Direction about advertisements: Cholrem Pty Ltd

Statements that the goods have specific therapeutic uses including that the goods can:

• Reverse heart disease^[3],[4]
• Reduce angina^3,[5]
• Reduce peripheral artery disease⁵
• Rapidly reduce or remove arterial plaques^3,4
• Reduce atherosclerosis⁴
• Benefit stroke patients^4,5
• Assist with Niemann-Pick disease⁴

Subsection 42DLB(1) where subsection (9) applies

A person contravenes subs 42DLB(1) of the Act where subs (9) applies in circumstances where the person advertises, by any means, or causes the advertising, by any means of a therapeutic good, and the advertisement refers to a therapeutic good that is not entered in the Register and is prescribed by the Therapeutic Goods Regulations 1990 (the Regulations) for the purposes of this subsection, other than a reference authorised or required by a government or government authority (not including a foreign government or foreign government authority).

Regulation 7 of the Regulations provides a list of prescribed goods for the purposes of subs 42DLB(9) of the Act, and includes at (i) therapeutic goods that are neither the subject of an exemption, approval or authority under the Act nor an exemption, approval or authority under regulations under the Act.

The advertisements found at the link set out in the column ‘Website page URL’ and example statements that are provided in the column ‘claims/representation/statements’ promote the use and supply of the goods set out in the ‘Therapeutic goods’ column as a therapeutic good within the definition provided in the Act.

The goods are not entered in the Register, nor subject to any exemption, approval or authority under the Act or regulations made under the Act. The references to those goods in the advertisement were not authorised or required by a relevant government or government authority. The advertisements therefore contravened subs 42DLB(1) where subs (9) applied.

Statements that the good has specific therapeutic uses including that the good can:

• Reverse heart disease^3,4
• Reduce angina^3,5
• Reduce peripheral artery disease⁵
• Rapidly reduce or remove arterial plaques^3,4
• Reduce atherosclerosis⁴
• Benefit stroke patients^4,5
• Assist with Niemann-Pick disease⁴

Subsection 42DLB(1) where subsection (4) applies

A person contravenes subs 42DLB(1) of the Act where subs (4) applies in circumstances where the person advertises, by any means, or causes the advertising, by any means, of a therapeutic good and the advertisement contains a restricted representation (whether in express terms or by necessary implication), and neither an approval under s 42DF of the Act nor a permission under s 42DK of the Act is in force in relation to the restricted representation.

An advertisement about therapeutic goods that refers to a form of a disease, condition, ailment or defect identified in the Code as a serious form of a disease, condition, aliment or defect is a restricted representation (see s 42DD of the Act). Section 28(a) of the Code provides a form of a disease, condition, ailment or defect is a serious form if it is medically accepted that the form requires diagnosis or treatment or supervision by a health practitioner who is suitably qualified, except where the form has been medically diagnosed and medically accepted as being suitable for self-treatment and management.

The advertisements found at the link set out in the column ‘Website page URL’ and example statements are provided in the column ‘claims/representation/statements’ promote the use and supply of the goods, set out in the ‘Therapeutic goods’ column, in relation to heart disease, stroke and Niemann-Pick disease. Heart disease, stroke and Niemann-Pick disease are serious medical conditions within the meaning of s 28 of the Code, and references to such conditions are restricted representations, which must not be used in advertising unless expressly approved or permitted by the Secretary under s 42DF or 42DK of the Act.

There are no current approvals or permissions under ss 42DF or 42DK of the Act which apply to the representation made concerning the goods in relation to treating or reducing heart disease, nor the claims with respect to stroke or Niemann-Pick disease.

Statements that suggest or imply the good has been recommended or approved by or on behalf of a government authority, including the following statements from the video located at the Cholrem Science Webpage4 underneath the heading ‘Interview Founder of Cavadex November 2024’:

Interviewer:

‘So why do you think the TGA are leaving you alone?’

