New drugs being tested for the first time in humans--especially "innovative technologies" such as artificial antibodies--should be monitored with far greater care, says a report issued today by U.K. experts on clinical research. The 19-member panel, chaired by Gordon Duff, professor of molecular medicine at the University of Sheffield, was set up after an experiment aimed at testing the safety of an antibody product called TGN1412 went badly wrong in London last spring. The so-called Northwick Park drug trial caused organ damage to six healthy volunteers (Science, 24 March, p. 1688).
In all, the government-assembled panel made 22 specific recommendations to regulators at the Medicines and Healthcare products Regulatory Agency (MHRA), the U.K. equivalent of the U.S. Food and Drug Administration. Much of that advice is aimed at gathering data on drug toxicity more rapidly and sharing it more widely. For example, the report calls on regulators and developers of new medicines to reveal unpublished preclinical results if the data seem "relevant to the safety of human exposure." The "ultimate goal," the panel says, should be to create an "open access database" of "safety-critical information," including confidential material that might initially be stored behind a security wall to protect companies' intellectual property. The report also notes that a team of 20 scientists at the U.K. National Institute for Biological Standards and Control created a test tube in the past 6 months that mimics the dangerous response that TGN1412 set off in human volunteers. Applying this new technology when similar products are tested in the future might reduce the risk of new mishaps, Duff indicated.
MHRA Chief Executive Kent Woods issued a statement welcoming the advice and claiming that the agency "has already implemented" its key recommendations. MHRA is planning to establish a new special advisory group to keep watch on potentially risky products. Aisling Burnand, chief executive of the BioIndustry Association in London, also welcomed the recommendations but urged people to remember that the TGN1412 trial "was wholly exceptional."
Others are not satisfied with the report, however. David Glover, the former medical director of Cambridge Antibody Technology, a U.K. biotech firm, and now a consultant, faults the government for failing to investigate thoroughly why the MHRA missed the errors that led up to the TGN1412 accident. Glover says that U.K. government scientists had already shown that it was possible to create a test-tube assay mimicking the volatile response seen in humans; he thinks the MHRA should have compelled the drug developer to produce a test based on the drug's mechanism in humans and carry it out before the trial started.