
"The Appalling Poling Saga"
• Under the Wire to the IACC
• Repetition & Unreason
• Gaming the System
• The IACC Invites Your Opinion
• Speak Out for Services
• An Inquiry Emerges
• The Industrial Treatment
• A Fine White Powder
• A Critical Absence of Data
• Inspecting the Outstretched Palm
• Billing the Adversary
Autism & Disability Sites & Blogs
Abnormal Diversity
Action for Autism
Along The Spectrum
Andrea's Buzzing About
The Art of Being Asperger Woman
Ask An Aspie
The ASMan
Asperger Square 8
Asperger's Conversations
Aspie Dad
Aspie Home Education
ASPIES
Aspies For Freedom
Autiemom Speaks Out
Autism All The Time
Autism & Computing
Autism Blog
The Autism Crisis: Science & Ethics of Autism Advocacy
Autism Diva
Autism Natural Variation
Autism Podcast
Autism Squeaks
Autism Street
Autism Vox
Autism Watch
Autism's Edges
Autismland
AutisMusic
Autistic Adults Picture Project
Autistic Advocacy
Autistic Conjecture of the Day
Autistic Dad
Autistic Health
Autistics.org
Ballastexistenz
Bartholomew Cubbins on Autism
Chewing the Fat
Club 166
Commentary on the State of the World
Desperately Seeking Ethics & Reason
dkmnow
Ed's Blog
The Family Voyage
Greener Pastures
Grey Matter/White Matter
Hard Won Wisdom
Hazardous Pastimes
Hollywood Spectrum
Homo Autistic
Hyperlexia
Hypnagogic Malcontent
I Speak of Dreams
Ian Johnson's neurodiversity blog
in regione caecorum rex est luscus
Incorrect Pleasures
Interverbal
iRunman Blog
Jedi Workshop
The Joy of Autism
Killer of Sacred Cows
The Kingdom of Laurentius Rex
Left Brain/Right Brain
Life in the New Republic
The Life That Chose Me
Mainstream Parenting
Memory Leaves
meow meow meow... blah blah blah
Misadventures from a Different Perspective
The Misbehaviour of Behaviourists (Discussion Board)
Mom Not Otherwise Specified
Mom to Mr. Handsome
More Than a Label
Mother of Shrek
My Act of Combating Neurobigotry
My Son Has Autism
My Son's Autism
Neurotypicals Are Weird
No Autistics Allowed
Not Mercury
OASIS
Odd One Out
Oddizms
One Dad's Opinion
Parenting a Complex Special Needs Child
PosAutive
Pre-Rain Man Autism
Processing in Parts
Radio Calico
Ragged Edge
Random Reminiscing Ramblings
The Rettdevil's Rants
Sam I Am
Shh... Mum Is Thinking
Silver Cuckoo
Slurping Life
Snippets: Short Takes on Autistic Topics
So Much For Mercury
Stop. Think. Autism.
Susan Senator
Sweet Perdition
This Mom
This Mom
This Way of Life
A Touch of Alyricism
Translating Autism: Autism Research
29 Marbles
Unstrange Minds
Victoria's Corner
We Go To School To Think
Whirled Peas
Whitterer on Autism
Whose Planet Is It Anyway?
Wikipedia on Neurodiversity
Zoe Notes
Older Advocacy Letters
Anti-Mercury or Anti-Vaccine?
Autism & Human Rights (CAC)
Autism & Personhood (NIMH)
The Autism Epidemic & Real Epidemics (MIND)
Autism, Mercury & Politics (Globe)
Babies & Autism (Newsweek)
Deadly Immunity? (Salon)
Evidence of Venom (David Kirby)
Lenny Schafer's Inquisition
On "My Name Is Autism"
On Generation Rescue's "Rescue Angels"
Parents vs. Research (NYTimes)
What Caused the Autism Epidemic? (NYTimes)
Petitions
Autism Speaks: Don't Speak For Me
Justice & Equal Rights for Adults With Autism
Our Names Are Autism, Too
Petition to Defend the Dignity of Autistic Citizens
Science Sites & Blogs
Aetiology
The Angry Toxicologist
Bad Science
Bartholomew Cubbins on RNA
Black Triangle
Brain Maps
Confessions of a Quackbuster
Corpus Callosum
The Daily Transcript
Denialism
EpiWonk
Ethics of Vaccines, Center for Bioethics, U Penn
Existence Is Wonderful
GNIF Brain Blogger
Good Math, Bad Math
Holford Watch
Immunoblogging
Junk Food Science
Neuroethics & Law
Neurologica Blog
NHS Blog Doctor
Pathophilia
Pharyngula
A Photon In the Darkness
Pure Pedantry
Quackwatch
Respectful Insolence ("Orac Knows")
Science Evidence
Science-Based Medicine
Scientifically Minded
Skeptico
Terra Sigillata
Vaccine: The Book
Law & Politics
Citizen Media Law Project
Citizen Vox
Consumer Law & Policy
Drug & Device Law
Heraldblog
Legal Blog Watch
The Legal Satyricon
Majikthise
NY Personal Injury Law Blog
Overlawyered
Pharmalot
Point of Law
Public Eye
Volokh Conspiracy
Family & Friends
Ballistic Groove Cannon
Dave Seidel :: Wavicle
Mysterybear
12 April 2007
To the Council of Bishops, the General Board of Global Ministries, the General Board of Church and Society, and the Women’s Division of the United Methodist Church, and the Virginia Interfaith Center for Public Policy:
I am writing to express numerous concerns about the “vaccine safety” campaign being conducted by Rev. Lisa Sykes of Richmond, Virginia, within the United Methodist Church and Women’s Division, advocating immediate removal of all mercury-containing substances in FDA-regulated pharmaceutical products. The success of Rev. Sykes’ efforts thus far is evident in the 2005 passage ƒby the Virginia and Kansas Conferences of the United Methodist Church of the resolution, Protecting Children from Mercury-Containing Drugs, and the Women’s Division’s recently-announced sponsorship of a two-day seminar, The Truth Is Coming to Light, to be held at the Simpsonwood Retreat Center in Atlanta, Georgia, on June 6-7, 2007. According to a United Methodist Church press release, the seminar is intended to “educate the faith community about the dangers of vaccines and other drugs that contain the mercury-preservative Thimerosal as a step toward protecting children from this toxin.”
