The Panic Virus

by Seth Mnookin; Dan B. Miller

  On Friday, June 15, four days after the hearing began, the petitioners called Marcel Kinsbourne, their last witness, to the stand. Kinsbourne, a medical doctor who had no clinical practice and whose primary interactions with patients for the previous seventeen years had been in preparation for litigation, was well acquainted with the Vaccine Court: He’d already appeared as an expert witness in at least 185 separate cases—and that figure did not include the many cases he’d testified in that had been settled before a judgment was issued or any of the cases he was involved with that were still pending before the court.60

  During the course of his testimony, Kinsbourne demonstrated the risks of relying on someone who, in the words of one of the Special Masters, “suffers from the stigma attached to a professional witness” and “derives considerable income from testifying in Vaccine Act cases.” In the expert report he prepared for the Cedillo trial, Kinsbourne included a chart indicating all the various causes for autism. It was similar to a chart Kinsbourne incorporated into a chapter he wrote in a textbook titled Child Neurology—but as the Justice Department’s Vince Matanoski pointed out, it was not identical.

  MATANOSKI: You developed a chart on the concomitance of autism?

  . . .

  KINSBOURNE: There is this long, rather dreary list of names.

  MATANOSKI: Yes, actually, I think we could show you what it looks like in your book chapter. . . . Under that you listed viral as one of the [causes]. You listed three different viral concomitances.

  KINSBOURNE: Yes.

  MATANOSKI: There they are: rubella, herpes, and cytomegalovirus.

  KINSBOURNE: Okay.

  MATANOSKI: Now, in your report you pretty much reproduce this chart.

  KINSBOURNE: Yes.

  MATANOSKI: There was one change. You added one. You added measles.

  KINSBOURNE: Right.

  MATANOSKI: Anything happen in the last year to cause you to add measles to that chart?

  KINSBOURNE: Nothing happened, but my mind being so much on this seemingly endless litigation I thought to myself, Hey, you didn’t put in measles.

  MATANOSKI: I see.

  The tenor in the courtroom was dramatically different the following Monday, when the government began calling to the stand the ten witnesses who supported its position. Where Aposhian had seemed disoriented, Jeffrey Brent, a medical doctor who is one of around 250 board-certified medical toxicologists in the United States and is the former president of the American Academy of Clinical Toxicology, appeared measured and deliberate; where Byers’s behavior had been occasionally bizarre, the London-based molecular biologist Stephen Bustin was devastatingly blunt. Finally, there was the testimony of Eric Fombonne, the director of the psychiatry department at the Montreal Children’s Hospital, where he helped launch an autism clinic. Where Kinsbourne had relied on his interpretation of some of the Cedillos’ home videos and on Theresa Cedillo’s recollections of events to support his claim that Michelle had a dramatic onset of autism a week after her first MMR shot on December 20, 1998, Fombonne used contemporaneous notes from Michelle’s doctor’s visits to show that no such change had occurred. Unlike Kinsbourne, who had never before used videos to retroactively diagnose patients, Fombonne had years of experience in that area, and he pointed to numerous examples of Michelle’s displaying behavior associated with autism before her first birthday, including repetitive “hand-flapping” and a failure to make eye contact, respond to her name, play with toys, use communicative gestures, use words, or even use nonverbal sounds to interact. Finally, Fombonne noted, Michelle’s medical records indicated that her head circumference was abnormally large throughout the first year of her life, which is a well-known hallmark of autism.

  As stark a contrast as the testimony of the two sides’ expert witnesses provided, what stood out even more was the extent to which the Cedillos’ case, and by extension those of thousands of other Omnibus families, were intertwined with the work of Andrew Wakefield. To start with, it was Theresa Cedillo’s conversation with Wakefield at the 2001 ARI/DAN! conference that confirmed her and her husband’s suspicion that Michelle’s autism had been the result of a vaccine injury. Since 2003, Michelle had been under the care of Arthur Krigsman, Wakefield’s partner at Thoughtful House, and hundreds of pages of Krigsman’s notes were introduced into evidence to support the Cedillos’ case. Even the test results the Cedillos relied on to demonstrate that Michelle had been infected with the measles virus—results that, as the Cedillos’ lawyers wrote in a brief, were the “sine qua non in [Michelle’s] quest for entitlement”—were tainted by their association with Wakefield: They came from the discredited (and defunct) lab in Dublin that Wakefield had colloborated with over a period of several years.

