Our son, Alexander Horwin, was a wonderful, intelligent and handsome child who loved life. He wanted to be with his mommy and daddy, go to school, grow up, and experience the wonders of being alive. He had many dreams and plans. His parents wanted to show him the world. After fighting heroically to survive, Alexander Horwin died on January 31, 1999, of brain cancer. He was “almost three,” as he liked to say.

Alexander was diagnosed on August 10, 1998, with medulloblastoma, a highly malignant and deadly brain tumor. Within three weeks of his diagnosis, he was tumor-free as a result of two brain surgeries. My wife and I found the best cancer treatment to ensure this tumor would not return. A medical doctor in Texas offered an effective and non-toxic treatment that had cured children with medulloblastoma and other brain cancers.[1] We took Alexander to the clinic on September 21, 1998, and we were told that Alexander could not be treated because he did not meet the FDA criteria. Even after nearly twenty-three years of safe and effective use, this brain cancer treatment was not FDA approved and the FDA required that our son first undergo the “approved therapies”—chemotherapy and/or radiation therapy.[2] After these orthodox therapies were administered and the tumor returned, the FDA would allow Alexander to be treated with the non-toxic therapy.[3]

Alexander began chemotherapy on October 7, 1998. Three months later, while still on his chemo protocol, the brain cancer returned and spread throughout Alexander’s brain and spine. On January 18, 1999, after an MRI, we were told that Alexander had thirty new tumors. Our son died thirteen days later.

After our light and joy was gone, my wife and I were faced with three questions. We wanted to know why the cancer had returned and spread while Alexander was still on his “state-of-the-art” chemotherapy protocol. We also wanted to understand why the FDA would stop our two and one-half-year-old son from receiving a non-toxic therapy that could have saved his life. Our third question was why had Alexander been stricken with cancer at such a young age?

In respect to the first two questions, we conducted extensive research into the efficacy and safety of the treatment of pediatric brain tumors. What we discovered was disturbing. For example, the individual chemo drugs Alexander was given were listed with the World Health Organization’s International Agency for Research on Cancer as known and suspected human carcinogens.[4]

In addition, the chemotherapy administered to Alexander had already been deemed a failure in the treatment of this disease years before.[5] Oncologists had discussed in their peer-reviewed medical journals that their treatment for young children with medulloblastoma was ineffective. Their articles contained admissions such as “Aggressive treatment of medulloblastoma, the most common pediatric brain tumor, has not improved survival”[6] and “For many years, chemotherapy has been utilized for the treatment of malignant brain tumors with minimal success.”[7]

Although pediatric oncologists had admitted in their peer reviewed publications that they did not have a safe and effective treatment for a patient like Alexander, this did not dissuade the FDA from preventing access to other cancer therapies. The fact that the FDA never met Alexander or talked to his doctors or looked at his MRI’s, lab work, or pathology report made no difference. From 3,000 miles away, the FDA blindly made life and death medical decisions for our son and he died.[8]

Our investigation also revealed that cancer was an industry and chemotherapy was big business.[9] The requirements of FDA approval for non-toxic therapies for cancer translated into pharmaceutical industry control.[10] Only large drug companies could afford the hundreds of millions of dollars to see a drug through the approval process. This put pressure on creating an attractive return on investment which meant that drugs had to be profitable. The non-toxic therapy Alexander was denied was significantly less expensive and less profitable than chemotherapy and, therefore, represented economic competition to the cancer industry.[11]

Why Did Alexander Get Brain Cancer?

The third question we faced was why our child was stricken with brain cancer. This inquiry led us to speak with scientists and medical doctors throughout the world and ultimately led us to court in a precedent setting case against a major pharmaceutical company. The findings of this inquiry are reported here for the first time.

Risk Factors for Cancer

Alexander was delivered “naturally” without an epidural or any other medications or drugs. He was born healthy and breast-fed for the first four and a half months of his life. He ate organic baby foods or those prepared by his mother from homemade quality ingredients. He was a strong child and by the time he was one year old, he was in the top ten percent for weight and height. Cigarettes were never smoked in his house. His parents had white-collar jobs. There was no cancer history in his family.[12] In short, he was exposed to no known risk factors for cancer.

