http://www.timesonline.co.uk/tol/news/uk/health/article3642927.ece
Dr Sharma was a prominent psychiatrist who often appeared on the BBC
and wrote books on mental illness
Rajeev Syal
A psychiatrist is expected to be struck off this weekend after being
found guilty of conducting unethical drug tests on mentally ill
patients.
Tonmoy Sharma, a former lecturer at the Institute of Psychiatry,
wrongly recruited patients in unsolicited telephone calls without
contacting their nurses or carers, the General Medical Council has
found. After being paid to conduct the tests by drug companies, he
failed to seek proper approval from medical bodies and then misled
the companies about his methods.
He also wrongly described himself as being a professor and falsely
claimed that he had a PhD.
The General Medical Council ruling, which examined Dr Sharma's
research over ten years, could force the pharmaceutical industry to
reexamine the way in which research on psychiatric drugs is
commissioned and conducted.
A report by the GMC's Fitness To Practise panel concluded this week
that Dr Sharma had put mentally unwell patients at risk and ethical
rules had been wilfully flouted.
"The findings of the panel indicate serious failings of personal
integrity and honesty, of good clinical research practice, as regards
to potential welfare of patients and participants in ethical
research . . . which risks bringing the reputation of the medical
profession into disrepute.
"The panel has found that the facts proved against you would not be
insufficient to support a finding of serious professional
misconduct," it reads.
Dr Sharma, 42, who trained in India, was a prominent psychiatrist who
often appeared on the BBC and wrote books on mental illness.
Leading drug companies such as Novartis and Sanofi paid him from 1996
to conduct trials of antipsychotic drugs on patients with
schizophrenia and Alzheimer's disease.
He worked as a consultant psychiatrist for the South London and
Maudsley NHS Trust and recruited patients in Kent and parts of the
capital for the research, according to reports.
His position at the institute helped him to secure funding, said to
be almost £1 million, from five drug companies. Most of the money was
channelled through a private company that he had set up called
Psychmed.
The Association of the British Pharmaceutical Industry asked the GMC
to examine his conduct two years ago after concerns that he had
failed to obtain proper approval from ethical committees to conduct
the tests.
These approvals are vital in any trial to protect the patients taking
part.
The panel found that during 2003 patients were recruited to Dr
Sharma's studies by telephone and without any contact with their GPs
or psychiatric nurse of carer, and without adequate information about
the tests themselves. This was unprofessional, risked patient care
and risked patient welfare, the GMC concluded.
On a number of occasions, Dr Sharma failed to obtain approval from
proper ethical committees before testing drugs on patients.
The companies that paid for the research were also misled, according
to the GMC report. Dr Sharma was commissioned to conduct work by the
drug company Eli Lilly and the Janssen Research Foundation. He
instead chose to use identical patients for both studies and tried to
conceal this from the bodies. As a result some patients underwent MRI
scans and tests that had not been approved by the patients or by an
ethics committee.
"The panel is satisfied that in acting the way you did your intention
was to conceal from each sponsor the fact that you were using the
identical group of patients for their studies," the report says. "As
a consequence, the patients were subjected to tests beyond those
approved . . . The panel is satisfied that your conduct towards them
[the companies] was dishonest. It was also unprofessional and not in
the best interests of the study patients."
In April 1999 Dr Sharma became the main investigator for a study on
behalf of Novartis into the effect of the Alzheimer's drug Exelon.
The GMC found that Dr Sharma generated a misunderstanding that the
Novartis study was affiliated to the Institute of Psychiatry. He also
tried to disguise that the research was being conducted by his
company Psychmed, not the institute.
The GMC's panel will consider today whether Dr Sharma is guilty of
serious professional misconduct. Insiders say that he can expect to
be struck off the medical register.
Mr Sharma, who represented himself during the GMC hearing, could not
be contacted yesterday.
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