Observers call for rules to be tightened.
A drug trial that took a shocking turn in London last week may have far-reaching effects on policy. Its failure, experts say, could change restrictions on clinical research and increase scrutiny of the private companies that carry out the majority of clinical trials.
“There's going to be a lot of soul searching,” says Thomas Murray, a bioethicist at the Hastings Center, a think tank in Garrison, New York.
As Nature went to press, two previously healthy young men were in critical condition and another four seriously ill at Northwick Park Hospital in London. On 13 March, they received intravenous injections of TGN1412, an antibody made by Boehringer Ingelheim for TeGenero, a small, privately owned biotechnology firm in Würzburg, Germany. The drug was being developed to fight autoimmune diseases and leukaemia. Parexel International, a contract research organization based in Waltham, Massachusetts, that operates in 39 countries, was running the trial for TeGenero.
“Was informed consent adequate? Were the right subjects selected? Were the right doses given? This better have been done right, or some tough questions are going to come up for the private, commercialized research sector,” says Arthur Caplan, a bioethicist at the University of Pennsylvania, Philadelphia.
Within one to two hours of being injected, the six volunteers suffered violent reactions that included headache, backache, nausea, a drop in blood pressure and, ultimately, multiple organ failure. The trial was the first test of the drug in humans; it was immediately suspended by the UK Medicines and Healthcare Products Regulatory Agency, which is now investigating.
Thomas Hanke, chief scientific officer for TeGenero, says that the company had “no preclinical evidence whatsoever” that the drug might be unsafe, and that no adverse effects had been observed in rabbit and monkey studies.
But some observers say the company should have been more cautious, because the drug aimed to bypass the immune system's natural control mechanisms (see ‘The drug test: what went wrong?’). “You are going beyond the regulatory network, so all hell can break loose,” says Angus Dalgleish, an immunologist at St George's Medical School in London.
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Wadman, M. London's disastrous drug trial has serious side effects for research. Nature 440, 388–389 (2006). https://doi.org/10.1038/440388a
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DOI: https://doi.org/10.1038/440388a
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