Although at first glance, Rev. Sykes’ campaign within the church may appear to be wholly humanitarian in nature, it is in fact related to a long-term campaign within the courts, initiated in the late 1990’s by a group of parents relying on a disputed body of evidence, doctors marketing “autism treatments” on the basis of that evidence, and personal injury lawyers eager to press potentially lucrative claims. In the past five years, the number of Vaccine Injury Compensation Program (VICP) claimants attributing their children’s autism to iatrogenic, actionable, vaccine-induced “mercury poisoning” has exploded from 100 to nearly 5,000, necessitating the consolidation of these cases into a single Omnibus Autism Proceeding (OAP). Numerous civil suits have also been filed in which plaintiffs seek to extract money damages from government agencies, corporations and doctors they hold at fault for supposedly “poisoning” their children. Public relations efforts to garner support for the scientific and legal arguments of plaintiffs have escalated as the June 2007 date for causation hearings approaches. These efforts are receiving considerable moral, financial and logistical support from those leaders of the United Methodist Church and Women’s Division responsible for coordinating the upcoming Simpsonwood Retreat to coincide with a demonstration at the Centers for Disease Control sponsored by the plaintiffs’ advocacy group, Moms Against Mercury.
Rev. Sykes has represented her campaign as a struggle between good and evil, a valiant crusade to protect the most vulnerable individuals in society from heartless, indefensible baby poisoners, a battle against dark forces responsible for perpetrating heinous crimes against humanity and stealing from children “the future that God intends for them.” The situation is not so simple as that. The current litigation-inspired “vaccine safety” crusade is also a for-profit enterprise in which Rev. Sykes and her colleagues have a significant financial stake. That stake — as well as the full range of arguments and evidence relevant to the “vaccine safety” debate — should be fully disclosed to all persons invited to consider her arguments, the evidence she presents to support them, and the “experts” upon whom she relies.
I urge the United Methodist Church and Women’s Division to consider the possibility that Rev. Lisa Sykes and her team of legal and medical advisers might be sincerely mistaken in their conclusions regarding the cause of autism; that their quest for multi-million-dollar money damages and assumption of bad faith on the part of many specific and nonspecific targets of blame, may have impaired their judgment and capacity for objectivity; and that a campaign that appears to support a valiant search for justice conducted by righteously aggrieved underdogs may in fact support a dogged search for validation of a scientifically insupportable idée fixe by those determined to exact retribution for imagined injustices, and determined to prevail in debate and high-stakes litigation regardless of the merit of their arguments.
I here offer a review of Rev. Sykes’ campaign in the United Methodist Church, as documented in various official and unofficial publications, followed by a discussion of recent litigation related to autism and vaccines, thimerosal-related court and administrative rulings, and posts made by Rev. Sykes to online newsgroups. Finally, I pose a series of questions for consideration by leaders and members of the United Methodist Church and Women’s Division, as well as by anyone who seeks to become more fully informed about the complexities of the debate over thimerosal in vaccines. I am not a member of the United Methodist Church, but am nonetheless moved to express these concerns, as the actions of the Church have the potential to affect the welfare of people of all faiths.
Links to source material are embedded in this letter, and a list of selected references is included at the end. I have also published this letter on Neurodiversity Weblog.
Lisa Sykes is Associate Pastor of the Welborne United Methodist Church in Richmond, Virginia, and a member of The United Methodist Church Women’s Division. She is also wife of Seth Sykes, mother of an autistic son born in 1996, co-founder of the Coalition for Mercury-Free Drugs (CoMeD), and a member of the Institutional Review Board (IRB) of the Institute for Chronic Illnesses. From the year 2000 onward, Rev. Sykes has addressed numerous letters, testimony and petitions to federal and state government officials, public health and regulatory agencies. In these communications, she has described the events that led to her son’s diagnosis of autism in 1998, when he was 2¼ years old, her subsequent communications with Dr. Mary Megson and the testing which preceded Dr. Megson’s diagnosis of her son with “multiple metal toxicity” and commencement of an extended course of chelation. Rev. Sykes has called for the removal of all mercury-based preservatives from vaccines, and has proclaimed her conviction that staff of the U.S. Centers for Disease Control, the U.S. Food and Drug Administration, vaccine developers and medical professionals have conspired to minimize and conceal the risks of the antimicrobial thimerosal and thereby poison a generation of children through vaccines. Rev. Sykes has also urged members of the scientific community to “apprentice themselves” to those researchers and healthcare practitioners who support the debatable notion that the majority of autism diagnoses are a consequence of and misdiagnosis for iatrogenic mercury poisoning.
In 2004, Rev. Sykes and Kansas Methodist Kelly Kerns embarked upon a campaign to enlist their denomination’s support for the cause of “vaccine safety.” In June 2005, the Virginia United Methodist Women, the United Methodist Virginia Conference and the United Methodist Kansas Conference passed the resolution, Protecting Children from Mercury-Containing Drugs, on which Rev. Sykes was first signatory. After an extended series of “whereas” statements referring to United Methodist social principles and history, and characterizing thimerosal in FDA-approved vaccines as “poison,” the resolution concludes:
Be it resolved, that the Virginia Annual Conference of the United Methodist Church does hereby call upon the Secretary of Health and Human Services, the Food and Drug Administration, and the Centers for Disease Control and Prevention to come to the protection of the people, especially the unborn and the children, by:
Immediately advocating that mercury-free stocks of vaccines and other pharmaceutical products be prioritized for pregnant women, newborn infants, and children,
Providing an opportunity of informed consent to individuals about to receive mercury exposure through their drugs/pharmaceutical products/biologics/vaccines, detailing the known risks of its toxicity and Federal Safety Guidelines for Exposure to mercury,
Moving to ban the presence of any mercury compound in a drug/pharmaceutical product/biologic/vaccine, prescribed or over-the-counter, unless the presence of that mercury compound has been proven clinically to have no adverse effects,
And that the Virginia Conference of the United Methodist Church refers this resolution to: the General Board of Global Ministries and the General Board of Church and Society for further action; the Interfaith Center for Public Policy for further action; the Council of Bishops for their examination.
