As far as retroviruses
are concerned,
"It is now recognised
that pigs carry an edogenous retrovirus--porcine endogenous retrovirus,
or PERV. Reports that PERV can infect human primary cells and cell lines
in vitro are of concern….. Important features of retroviruses
include clinical latency (where the first presentation may occur many
years after the initial, often asymptomatic,infection); a range of disease
manifestations, including direct immunosuppression (eg HIV); and an association
with opportunistic infections, malignancy and central nervous system
disease…. Retroviruses are transmitted in various ways, including horizontal
transmission from animal to animal in a population via sexual contact
of blood, and vertical transmission from mother to offspring. A feature
is their ability to move across species and emerge in the new species with
a different patten of disease and mode of transmission." NHMRC draft guidelines
This is how the NHMRC assessed the public health risks associated with
PERV:
6.4 Assessing the public health
risks associated with PERV
A chain of
events would be required for PERV to pose a public health risk:
(i) infectious
PERVs must exist that are able to infect human cells (this
condition has been met);
(ii) such viruses
must be present in the germ line of pigs bred for xenotransplantation
(this condition is met for most, but not all, such pig herds);
(iii) the viruses
must be expressed in transplanted cells, tissues or organs (this has been demonstrated in vivo in immune deficient mouse
models only);
(iv) expressed
PERV must infect the xenotransplant recipient (risk unknown
to date);
(v) replication
and spread through the recipient must take place (risk unknown
and not demonstrated in any human or animal model); and
(vi) transmission
to others must occur (risk unknown and not demonstrated
in any human or animal model) (Stoye 1998).
However, one doesn't have to
seek much and one will find that there is much more known
than the NHMRC discussed in the Guidelines and its public statements.
This is an excerpt from a description from the Council of Europe. Note
especially the aspect of PERVs transmitted genetically to
progeny, a very important detail not covered in the Guidelines, nor
in public statements made by the NHMRC in the "thumbs-up"
campaign (?) to go ahead.
The special interest in retroviruses is based
on their ability to integrate into the genome of infected cells. Retroviruses
are RNA-viruses, which use a viral enzyme, the reverse transcriptase
(RT) to transcribe the single-strand RNA into double-strand DNA, which
then will be integrated as provirus. So called exogenous retroviruses
such as HIV-1 infect specific target cells and integrate into the genome
of these cells. Proviruses will therefore not be found in other cells
of the organism. If, however, a retrovirus infects an oocyte or a sperm
cell, which gives rise to a new organism, every cell of the body will contain
the integrated provirus. Such retroviruses are termed endogenous. Endogenous
retroviruses may, on one hand, be expressed as infectious virus particles,
and on the other they will be transmitted like normal genes to the progeny."
During the public meeting in Sydney
on August 21st, (a member of the NHMRC panel) minimised
PERV risk by saying that they could (and this is my recollection, but
without the transcript being made available publicly, I could be not
exact in every word) "PERVs could probably be screened out."
There was an implication
that then the already deemed low possible risks would be made even lower,
and that the process would therefore be safe. The complexity of keeping
another species from transmitting zoonosis when cellular intermixing
is the object is far greater than was presented by the NHMRC, as the
Council of Europe explains, and note that they say that PERVs cannot
be eliminated:
In order
to obtain pathogen free animals for xenotransplantation, known bacteria,
fungi, parasites and viruses including exogenous retroviruses may be
eliminated by (i) selection of uninfected animals, (ii) by treatment with
antibiotics and antiparasitical reagents or (iii) by vaccination of the
animals. To achieve this, animals have to be tested for the presence of
all microorganisms listed in Tab. 3, 6, 7, 11 and 12. At present an additional
risk comes from unknown microorganisms which may not be detected, and from
endogenous retroviruses, which cannot be eliminated.
Further, on the possibility
of obtaining biologically "clean" animals, the Council continues,
The decision has to be made by scientists
and the public, taking into consideration ethical aspects, the expensive
investments into SPF containment, basic research and the need to develop
assays to test animals.
Even for the most commonly used
laboratory animals, mice and rats, the task is difficult, and zoonosis is
a problem which comes up repeatedly in the lab manual, Infectious
Diseases of Mice and Rats.
