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INDEPENDENT PUBLIC INQUIRY INTO GULF WAR
ILLNESSES
MINUTES OF PROCEEDINGS
held at 1 The Abbey Garden, London, SW1P 3SE
on Wednesday 1 September 2004 - DAY NINE
Lord Lloyd of Berwick, in the Chair
Dr Norman Jones
Sir Michael Davies
(From the Shorthand Notes of: W B GURNEY & SONS LLP,
Hope House, 45 Great Peter Street, LONDON SWIP 3LT)
DR MERYL NASS, Called
44. THE CHAIRMAN: We are very grateful to you for coming to help us with
our inquiry. Have you, as it were, come specifically for this inquiry or
did you just happen to be in England at the time? A. No, I have come for
this meeting.
45. THE CHAIRMAN: In that case, I thank you all the more because I think
it is a splendid thing to have done. Before you help us with our task,
could you just give your name and address for the purposes of the
shorthand note. A. My name is Dr Meryl Nass. I practise at Mount Desert
Island Hospital, 10 Wayman Lane, Bar Habor, Maine, USA. I practice
general internal medicine primarily now as a hospitalist which means
that
I take care of hospitalized patients. In my 24 years’ practice, I have
been an emergency physician and practiced outpatient internal medicine.
For four years, I had a private practice and this allowed me to do what
I
wanted or what I found I had to do with patients and I will explain what
that means. About the same time, I opened my own private practice and I
became involved with investigating anthrax vaccine and the role of
vaccines in chronic illnesses and, before that, I really was not aware
that there was a problem. I was interested in Chronic Fatigue Syndrome
and chronic Fibromyalgia at that time and made it known that I was
interested in seeing patients with those diagnoses. I began to get
referrals and I only took patients on referral. So, I started seeing a
number of those. Then, some patients with Gulf War Syndrome/Gulf War
illnesses found me and started coming and then eventually patients who
became ill after anthrax vaccine that they had gotten subsequent to the
Gulf War. Eventually, I was spending about 60 per cent of my time with
this sort of patient as well as writing and speaking on these subjects.
It was very exhausting; these patients are the most difficult I have
ever
had the pleasure to work with. I was diagnosed with a meningioma of my
spinal cord two years ago and had to have surgery and close my practice
and I was out of work for eight months. When I was able to go back to
work, I was not as energetic as I had been before and I could not keep
working 80 to 100 hours a week, so now I only see these patients one day
a week and I see normal patients the rest of the time. It is so
refreshing and energizing to take care of patients who are easy to
diagnose and treat and for whom you can predict a course of treatment
once you begin to see them.
I have pointed out that I am not an academic but I have done fairly
extensive evaluations on 600 to 700 patients with this combination of
disorders and I have been in contact with, by phone or e-mail or meeting
at conferences, probably at least 2,000 more who have alleged some
injury
following anthrax vaccine and who have asked me, "Does this sound like
something related to the vaccine?" or have asked me to review the
records
or something like that and now I cannot handle the volume. I get several
contacts a week from those people. Fortunately, there has been an
organization developed called the Military Vaccine Education Centre and
I
refer these patients on to them so that information about their clinical
condition can be elicited and they can be given some help from other
people who are ill or given some information about physicians who may be
knowledgeable in their care.
At the same time, after I closed my practice, one of the first things I
did after surgery was go to a meeting of the Research Advisory Committee
on Gulf War Illnesses and tell them how I was treating patients with
Gulf
War illnesses. They were very interested, so I wrote it down, made a
protocol and gave it them and I also put it on my website and I could
make that available – I did not think to do it beforehand. As I say, I
do
not cure any of these patients, I merely do what doctors have always
done
which is try to chop them into treatable pieces. Sometimes there is some
commonality to the symptoms. In other words, I might have a patient with
endocrine disorders and candidiasis but, in general, if they have sleep
disorder, I treat sleep; if they have diarrhea, I treat diarrhea; if
they have pain, I treat pain. So, it means that you are putting them on
a
lot of medications, vitamins and sometimes food supplements, a lot of
different therapies, and you do get functional improvement in the vast
majority to some extent, I would say on average 10 to 15 per cent
depending on the patients. There are occasional patients who do better
than that. Unfortunately, it is a lot of out-of-pocket expense for them
and you are looking at probably lifelong treatment with medication. A
lot
of these people are on more than ten medicines and they may have a sleep
apnoea machine for use at night. So, although there are treatments and I
think it is very important that one can offer these people something in
the way of treatment, you can have a normal therapeutic relationship
with
them, you are not just their psychiatrist hearing about the problems. I
think that is critical but it is limited. I am going to be a little
choppy in my presentation and go over things that I did not necessarily
emphasis in what I wrote and I would like you to interrupt me freely.