A press release posted on the Virginia Interfaith Center website described the resolution and the event at which it was announced:
Mercury in Vaccines is Poison
A Virginia pastor today called for the removal of mercury from children’s vaccines from the grieving pulpit of her experience, her son has autism.
Reverend Lisa Sykes, Pastor of Christ United Methodist Church, in Richmond, Virginia is the mother of a 9 year-old boy, W[…], who is diagnosed with autism. When her son was immunized as a baby, mercury was present at levels exceeding federal safety guidelines, as is the case with all children receiving the vaccines.
Boosted by a landmark resolution, “Protecting Children from Mercury-Containing Drugs,” at the Virginia Annual Conference of the United Methodist Church, Rev. Lisa Sykes and a team of researchers released evidence today linking mercury in vaccines to several disorders such as autism. The resolution, calling for children to be safeguarded from poisoning by mercury-containing vaccines asks that citizens of all ages to be warned that mercury has been commonly administered in products such as the flu and tetanus shots.
Addressing W[…]‘s clinical evidence of mercury toxicity, Dr. Mary Megson of Richmond, Virginia, Director of the Pediatric and Adolescent Ability Center and Professor of Pediatrics at Virginia Commonwealth University, presented clinical observations of the child including the links between mercury poisoning and W[…]‘s symptoms of autism.
Dr. Mark R. Geier and David A. Geier, the only independent researchers to analyze the Centers for Disease Control and Prevention (CDC)‘s previously closed vaccine safety database, presented new findings from a peer-reviewed scientific/medical study, A Two-Phased Population Epidemiological Study of the Safety of Thimerosal-Containing Vaccines: A Follow-up analysis, only recently published in the International Medical Journal for Experimental & Clinical Research (Medical Science Monitor). The Geier research found a consistent and significant link between exposure to mercury in childhood vaccines and neurological disorders such as autism, speech/language disorders, Attention Deficit Disorder (ADD), and neurodevelopmental disorders in general.
Dr. Boyd E. Haley, Chairman of Chemistry at the University of Kentucky, described his own research that mercury exposure is also implicated in the neurodegenerative process in Alzheimer’s Disease.
Remarks by Bishop Charlene Kammerer, Episcopal Leader of the United Methodist Annual Conference, addressed the urgency of protecting children from unwarranted mercury exposure. Conveying the support of the Annual Conference, Bishop Kammerer explained that the United Methodist Church would be taking actions to ensure mercury was removed from vaccines.
The faith community is mounting a campaign in Virginia and several other states to advocate mercury-free vaccines as a result of the Geier and Haley research as well as the well documented case of W[…] Sykes. (June 15, 2005)
A collection of documents associated with the press conference was also posted to the Interfaith Center website, including biographies and written commentary by Dr. Geier and Professor Haley, articles by Dr. Geier (including the “Two-Phased Study”), and the text of numerous newspaper articles, many of them featuring Rev. Sykes.
At an April 2006 demonstration in Washington, D.C., Rev. Sykes donned her clerical robes, called for justice, and prayed:
“…for the greedy and those who love power so much that they would seek profit over safety, and sacrifice children instead of wealth. We pray for those who have surrendered the truth, and government officials who have failed to seek it. These, too, like so many of our injured children, cannot see, they cannot hear, and they remain silent.” (April 6, 2006)
A United Methodist News Service article, Pastor Campaigns Against Mercury in Vaccines, reported on Rev. Sykes’ presentation to the Spring 2006 Women’s Division Board of Directors Meeting. Simultaneously, the Renew Network for Christian Women issued, Mercury-Containing Drugs Should Be Banned. After describing Rev. Sykes presentation — in which she claimed that “we are contaminating our own children” and spreading poison worldwide through distribution of thimerosal-containing vaccines — author Sharon Lodovic referred to the controversy surrounding the hypothesis that autism is a consequence of vaccine injury, and concluded:
“Well organized activist parents continue their advocacy and litigation efforts, convinced their case about thimerosal can be proven… Our prayers are with all who seek to relieve the suffering for these parents and children.”
In February 2007, the United Methodist Virginia Conference published a “Lenten Devotional” in which Rev. Sykes offered her interpretation of Scripture, and urged the faithful to take action:
“[M]y son is disabled, unnecessarily injured by mercury he received in his vaccines. Like Abram, we are cast down. Today do our children and pregnant women and others still receive dangerous levels of mercury in their flu shots, with no informed consent. In developing nations, even more shots have mercury. The era of administered mercury is the darkest part of the night. My beloved Virginia Conference and the Women’s Division of the United Methodist Church are lights in this awful darkness. We are seeking to safeguard the children, that they may live and that their lights may shine, even as God intends — as brightly as the stars in the heavens… Contact your elected representative and tell them you want children protected from mercury-containing drugs… God, give us strength to safeguard our children and the future you intend for them. Amen.” (February 26, 2007)
The United Methodist Women Women’s Division recently announced its sponsorship of a two-day seminar, The Truth Is Coming to Light, to be held at the Simpsonwood Conference and Retreat Center in Atlanta, Georgia, on June 6-7, 2007. A press release by Barbara Wheeler, executive secretary for communications of the Women’s Division, described the purpose of the seminar, and quoted Women’s Division executive Julie Taylor:
“The event will educate the faith community about the dangers of vaccines and other drugs that contain the mercury-preservative Thimerosal as a step toward protecting children from this toxin… At the conclusion of this educational event, two grassroots organizations, Moms Against Mercury and the Coalition for Mercury-free Drugs (CoMeD) will hold a rally at the Centers for Disease Control and Prevention and a press conference nearby in Atlanta.”
