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The drug administration has the authority to prevent misleading advertising. So why can’t it stop Craig Kelly’s lyrics?

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Earlier this month, many Australians received a text message asking them to visit the Australian Government’s “COVID-19 Vaccine Adverse Event Report”.

It encouraged recipients to “click the uaptga.info link” and informed them that the message was “Authorized by Craig Kelly,” a former Liberal MP who recently joined Clive Palmer’s United Australia Party as leader.

Was it legal Probably yes. But there is still a problem.

The tricky text

The text was strange and tricky. It represented an association that made an unlikely portmanteau of acronyms. The letters “uap” (the United Australia Party) were strangely associated with the acronym “tga”, which usually stands for the Therapeutic Goods Administration – the Commonwealth government’s regulator of medicines and other health treatments.

In addition, the domain ending – “.info” – indicated that the link could be a source of information.

Although unsolicited, the sending of the text was probably legitimate. “Electronic messages” authorized by political parties are usually exempt from the spam law or can be otherwise protected as political communication.

Read more: Craig Kelly’s move to Palmer’s United Australia Party shows the need for urgent electoral reform

Tapping the link redirected users to the United Australia Party’s media website. There, visitors came across several image files. These were five-page screenshots extracted from a 73-page document created with TGA’s Database of Adverse Event Notifications (DAEN).

To be clear, this “report” was not written by any scientist or employee of the TGA. It was a user generated “dump” of notification data. Similar to a printout of the first few pages of a Google search result, the images provided some of the search results in the adverse event reporting database to the regulatory authority.

‘Report’ or ‘Data’?

The problem is that these screenshots captured some (but not all) of the TGA’s data on certain adverse events. The data recorded what was reported to the TGA – as opposed to what was reviewed or confirmed by the regulator – about patients who had received a COVID-19 vaccine.

These notifications can come from doctors, members of the public, general practitioners, nurses, and others. It also contained unchecked notification data of Australian deaths.

Since the website consisted of images that were taken from the TGA database, the TGA logo was also visible at the top. But incongruously, there was a campaign video with Kelly and the UAP at the bottom of the page.

The TGA’s legislative powers may need to be extended to include communications that are not purely advertising.
AAP / Dave Hunt

The possible effects of the text

Out of context, unexplained and incomplete, the screenshots can mislead even a careful reader of the material. But since millions receive the text completely unprepared, it can be assumed that some, through no fault of their own, will draw the wrong conclusions from it.

After all, there is little to frame this data. Almost nothing suggests that it is the unchecked list of notifications. And no disclaimer makes it clear that the materials are silent about the all-important medical concept of causality.

Other than known as Etiology, it is the scientific study of how these events were caused. Such disclaimers, which actually appear on the DAEN portal, have mostly been omitted from the screenshots.

Even the footnotes that would normally explain the meaning of the contents of each column had been cut out of the screenshots.

Read more: How Political Parties Legally Harvest and Use Your Data to Bombard You with Election Spam

The regulator’s response

The TGA responded to this appropriation of its database materials in two ways.

It initially issued a statement confirming that his lawyers had written to Kelly and his party. However, that statement confirmed that the regulator had only made allegations of copyright infringement, along with a demand that Kelly stop sharing “incomplete extracts from DAEN reports” that “could be seriously misleading.”

To a lesser extent, the regulatory authority temporarily suspended the DAEN’s ability to generate PDFs.

Why can the TGA no longer?

So why doesn’t the TGA have a clear legal path, except perhaps under copyright law, to prevent the spread of misinformation?

In short, because the texts are probably not advertising.

In 2018, the powers of the TGA to control communication about pharmaceuticals were significantly expanded. Several reforms have clarified and expanded the regulator’s powers to take civil and criminal action against those who illegally advertise medicinal products.

The powerful new laws were quickly used to stop illegal advertising, with one case resulting in a $ 10 million fine.

