Why can’t Australia make mRNA vaccines? Because we don’t make enough ‘deep technology’ companies

Pfizer/AP

Julian Waters-Lynch, RMIT UniversityCaught out by its strategy to bet on COVID-19 vaccines that could be made in Australia, the federal government is now scrambling to manufacture mRNA vaccines locally.

Its “approach to market” strategy has effectively asked companies how much government money they need to do so. But even with subsidies, this plan will take years.

So why can’t Australia make the mRNA vaccines?

That’s not actually the right question to ask. The crucial issue is why Australia hasn’t been producing the type of companies that can make mRNA vaccines. Why don’t we produce more start-ups like BioNTech or Moderna – the two companies that developed and brought the mRNA vaccines to market?

Answering this question is important not just to vaccines but to the whole range of “deep technologies” that will shape economic development and sustainability in the 21st century.

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Australia may miss out on several COVID vaccines if it can’t make mRNA ones locally

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What is deep technology

Technology is generally defined as the application of new knowledge for practical purposes. Deep technology is slightly different. It refers to the type of organisation required to bring certain types of technological innovation to fruition.

It is more accurate to talk about deep technology ventures. BioNTech and Moderna are two such examples. Both are relatively young companies — BioNTech was founded in Germany in 2008, Moderna in the US in 2010 — that have brought to market a technological solution underpinned by substantive advances in scientific research, engineering and design.

Deep-tech ventures span advanced materials, artificial intelligence, biotechnology, blockchains, robotics and quantum computing. A few are now household names, such as Tesla and SpaceX, but most fly under the radar of public awareness, as Moderna and BioNTech did before the pandemic.

They include synthetic biology companies such as the Ginkgo Bioworks and Zymergen, which can program organisms to create completely new biologically based materials for use in manufacturing. These “biofoundries” can produce everything from biodegradable plastics, new protein-based foods to probiotic microorganims that improve human health.

There are advanced engineering companies such as Carbon Engineering and Climeworks, working on ways to suck carbon dioxide from the air to use for industrial purposes.

There are experimental energy companies such as Commonwealth Fusion Systems and Helion, which are working on making the holy grail of clean energy technology, nuclear fusion, a reality.

Australia’s problem with deep tech

Australia’s problem with deep technology ventures isn’t to do with the quality of our science and research. We produce, per capita, nearly twice as many scientific research papers as the OECD average.

We also have some great support structures, such as the CSIRO, the national research and science agency, and Cicada Innovations, the deep-tech venture incubator in Sydney.

The problem is our inability to take our scientists’ knowledge and turn it into innovative ventures. Other countries are much more successful at this. Britain, Germany and France, for example, all publish fewer research papers than Australia per capita but produce far more patent applications — a key indicator of potential research commercialisation. The US produces nine times as many per capita.

The ‘valley of death’

Australia’s primary challenges here are related to the culture of innovation and entrepreneurship and our current mechanisms for long-term venture funding.

Deep-tech ventures usually require longer time horizons to translate new scientific insights into commercially successful products. Few universities are set up to see this process through. Public funding mechanisms prioritise basic research leading to publications, not the entrepreneurial processes required to find a market fit for a new product or solution.

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Nor are venture capital funds — the normal providers of seed funding — well placed to fund deep technology ventures. This is partly because the science itself can be difficult to understand. Also many funds prioritise ventures that can “exit” through an acquisition or public offering within 10 years.

The complex science and length of time needed to commercialise deep tech mean many good ideas die in the so-called “valley of death” — the gap between initial seed funding and sustainable revenue generated from product sales. This gap is filled in some countries by investments from sovereign wealth funds, more “mission” oriented government programs and even prizes. Australia has yet to emulate these solutions.

These issues help explain why Australia’s investment in R&D as a portion of GDP over the past decade has declined, from a peak of 2.3% in 2008 to 1.8% in 2019. That puts us below the OECD average (2.47% in 2019), well behind innovation leaders such as Israel (4.9%), South Korea (4.6%) and Taiwan (3.5%).

In 2020 only 12 Australian companies were listed among the world’s top 2,500 R&D leaders (as ranked by EU Industrial R&D Investment Scoreboard). This compares with Taiwan (88), South Korea (59) Switzerland (58), Canada (30) and Israel (22).

What can we do about it?

Australia’s future economic prosperity depends on our ability to translate scientific advances into innovation and entrepreneurship. Technological innovation is the only driver of economic growth over the long term. MIT professor Robert Solow won the 1987 Nobel Prize in Economics for his work demonstrating this point.

To correct our trajectory requires more “patient” capital. We are one of the world’s wealthiest nations on a per capita basis, but too much wealth is locked up in property ($8 trillion) and superannuation funds ($3.8 trillion) opting for “safer” investments.

If just 0.1% of superannuation assets were allocated to fund deep technology ventures, Australia would have a fund about as large as the nation’s entire current venture capital pool invested in the past financial year.