From my perspective, the issue of whether anthrax vaccine or vaccines in
general have contributed to Gulf War Syndrome has already been
established. There are two kinds of studies: there are studies that look
at vaccines in general and of course these are all self-report studies,
and then studies that ask specifically, "Did you take anthrax vaccine?"
Kong(?) in the VA epidemiology service showed that people who reported
receiving anthrax vaccine at the time of the Gulf War had twice as many
of those large variety of symptoms as those who reported not receiving
it. Shung looked at Ohio veterans and found that those who thought they
had the anthrax vaccine were much more likely to. The Boston Group of
Proctor and White also threw anthrax vaccine into the exposures they
were
eliciting information about and found that there was a relationship.
46. THE CHAIRMAN: And the background to this, if you would just remind
us, is that, unlike the British veterans, almost all of whom had the
anthrax vaccine, that was not true of the United States veterans because
there was not enough anthrax vaccine to go round, as I understand it. Is
that correct? A. I put one document in your package today – I do not
think they have been given out yet – which is signed by a major shortly
after the Gulf War and it said, "I have asked these various people about
how much anthrax vaccine was distributed and these are the numbers we
are
going to use when the Office of the Surgeon General is asked, ‘How many
people received anthrax vaccine?’" We have no reliable documentary
evidence of how many people received it and how many doses and I do not
feel that the numbers that have been provided by the Defence Department
are necessarily valid because there has been no support for those
numbers
and that document shows that it is a rough estimate.
47. THE CHAIRMAN: The question I asked is, is it not right that not
every
US veteran --- A. Not everybody but the majority that I meet say they
believe they had it. I just do not know. That document and all the
subsequent reports from the Federal Government have been that 150,000
people received 268,000 doses of anthrax vaccine and that only 8,000
doses of botulinum toxoid vaccine were given. There are many questions
about how much vaccine was available and even where it was manufactured,
whether it was tested, whether it was FDA approved. I spoke once to Jack
Melling about how much they had in the UK and he said that they had
plenty in the UK and that they even wound up selling a large number of
doses to Saudi Arabia. So, if you really had excess capacity and we were
short, why sell it to Saudi Arabia? Why not sell it to the United
States?
I think it is a question.
Steele only asked about vaccines in general and of course she showed
that
there was an important relationship. In UK veterans, Cherry and Wessely
both asked. Cherry did not put it in her published paper but I had asked
her specifically about anthrax vaccine and she said that, yes, there was
a meaningful relation, she did not go into the statistics. In Canada,
Goss-Gilroy looked at anthrax and plague vaccines together. The plague
vaccine, by the way, came off the market a few years later for two
reasons, I think. It was found that it did not work on inhalation
plagues
and that it was not a good biological warfare vaccine and I think there
may have been some other problems with it that have not really been
identified, so I think plague may have been a contributor but it was not
routinely given to American troops, just to Canadian. So, those are
seven
studies that are all in agreement. The Army is the only group that has
published a series of studies that says that anthrax vaccine is not a
problem, but even the FDA has problems with the Army studies which they
mention in the current package insert for the vaccine; they say that
there are Army studies and Department of Defence studies which have all
these methodologic limitations. So, I have avoided paying attention to
those studies and I think there is good reason for that.