  It wasn’t just personal connections that yoked the Omnibus families to the infamous gastroenterologist. The entire dual-causation argument was dependent on Wakefield’s theories being correct. Despite all the studies contradicting Wakefield’s conclusions, despite indications that he’d had a financial stake in an alternative to the MMR vaccine, despite the disavowals of his co-authors and his forced departure from the Royal Free Hospital and the worldwide condemnation of his research methods, Andrew Wakefield remained the single most important figure in the vaccines-cause-autism movement. In the course of the Cedillo trial, the government called on a former graduate student of Wakefield’s named Nicholas Chadwick to testify. Chadwick, who’d worked in Wakefield’s lab in the late 1990s, said that he’d alerted Wakefield that he’d been unable to detect the presence of measles virus in the twelve children who were the basis of Wakefield’s 1998 Lancet paper. What’s more, Chadwick said, he’d discovered multiple instances in which patient samples had been contaminated by positive controls. In both cases, his warnings were ignored.61

  In her closing argument on June 26, 2007, Sylvia Chin-Caplan tried to spin this latest humiliation as an indication of the legitimacy of her argument. “The final point I want to make is what this case is about,” she said. “It is not about Andy Wakefield. It’s not. It’s about Michelle Cedillo. It’s about the 4,800 families looking for justice. . . . And to hear a government’s case that is based on a smear campaign, a character assassination, hearsay, innuendo, traveling around the world collecting information, using government resources against somebody who is not a party, who is not a witness, who is not offering evidence, is outrageous. It’s not about Andy Wakefield. It’s about the Cedillos.”

  With that, Chin-Caplan rested her case. It was a passionate plea that unintentionally exposed the moral and scientific bankruptcy of all those who’d encouraged the families of children with autism to blame vaccines. In the larger scheme of things, the Omnibus hearings were not about the Cedillos—they were about establishing whether there was any scientifically reliable evidence that connected autism to vaccines.

  Six months later, on December 24, 2007, Age of Autism (sponsored by Lee Silsby Compounding Pharmacy—“The leader in quality compounded medicine for autism”) named Michelle Cedillo its “Child of the Year.” “We are pleased to announce our annual Age of Autism Awards during this holiday week of celebration,” the announcement read. It went on to quote a nominating letter from a woman who “was herself the mother of an affected child”:

  Michelle braves each day waiting for relief. When relief doesn’t come, she waits for the next. All the while, Michelle remains unimpressed by the glitter of fame, unmotivated by the promise of material wealth, and undeterred by the ignorance of those who refuse to understand. These Warrior Children who have engulfed our hearts and to whom we dedicate so much of ourselves are, truly, the hardest working children on this spinning orb. Through it all, they are able to somehow find the strength to persevere. And, like so many, Michelle Cedillo has proven herself to be the Warrior Child she never asked to be, but has become, nonetheless.

  * * *

  In a typical court proceeding, once closing arguments have concluded, the buzzer has, for all intents and purposes, sounded. That was n
ot the case in Cedillo v. Secretary of Health and Human Services: Following the conclusion of the twelve-day hearing, it took more than a year of dueling corrections before both sides were satisfied with the accuracy of the 2,917-page trial transcript. By the time the Office of Special Masters released a statement on September 29, 2008, that the “evidentiary records are now closed,” more than five hundred pages of post-hearing briefs and motions had been filed in the Cedillo trial alone.62

  On February 12, 2009, seven years after the start of the proceedings, rulings were issued for the first three Omnibus Autism cases. In the preface to his 183-page decision, George Hastings, the Special Master who presided over the Cedillo trial, highlighted just how much ground had been covered. “The evidentiary record,” he wrote, “is massive. This record dwarfs, by far, any evidentiary record in any prior Program case.” In addition to testimony from twenty-eight expert witnesses, there were 939 pieces of medical literature, many of which ran to hundreds of pages. Among the documents submitted as part of the Cedillo case were 7,700 pages of Michelle’s medical records, which covered a range of subspecialties including epidemiology, gastroenterology, genetics, immunology, molecular biology, neurology, toxicology, and virology.

