Subject: DR. MARTIN TESTIMONY ON POLIO
Dr. Lanctot starts the ball rolling by asking Dr. Martin to speak
about
polio vaccine...
He traces the history of the illness from when it first appeared in
1878, followed by the first epidemic outbreak in 1888, in Sweden,
ending
up with the work of Dr. Jonas Salk in the 1950s. He explains that the
latter developed an inactivated polio vaccine, which he grew in monkey
kidney cells. But, he notes, inactivating it too much makes it
ineffective, while not enough can cause the illness. The first
production lots werent inactivated enough.
He then recalls how Dr. Bernice Eddy, who worked at the Bureau of
Biologics (formerly the Laboratory of Biological Standards), observed
that many of the vaccine lots that were being submitted to her Bureau
contained residual live virus. This was even more of a problem because
the industry making the vaccines was only submitting those lots that
did
not contain live virus. In reality, he adds, in their own
preparations,
they were finding that the assumptions made by Dr. Salk that you could
inactivate polio virus with one to 4,000 concentration of formaldehyde
were erroneous...
"Dr. Eddy reported this to her superiors and sent photographs of
monkeys
that were coming down sick with the vaccine. There was some concern
that
there was still a live virus. Nevertheless, with a lot of fanfare, the
results of Dr. Salks program were proclaimed 100% successful,
followed
within a month by the recall of the vaccine because some one hundred
children had developed a paralytic disease. That was all ascribed to a
batch coming from Cutter Laboratories in Berkeley, California, though,
again, internally, it was known that there were many preparations of
vaccine submitted to the Bureau that had live virus in them, not only
Cutters, but the focus was to blame Cutter.
There were other investigators at the time who expressed concern that
the initial Salk vaccine was effective only if it had some live virus
and, if it were totally killed, it was basically ineffective. That
problem, instead of being addressed up front, was drawn out through
the
period from 1956 to 1960 by increasing the concentration of polio
virus.
It was clear that, if you did have a fully inactivated virus, you
could
immunize against polio, but it wasnt just a single injection, it was
going to be multiple injections, and slowly, the immunization became
more accepted and the people who did object to it, Dr. Rattner in
Illinois and others, were basically shunned and stymied...
Basil OConnor, who was a big proponent of the vaccine, had introduced
legislation that would make polio vaccination compulsory, primarily as
a
way of reducing some of the stocks of polio vaccine that were
accumulating..
In contrast to Dr. Salk, who took the viewpoint of using an
inactivated
polio vaccine, the other approach was to go with an attenuated live
vaccine, and Dr. Sabin is best known for that... An American, Dr.
Sabin
never had the opportunity to do early trials in his country but did
have
the opportunity to do major trials in Europe, particularly in the
Soviet
Union. In contrast to the Salk virus that was struggling, the Sabin
vaccine was acutely efficacious even in abruptly interrupting ongoing
epidemics. And whats more, it only required an oral dose, was less
expensive and easy to deliver...
Given the disappointment with the Salk vaccine, and the efficacy of
the
Sabin vaccine, the Bureau of Biologics decided to accord a production
license for the (Sabin) vaccine...
At about the same time... Dr. Bernice Eddy worked in collaboration
with
Dr. Sarah Stewart, one of the pioneers to show that viruses, mammalian
viruses, can cause cancer... They were the first to describe how a
virus
out of one animal could induce cancer in another (in this case
hamsters). This was a major thrust of what subsequently became the
National Cancer Institutes viral oncology program...
Dr. Eddy was aware that people were using monkey kidney cells to make
polio vaccine. She had an interest in polio vaccine. She took extracts
from monkey kidney cells that were being used for testing polio
vaccines, injected the extracts into hamsters and observed that the
hamsters developed cancers. She took that information to Dr. Smadel,
her
boss at the time, who totally dismissed it, saying that she was wrong,
that they were lumps, not cancers.
Some months later, I think in 1960, out of frustration, while she was
at
a meeting on polyoma viruses in New York, she mentioned, by the way,
that one could also get cancers using Rhesus monkey kidney cell
extracts. She was severely chastised by her boss and others for daring
to raise the possibility that there could be oncogenic activity in
poliomyelitis. Dr. Sabin was upset by this. Everybody was upset.
