAVAZZINI:               Just a quick correction here- it was a research group at Flinders University that in 2010 had funding from the US National Institutes of Health discontinued. They now have approval for phase II trials of a SARS-COV2 vaccine, but are still looking for the necessary funding.

You know, it’s not – this isn’t just market failure is it? The whole story’s political and market failure. Just blaming these pharmaceutical corporations is clearly insufficient.

MIC CAVAZZINI:               And I guess actually that brings to mind when I was pressing you on the difference between intellectual property of medicines versus books and so on, the difference here is that the penalty for not having acted on that perhaps speculative research and development is now in the trillions of dollars on top of the human cost.

OWAIN WILLIAMS:         Yes. You know, there’s a famous hockey stick curve, inverse hockey stick, about preventative health, is that there’s an initial cost spike as you invest to eliminate or to vaccinate or prevent or whatever your bag is. And then the long handle of the hockey stick trails away. So costs go down because of that initial investment. So a disease burden maps on to it – that’s public health.

You know, Australia dodged a bullet with COVID. Public health was gutted in 2012, absolutely gutted. The fact that we got away with this is just remarkable. The UK did the same – cut public health to ribbons. And all of this vaccine circus is one thing, but there’s other forms of prevention as well and we haven’t invested in them. We’ve left it all to the market. So what do we do to introduce both pull and push mechanisms to secure new systems of innovation? The literature has been there for a long time – we need to increase the amount of activity that goes on in the public domain. Let’s also think about how we reward innovation undertaken by market means.

MIC CAVAZZINI:               So do you think it requires more than just reducing the TRIPS protections from 20 years to 5 or 10 years?

OWAIN WILLIAMS:         Well that would be a good start – that would be a good start.

MIC CAVAZZINI:               So you could imagine that the IP starts with the government as the early investor and then they might grant licences out to manufacturers based on their targeted goal, we’re going to provide.

OWAIN WILLIAMS:         Well that would be the public route. The market route – in the market route what you need to do is delink innovation from the eventual price. So there’s all sorts of mechanisms that you can introduce for that. Prize funds, health impact funds. Does your drug work, how many people does it serve? Let’s calibrate the reward according to its health impact.

MIC CAVAZZINI:               And some countries have stepped up. In Germany the cancer drug imatinib costs about 60% of what it does in the US. And they have a law – the Act on the Reform of the Market for Medical Products, or if you prefer Arzneimittelmarkt-Neuordnungsgesetz

PETER HILL:        That’s what I prefer.

MIC CAVAZZINI:               – which requires that new drugs be priced on their efficacy relative to existing ones. So that where no additional benefit is found, companies can’t charge any additional price. And even where the new drug is better the extra costs are negotiated with what the public and private insurers are prepared to cover, such as that the patient is no worse off.

OWAIN WILLIAMS:         There’s all sorts of stuff going on now. The Italian move is fantastic – transparency from brass tacks. Where are your sources of money? How is it being financed? And what does that cost you to get this drug out of the factory door? And you be transparent about it. OK, let’s work out a deal where that’s cost you $500,000 AUD or a billion AUD, you’re reward for that is a multiple of five. Off you go – off you go. And you’re not allowed any secondary patent of that and that patent only covers you for high income countries. In some ways the game, despite their influence, they are under the cosh presently, and it’s not just COVID. At the same time there’s downward cost pressures in health.

MIC CAVAZZINI:               You edited a special issue of the Review of International Political Economy in which there was a great article by Professors Shadlen, Sampat and Kapczynski who – they’re are all Professors in the law and economics of health. They do make the point that the ratio of R&D costs to returns is higher in the pharma industry than in most other industries. For a start it’s a lot of work to get translational research into clinical settings and even then it’s expensive to run trials. I was told at the Glaxo labs in the UK that only 1 in 20 candidates ever makes it to the market. So you wouldn’t argue with any of these premises would you?

OWAIN WILLIAMS:         Not particularly. I mean the attrition for all – as you say, the attrition for vaccines and drugs is really high. Drug production is costly, nobody challenges that. It’s an extraordinarily costly process, and risky process. But the costs are routinely exaggerated.

MIC CAVAZZINI:               Well I read about imatinib in an editorial in the journal Blood by the experts in Chronic Myeloid Leukemia consensus group. And they wrote that the total cost for bringing a new cancer drug to market is at most $1 billion US and in some cases it may even be a tenth of that. Whereas in 2012 alone imatinib brought $4.7 billion to Novartis which accounted for 10% of its revenue. So that puts paid to the idea that companies need 20-year patents and then then –

OWAIN WILLIAMS:         Yeah. I don’t think we need to worry about big pharma taking a hit. The billion dollar is a very contested figure. Now these firms are hardly ever out of the top 20 Fortune 500 companies, and that’s quite remarkable. And I think some element of sense and reality in an area which is ostensibly about welfare goods – not private goods, welfare goods for health – it really does genuinely make me boil with anger. And the fact that we publicly can put people on the moon but we can’t think how to develop drugs publicly is again, it doesn’t bear any critical scrutiny.

