Principles and Practice of Pharmaceutical Medicine

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13 visit dates coincided with the investigator’s own
holiday. Some of the ECGs and X-rays had been
tampered with to remove dates and patient identi-
fication. Perhaps the most damning evidence was
that patients at this site showed an apparent rise in
drug metabolite levels at a time point when all
other sites recorded a fall, and they reported one-
eighth of the number of adverse events of other
sites. Anderton had his name erased from the
Medical Register after being found guilty of
serious professional misconduct.


Inappropriate attribution of authorship
and gifted authorship on publications


Of all the abuses of scientific research, gift author-
ship is the most common and the most lightly
regarded. This is nowhere better illustrated than
in the Pearce/Chamberlain case described above.


Inciting others to be involved
in research misconduct


Robert Fiddes was an eminent researcher in the
United States. In a lengthy and detailed fraud run-
ning over several years he changed patient notes to
show that they had a specific false condition, and
instructed his study staff to buy bacteria from a
commercial supplier and send it to testing labora-
tories under the names of patients. He used cervical
smears from other sources and entered the results
into the patient notes, and used blood from employ-
ees, passing it off as being from patients. He made
his staff wear Holter monitors and took ECGs from
them, again claiming that they were taken from
patients. Despite pharmaceutical company and
FDA inspections, the fraud was only recognized
when a former employee blew the whistle. Fiddes
was sentenced to 15 months in prison, and fined
almost a million US$.


Collusion in or concealment of research
misconduct by others


The General Medical Council (GMC), the United
Kingdom’s governing body for doctors, has made it


clear that a doctor’s failure to report allegations or
evidence of scientific fraud and misconduct to the
appropriate body, if he or she suspects research
fraud, will result in that doctor also facing disci-
plinary action. This happened to Prof Timothy
Peters, who knew that a colleague, Anjan Banner-
jee, had fabricated data in a clinical trial and did
not report it. Both men were found guilty of
serious professional misconduct: Dr Bannerjee
was suspended and Prof Peters received a severe
reprimand. His punishment was less than it might
have been because of his previous exemplary
career and because the case was already 10 years
old.
However, it is not uncommon for those who
expose the wrongdoing of others in any area to
experience negative consequences, despite legisla-
tion to provide a framework and protection for
them. Damage to whistleblowers who act in good
faith can usually be avoided, but it is essential that
they are properly assessed and managed by some-
one experienced in the role.
Perhaps this, in part, explains why more biome-
dical fraud is not exposed, even though it may have
been recognized. For example, it took some years
before Phil Vardy reluctantly blew the whistle on
McBride. He was not the only whistleblower to
become a victim. Dr David Edwards was a partner
in Geoffrey Fairhurst’s General Practice in the
United Kingdom when he reported Fairhurst to
the GMC for research misconduct. There was a
long wait for a hearing, during which his marriage
came under extreme stress. After the guilty verdict
on Fairhurst he had graffiti sprayed on his surgery
door by angry patients, and was faced with finan-
cial ruin for some time.

Malicious unfounded accusation
of misconduct against another

It is perhaps fear of being shown to be wrong that
holds many back from making allegations of
research fraud. The term of whistleblower does
not have a good connotation and is being widely
replaced by such euphemisms as ‘Open-Practice
Policy’. It is in an attempt to minimize risk both to
those who report suspected fraud and to those

49.4 WHAT CONSTITUTES RESEARCH FRAUD? 635
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