Deadly Choices: How the Anti-Vaccine Movement Threatens Us All - Paul A. Offit (2010)
Chapter 6. Justice
He handed us fiction after fiction and we printed them all. Because we found him—entertaining. It’s indefensible. Don’t you know that?
—CHUCK LANE, SHATTERED GLASS
On February 12, 2009, the Vaccine Injury Compensation Program (VICP) issued a verdict that made international headlines. For several years the VICP had considered five thousand cases brought by parents claiming that vaccines had caused their children’s autism. The trial, called the Omnibus Autism Proceeding, was unusual; only once before had vaccine court considered what amounted to a class-action lawsuit. If successful, the action threatened the viability of a program that had once saved vaccines. It was a seminal, defining moment.
And the verdict surprised everyone.
During the twenty years of its existence, the VICP had been generous with its money. Plaintiffs had several ways to win. The program could simply concede that a claim was valid. For example, money was immediately given to any child paralyzed by Albert Sabin’s oral polio vaccine. If a suspected injury (such as autism) wasn’t considered to be valid, federally appointed judges called “special masters” heard the cases in vaccine court. If the special masters denied the claim, three options remained. The petitioner could appeal to the United States Court of Claims or, failing that, to the Federal Circuit Court of Appeals; or, failing that, could sue vaccine makers in state courts. Over the years the amount of money available to the VICP, which came from a federal excise tax on every dose of vaccine, got bigger and bigger; by 2009, the program had $2 billion at its disposal and the average award was $900,000.
Vaccine court was an unusual place. When it first started awarding money in 1988, the compensation table was relatively loose and the VICP compensated injuries that weren’t caused by vaccines. For example, in 1992 it ruled that DTP had caused a child’s epilepsy, even though the child in question had Rett Syndrome, a genetic disorder known to cause seizures. The court also routinely compensated parents whose children died from Sudden Infant Death Syndrome even though studies had shown that SIDS wasn’t caused by vaccines. Other awards were even more bizarre. Petitioners successfully claimed that a child’s crying or irritability or sleepiness following DTP was evidence of brain damage leading to attention deficit disorder. One lawyer later acknowledged that at least a third of all claims against DTP weren’t valid. Probably the best example of the carnival-like atmosphere of vaccine court was the complaint by one petitioner that, following a rabies shot, her dog was “stupider.”
In 1995, everything changed. To applause from the medical community, the VICP’s vaccine-injury-compensation table was tightened. No longer could parents successfully claim that DTP vaccine caused permanent brain damage or SIDS or genetic disorders. Barbara Loe Fisher, who had helped create the program, was angered by the change. “The federal compensation system that we were told would be ‘simple justice for children’ has become a cruel joke.” Fisher had no need to worry; the procession of inexplicable rulings had only begun.
First was the strange case of Margaret Althen. On March 28, 1997, Althen, forty-nine years old, received tetanus and hepatitis A vaccines. Two weeks later, she suffered headaches and blurred vision. Following a series of medical tests, Althen’s doctors diagnosed a disease similar to multiple sclerosis. By the time the Althen case appeared before the VICP, abundant evidence existed that vaccines didn’t cause her condition. So, the special master turned down Althen’s request for compensation. But judges in the Federal Circuit Court of Appeals disagreed. They argued that plaintiffs’ lawyers had to do only three things: propose a theory for how a vaccine could cause a disease, propose a logical sequence of cause and effect, and show that the two events were connected in time. Plaintiffs’ lawyers didn’t have to provide any epidemiological or biological evidence to prove their case. All they had to do was show that a disease had followed a vaccine and propose a theory for how it could have happened—a very low bar.
Next was the Capizzano ruling. On May 3, 1998, Rose Capizzano received her second dose of hepatitis B vaccine, following which she developed a rash and stiff, painful joints. Later, doctors diagnosed rheumatoid arthritis. Again, evidence refuted the notion that hepatitis B vaccine caused rheumatoid arthritis. So the special master rejected the claim. But, as had been the case with Margaret Althen, the Federal Circuit Court of Appeals overturned the decision. Judges in the Appeals Court noted that Capizzano’s doctor believed the vaccine had caused her arthritis, and that was good enough for them. They ruled, “Medical records and medical opinion testimony are favored in vaccine cases, as treating physicians are likely to be in the best position to determine whether a logical sequence of cause and effect show[s] that the vaccination was the reason for the injury.” This ruling meant that the treating physician could trump medical consensus, trump the weight of epidemiological and biological evidence, and trump decades of collective clinical experience. All could be cast aside by the opinion of one doctor.