PETER HILL:        It’s interesting that Owain uses the example of space travel being entirely publicly funded, and yet now privately funded space travel on the back of that may well commercialise space in ways that we haven’t anticipated. And my anxiety is even with the best of collaborative public endeavour we still face the possibility that the commercial drivers and the national drivers will see a very distorted response if we are successful in getting the right vaccine identified.

MIC CAVAZZINI:               For more on this theme I highly recommend the Citation Needed podcast. Episode 110 sowed the seeds for some of my story, but every episode is provocative. I also want to share one final observation described in Nature Reviews Drug Discovery. In the 1950s the rate of new drugs approved by the FDA per billion US dollars invested was over 50. These days that figure has dropped below one, despite all the advances in technology and computing. Some of this is due to more cautious safety and quality regulation and the expectation of ever more targeted drugs. But the short termism of corporate pharma, and the many barriers to sharing of information also play a big part.

Even Isaac Newtown acknowledged that he had stood on the shoulders of giants, and he probably would have recognised the role of serendipity too. It’s been estimated that at a quarter of all drugs in use in 2012 were discovered by accident and for chaemotherapies it could be over a third. A conservative approach to early stage research too will reduce the likelihood of such finds.

Let me use this theme of chance and foresight as a tenuous segue to the second part of this episode. This comes from Associate Professor Adam Kamradt-Scott who we heard from in Episode 63 discussing the performance of the World Health Organisation during the unfolding of the COVID pandemic.

To assess whether the global community is up to the task of protecting public health in future, we have to consider whether COVID-19 really is as exceptional as some have made out. With a death toll of over a million people out of about 40 million known cases, this gives a case fatality rate of 2.5 percent, say.

Compare this to SARS, which had a case fatality rate close to 15% from about 8100 cases. The middle-east respiratory virus was even more lethal with a CFR of 34% but infected only around 2500 people. A factor in the low transmission rates of these earlier coronaviruses is that people were already very sick by the time they were contagious. As a result
they’d be at home or in a hospital bed and it’s family members and health workers and who were most at risk of infection. But many people infected with SARS-CoV2 have minimal symptoms so they continue to wander around town shedding virus unsuspectingly.

So the two parameters of severity and transmission rate are to some extent inversely correlated, and the atypical flus of recent years show how great a range they can span. Swine flu is estimated to have been transmitted to a fifth of the world’s population and is now endemic, although it only causes death in 0.1 percent of cases. At the other extreme, the H5N1 avian influenza of 2004 had a terrifying case fatality rate of 60% from the 650 people infected over ten years.

The real question is whether a future mutant influenza or coronavirus will find a more catastrophic “sweet spot” of transmissibility and deadliness. And whether we will be any better prepared.

Adam Kamradt-Scott was involved in a couple of simulations in 2006 and 2008 to see how Australia’s health sector and government coordination would respond to a flu pandemic. One weakness that he has noted is that the Commonwealth Serum Laboratories were actually privatised 25 years ago. Not only does it now cost the government more to buy the seasonal flu vaccine, but it can lead to some conflicts of interest. 2009 saw a particularly bad influenza season on top of the swine flu, and vaccine production around the world was at capacity. The United States placed an order with CSL for 36 million doses of the swine flu vaccine and it took some negotiation by the Australian government to guarantee that a portion of these would be kept at home before the US order was filled.

After this interview was recorded our Prime Minister committed
$107 million towards assessing supply chain resilience issues of this nature. Other gaps are also being filled in quickly, but expensively, to resolve the cold-chain transport issues for mRNA vaccines like Pfizer’s, which can’t be manufactured here and degrade quickly at temperatures higher than -70 degrees Celsius.

ADAM KAMRADT-SCOTT:             But of course one of the big challenges that we faced, particularly after the 2009 pandemic, was this phenomenon which is described as pandemic fatigue. And this emerged partly because historically we’ve seen pandemics emerge every couple of decades. In 2005 the spread of H5N1, bird flu, concerned a lot of people. There was a lot of investment then put into strengthening global capacity and response. But then swine flu hit, so it wasn’t bird flu. And everyone after that went, “We’ve been focusing on pandemic preparedness now for solidly 4, 5 years. We’ve had a pandemic – we don’t have to worry about this for another 20 odd years or more.”

You know we’ve seen people not paying attention to developing things like PPE stockpiles. And in fact here in Australia I have it on reasonably good authority that our national medical stockpiles were progressively whittled away. Which left us in the situation that we are in, whereby suddenly we’re finding that we don’t have enough masks, we don’t have enough gloves, we don’t have enough face shields and so forth. Now that should never be allowed to happen ever again. You keep the national medical stockpile turning over so that all of the equipment is still safe and current. And we need to put in place those sorts of systems in the future so that we don’t find ourselves in that sort of situation again.

MIC CAVAZZINI:               Which lessons from those simulations did fall into place effectively during COVID?

ADAM KAMRADT-SCOTT:             Broadly the response has unfolded effectively as anticipated, really. Elements like the National Cabinet basically were an example of what we had already planned, except back in 2008 the mechanism by which the government would coordinate was the Council of Australian Governments. And the only different between COAG and the National Cabinet basically is that it has representation of local government. And even the unfortunate situation with Victoria, again we kind of predicted that this could conceivably happen, and then state governments would respond in particular ways.

