The views and opinions expressed in this report are those of the author and are not representative of any other individual or group, although the same views may shared.
The conclusions drawn are based upon the research that the author has done, both in the UK and in consultation with overseas agencies.
In August 1990 Saddam Hussien of Iraq invaded Kuwait, claiming it as a legitimate state of Iraq. Through the media the whole world witnessed alleged acts of brutality committed against the people of Kuwait by the Iraqi soldiers.
This spurred the formation of a coalition, made up of many nations around the world to come to the aid of Kuwait. The coalitions aim was to protect the Kuwaiti’s from further atrocities and eventually drive the invader from Kuwaiti soil.
However, there was a hidden agenda, one which was not widely publicised as I recall. That was the concern over the worlds oil supply, after all Kuwait was a major player in the supply of oil. It would be unthinkable for a mad man like Hussien to gain control of such a rich resource.
Britain decided to send aircraft, armour and ships to the area as their contribution to the coalition. In addition to the hardware, many men and women were also sent. The reported figure is that between 45,000 and 55,000 of Britain’s fittest sons and daughters took part.
In the background, the MOD and their scientists and officials were not only weighing up the best way of driving Saddam out of Kuwait, they were also pre-occupied with how to protect the people they had sent from the very real threat of chemical and biological warfare (CBW).
The protection of the troops was not only proper it was the duty of the Government and the MOD as employers. This will be the focus of this report, we will examine the response by MOD to the known and perceived threat faced by the troops in the theatre of operations.
The actual conflict produced very few casualties compared to figure that could have been expected, however, even a few are too many!
Since the conflict that casualty level has grown, we now have upwards of two thousand who are ill, we have seen many of our comrades die prematurely and many others who have been unable to handle the strain of what is happening to them. They sadly, have taken their own lives. Statistically, a few thousand doesn’t sound to high when bearing in mind that there were up to 55,000 participants in the Gulf. However, a few thousand becomes more significant when you consider that up to half of this figure could have been spread out between Cyprus, Bahrain, Oman and the various ships and other locations not in the theatre of operations.
Those of us who served in the Gulf, that are now ill, have to find out the cause of this condition. We need this information so we may get the treatment we need, however, a stronger mandate for our work is to stop this situation ever occurring again. Future combatants will face the same or similar threats again, we don’t want them to face potential damage by medical countermeasures that may given to protect them without the proper research being carried out before hand!
The Author of this report, Dave Austin, is a serving member of the Royal Air Force who has served for over 21 years and recipient of the LS&GC Medal. He is an avionics technician currently located at RAF Wittering. Current duties are the servicing and repair of PC’s on the station as part of the station’s IT Cell.
On 6th January 1991 he received his orders to go to Dhahran in Saudi Arabia. His duties were to support the laser guidance systems fitted to many of the RAF’s combat aircraft that were currently in theatre. This duty was shared by two Corporal’s working alternate shifts.
On 8th January 1991, he went to RAF Wyton to receive a batch of vaccines, two of these were medical countermeasures, namely anthrax and pertussis. At the same sitting he also received a yellow fever booster and oral polio. Although he was told what these vaccines were by name, he was not informed of the reason for these vaccines being given, nor was informed consent sought by the administering Doctor. It must be noted that the author knew nothing of the mechanism of informed consent and his right to refuse the vaccines!
On the 19th January 1991 he was in the Gulf, by now he was taking Nivaquine and Proquanol. This lasted for only a short period as anti-malarial treatment was ceased some days before the conflict started.
In the early hours of the 17th January 1991, the order was issued to commence taking Nerve Agent Pre-treatment Set tablets (NAPS). He continued to take NAPS, strictly observing the dosage on the packaging up until the day that the cease-fire was signed. No order was ever given to stop taking NAPS, the authors decision to stop taking them was made personally based upon the fact that hostilities had ceased.
On the 28th January 1991, he attended the daily intelligence brief. This was not a classified brief as the British Aerospace Expatriates also attended. However, at the end of this brief, the RAF people were instructed to make their way to the Electrical Bay for a further classified briefing. No civilians were allowed into this briefing. The essence of this briefing was to inform us that a new vaccine had arrived in theatre that would afford us protection in the event of biological warfare agent (BW) attack. The Sergeant giving the briefing, himself an electrical technician, told us that if we had this vaccine we would survive a BW attack, however, without it, survival would not be guaranteed. Was this sufficient information for a recipient to be able to make an informed consent.
