Letter of complaint

Re alleged Inappropriate and Illegitimate Promotion by Pfizer under ABPI Code of Practice for the Pharmaceutical Industry 2021

TO:

Heather Simmonds

Director

PMCPA

7th Floor

Southside

105 Victoria Street

London

SW1E 6QT

 

Delivered by email

complaints@pmcpa.org.uk

For the urgent attention of Heather Simmonds, Director of the Prescription Medicines Code of Practice Authority (PMCPA)

Cc: advertising@mhra.gov.uk

 

Dear Ms Simmonds

We are writing on behalf of UsForThem, a parent-led campaign group calling children’s needs to be prioritised during the pandemic response. The purpose of this letter is to complain about a recent article and video posted on the BBC news website [ https://www.bbc.co.uk/news/health-59488848]. The item consists of an interview with the CEO of Pfizer, Dr Albert Bourla. The interview is conducted by the BBC medical editor Fergus Walsh and appears in the “Health” section of the BBC site. It is entitled “Pfizer boss: Annual Covid jabs for years to come” and was posted on the 2nd of December 2021. Please note that this piece was not written by a BBC financial journalist and did not appear in the “Business” section of the BBC site. Thus, Pfizer cannot claim any exemptions under the Code that might be applicable to business-related materials as set out in clause 26.2.

The article is published by the British Broadcasting Corporation. The interview is conducted by a British-based journalist and includes much specific discussion of the management of Covid-19 using Pfizer’s product in the UK.  Therefore, it is our understanding that it falls within the scope of the ABPI Code of Practice 2021 (the Code).

Promotional Nature of the Material

We are of the opinion that the tone, content and means of dissemination of this article and the associated video are extremely promotional in nature. The PMCPA’s definition of what constitutes promotion is set out in Clause 1.17 of the Code:

“Promotion means any activity undertaken by a pharmaceutical company, or with its authority, which promotes the administration, consumption, prescription, purchase, recommendation, sale, supply or use of its medicines.”

Much of what Dr Bourla says in this interview, and is reported to have said, clearly fulfils your definition of promotion of a Pfizer product, namely their Covid-19 vaccine.  Some examples are as follows:

“People will be likely to need to have annual Covid vaccinations for many years to come.” “….to maintain very robust and very, very high levels of protection.”

“I believe we have saved the global economy trillions of dollars”

“Vaccines have helped save millions of lives during the pandemic and without them the fundamental structure of our society would be threatened.”

“Immunising that age group [children under the age of 11] in the UK and Europe would be a very good idea”

“So, there is no doubt in my mind that the benefits completely are in favour of doing it [vaccinating children against Covid-19]

In addition to promotion of the Pfizer vaccine there are also promotional statements about another Pfizer product in development. “Pfizer has also developed an antiviral pill Paxlovid which in trials cut hospital admissions and deaths by nearly 90%.”

I make few comments at this stage about the truth, accuracy or substantiability of any of these statements except to say that none of them are substantiated within the article, and very few of them are capable of being evidenced.  Furthermore, several exaggerated and superlative claims are made and statements are unbalanced in that they give no information about potential risks associated with the use of their vaccine, or of its unlicensed status.  Breaches of clauses 6.1, 6.2 and 14.4, at the very least, have taken place here.  However, at this stage, I am principally using these statements to clearly establish that the content and tone of this material are promotional.

 

Inappropriate and Illegitimate Promotion

Having established the promotional nature of this material, it is then necessary to ask whether it is appropriate for Pfizer to promote their product in this way.  We strongly believe that it is not. We would like to refer you to three earlier cases of complaints against Pfizer for promoting their Covid-19 vaccine illegitimately online. These cases are: AUTH/3422/11/20, AUTH/3438/12/20 and AUTH/3437/12/20. In these cases, it was the judgement of the PMCPA that Pfizer’s covid-19 vaccine regulatory status was that of a temporary approval for emergency use only.  The PMCPA clearly stated in these judgements that the vaccine was not a licenced medicine, and that Pfizer were guilty of promoting an unlicensed medicine in breach of clause 3.1 of the Code. We are not aware that the UK regulatory status of Pfizer’s covid-19 vaccine has changed since these judgements were made and therefore Pfizer is, with this Bourla material, once again in breach of clause 3.1 of the Code.  Furthermore, in view of the fact that Pfizer have had several findings against them of a similar nature in the past 6 months it would be appropriate to say that they are also in breach of clause 3.3 (Compliance with undertakings).

