Thursday, October 21, 2021
HomeCOVID-19Innova’s iniquity, Part 2: Protected by the UK regulator

Innova’s iniquity, Part 2: Protected by the UK regulator

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MY original investigative report on Innova Medical Group’s Lateral Flow Test (LFT) last June was timely. The four parts were published in June, before and after the United States Food and Drug Administration (FDA) told the public to stop using the tests ‘by placing them in the trash’. It was a dramatic announcement, not just highlighting serious concerns about the performance of the lateral flow test, but warning that it presented ‘a risk to health’. 

Shockingly, the UK government decided to take no notice. Instead they doubled down on their £4billion investment in the product.

In response to the FDA warning, the Medicines and Healthcare products Regulatory Agency (MHRA) released a statement which announced that ‘following a satisfactory review’, MHRA was extending authorisation of NHS Test and Trace lateral flow devices: ‘A full risk assessment was undertaken by DHSC as legal manufacturer of the LFDs in the UK and the MHRA has undertaken a thorough review to ensure that we were satisfied with the assessment and any action proposed’.

While Americans were busy throwing them in the trash, the UK extended the exceptional use authorisation (EUA) of the Innova LFT until August 28.

It is now well past that August 28deadline and there has been no further official extension of the EUA by the MHRA. Yet schools, colleges and universities are once again strongly encouraging students to use these unauthorised lateral flow tests. As well as risking health, the test will continue to inflate case numbers as a result of its proven unreliability and inaccuracy and will be a ‘tool’ in the Prime Minister’s box of tricks to ‘justify’ yet another lockdown this autumn/winter. 

The MHRA’s intransigence is matched by its inattention to accuracy. Its classification of  the Department of Health and Social Care (DHSC) as the ‘legal manufacturer’ of the Innova test in the UK is simply incorrect. Xiamen Biotime Biotechnology in China is the manufacturer, with Innova Medical Group acting as exclusive global supplier. 

But the MHRA and the Innova lateral flow test scandal does not end there. A reply to Freedom of Information requests made to the MHRA by a TCW reader, Duncan Carmichael, for the data and rationale behind their decision to extend LFT emergency authorisation reveals both a lack of transparency and discreditable abuses of loopholes. The email he received from the MHRA Customer Services which he gives us permission to publish is set out in full below and my critique follows.

The MHRA response raises many questions. Firstly, it identifies the DHSC, a ministerial department of the government funded by the UK taxpayer, as a private business. The irony is that a credible argument can be made that the DHSC, headed by Matthew Hancock at that time, behaved as if it was a private business in which ‘friends and family’ were rewarded handsomely, the scandalous ‘VIP lane’ for lucrative PPE contracts being a prime example of this. 

But classifying the DHSC as the ‘legal manufacturer’ of the Innova LFT and by doing so, a business, the MHRA egregiously abuses the loophole of section 44 under the Freedom of Information Act making it exempt from releasing the information requested under the Act. The fact that ‘other legislation’ exists prohibits their disclosure of it. In this case, it is section 237 of the Enterprise Act 2002 which ‘prevents the disclosure of “specified information” that relates to the affairs of an individual or business which a public authority has obtained in connection with the performance of certain functions’.

In this extraordinary case, the MHRA is stating that it is exercising its ‘consumer protection’ function in its role as a regulator of medicines and healthcare products, included as a specified function under schedule 14 of the Enterprise Act 2002. In short, the MHRA, a regulatory agency which is supposed to protect the interests of the public, is instead protecting the DHSC, which it has remarkably classified as a business shielded by the Consumer Protection Act. 

The MHRA email written by the customer service department, conveniently copies and pastes the paragraph below, the same paragraph used in its earlier response to the FDA warning, published on the Government’s website in June. 

‘In exceptional circumstances the MHRA can issue EUAs allowing medical devices to be used that have not followed the standard approval process. The EUA process has been used during the pandemic to ensure that the health system has access to critical products. Once an EUA is issued following an assessment by the MHRA, the products given approval through this process are closely monitored by the MHRA.’

Again, the mention of not following ‘the standard approval process’ is made alarmingly clear. How is this admission from the MHRA supposed to garner public confidence in the Innova LFT? It simply fails to. 

The MHRA states that ‘the burden of proof is on the legal manufacturer [in this case DHSC not Innova/Xiamen Biotime Technology] to provide sufficiently robust data as to be able to demonstrate that their test performs as intended.’ 

This provides a convenient way for the MHRA to shirk responsibility and transfer it to the DHSC. How can the public trust the data coming out of the DHSC will be ‘sufficiently robust’ when it’s doing its own self-evaluation, having procured close to £4billion worth of these tests? 

To exacerbate the matter, the MHRA states the legal manufacturer of the Innova professional use test is Xiamen Biotime but the DHSC is the legal manufacturer of the ‘repurposed self-tests’. It is questionable why the MHRA have chosen to separate the test into two versions with two different ‘legal manufacturers’ when it is the same test made by the same manufacturer, Xiamen Biotime, in China. 

If there’s any credibility left in the MHRA, it vanishes under their rubber stamp approval of the evidence supplied by the DHSC, where they conclude ‘there is a satisfactory likelihood that when used in combination with other measures the DHSC rapid lateral flow self-tests have the potential to moderately reduce the number of infected individuals.’ In other words, they’re satisfied with just how inferior these tests are, enough to extend their EUA of it. 

Whilst the MHRA believes it is ‘the role of the DHSC and NHS Test and Trace to determine how the tests are deployed in the UK and to ensure they are fit for purpose’, there are experts, such as Jon Deeks, professor of Biostatistics from Birmingham University, who has concluded they are certainly ‘not fit for purpose’ and has heavily questioned how they’ve been deployed, as self-testing kits for anyone above the age of 12 without symptoms. 

In January 2021, he wrote in the BMJ: ‘In the face of so much potential for harm and so little evidence of benefit, why is the government pushing the rollout? It seems at least plausible that this is because hundreds of millions of Innova testing kits were purchased before it was known how they would perform in people without symptoms and when administered by less than expert hands.’ There is ample evidence in my investigative reports on Innova to support his statement.

Following the FDA’s warning, Deeks said: ‘There have been many problems with transparency in the evidence to support the government’s policies for use of this lateral flow test, which negatively impacts on uptake. Given the more serious concerns identified by the FDA, it is essential that full explanations and data are provided to explain decisions made about its continued use, if that is the decision made.’

In short, this government and its agencies have failed to be transparent by not providing the data/evidence to support the argument for the exorbitant cost of the DHSC/NHS Test and Trace scheme or even to show that it has been an effective endeavour. They have also failed to show any substantial evidence to support their decision to extend the EUA of the Innova LFT. The MHRA’s email to Mr Carmichael and their statement published on the government’s website exemplifies this. 

In Part 3 of my follow-up report, I shine light on the overreaching tentacles of Innova Medical Group. 

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Sonia Elijah
Sonia Elijah has a background in Economics. She's a former BBC researcher and now works as an investigative journalist. Follow her on Twitter @sonia_elijah.

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