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Global Pharma - Globalizing Human Subjects Research (Ethics as Workable…
Global Pharma - Globalizing Human Subjects Research
commercialized clinical trials
US based contract research org
performed in political and economic instability
ethical variability - how international ethical guidelines are being recast
More human subjects
demand
sheer number of trials being run
satisfy US regulatory demands
some therapeutic categories, hypertension overwhelmed by new drugs - competitions to get approval
drug pipeline explosion, patent applications for new compounds
shift in the very science of drug development
finally, available pool of human subjects in US is shrinking - before 1970s 90% of drugs were first tested on prisoners. after that use of prisoners were banned for particular phase testing
Treatment Naivete
Chernobyl nuclear disaster
combination of local public health crisis and scientific interest
demarcating disease - used to be to prevent disease, now used to carve out new catchment areas of human subjects to target because of their treatment naivete
Ethical Variability - Constructing Global Subjects
controversy over placebo use in Africa - AZT trial
unresolved debate = ethical imperialism or ethical relativism?
AZT trial prompted the sixth revision of the Helsinki Declaration (human biomedical research)
revision : against placebo use when standards of treatment are known. new methods can only be tested against existing standards.
Pharma - placebo use lower cost, produce unambiguous evidence of efficacy
Helsinki wasn't enforceable, FDA cited ICH pg 44 motivated by high quality data
Trial Methods
Active Control Trials
Study defects
poor patient compliance, poor diagnostics criteria, use of concomitant medication
Placebo Control Trial
able to distinguish between effective and ineffective treatments
Ethics as Workable Document
Regulatory decision making at the transnational level encourages the evolution of "local" experimental terrains whose ethics are workable adn whose subjects can be variably protected under current international code of ethics such as Helsinki Declaration
currently no US legislation or international regulatory policy us aimed at controlling or monitoring globalizing clinical trials
FDA - currently only requires foreign review board approval. the was a suggestion to use a US and foreign review board p48
Pfizer = Trovan antibiotics but was taken off shelf because of liver damaging side effects.
Attempt to gain FDA approval
City of Kano during bacterial meningitis outbreak
pediatric victims most likely treatment naive
Doctors without borders was already distributing cheaper antibiotics, proven effective for treating bacterial mengingitis at main local hospital
Pfizer team went to hospital and selected 100 kids waiting in line. did not explain experiment. informed consent was backdated. to show trovan as more efficarious, some were given low dosing of the standard of care for meningitis (ceftriaxone) -- led to 11 deaths
case was filed in US courts
language of crisis instrumental in granting legitimacy in questionable experiments
Chernobyl - conduct genetically engineered hematopoetic growth factor molecule - to treat leukemia
Biological Citizenship
trovan & chernobyl - humanitarian crisis create "ethics free" space