The vaccine was administered later that day, at the same time as a second dose of anthrax and Pertussis. Again, informed consent had not been sought or even requested. Based on the briefing that morning we had decided to accept it anyway, we wanted to survive! On examining his Bmed 27, his personal record of vaccinations received, he noted that the new vaccine was called "CUTTER".
This round of vaccinations did cause side effects, in some they were mild, in others they were sufficient to force them to go to their quarters as they became violently ill for a few days. This highlights, that everyone is an individual in terms of reactions to vaccines.
Apart from the vaccines mentioned, the author received none of the other more common, travellers type vaccines although all of his were out of date. He had requested them but had always been denied them for one reason or another, both in the UK and in theatre.
On 14th March 1991, the author returned from the Gulf. Even at that time he knew he had changed, he was tired and irritable. It was not until June 1991 that he first reported sick, with these symptoms. He was told it was battle stress and that it would pass with time.
For the next two years or so the author got worse, more symptoms started to manifest themselves, perhaps most disturbing was the fact that he had become violent towards his wife. He had frequent bouts of violence in the family home, but could never recall them afterwards. He also started to stare into space, just drifting in and out of conversations, again unaware of what was happening!
This continued until late 1993, he watched a programme on channel 4 about the effects that the American troops were exhibiting since their return from the Gulf. There were many similarities between what the author had experienced and what was being shown on the TV.
From that date on he has been actively involved in researching this illness and the possible link with what happened to him and others in the Gulf.
On 31st August 1996, the Author founded the UK GulfWeb and published it on the Internet in order to efficiently pass on his research to those that require it.
Now the Author lives alone following his divorce, he is now permanently medically downgraded and is working out his remaining 18 months of service. He continues to maintain his links with veterans both locally and internationally and the UK GulfWeb continues to thrive as a respected site for information.
In this report I intend to only deal with the actual CBW countermeasures that were actually used in a widespread manner. I will not be dealing with botulinum toxin (BTx), biological agent treatments set (BATS), the Combo Pen as these were not, at least to my knowledge used. As such it follows that it is unlikely they could be contributory to illnesses now being experienced by veterans.
Throughout this section I will refer to the MOD’s recently published paper:
"BACKGROUND TO THE USE OF MEDICAL COUNTERMEASURES TO PROTECT BRITISH FORCES DURING THE GULF WAR (OPERATION GRANBY)"
When I do refer to it I will simply call it the Background Paper, quoting the paragraph number.
Much of the material presented in this report was gleaned as a result of the author’s own research and were possible it will be reproduced if necessary, however, most of it is available on the UK GulfWEB.
The actual agents that will be addressed are:
As far as possible I will attempt to address each agent in it’s own right, however, overlap between anthrax and pertussis is unavoidable.
In my final summation I will attempt to bring all the information together and pose a list of outstanding questions that need to be addressed as soon as possible.
It must be borne in mind that when reading this countermeasures section that all errors and assumptions made by Government were made by the previous Government, initially that of Mrs Thatcher, then that of Mr Major. The new Government cannot as far as I am concerned be held responsible for that catalogue of errors that went before. Notwithstanding this, they are responsible as employers, for investigating and continuing to investigate what really happened and help those who are suffering either through treatment or financially or both if necessary! Costs should not enter into the equation, the people who travelled out there were willing to pay the ultimate price.
How was this vaccine procured? This has been the subject of much research by the author dating back to early 1994. At that time the only lead was the name of the vaccine and the batch number. It wasn’t until 1992 that it became widely known that this vaccine was in fact plague, you may recall that in the Bmed 27, this vaccine was called CUTTER.
The author formally asked MOD for details regarding this vaccine through the correct channels, but in every reply it was made known to him that it was classified. Hence, many letters were written to the manufacturers, initially Greer followed by Miles/Cutter and finally Bayer in a quest for information. They were kind enough to respond to my enquiries in a positive fashion, even sending me a product data sheet. They put me onto the Defense Personnel Support Centre (DPSC) in the US. This gave me my lead into the Freedom Of Information Act (FOIA) which did prove to be useful, although never giving me the full picture it did allow me to draw the right conclusions.
Bayer, who took over responsibility for this vaccine from Miles/Cutter were also very helpful, I had correspondence with both their US and UK offices.
Now how did this vaccine come into the hands of the UK Government; to go back to the start, it was shipped from the manufacturers on 7th November 1990 to Mechanicsburg Supply Depot in the US for storage. From the Background Paper para 86 we can see that MOD in fact placed an urgent order for 4000 vials of this vaccine. There were some advanced samples sent to the National Institute for Biological Control and Standards (NIBSC) for testing.
