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.
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?
There are deficiencies and biases inherent in the GLP system which industry has been quick to exploit and regulators have apparently been unable to grasp. Most of the problems originate with the cost of the system.
Registration fees are significant, and the extra administration demanded, plus the work, materials and storage facilities needed for long-term archiving don't come cheap. Contract laboratories can pass these costs on to their industrial clients in return for providing the added value of data from a GLP establishment. Some of these GLP studies do get published in the peer-reviewed scientific literature, but only if they reach conclusions their clients want to broadcast to the world.
State funded laboratories are rarely GLP: they can't afford it, and the evolving nature of their cutting-edge research, multiplicity of collaborations, individual and small group projects don't lend themselves to the procedural restrictions imposed by GLP. Quality control in such research is carried out by other scientists through the traditional route of publication, peer review and independent replication of the studies.
Auditing is a major expense for regulators. In the EU, GLP requires Member States to audit the laboratories every two years. This involves several trained inspectors for up to five days at a time. Elsewhere in the world the requirements (and standards) are lower. In the USA, where many large agri-chemical companies and many GLP laboratories are located, any facility can declare itself "GLP safe" without the need for external audit. It's then the task of the Environmental Protection Agency (EPA) to play catch-up and monitor compliance. In reality, the Agency only has funding for 4 or 5 GLP inspectors for the whole country, and not much auditing is actually going on.
Another problem is referred to by one author as "ossification" (but might be better termed "fossilisation"). This refers to the use of old standard techniques for safety testing when much more sophisticated, informative and relevant ones have been developed.
The repeated use of a standard set of analyses suits the contract laboratories: large numbers of such tests are easy to run on existing equipment for minimal cost, and the results can be compared with historical data (a useful excuse for dismissing or disguising results you don't want to see). Cutting-edge technique development, which is increasingly revealing subtle but very serious chronic harm from many substances previously 'proven safe', tends to come from non-GLP state-funded laboratories. Their findings are casting doubts on the ability of the fossilised techniques to tell us what we need to know about substance safety.
GLP ensures screeds are written down to satisfy the auditors, and that the results are very consistent (regulator-friendly), but they're not necessarily valid. In other words, they're not necessarily measuring what the investigators are supposed to be measuring (harm!).
Sadly, GLP also doesn't ensure that the records it demands are honest. For example, if a test animal inconveniently dies (providing a proof of harm your client has paid you to disprove), just replace it with a healthy one and put the dead beast's identification tattoo in with the archived samples from the substitute. For example, if you don't want to record tumours (evidence of serious harm), just call them 'inflammations'. For example, if the data aren't going to satisfy the desires of your client, just re-write them.
As recently as the end of 2019, a massive fraud was uncovered in one of Germany's largest animal testing laboratories, Laboratory of Pharmacology and Toxicology (LPT). The scam had been on-going since 2005, and didn't come to light during auditing, but only after an undercover investigator went to work in an LPT facility.
Because regulators have officially embraced Good Laboratory Practice, they've backed themselves into a corner where they can be controlled by the industries they're meant to be regulating: 'safety' studies entirely dictated by industry, unpublished and concealed from critical review are commissioned from GLP laboratories which regulators are then obliged to accept. At the same time, regulators are persuaded to reject any tests carried out in non-GLP establishments. These are the very tests sophisticated enough to reveal subtle harm and chronic disease. Unwelcome published results are dealt with by launching a concerted PR offensive against the authors and their non-GLP methodology [1,2].
The outcome of this (some would say absurd) situation, has never been more obvious than in the opposing conclusions about the carcinogenic potential of glyphosate herbicide reached by the International Agency for Research on Cancer (IARC) and regulatory bodies. Data accepted as valid by the IARC was limited to published, peer-reviewed studies while secretive, industry-sponsored studies were rejected as unreliable: regulators, on the other hand, largely restricted their considerations to those very studies the IARC rejected [3]. Indeed, the discredited LPT facility had produced one in seven of the studies used by EU regulators in its re-approval of glyphosate in 2017. In view of the fraud uncovered, the validity of these submissions is in serious doubt.
