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Rogue virus in the vaccine: Early polio vaccine harbored virus now feared to cause cancer in humans

San Francisco Chronicle - Sunday, July 15, 2001
William Carlsen, Chronicle Staff Writer

A growing number of medical researchers fear that a monkey virus that contaminated polio vaccine given to tens of millions of Americans in the 1950s and '60s may be causing rare human cancers. For four decades, government officials have insisted that there is no evidence the simian virus called SV40 is harmful to humans. But in recent years, dozens of scientific studies have found the virus in a steadily increasing number of rare brain, bone and lung-related tumors - the same malignant cancer SV40 causes in lab animals.

Even more troubling, the virus has been detected in tumors removed from people never inoculated with the contaminated vaccine, leading some to worry that those infected by the vaccine might be spreading SV40. The discovery of SV40 in human tumors has generated intense debate within the scientific community, pitting a handful of government health officials, who believe that the virus is harmless, against researchers from Boston to China who now suspect SV40 may be a human carcinogen. At stake are millions of research dollars and potential medical treatments for those afflicted with the cancers SV40 may be causing.

In April, more than 60 scientists met in Chicago to discuss the controversial virus and how it works to defeat certain cells' natural defenses against cancer.

"I believe that SV40 is carcinogenic (in humans)," said Dr. Michele Carbone of Loyola University Medical Center in Maywood, Ill. "We need to be creating therapies for people who have these cancers, and now we may be able to because we have a target - SV40." But scientists at the National Cancer Institute say their studies show almost no SV40 in human tumors and no cancer increase in people who received the contaminated vaccine. "No one would dispute there's been a widespread, very scary exposure to the population of potentially cancer-causing virus," said Dr. Howard Strickler, NCI's chief investigator. "But none of our studies and other major analyses have shown an inkling of an effect on the population."

Critics charge, however, that the few studies done by the government are scientifically flawed and that health officials have downplayed the potential risks posed by SV40 ever since they learned in 1961 that the virus contaminated the polio vaccine and caused tumors in rodents. "How long can the government ignore this?" asked Dr. Adi Gazdar, a University of Texas Southwestern Medical Center cancer researcher. "The government has not sponsored any real research. Here's something possibly affecting millions of Americans, and they're indifferent.

"Maybe they don't want to find out."

The recent SV40 discoveries come at a time of growing concern over the dangers posed by a range of animal viruses that have crossed the species barrier to humans, including HIV, which scientists now believe came from chimpanzees and ultimately caused the AIDS epidemic. Based on dozens of interviews and a review of the medical research, this is the story of how the campaign to eradicate polio may have inadvertently permitted another potentially deadly monkey virus to infect millions of people - and why the government for years discounted the accumulating evidence suggesting that SV40 may be a health risk for humans.

Polio epidemic, 1955

During the first half of the 20th century, polio struck down hundreds of thousands of people, leaving many paralyzed - some in iron lung machines - and killing others. The worst year was 1952, when more than 57,000 polio cases were reported in the United States. Three thousand died. Then on April 12, 1955, Dr. Jonas Salk, a slightly built, soft-spoken researcher from Pittsburgh, mounted the podium at the University of Michigan and announced that he had developed a vaccine. That afternoon, the government licensed the vaccine for distribution.

Salk's vaccine was made by growing live polio virus on kidney tissue from Asian rhesus monkeys. The virus was then killed with formaldehyde. When the vaccine was injected in humans, the dead virus generated antibodies capable of fending off live polio. Dr. Dwight Murray, then chairman of the American Medical Association, called Salk's announcement "one of the greatest events in the history of medicine." Within weeks, the stockpiled vaccine was being injected into the arms of millions of people worldwide.

Virus and the tumors, 1959

Four years later, Bernice Eddy, a researcher at the National Institutes of Health, noticed something strange while looking through her microscope. Monkey kidney cells - the same kind used to make the vaccine - were dying without apparent cause. So she tried an experiment. She prepared kidney extracts from eight to 10 rhesus monkeys and injected tiny amounts under the skin of 23 newborn hamsters. Within nine months, "large, malignant, subcutaneous tumors" appeared on 20 of the animals.

On July 6, 1960, concerned that a monkey virus might be contaminating the polio vaccine, Eddy took her findings to Dr. Joseph Smadel, chief of the NIH's biologics division. Smadel dismissed the tumors as harmless "lumps." The same year, however, at a Merck laboratory in Pennsylvania, Dr. Maurice Hilleman and Dr. Ben Sweet isolated the virus. They called it simian virus 40, or SV40, because it was the 40th virus found in rhesus kidney tissue.

Immunization campaign, 1961

By then, the nation was winning the war against polio. Nearly 98 million Americans - more than 60 percent of the population - had received at least one injection of the Salk vaccine, and the number of cases was plummeting.

At the same time, an oral polio vaccine developed by virologist Albert Sabin was in final trials in Russia and Eastern Europe, where tens of millions had been inoculated, and it was about to be licensed in the United States. Unlike the Salk vaccine, the oral version contained a live but weakened form of polio virus and promised lifelong immunity.

But U.S. Public Health Service officials were worried. Tests had found SV40 in both the Sabin and Salk vaccines - it was later estimated that as much as a third of the Salk vaccine was tainted - and that SV40 was causing cancer in lab animals. In early 1961, they quietly met with the agency's top vaccine advisers. The agency found no evidence that the virus had been harmful to humans, but in March, the officials ordered manufacturers to eliminate SV40 from all future vaccine.

New procedures were adopted to neutralize the tainted polio virus seed stock and SV40-free African green monkeys were used to produce the bulk vaccine instead of rhesus monkeys. But officials did not recall contaminated Salk vaccine - more than a year's supply - still in the hands of the nation's doctors. And they did not notify the public of the contamination and SV40's carcinogenic effect on newborn hamsters.

Hilleman would later explain that government officials were worried that any potentially negative information could ignite a panic and jeopardize the vaccination campaign. The first public disclosure that the Salk vaccine was contaminated came in the New York Times on July 26, 1961. A story on Page 33 reported that Merck and other manufacturers had halted production until they could get a "monkey virus" out of the vaccine. When asked to comment, the U.S. Public Health Service stressed there was no evidence the virus was dangerous.

No cause for alarm, 1962

The next year, a young Harvard-trained epidemiologist named Dr. Joseph Fraumeni joined the National Cancer Institute and was assigned one of the agency's most important projects: to determine if there was any cancer increase among those injected with the Salk vaccine. His research would form the basis of the government's position for decades. Working with two colleagues, Fraumeni tested stored vaccine samples from May and June of 1955, the first months of the national immunization campaign, then ranked the samples according to how much SV40 they contained - no, low or high amounts.

It would be the only time U.S. health officials measured the level of SV40 in the 1955-1962 vaccine. Stored samples from that period were later discarded. Fraumeni identified the states where the SV40-contaminated vaccines had been distributed during those two months. California, for example, received vaccine with a low level of the virus.

The study looked at cancer mortality rates for 6- to 8-year-old children vaccinated during that narrow time frame, tracking the group for four years. The findings, which were published in the Journal of the American Medical Association, showed no significant difference in cancer deaths in states with high or low levels of SV40 in the vaccine when compared with cancer deaths in states with no SV40 in the vaccine.

Cleveland children, 1976

Fourteen years later, after isolated reports linking the virus and human cancers, Fraumeni decided to look at another group that had received contaminated vaccine. The group had been the subject of experiments conducted in the early 1960s at Cleveland Metropolitan General Hospital. To determine the effect of different amounts of the vaccines, researchers at the hospital inoculated newborns from mostly lower-income black families with doses ranging up to more than 100 times the dose recommended for adults.

The experiments took place over three years and involved 1,073 infants. Most were given Sabin oral vaccine later determined to contain SV40. From 1976 to 1979, Fraumeni and his associates sent letters to the children - now age 17 to 19 - but fewer than half responded. The researchers found no SV40-related health problems from exposure to contaminated vaccine.

However, their 1982 report published in the New England Journal of Medicine acknowledged the study's limitations: A majority of the children had not responded; SV40-related cancers might take longer than 17 to 19 years to develop, and SV40 appears less likely to infect humans through the oral vaccine.

Nevertheless, they called their findings "reassuring and consistent with the prevailing view that SV40 is not carcinogenic in human beings." Then they decided to end the study, citing "the mounting complexities and obstacles in tracing this particular group and the negative results to date." The study's closure appeared to end the government's research into the virus. But a few years later there would be a tectonic shift in SV40 research.

First discovery, 1988

In Boston, two researchers stumbled onto something disturbing. Dr. Robert Garcea and his assistant, Dr. John Bergsagel, were using a powerful new tool called polymerase chain reaction, or PCR, to look for a pair of common human viruses in children's brain tumors. But a different DNA footprint kept popping up in more than half the tumors. They finally realized they were seeing SV40.

For more than a decade, scientists had reported sporadic findings of SV40- like proteins in human tumors. But the earlier tests were primitive and the results suspect. PCR, however, is capable of amplifying infinitesimal fragments of DNA, which makes detections far more credible. The findings were troubling. The researchers noted in their published report that the children were too young to have received the contaminated vaccine. But somehow the virus had infected them and embedded itself in their tumors.

Mesothelioma, 1988

That same year, Dr. Michele Carbone was surprised to find a milky, rind like tumor in a laboratory hamster at the National Institutes of Health in Bethesda, Md. The animal was one of a group given an SV40 injection directly into their hearts. Sixty percent of those hamsters developed the fatal cancer called mesothelioma.

Carbone, a postdoctoral fellow at the institute, knew that SV40 caused tumors in hamsters but only in specific locations where large doses of virus were injected. Here the mesothelial membrane lining the lungs apparently became cancerous from minuscule amounts of SV40 shed by the tip of the needle on the way to the hamsters' hearts. So he tried another experiment, this time injecting SV40 directly into the thin mesothelial walls of another group of hamsters. Within six months, every animal developed mesothelioma.

Carbone was puzzled. Mesothelioma is a rare cancer. Few human cases were reported before the 1950s, but its incidence had been increasing steadily, reaching several thousand cases a year in the United States by 1988. Studies had linked mesothelioma to asbestos exposure - with tumors usually appearing many decades later. Yet 20 percent of victims had no asbestos exposure. Carbone decided to use PCR to test 48 human mesotheliomas stored at the NIH. He was stunned: 28 of them contained SV40.

More cancers, 1996

PCR unleashed a wave of SV40 discoveries.

By the end of 1996, dozens of scientists reported finding SV40 in a variety of bone cancers and a wide range of brain cancers, which had risen 30 percent over the previous 20 years. Then, Italian researchers reported finding SV40 in 45 percent of the seminal fluid samples and 23 percent of the blood samples they had taken from healthy donors. That meant SV40 could have been spreading through sexual activity, from mother to child, or by other means, which could explain how those never inoculated with the contaminated vaccine, such as the Boston children, were being infected.

Government assurances, 1996

At the National Cancer Institute in Bethesda, officials were growing increasingly concerned about the SV40 discoveries. The findings were of particular interest to Fraumeni, who had been promoted to director of NCI's Division on Cancer Epidemiology and Genetics. His earlier studies concluding that SV40 posed little or no health risk were now under challenge.

But the scientific community was skeptical of the recent SV40 discoveries. As a potent carcinogen in lab animals, SV40 had been used for years as a tool to study cancer. Therefore, the powerful PCR test was suspected of finding stray SV40 fragments that might have contaminated laboratories.

