And there went out a champion from the camp of the Philistines, named Goliath of Gath, whose height was six cubits and a span.
—1 SAMUEL 17:4
In the summer of 2007, parents of children with autism took their case to court. Called the Omnibus Autism Proceeding, it was an unusual lawsuit. Parents weren’t suing the company that made thimerosal (Eli Lilly) or the company that made MMR (Merck) or the companies that made vaccines containing thimerosal (Merck, GlaxoSmithKline, Wyeth, Sanofi Pasteur, and Novartis). They were suing the federal government in a federal court. This wasn’t their preference. They would much rather have argued their cases in state courts in front of juries. In federal court they would have to convince a panel of three judges. But they had no choice; no one can sue a vaccine maker without first going through this unusual court.
IN 1986, FOLLOWING A SERIES OF LAWSUITS THAT THREATENED to end vaccine manufacture for American children, Congress passed the National Childhood Vaccine Injury Act. Included in the act was the Vaccine Injury Compensation Program. If parents felt their children had been harmed by vaccines, they sued the federal government for compensation, making their arguments in front of federally appointed judges. As a consequence, the number of lawsuits brought against vaccine makers declined dramatically.
At the heart of the Vaccine Injury Compensation Program sits a list of known vaccine injuries. If studies have clearly shown that a vaccine had caused harm, children are compensated. For example, Albert Sabin’s live weakened polio vaccine—the one that had been dropped onto sugar cubes and given to children in the United States between 1962 and 1998—was a rare cause of paralysis. Every year, between six and eight American children were paralyzed by this vaccine. Under the federal compensation program, children harmed by Sabin’s vaccine were compensated quickly. They didn’t have to take their case to a state court, where the process is slower and more expensive. On the other hand, claims not supported by scientific evidence, such as paralysis caused by chickenpox vaccine or diabetes caused by Hib vaccine, haven’t been compensated.
The Vaccine Injury Compensation Program is designed so that a decision can be reached within 240 days (so it’s quick); the average compensation is about $900,000 (so it’s generous); and the program is based, for the most part, on a preponderance of sound scientific evidence (so it’s fair). But the federal program doesn’t completely protect vaccine makers. If petitioners are unhappy with the judge’s ruling in federal court, they can always take their cases to juries in state courts. This possibility scares pharmaceutical companies, and for good reason. Juries have historically been poor judges of scientific and medical truths. One notable example was the case against Bendectin, a drug that treated morning sickness in pregnant women. Bendectin was driven off the market in the 1980s by lawsuits claiming that it caused severe birth defects. At the time of these jury verdicts, twenty-seven separate studies had shown the incidence of birth defects was the same in women who did or didn’t take the drug.
VACCINE COURT WAS ORIGINALLY DESIGNED TO HANDLE ONE CASE at a time. But between 1999 and 2007, more than 5,000 parents filed claims that vaccines had caused their children’s autism. This was twice the number of claims filed for all other vaccine-related injuries in the twenty years since the program had begun. Because of the number of claims and because the federal judges knew that it would be impossible to hear each case individually, they recommended that autism claims be tried together, like a class-action lawsuit. “There’s never been another case like this,” said Kevin Conway, one of the lawyers for the petitioners. With average individual awards of close to $1 million and thousands of petitioners, it was possible that a ruling in favor of the petitioners could exhaust the $2 billion available to compensate claimants. Much was at stake.
PETITIONERS CLAIMING VACCINES CAUSED AUTISM HAD THREE DIFFERENT theories: MMR caused autism; thimerosal caused autism; the combination of MMR and thimerosal caused autism. The federal judges decided to try the last theory first. To represent the theory that MMR and thimerosal together caused autism, the petitioners chose Michelle Cedillo, a twelve-year-old girl from Yuma, Arizona.