“‘The children and families that are affected by mercury-poisoning are marginalized in their efforts to uncover the truth about this toxin,’ Ms. Taylor said. ‘They are individuals questioning large agencies of the government and pharmaceutical companies about the use of mercury.’” (March 6, 2007)
The broader context of this campaign within the United Methodist Church is documented in Internet newsgroup archives and U.S. federal court and administrative records. On October 2, 2000, attorney Clifford Shoemaker of Vienna, Virginia, submitted to the Vaccine Injury Compensation Program Claim No. 1:00-vv-00591-UNJ in which Rev. and Mr. Sykes alleged that their then-four-year-old autistic son was injured by the Hepatitis B vaccine, and sought $250,000 compensation. Theirs was among the first VICP petitions filed alleging that thimerosal-containing vaccines had caused apparently neurologically-typical children to become autistic. Dr. Mary Megson began to develop clinical evidence of “mercury toxicity” in November 2000, a month after the claim was filed, by ordering a “provoked test,” which artificially raises urine mercury levels above a patient’s steady state, from Doctor’s Data, a laboratory specializing in nonstandard toxicity tests. This was consistent with the strategy later described in a newgroup post by the mother of an autistic child:
“I’ve been talking to several lawyers and get the feeling in the end that they’re all going to want clients who are doing chelation with lots of tests to show what’s coming out. The lawyer I talked to today said I should test after every single round… I faxed Dr. Holmes and told her to set us up on a schedule that would help our case and she said, “Be very careful on this endeavor. The real key to “proving” mercury toxicity where it will stand up in court is showing enough abnormalities that only mercury can cause, not how much mercury is actually coming out, especially now that we are on to brain mercury. This does not ever come out in huge loads.” I totally agree with her but the lawyers I’ve talked to say I won’t have a chance without testing. I wanted to let everyone know so especially the parents who are just starting chelation, make sure you get plenty of testing done if you plan on pursuing a law suit.” (November 30, 2001)
Online client recruitment efforts by vaccine injury lawyers began in early 2001, with announcements that claimed that “The link between autism and mercury poisoning is now conclusive,” and alleged that vaccine researchers and public health professionals had colluded to conceal data implicating thimerosal as a cause of autism. The formation of the Vaccine Injury Alliance was announced in August 2001 by attorney Jeff Sell, who now serves as Director of Chapters and Memberships of the Autism Society of America. In a January 2002 post to the Autism-Mercury newgroup, Mr. Sell responded to a father who expressed reservations about the wisdom of pursuing litigation, speculated about the potential profits to be made, and revealed his and his colleagues’ then-current litigation-related investments:
“I don’t think ‘the pharm companies will just declare bankruptcy and/or congress will just end up bailing out pharm companies/doctors from liability and no one will get much of anything?’ If I did we surely would not have invested over a million dollars to date in these cases. I fully understand that folks will need serious money to provide for their children and loved ones — I have autistic twins remember, so I get a double whammy on everything from nutritional supplements to OT services.” (January 21, 2002)
Targeted recruitment resulted in an increase in the VICP caseload from 100 cases in January 2001 to 400 a year and a half later. In August 2002, the Omnibus Autism Proceeding (OAP) was established to expedite processing of these claims, including the one filed by Rev. and Mr. Sykes. Shortly thereafter, in September 2002, Gregory David Kincaid of Olathe, Kansas, and two attorneys from the Boston vaccine-injury firm Conway Homer & Chin-Caplan, filed the first of six vaccine-injury claims in which Mrs. Kelly Kerns alleged that all three of her children were injured by vaccines. These, too, were incorporated into the Omnibus Autism Proceeding.
In October 2002, Rev. and Mr. Sykes voluntarily withdrew their claim, and three months later gave notice of their intention to file a civil suit.
On March 14, 2006, Rev. and Mr. Sykes filed Lisa Sykes et al. v. Glaxo Smith-Kline et al. (Case 2:06-cv-01111-LS) in the U.S. District Court for the Eastern District of Pennsylvania. The complaint alleged that their now-ten-year-old autistic son was injured by thimerosal contained in Rh immune globulin administered to Rev. Sykes during her pregnancy, and by vaccines administered to him during his first three years of life. They asserted that the Rh immune globulin and vaccines manufactured by the defendants were “unreasonably and dangerously defective” by virtue of their thimerosal content; that the defendants negligently failed to offer safer alternatives to these products; that the defendants negligently failed to warn health care professionals of the contents and supposed dangers of these products; and that the defendants intentionally withheld information from the federal Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services (HHS) regarding the safety, efficacy, risks and dangers of the thimerosal contained in their products.
Rev. and Mr. Sykes requested $20,000,000 in damages from defendants Glaxo-SmithKline, Wyeth, Inc. and Bayer Pharmaceuticals Corporation.
The Sykes’ legal team is composed of eight attorneys from six firms in four states. All but one is a member of the Executive Committee of the Petitioner’s Steering Committee for the OAP, which now includes over 5,000 claims. Dr. Mark Geier, Dr. Mary Megson and Professor Boyd Haley, whose work was praised at the press conference announcing the UMC mercury resolution, are all serving as expert witnesses to plaintiffs in the OAP, and also provide expert testimony in civil litigation.
On March 28, 2007, Judge Lawrence F. Stengel of the United States District Court for the Eastern District of Pennsylvania issued a ruling in Sykes v. Glaxo. The 67-page Opinion and Order provides his detailed analysis of the issues raised, leading to his dismissal of all claims against Glaxo and Wyeth. (A product-liability lawyer’s perspective on the decision can be found on the Drug & Device Law weblog.) Judge Stengel reasoned that the purpose of the Vaccine Act could not be served if defective design claims against vaccine manufacturers could be tried before juries; and that a manufacturer cannot be held negligent if the products in question were produced in accordance with FDA-approved specifications, and administered in a manner consistent with the generally accepted practice of medicine. The plaintiffs argued that the defendants should have added safety warnings to their products more extensive than those required by the FDA; Judge Stengel determined that such warnings would be false, misleading, and not supported by scientific evidence, and that to add such warnings to FDA-approved products would constitute misbranding. Judge Stengel did not find Bayer’s arguments regarding defective design and inadequate testing as persuasive as their motion to transfer venue, so after dismissing the “failure to warn” claims, he transferred the remaining claims against Bayer to the Eastern District of Virginia.
Judge Stengel also observed that the plaintiffs had offered no evidence to substantiate their accusation that the defendants deliberately concealed evidence of the hazards of thimerosal during the FDA approval process.
“The purpose of the heightened pleading standard for fraud claims is ‘to give[] defendants notice of the claims against them, provide[] an increased measure of protection for their reputations, and reduce[] the number of frivolous suits brought solely to extract settlements.” In re Burlington Coat Factory Sec. Litig., 114 F.3d 1410, 1418 (3d Cir. 1997). “and conclusory allegations will not suffice. Plaintiffs must accompany their legal theory with factual allegations that make their theoretically viable claim plausible.” Id.