In 2020, a review of the reforms found that, with some tweaks, they are largely effective and fit for purpose. Some COVID-related recommendations were made, including that the TGA should consider “responding to non-compliant advertising with sanctions and penalties in a timely manner”. However, unsurprisingly, the review found no indication that the scope or meaning of “advertising” should be broadened.

The problem is, none of these reforms have empowered the TGA to handle communications that are not advertising.

While the legal definition of advertising is comprehensive, the key requirement is that the material “is intended, directly or indirectly, to facilitate the use or delivery of the [therapeutic] Was”.

And despite extensive legislation for such advertisements with a separate advertising code, the real thing is that the scheme is designed to control commercial activities that could endanger the safety and health of consumers.

It is questionable that the law did not consider a situation where political material could indirectly degrade or “downgrade” a therapeutic good that could endanger the safety of health consumers.

Restricted and prohibited representations

On the other hand, the TGA has some other powers. It can take civil or criminal action against anyone who publishes what the law calls “restricted” or “prohibited” representation.

Limited representation includes advertising relating to an illness, condition, condition, or defect that is classified as serious, such as: B. COVID-19.

TGA Pete Evans’ company has so far fined the use of this power with almost 80,000 US dollars to promote the so-called BioCharger device for the “Wuhan coronavirus”, among other things.

“Prohibited Representations” generally relate to specific products and prevent manufacturers from making improper claims about them. This includes, for example, calling something a disinfectant or an antiseptic when it isn’t.

But again, the problem with both restricted and prohibited displays is that they are only enforceable if they appear in commercial advertisements or on product labels.

In addition, the TGA’s Advertising Code lays down a number of important principles relating to advertising, including that it

Truthful, balanced and not misleading or likely to be misleading, including in their claims, representations, representations and comparisons.

Again, these requirements only apply to “Approved Ads”.

The party line

Before the TGA published its statement, Clive Palmer, now chairman of the UAP, initiated the widespread publication of the TGA materials. Palmer said he welcomed the TGA’s “legal threats”, claiming the “report” showed that “treatment with the COVID-19 vaccine was responsible for the deaths of 483 Australians and over 46,000 side effects.”

At a later press conference, Palmer streamlined the dissemination of this incomplete data as “nothing more than the dissemination of a government report.” He also expressed an intention to commence a subpoena and investigation into TGA and Ministry of Health officials in future litigation.

Declaration by the supervisory authority

Before these statements, TGA boss John Skeritt had already made it clear in a radio interview that these data should be viewed with great caution. The only thing the regulator found, he found, was that nine Australians had died in circumstances associated with an etiological (or cause and effect) association with a vaccine.

Given this clarification, the United Australia Party’s stated desire to investigate the health department and TGA sounds strange. However, it follows other actions that Clive Palmer took through his foundation in 2020 regarding therapeutic products.

In April and May 2020, the Palmer Foundation imported approximately 32.9 million “doses” of hydroxychloroquine – some time before vaccines were developed – as a gift to the Australian Government’s National Medical Stockpile. The donation was announced in newspaper advertisements across the country.

By May 2020, around 7 million tablets had been tested and analyzed in a TGA-certified facility and placed in the government’s strategic reserve.

But hydroxychloroquine had never been approved for the treatment of COVID-19 in Australia. And by the time the donated shipment reached the health department, hydroxychloroquine was already limited to five specialties by doctors.

Read more: The Difference Between Government Advertising and Political Advertising

Remedies and Modern Politics

COVID-19 has presented the regulation of medicinal products with new challenges. And when dubious claims about medicine are made by politicians in the political – as opposed to the commercial – context, it seems that neither the Medicines Act nor the Australian Consumers Act will provide a clear way of stopping them.

Of course, the implicit freedom of political communication, first recognized by the High Court of Australia in 1992, is expected to offer strong protection to politicians who share relevant information with their would-be voters or (re-voters).

Nevertheless, in recent years the worsening state of uncontrolled political speech has led politicians and legal experts alike to push for the federal truth in the laws on political advertising.

While some have expressed doubts about the practicability of these proposed reforms, we may have to take our scientific data from politicians with a healthy pinch of salt until such a reform is realized.

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