On June 11, 2007, George Hastings, the judge in charge of the Cedillo trial, called the court to order. In the late 1980s, Hastings, a graduate of the University of Michigan Law School, had served as an assistant chief for the Tax Division of the U.S. Department of Justice. Before that he had served in the Appeals Division, and before that he had been the news editor for a television program called Good Morning Michigan. Sitting to Hastings’s left was Denise Vowell, a recently retired chief trial judge for the U.S. Army. Vowell was a member of the Women’s Army Corps and an officer in the Military Police. On Hastings’s right sat Patricia Campbell-Smith. During the 1990s, Campbell-Smith had worked for Liskow and Lewis, a New Orleans law firm specializing in environmental law. The judges decided Hastings would be in charge of the first trial, and Vowell and Campbell-Smith would be in charge of the next two. All three judges had one thing in common: none had a professional background in science or medicine. Hastings was a tax lawyer, Vowell was a military lawyer, and Campbell-Smith was an environmental lawyer. Although scientists had already rendered a verdict on whether MMR or thimerosal caused autism, these three judges would be the final arbiters of scientific truth.
Federal Claims court, located across from the White House on Lafayette Square, seats 400 people. But despite requests by parent advocacy groups to hold the hearing in a much larger venue, only fifty showed up—mostly lawyers and journalists. After his opening remarks, Hastings described how the proceedings would work. “Today we are here for two purposes. One purpose is to hear the claim under the Vaccine Act of Michelle Cedillo. Michelle is a twelve-year-old girl who lives in Arizona and who has been diagnosed with autism and a number of other medical conditions. The first purpose of this hearing is to determine whether Michelle’s autism and her other medical conditions were vaccine-caused.
“However, there is another equally important purpose to this hearing. That is, Michelle is one of nearly five thousand children diagnosed with autism or similar disorders to have filed claims under the Vaccine Act. These five thousand claims have been grouped together in a joint proceeding known as the Omnibus Autism Proceeding.
“The committee of attorneys who represent the petitioners in the Omnibus Autism Proceeding has designated Michelle’s case as the first test case in that proceeding. Therefore, at this hearing today and over the next three weeks, we will hear not only about Michelle’s own condition, but also extensive expert testimony concerning the petitioners’ first general causation theory; that is, the general theory that MMR vaccines and thimerosal-containing vaccines can combine to cause autism.”
Thomas Powers, from the Portland, Oregon, law firm of Williams, Love, O’Leary and Powers, was the first to speak on Michelle Cedillo’s behalf. Powers’s firm had successfully filed lawsuits against the makers of silicone breast implants, as well as against Fen-Phen, a weight loss product associated with heart problems, and the Dalkon Shield, an intrauterine birth control device found to cause severe infections and infertility. Class-action awards for the Dalkon Shield had totaled more than $2 billion; for breast implants, nearly $5 billion; and for Fen-Phen, $21 billion (and counting). These awards had made Williams, Love, O’Leary and Powers one of the richest, most powerful law firms in the United States.
Sylvia Chin-Caplan, from the Boston law firm of Conway, Chin-Caplan and Homer, also represented Michelle Cedillo. Chin-Caplan’s firm specialized in claims before vaccine court, which allows lawyers to receive only 4 percent of awards. Trying cases before vaccine court isn’t a very good way for personal-injury lawyers to make a lot of money. So unlike Thomas Powers and his partners, Chin-Caplan’s firm was neither rich nor powerful, operating out of a modest three-story walk-up downtown.
After he made his opening remarks, George Hastings probably hoped that the lawyers would discuss Michelle’s case in a collegial, friendly manner. It wasn’t to be. Powers began by accusing the federal government and pharmaceutical companies both of hiding information and of collusion. “From day one,” said Powers, “the [federal government] and industry have been on the same side of the table standing shoulder-to-shoulder doing everything they can to make sure that this climb toward proving causation is as long and as steep and as hard as it can possibly be.” Powers was also upset that he couldn’t bypass federal vaccine court, having failed to get autism cases in front of a jury in Oregon. “Way back in 2002 before the [Omnibus Autism Proceeding] was set up, some families had filed lawsuits in the civil justice system asking the courts and particularly asking juries to decide the issue of whether they had been injured by vaccines, suing the pharmaceutical industry and the vaccine manufacturers directly.” Powers was a veteran of massive litigation against pharmaceutical companies; he knew where the money was. In Federal Claims court, awards would be much smaller. “As one would expect—and I totally expected it,” continued Powers, “pharmaceutical industry lawyers were on the other table telling the federal judge to dismiss the case and send these children out of the courthouse. They shouldn’t have a claim in front of a jury and they should instead come to the Vaccine Program. What I didn’t expect is that the U.S. Government would stand literally, physically shoulder-to-shoulder with industry telling a U.S. District Court judge that these children ought to be tossed out of [civil] court and they ought to come here, taking the side of industry from day one.”