The Althen and Capizzano rulings opened the door for a series of embarrassing decisions. Between 2001 and 2008, the court ruled that hepatitis B and Hib vaccines caused paralysis, MMR caused epilepsy and fibromyalgia (a disorder of unknown cause characterized by muscle pain and fatigue), hepatitis B vaccine caused Guillain-Barré Syndrome, and rubella vaccine caused chronic arthritis, despite abundant evidence showing that they didn’t. But no decision was more illogical, more ill-founded, or (for those concerned about the viability of the program) more worrisome than that involving Dorothy Werderitsch.
On November 11, 1992, Werderitsch, a thirty-three-year-old nurse, received her first dose of hepatitis B vaccine; a month later, she received her second. Soon after, she suffered numbness on the left side of her body; then she lost vision in one eye. On February 2, 1993, after a series of medical tests, doctors had a diagnosis: multiple sclerosis. On May 26, 2006, a special master ruled that Dorothy Werderitsch’s multiple sclerosis was caused by hepatitis B vaccine.
The notion that hepatitis B vaccine caused multiple sclerosis wasn’t supported by the science. For one thing, the viral protein in the vaccine (hepatitis B surface protein) and the viral protein in blood found during natural infection are identical. So a disease caused by the vaccine should also be caused by natural infection. But multiple sclerosis isn’t more common in people with hepatitis B virus infections; it’s less common. Also, two large epidemiological studies, performed by researchers at Harvard’s School of Public Health and McGill University in Montreal—involving tens of thousands of subjects and published in the New England Journal of Medicine—found no evidence of an association. When the special master decided that hepatitis B vaccine caused Dorothy Werderitsch’s multiple sclerosis, both of these studies had already been published.
The rulings in favor of Althen, Capizzano, and Werderitsch frightened those concerned about what could happen in the vaccine-autism cases.
Perhaps the best person to provide a look behind the curtain of the Vaccine Injury Compensation Program is Lucy Rorke-Adams, a professor of pathology at the Children’s Hospital of Philadelphia. Every time a child’s death is linked to a vaccine, Rorke-Adams examines the brain. Her unusual role in the VICP is explained by her remarkable story.
Rorke-Adams is the fifth and last daughter of Armenian immigrants who barely escaped Turkish persecution. Although she was born and raised in St. Paul, Minnesota, her parents spoke only Armenian. “When I entered kindergarten, I couldn’t speak English and sat on a swing in the doorway between the classroom and cloakroom and cried,” she recalled. Between 1947 and 1957, Rorke-Adams earned a bachelor of arts, master of arts in psychology, bachelor of science in medicine, and doctor of medicine, all from the University of Minnesota. After medical school she began an internship in Philadelphia. There she met the scientist who changed the course of her career. “The chairman of pathology at Philadelphia General Hospital was William Ehrich,” she recalls. “Dr. Ehrich had been a pupil of Ludwig Aschoff, who had been taught by Frederich Daniel von Recklinghausen, who in turn was educated by Rudolf Virchow, the father of pathology. I regard myself as Virchow’s great-great-granddaughter, scientifically speaking!” (All these legendary German pathologists have been immortalized by medical terms bearing their names.)
Lucy Rorke-Adams, a neurologist at the Children’s Hospital of Philadelphia, was a key expert in cases of children suspected of suffering or dying from vaccines. (Courtesy of Lucy Rorke-Adams.)
After more than forty years in the field, Rorke-Adams is recognized as one of the world’s foremost pediatric neuropathologists, consulted by colleagues worldwide. When Albert Einstein died, she received a section of his brain to study. It is a testament to the thoroughness and rigor of defense attorneys in vaccine court that they turn so frequently to Rorke-Adams for her expertise.