So Dr. Howard Strickler, one of Fraumeni's epidemiologists, led a study using PCR on 50 mesotheliomas from Armed Forces hospitals across the country. And he found no SV40. Although the findings bolstered the government's long-standing position that SV40 did not appear to be a health risk, federal officials decided to convene a conference on the virus. In January 1997, 30 scientists gathered at the National Institutes of Health in Maryland. Garcea, Carbone and others presented their evidence showing SV40 in tumors and pleaded for research funding.

Strickler presented his mesothelioma study, as well as new research he had just completed, this time working with Fraumeni. Their new study compared 20 years of cancer rates of people born between 1947 and 1963, and therefore likely to have been exposed to the contaminated polio vaccine, with people born after 1963, who they believed weren't exposed.

Their study found no significant difference between the two groups.

Letter of protest, 1998

But when Susan Fisher read Strickler and Fraumeni's study in the Journal of the American Medical Association, she fired off a letter of protest to the publication. An epidemiologist at Loyola University Medical Center in Maywood, Ill., Fisher challenged the study's methodology, calling it "an error in judgment" and misleading. Using the same 20-year national cancer database for the two groups, Fisher compared people of the same age - "because these cancers are highly correlated with age" - and she came up with very different results.

Studying 18- to 26-year-olds who probably had been exposed to the contaminated vaccine, Fisher found a 19.6 percent greater incidence of the two major brain cancers linked to SV40 when compared with the incidence in people the same age who were not exposed. She also found 16.6 percent more bone cancers and 178 percent more mesotheliomas among those exposed to the vaccine.

But Fisher cautioned against comparing the two groups. She argued that if SV40 is being transmitted and circulating in the population, then many people in the "unexposed" group would also be carrying the virus and that would undermine the comparison.

Two types of SV40, 1999

For years, researchers had believed that all SV40-contaminated Salk vaccine made between 1955 and 1963 had been used or discarded. Then in 1999, Carbone was contacted by a former public health director in Oak Park, Ill., who said he had seven sealed vials of vaccine dated October 1955 in a refrigerator in his basement. Carbone, who had left the NIH and joined the faculty at Loyola University Medical Center, ran tests on the vaccine and made a startling discovery: Not only was the vaccine contaminated, it contained a second form of the virus - an "archetypal" SV40 strain.

Although manufacturers switched from rhesus monkeys to SV40-free green African monkeys to grow the bulk vaccine in 1961, they have continued to use potentially contaminated polio seed strains originally grown on the rhesus monkey tissue to start the bulk vaccine process. Manufacturers check the purity of their vaccine with a series of 14-day tests to detect whether any SV40 slipped through. But when Carbone replicated the tests, he found that the second, slower- growing "archetypal" strain took 19 days to emerge. It was possible, Carbone noted in a published report, that this second strain of SV40 had been evading manufacturers' screening procedures for years - and infecting vaccine recipients after 1962.

Controversial study, 2000

Meanwhile, a new study led by Strickler had bogged down in bitter internal conflict.

After the NIH's 1997 conference, nine laboratories were recruited to participate in a government-sponsored study to determine if tests were really finding SV40 in tumors or whether earlier detections were the result of laboratory contamination. Carbone and other researchers considered the study unnecessary. A similar multilab study led by Dr. Joseph Testa of Philadelphia had just been completed, and it virtually eliminated the contamination theory. The prestigious journal Cancer Research published Testa's findings in 1998.

But Strickler pressed on.

An independent laboratory in Maryland prepared mesothelioma samples for the nine labs.

When tests revealed almost no SV40 in the tumor samples, some participants questioned the preparation methods used by the Maryland lab. They also challenged Strickler's written conclusion implying that contamination had caused the earlier findings of SV40 in tumors. If Strickler was right, the earlier SV40 detections were probably the result of stray SV40 in the labs. But critics argued that the study was scientifically flawed and should be scrapped.

The dispute became so contentious that FDA officials were forced to intervene and a neutral arbitrator assigned to mediate. Finally, in early 2000, more than two years after the study was initiated, a carefully rewritten report emerged for publication. It concluded that contamination was an unlikely explanation for earlier SV40 findings. Then it struggled to explain the discrepancy between earlier detections of SV40 in about half of all mesotheliomas tested and the fact that the nine labs found the virus in only slightly more than 1 percent of the study's tumor specimens.

The report noted that discrepancy might be because of the inefficiency of the method used by the Maryland lab to recover DNA - like the genetic sequences of SV40 - from the mesothelial tissue to create the test samples. The Maryland lab also had inadvertently contaminated some of the laboratory controls and "theoretically" could have contaminated others. The report concluded by calling for further research. Despite the study's ambivalent conclusions and technical problems, the NCI submitted it to Cancer Research, the journal that had published Testa's study.

It was rejected.

Further discoveries, 2000

In laboratories around the world, researchers continued to find SV40 in a widening range of tumors that now included pituitary and thyroid cancers and some lymphomas. Meanwhile, an NCI investigator named Dr. David Schrump was able to gut a common respiratory virus and use it to deliver genetic material called "antisense" into SV40-infected mesothelial cells and stop the cells' malignant growth.

His discovery, which was patented by the government, strongly suggested that SV40 contributed to mesothelioma and that a treatment might be possible. Then in August, Carbone and several colleagues published a major study providing a "mechanistic" explanation of how SV40 contributes to the uncontrolled growth of mesothelial cells. The key, they found, was the large number of "tumor suppressor" proteins found in the mesothelial cells that makes them unusually susceptible to SV40.

In most human cells, they said, the virus reproduces itself and kills the infected cell in the process. But in mesothelial cells, SV40 is especially attracted to the "tumor suppressor" proteins and binds to them, knocking them out of action. The virus then lives on in the cell. The result, they said, is a rate of malignant cell transformation in tissue cultures 1,000 times higher than has ever been observed. In a paper published in the Proceedings of the National Academy of Science, Carbone further explained that asbestos fibers appear to act as a co- carcinogen in mesothelioma by somehow suppressing the immune system's response, which is designed to kill the infected cells.

Chicago conference, 2001

Carbone and others believed that the time had come for another conference on the virus he calls "a perfect little war machine." In April, more than 60 scientists gathered on a warm weekend at the University of Chicago's downtown conference center. Despite numerous faxes and certified letters inviting him, Strickler declined to attend.

Carbone opened the conference by confronting the question of whether SV40 is present in humans.

"Sixty-two papers from 30 laboratories from around the world have reported SV40 in human tissues and tumors," he said. "It is very difficult to believe that all of these papers, all of the techniques used and all of the people around the world are wrong." For two days, scientists from as far away as China and New Zealand presented the results of their studies, with almost every speaker concluding that SV40 was present in the tissues they examined.

One of the newest discoveries came from Dr. Jeffrey Kopp, an NIH scientist who reported finding SV40 in a high percentage of patients with kidney disease. The virus was also present, he said, in 60 percent of a new "collapsing" type of renal disease that was unknown before 1980 but has since increased rapidly in incidence. There were also reports on efforts to develop a vaccine, recently funded by the NCI, that would allow the immune system to target and eliminate SV40. At times, the meeting took on almost revivalist overtones as scientist after scientist said he or she was initially very skeptical of SV40's presence in human tumors but was now a believer. "I was a hard sell," said Testa, the Philadelphia geneticist who conducted the first multilaboratory tests, noting that the study had convinced him.

Gazdar, the cancer researcher from Texas, showed a slide describing his transformation: "Nonbeliever -- Believer - Zealot." The conference concluded with a consensus among the leading scientists that SV40's presence in human tumors was no longer in question. They were more circumspect about the virus' possible role in causing cancer. If SV40 is a human carcinogen, they said, the virus probably requires interaction with other cancer-causing substances like asbestos.

Dr. Janet Butel from Baylor Medical College in Houston said that it simply might be too soon to make a determination, citing the many years it has taken to establish that other viruses cause cancer. But even renowned tumor biologist George Klein from Sweden said he was impressed by Carbone and Schrump's work.

"This strongly suggests that the virus plays a role (in causing tumors)," said Klein, a former chairman of the Nobel Assembly.

Low priority, 2001

In May, shortly after the conference, Strickler's multilab study was published in a small journal called Cancer Epidemiology, Biomarkers & Prevention. Carbone and other SV40 experts dismissed the study. "A garbage paper in a garbage journal," said Garcea, now on the faculty at the University of Colorado School of Medicine.

But Strickler strongly defends the study. He said it was the first to use strict controls not used in other studies. He acknowledged, however, that the study "doesn't prove that SV40 is not out there." Strickler, who now teaches at Albert Einstein School of Medicine in New York, said he remains skeptical about whether SV40 has infected humans, a suspicion he says is shared by the broader scientific community.

But the NCI recently acknowledged that there is evidence to suggest that SV40 "may be associated with human cancer." The NCI statement, released last month, also said that SV40's interaction with "tumor suppressor proteins" indicates "possible mechanisms that could contribute to the development of cancer." Top NCI officials declined to be interviewed on the record for this report. Fraumeni also declined several requests for an interview.

Dr. James Goedert, the chief of the NCI's Viral Epidemiology Branch who supervised Strickler's work, said that if SV40 is in human tumors, it must be at extremely low levels. To critics who claim the government has downplayed SV40's potential health risks, Goedert responded: "Absolutely not." He acknowledged that research is needed to resolve the question of whether SV40 is prevalent in the human population and, if so, how it might be spreading. But Goedert said he has no plans for such studies.

"It's not our highest priority," he said. Key figures in developing vaccines and tracing SV40 Dr. Jonas Salk Developed the first polio vaccine using killed virus in 1955. Virologist Albert Sabin Developed an oral vaccine using weakened live virus. Dr. Robert Garcea Used new technology to trace SV40 in children's brain tumors. 

Q&A on polio vaccine contaminated with SV40 Q: How widespread is the SV40 infection?

A: Scientists and government health officials don't know because no comprehensive studies have addressed the question.

What is known: During the 1950s and '60s, more than 100 million people worldwide were given SV40-contaminated polio vaccine. The virus also has been found in people who did not receive contaminated vaccine, as well as laboratory workers and monkey handlers. No studies, however, have examined how SV40 might be transmitted between people, or if somehow humans might have become infected with SV40 before the introduction of the tainted vaccines.

Q: Can I be tested for SV40?

A: An accurate blood test does not exist. Current antibody blood tests can be inaccurate, scientists say, because they may also detect the presence of other closely related viruses, and SV40 may be present at such a low level that no antibodies are produced. Researchers are working to create an effective test.

Q: Is the current polio vaccine safe?

A: Vaccine producers, health officials and most scientists believe that it is safe. Manufacturers say they take elaborate steps to test their vaccine for SV40, and the government says it recently tested vaccine samples back to 1972 and found no trace of SV40.

Some scientists, including Dr. Michele Carbone, have raised questions about whether manufacturers' testing techniques have been adequate. Carbone, however, tested vaccine from 1996 and found no SV40. He has had his children inoculated.

Q: In which kinds of cancers has SV40 been found?

A: The virus has been detected in rare cancers:

-- Mesothelioma, a fatal tumor of the membrane surrounding the lungs. Few cases were reported prior to 1950, but the incidence has grown in the United States to 2,000 to 4,000 cases a year, with greater incidence in Europe.

-- Brain cancers: Primarily ependymoma and choroid plexus tumors, but also astrocytoma, glioblastoma, medulloblastoma and meningioma. These make up a total of less than 1,000 U.S. cases each year.

