December 2021
In the 1970s, there was a massive scandal when America's largest contract research laboratory, responsible for a third of all its pre-approval toxicology testing, was found to have been manipulating studies and systematically falsifying experimental data for over a decade.
Industrial Bio-Test Laboratories (IBT) carried out around a third of US pharmaceutical and chemical product safety testing during the 1950s, 1960s and 1970s.
When the Food and Drug Administration (FDA) audited the company, 71% of its studies were invalidated, and thousands were found to be fraudulent or grossly inadequate.
What started as serious concerns about poor quality research expanded into a criminal investigation, and in 1983 three men from IBT were convicted for fabricating key safety tests to gain government approvals. The fraud brought into question 15% of the pesticides approved for use, besides many pharmaceuticals and industrial chemicals.
IBT clients included Monsanto, Dow, and DuPont.
America's response to this fraud was to devise 'Good Laboratory Practice' (GLP). This quality assurance system provides a legal framework which specifies, for example, standard requirements for equipment and facility maintenance, experimental conditions, documentation of all procedures and data, archiving of all findings and materials, monitoring of personnel, and external auditing of test facilities.
Good Laboratory Practice was introduced into America in 1978 and adopted by the Organisation for Economic Co-operation and Development (OECD) in 1992 making it a world-wide standard. It was formally adopted by the EU in a 2004 Directive.
Problem sorted.
Or, is it?