This is the response to the report I handed to MOD on 16th December 1997 which can be found here, it may be worth downloading and printing both documents to ease reading! The Medical Countermeasures paper which is cited in both of these documents can be found on this site here, again it might be worth downloading this also so you have the full picture.

Dear Corporal Austin,

Thank you for your report "Operation Granby: A Humanitarian Mission to Aid Kuwait", which you handed over on 16^th December at your meeting with your constituency MP Sir Brian Mawhinney and Dr John Reid, Minister of State for the Armed Forces. I was glad to have met you on that occasion. Your report highlighted a number of questions to which I have been asked to reply, I apologise for the delay in responding. I have grouped my answers below under subject headings for ease of reference.

You suggested that the rules for Named Patient Basis administration of unlicensed products are clear, based on the Miles letter which you attached to your report. In Fact, the so-called "Named Patient Basis" is not statutorily recognised term but is widely used as a term of art to cover a range of exemption schemes under parts 2 and 3 of the Medicines Act 1968, which relate to the importation, supply and administration of patients under the care of a doctor or other medical professional. You asked whether a prescription was required to authorise administration of the vaccine for each individual. As mentioned above, such matters were, at the time of the Gulf War, covered by the provisions of the Medicines Act 1968. The question of whether this Act applied to the Ministry of Defence, an institution of the Crown, is not a matter which I give a definitive answer. The Act is not itself expressed to bind the Crown and MOD legal adviser's view, supported by the Department of Health's legal adviser, is that the licensing provisions of the ACT were not intended to bind the Crown and therefore probably did not do so at the time of the Gulf War. That said, a definitive "answer" can only be given by a court ruling on this matter.

Regarding the question of whether MOD was aware in 1990 that pertussis vaccine used was not licensed for use in adults, I believe that the answer is no; MOD has only recently been informed by the Medicines Control Agency that the specific instruction on the datasheet "not recommended for use in adults" effectively means that the vaccine is not licensed for use in adults.

Turning to your question about licensing of NAPS, I can assure you that the use of NAPS during Operation Granby was in no way used to support the our subsequent application for a UK product license for NAPS. Such trials as are required for this purpose require closely controlled conditions and detailed clinical monitoring of subjects, which could would not have been possible under field conditions. Furthermore, I am sure you will be aware that very few, if any, records were kept of NAPS consumption during Operation Granby. The human trials to support the application for a license for NAPS were conducted at Porton Down and at the Institute of Naval Medicine. As described in the medical countermeasures paper (paragraphs 135-140) these included trials specifically designed to investigate the effects of stress (heat plus exercise). However, I am not aware of any trials being conducted to investigate the effects of increased heart rate whilst taking NAPS.

You asked whether MOD scientists were aware of the possible side effects of administering the anti-BW vaccines together, and if so why recipients were not warned of these. I am unable to add anything to the very detailed description contained in paragraphs 61 to 67 of the Medical Countermeasures paper (about the events surrounding the Department of Health's fax which was sent to MOD in December 1990), except to say that a fact finding team is currently investigating the implementation of the anti-BW vaccination programme in theatre, and will no doubt collate any information about what troops in different units may have been told about possible side effects prior to receiving the inoculations. The findings of the fact-finding team will be made public when their work is completed.

You also asked how troops could have noticed and reported the symptoms of a BW attack with anthrax or plague, had one occurred, given the lack of specific training. Firstly a biological detection system capable of identifying both these agents was fielded in the Gulf for the duration of the ground war. Secondly, I believe any such attack would have been very evident to local commanders, given the severity and rapid onset of disease, as described in paragraphs 33, 34, 74 and 75 of the Medical Countermeasures report. Furthermore, a morbidity reporting system was in place during Operation Granby which involved medical incident reports being returned to CBD Porton Down each day; the raw data from these reports was analysed at CBD. CBD found no evidence of an undetected CBW attack. Any concentration of similar symptoms would have signalled immediate further investigation.

You asked about MOD's guidelines regarding informed consent when giving vaccines. I am sure you will understand that I am unable to comment of current policy. The policy in 1990-91 was that all anti-BW vaccines were to be administered with voluntary informed consent; we are aware, however, that many veterans consider this policy to have been breached in practice and the fact finding team mentioned above is investigating this matter.

As to the policy regarding when to stop taking NAPS, this is obviously dependent on the local threat assessment. I am told that an order to cease taking NAPS was promulgated from the NBC cell in Al-Jubayl through the chain of command at the cessation of hostilities in the Gulf on 28 February 1991. All personnel in theatre should, therefore, have been informed accordingly.

You ask why it took some 5 months for anti_BW vaccinations to begin. As the Medical Countermeasures paper makes clear, at the time of the Gulf War MOD did not hold a stock of vaccine against the possible requirement to immunise against BW agents because vaccines are expensive and have a limited life. Hence, there was an unavoidable time delay while stocks of vaccine were procured and tested. I can confirm that Cutter Plague vaccine batch 10H03A is a sub lot of batch 10H03, for which a FDA release letter was available. I can also confirm that standard dosage, as recommended in anthrax, plague and pertussis data sheets, was used in anti-BW vaccination programme.