  Despite having access to the same information, the three Masters who ruled on the dual-causation test cases had worked independently of each other to reach their verdicts—which made the unanimity of their conclusions all the more unassailable. In page after page of unexpectedly gripping legal writing, they laid out in a way that no journal article or literature review ever had just how one-sided this dispute actually was. Their blunt assessment of each side’s appointed experts articulated what the trial’s observers had been saying to themselves all along: At every point of comparison, the government’s witnesses were “far better qualified, far more experienced, and far more persuasive than the petitioners’ experts.” One of the Masters characterized Vera Byers’s testimony as “disjointed,” “often unclear,” and “stray[ing] into matters beyond her expertise,” and wrote that her “insistence that it was acceptable” to use figures for adult immune systems to determine appropriate readings for children and infants was “frankly, incredible.” The best that could be said about H. Vasken Aposhian’s testimony was that it was “reasonably coherent,” although he was “at times unfocused and sometimes non-responsive.” And a “fair assessment” of the differences between the information in Marcel Kinsbourne’s expert report and his published work was that he “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.”

  After making clear that the Cedillo case had been a rout, Hastings emphasized that the petitioners had not been asked to clear a particularly high bar. “I have not required a level of proof greater than ‘more probable than not,’ which has also been described as ‘50 percent plus a feather,’ ” he wrote. “I have looked beyond the epidemiologic evidence to determine whether the overall evidence—i.e., medical opinion and circumstantial evidence and other evidence considered as a whole—tips the balance even slightly in favor of a causation showing as to any of Michelle’s conditions.” It did not: “This is a case in which the evidence is so one-sided that any nuances in the interpretation of the causation case law would make no difference to the outcome of the case.”

  Hastings devoted the final three paragraphs of his ruling to the Cedillos themselves. It would be an abrogation of his duty, he wrote, to find in the family’s favor—and unfortunately, he was unable to hold those most at fault responsible.

  The record of this case demonstrates plainly that Michelle Cedillo and her family have been though a tragic and painful ordeal. I had the opportunity, in the courtroom during the evidentiary hearing, to meet and to observe both of Michelle’s parents, and a number of other family members as well. I have also studied the records describing Michelle’s medical history, and the efforts of her family in caring for her. Based upon those experiences, I am deeply impressed by the very loving, caring, and courageous nature of the Cedillo family. Those family members clearly have done a wonderful job of coping with Michelle’s conditions, and in caring for her with great love. I admire them greatly for their dedication to Michelle’s welfare.

  Nor do I doubt that Michelle’s parents and relatives are sincere in their belief that the MMR vaccine played a role in causing Michelle’s devastating disorders. Certainly, the mere fact that Michelle’s autistic symptoms first became evident to her family during the months after her MMR vaccination might make them wonder about a possible causal connection. Further, the Cedillos have read about physicians who profess to believe in a causal connection between the MMR vaccine and both autism and chronic gastrointestinal problems. They have visited at least one physician, Dr. Krigsman, who has explicitly opined that Michelle’s own chronic gastrointestinal symptoms are MMR-caused. And they have even been told that a medical laboratory has positively identified the presence of the persisting vaccine-strain measles virus in Michelle’s body, years after her vaccination. After studying the extensive evidence in this case for many months, I am convinced that the reports and advice given to the Cedillos by Dr. Krigsman and some other physicians, advising the Cedillos that there is a causal connection between Michelle’s MMR vaccination and her chronic conditions, have been very wrong. Unfortunately, the Cedillos have been misled by physicians who are guilty, in my view, of gross medical misjudgment. Nevertheless, I can understand why the Cedillos found such reports and advice to be believable under the circumstances. I conclude that the Cedillos filed this Program claim in good faith.