In terms of isolating anthrax vaccine alone, Wessely, Kong, Shung and
the
Boston Group have done that. Then we have of course the non-deployed
vaccinated veterans who had more than just anthrax vaccine, but we have
a
fairly significant number in both countries who are ill. Now we have a
very large number of people who, prior to the last two years, were given
only anthrax vaccine alone and were becoming ill. Sometimes, with the
intent to go into Iraq, they were giving anthrax, smallpox and a variety
of other vaccines but, on average, perhaps about five vaccines close
together. So, the anthrax exposure is sort of polluted by that
combination and I do not know and I do not know if anyone knows whether
the adverse event rates are any higher with the combination; I do not
think there is any data on that.
The data that I think is very interesting but is not of good statistical
value is the data from the various reports of which there are I think
over 3,000 now and it is hard to get a current copy –I have a copy when
there were 2,000 – and the fact that some of those – the FDA said a few
and I thought many, up to ten per cent – seemed to meet the very loose
case definition of Fukuda at CDC about Gulf War Syndrome. I was
extremely
surprised, as I said, when I opened this practice on 1 January 1999 and
started treating patients because I never, in my wildest dreams, thought
that the people who were getting sick from anthrax vaccine would
clinically look almost identical to these patients I was seeing with
Gulf
War Syndrome, with Fibromyalgia and Chronic Fatigue Syndrome.
48. THE CHAIRMAN: Can I just interrupt you for the moment because you
say
that you are not an academic but you have obviously made a great study
of
all the papers on this subject and you also have clinical experience
which of is very valuable, but can you just give us, as it were, where
it
is you are actually going to go on this. Have you been able to reach any
sort of conclusion about the contribution which anthrax vaccine made to
the Gulf War illnesses? What is your view? Do not tell us what everybody
else’s view is. A. I see what you are saying. I believe that anthrax
vaccine alone is capable of causing a Gulf War Syndrome in a susceptible
recipient. I think there was too much illness. In the United States, the
VARAC is estimating that 25 to 30 per cent of Gulf War veterans came
home
ill. I do not think anthrax vaccine causes that high a rate. I think it
depends on the lot because, in the Donta survey, they did not have 30
per
cent reporting from chronic illness afterward. All my evidence is
basically anecdotal and I am guessing a rate of ten to 20 per cent and
there is a very wide range of severity, so that some people may just
have
arthritis and other people will have severe problems and be unable to
work. So, on this continuum, when I say ten to 20 per cent, I do not
know
whether it is a case of are most of the people really sick or are most
of
the people quite well?
49. THE CHAIRMAN: Am I right in thinking that the anthrax vaccine in the
United States was chemically different from the Anthrax vaccine which we
manufactured? A. People say it was different in three ways but they were
not major ways. We are speaking theoretically now. The way the vaccine
should have been made is that you use a different strain of anthrax but
both similar, you use different culture conditions in terms of
microaerophilic(?) etc, you use slightly different equipment and a
slightly different adjuvant. Theoretically, none of those things should
have made a big difference. You had a little more (?) factor and lethal
factor in yours, but both of them were very dirty vaccines made
generally
the same way. That is theoretically. When you actually get down to the
nitty-gritty and start looking at the FDA inspection reports of the
plant, then you throw up your hands and you are quite concerned because
you see that none of the procedures that should have been followed in a
vaccine manufacturing organization were being followed, not only for
anthrax vaccine but there were enormous numbers of quality control
failures in the United States in all the products that were made at that
factory. We thought we were the only ones with that problem but you
apparently had some similar problems here in the UK because your
manufacturing facility also had to be shut down and revamped, so there
was a period of a couple of years when both countries …
50. THE CHAIRMAN: So, the vaccines themselves were different, I think
that is probably established. A. Yes.
51. THE CHAIRMAN: And also of course in the United Kingdom we use
Pertussis as the adjuvant whereas you did not use an adjuvant at all. A.