The procurement method is interesting in itself as it effectively cut out any civilian knowledge that this was happening, even the manufacturers and their UK offices didn’t know. I find this interesting for the following reason, as a result of correspondence with Miles/Cutter and Bayer UK there is an inference of a mechanism that should have been complied with when obtaining this non UK licensed vaccine. I reproduce the quotes in question below:
On 27th February 1995 in a letter from Bayer UK the following appeared:
"Bayer used to hold small quantities of plague vaccine, largely for named patient use at the request of British Airways, and batch samples have been sent to CBDE Porton Down at intervals. I have made a careful search of our files and confirm that batch 10H03A was never imported at Bayer's request, or with our knowledge, into the UK."
Additionally on August 11th 1994 Dr Ralph Rousell of Miles wrote: (see Annex A)
"Plague vaccine was licensed in the USA and Canada (US License No. 8; Canadian License No. 28). A license was never applied for in the UK but it was available for usage in the UK on a named patient basis."
As you will see from the above, both quotes mention a mechanism known as "named patient basis". It is clear from the procurement trail that the Government chose to use, that this mechanism was not employed.
At the time of writing I have no idea what this mechanism might afford or the conditions attached to it, however, this is currently under research.
New information just arrived from Bayer UK provides a summary of their understanding of "named patient basis" based on the Medicines Act. Bayer stress that these are the regulations covering civilian practitioners and do not know if there are different rules for the Military. Are the rules different for the Military? (This can be found at Annex B)
One other odd occurrence that comes to light is shown up in the following quote:
The DOD in the US did state in letter to me under the auspices of the FOIA, dated 23rd October 1996;
"According to these records DPSC did not sell any Foreign Military Sales of the plague vaccine during the time of Operation Desert Shield/Storm" (approx. dates would have been Aug 1990 through to March 1991)
This directly contradicts the current explanation of how the vaccine was procured, maybe the DPSC’s remarks above are a mistake or were they trying to cover up the fact that it had been sold to the UK without using the "named patient basis", only time will tell.
Moving onto testing, you have already seen that this was tested by the NIBSC, they have stated this in letters to me. In addition they also quote batch number 10H03A, in the Background Paper para 88 MOD state that the batch numbers are not recorded. Additionally in the Background Paper para 89 they state that Food and Drug Administration (FDA) Release Letters were available for batch numbers 10G05, 10H02 and 10H03, no mention of 10H03A, how significant is the "A" in the batch number? (letters from NIBSC can be found at Annex C & D)
Regarding administration of the vaccine itself, it seems clear that MOD didn’t have a copy of the instructions for use leaflet, if they had, then they would have been in a position to realise that it is recommended that this vaccine is not given to people who have certain hypersensitivity’s or at the same time as certain other vaccines, I quote from the instructions for use leaflet:
And
"Drug Interactions
When practical, Plague Vaccine should not be given on the same occasion as typhoid or cholera vaccines to avoid the possibility of accentuated side effects. "
As I recall, I was never asked if I had sensitivities to any of the above. And to the best of my knowledge there was no follow up on any of us regarding side effects, you may recall some suffered quite nasty effects after this vaccine.
I posed a question regarding side effects to Mr. Clay Sisk of Greer, his reply is below:
"The symptoms you have related could have been caused by the combination of shots received".
"Anthrax pertussis (whooping cough) and Yersinia pestis (plague) are all bacterial vaccines, each of which cause similar side effects and if given together, can cause additive reactions. If given together, one should expect a high rate of systemic reactions, such as malaise, muscle soreness, headache and possible fever. Giving the vaccines in different arms or muscles may be helpful in minimizing local reactions at the injection site, but the systemic reactions will likely be the same. It is a medical decision as to whether the expected higher rate of reactions are acceptable to achieve earlier vaccination protection than could be gained by staggering the vaccinations further apart."
Please do not hesitate to contact us if you require further information.
One further point to note regarding plague, the disease itself, is that service people were not made aware of the likely signs of the onset of this disease. It begs to be asked, how would we know if we had been afflicted with this disease and thus, how would we know when to alert medical personnel?
Taken individually, both of these vaccines are known and have been in use for a long time. However, pertussis is obviously more well known as whooping cough vaccine and is widely used for vaccinating children. Whereas, anthrax vaccine is limited in it’s use to certain area’s of work, for example those working in the processing of animal products and slaughter houses. In fact if you mention to a layman that you have been vaccinated against anthrax you are more often than not shown a look of horror and surprise. In fact I got a similar response from the last Prime Minister, John Major when I told him this!