Rorke-Adams has now evaluated the brains of thirty-three children who died after vaccination or whose unexplained seizures required a brain biopsy. She is still waiting for one to show that vaccines were the cause. “What I did find,” she recollects, “is a variety of abnormalities and sundry diseases that could explain what the kids had.” Rorke-Adams found that some children had died from malformations, degenerative diseases, vascular disorders, and infectious diseases; others, from accidental smotherings or child abuse. “So, the bottom line,” she says, “is that there is no evidence, in terms of scientific evaluation and now pathological evaluation, of anything that one can ascribe to a vaccine.” But despite her expertise, and despite the fact that she has supported her evaluations with cogent, well-researched opinions, Rorke-Adams often finds that petitioners prevail. And they prevail behind their principal expert: John Shane, a man who claims to be an expert in neuropathology even though according to Rorke-Adams he has no specific training or standing in the field.
Shane was the chief of pathology at Lehigh Valley, a community hospital north of Philadelphia. “John Shane has testified under oath that because he was responsible for all of the neuropathology at Lehigh Valley Hospital for forty to forty-five years, that he is an expert in neuropathology,” says Rorke-Adams. “His knowledge of the infant brain is sketchy at best. For example, he is unable to distinguish inflammatory cells, called lymphocytes, from cells in the brain of a baby that look like lymphocytes, but which are actually primitive nerve cells. In [the case of] one baby he testified that the vaccine had caused encephalitis [inflammation of the brain], when in reality the brain was entirely normal. Unfortunately, the special master hearing the case allowed herself to be convinced of this absurdity.” The cells that John Shane had confused with inflammatory cells are called “primitive neuroectodermal cells”: a cell type on which Rorke-Adams, unlike Shane, has published extensively.
Rorke-Adams described another example of Shane’s questionable expertise in evaluating infant brains. “Shane claimed that the vaccine virus had damaged myelin resulting in a demyelinating disease,” she recalled. But Shane was claiming the impossible. “Myelination of the developing nervous system is far from complete at the time of birth,” says Rorke-Adams. “[That’s why] human newborns, unlike calves or foals, cannot jump out of the womb and run around the delivery room. Although myelination isn’t complete until early childhood, it is sufficiently advanced by 12 to 18 months of age to allow a baby to crawl and start walking. However, at six months of age, certain portions of the brain have little myelin. If there is little or no myelin it isn’t possible to have a demyelinating disease. Therefore, demyelinating diseases aren’t generally found in children less than one year of age.” (Rorke-Adams is in an excellent position to know this, having published the seminal and much-referenced book Myelination of the Brain in the Newborn.)
Shane’s problems weren’t limited to his lack of expertise in neuropathology. A lawyer friend named John Karoly asked Shane to witness a will of Karoly’s brother, Peter, written after Peter and his wife had died in a plane crash. Karoly wanted part of his brother’s multimillion-dollar estate; so Shane witnessed Peter’s faked signature. Unfortunately for Shane and Karoly, Peter Karoly already had a will on record. The criminal complaint against John Karoly, Jr., and John Shane was filed in U.S. District Court on September 25, 2008. According to U.S. Attorney Laurie Magid, “The defendants conspired in a fraudulent scheme to forge the wills of Peter Karoly and Lauren Angstadt in order to unlawfully benefit from their tragic deaths. Their actions were not only illegal; they subverted the true intentions of the victims.” Six months later, Karoly was charged in a $500,000 tax evasion scheme. In a plea bargain that included renouncing his claim against his late brother’s estate, the previous charges against Karoly and Shane were dropped.
The story of John Shane—a professional witness with questionable expertise and integrity—would be repeated in the Omnibus Autism Proceeding.
Among the first to claim that vaccines might cause autism was Barbara Loe Fisher. In A Shot in the Dark she wrote, “With the increasing number of vaccinations American babies have been required to use has come increasing numbers of reports of chronic immune and neurologic disorders ... including ... autism.” At the time, Fisher’s claim had little traction; few parents carried the banner. But, when a British doctor said it, everything changed.
In 1998, Andrew Wakefield, a surgeon working at the prestigious Royal Free Hospital in London, published a paper in the well-respected medical journal The Lancet. The paper, densely titled “Ileal-Lymphoid-Nodular Hyperplasia, Non-Specific Colitis, and Pervasive Developmental Disorder in Children,” reported the stories of eight children with autism. Wakefield claimed that all the children had received MMR, all had symptoms of autism soon after, and all had inflammation of their intestines. In his paper, Wakefield proposed a series of events: measles vaccine entered the intestines causing inflammation; once inflamed, the intestines became leaky, allowing harmful proteins to enter the blood, travel to the brain, and cause autism.
