KEN HARVEY. TGA fails to act on Palmer’s hydroxychloroquine advertisements

The recent decision by the Therapeutic Goods Administration (TGA) to drop its investigation into advertisements for hydroxychloroquine splashed over 3 pages of national newspapers by Clive Palmer is the latest example of its regulatory failure.

The reported excuse from the TGA that, ‘The information was assessed as not intended to promote the sale of the product’ is not only wrong but dangerous.

I have asked the TGA to provide an explanation as to why this matter was not pursued.

‘Advertise’ is defined in the Therapeutic Goods Act 1989 as, ‘any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods…’. In addition, prescription medicines are prohibited from being directly advertised to the public.

The following statements were made on the first page of Palmer’s 3-page advertisement, ‘hydroxychloroquine was the best hope for those suffering COVID-19’ and ‘the best treatment for its citizens should the worst occur’ and ‘it was critical that the drug remained available in hospitals for those who needed it to treat COVID-19’.

In my opinion, these unbalanced, misleading and unscientific statements clearly promote the use of this medication.

In addition, the 2nd and 3rd page of Palmer’s advertisement, ‘COVID-19 Response and Action’ rely selectively on a discredited French study, fail to mention negative trials and omit mention of serious adverse events. Current Australian and overseas recommendations do not support the use of hydroxychloroquine for COVID-19.

Until ongoing clinical trials have been peer-reviewed, published and replicated, it is unethical and dangerous to promote the use of this medication. Not only does this create false hope among the public, but it also pressures medical practitioners to prescribe inappropriately.

The TGA has apparently chosen to ignore or misinterpret the long-standing definition of advertising. It appears the TGA thinks it means ‘sale’, which is clearly not in accord with the definition in the Therapeutic Goods Act.

I have alleged that Palmer’s advertisements breach numerous provisions of the Therapeutic Goods Act 1989, and the Therapeutic Goods Advertising Code (No.2) 2018.

I have asked the TGA to explain why it has not conducted a full investigation into this matter and why the penalties available under the law for such advertising have not been instituted (s.21B of the Act).

Disregard of the Palmer advertisement is an encouragement for businesses to game the regulatory framework by expressing harmful information without consequence because the promotional statement does not directly solicit a sale.

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Dr Ken Harvey is a public health physician and consumer advocate with expertise in medicines policy. Dr Harvey currently represents Choice on the Therapeutic Goods Advertising Consultative Council, is President of Friends of Science in Medicine and an Associate Professor in the School of Public Health and Preventive Medicine, Monash University. W: https://www.medreach.com.au/

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11 Responses to KEN HARVEY. TGA fails to act on Palmer’s hydroxychloroquine advertisements

  1. Avatar Tony Pun says:

    I concur with the sentiments of Prof Ken Harvey on lack of action by TGA. However, I do not see big danger in Australia where this drug is not available over the counter for self-medication. GPs are unlikely to prescribe them without due regard for the severe & fatal contraindications or its use under strict guidelines in a hospital settings.

    Chloroquine re-surfaced during covid-19 pandemic as a consideration for treating Coronavirus and Respiratory Distress Syndrome ((https://www.genengnews.com/a-lists/how-to-conquer-coronavirus-top-35-treatments-in-development/). The theoretical considerations for the use of Zn++ and Chloroquine and preliminary findings in China and Korea were discussed https://www.quora.com/Can-chloroquine-and-zinc-be-used-to-stop-the-coronavirus/answer/Anthony-Pun)

    FDA waived the restrictive use of Chloroquine for COVID-19 with an Emergency Use Authorization but pointing out serious side effects including cardiac rhythms problem. An article in the Medical Journal of Australia, does not recommend it for general use.

    The Medical Journal of Australia also warned about the use of Chloroquine based on lack of clinical evidence of efficacy. The shortage of this drug has resulted a call by ASID in an immediate cessation of use other than for rheumatological conditions

    Billionaire, Clive Palmer has purchased 32,900,000 doses of hydroxychloroquine, and donated the supply to the National Medical Stockpile. Would he be responding to the limiting supplies of this drug in Australia and be ready if pandemic strikes Australia or some third world country which can afford the previous medicine? Devil or Saint?

    • Clive Palmer is neither a devil or saint. He is a businessman. His decision to purchase hydroxychloroquine and donate an unnecessary drug to the national stockpile was presumably made for business reasons. One could speculate that these might include taxation benefits &/or political influence. Similarly, the $83.7 million he spent at the last election.

  2. Avatar Michael Keating says:

    Thanks for this. As a former Head of the Australian Public Service, it looks like politicisation of the Authority to me too. The insidious thing about this sort of politicisation is that the people concerned are not told what they must find/decide; instead they try to second-guess what the political master wants them determine.

  3. Peter Sainsbury Peter Sainsbury says:

    What absolute tosh. Well done, Ken, great to see you’re still fighting the good fight and exposing – difficult to know what – dumb regulations? incompetence? stupidity? corruption? political interference? I’m sure that Palmer’s principal aim was selling Palmer but he was counting on desperate uninformed people wanting to use the drug for a completely unapproved purpose to achieve his aim. The ad was undoubtedly advertising the drug and promoting its use and he knew it. Who’s going to pick up the cudgel when you eventually retire, Ken?

  4. Avatar Peter Johnstone says:

    What’s happened to accountable public service? This would seem to be within the jurisdiction of the Commonwealth Ombudsman who at least has the authority to report publicly.

  5. Avatar Bill Arnold MPS says:

    Before that even; how does someone who (to my knowledge) has no Health/Poisons qualification which would permit him to buy a Schedule 4 Prescription only product do so ?

  6. Avatar Jim KABLE says:

    I was shocked at the Yellow Pages inserted into Nine-media group’s The SMH. What on earth! The same medication important for Lupus sufferers as I understand it – but blatantly promoted by the unhinged US President as a possible probable maybe who knows cure for Covid-19 just earlier splashed all over our news services would clearly endanger the kinds of lives here of those already drenched in a pro-Trumpian spray out of Murdoch-oriented media outlets. If this is true that the TGA is letting this slip through then surely we need to know the names of the officials and the Minister who has oversight on this matter! We are speaking of lives here! Australian lives! And a criminal kind of act – from Clive…

  7. Avatar Phillip Cornwell says:

    Incompetence, spinelessness or worse? Pray the TGA’s failure to act on Palmer’s hydroxychloroquine ads is not down to the politicisation of the public service. Palmer’s $80m secured a ‘miracle’ win for the Coalition & now he threatens the same trick in the Qld State election

  8. Avatar Kerry Breen says:

    Thanks Ken. Very well stated. Perhaps you might like to remind the readers of P&I how the TGA is funded?

  9. Avatar Frank O'Connor says:

    Mmm … by failing to act it could be said that the TGA promotes medical quackery.

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