We now know that blood banks
and hospitals have become vectors for disease. The US Red Cross is
examining its own response to xenograft recipients, and they are looking
at the narrowest definition of risk in terms of blood donors.
Thus, infection could bealso be spread by the health agencies' response
to risk.
If we look at a prospective xenograft recipient, even in
Australia's part socialist medical system, the public is footing the
bill for what is seen to be a private-only procedure, as the costs are
exorbitantly high. Thus, only the wealthy will have this as a choice,
though the whole community is subjected to the disease impact and costs,
and for the "surveillance" (NHMRC term) part of this process, it is both
unstated as to who will pay and what the surveillance will be, but certainly
the burden of public health monitoring for public health purposes, and notification
for same, will fall on the taxpayer, though the benefactors are private
in two ways: the small percentage of our species that could have access
to this procedure, and the companies who are selling it.
In terms of capitalist theory, this is the inverse of user pays.
It turns dry, rightist economics on its head. And as for a socialist system,
it fails utterly, as it puts the individual and private corporation above
society as a whole, both in the society paying for the bulk of the "research",
and society paying in both the research stage
and the commercial stage, in disease risk and burden.
The problems that
the BSE Inquiry showed, we also experienced in Australia during zoonotic
outbreaks. Turf wars, lack of coordination and information sharing,
industry protection, cults of secrecy. Because
disease is an international problem, it must be faced with maximum efficiency,
and that is just for the rising number of zoonoses that we are facing
now. Xenotechnology puts a new burden on the world to identify, coordinate,
treat, prevent (when we cannot even do these things with the status quo).
The 2002 workshop organised to examine the problem of emerging
zoonotic diseases stated:
"Collaboration can
be improved at the international level as well. Although many international
activities have succeeded, often via the WHO, difficult circumstances
have required the involvement of institutions outside the usual public
health agency loop, such as agricultural agencies. This was true when the
West Nile virus emerged in the United States in 1999, when the H5N1 influenza
virus emerged in Hong Kong in 1997, and when the Hendra virus emerged
in Australia in 1994. In each case, turf issues arose, and in some instances
efforts to protect agricultural markets seemed to be deemed more important
than efforts to protect the public health....We may have been lucky that
these zoonotics did not spread to cause further harm, but who is to say
what the next agent will be like? The next step in solving such turf issues
will involve recognizing the primacy of prevention and control of human
disease."
Even in a minor
outbreak, our present health care system cannot cope. The meningococcal outbreak in Sydney in August, 2002, garnered
a top-of-the-page 3 headline in the Sydney Morning Herald: "Hospitals
swamped as parents panic". Hospital emergency departments across
Sydney have been struggling to cope…
The State of Missouri has been so worried about a major disease
outbreak that in its Public Health Emergencies: Environmental
Issues assessment, published in 1999, almost the first half of the
11 pages was devoted to pandemics. Some excerpts:
'76 swine flu and '97 Hong Kong
flu outbreaks
…two more recent outbreaks have
caused great alarm in the medical community. In 1976, a swine-type influenza
virus appeared in a US military barracks (Fort Dix, New Jersey). Scientists
determined it was an 'antigenically drifted variant of th feared 1918
virus. Fortunately, a pandemic never materialized…
In March, 1997, scores of chickens
in Hong Kong's rural New Territories began to die--6,800 on three farms
alone. The virus was especially virulent, and made an unusual jump from
the chickens to humans….
While the outbreak highlighted
the success of the surveillance network, it also showed how dangerously
mutable influenza viruses can be. In their most sinister forms, such
as the 1918 Spanish Flu, they can be as deadly as any disease known to
man.
Measure of
Probability and Severity
Health officials age there is
a high probability we will see another dangerous new strain of the influenza
virus sometime in the future, accorting to the Missouri Department of
Health. In fact, a world-wide influenza outbreak on the scale and severity
of the Spanish Flu is not far-fetched, an, in fact, is expected by many
experts….
Impact of the Hazard
For planning purposes, it would
be reasonable to assume a rapid movement of a pandemic flu virus from
major metropolitan areas to rural areas of the state. The effect of a
pandemic on individual communities will be relatively prolonged--weeks
to months. The impact of the next pandemic could have a devastating effect
on the health and well being of Missouri citizens an the American public.
