saying, ‘The head of department’s name is always
put on reports out of politeness. I was not part of
this work, but I have always trusted Mr Pearce’.
When the fraud was discovered, thanks only to a
whistleblower, both men found their careers effec-
tively ended.
The most commonly fabricated documents are
consent forms and patient diary cards. The diary
cards allegedly submitted by the patients of a gen-
eral practitioner (GP) in northern England were all
immaculately completed and in pristine condition.
This marked them out from the cards collected
from other investigational sites, which were dirty
and showed signs of frequent handling. Addition-
ally, the handwriting on all diary cards was very
similar, and an idiosyncratic mark made by the
investigator when he wrote was noted many times
on the diary cards. The doctor was found guilty of
fraud and his licence to practice medicine was
withdrawn.
Falsification: the deliberate distortion
or omission of undesired data/results,
including the dishonest
misinterpretation of results
William McBride, an Australian obstetrician,
wrote a letter to the Lancet in 1961 in which he
suggested that the drug Thalidomide, when given
to pregnant women, was causing severelimb defor-
mities in their babies. Nobody else had raised con-
cerns at that time about the dangers of this drug.
McBride’s hypothesis was based on limited anec-
dotal observations, but he was subsequently shown
to be right and thalidomide was removed from the
market. In 1982, he published research that showed
that the active substance in Debendox, a drug for
morning sickness of pregnancy, caused birth
defects in rabbits. The manufacturers took the
drug off the market, but no researchers could repro-
duce his work. It later transpired that McBride had
altered research results, and Debendox had no
teratogenic effects. Ten years later, McBride was
found guilty of scientific fraud by a medical tribu-
nal and removed from the Medical Register.
Manipulation of data is seen when attempts have
been made to show larger differences between
groups than really exist, to reduce the variability
of results or to invent extra data. In a study of
diabetic neuropathy, the results showed that there
was significantly better pain relief with the active
treatment than with placebo. However, at one
site the patients worst affected by the disease all
received active medication, while those least
affected were apparently randomly allocated to
placebo. Analysis of the patients at this site
showed statistically significant improvement on
the study drug, whereas analysis of the other
sites excluding that one site did not. It was found
that the investigator had a means of accessing the
randomization code so that he could allocate the
patients to what he had decided was the ‘correct’
medication, thus skewing the data to support his
hypothesis.
Plagiarism: the deliberate
unacknowledged presentation/
exploitation of the work and ideas
of others as one’s own
The culture in schools and universities seems
increasingly accepting of a certain amount of
plagiarism. A recent survey in the United King-
dom showed that 16% of respondents had plagiar-
ized work more than once and that a further 9%
had plagiarized once, most commonly by copying
material for essays from the Internet. The detec-
tion rate was only 3%. Although not actively
condoned, plagiarism is not always dealt with as
firmly as one might hope. Submitting another’s
essay as one’s own work may well amount to
fraud, and if it seems to have been accepted, one
barrier to committing further fraud has been
removed. Given the low rate of detection com-
pared with the rate of plagiarism, it would seem
that there needs to be significant attention paid to
the education of tomorrow’s researchers as to
what constitutes good scientific and ethical beha-
vior. This underlined by the fact that 24% of
those students who replied to the survey claimed
to have received no guidance as to what consti-
tuted plagiarism. Education of students and scien-
tists as they enter theirresearch career must,
therefore, include the concept of research honesty
and ethics, as well as trial design and methodol-
ogy.
49.4 WHAT CONSTITUTES RESEARCH FRAUD? 633