Dangerous Confidence in “Good Laboratory Practice”

Introduction

Our authorisation system for chemicals is based on the principle that manufacturers must prove, by means of scientific studies, that their products do not pose unacceptable risks to public health and the environment. It is therefore also the responsibility of manufacturers to commission certified contract laboratories to carry out the toxicological studies necessary for the approval procedure. As a guarantee against manipulation and falsification of these "regulatory" studies, regulatory authorities worldwide rely on the certified standard of "Good Laboratory Practice" (GLP). This standard provides for strict documentation requirements and regular internal and external controls. However, the current fraud scandal involving a German contract laboratory certified according to GLP, shows that this trust is unlikely to be justified. According to reports, GLP studies have been manipulated and falsified there since 2005.

In October 2019, the investigative ARD news magazine FAKT shocked Germany with serious fraud allegations against one of the largest German animal testing laboratories, the Laboratory of Pharmacology and Toxicology (LPT) Hamburg. This company is a contract laboratory which carries out regulatory studies on behalf of the pharmaceutical and chemical industry. Until now, the authorities considered studies carried out under GLP to be reliable and forgery-proof. GLP is a legally binding standard for regulatory studies, which was introduced in the late 1970s to prevent scientific fraud.

The current case came into play after an animal welfare activist who had infiltrated one of the three LPT branches, reported serious manipulation of a drug study. After broadcasting a TV report on the subject, several former employees came forward and described similar breaches, which date back to 2005.

Recent research now shows that LPT has also produced studies that were part of the study package for the EU-wide approval of glyphosate in December 2017: one in seven studies in this package, which was the basis to grant re-approval for glyphosate, came from LPT. These findings are worrying in two ways:

- On the one hand, there is the fundamental question of whether the risk assessments for medicines, pesticides and chemicals based on LPT studies can be trusted.

- Even more worrying is the general realisation that laboratories, despite the supposedly "tamper-proof" GLP standard, are apparently able to falsify studies over years and decades without being noticed by the control authorities. The classification of glyphosate as "non-carcinogenic" and "not genotoxic“ is based, among other things, on the European authorities' full confidence in the GLP system. In the EU assessment process GLP studies were automatically classified as reliable; This is in stark contrast with the numerous "non-GLP studies" from university research, peer reviewed and published, most of which have reported evidence of a genotoxic effect and an increased risk of lymphatic cancer in users of glyphosate, which were disqualified by the authorities as „unreliable“.

The LPT counterfeiting scandal reveals the failure of a regulatory system, that places the commissioning and preparation of studies in the hands of industry. At the same time, it confirms the urgency of a fundamental reform of this system for identifying the risks of chemicals, as called for by the European coalition "Citizens for Science in Pesticide Regulation" in October 2018.

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