A recent study linking a component of vaccines to signs of autism in mice is set for retraction after scientists thoroughly demolished the study’s design, methods, and analysis—and then, for good measure, spotted faked data.

The original study, led by Christopher Shaw and Lucija Tomljenovic of the University of British Columbia, suggested that aluminum in vaccines can alter immune responses and trigger the development of autism. (Aluminum adjuvants are used in some vaccines to boost protective immune responses.) The study is just the latest in a long line of publications from the researchers who appear unwavering in their effort to reveal supposed neurotoxic effects of aluminum in vaccines even though dozens of studies have found no evidence of such toxicity.

This isn’t the first time their work has drawn sharp criticism and a retraction; in fact, the researchers have been roundly criticized by peers, experts, and even the World Health Organization. In 2012, the WHO made the unusual effort to specifically call out two of Shaw and Tomljenovic’s publications, calling them “ seriously flawed .” The WHO laid out specific failings of the work and noted an assessment by the Food and Drug Administration that reinforced the safety of aluminum in vaccines, which is backed by clinical trial and epidemiological evidence.

In 2015, criticism erupted again, including a hammering from David Juurlink, head of the division of clinical pharmacology and toxicology at Toronto's Sunnybrook Health Sciences Centre. “The lines of reasoning used to support their various assertions are exceedingly thin, and in several instances, they draw inferences from their data that no objective reader could possibly draw,” he told The Globe and Mail at the time. UBC defended Shaw and Tomljenovic, citing academic freedom.

Last year, another study by the pair was pulled, then fully retracted from the journal Vaccine, according to Retraction Watch. The study claimed that aluminum adjuvants in the human papillomavirus (HPV) vaccine Gardasil caused behavioral changes in mice. According to Vaccine, the study was retracted due to “serious concerns regarding the scientific soundness of the article.” (The study was republished later that year in the journal Immunologic Research, after revisions.)

Controversy booster

Scientists had similar complaints about the researchers' new mouse study, which was published in the Journal of Inorganic Biochemistry. In a series of blogs and forum posts, scientists pointed out flaws and weaknesses throughout the study, including, but not limited to:

Injecting aluminum under the rodent’s skin, rather than into muscles, which is how vaccines are delivered

Using dosing regimens that make incorrect assumptions about the development of mice and do not mimic vaccine schedules in children

Studying genes based on outdated literature

Using an outdated and inaccurate method to assess gene activity

Using inappropriate statistical tests

“Clear and deliberate” removal of control data

Being funded by private foundations that question the safety of vaccines, which is noted in the study. (A report in 2015 noted that it had received nearly $900,000 in grants from the foundations).

An online journal club, PubPeer, hosted a discussion where scientists quickly spotted that data on gene activity (semi-quantitative RT-PCR results) and protein amounts (Western blots) had been manipulated, duplicated, and re-labeled.

Science blogger The Mad Virologist did an independent analysis, concluding:

There are irregularities in both the semi-quantitative RT-PCR and Western blot data that strongly suggest that these images were fabricated. This is probably the most damning thing about the paper. If the data were manipulated and images fabricated, then the paper needs to be retracted and UBC needs to do an investigation into research misconduct by the Shaw lab.

Similarly, David Gorski, an oncology professor and surgeon at Wayne State University who blogs under the name Orac, called the study “anti-vaccine pseudoscience.” Dr. Gorski concluded:

Not only do we have poorly done and analyzed experiments, but we also have self-plagiarism and, quite possibly, scientific fraud.

John Dawson, the editor of the Journal of Inorganic Biochemistry, told Retraction Watch that “the paper by Shaw and co-workers is being retracted jointly by the authors and the editor.” A statement on the retraction is forthcoming. Ars reached out to Dawson about the study's overall quality and will update this story with his response.

In e-mail comments to Ars, Shaw acknowledged problems with the data but took no blame.

We don’t know how some images in the manuscript came to be altered. We investigated when the first suggestions came out in Pubpeer and confirmed that some of the images had indeed been manipulated. We don’t know by whom or why. The first author, Dr. Dan Li, denies doing anything wrong, but has not provided any information about this in spite of repeated questions from us. We are continuing to pursue these questions, but as she is now at another institution, we can’t force her to comply.

Ars made several efforts to get in touch with Li but has received no response. Shaw said she left the lab in 2015 and took the data with her. But she was still listed as being at UBC on the study, which was submitted in January 2017. Shaw said this was an “error in proofreading.”

Dan Li, who also goes by Alice Li, has retained a lawyer, according to Shaw. The lawyer Shaw named did not immediately respond to Ars’ request for comment.

As for Shaw, he says the altered images “were not significant anyway.” He plans to repeat the work but says that the link between aluminum and autism has not been “debunked.”

In response to the criticisms from scientists online, Shaw was dismissive.

“Anti-vaccine” researcher is an ad hominem term tossed around rather loosely at anyone who questions any aspect of vaccine safety. It comes often from blogs and trolls, some of which/whom are thinly disguised platforms for the pharmaceutical industry... Anyone who questions vaccine safety to whatever degree gets this epithet. My view: I see vaccines as one of many useful medical interventions. Prophylactic medicine in all of its forms is great, and vaccination is a way to address infectious diseases with the goal of preventing them. But, much like other medical interventions, vaccines are not completely safe for all people, nor under all circumstances.

In follow-up questions, Shaw said that if future data does not support a link between autism and aluminum, he would reconsider his hypothesis and research. But there’s reason to be skeptical. When the WHO criticized his work in 2012 and pointed out a large body of research showing vaccine safety, Shaw responded that the WHO is “entitled to its opinion."