A recent study linking a component of vaccines to signs of autism in mice is about to be retracted after scientists thoroughly scrapped the study’s design, methods and analysis — and then, for the record, falsified data have discovered.
The original study, led by Christopher Shaw and Lucija Tomljenovic of the University of British Columbia, suggested that aluminum in vaccines may alter immune responses and trigger the development of autism. (Aluminium adjuvants are used in some vaccines to boost protective immune responses.) The study is just the latest in a long line of publications by the researchers who seem unwavering in their effort to expose putative neurotoxic effects of aluminum in vaccines, though dozens studies have found no evidence of such toxicity.
This isn’t the first time their work has faced sharp criticism and withdrawal; in fact, the researchers have been roundly criticized by colleagues, experts, and even the World Health Organization. In 2012, the WHO made the unusual attempt to specifically highlight two publications by Shaw and Tomljenovic, calling them “seriously flawed”. The WHO noted specific shortcomings of the work and noted a Food and Drug Administration review that strengthened the safety of aluminum in vaccines, which is supported by clinical trials and epidemiological evidence.
Criticism erupted again in 2015, including from David Juurlink, head of the department of clinical pharmacology and toxicology at the Sunnybrook Health Sciences Center in Toronto. “The reasoning used to support their various claims is extremely flimsy, and in several cases they draw conclusions from their data that no objective reader could ever 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Last year, another study by the pair was retracted and then completely withdrawn from the journal Vaccine, according to Retraction Watch.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 According to Vaccine, the study was withdrawn due to “serious concerns about the scientific soundness of the article.” (The study was republished in the journal later that year Immunological examinationafter revisions.)
Driver of controversy
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 the muscles, is how vaccines are delivered
- Using dosing regimens that make incorrect assumptions about mouse development and do not mimic childhood vaccination schedules
- Studying genes based on outdated literature
- Using an outdated and imprecise method to assess gene activity
- Use of inappropriate statistical tests
- “Clear and Conscious” Deletion of Control Data
- Is funded by private foundations that question the safety of vaccines, which is noted in the study. (A 2015 report noted that it received nearly $900,000 in grants from the foundations).
An online journal club, PubPeer, hosted a discussion in which scientists quickly discovered that data on gene activity (semi-quantitative RT-PCR results) and protein amounts (Western blots) had been manipulated, duplicated, and relabeled.
Science blogger The Mad Virologist did an independent analysis and concluded:
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 devastating thing about the paper. If the data was manipulated and images were fabricated, the paper should be retracted and UBC should investigate misconduct by the Shaw lab.
Similarly, David Gorski, a Wayne State University oncology professor and surgeon who blogs under the name Orac, called the study “anti-vaccine pseudoscience.” Dr. Gorski concluded:
Not only do we have poorly conducted and analyzed experiments, but we also have self-plagiarism and possibly scientific fraud.
John Dawson, the editor of the Journal of inorganic biochemistry, told Retraction Watch that “Shaw and colleagues’ paper is being retracted jointly by the authors and the editor.” A statement about the withdrawal will follow. Ars reached out to Dawson about the overall quality of the investigation and will update this story with his response.
In email comments to Ars, Shaw acknowledged problems with the data but took no blame.
We don’t know how some images in the manuscript were changed. We investigated when the first suggestions appeared in Pubpeer and confirmed that some 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 despite repeated inquiries from us. We keep asking these questions, but since she is now in a different facility, we can’t force her to comply.
Ars made several attempts to contact Li, but received no response. Shaw said she left the lab in 2015 and took the data with her. But she was still listed as being with UBC in the investigation, which was filed in January 2017. Shaw said this was a “proofreading error”.
Dan Li, also known as Alice Li, has hired a lawyer, according to Shaw. The attorney Shaw named did not immediately respond to Ars’ request for comment.
As for Shaw, he says the altered images “weren’t significant anyway.” He plans to repeat the work, but says the link between aluminum and autism has not been “debunked”.
In response to criticism from scientists online, Shaw was dismissive.
“Anti-vaccine” researcher is one ad hominem term thrown around rather loosely to anyone questioning any aspect of vaccine safety. It often comes from blogs and trolls, some of which are thinly disguised platforms for the pharmaceutical industry… Anyone who questions the safety of vaccines to any degree gets this nickname.
My opinion: I see vaccines as one of many useful medical interventions. Prophylactic medicine in all its forms is great, and vaccination is a way of dealing with infectious diseases with the aim of preventing them. But like other medical procedures, vaccines are not completely safe for all people and under all circumstances.
In follow-up questions, Shaw said if future data doesn’t support a link between autism and aluminum, he would reconsider his hypothesis and research. But there is reason to be sceptical. When the WHO criticized his work in 2012, pointing to a large number of studies proving the safety of vaccines, Shaw replied that the WHO “is entitled to its opinion”.