October 7, 2016The North American Menopause Society 2016 Annual Meeting

Significant gender inequities persist in two general areas of biomedical science:

Biological sex and gender insufficiently reported in research studies

Women are underrepresented as basic and clinical researchers in academic medicine

While these issues may seem unrelated, addressing both will diversify knowledge and interdisciplinary research teams, improve science produced and quality of health care provided

Sex: Biological and physical characteristics that define men and women

Gender: Socially constructed roles, behaviors, activities, and attributes that a given society considers appropriate for men and women

1. No effect in either or

2. Equal effect in and

3. Sex/Gender-Specific: only in or

4. Sex/Gender-Sensitive: > effect in or

5. Opposite effect in and

From Cora Lee Weatherington, NIH

<<Video Clip Removed Due to Size.>> twice as likely to be referred within a month of blood in urine (36% vs 17%)

more likely to have UTI, doubling chance of >6 month delay in diagnosis

more likely to have non-urothelial cancer of the bladder (10-12% vs 5-7%)

Histologic type doesn’t fully explain sex/gender disparity in survival

Burge F, Kockelbergh R. (2016) Urologia Internationalis

Naltrexone: FDA approved for use in alcohol and opiate dependence RCT (n=164) 150mg/kg for 12 weeks vs placebo

reduction in both use and severity increase in both use and severity

If they didn’t analyze by sex, the effect would appear attenuated Pettinati et al. (2008) Journal of Substance Abuse Treatment Pettinati et al. (2008) Journal of Substance Abuse Treatment

Despite higher mortality rates, healthcare providers underestimate CVD risk in

less likely to receive aspirin, heparin, beta-blockers, cardiac catheterization, angioplasty, and bypass surgery after MI are referred for invasive therapies later, have more

comorbidities, and worse outcomes are underrepresented in most clinical cardiovascular

research

Bogaev RC (2016) Current Cardiology Reports

Sex: Knee and hip anatomy, imbalanced leg muscle strength and looser tendons and ligaments make more likely to injure knees during sports

Injuries increase risk of osteoarthritis later in life

Gender: Walking in high heeled shoes increases stress on the knee joint that increases arthritis risk

NIH Office of Research on Women’s Health

1977: FDA guideline to exclude any “premenopausal female capable of becoming pregnant” from phase 1 and phase 2 studies

Designed to protect vulnerable populations after thalidomide and DES

1985: U.S. Public Health Service Task Force on Women’s Health Issues report

“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.”

1986: Following the issuance of PHS report, NIH established a policy for the inclusion of women in clinical research

Researchers should “note and evaluate gender differences” Policy urged rather than required compliance

Policy was announced in October 1986 Guide for implementation not issued until July 1989 Not applied consistently until 1990 Encouragement of gender analysis not implemented Grant application instructions not revised to include policy Division of Research Grants instructed reviewers not to consider the inclusion of women and minorities as a factor in scientific and technical merit Policy does not apply to intramural NIH studies

Following 1990 GAO report, creation of the NIH Office of Research on Women’s Health to:

Strengthen research related to diseases, disorders and conditions that affect women Ensure that women are appropriately represented in biomedical and behavioral research supported by NIH Foster the increased enrollment of women in biomedical research

NIH-supported clinical research should include women and minorities as subjects “in approximately equal numbers of both sexes. …unless different proportions are appropriate because of known prevalence, incidence, morbidity, mortality rates, or expected intervention effect.”

Women of childbearing potential cannot be routinely excluded without a strong scientific rationale Cost is not an excuse

2001: NIH Policy and Guidelines on the Inclusion of Women and Minorities were updated to provide guidance on reporting analyses of sex/gender and racial/ethnic differences in intervention effects for phase 3 clinical trials

NOT-OD-15-102 (2015) require grant applicants to address consideration of sex as a biological variable in the Research Strategy section of the application

Extends mandate to include women in preclinical research and animal studies Applicants must “explain how relevant biological variables, such as sex, are factored into research designs and analyses”

<<Video Clip Removed Due to Size.>>

RCTs published in 2004 & 2009 in 9 journals NEJMJAMAAnnals of Internal MedicineAmerican Journal of MedicineJournal of Clinical Oncology

