Human Albumin Solution (Hansard, 28 July 1998)

§ Mr. Dobson

(holding answer 14 July 1998): The safety of human albumin solution when used in resuscitation of critically ill patients has been questioned in a paper by the Cochrane Injuries Group published in the British Medical Journal (25 July 1998). This presents the findings of a systematic review of more than 30 clinical trials examining the effects of albumin in the treatment of seriously ill patients. Individually, these trials have many limitations but, taken together, they suggest that seriously ill patients given albumin may be less likely to survive their illness than if they are given alternative fluids. However, it is uncertain whether albumin is responsible for extra deaths or why it might be harmful. The paper states that the use of human albumin in the management of such patients should be urgently reviewed but no specific advice is given.

An article in The Observer of 26 July has questioned the handling of this issue by the Chief Medical Officer and the Medicines Control Agency. Following a telephone call with the Deputy Chief Medical Officer, one of the authors of the paper, Dr. Roberts, sent information on the systematic review to the Chief Medical Officer on 12 March. This was given very careful consideration before the Chief Medical Officer wrote back to Dr. Roberts on 27 April. He reinforced the Deputy Chief Medical Officer's advice that this information should be sent to the Medicines Control Agency, who are responsible for advice on licensed medicines containing human albumin. Dr. Roberts sent a draft of the paper to the Medicines Control Agency which was received by them on 28 April.

The paper was evaluated and the advice of the Committee on Safety of Medicines based on the evidence available was sought on 13 May. Further information was requested from Dr. Roberts on 14 May and a reply was received on 19 May. A full evaluation of the findings of the systematic review and the individual clinical trials included in the review was made. It was considered by the Committee on Safety of Medicines on 28 May. The Committee's view was that they did not consider withdrawal of human albumin products was warranted and 172W advised an Expert Working Party be set up to consider the implications of the review for the use of human albumin. Experts in intensive care, burns, paediatrics, hepatology and cardiothoracic surgery were identified and on 25 June were invited to join the Expert Working Party. It met on 23 July. The Expert Working Party did not consider that withdrawal of human albumin products was warranted but requested further data on similar products to albumin, as some evidence on the colloid alternatives to human albumin also suggests an associated increase in mortality. The EWP is to meet again in September to consider this aspect.

Information was sent to hospital specialists through the CMO' s Epinet cascade on 24 July, informing them of actions being taken, and an article will shortly appear in the CMO Update which is circulated to all doctors in England. Meanwhile, it is important that when human albumin is to be given, the precautions in authorised product information and the British National Formulary are followed.

This matter has been considered very carefully. Those responsible for advising me on licensing of human medicines have concluded that on the evidence available to them it is currently more appropriate to leave human albumin available for clinicians who wish to use it for the benefit of their patients than to ban it.