  Thus, I feel deep sympathy and admiration for the Cedillo family. And I have no doubt that the families of countless other autistic children, families that cope every day with the tremendous challenges of caring for autistic children, are similarly deserving of sympathy and admiration. However, I must decide this case not on sentiment, but by analyzing the evidence. In this case the evidence advanced by the petitioners has fallen far short of demonstrating such a link. Accordingly, I conclude that the petitioners in this case are not entitled to a Program award on Michelle’s behalf.

  It was hard not to interpret Hastings’s harsh language as an indication of what might have occurred had Theresa Cedillo never attended an ARI/DAN! conference, never met Andrew Wakefield or Arthur Krigsman, never gotten caught up in a theory that, when all the cards were on the table, proved to be a bit of chicanery barely worthy of a boardwalk three-card monte dealer.

  As Sylvia Chin-Caplan said in her summation, there were many people who behaved outrageously during the seven-year run-up to the Cedillo trial, but it wasn’t, as she tried to argue, the government’s lawyers or their expert witnesses. It also wasn’t the Special Masters, whom Chin-Caplan accused of being “arbitrary and capricious” and “simply unfair” at an AutismOne presentation she gave with Krigsman titled “Autism and Vaccines in the US Omnibus Hearings.” The people who behaved outrageously were all those who stoked those 4,800 families’ sense of injustice, who dangled hopes of sudden recoveries, who sold bogus “supplements” and $70,000 miracle cures, who told parents that if their children weren’t getting better it was because they weren’t trying hard enough, who built their medical practices on the backs of parental anxiety, who wrote books and newspaper articles and broadcast TV shows and radio programs based on what made a good story and not on the truth, and who convinced the Cedillos to act as front-line troops in a war built on lies.

  59 The PSC ultimately decided not to present any test cases for the MMR theory (or “causation theory #2”) under the assumption that the decisions in the joint theory cases would determine whether there was sufficient evidence to show that the MMR vaccine could cause autism in certain circumstances.

  60 It wasn’t just the American legal system that Kinsbourne was familiar with: Along with Andrew Wakefield, he had been one of the three highest-paid witnesses in a similar mass vaccine-related lawsuit in the U.K.

  61 Whil
e testifying in a different Omnibus test case, Bert Rima, one of the world’s leading measles experts and the head of the School of Biomedical Sciences at Queens University in Belfast, described a similar situation that had occurred in 1992, when Wakefield invited a number of prominent measles virologists to give him their opinion on his work. “I attended two of those meetings,” Rima said, “and I came to the conclusion that whatever material was put in front of me was highly selective. When criticisms were made, they were not followed up.”

  62 Including among those was an “interim attorney’s fees” bill submitted to the Vaccine Court by Sylvia Chin-Caplan’s law firm for a total of $2,180,855.29. Less than $20,000 of that was used to reimburse the Cedillo family for the out-of-pocket expenses they incurred during the trial. In addition to travel and lodging, those expenses included a personal check for $1,200 Marcel Kinsbourne demanded from the family as an initial retainer for his services.

  EPILOGUE

  Almost exactly one year after the Cedillo verdict was issued, a Fitness to Practise Panel convened by the U.K.’s General Medical Council concluded its own hearings on the autism-vaccine debate—and unlike the Omnibus trials, these did focus explicitly on Andrew Wakefield. The panel’s concern was, as its name implied, fairly narrow: Its job was to determine whether Wakefield had acted ethically and responsibly while conducting research on children. (Two of Wakefield’s collaborators on the 1998 Lancet paper were also under investigation.) The hearings, which were the longest and most expensive in the council’s century-and-a-half-long history, included 148 days of testimony spread out over two and a half years.