Nerve Agents (Hansard, 25 November 1994)

§ Mr. Soames

These are matters for the Chemical and Biological Defence Establishment, Porton Down, under its framework document. I have asked its chief executive to write to the hon. Member.

Letter from Dr. Graham Pearson to Dr. David Clark, dated 25 November 1994: QUESTION 25, ORDER PAPER DATED 22 NOVEMBER 1994

1. Your Parliamentary Question to the Secretary of State for Defence asking what tests were carried out at the Chemical and Biological Defence Establishment at Porton Down to analyse the effects of prolonged use of nerve agent pretreatment set tablets has been passed to me to answer as Chief Executive of the Chemical and Biological Defence Establishment.
2. The role of the Chemical and Biological Defence Establishment is to ensure that the United Kingdom Armed Forces have effective protective measures against the threat that chemical or biological weapons may be used against them. As such it is necessary to evaluate the effectiveness of medical countermeasures.
3. A number of studies were carried out using Service volunteers to evaluate the acceptability of using pyridostigmine bromide and whether such use had adverse side effects or was affected by the nature of the duties of the Service personnel. These studies which lasted for up to eight weeks included the assessment of the effects of NAPS on volunteers undergoing strenuous exercise and of a thermally stressful environment. No significant differences were found between subjects who had received a placebo and those who had received pyridostigmine bromide.
4. These studies concluded that pyridostigmine bromide in NAPS gives considerable protection against all organophosphorus nerve agents with no significant adverse effects. These results formed part of the Ministry of Defence's license application to the Medicines Control Agency which resulted in pyridostigmine bromide in NAPS being licenses under Product License Number 4537/0003.

QUESTION 24, ORDER PAPER DATED 22 NOVEMBER 1994

1. Your Parliamentary Question to the Secretary of State for Defence asking if the nerve agent pre-treatment set tablets administered to members of the British Armed Forces in the Gulf War had been put through the normal medical trials, and if he 462 will make a statement has been passed to me to answer as Chief Executive of the Chemical and Biological Defence Establishment.
2. The role of the Chemical and Biological Defence Establishment is to ensure that the United Kingdom Armed Forces have effective protective measures against the threat that chemical or biological weapons may be used against them. As such it is necessary to evaluate the effectiveness of medical countermeasures.
3. One of the current in-service medical countermeasures to nerve agents is the Nerve Agent Pretreatment Set (NAPS) which contains pyridostigmine bromide. This has been put through the normal medical trials and is a licensed drug. This only entered service after careful and considered evaluation. Following a series of animal studies pyridostigmine bromide was chosen for evaluation as an oral pre-treatment in man as it was a British Pharmacopoeial drug which appeared to combine efficacy and duration of action within an acceptable safety ratio.
4. Volunteer studies were carried out at CBDE to identify the effective oral dose regimen which in conjunction with therapy would provide protection against nerve agent poisoning whilst producing minimal or nil side effects under a range of conditions. The conclusion was that 8 hourly dosing with 30 mg of pyridostigmine bromide was acceptable.
5. Pyridostigmine bromide is listed in the British Pharmacopoeia and has been licensed in the United Kingdom since 1955 by Roche Products Limited as a treatment for myasthenia gravis, paralytic ileus and post-operative urinary retention. In adults with myasthenia gravis the usual daily dose is in the range 300–1200 mg, often over a period of many years or for life. The NAPS daily dose is 90 mg.
6. Pyridostigmine bromide is licensed to the Ministry of Defence by the Medicines Control Agency under Product License Number 4537/0003 for use in the pre-treatment of Service personnel at risk from poisoning from organophosphorus nerve agent.