“We saw human guinea pigs explode”
BMJ 2007; 334 doi: https://doi.org/10.1136/bmj.39150.488264.47 (Published 15 March 2007) Cite this as: BMJ 2007;334:566
- L Stobbart, department of health research capacity development research fellow1,
- M J Murtagh, lecturer in social science and public health1,
- T Rapley, research associate1,
- G A Ford, professor of pharmacology of old age2,
- S J Louw, consultant physician3,
- H Rodgers, reader in stroke medicine3
- 1Institute of Health and Society, Newcastle University, Newcastle upon Tyne NE2 4HH
- 2Stroke Research Group, Institute for Ageing and Health, Clinical Research Facility, Royal Victoria Infirmary, Newcastle upon Tyne NE1 4LP
- 3Newcastle upon Tyne Hospitals NHS Foundation Trust, Department of General Internal Medicine, Freeman Hospital, Newcastle upon Tyne NE7 7DN
- Correspondence to: M J Murtagh m.j.murtagh@newcastle.ac.uk
Media coverage has been shown to affect patient and public participation in medical services.1 Following the publicity surrounding the TGN1412 trial at Northwick Park Hospital in 2006,2 3 4 we might expect heightened media interest to affect recruitment of patients and healthy volunteers to medical research. Public discussion and awareness of this incident may have implications for science as a whole, ultimately generating changes in legislation governing the conduct of phase 1 studies in particular and clinical research in general. Concerns regarding inducements for recruiting volunteers to trials may also precipitate changes to the level and nature of payment for involvement, which may in turn further affect recruitment.
The story
On 13 March 2006 eight men took part in a “first in man” phase 1 clinical trial of TGN1412, a humanised agonistic anti-CD28 monoclonal antibody being developed by TeGenero to treat various diseases in which T cells are involved, such as chronic inflammatory disorders or haematological malignancies. Within hours those receiving the drug experienced serious side effects caused by a severe inflammatory response, resulting in multiorgan failure due to a “cytokine storm,” for which they were managed in intensive care; some spent more than three months in hospital. Longer term effects for all of the volunteers remain unknown. The story broke in the printed media on 15 March, although radio news bulletins late the previous evening carried the first reports. Headlines were initially conservative but became more dramatic as the story quickly attained “scandal status.”5
The setting: print media
Journalists do not merely report news but actively “produce stories,” and in doing so they construct a representation of reality for public consumption.6 However, the public is not necessarily complicit. These representations can influence public opinion and action, but …
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