The word "adjuvant" means stimulating extra non-specific immunity. You
have another adjuvant in your vaccine which was alum, which is also an
adjuvant, the aluminium phosphate. The Pertussis was again meant to
stimulate immunity even more. I do not know if they were mixed in the
same bottle or separate. In the United States, if you had mixed them in
the same bottle, it would have been experimental but, if you gave one in
each arm, it would not have been. We did not use Pertussis, no. Did we
use other adjuvants to boost immunity during the first Gulf War is a
question that I have … I feel bad because I am probably one of the very
first people who ever raised this issue back in March 1998 when somebody
had given me old newspaper articles about squalene in vaccines and I
said, "That is interesting" and I got all my old papers on anthrax and
starting seeing that there had been a whole series of these various
adjuvant boosters that had been used which took a vaccine that was of
very low efficacy and turned it into a high efficacy vaccine and none of
these immune boosters are licensed in the United States and I do not
believe that they are licensed in the UK either. So, they were used in
animal experiments and they subsequently have not been licensed.
Squalene
is one component of several of these and I know Les Bailey at Porton
Down, Les and Peter Turnbull as well as Ivins and the rest at Fort
Detrick, have used Trimix(?) – these are the trade names – E-tox(?),
MF59, myo-phospholipids and a few others in the animal experiments and
there are certainly big questions about whether those things will
contribute to the development of auto-immunity in humans.
52. THE CHAIRMAN: Your evidence is to this effect, that it is your
belief
that anthrax vaccine on its own without an adjuvant can cause what we
are
calling Gulf War illnesses in a certain number of veterans. A. Whatever
is in the vials alone I believe can cause Gulf War Syndrome. The
Department of Defence owns the entire stockpile and will not allow me or
anybody else to have a bottle to test to find out what is in it. So, I
am
working on the assumption that there is no squalene and no unlawful
adjuvant in any of those bottles that are available today. Going back to
the Gulf War, we have nothing available to test that is accessible,
although FDA would have been given vials that were released. The United
States likes to do things very similarly to Britain and vice-versa. When
we started the anthrax programme in 1998, we managed to get Canada, the
UK and Australia to start programmes around the same time and the fact
that the UK was using these adjuvants back in the Gulf War suggests to
me
that certainly the Americans thought about it. I would have thought
about
it if I was the Army Surgeon General. Here we have this vaccine that is
likely not to work, we are worried. I was very frightened; I was quite
concerned and was making suggestions that we needed to produce an
antiserum at that point in order that we would have a post-exposure
treatment. I am sure that it was considered. As to whether it was used,
I
have seen no documentary evidence that would answer that question one
way
or the other.
53. DR JONES: Might I add my appreciation to that of Lord Lloyd for you
coming here. I have some points arising from your paper and from your
presentation. This is a little bit off at a tangent but not very much.
On
page 4 you raise what appear to be cogent queries about the doxyclycline
trial. I wonder if you would like to say something about your concerns
there. Coming to the nub of it, do you think there is still a
possibility
that could be involved? A. Yes. I do not think it has been established.
Mycoplasma is sort of like Lyme disease in that if you look for it you
find it in a certain percentage of people. According to Nicholson, using
his techniques, which are more sensitive than almost everybody else’s,
he
says that about nine per cent of the general population are positive,
asymptomatic, and maybe up to 30-50 per cent of chronic fatigue patients
are positive, and 50 per cent or more of the Gulf War. If you go to a
highly endemic area for Lyme and do serologies you will find a lot of
positive serologies, but how many of those people are actually sick, it
would probably take something else, either a genetic predisposition or
another noxious exposure that maybe inhibits immunity, or some
combination. Again, all I can do is guess. I guess that there is
probably
a variety of chronic infections which exist, often in harmony with us
until something else happens, and that may be one of those and Lyme may
be another, and that if the immune system has been damaged in these Gulf
War vets then --- certainly I have had a number of patients who do
improve when they take chronic antibiotics. Nobody wants to take chronic
antibiotics, so they go on them and they go off them, and then they get
sick so they go back on them, they get better and then they go off them.
I cannot explain it so it may be other effects of the doxyclycline, but
Zypro(?) works and a variety of antibiotics can perform the same
function. On my website I collected one or two abstracts to show that
when dog vaccines were tested there was in a number of dog vaccines.
