Suspected research fraud: difficulties of getting at the truth

Introduction

In April 1992 the BMJ published a randomised controlled trial on the effects of dietary intervention to prevent further heart attacks in susceptible patients.1 One of its key findings was that a year of a low fat, fibre rich diet almost halved the risk of death from all causes.

This study went on to become a “citation classic,” cited 225 times (at the time of writing), including in guidelines, and its lead author, Dr Ram B Singh, went on to publish many papers in other journals. During the process, he became the focus of a concerted, but informal, international investigation into suspicions of scientific misconduct and data fabrication, spanning well over a decade.

Suspicions are raised

After the publication of his paper in April 1992, Dr Singh submitted another study (manuscript 924479) to the BMJ in October that year. The study was a two year follow-up trial of the influence of diet and moderate exercise on cardiovascular health (the Indian diet heart study).

The external reviewer pointed out the absence of deaths from other causes, which he deemed “would be incredible.” Many of the risk factors “appear to move significantly in the desired direction,” he observed, concluding that “this trial may be reporting a more striking total benefit than most previously reported trials.”

The editorial committee also had several concerns about the reliability of the data, which were based on “questionnaire reports and poorly described assessments of food intake.” The participants were “extremely heterogeneous,” and no attempt had been made to control for the effects of smoking.

Other …