Then Powers reprised a theme sounded by parent advocacy groups, Robert F. Kennedy Jr., and David Kirby: the government had hidden data that would have proved his case. “Something else that we’ve seen happen in the last five years in this program is a simple inability to get important, critical information and evidence,” said Powers. “In the criminal justice system there’s a process called discovery. It’s available as a matter of right. If a party for litigation believes that somebody on the other side has relevant information, material information, they’re entitled to simply ask for it and they get it. And if they don’t get it, the judge tells the other side you’ve got to cough it up. [But] there’s no right to discovery in this program. A lot of the evidence and a lot of the information on science and medicine are controlled by the federal government, but we can’t get them. They have it. They’re generating it. And we largely cannot get it.” Powers was setting up a justification for an appeal. If his side didn’t win this case, he was saying, it was because the government didn’t supply the documents necessary to win it.
Vincent Matanoski represented the defense. A former captain and judge advocate general for the U.S. Navy Reserves and now a lawyer for the Department of Justice, Matanoski was angry at Powers’s accusations of collusion and cover-up. Abandoning his original opening statement, he responded to Powers: “Mr. Powers tried to present the government in that federal case in Oregon [as] standing shoulder-to-shoulder with vaccine manufacturers. Well, I happen to be the government attorney who appeared in Oregon, and I remember very distinctly who I was standing shoulder-to-shoulder with. I was sitting next to Mr. Powers and his partner Mr. Williams at the table. And, in fact, my case, in very pertinent parts, stood opposite to several points that the vaccine manufacturers were making. [Mr. Powers] then complained about the frustrations the [petitioners] have had in discovery. In fact, the [petitioners] have received more data from the government in these proceedings than in all other vaccines cases combined over the twenty-year history of the program. He has received over 218,000 pages of government documents. He complains that the answers weren’t in them. These were the documents he requested. These were the documents the [petitioners] sought.”
Any semblance of collegiality between the government and the petitioners was shattered by the opening thrusts and parries of the lawyers. Now it was time to determine whether Michelle Cedillo’s autism was caused by vaccines.
ON THE FIRST DAY OF THE TRIAL, MICHELLE’S PARENTS ROLLED her into the hearing room in a wheelchair. Gardiner Harris of the New York Times described the scene: “She wore hearing protection similar to that worn by heavy machinery operators. She hit herself repeatedly and made loud grunting noises.” During the previous year, Michelle’s parents—Theresa, a home-maker, and Michael, a utility worker—had spent more than $18,000 taking care of their daughter. Everyone sitting in the courtroom on that first day was moved by the desperate nature of Michelle’s condition and by the singular devotion of her parents to helping her.
Chin-Caplan began by describing the sad, isolated life of Michelle Cedillo: “Michelle was born on August 30, 1994. She weighed eight pounds, roughly, and her Apgars [a ten-point scale of a baby’s health measured one and five minutes after birth] were nine and nine. In other words, she was perfectly healthy. [The day] after she was born, she received a hepatitis B immunization. It contained 12.5 micrograms of mercury. Her parents didn’t know about [the danger of] it. The majority of the health profession didn’t know about it.
“Michelle went for her regular doctor visits. This was the first child. This was the only child. They wanted this child very badly, and they were going to give her the very best medical care that she could ever have. They gave her all her immunizations because that was what was recommended. One month after she was born she went for hepatitis B immunization number two, another 12.5 micrograms of mercury. So we now have 25 micrograms of mercury, a cumulative dose in a child who is only one month old. By the age of seven months Michelle had received three DPT immunizations, three hepatitis B immunizations, and each DPT combined with [another vaccine] contained 25 micrograms of mercury. So you add up the math. During this period of time Michelle seemed to be okay. The pediatrician didn’t think that there was anything wrong with her.