-- Bone cancers: Primarily osteosarcoma but also chondrosarcoma and giant cell tumors. These also make up less than 1,000 cases annually.

-- Other cancers: A few detections in pituitary and thyroid tumors and lymphomas.

Report sources

The sources for this report include the books "The Saga of Jonas Salk" by Richard Carter and "The Health Century" by Edward Shorter; articles in Atlantic Monthly and New York magazine; newspaper archives at The Chronicle and the New York Times; transcript of the 1997 National Institutes of Health Conference in Bethesda; a review of dozens of scientific journal articles and scores of interviews.

Related series: Quest for the Origin of AIDS.

How SV40 contaminated polio vaccine

When Dr. Jonas Salk introduced the first polio vaccine in 1955, it was hailed as "one of the greatest events in medicine." Within 10 years, U.S. polio cases plummeted from 30,000 to less than 1,000. But in 1960, a monkey virus called SV40 was found in the Salk vaccine. As much as one-third of the vaccine was contaminated. SV40 was also found in earlier versions of an oral vaccine developed by Dr. Albert Sabin that replaced the Salk vaccine in the 1960s.

When it was discovered that SV40 caused cancer in lab animals, U.S. health officials ordered vaccine manufacturers in 1961 to eliminate the virus from all future vaccine, although questions remain about whether they succeeded with the Sabin vaccine. .

Making the Sabin vaccine: 1955-1961 Starting in the mid-1950s, both Sabin and Salk vaccines are made by growing polio virus on kidney tissue from Asian rhesus monkeys, which are natural hosts for the simian virus known as SV40.

Special weakened seed strain of polio virus developed by Sabin is grown on rhesus kidney tissue to make large bulk amounts of vaccine. SV40 from the kidney tissue contaminates the vaccine.  Making the vaccine safe: 1961 In 1961, after SV40 is discovered in the vaccines, U.S. health officials order manufacturers to eliminate SV40. Antiserum is used to neutralize SV40 in seed stock, and SV40-free African green monkeys are used to grow bulk vaccine. But some researchers believe small amounts of SV40 may have survived. .

Testing Manufacturers check the safety of the vaccine pools by using a series of 14- day growth tests to see if SV40 is present. Making the Salk vaccine: 1955-1961 Full strength polio virus is grown on rhesus kidney to make bulk Salk vaccine. SV40 from the kidney tissue contaminates the vaccine. The polio virus is then killed with formaldehyde, but some SV40 survives. .

Making the vaccine safe: 1961 In the original vaccine, the SV40 survives, contaminating up to 30 million Americans. But after 1961, African green monkeys are used to grow bulk vaccine and SV40 is eliminated.

Sources: Children's Hospital of Philadelphia; SEER; virus images by Jean Yves Sgro, University of Wisconsin; Chronicle research

BIBLIOGRAPHIC NOTE

For more information about the simian virus SV40, the following studies or scientific reviews were published during that past year:

A multicenter evaluation of assays of detection of SV40 DNA and results in masked mesothelioma specimens. Strickler H, Goedert J., Cancer Epidemiology, Biomarkers & Prevention. Vol. 10, 523-532, May 2001.

Simian virus 40 and human cancers, Strickler H., Einstein Quarterly J. Biol. and Med. (2001) 18:14-21. This includes a detailed bibliography that will lead readers to earlier scientific articles.

Oral polio vaccine and human cancer: a reassessment of SV40 as a contaminant based upon legal documents. Kops S., Anticancer Research (2000) 20: 4745-4750.

Human mesothelial cells are unusually susceptible to SV40-mediated transformation and asbestos cocarcinogenicity. Bocchetta M, Di Resta I, Powers A, Fresco R, Tosolini A, Testa J, Pass H, Rizzo P, Carbone M., Proc. Natl. Acad. Sci. USA, Vol. 97, Issue 18, 10214-10219, Aug. 29, 2000.

In addition, a bibliography of journal articles by leading SV40 researcher Dr. Michele Carbone can be viewed by clicking on the following link: www.chestsurg.org/carbone7.htm

E-mail William Carlsen at wcarlsen@sfchronicle.com.

 

Today's News Stories News Archive:
SV40, polio vaccine, and cancer: Now beyond coincidence?
http://news.bmn.com/news/story?day=020410&story=2
9 April 2002 10:40 EST by Apoorva Mandavilli, BioMedNet News San
Francisco -

At the American Association of Cancer Research meeting here today, controversy continued to swirl around accusations that contaminated polio vaccine stocks are to blame for certain  cancers, based on the publication a month ago of two high-profile papers linking the simian virus SV40 to human lymphomas.

Less than a week after the papers were published in March, the US National Cancer Institute contacted the researchers to establish plans to send blinded results to three independent labs, lead researcher Adi Gazdar told BioMedNet News today.

But Gazdar seems unconvinced of the NCI's intentions. "They just want to prove us wrong," he said.  Gazdar and his colleagues scanned 99 lymphomas, 235 epithelial tumors and 40 control tissues for the virus. They found the virus in 43% of non-Hodgkin's lymphomas, 9% of Hodgkin's lymphomas, and in none of the control tissues. A second team independently found the virus in 42% of non-Hodgkin's lymphomas, "almost unbelievable agreement," said Gazdar, who is professor of pathology at the University of Texas Southwestern medical center.

"These are very respectable labs with basically identical results," said Michele Carbone, associate professor of pathology at Loyola University in Chicago.  The "clear clustering of positives" is "no accident," he told BioMedNet News.

This is not the first time scientists have linked SV40 to human cancers. Researchers suggested for years that millions of vials of polio vaccine, contaminated with SV40, infected individuals between 1953 and 1963 and caused human tumors. Until recently, they were inevitably met with skepticism, even contempt - and some NCI researchers published directly contradictory results.

In 1997, the US National Institutes of Health, with other organizations, organized an international conference to review the SV40 literature and address the possibility that the virus causes human tumors. At the meeting, Carbone, presented his then-controversial data linking the virus to mesotheliomas. (Since then, more than 30 independent reports have confirmed his results).

After the meeting, Carbone says, a conscientious Chicago public health official contacted Carbone and gave him the last remaining stocks of polio vaccine from the 1950s. In her paper, Butel isolated a strain of SV40 from three patients that closely matches the strain Carbone sequenced from the polio vaccine vials.

The evidence proves Butel's results are no artifact, Carbone says. "You cannot contaminate with something that doesn't exist," he said. "This thing only exists in my freezer."

Since publication of their research in the Lancet last month, Gazdar and his colleagues have been investigating rarer subtypes like leukemia and multiple myelomas. The experiments have not been proceeding as fast as they would like, Gazdar says, partly because "there's no government funding" for the research. "The lymphoma story might force them to [fund it]."

An important next step, Gazdar says, is to prove that the SV40 virus causes lymphomas and isn't just a "passenger" in the cells. That is no easy task, since researchers have only been able to isolate the virus in rare instances. For the most part, they believe, the virus launches a "hit-and-run" attack, initiating a cascade of tumorigenic events before it is destroyed by the body.

Still, it is critical that this research continue, Gazdar says, because molecular and immunologic data suggest those born after 1963 have also been exposed to the virus, via horizontal or vertical transmission, or through sexual contact.

The rates of mesotheliomas, lymphomas and brain tumors have also all gone up "dramatically" in the last 30 years. "Coincidence or not, we have to find out," he said. "It's something to think about."

"Now Carbone was asking Pass for his help in proving a controversial theory he had developed about the origins of mesolthelioma, a deadly cancer that afflicts the mesothelial cells in the lining of the chest and the lung. Mesolthelioma was virtually unheard of prior to 1950, but the incidence of the disease has risen steadily since then. Though it is considered rare-accounting for the deaths of about 3,000 Americans a year, or about one half of one percent of all domestic cancer deaths-the disease is particularly pernicious. Most patients die within eighteen months of diagnosis.

Pass, one of the world's leading mesothelioma surgeons, knew, like other scientists, that the disease was caused by asbestos exposure. But Carbone had a hunch he wanted to explore. He told Pass that he wondered if the cancer might also be caused by a virus-a monkey virus, known as simian virus 40 or SV40, that had widely contaminated early doses of the polio vaccine, but that had long been presumed to be harmless to people.

Pass listened as Carbone described for him the history of the early polio vaccine. A breakthrough in the war against polio had come in the early 1950's, when Jonas Salk took advantage of a new discovery: monkey kidneys could be used to culture the abundant quantities of polio virus necessary to mass-produce a vaccine. But there were problems with the monkey kidneys. In 1960 Bernice Eddy, a government researcher, discovered that when she injected hamsters with the kidney mixture on which the vaccine was cultured, they developed tumors. Eddy's superiors tried to keep the discovery quiet, but Eddy presented her data at a cancer conference in New York. She was eventually demoted and lost her laboratory. (Gosh, that sounds so much like Wakefield doesn't it. Interesting how history repeats itself. Suzan's comments.) The cancer-causing virus was soon isolated by other scientists and dubbed SV40, because it was the fortieth simian virus discovered. Alarm spread through the scientific community as researchers realized that nearly every dose of the vaccine had been contaminated. In 1961 federal health officials ordered vaccine manufacturers to screen for the virus and eliminate it from the vaccine. Worried about creating a panic, they kept the discovery of SV40 under wraps and never recalled existing stocks. For two more years millions of additional people were needlessly exposed-bringing the total to 98 million Americans from 1955 to 1963. But after a flurry of quick studies, health officials decided that the virus, thankfully, did not cause cancer in human beings."End quote

But, alas, the research has shown, as demonstrated and revealed in this well-written article, that it does indeed cause cancer. In fact it is THE most oncogenic virus known to man.

Another excerpt:
"The virus has also been located in other kinds of tumors. More than a dozen laboratories have found SV40 in various kinds of rare brain and bone tumors. In 1996 Carbone reported that he had found SV40 in a third of the osteosarcomas (bone cancers of a type that afflicts about 900 Americans a year and nearly half of the other bone tumors he tested-research that has since been confirmed by numerous laboratories. The virus has also been detected in pituitary and thyroid tumors.

The possibility of a link between SV40 and brain tumors is particularly intriguing. Like mesothelioma, brain tumors have become dramatically more common in recent years. Brain tumors will be diagnosed in about 3,000 children in the United Stated alone this year. In 1995 Janet Butel, the chairman of the department of molecular virology and microbiology at the Baylor College of Medicine, in Texas, and her chief collaborator, John Lednicky, also a Baylor virologist, reported that they had found SV40 in a number of children's brain tumors. Butel and Lednicky reported that DNA sequencing revealed that the virus was not a hybrid but rather authentic SV40-the same as the SV40 found in monkeys. In the fall of 1996 an Italian research team, led by Mauro Tognon, of the University of Ferrara, announced that it had found SV40 DNA in a large percentage of brain and neurological tumors, including glioblastoma, astrocytomas, ependymomas, and papillomas of the choroid plexus. The researchers suggested that SV40 may be a "viral co-factor" involved in the sharp rise in human brain tumors. Late last year an extensive study undertaken in China reinforced those results. The study examined sixty-five brain tumors, finding SV40 in each of the eight ependymomas and two choroid-plexus papillomas, common brain tumors among CHILDREN.(my emphasis). It also found the virus in 33 to 90% of five other kinds of brain tumor examined. The authors, writing in the November, 1999, issue of Cancer, noted that the virus was actively expressing proteins.

