British drug regulators criticize U.S. research company over trial that left volunteers very ill

Photo: British drug regulators criticize U.S. research company over trial that left volunteers very ill

Research firm Parexel International, based in Waltham, Massachusetts, failed to follow several trial procedures, including keeping proper patient records, ensuring 24-hour medical cover and checking insurance, according to the final report into the trial by Britain's Medicines and Healthcare products Regulatory Agency, or MHRA.

Six volunteers took part in a trial for test drug TGN1412, designed to treat autoimmune and inflammatory diseases and leukemia,  but within hours of being given doses of the drug they suffered convulsions, organ failure and ultimately lapsed into comas.

One of the men, Ryan Wilson, remained in a hospital where officials said he was making steady progress. But Wilson has told reporters that he could lose parts of his fingers and toes to gangrene, the AP reports.

The report confirmed interim findings by investigators that the adverse reaction seen in the men was most likely down to an "unpredicted biological action of the drug in humans."

The men received correct doses and there was no sign of contamination or manufacturing errors, the report said.

Parexel, whose British research unit is based at London's Northwick Park Hospital, failed to complete the full medical background of a trial subject in writing and allowed two volunteers who received placebos to leave the premises before checks had been carried out to confirm they were safe to go home, the report said.