E-drug: American research without a requirement for American IRB review (cont)
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I think one of the things that needs to be addressed is the fact that
conducting clinical trials is a business in and of itself. There are huge
multinational corporations -- Contract Research Organisations as they're
called -- which are contracted to other huge corporations known as
pharmaceutical companies. The CROs undertake to get the results the drug
companies want so the drug companies' drugs can be marketed
lickety-split in the markets that will yield the highest return on
investment. The CROs will oversee the trials in the location that
yields the desired results in the shortest amount of time.
Governments rise and fall to ensure that these kinds of objectives
are achieved. In another era and in another field, the government of
Guatemala was overturned so that United Brand would continue to grow
bananas using underpaid and super-exploited labour. That's just one
example among hundreds during the last 100 years.
That probably sounds overly cynical, but the whole area of clinical trials
is a mean and cynical business. Clinical trials yield results that are
suspect because they are overshadowed by the main thing that fuels
them in the first place, and that is making big profits. One of the
things that
should be placed under scrutiny is the ethical framework which
governs the trials. Birth control pills were tested on unsuspecting
Puerto Rican women more than 50 years ago so that the manufacturers
could make money selling them first to hopeful women in northern
countries and later to anyone else who could afford them. Human
insulin is replacing animal-sourced insulins around the world despite
the controversy that surrounds the trials that led to FDA and MCA
approval in 1982 (after a mere 5-month review). Human insulin, the
poster child of the biotech industry, is a good example of how
clinical trials can be manipulated to support industry profits over
health and safety of patients.
The whole clinical trial industry needs to be scrutinized. The issue isn't
just whether or not American standards are being applied in developing
countries, because American standards are also designed to support
industry objectives first and human health second. The main question
for our time in history is whether investors should have anything
whatsoever to do with testing the safety and viability of drugs, no
matter where those tests are conducted or who they are conducted on.
Colleen Fuller
Vancouver, BC
"Colleen Fuller" <cfuller@telus.net>
[Please, always add affiliation. BS]
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