“In December 1995, Michelle went in for another immunization. She went for her MMR. One week later, Michelle developed a fever of 105. Her mother called the doctor and she was told there’s a flu going around, a very bad flu. Keep her home. Nurse her, and she’ll recover. The fever stayed up there; 105 on December 27; 105 on December 28; 105 on December 29; 105 on December 30 and yet she was told it’s the flu. Finally, on December 31 it broke. And her mother thought. ‘Thank God, it’s finally gone.’”
Michelle’s fever wasn’t gone for long. On January 5, 1996, it returned, lasting two more days. Chin-Caplan continued: “After that, Michelle’s family noticed that she wasn’t speaking. She was totally silent. Before that she had been interacting with her parents, with her grandparents. She began interacting with her cousins. She was babbling. She was reaching for her toys. She was practically walking. She was sitting up by herself. [But then] she entered a little world of her own. She started engaging in repetitive behavior. The family would say ‘Michelle, Michelle!’ She ignored them like she had never heard them.” Eighteen months after Michelle received MMR, in July 1997, doctors told Theresa and Michael Cedillo that their daughter had autism.
Michelle’s troubles didn’t end there. She began to have frequent bouts of diarrhea, vomiting, and stomach pain. Theresa Cedillo, frustrated that her daughter’s symptoms were worsening, searched the Internet for answers. There she came upon DAN. She was excited to read about a DAN meeting in her area—a meeting where British gastroenterologist Andrew Wakefield would be speaking. “Theresa went to this conference,” said Chin-Caplan, “and she stood in the back of the room and she listened to Dr. Wakefield talk. She stood in the room and she waited for him to finish speaking so that she could catch him and try to get his attention about helping her child.” Eventually, Theresa brought Michelle to see Dr. Arthur Krigsman, who was now Andrew Wakefield’s partner at Thoughtful House in Austin. In January 2002, Michelle had an intestinal biopsy that, according to Unigenetics (John O’Leary’s laboratory in Ireland), contained measles virus. “Her childhood has passed right before our eyes,” said Theresa Cedillo, “spent in hospitals and doctors’ offices, not in parks and with little friends. The trauma of the sheer human suffering she endures every day is beyond explanation and understanding, filling us with overwhelming anguish.”
For the next five days, Sylvia Chin-Caplan called upon a series of experts to connect the dots—to make sense of what had happened to Michelle Cedillo. First to testify was Vas Aposhian, an eighty-one-year-old professor of molecular and cellular biology at the University of Arizona and a professor of pharmacology at the University of Arizona School of Medicine. Aposhian said autistic children had less mercury in their hair than nonautistic children because they had a “mercury efflux disorder”: they simply couldn’t rid themselves of mercury. (Aposhian’s claims were in direct contrast to Boyd Haley’s claims that autistic children had more mercury in their hair than nonautistic children.) Aposhian said that when autistic children were treated with chelating agents, large amounts of mercury poured out of their bodies in the urine.
Next up was Arthur Krigsman, who displayed a poster he had recently presented at a national meeting. The poster told the stories of children whose symptoms were just like Michelle’s. Krigsman said he was certain that Michelle’s intestinal symptoms were caused by a long-standing, destructive measles infection caused by MMR. Chin-Caplan asked him how he could be so sure. Krigsman, pointing to his poster, said, “[It’s] the same patients, the same bowel findings, and the same findings of measles virus genome. The pattern of inflammation that I was seeing was consistent with a viral infection.”
Next was Vera Byers, an immunologist. Byers was impressed by Michelle’s reaction to MMR. “[Michelle] had received her MMR vaccination at age fifteen months,” she said. “Then a very colorful and dramatic set of circumstances occurred. Seven days later she developed a high fever, which essentially lasted for two weeks.” Byers was confident that Michelle’s reaction was caused by a “dysregulated immune system.” Chin-Caplan asked, “Did you come up with potential possible causes?” “Yes,” said Byers. “I find that both the thimerosal that she had received in her prior injections before MMR and the one or two [injections of thimerosal] subsequent to MMR were both responsible.”