Recent research also indicated that SV40 has gained a secure foothold in the human species. In 1996 Tognon and his collaborators reported that they had also found the virus in 45 percent of sperm samples and 23 percent of the blood samples they tested from healthy people, suggesting that the monkey virus could spread through sexual contact or unscreened blood products. In 1998 the presence of SV40 antibodies in human blood samples was reported by Butel, who tested several hundred American blood samples and found antibodies to SV40 in about 10 percent of them. Butel's laboratory also tested samples from children born from 1980-1995-decades after the contaminated vaccine was removed from the market. A surprising six percent tested positive-offering evidence that the virus may now be spreading from person to person, including from mother to child."

 
[Here is a remarkable piece of investigative journalism on the SV40 virus and the contaminated polio vaccines being linked to all kinds of cancers - part of this article was picked up in the Houston Chronicle too. Please see bottom of note for the email address to send letters of thanks to the journalist. Dawn]   

http://www.sfgate.com/cgi-bin/article.cgi?file=/chronicle/archive/2001/07/15
/MN193825.DTL
 

Editor's Note:

When we first ran Geraldo's first story, SV-40, A Deadly Cure? we thought it was a bit on the conspiratory side, but it seemed well researched. We were pleased that many other journalists also investigated the material, proving the sad truth that Geraldo reported in ViewZone.

Research has now firmly linked many of today's cancers with tainted virus vaccinations given in the early 1950s. Could there be any more shocking and horrific revelations like this? We didn't think so - but we were wrong.

The latest horror story is posted HERE: SV40 Part Two for you to ponder. As you read it, also do not forget the Black Americans that were knowingly infected with Syphilis or the soldiers made to march through the fallout of our nuclear bomb tests...

But first, read Geraldo Fuentes original story.

It was 1956. I was only six years old and attended grade school in Springfield, Massachusetts. I was too young to recollect the first round of polio vaccinations, but I have a few memories. I remember that my first grade class was escorted to the school gymnasium. There was a peculiar smell in the air. I think it was probably rubbing alcohol. And some of the other kids were crying. The shot itself wasn't so bad. I didn't cry, but my best friend did. At the end of the ordeal we all got a lollipop.

A few years later, when we marched again to the gymnasium it was different. There was no crying and no alcohol odor. Instead, there were long tables bearing neat rows of small paper cups, filled about half way with a liquid that tasted like bitter orange juice. White clad Nurses watched as each child drank the vaccine. There was no lollipop and, after we handed back the cup, we simply returned to class.

The government had initiated the mandatory polio vaccination programs in 1955. Prior to this, polio had killed or crippled thousands of children and adults all over the world. Attacking the central nervous system, this viral infection was transmitted by human contact, sewage and even by contaminated milk. Victims who contracted polio would incubate the virus in their intestines, where it would multiply and enter the lymphatic system. Eventually the virus would penetrate the nerves and travel along nerve paths, destroying neurons and rendering the muscles connected to them paralyzed.

The polio epidemic reached its height in 1952. It turned thousands of victims into cripples and confined countless children to large pressure chambers called "iron lungs," which helped them to breath when their diaphragm muscles were stilled. There was and still is no treatment for polio. Aside from attempts to maintain life functions, the disease must run its course.

And so, in 1955, just one year before I received it, Jonas Salk had performed no small miracle when he successfully mass-produced an effective polio vaccine by growing a form of the virus on the kidneys of rhesus monkeys. This virus would be harvested, killed, and given to healthy children like me, who would then develop antibodies which would kill any future invasion of the body by the polio virus.

This happy story of medical marvel has a deadly glitch. And it is especially deadly if, like me, you received your vaccinations in the 1950s, in certain states like Massachusetts.

In 1960, researchers discovered that the polio vaccine distributed to certain states was infected with another virus called "Simian Virus 40." SV-40 is a monkey virus that is not normally found in humans. Unknown at the time, it was present in hundreds of rhesus monkeys that were used to grow and harvest the polio vaccine. Injected into research animals, the SV-40 virus causes brain and lung cancers. Now, some forty years later, its effect on humans is just being investigated.

SV-40 has appeared in 61% of all new cancer patients -- patients too young to have received the contaminated vaccine being administered forty years ago!

Michele Carbone, Assistant Professor of Pathology at Loyola University in Chicago, has recently isolated fragments of the SV-40 virus in human bone cancers and in a lethal form of lung cancer called mesotheliomas. He found SV-40 in 33% of the osteosarcoma bone cancers studied, in 40% of other bone cancers, and in 60% of the mesotheliomas lung cancers. Dr. Carbone believes this study explains why 50% of the current mesotheliomas being treated were no longer occurring in association with asbestos exposure, their traditional cause.

Researchers from the Institute of Histology and General Embryology of the University of Ferrara, lead by Dr. Fernanda Martini, discovered SV-40's presence in a variety other tumors. They found the rhesus monkey virus in 83% of choriod plexus papillomas, in 73% of ependymomas, in 47% of astrocytomas, in 50% of glioblastomas, and in 14% of meningiomas.

SV-40 also has been found in 23% of blood samples and 45% of sperm fluids taken from normal individuals! Researchers have determined the SV-40 virus can be transmitted sexually and through blood transfusions.

Even more shocking, SV-40 has appeared in 61% of all new cancer patients -- patients even too young to have received the contaminated vaccine being administered forty years ago! How could this happen?

My second vaccination was from a cup. This was the brainstorm of the FDA. Instead of getting the "dead" virus in an injection, the Federal vaccination policy mandated that children should be given the new live "oral polio vaccine" (OPV). This decision was based upon the belief that the OPV recipient would "shed" the virus through body contact with other non-vaccinated children and adults, thereby spreading the "live" virus throughout the population. Since the infection was extremely small, it would produce the desired antibodies while posing no threat of contracting polio. This, it was thought, would assure the total immunization of America and the eradication of the disease. The public was never informed that this national health strategy was being implemented, despite several cases of polio which were directly attributed to the vaccine.

By 1963, the estimated number of tainted polio vaccinations was estimated to be upwards of 98-million!

The SV-40 virus that contaminated the oral polio vaccine quickly spread from child to child and from child to adult, crossing state lines and national boundaries. By 1960, when the virus was first detected, it was already too late to prevent its dissemination throughout the population. The FDA quietly and gradually instituted a program to eliminate rhesus monkeys, who harbor the SV-40, and replace them with African Green monkeys that are free of the virus. By 1963 the monkeys had been replaced but the estimated number of tainted polio vaccinations was estimated to be 98-million!

According to the National Institutes of Health, high levels of SV-40 were identified in polio vaccines in Washington, Oregon, Wyoming, Utah, Minnesota, Iowa, Wisconsin, Illinois, Michigan, Pennsylvania, Washington DC, Maryland, Delaware, New York, Connecticut, Rhode Island, Massachusetts, Vermont and New Hampshire. Low levels of SV-40 were found in California, Arizona, New Mexico, Colorado, Texas, Kansas, Nebraska, North Dakota, Missouri, Louisiana, Georgia, Tennessee, Kentucky, Ohio, and West Virginia. Polio vaccines in the other states show no SV-40 present.

This revelation has only recently come to public attention. Many people, like myself, were unaware that a potential for cancer had been implanted in their body. Researchers say that, by age fifteen, the virus stops shedding to others. I cannot but wonder how many people I contacted between the age of eight and fifteen... Did I shed the SV-40 virus to my mother, who eventually died of brain cancer? Will I contract brain, lung or bone cancer? Many other people in my age group are asking similar questions.

A number of public statements have been made by the National Cancer Institute in the past few months, attempting to put their spin on these disturbing revelations. In an statement published in the January (1999) New England Journal of Medicine, the institute states that there is no evidence of an increase in humans of the types of cancers found in laboratory animals that have been injected with SV-40. But other researchers remind us that SV-40 has already been found in a wide variety of other tumors. It has been shown that individuals who received the tainted oral vaccine demonstrate a higher occurrence of these cancers.

For example: people who lived in Massachusetts and Illinois in the 1950s, and received identified lot numbers of the contaminated oral vaccine, are now contracting osteosarcoma bone tumors at a rate of ten times more than those who received the vaccine free of the SV-40.

But the National Cancer Institute has been silent about these facts.

There needs to be more demographic studies to explore the relationship of SV-40 to adult onset cancers. Not surprisingly, the US government and its agencies are reluctant to pursue this matter. In fact, requests to the National Institute for Health for grants to study the SIV and simian cyto-megalovirus (SCMV) were recently denied. Microbiologist Howard Urnovitz, Ph.D., may have an explanation as he stated in the Boston Globe:

"that almost 100 million Americans were exposed (to SV-40) through a government sponsored program, but for over 30 years, there has been virtually no government effort to see if anyone's been harmed by the exposure." He added, "The government will not fund science that makes it look culpable."

Another method used by the National Cancer Institute to divert public concern is to issue statements that "many of the cancers under suspicion were contracted by people who are too young to have received the tainted vaccine in the 1950s." This argument, although true, ignores the potential of spreading the live SV-40 by "shedding" through personal contact. The oral polio vaccine was designed to be transmitted to non-vaccinated individuals by this very method. In fact, this was the reason that OPV was preferred over injection. If SV-40 is still being spread by contact today it is not surprising that these cancers are now affecting younger people.

Regardless of blame, severe damage to world health has already been done by the unsavory practice of growing vaccination products in animals. An example of these horrors was presented by Dr. Urnovitz at the Eighth Annual Houston Conference on AIDS.

Dr. Urnovitz revealed significant evidence that human immunodeficiency virus type 1 (HIV-1) is a monkey hybrid virus which was produced when 320,000 Africans were injected with polio virus contaminated with live simian immunodeficiency virus (SIV) in the late 1950's.

Apparently, viral fragments combine easily with other viruses to produce these hybrids called "chimeras." Prior to this revelation, health officials were blaming AIDS on the habit of certain Africans to consume monkey flesh.

What can be done now? "Make it in anything but animals," said Barbara Loe Fisher of the National Vaccine Information Center, which criticizes vaccine safety. "We have the technology to make vaccines in human cell lines that are clean," said Dr. Michele Carbone of Loyola University Medical Center, one of the first to discover SV-40 inside human tumors.

Until then we can only hope that researchers continue their work, regardless of the repercussions. Millions of people are already infected with SV-40 and are in danger. Many cancers do not develop until mid-life. Future generations must be protected. We must prohibit any future contamination of the world population, whether for our own good or not, by well-meaning governmental agencies.

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
www.researchprotection.org
Tue, 06 Aug 2002 20:24:12 +1200
Contact: Vera Hassner Sharav
212-595-8974 FAX 212-595-9086
veracare@rcn.com

The anthrax vaccine is not the only vaccine that has been linked to severe, debilitating illness.  And this is not the first time that government public health agencies lied to the public about the health hazards associated with a vaccine. In her July 19 column in The Wall Street Journal (below), Sharon Begley reported that in 1961 the U.S.  Public Health Service learned about SV40  contaminated polio vaccines given to (possibly) 98 million babies and kept that information from the public.

SV40 (known as the "monkey virus")  is a known carcinogen that may change DNA to make humans more vulnerable to cancer.  One year earlier, on July 15, 2001, The San Francisco Chronicle brought the issue to light: "Based on dozens of interviews and a review of the medical research, this is the story of how the campaign to eradicate polio may have inadvertently permitted another potentially deadly monkey virus to infect millions of people - and why the government for years discounted the accumulating evidence suggesting that SV40 may be a health risk for humans."