After Alexander passed away, we spent thousands of hours in various medical libraries researching the history of cancer in children. Many of these books and articles discussed how certain human cancers such as cervical cancer, Burkitt’s Lymphoma, and T-Cell Leukemia were known to be caused by viruses.[13] In addition, the works of some of the earliest neurosurgeons suggested that medulloblastoma had a gestation time of approximately seven months.[14] We counted back seven months from the time Alexander was diagnosed and asked ourselves whether our son had been exposed to anything unusual during this period or whether he had been sick with a virus. We checked the pediatrician’s medical records and noted that Alexander was administered his oral polio vaccine on November 7, 1997, eight months before he demonstrated the first signs of brain cancer.

The Oral Polio Vaccine (Orimune)

The oral polio vaccine, brand name “Orimune,” was manufactured by Lederle Laboratories.[15] This live attenuated poliovirus was originally created by Albert Sabin in the early 1960’s.[16] It was a trivalent vaccine meaning that it contained three different strains of poliovirus.[17] Each strain was originally grown on the kidney cells of rhesus monkeys.[18]

Casting a very wide net, we wondered if there were any connection between poliovirus and cancer, and we placed those two terms in a key word search in Medline.[19] Twelve scientific articles appeared with titles like: “Simian virus 40-Contaminated Polio Vaccine and Cancer Rates,”[20] “Simian Virus 40, Poliovaccines and Human Tumors: a Review of Recent Developments,”[21] and “SV40-Contaminated Poliovirus Vaccine and Childhood Cancer Risk.”[22] We wondered what Simian Virus 40 (SV40) was and whether it was involved in Alexander’s brain cancer.

Did SV40 Cause Alexander’s Brain Tumor?

My wife and I decided to have the tumor tissue saved from Alexander’s brain cancer,[23] tested to determine if it contained SV40 and, if so, whether there was evidence that SV40 had caused the cancer. The leading SV40 scientists in the United States performed five tests at five different laboratories. The polymerase chain reaction DNA technology was used along with other sophisticated techniques such as laser micro-dissection. These tests demonstrated that SV40 was in Alexander’s brain tumor cells and that the virus was active in creating the cancer.[24]

Where did the SV40 come from that Caused Alexander’s Tumor?

According to the published literature there were several plausible routes by which SV40 could be transmitted to humans: contaminated polio vaccines,[25] blood,[26] and transplacentally,[27] while the child is still in the womb. My wife and I underwent a series of tests to determine whether or not we carried the virus. Blood, urine, and semen were checked and rechecked using different methodologies including DNA PCR. Different SV40 laboratories were involved from the United States and Europe.[28] All tests were negative for SV40. In addition, my wife had “banked” her cord blood[29] with a private lab when Alexander was born. This blood was also tested by PCR and was negative for SV40 providing evidence that neither Alexander nor his mother carried the virus at the time of Alexander’s birth. Of the three plausible routes of transmission, this suggested that one or more of the polio vaccines Alexander was administered contained SV40.

The Salk IPV that Alexander received was no longer grown on monkey kidney cells taken straight from monkeys.[30] In addition, other steps had been implemented that would help prevent SV40 contamination in IPV.[31] The oral polio vaccine, however, was still grown on primary monkey kidney cells[32] (kidneys removed from live monkeys) and there was no evidence that the original contaminated poliovirus seed stocks were ever replaced.[33] In addition, the original flawed 14-day SV40 tests implemented in 1961 were still in use.[34] Moreover, in December 1999, one of the leading SV40 scientists Michele Carbone, Ph.D., M.D., tested contaminated polio vaccines from 1955 and found that the vaccines contained more than one strain of SV40.[35] The new strain he detected was slow-growing and would take at least nineteen days to appear in cell culture, five days past the federally mandated 14-day observation period.[36] Dr. Carbone and his colleagues wrote that his study suggested that any slow-growing SV40 present in the vaccine would have gone undetected.[37] The scientists also wrote, “they were surprised to learn” that more sophisticated techniques were not used to screen polio vaccines for SV40.[38] Finally, a peer reviewed scientific article written by an attorney suggested that internal documents from the country’s primary oral polio vaccine manufacturer, Lederle, failed to demonstrate that the company had removed SV40 from all of its seeds used to make its polio vaccine.[39]

On January 31, 2000, my wife and I filed a lawsuit against American Home Products, the parent company of Lederle, for the wrongful death of Alexander Horwin.[40] It was the first lawsuit to allege that an SV40-contaminated polio vaccine had been responsible for a death. A three-week Daubert hearing was held in the United States District Court for the Central District of California from February 11 to February 28, 2003. At this hearing, one of our causation experts, a leading SV40 scientist, testified that he had reviewed thousands of pages of internal Lederle documents that demonstrated it was likely that the SV40, which caused Alexander’s cancer, came from the oral polio vaccine that he was administered.

