by Todd Neale
The status of a new inflammatory bowel condition identified in the retracted Lancet paper that linked the MMR vaccine and autism — autistic enterocolitis — appears to be in limbo.
The 1998 paper by Andrew Wakefield, MBBS, and colleagues was fully retracted by The Lancet in February, although the alleged and repeatedly disproven vaccine link was dropped in 2004 after 10 of the 13 study authors rejected the claim.
It was revealed that year that Wakefield received funding — secretly — from plaintiffs’ lawyers in suits against vaccine makers.
According to journalist Brian Deer, who conducted the investigation for London’s Sunday Times that ultimately led to the exposure of inconsistencies in the study and the paper — and a conclusion by the U.K. General Medical Council that Wakefield was dishonest and unethical — the full retraction calls into question all of the findings, not just the vaccine-autism link.
“Now the Lancet paper is retracted, its findings don’t officially exist,” Deer wrote in a news feature in BMJ.
That includes the nonspecific colitis identified in 11 of the 12 children with developmental disabilities, which Wakefield dubbed “autistic enterocolitis.”
According to Deer, Wakefield still believes the disease is real. He started a clinic in Austin, Tex., called Thoughtful House Center for Children, to conduct research and treat the condition, but recently stepped down as its head.
In BMJ, Deer described the evolution of the histopathological findings in the Lancet study.
When the pathology department used by the study investigators initially analyzed the biopsy samples, it concluded that they were normal, with possible disease in one child.
However, Deer wrote, “this inflammation resolved after two months’ enteral feeding with a product now marketed as Modulen. A repeat ileocolonoscopy found no abnormality, and a food intolerance was diagnosed.”
But after a secondary, unplanned review of the samples by three of the study authors, 11 of the 12 children were determined to have nonspecific colitis.
In an accompanying BMJ editorial, Nicholas Wright, MD, PhD, warden of Barts and The London School of Medicine and Dentistry, wrote that “nothing is intrinsically wrong with such a review, but this process should have been controlled, monitored, and led by the professional pathologists in the team. It is by no means clear that this is what happened.”
The samples are no longer available, but pathology reports for all but one of the children are.
Deer showed them to independent experts, including Karel Geboes, MD, PhD, a professor in the gastrointestinal pathology unit of the Catholic University of Leuven in Belgium.
Geboes determined from the reports that eight were normal and “three showed focal active colitis (of unclear significance),” Deer wrote.
“So is autistic enterocolitis just a normal finding in biopsy specimens from autistic children? Wakefield says ‘No’: the disease is real,” Deer continued.
“But recent analyses of fecal calprotectin (a marker for possible inflammatory bowel disease) and stool patterns in autistic children have failed to find any distinctive inflammation,” he wrote.
In addition, he noted, a recent review reported in Pediatrics, “while stressing a need for better gastrointestinal services, hasn’t identified anything special in autistic patients.”
In his editorial, Wright concluded that, “in view of the lack of data and the entrenched position of many of the protagonists and antagonists, any firm conclusion [about the existence of autistic enterocolitis] would be inadvisable.”
Todd Neale is a MedPage Today staff writer.
Originally published in MedPage Today. Visit MedPageToday.com for more pediatrics news.