Kyle Hodgetts:

‘I think it's because they know our product is a cure for heart disease. Now can you imagine the public backlash if the TGA was to try and shut down a product that cures heart disease, saves lives. They shut it down. And can you imagine a year later It's proven that product actually worked. Could you imagine the backlash the TGA would get? They know for a fact we're not harming anyone. They know it works. The science is there. We publish papers.’

Subsection 42DLB(1) where subsection (6) applies

A person contravenes subs 42DLB(1) of the Act where subs (6) applies in circumstances where the person advertises, by any means, or causes the advertising, by any means of a therapeutic good and the advertisement contains a statement, pictorial representation or design suggesting or implying the goods have been recommended or approved by or on behalf of a government or government authority (including a foreign government or foreign government authority), other than:

1. a statement of the availability of the goods as a pharmaceutical benefit; or
2. a statement, pictorial representation or design authorised or required by a government or government authority (not including a foreign government or foreign government authority); or
3. a statement, pictorial representation or design prescribed by the regulations for the purposes of this paragraph.

The advertisements found at the link set out in the column ‘Website page URL’ and example statements that are provided in the column ‘claims/representation/statements’ imply the goods, set out in the ‘Therapeutic goods’ column, are recommended or approved by the TGA. None of subparagraphs 42DLB(6)(a)-(c) apply in relation to the advertisement.

Statements including the following statements from the video located at the Cholrem Science Webpage4 underneath the heading ‘Interview Founder of Cavadex November 2024’:

Kyle Hodgetts:

‘In 2020, I registered my product – Cavadex – with the TGA … The TGA, because our product is an excipient not an active ingredient, they didn’t know where to put us in their normal drug regulations. So they said to Professor [REDACTED] to deregister our product from the TGA because, while it’s registered, they were obliged to regulate it but they didn’t know how to regulate it so they said can you just deregister it. They knew it was harmless.’

…

Interviewer:

‘So why do you think the TGA are leaving you alone?’

Kyle Hodgetts:

‘I think it's because they know our product is a cure for heart disease … They know for a fact we're not harming anyone. They know it works.’

Subsection 42DMA(1) of the Act ( subparagraph 8(1)(a) of the Code)

A person contravenes subs 42DMA(1) of the Act in circumstances where the person advertises, by any means, or causes the advertising, by any means of a therapeutic good and the advertisement does not comply with the Therapeutic Goods Advertising Code (the Code).

The Code includes, at subparagraph 8(1)(a), that an advertisement about therapeutic goods must be accurate, balanced and not misleading or likely to be misleading.

The advertisements found at the link set out in the column ‘Website page URL’ and example statements that are provided in the column ‘claims/representation/statements’ are likely to be misleading for reasons including that they imply:

• Cavadex was registered in the Australian Register of Therapeutic Goods (ARTG), in circumstances where Cavadex has not been registered on the ARTG and instead was previously listed;
• the Therapeutic Goods Administration (TGA) asked Cholrem to ‘deregister’ its products in the ARTG because the TGA did not know how to regulate the relevant goods, in circumstances where the TGA did not make such representations; and
• the TGA had determined that Cavadex is safe and effective as a cure for heart disease, in circumstances where the TGA has not made any such determination.

Statements that suggest or imply the good is safe and without side effects, including:

• Patients using RemChol report :

  …

  No side-effects³

• You can’t hurt yourself with it [Cavadex] (Video located at the Cholrem Science Webpage⁴ underneath the heading ‘Interview Founder of Cavadex November 2024’).
• Dr [REDACTED] reports all patients getting better and that Remchol-Cavadex reduced arterial plaques in his patients without any adverse side-effects.⁴

Subsection 42DMA(1) of the Act ( subparagraph 9(1)(a) of the Code)

A person contravenes subs 42DMA(1) of the Act in circumstances where the person advertises, by any means, or causes the advertising, by any means of a therapeutic good and the advertisement does not comply with the Therapeutic Goods Advertising Code (the Code).

The Code includes at subparagraph 9(1)(a) that an advertisement about therapeutic goods must not contain any statement, pictorial representation or design that, expressly or by implication, represents the goods to be safe, or without harm or side effects.

