The Time Has Arrived for Sex-Specific Reporting of Research Results

Cardiovascular disease (CVD) is the most common cause of death in American women and accounts for a full one-third of all deaths.1 Although the common perception may be that CVD affects mainly men, there is equal prevalence of this disease between the genders by the age of 40, and by the age of 60 more women than men are affected. More women than men have died from CVD causes on a yearly basis since the mid 1980s, and whereas the CVD mortality has steadily declined in men over the past 30 years, it has remained steady in women until very recently when CVD mortality was noted to decrease for both genders.2 See accompanying article on page 277 The impact of cardiovascular disease (CVD) on the health status of American women is gaining more recognition and has become the focus of public education efforts such as the “Go Red for Women” campaign sponsored by the American Heart Association and the “Red Dress” project sponsored by the Department of Health and Human Services, the National Institutes of Health (NIH), and the National Heart Lung and Blood Institute (NHLBI). These programs are, in part, a response to the increasing awareness of cardiovascular disease as a major source of morbidity and mortality in U.S. women. The importance of CVD as a major source of mortality in women was recognized early on by federally funded institutes including the Public Health Service Task Force, which brought attention to concerns about the health information available to women and the historical lack of research focus on women’s health in its 1985 Report of the Public Health Service Task Force on Women’s Health Issues .3 In response to this report, the National Institutes of Health adopted a policy for the inclusion of women in clinical research …

The aim of his research was getting acquainted with psycho-physiological functions of highly qualified judo competitors of various weight categories. 14 competitors, representatives of Poland in judo took part in the research. The age of the researched competitors ranged between 20-30 years (23,1±2,7), and period of training 6-20 years (12,8±4). Specially designed set of computer program Selftest («Dinamo» Kiev) was used in the research. In the result of the research different level of activity manifestation of psycho physiological functions of judokas depending on weight category was revealed.

Does sex matter?: an update on the implementation of sex as a biological variable in research.

Changing the Face of Cardiovascular Trial Participation: Moving Beyond Middle-Aged White Guys

Cardiovascular disease (CVD) in women has been historically understudied. For many years, heart disease had been thought to be primarily a “man’s disease.” Consequently, women have been significantly under-represented in longitudinal studies of disease history and in clinical trials. High-quality data from women at the extremes of age, with multiple co-morbidities, and from racial and ethnic minorities have been particularly rare. In order to increase awareness of cardiovascular prevention among women, in 1999 the American Heart Association (AHA) published its first women-specific clinical recommendations for the prevention of CVD.1 In 2004, the AHA and multiple other collaborating organizations subsequently sponsored “Evidence-Based Guidelines for Cardiovascular Disease Prevention in Women,” which underwent updates in 2007 and 2011. As a result of these and other related initiatives, the rate of public awareness of CVD as the leading cause of death among US women has increased from 30% in 1997 to 54% in 2009.2 CVD-associated death among US women has declined significantly over this time period.3,4 Yet substantial work still needs to be done to improve women’s cardiovascular health. CVD remains the number one killer among women.4 As the obesity epidemic continues, we are actually finding increases in coronary heart disease (CHD) death among young women 35 to 54 years of age.2 Morbidity and mortality from stroke and hypertension remain high.4 In addition, substantial outcomes disparities continue for women from racial and ethnic minorities.4 We have therefore dedicated our topic summaries in this issue of Circulation: Cardiovascular Quality and Outcomes to CVD in women. We have included only those studies where authors provided a convincing a priori reason to study a particular disease process or clinical intervention in women and reported primary endpoints that were sex-specific. We have included articles on the representation of women …

