MEDICINE AND HEALTH:
Tragically Wrong

By Arthur Allen

Thousands of parents are convinced that a routine vaccination made their children autistic. Now, many of those parents are taking their claims to court. Unfortunately, emotion, not science, may prevail. By Arthur Allen.

Last summer, a special court in Washington, D.C., heard testimony in the first test case of a medical controversy that has brought 10,000 families into litigation. The parents of Michelle Cedillo, a severely autistic and mentally retarded 12-year-old, argued a novel and complex theory: that vaccines containing the mercury-based preservative thimerosal had damaged her immune system, leaving her vulnerable to a chronic infection—allegedly caused by the weakened measles virus in another shot, the MMR vaccine— that spread to her brain, scrambled her neurotransmitters, and turned her autistic. Fragments of this idea had been hypothesized in obscure medical journals, but its presentation in the U.S. Court of Claims’ Office of Special Masters, known colloquially as the vaccine court, marked the first time this theory had ever been aired in court.

The trial was a long time coming, but it was only the latest chapter in the remarkably controversial history of vaccination. The nation that joyfully embraced Jonas Salk’s polio vaccine in 1955—and its promise to deliver people from a pathogen that had paralyzed and killed thousands— had taken on a more suspicious mood by the 1970s. Diseases prevented by vaccines had grown rare and lawyers inspired by consumer activist Ralph Nader had proliferated. A polio-stricken Texas girl, Anita Reyes, successfully sued Wyeth Laboratories in 1974 over its oral polio vaccine, even though the judge found that the vaccine’s risks, though rare, were wellknown and unavoidable (the oral polio vaccine was replaced by the safer killed-virus vaccine in the late 1990s). The climate of vaccine skepticism intensified after the 1977 swine flu fiasco, in which thousands of litigants claimed they had contracted an autoimmune disorder called Guillain-Barre syndrome after President Ford’s hasty campaign to vaccinate the entire country against a pandemic flu strain, which never materialized. Then, in the 1980s, hundreds of parents of brain-damaged children began suing manufacturers of the whole-cell pertussis vaccine component of the diphtheria- tetanus-pertussis (DTP) shot. In one case, a jury awarded a family $26 million at a time when the entire pertussis (whooping cough) vaccine market was worth about $2 million.

The idea that vaccines can be blamed for autism has gained surprising public currency during the past six years. Leading U.S. lawmakers of both parties have held hearings, pressured public health authorities, and introduced bills to demand vaccine safety studies. Environmentalists, entertainers, and even a handful of scientists have accused the government of a massive cover-up. A shockingly large number of parents are treating their autistic children with bizarre combinations of medicine and supplements on the assumption that the condition is the byproduct of vaccines. Vaccine suspicion has been promoted in newspaper and television news accounts and on innumerable Internet blogs. Perhaps most important, the purported vaccine link to autism has penetrated the consciousness of parents of young children with the tenacity and durability of the juiciest gossip. Pediatricians encounter the claim every day as they urge parents to vaccinate their babies. It has, in short, become an urban myth.

Although most in the mainstream news media have by now dismissed the vaccine-autism theory as scientifically unsupported, it is not a trivial issue, especially now that the federal court has started to examine the theory. Thousands of claims are before the vaccine court, which Congress established in 1986 as a way to compensate the families of children who have suffered serious adverse reactions after receiving vaccines mandated by state law for school or day care admission. The autism omnibus litigation is by far the largest set of cases to come before the court.

The vaccine court relies on a combination of science, law, and its own political history in determining those children eligible for payouts. Because of the court’s complex mission, it is hard to predict whether it will dismiss the highly dubious theories of a vaccine link to autism. Should the claims prevail, they could cut deeply into the $2.5 billion trust fund the program has built up from excise taxes on vaccines. A victory for the claimants could also seriously damage public confidence in the national vaccination program, a powerful weapon in the fight against infectious diseases. A ruling on the Cedillo case is expected in the first half of 2008, but the court does not expect to clear its docket of autism cases for at least three years.

