I for one expected the outcome of this sham of an investigation to let GSK off the hook. I said so to both the MHRA and on my blog (many times).
What I didn't expect was the complete lack of empathy shown by the MHRA over those poor children that have suffered at the hands of this awful drug. To those that have died as a result of taking Seroxat, your investigation was meant to bring closure to the ones they left behind. Justice was supposed to have been seen to be done. You failed.
Your statement, Mr Woods, does not warrant publication. It is what patients have been telling the MHRA for years - only to be ignored by yourself and your incompetent team... until now.
I understand the story was leaked to the press, Mr Woods. You have a mole in the MHRA it seems? I hope that mole can come forward sometime in the near future.
Are you aware of The Influence of the Pharmaceutical Industry paper Mr Woods? This one was printed in March 2005.
Here's a few extracts to gloss over:
"Very soon after the appointment of the EWG, GSK submitted evidence to the MHRA to support a licensing application for Seroxat use in children. Suspecting a problem, the MHRA requested further data from GSK and, in June 2003, unexpectedly issued a warning to advise against the use of Seroxat in children."
They had the audacity to ask you for a license for children when they knew their drug could cause death in children! That in itself should warrant criminal charges!
"There appears to have been a lack of effective warnings relating to the frequency of withdrawal symptoms experienced with Seroxat. Both the manufacturers, GSK and the regulators, MHRA, claimed they had acted promptly and appropriately in this respect. However, working papers seen by the EWG state that the original licence application recorded Seroxat withdrawal reactions in 30% of patients. The regulators denied this. Three separate reviews conducted by the MCA/CSM in the 1990s were all based on Yellow Card counts, and produced misleadingly low estimates of the risk level"
and this from your Chairman, Alasdair Breckenridge:
"When a drug is licensed and for the first few years until there is good clinical trial evidence, one cannot say what the incidence of an adverse reaction is. You cannot tell that from yellow card reports"
Your system failed and because of this lives were lost. You then waste 4 years investigating what you already knew!
Dr June Raine of the MHRA was told almost 8 years ago by the world's leading expert on SSRi's, Prof. David Healy, that Seroxat can cause suicidality. He wrote the day after the Court case in “Cheyenne, Wyoming… found GlaxoSmithKline guilty on several accounts including the count that Paroxetine can cause suicidality, that it specifically did so and contributed to the wrongful death of Don and Rita Schell as well as Deborah and Alyssa Tobin and that the company had been responsible for a failure to test and a failure to warn”.
Why did you not act upon this?
Are you going to now publically acknowledge that Prof. Healy was right?
Are you going to ask why Dr June Raine of the MHRA did not take him seriously?
For years The MCA/MHRA, patient support groups (funded by pharma) and GlaxoSmithKline have publically ridiculed David Healy. He gave you the evidence and you ignored it.
Are both parties pleased with the outcome Mr. Woods? Did you celebrate at the end of this 4 year farce?
Children have died, families have been ripped apart, GP's have prescribed 'off label' and YOU knew.
Would you like to make an official statement to Stephanie Gatchell, Mr Woods? Do you even know who she is, Mr Woods?
Are you even bothered, Mr Woods?
So the investigation is over. GSK did wrong and are let of the hook. What now, Mr Woods?
Have you had a chance to read through the Glenmullen report yet, Mr Woods? I sent it to the MHRA the day it was released. It clearly shows an increased rate of suicidality in ALL patients NOT just children. 9 pages were missing from this report. You may want to ask Sen Grassley for these, he wrote to GSK and demanded them! Again, someone else doing the job of the regulator.
Am I right to suggest that this will be investigated too?
Will you be liasing with GlaxoSmithKline over this?
You have failed on a grand scale. You failed as the MCA with the Myodil debacle. You would have thought then that lessons would have been learned. But here we are once more. A catalogue of errors, evidence that you knew about the dangers almost 8 years ago but did nothing.
I want you to go home tonight Mr.Woods and light a candle. As it burns I want you to look deep inside the flame. Search inside for your conscience. You and your regulators have once again let down the British public. You have once again stood by and let children suffer. Your close ties with the industry have never been so apparent as what they are today following the results of your sham of an investigation.
I would like to take this opportunity to offer my sincere condolences to all those family members who have had to bury/cremate their children because of GlaxoSmithKline's Seroxat and because the Medicines Regulator here in the UK refused to listen to patients and the World's leading SSRi expert.
I'm absolutely livid.
God only knows what the bereaved families are going through!