Andrew Wakefield is both revered and reviled. To a small group of parents, he’s a hero who won’t back down from his assertion that the measles, mumps and rubella (MMR) vaccine can cause autism.
To most, however, he’s the man who authored a fraudulent study that has been refuted many times and was retracted by the journal that published it, a man whose views carry dangerous consequences for all of us. They will tell you that the former doctor—stripped of his license in 2010 by the U.K.’s General Medical Council for ethical violations and failure to disclose potentially competing financial interests—has derailed public confidence in vaccination programs that were safely eradicating serious and highly contagious diseases.
In the wake of the most recent measles outbreak in the U.S.—which began at the Disneyland theme park in Southern California in late December 2014 and has since spread to 17 states and infected more than 100 people—Wakefield defends his views about the measles vaccine. “The responsibility lies squarely on the shoulders of those that have been involved in vaccine policymaking, which is totally inadequate and bordering on dangerous,” he says. “The government has only themselves to blame for this problem.”
The now-retracted paper that set the MMR-autism dominoes tumbling was published by Wakefield and a dozen co-authors in The Lancet in February 1998. It provided case histories for 12 children, exploring incidences of chronic enterocolitis, inflammatory bowel disease and regressive developmental disorder—as well as immunization with the MMR vaccine. “In eight children, the onset of behavioral problems had been linked, either by the parents or by the child's physician, with measles, mumps, and rubella vaccination,” the authors wrote.
Vaccination rates in the U.K. plummeted after publication of that paper, and the study helped launch the anti-vaccine movement in the U.S. In a National Consumers League survey conducted in the U.S. last year, one-third of parents with children under the age of 18 and 29 percent of adults overall believe that vaccinations can cause autism.
In the 1980s, the U.S. Centers for Disease Control and Prevention (CDC) launched efforts to curb measles outbreaks by increasing immunization rates, says Dr. Robert Amler, who led the push. The CDC worked with state legislatures to require every child to provide proof of immunization in order to enroll and stay in public or private school, and began to see reductions in measles cases within four or five years. By 2000, indigenous transmission of measles was stamped out in the U.S., according to Dr. Walter Orenstein, chair of the National Vaccine Advisory Committee and former director of the CDC's National Immunization Program.
But measles has been coming back of late, and 2014 saw the highest measles cases count (more than 600) since the disease was declared eradicated in the U.S., the CDC says. And there were more cases of measles in January 2015 than in all of 2012. Between January 1 and February 6, 121 cases of measles were reported.
Wakefield dismisses the notion that he bears any responsibility for the current outbreak, despite decreasing vaccination rates in some parts of the country and the perpetuated fear of an MMR-autism link: “The people who put the blame on me are really just displacing their inadequacy on others.”
He points out that his now infamous study never asserted a causal relationship between the MMR vaccine and autism. “We merely reported the parent’s description of what happened to their children, and the clinical findings,” he says. “We made no claims about the vaccine causing autism. In fact, we said this does not prove an association. And all we urged was further research.” The authors of the paper wrote at the time, “We did not prove an association between measles, mumps, and rubella vaccine and the syndrome described."
However, during a press conference two days before the paper’s publication, Wakefield was already pushing for the use of separate vaccines over the combined MMR. “With the debate over MMR that has started,” he said then, “I cannot support the continued use of the three vaccines given together. We need to know what the role of gut inflammation is in autism…. My concerns are that one more case of this is too many.”
Asked recently whether he still believes the MMR vaccine causes autism, Wakefield responded unequivocally. “Yes, I do. I think MMR contributes to the current autism epidemic.”
For years, Wakefield has repeatedly stated his opinion that the risk lies with the MMR vaccine—not single vaccines. “MMR does not protect against measles,” he says. “Measles vaccine protects against measles.” He argues that the reason we are seeing more cases is because the U.K. and U.S. governments took the single vaccines off the market, leaving the MMR as the only option—and that, increasingly, parents reject that option.
Merck, the maker of MMR, stopped making the three monovalent (or single) vaccines for measles, mumps and rubella in 2008 due to manufacturing constraints, a company spokeswoman says. In 2009, based on input from the CDC’s Advisory Committee on Immunization Practices, customers and professional societies such as the American Academy of Pediatrics and the American Academy of Family Physicians, Merck decided not to resume production of the single vaccines and to focus resources on the combined MMR vaccine.
Today most public health officials stand by the combined vaccine. “There was no evidence for the need for individual vaccines,” says Orenstein. “The safety was thought to be comparable. It avoided three injections and extra visits and made it easier to get children protected.”
Moreover, the combined vaccine makes sense, says Amler. The body is designed to handle multiple things at once, and it has been “shown again and again that giving more than one antigen” at a time creates “no increase in side effects or adverse effects.” On the other hand, if health care providers were to administer antigens individually, it would lead to more doctor visits and would “hurt the chances that the child is going to get fully protected on time.”
Critics have contended that Wakefield’s advocacy for a single measles vaccine is financially motivated. Investigative journalist Brian Deer claimed in his scathing takedown in the BMJ that Wakefield used fraudulent data gathered, as the General Medical Council found, with “callous disregard for the distress and pain the children [subjects] might suffer.” Deer also revealed that Wakefield had filed an application at the U.K. patent office for a new “vaccine/therapeutic agent” for measles and inflammatory bowel disease in June 1997, several months before the Lancet study was published.
Today, Wakefield claims that patent was not for a vaccine. "What we had was a naturally occurring substance that occurs in breast milk. It’s not a drug or vaccine, it’s a nutritional supplement, but it boosts the immune system."
