MOH Press Release in response to press statement issued on 6 July 2004 on behalf of Professor Simon Shorvon
8 July 2004
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08 Jul 2004
The press statement issued on behalf of Professor Simon Shorvon by the Medical Protection Society (ST, TODAY of Jul 8) is inaccurate and misleading.
In Singapore, 3 separate inquiries and hearings were conducted to look into allegations concerning the Research Project led by Professor Shorvon. These were:-
An inquiry conducted by the Ministry of Health ("the MOH Inquiry");
An inquiry commissioned by the National Neuroscience Institute on the direction of the National Healthcare Group Pte Ltd ("the NNI Inquiry"); and
Proceedings commenced by the Singapore Medical Council ("the SMC proceedings").
All 3 inquiries and hearings separately concluded that Professor Shorvon had seriously breached ethical and professional standards.
The MOH Inquiry
The MOH Inquiry examined the system and procedures relating to the ethics approval and conduct of the Research Project led by Professor Shorvon. It was held over two months. Fifty-three witnesses were called to give written and verbal evidence.
Professor Shorvon, who was the lead Principal Investigator of the project, gave a written submission in response to the allegations and appeared before the MOH Committee of Inquiry to provide clarification and further evidence.
Following a thorough review of the facts, documents and evidence, the Committee of Inquiry identified four key areas of breaches:
1) Ethics Approval Process
Professor Shorvon failed to provide the hospital ethics committees with important details of the study methodology in the research protocol for the Parkinson's Disease subjects. These details would include how potential subjects were to have been identified, and that "on-off" L-Dopa testing and videotaping of the movement of study subjects would be carried out. He misled the ethics committees into thinking that he was only going to extract blood.
2) Medical Confidentiality
Details on patient recruitment methodology were not provided to the hospital ethics committees for ethics approval and patients were recruited without the knowledge of their attending physicians.
3) Conduct of the Study
Written consent from study subjects for "on-off" L-Dopa testing and videotaping of the movement of study subjects was not obtained. Some of the study subjects even had their treatment regime modified (e.g. delaying the subject's usual dose of L-Dopa and, in some cases, substituting a normal-release equivalent for the subject's usual slow-release formulation). These tests were conducted without proper safeguards and exposed the study subjects to unacceptable risks.
4) Administration and Organisation of the Study
There was no clear definition of roles and responsibilities of the individual members of the project team, and no proper administration and organisation of the study.
The NNI Inquiry
The NNI Inquiry was a thorough inquiry into the nature and conduct of the Research Project. A full review of all available documents related to the Research Project and comprehensive interviews with individuals related to the Research Project were undertaken. A total of 55 witnesses gave evidence.
Professor Shorvon agreed to give evidence and was interviewed by the NNI Inquiry Panel. Throughout the inquiry process, Professor Shorvon was represented by Senior Counsel. Additionally, Professor Shorvon was given clear opportunity to refute the allegations against him. The NNI Inquiry Panel, upon review of all the evidence, concluded that the Research Project was badly managed and conducted unethically. In particular, it found that:
Patient confidentiality was breached;
Testing on human subjects was done without the approval of the relevant Ethics Committees;
Human subjects researched upon were exposed to risks. No competent medical assessment was made as to the suitability of the human subjects to be researched upon. The human subjects had been treated like guinea pigs; and
The human subjects did not give informed consent to the testing that was done on them.
The NNI Inquiry Panel produced a detailed report on its findings. On 22 March 2003, Professor Shorvon was given a copy of the NNI Inquiry Panel's Report. He was invited to give his comments.
On 31 March 2003, Professor Shorvon appeared, with his lawyers, before the Board of Directors of the National Healthcare Group Pte Ltd and said that he accepted the NNI Inquiry Panel's Report without qualification. Professor Shorvon also confirmed this in writing. Professor Shorvon's letter dated 31 March 2003 in response to Chairman, National Healthcare Group Pte Ltd's letter of 25 March 2003 are enclosed.
The SMC Proceedings
Professor Shorvon was, at the material time, a registered medical practitioner in Singapore. It was by virtue of such registration that he was entitled to carry out his duties as a neurologist at the National Neuroscience Institute. As a result of the NNI Inquiry, a complaint was lodged with the SMC against Professor Shorvon. The SMC has statutory obligations to uphold high standards of practice and ethics among medical practitioners in Singapore.
The SMC investigated the allegations against Professor Shorvon. Thirty charges relating to the following issues were brought against Professor Shorvon:-
That Professor Shorvon, as the lead Principal Investigator ("PI") for the Research Project and being responsible for the manner in which his research team had carried out the L-Dopa testing, had failed to safeguard the best interests of the Parkinson's Disease ("PD") subjects (patients) researched upon, thereby exposing them to unnecessary risks.
That Professor Shorvon, as the lead PI for the Research Project and being responsible for the manner in which his research team had carried out the L-Dopa testing, had failed to obtain informed consent from the PD subjects (patients) to the L-Dopa testing that was conducted on them;
That Professor Shorvon breached patient confidentiality in obtaining patients' medical data and records from Tan Tock Seng Hospital and Singapore General Hospital without the patients' consent for use in the Research Project; and
That Professor Shorvon carried out L-Dopa testing on human PD subjects (patients) without obtaining prior Ethics approval from the Tan Tock Seng Hospital Ethics Committee and the Singapore General Hospital Ethics Committee.
Professor Shorvon was given full opportunity to answer to the charges. However, he chose not to participate in the SMC proceedings.
The SMC held its Inquiry from 9 to 13 February 2004, 16 to 19 February 2004 and 24 February 2004 in respect of the 30 charges. At the conclusion of the Inquiry, the SMC Disciplinary Committee found Professor Shorvon guilty of all the 30 charges. The Disciplinary Committee took a very serious view of Professor Shorvon's misconduct. He was accordingly censured, struck off the Register of Medical Practitioners and fined.
The SMC had informed the General Medical Council of UK of the Complaints Committee's decision on 16 September 2003 and the outcome of the Disciplinary Committee's inquiry on 2 March 2004.
The Press Statement issued on behalf of Professor Shorvon
The press statement of 6 July 2004 wholly contradicts Professor Shorvon's earlier position taken in Singapore where:-
He clearly and unequivocally accepted the findings made by the NNI Inquiry Panel against him; and
He chose not to put forward any defence in response to the charges before the Disciplinary Committee of the SMC.