CDC estimates that in the US alone:
·
Up to 200 million persons will
be infected.
·
Between 40 and 100 million persons
will becoe clinically ill
·
Between 18 and 45 million persons
will require outpatient care.
·
Between 300,000 and 800,000
persons will be hospitalized.
·
Between 88,000 an 300,000 people
will die nationwide.
·
Effective preventiv and therapeutic
measures--including vaccines and antiviral agents--will likely be in
short suppoly, as well as antibiotics to treat secondary infections.
·
Based on the CDC's preliminary
estimates, economic losses from the next pandemic may range from $71
million to $166 billion, depending on the attack rate.
In a strange irony, the
nation with the biggest push in xenotechnology, the USA, also has a health
crisis on its hands, one in which thousands of ageing people are being pushed
out of the health system because they cost too much in terms of physicians'
insurance premiums. Thus, the section of the community that is the most
likely to be carriers is the least able to report sickness. As for the
recommendations that Missouri made to be prepared, they are trying but
with funding for essential services cut to states all around the nation,
their health care crisis and Australia's, and the UK, and and and--who
amongst nations would be prepared for even a pandemic of a quickly manifesting,
identifiable disease for which there could be vaccines at the ready? And then there is the problem of carriers.
We have two problems there.
The problem of humans and the "goods" as they are termed. Each can harbour
without any signs, as this excerpt from Infectious Diseases
of Mice and Rats explains.
Infection Versus Disease
A common misconception, even among senior scientists and
laboratory animal specialists, is that infection is synonymous with disease.
Bacterial infections of rodents include pathogens, opportunists, and
commensals, of which the last two are by far the most numerous as constituents
of the normal flora on mucosal and body surfaces. Similarly, the viral
and parasite pathogens of rodents vary considerably in pathogenicity. Also,
it is important to distinguish between subclinical(inapparent, covert,
or silent) and clinically apparent infections. Two types of subclinical
infections are recognized: dorman (the agent can be recovered) and latent
(the agent cannot be recovered by direct methods and its presence must
be inferred by indirect methods).
Most natural infections due to pathogens in mice and rats
are subclinical. Thus, clinical manifestations of pathogen infections
in these species have only limited diagnostic value. Also, it cannot
be overemphasized that aberrations in research results due to natural
infections often occur in the absence of clinical disease. Thus, prevention
of infection, not merely prevention of clinical disease, is essential.
Xenotechnology complicates
the subclinical to a degree that makes each species a constant subclinical
vetting nightmare. And we're not even talking about mutation of viruses,
yet another headache with the burden of disease we are fighting against
even now.
Although (a member of the NHMRC panel), in the Sydney public
meeting, sought to reassure, in saying "We have lived with pigs for thousands
of years," no mention was made of the Fort Dix outbreak, the recent Nippah and Hendra outbreaks, which
also "surprised" scientists, nor the fact that in the foot-and-mouth
outbreak in the UK in 2001, the Roslin's Institute's funding was pulled
for their transgenic pig project as soon as the outbreak hit the media (is
investor wariness re corporate liability going to be the only way to slow
what became clear was rampant laissez faire xenotechnology worldwide?)
In fact, neither the public meeting, nor the NHMRC showed
any of the concerns that hit the xenotech industry every time an outbreak
occurs. This side of the story was told by the ABC News during the UK
swine fever outbreak in 2000, and while the Nippah virus was still active
at least in the news, in Malaysia. Yet this was not part of the presentation,
nor the Guidelines, and certainly is not a factor in the push to go ahead.
Genetic
transplants under threat from disease
American researchers have confirmed
what many in the medical fraternity feared, that viruses lying dormant
in pigs and other animals could cause serious diseases in healthy, fit
humans. Not just any disease though, potentially deadly new viruses reminiscent
of AIDS, Nippah and Ebola. The latest findings have devastated the prospect
of genetically engineering transplants for humans being harvested from
animals an industry potentially worth tens of billions of dollars. Swine
fever is spreading throughout the UK pig herd and Nippah virus is still
active in Malaysia, now threats to humans has shut down research into genetically
modified pig transplants, both here in Australia and overseas. Research
was published showing that pig viruses had jumped a species to mice. Throughout
the world as a result, pig to people research is being abandoned, Australias
only program looking to plant genetically engineered pig cells into diabetic
patients has also been suspended, following those fears of humans being
stricken with pig viruses.