CirculationJournal of Infectious DiseasesObstetrics and GynecologyAmerican Journal of Obstetrics and Gynecology

Geller et al., 2006, Journal of Women’s Health Geller et al., 2011, Journal of Women’s Health

Studies 2004 n (%)

2009 n (%)

Analyzed data by sex 6 (13) 14 (25)

Explained why they did not analyze by sex 9(20) 6 (11)

Did not analyze by sex or explain why not 31 (67) 36 (64)

Total 46 (100) 56 (100)

2016 GAO report found that women were 54% of subjects in NIH research but NIH does not track analysis and reporting by sex

Federal reporting focuses on enrollment

No summary data on clinical trials compliance with inclusion policy

Program officers enforce inclusion policy without a mechanism to track enrollment, analysis or reporting by sex

GAO-16-13 Women in NIH Clinical Trials

NIH: Enforce requirement that analysis plans include reporting by sex Ensure that study sections consider plan to incorporate sex/gender into analysis and reporting

Journals: Require sex/gender analysis and reporting in manuscripts as appropriate Audit for gender-based bias in reviews

PLOS ONE has strict policies for how we expect peer review to be performed and we strive to ensure that the process is fair and civil. We have taken a number of steps to remedy the situation. We have formally removed the review from the record, and have sent the manuscript out to a new editor for re-review. We have also asked the Academic Editor who handled the manuscript to step down from the Editorial Board and we have removed the referee from our reviewer database.

--Damian Pattinson, PLoS Editorial Director

http://blogs.plos.org/everyone/2015/05/01/plos-one-update-peer-review-investigation/

47%

46%

43%

32%

20%

22%

14%

12%

0 10 20 30 40 50

Medical Students

Residents/Fellows

Assistant Professors

Associate Professors

Full Professors

Division/Section Heads

Department Heads

Deans

Representation of Women (%)

Source: Association of American Medical Colleges

48% 45%

41%

29% 25%

30%

0%

10%

20%

30%

40%

50%

1997 2005 2011

Male

Female

N=226/471

N=212/471 N=163/

397

N=50/ 173

N=55/ 217

N=73/ 240

Men 15

Men 19

Women 3

Women 4

0

5

10

15

20

Deans Department Heads

Despite gains in the #s of women in faculty positions, gender disparities remain pronounced at UIC, particularly at full professor level & leadership roles

UIC data similar to national data “About average”

2015 study found 5 major themes: Perceived wide spectrum in gender climate Lack of parity in rank and leadership by gender Lack of retention of women in academic medicine (the ‘‘leaky pipeline’’) Lack of gender equity in compensation Disproportionate burden of family responsibilities and work-life balance on women’s career progression

Although most men and women sincerely hold egalitarian beliefs, those beliefs alone do not guarantee impartial evaluation of others

The goal is to make the invisible factors that slow women's progress visible, so fair treatment of men and women is possible

Source: Valian. Why so slow? The advancement of women. 1998. Cambridge, MA: MIT Press

Stereotypes about groups of people that individuals form outside their own consciousness

Patterns based on small bits of information

Often incompatible with our conscious values

Impacts hiring, persistence, and promotion

Fassiotto et al. 2015; Burgess et al. 2012; Moss-Racusin et al. 2012

When symphony orchestras switched to “blind” auditions (i.e., behind a screen)– increased hiring of women by 25% (Goldin & Rouse, 2000)

BEFORE4 /103 = 3.9% women

AFTER34 /95 = 36% women

The Chicago Symphony Orchestra

Recommendation letters for faculty Similarities but more “standout” adjectives for males

Women were described as “easy to get along with” and “good in groups” while men “initiated,” “started,” and “spearheaded”

Female letters shorter, contained more “doubt raisers” & focus on teaching; males as researchers

(Schmader et al., 2007; Trix & Psenka, 2003)

“Karen Miller” and “Brian Miller” (two names attached to same real CV)

Both male and female academicians were: More likely to hire a potential male colleague than an equally qualified female colleague

More likely to positively evaluate the research, teaching, and service of a male job applicant over a female job applicant

