• Pharmaceutical Testing in a globalized world
• biomedicine and biosciences
◦ culturally, historically distinct medical system
◦ politically and economically
◦ symbolically (associated with the West)
• What is the pharmaceutical industry doing when it tests drugs "off-shore"?
◦ what is the incentive? why is it lucrative?
◦ cheaper to run their trials there, people are poor and desperate
◦ better control population, limited all the variables, people aren't on lots of
• What are the assumptions and implications of this practice?
◦ many of these trials are conducted on people who don't really know the
consequences of that participation and the after-effects of the drugs
◦ weak regulatory structure
◦ even those these places are supposed to conform to FDA level rules,
there is little accountability
◦ these research organization that are contracted to do this clinical trials,
there is no onus on these researchers to actually report all the details of
their tests, just enough to get the drug legitimated
◦ very difficult to track how many experiments and trials have been done like
◦ no central database
◦ there isn't a law that they have to openly disclose all their results and
• How does Big Pharma use the media to market prescription drugs? Are
consumers being misled?
◦ has contributed to the creation of certain diseases (ADHD)
◦ it is a lucid and clear example of how diseases are culturally and socially
constructed for profit
Global Clinical Research Organizations
• historically clinical trials were conducted by govt agencies and universites
• shift to be contracted out to organizations abroad
• self-regulated, adn referred to as CROs (Global Clinical Research Organizations)
• very profitable industry
KUANTUM - your eye on clinical research
• remarkable potential w respect to medical centres, investigators and patient
• What is happening to US Drug Trials?
◦ Easier to recruit ◦ "Drug naive"
◦ Regulations less stringent
◦ Little risk of litigation
◦ Fewer ethical concerns
◦ FDA doesn't monitor
Documentary: Deadly Medicine
• Where are the drug trials going?
• What are "rescue countries?"
• What is happening once a drug is tested?
• What does an "off label" mean?
◦ it's used for something other than what it's supposed to be prescribed for
◦ it's used t