The basis of this expert’s opinion included:
1) Lederle’s OPV seeds used to make its vaccine came from Merck.[41] These seeds (Sabin Original Merck or SOM) came from Sabin Original (SO).[42]
2) The scientific literature demonstrated that SO was contaminated with SV40.[43]
3) Dr. Sabin had also admitted that his seeds were contaminated with SV40.[44]
4) There was no evidence that Lederle discarded the SV40 contaminated OPV seeds or effectively neutralized the SV40 in the seeds.[45]
5) Lederle did not use the SV40-neutralization procedures recommended by Dr. Sabin.[46]
6) Monkeys used to produce OPV were not tested for SV40 by Lederle because of economic considerations.[47]
7) Lederle’s protocols allowed retesting of contaminated vaccine lots instead of discarding them.[48]
8) SV40 had shown up in Lederle’s OPV in the past.[49]
9) The OPV harvest ultimately administered to Alexander demonstrated a viral contaminant that was most likely SV40.[50]

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.[51] Nonetheless, the court 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 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.[52]. 

“Truth is born into this world only with pangs and tribulations, and every fresh truth is received unwillingly. To expect the world to receive a new truth or even an old truth, without challenging it, is to look for one of those miracles which do not occur.”
-- Alfred Russel Wallace

References:

* Mr. Michael Horwin, M.A., J.D. and his wife Raphaele Horwin, M.A., M.F.S. testified in front of the U.S. Congress on June 7, 2000 in hearings entitled Cancer Care For The New Millenium - Integrative Oncology. Mr. Horwin is a magna cum laude law school graduate and winner of the National Scribes Award for article “War on Cancer”: Why Does the FDA Deny Access to Alternative Cancer Treatments?, 38 Cal. W. L. Rev. 189 (2001). He has written a number of articles on pediatric vaccines and health freedom that have been published in law and health publications. The Horwin’s lawsuit as described in this article is the first case alleging that Simian Virus 40 (SV40) was responsible for the cancer and death of a child, in this case, their son Alexander. As they do in all their writings, the Horwin’s dedicate this article to their son Alexander and to other children who have been injured or killed by the very vaccines designed to protect them. For more information, see the Horwins website: www.ouralexander.org.

[1] See Burzynski Patient Group, Antineoplaston Therapy (2003), at www.burzynskipatientgroup.org/antineop1.htm (last visited May 15, 2003). Dr. Stanislaw R. Burzynski can only accept patients who meet a FDA approved clinical protocol. See ClinicalTrials.gov, Active and Clinical Trials of Antineoplastons (2003), at www.clinicaltrials.gov (last visited May 15, 2003). The overwhelming majority of these protocols require that children be administered chemotherapy and radiation first and the tumor must return. However when the tumor returns, most children only live a few weeks and do not meet the life expectancy requirements of the FDA approved protocol—a horrific catch-22. See ClinicalTrials.gov, Phase II Study of Antineoplastons A10 and AS2-1 in Children with Primitive Neuroectodermal Tumors (2003), at www.clinicaltrials.gov/ct/gui/show/NCT00003460;jsessionid=FEA9437E6916940E384B420BADA873AA?order=19 (last visited May 15, 2003). When permitted, Dr. Burzynski has cured children with astrocytomas (see, for example, Matthew Anderson), brainstem tumors (see, for example, Jessica Ressel), optic-hypothalamic gliomas (see, for example, Paul Michaels), medulloblastomas (see, for example, Dustin Kunnari), and other brain tumors (see, for example, Shontelle Hiron). Burzynski Patient Group, Our Stories: Burzynski Patient Group Directory (2003), at www.burzynskipatientgroup.org/stories.htm (last visited May 15, 2003).

