TGN1412 drug trial nightmare could have been prevented

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Terry Hamblin, a retired professor of medicine from Southampton, says that he conducted a trial using an antibody similar to the one in TGN1412 -- which caused rapid, serious side effects in six previously healthy volunteers in March. Hamblin's trial was unsuccessful, and the trial information -- along with details on side effects such as rigors, hypotension and fever -- was never published because Hamblin did not believe medical journals would be interested. Hamblin also says he was not required to inform regulators of the side effects in his study.

However, many believe that if his trial had been made public, the design of the TGN1412 trial may have been altered to be less dangerous for volunteers. Hamblin's trial, for example, administered the experimental drug slowly, over a period of several hours, to allow him to properly identify and stop negative side effects. TeGenero -- the company that makes TGN1412 -- has come under fire for its trial design, which some critics say did not follow the standard research practice of administering experimental drugs slowly and in very low doses.

Hamblin's trial information was presented in June 2006 to a UK commission seeking to make information on phase-one human drug trials public. Professor Gordon Duff, the commission's chair, has made several recommendations to the pharmaceutical industry to help remedy the TGN1412 disaster. The industry has accepted many of Duff's recommendations, including agreeing to publish the trial results of drugs that are successfully licensed or about which the drug company's own employees have safety concerns. But the industry has rejected Duff's call to publicly disclose all phase-one trial results like Hamblin's - seemingly the one step that would have prevented this latest tragedy.

"Pharmaceutical drug trials remain steeped in secrecy," said Mike Adams, a prominent critic of current drug industry practices. "It is very clear that drug companies value intellectual property more than human lives."

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