Objective: This study examined ethnic disparities in antipsychotic therapy in a population with significant Asian representation. Methods: Using a cross-sectional retrospective study design, self-reported ethnicity data pooled from three cycles of the Canadian Community Health Survey were linked to 2005 administrative data on physician, hospital, and pharmaceutical use in British Columbia, Canada. Logistic regression was used to model the association between ethnicity and the likelihood of filling one or more prescriptions for any antipsychotic, with controls for sex, age, residence, immigrant status, income, health status, and diagnoses of schizophrenia, bipolar disorder, depression, and dementia. Results: Of the 27,658 individuals in the sample, 2.2% filled at least one antipsychotic prescription. The proportion varied across ethnic groups: Chinese, 1.0%; other Asians, 1.2%; whites, 2.3%; nonwhite non-Asians, 2.8%; and mixed ethnicity, 4.3%. After adjustment for patient characteristics and diagnoses of schizophrenia and bipolar disorder, the likelihood of filling a prescription was found to be lower among Chinese (odds ratio [OR]=.47, 95% confidence interval [CI]=.24–.90) and higher among persons of mixed ethnicity (OR=3.19, CI=1.49–6.83). Further adjustment for depression and dementia diagnoses did not significantly change the ORs for the Chinese (OR=.49, CI=.25–.98) and the mixed ethnic groups (OR=2.97, CI=1.30–6.80). Conclusions: Consistent with the existing literature on ethnic disparities in antipsychotic therapy, the study found evidence of persistent disparities in a population that has a significant number of Asians. Further studies should be done to identify possible causes of these disparities and to identify potential interventions that may reduce or eliminate them. (Psychiatric Services 62:1026–1031, 2011)

In 2009 Dr. Bernard Prigent, the Vice-President and Medical Director of Pfizer, was appointed a member of the Canadian Institutes of Health Research (CIHR) Governing Council1. Historically, an infiltration of this kind is nearly unprecedented in Canada. The pharmaceutical industry has long been a source of funding for research, sponsoring public endeavours in basic-science. While the radiological community has previously been unaffected, the evolving disciplines of molecular imaging, interventional oncology and others bring the specialty in closer contact with the pharmaceutical industry. The investment is advantageous for corporations like Pfizer, which can appropriate data from discoveries for future market use. However, the appointment of Prigent at the level of explicit policy allows him to recommend actions which favour the pharmaceutical industry. Public Citizen, an umbrella organization housing a number of interacting groups such as the Health Research Group and Global Trade Watch, has commented that the arrangement represents a clear conflict of interest [1]. The council to which Prigent belongs wields significant power over the CIHR. Among its responsibilities are the formation and discontinuation of institutes which evaluate the CIHR, the appointment of subordinate directors, and budget approval. Moreover, members of the Governing Council are permitted to advise the Minister of Health as to whom directorial candidates should be.CIHR President Alain Beaudet regards the appointment as another milestone in a series of inevitable events intertwining the public and private sectors, as Canada seeks to meet its Science and Technology Strategy put forth in 2007 [2]. He reasons that facilitating the success of industry is the only way to ensure continued investment, and that the increasing reality of industry sponsored co-funding on ambitious projects is here to stay. At one time, Dr. Beaudet sat on the peer-review committee for the National Institutes of Health (NIH) when members of industry sat comfortably among academic representatives on the Advisory to the Director, which is analogous to the Governing Council. Since then, there has been a divergence in philosophy between the NIH and CIHR. The criteria for conflict-of-interest appointments have become much stricter with the United States review body, and no pharmaceutical executives sit on the advisory board [3]. The CIHR apparently does not feel so compelled.One of the overriding issues with industry-funded research initiatives is that resultant work often becomes exclusively licensed to industry. If it is true that industrial-academic partnerships are necessary, it is accepted that researchers may redefine their priorities in order to court grants [4]. Notably, Prigent himself does not have control over grant recipient selection. This instead falls to the Scientific Council, as Russell Williams, President of RD the largest in the country’s history.There is precious little reason to believe any Governing Council member with employment obligations to one a pharmaceutical would defer to any contradicting ethical suggestions. Thus, a systematic upheaval may be required to remove ethical conflicts entirely. No arrangement at the NIH or CIHR is permanent, and it is up to the next generation of medical professionals to decide just what we feel is appropriate for our country’s grant-making body.

