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 1950’s. 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 weren’t 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. Salk’s 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 Cutter’s, 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 wasn’t 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 O’Connor, 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 what’s 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 Institute’s 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 couldn’t 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 didn’t 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."
(Author’s 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 it’s 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 hasn’t 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 weren’t. 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 I’ll leave for the record, a cyto-megalovirus contingency plan arranged by Lederle at the time. The arguments were similar to the ones in 1968: There’s been such a long experience of this vaccine with no adverse effects, you can’t 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, there’s 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 Bureau’s 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 wasn’t 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 country’s (U.S.) protection against potential biological warfare. A number of companies had given up making vaccines. It’s 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 it’s 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 can’t afford any outside money... Indirectly, what that was saying to me was that they’re 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 I’ve 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 that’s 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 I’ve covered the situation of polio vaccines. Once one addresses that as an issue, then it’s 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 there’s a ceiling above them that doesn’t 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, they’re open.
For political reasons, that does not come to the fore. That’s why I enjoyed reading the (Dr. Lanctot’s) book, as a way of saying, yes, this is a structural flaw in the system. When asked how it should be regressed, it’s essentially that, if we do have public health agencies, FDA and CDC, that are going to represent the public health interest, then it’s 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 didn’t 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 I’ll 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 they’re 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 there’s 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, there’s 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 what’s 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."
