During 1989, a contract research organisation was commissioned by three different pharmaceutical companies to undertake a series of clinical trials in general practice. The first of these was on a new product for the treatment of hypertension; the second was a multicentre paediatric asthma trial; and the third was also a multicentre trial on a product for the treatment of asthma.10
The contract research company recruited Drs CJ Chandnani and CJ Vishin, in partnership in Rothwell, Leeds, amongst others, to take part in these trials, both these doctors having previously conducted clinical trials for the organisation, and with which no unsatisfactory features had been associated. The doctors signed formal agreements with the organisation on accepting, on each occasion, the conditions applying to the conduct of the three different trials.
The first trial required, amongst other things, the completion of diary cards by the patients. However, the completion of these cards gave rise to suspicion, and as a result Dr Chandnani was visited by the quality assurance manager. The handwriting on the diary cards was remarkably similar to that of Dr Chandnani, and they were in pristine condition, unlike those of the patients of the other investigators in the trial, which showed the expected signs of frequent handling.
When asked how he had obtained such good records, in similar handwriting to his own, Dr Chandnani stated that he was very careful to instruct patients on the correct method of completing diary cards, that none of his patients had requested his advice in completing the cards, and that they had not copied his handwriting.
One patient had apparently completed the diary card for an extra seven days, during which time the card was actually in the possession of the company. Dr Chandnani's explanation that his patient must have turned over two pages at once and then crossed them out and entered them on the correct page was not substantiated by close examination of the diary card. The circumstantial evidence pointed to the diary cards having been completed by Dr Chandnani himself.
In the second trial, diary cards completed by patients were also used. Patients had to record the daily medication, and the times when it was taken, severity of asthma symptoms and daily morning and evening peak flow readings measured by three successive "blows" each time. According to the age of the patients involved, the recording on diary cards was either by the patient, a parent, guardian or friend.
The data for all the patients recruited by Drs Chandnani and Vishin were completed with the minimum of delay, which indicated rapid recruitment and rapid completion of the study.
Later in 1990, the contract research organisation was contacted about another study by a different company and Dr Chandnani again agreed to participate. As with the paediatric asthma study, he recruited all his patients very quickly. One patient, however, was noted to be a protocol violator, as the monitor found that the initials of this one patient were the same as a patient participating in a safety study for a third pharmaceutical company, and it turned out that these two patients were indeed one and the same.
The pattern of data recorded by Drs Chandnani and Vishin in this trial differed considerably from the pattern observed by the other investigators taking part in the same study; the variability in the readings of morning peak flow measurements from the patients of Drs Chandnani and Vishin were markedly less than the considerable variability in readings from all the other patients. With regard to Dr Chandnani's patients, they were all purported to have recorded peak flow readings to the nearest "2", which is not within the sensitivity of the instrument recording peak flow, and such accuracy was not the case for any other patients - including those of Dr Vishin -who recorded to the nearest "5" or "10".
With regard to the handwriting on some of the patient diary cards, these again showed a marked similarity to the handwriting of Dr Chandnani himself. He characteristically used a "double dot" after writing initials, and there were many examples of the "double dot" phenomenon in the diary cards purported to have been completed by his patients.
In the third study, the contract house trial director was alarmed by the conduct of Drs Chandnani and Vishin in the other two studies, and made a particular point of monitoring all aspects of the study very closely. He found that patient recruitment and attendance for review had been much better than would be expected, and than had been demonstrated at other centres involved in this particular trial. He also examined the trial materials returned by the two doctors and found that unused tablets had been returned in containers showing no signs of wear and tear. Consequently, data were extracted from the case record forms for statistical examination. Scatter plots were produced and compared with data from other investigators in the study. The data from the suspect investigators demonstrated blood pressure readings much more consistent than would be expected with normal variation, in distinct contrast to the data from other investigators.
Most serious and conclusive of all, blood samples, which had been taken for other purposes, were assayed for the investigational drug and its metabolites and these could not identified in samples provided by Drs Chandnani and Vishin. Samples from other investigators were also analysed and showed good correlation with the expected intake of the trial drug. So it was proved beyond all shadow of doubt that the patients had not taken the product at times they were supposed to have taken it, if at all.
Much of the above evidence was circumstantial at the time, but documents were subsequently found, which substantiated all the points made. Further investigation confirmed that some of the patients of Drs Chandnani and Vishin were not involved in the studies mentioned above in which they were purported to have taken part. The sum total of the evidence led to the inevitable conclusion that both these doctors had acted fraudulently, which justified their referral to the General Medical Council.
At a hearing before the Professional Conduct Committee, Drs Chandnani and Vishin were found guilty of serious professional misconduct, and their names were erased from the Medical Register.
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If you suffer with asthma, you will no doubt be familiar with the uncomfortable sensations as your bronchial tubes begin to narrow and your muscles around them start to tighten. A sticky mucus known as phlegm begins to produce and increase within your bronchial tubes and you begin to wheeze, cough and struggle to breathe.