During 1986, Reckitt and Colman undertook a clinical trial on a new antidepressant medicine, for which it required a number of consultant psychiatrist investigators. One such doctor, much respected in Durham, the city where he was employed as a hospital consultant, was Dr VA Siddiqui.6
This doctor presented all the data needed for the 15 patients he had entered into a clinical trial following a long session one Saturday afternoon when he had sat down and invented much of it. The record forms were all too neat, and were all submitted at the same time; this raised doubts in the mind of the CRA, and thence of the medical adviser, in charge of the trial. This doctor happened to be one of a number of consultants taking part in a pivotal study for a new tricyclic antidepressant - sadly, unbeknown to the CRA, he was involved in seven other trials at the same time, many of them potentially sharing the same patient population. The local ethics research committee had expressed mild surprise that he had submitted so many trial protocols for approval, but had never queried whether he could manage them all at the same time. His reputation in his home city was one of great dedication to duty.
When the data arrived, unexpectedly complete in view of the recruitment difficulties that the doctor had reported, the CRA went to great lengths to check the source data, and found considerable difficulty in doing so. For some reason, the doctor chose to refer his haematology and biochemistry specimens to two different laboratories - one in Durham and one in Bishop Auckland. Neither laboratory had any data at all for one patient, but both laboratories had some data for all the other patients, but not what the investigator had submitted to the company. When challenged by the medical adviser, he denied that he had fabricated any of the information, claiming that, under stress at the time, he had handed the management of this particular trial to his registrar. He could not remember her name, and she had now left. At this stage the Regional Health Authority was asked for its help - not to investigate a possible crime, because there was no evidence of harm to any patients - but to supply the name and new address of the registrar. She was written to by the company at this address, several hundred miles away, and in her reply she indignantly and forthrightly denied that she had had anything whatsoever to do with her previous consultant's research projects. Because he had so many, she and her colleagues never had time to do anything other than look after all the NHS patients who, she implied, rather suffered from her erstwhile chief's involvement in other things.
The case was a strong one, and the ABPI assisted the member pharmaceutical company to bring the doctor's activities to the attention of the General Medical Council by means of a simple statutory declaration. The case was considered by the professional conduct committee. The doctor concerned was found guilty of serious professional misconduct, and his name was erased from the Medical Register.
The immediate aftermath was most unfortunate. Because there was no local mechanism for investigating this sort of misconduct, no one locally knew anything about it, and the doctor involved certainly did not talk about it. When the news broke that evening, the local paper carried banner headlines - and the local medical community was horrified and incredulous. How dare the ABPI and a pharmaceutical company do this to one of their highly respected colleagues? That was the last time they would have anything to do with that particular company, and they banned the company from access to the Postgraduate Medical Centre forthwith. Fortunately, the Regional Medical Officer and the Clinical Tutor agreed to a meeting with the ABPI, which was held on site in Durham, at which it was possible to relate the facts - specifically the iniquities of the doctor and the integrity of the GMC - to representatives of the local doctors. The status quo ante was restored as a result, but the immediate effect had been disastrous.
There is no doubt that this was a pivotal case. Despite the initial adverse response, on reflection it was appreciated that appropriate action had indeed been taken against a doctor who had fabricated data, falsified the results of a clinical trial, and exploited both his patients and the pharmaceutical company. It was realised that any pharmaceutical company that did not take action against a doctor committing fraud or research misconduct would itself be vulnerable; the media had praised the company for its action, once the facts were fully revealed, and could be expected to pillory a company that did not pursue a similar policy in similar circumstances.
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