A Remedy for False Cures?

Australia’s Therapeutic Goods Administration has been more vigilant in policing advertisements for unproven COVID-19 ‘treatments’. But have some slipped through the cracks?

This article was first published on Pursuit. Read the original article. It is co-authored with Professor Megan Munsie.

Beware false COVID-19 cures.

The COVID-19 pandemic has seen the emergence of multiple dangers. The obvious public health danger is the novel coronavirus strain and the disease itself.

But a secondary threat has emerged for health consumers.

Since March, several unregistered ‘treatments’ for COVID-19 have been advertised to the public. Most are untested and unproven.

A controversial example was the Biocharger NG, a “hybrid subtle energy revitalization platform”. That product was unlawfully promoted as a COVID-19 remedy by former celebrity chef Pete Evans. Evans’ company was issued infringement notices totalling $A25,200.

Although no clear cases of liability have arisen in Australia, it’s not difficult to imagine these advertisements causing harm. In a period already witness to anxious consumer behaviour, a spell of pharmaceutical panic-buying might just be too predictable.

The administrative body responsible for controlling drug advertising in Australia is the Therapeutic Goods Administration (TGA). The TGA wields considerable regulatory power to ensure no individual or company promotes unproven therapeutic goods to the public.

In recent months, the TGA has used its powers rather vigilantly. But unlike the newly-crafted emergency orders declared in our states and territories, the TGA’s swift and strict response comes from pre-existing levers.

The TGA’s Regulatory Clout

The TGA’s ability to act against “restricted” and “prohibited” advertisements emanates from legal amendments made as long ago as 2003.

But more recent changes have enhanced the TGA’s powers.

Following a major review, the TGA became the sole complaints handling body for drug advertising nationally in 2018. Further amendments that year gave the TGA a more punitive offence regime.

In many ways, COVID-19 has been the first real test of this greater regulatory clout.

Communication over Complication

But the TGA is a complicated organisation with complicated rules.

After years of incremental tinkering, the therapeutic goods legislation is diffuse and intricate. If this legal complexity alienates consumers at the best of times, it must bewilder during a global pandemic.

The administration’s principal regulatory powers come from the Therapeutic Goods Act 1989 (Cth). But several subordinate materials, including the Therapeutic Goods Regulations 1990 (Cth), the Therapeutic Goods Advertising Code (no 2) 2018 (Cth) (or, ‘the Code’ for short) and dozens of guidance documents, supplement this primary law.

The pandemic has required the TGA to improve its communications to cut through this complexity. Now more than ever, up-to-date guidance has been crucial to reach stakeholders and consumers.

To that end, the regulator has issued several important warnings on its main website and in its specialised ‘advertising hub’.

As COVID-19 was just emerging, the TGA announced that any therapeutic goods advertisement referring to the ‘novel coronavirus’, whether explicit or implied, would be a “restricted representation”.

Although the warning did not explain the mechanics of the legislation, identifying and controlling “restricted representations” is central to the TGA’s advertising controls.

So, What Exactly is a ‘Restricted Represntation’?

The primary law defines a “restricted representation” as a representation about therapeutic goods referring to a disease, condition, ailment or defect that the Code classifies as “serious”.

Back in 2005, the Code listed a range of “serious” diseases, stopping advertisers from promoting related treatments without permission. But today, the Code provides more flexible criteria.

A ‘serious’ disease may be one that, for instance, requires practitioner-led diagnosis, testing or screening.

COVID-19 was quickly identified as a serious disease, and advertising referring to it was said to be a restricted representation. But what kinds of penalties can be imposed?

Enforcing restricted Representations

In 2018, the TGA introduced a new offence regime for unlawful advertising.

Publishing an advertisement likely to result in harm was now an aggravated criminal offence, punishable by a jail term of up to five years and a fine of up to $A888,000 (or both). Civil penalties for non-compliant advertising could incur fines of more than $A1.1 million for individuals or $A11.1 million for body corporates.

Given the quantum of these maximum penalties, it’s arguable that the actually-issued infringements have been minor.

In June, a Sydney-based chemical company was fined $A63,000 for unlawfully advertising a medicine known as RibaMin. On its website, the ingestible tablet was described as a “low-cost effective treatment for the devastating COVID-19 virus (and possibly other related viruses or mutations)“.

It was the lone ‘pharmaceutical’ amid a host of maintenance chemicals, including concrete polishing and graffiti control products.

Earlier in June, a Cairns-based technology company was fined $A50,4000 for advertising a large tank said to produce a purified form of molecular hydrogen as a treatment for COVID-19.

In addition to these novel products, a Melbourne-based company was fined $A12,600 for unlawfully advertising a seemingly more conventional product – a COVID-19 test kit. But as the advertisement referred to COVID-19 without TGA permission, it was a restricted representation.