Dr. Maurice Hillerman of Merck, was also concerned that the Rhesus
monkey kidney cells had some form of agent in them. He wanted to see
if
he couldnt find a better batch of kidneys. In the beginning of
vaccine
production, 50% of the renal cultures had to be rejected because of
the
presence of adventitious viral agents. Most of these were phony
viruses
but some were adamant and still others unidentified. But the Bureau
didnt have this information since the only batches it received were
passed by the manufacturers. In reality, the companies were excluding
many batches because of the presence of apparent adventitious
agents...
After his experiments with other kidneys, those of African Green
monkeys, Dr. Hillerman noted a very strong cytopathic effect. He
subsequently identified that virus as SV4O, SV referring to the simian
virus and 40, to the fortieth virus identified in Rhesus monkey kidney
cells... That allowed Dr. Eddy to say that this was the same virus
that
she had found. Eventually, people came to realize that there was SV4O
virus in many of the polio vaccines that were being produced, both in
the live polio vaccine and, unfortunately, in a way, in the
inactivated
vaccines."
(Authors note: After many years, Dr. Eddy did finally appear before
Congress in 1972 and told the members that if they continued to allow
contaminated vaccines to go out there would be an epidemic of cancer
over the next twenty years.)
"It was of interest and again reported, I think its in the book, The
Health Sentry, that when Dr. Hillerman made his observation about
SV4O,
his first reaction was that it would be in the live vaccine, not the
killed vaccine, and how fantastic that was because it meant that
America
would do well in the Olympics because all the Russians would be laden
down with tumors as the result of having had SV4O. In reality, it
turns
out that the oral administration of SV4O is less infectious than the
direct injection of non-inactivated SV4O, and there were many more
Americans that were exposed and had data of SV4O infections than there
were people that had been recipients of the live viral vaccines.
I would just mention as an aside, at first, there was not so much a
cover-up, but there was no desire to raise concerns that there might
be
a cancer-causing virus in the vaccines. So, there was a pretty active
suppression of that information. Even now, when the occasional
investigator has described SV4O sequences in certain forms of cancer
in
humans, there is a great shunning of that information in the sense
that
the FDA hasnt responded back to say, that we should be looking at
this
issue afresh, even though the individuals who are now coming down with
SV4O sequences are younger than those people who would have received
these contaminated vaccines, suggesting that SV4O is, in fact,
percolating through the community and can be a potential concern as
invoking certain forms of cancer.
To go back to the politics within the Bureau of Biologics at the time,
there was the switching from inactivated vaccine to live vaccine, then
this awful realization that there was SV4O as a contaminant in the
vaccine, and they went back to Dr. Sabin, asked if he still had
sufficient stocks that they could go back to his original stocks to
make
vaccine, and realized that there werent. So, they undertook a program
to cleanse SV4O out of the stocks of vaccines and transfer the whole
production from Rhesus monkeys to African green monkeys. That was done
rapidly, the great concern was to maintain the polio (vaccine)
production loss to a minimum...
A joint study was undertaken by the Bureau and Lederle in 1972 to
address the question of, again, potential vaccine contaminants. All
eleven monkeys examined in 1972 had their kidneys grown out and all
grew
out cytomegalovirus. African green monkey simian cytomegalovirus grew
out from all the kidney cell lines. Only four of them would have been
detected by the normal techniques for developing or detecting
cytomegalovirus without a special effort to identify it...
This was a major concern. There was, which Ill leave for the record,
a
cyto-megalovirus contingency plan arranged by Lederle at the time. The
arguments were similar to the ones in 1968: Theres been such a long
experience of this vaccine with no adverse effects, you cant now, all
of a sudden, raise this as a big issue...
Live polio viral vaccines are still made in African green monkey
kidney
cells today, now. I will spend some time if you want me to go on to
current efforts to redress this problem, but at the moment, live polio
virus vaccines are still made in kidney cells of African green
monkeys,
and the monkeys used are sero positive. Besides the megalovirus,
theres
no reason not to suspect that cytomegalovirus would not be present in
these vaccines...
What came together then was a batch of vaccine which appeared to have
phony virus, live particles and batches of vaccines that would give
positive assays for reverse transcriptase as initially defined,
batches
of polio vaccines that would produce a cytopathic effect that was
uncharacterized on the cell lines that were being tested on and could
be
passed between different cell lines, and that came to my attention as
head of the viral oncology branch of the Bureaus Division of
Virology.
