Diluted Thinking

in Australian healthcare

AVSN: Failure to Comply - TGA Complaint 2012-04-022

Background

During 2012, two complaints about the AVSN promoting the use of black salve as a cancer treatment were made to the Complaints Resolution Panel (CRP) of the Therapeutic Goods Administration (TGA).

The first complaint, TGA Complaint 2012-04-022, was in regard to the AVSN selling Elaine Hollingsworth's DVD One Answer to Cancer in their online shop.

The second complaint, TGA Complaint 2012-05-013, was in regard to advertisements for black salve made by Meryl Dorey and Leon Pittard during the Fairdinkum Radio show. Please visit the TGA's website to view the determination for TGA Complaint 2012-05-013

On 15 May 2012, by order of the TGA , the AVSN stopped selling the One Answer to Cancer DVD online. However, the AVSN advised their customers that they would still accept phone and email orders for existing stock. The page advertising the DVD remained online with the advertising blurb removed and replaced with a lengthy rant about the TGA.

In the Complaints Resolution Panel Determination for Complaint 2012-04-022 Black Salve (dated 3 December 2012), the AVSN was ordered to make:

The AVSN failed to publish the retraction.

Please refer to my previous post AVSN - Black Salve - TGA for further information.

Australian Vaccination-Skeptics Network fails to comply

On 16 May 2013, the Therapeutic Goods Administration (TGA) published their Decision under regulation 9 of the Therapeutic Goods Regulations 1990 in relation to an advertisement about the product 'black salve' (Complaint No. 2012-04-022). The background section states (emphasis is mine):
"On 13 May 2013, the delegate of the Secretary to the Department of Health and Ageing (the Delegate) for the purposes of regulation 9(1) of the Therapeutic Goods Regulations 1990 (the Regulations) decided to order 'the Australian Vaccination Network Inc' (the AVN) to carry out actions in relation to a website advertisement at www.avn.org.au promoting the product 'black salve' and a DVD entitled 'One Answer to Cancer'.

The decision was made by the Delegate on review of the recommendation from the Complaints Resolution Panel (the Panel) under section 42ZCAI(3) of the Regulations on 31 January 2013 in relation to the 'black salve' internet advertisement, the subject of Complaint No. 2012/04/022. The recommendation to order the AVN to carry out specified actions in relation to the website advertisement was made as the AVN had not fully complied with the Panel's determination issued on 3 December 2012.

The Order made to the AVSN

Under regulation 9(1) the Delegate ordered the AVSN as the Advertiser to:
  1. not to use any representations that 'black salve' is for any therapeutic use, is safe or free of side effects, or offers any benefits in relation to cancer (including skin cancer), together with any representations that compare 'black salve' with cancer medicines or imply that cancer medicines are harmful or ineffective;
  2. not to use the representations in (a) above in any other advertisement including in the promotion of the DVD 'One Answer to Cancer'; and
  3. to arrange for publication on the website www.avn.org.au of a retraction in the form of, and in accordance with, the conditions set out in the attachment to the order.

Considerations imposed on the order

  1. within 10 working days of being notified of this order, the AVN will provide evidence to the Delegate of compliance with this order; and
  2. within 10 working days of being notified of this order, the AVN will provide a written response to the Delegate that the AVN will continue to abide by this order.

Retraction Notice

The AVSN was ordered to publish the following retraction.
Note: the CRP order includes detailed instructions on how the retraction notice is to be displayed on the website including that it appear on the front page of the website (without scrolling), minimum size, minimum font-size, and font-colours.

An advertisement promoting illegal therapeutic goods under the name "Black Salve", which we published on this website, should not have been published. In publishing the advertisement, we misled and abused the trust of consumers

In the advertisement we unlawfully made claims that Black Salve is safe, and that it can be used as an effective treatment for cancers including skin cancer. We also claimed that cancer medicines are harmful and cause cancer, and are ineffectual

A complaint about the advertisement was recently upheld by the Complaints Resolution Panel. We provided no evidence whatsoever to support the claims we made, and the Panel found that the claims were unlawful, misleading, and unverified and breached the Therapeutic Goods Advertising Code (Code).

The full text of the Panel's determination can be found at: www.tgacrp.com.au/complaints

The delegate of the Secretary for the purposes of regulation 9 of the Therapeutic Goods Regulations 1990 also found that the claims and representation in the advertisement were unlawful, inaccurate and misleading in breach of the Code.

The attention of consumers is directed to the safety information from the Therapeutic Goods Administration at: Black salve, red salve and cansema on the TGA website.

The AVSN Shop today - One Answer to Cancer DVD

The following images are screenshots of the AVSN website, obtained 17 May 2013.
Note: Customers have not been able to purchase the DVD from the AVSN shop since 15 May 2012.

image: AVN shop DVD section
The AVSN shop promoting its Current Top Seller, "One Answer to Cancer" DVD

image: AVN shop, One Answer to Cancer DVD page
The AVSN shop's "One Answer to Cancer" DVD page

The following excerpt is the text from the AVSN's shop One Answer to Cancer DVD page. This has been the text of the page since May 2012. All emphases are the AVSN's:

Product Description

Important - Please Note - The Australian Government do NOT want you to know about the information contained in this video:

On May 15th [Ed: 2012], the AVN agreed to remove the following item from our web store. This is due to complaints sent in to the Therapeutic Goods Administration (TGA) by members of the organisation, Stop the AVN. This organisation does not believe in freedom of communication, speech or choice in Australia. In fact, they expressly oppose these basic rights.

The Therapeutic Goods Administration (TGA) is a government body that is meant to license all therapeutic products (drugs, vaccines, etc) and ensure that they are safe and effective. Since 1998, the TGA has been operating under what is called 'cost recovery'. This means that they receive NO funding from the government whatsoever. All their operating expenses are covered by licensing fees. In other words, they are totally beholden to those they are meant to regulate. Instead of protecting the public - they seem to be more likely to protect the drug companies and medical community.

The TGA has ordered us to stop selling this DVD because, according to their code, providing information about products is exactly the same as selling the product that is discussed on this DVD - Black Salve. Even if we were to give the DVD away, they would consider that promoting the use of Black Salve. Just by putting this information on our website, we are no doubt at risk of being in breach of government regulations in this regard.

Please be aware, this is a genuine risk. Australia purports to be a democracy but the control over what you can see, read, hear and learn is held by the government and the government does not necessarily have your best interests at heart.

Do you care about your rights? Do you believe that YOU should be able to access information on these issues without government censorship?

Are you a natural health practitioner who feels that you should be able to let others know information about the products and treatments you provide?

Then it is time to get involved and become active in protecting YOUR RIGHTS and the rights of YOUR CHILDREN!

Join with the AVN - we have already let too many rights slip through our fingers. Contact our head office by email - info@avn.org.au or phone - 02 6687 1699 - and ask what you can do to help. There is very little time and much to do.