A TAINTED REPORT

The vaccine-autism case had its genesis in 1996, when a British legal firm approached gastroenterologist Andrew Wakefield of London’s Royal Free Hospital and asked him to examine a group of children whose parents were suing the pharmaceutical giant Merck. The parents alleged that after being vaccinated with MMR, a vaccine that contains weakened measles, mumps, and rubella viruses, their children had developed the distressing constellation of repetitive movements and language deficiencies known as autism. Wakefield had published a paper that hypothesized a link between MMR vaccination and inflammatory bowel disease, and the children in the 1996 case had an assortment of bowel problems as well as autism.

A year later, Wakefield filed a patent for a single-valent measles vaccine— a shot useful only should public confidence falter in the existing three-in-one MMR vaccine. Then, in February 1998, Wakefield took a step that would cause just such a dip in public confidence: he published a report in the prestigious journal Lancet of twelve autistic children with severe gastrointestinal problems, eight of whom were reported to have become ill after MMR shots. Wakefield’s hypothesis was that the measles component of the vaccine had infected the children’s intestines, causing them to leak poisons into the blood that caused brain damage. Wakefield did not mention the litigation or his patent application to the Lancet or his colleagues. When the true context of the study was revealed by a British investigative journalist six years later, the Lancet withdrew part of his paper.

This tainted report is the primary origin of the notion that vaccines cause autism. Even before Wakefield’s MMR hypothesis, some crackpot theorists were blaming autism as well as many other mental illnesses on the DTP shot, which has been around since the 1940s. Since Wakefield made his claim, the autism theory has expanded to include other vaccines, in particular those containing thimerosal.

A large segment of the British press fell in love with Wakefield and his sick children, and fears of MMR caused vaccination rates to plunge in Great Britain from 92 percent in 1998 to as low as 79 percent in 2002, setting off measles outbreaks that killed three children. Even though his theory has been convincingly debunked, a number of British tabloids keep it in play. The parents of some autistic children are intensely loyal to Wakefield, in part because he diagnosed and treated their children’s gastrointestinal problems and in the process ameliorated some of their autistic behaviors. (Studies show no indication that autistic children suffer gut or immune problems at rates higher than other children, but the symptoms of these disorders are undoubtedly more problematic in children who have extreme difficulty communicating the nature of their pain and suffering.)

THE MAKING OF A VILLAIN

If the MMR theory blossomed full-blown from the head of a British physician, the thimerosal issue’s origins were more complex, and it was thimerosal that grabbed the attention of American parents—as well as a group of trial lawyers who saw in it an opportunity for a tort bonanza on a scale similar to those engendered by tobacco, asbestos, and silicone breast implants. Thimerosal, a bactericide whose active ingredient is ethyl mercury, was introduced to some packages of vaccines in the 1930s to ensure sterility and prevent the periodic outbreaks of septic shock in children vaccinated from bacteria-infested vials. Few people at the time knew or cared that there were a few dozen millionths of a gram of mercury in their vaccines until the late 1990s, when science became aware of the potential neurotoxicity of small dosages of organic mercury, a compound omnipresent in the environment but concentrated in the flesh of seafaring mammals and predatory fish. After two of three large studies conducted among maritime populations showed subtle neurological damage—slower response times, tics, and the like—in elementary school–age children whose mothers had consumed large quantities of seafood, an expert panel convened by the National Research Council decided to endorse an extremely conservative EPA reference dose for the consumption of methyl mercury, which seems to be slightly more neurotoxic than ethyl mercury but similar to it.

The buzz around these mercury studies soon reached environmentally minded members of Congress, and in 1997, Representative Frank Pallone (D-New Jersey) wrote into the FDA Modernization Act that the agency must take stock of all medical products containing mercury. While conducting that inventory, in 1999, three FDA scientists realized that the total thimerosal content in the hepatitis B, Haemophilus influenza type B, and diphtheria-tetanus-pertussis shots given to babies by 6 months of age would potentially put them over the EPA threshold—if one accepted the problematic assumption that the effects of ethyl and methyl mercury were the same. At the time, Neal Halsey, a Johns Hopkins University vaccine safety expert, happened to be visiting the FDA’s biologics center, which regulates vaccines. He set off alarm bells within the public health world about the supposed dangers of thimerosal, leading to an emergency meeting at the American Academy of Pediatrics in Washington, at which it was decided to ask drug manufacturers to replace thimerosal-containing vaccines with thimerosal-free versions.

