Drug trial company ‘warned’ of potential side effects

Reports that emerged over the weekend have suggested that both the company behind the disastrous TGN1412 drug and the government’s drug safety authority were both aware of the dangers the trial posed.

According to both the Observer and the Independent newspapers, TeGenero, the German manufacturer of TGN1412, was aware that adverse side effects may be experienced by the clinical trial volunteers.

TeGenero informed the Medicines and Healthcare Products Regulatory Authority (MHRA) that tests of similar drugs had led to serious adverse effects in humans, according to the Independent.

These side effects are known as cytokine storm or cytokine release, where the drug encourages a massive release of antibodies.

The Observer reports that the consent forms the patients had to sign included information about a number of possible side effects, including immunosuppression autoimmunity, cytokine release and anaphylaxis.

However, the MHRA said the risks had not been ignored, offering that the dilution in dosage was enough precaution.

“The possibility of a cytokine storm was specifically considered and tested for in a particular species of monkey which showed no toxic reaction. With a 500-fold dilution the protocol for the study was as precautionary as you could get,” said Professor Kent Woods, chief executive of the MHRA, according to the Independent.

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