“Escalating Human Experimention”: FDA Only Inspects 1% of Overseas Drug Trial Sites
“ … The findings drew a considerable level of comment from groups that monitor public health in the US, notably Public Citizen who said the report ‘confirms some of the worst fears about the serious dangerous of escalating human experimentation.’ … “
By Gareth Macdonald
Outsourcing Pharma
June 24, 2010
The US FDA only reviews a fraction of trials conducted outside the country according to research by the Department of Health and Human Services (HHS).
According to the new HHS Office of Inspector General report 80 per cent of marketing applications for pharmaceuticals and biologics approved in the US contain data from trials conducted outside the country.
However, despite this high reliance of overseas clinical research data, the Food and Drug Administration only inspected 0.7 per cent of clinical trial sites outside the country in 2008, compared with 1.9 per cent in the US.
The study also suggested that the agency may even be unaware of some early-phase studies conducted in the developing world as a result of submission failure or of logistical difficulties.
The findings drew a considerable level of comment from groups that monitor public health in the US, notably Public Citizen who said the report “confirms some of the worst fears about the serious dangerous of escalating human experimentation.”
Group spokesman Sidney Wolfe put it more directly, telling the Associated Press that: “The quality of data used by the FDA as a basis for approving the drugs being studies may well be flawed, resulting in dangerous, incorrect decisions to approve drugs.”
for more....
http://www.antifascistencyclopedia.com/allposts/fda-only-inspects-1-of-overseas-drug-trial-sites
“ … The findings drew a considerable level of comment from groups that monitor public health in the US, notably Public Citizen who said the report ‘confirms some of the worst fears about the serious dangerous of escalating human experimentation.’ … “ By Gareth Macdonald
Outsourcing Pharma
June 24, 2010
The US FDA only reviews a fraction of trials conducted outside the country according to research by the Department of Health and Human Services (HHS).
According to the new HHS Office of Inspector General report 80 per cent of marketing applications for pharmaceuticals and biologics approved in the US contain data from trials conducted outside the country.
However, despite this high reliance of overseas clinical research data, the Food and Drug Administration only inspected 0.7 per cent of clinical trial sites outside the country in 2008, compared with 1.9 per cent in the US.
The study also suggested that the agency may even be unaware of some early-phase studies conducted in the developing world as a result of submission failure or of logistical difficulties.
The findings drew a considerable level of comment from groups that monitor public health in the US, notably Public Citizen who said the report “confirms some of the worst fears about the serious dangerous of escalating human experimentation.”
Group spokesman Sidney Wolfe put it more directly, telling the Associated Press that: “The quality of data used by the FDA as a basis for approving the drugs being studies may well be flawed, resulting in dangerous, incorrect decisions to approve drugs.”
for more....
http://www.antifascistencyclopedia.com/allposts/fda-only-inspects-1-of-overseas-drug-trial-sites
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