“Here, the plaintiffs’ fraud claims are no more than a recitation of the Vaccine Act language. The Sykes do not support their claims of wrongdoing with specific factual allegations, such as what material was withheld or when it was withheld. Moreover, the defendants’ disclosure to the FDA of their products’ thimerosal ingredient during the licensing process of the vaccines and the FDA’s continued testing and current position on thimerosal, i.e., that there is no causal link between the preservative and neurological injury, lead to the conclusion that permitting the plaintiffs an opportunity to replead this claim would be pointless. Accordingly, the plaintiffs’ allegations that the vaccine defendants intentionally withheld information from the government are dismissed with prejudice.” (pp. 29-30)
Rev. and Mr. Sykes appealed the decision the day after the ruling was issued. (I have made an archived docket report current to the date of the appeal and selected filings in this case freely available online; the updated docket is viewable on the website of the U.S. Court for the Eastern District of Pennsylvania to PACER account holders.)
Judge Stengel’s decision complements the FDA’s September 26, 2006 response to the Coalition against Mercury Free Drugs (COMED) petition (FDA Docket CP2004P-0439/CP1), on which Mr. And Mrs. Sykes were signatories. That petition demanded an immediate ban on the use of any mercury-containing substances in FDA-regulated products, on the grounds that they are inherently unsafe regardless of their approval by the FDA. As in Sykes v. Glaxo (though far more dramatically), the COMED petition and Rev. Sykes’ subsequent addendum to it alleged a conspiracy to conceal vital information, orchestrated by unnamed individuals united in venal disregard for the health, safety and “bodily integrity” of their fellow human beings:
“[H]igh government officials by authorizing the manufacture, distribution, and, most importantly, the use of vaccines and other drugs and biological products containing neurotoxic ingredients, including, but not limited to, Thimerosal that have not been unequivocally proven to be safe (within at least a 10x safety margin) to all who may receive said products have been and are, in effect, responsible for performing uncontrolled involuntary experiments on susceptible pregnant women, fetuses, newborns, children, and the rest of the public under the guise of protecting them from various diseases.” (pp. P-46-7; August 4, 2004)
“Surely the scope of this criminal conspiracy and collusion between government and the pharmaceutical industry is reflected in the failure of even one single government agency to act decisively in stopping the damage to human life and our nation’s well-being… We suggest you treat the insidious presence of mercury, at neurotoxic levels as a preservative named “Thimerosal” in our drug supply, as an instance of domestic terrorism, and respond appropriately.” (Sykes comment, p. 14; November 15, 2004)
Whereas the opinion in Sykes v. Glaxo primarily addresses questions of tort law and jurisdiction, FDA Assistant Commissioner Jeffrey Shuren offered a point-by-point analysis of the petitioners’ scientific arguments. Shuren determined that the licensed and approved products which the petitioners sought to ban are in fact safe (with safety defined as a favorable risk/benefit ratio, rather than an absolute absence of risk); that exposure to mercury through vaccines, other biologics and drugs is minimal, particularly since thimerosal has been removed from most vaccines routinely administered to infants; that the few products still containing more than a trace amount of thimerosal are safe; that the studies and arguments presented by the petitioners did not support their assertions; and that their legal arguments were without merit. In response to the petitioners’ accusations of conspiracy on the part of FDA officials and others, Shuren commented:
“[H]ere you are not denying that the vaccines and other products have prophylactic or therapeutic value to those who take them. Nor have you provided any evidence to claim that FDA officials have been hired to conduct “uncontrolled involuntary experiments” on people. Nor do you claim that FDA has hidden any facts from those who will use thimerosal-containing products. You simply disagree with the conclusions that FDA draws from those facts. As explained above, however, FDA’s conclusions are based on sound scientific principles.” (September 26, 2006)
In October 2006, the members of CoMeD requested a stay of the FDA’s decision. The 130-page Petition for Stay of Action expanded upon the original petition’s allegations, and included a call for criminal prosecution:
“[Y]our collusive actions with those vaccine manufacturers who have, since 1973, knowingly held themselves above the law, fall within the umbrella established by the criminal RICO (Racketeering, Influencing, and Corrupt Organizations) statutes as set forth in 18 U.S.C.A Sec 1961 et seq. and, in light of the recent licensing of another Thimerosal-preserved influenza vaccine, we are compelled to request the court to initiate and pursue such actions.” (p, S-R-20)
“We find that, as agents of the government, you are even more culpable for your knowing actions than the doctors in “In re Cincinnati Radiation Litigation.” Worse than being the hired agents, we find and the CoMeD petitioners asserted that, as the order givers, you, like some of the high governmental officials in the war crimes trials in Germany and Japan, are responsible.” (pp. S-R-115-6; October 21, 2006)
The CoMeD appeal (FDA Docket CP2004P-0349/PSA1) remains pending.
Another relevant legal decision was rendered on July 6, 2006, in the U.S. District Court for the Middle District of North Carolina, in the case Doe v. Ortho-Clinical Diagnostics (Case No. 1:03-CV-00669). Like the Sykes family, the plaintiffs alleged that their autistic child had been injured in utero by thimerosal contained in an Rh immune globulin injection. After an extended hearing to ascertain the reliability and adequacy of testimony offered by the plaintiffs’ designated experts, Judge James Beaty excluded Dr. Mark Geier’s testimony.