Evaluating the TGA’s Response

Though the pandemic has tested all levels of Australia’s healthcare system, it has been a special test for the TGA.

From all appearances, the TGA has been more vigilant than ever in policing non-compliant advertising during the COVID-19 pandemic. However, it’s possible some non-compliant advertising has slipped through the cracks.

In early April, the US Federal Drugs Administration (FDA) wrote to a Perth-based company promoting herbal remedies to animals, including COVID-19 treatments.

The FDA warned the company that it had violated US law by making its products available for purchase by US citizens.

But it seems no infringements were issued to the company by the TGA, possibly due to a regulatory exception that excludes homeopathic practitioners from the regulatory regime, or because the goods were not advertised for human use.

Moreover, the TGA has been criticised for not imposing more stringent penalties during the COVID-19 period.

As one critic noted, the fine imposed on Pete Evans’ company for advertising the “energy revitalization platform” is less than the cost of just two of those unapproved devices.

Time will inevitably reveal whether the TGA has responded adequately to the unlawful advertising of unapproved products during COVID-19. What’s clear, however, is that the TGA has never been better equipped to control false cures than now.

The Nose Knows: Peter Goodrich in Critical Inquiry

Just a short note to recommend Peter Goodrich’s remarkable new article, “Proboscations: Excavations in Comedy and Law,” published in the Winter 2017 issue of Critical Inquiry (volume 43, issue 2), “Comedy: An Issue,” edited by Lauren Berlant and Sianne Ngai. I’m sure that there are many fantastic pieces to be discovered in this installment of the excellent journal; however, it was Goodrich’s article that caught my eye, via (I should add) the Critical Inquiry Facebook page, which evidently does pretty effective promotional work for an academic journal. (I hasten to add, here, that it is my intention over the next few months to cut down my own use of social media; anecdotally, at least, I have borne witness to the publishing successes of many who have done so, and, only yesterday, I was prompted to read this article, “Quit Social Media. Your Career May Depend on It,” in the New York Times.)

I had not read any of Goodrich’s writing before—although I certainly should have done. After all, he is the editor of Law and Literature (Taylor & Francis), a journal to which I’d certainly like to submit something in the future. Since reading this wonderful article, I have borrowed no less than four of his other books, including Oedipus Lex: Psychoanalysis, History, Law, whose introduction has already proved itself as clever and as subtly ludic as, though less whimsical than, his “Proboscations.”

Among the many memorable lines in “Proboscations,” a few are quickly worth quoting. But, before that, some background. The article’s central contention is that the nose is a metonym for one’s sense of the humorous, for one’s instincts when it comes to what is witty. “The genius of the law is in its nose,” Goodrich writes in the article’s opening line. Accordingly, if one wishes to succeed in the law, then they must learn to “proboscate, which is to say to exercise the combination of wit and judgment that historically marks the pince-nez of legal reason.” In what follows, Goodrich offers an analysis of the manifold ways in which “jocastic judgment” interferes with, but does not always transform, the sobriety, the “melancholegalism,” that defines the dry, deliberative method espoused by “the Court,” which, as Goodrich assures us, is the word simply given to the judge and their deliberations, who, in a strangely chiasmic logic, is also only ever known, ever seen, as something that they are not, as a “synecdoche in the form of the collective noun the court.”

“The facts should determine the judgment, poetics should generate justice, and this is what the setup suggests,” Goodrich notes. In fact, this distinction—between the dryness of reason and the vivacity of its expression—suggests nothing less than “a possibility of wit leading to an appropriate decision, but none arrives.” In other words, while wit may be determinative of legal judgment in some undetectable, inexplicable, or—to put it somewhat more in the active—some unexplained way, a clear distinction must always be drawn between the two, drawn, in fact, during the act of adjudication itself, a process during which what Goodrich calls “a premonitory détournement . . . the excision of wit from judgment” must be conducted, when the erasure of the humorous from the hermeneutic “is signaled” and thence forgotten. It is this “moment along the way” that Goodrich’s article seeks to unpack, an ontological shift in the discursive text of the law that he says “deserves a moment of cautious reconstruction.” The question, then, is “When—and why—does comedy become curial?”

I have not done justice to the many quotable morsels that appear in Goodrich’s wonderful prose, nor to the substance of the article itself, which deals with much more than I have dealt with in my summary (including, for one, Sterne’s Tristam Shandy). Nevertheless, it’s a fascinating essay, one that reaffirms the possibilities of humour in academia, a feeling, an emotion, and a performance with its own uneasy place in research. Although, having said that, I think that Goodrich’s work perhaps less advertises the profits of analysing and explaining humour than it reveals the marvelous effects of reproducing it, of showing what can be achieved when a writer’s varied forms of “rhetoric” so impressively “mirror the subject matter” it addresses. That these poetics, these rhetorics, form a part of the work of judgment, of the “science” of the law, is something that Goodrich dares to think makes a difference—indeed, it is a difference, and a subject, about which we know too little.