We also need leadership around a shared vision of the benefits of deep technology entrepreneurship. Not enough Australians recognise the importance of science and technology in driving both economic prosperity and addressing global challenges. Some are even suspicious that technology causes more problems than it solves.

But these ventures will be crucial to addressing pressing development and sustainability challenges, including climate change.

Tomorrow’s economy and society will be built with today’s scientific breakthroughs in deep technology ventures.

Julian Waters-Lynch, Lecturer Entrepreneurship, Innovation and Organisational Design, RMIT University

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Creation of the COVID-19 Vaccines

National Cabinet leaves us in the dark about reopening the nation, so we’re left joining the dots

Stephen Duckett, Grattan Institute and Anika Stobart, Grattan InstituteNational Cabinet met on Friday after a week of intensifying debate about the vaccination thresholds in the national plan for reopening the nation.

While expectations for the meeting were high, there was no showdown — at least as far as we know.

The current plan is vague, with words such as “may occur” and only subject to “in principle” agreement.

And the Doherty Institute modelling, which underpins the plan, acts as a fig leaf for the Commonwealth government to hide behind. So the plan has survived to live another day.

Deferring the day of reckoning has papered over the cracks. National Cabinet is holding tight for another week and awaiting further modelling.

A decision to hold tight is likely a compromise between the three factions in the virtual meeting room. But it leaves many questions unanswered.

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We have three factions

1. Commonwealth and NSW

In one faction, you have the Commonwealth and New South Wales, both committed to easing restrictions according to the vaccination thresholds set out in the Doherty report: 70% and 80% of the population aged 16 and over.

Prime Minister Scott Morrison probably wanted to hold firm. After repeated failures to hit his vaccine rollout targets, he cannot afford another change in the plan.

At the same time, NSW Premier Gladys Berejiklian has probably recognised she has lost the fight to control COVID in her state and wants political cover to claim victory. She has already announced the easing of some minor restrictions for fully vaccinated people.

2. Other states handling NSW leaks

In the second faction, you have states such as Queensland and Victoria affected by leaks of COVID cases from NSW.

These states would have wanted the modelling to reassure them their health systems would not be overwhelmed if they started to ease strong public health measures at low vaccination thresholds.

3. COVID-zero states

The third faction comprises the COVID-zero states, such as Western Australia, which would be concerned about any heightened risk of COVID leakage from other states.

These states only see downsides from easing restrictions too early, when not enough people are vaccinated. They do not want to throw away the benefits of their hard-won COVID-zero status.

How to broker peace?

To reconcile these conflicting positions, the leaders found peace in process: they decided to seek more information.

They agreed to establish a cross-jurisdictional working group, led by the heads of health departments, to investigate health and hospital system capacity and workforce needs in the next phases of the national plan.

This work will draw on the Doherty modelling, which shows many deaths will occur months after lockdowns end.

The group is due to report back by next week, presumably taking into account rapid advances in our understanding of how Delta might impact our health systems.

The other states will not want to replicate the makeshift responses NSW was forced into — such as triage tents to assess patients — because of escalating hospital admissions.

This process may provide a way out for the Commonwealth. At the moment, states are highlighting the impacts of the Commonwealth’s failures on slow vaccination rollouts. But they could be brought around by a big-enough payment to compensate for the increased pressure reopening could put on their hospital systems.

As former Prime Minister Paul Keating said, “never get between a premier and a bucket of money”.

States will also need more Pfizer doses. At the moment, the lion’s share of the available Pfizer doses is going to NSW, leaving GPs in other states — especially Victoria — scrambling to find doses to meet demand.

Although these side-deals will not mean the states come out ahead, at least, financially, they will not be so far in the red.

How about the Doherty modelling?

As the National Cabinet’s behind-the-scenes negotiations were going on, the Doherty Institute reconfirmed its recommendation of the 70% and 80% (adult population) vaccination thresholds. It continues to undertake further modelling, including specification of public health measures in areas of low vaccination coverage.

While the thresholds may not have changed, further modelling is yet to show how Australia’s rapidly rising COVID-19 case numbers impact the phasing, and the substance, of the plan.

For instance, specific policy measures, such as exempting vaccinated people from restrictions, must be incorporated into the modelling, since vaccinated people can still spread the virus.

What privileges are extended to fully vaccinated people — holders of a validated vaccine passport — will be one of the next big challenges for the states, both politically and in terms of implementation and monitoring.

How does vaccinating 12 to 15-year-olds fit in?

National Cabinet’s meeting took place the same day the Australian Technical Advisory Group on Immunisation (ATAGI) recommended vaccination for 12 to 15-year-olds, to begin on September 13.

But there were no updates to the national plan to include this age group as part of the total population vaccinated. The plan’s targets are still expressed as a proportion of the population aged 16 and over, rather than of the population soon eligible to be vaccinated, those aged 12 and over.

