In February 1991 the Astra Clinical Research Unit set up a four-centre general practitioner clinical trial in Glasgow, designed to compare felodipine ER once daily with nifedipine SR twice daily given as monotherapy for the treatment of patients with mild to moderate hypertension. One of these four centres was Dr David Latta's practice. The data submitted to the company by Dr Latta during the course of this trial were so at variance with what would be expected, and with what were in fact submitted by the other centres, that a source verification audit was conducted.
The following results were obtained:
1 All 22 patients had exactly 100% compliance.
2 All 22 patients had returned all the empty blister packs in which the trial medication was supplied.
3 All 22 patients had kept drug boxes in pristine condition.
4 21 of the 22 patients had period lengths on treatment of exactly 28 days.
5 All 22 patients completed quality-of-life questionnaires, and all were in pristine condition. There were no changes of mind or mistakes in the questionnaires.
6 No patients in the study reported any adverse experiences.
7 No patients withdrew from the study, and all 22 patients completed the study as per protocol.
8 The range of BP readings was extremely small, and an exceptionally large proportion of patients maintained a heart rate of 74.
(All the above points were not in accord with usual trial experience, in which considerable variation in patient behaviour is seen, and this in itself raised suspicion. However, subsequent points were of greater concern.)
9 Most of the blood test results were on forms which had had the patient's name or sample date cut off the source document. Some of the documents had been stamped by the laboratory with a date preceding the date on which the sample was supposed to have been taken; some of these dates had been altered in pen to the correct date.
10 The doctor claimed to have used pseudonyms for the samples he submitted, but had forgotten them, and so copies of the damaged laboratory report forms could not be obtained.
11 Some of the damaged laboratory report forms appeared to have been signed by a doctor who had left the laboratory in December 1990, three months before the first patient was recruited.
12 The consent forms were all produced retrospectively and a number of these forms appeared to have been signed by the same hand.
13 No record of any of the patient data generated during the course of the trial was entered into the patients' NHS records; separate NHS record cards were generated, retrospectively, from data recorded in the clinical trial record forms, some in the presence of the trial monitor. These were therefore meaningless as source data.
14 The ECGs for eight patients appeared identical; for a further four patients they appeared differently identical; and for a further seven patients again appeared identical. This implies that for 19 patients just three ECG tracings were used.
15 The study file had not been used, and no record of drug accountability was taken.
The sum total of the above was so at variance with what would be expected that it was highly likely on the grounds of probability that some of the data generated by Dr Latta in this trial was fraudulent, and the evidence was therefore submitted to the General Medical Council. At a hearing before the Professional Conduct Committee, Dr Latta was found guilty of serious professional misconduct, and his name was erased from the Medical Register.
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