Anthrax vaccine is produced by the Centre for Applied Microbiology and Research at Porton Down. It is licensed in the UK and is prescription only medicine. The course of vaccination comprises four doses of 0.5ml, given at periods of three weeks for the first three doses, followed by a fourth after six months.
According to the background paper para 42 it would take 32 weeks for this to happen which was too long and would leave UK forces unprotected. It has to be asked why was it left so late for the anthrax vaccine to be given, which was around the beginning of January, five months after the first troops set foot in the region!
In an attempt to speed up the usefulness of this anthrax vaccine, it was decided to add something to increase the efficacy of the vaccine. Enter pertussis, this was the chosen addition to help a resistance to anthrax build up quicker in the body. We will look at this closer in a moment.
Pertussis is a child vaccine, used to vaccinate children whilst still infants to protect them from the ravages of whooping cough. The vaccine was procured from the Welcome Foundation and a French company known as Merieux. According to the background paper para 56 the Welcome vaccine was not recommended for use in adults and the MCA has recently advised the MOD that it was not licensed for this purpose. Did MOD know of this at the time? The French vaccine product insert only advises that the vaccine is given in the first 3 months of life, again that would indicate that it was not for use in adults. Again, did MOD research this or not?
I briefly touched on the reason for giving these vaccines in combination above, to increase the efficacy of anthrax by introducing a helper agent, known as an adjuvant.
A point to note at this juncture is that both of these vaccines already contained alum, which is a recognised and approved adjuvant, so by the very nature of giving these vaccines at the same time the recipient had two doses of adjuvant (alum) and then the body was also faced with the introduction of a 3rd dose of adjuvant, pertussis in this case. (See Annex E pages 6 & 7 for a discussion on adjuvants by the DOD)
According to the background literature, this combination was in the "idea" stage, it was not proven through clinical trials. In fact it states in the background paper para 51 "the authors concluded that further tests would be needed to determine optimum dose sizes and schedules in relation to protection against challenge with a series of strains, various challenge sizes and challenge by respiratory and oral routes.
From the above we can see that the regimen for the use of this combination had been far from established, hence, I would argue that this would make this combination experimental by nature. It would be interesting to know how the regimen that we were given was established, on the face of it seems that it was decided to give the troops standard doses of each vaccine in the hope that this would be alright!
What’s more, as this was an experimental combination, although given with good intention, the recipients were not made aware of this fact. Nor were they made aware of the facts regarding informed consent or their human rights with regard to medical experimentation. For the most part it seem that the troops "blind faith" was taken advantage of in the administration of this combination. The MOD and it’s scientists must have been aware of this fact at the time, especially when one considers their involvement in experiments at Porton Down, in this case there really is no excuse for the plain violation of Human rights that are portrayed here.
According to the background paper para 61 MOD intentionally kept the proposed use of this combination from the NIBSC, why was this so, were they afraid that they would be persuaded from using this combination that they felt would clearly help keep battle field casualties to a perceived minimum!
From the background paper para’s 62 & 63 NIBSC had deducted the MOD’s intentions with regards to these vaccines and subsequently decided to carry out their own tests for interactions.
As a result the Department of Health (DOH) faxed details of animal testing carried out by NIBSC to the MOD. The fax highlighted that when the vaccines were tested on their own on lab animals there was no unusual degree of toxicity found, however, when given together there was evidence of severe loss of condition and weight loss in the animals.
This was offered as well intentioned advice in view of the fact that there had been no human experiments of this nature carried out, this was to be done later, in the Gulf!
According to the background paper para 67 it seems that this advice was not taken into account when formulating policy on the anti BW programme. However, it seems that MOD officials who needed to know this information were never privy to it at the time, apparently due to some clerical cockup. This is clearly unacceptable as it could have meant the difference between life and death for those in theatre.
A few years ago I wrote to the FDA to ask if they had used pertussis as an adjuvant for anthrax. In the reply, which I no longer posses, they stated that they would not consider using this combination.
This seems to borne out in Annex E pages 4 to 6 as whooping cough/pertussis is not listed as a vaccine given, nor is it listed as a Desert Storm vaccine.
Even to this day, the safety of this combination has not been determined although it is being addressed now under a new MOD research programme announced in July of 1997. Roughly six years too late!
NAPS, I can recall being taught about these back in the early eighties, the wonder pill that would protect you from the effects of nerve agents. At that time our potential foe was the former Soviet Union.
