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BMJ report questions swine flu jab transparency

Investigations unearthed internal reports suggesting problems with Pandemrix safety

Louise Prime

Friday, 21 September 2018

The BMJ has this morning published an investigation* into events around the 2009 vaccination programme against influenza H1N1 (swine flu) that it said indicated large discrepancies in rates of adverse event reporting for Pandemrix compared with other GSK pandemic influenza vaccines, and revealed that neither the manufacturer nor some public health bodies seemed to have made public the reports that they had received.

The BMJ’s associate editor and author of the feature, Peter Doshi, said the events “raise fundamental questions about the transparency of information”. He questioned when public health officials have a duty to warn the public about possible harms of vaccines detected through pharmacovigilance, how much detail the public should be given, and whether the provision of this information should be proactive or passive.

Doshi’s colleague Tom Jefferson, a medically trained epidemiologist, was hired as an expert witness by solicitors involved in a lawsuit alleging that GSK’s H1N1 vaccine Pandemrix had caused narcolepsy. Jefferson said that when last year he saw a copy of the GSK safety reports that had been emailed within the company and to at least one regulator (Ireland), and the adverse event tables within them, he “just fell off the chair. A consumer can figure out what’s going on here”. His own calculations using the data in the tables “showed large differences between Pandemrix and Arepanrix” (a similar H1N1 vaccine from GSK that, like Pandemrix, also contained AS03 adjuvant), as well as an H1N1 vaccine from GSK without adjuvant.

Jefferson said he was struck not only by the fact that the odds ratios for adverse events were so high, but also that “nobody had tabulated and analysed them” – the necessary data were there in the GSK reports, but the reports did not contain the calculations for the odds ratios.

The BMJ made its own analysis of the rates of adverse events and, Doshi reported: “For a range of concerning adverse events, reports were coming in for Pandemrix at a consistently higher rate than for the other two GSK pandemic vaccines – four times the rate of facial palsy, eight times the rate of serious adverse events, nine times the rate of convulsions. Overall, Pandemrix had, proportionally, five times more adverse events reported than Arepanrix and the unadjuvanted vaccine.” Yet, he said, it appears that neither GSK nor the health authorities made public this information.

He pointed out that GSK – citing ongoing litigation – declined to answer the BMJ’s questions about whether it had investigated those discrepancies, told healthcare providers about them, or considered taking Pandemrix off the market or recommending an alternative. Nor would the UK Department of Health answer why it recommended Pandemrix over Baxter’s unadjuvanted H1N1 vaccine Celvapan.

Doshi also cited Jefferson, who noted that even once the swine flu pandemic was waning the Irish government kept inviting people to get vaccinated; and a member of the Irish parliament who called the adverse events after Pandemrix a “completely avoidable catastrophe”.

Furthermore, said Doshi, it is hard to discern how much the European Medicines Agency (EMA) knew or could have known about the comparative safety of GSK’s pandemic vaccines. He said the EMA told the BMJ that it “does not perform comparative benefit and risk evaluations between products approved in the EU, or between EU products and products approved or used outside the EU”.

He noted that although these specific vaccines are out of use, because they related to a pandemic that has long since passed, these events “raise fundamental questions about the transparency of information”.

He concluded by asking: “When do public health officials have a duty to warn the public over possible harms of vaccines detected through pharmacovigilance? How much detail should the public be provided with, who should provide it, and should the provision of such information be proactive or passive?

“If history were to repeat itself, does the public have a right to know?”

*Doshi P. Pandemrix vaccine: why was the public not told of early warning signs? BMJ 2018; 362: k3948 doi: 10.1136/bmj.k3948

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