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This means 12 to 15-year-olds are completely missing from the plan. It makes no sense for the nation to track progress towards vaccination targets without including this group.

Any plan to ease restrictions must also consider the impact on children and their education, especially for those under 12, who are not expected to be vaccinated this year.

What next?

While National Cabinet might be holding tight, there is still much work to be done to fill the many gaps in the current plan. We still need a robust national plan all states can sign up to, without hedging or caveats.

Stephen Duckett, Director, Health and Aged Care Program, Grattan Institute and Anika Stobart, Associate, Grattan Institute

This article is republished from The Conversation under a Creative Commons license. Read the original article.

‘Don’t leave the esky in the sun’: how to get cold vaccines to hot, remote, Australia

from www.shutterstock.com

Tobias Speare, Flinders University and Suzanne Belton, Menzies School of Health ResearchThere’s a rush to vaccinate vulnerable remote Aboriginal communities in New South Wales after spread of the coronavirus out of metropolitan areas has led to a state-wide lockdown.

So focus is turning to how quickly we can get COVID-19 vaccines over vast distances, far from vaccine warehouses in the cities, into remote Australians’ arms.

But transporting vaccines to remote Australia isn’t new. Nor are the challenges that must be overcome to keep vaccines at the right temperature on the long and bumpy journey to remote clinics.

Here are some of the practical issues nurses, Aboriginal and Torres Strait Islander health practitioners, community health workers, pharmacists and others face when vaccines are transported vast distances by road, air or on water.

It’s a long way

The vast distances and isolated communities of remote Australia pose significant challenges to transporting vaccines. Then there are the environmental extremes, with freezing winter nights and scorching summer days, plus monsoonal rains and cyclones often interrupting transport services and making regions inaccessible for weeks.

Keeping vaccines at the right temperature over large distances, over days and weeks, can be challenging. But vaccines are temperature-sensitive products, and their effectiveness is dependent on correct storage. If a vaccine is too hot or too cold it may be damaged and not work as well.

So it’s critical to keep vaccines at the right temperature to ensure their safety and efficacy.

For non-COVID vaccines and the AstraZeneca COVID vaccine, the recommended cold chain — between 2℃ and 8℃ — must be maintained from the place of manufacture to administration in the community.

However, transport and storage requirements for the Pfizer COVID vaccine are different. Unopened vials of the vaccine need to be stored and transported at domestic freezer temperatures, between -25℃ and -15℃, for up to two weeks.

Unopened vials may also be stored at domestic refrigerator temperatures, between 2℃ to 8℃, for up to five days. Once a Pfizer vaccine has thawed it should not be re-frozen.

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Keeping vaccines in the recommended temperature range over long distances often means styrofoam boxes and regular eskies are inadequate, particularly when the transit time is likely to be three to four days. Transporting vaccines to remote Australia requires special infrastructure, including dedicated vaccine fridges and insulated containers.

If there’s a cold-chain breach, when vaccines are exposed to temperatures outside the recommended range, the vaccines may become damaged and might need to be thrown away and replaced.

Such breaches are estimated to have cost the Australian health system at least A$25.9 million in replacement vaccines over a five-year period. This estimate is pre-COVID, so the figure is likely higher if we take into account any cold-chain breaches with COVID vaccines.

There is a significant risk of this happening in remote Australia.

All staff need to be aware

All staff involved in the vaccination process, from manufacture to transport to administration, must understand the need to maintain the cold chain and the risks associated with cold chain breaches.

This includes knowing the correct way to pack the vaccines in an insulated container (such as a vaccine cold box, esky or styrofoam box), using temperature monitors, and what to do when there’s a cold-chain breach.

However, there are few training materials dealing with vaccine cold chain in remote Australia. And with high staff turnover, it’s difficult to know everyone in the chain has the right training.

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We made a video

A team at Flinders University collaborated with Irene Nangala — a Pintupi elder and director of Western Desert Nganampa Walytja Palyantjaku Tjutaku Aboriginal Corporation (Purple House), an Aboriginal community controlled organisation in Alice Springs — to make a short educational video called Vaccine Story.

The video depicts the journey a vaccine takes from a supply centre to a remote Australian community in a culturally appropriate manner.

This freely available video is especially useful for non-clinical staff, who may not otherwise receive professional training or updates.

Vaccine Story follows an esky full of vaccines from the city to remote Australia.

Transport is important

The video also looks at the importance of transport in maintaining the cold chain, especially in the “last mile” of vaccine logistics.

For remote Australia, variable and unreliable transport add extra logistical challenges. Freight to remote communities is often limited with infrequent or non-existent services.

So local clinics and supply centres need to be adaptable and resourceful to ensure vaccine supply. The right transport option for one day might not be the best for another. Staff need to ask:

• is there a bus travelling to the community today?
• can the visiting specialist team take the esky with them on the plane?
• can the patient-transport driver pick up the vaccine from the pharmacy?
• how are the roads today?