As a consequence of Wakefield’s paper, many parents abandoned MMR. (It is interesting to note that fears of both pertussis and MMR vaccine originated in England. “I think our media [have] a lot to do with it,” says David Salisbury, director of England’s Department of Immunization. “[The United States] has basically three newspapers that cross the country [the New York Times, the Wall Street Journal, and USA Today] and the rest are very much local newspapers. We have at least fifteen national-level newspapers. So our journalists are competing for coverage of a smaller population divided amongst a much greater number of papers. And I think that leads to more histrionic, more aggressive reporting to seize the audience.” Salisbury sees another connection between the pertussis and MMR scares: “The younger mothers of children who are being offered MMR were the daughters of women who had not [given them] the pertussis vaccine. So the grandmother was not a trivial person in the MMR issue.”)
Predictably, outbreaks of measles swept across the United Kingdom and Ireland, causing hundreds of hospitalizations and four deaths. In the United States, parents of a hundred thousand children chose not to vaccinate them. The worldwide panic following Wakefield’s paper caused researchers to take a closer look. Investigators found that children with autism were not more likely to have measles vaccine virus in their intestines; and they were not more likely to have intestinal inflammation. Further, no one identified brain-damaging proteins in the bloodstream of children who had received MMR. Finally, twelve separate groups of researchers working in several different countries examined hundreds of thousands of children who had or hadn’t received MMR. The risk of autism was the same in both groups. For scientists, these studies ended the concern that MMR caused autism.
Brian Deer (right), an investigative reporter, confronts Andrew Wakefield. Deer almost single-handedly exposed improprieties in Wakefield’s research. (Courtesy of AFP/Getty Images.)
Because no one could confirm his work, Wakefield lost credibility among his colleagues. Then he suffered further disgrace. Brian Deer, a journalist working for the Sunday Times of London, found that the parents of five of the eight children described in Wakefield’s paper were suing pharmaceutical companies, claiming that MMR had caused autism. Deer also found that the personal-injury lawyer who represented these children, Richard Barr, had given Wakefield £440,000 (about $800,000) to perform his study, essentially laundering legal claims through a medical journal. When Wakefield’s co-authors found out about the money, ten of thirteen formally withdrew their names from the paper, distancing themselves from the MMR-causes-autism hypothesis. Finally, one of Wakefield’s co-workers, Nicholas Chadwick, testified that Wakefield had published the finding that autistic children had measles vaccine virus genes in their spinal fluid when he knew that the test was incorrect. Wakefield eventually left England, landing at a clinic called Thoughtful House in Austin, Texas, where he offered a variety of “cures” for children with autism.
Throughout Wakefield’s rise and fall, Barbara Loe Fisher supported him.
In 2000, after biological and epidemiological studies refuted his hypothesis—and after measles had killed four children in England and Ireland because their parents were afraid of MMR vaccine—Barbara Loe Fisher’s National Vaccine Information Center gave Andrew Wakefield the “Courage in Science Award.”
In 2002, after Kreesten Madsen and his colleagues published a large, carefully performed study of Danish children in the New England Journal of Medicine showing no association between MMR and autism, Fisher refused to believe it: “I can tell you this has not put everything to rest for parents of kids who are functioning perfectly well and then get vaccinated and start to regress. The experience of the people is coming up against the wall of denial by science and medicine.”
In 2004, after the Institute of Medicine concluded that evidence clearly refuted Wakefield’s hypothesis, Fisher again saw foul play. “This report is a case of political immunology masquerading as real science,” she said. “With it, the Institute of Medicine takes a step toward weakening its reputation as an independent body capable of making an objective scientific analysis [that isn’t] influenced by government policy and industry profits.” As had been the case with diabetes and multiple sclerosis, Barbara Loe Fisher refused to believe that scientific studies exonerating vaccines were anything other than a vast international conspiracy to hide the truth.
