Is What Is Good for the Gander Really Good for the Goose?

“…These incomplete safety and efficacy data may mean that more women are experiencing adverse events for a device lacking a mortality benefit, a situation unlikely to be ameliorated without FDA guidance. 32 There are some limitations to our study. One is that we relied on the publicly available SSEDs and Circulatory System Device Panel meeting materials as our data sources.…”

Section: Discussionmentioning

confidence: 94%

Gender Bias in Studies for Food and Drug Administration Premarket Approval of Cardiovascular Devices

Dhruva

Bero

Redberg

2011

Circ: Cardiovascular Quality and Outcomes

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Background-Cardiovascular devices can have different safety and effectiveness profiles in men and women. The type and quality of sex-specific data reviewed by the Food and Drug Administration (FDA) before approval of these devices are unknown. Methods and Results-We performed a systematic review of the demographics, comments on gender bias, and analysis of results by sex for 78 high-risk cardiovascular devices that received premarket approval by the FDA between 2000 and 2007. FDA summaries of evidence did not report sex of enrollees in 34 (28%) of 123 studies. For studies reporting sex distribution, the study populations were, on average, 67% men. There was no increase in the enrollment of women over time. Explanations for the relatively low percentage of women often stated that the trials reflected either underlying disease distribution or referral rates for similar procedures or that the sex distribution reflected similar or previous trials. Forty-one percent of studies included a gender bias comment or analysis, and 12 (26%) of 47 of these analyses identified some difference in device safety or effectiveness by sex. Conclusions-There is a lack of sex-specific safety and effectiveness data for high-risk cardiovascular devices before FDA approval. The justifications for this lack of evidence may perpetuate the status quo. More rigorous FDA requirements for sex-specific data before device approval could present an opportunity to improve cardiovascular outcomes. (Circ Cardiovasc Qual Outcomes. 2011;4:165-171.)Key Words: cardiovascular diseases Ⅲ women Ⅲ sex Ⅲ health policy I n 1985, the US Public Health Service Task Force concluded that "the historical lack of research focus on women's health concerns has compromised the quality of health information available to women as well as the health care they receive." 1 The following year, the National Institutes of Health (NIH) adopted a policy statement encouraging inclusion of women and minorities in all federally funded research, 2 and the Food and Drug Administration (FDA) in 1988 specifically called for studies of whether safety and effectiveness were similar within population subgroups defined by characteristics such as age, sex, and race. 3 Around this time, the medical research community was gaining appreciation for the plausible biological basis of sex differences in disease. In 1990, the American Medical Association Council on Ethical and Judicial Affairs concluded that "medical treatments for women are based on a male model, regardless of the fact that women may react differently to treatments than men or that some diseases manifest themselves differently." 4 In response to concerns raised by medical researchers and women's health advocates, the Government Accountability Office audited clinical trials funded by the NIH or submitted to the FDA in support of drug marketing applications and in a 1990 report, observed "little progress" by the NIH in implementing its inclusion policies and concluded that these had not been well communicated or understood within NI...

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“…For example, Medicare has spent billions on implantable cardioverter-defibrillators for primary prevention of sudden death in women, despite the fact that there are no data from clinical trials to show any mortality benefit in women. 3,4 Data on therapeutic benefit should be gathered prior to Food and Drug Administration approval and Medicare coverage, as patterns of care become established quickly after approval. This is especially true in light of the unsustainable increase in health care expenditures, including Medicare costs.…”

Section: Clinical Trial Enrollment and Progress In Women's Healthmentioning

confidence: 99%

Highly Sensitive Cardiac Troponin T Assay, Cardiac Disease, and Mortality Risk—Reply

Lemos¹,

Christenson²,

deFilippi³

2011

JAMA

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To the Editor: Dr deFilippi and colleagues 1 provided evidence that cardiac troponin T (cTnT) measured with a new high-sensitive assay in at-risk individuals 65 years or older was associated with heart failure and cardiovascular death. These results add to the PEACE study findings that indicated an association between the sensitive cTnT measurement in a population with stable coronary artery disease and these same 2 outcomes. 2 Dr de Lemos and colleagues extended this work to a younger (aged 30-65 years) populationbased sample and also demonstrated that higher concentrations of cTnT were associated with higher rates of both cardiovascular and all-cause mortality. 3

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Is What Is Good for the Gander Really Good for the Goose?

Cited by 12 publications

References 11 publications

Meta-Analysis of Statin Effects in Women Versus Men

Meta-Analysis of Statin Effects in Women Versus Men

Gender Bias in Studies for Food and Drug Administration Premarket Approval of Cardiovascular Devices

Highly Sensitive Cardiac Troponin T Assay, Cardiac Disease, and Mortality Risk—Reply

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