SV 40

Simian Virus 40 (SV40)

July 29, 2002
Our Letter to the Immunization Safety Review Committee

This letter was sent to the Immunization Safety Review Committee regarding their research into Simian Virus-40 Contamination of Polio Vaccine and Cancer which took place on July 11-12, 2002 in Washington, DC. In it we discuss the dangers of SV40 to some children and the committee’s responsibility to protect the public health despite any conflicts of interest:

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.”1 “Aggressive treatment of medulloblastoma, the most common pediatric brain tumor, has not improved survival.”2 “[T]he absolute benefit of chemotherapy for the treatment of medulloblastoma in childhood is, as yet, not proven.” 3“The median time to progression [return of the tumor] was 6 months.”4 “For many years, chemotherapy has been utilized for the treatment of malignant brain tumors with minimal success.”5 “The outcome for the majority of children with malignant brain tumors remains poor, despite surgery, irradiation and conventional chemotherapy.”6

Various studies have found that medulloblastoma can contain SV40.7 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.8 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

Notes:
1. H.S. Friedman & S.C. Schold Jr. Rational Approaches to the Chemotherapy of Medulloblastom, 4 NEUROL CLIN. 843-53 (1985).

2. M.D. Weil, et al., Influence of a Child’s Sex on Medulloblastoma Outcome, 279 JAMA 1474-76 (1998).

3. S. Attard-Montalto, et al., Is There a Danger in Delaying Radiotherapy in Childhood Medulloblastoma?, 789 BR. J. RADIOL. 807-13 (1993).

4. J. R. Geyer, et al., Survival of Infants with Primitive Neuroectodermal Tumors or Malignant Ependymomas of the CNS Treated with Eight Drugs in 1 Day: A Report from the Childrens Cancer Group, 12 (8) J. CLINICAL ONCOL. 1607-15 (1994).

5. M.D. Prados & C. Russo, Chemotherapy of Brain Tumors, 14(1) SEMIN. SURG. ONCOL. 88-95 (1998).

6. J. L. Finlay, The Role of High-Dose Chemotherapy and Stem Cell Rescue in the Treatment of Malignant Brain Tumors, BONE MARROW TRANSPLANT (1996 & Supp. 3, 18:S1-5).

7. Huang H., et al. Identification in human brain tumors of DNA sequences specific SV40 large T antigen. Brain Pathol 1999 Jan;9(1):33-42.
Zhen H.N., et al. Expression of the simian virus 40 large tumor antigen (Tag) and formation of Tag-p53 and Tag-pRb complexes in human brain tumors. Cancer 1999 15;86(10):2124-32.
Martini, F., et al. Simian Virus 40 Footprints in Normal Human Tissues, Brain and Bone Tumours of Different Histotypes; 1997. Brown F, Lewis AM (eds): Simian Virus 40 (SV40).
Krieg, P., et al. Episomal simian virus 40 genomes in human brain tumors Proc Natl Acad sci USA 1981 Oct;78(10):6446-50.

8. For example: Dr. Medoff your university, the Washington University School of Medicine, has received $8 million from the NIH from1993 to 1998. Dr. Foxman you have personally received over $2.7 million from the NIH from 1992 to 1998. From September 2000 to September 2001 your team received an additional $676,443. Dr. Goodman your university, Johns Hopkins, is the recipient of the largest amount of NIH funds - $210 million in 1997 alone. Dr. McCormick your department at the Harvard School of Public Health is partly funded by “federal funds” and the NIH. Dr. Parkin you have worked directly for the federal government as an epidemiologist at the CDC. Dr. Wilson you have served with the U.S. Public Health Service. Dr Shaywitz you have personally received approximately $15.5 million worth of NIH grants from 1992 to 1998.

Simian Virus 40 (SV40) July 29, 2002 Our Letter to the Immunization Safety Review Committee This letter was sent to the Immunization Safety Review Committee regarding their research into Simian Virus-40 Contamination of Polio Vaccine and Cancer which took place on July 11-12, 2002 in Washington, DC. In it we discuss the dangers of SV40 to some children and the committee’s responsibility to protect the public health despite any conflicts of interest: 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.”1 “Aggressive treatment of medulloblastoma, the most common pediatric brain tumor, has not improved survival.”2 “[T]he absolute benefit of chemotherapy for the treatment of medulloblastoma in childhood is, as yet, not proven.” 3“The median time to progression [return of the tumor] was 6 months.”4 “For many years, chemotherapy has been utilized for the treatment of malignant brain tumors with minimal success.”5 “The outcome for the majority of children with malignant brain tumors remains poor, despite surgery, irradiation and conventional chemotherapy.”6 Various studies have found that medulloblastoma can contain SV40.7 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.8 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 Notes: 1. H.S. Friedman & S.C. Schold Jr. Rational Approaches to the Chemotherapy of Medulloblastom, 4 NEUROL CLIN. 843-53 (1985). 2. M.D. Weil, et al., Influence of a Child’s Sex on Medulloblastoma Outcome, 279 JAMA 1474-76 (1998). 3. S. Attard-Montalto, et al., Is There a Danger in Delaying Radiotherapy in Childhood Medulloblastoma?, 789 BR. J. RADIOL. 807-13 (1993). 4. J. R. Geyer, et al., Survival of Infants with Primitive Neuroectodermal Tumors or Malignant Ependymomas of the CNS Treated with Eight Drugs in 1 Day: A Report from the Childrens Cancer Group, 12 (8) J. CLINICAL ONCOL. 1607-15 (1994). 5. M.D. Prados & C. Russo, Chemotherapy of Brain Tumors, 14(1) SEMIN. SURG. ONCOL. 88-95 (1998). 6. J. L. Finlay, The Role of High-Dose Chemotherapy and Stem Cell Rescue in the Treatment of Malignant Brain Tumors, BONE MARROW TRANSPLANT (1996 & Supp. 3, 18:S1-5). 7. Huang H., et al. Identification in human brain tumors of DNA sequences specific SV40 large T antigen. Brain Pathol 1999 Jan;9(1):33-42. Zhen H.N., et al. Expression of the simian virus 40 large tumor antigen (Tag) and formation of Tag-p53 and Tag-pRb complexes in human brain tumors. Cancer 1999 15;86(10):2124-32. Martini, F., et al. Simian Virus 40 Footprints in Normal Human Tissues, Brain and Bone Tumours of Different Histotypes; 1997. Brown F, Lewis AM (eds): Simian Virus 40 (SV40). Krieg, P., et al. Episomal simian virus 40 genomes in human brain tumors Proc Natl Acad sci USA 1981 Oct;78(10):6446-50. 8. For example: Dr. Medoff your university, the Washington University School of Medicine, has received $8 million from the NIH from1993 to 1998. Dr. Foxman you have personally received over $2.7 million from the NIH from 1992 to 1998. From September 2000 to September 2001 your team received an additional $676,443. Dr. Goodman your university, Johns Hopkins, is the recipient of the largest amount of NIH funds - $210 million in 1997 alone. Dr. McCormick your department at the Harvard School of Public Health is partly funded by “federal funds” and the NIH. Dr. Parkin you have worked directly for the federal government as an epidemiologist at the CDC. Dr. Wilson you have served with the U.S. Public Health Service. Dr Shaywitz you have personally received approximately $15.5 million worth of NIH grants from 1992 to 1998. HOME © Raphaele and Michael Horwin, 1999 - 2002