[2] Letter from Robert J. DeLap, MD, PhD, Director of the Division of Oncology Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, to Dr. Burzynski, Burzynski Research Institute, at paras. A.1., D.22 (June 12, 1996) (on file with the author) [hereinafter DeLap Letter]; see also Press Release, Jones Joines Keyes, Colleagues in Fight to Return Medical Choice to Patients, at http://jones.house.gov/html/021600.html (last visited May 15, 2003) [hereinafter Jones Press Release].

[3] See Jones Press Release, supra note 2.

[4] Cyclophosphamide is listed as a known human carcinogen. See IARC Monographs Programme on the Evaluation of Carcinogenic Risks to Humans, Cyclophosphamide (Group 1) (2003), at http://www-cie.iarc.fr/htdocs/monographs/suppl7/cyclophosphamide.html (last visited May 26, 2003). Cisplatin and Etoposide are listed as Group 2A: Probably carcinogenic to humans. See IARC Monographs Programme on the Evaluation of Carcinogenic Risks to Humans, Overall Evaluations of Carcinogenicity to Humans (2003), at www-cie.iarc.fr/monoeval/crthgr02a.html (last visited May 15, 2003).

[5] Amar Gajjar et al., Medulloblastoma in Very Young Children: Outcome of Definitive Craniospinal Irradiation Following Incomplete Response to Chemotherapy, 12 J. Clinical Oncology 1212, 1212–16 (1994).

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

[7] M.D. Prados & C. Russo, Chemotherapy of Brain Tumors, 14 Semin. Surg. Oncol. 88–95 (1998).

[8] This story, the role of the FDA, and the reasons for my son’s death were discussed in Michael E. Horwin, “War on Cancer”: Why Does the FDA Deny Access to Alternative Cancer Treatments?, 38 Cal. W. L. Rev. 189 (2001). This article won the 2002 Scribes Law Review Competition. This information was also presented to the U.S. Congress when my wife and I testified before the U.S. House of Representatives Committee on Government Reform for the Hearings on Integrative Oncology—Cancer Care for the New Millennium— 106th Cong. (June 7, 2000).

[9] Horwin, supra note 8.

[10] Id. For example, according to Congressman Berkley Bedell, “It costs millions and millions of dollars to go through the FDA approval process. This freezes out anyone except giant corporations, and makes it utterly impossible for any low cost non-patentable medicines to get into the system.” Patient Access to Alternative Treatments: Beyond the FDA, Hearings Before the House Government Reform Comm., 105th Cong. (Feb. 4, 1998) (statement of the Hon. Berkley Bedell).

[11] Horwin, supra note 8, at 218.

[12] Alexander’s great grandmother would out-live her great grandson and would subsequently die at the age of 89 of cancer.

[13] For the relationship between Human Papilloma Viruses 16 and 18, and cervical cancer, see Richard C. Reichman, Human Papillomavirus Infections, in Harrison’s Principles of Internal Medicine, § 12, pt. 190, at 1098–1100 (Anthony S. Fauci et al., eds, 14th ed. 1998); For the relationship between Epstein Barr Virus and Burkitt’s Lymphoma, see Jeffrey I. Cohen, Epstein-Barr Virus Infections, Including Infectious Mononucleosis in Harrison’s Principles of Internal Medicine, § 7, pt. 186, at 1089–91 (Anthony S. Fauci et al., eds, 14th ed. 1998). For the relationship between HTLV 1 and 2, and Adult T-cell Leukemia, see Anthony S. Fauci & Dan L. Longo, The Human Retroviruses in Harrison’s Principles of Internal Medicine, §14, pt 192, at 1104–11 (Anthony S. Fauci et al., eds, 14th ed. 1998).

[14] Percival Bailey & Harvey Cushing, Medulloblastoma Cerebelli: A Common Type of Midcerebellar Glioma of Childhood, 14 Archives of Neurology & Psychiatry 192–224 (1925).

[15] Physicians’ Desk Reference 1528 (53d ed. 1999).

Between 1961 and 1976 there were three manufacturers of oral poliovirus vaccine in the United States. In the early 1970’s, Wyeth Laboratories withdrew its vaccine from the marketplace. By the end of 1976, Pfizer stopped manufacturing vaccine for sale in the United States. From the latter part of 1977 until the end of 1999, only Lederle has manufactured this product for the United States market. In the year 2000, the Centers for Disease Control no longer recommended the use of Oral Polio Vaccine in the United States.

