UK clinical trial disaster: One man still hospitalized
Five of six subjects sent home by May
Two months after the clinical trial disaster that sent six healthy volunteers into intensive care and left one man still hospitalized by the end of May, a British investigation found no apparent errors or cause for the adverse events.
The Phase I trial involved a humanized agonistic anti-CD28 monoclonal antibody, called TGN1412, to treat cancer and autoimmune diseases. TeGenero contracted with Parexel International of Boston, MA, which conducted the trial at the Parexel unit of Northwick Park Hospital in London.
Six young men were injected with TGN1412, and two received a placebo. The six men who received the study drug became seriously ill, with inflammation, vomiting, severe pain, swollen heads, and unconsciousness. The two men who received the placebo were fine.
The sick men were transferred to critical care at Northwick Park Hospital, where they received organ support. By April 5, 2006, five of the men had been discharged from the hospital, but one remained.
British media reports say the man still hospitalized will spend six months in the hospital and has suffered multiple organ failure, pneumonia, and may possibly lose parts of his fingers and toes.1
The Medicines and Healthcare products Regulatory Agency (MHRA) of Great Britain, which investigated the adverse events, issued an interim report that found no evidence of problems in the manufacturing of the product that was given to trial participants.
"Subject to the completion of the outstanding tests, MHRA takes the view that the adverse incidents did not involve errors in the manufacturer of TGN1412 or in its formulation, dilution or administration to trial participants," the MHRA report concludes.
The report further states, "The MHRA therefore concludes that an unpredicted biological action of the drug in humans is the most likely cause of the adverse reactions in the trial participants."
The MHRA also notes that the Secretary of State for Health has agreed to establish a group of leading international experts in the field to consider what changes to clinical trials may be required.
At the very least, there will be a greater focus on informed consent publicly. The UK incident provided the international media with yet another opportunity to use the term "human guinea pig" and to direct public attention to a research disaster.
Norman M. Goldfarb wrote in the Journal of Clinical Research Best Practices, about the informed consent process in the TeGenero TGN1412 trial, and he found examples of biased language and trivialization of clinical trial participation.
For instance, the TGN1412 study's subject recruitment posting at www.drugtrial.co.uk stated, "You'll have plenty of time to read or study or just relax—with digital TV, pool table, videogames, DVD player, and now FREE Internet access! You can even just catch up on some sleep!"2,3
References
- UK drug trial victim may lose his fingers, toes. BBC News. April 16, 2006.
- Goldfarb NM. Informed consent in the TeGenero TGN1412 trial. J Clinical Res Best Practices. 2006;2(5):www.firstclinical.com.
- TeGenero trial adverse events raise safety, consent issues. Clinical Trials Advisor. April 20, 2006.
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