That was almost 17 years ago that I first heard about NAPS, it is alarming that it took until 1993 to obtain a license for these pills. Similar to Mestinon, a tablet used by Myesthenics to help treat their disease, Myesthenia Gravis. They use them at a much higher dose than the forces did, in fact Mestinon is licensed in 60 mg tablets, whereas NAPS are only 30mg, half the size and one would imagine half the dose! Both contain pyridostigmine bromide as the active constituent, however, Mestinon is properly licensed for it’s use, treating those with Myesthenia.
In contrast, as we have seen it took a long time for NAPS to be licensed to protect troops against possible attack from nerve agents. As we can see from the background paper para’s 135 through 140 that trials were carried out on NAPS, in fact the tests date back to 1972. The maximum time that the trial participants took NAPS for was 4 weeks, this was the maximum time. Para 137 informs of trials carried out on people at various temperatures which closely resemble those of the desert, it was found that a decreased heartbeat was observed in those who undertook exercise, these measurements were pre and post exercise. What does not appear to have been simulated or may be could not have been simulated, was the dramatic increase in heart rate when the air raid sirens went off and the additional flow of adrenaline that accompanied this. What effect did NAPS have on heart rate when this was happening?
NAPS were only to be taken when ordered to do so, this was clearly stated on the packaging and is also taught when one does their ODT training annually. There can be no doubt as to when one should start taking NAPS, there should also be no doubt regarding the dose rate, one tablet every eight hours. That is very clear, however, there is one giant omission here, when does one stop taking NAPS. We didn’t know, there is no directions relating to stopping on the packaging, there is nothing taught in the training relating to stopping, so when does one stop? Due to the absence of instruction, either on the packaging or during tuition it was thought that we would be ordered to stop, just like we were ordered to start!
In the authors case this order never came, hence he continued to take his daily dose, as did many of his comrades, until the cease fire was signed. Only then did they think it prudent to stop. This meant that they had been taking NAPS for far longer than the testing had been which was four weeks. If they should have stopped earlier, then there was ample evidence to alert the authorities that an order to that effect should be given, after all the troops were only issued with one seven day pack at a time, then they had to return to stores to draw another pack. Did anybody really know when we should have stopped?
Furthermore, at the time that these tablets were being taken, under order by a non medical officer, they were still unlicensed and possible interactions with the other medications were largely unknown as they had not been investigated, at least by the manufacturers of the other drugs used, after all why should they have done. Hence it follows that responsibility for this lie firmly in the hands of the MOD, the troops employer who, for whatever reason had not done this either. It follows on that this was yet another addition to the experimental cocktail that British troops were ordered to take, unknown to them that they were involuntary subjects of a gigantic medical experiment, the size of which was not recorded or properly documented by their employers.
The question begs to be asked, who were the mass trials of NAPS done on and on what data was the license finally granted by the authorities? I would argue that the troops in the Gulf made up the numbers for a mass test, again unwittingly!
From the above report it will be plain that the author has not attempted to blame any of these drugs for the illness now exhibited by many of those returning from Operation Granby, how can he, he is:
However, it must be argued that the evidence to deny causation neither exists. It would be reasonable to most to come to the conclusion that in view of the lack of medical knowledge relating to this cocktail, that it could well have been contributory or even, solely responsible for the illness now known as Gulf War Illness. But this must be proven scientifically before firm conclusions can be made.
What the author has tried to do in this report is to illustrate how the rights of human beings have been violated without real due care and attention by their employer. The fact that the possible interactions of the cocktail were largely unknown at the time of use arguably makes this whole sorry story into a medical experiment.
There is a document which can be found on the UK GulfWEB:
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which gives guidance for obtaining informed consent from individuals partaking in medical experiments, again no heed seems to have been taken of this document, even though it was adopted in the same year as troops were shipped out to the Gulf in response to Saddam’s actions. Again this adds weight to the fact that no real concern was given towards the troops rights by the employer.
Undoubtedly the MOD were faced with a harsh choice in protecting their personnel who went to the Gulf, to vaccinate and hope for the best or tell them the truth, that it was all experimental, or rely on the troops blind faith and medical ignorance and pursue the proposed regimen for protection.
The MOD chose the latter, which amounts to gross negligence and violation of the rights of those concerned, for this they must be made culpable and where necessary made to pay for their wrong doing.
Perhaps a better choice, or the only choice in this situation would have been not to send any one at all in the view that no on really knew what effect this cocktail would have, nor did they even know if it would really afford the protection that was hoped for in the event of CBW attack.
After all, is the price of oil, foreign oil worth the cost of one drop of human blood, whatever the nationality!
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