A Physiological Marriage Made in Heaven: Treating and Measuring the Brain Through Stimulation.

Human versus mouse eosinophils: “That which we call an eosinophil, by any other name would stain as red”

In September of this year, the US Food and Drug Administration (FDA) Center for Devices and Radiological Health published a document entitled, “Strengthening Our National System for Medical Device Postmarket Surveillance.”1 In addition to summarizing the current process and mechanisms for monitoring medical devices after commercial approval, the document proposed the following specific actions to improve the efficiency and quality of postmarket surveillance of medical devices in the United States: > 1. Establish a unique device identification system and promote its incorporation into electronic health information; > > 2. Promote the development of national and international device registries for selected products; > > 3. Modernize adverse event reporting and analysis; and, > > 4. Develop and use new methods for evidence generation, synthesis, and appraisal. [1, p. 4] The intended focus of this initiative is laudable and much needed, as the current system, discussed in this journal earlier this year,2 is widely believed to be overly time consuming and expensive, and to place the United States at a competitive and technological disadvantage to many other countries. As with many of the investigational mechanisms used to assess new medical technologies, these initiatives are likely to lend themselves most easily to devices that are used widely and in relatively consistent applications. With the introduction and evolution of this forward thinking upgrade of the postmarket medical device surveillance system, let us hope that low-volume, off-label, and other marginal device use remains within its purview so that we can collectively move toward a better understanding and oversight of such device applications, as well as those with broader market applications. It is no secret that the majority of transcatheter interventions for congenital heart disease in the United States are performed with devices that are not …

Introduction: The high number of immigrants in North America underscores the need for cardiovascular (CV) health and promotion in these racially and ethnically diverse populations. Although some immigrant races/ethnicities have high cardiovascular mortality, it remains unclear whether there are investments in cardiovascular health promotion and prevention for immigrants for both the United States and America. We aimed to compare American and Canadian national investments cardiovascular health promotion and prevention for immigrants. Methods: We queried the National Institute of Health (NIH) and the Canadian Institute of Health Research (CIHR) databases from 2006 to 2019 for grants supporting projects in diseases prevention and promotion targeting immigrants. We compiled annual funding and normalized the annual data for the number of immigrants and Gross Domestic Product (GDP). We completed normalized descriptive statistics for comparative analysis and presented funding trends over a 14-year period. Results: There were 74 and 50 project grants awarded by the NIH and CIHR, respectively. Between 2007 to 2013, the NIH spent relatively less per immigrant than the CIHR. From 2014 onward, funding trends reversed as the NIH outspent the CIHR. Over the 14-year period, the NIH and the CIHR funded an annual mean of $59.8/1000 immigrants and $79.1/1000 immigrants, respectively. Conclusion: Although the number of immigrants is rising, the relative national funding for CV health promotion and prevention in the USA and Canada is generally decreasing over the last 5 years. Absolute CIHR funding is progressively decreasing since 2008, while NIH grant expenditure has demonstrated an overall pattern of increase over the last 14 years. Policymakers should consider more comprehensive investment in CV health promotion and prevention for immigrants.

