SV-40 Contamination of
Dr. John Martin
Center for Complex Infectious Diseases
3328 Stevens Ave
Rosemead CA 91770
SV-40 is a small double stranded, circular DNA virus of rhesus monkey origin. It is
closely related to JC and BK viruses of human origin. While BK virus may not cause human
disease, JC virus can cause a very severe brain illness in HIV infected patients, that is
called progressive multifocal leukoencephalopathy or PML. SV-40 is also distanly related
to human papillomaviruses, some of which cause cervical cancers.
SV-40 infection is now widespread within the human population almost certainly as a
result of poliovaccine produced in rhesus monkey kidney cells during the 1950s. A recent
study showed infection in 23% of blood samples from normal individuals. The virus can also
be detected in sperm fluid and is likely to be passed congenitally to future generations
(Martini et al. SV40 Early Region and Large T Antigen in Human Brain Tumors, Peripheral
Blood Cells, and Sperm Fluids from Healthy Individuals. Cancer Research 56: 4820-4825,
1996). As the title indicates this paper also confirms previous reports that SV-40 is
present in a significant proportion of human brain tumors. Other reports have shown SV-40
in human brain tumors, e.g. Bergsagel et al. New England Journal of Medicine 326: 988-993,
1992. SV-40 has also been detected in a high proportion of human mesotheliomas (Carbone et
al. Oncogene 9: 1781-1790, 1994); and in bone tumors called osteogenic sarcomas (Carbone
et al. Oncogene 1996). FDA has been reluctant to act on reports of SV-40 but will have to
respond to forthcoming publications in the "New Yorker" and "Money"
SV-40 contamination was detected in the rhesus monkey kidney cells used to make
poliovaccine as early as 1960. A Federal employee, Dr. Bernice Eddy, decided on her own
inititive, to test extracts from the monkey kidney cells used to make poliovaccine for
possible cancer causing agents. She chose to use newborn hamsters since these animals
developed tumors with a type of virus she and Sarah Stewart had discovered in mice and
named polyoma virus. The inoculated hamsters developed tumors similar to those induced
with polyoma virus. The results of Dr. Eddy's unauthorized testing was meet with the same
scorn and indifference as her earlier warings that some of the initial lots of Salk
vaccine retained live poliovirus. Again, frustrated by the unwillingness of her
supervisors to act on her tumor findings, Dr. Eddy went around channels and disclosed her
results in a 1990 scientific meeting. Her punishment was to be taken off poliovaccine
safety testing and prohibited for over a year from submitting her work for publication.
Dr. Eddy's findings did however leak out and were replicated by Drs. Sweet and Hilleman at
Merck. Initially, Hilleman thought the SV-40 problem would apply mainly to the live polio
vaccines developed by Dr. Sabin and used extensively in the Soviet Union. He even
suggested that the Russians would be no threat at the upcoming 1962 Olympics because they
would be dragging with tumors (The Health Century, by Edward Shorter).
Unfortunately, it was soon realized that the polio vaccine developed by Dr. Salk was the
more dangerous because the 1:4,000 dilution of formaldehyde, which barely inactivated the
poliovirus, did not fully inactivate SV-40. Because the Salk vaccine was injected through
the skin, it allowed the SV-40 a better chance to infect.
To his credit, Dr. Hilleman repeatedly sounded warnings about the risks inherent in the
use of monkey tissue for vaccine production. For example, he has made the following
comments " ...use of tissues of wild-caught animals is just asking for trouble
because of the lack of control and the known high proability for viral contamination.
Monkeys are too expensive to be grown in specific pathogen-free colonies and, hence, the
simple solution to the monkey problem is to eliminate the monkey" and also "The
tissues of wild-caught animals, and certainly monkeys, are commonly infected with wild
viruses. The simplest way to solve the monkey problem is to eliminate the monkeys and this
is being done using diploid cells. Monkey tissues came into use by historic decisions to
use monkey kidney to make poliovaccine. There is no need to continue using monkeys when
acceptible alternatives are available." This advice was never taken especially in the
face of pressure from Lederle/American Cyanamid to continue to use monkeys.
The main result of finding SV-40 virus in rhesus monkeys was simply to switch
poliovaccine production to African green monkeys. Existing stocks of SV-40 poliovaccines
were not withdrawn from the market, nor was any effort made to suspend the military's use
of adenoviral vaccines, also known to contain SV-40. Short termed follow studies on some
of the children exposed to SV-40, to see if brain tumors had developed, satisfied those in
charge of Public Safety, that no harm had been done.
Since the hamster tumor model required virus exposure to newborn animals, Public Health
officials should have predicted the need to maintain surveillance for the subsequent human
generation. Now that evidence is accumulating that a problem exists, the continued
reluctance of FDA to respond is, to say the least, disappointing.
The overall story with SV-40 is being replicated with the resistance of FDA and of
Industry to meaningfully address the question of other monkey viruses having been
transmitted to humans through poliovaccines. While the African green monkey is generally
free of SV-40 virus, it does carry a number of viruses, including simian cytomegalovitrus
(SCMV). As an aside, rhesus and not African green monkeys are used for testing the
virulence of live polio vaccines, because even the control African green monkeys often
show evidence of neural infection.
In an effort to underscore, the need for a more responsive FDA, samples of a 1954 polio
vaccine, held by Dr. Ratner, a Public Health official whose concerns about poliovaccine
safety had been largely ignored, have been sent to investigators studying SV-40 to show
how easy it is to detect contaminants using the PCR assay. This assays was not available
in the 1950s, but now that it is, there is no excuse for not using it on polio and other
vaccines to exclude contaminants including SCMV and related stealth viruses. A copy of Dr.
Carbone's latest paper will be posted shortly. Additional information can also be found in
the Handouts under Publications and Presentation section.
Martin, W. John. 1997. SV-40 Contamination of Poliovirus Vaccine.
Available online: http://www.sonic.net/daltons/melissa/sv-40.html
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