I sent electron micrographs to three outside experts to ascertain if
these were the dreaded Type C retroviruses or not. The answers came
back
no, but there was so much debris and DNA in the vaccine that it was
impossible essentially to do a nice clean prep of the viral vaccines,
of
the viruses. That was my first indication that, in fact, the vaccines
were rather crude.
I use the word "gamish" because all that was being done was to take
monkey kidneys, make a primary culture, allow that to grow for two
weeks, because, if you wait for three weeks, the cytomegaloviruses
were
coming out, add the polio virus vaccine and, 48 hours later, take that
material, dilute it out and give that as the vaccine...
There was a lot of extraneous DNA in the vaccine... This was a problem
that excited me, where was this DNA coming from? We heard a number of
stories... All these things were coining, but it wasnt clear. I
really
felt uncomfortable to the point of making a nuisance of myself...
Finally, in the corridor of the Bureau, Hank Meyer, who was then its
director, told me to stop working on this... Still persisting in my
inquiries, the issue came up that vaccine manufacturing was an
essential
component of industry, this countrys (U.S.) protection against
potential biological warfare. A number of companies had given up
making
vaccines. Its an economically risky business. If one criticizes, in
this case, Lederle, too much and they stop production, then all the
production will go to Switzerland. The Swiss would then be bought out
by
the Russians, and then there will be biological warfare...
That stays as a memory of the way the government works... I have
approached individuals to try and understand why that system would
operate like that. The major explanation was that the regulatory
authorities are controlled by and depend on the industry, and so,
industry growth, if you want, calls the shots.
This issue really came back into focus, my focus, when we were looking
for viral causes of what appears to be an ever increasing prevalence
of
neuropsychiatric, neurobiological dysfunctional brain syndromes, and
so
forth. Over the last several years, I have sought evidence of viral
infections in patients both in terms of patients with the chronic
fatigue syndrome, autism, neurobiological disorders, comas of unknown
origin, and so forth, major psychiatric illness. The one virus which
we
were able to isolate and characterize is unmistakably African green
monkey cytomegalovirus.
I had notified centers for disease control by way of a manuscript and
a
request to transfer some of this information when I first had it,
which
was back in 1994, without any real success, but when the data was
unequivocal, which was in 1995, we contacted the Bureau. At that
stage,
we were really just trying to get some reassurance that they no longer
used monkey kidneys to make polio vaccines and were told that
unfortunately they still did...
I was given some reassurance in March 1995, that something would
happen,
a lot of correspondence back and forth... I was advised in June that I
should come to a meeting on cell substrate safety that was being
sponsored by the FDA and the pharmaceutical industry... I presented
our
concerns with this use of African green monkey vaccines. Questions
were
raised as to whether it would be a problem with live vaccine or killed
vaccine. I said its probably more likely a problem with live
vaccines.
I gave them a proposal that said that it would be prudent to test the
monkeys used in vaccine production for cytomegalovirus, particularly
the
derivatives of cytomegaloviruses. It would be worthwhile to test
current
vaccine lots as well as past vaccine lots and it would be important to
do a prevalent study to see how many people may be infected with
simian
African green monkey cytomegalovirus, a fairly straightforward
proposal... The issue was straightforward, that people know that there
are cytomegaloviruses in the monkeys. People are not testing for them,
and people should be testing for them...
The formal response came back from FDA in January 1996, which was
essentially: thank you.. our budgets are tight... we cant afford any
outside money... Indirectly, what that was saying to me was that
theyre
under great constraints to deal with anything that might be considered
a
proprietary interest of the vaccine manufacturers."
He also submitted a proposal to the CDC and the Advisory Committee on
Immunization Practices that advises CDC, with similar results.
"What Ive tried to picture is that, if one had the choice, again, of
making a vaccine, one would be unwise to go to Africa, to take monkeys
straight out of Africa, take out their kidneys, grow their kidneys for
two weeks, add another virus that could allow for a combination type
event, and 48 hours later, take it, a crude gamish mixture, and give
it
to every child in the country... You could say, that there is enough
experience that thats being safe and not a hazard. The problem with
that is that people are in full agreement that there has never been
any
instrument in place to look for longterm complications of vaccines.