There is no published literature to show that human vaccines have been
--- they must have been tested by the manufacturer but there are a lot
of
things that in the manufacture of biologics are better left unlooked-at
by manufacturers and by FDA, so we have no knowledge about that.
Certainly theoretically could have got through the filter that was used
in the wide sterilization step, so theoretically it is possible there
was
in that. Of course there could have been mycoplasma from other modes of
transmission and it was only that mycoplasma that was acting as a
comensold(?) becoming pathogenic, so I cannot answer these questions.
You
guys are very bright. These are the questions that research should be
addressing.
54. DR JONES: Just one last thing about the doxyclycline trial. You have
made some very interesting financial calculations which rather throws
doubt on the calculations of the research working group. Have you done
anything to publicize that concern. It does seem different by an order
of
magnitude. A. Yes, two orders of magnitude.
55. DR JONES: Two orders of magnitude? A. I did not actually. At the RAC
meeting in February 2003 they had a new woman who was the head of VA
research throughout the VA system and she was sacked about eight months
later, but she was there and she spent a long time presenting these two
studies, and I had been on the phone with Sam Donta just a month or two
earlier and he said to me in his words that this was a failed trial.
Donta and I have known each other from conferences and we had shared
some
patients. He said that the effects we were getting at three and six
months did not show up at 12 but we had a lot of dropouts, and I
considered it a failed study and I think it showed either way and one
has
to do another study. Then when she presented it she said that the
doxyclycline did not work. I stood up there and said, "You know, that is
really not the way ---", and she had just come in. She had been two
weeks
in that job and I figured then they had given her the wrong information.
I knew of several people high up in the VA research system, part of
whose
job appears to be to control research on Gulf War syndrome, and so I
said, "This is what Sam Donta told me". Well, I am sure they immediately
got back to him and he got his hands slapped because when I talked to
him
later he said, "That was not really what I told you. I said this and
that
and we need more research but da-di-da". I did not talk about the amount
of money because I had not really --- I actually have with me that
yearly
report where they give the amount of money and I had not paid attention
to that earlier; I was more interested in the science, but then I
thought
--- I think the trial actually cost $20 million at the end. I cannot say
that for certain because I do not have documents to show it, but I think
it was more than 12, and there are 48 authors, so I guess a lot of
people
got money for being in this but there was very little --- if you compare
the Weseley trial where they surveyed almost 10,000 veterans and did a
lot of good statistical analysis, and these people who looked at under
500 and cost many times more, how did that happen? I do not know. I do
not do clinical trials but it seemed ridiculous.
56. DR JONES: It is a very interesting point anyway. Thank you very
much.
Can I address the question of definitions? Somewhere in your spoken
testimony this morning, and I think I got you right and please correct
me
if I did not, you referred to the rather loose (I think was the word
used) definition of Gulf War syndrome by Fukuda of the CDC. Would you
like to expand on that a bit? What do you mean? Why is it loose? A. It
does not exclude enough people. It is not specific enough. Lea Steele
actually developed a better case definition where she -----
57. DR JONES: Who was that? A. Steele, a very good --- she took that
data
and spent a couple of years really looking at it and it was her data
where she did it. That was just her and the people who collected it. She
has also gone beyond that now and looked at several other studies and
showed that in each study there is a base line rate of this sort of
illness or syndrome in whatever population you look at and in the
different studies that base line is different depending on how you
define
your syndrome, but that there seems to be an excess rate of about 25-27
per cent on the basis of Gulf War service. What would be a clinically
more useful definition would be something that is much more specific but
for me, in terms of getting my patients disability compensation when I
think they deserve it, the definition works very well because almost
everybody I see fits the definition.
58. DR JONES: Can I interrupt there? When you say the definition works
very well, that is the definition you use? A. No, the Fukuda definition.