Through her experts, Chin-Caplan had tried to provide an explanation for Michelle Cedillo’s autism. Vas Aposhian said Michelle was less able to rid mercury from her body than other children. Vera Byers said mercury from vaccines had damaged Michelle’s immune system. And Arthur Krigsman explained that with her immune system damaged, Michelle was unable to prevent measles vaccine from damaging her intestinal lining. Only one piece was missing. How did immune suppression caused by mercury and long-standing intestinal inflammation caused by MMR add up to autism?
Marcel Kinsbourne, a professor of pediatrics at the Hospital for Sick Children in Toronto, provided the final piece of the puzzle. “The measles vaccine virus was able to access the brain, invade neurons without killing them [and] evoke a vigorous [immune] response,” said Kinsbourne. “[As a consequence] the inflammation that resulted from that response damaged critical circuits in the brain.” In short, measles vaccine virus had invaded Michelle’s brain and caused autism. In support of his theory, Kinsbourne pointed to Unigenetics’ detection of measles virus in the spinal fluids of autistic children. With that, Sylvia Chin-Caplan rested her case. Now it was Vincent Matanoski and the defense team’s turn. They started by questioning the expertise of Aposhian, Byers, and Kinsbourne.
Vas Aposhian had testified that autistic children had greater quantities of mercury in their bodies than nonautistic children. Cross-examination of Aposhian revealed that the study on which he based his theory had been clearly refuted by other investigators. Further, Aposhian was not a toxicologist, geneticist, clinician, immunologist, or virologist; he had never taken care of a child with autism; he had never published a paper about thimerosal toxicity; and he had spent most of his time testifying in court on behalf of plaintiffs. But Aposhian’s most embarrassing moment came after he described the Minamata Bay disaster. On cross-examination, Aposhian had to agree that despite this massive mercury poisoning, young children had not appeared to develop autism. Further, he was forced to admit that studies of mercury poisoning involved doses of mercury far greater than those contained in vaccines. Backed against the wall, Aposhian struck out when the examiner asked the next logical question: “Would you agree that any substance is either toxic or nontoxic based upon the dose?” “No,” said Aposhian. “This is an ancient form of quotation that until recently we taught in medical schools, and in undergraduate school, and in graduate school. No longer can we use that ancient saying, and it’s very ancient. This is the year 2000; it’s not the year 1000 B.C.” Aposhian concluded that “we no longer believe that the dose makes the poison.”
Vera Byers, who said thimerosal had caused a “dysregulation” of Michelle’s immune system, also had her credibility challenged. Byers had described herself as a member of the faculty of the University of Nottingham and later the University of California at San Francisco (UCSF) as well as a member of the clinical team “that got Embrel approved.” (Embrel is a drug used to treat diseases like rheumatoid arthritis and psoriasis.) But Byers wasn’t on the faculty at either Nottingham or UCSF, and her name never appeared on the Biologics License Application to the FDA for the approval of Embrel. Further, although Byers had claimed to be a toxicologist—indeed, her testimony centered on the supposition that thimerosal harmed the immune system—she had no formal training in toxicology, saying she had only taken courses in medical school. When questioned by Matanoski, she didn’t know the chemical structure of thimerosal or the molecular weight of mercury, arguing she had relied on Vas Aposhian to know those things. (Aposhian wasn’t a toxicologist either.) Finally, Byers hadn’t taken care of patients in more than fifteen years, but instead had been spending all of her time running a consulting company called Immunology Incorporated, which provided testimony for personal-injury lawyers on toxins in the environment.
Arthur Krigsman, also an important witness for the petitioners, had claimed that the intestines of children with autism were studded with measles vaccine virus, as detected by both Andrew Wakefield in his laboratory and John O’Leary at Unigenetics. On cross-examination, Matanoski’s colleagues didn’t challenge what Krigsman had said. They just had him say it again, thereby setting him up for the surprising testimony of two British researchers a couple of days later.
Matanoski’s final target was Marcel Kinsbourne, who had explained that measles vaccine virus caused autism by entering the brain and damaging nerve cells. But Marcel Kinsbourne wasn’t a virologist. When questioned about how measles vaccine virus left the intestine and entered the brain, he struggled. Further, Kinsbourne hadn’t cared for children in more than seventeen years. Chin-Caplan’s choice of Marcel Kinsbourne as her autism expert would soon come back to haunt her.
