KEN HARVEY. Formal response from the TGA

Dr Ken Harvey has provided the following formal response from the TGA as an update to his article (Pearls and Irritations, 7 May,

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 hydroxychloroquine 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 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 his concern 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.

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:

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4 Responses to KEN HARVEY. Formal response from the TGA

  1. Bill Arnold says:

    How did he get an Import Licence ? I am not aware that he has any Health qualification that would allow him to import a Schedule 4 Prescription Only preparation.

  2. Anthony Pun says:

    The jury is not out yet chloroquine and Zn++ treatment. It has now become really controversial. Further studies is required to explain the fatal contraindications whether it is fatal to a person with an underlying heart problem or not. For a dying patient, would that be a drug of last resort?

    • Andrew Fleischer says:


      It’s become political.

      No one has suggested it doesn’t need further study in this context but it’s been FDA approved since 1955. It is very well understood….

      Presently used in South Korea, Malaysia, Chine, Japan, the Netherlands, parts of the US, Senegal, Uganda, Costa Rica etc. to great effect if given early.

      Recent studies in the US used HCQ by itself in late stage/severe patients. Designed to fail imo.

      Now why would they do that?

  3. Andrew Fleischer says:

    And yet did the TGA actually investigate the efficacy of HCQ?

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