Drugs, Devices, and the FDA: Part 1: An Overview of Approval Processes for Drugs

Uncommon disorders in the spotlight

In recent years, claims have been made by segments of the research community and by women's health advocacy groups that clinical research practices and policies have not benefitted women's health to the same extent as men's health. Central to these claims has been an assertion that women have been inadequately represented as subjects of clinical studies and that as a result neither health conditions unique to women — e.g., menopause — nor women's manifestations of health problems affecting both sexes — e.g., heart disease — have been investigated sufficiently.The scientific community, including federal agencies that sponsor and regulate clinical studies, is increasingly responsive to these claims and is taking steps to raise the level of women's participation in clinical studies. Controversy and concern have surrounded these actions, however. Two of the claims that have been made are: (1) that women are more difficult to study than men because of their cyclical hormonal changes; and (2) that conducting gender-specific subgroup analyses would increase the size of study populations, raise the cost of studies, and thereby reduce the number of studies that could be performed with the limited resources available. In addition, controversy over the inclusion of women of childbearing potential and pregnant women has been particularly salient. Concerns have been expressed about avoiding potential harm to existing or potential fetuses and about the possible legal and financial ramifications of such harm. A further concern involves the perceived difficulties in enrolling women in studies and retaining them for the duration of the studies.Against this backdrop, the Office of Research on Women's Health at the National Institutes of Health (NIH) asked the Institute of Medicine (IOM) in October 1992 to establish the Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies. The Committee's charge was to: (1) consider the ethical and legal implications of including women, particularly pregnant women and women of childbearing potential, in clinical studies; (2) examine known instances of litigation regarding injuries to research subjects and describe existing legal liabilities and protections; and (3) provide practical advice on these issues for consideration by NIH, institutional review boards (IRBs), and clinical investigators.The 16 Committee members came from diverse backgrounds: bioethics, law, epidemiology and biostatistics, public health policy, obstetrics and gynecology, clinical research, pharmaceutical development, social and behavioral sciences, and clinical evaluative sciences. Chaired by two of the authors of this article, Ruth Faden and Daniel Federman, and coordinated by the third, IOM Study Director Anna Mastroianni, the Committee met five times over a fourteen-month period, convened a one-and-one-half day invitational workshop, and commissioned several background papers. The Committee's deliberations were complicated by the announcement of new federal policies late in its term. Specifically, the Food and Drug Administration (FDA) issued guidelines (FDA 1993) to replace its 1977 guidelines, which prohibited the inclusion of women of childbearing potential in early phases of most clinical drug trials. In addition, Congress passed the NIH Revitalization Act of 1993 (P.L. 103-43), which contains provisions mandating the inclusion of women and racial and ethnic minorities in NIH-sponsored clinical research. In February 1994, the IOM Committee publicly issued its final report and recommendations, Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, publishing the workshop presentations and commissioned papers in a separate volume.

Sudden cardiac death (SCD) is a major public health problem in North America, responsible for approximately 400 000 deaths annually.1,2 Most episodes of SCD in ambulatory populations result from ventricular tachyarrhythmias,3 whereas bradyarrhythmias may be important in some populations, notably hospitalized patients with advanced heart failure4 (Figure 1). A prior article in this series by Zipes and Wellens2 provides a detailed review of the pathogenesis of SCD, its underlying causes, and treatment strategies. Figure 1. Mechanisms of SCD in ambulatory persons. Most SCDs result from ventricular fibrillation. VT, bradyarrhythmias, and other mechanisms account for the remainder. ### ICD Therapy The availability of a therapy that reliably terminates the vast majority of life-threatening tachyarrhythmic and bradyarrhythmic events has tremendous clinical appeal. The implantable cardioverter defibrillator (ICD) represents such a therapy. Despite its appeal, the ICD is imperfect. Currently, systems are costly, have a limited life expectancy, and are subject to complications in the long term.5,6 Furthermore, many patients at risk for SCD are at risk of dying from causes that the ICD would not alter. The impact of ICD shocks also merits consideration. Evidence links multiple shocks with myocardial injury7 and fibrosis,8 and sporadic shocks are associated with significant, independent reductions in quality of life. Compared with patients not having shocks, patients in the Antiarrhythmics Versus Implantable Defibrillators (AVID) trial who had ≥1 shocks in the initial year of follow-up had significant declines in self-perceived physical functioning and mental well-being, independent of ejection fraction (EF), social circumstances, and medication use. The reduction in quality of life associated with shocks was of a magnitude similar to clinically important adverse effects from amiodarone.9 Cost-efficacy is a vital issue in settings of limited or restricted health care resources6 and is particularly relevant as ICD use is expanded to …