In January 2010, after England’s General Medical Council ruled that Wakefield had acted with “callous disregard” for children when he had subjected them to spinal taps, endoscopies, and intestinal biopsies; had brought the medical profession “into disrepute” when he had paid children £5 for their blood at his son’s birthday party; and had “failed in his duties as a responsible consultant” in not getting approval for his studies from an ethics review board, Barbara Loe Fisher continued to stand by him. “The General Medical Council inquisition was never about the three doctors they put on the rack and found guilty on most counts,” she wrote. “It was always about declaring vaccine science and policy innocent on all counts. And creating a horrible warning to any young doctor, who even thinks about investigating or talking about better defining vaccine risks, to think again, shut up, and salute smartly.”
Andrew Wakefield leaving the General Medical Council hearing into his alleged misconduct, July 2007. (Courtesy of Lindsey Parnaby/epa/Corbis.)
One week later, when The Lancet formally retracted Wakefield’s paper, Fisher fought back. Typically, bad science disappears in a fog of irreproducibility, never requiring a formal retraction. Journal editors retract only those studies they believe were falsified or misrepresented. Fisher, however, saw conspiracy: “[The retraction] sends a signal to the rest of the scientific community that when you dare to investigate the link between vaccination and autism, you do that at your own professional risk.” Barbara Loe Fisher failed to note that many scientists before Wakefield had published papers proving the rare tragic consequences of vaccines without risking their career—for example, William Sawyer, who showed that a yellow fever vaccine had been contaminated with hepatitis B virus; Neil Nathanson, who showed that a polio vaccine wasn’t properly inactivated, causing children to become paralyzed and die; and Trudy Murphy, who showed that an early rotavirus vaccine caused intestinal blockage, killing one child. Scientists and public health officials didn’t marginalize Wakefield because he had challenged the belief that vaccines are absolutely safe; they did it because he was wrong—clearly and inescapably wrong.
On February 18, 2010, Andrew Wakefield, tarnished by The Lancet’s retraction, resigned his position as scientific director of Thoughtful House. Two months later, the General Medical Council struck Wakefield’s name from the medical register, eliminating his ability to practice medicine in England.
One year after Wakefield proposed that MMR caused autism, the vaccine-autism hypothesis shifted. In 1999, the American Academy of Pediatrics and the Centers for Disease Control and Prevention worried that children might be receiving too much mercury in vaccines, called for pharmaceutical companies to remove a mercury-containing preservative called thimerosal. The frightening and precipitous manner in which this was done gave rise to several groups that believed mercury in vaccines caused autism: SafeMinds, Moms Against Mercury, Generation Rescue, and the Autism Action Coalition. Now, parents weren’t scared just of MMR; they were scared of any vaccine that contained thimerosal.
Again, the academic and public health communities responded, performing six large epidemiological studies examining the risk of autism in children who had or hadn’t received vaccines containing thimerosal. The results were reproducible and clear: thimerosal didn’t cause autism. Consistent with these studies, after the spring of 2001, when thimerosal was taken out of all vaccines recommended for young infants, the prevalence of autism continued to climb.
Science had answered the question of whether MMR or thimerosal caused autism. But it would be the special masters in vaccine court who would render the final verdict.
By July 2002, vaccine court, which was designed to handle individual cases, had received more than three hundred claims that vaccines caused autism. It was only the beginning—the number would eventually exceed five thousand. To handle the massive workload, Gary Golkiewicz, who had been the Chief Special Master of the VICP since its inception, decided to let the petitioners’ lawyers select a few cases to represent specific theories. Although Golkiewicz’s decision made it possible to deal with the onslaught of claims, the Omnibus Autism Proceeding dominated the court’s time; of the eight special masters, eight law clerks, and two staff attorneys available to the VICP, half devoted themselves solely to the autism hearings. And Golkiewicz felt the pressure. Although he praised both plaintiff and defense lawyers for their willingness to find “creative solutions to overcome the lack of sufficient resources,” he knew the program had been stretched beyond reason. “Dedication and hard work have their limits,” he said. “And I sincerely believe that we have reached that limit.”
The Omnibus Autism Proceeding entertained two theories. The first was that the combination of MMR plus thimerosal in vaccines caused autism; the second, that thimerosal alone was responsible. Both of these theories would be represented by three cases. The children representing the first theory were Michelle Cedillo, Yates Hazelhurst, and Colten Snyder.