Each of these options presents new challenges. Non-clinical staff may have to be trained in how to handle vaccines and the importance of maintaining the cold chain.

For example, the esky needs to be safely secured in the car. If it bounces around, the ice bricks may come into direct contact with the vaccines, which can cause them to freeze (the vaccines are generally separated from the ice with packing materials).

Staff will have to consider the temperature in a car, bus, the hull of a plane or on a barge. Vaccines will have to be handed over to the right person, not left on the runway or on the clinic doorstep in the sun.

There must be good lines of communication so everyone knows where the vaccines are.

The electricity’s out

Vaccines need to be stored in dedicated vaccine fridges when they reach the clinic in remote Australia.

However, challenges in maintaining the cold chain don’t stop there. It’s common in remote communities for electricity outages that mean vaccine fridges go off. Clinic staff need to be trained in how to manage these situations.

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It’s a long road

Despite these significant logistical challenges, vaccines have been successfully shipped to remote Australia for years before COVID vaccines became urgently needed.

But with the latest COVID cases in remote NSW, we’re reminded just how different the vaccine cold chain is in the bush compared with the city.

So all eyes are on looking after this precious cargo, including maintaining the cold chain.

Tobias Speare, Lecturer, Pharmacy Academic, Rural and Remote Health NT, Flinders University and Suzanne Belton, Associate professor, Menzies School of Health Research

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Can Australian employers make you get a COVID-19 vaccine? Mostly not — but here’s when they can

Onchira Wongsiri/Shutterstock

Joo-Cheong Tham, The University of MelbourneAustralia’s official policy on vaccines is that they be voluntary and free. But the federal government hasn’t shut the door completely on employers pursuing mandatory policies of their own.

Last week the federal government reiterated it won’t use its powers to give employers a free hand to mandate vaccines. Yet Prime Minister Scott Morrison also said:

Decisions to require COVID-19 vaccinations for employees will be a matter for individual business, taking into account their particular circumstances and their obligations under safety, anti-discrimination and privacy laws.

So far just two Australian companies — regional air carrier Alliance Airlines and canning company SPC — have declared they will make a COVID-19 vaccination mandatory for their workers.

The reason so few have declared such intentions is because the law isn’t on the employer’s side. There are only limited circumstances where workplace vaccine mandates are likely to be found lawful.

Mandatory vaccines are an exception, not the rule

Safe Work Australia, the federal work health and safety regulator, and the Fair Work Ombudsman, the agency responsible for compliance with federal workplace laws, have both made it clear that most employers can’t make you get a vaccine.

Safe Work Australia’s guidance says “most employers will not need to make vaccination mandatory” to meet their workplace, health and safety obligations.

The exceptions are when public health directions require them to do so. Examples are the New South Wales health order requiring specified classes of quarantine facility, transport and airport workers to have had at least one vaccine shot, and the Queensland order that health service employees in residential aged care be fully vaccinated by October 31.

The Fair Work Ombudsman says an employer needs to have a compelling reason before requiring vaccination of workers. Two conditions stand out:

1. Employees must interact with people with an elevated risk of being infected with coronavirus. For example, if they work in hotel quarantine or border control.
2. Employees must have close contact with people who are most vulnerable to the health impacts catching COVID. For example, if they work in aged care.

This second condition aligns with rulings in unfair dismissal cases involving employees refusing influenza vaccinations. In three such cases this year, the Fair Work Commission (Australia’s federal industrial tribunal) said it was reasonable for employers in the aged care and child care sectors to insist on vaccination as a condition of employment.

But overall, the Fair Work Ombudsman said:

In the current circumstances, the overwhelming majority of employers should assume that they can’t require their employees to be vaccinated against coronavirus.

Trampling on worker rights

This legal context could, of course, be changed by the federal parliament amending the Fair Work Act to expressly authorise employer mandates.

Given the composition of the senate, this might prove impossible to achieve. But even if it were possible, there are good reasons to oppose it — even while acknowledging the clear public health benefit of COVID-19 vaccinations.

At stake are fundamental principles of worker rights. In the words of the International Labour Organisation’s 1944 Declaration of Phildelphia, workers have the right to “pursue both their material well-being and their spiritual development in conditions of freedom and dignity”.

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Any decision to limit fundamental rights is best done through accountable public institutions, rather than private entities motivated by commercial considerations.

Public health orders give the community confidence that such decisions have been informed by expert advice, and that different stakeholders have had a chance to be heard (as employer groups and unions have had with the federal vaccine roll-out).

Opening a can of worms

Unions and employer groups largely agree that, in the limited situations where there are workplace vaccine mandates, they should be backed by public health orders.

Business Council of Australia chief executive Jennifer Westacott says vaccination should be “driven as much as possible through public health orders, not left to individual employers”.