The advertisements found at the link set out in the column ‘Website page URL’ and example statements that are provided in the column ‘claims/representation/statements’ imply or expressly represent the goods, set out in the ‘Therapeutic goods’ column, are safe and without harm or side effects.

Statements that suggest or imply the good is infallible or miraculous, including:

• Dr [REDACTED] reports all patients getting better⁴

And the following statements from the video located at the Cholrem Science Webpage⁴ underneath the heading ‘Interview Founder of Cavadex November 2024’:

Kyle Hodgetts:

‘After I did the trial, did an angiogram and my plaque had reduced, my cholesterol, my liver, everything went back to normal it was like a miracle.’

Kyle Hodgetts:

‘All our product goes through, but now a lot of doctors are talking to the FDA saying this is a miracle treatment, people are going off their statins, people are going off their blood pressure medication.’

Subsection 42DMA(1) of the Act ( subparagraph 9(1)(c) of the Code)

A person contravenes subs 42DMA(1) of the Act in circumstances where the person advertises, by any means, or causes the advertising, by any means of a therapeutic good and the advertisement does not comply with the Therapeutic Goods Advertising Code (the Code).

The Code includes at subparagraph 9(1)(c) that an advertisement about therapeutic goods must not contain any statement, pictorial representation or design that, expressly or by implication, represents the goods to be infallible, unfailing, magical or miraculous.

The advertisements found at the link set out in the column ‘Website page URL’ and example statements that are provided in the column ‘claims/representation/statements’ imply the goods, set out in the ‘Therapeutic goods’ column, are infallible or miraculous.

Statements that delay or discourage, or are likely to delay or discourage, persons from seeking necessary medical attention, including:

• No more need for by-pass surgery.⁵

Subsection 42DMA(1) of the Act ( subparagraph 9(3)(b) of the Code)

A person contravenes subs 42DMA(1) of the Act in circumstances where the person advertises, by any means, or causes the advertising, by any means of a therapeutic good and the advertisement does not comply with the Therapeutic Goods Advertising Code (the Code).

The Code includes at subparagraph 9(3)(b) that an advertisement about therapeutic goods must not contain any statement, pictorial representation or design that, expressly or by implication delays or discourages, or is likely to delay or discourage, persons from seeking necessary medical attention.

The advertisements found at the link set out in the column ‘Website page URL’ and example statements that are provided in the column ‘claims/representation/statements’ may delay or discourage persons using the goods, set out in the ‘Therapeutic goods’ column, from seeking necessary medical attention.

Statements that are inconsistent with a public health campaign, including:

• [REDACTED] was refused stents by his doctors because he was a heavy drinker and smoker. After just 2 months on RemChol his condition improved dramatically without any lifestyle changes.⁵

Subsection 42DMA(1) of the Act ( section 10 of the Code)

A person contravenes subs 42DMA(1) of the Act in circumstances where the person advertises, by any means, or causes the advertising, by any means of a therapeutic good and the advertisement does not comply with the Therapeutic Goods Advertising Code (the Code).

The Code includes at section 10 that an advertisement about therapeutic goods must not be inconsistent with a public health campaign.

The advertisements found at the link set out in the column ‘Website page URL’ and example statements that are provided in the column ‘claims/representation/statements’ state that if taking the goods, set out in the ‘Therapeutic goods’ column, there is no longer a need to undertake lifestyle changes such as reducing alcohol intake and ceasing smoking to manage and control heart disease. This message goes expressly against health campaigns regarding smoking (National Tobacco Campaign) and excessive drinking ( National Alcohol Strategy 2019–2028) to maintain good health.

Testimonial statements made by a person who is engaged in the marketing and supply of the goods.

The entirety of the video located at the Cholrem Science Webpage⁴ underneath the heading ‘Interview Founder of Cavadex November 2024’. This interview with Kyle Hodgetts provides a testimonial of his experience with Cavadex, including the claimed reversal of heart disease. Kyle Hodgetts is also the founder of Cholrem, the company responsible for Cavadex.

