BIO 416 Lecture Notes - Lecture 14: Dallas Buyers Club, National Institutes Of Health, Menopause
Monday, November 14, 2016
BIO 416 Week 14 (?) In Class Notes
Recitation Notes
About the Essay Exam: Feedback from Essay Exam 1
-They’re looking for clarity in argument
-This next one will be asking about Human Subjects
Dallas Buyer’s Club - Discussion About the Movie:
-Ethics - the different medications available in other countries
-What’s the doctor’s ethical obligations to a patient asking about the medications from
other countries? If they weren’t FDA approved?
-FDA has a responsibility to take things slow just as the legal system has an
obligation to take things slow
Pharmaceutical Industry’s Role:
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Week 14: Human Subjects, Justice, Research
Next week: no sections
Final revised case due Monday
Exam II posted - due December 5
There is lecture on Monday
Broadening The Applicability of Clinical research
-Justice is a kind of interesting topic because it’s done a “flip flop” in recent years
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Monday, November 14, 2016
-Readings from this week were from the 1990s
-In history the participants have mainly consisted of white males aged 20-50 years
Rebecca Dresser
-it does simplify the science when you have a homogeneous subject pool
-Reduce variation in research subjects
-Protect health of pregnant women and potential fetus/child
Some of the pushback: is this enough reason to stick with a uniform population?
-If it’s just about simplifying data, could you not have other homogeneous groups of
subjects?
-Narrow data reduces the value of the research - yes, you get cleaner data with a
smaller group, but you don’t have knowledge with a broader population
-People of different racial groups, ages, genders will be using these drugs/
treatments so the application from studying on a small and uniform group of
subjects isn’t really that great
On Exclusion of Women and Minorities
-Protect health of women and potential fetus/child
-This premise assumes that all these women that go into research participation are
fertile, sexually active, and bad at using contraception
-Think about breast cancer patients - not all women are going to be having
children
-Break down the studies:
-Is this a study that will actually cause risk? If not, what’s the justification of
excluding women?
-Well maybe there is a risk but there could be a significant benefit to the mother. If
there’s a potential benefit you can set up requirements
-In other words, there are options to avoid the bad long term outcomes
(fallitomide case) you manage it in other ways rather than flat out excluding
women
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