Scathing review of the TGA

“DRUG REGULATOR FOR HIRE” –  SCATHING REVIEW OF THE TGA CONTAINED IN NEW UK REPORT ON WORLD REGULATORY BODIES

Last month, the British Medical Journal (BMJ) published its findings on the funding, transparency and decision-making processes of six of the world’s leading regulators, including Canada, Europe, Japan, the UK, the US and Australia.

The report gives a scathing review of the TGA, Australia’s national pharmaceuticals and medical devices regulator.

According to BMJ’s investigation, the TGA is riddled with ‘Conflicts of Interest’ as a result of its overwhelming reliance on ‘industry monies’.

Nearly 100% of the TGA’s $170m Budget in 2021, the report found, comes from the pharmaceutical industry’s “user fees” – a level regarded as “unacceptable” by experts.

US Drug regulation Expert, Donald W Light commented that:

“Like the FDA, the TGA was founded to be an independent institute.  However, being largely funded by fees from companies whose products it is charged to evaluate is a FUNDAMENTAL CONFLICT OF INTEREST AND A PRIME EXAMPLE OF INSTITUTIONAL CORRUPTION.”

“It’s the opposite of having a trustworthy organisation independently and rigorously assessing medicines” he continued.

“THEY’RE NOT RIGOROUS, THEY’RE NOT INDEPENDENT, THEY ARE SELECTIVE AND THEY WITHHOLD DATA.”

Ouch!

The TGA also copped a serve for the blanket of secrecy it imposes on the Conflict of Interest declarations made by members of its Advisory Committee on Vaccines.

Forced to lodge a FOI request to try and obtain the information, researchers received a heavily redacted document from TGA with all names and declaration details blacked out.

When challenged, the TGA said COI declarations are “personal information” and therefore exempt from FOI.

The researchers then contacted members directly, asking if they would be willing to make a ‘voluntary’ disclosure of their declarations, but received no response.

Also heavily criticised was TGA’s practice of granting approvals without reference to the original patient trial datasets.

TGA, the report said, prefers to rely on “the Summary information provided by the vaccine manufacturer”.

Something which may explain the staggeringly high number of approvals the TGA hands out – 9 out of every 10 applications received in 2021 were approved by the agency.

According to Canada’s regulatory expert, Joel Lexchin:

“The TGA should not be relying on the analysis of that data produced by the drug companies.  Rather the TGA should be re-analysing the source data”.

It should also be “holding public hearings before new drugs are approved so that it can hear from members of the public and outside scientists”.

Overall, the authors said they “found that industry money permeates the globe’s leading regulators, raising questions about their independence, especially in the wake of a string of drug and device scandals”.

https://www.bmj.com/content/377/bmj.o1538 – Warning – Fee payable to access full report.