Below is a letter I urge you to read carefully from Michael and Raphaele Horwin to Senator Dan Burton. The Horwins have been involved in a lawsuit with American Home Products over the death of their 2-year-old son Alexander. Alexander died of cancer, and his tumor was tested and found to contain the SV40 virus. The Horwins maintain that Alexander was infected by the oral polio vaccine he received.

They collected what seemed to be rather strong evidence that this vaccine was the only reasonable means by which Alexander could have been infected with this virus. Their letter tells the story in full, but in short their lawsuit was dismissed. Their attorney has prepared rebuttal arguments and if that fails will file an appeal.

The Horwins are making their plight public to prevent this from happening to other children and adults. Now that their lawsuit has been dismissed they will likely not be able to get this case to a jury where they hoped to tell the world about this catastrophic problem (and disclose the damning documents from Lederle which they found through discovery in this case).

I also encourage you to check out the Horwin's website at http://www.ouralexander.org.

A note about the SV40 virus:

According to Regis Vilchez, M.D., M.Sc., who has studied the SV40 virus,

"There are no commercial tests to evaluate SV40 infection. Serologic assays such as ELISA for SV40 have a low sensitivity. In addition, a recent FDA panel concluded that none of the current ELISA tests for SV40 are reliable for research or diagnostic. While the serum neutralizing antibody test is the recognized gold standard serologic test for SV40, it has low sensitivity and requires great labor.

"Therefore, molecular assays such as polymerase chain reaction (qualitative and quantitative) have been used to study the relation of SV40 infections and human malignancies. These tests are currently for research purposes but different laboratories (including ours) are working to establish them for commercial and diagnostic use. Indeed, this is one of the recommendations of the Institute of Medicine for studies of SV40 in humans. We hope they will be available to patients in the near future."

Additionally, the test is not performed by medical institutions because there is no therapy that can be offered to individuals who may test positive. Individuals who want to be tested for legal reasons should contact a lawyer who works with this issue. Lawyers may be more familiar with labs that may offer this type of service on a case-by-case basis.

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

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:

Alexander, 11/97

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.[1] 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.[2] 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[3] 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." [4] Dr. Salk then passed this strain through fourteen living monkeys and two cultures of monkey testicular cultures.[5] 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.[6] 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.[7] 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.[8] 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.[9] 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.[10]

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.[11] 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.[12] 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.[13] 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 ... "[14]

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.[15] It was estimated that 10% to 30% of the vaccines contained live SV40.[16] 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).[17] Incredibly, this agency did not order a recall of any of the SV40-contaminated vaccines.[18] 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.[19]

Continued on page 2

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.