Although British authorities say that a drug trial which made six healthy young men violently ill was conducted properly, critics have savaged their informed consent form. The drug, TGN1412, was a monoclonal antibody, a promising type of treatment which has seldom been approved for humans.
Bioethicists claim that the document did not sufficiently inform participants of possible dangers and did not depict the treatment as a novel drug that could harm the body’s immune system. The 13-page form also appealed to the subjects’ need for money and threatened to withhold their ?2,000 payment if they withdrew early.
The drug company “failed to adequately disclose the degree of uncertainty around a first-in-man trial,” said Michael Goodyear, a Canadian cancer physician and research ethicist. “The risks were well known. They’re not disclosed in the consent form.”
Goodyear and two other medical ethicists assessed the study’s risk- disclosure form for Bloomberg News. Parexel, a US company which conducts clinical trials for pharmaceutical companies, has declined requests to release the document. TeGenero, the small German biotech which designed the drug, says it did not have a copy. The bioethicists had several gripes, according to Bloomberg:
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