Aposhian, Byers, and Kinsbourne had one thing in common: all had spent the past decade or more of their careers as professional witnesses for plaintiffs. Vincent Matanoski later commented on the petitioners’ choice of experts when he addressed the judges: “Ask yourself on the credibility of witnesses where they’re coming from. Is their place of business the hospital, or is it the courtroom? Do they get paid to testify, or do they testify to get paid?”
MATANOSKI’S DEFENSE TEAM THEN PROVIDED SEVERAL EXPERTS who refuted the theory that MMR had caused Michelle Cedillo’s autism. The first was Eric Fombonne.
Fombonne had trained at the Maudsley Hospital and the Institute of Psychiatry in London under Michael Rutter, one of the founders of child psychiatry as a scientific discipline. At the time of his testimony he was the head of the Division of Child and Adolescent Psychiatry and the director of the Autism Spectrum Program at Montreal Children’s Hospital, as well as a professor of psychiatry at McGill University. Specializing in children with autism, Fombonne diagnosed more than 300 new cases every year. During his twenty-three-year career, Fombonne had published more than 160 research papers and 34 book chapters. He was on the editorial board of the Journal of Psychology and Psychiatry , an associate editor of the Journal of Autism and Developmental Disorders, and the president of the scientific committee for the International Meeting for Autism Research, the premier gathering for researchers in the field. Eric Fombonne was, in short, one of the world’s leading experts on autism.
Fombonne contended that Michelle Cedillo’s symptoms of autism appeared well before she had ever received MMR. To prove it, he showed the court a series of videotapes taken by her parents. One was from August 30, 1995, during Michelle’s first birthday party. “Before we look,” said Fombonne, “it’s useful to try to portray in your mind what is typical of the first birthday party. So you will see there is cake, there is a gift, people sing. What you would expect from the child [is that] the child would be excited; there would be pleasure on the face of the child. If a child is called he would [pay attention] to the name. He would have a lot of interactions with people around. There would be a lot of showing, pointing, or gestures used to communicate. And if not words, you would at least hear babble.” But that’s not what Eric Fombonne saw when he watched the videotape of Michelle Cedillo. He focused on the segment of the tape where everyone was singing. “You need to pay attention to ‘Happy Birthday, Michelle, Happy Birthday, Michelle,’” said Fombonne. “Twice or three times you will see that when she’s spoken to, she doesn’t [pay attention] at all. She’s not [paying attention] to the face, she’s not looking, she’s not responding. There is no gesture, no pointing, no showing. We don’t hear any babble. Her facial expressions are restricted and reduced. She doesn’t join in when there is excitement.” Fombonne was certain that after watching this tape, any autism expert would say that Michelle was autistic. The videotape of Michelle Cedillo’s first birthday party was made four months before she received the MMR vaccine.
Fombonne later examined a videotape from December 17, 1995, when Michelle was fifteen months old, one month before she received MMR. “There is no word at all which is uttered by [Michelle] during this sequence,” said Fombonne. “We just heard a few babbling sounds which are, again, guttural: not directed to others, directed to herself. We see flapping movements of the hand.” Fombonne pointed to a scene where Michelle was handed several balls. “With the balls, which were a gift from her grandpa, she doesn’t do anything. She doesn’t explore them or play with them in any sort of way. Any child her age should play with toys she’s given. Soon you are going to see something that is even more typical of autistic behaviors. Children with autism often have these very typical hand and finger movements whereby they move their fingers in their visual field like this.” Fombonne feigned fascination as he slowly moved his hand, fingers spread widely, across his face. “They are absorbed by this,” he said, pointing to the tape. “You are going to see this in six seconds. When her mother calls her, she doesn’t respond. Rather, she engages in this stereotypical hand movement.” Fombonne concluded his presentation of the videotapes: “This clearly suggests that [Michelle’s] abnormal development occurred much before the MMR injection.” Asked whether he was sure of his diagnosis, Fombonne didn’t hesitate. “This set of findings based on video analysis is very consistent with autistic spectrum disorder,” he said. “I have no doubt in my mind.”
