‘Enough is enough’: Medical organisations throw support behind TGA

Twenty-eight leading health and medical organisations and more than 60 clinicians and scientists have declared that they ‘stand beside Australia’s key medicines regulator’ in a statement of support published on the Public Health Association Australia’s (PHAA) website.
 
‘Recent report of threats, intimidation and harassment aimed at TGA [Therapeutic Goods Administration] leadership and staff are a reason for serious concern and is an unacceptable development,’ the statement reads.
 
‘We express full support for the vital work the TGA does to assess and regulate new medicines and vaccines.
 
‘The TGA has a strong reputation for being expert, independent and rigorous in its assessments of new products, and is similarly rigorous in its assessment of the safety of vaccines, so as to improve and protect the health of all Australians.’
 
The statement goes on to highlight the TGA’s role ‘to challenge, and where necessary, prosecute’ those who seek to mislead the Australian public about important health information in pursuit of their own interests.
 
‘This role is particularly important in the current global health crisis,’ it reads.
 
The backing of the TGA follows a government briefing on Thursday, during which the regulator’s national manager Professor John Skerritt revealed to those involved in the pandemic response that the agency and its staff have been the targets of harassment.
 
PHAA CEO Adjunct Professor Terry Slevin told newsGP that many of the representatives at the meeting, including the RACGP’s Dr Karen Price, ‘were very quick to sign on’ to show their support.
 
‘By nature, the regulator is always the meat in the sandwich,’ he said.
 
‘There are people in the marketplace who are keen to have their product approved or to make claims about their product, and a regulator has to run an evidence-based eye across that. It has to sometimes do unpopular things, enforcing the rules, pushing back on those who are enthusiastic about their products, and sometimes their supporters.
 
‘But this is a different level.’
 
As well as the TGA being subject to threats through social media, individual staff have also reportedly been targeted. Personal phone numbers have been made public across various networks, with people being encouraged to call and express their anger and support for particular campaigns and drugs.
 
‘Some of it is particularly nasty and threatening behaviour,’ Adjunct Professor Slevin said.
 
Earlier this month, the regulator came under attack after acting on the advice of the Advisory Committee for Medicines Scheduling, and placing new restrictions on GPs prescribing oral ivermectin.
 
Last week, on 15 September, the TGA also issued a statement that its lawyers had written to Federal MP Craig Kelly demanding his party stop distributing incomplete extracts of adverse event reports relating to COVID-19 vaccines amid concerns it ‘could be seriously misleading’ the public.
 
Adjunct Professor Slevin said the regulator’s role could not be underestimated, particularly during the pandemic.
 
‘They’re working extraordinary hours,’ he said.
 
‘[It is] an extraordinary challenge in doing the ongoing assessments of medicines and vaccines, as well as the normal workload of other products coming out into the marketplace for assessment.
 
‘They’re drawing upon evidence from the northern hemisphere and are often having to participate in meetings well outside of normal business hours in Australia.
 
‘So for them to hear that the people in the health and medical research world – senior clinicians and leading organisations who do give regard and respect to evidence and science – are standing beside them, I think, is certainly valuable.’
 
But beyond that, Adjunct Professor Slevin said he hopes it sends a message to people inciting violence against the TGA that ‘it is not acceptable behaviour’.
 
‘The supporters of this statement felt it was time to draw a line in the sand and say, “enough is enough”,’ he said.
 
‘This isn’t acceptable practice and mounting these kinds of campaigns should be treated with the derision that it deserves.’
 
The PHAA’s statement says it is imperative for the TGA to continue to be an independent, diligent, evidence driven, and responsible medicines regulator ‘focused on serving the health interest of Australians’.
 
‘Individuals and/or organisations with vested interests must not be allowed to undermine or derail their vitally important work,’ it reads.
 
‘Now is a time when Australians must have confidence in the assessments and recommendations of the TGA, and we believe Australians’ trust in the TGA is well placed.’
 
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