"How long can the government ignore this?" asked Dr.  Adi Gazdar, a University of Texas Southwestern Medical Center cancer researcher.  "The government has not sponsored any real research.  Here's something possibly affecting millions of Americans, and they're indifferent. "Maybe they don't want to find out."

"The recent SV40 discoveries come at a time of growing concern over the dangers posed by a range of animal viruses that have crossed the species barrier to humans, including HIV, which scientists now believe came from chimpanzees and ultimately caused the AIDS epidemic.  Based on dozens of interviews and a review of the medical research, this is the story of how the campaign to eradicate polio may have inadvertently permitted another potentially deadly monkey virus to infect millions of people - and why the government for years discounted the accumulating evidence suggesting that SV40 may be a health risk for humans."

[See, William Carsen, Rogue Virus in the Vaccine:Early Polio Vaccine Harbored Virus Now Feared to Cause Cancer in Humans, the San Francisco Chronicle,

 http://www.sfgate.com/cgi-bin/article.cgi?file=/chronicle/archive/2001/07/15 / MN193825.DTL; William Carlsen, New Documents Show the Monkey Virus is Present in More Recent Polio Vaccine, San Francisco Chronicle, July 22, 2001,
http://www.sfgate.com/cgi-bin/article.cgi?file=/c/a/2001/07/22/MN173141.DTL

See also, Nicholas Regush, The Monkey Connection, ABC News,

 http://abcnews.go.com/sections/living/SecondOpinion/secondopinion_47.html ]
Begley interviewed a former public health official, H.M.  Ratner, who had refused to inoculate babies with the contaminated vaccine and kept a batch as evidence.

THE WALL STREET JOURNAL SCIENCE JOURNAL
Are Tainted Vaccines Given to Baby Boomers Now Causing Cancer?

By Sharon Begley 07/19/2002, B1 SNAPSHOTS OF YOUR government at work:

-- 1961.  The U.S.  Public Health Service, having learned in 1960 that millions of batches of polio vaccine were accidentally laced with a simian virus (vaccine was grown on minced monkey kidneys), quietly orders manufacturers to rid the vaccine of the contaminant, called SV40. PHS issues neither recall nor public announcement.  Contaminated stocks already distributed are used until 1963.

-- 1999.  H.M.  Ratner, a former public-health official in Oak Park, Ill., invites Michele Carbone of nearby Loyola University School of Medicine over for coffee.  In 1955, Dr.  Ratner says, he had refused to administer the Salk polio vaccine.  He felt it might not be safe.  But  he kept seven vials in his basement refrigerator for 44 years, hoping that, one day, someone would be interested in them.  Someone is.  Dr. Carbone is investigating the possibility that SV40-contaminated polio vaccine made by several manufacturers was, decades after being given to about 98 million baby boomers, increasing the risk of three rare cancers.

-- 2002.  Last week, the Immunization Safety Review Committee of the Institute of Medicine (IOM) meets to consider evidence for and against that unthinkable hypothesis. Amid dueling data, some facts are uncontested.  An estimated two-thirds of the polio vaccines -- the oral Sabin and the injected Salk -- administered from 1955 to 1963 contained SV40, including the vials Dr. Ratner saved.  Contaminated vaccine was also given to children and some adults in Australia, Canada, Denmark and Germany, and possibly Russia, Mexico and other countries.

SV40 IS A KNOWN carcinogen.  It targets the lung's mesothelial cells, brain cells, bone cells and blood cells, producing a protein that knocks out two human tumor-suppressor genes, p53 and Rb.  There is no reliable blood test for SV40 exposure. Government data show the incidence of SV40-linked cancers has risen.  A brain cancer called ependymoma is up 25%.  Bone malignancies are up 23%.

Mesothelioma (infamous for being triggered by asbestos) is up 90%.  All are extremely rare: Ependymoma, for example, strikes one in a million. Are the rising cancer rates coincidence?  In 1994, Loyola's Dr.  Carbone and colleagues examined human mesotheliomas.  He found SV40 genetic sequences in 29 of 48 studied.  SV40 has now been found in up to 80% of mesotheliomas in the U.S.  and Europe.  Dozens of labs have found SV40 in bone and brain cancers.  Those, as I said, are rare.  Epidemiologist Howard Strickler of Albert Einstein College of Medicine in New York, a leading skeptic of the vaccine-cancer link, notes that many studies fail to find SV40 in human tumors.

In March, however, researchers led by Janet Butel of Baylor College of Medicine, Houston, reported that 42% of the non-Hodgkin lymphomas they analyzed contained genetic sequences from SV40.  And not just any SV40: In several tumors, it was precisely the genome of the SV40 in the vials of the 1955 polio vaccine that Dr.  Ratner had held onto, waiting for someone to care.  Lab-grown SV40 harbors a variant genome.  There might be other sources, in addition to vaccine, of this strain of SV40, but to more and more scientists Dr.  Butel's findings were the smoking gun.

WITH NON-HODGKIN lymphoma, we're no longer talking about rare malignancies. This cancer has spiked 82% in the U.S.  since 1973, epidemiologist Susan Fisher of the University of Rochester, New York, told the IOM panel, with 56,200 new cases in 2001 and 24,000 deaths.

An analysis by Dr.  Strickler shows no extra cancers among people thought to have been exposed to SV40-laced polio vaccine -- or, no extra increase that can't be explained by chance.  Trouble is, with no test for SV40 exposure, it's impossible to be sure you're comparing an exposed to an unexposed group.  You might be comparing populations exposed to SV40 with populations also exposed.  Of course there'd be no difference.

What are the ramifications of this?  Today's children are at no risk from polio vaccine; it's now grown in SV40-free cells. The public-health risk from SV40-laced polio vaccine is .  .  .  well, one scientist told me it's "minimal." Another says "unknown." Tumors linked to SV40 are, except for lymphomas, so rare that even a doubling of risk due to SV40 still leaves you with good odds of never developing these cancers.

A wild card, though, is the World Trade Center collapse, which released asbestos into the air.  Although SV40 alone rarely causes mesothelioma, when you add asbestos to the mix, all bets are off.  The IOM committee's conclusions on SV40, polio vaccine and cancer are due out by the end of summer.

(Copyright (c) 2002, Dow Jones & Company, Inc.)

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Sewage Yields Clues to SV40 Transmission

http://jama.ama-assn.org/issues/v288n11/ffull/jmn0918-1.html
(entire paper available at URL)

Washington
It was a dirty job and nobody had to do it. But an international team of scientists did it anyway, testing dozens of sewage samples for simian virus 40 (SV40),  which in the 1950s and 1960s contaminated millions of doses of  polio vaccine. The unsavory task yielded compelling evidence of person-to-person transmission of SV40, evidence that complicates the contentious  search for links between the monkey virus and human cancers.

The sewage study is a wild card. In their figuring, epidemiologists assume that only certain recipients of the vaccines were exposed to SV40. This assumption allows them to isolate SV40 as a variable and gauge whether cancer rates increased after 1961, when the last known contaminated vaccines were given. But what if SV40 circulates in people like it does in monkeys?

"If SV40 is transmitted from person to person and I'm not saying that it is that would throw the epidemiology off," said Susan Fisher, PhD, chief of the epidemiology department at the University of Rochester School of Medicine, during a July presentation to the vaccine safety review committee assembled by the Institute of Medicine (IOM). "Any cohort called 'unexposed' after 1961 may not truly be unexposed." If no group is truly unexposed, the effect of SV40 on cancer rates would be difficult to discern.
 

Speaking of sewage.

Isolation of vaccine-derived type 1 polioviruses displaying similar  properties to virulent wild strain Mahoney from sewage in Japan. Horie H, Yoshida H, Matsuura K, Miyazawa M, Wakabayashi K, Nomoto A,  Hashizume S. Japan Poliomyelitis Research Institute, Higashimurayama-shi, Tokyo,  Japan.

Type 1, 2, and 3 vaccine-derived polioviruses were isolated from a sewage disposal plant located downstream of the Oyabe River in Toyama Prefecture, Japan, between October 1993 and September 1995. Neurovirulence was analyzed in 13 type 1 vaccine-derived strains,  using mutant analysis by polymerase chain reaction and restriction enzyme cleavage (MAPREC). Nine strains (69%) were estimated to have  marked neurovirulence. Some of the neutralizing antigenic sites,  temperature sensitivity, and plaque-forming ability of two virulent vaccine-derived poliovirus strains were similar to Mahoney strain.  The neutralizing activity of human sera obtained after oral poliomyelitis vaccine (OPV) administration against one of the virulent vaccine-derived polioviruses was examined. Although all  human sera showed sufficient neutralizing activity for the prevention of poliomyelitis by vaccine-derived poliovirus strains, a lower titer  than that against Sabin type 1 strain was observed. Vaccination  against virulent vaccine-derived poliovirus will be effective. However, the environmental presence of viruses that have properties  similar to those Mahoney strain is a threat. The introduction of inactivated poliovirus vaccine (IPV), and well-maintained herd immunity, together with reinforced environmental surveillance is  important for the final phase of the polio eradication program by the World Health Organization (WHO). J. Med. Virol. 68:445-451, 2002.  Copyright 2002 Wiley-Liss, Inc.

 

Received this from Raphaele Horwin - letter to the IOM committee

Their lawsuit is continuing.  More info on that in November, hopefully.

Raphaele says......
"We wish that we could say more at this time, but the information in the 4 page letter is still important for parents. (check out the footnotes) "

******
July 29, 2002

Immunization Safety Review Committee:
Marie McCormick, M.D., Sc.D. (Chair), Ronald Bayer, Ph.D., Alferd Berg, M.D., M.P.H., Rosemary Casey, M.D., Joshua Cohen, Ph.D., Betsy Foxman, Ph.D., Constantine Gatsonis, Ph.D., Steven Goodman, M.D., M.H.S., Ph.D., Ellen (Abby) Horak, M.S.N., Michael Kaback, M.D., Gerald Medoff, M.D., Rebecca Parkin, Ph.D., Bennett Shaywitz, M.D., Christopher Wilson, M.D., Richard B. Johnston, Jr., M.D.

Dear Members of the Immunization Safety Review Committee:

This letter is written regarding the public meeting on SV40 Contamination of Polio Vaccine and Cancer that took place on July 11, 2002 and we ask that it be added to the record.

Our lives were full of joy when on June 7, 1996 our first and only child was born.  We named him Alexander Roy Horwin and he grew tall and strong. He could speak French and English by the age of two.  He loved the ocean and wanted nothing more than to grow up, go to school, and see the world with his mommy and daddy.

We were a hard working happy family building our future.  But everything came apart on August 10th, 1998.  On that day, we were told that Alexander  had a pediatric brain tumor called medulloblastoma. The next six months became a race against time to try to understand the disease, find the appropriate treatment, and save Alexander.  However, despite two operations and three rounds of “state-of-the-art” chemotherapy Alexander died on January 31, 1999, six months after being diagnosed.  He was not yet three years old.

After he died, we were told that there was monkey virus in Alexander’s brain called SV40.  We visited medical libraries and discovered a vast body of literature on this virus.  There were numerous studies performed at reputable universities that demonstrated that the existence of this virus has been known for forty years.  Other studies from leading virologists, microbiologists, and pathologists reported how the virus had been found in human cancers, including pediatric brain tumors, using a variety of technologies.  In addition, there were literally thousands of articles that described how SV40 was the “gold standard” to transform (i.e. turn malignant) normal human cells in vitro.