That hasty decision created a rift among vaccinologists, with some, such as rubella and rotavirus vaccine inventor Stanley Plotkin, dismissing the decision as something out of Alice in Wonderland: “First the sentence, then the trial.” Others, including measles vaccine inventor Sam Katz, felt that as custodians of a vaccination program that relied on public trust, medical experts had no choice but to be cautious and proactive. World Health Organization officials were incensed, fearing that the U.S. decision would set a damaging precedent for Third World countries that could not afford the more expensive, single-dose thimerosalfree vaccines.

If the move was considered excessively cautious by some in the public health world, an angry “too little, too late” reaction erupted among a group of parents who quickly latched onto mercury as the key to their children’s woes. Within a few years, activists in Congress and in most state legislatures were agitating for a ban on all thimerosal-containing vaccines (although by 2002 thimerosal had been phased out of the three pediatric vaccines mentioned above, many influenza shots still contained the preservative) and to expose what they claimed was a conspiracy by government scientists and the pharmaceutical industry to suppress evidence that thimerosal-containing vaccines had caused an “epidemic” of autism.

It was certainly reasonable to ask whether thimerosal had played a role in autism spectrum disorders, for the diagnosis of these disorders has mushroomed in recent decades. While this now seems largely due to changes in the social, educational, and psychiatric categorizations of childhood mental illness, that was not clear from the outset. But the “mercury militia,” as some have described these groups, was primed from the start to believe the thimerosal theory. It found a ready template of fringe science and alternative medicine on which to feed and grow; there were hundreds of Chicken Littles convinced that heavy metals and industrial chemicals had made modern life more hazardous than at any previous time. Networks of tort lawyers, alternative medical practitioners, supplement peddlers, and antivaccine activists provided a medico-ideological bedrock, as well as financial resources, for the campaign against thimerosal.

In particular, the campaign fused with a decades-long battle against mercury- containing dental amalgams. Some of the main players in the thimerosal battle had cut their teeth, as it were, fighting the “amalgam wars” against the dental establishment, which rejected claims that amalgams were responsible for Alzheimer’s disease, multiple sclerosis, and other conditions. Boyd Haley, an amalgam warrior who teaches chemistry at the University of Kentucky, quickly jumped into the thimerosal fray as a consultant to litigants and activists. He and other amalgamistas also helped introduce chelation therapy, which leaches heavy metals from the body, as the latest in a long series of “miracle cures” for autism.

ACTIVISTS OUTFLANK SCIENTISTS

The moment these networks turned their searchlights onto vaccines may have occurred in 1998, at a meeting of alternative practitioners known as Defeat Autism Now! (DAN) founded by the late San Diego psychologist Bernard Rimland. He was revered in autism circles because of his 1964 book Infantile Autism, which debunked Bruno Bettelheim’s notorious “refrigerator mother” theory of autism. After publishing the book, Rimland began promoting one unproven autism therapy after another, claiming each time that the latest approach—special diets, megavitamins, herbs—would ameliorate or even “cure” autism. Rimland, who was also antivaccine, had linked the whole-cell pertussis vaccine to autism years before. At a meeting of DAN practitioners in 1998, physician Stephanie Cave of Baton Rouge reported that she had been chelating autistic children and that some of them emitted large amounts of mercury.

When public health authorities announced a year later that thimerosal levels in vaccines may have exceeded EPA thresholds, the idea of mercury poisoning clicked among DAN practitioners, some of whom helped create a group called SafeMinds. That group worked closely with a group of alternative practitioners and antivaccine activists and with a staffer in the office of Representative Dan Burton (R-Indiana). Burton, a longtime champion of alternative medicine who attributed his grandson’s autism to vaccines, held multiple hearings before the Government Reform Committee, which he chaired for several years, assuring that antivaccine ideas got wide play.