I can choose my definitions by which paper I am going to cite, but for
compensation purposes, and I am sure probably they will get rid of it
for
that reason, it is easy to justify a person with Gulf War syndrome
because you say they met CDC ‘s own case definition, but in terms of
better defining who has this syndrome and establishing severity and
assessing the value of treatment, we need much better definitions. It is
interesting because if you look at the way the case definitions have
developed for fibromyalgia and Chronic Fatigue Syndrome and chemical
sensitivity, the case definitions are totally different and yet they are
--- it is the blind man and the elephant, you know, and we need to get
all the blind men together.
59. DR JONES: Just on the same subject, would I be right in concluding
then that when you say that by your definition Gulf War syndrome you
believe could be caused by anthrax vaccine, you are actually using Gulf
War syndrome there in a sort of epidemiological sense rather than a
specific medical cluster of complaints? A. I am not sure what you mean.
60. DR JONES: I am not sure either. At the back of your mind when you
use
your definition of Gulf War syndrome is this excess of unexplained
symptomatology. A. Yes. I would say when I make that determination I am
usually looking for cognitive problems because the vast majority have
that. If they do not have cognitive problems I am scratching my head,
"Do
you really have this?". I am looking for some emotional disorder too
because most of them have that, and I am looking for unexplained pain,
some type of gastro-intestinal function that is different than they had
previously. Not all of them have this, but I am looking for that sort of
thing that I am used to seeing, so that is my definition. I saw a
patient, and I was not sure if he met my definition. He was a very
bright
guy. He had worked at Walter Reed as an administrator and was about to
start pilot training and had the anthrax vaccine and he wound up with a
Stevens-Johnson syndrome and oral ulcers and bronchial tract ulcers, and
he came to see me and he had a swollen leg and he said a couple of
months
before he had had a swollen leg on the other side. I looked and he had a
deep vein thrombosis, quite severe, and I said, "You have got to go to
the hospital right now", and of course he did have deep vein thrombosis
and he had a pulmonary embolism, and now he is on Cumedin. He was quite
good cognitively and I thought he had a pretty mild case, but he was
absolutely devastated because he did not get to do his pilot training.
61. DR JONES: have you any comments on how the company making the
original US anthrax vaccine got away with these apparently faulty
procedures for so long? A. Yes. The FDA was, we think, not permitted, we
think not permitted --- let me take that back. The FDA was not
performing
a hands-on review of the anthrax part of the factory for some number of
years, we do not know how many years, and they were told that their
inspectors were not vaccinated for anthrax so they could not go into the
anthrax sections. It was a very large compound with 30-50 buildings on
it, and in the 1996 inspection report that the FDA made of this large
facility there is the statement, "We did not go into the anthrax section
because the army was performing the inspections", and of course that got
the FDA into a little trouble because they are legally required to
inspect everything. They had been sending warning letters to this
factory
through the nineties and finally --- I have got a copy of the last one
in
1996 where they said, "We are going to shut you down", because the
factory was not responding, was not making the appropriate upgrades.
There were a number of other reasons why they did not get shut down.
They
were passing faulty information to the FDA and the FDA for some large
period of time had never done any independent testing on the vials they
were given. They had justified the numbers they were receiving from the
factory with actual batch records, so the Defence Department wanted to
start this big programme. According to the JAL only 200,000 people had
ever got this vaccine before in the United States. We do not know if
that
number is correct either. Then they gave it to 150, maybe 1,000, people
during the Gulf War and we do not know if it made them sick, and now
they
want to vaccinate two and a half million service members and keep on
vaccinating and give them an enormous number of inoculations, yearly
boosters in the US, six or 18 months here, for over a year. So FDA
finally went in and looked around at the anthrax section, looked at the
records, and of seven million doses that had already been approved and
released by FDA for use they immediately quarantined five million of
them. They did not allow them to be used.
62. THE CHAIRMAN: So they were taken out of -----? A. They were taken
out
immediately because they found that they had failed all kinds of testing
and the manufacturers were legally supposed to give them the results of
all testing, but they just kept re-testing and re-testing until they got
a passing number, gave the FDA the passing number and did not tell them
about anything else they had done. When you read that inspection
reportyou are just horrified and I would be happy to make copies of it
available.