Despite this body of knowledge, we discovered that the federal government had decided that SV40 was not a virus that deserved serious concern.  Now, your committee has a rare opportunity to change this long-standing position.  This opportunity may never present itself again.  An objective report from your committee will be a significant step towards defeating this deadly virus.


The Evidence

We ask you to consider the evidence - objectively.  Compare SV40 with other known human carcinogens.  Consider which human carcinogen can:
A)    transform a variety of human somatic cells on contact in vitro; 
B)    create tumors/cancers in animal models with regularity;
C)    be found in the same human cancers that it creates in animals in vivo? 
We challenge you to find another known human carcinogen that is as carcinogenic as SV40.

If you are perplexed about the uncertainty of the epidemiology, consider that there is no unexposed cohort.  Documents now conclusively prove that SV40 was never removed from the vaccine stocks after 1963.  The contaminated oral polio vaccine seeds from Dr. Sabin were so full of SV40 that they were used as the source of SV40 by the early virologists.  These SV40 contaminated seeds were never thrown away, but instead have been used to make Oral Polio Vaccine (OPV) for millions of children over the last four decades.  Moreover, despite their assertion to the contrary, the manufacturer of OPV continued to use Rhesus Monkeys after 1963 as a  substrate for the manufacture of the vaccine.

Err on the Side of Caution

Being a member of this IOM committee comes with a serious responsibility - not to gamble with the public health.  That means that you must focus on the ramifications of your decisions and must err on the side of caution. Why is this important?  Consider what happens when an authority labels an agent as a carcinogen or pathogen.  Serious efforts are made to understand the agent’s etiology and epidemiology.  Funding is made available to discover ways to treat individuals who carry the agent.  And newer, more rational therapies are employed to attend those who have a disease process related to the agent.  If you think the data regarding SV40 and human cancers is not 100% perfect be cautious with what you decide.  How many more people will have to die with SV40 positive cancers before the data is flawless?

More rational therapies are needed for SV40 positive cancers right now. For example, there is no orthodox treatment for medulloblastoma in young children.  The following quotations come from reputable medical journals:

“[In] medulloblastoma, the most common primary tumor of the CNS [central nervous system] in childhood. . .[t]he role of adjuvant chemotherapy is unclear. . .virtually no cures are reported.” “Aggressive treatment of medulloblastoma, the most common pediatric brain tumor, has not improved survival.” “[T]he absolute benefit of chemotherapy for the treatment of medulloblastoma in childhood is, as yet, not proven.” “The median time to progression [return of the tumor] was 6 months.” “For many years, chemotherapy has been utilized for the treatment of malignant brain tumors with minimal success.” “The outcome for the majority of children with malignant brain tumors remains poor, despite surgery, irradiation and conventional chemotherapy.”

Various studies have found that medulloblastoma can contain SV40. Moreover, the biological mechanisms of SV40’s oncogenic potential is well understood - the virus binds to p53 and RB.  As you know p53 is a tumor suppressor gene. It drives a damaged cell towards apoptosis.  As you may also know, cytotoxic cancer therapies (i.e. radiation and chemo) rely on an intact tumor suppressor system because these agents cause point mutations, strand breaks, and other disturbances to a cell’s DNA.  Without a working p53 gene, chemo and radiation do nothing more than to take a transformed cell and create more mutations.   However, children are only permitted to be treated with surgery, chemo and radiation.  Greater focus on the role of SV40 in these cancers will lead to more rationale therapies.  This is another example of the type of progress your committee can facilitate right now.

The Role of the Federal Government

Given all that we already know about SV40, why does the federal government report the virus is not yet a serious concern?  Why has the federal government refused to spend $.01 to investigate why a monkey virus that is considered the “gold standard” in creating human cancers in vitro (including brain cancers) is often found in pediatric brain tumors?  The rhetoric from government scientists at the 1997 SV40 Conference in Bethesda is the same rhetoric from these same scientists at the IOM Committee meeting on July 11, 2002.  In the intervening five years how many children have died of SV40 positive cancers?  How much farther has SV40 spread throughout the U.S. and the world?

The federal government has ostensibly mandated a product (OPV) for consumption by millions of American children for forty years.  During these four decades, the federal government was in charge of ensuring the safety of this vaccine.  But, it was misled by at least one vaccine manufacturer. A product the government thought was pure and safe was contaminated and potentially deadly.  Now, the government is faced with potential embarrassment and liability resulting from this deception.

Each one of you has been chosen to participate in this committee because of your outstanding scientific achievements.  But, most of you owe your careers to some extent to the funding you have received from the federal government.  As recipients of tax money, you can demonstrate that scientists who receive NIH funding act responsibly and independently despite the less than stellar record of the government’s earlier decisions. In addition, most of the universities that each of you are affiliated with receive substantial contributions and grants from vaccine manufacturers including the corporation responsible for the contaminated OPV.  An objective and unbiased investigation from your committee will proclaim to the American people that decisions that affect millions of lives especially children’s lives are not for sale.

Conclusion

Our son, Alexander was not the first child to die from a SV40 positive brain cancer and, unfortunately, he was not the last.  SV40 concerns all children, yours included.  Do your children or grandchildren harbor SV40 in their blood?  Is there a deadly tumor that will be born out of the joining of a SV40 virion and a cell somewhere in their body?  What happens if they were diagnosed with a SV40 positive cancer?  Statistically, there is no cure.  And, unfortunately, the probability of such an occurrence is increasing.  Cancer is now the leading cause of death by disease in children and pediatric brain tumors have been increasing steadily at a rate of about 3% a year.  As you reflect on your roles as vanguards of the public health, consider also your own children and your children’s children.

History will judge the wisdom of your decisions.


Sincerely,

Michael Horwin M.A., J.D.               Raphaele Horwin M.A., MFS

Alexander

More from his father:
  http://www.mindspring.com/~chiroken/health_news.htm Editorial Reply Re: Congressional Hearings on Vaccines and Autism

Mandating Vaccines: Government Practicing Medicine Without a License?

        Editorial Reply Re: Congressional Hearings on Vaccines and Autism
      - GCN - NEWS @ 8:31 am PST
      From: Dawn Richardson PROVE

      This is a phenomenal letter written by a parent of a vaccine injured child in response to an editorial comment published on WebMD. It clearly illustrates the incestuous ties some of those who make vaccine decisions for our children have with drug companies. These are the very people who are critical of the parents and elected representatives who are doing such a great job shedding light on some of the dangers of vaccines because of the threat the truth poses to their pocketbooks. The internet (source of all this information) is a wonderful thing.
     

      In Reply to Editorial Comment from: Wayne L. Pines Re: Congressional Hearings on Vaccines and Autism

      Wayne L. Pines, you belittle Congressman Burton as an "angry grandfather" when his goal is to make vaccines safer for children.  Your feeble attempt to undermine Congressman Burton's efforts made sense only after your ties to the vaccine manufacturers and drug companies were revealed. This is a day in your life Wayne L. Pines. Let's see who you really are and then people will understand that your words are meaningless because they are motivated by avarice.

      You started your career in Washington as the associate editor for The Pink Sheet a pharmaceutical trade magazine. Then you went to  work at the FDA for 10 years from 1972 to 1982. Your next job was  with the PR firm Burson-Marsteller. After that, you got a job with APCO Associates. Then you joined a company called Therametrix (1). In between you became involved with various pharmaceutical trade groups such as the Food and Drug Law Institute (2), the Drug      Information Association (3), and the Internet Healthcare Coalition (4).

      Now let's start connecting the dots to see why you would not want a public discussion about how to improve the safety of our children's vaccines. We'll pick-up your career after you leave the FDA. You immediately landed a job with the PR firm Burson-Marsteller (a subsidiary of the advertising agency Young & Rubicam). Your title there was executive vice president. Marsteller clients include  Monsanto and their bio-engineere foods and Dow-Corning and their silicon breast implants. In addition, Marsteller has several large drug companies as clients including Eli Lilly. Lilly produces the drug Prozac which has accumulated more adverse reaction reports than any substance (besides vaccines) in the history of the FDA's adverse drug reporting system. Documents released under the Freedom of Information Act challenged the veracity of Prozac's clinical trials that led to FDA approval. Lilly's PR firm Burson-Marsteller was called in to do damage control. There, according to the Campaign  Against Fraudulent Medical Research, it was reported that you helped Lilly get past its troubles by exploiting your contacts with current FDA officials (5).

      You then became president of the Health Care Practice of APCO Associates a "communications consulting firm." According to PR Watch, APCO Associates specializes in setting up front groups and coalitions for the tobacco and insurance companies (6). In fact, APCO's website boasts that "excellence in public affairs and public relations, like excellence in art, is about the power of   communication" (7). No it's not. Excellence in public affairs is about honest communication and adding substance to the public discourse. It's what Congressman Burton is doing. It's not about       ridiculous, crude and poorly veiled attempts to protect and further your client base. You may think excellence in public affairs and public relations is about power, but power won't help you when it   comes to our children. As much as it may disturb your plans, parents will not sacrifice the health and lives of their children in order to drive up the stock prices of your drug company clients.

      Next you joined Therametrix whose website gloats that "Wayne L.Pines is a world-renowned health care consultant (who) has consulted for virtually all of the major pharmaceutical companies..."(1). It also states that Therametrix is a "medical marketing research agency that serves the pharmaceutical, biotechnology, medical device and consumer health products industries" (8). Your clients are listed as  including: Abbot Laboratories, Bayer, Bristol-Myers Squibb, Du Pont
      Pharmaceuticals, Eli Lilly, Glaxo Wellcome, Novartis
      Pharmaceuticals, Pharacia & Upjohn, Procter & Gamble
      Pharmaceuticals, Roche Laboratories, Schering-Plough, Triangle
      Pharmaceuticals and Warner Lambert - all of them drug and vaccine
      manufacturers (9). Your company's mission statement declares, "We see nothing more important than meeting our client's needs" (9). I don't doubt it.

      You are also on the marketing and advertising committee of the Drug Information Association which describes itself as a "member-driven scientific association with a membership of over 22,000 primarily from the regulatory agencies, academia, contract service organizations, pharmaceutical, biological and device industry, and  from other health care organizations" (10). Who are some of the
      other committee members in the Drug Information Association? They include Dr. R. Venkataraghaven of Lederle Laboratories (3)manufacturer of Orimune, Tetramune and other vaccines, Dr. Elizabeth B. D'Angelo of AstraZeneca (3), and Dr. John F. Bedard of  Bristol-Myers Squibb (3). The board of directors include Stuart W. Cummings of Merck, Sharp & Dohme manufacturer of the vaccines associated with autism - MMR, MR Vax, Meruvax II, Mumpsvax, Varivax  and others, Francoise de Cremiers of Wyeth-Ayerst another major  vaccine manufacturer, Charles C. Depew of SmithKline Beecham,  Brenton James of Glaxo Wellcome, Murray Lumpkin of the FDA, and Irwin G. Martin of Parke-Davis (11).

      In addition, you are a member of the Food and Drug Law Institute  which describes itself "as a private organization, not affiliated  with the FDA.(but our) mission, however, does relate to the   activities, policies and procedures of the FDA..."(12). As a participant in this institute you work with the other members, and in fact, you are scheduled to moderate one of the institute's conferences on medical technology, drugs and biologics (i.e. vaccines) in June of this year (2). Nearly every drug company  including the major vaccine manufacturers is a member of this organization. The list includes: American Home Products (i.e.Lederle), Bayer, Medeva Pharmaceuticals, Merck & Co., Organon Teknika, and SmithKline Beecham.

