7 September 2006
To: The Lancet Editors:
In a medical world which still requires explicit or tacit observance of Hippocratic ethic, it is surprising that this huge trial in 21 countries world wide, organised by the British MRC, has not attracted any comment. The procedure (p 288) specifies that clinical outcomes like disease progression, survival, safety, tolerability and therapeutic success are secondary objectives. The primary objectives are to assess the effect on viral load and CD4 counts.
This priority might be justified as a hard-nosed evasion of clinical and subjective variables if the design of the trial recognised these and included relevant statistical and logistic variables. But it does not. Criteria for eligiblility are entirely subjective ("If the investigator and patient judged
and the investigator thought that the patient was likely to adhere to the first of four alternate reginens for at least 6 months"). There is no differentiation of patients by age, sex, location (Except country), category or maintenance of risk behaviour, or of corroborated adherence to the various changes in regimens. Nor is there any recognition of the wide differences whereby HIV/AIDS can be registered under 26 or more diagnostic labels within which there are further critical differences. It is surprising that the MRC and the Lancet ignore all this but not surprising that the results, even on the limited biomedical assessment are unimpressive because there is no control group whereby natural recovery or worsening could be assessed.
Gordon T. Stewart MD
Emeritus Professor of Public Health
University of Glasgow