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  • Title: Rebuilding confidence in oral contraceptives: a new imperative in family planning.
    Author: Spitzer WO.
    Journal: Br J Clin Pharmacol; 1996 May; 41(5):359-63. PubMed ID: 8735675.
    Abstract:
    On December 14, 1995, the first public presentation of results of the Transnational Case-Control Study of Oral Contraceptives and the Health of Young Women was made at the winter meeting of the British Pharmacological Society at Brighton. Four weeks later, those results and further analyses were published in the British Medical Journal. There has been much debate about them in Europe and elsewhere. I feel privileged to have been invited to write a Leading Article about the safety of combined oral contraceptives in the British Journal of Clinical Pharmacology. These are personal opinions about the meaning of all the recent pharmacoepidemiological findings. With an historical context as the background I have added my personal reflections as a scientist and a public health doctor. These views do not necessarily reflect the views of my co-investigators. On December 14, 1995, the first public presentation of results of the Transnational Case-Control Study of Oral Contraceptives and the Health of Young Women was made at the winter meeting of the British Pharmacological Society at Brighton. Four weeks later, those results and further analyses were published in the British Medical Journal. There has been much debate about them in Europe and elsewhere. I feel privileged to have been invited to write a Leading Article about the safety of combined oral contraceptives in the British Journal of Clinical Pharmacology. These are personal opinions about the meaning of all the recent pharmacoepidemiological findings. With an historical context as the background I have added my personal reflections as a scientist and a public health doctor. These views do not necessarily reflect the views of my co-investigators. In light of the findings of recent pharmacoepidemiological studies suggesting an association between third generation oral contraceptives (OCs) and cardiovascular and cerebrovascular events, an investigator of one of the studies discusses in this essay why he believes OC use is becoming safer. First generation OCs with a higher estrogenic content (50 mcg) were associated with an increased risk for major cardiovascular and cerebrovascular events. The second and third generation OCs have a much lower estrogen dose, reducing the risk for these events appreciably. Current debate is over whether the occurrence of thrombosis in users of third generation OCs warrants regulatory action. The relative risk for venous thromboembolism (VTE) for users of these OCs in the Transnational Study is small (1.5) albeit statistically significant. This risk may be due to background noise or unavoidable bias. The publication of a meta-analysis of the most recent studies on this association does not describe the methods used. The author of the meta-analysis study ignores the fact that all four studies found weakness of the ratios. Yet, if left unchallenged, the meta-analysis findings can be cut in stone. In the UK, the Committee on Safety of Medicines (CSM) and the Medicines Control Agency warned providers about third generation OCs. The warnings were published based on unpublished findings about VTE. The investigator of one of the pharmacoepidemiological studies offered to show statutory authorities the unpublished findings in confidence if they were concerned. Instead, the authorities issued a letter to all UK physicians informing them about the increased risk of VTE associated with third generation OC use. Other studies have since been reassuring. The US Food and Drug Administration has not taken such drastic steps as the CSM. The resulting public anxiety responding to publicity in the medical and lay press effected early termination of the transnational case control study on OCs and myocardial infarction (MI). So far, it has found much lower risks for MI than those of earlier studies. In conclusion, the medical community needs to begin restoring confidence in OCs.
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