On the subject of membrane glycosylation,
(a member of the NHMRC panel) spoke of it as a way to make the technology
work in the terms of 'and another problem we've solved'. We were not
told any other point of view such as: "However, if membrane glycosylation
is reduced or removed, the pig's immune-recognition system could be damaged
and a currently subdued PERV might reactivate and cause diseases that
are transferred with the organ."
Perfusion was spoken about enthusiastically by (a member
of the NHMRC panel) in the Sydney meeting and also by Dr. Breen in his
interviews.
Stated, in the public meeting: patients
after having had perfusion years ago, exhibited no signs that anything
had changed with them as far as pig cells, etc. On this point I spoke
to a Committee member afterwards, saying that Peter Collignon wrote differently
about this (his paper cited in the NHMRC Guidelines, as a matter of fact)
and the Committee member said that the Committee knew this, but yet,
NO ONE contradicted when their colleague made this public statement of
assurance. This is just one example of what made a public information
meeting sound like a sales talk.
But let's say that
xenotransplants go ahead. What are we going to do about monitoring? Is monitoring optional,
as the NHMRC suggests: "While it is
expected that…most patients will adhere to the request for lifelong monitoring,
individual recipients may withdraw their consent." In our
free society, we are not contemplating quarantining the recipient, the
contacts with the recipient, the activities the recipient undertakes,
making the recipient and all contacts wear masks. And what about refraining
from sex, (or having children, such as the UK has mooted), restricting
work in certain industries? Access to public transport, right to travel
abroad or into our country? And how far do we define contacts with others
as a risk? Do we restrict how they live? For instance, retirement communities
would be perfect incubation units for disease. Do we have special hospital
wards for suspicious symptoms' holders? What about a recipient married
to a pilot? What do we do if recipients disobey what they agree to? Because the air they exhale, the bodily fluids they leak, dead
or alive, could kill innocents - recipients are dangers to society, without
society even knowing.
On the important
human genetic aspect of xenotechnology, what are we to do? This has not been addressed by the Guidelines. The capacity
of PERV to be transferred to offspring was mentioned by (a member of
the NHMRC panel), but the significance was never picked up in the public
meeting, nor has it to date, by the Committee. In the UK, having recipients
agree to not have children has been discussed, but with the public risk
wholly dependent on trusting a recipient not to, the only way to make
sure that children do not occur, is to have recipients also agree to
be sterilized, something that I do not think has been considered anywhere,
though the case of xenotransplantation heightens the importance of the
individual to historically unprecedented levels, at the risk of our entire
species.
And how do we monitor
and deal with corporations? In August 2002,
the New York Times reported that it took eleven
months for the US FDA to recall faulty implant tissue.
"The agency said 27 people had developed serious infections
after receiving tissue implants processed by the company, and one of
them had died. The Centers for Disease Control and Prevention learned
about possible problems with the tissues in November." The precautionary
principle meets the profit principle. When these two principles meet the cost-cutting needs
of government, we have this outcome (from the UK's xenotechnology industry
lobbying group): ""Given that it is
likely that the Government's concern with risk is associated with cost…"
One reason that outbreaks have spread is the wish by agencies
and politicians, to "not alarm". The reasons for this range from the laudable
to the less so, but the motivation has led to the problem of the public
being told that the risk is lower than it is, or that, and in the case of
xenografts this is happening now, that the risk is quantifiable and low,
when it is in fact, both unquantifiable, given
that the number of possible diseases and their virulence is entirely
unknown, and of globally catastrophic potentiality.
The 2002 Zoonose Workshop stated in its conclusions, that
(internationally and within nations) coordination was poor, information
inadequate between agencies and to the public, misinformation common,
and science woefully still at a surprisingly low level of knowledge about
how disease works, especially when put against the ability to bring on
disease risk. This workshop had heavy representation and funding from
industry, and it shows in the uncharacteristic timidity in which it approaches
xenotechnology.