We would now like to turn to specific complaints about statements and claims made in this promotional piece (some of these statements and claims have been listed above). As we explained earlier UsForThem are an organisation established to help protect the interests of children during the pandemic response, and so we are here going to confine ourselves to those statements and claims relating to children:

  1. “Immunising that age group [children under the age of 11] in the UK and Europe would be a very good idea.” Here, Dr Bourla recommends vaccinating healthy British children under the age of 11 against Covid-19. He is making a claim for the clinical efficacy and safety of his product, its risk/benefit balance, even though the vaccine has not yet been included in the emergency use temporary approval for use in children this young in the UK.  This is a breach of clause 3.1.
  2. “Covid in schools is thriving”……“This is disturbing significantly the educational system and there are kids that will have severe symptoms”  Severe covid is rare amongst children of school age in the UK and while the virus does circulate in schools, schools have typically reflected community transmission throughout the pandemic. Neither has covid itself had a significant impact on disturbing children’s education in the UK. The ‘disturbance’ to the UK educational system has resulted from political decisions made by governments, not the virus. Indeed, we know that the UK had the second highest rates of school closures in Europe, except for Italy – a result of political decisions.

There is simply no evidence that healthy schoolchildren in the UK are at significant risk from the SARS COV-2 virus and to imply that they are is disgracefully misleading. Once again, these are breaches of clauses 6.1 and 6.2

  • So, there is no doubt in my mind that the benefits completely are in favour of doing it” This is probably the most egregiously false and misleading of Dr Bourla’s statements. It completely neglects to consider that there are potential risks to healthy children associated with administration of the COVID-19 vaccine. I refer you to the documents below.

Pfizer leaflet listing side effects https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/information-for-uk-recipients-on-pfizerbiontech-covid-19-vaccine

Latest government advice re myocarditis to healthcare workers detailing rates of myocarditis in hospitalised children https://www.gov.uk/government/publications/myocarditis-and-pericarditis-after-covid-19-vaccination/myocarditis-and-pericarditis-after-covid-19-vaccination-guidance-for-healthcare-professionals

Latest Adverse events reported for Pfizer https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1038175/COVID-19_mRNA_Pfizer-BioNTech_Vaccine_Analysis_Print_DLP_24.11.2021.pdf

]. Indeed, the conclusion of the Joint Committee on Vaccination and Immunisation earlier this year when asked to give their opinion on this very subject in relation to the older cohort of children of between 12 and 15 was as follows:

 

“The available evidence indicates that the individual health benefits from COVID-19 vaccination are small in those aged 12 to 15 years who do not have underlying health conditions which put them at risk of severe COVID-19. The potential risks from vaccination are also small, with reports of post-vaccination myocarditis being very rare, but potentially serious and still in the process of being described. Given the rarity of these events and the limited follow-up time of children and young people with post-vaccination myocarditis, substantial uncertainty remains regarding the health risks associated with these adverse events.

Overall, the committee is of the opinion that the benefits from vaccination are marginally greater than the potential known harms (tables 1 to 4) but acknowledges that there is considerable uncertainty regarding the magnitude of the potential harms. The margin of benefit, based primarily on a health perspective, is considered too small to support advice on a universal programme of vaccination of otherwise healthy 12 to 15-year-old children at this time. As longer-term data on potential adverse reactions accrue, greater certainty may allow for a reconsideration of the benefits and harms. Such data may not be available for several months.”

This conclusion hardly seems to be consistent with the opinion of the CEO of Pfizer that there is “no doubt” or that “the benefits completely are in favour”.  In the circumstances we think it clear that not only has there been breaches of clauses 6.1 and 6.2 but also, the failure to promote rational use of the medicine, the misleading presentation of the risk/benefit profile and the use of exaggerated, all-embracing claims (“no doubt” and “completely in favour”) represent a breach of clause 14.4 too.

Whether Pfizer, or indeed the BBC, like it or not, opinion about the benefits and risks of vaccinating healthy children against an infection which poses little risk to them, and the ethical considerations of exposing healthy children to the risks of vaccination (no matter how rare these effects may be) in order to protect adults or vulnerable members of society, is not settled.  For a pharmaceutical company to be behaving, on a public platform, as if it is, is wrong.  This material is therefore also in breach of the requirement of clause 6.1 that “emerging clinical and scientific opinions which have not been resolved in favour of one generally accepted viewpoint must be referred to in a balanced manner”.