      I could go on and on about your affiliations with vaccine manufacturers and drug companies but I believe the point has been made ad nauseam.

      One of Congressman Burton's assertions is that an inherent conflict of interest may exist amongst the people who decide what gets injected into our children's veins. The Congressman understands that many of the individuals in our halls of government who make health decisions affecting our children get money from the very drug companies they are supposed to be regulating. During the hearings,  when Coleen Boyle of the CDC was asked if she thought there was  anything wrong with such a conflict she was literally speechless.  Wayne L. Pines your behavior is a text book example of what  Congressman Burton and tens of thousands of parents disdain.

      As a former employee of the FDA you use your clout to influence what should be a scientifically sound, reasonable and objective decision making process. But even with all of your industry's money and consultants and PR firms and communication experts and doctors on payrolls you are still missing one key ingredient - the truth. The truth can't be bought, spun, manipulated, or turned into a sound bite. Parents know the truth when they watch their children become ill, disabled and die. So despite your supreme efforts to sell more vaccines, we will not allow some greedy industry to decide what is safe and to dictate to us what should be put into our children's bodies.

      Wayne L. Pines go back to your "medical marketing research agency" and your "communications consulting firm," shut up, and leave our children alone.

      Sincerely,

      Michael Horwin Father of Alexander - a vaccine injured child who passed away at the age of 2 ½ years old

      Footnotes:
      1) http://www.therametrix.com/staff.html
      http://www.therametrix.com/wayne.html
      2) http://www.fdli.org/conf/medsymagd.htm
      3) http://www.diahome.org/dhp2d12.htm
      4) http://www.ihealthcoalition.org/content/fda_1.html
      5) http://www.pnc.com.au/~cafmr/newsl/prozac.html
      6) http://www.prwatch.org/prw_issues/1996-Q3/index.html
      7) http://www.apcoassoc.com/gallery/gallery.html
      8) http://www.therametrix.com/company.html
      9) http://www.therametrix.com/clients.html
      10) http://www.diahome.org/
      11) http://www.diahome.org/dhp2c.htm
      12) http://www.fdli.org/about/index.html
 

VITAL info here as MUCH cannot be revealed as court required gag June 7, 2003 - ALL TO BE SECRET

Child who was born in 1996 - did not have SV40 in cord blood but did later after vaccine and parents do not have

But you can figure out much from below...........still contaminated vaccine

They lost their case due to the judge and he defendant asked for and was granted a Protective Order.  As a result, all of its production documents cannot be quoted directly or shared with Congress, the media, or health authorities.  However, our motions and pleadings are in the Court Record and have not been put under a Protective Order.  Therefore, we are able to cite our own arguments set-out in these papers.  We believe this Protective Order should be lifted because public health interests should take precedence over the interests of pharmaceutical companies
*******

Letter sent to The Honorable Dan Burton, Chairman of the House Government Reform Subcommittee on Human Right and Wellness, to Demand a Congressional Investigation and Hearing on the Introduction of Simian Virus 40 (SV40), a Cancer-Causing Monkey Virus, into the American Population From Contaminated Polio Vaccines

1.  2 issues here - SV40 in polio vaccine found in Alexander's tumor (it was not in his cord blood & parents did not have so did not inherit from them).  He got polio vaccine (see point by point below)

2.  An SV40 positive cancer means that chemo and radiation will be ineffective and they did not know this & accepted this type of treatment for Alexander.......and not allowed the treatment they wanted. - the FDA would not allow our son to have access to a non-toxic cancer therapy that offered him the best chance of saving his life.

SV40 is not only responsible for causing the cancer, but also for making these particular cancers incurable.  Orthodox cancer therapies such as chemotherapy and radiation can not cure an SV40 positive cancer.  Pediatric brain cancers and other solid cancers have been found to contain SV40. SV40 binds with the tumor suppressor genes p53 and RB and stops tumor cells from undergoing apoptosis (programmed cell death).   Apoptosis is what radiation and chemo depend on to work in order to trigger the cancer cell to die.  Exposing SV40 positive cancer cells to chemo and radiation does not kill the cells but simply creates more genetic mutations - making the cancer more aggressive.  The bottom-line is that SV40 causes human cancer, stops orthodox cancer therapies (i.e. chemo and radiation) from providing any benefit, and can make the cancer even more aggressive.

http://www.ouralexander.org/BurtonSV40%20Letter%20(2003).doc

June 7, 2003

The Honorable Dan Burton
Chairman of the House Government Reform
Subcommittee on Human Rights and Wellness
U.S. House of Representatives
2157 Rayburn House Office Building
Washington, DC 20515

By Facsimile

Letter to Demand a Congressional Investigation and Hearing on the Introduction of Simian Virus 40 (SV40), a Cancer-Causing Monkey Virus, into the American Population From Contaminated Polio Vaccines

Dear Representative Burton:

I am writing this letter on June 7, 2003.  Exactly seven years ago, on June 7, 1996, my son Alexander was born.  He would die in my arms 30 months later in a little motel room in Houston, Texas as we, his parents, tried desperately to safe his life.  This letter is written in commemoration of Alexander's short life and the injustice that befell him and the cause of the brain tumor (medulloblastoma) that killed him. 

This letter is also the result of four long years of struggle by myself and my husband to find out why our beautiful healthy young son would be stricken by cancer.  Now, our lawsuit against the manufacturer of the oral polio vaccine, American Home Products, (i.e. Lederle), has come to a close.

  As a result, much of the information that has been under a protective order for over three years has been entered into the public record through our legal documents filed with the Federal Court for the Central District of California in Los Angeles.   What happened to Alexander is not an isolated event.  We contend that his death was caused by a Public Health Disaster that has befallen others and will continue to kill children until it is addressed.

On August 12, 1999, we wrote you when you where Chairman of the Committee on House Government Reform in support of your investigations into pediatric vaccines - Vaccines; Finding the Balance Between Public Safety and Personal Choice.  In this letter we described how various childhood vaccines contain known carcinogens and yet not a single vaccine is tested for carcinogenicity.  While shampoos and cosmetics are tested to see if they cause cancer, incredibly, biological substances that are squirted or injected into healthy infants and children have never been tested.

On June 7, 2000, My husband and I also appeared before your Committee to discuss the FDA's control of effective non-toxic pediatric cancer therapies in Cancer Care for The New Millenium - Integrative Oncology.   During our sworn testimony we described how Alexander suffered enormously and unnecessarily as a result of the administration of four toxic but ineffective chemotherapy drugs (vincristine, cytoxan, etoposide, and cisplatin - Protocol CCG 9921).  We described how the FDA would not allow our son to have access to a non-toxic cancer therapy that offered him the best chance of saving his life. We presented photographs to your Committee that demonstrated how Alexander struggled to stay alive and then suffered a horrific death.

From your own considerable effort in investigating vaccine production, testing, and safety you know that childhood vaccines contain formaldehyde (i.e. formalin), mercury (i.e. thimerosal), aluminum, and other toxic substances.  In addition, vaccines can also contain animal viruses - contaminants from the animal substrates upon which the vaccines are manufactured.  One of these viruses, a monkey virus called Simian Virus 40 is carcinogenic and found its way into the oral polio vaccine (OPV) and the inactivated polio vaccine (IPV) in the late 1950's and early 1960's.  Such an event was not surprising because monkey kidneys contain a multitude of simian viruses and the polio vaccine is grown on monkey kidney cells. 

The oral polio vaccine is a "live" trivalent vaccine which means that it contains three strains of poliovirus - Types I, II, and III, and each strain is attenuated (i.e. weakened).  Dr. Albert Sabin, who was responsible for the creation of the licensed OPV, had to passage  his poliovirus strains through a myriad of animals and animal host cells in order to attain the right virulence-strong enough to illicit an immune response, but sufficiently attenuated so as to not cause polio in the recipient.  For example, Type I has the following lineage: 

In 1941, Drs. Francis and Mack isolated the Mahoney poliovirus "from the pooled feces of three healthy children in Cleveland."    Dr. Salk then passed this strain through fourteen living monkeys and two cultures of monkey testicular cultures.   In 1954, the strain (now called Monk14 T2) was given to Drs. Li and Schaeffer who subjected the virus to nine more passages through monkey testicular cultures.   Next, the strain (now called Monk14 T11) underwent fifteen more passages in monkey testicular cultures, eighteen passages in monkey kidney cells, two passages through living rhesus monkeys skin, and additional passages through African Green monkey skin and monkey kidney cell cultures.   This strain was now called MS10 T43 and LS-c.  In 1956, Dr. Sabin took this virus and passaged it through seven cultures of African Green Monkey kidney cells.   That same year, the pharmaceutical company, Merck, Sharp & Dohme, passed the strain (now called LS-c, 2ab/KP2) through a rhesus monkey kidney cell culture.   The resulting material was called Sabin Original Merck (SOM) and was provided to Lederle in 1960 as the seed material to manufacture its polio vaccine.

Types II and III were created in a similar fashion.

Once the strains were isolated, the pharmaceutical companies needed a method to propagate the viruses in order to produce the vast quantities of vaccine needed for nation-wide immunization campaigns.  This required a substrate upon which the poliovirus could be efficiently grown and harvested.  Kidney cells from rhesus monkeys were chosen because they were found to be an effective growth medium.   A small quantity of poliovirus could be added to the minced kidneys removed from these monkeys and within a few days, large quantities of poliovirus could then be harvested from these same monkey cells.

Between 1959 and 1960, Bernice Eddy, Ph.D., of the National  Institute of Health (NIH) examined minced rhesus monkey kidney cells under a microscope.   These were the cells of the same species of monkeys used to create and produce the oral polio vaccine.  Dr. Eddy discovered that the cells would die without any apparent cause.  She then took suspensions of the cellular material from these kidney cell cultures and injected them into hamsters. Cancers grew in the hamsters.   Within a few months, the virus responsible for creating these cancers would be isolated and identified by Dr. Eddy and other scientists.  Because it was the 40th simian virus found it was named simian virus 40 (SV40).

According to the FDA:

The discovery in 1960 that a DNA tumor virus, designated simian virus 40 (SV40), was an inadvertent contaminant of rhesus monkey cells, and consequently the poliovirus and adenovirus vaccines that were made in these cells, was a watershed event in vaccine development…"

By 1960, the Salk injectable polio vaccine (IPV) had been administered to about 98 million American children and adults, and Sabin's oral polio vaccine (OPV) had been administered to about 10,000 Americans and millions in the USSR where the clinical trials had been conducted.   It was estimated that 10% to 30% of the vaccines contained live SV40.   The federal agency in charge of vaccine licensing and safety at the time was the Division of Biologics Standards (DBS) of the National Institute of Health (NIH).   Incredibly, this agency did not order a recall of any of the SV40-contaminated vaccines.   The tainted vaccines continued to be administered until 1963 when they were all used and replaced by allegedly SV40-free vaccines as required by the new federal regulations promulgated in 1961.