The amount of evidence to be considered was overwhelming. “It should be recognized that the evidentiary record, based upon which I decided this case, is massive,” wrote one special master. “This record dwarfs, by far, any evidentiary record in any prior Program case. The record contains about 7,700 pages of Michelle Cedillo’s medical records alone. The hearing transcripts totaled 2,917 pages in Cedillo, 1,049 pages in Snyder, and 570 pages in Hazelhurst. In addition, the amount of medical literature filed into the records of the three cases was staggering. I have not attempted to calculate the total number of pages of these documents, but clearly the total runs well into the tens of thousands.” The amount of evidence delayed the decision. The three test cases were heard in June, October, and November 2007; but a decision wasn’t reached until February 2009.
There were other concerns. If the special masters decided in favor of the five thousand children, the cost could be as high as $4.5 billion, wiping out reserve funds. Although scientific studies didn’t support the notion that MMR or thimerosal caused autism, many believed that the special masters would rule in favor of the plaintiffs. For one, the VICP had made a series of recent decisions that weren’t supported by science—the oddest of which favored Dorothy Werderitsch’s outrageous claim that hepatitis B vaccine caused multiple sclerosis. Also, that “experts” like John Shane had been allowed to testify was bad enough. But special masters had done more than just allow his testimony; they’d deferred to it. Finally, and most worrisome, the program was caught between two competing objectives. Was it the job of the VICP to stick to the science? Or was it to keep dissatisfied parents from suing vaccine makers directly, threatening the availability of vaccines for American children? The court struggled to determine which of these two positions would most likely prevent a repeat of the pertussis-vaccine litigation in the 1980s. Gary Golkiewicz felt that Congress had never clearly defined the program’s role. A year before the first verdict in the Omnibus Autism Proceeding, he said, “There is a tension between these two objectives: a tension that affects dramatically the litigation of cases, the parties’ arguments, and ultimately who wins.”
Despite the fears of many, the special masters made it clear that during the Omnibus Autism Proceeding they were going to stick to the science—plausible theories (as in the Althen ruling) or unsupported opinions from treating doctors (as in the Capizzano ruling) weren’t going to be enough. In the case of Colten Snyder, the special master wrote, “No one who observed the hearing could doubt [the parents’] commitment to Colten, or their good-faith belief that Colten’s condition [was] the result of his childhood vaccines. In this respect, they mirror the anecdotal accounts of the struggles of many other parents of autistic children. However, in this court, as in all other courts, subjective belief is insufficient as evidence of causation.” In the case of Yates Hazelhurst, the special master wrote, “The Hazelhursts’ experience as parents of an autistic child ... has been a very difficult one. [I am] moved as a person and as a parent by the Hazelhursts’ account and again extend to the Hazelhursts very sincere sympathy for the challenges they face with Yates. [My] charge, however, does not permit decision making on the basis of sentiment but rather requires a careful legal analysis of the evidence.”
On February 12, 2009, the special masters issued their verdicts. They were unanimous. All rejected the notion that MMR plus thimerosal-containing vaccines caused autism, finding not a shred of evidence to support the theory. They rejected the plaintiffs’ contention that thimerosal caused immune suppression, that measles vaccine damaged the intestine, and that measles vaccine traveled to the brain and caused autism. Their verdicts were unequivocal, leaving not a crack in the door for successful litigation in the future. One special master wrote, “Sadly, the petitioners in this litigation have been the victims of bad science, conducted to support litigation rather than to advance medical and scientific understanding of autism spectrum disorder. The evidence in support of petitioners’ causal theory is weak, contradictory, and unpersuasive. This is particularly apparent when considering the impressive body of epidemiologic evidence contradicting their theories.” Another likened the plaintiffs’ theory to a scene from Through the Looking Glass: “To conclude that Colten [Snyder]’s condition was the result of his MMR vaccine, an objective observer would have to emulate Lewis Carroll’s White Queen and be able to believe six impossible, or at least highly improbable, things before breakfast.”
The special masters also made it clear that the John Shanes of the world—nonexperts posing as experts—would no longer be tolerated, at least not with so much at stake. “The quality of the petitioners’ experts paled in comparison to the world-class experts proffered by the respondent,” wrote one special master.