 

The Relationship of Pharmaceutical Companies with The Public

Clause 26 of the Code deals with “Relations with the Public, Including Patients and Journalists”. Clause 26.1 requires that “Prescription only medicines must not be advertised to the public”. This clause also states that “This prohibition does not apply to vaccination and other campaigns carried out by companies and approved by the health ministers”.  We are also aware that, in previous cases (AUTH/3422/11/20, AUTH/3438/12/20 and AUTH/3437/12/20), the PMCPA has judged that the prohibition within clause 26.1 relating to promotion to the public does not apply to Covid-19 vaccines as they are unlicensed and therefore cannot be described as prescription only medicines.  The PMCPA described this as a decision based on a “narrow technical point”.  We are however also aware that there is a new clause in the Code, clause 11.3, which deals with temporary authorisation for sale or supply without a marketing authorisation. “In response to certain types of public health emergency, under UK law, the licencing authority may temporarily authorise the sale or supply of a medicine without a marketing authorisation”. Pfizer’s covid-19 vaccine falls within the scope of this clause. Clause 11.3 requires that “a medicine with a temporary supply authorisation must not be promoted unless it is part of a campaign that has been approved by the health ministers.” And “The campaign must be approved by the health ministers and all relevant requirements of the Code will apply.” Furthermore, clause 11.3 requires that “Companies should contact the MHRA for information regarding approval of materials and activities”.  Such is the poor quality of this activity, and these materials, which are the subject of this complaint, in terms of their lack of compliance with the Code that we find it difficult to believe that they have undergone the required prior scrutiny and approval by the MHRA on behalf of the ministers. Therefore, we believe that there has also been a breach of clause 11.3. Furthermore, clause 26.1 contains the following statement “In addition, such campaigns should include a general reference to the reporting of side-effects as it is unlikely that the requirements of clause 26.4 will apply as the relevant material is not intended for patients taking a particular medicine”.  You will be aware that clause 26.4 relates to the provision of information about reporting of side-effects.  It is not clear to us whether clause 26.4 is applicable here or not but as no information whatsoever was provided about reporting of side effects, or indeed the side-effects themselves, then there must have been a breach of either clause 26.4 or 26.1.

As we have pointed out above, Clause 26 of the Code deals with “Relations with the Public, Including Patients and Journalists”. Contained within the supplementary information to this clause is some excellent advice to pharmaceutical companies when dealing with the media: “Particular care must be taken in responding to approaches from the media to ensure that the provisions of this clause are upheld.

Attention is drawn to the Blue Guide Appendix: Reporting to the public on medicines: Advice for journalists and patient organisations produced by the Medicines and Healthcare products Regulatory Agency (MHRA)”

We took the Code’s advice ourselves and consulted the MHRA document cited https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/956846/BG_2020_Brexit_Final_version.pdf .  It contains some useful statements and advice from the MHRA which are relevant to this case:

“The key point is that these controls (and the penalties for breaches) apply to any person who promotes a medicine – not just the manufacturer.  This can potentially include newspaper or magazine articles, or information disseminated by a patient organisation” [Or presumably a broadcasting or web-based organisation]

“But articles should not actively encourage readers to seek a particular product from their healthcare provider and must take care not to exaggerate the potential benefits”

“Articles discussing healthcare issues, particularly medicines, ought to be factual, well balanced and accurate”

We are aware that the PMCPA are not responsible for ensuring adherence to the rules set out in the MHRA Blue Guide, but we have copied the MHRA advertising standards unit into this letter in case they consider that additional investigations need to be carried out.

Supplementary information to clause 26 of the Code states that “In the event of a complaint which relates to the provisions of this clause, companies will be asked to provide copies of any information supplied, including copies of any relevant press releases and the like.  This information will be assessed to determine whether it fulfils the requirements of this clause”.  We have no way of knowing whether Dr Bourla’s interview with the BBC was or was not solicited by Pfizer. Similarly, we have no way of knowing whether Dr Bourla was formulating his answers based on briefing notes prepared by the Pfizer communications department, or, indeed, whether Mr. Walsh prepared his written article with the aid of written briefing notes or press releases provided by Pfizer.  This information would no doubt inform and guide your judgements about this case, and we are sure that you will be seeking it during your investigations.

Summary

In summary, this article, and the video associated with it, constitute promotion by Pfizer of its unlicensed medicine which falls within the scope of the ABPI Code of Practice for the Pharmaceutical Industry 2021. The material contains numerous breaches of clauses 3.1, 6.1 and 6.2. It also contains breaches of clauses 11.3,14.4 and 26.1 (or26.4). Pfizer have also failed to maintain high standards and brought discredit upon your industry so breaches of clauses 2 and 5.1 must also be taken into consideration. Furthermore, bearing in mind that Pfizer was found guilty of illegitimately promoting its COVID-19 vaccine using the internet less than six months ago, a breach of clause 3.3 (breach of undertaking) must also be considered.

Thank you very much indeed for dealing with this complaint,

Yours sincerely,

 

Molly Kingsley

Director

(Signed digitally) On behalf of UsforThem