SV40 from Polio Vaccines
Have polio vaccines been responsible for the spread of SV40 throughout the population?
The answer is “yes.”
To better understand the question and the answer it is important to recognize three distinct time periods:
|Prior to 1961||
All health authorities agree that both the Salk Inactivated Polio Vaccine (IPV) and Sabin Oral or “live” Polio Vaccine (OPV) were contaminated with SV40 up until 1961. The contamination has been estimated to have exposed up to 30 million Americans and millions more in the USSR (where the OPV clinical trials were conducted) and other countries. In 1961, federal regulations went into effect in the U.S. (and similar regulations went into effect in other parts of the world) that required that polio vaccines be free of SV40. The new regulations in the U.S., however, did not require that: 1) the SV40 contaminated seeds used to make every “batch” or “lot” of vaccine be discarded; 2) the recently manufactured contaminated vaccines be discarded.
In the U.S., federal law did not require that SV40 contaminated vaccines be discarded if they were manufactured before the new regulations went into effect. This meant that vaccines contaminated with SV40 were administered to children and adults until they were used up. This is estimated to have happened some time in 1963. Millions of people were unnecessarily exposed to SV40 because of economic pressures (the vaccine manufacturers did not want to throw away millions of vaccine vials) and political concerns about the public’s trust in the government’s polio vaccine campaign. (The federal government did not want publicity about manufacturing problems related to polio vaccines especially after the so-called Cutter incident in which children were reportedly paralyzed and killed from virulent polio vaccines.)
What happened after 1963 is debated. Government authorities believe that there were no contaminated vaccines released after this period. Others think that this is not the case. The argument comes down to two sets of evidence: 1) what was actually done by the manufacturers to ensure that SV40 was removed; 2) what various studies have revealed.
Obviously, the best way to answer this question is for the government to demand (or for manufacturers to volunteer) to open their freezers and allow independent SV40 scientists to test the vaccine materials in cold storage. Given the public health implications one would think that such steps should have been undertaken years ago. They have not. The government has never demanded that independent testing be performed and the manufacturers have never volunteered.
IPV versus OPV
After 1961, IPV was no longer grown on monkey kidney cells taken straight from monkeys. Instead it was grown on Vero cells, a continuous line of monkey kidney cells that are grown for the express purpose of providing an advantageous agent-free cell culture medium. In addition, other steps had been implemented that would help prevent SV40 contamination in IPV. These steps included the addition of the required amount of formalin and the use of column chromatography. In contrast, the oral polio vaccine was still grown on primary monkey kidney cells (kidneys removed from live monkeys) and there was no evidence that the original contaminated poliovirus seed stocks were ever replaced. Therefore, the following discussion will focus on OPV.
What was Done by Manufacturers to Ensure SV40 Removal
A) The OPV manufacturers allegedly introduced rabbit anti-SV40 antibodies into their seeds.
The SV40 contaminated seeds were used to manufacture all subsequent polio vaccines for the next 40 years. Rabbit anti-serum was added to the seeds. It was theoretically designed to eliminate the SV40. There are a number of problems with this approach, however, including:
The methodology as to how this was performed has never been made publicly available for scientists to assess.
Testing to determine the success of this methodology (whether it worked) has never been made publicly available.
Testing to determine whether the antibody actually removed SV40 has never been made publicly available. (In fact, most antibodies bind to viruses flagging them for consumption by other cells. Antibodies themselves may not physically remove a virus.)
In essence, we are told that the anti-serum worked to remove infectious SV40 without any proof whatsoever.
B) The OPV manufacturers also used an infectivity test to look for SV40 during production.
Manufacturers initiated government-mandated testing that was based on infectivity assays. In essence, they took the monkey kidney cells upon which the vaccine would be grown and:
1) Looked at them through a microscope to see if they demonstrated SV40;
2) Took fluids from them;
3) Introduced those fluids into other cell cultures;
4) Waited 14 days;
5) Saw whether the other cell cultures were changed as a result of the presence of SV40.
6) Recultured and repeated.
These tests were not designed to detect the contaminating viruses themselves. One cannot see SV40 or any virus with a standard light microscope or the naked eye. Instead, this test relied on the observation of the presumed effect of an SV40 infection on certain tissue cells to demonstrate the presence of the virus.
There are several problems with this, but the most glaring is that there never has been a single independent study that has confirmed that such testing is sufficiently sensitive to reliably detect all SV40. Instead, we have just the opposite. There have been many studies performed in the early 1960’s (right after these tests went into effect) that proved that the testing would not detect SV40 with any reliability. See SV40 Chronology for examples.
