Laboratory Fraud is a growing “elephant in the room” for science In New Zealand.
By Brian Jones.
Last summer (2017/18) as I worked as a Biosecurity auditor in Australia, I became aware of the growing problem of “Laboratory Fraud” and the apparent total absence of any mechanism in New Zealand (or Australia) to audit for such practices. True, the RSNZ has a Code of Conduct for members but that has limited effect, assuming that members have even read it!
Indeed there seems to be a general perception that if Laboratory Fraud exists at all, it’s not a problem here.
However, an Australian ABC Four Corners program in 2018 highlighted how bovine blood products were illegally smuggled into Australia as FACS buffer using false labels, before being relabelled as “Australian sourced” and re-exported. The assumption by buyers would be that the bovine serum was FMD free and thus exact a price premium, over serum sourced from South America (the real origin).
At the heart of the conspiracy was the firm PAA Laboratories, which was based in Austria, and acquired by GE in 2011. It was not Australian audit practices that picked it up. It was GE who discovered the scam and reported it to Australian authorities. In both Australia and New Zealand there is a perception that criminal activity does not occur in testing laboratories, therefore there is no need to audit for it.
The second “wake up call” for Australia was the outbreak of White Spot Syndrome in Queensland prawns in late 2017, which on investigation showed that a number of large importers, between them controlling over half the import licences for frozen prawns, were systematically gaming the biosecurity controls such that about 70 % of prawns on sale were infected with live exotic white spot virus (WSSV). Yet every shipment purported to have a test certificate to say that it had been tested (in Australia) by a NATA accredited test to be WSSV free. That investigation suggested that “trusted importers” is an oxymoron and that commercial laboratories may be providing test results that may be at variance with that obtained by government laboratories.
There are basically three types of laboratory fraud:
1) The first is relatively well known. It involves researchers who cheat on their experiments and publish false data in papers. This has been around for some time and is generally perceived as a “fringe” problem (but is it??).
The issue is, that for an increasing number of labs, funding requires the publishing of novel research results. The financial incentive to produce research that is leading edge but totally spurious is large. A 2018 NZ media report highlighted the role three Auckland University staff had taken in uncovering a huge medical research fraud in Japan, involving 33 research trials and over 50 animal trials. In 2017 China cracked down on some 400 researchers who were authors of 107 subsequently retracted papers in the Journal “Tumor Biology”. In 2018, China assigned the Ministry of Science and Technology responsibility for managing investigations and ruling on cases of scientific misconduct, taking the responsibility off individual institutes. The Chinese academy of Social Sciences takes responsibility for social scientists.
2) Commercial laboratories that issue false test reports for money. This is estimated by the global insurance industry to be a US$3 billion a year industry and affects food, healthcare, environmental and product testing for commercial gain.
This type of fraud falls into two broad types: a laboratory that is owned or has been captured by the client; or an independent laboratory that issues “favourable” test certificates for money. At one level this fraud is simply the issuing of false reports for which no actual testing was done. A more subtle approach is to use a test method that is flawed such that it gives the “right” result. This is particularly easy with real time PCR which is generally assumed to be infallible and is usually not (that’s a subject for a separate blog!). Disturbingly, this type of dodgy PCR can become an “accredited test” and bear a NATA or IANZ logo.
It is a crime that is particularly difficult to detect in normal quality audits (such as IANZ or NATA) as the auditor is not looking for deliberate fraud. It is also generally not appreciated that real time PCR results are machine specific and when the software is updated, the batch of reagents is changed, the machine platform is changed or the operator is changed, the test should be revalidated. The test is also sensitive to the number of cycles and the use of “cut-offs” in the amplification curve which can be manipulated to achieve the “right” result. All of this is documented in the literature, if you look, but most labs ignore the huge amount of work involved in true on-going validation of a test.
As long ago as 1997 the US authorities were promoting the use of compliance programs in testing laboratories. It is a pity that such a code (available online) is not mandated in Australasian labs. Yet this type of crime is certainly not foreign to New Zealand.
In 2017 NZ Steel and Tube were taken to court by the Commerce Commission in part over batch test certificates for non-compliant steel mesh that they sold. Again, in its December 2017 Newsletter IANZ reported that fake IANZ documents had been detected in NZ and had also been referred to the Commerce Commission.
3) Companies that promote fake research to both support their product and rubbish results from competing research that suggests that their product is flawed. The latest in a line of large companies to be accused of that is Monsanto, over the carcinogenic properties of ”Roundup”. Revelations produced in US courts include confirmation that the company hardly tested the real-world toxicity of its products, actively avoided pursuing studies which might show unwelcome results, and ghost wrote the studies of supposedly independent scientists. The documents also show Monsanto systematically attacked scientists whose research threatened their profits (https://www.csu.edu.au/research/grahamcentre/news/feature-stories/feature-story/2018/glyphosate-and-fake-news).
Its perhaps time the NZ science community, and the bureaucrats who oversee the science (and social science) budgets, took a harder look at the provenance of the research they pay for and rely on. We might pride ourselves that New Zealanders “don’t do that sort of thing” but the limited evidence available suggests that some probably do.