In 1961, federal regulations were implemented to ensure that SV40 would no longer contaminate the polio vaccine.  Despite these regulations, we contend that the OPV has been sporadically contaminated with SV40 for the last four decades.  As a result, we allege that some of the children who have been administered the contaminated vaccines have been stricken with cancer and others are at risk.  The main points are summarized below:

1) SV40 (Simian Virus Number 40) is a cancer causing monkey virus found in the kidney cells of Rhesus and African Green Monkeys.  The kidney cells of these two species of monkeys comprise the substrate that has been used to create poliovirus strains and manufacture the oral polio vaccine for four decades.
2) SV40 is a human carcinogen for brain cancer and mesothelioma and it is a suspected carcinogen in osteosarcomas (bone cancers) and Non-Hodgkin's Lymphomas.
3) Alexander was administered the OPV in November 1997.  He was diagnosed with a brain tumor in August 1998.  Alexander died on January 31, 1999. 4) Four independent laboratories using DNA testing and laser micro-dissection found SV40 in Alexander's brain tumor.
5) SV40 has been found in the cancers of many other children.  Pediatric brain tumors and other childhood cancers including osteosarcomas (bone cancer) and Non-Hodgkins Lymphomas have been found to contain SV40.
6) When Alexander was born on June 7th, 1996, I had his cord blood saved and stored by a private laboratory.  The cord blood was the blood shared by Alexander and myself at the time of Alexander's birth.  We had this blood tested for SV40.  This marked the very first time the cord blood of a child
with an SV40 positive brain tumor would be tested for SV40.  To the astonishment of the scientists it was negative for SV40.  This suggested that at the time Alexander was born he had not been exposed to SV40.
7) It is known that SV40 can be spread through contaminated blood so my husband and myself underwent a battery of tests from 2000 to 2001.  Using a variety of sophisticated DNA tests to isolate the genetic fingerprint of the SV40 virus including Polymerase Chain Reaction (PCR), the scientists checked blood, urine and semen multiple times looking for any trace of SV40 (even antibodies).  The scientists were once again surprised.  Despite the repeated tests by leading SV40 laboratories both in the United States and Europe, we had absolutely no trace of SV40. 
8) The scientists concluded that Alexander did not get SV40 from his parents, nor did he give SV40 to us.
9) The original oral polio vaccine (OPV) seed stocks created by Dr. Albert Sabin and used to make OPV since 1961 were known to be contaminated with SV40.  In fact, SV40 was isolated from Sabin's OPV seeds - the original material used to make OPV for four decades.   
10) Dr. Sabin had admitted that OPV seeds were contaminated with SV40 in a peer-reviewed scientific publication.    Dr. Sabin wrote, "The three types of the large lots produced by Merck, Sharp and Dohme in rhesus monkey kidney cell cultures contained SV40."
11) Lederle, the sole American manufacturer of OPV for many years, received their OPV seeds from Merck, Sharp and Dohme.  There is no evidence that Lederle ever tested their seeds for SV40 nor discarded their presumably contaminated seed stocks.   
12) There are Lederle documents (not under a protective order) that demonstrate that their early OPV vaccines were contaminated with SV40.
13) Lederle did not use the SV40-neutralization procedures recommended by Dr. Sabin.  
14) Monkeys used to produce OPV were not tested for SV40 by Lederle because of economic considerations.
15) After reviewing all of the Lederle records and the Lederle systems in place, our expert concluded that the contamination detected in the OPV material ultimately administered to Alexander was SV40.
16) The medical literature is unequivocal - the pediatric brain cancer rate in the U.S. has been climbing at a rate of approximately 3% for the last four decades.
17) A recent study has demonstrated that 11% of Americans are currently infected or have been infected with SV40.

SV40 is not only responsible for causing the cancer, but also for making these particular cancers incurable.  Orthodox cancer therapies such as chemotherapy and radiation can not cure an SV40 positive cancer.  Pediatric brain cancers and other solid cancers have been found to contain SV40.
SV40 binds with the tumor suppressor genes p53 and RB and stops tumor cells from undergoing apoptosis (programmed cell death).   Apoptosis is what radiation and chemo depend on to work in order to trigger the cancer cell to die.  Exposing SV40 positive cancer cells to chemo and radiation does not kill the cells but simply creates more genetic mutations - making the cancer more aggressive.  The bottom-line is that SV40 causes human cancer, stops orthodox cancer therapies (i.e. chemo and radiation) from providing any benefit, and can make the cancer even more aggressive.

Despite these facts, children diagnosed with cancer are not given a choice of whether they should undergo debilitating and toxic chemo and radiation. Alexander should have been tested for SV40 upon his diagnosis, not after he died.  He should not have been administered ineffective and unnecessary chemotherapy which provided no benefit and only made him suffer.  Children with SV40 positive cancers (or p53 mutations) should not be used as guinea pigs and profit centers for pediatric oncologists, hospitals, and pharmaceutical companies.

A Congressional Hearing should be immediately convened to examine how a federally policed vaccine program has introduced a deadly monkey virus into countless American men, women and children for the past 45 years and what the public health consequences have been of this tragedy.

This government investigation should demand to know:

· Why a vaccine manufacturer was allowed to use vaccine seed stocks for four decades that came from a source contaminated with SV40? · Why did this manufacturer violate federal regulations and allowed contaminated vaccines to be released? · Why weren't sophisticated tests to detect SV40 during OPV production and to eliminate the virus ever required by the federal government? · Why aren't children with cancer tested for SV40 when they are diagnosed, not when they are dead, because an SV40 positive cancer means that chemo and radiation will be ineffective? · Why is there a significant percentage of Americans (children and adults) walking around with evidence of having had an SV40 infection and what does that mean for their risk of cancer and chances for a successful treatment?

Like our son, many children are already dead, victims of this virus, and many adults will be stricken later.  Time is of the essence, not for our beloved Alexander anymore, but for other children who are infected with this cancer causing virus. 

Sincerely,


Raphaele Moreau-Horwin M.A., M.F.S.                               Michael
Horwin, M.A., J.D.

www.ouralexander.org

Footnotes
1 The case was Horwin v. American Home Products, American Cyanamid Company, Lederle Laboratories, Case No. CV00-04523 WJR (EX), United States District Court for the Central District of California originally filed on January 31, 2000.  The District Court Judge decided that the testimony of the plaintiffs' experts on the issue of whether SV40 caused Alexander's tumor was admissible under the Daubert standard. (United States District Court Central District of California Tentative Ruling Case No. CV00-04523 WJR (EX), Daubert Motion, Thursday May 8, 2003.)  Nonetheless, the judge excluded critical evidence related to the source of SV40 because it believed that it could require that all exhibits used to qualify a witness under Daubert be identified in a FRCP Rule 26(a)(2) disclosure.  After excluding critical evidence, the court decided that since there was no
direct evidence that the dose of Orimune administered to Alexander was contaminated that the expert's opinion was inadmissible under Daubert.  As a result, the judge granted the defendant's (Lederle's) motion for summary judgement. 
  2 The defendant asked for and was granted a Protective Order.  As a result, all of its production documents cannot be quoted directly or shared with Congress, the media, or health authorities.  However, our motions and pleadings are in the Court Record and have not been put under a Protective Order.  Therefore, we are able to cite our own arguments set-out in these papers.  We believe this Protective Order should be lifted because public health interests should take precedence over the interests of pharmaceutical companies
  3 Passage is defined as the introduction of infectious material into an experimental animal or culture medium followed by recovery of the infectious agent.  Dorland's Medical Dictionary, 25th edition, page 1146. 4 A.B. Sabin, A.B. & L. Boulger, History of Sabin Attenuated Poliovirus Oral Live Vaccine Strains. 1 J. BIOL. STAND. 115, 115-18 (1973).  The Mahoney virus was isolated in 1941 by Drs. Fancis and Mack.
5  Id.
  6  Id.
  7  Id
  8  Id
  9  Id
10  Id. 
11 M.R. Hilleman, Discovery of Simian Virus (SV40) and its Relationship to Poliomyelitis Virus Vaccines, in SIMIAN VIRUS 40 (SV40): A POSSIBLE HUMAN POLYOMAVIRUS, 94 DEV. BIOL. STAND. 183-90 (F. Brown & A.M. Lewis eds., 1998).
12 Bernice E. Eddy, Tumors Produced in Hamsters by SV40, 21 FED'N PROC 930, 930-35 (1962) [hereinafter Eddy I]; Bernice E. Eddy et al., Identification of the Oncogenic Substance in Rhesus Monkey Kidney Cell Cultures as Simian Virus 40, 17 VIROLOGY 65-75 (1962) [hereinafter Eddy et
al. II]; EDWARD SHORTER, THE HEALTH CENTURY 195-99 (1987).
13 Eddy I, supra note 34, at 930; Eddy et al. II, supra note 34, at 65.
14 Simian Virus 40 (SV40): A Possible Human Polyomavirus, Developments in Biological Standardization Vol. 94, 1998.
15  INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES, IMMUNIZATION SAFETY REVIEW: SV40 CONTAMINATION OF POLIO VACCINE AND CANCER 4, 21 (Kathleen Stratton et al. eds., 2002), http://www.nap.edu/books/0309086108/html (last visited May 26, 2003) [hereinafter IMMUNIZATION SAFETY REVIEW].
16  Id.
17  National Institutes of Health (NIH) Division of Biologics Standards (DBS) was a forerunner of today's Center for Biologics Evaluation and Research (CBER).  Paul Parkman, Harry Meyer, Jr., MD Lecture, CBER Centennial-Slide Presentation (Sept. 23-24, 2002), at http://www.fda.gov/cber/summaries/cent092302pp.htm (last visited May 26,
2003).  "The transfer of DBS to the Food and Drug Administration took place in 1972."  Id.  The DBS became the FDA's Bureau of Biologics (BoB).  Id. "Later incarnations of this organization included the Center for Drugs and Biologics (CDB) and finally, the present day Center for Biologics
Evaluation and Research (CBER)."  Id.
18  Immunization Safety Review, supra note 45, at 21.
19  Id.
  20  A.B. Sabin, A.B. & L. Boulger, History of Sabin Attenuated Poliovirus Oral Live Vaccine Strains. 1 J. Biol. Stand. 115, 115-18 (1973).

  21Adi F. Gazdar et al., SV40 and Human Tumours: Myth, Association or Causality?, 2 Nat. Rev. Cancer 957, 957-64 (2002). In addition, in July 2002, the National Academy of Science Institute of
Medicine (IOM) Immunization Safety Committee convened a study into SV40 and cancer which culminated in a report published in October 2002.  According to the IOM report "SV40 Contamination of Polio Vaccine and Cancer": The committee concludes that the biological evidence is strong that SV40 is a transforming [i.e., cancer-causing] virus, . . . that the biological evidence is of moderate strength that SV40 exposure could lead to cancer in humans under natural conditions, [and] that the biological evidence is of moderate strength that SV40 exposure from the polio vaccine is related to SV40 infection in humans. See Immunization Safety Review: SV40 Contamination of Polio Vaccine and Cancer.
  22John A. Lednicky and Janet S. Butel, Simian virus 40 regulatory region structural diversity and the association of viral archetypal regulatory regions with human brain tumors, Semin Cancer Biol. 2001 Feb;11(1):39-47. Bharat Jasani, et al., Association of SV40 with human tumours, Semin Cancer Biol. 2001 Feb;11(1):49-61.
23 See Sara Stinebaugh and Joseph Melnick, Plaque Formation by Vacuolating Virus SV40, Virology Vol. 16, March 1962 ("The strain of virus (SV40) used was isolated from Sabin's lot of type 2 oral poliomyelitis vaccine . . . ."); Asaria Ashkenazi and Joseph L. Melnick, Induced Latent Infection of Monkeys with Vacuolating SV40 Papova Virus: Virus in Kidneys and Urine, Proceedings of t