“[Dr. Geier] is a medical doctor who specializes in obstetrical genetics with a Ph.D. as well in genetics. He is board certified in medical genetics and forensic medicine. However, it is significant to the Court that he is not board certified in pediatrics or in pediatric neurology, nor is he certified as an epidemiologist or biostatistician… The Court has taken into account, as well, the fact that Dr. Geier has testified as an expert witness in about one hundred cases before the National Vaccine Injury Compensation Program of the United States Court of Federal Claims. It is noteworthy that in more than ten of these cases, particularly in some of the more recent cases, Dr. Geier’s opinion testimony has either been excluded or accorded little or no weight based upon a determination that he was testifying beyond his expertise.” (pp. 8-9)
“Dr. Geier […] relied upon a number of disparate and unconnected studies, including the findings of Dr. Haley and Dr. Lucier, to reach a piecemeal conclusion with respect to general causation that the small amount of thimerosal received in this case by the mother of Minor Child Doe during the course of her pregnancy and shortly after the child’s birth, could cause autism. Dr. Geier’s methodology consisted of attempting to connect various individual studies that had developed the existence of certain findings… [M]uch of Dr. Geier’s analysis, based upon his collective review of a motley assortment of diverse literature, proved, in the Court’s view, to be overstated… This Court must find more than the “hypothesis and speculation,” engaged in by Dr. Geier in this instance, in order to allow Dr. Geier to rely upon the methodology he used in forming a conclusion based upon his review of the literature presented to the Court. In any event, Dr. Geier’s conclusion in this matter is not supported even by the literature he presented to the Court. Moreover, Dr. Geier’s conclusion that the peer-reviewed literature he has relied upon supports his theory that autism can be caused by thimerosal is flatly contradicted by all of the epidemiological studies available at this time. Thus, while Dr. Geier’s presentation of the literature as part of his methodology might at first glance appear convincing, the disconnected literature he presents does not add up to the opinion and conclusion that Dr. Geier is offering.” (pp. 10-15)
“Although Dr. Geier is neither an epidemiologist or biostatistician, Dr. Geier’s studies examined the incidence of autism by comparing reported incidents of adverse events after the administration of the Diphtheria, Tetanus & Pertussis (“DTP”) vaccine that contained thimerosal against reported incidents of adverse events after thimerosal was removed from the DTP vaccine. However, the Court finds that Dr. Geier’s published VaERS studies have been severely criticized by The Institute of Medicine as having “serious methodological flaws,” analytic methods that were “non-transparent,” and generally “non-contributory with respect to causality.” (pp. 15-16)
“Plaintiffs have failed in each instance to show: (1) that the theory employed by Dr. Geier is generally accepted in the scientific community; (2) that Dr. Geier’s most recent and most applicable work concerning RhoGaM has been subjected to peer review and publication; and (3) that Dr. Geier properly controlled his studies and maintained standards… Moreover, the Court is particularly concerned as to a potential bias in Dr. Geier’s methodology and ultimate conclusion given the recency of Dr. Geier’s research into the cause of autism, which he admittedly began in only the last two and a half years, a time period that also represents the pendency of this lawsuit. (pp. 16-17)
Judge Beaty dismissed Professor Haley’s testimony in a footnote:
“The Court… finds that Dr. Haley’s report does not state an expert opinion that thimerosal causes autism, rather just that he has a theory about how such a thing could happen. At best, he expressed “strong belief” that the cause of “neurodevelopmental disorders in infants” is exposure to an organic-mercury compound such as thimerosal… Significantly, the Court notes that neither Dr. Haley nor Dr. Lucier asserts that he is an expert on autism nor are they offered as such. In any event, the Court finds that neither of the proffered reports of Dr. Haley nor Dr. Lucier are sufficiently reliable under Daubert on the general causation issue because neither is relevant to the “task at hand.” It would be an unacceptable scientific leap to suggest that they serve as proof, by a preponderance of the evidence, of Plaintiff’s claim that the thimerosal in RhoGaM can cause autism… Accordingly, the majority of the Court’s opinion is focused only on the testimony of Dr. Geier, Plaintiffs’ primary general causation expert and single specific causation expert. Nevertheless, it is the Court’s finding that the discussion and analysis herein regarding the relevant scientific literature applies equally to the proffered reports of Drs. Haley and Lucier, which also purport to survey the relevant literature in coming to their respective conclusions.” (p. 4, footnote 3)
Since Dr. Geier was the plaintiffs’ sole expert on both questions of general autism causation and the specific causes of the child’s autism, yet his testimony was deemed unreliable, the plaintiffs failed to meet their burden of proof, and all claims against the defendants were dismissed.
A range of scientific evidence regarding the possible role of mercury-based preservatives in the causation of autism is referenced and analyzed by the judges and administrators who adjudicated these cases. Much of this material is available for public viewing on court websites, and also on the websites of organizations such as the Immunization Action Coalition, Every Child By Two and the U.S. Centers for Disease Control.
General causation hearings for cases in the Omnibus Autism Proceeding are scheduled to begin in June 2007. Coordinated efforts to garner popular support for plaintiffs are being spearheaded by ad hoc litigants’ advocacy groups such as the National Autism Association (NAA) (whose Board Chairman is a staff member of the vaccine injury firm Waters & Kraus and plaintiff in the now-dismissed class action lawsuit, Bothwell v. Abbott) and the two-woman Moms Against Mercury, coordinators of the “Simpsonwood Remembered” rally scheduled to follow the UMW’s “educational event.”
One week after the United Methodist Church Women’s Division announced the Simpsonwood seminar, Rev. Sykes posted to the Evidence of Harm discussion list — the online nerve center of the “vaccine safety” campaign — another press release, more militant in tone than the one published on the Women’s Division website.
Simpsonwood Teach-In and Rally
Hi Everyone!
Below is the press release for the teach-in sponsored by the Women’s Division and the Rally sponsored by MaM and CoMeD. I wanted to be sure everyone on this list was aware of these events. If you share my conviction that mercury is the trigger for the condition many call autism, but which I instead call mercury-poisoning, please consider making the trip to Georgia in June. I have many goals for this June event, but one goal that is particularly special is trying to unite the parent community in witness. If anyone has questions about the events, the Women’s Division of the UMC and its leadership, etc., please post back, and I will try to answer them.
Blessings, Lisa Sykes
On June 7 & 8, 2000, at a religious retreat center in Norcross, Georgia, called Simpsonwood, leaders of the CDC, FDA, and Pharma gathered to discuss troubling studies. These studies showed a strong correlation between mercury exposure from vaccines and the risk of tics, speech/language disorders, and other neurodevelopmental disorders in children.
The “transcripts” from that meeting record an overriding concern among most participants for protecting vulnerable agencies/companies from liability, but almost no concern for protecting vulnerable children from mercury poisoning. Instead, participants were asked to protect—not the children—but the information discussed in this closed-door meeting.
The studies presented there were manipulated several times until, in 2002, most of the statistical associations found originally became less than significant, and only then were the final “results” shared with the Institute of Medicine in 2004.
