30th March 2022
Dr Kevin Coleman
188 Scenic Highway
Terrigal NSW 2260
Submission to New South Wales Parliament Inquiry into the use of primates and
other animals in medical research in New South Wales.
Dear Committee members,
I am a 67 year old retired Australian born GP with a background in maternal
–child health and public health. I was formerly an HIV / AIDS Co-ordinator for
the Western NSW Public Health Unit (1994); and the last GP obstetrician in
Cobar (1995-2006). I’ve spent over half my medical career in rural and remote
locations in PNG, outback Australia and rural South African locations.
Over the past 40 years, I have witnessed the triumphs and failures of biomedical
research at the coalface~ Neonatal and child ICU to remote outback clinics. To
admit a patient to Cobar Hospital, suffering a myocardial infarction ~ dissolving
a potential lethal clot in his coronary artery, and shipping my fellow citizen to
the Royal North Shore Hospital for stenting and return to Cobar Hospital on the
mend within 24 hours is a fantastic achievement. To deny such technological and
human achievements would be churlish.
And yet, the commercialisation and corporatisation of biomedical research
backing these achievements has an unsavoury underbelly. A lack of
transparency, accountability, informed consent and indeed justice prevail in our
biomedical research culture. This week, the prestigious journal Nature reports
“A quarter of medical researchers involved in clinical (Human) trials in Australia
did not declare funding from pharmaceutical companies.” 1 Declaring conflicts of
interest in Australia relies on an honour system. “This is not an issue of weeding
out a few bad apples, “ co-lead author Associate Professor Barbara Mintzes from
Sydney University says. “Based on our findings, the issue of incomplete and
inaccurate disclosure is widespread.” 2
This report simply re-confirms the widespread acknowledgment that extensive
industry influence is undermining “the integrity of scientific investigations, the
objectivity of medical education, the quality of patient care, and the public’s trust
in medicine.” 3
1 Clare Watson. Undisclosed industry payments rampant in drug trial papers.
Nature news 24 th March 2022.
2 Lucy Carroll and Liam Mannix. The Sydney Morning Herald March 13, 2022.
3 Ray Moynihan et al. BMJ 2019;367: 16576 doi: 10.1136/bmj.16576
What has this to do with Animal Research?
Animal research has been considered the cornerstone of biomedical research;
proponents claiming the benefits to humans are self-evident. This is not
supported by evidence. 4 The Collaborative Approach to Meta-Analysis and
Review of Animal Data from Experimental Studies (COMRADES) compelled John
Ioannidis ~ Professor of Health Research and Policy at Stanford University to
comment on the serious bias in animal studies such that “it is nearly impossible
to rely on most animal data to predict whether or not an intervention will have a
favourable clinical benefit-risk ratio in human subjects.” 5
Many promising findings from animal research fail in human trials. It is argued
that the narrow reductionist approach of biomedical research fails because it
relies on animal models in the lab, which fail to reproduce the biological,
psychological and social relationships which impact the ecology in which human
disease and indeed health evolve.
The “Focus on the model and not the disease” approach in Alzheimer’s research
epitomised the limitations and indeed failure of this approach. 6 Billions of
dollars have been wasted and millions of animals needlessly sacrificed chasing
the dominant scientific hypothesis “the Beta-Amyloid hypothesis” for
Alzheimer’s dementia, which after forty years has been found wanting. We still
have no cures, and little reflection on the cause of this waste of life and precious
research dollars.
Humans and animals be they lab rats, baboons or pigs share a common
evolution, but differing trajectories have ultimately led to differing physiology,
leading to differences in drug metabolism, explaining in part the failure of most
pre-clinical (Animal) trials in leading to effective clinical outcomes in humans. 7
The failure rate of pre-clinical animal research translating into effective clinical
therapies has been conservatively estimated as 96%. 8 Is this really good enough?
Is this a good use of scarce research dollars?
Over the past decade, the CRISP-R gene editing technology has been deployed to
edit genomic DNA (our genetic heritage) with lab RNA (the messenger).
4 Pandora Pound and Michael Bracken. Is animal research sufficiently evidence
based to be a cornerstone of biomedical research ? BMJ 2014 ; 348
doi:https//doi.org/10.1136/bmj.g3387
5 Ioannidis JPA Extrapolating from animals to humans. Sci.Trans Med 2012; 4, 1-
6 Susan Fitzpatrick. Asking the right questions in Alzheimer’s research. Issues in
Science and Technology. Fall 2018
7 Greek R, Menache A. Systemic reviwer of animal models: methology versus
Epistemology. Int J Med. Sci. 2013; 10:206-21
8 Pippin J. Animal research in medical sciences: Seeking a convergence of science,
medicine and animal law. South Texas Law Review 2013; 54:469-511
Invariably describe as a “Genetic scissors”, this technology had been in clinical
application for a very short period of time, and the jury is still out as to medium
to long-term safety. Is this good enough? Are we proceeding with due
diligence?
