Is the Yellow Card Road Going in the Right Direction?

In 1963, following the dreadful consequences of giving thalidomide to pregnant women, the UK Government set up the Committee on Safety of Drugs, chaired by Sir Derrick Dunlop. In May 1964, he wrote to all UK doctors (a mammoth task with no information technology to support it) asking them to report “any untoward condition in a patient that might [his italics] be the result of drug treatment”. He also promised that such reports “will be treated with complete professional confidence” and “will never be used for disciplinary purposes or for enquiries about prescribing costs”. The UK Medicines and Healthcare products Regulatory Agency has recently ‘celebrated’ the 50th anniversary of what became known as the ‘Yellow Card System’ for reporting suspected adverse reactions to medicines. Professor David Finney (born January 1917) was at that ‘celebration’ and he was a pioneer in statistical approaches to assessing the reports, with his first paper in the area being published in 1963. He also worked with the WHO, where, in 1969, Patwary [1] wrote an internal report (confidential at the time) that set out many of the statistical principles in utilising these ‘spontaneous reporting’ data, and these were clearly summarised by Finney [2]. The ability to analyse all the reports was limited by the information technology of the time, but more than 40 years on, the situation has changed dramatically. The strictures on confidentiality may have prevented independent statisticians applying their minds to make best use of the data but, worldwide, there is now much greater openness.