Having become aware of the “Simpsonwood meeting” held at Simpsonwood United Methodist Retreat Center, and of the danger of mercury in vaccines and other drugs, the Women’s Division of the United Methodist Church is sponsoring “The Truth is Coming to Light,” a teach-in on the dangers of mercury in medicine. Fittingly, this historic event will be held at Simpsonwood Retreat Center June 6 & 7, 2007, to mark the 7th anniversary of the closed-door meetings.
For information on the history of United Methodist Women’s work with issues related to mercury poisoning and children’s health, visit www.umwmission.org.
What was said in secret will be spoken in public. Now, instead of government officials and industry executives protecting mercury and those culpable for its presence in baby shots, the faith community and parents of mercury-poisoned children will gather at the gates of the CDC, on June 8, to protect children from mercury in medicine and the danger it represents. More information on the rally can be found at www.momsagainstmercury.org.
In addition, the Women’s Division and all those attending this rally will call for the right of informed consent before any drug containing added mercury is administered, because mercury is a known poison and carcinogen.
The Simpsonwood Remembered Rally
Be Part of History!
Be There!
(March 13, 2007)
On March 28, 2007 — the day Judge Stengel issued his opinion in Sykes v. Glaxo — Rev. Sykes returned to the Evidence of Harm List to discuss the upcoming Simpsonwood retreat:
Press Conference, Simpsonwood Event
“First, my thanks to Dr. King for his comments on the upcoming Simpsonwood teach-in and rally. One thing I learned, when the Methodist resolution first passed here in Virginia, is that when a mainline denomination speaks out on the morality of a current medical practice it makes national news: AP, MSNBC, etc. That article was all over the nation. On June 6, 7 & 8, 2007, it is our chance once again to pull national headlines favorable to our side. For these headlines to come with photos/footage of significant numbers of parents in support of this faith-based (no longer just parents) challenge to putting poison into children will speak volumes. Moms Against Mercury is organizing the rally and press conference on June 8, and any of you who have attended the rallies and conferences they have organized know what a fabulous and professional job they do! The Women’s Division of the United Methodist Church, which has led social reforms many times before, is sponsoring the teach-in on June 6 & 7. The Women’s Division is getting emails from all over the country, from appreciative parents astounded that this organization would be so bold, on behalf of us and our kids! Be a part of making history! Go to www.umwmission.org and www.momsagainstmercury.org for more information!” (March 28, 2007)
Rev. Sykes reassured her listmates that her United Methodist Church Women’s Division colleagues were committed to presenting her perspective on vaccine safety:
They know where they stand
This summer will be critical, with the Omnibus events upcoming, and more and more in the press. As the date nears, we need to focus the media, and through them, the ordinary folk of the nation, on the issue of vaccine safety, and specifically the danger of mercury and the evidence of facts about it being buried. The opportunity to do this comes through our first institutional ally to undertake advocacy on our behalf.
At just the right time, June 6 & 7, the Women’s Division will hold a teach-in at Simpsonwood to educate those who had no idea what happened there and what happened to our kids. When the church says it’s wrong to put poison in a baby, or anyone else, and what can the establishment say? Faith traditions affirm every single individual life as precious, and TODAY’s piece gives me great hope that what will be said at Simpsonwood will reverberate in the media and the minds of our nation. So will the witness of the faith community at the gates of the CDC.
I spoke with a WD exec last week. Someone had called asking that they present “both sides of the (mercury) issue” and this wonderful leader of the Women’s Division simply said, “No.” The Women’s Division believes in informed consent and it knows mercury is a neurotoxin. They know where they stand. On our side. I invite you to stand with them and with me. (April 1, 2007)
When a fellow list-member inquired whether the Women’s Division had taken a position regarding flu shots for adults, observing that many churches conduct flu shot clinics for their parishioners — a practice she felt was “nonsense” — Rev. Sykes replied:
“The short answer is: “Yes, but we’re working to change that!” The Women’s Division is one agency of the larger denomination, and does not emcompass the whole; they are “our door” into the “house,” if that makes sense. So they will be the ones to educate the rest of the denomination as well as others on mercury. I have no doubt that there are UM churches, among many other faith gatherings, that still give flu shots, unaware of the risks/danger. Through Simpsonwood, we will for the first time be officially alerting the heirarchy of this information. Consider how many UM hospitals, medical colleges, health ministries there are… impact, with time, could be huge. With awareness, will come action, and with action, change. It can’t come soon enough!” (April 2, 2007)
That same day, a father described to his listmates the speedy response of Women’s Division Director Mary Baldridge to Rev. Sykes’ request for political lobbying assistance.
Credit where credit is due
Recently, as many of you may know, we had our annual hearing in Annapolis to attempt to get mercury taken out of vaccines. Without going into much detail, about a week before our hearing, Dr. Mark Geier (a local Maryland Hero) dropped me an email and suggested that we should attempt to get a representative from the Women’s Division of the United Methodist Church. “What a great idea!,” I thought but we were running out of time. After all there has to be hundreds of thousands of United Methodists who reside (and vote) in Maryland. I had heard several impassioned speeches by Rev. Sykes in Washington, DC, and the Women’s Divison I knew has had a storied history of taking up causes such as slavery and woman’s voting rights and most recently taking neurotoxins out of vaccines. Since I had just gotten an email from the Rev. Lisa Sykes inviting us to attend the “new and improved” Simpsonwood hearings, I figured I would give it a shot not sure if it was a spamming email or not. Much to my surprise, Reverend Sykes was quick to respond. Although with an apology for not being able to come to Maryland herself, she would make sure that a representative would be there to represent the Women’s Division of the United Methodist Church. Soon after that, I received an email from Mary Baldridge who simply wanted to know the time and the place. Mary was very formidable speaker and was able to get her testimony both written and verbal on the record in the short time allowed. Although we were not able to get our bill passed in this session, we were able to for the first time get mercury free language attached to an amendment on the Vaccine Purchasing Act. My reason for writing this is to thank Rev. Sykes, Mary Baldridge and the Women’s Division of the United Methodist Church for making their services available and promising to continue to help us as we attempt to get legislation passed in Maryland, in other states and on the federal level. And also to encourage those in other states who are fighting to get legislation passed…that it might not be a bad idea to call your local Women’s Division of the United Methodist Church.
