During my correspondence over the previous two years with Dr June Raine, Director, Vigilance, Risk Management of Medicines, MHRA, I have established the following.
The MHRA automatically destroys clinical trial data after only 5 years making accountability of pharmaceutical companies impossible.
Also, not one company has ever been prosecuted by the MHRA for withholding negative clinical trial data.
Ativan is an addictive tranquilliser with harmful side effects and many people are still addicted to Ativan and last year nearly 1 million prescriptions and rising were still being issued. There were inadequate warnings on the Ativan ABPI data sheet from 1972 until
1990, even though these warnings were listed in Australia, the US and Canada during this period including convulsions, tremor, abdominal and muscle cramps, vomiting, sweating with additional warnings of anxiety, agitation, irritability, tension, insomnia.
Also, despite assurances from MHRA officials, these warnings are still unavailable to the public because the Summary of Product Characteristics (old ABPI data sheet) is not available on the electronic medicines compendium website, or indeed any website.
I also asked Dr Raine for an explanation as to why it took over 10 years to add dependency warnings to the Tranxene data sheet, yet another addictive tranquilliser, but Dr Raine was unable to due to destroyed records as described in this statement:
“As I explained in relation to Ativan, our records for this period are not complete and I have not been able to establish what caused the delay in adding the information about withdrawal reactions to the datasheet for Tranxene”
This behaviour is evident in other addictive psychotropic drugs with harmful side effects and withdrawal reactions, for example, it took 12 years for the MHRA to establish that Seroxat, the most widely prescribed SSRI at the time, caused serious withdrawal reactions. The MHRA also knew it was being prescribed to children, yet failed to ask GSK for evidence that it was safe for under18s and that it caused an increase in the rate of self-harm and suicidal behaviour.
These time lapses of 10 – 20 years are not acceptable. The purpose of a regulatory authority is that precautions are put in place before patients are harmed, not afterwards. The SPC (old ABPI data sheet) and the PIL are still the main sources of information for prescribers and patients and these vast time lapses have resulted in patients being harmed and the cause of many suicides.
This is just the tip of the iceberg and similar problems have arisen with other drugs like Avandia, Vioxx. The MHRA seems to be the last to know yet the agency claims to be pharmacovigilant.
Now we have another instance with defective silicone in the PIP breast implants, 6 years after surgeons publicly raised concerns
Andrew Lansley incorrectly accused companies which performed the surgery of “not stepping up to their responsibilities” but in reality it is the MHRA’s responsibility in failing to provide adequate warnings yet again and is a pattern of behaviour which the Secretary of State for Health needs to address.
John Perrott
