Effect of 1995 pill scare on rates of venous thromboembolism among women taking combined oral contraceptives: analysis of General Practice Research Database

Farmer, Richard; Williams, Tim; Simpson, Erroll T.; Nightingale, Alison

doi:10.1136/bmj.321.7259.477

Cited by 66 publications

(45 citation statements)

References 14 publications

(10 reference statements)

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“…Although the statement noted that "for the vast majority of women, the pill is safe," some subsequent research suggested that it was followed by a spike in conceptions and abortions without a decrease in venous thromboembolism incidence among pill users. 32,33 Replication of this sad experience in the United States should be avoided.…”

Section: Do the Current Product Labels Adequately Reflect The Risk-bementioning

confidence: 94%

Combined Hormonal Contraceptives and Venous Thromboembolism

Raymond

Burke

Espey

2012

Obstetrics & Gynecology

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To date, 13 studies have provided data on the risk of venous thromboembolism associated with combined oral contraceptives containing drospirenone or the norelgestromin-containing contraceptive patch. The studies varied in their conclusions about whether these methods are associated with higher risks than combined oral contraceptives containing other progestins: the primary reported measures of association (adjusted odds ratios, incidence rate ratios, or hazard ratios) ranged from 0.9 to 3.3. All of the studies had weaknesses in population selection, data validity or completeness, or analysis that may have led to biased or spurious findings. Venous thromboembolism is rare; if the contraceptive methods of interest do confer a higher risk of thromboembolism, only an additional 5-10 per 10,000 users per year would be affected. The important message for patients, clinicians, and policy makers is that the benefits of all contraceptive methods markedly outweigh their risks, primarily because they prevent pregnancy, an inherently hazardous condition. Product labels for hormonal contraceptives should emphasize their substantial health benefits and established safety.

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Section: Do the Current Product Labels Adequately Reflect The Risk-bementioning

confidence: 94%

Combined Hormonal Contraceptives and Venous Thromboembolism

Raymond

Burke

Espey

2012

Obstetrics & Gynecology

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“…Essentially two research teams used different methods to investigate this question and drew opposite conclusions from the same dataset -in this case the GPRD. (Farmer et al 2000) found the incidence of venous thromboembolism did not fall following the 1995 'pill scare' and subsequent reduction in pill use, whilst (Jick et al 2000) re-analysed the data and contested that the risk with third generation preparations was around twice that of those containing levonorgestrel. Whilst Farmer et al (2000) used a time correlation study, Jick et al (2000) used a cohort plus nested case-control designs, controlling extensively for potential confounders and including a time correlation approach for comparison.…”

Section: Iv) Data On Outcomes May Not Reflect the Priorities Of Servimentioning

confidence: 99%

Database use in psychiatric research: An international review

Higgins

Howard²

2005

Eur. J. Psychiat.

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-Objective: Whilst database use for the purposes of audit is well established amongst clinicians, their research potential has yet to be fully realised. This review provides an international perspective on research using databases in psychiatry, considering the advantages and constraints of their use.Method: Large databases used in psychiatric research were identified through a systematic search of MEDLINE and EMBASE databases. The types of research conducted with these databases were then grouped into categories for discussion. A narrative synthesis of results is presented, illustrated with examples.Results: Research identified included pharmacoepidemiology, perinatal, aetiological, suicidology and health service research.Conclusions: Databases have been used to address a range of questions in psychiatry, often by employing linkage between clinical and national administrative databases. The success of such research is not only dependent on appropriate methodology and database design, but also on clinician commitment to data entry. Further exploitation of linkage potential between databases is envisaged, alongside international development of clinical databases designed with the purpose of research in mind.

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“…Moreover, the authors of one of the prompting studies corroborated their findings in a follow-up analysis, 22 whereas one group of the faultfinders was found in the Bpillory[ themselves because of methodological deficiencies in presenting the same data set in a different way, leading to a different conclusion. 23 This raised the issue of appropriate conduct of (pharmaco-)epidemiological research. 24,25 One wonders if the quality of epidemiological studies can be improved so that confusing debates are reduced.…”

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confidence: 99%