Australian Council of Trade Unions secretary Sally McManus says any mandate “has to be based on the advice of health professionals, not just made up by employers, and workers must be consulted, along with their union”.

Consultation does not appear to have been a feature of the announcements by Alliance Airlines or SPC, whose workers reportedly learnt of the company’s decision through the media.

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Other companies may be waiting to see the upshot — whether those policies lead to challenges either through the Fair Work Commission, which arbitrates unfair dismissal claims, or through federal courts for breach of workplace laws.

But most — from big employers such as Wesfarmers and Commonwealth Bank to boutique outfits such as Atlassian — will not be waiting. Their emphasis is on carrots, not sticks, for driving up vaccination rates.

If you find yourself out of step with both the Australian Council of Trade Unions and the Business Council of Australia, it’s a sign you are out on a legal limb, and need to consult an industrial lawyer.

Joo-Cheong Tham, Professor, Melbourne Law School, The University of Melbourne

This article is republished from The Conversation under a Creative Commons license. Read the original article.

COVID vaccines offer the pharma industry a once-in-a-generation opportunity to reset its reputation. But it’s after decades of big profits and scandals

Elsa Olofsson/Unsplash

Ray Moynihan, Bond UniversityJust weeks before the first COVID-19 cases emerged, Gallup published its latest poll on America’s views about business. At the bottom of the list of 25 sectors was the pharmaceutical industry. Below advertising. Below oil and gas. Below the banks.

The pandemic and the new vaccines have of course turned that reputation around, but let’s not forget why the pharmaceutical industry’s credibility sank so low.

Or how the industry got so big. One company, Johnson & Johnson, is currently worth around US$450 billion. About the same as the economy of Norway.

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The birth of the behemoths

The idea of the miraculous potion or cure-all dates back at least as far as Greek mythology. The goddess Panacea even gets a mention in the Hippocratic Oath.

The rise of the modern pharmaceutical industry is more recent, coming through the 19th century. On the eve of the 20th century, the German company Bayer famously launched its early blockbusters, including “Aspirin” and “Heroin.”

Around this time, US drug-makers were arguing for patent protections, or exclusive rights to market a drug for a specific period of time. By the 1950s, they’d won those arguments, and the US soon became the world’s biggest market for medicines.

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In addition to patents, the other special ingredient for success was the right to market pills directly to doctors, and in the US, directly to consumers via television commercials.

At the dawn of the 21st century, in those dark ages before Facebook and Big Tech, pharmaceuticals was among the most profitable industries on the planet.

Wonder drugs, miracle cures

Clearly many medicines extend lives and reduce suffering. And while we need caution with hyperbole, some discoveries are major breakthroughs.

Antibiotics revolutionised the treatment of deadly infections, and gave a boost to science at the same time.

In the 1940s, one of the first-published “randomised controlled trials” was a test of Streptomycin for the treatment of tuberculosis.

Streptomycin inventor Selman Waksman and two associates test the drug.
New Jersey Agriculture Experimental Station at Rutgers University/Wikimedia Commons

In the 1980s, another famous class of wonder drugs was developed, this time to tackle the HIV-AIDS epidemic. The mysterious new virus bringing many people a death sentence would soon become a manageable disease.

And while some cancers remain incurable, others are treated and even prevented with medicines that are simply miraculous.

Extortionate prices, evaded taxes

Yet, in each case, the golden drugs have a dark side. As the World Health Organization notes, overuse of antibiotics helped make antibiotic-resistance “one of the biggest threats to global health”.

Over-pricing and patent protections for HIV medicines put them out of reach of the world’s poorest, and prices only came down after massive global campaigns for greater access.

With cancer, companies have demanded huge prices for products offering sometimes minimal benefits.

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Extortionate prices were feeding drug company mega-profits, and at the same time driving down the industry’s reputation. In a notorious example, the cost of the life-saving Epipen skyrocketed more than 400%, helping make drug prices a big issue in the 2016 US presidential election.

The price of Epipens rose by more than 400%.
Shutterstock

Industry argues high prices fund vital research. Critics say companies can spend more on marketing than research, and their profits sometimes derive from taxpayer-funded science.

To make matters worse, the big pharmaceutical companies are also among the big tax avoiders. A 2015 Senate hearing in Australia heard companies were paying rates as low as one cent in the dollar.

A global report from Oxfam in 2018 concluded the pharmaceutical industry was “cheating countries out of billions in tax revenues”.

Toxic marketing causes harm

The major problem with the drug giants is their unhealthy influence over medical science. The industry dominates research, and there’s strong evidence that company-sponsored studies tend to have a bias which favours the sponsor’s product.

Medical education is also heavily sponsored, with evidence suggesting an association between a doctor accepting just one meal at an “educational event”, and prescribing more of the sponsor’s drugs.

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And the guidelines which can be so influential over a doctor’s prescribing decisions are too often written by medical experts with ties to drug companies.