Glyphosate is widely used in UK farming for pre-planting weed-clearance and pre-harvest crop drying. In the lead up to the EU re-approval of the herbicide, the National Farmers' Union (NFU) dutifully regurgitated industry spin. It dismissed safety concerns, and trumpeted the claimed benefits of glyphosate for the environment, for climate change, for farm labour and for crop yields. Much was made of academic studies indicating the "severe impacts" if the weedkiller were to be banned, and members were urged to lobby for glyphosate re-approval in Europe. Three years later, it emerged that Monsanto, manufacturer of glyphosate, had itself funded these studies. Apparently unwilling to admit it was duped, the NFU said it was "happy to add a line to the online article stating that the research on this occasion was funded by Monsanto". Similarly, the editor of the journal which published the research said "The authors did not advise me of the source of the funding. For this reason it was not disclosed. Conflict of interests is important but not relevant in this case. The paper will not be amended or retracted." (Our emphasis)
OUR COMMENT
As British agriculture struggles to cope with post-Brexit changes, the possibility of GM herbicide-tolerant crops (along with extra applications of chemicals) in UK fields is looming large.
There's an industry-led dearth of honesty, transparency and willingness to admit error, which is making a mockery of science. Sadly, this situation appears to be supported by some scientific journals.
We urgently need to decouple material safety testing from the manufacturing industry. We need regulatory bodies with the authority to dictate what tests must be carried out, who should do them, and how much industry should contribute to the costs. We need rules for validating up-to-date science, not 'good-practice' smokescreens.
Given industry's habitual attacks on any scientist and science it can't control, plus the need for contracted laboratories to get the 'right results' in order to ensure future business from their clients, safety studies must be "done in a double-blind fashion so that the manufacturer or regulated party has no way to trace the researcher or vice versa" (Wagner).
It's time to start agitating for honest, independent, unbiased, up-to-date safety testing of chemicals and novel foods.
Background
[1] GLYPHOSATE CARCINOGEN REACTIONS - May 2015
[2] POLITICAL FALLOUT OF UNSAFE MAIZE - October 2012
[3] RIGGING THE SCIENCE (AND THE REGULATIONS) - March 2019
SOURCES:
Wendy Wagner and David Michaels, 2004, Equal Treatment for Regulatory Science: Extending the Controls Governing the Quality of Public Research to Private Research, American Journal of Law & Medicine 30
Kevin C. Elliott, 2016, Standardized Study Designs, Value Judgments, and Financial Conflicts of Interest in Research, Perspectives on Science 24
John Peterson Myers, et al., 2009, Why Public Health Agencies Cannot Depend on Good Laboratory Practices as a Criterion for Selecting Data: The Case of Bisphenol A, Environemntal Health Perspectives 117:3
Dangerous Confidence in "Good Laboratory Practice", Factsheet prepared by Corporate Europe Observatory, PAN Germany and Global 2000, February 2020
Glyphosate is Vital, NFU February 2017
Glyphosate - the basics: Our Q&A, NFU 31.03.17
www.gov.uk/guidance/good-laboratory-practice-glp-for-safety-tests-on-chemicals
Damian Carrington, Revealed: Monsanto's secret funding for weedkiller studies, Guardian 12.03.20
Fraud in German laboratory casts additional doubts on the 2017 re-approval of glyphosate and on the entire EU pesticide safety evaluation procedure, PAN Europe Press Release, 11.02.20
Jonathan Latham, Extensive Chemical Safety Fraud Uncovered at German Testing Laboratory, Independent Science News, 12.02.20
Carey Gillam, Science shouldn't be fore sale - we need reform to industry-funded studies to keep people safe, Guardian 18.02.20
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