The plaintiffs’ witnesses suffered withering criticisms:
✵ Marcel Kinsbourne, a pediatric neurologist, had claimed that measles vaccine virus traveled to the brain and caused autism. The special master noted that Kinsbourne spent most of his time testifying for personal-injury lawyers in court: “Dr. Kinsbourne suffers from the stigma attached to a professional witness—one who derives considerable income from testifying in vaccine [court]. In the twenty years of the Vaccine Program’s existence, Dr. Kinsbourne has appeared as an expert witness in at least 185 decisions.” Further, the special master noted that Kinsbourne said one thing to his academic colleagues and another in court: “In a book chapter he authored, Dr. Kinsbourne included a chart on the causes of autism. In his testimony, he used the same chart, but with one addition; he included measles as a cause. Dr. Kinsbourne was unwilling to say measles was a cause of autism in a publication for his peers, but was willing to do so in a Vaccine Act proceeding.”
✵ Vera Byers, a Ph.D. immunologist, had claimed that thimerosal in vaccines had damaged the immune system. The special master wrote, “Dr. Byers’ credibility was not enhanced by several instances of apparent ‘resumé padding.’ Her [resumé] indicated that she was still on the faculty at the University of Nottingham, although her work ended there in 2000. Her [resumé] indicated that she was ‘Medical Director on the team responsible for filing a [license to the FDA] for Enbrel [an immune modifying drug].’ When informed that there was no record at the FDA of Dr. Byers playing any role in the Enbrel licensing application, she stated that the information did not make a difference. Dr. Byers’ [resumé] described her as a ‘medical toxicologist’ with ‘hands-on experience in assessing medical damage to over 3,000 patients in the past 15 years.’ [But] she had not seen patients, other than in a litigation context, for the prior seven years. Even without considering Dr. Byers’ apparent misstatements on her [resumé], I find that she is not a particularly good expert witness. [Her] insistence that it was acceptable to use adult norms to measure the immune function of infants and young children was, frankly, incredible.”
✵ Dr. Arthur Krigsman, a pediatric gastroenterologist, claimed that measles vaccine had damaged the intestine. The special master wrote, “Dr. Krigsman, after working as an attending physician at Lenox Hill Hospital in New York from 2000 to 2004, left that hospital’s employ under questionable circumstances. The hospital restricted his privileges to perform endoscopies, an invasive procedure with some risks, in the belief that he was performing medically unwarranted [procedures] for research purposes. Dr. Krigsman later joined Dr. Andrew Wakefield at a medical practice [Thoughtful House] in Texas. In 2005, Dr. Krigsman was fined $5,000 by the Texas Board of Medical Examiners, apparently because the website of the medical practice had represented that he was available to see patients at a time when he was not yet licensed to practice medicine in that state. Dr. Krigsman’s [resumé] stated that he was an ‘Assistant Clinical Professor’ at the New York University Medical School, but Dr. Krigsman acknowledged on cross-examination that he has never taught a class there. His [resumé] also listed four items under the heading of ‘Publications.’ But on cross-examination Dr. Krigsman acknowledged that only one of the four items had actually been published in the scientific literature.” (To put this in perspective, Lucy Rorke-Adams has 266 scientific publications.)
The special masters also revealed a more sinister aspect of the vaccines-cause-autism hypothesis—there was money to be made promoting it. No single expert better represented this unseemly side of the controversy than a Florida-based physician named Jeff Bradstreet, a witness in the trial of Colten Snyder. Bradstreet had promoted several cures for autism including secretin (a hormone made by intestinal cells to stimulate the secretion of pancreatic juices), chelation (to rid the body of mercury), immunoglobulin (administered by mouth and by vein), and prednisolone (a potent steroid that suppresses the immune system). He also prescribed dietary supplements he sold in his office. As noted by the special master, “The nutritional supplements prescribed by Dr. Bradstreet were also sold by Dr. Bradstreet.” Bradstreet had taken care of Colten Snyder for eight years, during which time Colten had visited his office one hundred and sixty times. Bradstreet had ordered laboratory tests (many of which were not approved by the FDA); and he had performed several spinal taps and inserted fiberoptic scopes into Colten’s stomach and colon. All these tests and procedures were expensive, potentially dangerous, and—according to the opinions of expert witnesses—of no value to the child.