Central to this marketing effort are these senior medical experts, sometimes called “key opinion leaders”, who claim to be independent yet accept fees for advice, consultancies or “educational” presentations to other doctors.

Just one meal at a sponsored educational event can result in a doctor prescribing more of that company’s drugs.
Shutterstock

A former top-selling drug company sales representative turned whistleblower put it plainly in a 2008 piece in The BMJ:

Key opinion leaders were salespeople for us, and we would routinely measure the return on our investment, by tracking prescriptions before and after their presentations.

If that speaker didn’t make the impact the company was looking for, then you wouldn’t invite them back.

Unhealthy marketing means the latest most expensive pill is too often favoured over older cheaper options, or doing nothing at all, causing much harm and wasting precious resources.

Corporate crime

In 2009 came the biggest health-care fraud settlement in history. Pfizer was forced to fork out a US$2.3 billion fine for illegal promotion, false and misleading claims about drug safety, and paying kickbacks to doctors. That included a US$1.2 billion criminal fine, the largest ever in a US criminal prosecution.

One of the whistleblowers in that case happened to be a member of a special Pfizer sales team promoting Viagra. He revealed doctors were taken to breakfasts, lunches, dinners, Broadway shows, baseball games, golf courses, ski fields, casinos and strip clubs.

In 2013, Johnson & Johnson paid out US$2.2 billion in civil and criminal fines for putting “profit over patients’ health”. The company had illegally promoted powerful anti-psychotic drugs as behaviour control for the elderly and most vulnerable, overstating benefits and playing down dangerous side effects, including stroke.

Drug companies have faced massive fines for putting profits over health.
Shutterstock

Other court documents around the same time exposed how the giant global company Merck used dirty tricks to try and defend its controversial anti-arthritis drug Vioxx. Merck created a fake medical journal and drew up secret lists of academic critics to “neutralise” and “discredit”.

In the end, Vioxx was taken off the market because it was causing heart attacks, with estimates in The Lancet suggesting it may have led to 140,000 cases of serious coronary heart disease.

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Investigation and reform

Scandals like Vioxx tarnished the industry’s image, and brought more intense scrutiny.

The US National Academy of Sciences produced a landmark report arguing the closeness between doctors and drug companies could jeopardise the integrity of science, the objectivity of education, the quality of care, and public trust in medicine.

A series of US congressional hearings on unhealthy marketing produced the Open Payments register, mandated by US law to publicly list every company payment to every doctor.

Many around the world are reforming further, moving from transparency to independence. Italy brought in a special tax on drug company promotion to fund public interest research. Norway doesn’t give doctors full credit anymore for industry-sponsored education.

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Guidelines governing Canadian doctors’ relationships with pharma companies under review

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But there’s a long way to go. A study in 2020 found 80% of the medicos who run the world’s most powerful doctors organisations still take money from drug and device companies. For research, for consultancies, for hospitality.

Even some agencies which assess drugs, notably the US Food and Drug Administration (FDA), still rely on significant funding from industry, which pays to have its products assessed.

And the harmful marketing has continued. Just last month, a group of drug companies, including Johnson & Johnson, agreed to pay a total of US$26 billion for their roles in fuelling the opioid epidemic.

A prescription for trust

One drug company chief reportedly said last year the industry had a “once-in-a-generation opportunity to reset” its reputation.

Given the dark arts that drove pharma’s credibility to rock bottom, its fanciful to imagine the pandemic will magically end the misleading marketing and the price gouging.

Any post-pandemic recovery requires meaningful reform.

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This article is part of a global Conversation series, The business of pharmaceuticals. You can read the other articles here.

Ray Moynihan, Assistant Professor, Bond University

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Coronavirus Update: Australia

Morrison government orders Pfizer ‘boosters’, while hoping new ATAGI advice will warm people to AstraZeneca

Michelle Grattan, University of CanberraWhile still struggling with a current shortage of Pfizer, the Morrison government announced it has secured 85 million doses of that vaccine for future “booster” shots.

This will be made up of 60 million doses in 2022, and 25 million doses in 2023. Delivery will start in the first quarter of next year.

Scott Morrison said on Sunday this was “prudent future proofing”, although there is still not definitive advice on when boosters will be needed.

Meanwhile the Australian Technical Advisory Group on Immunisation (ATAGI) has liberalised its advice on AstraZeneca.

It said in a statement on Saturday all people aged 18 and over in greater Sydney, including those under 60, “should strongly consider getting vaccinated with any available vaccine including COVID-19 Vaccine AstraZeneca”.

This was on the basis of the increasing risk of COVID and “ongoing constraints” of Pfizer, the advice said.

Last week Scott Morrison said the government was constantly appealing to ATAGI to review its advice on AZ according to the balance of risk. Many people have shied away from AZ, supplies of which are plentiful, after ATAGI’s caution about it for younger people because of rare blood clots.

