I. Roberts, A. Li Wan Po, I. Chalmers, Intellectual property, drug licensing, freedom of information and public health, Lancet 1998, 352, 726-729.
Freedom of information, when it suits
"When the BMJ published a systematic review last month from the Cochrane Injuries Group, there was widespread alarm. The meta-analysis concerned human albumin administration in critically ill patients, and the Cochrane investigators reported 'that for each patient category ... the risk of death in the albumin group treated was higher than in the comparison group'. The authors concluded that 'the use of human albumin solution in critically ill patients should be urgently reviewed and confined to the context of rigorously conducted, randomised controlled trials'."
This Lancet editorial (29 August 1998, 665) reviews the official response to this problem, detailed in the above paper, concluding that it tells "a disturbing story of reckless neglect by the UK Medicines Control Agency". Ditto the response of the UK government. When the Cochrane review was reported in The Observer newspaper, Health Secretary, Frank Dobson MP, declined to comment, saying he did "not have to respond to hysterical articles by ill-informed journalists in badly-edited Sunday newspapers". The Lancet editorial concludes:
"This tale of regulatory resistance and political rebuttal is a blow to the notion that government and its agencies will be aggressively pursuing a policy promoting freedom of information ... Rather than display concern for new evidence that one of its licensed products was harmful, the MCA obstructed Cochrane researchers from seeking further information that may have been relevant to their review.
"This unhelpful response is odd since the MCA's annual report claims that the agency 'is reviewing its existing policies on public access to information'. The aim is to be more open, but the MCA's actions belie their words, as do the government's ..."