The testimony of Eric Fombonne refuted the petitioners’ claim that Michelle’s autism occurred after she had received an MMR vaccine. Chin-Caplan’s only hope was to challenge the videotape observations point by point. But her autism expert, Marcel Kinsbourne, had never diagnosed a patient with autism, hadn’t seen any patients in almost twenty years, and hadn’t seen Michelle’s behavioral abnormalities on the videotapes. As a consequence, when Sylvia Chin-Caplan cross-examined Eric Fombonne, she never once questioned his observations or conclusions; nor did she bring back Marcel Kinsbourne to challenge him.
THE NEXT WITNESS TO BLOW UP THE THEORY OF THE PETITIONERS was Stephen Bustin, a molecular biologist. Bustin was the chair of Molecular Science at the University of London and one of the first scientists to use PCR, the technique used by Unigenetics to detect measles virus in children with autism. In 2000, Bustin wrote the definitive paper, published in a premier biomedical journal, Nature Protocols, on how to perform PCR. This paper had been cited by other researchers more than 1,000 times, a remarkable number. More recently, he had written A to Z of Quantitative PCR, often referred to by molecular biologists as the bible of PCR. In the past five years alone, Bustin had written nine book chapters about PCR. For his expertise, he had been honored by election into the prestigious Royal Academy of Medicine. Stephen Bustin was arguably the world’s expert on PCR.
When Andrew Wakefield declared MMR vaccine might cause autism, his claim was based in large part on finding measles virus genes in the intestines and spinal fluids of autistic children. Although Wakefield initially tested these samples in his own laboratory, he eventually sent them to Unigenetics in Dublin. So from January through May 2004, Stephen Bustin visited Unigenetics.
When Bustin examined Unigenetics’ methods, he found something that didn’t make sense. Unigenetics had taken samples from Andrew Wakefield and tested them using a type of PCR capable of detecting ribonucleic acid (RNA). Since measles virus contains only RNA, this was the only method that should have detected it. But on at least one occasion, Unigenetics detected measles genes using a type of PCR that could detect only deoxyribonucleic acid (DNA), and measles virus doesn’t contain DNA. Clearly, something was wrong. “I have very little doubt that what they are detecting is a DNA contaminant and not measles virus,” he said. Then Bustin found where the contamination was coming from. “One of the peculiar things that we noticed when we went to their laboratory,” said Bustin, “was that next to their PCR instrument was a room which was labeled ‘Plasmid Room.’ [Plasmids are small circular pieces of DNA that are grown in bacteria.] Obviously if you have hundreds of millions or thousands of millions of bacteria, each containing tens of hundreds of copies of DNA, you’ve got a massive potential for DNA contamination. So you never want to have any plasmid DNA anywhere near your laboratory where you’re doing the PCR. Once you’ve got DNA contamination, it persists for years and it gets into everything. If you’re handling bacteria or you’re handling plasmids, it gets into your hair, on your hands, [and] on your clothes.”
Bustin found other problems with Unigenetics. Typically researchers run samples in duplicate or triplicate so that a specimen can be double- or triple-checked—in this case, to make sure it really does contain measles virus genes. Unigenetics ran its specimens in duplicate, occasionally finding measles genes in one duplicate sample but not the other. Despite this inconsistency, the company still sent out reports claiming the presence of measles genes. Also, researchers always check themselves with positive and negative controls: positive controls contain known amounts of measles virus RNA, and negative controls contain no measles virus RNA. But in the hands of Unigenetics, the positive controls were occasionally found to be negative and the negative controls were found to be positive. This suggested that something was critically wrong with the company’s testing procedures. “I do not believe that there is any measles virus in any of the cases they have looked at,” Bustin concluded.
Usually medical laboratories, which perform services critical to the care of patients, are accredited by a central licensing board. This wasn’t the case with Unigenetics. “Was Unigenetics ever accredited?” Bustin was asked. “No, they were not,” he replied. Then, “Could this be part of the reason some of these problems weren’t detected earlier?” “Yes,” said Bustin. “I’m sure that is the case. [Pathologists] tried to recruit Unigenetics into a quality control program, which involves various laboratories in Europe and the United States. Unigenetics refused to take part in this. So there was never any independent quality assessment made of any of the work that was carried out by Unigenetics.” Bustin had known about problems with Unigenetics for more than three years, but because his findings related to litigation pending in the United Kingdom, he wasn’t allowed to comment to the press or the public. Now, during the Omnibus Autism Proceeding, he could finally speak out about what he had found. “It has been incredibly frustrating,” he told a reporter. “For three years we have been unable to reveal our findings. Now I want to get the message out about the O’Leary-Wakefield research. There’s nothing in it.”
