The failure of a drug trial that left six volunteers fighting for their lives in a London hospital cannot be blamed on the way the drug was made or administered, the final report of a government investigation has concluded. It did, however, criticise aspects of the trial's administrative procedures.
The report by the Medicine and Healthcare Products Regulatory Agency (MHRA) on events in March at the Northwick Park Hospital (BMJ 2006;332: 683, 25 Mar16565101) concludes that an “unpredicted biological action” of the experimental antibody treatment TGN1412 caused multiple organ failure in all six previously healthy male recipients. One of the six, a 20 year old, is still in hospital two and half months later.
Despite immediate claims from victims' lawyers of a “whitewash,” Kent Woods, chief executive of the Medicines and Healthcare Products Regulatory Agency (MHRA), said: “We are satisfied that the adverse incidents which occurred were not as a result of any errors made in the manufacture of TGN1412, its formulation, dilution, or administration to trial participants.”
Several experts had questioned the safety standards in place during the trial. One, Joe Collier, professor of medicines policy at St George's Hospital Medical School, London, said the MHRA had made sweeping conclusions that were beyond the remit of its investigation. He said, “There is a brief technical part of the report telling us things such as the product was free from contamination—and this is valuable. But its claim that it also gives insight into `any errors in the conduct of this trial' is thoroughly misleading, and the MHRA should be ashamed.”
Parexel, the company that carried out the phase I trial, was criticised in the report for a series of administrative errors. It failed to keep adequate medical records, and one of the doctors involved in the trial lacked sufficient training.
The report also said that no formal system was in place in the trial unit to ensure 24 hour medical cover, and it added that Parexel had failed to check sufficiently the insurance details of TeGenero, the company developing the drug.
The agency also found that volunteers who received the placebo were allowed to leave the trial before appropriate checks were done to confirm that they had indeed received dummy infusions rather than the antibody.
Herman Scholtz, Parexel's head of international clinical pharmacology, replied that it was “inevitable that following a highly detailed examination of systems and documentation, there would be areas cited for improvement.”
But Ann Alexander, the lawyer representing the two most seriously affected victims of the drug trial, condemned the report as “totally inadequate.”
Meanwhile, the health minister Andy Burnham announced the full membership list of an international expert group to investigate how clinical trials are conducted in the United Kingdom.
The group's chairman, Gordon Duff, professor of molecular medicine at Sheffield University, was appointed in April. He has been joined by 18 other scientists and lay members from Britain, Germany, and Sweden.