MHRA report - drugs trial lawyer slams regulatory body and their report into failed drugs trials
Solicitor Ann Alexander who represents the two most seriously affected victims of the Northwick Park drugs trial condemned the report released today by the Medicines and Healthcare products Regulatory Body MHRA.
She said it was "totally inadequate."
Ann Alexander called for an independent Inquiry into the conduct of the trial and a wholesale review into the MHRA who she described as an "insular organisation with an archaic approach."
"This disaster was bound to happen. We believe that the self regulation of this organisation was not appropriate for such complex scientific administration," said Ann.
Ann stressed: "Today's report is a whitewash and leaves very many questions unanswered. It gives no detailed information about the pre-clinical trials, about which there has been conflicting information since the trial was suspended. Were the animals involved appropriate for a comparison with human subjects? What were the effects on these animals? We question the reports findings that the reaction was unpredictable, and we call for independent scrutiny of these and many more questions raised, not answered, by the report."
She continued: "We also demand answers to the questions raised by the manner in which the human trials themselves were conducted. We have now had access to evidence that suggests that the human subjects were not treated for up to 5 hours after the first symptoms were reported. We also want answers to when the trial was suspended by Parexel in order for the Hospital to take over and treat the symptoms displayed horrifically by the subjects."
"The report also affirms that the type of drugs being tested was a new class of monoclonal antibody, and with such new drugs we question why the subjects were given the drug at a gap of only 10 minutes, and not a longer period which would have saved at least a couple of the subjects from suffering as they undoubtedly did."
Ann concluded: "Why did the MHRA not seek any outside expert opinion before they conducted this new and dangerous procedure? My clients and the general public are entitled to answers to these questions."
"We note with interest the conclusions of last year's Health Select Committee report on the influence of the Pharmaceutical Industry. It found a lack of transparency in the MHRA and complained that there was no public access to data. It also concluded that there was a "major failing in the regulatory system" and drew attention to the fact that the MHRA is "entirely funded by fees from those it regulates".
"The concerns of the Select Committee seem to have been confirmed by the MHRA's investigations. I now have little faith in the MHRA's ability to seek, obtain or make public detailed and relevant information about the clinical history of this trial or the manner in which it was conducted. I believe that an independent enquiry is now essential," said Ann.
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