Vas Aposhian, Vera Byers, Arthur Krigsman, and Marcel Kinsbourne had all said that their belief that MMR caused autism was based on Unigenetics’ finding measles virus in the intestines and spinal fluids of autistic children. When the problems with Unigenetics were revealed, they each sat quietly, saying nothing.
Unigenetics Laboratories is no longer in business.
WHEN ANDREW WAKEFIELD TESTIFIED IN FRONT OF DAN BURTON’S congressional committee in 2002 that he had found measles virus in the intestines of more than 150 autistic children, Unigenetics had done all of the testing. Indeed, John O’Leary, the owner and operator of Unigenetics, had sat next to him, supporting his claim. But Wakefield’s first paper—the one published in the Lancet that had started the controversy—wasn’t based on tests performed by Unigenetics. Rather, Wakefield’s Lancet paper was based on tests performed in his own laboratory. Andrew Wakefield didn’t do these tests himself; a research assistant did them. His name was Nicholas Chadwick, and he was the next to testify.
Beginning in 1996, Chadwick was in the operating room during the collection of both intestinal biopsies and spinal fluids from autistic children. “My role was to take the material, bring it to the lab, and then look for evidence of measles RNA,” he said. Although Chadwick’s videotaped testimony lasted for only one hour, it was devastating to the petitioners.
Q: Did you personally test the gut biopsy samples for measles RNA?
A: Yes.
Q: What tests did you perform?
A: A PCR test, a polymerase chain reaction.
Q: What results did you [find] from the gut biopsy materials for measles RNA?
A: They were all negative.
Q: They were all negative?
A: Yes. There were a few cases of false positives. [But] essentially all the samples tested were negative.
Q: Did you personally test cerebrospinal fluid samples from autistic children in the lab?
A: Yes, I did. Again, they were all negative.
Q: Did you inform Dr. Wakefield of the negative results?
A: Yes. Yes.
Q: You also state in your affidavit that Dr. Wakefield was aware of all of your negative results when he submitted his paper, which was published in 1998 to the Lancet.
A: Yes, that’s correct.
Q: Why wasn’t your name on the paper I just referenced?
A: I asked for my name to be taken off anything that related to PCR data because I wasn’t comfortable with the quality of the data.
Nicholas Chadwick testified that Andrew Wakefield had not only ignored data that disproved his contention, but he had also knowingly falsified them. If true, this revelation showed Wakefield had crossed the line from ill-conceived, poorly performed science to fraud.
Wakefield’s willingness to misrepresent data wasn’t new. Before he turned his attention to autism, Wakefield believed measles vaccine caused Crohn’s disease. At a national meeting, he claimed that people with Crohn’s disease had higher levels of measles antibodies in their bloodstream than people without the disease. One problem: David Brown was sitting in the audience. Brown, an internationally recognized measles expert, directed the WHO’s measles laboratory in the United Kingdom. He knew people with Crohn’s disease didn’t have higher levels of measles antibodies because he was the one who had performed the tests. When Brown stood up to challenge Wakefield’s statement, Wakefield had little choice but to withdraw it.
On cross-examination—even though their statements were devastating—neither Sylvia Chin-Caplan nor Thomas Powers challenged Stephen Bustin’s claim that Unigenetics Laboratory was unreliable or Nicholas Chadwick’s claim that Andrew Wakefield had falsified data. They simply asked a few perfunctory questions and got them off the witness stand as quickly as possible.
ON FEBRUARY 12, 2009, THE THREE JUDGES IN THE OMNIBUS Autism Proceeding issued a press release. Siding with the science, they ruled that the combination of MMR and thimerosal didn’t cause autism. Seven hundred pages long, the ruling was definitive, meticulous, and compelling, leaving virtually no room for a successful appeal.