One of SafeMinds’ most important actions was to publish, with an extremely contentious commentary, the transcript of a June 2000 conference at a retreat outside Atlanta where scientists from the Centers for Disease Control and Prevention (CDC) discussed a study that was being carried out to detect possible harm from thimerosal. The study examined children at health maintenance organizations (HMOs) that had been recruited into a vaccine safety surveillance network by an enterprising CDC scientist named Robert Chen. Drawing on HMO populations that included 2 percent of American children, Chen and his colleagues were able to perform large studies to examine theoretical or real vaccine injuries.

The system worked well in finding discrete vaccine-related problems, but it was more difficult to find a link between thimerosal and autism or related disorders, if such a link existed. First, nearly every child in these HMOs had received thimerosal-containing vaccines, so the CDC scientists were forced to search for different outcomes among children whose dosages had varied by only a few dozen millionths of a gram over a few months. Second, the HMO populations did not include large numbers of children with autism diagnoses; thus, the scientists examined symptoms—such as tics and speech or motor delays—that were not good surrogates for neurological diagnoses. Nevertheless, the vaccine safety branch dutifully carried out the study, and initially came up with a weak signal of neurodevelopmental delays associated with increased thimerosal ingestion. Because of the difficulty of the analysis and the sensitivity of the issue, the CDC called upon a group of vaccine experts, including industry representatives, to discuss the study.

At the meeting, a few participants expressed concern at the results; one said he wouldn’t vaccinate his newborn grandson with thimerosal-containing hepatitis B vaccine until they were clarified. Others worried—presciently— that the study would be fodder for tort lawyers. The great majority felt that given the complex variables involved, the trend line was an artifact of chance.

Although the study and its problems were discussed in public two weeks later at the CDC, SafeMinds used the conference transcript as the centerpiece of a slick public relations campaign claiming that the authorities were concealing something from the public—“evidence of harm,” as the freelance writer David Kirby titled his 2005 book on the thimerosal controversy. Kirby’s book presented a heroic tale of brave parents fighting faceless bureaucrats to find out the true source of their children’s terrible illnesses. It recruited hundreds of new parents of autistics to the cause.

The final version of the CDC study, published in Pediatrics in 2004, brought in data from a third HMO—and showed no link between increased thimerosal dosages and neurodevelopmental delays. SafeMinds dismissed the result as tainted and false, terms it also used to describe subsequent studies from Denmark, Britain, Canada, and Sweden, none of which showed a link between thimerosal and autism. In an effort to placate those critics, the CDC and other federal agencies have included Safe- Minds and other activists on panels overseeing autism studies, including work using the linked HMO databases.

Meanwhile, new and increasingly radical players jumped into the fray. Some activists made threatening phone calls to CDC scientists at home and at work, leading the FBI to investigate. A wealthy Portland-based couple, Lisa and Brad Handley, spent close to a million dollars publishing ads in the New York Times, USA Today, and other newspapers stating that autism, attention deficit/hyperactivity disorder (ADHD), and similar conditions were all misnomers for mercury poisoning. “It’s that simple,” they wrote. “The truth will set you free. There is no controversy.” The Handleys started a group called Generation Rescue that sent “Rescue Angels” to urge parents to chelate their kids, and claimed that hundreds had been cured of autism. (Testimonials posted on the Generation Rescue websites show that few of the children were actually cured; the behavior and mental processes of many autistic children, chelated or not, mature over time, and in many cases autistic symptoms become less severe.)

This public relations circus was not covered widely in the press. Major newspapers like the New York Times published a few items and then ditched the story as the ranting of a fringe. But the CDC and other public health officials did little to counter the antivaccine campaign, and smaller newspapers and electronic media continued to cover the story from the aggrieved parents’ perspective. Tort lawyers initially tried to have their cases argued before civil juries, but the 1986 National Childhood Vaccine Injury Compensation Act funneled the thousands of parents’ lawsuits into the vaccine court. When the mass of claims before the court had swelled to 4,800 by 2006 (an additional 4,500 parents filed notices of intent while awaiting the court’s early rulings) the special masters created an omnibus program. Three of the court’s special masters would be responsible for handling the litigation, which would be organized into three theories of harm: MMR vaccine alone, thimerosal-containing vaccines, or a combination of the two. Each of the claims in the three categories would be resolved using evidence and legal considerations ironed out in initial test cases such as the Cedillos’.

