BMJ Retracts 1989 Paper by 'Rogue' Scientist

Veronica Hackethal, MD

November 04, 2015

The BMJ has retracted a study published in 1989 after determining its findings were fraudulent. The retraction comes amid long-running controversy about scientific misconduct by senior author Ranjit Kumar Chandra, MD, PhD, formerly from Memorial University in St John's, Newfoundland. Dr Chandra is an internationally renowned nutrition researcher who has received numerous awards.

The retracted study was supported by the National Health Research Development Programme, Health and Welfare Canada, and the Mead Johnson Canada division of Bristol Myers. It claimed to be a randomized trial in which women with a family history of atopy and who planned to breast-feed were randomly assigned either to dietary avoidance of five common food allergens or to an unrestricted diet. Mothers without plans to breast-feed were randomly assigned to hypoallergenic casein hydrolysate, soy milk, or cow's milk formulas, all made by Mead Johnson Canada.

The authors claimed there were fewer and milder cases of eczema among babies who received casein hydrolysate compared with the soy and cow's milk formulas. Likewise, the researchers reported fewer and milder cases of eczema among breast-fed babies whose mothers followed a restricted diet compared with breast-fed babies whose mothers had unrestricted diets. The authors recommended that women with a family history of atopy avoid certain allergenic foods while breast-feeding, and that formula-fed babies of such mothers should drink formula with casein hydrolysate.

In a feature article published October 28 in the BMJ, freelance journalist Caroline White detailed the longstanding controversy about Dr Chandra.

Initial suspicions about Dr Chandra go back to 1993, when Vincent Osundwa, MD, who occupied the office next to Dr Chandra's research nurse Marilyn Harvey, questioned his scientific conduct. In 1994, Harvey reported to Memorial University that Dr Chandra may have falsified data, which triggered a preliminary internal investigation. Dr Chandra later tried to sue Harvey.

In 1995, Memorial did a second investigation called the Klefte report, which found Dr Chandra guilty of scientific misconduct, although the university failed to make these findings public. Investigators could not locate Dr Chandra's raw data, which Dr Chandra may have thrown away, according to White. The report highlighted Dr Chandra's "remarkable lack of communication and openness" in his research, including very little involvement with coauthors.

The university failed to act on the report's findings because Memorial is a publicly funded institution and Dr Chandra had threatened to sue, White reports.

In 2002, the BMJ rejected a follow-up to a study Dr Chandra had previously published in the Lancet in 1992. Peer review had raised doubts about whether Dr Chandra, as the only author, could have conducted such a large trial, and that "the data had all the hallmarks of being entirely invented." The prior 1992 study had claimed that a vitamin supplement patented by Dr Chandra improved memory in older people.

The BMJ raised concerns to Memorial, which replied that no case existed, while neglecting to mention the Klefte report. The BMJ requested raw data for examination, but Memorial declined, saying Dr Chandra had taken an unpaid leave of absence and had not responded to requests.

Dr Chandra then resigned after 27 years at Memorial and moved to Switzerland and India. In the meantime, Nutrition published the rejected BMJ paper. A study with similar conclusions as the Nutrition paper was also published in Nutrition Research, a journal founded and edited by Dr Chandra. One of the authors of that paper, Amit Jain, has never been identified.

In 2003, a letter to the Lancet raised doubts about the original 1992 Lancet study, stating that "some of the standard errors were statistically impossible." Yet, after review, the Lancet did not retract the paper. Also in 2003, a letter and editorial raised serious doubts about the 2001 Nutrition study.

In 2004, the Canadian Institute of Health Research said it could not investigate the Lancet and Nutrition papers because they did not fund the studies.

In 2005, Nutrition finally retracted the 2001 study, after which Dr Chandra threatened a $5 million lawsuit.

In 2006, a three-party documentary about Dr Chandra's scientific misconduct and possible financial deception aired on CBC. The series finally made the Klefte report public. In turn, Dr Chandra sued CBC, Jack Strawbridge (director of faculty relations at Memorial University), and Memorial for $132 million. Memorial later settled out of court with Dr Chandra. The court ruled in favor of CBC and ordered Dr Chandra to pay court fees.

In 2007, another independent report by Memorial found that the integrity of the institution's research procedures were "sound" and recommended further investigation into Dr Chandra.

Who Is to Blame?

Marc Masor, PhD, who managed and monitored Dr Chandra's infant formula study, believes Memorial is "ultimately culpable," and that the companies who funded the studies also share the guilt.

"If they were properly monitored, how could [Mead Johnson] possibly 'lose track of the study' [as it had told CBC], and how could Nestlé not be aware that their studies were published before the subjects were even enrolled?" Dr Masor rhetorically asked White.

In a statement to the BMJ, Catherine O'Brien, vice president of corporate affairs at Nestle Canada, said blame also falls on the journals who published the fake data, because they have a responsibility to ensure the accuracy of the scientific record.

Michael Meguid, MD, PhD, the editor of Nutrition, said he "accepts the blame," admitting he was "bamboozled" by Dr Chandra's reputation and "the lure" of publishing the follow-up of a study published in the Lancet, which could boost Nutrition's impact factor.

"[T]here's no question that an aura around an individual as being a good and important scientist and a man of distinction influences one's perception," Dr Meguid told White.

Dr Chandra has published more than 200 studies. So far, only the Nutrition and BMJ articles have been retracted. The BMJ has also contacted six journals listed in the Klefte report, and four have said they will review these issues.

Dr Chandra currently works as the managing director of a company based in India called Peridot Life Sciences, which sells nutritional supplements and has attracted the attention of the Indian government. Altogether, Dr Chandra has amassed about $2 million hidden in a "labyrinth of bank accounts," including offshore accounts, according to White. Dr Chandra claims the funds are held in trust for research purposes. He has refused to comment to the BMJ.

In a related editorial, Richard Smith, former editor-in-chief of the BMJ, and Fiona Godlee, current editor-in-chief of the BMJ, highlight claims made in the CBC programs that Dr Chandra received "substantial funding" for studies he never carried out, as well as the vitamin business he established, for which he used "fraudulent studies to encourage sales." Dr Chandra's case is "egregious," and "a major failure of scientific governance," they assert.

"This saga highlights a collective failure to defend the integrity of science," they write. "It is shameful that the university, Canadian authorities, and other scientific bodies have taken no action against Chandra and that is [sic] has been left to the mass media to expose his fraud. The biggest failing lies with the university."

The university, Canadian authorities, and the scientific community should learn from this case, the editors urge, by conducting an independent public inquiry and sharing its findings with the world. Moreover, they raise the possibility that scientific misconduct should become a criminal offense.

"All human activity includes misconduct, and there will be rogue scientists. What matters is how we respond when it occurs," they emphasize. "Science still has time to put its own house in order, but that time may quickly pass."

White has disclosed no relevant financial relationships. Smith, the former editor-in-chief of the BMJ, has appeared in the CBC programmes and gave evidence on behalf of CBC in the libel trial against it. He had his expenses paid to travel to Toronto but was not paid a fee.

BMJ. 2015;351:h5683, h5694. Feature full text, Editorial full text

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