Asked about some general practioners being reluctant to give AZ to people under 40, Morrison said he certainly hoped GPs “would be very mindful of the ATAGI advice”.

ATAGI is presently considering whether children between 12 and 15 years old should be vaccinated against COVID, with the government expecting advice in mid-August.

As the crisis continues in Sydney, on Sunday NSW reported 141 new locally acquired cases and two deaths, including a woman in her 30s. This followed Saturday’s report of 163 new cases in the previous 24 hours.

Victoria on Sunday reported 11 new local cases, and is on track to end its lockdown soon, as is South Australia.

Morrison again stressed the lockdown was the primary weapon in fighting the Sydney outbreak.

“There’s not an easy way to bring these cases down. And it’s the lockdown that does that work. The vaccines can provide some assistance, but they are not going to end this lockdown. What’s going to end this lockdown is it being effective.”

But NSW Premier Gladys Berejiklian, who tried unsuccessfully to get the vaccination program refocused on south west Sydney, the centre of the outbreak, has a different emphasis. “Please know that what will get us through this outbreak is a combination of our restrictions, but also of more people being vaccinated”.

Morrison has refused to alter the focus, saying this would “interrupt the rhythm of the national vaccine program”.

The federal government has found 50,000 extra Pfizer doses for NSW. Asked where these came from, Morrison said: “There are small variations in supply and delivery, which from time to time may ensure that there’s tens of thousands of doses that might be free at any given time.”

Morrison condemned Saturday’s Sydney anti-lockdown demonstration attended by thousands of people, which saw violence, dozens of people charged, and more being pursued where they can be identified.

He said it was not just selfish. “It was also self-defeating. It achieves no purpose. It will not end the lockdown sooner, it will only risk the lockdowns running further,” he said.

Asked about Queensland Nationals MP George Christensen, who attended a rally in Mackay, Morrison said: “As for other parts of the country that aren’t in lockdown, well, there is such a thing as free speech, and I’m not about to be imposing those sorts of restrictions on people’s free speech”.

Christensen said on Facebook, “Civil disobedience eventually becomes the only response to laws that restrict freedom. This is what we’ve seen in Melbourne today.”

Pressed on this, Morrison said: “The comments I made before related to an event that took place in Queensland where there are no lockdowns”.

The Prime Minister told the Liberal National Party state council in a virtual address on Sunday: “After a difficult start, the vaccine program is now making up lost ground, and quickly”.

Michelle Grattan, Professorial Fellow, University of Canberra

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Coronavirus Update: Australia

Is the COVID vaccine rollout the greatest public policy failure in recent Australian history?

Carolyn Holbrook, Deakin University; James Walter, Monash University, and Paul Strangio, Monash UniversityIs the Morrison government’s COVID vaccination rollout program one of Australia’s biggest ever public policy failures?

As COVID-19 infection numbers in locked-down Sydney show little sign of abating and Victoria extends its fifth lockdown, the prospect of life resuming some level of normality appears distant.

In recent weeks, we have learned more about the flaws in the federal Coalition government’s vaccination program. There’s the failure to procure sufficient vaccine and an accompanying over-reliance on the AstraZeneca vaccine.
The complications with rolling out the latter have exposed the shortage of supply of the Pfizer vaccine.

While other international leaders personally lobbied Pfizer executives for supplies, Prime Minister Scott Morrison and Health Minister Greg Hunt were inexplicably passive.

Then there is the sluggish pace of the “it’s not a race” vaccine rollout, particularly among vulnerable people, such as aged and disability care residents, and frontline health workers. Only 13% of Australia’s eligible population (those aged 16 and above) are fully vaccinated, while 35.3% are partially vaccinated. That’s a long way short of the goal of a fully inoculated adult population by October 2021, as initially promised.

Exacerbating these problems has been the lack of an effective public education campaign about the vaccine. This has left a vacuum, which anti-vaxxers and the vaccine-hesitant have filled.

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Read more:
View from The Hill: Morrison and Coalition sink in Newspoll on the back of rollout shambles

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Fallout from a shambolic vaccine rollout

Public confidence in the government’s handling of the vaccine rollout has sharply diminished. The latest Newspoll shows disapproval of the rollout jumping 11 points to 57%.

The policy missteps, which have Australia languishing at the bottom of the OECD for the proportion of its population that is fully vaccinated, have elicited a rising chorus of condemnation.

Some of the criticism comes from usually supportive sources, such as right-wing commentators Janet Albrechtsen and Miranda Divine.

Former Coalition prime minister Malcolm Turnbull claimed recently he couldn’t recall “a more black and white failure of public administration” than the vaccine program. Historian Frank Bongiorno declared the rollout “the worst national public policy failure in modern Australian history”.

Public confidence in the Coalition government and the prime minister has dropped due to the vaccine rollout.
Lukas Coch/AAP

How do we measure public policy failure?

There’s no doubt the Commonwealth government, measured by its inability to reach professed objectives, which are then repeatedly revised, has performed poorly.

