Intended for healthcare professionals

Rapid response to:

Editor's Choice

A tale of two vaccines

BMJ 2018; 363 doi: (Published 04 October 2018) Cite this as: BMJ 2018;363:k4152

Rapid Response:

Re: A tale of two vaccines - MHRA - 6 Reports of "rare" suspected ADR in 60 days ignored

Dear Editor,

As early as December 2009 the MHRA had already received six reports of suspected hypersomnia within a mere 67 days. These were reports associated with the administration of Pandemrix [1]. "Narcolepsy is a rare, natural illness, with around 10 new cases per million people every year" [2]. Although not as rare as narcolepsy, hypersomnia is rare. Six possible cases in 67 days [of a closely related condition and one potentially easily confused with the rarer narcolepsy] might be thought a large enough signal to warrant investigation, especially when under-reporting is taken into account. Irrespective of whether the cases were predominantly children, if many were children that suggests the signal should have been taken more seriously.

Narcolepsy and hypersomnias refer to a group of disorders for which excessive daytime sleepiness (ESD) is the core symptom, but when it is not due to insufficient sleep (sleep deprivation), disturbed nocturnal sleep, insomnia, circadian rhythm disorders, sleep-related breathing (sleep apnea) disorders or medical issues. In narcolepsy, other symptoms beside excessive daytime sleepiness are present as well and there is a tendency to falling asleep directly or extremely rapidly into Rapid Eye Movement (REM) Sleep (dreaming sleep). [3]

Should the MHRA have acted sooner to protect the public and especially their very small children?

The MHRA's 2011 explanation [2] was:
"Most reports of narcolepsy after exposure to Pandemrix vaccine came from Finland and Sweden. In September 2010, the European review concluded that the available evidence was insufficient to confirm a link between Pandemrix and narcolepsy, and that further studies were necessary to fully understand this issue. No restrictions on use of the vaccine were recommended.
After use of more than 6 million doses of Pandemrix vaccine in the UK, we have received 4 unconfirmed reports of narcolepsy following vaccination. These were received after the reports from Finland came to light. The reports so far in the UK are no more than we would expect to see by coincidence after vaccination.
After review of all of the available information, the case remains that a link between Pandemrix vaccine and narcolepsy has not been confirmed. Epidemiological studies are ongoing to further evaluate this."

No explicit mention is made of the six reports of hypersomnia received within 67 days by 21 December 2009 and whether any may have been narcolepsy confused with hypersomnia. And of course as explained in a prior response [4], the MHRA recorded the Yellow Card reported symptoms as if each one was a suspected Adverse Drug Reaction instead of investigating and recording the condition or syndrome indicated by the reported group of symptoms reported on the Yellow Card concerned.

Further, what was particular to Finland and Sweden's reporting systems which caught so many reports which the MHRA's Yellow Card systems appears to have missed?

Professor Bill Inman's criticisms of his adverse event reporting system, now the Yellow Card system, as inadequate could have been addressed in some good measure by the MHRA over the decades since its introduction.

Despite numerous drug scandals over that time one is tempted to think the MHRA appears less interested in keeping pharmaceuticals of questionable safety off the market than on. In my view it is time the MHRA was swept away with all the drug industry associations its personnel may have and for safety to be given priority over drug company profits.

However, it appears a complex web is woven. The longstanding problems of what appears to me to be drug industry bias amongst personnel in the Department of Health, including agencies like the MHRA, appears by inference to be in some way associated with anonymous senior civil servants. If it were otherwise one might argue that the problems could not continue and should be less likely to exist. That is coupled with the influence the pharmaceutical industry has invested heavily in acquiring throughout Government, the civil service, medical schools, the medical professions, medical societies, health charities and medical publishing. Generous donations and grants are known commonly and to be made on a routine basis. Throw in for good measure manipulation of the media, and daylight is less than likely to be shone to illuminate the darkness. [5]

[1] MHRA'S UK Suspected Adverse Reaction Analysis Swine Flu (H1N1) Vaccines – Celvapan and Pandemrix 31 December 2009

[2] MHRA PUBLIC ASSESSMENT REPORT Swine flu vaccines and antiviral medicines: UK post-pandemic safety review February 2011
Accessed 18 Oct 2018

[3] Narcolepsy, Hypersomnia and Excessive Daytime Sleepiness
Stanford Healthcare

[4] Re: A tale of two vaccines - MHRA Published Incomplete ADR Data 14th October 2018 Clifford G Miller

[5] The Influence of the Pharmaceutical Industry Fourth Report of Session 2004–05 Volume I Report, together with formal minutes Ordered by The House of Commons to be printed 22 March 2005

Competing interests: No competing interests

18 October 2018
Clifford G Miller
Lawyer with science background London England