the penalty? -a paltry £5000 fine
This article was sent to us by a member of the public, who has been diligently making complaints against various pharmaceutical companies, with some success. Thank you to a number of people who have been beavering away trying to do what the regulators should be doing, in holding the pharmaceutical industry to account!
The wheels of pharmaceutical regulation grind depressingly slowly but the industry self-regulatory body, the Prescription Medicines Code of Practice Authority (PMCPA) has just found Glaxosmithkline (GSK) guilty of making a misleading claim about its covid vaccine (Case AUTH/3760/4/23). Development and marketing of the vaccine is a joint venture between GSK and Sanofi.
The complaint
A member of the public complained about the claim, which was made in a GSK press release issued in 2022:
“The results showed a 64.7% efficacy against symptomatic SARS-CoV-2 infection in adults, regardless of their SARS-CoV-2 infection status prior to vaccination, and 75.1% efficacy in participants previously infected with SARS-CoV-2’.”
The complainant pointed out that these results were just the relative efficacy rates and that the UK’s Code of Practice for the pharmaceutical industry requires that the absolute efficacy rates should also be shown when discussing efficacy in this way. The absolute efficacy rates are much smaller than the relative rates, often being as low as 0.5% to 2.0%, for covid vaccines – depending on the precise endpoint, subject group and vaccine studied.
When it comes to the efficacy of their products, the pharmaceutical industry always likes to talk about relative rates rather than absolute rates. The reasons for this have already been well explained by others, including Carl Heneghan and Tom Jefferson on their excellent Substack “Trust the Evidence”. The reason is essentially that it enables pharma to present their products in the best light. A crude example of how this works might be to imagine a disease that has a 2% prevalence rate. That means that at any one time, out of 100 people, 2 will have the disease. If a new drug is found to have the effect of reducing the prevalence rate from 2% to 1% then the relative efficacy rate of the drug is said to be 50%. This means that the prevalence rate is reduced by a half. However, the absolute efficacy rate is much less than this, in this case it is only 1%. Now which of these efficacy rates do you think that any pharmaceutical company looking to sell this drug would be most keen to publicise? However, claiming 50% efficacy for your new drug in this way is misleading because it tells you nothing about the actual magnitude and importance of the effect. Without knowing the absolute rate too, it is impossible to know that the actual reduction in risk of catching the disease (already low) is really only 1%. A reduction in a prevalence rate from 100% to 50% would also represent a relative risk reduction of 50%, but with a much larger absolute rate reduction, also 50% in this example. Thus, without knowing the absolute rate, we are unable to assess the true magnitude and importance of any treatment effect.
This potential to mislead in communications about pharmaceuticals is acknowledged by the MHRA in its guide to the Medicines Advertising Regulations, The Blue Guide. On page 21 of the Blue Guide, in a section entitled “Encouraging Rational Use” is given clear and explicit guidance:
“Data, trials or studies that are not presented accurately or in context would be considered as exaggerating the properties of a product. Where a relative change is quoted, the absolute values should also be given to enable the reader to fully assess the magnitude of the claimed benefit.”
This requirement is further reflected in the Association of British Pharmaceutical Industry (ABPI) Code of Practice for pharmaceutical companies, compliance with which is enforced by the PMCPA. In this Code, Clause 6.1 makes it clear that:
“Referring only to relative risk, especially with regard to risk reduction, can make a medicine appear more effective than it actually is. In order to assess the clinical impact of an outcome, the reader also needs to know the absolute risk involved. In that regard, relative risk should never be referred to without also referring to the absolute risk. Absolute risk can be referred to in isolation”
Thus, the rules are clear for pharma in the UK when presenting the efficacy data for their products. So when it comes to their covid vaccines, why do pharmaceutical companies repeatedly appear to believe that these rules do not apply to them? Before the recent findings against GSK for misrepresenting their covid vaccine data in this way, both AstraZeneca (AUTH/3518/5/21) and Pfizer (AUTH/3519/5/21) were also found guilty in 2021 by the PMCPA of doing exactly the same thing for their covid vaccines. To be honest, this question is somewhat rhetorical as the potential commercial rewards for the fast and widespread uptake of covid vaccines (and not just in terms of sales) are self-evident and now demonstrable. With enthusiasm, a sensationalist media and desperate politicians rushed to seize and disseminate the message of these illegally presented relative efficacy rates in 2020 and 2021, providing no context regarding the very low absolute efficacy rates particularly for low risk groups such as the healthy young (for whom vaccine risks vastly outweigh any potential benefits). This has meant that, by the time the sluggish self-regulatory system has caught up with the offending pharma companies and their misleading claims, the damage had been done and the attendant commercial benefits had already been realised by the pharma companies. Just a reminder here that the Pfizer case took 22 months for the PMCPA to decide that the public had been misled, the AZ case 13 months and the GSK case 15 months.
This arrogant stance of being above the rules, even above the law, is at its most egregiously obvious in GSK’s response to the complaint, where they admit to being well aware of previous PMCPA decisions on these matters but state that these precedents do not apply to them. Fortunately the PMCPA were able to put them right in this regard. Rather amusingly, one of the reasons given by GSK to explain why previous decisions of the PMCPA do not apply to them was:
“neither Pfizer or AstraZeneca appealed the breaches of 7.2 (2019), and thus did not take full advantage of the self-regulatory process to argue their case at the Appeal Board.”
Indeed? So did GSK then seize the opportunity this time to argue their own case before the Appeal Board? No, they did not. I wonder why.