Subsection 42DMA(1) of the Act ( subparagraph 24(4)(a) of the Code)

A person contravenes subs 42DMA(1) of the Act in circumstances where the person advertises, by any means, or causes the advertising, by any means of a therapeutic good and the advertisement does not comply with the Therapeutic Goods Advertising Code (the Code).

The Code includes at subparagraph 24(4)(a) that an advertisement about therapeutic goods must not contain a testimonial if the testimonial is made by a person who is engaged in the production, marketing or supply of the goods.

The advertisements found at the link set out in the column ‘Website page URL’ and example statements that are provided in the column ‘claims/representation/statements’ about the goods, set out in the ‘Therapeutic Goods’ column, are made by Kyle Hodgetts, the founder of Cholrem Pty Ltd, and are therefore made by a person who is engaged in the marketing and supply of the goods.

Statements that, either expressly or by implication, endorse the use of the good by current or former health practitioners, including:

Dr [REDACTED], MD, FACC, FAARFM

• USA cardiologist Dr. [REDACTED]MD FACC FAARFM trialed Cavadex on himself with similar results. He then went on and supplied his patients with Remchol tubes… Dr. [REDACTED] reports all patients getting better and that Remchol-Cavadex reduced arterial plaque in his patients without any adverse side-effects. He also reported several other benefits for stroke patients and brain fog.⁴

Professor [REDACTED], MB, BS, PhD, FRACP, FCSANZ

• In relation to Cavadex, ‘Prof. [REDACTED]writes a report about Cavadex. “It will be the greatest therapeutic advance in cardiovascular medicine since the introduction of the statins.”’⁴

And the following statements from the video located at the Cholrem Science Webpage⁴ underneath the heading ‘Interview Founder of Cavadex November 2024’:

Dr [REDACTED]

‘I was certainly impressed by Kyle’s results and what the medication had done for him. When I looked at his blood tests, everything was improving. His cholesterol, his triglycerides, all of his blood markers were improving out of sight. His cholesterol went from ten, you know, down to six and then eventually down to four which was impressive to me. Perhaps the most surprising result of all was the fact that Kyle’s liver function tests were improving and this is despite being an incredibly heavy drinker. It was at this point that I realised this medication had massive potential in being a game changer in the treatment of heart disease.’

Dr. [REDACTED]:

’I use Cavadex in my patients with advanced and recurrent coronary disease…I’ve been delighted with the results…I’ve treated up to 150 of my patients with Cavadex…Cavadex is now the most important anti-atherosclerotic therapy in my armamentarium…’

Professor [REDACTED]:

‘Hi, I'm [REDACTED]. I've been a professor of medicine for over 40 years now, specialising in cardiology and in particular and cardiovascular pharmacology. Cyclodextrin in the form of Cavadex. At this stage has more safety data and more knowledge about the pharmacology than what we knew about the statins when they were first introduced.’

‘I think that there's a potential for this treatment to be even more important and have a greater impact than what statins have, and certainly it's the greatest advance that we've had in cardiovascular pharmacology for the treatment of atheromatous plaques since the statins came on the scene.‘

Subsection 42DMA(1) of the Act ( subparagraph 24(6)(d) of the Code)

A person contravenes subs 42DMA(1) of the Act in circumstances where the person advertises, by any means, or causes the advertising, by any means of a therapeutic good and the advertisement does not comply with the Therapeutic Goods Advertising Code (the Code).

The Code includes at subparagraph 24(6)(d) that an advertisement about therapeutic goods must not contain an endorsement about therapeutic goods must not be given, whether expressly or by implication by a current or former health practitioner, health professional or medical researcher.

The advertisements found at the link set out in the column ‘Website page URL’ and example statements that are provided in the column ‘claims/representation/statements’ about the goods, set out in the ‘Therapeutic goods’ column, are made by current or former health practitioners and a medical researcher.

The statements made by three health practitioners, either expressly or impliedly, endorse the use of Cavadex.