Many different determinants
contribute to the emergence of new zoonotic agents, and it is rare that
these factors act singly. Among the forces that shape their emergence
are human demographics and behavior; technology, industry, and agriculture;
economic development and land use; international travel, commerce, and
military expeditions; microbial adaptation and change; and breakdown
of public health measures. Indeed, social and environmental changes are
accelerating, in both the developed and developing worlds. The developed
world has the greatest travel and transport, providing particular risks
for rapid spread....Some observers also suggest that xenotransplantation...may
inadvertently introduce new zoonotic infections to recipients of such
material. This risk raises the burden of preventive responsibility on
scientists and research groups conducting such trials....Many gaps remain
in our understanding of zoonotic agents and
the diseases they cause. More research is needed on the pathogenesis
of zoonotics in relation to host biology....Despite spectacular achievements
in microbial genetics and genomics, we know relatively little about how
most zoonotic agents are maintained in nature or how they respond to environmental
(often anthropogenic) changes. The precise ecological factors that lead
to human infection and emergence are murkey, and textbook descriptions of
the epidemiology of most zoonotic diseases are at best simplistic. In order
to more effectively prevent or control zoonotic diseases, it will be necessary
to better understand the ecology of their respective etiologic agents.
Despite the increased attention put
to zoonoses now in the United States, due to the West Nile Fever, the
National Academy of Sciences still warned in August 2002, that genetic manipulation
of animals poses serious risks to the environment and human health, partly
because "the efforts to manage risks are disorganised and probably inadequate."
Some lessons from the BSE Inquiry:
By 1994 the Spongiform Encephalopathy Advisory Committee
(SEAC) evaluated the risk of transmissibility to humans as remote only
because precautionary measures had been put in place.
The Government did not
lie to the public about BSE. It believed that the risks posed by BSE
to humans were remote. The Government was preoccupied with preventing
an alarmist over-reaction to BSE because it believed that the risk was
remote. It is now clear that this campaign of reassurance was a mistake.....
The link between BSE and vCJD is now clearly established, though the manner
of infection is not clear.
The
20/20 Hindsight excuse:
It could not be said that
there could be a future excuse of safety "based on what we knew at the
time", nor a risk so low nor a cost/benefit analysis that justifies,
that we could pass even trials as an arguable procedure.
Liability. Sovereign
liability is already a reality, and given that governments are involved,
both in permitting, regulating, and funding xenotechnology, they would
be the most obvious targets for transnational legal suits, especially
since a pandemic would cause a domino effect of corporate bankruptcies.
Even now, how is insurance risk being calculated, and who is the final guarantor?
Whatever the claims--breach of duty of care, malfeasance, manslaughter,
and claims could be many and varied; even given certain conditions, genocide,
in our more extremist times, --the liability for purposely inserting the
capacity for an unknown number of diseases into the human species is an
incalculable, for which it looks like society will pay, in all ways.
As to profits, when the NHMRC mentions in the guidelines
"pressure" to proceed with xenotechnology, it crucially does not mention
where the pressure comes from. The public only sees the sufferers, just
as they do now in the efforts to limit medical liability.
An investors' newsletter advises, in "Smart Investors Ignore
Genomics, Look to New Products":
"Other long-term trends also favor the industry.
One is a graying population, said Jim Cavanaugh, president of Healthcare
Venture Partners. His firm has started a number of companies that focus
on "regenerative medicine" including Human
Genome Sciences, as well as xenotransplant companies BioTransplant and
Diacrin. Along with Genzyme, Diacrin is testing a treatment for Parkinson's
and Huntington's diseases that involve transplanting fetal pig cells into
patients' brains. "In the next 7-10 years we think the CNS (central nervous
system) area provides great opportunities for product development. These
markets will grow with increasing aging population," said Cavanaugh.
…. Yet another positive indicator that is sometimes
overlooked is the huge amount of government funding that goes into biomedicine.
Most of the money doled out by the National Institutes of Health (NIH),
an agency whose budget is also set to double within a few years."
This issue is not one for any country to deal with alone,
because xenotourism is already a concern, spawned by expectations of
competing regulations. That competition between nations exist, is illustrated
below, in this lobbying paper from the UK.