Disingenuous attempts by the prime minister and senior ministers to dissimulate, or deflect responsibility to others, have been well canvassed.

But are we ready to conclude that what we are seeing is a near-unprecedented instance of policy failure, especially when there are other pressing public policy issues on which the government has also been found wanting, most noticeably climate change?

There are three principal factors for measuring public policy success or failure.

The first is an assessment of how successfully the policy action ameliorates the problem it seeks to solve. This appraisal must take into account the consequences of that action. Consequences are often unintended and unanticipated. They might not become apparent for some time and can be difficult to quantify and link unequivocally to the policy in question. For example, the Coalition’s inclination to cease support for manufacturing in Australia has led, as is now evident, to our incapacity to meet the demand even for COVID vaccine production.

Second, an assessment of policy success or failure must consider the significance of the policy. That is, the failure of a minor government program has less negative impact than the failure of an economic, social, environmental or public health policy that affects the entire community.

Third, we must take account of the reputational enhancement or damage ensuing from a particular course of action. This may have decisive effects on a government’s electoral prospects.

Applying these measures, we can say that, to date, the Morrison government’s approach to the COVID vaccination rollout fares badly on all three criteria.

On all three measures of policy effectiveness, the vaccine rollout fails.
Mick Tsikas/AAP

The vaccine rollout has failed the tests of public policy success

The problem is not that the proposal – a level of vaccination that will enable the community to “live with” endemic COVID – is misconceived. It is that incompetent planning, logistics and implementation have so far prevented it from sufficiently ameliorating the threat we face.

We can see, from international comparisons, the dimensions of risk while COVID remains insufficiently checked and potentially able to generate more dangerous mutations.

Second, the significance of success or failure in this domain – brought home by recurrent lockdowns – is manifest. There are negative flow-on effects for the entire community, not only in containing the virus, but also with clear impact on the economy, mental health, domestic violence and trust in government.

We are also confronted with counter examples: Seattle, for instance, in dire circumstances not so long ago, is now more or less back to normal because of the swift uptake of vaccination.

Third, the reputational damage to the federal government is evident in a string of public opinion polls that have found a substantial decline in confidence in the Coalition and the prime minister.

… but there is one that is worse

Some other examples help us flesh out the picture. One is a public policy from recent decades that did not achieve its intended purpose: the Rudd government’s Resource Super Profits Tax and its successor negotiated by the Gillard government, the Minerals Resource Rent Tax.

These policies failed on at least two levels. First, they did not reap anything like the revenue that was forecast. Second, the taxes were electorally damaging for the Labor governments, engendering a fierce backlash from the mining industry.

A more significant public policy failure, with consequences that took much longer to become apparent, was the Howard government’s Aged Care Act of 1997. This legislation established the framework for the funding and regulation of the aged care system. Partially privatising the aged care sector, that policy regime is widely recognised as being responsible for the underfunding of the system and associated chronic shortcomings, which the recent royal commission thoroughly documented.

Perhaps the biggest public policy failure of recent times relates to climate action where, as with COVID vaccination, Australia ranks last among developed economies.

This has been a product of the failure of the parties, but in particular of internecine battles within the Coalition and a brutal politics that, as Martin Parkinson argues, brought about “a fracture of the political centre”, rendering it incapable of the negotiation and consensus necessary for resolution.

While the vaccine rollout has been a failure, inaction on climate change represents the biggest policy failure in recent times.
AAP/Department of Defence handout

Indeed, the intractability of climate change as a policy problem suggests that it, rather than the handling of vaccine rollout, is the biggest failure of modern times.

Despite the chaos that has been well documented, the required levels of vaccination can still be achieved, even if belatedly. The situation is potentially capable of resolution, and possibly in time for Seattle-like “normality” to be re-established. Adequate climate action, on the other hand, still appears to be incapable of resolution under this government.

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Read more:
Spot the difference: as world leaders rose to the occasion at the Biden climate summit, Morrison faltered

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But will the Morrison government’s mishandling of the vaccine rollout be politically fatal? Certainly, falling confidence in the rollout is translating into a decline in support for the Coalition. Yet we should be wary of jumping to conclusions.

The prime minister has until next May to hold an election. The government has ample time to play catch-up with the rollout. If further outbreaks are contained and the elusive herd immunity is achieved by then, lockdowns will have become a thing of the past. The relief at being able to move on may obliterate current disquiet.

Further, in normal circumstances, policy virtue is not necessarily synonymous with political success. The last federal election was an indicator of this. The Coalition triumphed despite a threadbare policy program. In other words, policy prowess is only ever one measure of a government’s success.

Carolyn Holbrook, ARC DECRA Fellow at Deakin University, Deakin University; James Walter, Professor of Political Science, Monash University, and Paul Strangio, Professor of Politics, Monash University

This article is republished from The Conversation under a Creative Commons license. Read the original article.