It was a short statement from the US president on Tuesday. But Prof Paul Kelly says Donald Trump’s advice that pregnant women shouldn’t take paracetamol based on unfounded links to rising rates of autism was “thrown out there like a bomb” that health professionals were left to defuse.
Kelly, who retired last year as Australia’s chief medical officer, says: “How many experts have had to spend time thinking about that and coming up with counter arguments?”
The misinformation is especially worrying considering the US has traditionally been seen as a “beacon for evidence-based guidance in public health”, says Prof Sharon Lewin, the director of the Peter Doherty Institute for Infection and Immunity.
Australia has for so long looked to, and benefited from, three longstanding, well-funded and trusted US institutions that make up its health infrastructure: the Centers for Disease Control (CDC), the Food and Drug Administration (FDA) and the National Institutes of Health (NIH).
But since Trump’s pick of anti-vaccine activist Robert F Kennedy Jr as the US secretary of health and human services in February, these institutions are being hollowed out with budget cuts and mass firings, including the replacement of experienced scientists by those who have no medical or scientific training.
“The foxes are really in the hen house at the moment,” Kelly says. “This is an anti-science, anti-expert crusade, which is happening from the current administration … that has ongoing effects throughout the world, including here in Australia.”
So how does Australia rely on these institutions and what will we do without them?
Will it affect our access to medicines?
The FDA plays a crucial role in the approval of many drugs that we use in Australia, and “an FDA that’s not functioning is a big risk for our access to the latest and most effective medicine”, Lewin says.
For drugs to come to market, they have to be approved by an initial regulatory body. It takes a lot of work to approve a brand new drug, requiring a level of sophistication and speed that the FDA has had the resources to commit to, she says.
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The second-line approval is what is given in each individual country, Lewin explains. In Australia, the Therapeutic Goods Administration goes through its own approval processes for each medicine entering the market.
But “getting an initial drug to market most commonly goes through the US FDA”.
What about the research the US produces?
There could be fewer innovations coming through the pipeline for approval, as the NIH – the largest public funder of biomedical research in the world – is facing the threat of its budget being dramatically cut.
In May the White House proposed reducing its budget by roughly 40%, but both chambers of Congress have pushed back against the measure as they are tasked with finalising the budget ahead of the new fiscal year in October.
NIH’s research has led to “much of what we have today in modern medicine” when it comes to the development of medicines, therapeutic goods and new methods of clinical practice, Kelly says. That includes “pretty much every vaccine that’s been developed in the last 50 years”.
Dr Tony Gill, the president of the faculty of public health medicine within the Royal Australasian College of Physicians, says the Covid mRNA vaccines were a “classic example” where the new technology had been around before the pandemic but it was the large injection of funds from the US that allowed the research to progress so rapidly and have a significant effect on the control of the virus.
Australians have not only benefited from the innovations funded by the NIH, but our decision makers have also referenced its enormous peer-reviewed research in forming health policies, programs and guidance, Kelly says.
However, those reports are now being changed in insidious ways, such as not being able to mention the word “diverse”, even when it is the standard way of talking about something that has nothing to do with gender or racial diversity, Kelly says.
Any cuts in the budget of the NIH, as well as the disruption of its grants, will be hard to quantify, Kelly says. While “we won’t notice it, probably, immediately, the various pipelines for the development of medicines, therapeutic goods and other health things are essentially stopped now”.
“It will take decades to fix what’s happened in the last nine months, if indeed it ever is,” he says. Kelly believes China will step in to fill the gap, as in the last 20 years it has invested in its research infrastructure and universities.
Will Australia need to step up?
Many of the NIH’s grants have already been cut, Lewin says, for reasons such as diversity, equity and inclusion, focusing on issues such as HIV and transgender women, because of policies against particular institutions.
The NIH in May also cut all money to partners overseas, including many grants given to Australians like Lewin, whose research into curing HIV has been funded by the US for close to 15 years.
But a new mechanism the NIH announced last week for funding foreign research has left Lewin “optimistic” she will be able to continue her work with her international collaborators. However, she acknowledges it is an environment where everything is constantly “changing very quickly”.
Kennedy halted $500m in mRNA vaccine research in August – a move that an editorial in Nature called “the highest irresponsibility” for a technology that had already played a key part in saving millions of lives during the pandemic, and is showing potential for treating cancers, autoimmune diseases and inherited conditions.
Terry Slevin, the CEO of the Public Health Association of Australia, says domestic investments like the mRNA manufacturing capability in Victoria will become even more important so Australia can be self-reliant, as will engagements with south-east Asia and other countries besides the US.
Lewin says the situation could become an opportunity for Australia to recruit scientists who want to leave the US, as “Australia will need to step up if we don’t have the brilliant science coming out of the US, particularly in the areas of infectious diseases”.
Do we have our own CDC?
During Kelly’s tenure as Australia’s chief medical officer he says he often went to the CDC website for advice because it was an important and transparent source of information.
With an 80-year history, the CDC was able to respond to the Covid pandemic by relying on the infrastructure it had already built through prior investments in HIV, TB, antimicrobial resistance, enteric diseases, and global immunisation and influenza programs.
The CDC has been “an important means of ensuring that there is a genuine international standard – and it’s a high standard – when it comes to developing approaches and responses to public health crises,” Slevin says.
Kelly describes the US CDC as the model for similar organisations popping up around the world, including in Australia. Australia’s Centre for Disease Control, set to become operational in January, will provide analysis and advice on public health risks to governments, as well as coordinate action to prepare for, and respond to, these risks.
Gill says “what has been seen and said by others to be political interference into the work of the [US] CDC” reinforces the need for the new Australian CDC “to ensure that we can have independent, sovereign, evidence-based advice to government”.
Slevin agrees the timing of Australia establishing its own CDC and “standing on our own two feet” is even more urgent so that we become less reliant on other countries.
Australia could also be more vulnerable to the spread of infectious diseases as result of the US’s administrations cuts to its CDC’s overseas work – which in the past has helped control outbreaks like Ebola – as well as its overseas development arm, USAID, delivering programs around vaccination for children and sexual health.
“So we are all at risk,” Kelly says.