While he continues to champion the single vaccine and to blame government regulators for suggesting that it be discontinued, Wakefield is also pushing an MMR-autism connection. Asked if he had done further research to prove a causal link, Wakefield said he had published roughly 15 additional papers that dealt with the gastrointestinal disease that linked the MMR vaccine to autism.
Almost all of the medical community disagrees with him. Several studies have put his hypothesis to the test and looked at thousands of children, not just 12. A 1999 study of 498 children published in The Lancet did not support a causal association between MMR and autism. A 2002 study of 535,544 children vaccinated in Finland showed no association between MMR vaccination and encephalitis, aseptic meningitis or autism. Another 2002 study, which looked at 537,303 children born in Denmark, provided “strong evidence against the hypothesis that MMR vaccination causes autism,” the authors wrote. Wakefield takes issue with the Danish study, saying that the methodology was flawed.
However, though it’s difficult to prove a negative, Amler argues that “study after study after study has failed to show association. [It’s] simply not there.”
In a rigorous 2012 immunization safety review looking at “Adverse Effects of Vaccines: Evidence and Causality,” the Institute of Medicine (IOM) reviewed 22 studies related to vaccines and autism. The nonprofit, which Orenstein calls an “independent group not influenced by industry or government,” chose the same Danish study as one of only a handful that did not have serious limitations or flaws in design or methodology. Ultimately, the review rejected a causal relationship between the MMR vaccine and autism.
Wakefield says the CDC has known for years about an association between the MMR vaccine and autism and created a “smokescreen” to “protect special interests.” He has received, he says, 5,000 pages worth of documents, transcripts and recordings from a whistle-blower that “confirm beyond a shadow of a doubt that CDC were involved in fraud to cover this up.”
Claims of a CDC cover-up, Orenstein says, are based on a 2014 paper titled “Measles-mumps-rubella vaccination timing and autism among young African American boys: a reanalysis of CDC data,” by Brian Hooker, which was published in the journal Translational Neurodegeneration. That paper reevaluated a data set from a 2004 study undertaken by CDC researchers and published in Pediatrics; Hooker reported that African-American boys who received the MMR vaccine before 24 or 36 months of age were more likely to be diagnosed with autism. However, like Wakefield’s 1998 Lancet study, it was later retracted because of undeclared competing interests as well as “concerns about the validity of the methods and statistical analysis,” the editors wrote. “The Editors no longer have confidence in the soundness of the findings.”
Two documents Wakefield sent to Newsweek, recent letters submitted by Wakefield and Hooker to the CDC and the U.S. Department of Health and Human Services, allege that the CDC researchers who wrote the 2004 study reformatted age groups and replaced school records with birth certificates (in order to deceptively exclude some participants) to avoid reporting a statistically significant increase in autism.
In a statement published on its website, the CDC explained it chose to include only children with birth certificates rather than all the children because these documents offered information on additional characteristics that could be risk factors for autism, such as a child’s birth weight, the mother’s age and education, which school records did not.
It also said the findings showed that vaccination between 24 and 36 months was slightly more common among children with autism. “This finding was most likely a result of immunization requirements for preschool special education program attendance in children with autism,” the CDC says. It did not comment on the alleged reformatting of age categories in its statement and did not respond to Newsweek’s request for comment.
“Additional studies and a more recent rigorous review by the Institute of Medicine have found that MMR vaccine does not increase the risk of autism,” CDC reiterated in its statement.
Wakefield takes strong issue with the CDC and calls for the establishment of an independent organization, “like the FAA, that investigates allegations of vaccine injury and conducts the science. We need to take all financial and political incentive out of it and put child safety above everything else.”
But other federal agencies that seem to have little stake in the vaccination program have come to similar conclusions. The U.S. Court of Federal Claims issued a decision in 2009 as part of its Omnibus Autism Trials in the case of Cedillo v. Secretary of Health and Human Services, in which Special Master George L. Hastings Jr. wrote, “Considering all of the evidence, I found that the petitioners have failed to demonstrate that...the MMR vaccine can contribute to causing either autism or gastrointestinal dysfunction.”
Recently, the federal Vaccine Injury Compensation Program awarded millions of dollars to two children with autism. However, the case documents are sealed, and it is unclear whether the vaccine-induced encephalopathy cited in both cases had anything to do with the children’s diagnoses of autism.
Meanwhile, Amler says that the CDC continuously evaluates and reevaluates its immunization recommendations. For example, he says, a rotavirus vaccine introduced in the late 1990s turned out to have an uncommon complication after moving from trials into widespread use. Although it was a rare complication and “in aggregate, less severe [a problem] than all the babies admitted with rotavirus,” Amler says, the CDC pulled it. The rotavirus vaccine now given to babies was introduced years later and has not resulted in the same kinds of complications.
“We do have mechanisms to evaluate and make changes when the data or science shows that there are risks that were unanticipated or when the benefits no longer outweigh the risks,” says Orenstein. He explains that the Advisory Committee on Immunization Practices works as a built-in safeguard at the CDC to make new recommendations when necessary and to develop the routine immunization schedule along with the American Academy of Pediatrics and the American Academy of Family Physicians.
While Wakefield insists that the “the dam is about to burst” and we’ll all soon see that he’s been right all along, major professional organizations like the American Academy of Pediatrics and groups like Autism Speaks continue to emphasize the safety and efficacy of the MMR vaccine and urge parents to fully vaccinate their children. The bottom line, says Amler, is that all the evidence points to the fact that “being exposed to the measles virus is a greater threat than any side effect or adverse reaction.”