One year after the verdicts on the first theory had been filed, on March 12, 2010, the special masters ruled on the second theory proposed by the plaintiffs: thimerosal alone caused autism. Again, their verdict was unequivocal. They ruled that the theory was “scientifically unsupportable,” and the evidence “one-sided.” And they remained angry at the cottage industry of false hope that had sprung up around children with autism, writing, “[Many parents] relied upon practitioners and researchers who peddled hope, not opinions grounded in science and medicine.”
The special masters had delivered a fatal blow to the vaccines-cause-autism hypothesis. But who really lost? It certainly wasn’t the plaintiffs’ experts. Although singled out for their lack of expertise and of personal integrity, all will likely testify in future trials, charging handsomely for their services. And it wasn’t doctors like Arthur Krigsman, referred to by a special master as one of the “physicians who are guilty, in my view, of gross medical misjudgment.” Krigsman will likely continue to offer “cures” for children with autism. Or doctors like Jeff Bradstreet, who will continue to sell dietary supplements and perform endoscopies and spinal taps on children whose parents believe in him, and are more than willing to pay out-of-pocket for his services. And it certainly wasn’t the plaintiffs’ lawyers, who will continue to try their cases in vaccine court and collect their fees independent of whether they win or lose. (The law firm of Conway, Homer and Chin-Caplan submitted a bill to vaccine court for $2,161,564.01.) Rather, the losers were Theresa and Michael Cedillo and their daughter Michelle, Rolf and Angela Hazelhurst and their son Yates, and Kathryn and Joseph Snyder and their son Colten. Under the misdirection of doctors and lawyers, these parents had come to vaccine court looking for relief from the financial burden of caring for their autistic children. But they’d come to the wrong place. Even setting aside the fact that vaccines don’t cause autism, providing services for parents of autistic children through the VICP would have been an ineffective way of getting these children what they needed. Also, it would have unfairly excluded autistic children who hadn’t been vaccinated. If doctors and lawyers in the Omnibus Autism Proceeding really cared about the autistic children they represented, they would have directed their time, energy, and money toward finding mechanisms to provide needed services. But they didn’t. And that’s because the anti-vaccine movement had taken the autism story hostage—scaring parents about vaccines; providing a source of revenue for personal-injury lawyers with direct ties to anti-vaccine activists; and driving patients into the waiting arms of anti-vaccine doctors who sold false hope, usually directly out of their offices. Many in the autism community were angry that anti-vaccine activists had diverted so much attention away from the real cause or causes of autism.
The Omnibus Autism Proceeding showed just how far public health officials and academia had come since the days of DPT: Vaccine Roulette. In 1982, when Lea Thompson claimed pertussis vaccine caused brain damage, science hadn’t advanced far enough to challenge her contention. During the next twenty-five years, studies showed that children who received pertussis vaccine weren’t at greater risk of permanent brain damage and that the real cause of the damage was a defect in how brain cells transported certain elements, such as sodium, across the cell membrane. Unfortunately, by the time scientists figured this out, many companies had permanently abandoned vaccines. The vaccines-cause-autism scare was different; this time the public health community was ready. When the Omnibus Autism Proceeding started, epidemiological and biological studies had already gone a long way toward exonerating vaccines. The science was in, and the special masters knew it. One stated, “The Omnibus Autism Proceeding began in 2003 with a plea by the Petitioners’ Steering Committee to ‘let the science develop.’ The science has developed in the intervening years, but not in the petitioners’ favor.”
In the 1980s, anti-vaccine crusaders—through a series of devastating lawsuits—drove many vaccine makers out of the business; as a consequence, only a handful remain. This, at least in part, has contributed to two decades of periodic shortages involving almost every vaccine. But, because of the National Childhood Vaccine Injury Act, companies’ fears of litigation have almost disappeared. And, although fragile, the market for vaccines has stabilized. Another and far more damaging consequence of anti-vaccine activism has been the activists’ passionate campaign against vaccine mandates. They want to make vaccines optional. And, during the past three decades, they’ve gotten much of what they’ve wanted.