Deadly Choices: How the Anti-Vaccine Movement Threatens Us All (16 page)

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Authors: Paul A. Offit M.D.

BOOK: Deadly Choices: How the Anti-Vaccine Movement Threatens Us All
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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.)

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