Dr. Gillian Einstein: Importance of Sex as a Basic Biological Variable in Preclinical Research

Dr. Gillian Einstein: Importance of Sex as a Basic Biological Variable in Preclinical Research


– IT’S INCREDIBLY IMPORTANT
TO CONSIDER SEX AS A BASIC BIOLOGICAL VARIABLE IN RESEARCH
BECAUSE, WELL, HALF OF OUR POPULATION IS, UH–
IS OF ONE SEX OR ANOTHER SEX, AND WE KNOW FROM THE SCIENCE
THAT THERE ARE MANY, UM– THERE ARE MANY
DEVELOPMENTAL, UH– DEVELOPMENTAL ASPECTS THAT INFLUENCE, UM,
BIOLOGY ACCORDING TO SEX. UM, THERE ARE MANY LIFE
CIRCUMSTANCES THAT INFLUENCE BIOLOGY ACCORDING TO SEX,
AND THERE ARE, UM, CHANGES IN BIOLOGY
OVER A LIFETIME THAT INFLUENCE UM, OUR RESPONSE TO DISEASES AND OUR RESPONSE TO, UM, LIFE
CIRCUMSTANCES ACCORDING TO SEX. SO IT’S REALLY
IMPORTANT TO CONSIDER SEX. IT’S, UH, JUST THE BASIC
BIOLOGICAL VARIABLE. YOU NEED TO ASK YOURSELF, DO
YOU WANT TO STUDY ONLY FEMALES? IS YOUR QUESTION, UM, MORE
APPROPRIATE ONLY FOR MALES? YOU NEED TO ASK YOURSELF, UM, IF YOU’RE GOING TO STUDY FEMALES
OR INCLUDE FEMALES, DO YOU WANT
TO STUDY, UM, FEMALES IN THEIR REPRODUCTIVE LIFE, OR DO
YOU WANT TO STUDY THEM IN REPRODUCTIVE SENESCENCE, AND, OF COURSE, RODENTS HAVE
SOMETHING CALLED REPRODUCTIVE SENESCENCE, WHICH IS ACTUALLY
NOT THE SAME AT ALL AS HUMAN MENOPAUSE. SO IF YOU’RE THINKING ABOUT, UM,
WANTING TO MAKE YOUR EXPERIMENT RELATE TO A HUMAN CONDITION,
YOU THEN HAVE TO ASK YOURSELF, IS THIS THE APPROPRIATE MODEL? IN ORDER TO THINK ABOUT THE
INCLUSION OF FEMALES AND MALES IN ANIMAL WORK, WE NEED TO
REVISIT SOME OF OUR TRIED AND TRUE SCIENTIFIC ASSUMPTIONS. SO ONE SCIENTIFIC ASSUMPTION
IS THAT YOU DON’T REPORT NEGATIVE DATA. IT’S COMING UP OVER AND
OVER AGAIN IN THIS MEETING, THIS WORKSHOP, THAT WE NEED
TO REPORT NEGATIVE DATA. WE NEED TO KNOW WHEN THERE ISN’T
A DIFFERENCE AS WELL AS WHEN THERE IS A DIFFERENCE, UM, AND WE NEED TO UNDERSTAND
THE CONDITIONS UNDER WHICH THE NEGATIVE DIFFERENCE OR THE
POSITIVE DIFFERENCE OCCURRED. SO A FAMILIARITY WITH THE
NUANCES OF BOTH THE MODEL YOU WANT TO WORK WITH, UM, WHAT THE
ANIMALS THEMSELVES DO, UM, AND ALSO, UH, A FAMILIARITY
WITH THE NUANCES OF HORMONES. UM, I THINK A LOT
OF PEOPLE THINK THAT, UM, A HORMONE IS A HORMONE
IS A HORMONE, BUT, OF COURSE,
THERE’S 17-BETA ESTRADIOL. THERE’S ESTRONE.
THERE’S ESTRIOL. THE QUESTION IS, WHICH ARE YOU
GOING TO STUDY, AND ARE YOU GOING TO STUDY THEM OPPOSED
WITH PROGESTERONES? ARE YOU GOING TO STUDY
THEM OPPOSED WITH SYNTHETIC PROGESTOGENS? WHAT–
WHAT IS GOING TO HAPPEN? SO IT IS COMPLEX,
BUT THERE ARE MANY GOOD REVIEW PAPERS OUT THERE NOW BECAUSE THE FIELD HAS BEEN
DEVELOPING, I THINK, STRATEGICALLY WITH
AN EYE TOWARD THIS MOMENT WHEN THE NIH, THE CANADIAN
INSTITUTES OF HEALTH RESEARCH, AND THE EUROPEAN UNION WILL BEGIN TO DEMAND FOR THE GOOD– THE GOOD OF
SCIENCE THAT INVESTIGATORS BEGIN TO INCLUDE MALES AND
FEMALES IN THEIR MODELS. THERE ISN’T ANY CONDITION IN
WHICH THIS ACTUALLY WON’T BE IMPORTANT, BUT I THINK
ALZHEIMER’S DISEASE IS AN INCREDIBLY IMPORTANT
CONDITION IN THIS REGARD, UM, BECAUSE ALZHEIMER’S DISEASE IS
A MULTIFACTORIAL DISEASE UNLESS YOU’RE STUDYING EARLY ONSET,
AND EARLY ONSET ONLY AFFECTS A VERY SMALL PROPORTION
OF PEOPLE. SO WE KNOW, FOR EXAMPLE, IN MEN THAT TRAUMATIC HEAD INJURY
RISK– THAT COMES FROM RISK-TAKING
BEHAVIOR THAT’S MORE COMMON IN MEN THAN WOMEN, THAT THIS IS A RISK
FACTOR FOR ALZHEIMER’S DISEASE. WE KNOW THAT STROKE–WHICH IS
MORE COMMON IN MEN THAN WOMEN, AT LEAST PRIOR TO– PRIOR TO MENOPAUSE IN
WOMEN–UM, THAT STROKE IS A RISK FACTOR FOR ALZHEIMER’S
DISEASE IN MEN, BUT WE ALSO KNOW IN WOMEN THAT
IT LOOKS LIKE ACTUALLY HAVING YOUR OVARIES REMOVED BEFORE
NATURAL MENOPAUSE IS A RISK FACTOR FOR ALZHEIMER’S DISEASE, AND THAT’S A VERY
GENDERED CONDITION.

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