A “SELECTIVE” Course Proposal on Gender Based Medicine

Biegon A, Acosta-Martinez M and Chandran L.Stony Brook University School of Medicine, Stony Brook NY

BACKGROUNDStony Brook University School of Medicine introduced a fully revamped curriculum (LEARN) for medical students with special focus on active learning and self directed learning. We plan to offer a four-week “selective” (selected elective) on gender based medicine in the third phase of the curriculum. This will be one of six “selectives” in the school, with every student required to choose two of the six selectives, allowing for individualization and self direction among learners.

Objective: Design an introductory course on gender based medicine addressing learner needs for individualization and flexibility while stimulating “habits of inquiry” necessary for future physicians.

APPROACHThe course will use a “flipped class room” approach with assigned pre readings and subsequent interactive team work in class. 12 two hour in class sessions lead by course leaders and students will cover the following topics (selected illustrations shown for each topic). To facilitate active learning, each student will choose a medical condition or drug class, examine it using the “gender lens”, and give a 15 min presentation to their peers. Where literature searches yield no relevant information students will be asked to design a preclinical or clinical research project likely to yield the missing data. Participants are expected to appreciate the large gap in knowledge pertaining to women’s health resulting from the historical exclusion of females from clinical and preclinical research and be able to develop and implement the necessary tools to overcome this gap in clinical practice and biomedical research

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9. Future perspective: Defining the 51% minority-research and more research

1. Historical perspective: from Gender-biased to Gender based medicine

1200-1800: Women were seen as inherently evil and sexual, and therefore easy targets for the devil. Women (often midwives or herbalists) represented more than 90% of those executed for witchcraft in Europe and the US.

1859:The proposition that women, as a sex are not fit to practice medicine—that their weak physical organization renders then unfit for such duties and exposures—that their physiological condition during a portion of every month disqualifies them from such grave responsibilities, is too nearly self evident to require argument (AMA).

1977: FDA guidelines exclude women of child bearing potential (broadly defined as the “capacity” to become pregnant) from participation in phase I and II clinical trials.

1920: US women win the right to vote

1945: Harvard Medical School removes ban on accepting female medical students

1993: FDA mandates participation of women in clinical trials and data analysis by sex

1993: NIH issues requirement to include women in NIH sponsored clinical trials

2015: NIH issues mandate to consider sex as a biological variable in NIH-funded research (will take effect January 25, 2016)

2. Gender and hormonal environment affect disease prevalence

3. Gender-specific disease presentation Myocardial infarction in men and women

4. Gender- and hormone-related adverse effects of medication: modulation of Pharmacokinetics and pharmacodynamics

5. Gender- and hormone related adverse effects of medical devices and procedures

Coronary angioplasty: Procedure related mortality six times Higher in women (1.7% vs 0.3%, p<0.001)Cardiac surgery: Women have significantly higher risk of new neurological events with higher 30 day mortality

6. Sex X age interactions in disease prevalence and outcome Examples from head injury and stroke

7. Drugs in pregnancy: the last frontier Drugs considered safe in pregnancy (FDA category A0, 2014

8. Psychosocial aspects of sex differences in care-giver and care-seeker perception of disease

• Women account for 66% of doctor visits in the US• Women are less likely than men to be treated aggressively (e.g. in stroke)• Female physicians spend significantly more time with patients relative to male physicians