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.
CHAPTER 7
Past Is Prologue
History, despite its wrenching pain, cannot be unlived; but, if faced with courage, need not be lived again.
—MAYA ANGELOU
In a sense, Barbara Loe Fisher has been around for a hundred and fifty years. That’s because the anti-vaccine movement didn’t start with the pertussis vaccine in the 1970s. It started with the smallpox vaccine in the 1850s. Remarkably, every aspect of the modern antivaccine movement—every slogan, message, fear, and consequence—has its origin in the past. But in contrast to the modern-day movement, the final outcome of the first anti-vaccine movement is known—and remains a painful, unheeded lesson in how the rights of the individual can trump the good of society.
The first vaccine prevented a disease that killed more people than any other: smallpox. The disease would start benignly with fever, headache, nausea, and backache—symptoms common to many in
fectious diseases. The symptoms that would follow, however, were unmistakable. The face, trunk, and limbs erupted in pus-filled blisters that smelled like rotting flesh—blisters so painful that victims felt like their skin was on fire. Worse: smallpox was highly contagious, spread easily by coughing, sneezing, or even talking. As a consequence, smallpox infected almost everyone. Pregnant women suffered miscarriages, young children had stunted growth, many were permanently blinded, and all were left with horribly disfiguring scars. One in three victims died from the disease.
“The smallpox was always present,” wrote a British historian in 1800, “filling the churchyard with corpses, tormenting with constant fears all whom it had not yet stricken, leaving on those whose lives it spared the hideous traces of its power, turning the babe into a changeling at which the mother shuddered, and making the eyes and cheeks of a betrothed maiden objects of horror to the lover.”
Smallpox killed more people than the Black Death and all the wars of the twentieth century combined; about five hundred million people died from the disease. And it changed the course of history. The virus claimed the lives of Queen Mary II of England, King Louis I of Spain, Tsar Peter II of Russia, Queen Ulrika Eleonora of Sweden, and King Louis XV of France. In Austria, eleven members of the Hapsburg dynasty died of smallpox, as did rulers in Japan, Thailand, Sri Lanka, Ethiopia, and Myanmar. When European settlers brought smallpox to North America, they reduced the native population of seventy million to six hundred thousand. No disease was more feared, more destructive, or more loathsome than smallpox.
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