Stanley P. Kops, Oral Polio Vaccine and Human Cancer: a Reassessment of SV40 as a Contaminant Based Upon Legal Documents, 20 Anticancer Res. 4745, 4746 (2000).

[16] Id. As of 2000, Orimune is no longer sold in the United States.

[17] Michele Carbone et al., Simian Virus 40, Poliovaccines and Human Tumors: A Review of Recent Developments, 15 Oncogene 1877, 1877–88 (1997).

[18] Id.

[19] Medline is a database of over twelve million article references published in biomedical journals and magazines. It is made available through the National Library of Medicine.

[20] Michael D. Innis, Simian Virus 40—Contaminated Polio Vaccine and Cancer Rates, 280 JAMA 1481–82 (1998).

[21] Carbone et al., supra note 17, at 1877.

[22] Susan Gross Fisher, SV40—Contaminated Poliovirus Vaccine and Childhood Cancer Risk, 279 JAMA 1527–28 (1998).

[23] The hospitals where the Alexander’s surgeries were performed had frozen and/or formalin fixed paraffin embedded brain tumor tissue.

[24] Daubert hearing held in the United States District Court for the Central District of California from February 11–28, 2003, Horwin v. Am. Home Prod., No. CV00-04523-WJR (C.D. Cal. 2003) (Testimony from John Lednicky, Ph.D. and Adi Gazdar, M.D., Ph.D).

[25] Hilleman, supra note 28, at 183–90.

[26] F. Martini et al., SV40 Early Region and Large T Antigen in Human Brain Tumors, Peripheral Blood Cells, and Sperm Fluids from Healthy Individuals, 56 Cancer Res. 4820–25 (1996).

[27] Farwell et al., supra note 81, at 261–64; Farwell et al. II, supra note 81, at 657–64; Heinonen, et al., supra note 81, at 229–35.

[28] Bharat Jasani, Ph.D., F.R.C.Path. of the University of Wales College of Medicine coordinated the testing.

[29] Cord blood is blood from the umbilical cord taken at birth. It represents blood circulated between mother and child.

[30] The poliovirus is grown on Vero cells, a continuous line of monkey kidney cells that are grown for the express purpose of providing an advantageous agent-free cell culture medium. Physicians’ Desk Reference 809 (56th ed. 2002).

[31] Id. These steps included the addition of formalin and the use of column chromatography. Id.

[32] See Physicians’ Desk Reference 1528 (53d ed. 1999).

[33] See Brock et. al., supra note 55, at 217–19.

[34] Id. at 218.

[35] See Paola Rizzo et al., Unique Strains of SV40 in Commercial Poliovaccines from 1955 Not Readily Identifiable with Current Testing for SV40 Infection, 59 Cancer Res. 6103, 6103–08 (1999) [hereinafter Rizzo et al. II].

[36] Id. at 6106.

[37] Id. at 6107.

[38] Id.

[39] Kops, supra note 15, at 4745.

[40] The lawsuit was originally filed in Los Angeles Superior Court and was removed to federal court at the behest of the defendant due to diversity.

[41] Declaration of Stanley P. Kops in Support of Plaintiff’s Motion For Reconsideration (Case No. CV-00-04523 WJR (Ex) Pending in the U.S. District Court for the Central District of California.)

[42] Id.

[43] 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 the Society for Experimental Biology and Medicine, Vol. 111, October-December 1962 (“The [SV40] virus used was isolated from Sabin’s seed stock of type 3 oral polio-vaccine. . . .”).

[44] 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 three types of the large Lots produced by Merck, Sharp and Dohme in rhesus monkey kidney cell cultures contained SV40.”).

[45] Declaration of Stanley P. Kops at 120.

[46] Declaration of Stanley P. Kops at 120.

[47] Dr. Ronald Vallancourt, the responsible head of American Cyanamid, testified that the reason for the lack of testing of the monkey sera for SV40 was based on economic considerations.

[48] Declaration of Stanley P. Kops at 120.

[49] Id.

[50] Id.

[51] United States Distrct Court Central District of California Tentative Ruling Case No. CV00-04523 WJR (EX), Daubert Motion, Thursday May 8, 2003.

[52] Id.

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