And we used to joke about how – so back in 1918 when Spanish flu hit Australia to avoid the risk of anyone travelling from the East Coast to the West Coast and bringing Spanish flu with them, the WA authorities rolled boulders over the train tracks which was the only way that you could get to WA other than boat. And as a result of the Western Australian authorities’ measures the Australian Prime Minister at the time was in Perth and the Prime Minister then had to jump on a ship and sail around the bottom of Australia to get back to Melbourne. So yes, there’s a lot of similarities with the exercise scenario planning that we did in 2008 and what we’re seeing now.

MIC CAVAZZINI:               The coordination between jurisdictions in federal government hasn’t always been perfect. You’ve argued, you’re not the first person to advocate for an Australian Centre for disease control and prevention. Which of these problems could that resolve?

ADAM KAMRADT-SCOTT:             It’s a good question because obviously if you talk to the government and particularly the Department of Health they’ll maintain that actually what we’ve got a virtual CDC and that’s more than sufficient. The reality is though that having a national CDC brings with it a synergy. We probably would be able to much more readily and rapidly develop a definition of hotspots for instance, which would then be – have the weight of the Australian CDC behind it. And one of the benefits that the United States has is that they created the Public Health Commission Corps which is under the Department of Health and Human Services, but they’re a uniformed service. During peacetime they provide healthcare services to the Indian reservation populations. But in a crisis, in an emergency, they are a force of people that can be rapidly mobilised and deployed.

And in Australia obviously that would help right now with COVID, in Victoria. We wouldn’t have to be relying on the Australian Defence Force – we would actually have a civilian based uniformed corps that would be able to go around, do the door knocking and so forth. And there’s that immediately ability –

MIC CAVAZZINI:               With the right expertise.

ADAM KAMRADT-SCOTT:             Yes, absolutely. And obviously, that could be then – that force could be moved and mobilised as necessary. So in the piece that we wrote for the Conversation we sort of made the case that it should be based in Darwin. Not only to help provide that capacity to indigenous communities and rural and remote communities but also by basing it up in Darwin it then is much closer to the region in the event that we need to deploy for a natural disaster or whichever. Which is precisely why the AUSMAT team capability is based up in Darwin now. And it's basically just taking that AUSMAT idea and expanding it. And if we’re genuinely committed to bridging the gap in indigenous healthcare then a CDC or a commission core public health workforce would be one mechanism by which we could pursue that.

MIC CAVAZZINI:               You referred to that 2018 enquiry into preparedness. It resulted in a reported titled, “Diseases have no borders”. That’s consistent with the core capacities of the IHL we’ve talked about. The only one of the 15 recommendations of the report that was firmly rejected by the Department of Health, was the request to simply assess the case for an Australian CDC. It was argued that a national framework is a better option and that it doesn’t confuse the responsibilities of state and federal governments. And yet confusion is exactly what we’ve seen now.

I mean the Border Force and NSW Health have been blaming each other for the Ruby Princess debacle. Bizarrely Peter Dutton and Scott Morrison have both encouraged people to disregard state border closures without any sense of irony at all from these champions of border protection. But could an Australian CDC have nationwide jurisdiction to make those kind of decisions?

ADAM KAMRADT-SCOTT:             So we would need new legislation to give the CDC that sort of authority and power. But again, because one of the big advantages that Australia has over many other federalised countries in the world is our Quarantine Act 1908. There was some really forward thinking back then about the need for a national coordinated response. That capacity segues nicely into what we already have with the Australian health principles protection committee structures that sort of feed up. But the CDC and that public health core would be the workforce to make it all happen. To my mind it’s a pretty straightforward case.

MIC CAVAZZINI:               It all fits together.

ADAM KAMRADT-SCOTT:             Yeah. But understandably the politics around this has been what has stymied it for so many years. I mean again, one in a long line of people who have advocated for a CDC, the medical community and the Australian Public Health Association of Australia. They’re all to be congratulated for it but we still haven’t been able to get our political leadership to listen to us.

MIC CAVAZZINI:               That was Adam Kamradt-Scott ending this episode of Pomegranate Health. Thanks also to Peter Hill, Owain Williams and Deborah Gleeson for their contributions. The views expressed in this podcast do not necessarily represent those of the Royal Australasian College of Physicians. 

There is heaps more from these academics at the previous two episodes. You can subscribe to Pomegranate Health through Apple Podcasts, Spotify, Stitcher, Pocket casts or any one of the many apps out there. Or listen directly at our website racp.edu.au/podcast.

That’s also where I’ve credited the Fellows who help me edit each episode, and the musical composers that add so much to the production. You’ll also find lots more reading material, which all goes towards your CPD education. There’s a link to logging your credits at the website.

Please email an feedback and ideas to podcast@racp.edu.au or keep the conversation going at the Comments section for each episode. I’m Mic Cavazzini. I hope to hear from you

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28 Nov 2020
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