New Year, Renewed Focus

This year I’ll commence a short-term “project-to-publication” fellowship with the Australian Research Council Centre of Excellence for the History of Emotions. It will transpire only for a short 6 months, so I’ll have to make the most of it. One of the things that the Centre encourages its researchers to do is regularly blog about their research topic (though I’m sure it is more pressing for long-term fellows to do it). I was perhaps sorely in need of any kind of spur to blog, as I’ve never found any success in doing so in the past. Rather obsessed with web and text design as I have been, I have generally tended to waste time on learning to develop WordPress sites, and have neglected my writing production in the process. But no more (he says, hubristically). I have developed this basic site—and have accepted its flaws—precisely in order to focus entirely on my aims concerning writing production.

I was awarded the fellowship on the basis of a submission I prepared on what is really a peripheral research interest, a study of the history of neurology and its relationship to the development of knowledge about psychiatric disorder and the emotions. One of the aims of my proposal was to throw light on the development of neurology in the late twentieth century, and particularly on the litigation that arose in the context of the violent railway accidents that occurred both in Europe and Australia.

Perhaps the most famous case of “nervous shock,” the dubious name given to the psychiatric disorder resulting from a severe trauma or shock after an accident, remains an Australian one. Victorian Railways Commissioner v Coultas [1888] UKPC 3 was a case in which a pregnant woman, Mary Coultas, had been advised by a railway gate operator that it was safe to cross at a railway crossing when, in fact, a train was approaching her at high speed. While not struck by the train itself, the plaintiff fainted at the scene, and later suffered a miscarriage, losing her unborn child. On appeal, the Privy Council rejected Coultas’s claim for damages, finding that her claim, that she had suffered the injury of “nervous shock,” was just too remote from the alleged negligent act. One wonders, however, whether today such a plaintiff might be diagnosed with post-traumatic stress disorder (PTSD) rather than nervous shock, and, if the case were heard again, whether a claim of PTSD, with its freshness and ubiquity as a nosological category, might lend a new gravitas to the strict application of the remoteness test. But I digress.

The point of analysing cases such as Coultas is to show how the experts who appeared before the courts in these matters were not simply the sober-minded functionaries of the scientific method, the objective and impartial conveyors of the empirical gravamen of physiological truth. Rather, almost all of these experts intended to bolster their own professional reputations at a time when certain theories of biology, and indeed neurology, were only beginning to achieve institutional recognition. While leading neurologists of the time in Germany, such as Hermann Oppenheim, contended that nervous shock emanated from actual physical damage to the spine or brain, British neurologists tended to refute the proposition that physical or organic harm had precipitated the symptoms.

In an 1883 monograph on injuries without lesion, the British neurologist Herbert Page argued that “fright and . . . fright alone” produced these injuries, as well as many similar injuries grouped under the nosological category of “railway spine,” some of which had led to the “gravest disturbances of function, and even death or annihilation of function.” Indeed, for Page, as for William Tuke (the Quaker who developed more humane methods of caring for those with mental disorders), it was the mind, subject to so many emotional and affective turns, and not the body, that caused the symptoms of nervous shock to arise, however serious and damaging, however injurious, they were for the victim. Quoting Tuke with approval, Page’s book noted that any “anxious reflection upon any of the bodily sensations . . . may originate a host of imaginary disorders.” Among these, Page asserted, was the disease of “hysteria,” which, while it affected both men and women, was more commonly seen in the latter.

On the publication of his 1883 book (cited above), Page was appointed the President of the Neurological Society. This was a promotion that ensured that his view of nervous shock—his idea that the disorder was no more than an emotional illness, comorbid with hysteria—would attract the imprimatur of the neurological fraternity, not to mention the deference and respect of the courts. More than this, however, it was Page who had served as the surgeon-doctor to the London and North Western Railway Company; and it was perhaps Page, he who had so many times dismissed the legitimacy of nervous shock when acting for that company, who was responsible for the wholesale reconstitution of nervous shock as hysteria, a medical reclassification no less than embraced by Freud and Breuer in their Studies on Hysteria (1895). No doubt the unfortunate result in Coultas was but one of the many ramifications of Page’s formidable influence among British neurologists and their various debuts as expert witnesses in the English courts. With unmatched authority, Page shaped not only the taxonomy and nosology of neurological injury in the late nineteenth century, but the development of tort liability for psychiatric damage into the twentieth century.

It is with this kind of argumentation that I’ll be taking steps towards developing and submitting a few publications between now (January, 2017) and July of this year. I’ll be aiming for three.