Last month I wrote to both the British and European drug regulators regarding recent evidence that has surfaced in Douglas De Coninck's book, De busramp in Sierre: 1 Pill, 28 Dead. In short, the book centres around the 2012 bus crash that happened in the Sierre Tunnel, A9 Autobahn, Valais, Switzerland and alleges that the driver, Geert Michiels, 34, was in a destructive relationship and had also been medicated with GlaxoSmithKline's Seroxat. The generic name for Seroxat is paroxetine and it is better known in the US and Canada by its brand name Paxil and in Australia and New Zealand as Aropax.
My email to both medicine regulators can be read here (Email to Medicine Regulators Regarding 2012 Sierre Bus Crash)
The MHRA have now replied. As yet I have still not received a reply from the European regulator.
The MHRA reply is below ~ My follow-up questions follow the two page MHRA letter.
Click image to enlarge.
My reply to their response...
Dear MHRA,
Thank you for your recent correspondence.
I have some follow on questions that may or may not be deemed to fall under the Freedom of Information Act. If they do, then please treat them as such.
The study you refer to in your last correspondence with me, 'Suicidality and aggression during antidepressant treatment: systematic review and meta-analyses based on clinical study reports' showed that a number of clinical study reports were used of a wide range of antidepressants, one of which was fluoxetine. These reports, according to the published paper, were obtained from European and UK drug regulators.
Q1: You claim in your letter sent to me, ref GENQ-00113734, that Sharma's findings were "consistent with the outcome of previous regulatory reviews."
Given that fluoxetine was one of the antidepressants used in the Sharma study, do you still maintain that it is a safe and effective treatment for use in adolescents?
Q2: In the third paragraph of the letter you sent me you state, "With regards to your comments on the Yellow Card Scheme, this is a national scheme that collects reports for reactions occurring in the UK and therefore we cannot complete a report based on the book reference you have provided; De busramp in Sierre: 1 Pill, 28 Dead. As part of their pharmacovigilance responsibilities however Marketing Authorisation Holders are expected to monitor medical and scientific literature which discusses potential side effects to their products and to report these to the relevant national competent authorities as appropriate."
Now that you have been made aware of the De busramp in Sierre: 1 Pill, 28 Dead book, will you, as a regulator, be making any efforts to contact the Marketing Authorisation Holders regarding the findings of the author?
Q3: In Sharma's study the authors state that they had "only partial access to appendices with no access to case report forms, the harms could not be estimated accurately."
Based on this statement, have the MHRA or the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency had complete access to all appendices and case report forms?
If yes, could you please forward me all appendices and case report forms that Sharma et al never had access to.
If no, can you explain how a safety review panel (MHRA or the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency) can make an accurate decision when appendices and case report forms are missing.
Bob Fiddaman.
Related stories.
Did Seroxat Trigger the Fatal Sierre 2012 Bus Crash?
Sierre Bus Crash Revisited
Email to Medicine Regulators Regarding 2012 Sierre Bus Crash
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