Pandemrix – The Current Crisis

The flu vaccine is an annual vaccine which is used in health care professionals, carers, and at-risk groups in order to reduce the morbidity and mortality of flu. Its overall effectiveness varies as it is dependent on prediction of which form of influenza will cause disease.[1] Following the recommendation trust is put in pharmaceutical companies to produce enough safe vaccine to provide adequate cover. In 2009 Glaxo-Smith-Kline (GSK) released a swine flu vaccine in order to tackle the global pandemic that was thought to be looming. At this point it released an unsafe and under tested vaccine before turning into a conspiracy theorist’s ideal example.

In 2009 the world was concerned that a strain of swine flu called H1N1 was approaching pandemic levels. The main concern was that we were going to get a repeat of the deadly Spanish Flu of 1918-1919 which was also a H1N1 strain. Ultimately, this did not come to fruition. However, as part of emergency preparations the WHO and major countries around the world sought a large scale vaccination campaign. One of the vaccines in use was Pandemrix created by GSK. A wide variety of GSK representatives and governmental officials proclaimed it to be safe and thoroughly tested.

A recent BMJ article[2] suggests that the reality was that Pandemrix had significantly higher number of adverse effects, particularly in children. The most noted one at present is the increased risk of narcolepsy. While this in itself is a major issue, what the companies and indeed governments are accused of doing is equally frightening. Instead of being open and honest about these results (which GSK was aware of), the company is alleged to have lied and obfuscated, proclaiming their vaccine to be safe when this was untrue. According to the BMJ it has taken almost a decade and a law suit for the truth to come out.

This is what the BMJ proposes happened. GSK employed a number of methods which sound like they come straight out of conspiracy theory 101 to suppress the release of negative information. Specifically they state that GSK was aware of the data on adverse effects and discussed it through a series of reports that were kept in house. This information was supplied to health authorities but the BMJ alleges that it stopped there going no further. Additionally, the article questions what the purpose of agencies in charge of pharmacovigilance is if they don’t use the data given to protect the public. This has been considered a scandal in a number of countries including Germany (where it is alleged that senior politicians received an alternative vaccine to Pandemrix) and Ireland (where members of Irish parliament allege that the Health Service Executive continued to purchase Pandemrix despite having knowledge that it was dangerous.

GSK[3], the European Medicines Agency[4], and the Medicines and Healthcare Products Regulation Agency[5] dispute this. Both provided direct responses to the BMJ article in question. Members of GSK allege that the BMJ article represents poor science with equivalences and comparisons drawn across disparate and different population groups. Additionally, it states that the accusations of obfuscation are unfounded as all its information was made public to the regulatory bodies. Finally, it challenges the data provided in the BMJ article as incomplete due to differences in adverse reaction reporting in different countries. The overall argument here is supported by the EMA and the MHRA who state that they have been open with data as it comes in. Their argument is that once the evidence of narcolepsy arose they withdrew the vaccine awaiting further research. This is also supported by a 2015 article in Human Vaccines and Immunotherapeutics[6] which states that the data on narcolepsy was flawed in collection in any case (a note however that there appears to be a lot GSK involvement in this study, use that information as you will).

Despite the article coming out over 6 weeks ago the debate continues (for another interesting angle look at the response coming from Tom Jefferson[7] on the 2nd of October 2018 challenging the EMA position). There are a lot of questions that need to be answered generally in regards to this case. Additionally, it asks the question of what is the role of clinicians in these debates. Should there be an expectation that all clinicians read the EMA’s bi-weekly updates? How far should clinicians trust in policy and medicines that they are provided? Questions that should be easy to answer have to be asked again with this new information. Either way, this case will turn out to be important in the role of vaccination on the whole, in a mostly negative way.

Now, this case is disastrous for a number of reasons. Firstly, if true a large proportion of people developed adverse effects unnecessarily. Additionally, if the allegations of conspiracy are true this will just provide an “evidence base” from which anti-vaccine campaigners will accuse all vaccines of impropriety. However, even if untrue this calls into question the underlying transparency of the system and creates an antagonistic relationship between regulators, pharmaceutical companies, and clinicians. Fundamentally, this case doesn’t just impact those directly affected. It impacts on the wider global health community and anyone who needs a vaccine. The way we can salvage it is to show exactly how vaccine providers and creators embrace transparency.

Author Details: Dr. Eliot Hurn, Foundation Year 2 County Durham and Darlington Foundation Trust.

[1] World Health Organization, WHO Global Influenza Program, WHO Global Influenza Surveillance and Response System (GISRS). “Recommended Composition of Influenza Virus Vaccines for Use in the 2018-2019 Northern Hemisphere Influenza Season and Development of Candidate Vaccine Viruses for Pandemic Preparedness.” Recommended Composition of Influenza Virus Vaccines for Use in the 2018-2019 Northern Hemisphere Influenza Season and Development of Candidate Vaccine Viruses for Pandemic Preparedness, 22 Feb. 2018. http://www.who.int/influenza/vaccines/virus/recommendations/201802_qanda_recommendation.pdf?ua=1

[2] Doshi, Peter. “Pandemrix Vaccine: Why Was the Public Not Told of Early Warning Signs?” BMJ, 20 Sept. 2018, doi:10.1136/bmj.k3948.

[3] Breuer, Thomas, et al. “Thomas Breuer and Colleagues at GlaxoSmithKline Respond to Peter Doshi.” BMJ, 3 Oct. 2018, doi:10.1136/bmj.k4116.

[4] European Union, European Medical Agency, Arlett, Peter. “Rapid Response to BMJ: Re Pandemrix Vaccine: Why Was the Public Not Told of Early Warning Signs?” Rapid Response to BMJ: Re Pandemrix Vaccine: Why Was the Public Not Told of Early Warning Signs?, 26 Sept. 2018. http://www.ema.europa.eu/documents/other/european-medicines-agency-rapid-response-british-medical-journal-pandemrix_.pdf.

[5] Bryan, Philip, et al. “MHRA Response to BMJ Editor’s Choice – ‘A Tale of Two Vaccines.’” BMJ, 4 Oct. 2018, doi:10.1136/bmj.k4152.

[6] Verstraeten, Thomas, et al. “Pandemrix™ and Narcolepsy: A Critical Appraisal of the Observational Studies.” Human Vaccines & Immunotherapeutics, vol. 12, no. 1, 17 Sept. 2015, pp. 187–193., doi:10.1080/21645515.2015.1068486.

[7]Jefferson, Tom. “Pandemrix Vaccine: We Need a Fact Check on Statements by EMA.” BMJ, 2 Oct. 2018, doi:10.1136/bmj.k3948.

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