There are instruments to look for acute ill effects. In 24 hours, 48
hours, within the first week, people have that instrument, and they
can
quantify that, but the prospect of having an insidious disease of
delayed onset, which would overlap and mesh with existing diagnoses
that
could be viral induced and could account for illnesses, has not been
in
place. People are very reluctant to put that in place now because of
obvious political as well as financial implications...
The issue is still very sensitive... There have been so many
developments in molecular technology, assays, polymerize chain
reactions, other approaches, one would hardly make a vaccine and then
not want to utilize the benefits of new techniques from that...
Why do we still continue with very insensitive culture techniques
looking for adventitious viruses that were mandated back in 1960?
There
are so many improvements now. Why not bring that in? Again, the
argument
is that they do not want to do that because it might change the
situation with the acceptability of these vaccines, and they might
then
have to go back over old territory and realize that there are
complications that might have occurred because of these vaccines...
I think Ive covered the situation of polio vaccines. Once one
addresses
that as an issue, then its very easy to switch to rubella vaccines
that
were initially made in duck kidney cells and dog kidney cells and the
whole philosophy now that it is dangerous to switch species and take
potential viruses from one species and introduce them to another...
I should perhaps, while I think of it, mention the troubling
interactions with the people at FDA and CDC... The difficulty that I
found with these people is that theres a ceiling above them that
doesnt allow complete expression. It goes back to Dr. Eddy, Dr.
Smith,
and myself, when I was working there. There were observations made
about
vaccine safety concerns, but for political reasons, these were
suppressed, and yet, for internal discussions, theyre open.
For political reasons, that does not come to the fore. Thats why I
enjoyed reading the (Dr. Lanctots) book, as a way of saying, yes,
this
is a structural flaw in the system. When asked how it should be
regressed, its essentially that, if we do have public health
agencies,
FDA and CDC, that are going to represent the public health interest,
then its important that those agencies and people working for those
agencies feel free to have the opportunity to speak publicly about
what
they might find, and not be hemmed in by these proprietary concerns."
Now, after the lunch break, Dr. Martin continues with his testimony,
but
not for long...
"A final comment, I think the philosophy behind all of this is the
frustration that I sense inside these agencies as to the ability to
carry through common sense analyses. The issue came up in terms of
Gulf
War Syndrome where I was notified by somebody inside the Office of
Naval
Research, who asked why I didnt look at gamma globulin preparation
for
my stealth viruses? This, they said, is where you should be looking
for,
quote, "the stealth viruses", in the blood supply... It seems
inappropriate to be calling me and not have a mechanism inside the
system to address the fact that there could be adventitious viruses in
things like blood supply and vaccines...
One other comment, and Ill try to make this shorter. The issue of
interest with HIV vaccines and so forth. .. it is known that African
green monkeys have a retrovirus called simian immunodeficiency virus,
SIV. There is a general relationship between SIV and HIV, though
theyre
not that closely related that, by normal kinetic mechanisms, one could
see that they were both coming together. What is of interest is the
fact
that the African green monkeys brought out in the early part of the
century to America were SIV negative...
The question is as to whether or not SIV infections in the monkeys in
Africa may have, in fact, been introduced in this century and were not
an infection that predated hundreds of years but, rather, was
introduced
into the monkeys in some of the early experimentation done in vaccine
development, and theres a real interesting argument that, in fact,
man
may have infected African monkeys which then, in turn, processed the
virus and returned it back to man in the form of HIV
Again, I could cite other examples. There seems to be two cultures,
one
of people inside the regulatory agencies that speak very freely of all
these possibilities and the other, external indication from these
agencies, that everything is 100% safe, theres no problem...
What I would like to do is to go on with the general interest that I
have, as a physician, in terms of neurobiological diseases and how
some
of these may be related to viruses and then leave open for your own
consideration whether or not one area of needed investigation is to
look
at live viral vaccines as a potential source of new viruses introduced
into the community.
I will be presenting a series of facts that there are illnesses in the
community seen by neurologists, psychiatrists and rheumatologists for
which there is not a good understanding, and in fact, for which there
is
very little incentive to really get to the basis of whats going on.
As
well, how my research is addressing the fact that there may be viral
forms of stealth viruses causing disruptions of the nervous system."
-- Sheri (wncy2k@nccn.net), February 09, 2000.