It was reported that the Therapeutic Goods Administration (TGA) has dropped its investigation into newspaper advertisements taken out by the former federal politician Clive Palmer which said, ‘hydroxychloroquine was the best hope for those suffering COVID-19’.
An advertisement is defined in the Therapeutic Goods Act 1989 Subsection 3(1) as, ‘any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods, including where the statement, pictorial representation or design’.
In my opinion, the following statements on page 5 of Palmer’s 3-page advertisement, taken out in major Australian newspapers ( copied below), are clearly intended to promote the use of the drug:
- ‘hydroxychloroquine was the best hope for those suffering COVID-19’ and
- ‘the best treatment for its citizens should the worst occur’ and
- ‘Mr Palmer said it was critical that the drug remained available in hospitals for those who needed it to treat COVID-19’.
These statements are inaccurate, misleading and not in accord with current scientific opinion.
For example, pages 6 and 7 of the advertisement titled, ‘COVID-19 Response and Action’ (copied below) fail to mention that the early French study that hyped hydroxychloroquine has been discredited. It fails to mention negative trials of the fact that serious adverse events emerged in other trials. See:
- 08 April 2020, U.S. FDA. Warning Letter Genesis 2 Church – Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
- 14 April 2020, NEJM Drug Evaluation during the Covid-19 Pandemic.
- 14 April 2020, Hydroxychloroquine for COVID-19: What do the clinical trials tell us?
- 24 April 2020, U.S. FDA Drug Safety Communication regarding serious and potentially life-threatening heart rhythm problems reported with the use of hydroxychloroquine and chloroquine for the treatment or prevention of COVID-19.
- 27 April 2020, MJA Clinical trials for the prevention and treatment of coronavirus disease (COVID-19): The current state of play
- 29 April 2020, JAMA The Risks of Prescribing Hydroxychloroquine for Treatment of COVID-19—First, Do No Harm.
- 2 May 2020, The Saturday Paper: Palmer’s Snake Oil
- 7 May 2020, Pearls and Irritations – TGA fails to act on Palmer’s hydroxychloroquine advertisements
- 8 May 2020, Australian Prescriber, COVID-19 and the quality use of medicines: evidence, risks and fads
A number of trials are ongoing and until these have been peer-reviewed, published and replicated, my view is that it is unethical to promote this drug as Palmer has done. It will create false hope in the community and place pressure on medical practitioners to prescribe inappropriately. It also raises a serious question as to why the TGA dropped its investigation of this matter?
The TGA has apparently chosen to interpret the definition of advertising to mean ‘sale’ which, arguably, is not in accord with the Therapeutic Goods Act.
I have submitted a complaint to the TGA about this advertising (AC-TNBK7OQ6/2020). I have also asked for an explanation of the TGA’s interpretation of the Act in this case.
At a meeting of the Therapeutic Goods Advertising Consultative Committee (TGACC) held on 14/05/2020, Adjunct Prof John Skerritt, Deputy Secretary, Department of Health explained why the TGA had dropped its investigation into Clive Palmer’s 3-page hydroxychloroquine advertisements that ran in major Australian newspapers from April 28 to May 2, 2020.
Prof Skerritt said, ‘Taken as a whole, the TGA felt the advertisements primarily promoted Mr Palmer’s efforts in donating hydroxychloroquine rather than hydroxychlorquine itself. The TGA accepted this was a line-ball decision.
A key factor for TGA was that the product was going into the national medical stockpile and could only be released for clinical trials or use by doctors on the decision of the Chief Medical Officer or Deputy Chief Medical Officer.
It was noted the wording about the drug in the advertisement reflected careful legal crafting. In response to reports of inappropriate off-label prescribing of hydroxychloroquine the TGA placed prescribing restrictions on the drug on 24 March 2020; only certain specialists can now prescribe hydroxychloroquine to new patients.’
Dr Harvey reiterated that inaccurate and misleading statements in the advertisements about hydroxychloroquine were likely to create false hope in the community and had placed pressure on medical practitioners to prescribe inappropriately
- Launch of TGA Advertising Hub – Initial experience of submitting complaints
- Independent review: Therapeutic goods advertising
- Independent review: Consumer consultation