CRISP-R (Clustered Regularly Interspaced Short Palindromic Repeats) is
considered a game changer and allowed Xenotransplantation research to
proceed at pace. But is the benign portrayal of CRISP-R gene editing as a
precision intervention accurate? Some researchers caution that “focal” edition of
DNA may affect the whole genome as it behaves as an “All” in harmony with each
of our 24 chromosomes. Removal of a knot in a knitted garment may lead to an
unravelling of the whole; thus the legitimate concerns of many scientists about
so called “off-target” effects ~ the potential for collateral damage of our genome. 9
Clinical XENOTRANSPLANTATION, the transplantation of cells, tissues or organs
from non-humans to humans, crosses a species barrier that has evolved over
millions of years. We violate this evolutionary boundary at our collective peril.
Xenotransplantation research at the Sydney University (Royal Prince Alfred
Hospital and Westmead Hospital) is the most egregious example of all that is
wrong with biomedical research in NSW/ Australia. RPAH and Westmead
Hospital have been carrying out controversial xenotransplantation research for
over two decades. This unethical research on primates – baboons and pigs
involves the laboratory creation of hybrid primate-pig organs to be grown in
surrogate genetically modified pigs. Precise technical details are “Commercial in
confidence.” The baboons have reached their use by date and we are on the cusp
of clinical trials.
Lack of transparency, lack of informed societal consent and conflict of interest
have bedevilled this research for two decades. There has been little if any real
pubic consultation, according to three experts reporting on this: Professor Peter
Collignon- ANU; Professor Peter Sainsbury – Sydney University/ Australian
Health Ethics Committee (ret.) and Professor Anne Keogh a cardiologist at St
Vincent’s Hospital. 10
In 2018, the NHMRC updated the 2007 National Statement on the Ethical
Conduct of Human Research, providing a permissive framework for clinical
xenotransplantation trials to proceed. 11 Major ethical concerns have been voiced
and ignored in Australia. Professor Peter Collignon, an ANU based Public Health
expert, and NHMRC consultant opined in 1998:
9 Heidi Ledford. CRISP-R Babies ~ When will the world be ready? Nature 20 June
2019.
10 Anna Salleh. Dissent over animal to human transplants. ABC Science.17 Dec
2009.
11 NHRMC National Statement on the Ethical Conduct in Human Reseach 2007
(Updated 2018) E72
“Transplanting organs and tissues from animals to humans is one of the best
experiments we could devise to ‘create’ new infectious agents.” 12
The serious public biohazard of three baboons escaping from RPAH in 2020, was
casually dismissed with the comical narrative that it was just two baboon
“Wives” accompanying the male for a vasectomy. Professor Collignon’s concerns
persist. 13 His colleagues Prof Peter Sainsbury and Prof Anne Keogh share his
concerns. (personal communication)
“In most clinical trials, individual patients bear the risk of the experimental
treatment, with the community benefiting from scientific knowledge gained. In
Xenotransplantation this risk –benefit situation is reversed. All the benefits from
xenotransplantation accrue to the individual who gets the transplantation, if it
works. But most of the risk, if it occurs, goes to the community.” says Sainsbury.
“So it’s a complete reversal of the normal risk-benefit analysis.” 14
In the same manner donated blood is not routinely screened for COVID19, will
hybrid organs be screened for unknown pathogens such as viruses and prions?
There are historical precedents for medical interventions contributing to
significant public health crises.
In 2016, the Journal of Infectious Diseases published “Epidemic history and
iatrogenic transmission of blood-borne viruses in mid-20 th century Kinshasa.” by
Catherine Hogan et.al. The HIV-1 epidemic “grew more slowly before 1950, then
transitioned to a much faster exponential growth sometime between 1952 and
1968.” Their findings “represent the first empirical evidence for the hypothesis
that iatrogenic (Medical treatment) transmission played a role in the emergence
of the HIV-1 in Kinshasa in the mid-20 th Century.” 15
We know that those interventions were coercive, and may have been forced on
the population with the best of intentions, and yet unintended consequences can
remain hidden for decades.
As Australia gears up to deal a maturing epidemic of obesity / diabetes; and a
surge in cardiomyopathy following the Covid19 crisis, we may anticipate a
demand for more kidneys for an aging population, and hearts for younger folk
affected by an inevitable rise in autoimmune cardiomyopathy. As the NHMRC
moves to expand medical procedures involving animal to human transplantation,
we might all pause to consider the potential for iatrogenic harm.
12 Peter J Collignon. Controversies in Health Care. Xenotransplantation : do the
risks outweigh the benefits? MJA Vol 168 18 th May 1998.
13 Calla Wahlquist. Sydney baboon escape; the questions remain. The Guardian.
26 Feb 2020.
14 Anna Sellah see ibid see 10.
15 Catherine Hogan et.al. Epidemic history and iatrogenic transmission of blood-
borne viruses in mid-20 th century Kinshasa.
Our children and their grandchildren deserve due diligence with respect to
protecting their genomic inheritance.
Yours sincerely,
Kevin Coleman. MB.BS. (UNSW); DCH. (College of Med. South Africa) DTM&H
(Liverpool UK); MPH (UNSW); M GP Psychiatry (Monash)