63. DR JONES: That is very helpful; thank you very much. Can I change
the
subject? It certainly has been alleged that Squalene was used as an
adjuvant in effect for the US anthrax vaccination programme. Are you
aware of any evidence that Squalene itself can have toxic effects? A.
Everybody wants to know about the Italians who used MF59 in a ‘flu
vaccine a few years ago and I have seen no data on that, although maybe
Dr Sharma has some. I am not aware of Squalene being used in human
vaccines on any other occasion except in experimental studies of a
variety of vaccines – HIV vaccines, malaria vaccines and some others –
in
the United States. I have met at a conference a woman doctor, a
radiologist in Florida, who claims that she got a Squalene contaminant
adjutant for a herpes vaccine and that she became ill afterwards.
64. DR JONES: But it is anecdotal? A. That is it.
65. DR JONES: On page 2, reference 1, to your own work, I am afraid I do
not know what "PSR quarterly" is. What does PSR mean? A. That changed to
Medicine in Global Survival. I do not know if it is still around, but it
was the Physicians for Social Responsibility quarterly journal.
66. SIR MICHAEL DAVIES: Dr Nass, you say that when you were in private
practice you had people referred to you with chronic fatigue and
fibromyalgia and anthrax effects, but you also said that you had people
referred to you with Gulf War syndrome. Who decided that they had got
Gulf War syndrome before they came? Did they come with symptoms that
they
regarded as Gulf War syndrome, were they sent to you, or did you decide?
A. It was a variety of things. They sought me out, so they had certainly
decided. Some of them had been through the comprehensive clinical
evaluation programme at Walter Reed. There are some VA doctors and
para-professionals who were diagnosing them. All the VAs had a Gulf War
syndrome designated doctor. My ex-husband was one of the VAs. These
doctors were sent to some training and were supposed to be able to
identify them and brief them.
67. SIR MICHAEL DAVIES: And they were sent to you for what purpose if
other doctors were there to treat them as well? A. In the majority of
cases the other doctors said, "I do not know what to do for you". I
would
say, "I do not know what to you do with you either but we will try these
things".
68. SIR MICHAEL DAVIES: You did tell us earlier, but I am afraid, not
being a doctor myself, I have not noted them all down. What did you
offer
them in terms of medication? A. I will make this protocol available to
you. It is about eight pages long. I looked for endocrine levels. I had
eight young males, not only Gulf War; some Gulf War, some anthrax, some
chronic fatigue, eight males in their thirties and forties with low
testosterone levels, which really made me scratch my head and wonder how
common that is in the general population. I do not think we know but a
lot of the newly vaccinated anthrax people are reporting low libido,
non-peridoital(?) function sometimes, and some of them had had shrinking
of the testicles and this sort of thing. I am not sure what the
aetiology
is because we have an autopsy on one person who did have pondyrinis
nebdosa(?) affecting a testicular artery. I had another person who had a
testicular occipital(?) biopsy and everything was scarred so you could
not tell what the cause was. It is probably an auto-immune attack
because
we are seeing that in some other endocrine organs, but I do not really
know. We need to study it. It surprised me. There are things you can get
with testosterone. It is not easy to get testosterone into the body. You
wind up almost always injecting it because we have all these topical
treatments that do not work very well for these young people. They very
often had chronic diarrhoea, sometimes constipation but usually
diarrhoea.
69. SIR MICHAEL DAVIES: Is the reason that they were regarded as having
Gulf War syndrome that they had actually served in the Gulf? A. Yes.
70. SIR MICHAEL DAVIES: It was as simple as that, as others came to you
with chronic fatigue syndrome? A. How did I differentiate them
clinically?
71. SIR MICHAEL DAVIES: Yes. A. I do not think I could. I really wanted
somebody to help me with that. I believe there are common mechanisms to
these disorders. I wish I had some Vietnam vets because people have said
that some of the Vietnam vets have similar syndromes and dioxin
apparently can somehow have a general effect on immunity. Like the
speaker before me said, HIV then allows all these other things to
develop
and I think that is a good motto, to talk about what I have seen.