Please note: I am not a member of the United Methodist Church although I would seriously certainly consider becoming one should the need ever present itself. More churches should pick up this cause. My wife is currently seeking support of our local Catholic Archdiocese. (April 1, 2007)
No doubt there are certain autistic children who have suffered from vaccine injuries. However, I am convinced that truly injured children are far fewer in number than parents who have been retrospectively convinced that their children are autistic because they have been damaged. All a parent must do to file a VICP complaint is to state that their autistic child has been vaccinated, pay a filing fee, let the lawyers take care of the paperwork, then periodically administer chelation drugs to their autistic children and order urinalyses from Doctor’s Data, Inc. in order to produce “evidence of harm.”
The increase in numbers of parents convinced that their autistic children are “toxic” has been accompanied by a corresponding economic boom for entrepreneurs who represent speculation as if it were scientific fact, recommend experimental treatments with extravagant claims of efficacy when little data exists to support those claims, and encourage parents to take extreme risks with their autistic children’s health. I urge the United Methodist Church and Women’s Division to refrain from endorsing or appearing to endorse the work of anyone who claims to have discovered either a cause or cure for autism, for that endorsement will inevitably be used as fodder for a marketing campaign.
In a recent Autism One Radio interview, Dr. Mark Geier discussed his patent-pending “Lupron Protocol,” describing his experimentation with the drug on autistic teenage boys and girls, and claiming that the drug had cured several children of diabetes.
“We’ve come up with this treatment that seems to work not on every single kid but very, very well on the vast majority of kids that we have… We think that the main center of autism is the interaction between the glutathione pathway and the androgen pathway… Are we doing something experimental? The answer is yes and no… We’ve found virtually almost no children have any significant side effects… Virtually all, there’s only been a handful that haven’t markedly improved… We have several, actually, that used to require insulin because of diabetes, and when we got the control for the Lupron, they became non-diabetic…” (March 20, 2007)
Dr. Geier concluded the interview by announcing the United Methodist Church and Women’s Division’s endorsement of the mercury resolution, and its upcoming “educational event”:
“There’s going to be a big march this summer at the CDC in Simpsonwood, Georgia. You can contact the United Methodist Women’s Organization. The worldwide United Methodist Women’s Organization has made it their top priority to remove this sin, and they’re going to have a big meeting at Simpsonwood. For those who don’t know, Simpsonwood is the place where the CDC had their secret illegal meeting in which they said they knew it was thimerosal that was causing the epidemic but they weren’t going to tell anybody about it. So it’s only fitting that the meeting that’s going to march — and there are probably going to be tens of thousands of people marching on the CDC — be from the place where they committed their original fraudulent and illegal meeting.” (March 20, 2007)
I urge the United Methodist Church and Women’s Division to reconsider its sponsorship of The Truth Is Coming to Light.
Thank you for your consideration of my concerns. I welcome your reply, either directly, or through submission of comments to Neurodiversity Weblog, where I will publish this letter and responses to it.
Sincerely,
Kathleen Seidel
neurodiversity.com | honoring the variety of human wiring
Disclosure:
I am mother to two young adults, and have family members with autistic spectrum diagnoses and traits. I am also proprietor of the website neurodiversity.com and author of Neurodiversity Weblog. I have no conflicts of interest to declare.
Previous: Several Mentions & Many Thanks
Next: Carolina Credibility Check
Wow! – that’s comprehensive. Now, will Bishop Kammerer reply?
She should, but given the level of credulity evident there – perhaps not. It’s really odd what’s happening in Christianity these days, especially in the mainstream and particularly with the Uniting Church – here and in the US apparently. It seems to me they’ve completely lost the plot at least as far a basic Christianity goes and that’s very very sad. I mean I’d like to take a metaphorical axe to Richard Dawkin’s latest best seller and I will but these people make that venture that much more difficult.
— Alyric Apr 12, 08:20 PM #As always, excellent work, Kathleen. I sincerely hope the recipients of this article pay heed to the realities it so adequately sets forth.
— Steve Dionne Apr 12, 11:32 PM #Steve D
The CoMeD(y) appeal was tossed.
— TheProbe Apr 13, 01:26 PM #I especially enjoyed:
“Since Dr. Geier was the plaintiffs’ sole expert on both questions of general autism causation and the specific causes of the child’s autism, yet his testimony was deemed unreliable, the plaintiffs failed to meet their burden of proof, and all claims against the defendants were dismissed.”
Really got a laugh out of that one, but all of it was enjoyable. Was sorry to learn that she was the first to give her son the Lupron protocol. She really has to be deluded to go that far.
— Clay Apr 14, 01:42 AM #As a mother of a child with fragile x syndrome (the leading inherited cause of mental impairment including autism), my concern is that Rev Sykes, etc. should be investing large amounts of people, time and money into valid genetic research instead of misdirecting resources into very questionable and unproven theories. It’s amazing how people can be motivated to support a scientifically unproven cause when there is big $$$ to be realized, especially when lawyers get into the picture. Does this really help our children in the long run?
In my opinion, no! Let’s focus on valid research, not “pie in the sky”. Would I ever use my child as a guinea pig for Lupron? Absolutely not!
— Mary Apr 15, 05:59 PM #Thanks to everyone who’s visited, and thanks especially to those who've read all the way through to the end of the letter. I wish it hadn’t had to be so long, but there was a lot to document, and there were a lot of questions to ask.
The U.S. District Court for the Eastern District of Pennsylvania has made Judge Stengel’s Opinion freely available on its website.
— Kathleen Seidel Apr 16, 05:42 PM #It was well worth reading that to the end. I really hope you receive a courteous reply. It is enlightening to see all the strands tied together like that.
— Sharon Apr 25, 05:26 AM #Mary said:
As a mother of a child with fragile x syndrome (the leading inherited cause of mental impairment including autism), my concern is that Rev Sykes, etc. should be investing large amounts of people, time and money into valid genetic research instead of misdirecting resources into very questionable and unproven theories. It’s amazing how people can be motivated to support a scientifically unproven cause when there is big $$$ to be realized, especially when lawyers get into the picture. Does this really help our children in the long run?
In my opinion, no! Let’s focus on valid research, not “pie in the sky”. Would I ever use my child as a guinea pig for Lupron? Absolutely not!
Could not agree more. What a waste of money and time. The kids need that early intervention and ongoing services and there never seems to be enough money for that.
What a pity these science-know-nothings divert the limited funds.
— TheProbe Apr 25, 09:42 AM #