The Penalty
And GSK’s penalty for knowingly deceiving the public in this way? A stinging fine of £5000. Correct, just £5000! Where on earth is the deterrence in that? This company stood to make millions from a successful UK launch of their covid vaccine, and potentially billions in terms of global sales plus an uplift in their share price. In that context, £5000 does not even register as a marginal cost of doing business. It is risible.
The Mudslinging
More seriously, some of the content of the GSK response to this complaint is quite disturbing. At the bottom of page 6 of the case report, GSK takes the opportunity to attack and insult the complainant, and indeed anyone else who dares to criticise any aspects of the pandemic response. They berate their critics thus :
“The pandemic introduced a level of misinformation and conspiracy theories on social media that were unparalleled and risked derailing the efforts to bring the pandemic under control. One of the main targets for this was (and remains) anti-vaccine misinformation. When a Lancet paper included ARR rates, cynics seized on them to show how companies and governments were lying about vaccine efficacy and it fuelled vaccine hesitancy as it was difficult to explain the underlying statistics quickly and simply. Thus, the addition of absolute risk does not always provide greater clarity, but can, as in this example, fuel misunderstanding.”
The Reply
The complainant was understandably angry and upset by these slurs and submitted a rebuttal to the PMCPA, offering GSK the opportunity to apologise and withdraw that statement. GSK refused to do so. The complainant also asked that the rebuttal be published alongside the original GSK statement. This request was also refused and yet the PMCPA still published the GSK statement unchallenged in the final case report. Here is the complainant’s rebuttal to the GSK slurs, which the PMCPA have refused to publish.
“I believe this to be an ill-judged and regrettable public statement. The use of generalised and undefined slurs such ‘anti-vaccine’, ‘misinformation’, ‘cynics’ and ‘conspiracy theories’ to attempt, presumably, to silence and shame individuals with legitimate questions about the way that governments and other organisations behaved during the pandemic. GSK will be aware that many criticisms directed at pandemic measures, slated as ‘conspiracy theories’ or ‘anti-vax’ at the time, have subsequently been accepted as well-founded.
“People, such as myself, highly supportive of vaccination as a public health measure but critical and questioning of the way that covid vaccines specifically have been developed, licenced, promoted and used, have been slurred as ‘anti-vaccine’ or ‘anti-vaxxers’. I can only assume that this is a deliberate attempt to avoid an open, respectful and nuanced debate. It may well be “difficult to explain the underlying statistics quickly and simply” but when a pharmaceutical company itself chooses to use statistics to inform people about its products, then the Code [ABPI Code of Practice] simply requires that it does not do so in a way that is misleading. All I, and others, are asking is that we be given ALL the information we need to make our own minds up about the benefits and risks of those products.
“I am extremely concerned that any of the covid vaccine manufacturers would resort to using the term ‘misinformation’ to describe valid criticism of their activities. I would like to remind GSK that they have just been found guilty by the Panel of misrepresenting the efficacy of their vaccine to the British public. Irrespective of whether GSK decided to appeal [they did not], this, at the very least, illustrates that my complaint is worthy of more respect than is demonstrated by this statement by GSK. This is now the ninth case in which the PMCPA has found a pharmaceutical company guilty of misleading the British public about their covid vaccines. Since the introduction of these vaccines the PMCPA have (so far) found pharmaceutical companies (now including GSK) guilty of, amongst other things:
· Misleading the public by misrepresenting the efficacy of their covid vaccines
· Misleading the public by misrepresenting the safety of their covid vaccines
· Misleading the public by describing their covid vaccines as “safe”
· Promoting unlicenced medicines
· Bringing discredit on the pharmaceutical industry
“With all these rulings in mind, one surely must ask who are the true purveyors of ‘misinformation’. The conduct of these companies has already undoubtedly damaged public trust in pharmaceutical interventions.
“I suspect that GSK may come to regret this public statement. They may well want to consider whether a public retraction and an apology for it are now in order.”
Who are the ‘misinformants’ and where are the Regulators?
The above appears to be a reasonable and temperate response to the corporate arrogance and hubris demonstrated by GSK’s petulant reaction to the complaint. Since this rebuttal was first written, yet another pharma company, Moderna, has also been found by the PMCPA to have breached its Code of Practice by permitting the use of social media to solicit the recruitment of children into a covid vaccine clinical trial using unapproved and illegal financial incentives. HART reported on this trial last year. If we cannot trust these companies to play by the rules when they want to use our children in their clinical trials, then what can we trust them with? Should we believe anything they say at all? The product licence for this GSK/vaccine was withdrawn in the EU earlier this year, apparently at the request of the manufacturer. The licence continues in the UK, but as the 7th covid vaccine to enter the UK market, it is fortunately doubtful that large numbers of people have received it. And of course GSK have form, being the pharma company to have produced Pandemrix vaccine for swine flu in 2010, which was later withdrawn on safety grounds, and also having paid out $3billion, one of the biggest fines on record under the US False Claims Act.
It’s worth noting that none of the breaches of the rules and regulations referred to by the complainant, along with the Moderna case discussed above, were identified as a result of monitoring or scrutiny by the regulators, either the PMCPA or the MHRA. They all arose as the result of complaints brought by members of the public who were concerned, correctly as it turns out, that pharma appeared to be ignoring rules governing the development and sale of their products. Once again big pharma seems completely unwilling to accept that these rules exist to protect the public from being misled and exploited. Notably, the regulators demonstrate that they are not up to the job of properly enforcing those rules and, until they are, it seems that a well-resourced and highly motivated pharmaceutical industry will continue to run rings around them.
