Australian Drug Evaluation Committee (ADEC) 40th Anniversary

Abstract

The 40th anniversary of the Australian Drug Evaluation Committee, commonly known as ADEC, occurred in late July 2003. ADEC first met on Thursday 25 July 1963, under the Chairmanship of Dr Edgar Thomson, in the boardroom at the Royal Prince Alfred Hospital, Sydney. The Committee was composed of seven members eminent in the fields of clinical medicine and pharmacology. ADEC has met regularly since and its August 2003 meeting was its 229th meeting. Australia was centrally involved in the recognition of the teratogenicity of thalidomide. William McBride’s letter published in the Lancet in December 1961 attracted the world’s attention. In 1963, to a large extent as a result of the thalidomide experience, discussions took place between the Australian Department of Health and senior Australian clinicians on ways and means of more effectively exerting control over drugs causing serious adverse effects. The thalidomide experience had brought home to Australian health officials that there were not only benefits but also potential risks from the use of therapeutic compounds. As a result of these discussions, the then Minister for Health established an independent body, the ADEC, to advise on the safety of new drugs being imported into Australia and to formulate measures for the evaluation of possible adverse affects of drugs that were being used in Australia. The functions given to the new Committee were: • to make medical and scientific evaluations of such therapeutic substances that the Minister referred to it for evaluation; • to make medical and scientific evaluations of other therapeutic substances if, in the opinion of the Committee, it would be desirable to do so; and • to furnish such advice to the Minister as the Committee considered necessary related to the importation into, and the distribution within, Australia of therapeutic substances that were the subject of evaluations made by it. ADEC met three times during 1963. These meetings laid the foundations for what would become the evaluation process for new drug substances in Australia. General topics discussed at these early meetings included the functions of the ADEC, the definition of a new drug, details of the future Australian drug evaluation process using comparisons with international practice at the time and the role of the individual medical practitioner in drug safety surveillance. Standards for submission of data for importation of medicines into Australia were introduced as a result of the early recommendations of the Committee. The Committee also sought to ensure that companies were required to provide information about risks, as well as benefits, in promotional material for health professionals. The early ADEC made a number of important decisions in relation to individual product groups. Drug substances discussed by the Committee in 1963 included Enovid® 1, the first oral contraceptive approved by the US FDA, which was of great interest to the pharmaceutical industry at the time. In the wake of thalidomide, any drug with such widespread potential use in women of childbearing years encountered a rather cautious regulatory environment. ADEC advised of the need for medical supervision of patients using oral contraceptives. Interestingly, ADEC was not convinced of a cause and effect relationship between use of oral contraceptives and thrombosis at that time. It was 3 or 4 years later before studies in Europe showed convincingly the link between high-dose oestrogens and thrombotic events. The early ADEC also acted to discourage the use of some long-acting sulphonamides, which were widely used in general practice at the time. These sulphonamides were causing StevensJohnson syndrome, especially in children. There had been 19 cases reported in Australia, mainly in children, with four deaths. In 1964, ADEC undertook a detailed review of five Australian reports to it of deaths in patients using sympathomimetic drugs to treat severe asthma. Subsequently, the Committee published a warning in the January 1965 issue of the Medical Journal of Australia. This warning was an important stimulus to studies in the UK and elsewhere of the association between pressurised