In addition, in December 1999, one of the leading SV40 scientists Michele Carbone, Ph.D., M.D., tested contaminated polio vaccines from 1955 and found that the vaccines contained more than one strain of SV40. The new strain he detected was slow-growing and would take at least nineteen days to appear in cell culture, five days past the federally mandated 14-day observation period. Dr. Carbone and his colleagues wrote that his study suggested that any slow-growing SV40 present in the vaccine would have gone undetected. The scientists also wrote, “they were surprised to learn” that more sophisticated techniques were not used to screen polio vaccines for SV40. (Paola Rizzo et al., Unique Strains of SV40 in Commercial Poliovaccines from 1955 Not Readily Identifiable with Current Testing for SV40 Infection, 59 CANCER RES. 6103, 6103–08 (1999))
C) The OPV manufacturers allegedly used monkeys that were free of SV40 for production.
Again, we are told this without any proof whatsoever. In fact, like rhesus monkeys, African Green Monkeys can harbor SV40.
What Various Studies Have Revealed
The government has never demanded that statistically valid independent testing be performed and the manufacturers have never voluntarily opened their freezers to allow such testing. Therefore, there have been no comprehensive studies to determine whether SV40 has been present in some “batches” or “lots” of OPV after 1963. The few studies that have been performed have an enormous number of questions about how they were done. One recent example will illustrate:
On November 15, 2005 an article entitled Some Oral Poliovirus Vaccines Were Contaminated with Infectious SV40 after 1961 appeared in the journal Cancer Research. It essentially is comprised of two studies:
One study purportedly examined the “current or recent seed lots of all three poliovirus serotypes from Belgium, Canada, France, Germany, Indonesia, Iran, Japan, Mexico, United Kingdom, United States, EEVM, Vietnam, and the former Yugoslavia as well as WHO seed viruses.” These seed lots were “tested at the NIBSC.” The NIBSC is the United Kingdom’s National Institute for Biological Standards and Control which has many of the same responsibilities as the National Institute of Health and the FDA in the United States.
According to the study, “The samples tested consistently negative, except that the EEVM vaccine produced positive PCR signals…” EEVM is a manufacturer in Eastern Europe whose OPV was “widely used in many countries, including the USSR, the countries of eastern Europe, Asia, and Africa.”
So, here we have the major health authority in the U.K. saying that all polio vaccine manufacturers they tested were free of SV40 except for one in Eastern Europe that supplied vaccines to many countries other than Western Europe and the U.S. This, of course, is a very convenient result.
How thorough was this testing? Here’s what we do not know:
The methodology is referred to from a previous paper, but that methodology does not even include a test to determine whether the vaccine they were testing was polio vaccine. So we do not know what they were testing.
They state that they tested the “current or recent seed lots…” What does that mean? Did they test actual seeds (the parent material) or working seeds (the progeny)? How much did they test? How many milliliters? Was it statistically valid and if so where is the statistical analysis?
They state that they tested “all three poliovirus serotypes from Belgium, Canada, France, Germany, Indonesia, Iran, Japan, Mexico, United Kingdom, United States, EEVM, Vietnam, and the former Yugoslavia as well as WHO seed viruses…” They don’t say which manufacturers they tested. They don’t say what materials they tested. They don’t say how much they tested.
If a first year graduate student was to write-up a study like this no doubt they would get an “F.” But, this is the quality of the work that a major governmental body uses when it comes to SV40 and vaccines. The result in this paper is that the spread of SV40 is blamed on a major eastern European vaccine manufacturer whose vaccine did not come into the U.S. or U.K., and other vaccine manufacturers such as those in the U.S. and U.K. are off the hook.
As bad as this first study is, the second one is good. After the NIBSC found SV40 in the vaccines from the major eastern European vaccine manufacturer they shipped it off to independent labs, including Dr. Carbone at Loyola University in Chicago. There, Dr. Carbone’s group put the EEVM positive samples through a battery of tests including PCR, transfection, and direct infection of susceptible cell cultures. His analysis confirmed the presence of SV40 and even identified the strains. In discussing one of the strains, Dr. Carbone wrote, “The other strain that we detected, CPC-MEN, was originally isolated in 1984 from a human brain tumor in a German patient. The same virus was independently isolated from a brain tumor of a U.S. patient in 1995.” Here, there is evidence that a specific type of SV40 from the polio vaccine was found in human brain tumors in Europe and the U.S.
This is important information. The larger question, however, is why didn’t the NIBSC send all of its samples from “current or recent seed lots” of all three poliovirus serotypes from Belgium, Canada, France, Germany, Indonesia, Iran, Japan, Mexico, United Kingdom, United States, Vietnam, the former Yugoslavia and the World Health Organization to Carbone and other labs for independent analysis and confirmation? The answer to this question is telling.
This is the current status of studies on this question. Government laboratories and labs tied to vaccine manufacturers or government funding report that they tested various polio vaccines for SV40 and for the major western manufacturers everything is okay. These governmental sponsored studies, however, never allow their results to be independently verified as required by the scientific method.