WI LL “GOOD” SCIENCE HAVE TH E LAST WORD?

Testimony in the Cedillo trial was lopsided in the government’s favor. Its witnesses included one of the world’s leading autism experts, Eric Fombonne of McGill University; Dianne Griffin, a leading measles researcher; and extremely well-credentialed neurologists, virologists, toxicologists, and pediatricians. They presented a wealth of population studies showing no link between vaccines and autism, and reams of literature and expert testimony demonstrating that all previous cases of mercury poisoning involved hundreds or thousands of times the doses in vaccines. They also showed that the symptoms of mercury poisoning were not the same as those of autism and that the measles vaccine virus was not capable of causing autism.

The plaintiffs’ case, by contrast, relied on professional vaccine court witnesses and scientists whose expertise was not necessarily related to the matters in question. The strongest piece of physical evidence provided by the plaintiffs was related to the MMR thesis. In a paper published in 2002, Wakefield and his colleagues asserted that using polymerase chain reaction (PCR) technology, which can amplify small pieces of biological material, they had detected measles vaccine virus in the guts of many autistic children.

But government witnesses presented a convincing rebuttal. Steven Bustin, the world’s leading PCR expert, reported that the Irish laboratory that had conducted the tests was contaminated, causing scientists to mistake pieces of human DNA for measles RNA. The finding of measles vaccine virus, he said, was a false positive. After Bustin first reported his findings in 2004, the British vaccine court effectively tossed out the MMR litigation in Britain. His U.S. testimony could have a similar effect, because no other evidence supports the MMR link.

As the court ruminates on its autism verdict, let’s examine its track record and mission. Since 1989, the court has awarded about $725 million to 857 children and their families, rejecting about 1,900 other claims. A majority of the cases involved the whole-cell pertussis vaccine, which was replaced by a less reactive and undoubtedly safer sub-unit vaccine in 1996. The court has probably compensated many children whose injuries were not, in fact, due to vaccines. Many pertussis experts do not believe that whole-cell pertussis vaccine actually causes long-term brain damage. But in creating the court, Congress made it clear that it wanted to give parents the benefit of the doubt. These parents were, after all, agreeing to subject their children to the small risk of vaccination under state mandates that required them to be vaccinated.

Benefit of the doubt, however, is not a clearly defined legal standard, and as in all federal courts the special masters are bound to weigh scientific theories under the Supreme Court’s 1993 ruling in Daubert v. Dow Chemical, which tossed out “junk” science. But there are obviously some gray areas when it comes to determining what “good” science is. And the court is inevitably influenced by its mandate to recognize the sacrifice of children in the “war” against infectious disease. In other words, as pediatric neurologist Gerald Fenichel stated in 1991 in the context of the DTP cases, because many people feel that vaccines sometimes cause brain damage, “it is reasonable to compensate some number of people who perhaps have not been injured by the vaccine, to make the program work.”

The evidence in favor of a causative link between vaccines and autism is far weaker than the link to brain damage from whole-cell pertussis vaccine. Yet the attorneys representing autistic children clearly hope the court will lean more to a standard of compassion than scientific clarity. In his closing remarks in June, Tom Powers, the Cedillos’ attorney, argued that their case was really about the social compact implied by immunization campaigns, and trust—“the trust that the Cedillos and other families had in the immunization system that they participated in. . . . They trusted the program and they now are trusting you . . . to adjudicate their claims fairly.”

Because we give vaccines to healthy children, often under threat of school exclusion, we are obliged to make sure these products are as safe as possible, and to compensate the child whom vaccines harm. But what Powers left out was the court’s responsibility to ensure that good science is used to make that fair adjudication. An excess of compassion, in this context, could bankrupt a fund set up to help children with real vaccine injuries. And in damaging public confidence in vaccines, it could promote the proliferation of vaccine-preventable disease. Where is the compassion in that?

Special to the Hoover Digest.