72. SIR MICHAEL DAVIES: It is affecting the auto-immune system? Many of
the witnesses we have seen previously have referred to the effect of the
cocktail of inoculations and vaccines they had as being the cause of
their illnesses. You are being much more specific in saying that it is
down to one vaccine, which is anthrax. A. Yes. This is confusing and I
want to be as clear as I can to eliminate confusion. We have people who
were recently vaccinated. They had gotten their 15 shots during basic
training but anthrax vaccine is not given during basic training in the
United States, so these people then got anthrax vaccine at some later
time and often had symptoms immediately afterwards. During the Gulf War
everybody had cocktails. Nobody got anthrax vaccine alone that I am
aware
of. In the last two years everybody is getting cocktails again because
they are going to be deployed. They get anthrax vaccine in preparation
for deployment to Afghanistan or Iraq. That is how it has been for two
years, so that they have got smallpox as well and they have got other
vaccines. In Weseley’s study, which is a very good study, he asked
people
that had anthrax vaccine alone and said, "Yes, anthrax vaccine alone is
related", and he looked at cocktails and that is related. Even though
his
study is very good because he used self-reports and you did not have
people who only had anthrax, I am not sure you can make that
differentiation. Certainly in those people who were vaccinated from 1998
to 2002 who only got anthrax vaccine and maybe had their other shots
years before, I think that we have very good evidence that the anthrax
vaccine was making them sick. What about the cocktail? It makes sense
that if it is, let us say, over-stimulating the immune system and then
you are giving a cocktail of vaccines, many of which are
non-specifically
adjuvanting each other, you should have a synergistic effect, a
synergistic negative effect, on auto-immunity. That is the theoretical.
73. THE CHAIRMAN: Dr Nass, it only remains for me to thank you very much
indeed for crossing the Atlantic to give us this evidence. I think I can
say that you have obviously made a huge study of this subject and this
is
certainly much the most comprehensive paper we have had on the subject
of
the anthrax vaccine. I cannot remember another paper we have had on
anthrax vaccine which approaches this in detail. I just hope that the
relevant authorities in the United States pay attention to what you say
on the further research which is needed and the rather sombre warning
which you give in the last paragraph on page 21 of the paper. A. Thank
you. May I say one thing that I neglected to mention?
74. THE CHAIRMAN: Yes, of course. A. I wanted to let you know that
because the congressional hearings and the other efforts that were made
to try to halt these vaccinations until they were properly evaluated
were
not successful a group of military officers several years ago took legal
action and brought a case in the Federal District Court regarding the
legality of the licence for the vaccine because when it was licensed
there existed no good evidence in humans for either safety or efficacy.
The judge was persuaded by the initial filings and issued a temporary
restraining order in December, and for ten days the Department of
Defence
was not allowed to use the anthrax vaccine. After eight days the FDA
issued a final ruling, because it had never issued a final ruling on the
vaccine over 18 years, and the reason we believe they had not issued it
was that once it is issued it is subject to legal challenge and before
it
is issued you cannot really do anything about it. They issued that and
the judge dropped the injunction except for the six particular
plaintiffs
and the litigation continued. All the arguments were finished in June
and
we are now waiting for a decision. If the judge rules in favour of the
plaintiffs the military will not be allowed to use this vaccine any
longer unless and until they can get it properly tested and licensed.
75. THE CHAIRMAN: So if that happens you will have won your point? A. As
it were, but because they have been aware of this issue for many years
they have been working on quickly getting new anthrax vaccines into the
pipeline which may in fact be more reactogenic than the current
vaccines,
so I just thought I would bring that up because it may be something that
will happen. We will get a decision some time this year.
76. THE CHAIRMAN: Dr Nass, having come over I hope you are not going
straight back to the United States. A. No. I will be here a couple of
days, thank you.
THE CHAIRMAN: I do not think that is long enough because you do not
often
get weather like this in the UK. If I read the papers quickly, the
weather, certainly in the United States, is not going to be so very good
if the hurricane gets anywhere near where you live. Thank you again very
much.
The witness withdrew
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