Steinpreis, et al. Sex Roles, Vol. 41, Nos. 7/8, 1999

17-year longitudinal study of faculty from 24 U.S. medical schools found that women were paid $20,520 less than men After adjusting for leave of absence and part time status, women still earned $15,159 less than men Gender difference in initial salary and start-up package persists over entire career

Freund et al., 2016

Longitudinal study of faculty from 24 medical schools

Women had lower publication rates, total number of publications, and h-index scores (productivity)

2009 national survey of recipients of K08 and K23 awards found men more likely to receive R01 following K award (48% vs 37%)

Men published more following K award (33.6 vs 26.7, p=.001)

Men more likely to be married/partnered, have children, and hold rank of professor (p<.0001)

Raj et al., 2016; Jagsi et al., 2011

Analysis of reviewers’ critiques of 739 R01 grant proposals found that more critiques of female applicants’ included words about ability and standout adjectives

Greater praise for women didn’t translate to better score

For men, criticism was followed by advice

For women, it was followed by questions about their ability

Kaatz et al, 2016, Journal of Women’s Health

2014 national survey of recipients of K scholars found that women were more likely to report:

Perceptions of gender bias (69.6% vs 21.8%, p<.001) Personal experience of gender bias in professional advancement (66.3% vs 9.8%) Unwanted sexual comments, attention, or advances by a superior or colleague (30.4% vs 4.2%)

Jagsi et al., 2016, JAMA

Study at 5 medical schools found that the hierarchy of chairs/heads in academic medicine limits women’s advancement

Lack of participatory leadership, inclusive decision making, and transparency Indeterminate terms for department heads maintains status quo Women more likely to believe hierarchy caused career plateau than men

Conrad et al., 2010, Journal of Women’s Health

English biochemist Nobel scientist Tim Hunt said: (2015) “Female scientists cause trouble for men in labs. Scientists should work in gender-segregated labs.” “The trouble with ‘girls’ is they fall in love with you and they cause men to fall in love with them and cry when criticized.”

“Rosalind Franklin was so distractingly sexy the boys forgot to credit her with helping discover the structure of DNA”

- Tweet Quoted by Rachael Martin, NPR

Diverse working groups produce higher quality science Peer reviewed publications with mixed authors are cited 34% more often than those with gender-uniform authors Manuscripts by ethnically and geographically diverse teams have higher impact scores and more citations

Diversity fosters innovation, contributes to greater creativity, balances biases, and brings new perspective to problems (Campbell LG, et al.,2013; Freeman & Huang, 2014; www.nigms.nih.gov)

Support research on peer review process Review sessions with a reminder that “the vast majority of NIH reviewers try to overcome the influence of their stereotyped preconceptions on review of R01s Examine wording in funding announcements Study of bias habit-reducing interventions at the study section level

(Carnes et al. [2015] Acad Med; Duguid & Thomas-Hunt [2015] J Appl Psych)

Acknowledge diversity “Color blind” doesn’t work Everyone is different and that’s a good thing Flexibility in work/life issues is career-advancing not career-pausing Institutional change requires making explicit what may be implicit through addressing bias (Carnes et al., 2012)

Mentor junior faculty members to navigate the landscape successfully

Evidence-based practices including team mentoring, career development planning, and interdisciplinary collaboration Mock reviews of grant proposals, conference presentations, and personal statement for promotion and tenure packet Help women develop professional networks and productive collaborations

Institutional transformation Create universal policies that support work/life balance for all faculty members regardless of sex/gender or family composition Not enough to create the policies—need to change the culture around acceptability of family friendly policies

12 weeks family leave Automatic tenure hold

1 year for assistant professor who parents by birth or adoption for men and women (including those in same-sex partnerships) Not considered during promotion and tenure decisions

Modified teaching duties without reduction in effort or salary Dual-career academic couples have 33% salary subsidy Child/elder care resource and referral program

All colleges develop and implement a faculty mentoring program

Each Dean held responsible to ensure that a mentoring program is developed, implemented and evaluated All eligible TT and NTT faculty have mentors Respect for diversity “Train the trainer” sessions (8 hours) conducted in Spring 2012

Mentoring excellence may be considered in the annual review of faculty and in promotion process

You might think that in a world where we finally have a female presidential nominee, men would be over the smiling thing Apparently not!

Source: Fortune.com