Yes. That is correct. There are other issues too. Here is a link to the new defence joint expert witness insulin report:
https://drive.google.com/file/d/1SQ8sgUwerw8n5H_u-pRcHqJaxgqeef4K/view
To summarise:
We have concluded that the Jury were misled in important areas as follows:
a) Medical facts: the evidence for sepsis, leakage of the central line into surrounding tissues, and consideration of alternative causes for the hypoglycaemia.
b) Evidential facts: errors in the glucose results presented, changes in the glucose levels in response to TPN infusion connection/disconnection, ward-based blood glucose tests presented as if they were laboratory results.
c) Testing: that the results of the immunoassay tests can be relied upon, and that the Roche immunoassay method used at the Royal Liverpool University Hospital (RLUH) was specific for identification of insulin alone (endogenous or exogenous)- neither of which are correct.
d) Background error rate: this is at least 0.5-2% despite excellent quality control for the type of insulin immunoassay test used, which the jury were not made aware of.
e) Quality Control testing information was not revealed to the Court in expert witness evidence. The results showed a quality control test with high insulin and a low C-peptide.
f) Abnormal results: it is essential requirement according to published standards to undertake confirmatory testing of the immunoassay result using a different, more specific methodology, such as liquid chromatography mass spectrometry (LC-MS).
g) Reference ranges not applicable in small preterm infants for C-peptide results and insulin/C-peptide ratios. Studies in adults and older children were quoted which are not relevant, and the limited appropriate information was not referred to.
h) The testing did not meet acceptable forensic standards at the Liverpool laboratory in terms of analytical specificity, chain of custody, control testing for interfering substances, and obtaining confirmatory result using alternative available methods or another laboratory.
The new evidence undermines the validity of the results of the insulin and C-peptide testing presented in Court and shows that these immunoassay results cannot be safely relied upon (without undertaking further confirmatory testing).
There is now evidence that:
Shows that the presence of antibodies (IAA insulin autoantibodies and other antibodies such as HAMA) can interfere with the immunoassay result and cause falsely high insulin results.
Demonstrates that insulin autoantibodies can be transferred from mother to baby during pregnancy causing hypoglycaemia in the baby and falsely high insulin levels.
That IAA (insulin autoantibodies) can be found in pregnancy and in the umbilical cord blood of infants, that this is not rare, and that the prevalence can vary over time.
In the context of a falsely high insulin result the insulin/C-peptide ratio is meaningless.
Demonstrates there are alternative medical explanations which explain the hypoglycaemia in both babies, such as line failure, sepsis and perinatal stress-induced hyper-Insulinism (PSIHI). These alternative possibilities were not considered.
Indicates that the testing undertaken did not meet acceptable standards of clinical, laboratory or forensic practice, and therefore cannot safely be relied upon.
Our inescapable conclusion is that this evidence significantly undermines the validity of the assertions made about the insulin and C-peptide testing presented in Court.
Expert Biographies:
Dr Neil Aiton
- Consultant Neonatologist at Royal Sussex County Hospital since 1998. Over 25 years of neonatal care experience, extensive experience as an expert witness, especially in Family Court. Expertise in neonatal hypoglycaemia and hyperinsulinism.
Professor Alan Wayne Jones
- Retired Professor of Forensic Toxicology, senior scientist at Swedish National Laboratory of Forensic Medicine. Specialises in forensic toxicology, alcohol/drug pharmacology, and insulin as a toxic agent.
Dr Richard Taylor
- Consultant Neonatologist with 30 years of neonatal intensive care experience in Canada. Assistant Professor at the University of British Columbia.
Dr Adel Ismail
- Retired Consultant in Clinical Biochemistry and Chemical Endocrinology. Expert in endocrinology, chromatography, immunoassay errors, and clinical diagnostic accuracy. Extensive research, especially in immunoassay error detection and analysis.
Professor Matthew Johll
- Professor of Chemistry and Forensic Science, consultant for insulin-related forensic cases.
Dr Hilde Wilkinson-Herbots
- Associate Professor at University College London, expertise in probability theory, statistics, genetics, and epidemic modelling. Experienced in statistical consultancy for forensic sciences.
Professor Charles Stanley
- Paediatric Endocrinologist, Emeritus Professor of Pediatrics, internationally recognised expert in paediatric endocrinology, particularly hyperinsulinism and hypoglycaemia disorders.