The UK is a World-leader in xenotransplantation,
as it is in a number of areas of science, and has made past investments
to achieve this status. The economic gains to accrue from providing such
World-leading technology to other countries, or in attracting high technology
companies to the UK should not be ignored. We therefore advise that xenotransplantation
research should continue to be properly funded (arguably increasingly
so as progress is made and we begin the move from research to development)
and that the Government recognises that xenotransplantation is one reason
of many for the continued public support for UK science (from the science
base and the Higher Education Funding Councils through to Government's
Departments).
Who is recommending
and pushing this technology here? Because of competing interests, full
disclosure is imperative
(A member of the NHMRC panel)
used the USFDA as an argument for xenotechnology. Whatever state of
approval the technology has in the US, the problem of a revolving door
in regulatory agencies, and lobby money to add to the pressure to conform
to important business interests, makes this an inappropriate statement
of advocacy to use in Australia. We are, however, suffering from an increase
in both lobbying and revolving doors (e.g. Peter Reith, Michael Wooldridge
going straight from Minister to lobbyist to their former departments).
The extent of conflicts of interest is not known about by the public,
but it affects decisions and advice given to government, and the citizens
of the nation every day. Therefore, since the NHMRC is taking an advocacy
position, the members must be judged as if they were recommending the public
to buy shares in a company. We are investing in the health of our species,
and we cannot afford compromised advice.
Every member
of every Committee and Working Group should by law, be required to declare
their interests, for there are certainly
such conflicting interests now, that they would preclude advice given
should they be in the business of investment advisors. By interests, I
mean all grants and
lobby group connections in the field, and all funding and sources for
same, plus any pending possible conflicts of interest. These are currently
undisclosed, yet as living from grant to mouth is a reality of science
and research, they are an intrinsic part of the
reason why certain members have certain points of view. The public needs
to know, in all proposals.
Informed consent has been discussed, but, as in the user pays principle being
stood on its head, informed consent when it is discussed in the guidelines
has been, in reverse of how it should be considered. The informed consent
that needs to be obtained is the informed consent of the population
in the democratic exercise of their will. There has not been enough information
disseminated, not enough public discussion as to the public health and
social issues, not enough public forums.
"As to ethics, people
tend to think of ethics as some sort of arcane,
impractical enterprise, and therefore, optional. (this tendency
has been increased by the kind of discussions that have been made prominent
in the cloning/stem cell debate.) But it needs to be said loud and clear:
putting people at risk without their informed consent and/or without
hope of possible benefit is unethical and of prime importance in any
consideration of going ahead with something that affects us all." - Laura Purdy
In a democracy,
there should be no thumbs-up without democratic informed consent. This
process is not informing, nor is it open government.
Finally, in terms of community consent, how could we possibly
call this process and the information disseminated, democratic informed
consent. The most shocking part of the Sydney meeting was the expectation,
that in a city of five million people, a room with twenty chairs, and
two hours, was all that was needed for the public meeting, on a decision
that taken, could take us back to the times that the Decameron was written,
or beyond. In the meeting, leading assertions and arguable claims were
made to which there was no time, nor were there enough "public" in the
room, to politely have the chance to refute.
A subsequent phone call requesting transcripts of the public
meetings was answered this way:
"In answer to your question,
No we won't be publicly providing a record of public meetings on xeno.
We will be providing a report to the Working Party for them to consider,
along with the written submissions. Neither the written submissions nor
the public meetings will be made available to the public verbatim. They
will be reflected in the next version of the Guidelines, but they won't
be public records as such. But if there's anything we can help you with
about angles etcetera, feel free to ring us, particularly …. at the NHMRC."
This is the most important health issue of
our day, and one of which the public is almost wholly ignorant. At this point, this is how the process of decision-making
looks: A secret process, with almost no participation expected, and a
foregone conclusion as to the recommendations, regardless of the blithe
reassurances at the meeting that they, the recommendations, were not finalised.
How can we know what the submissions say, and criticisms are, if they
are to go through the filter of the advocates themselves?
In summation:
1.
The epidemiological risks from xenotransplantion
cannot be assessed as low when the mechanisms for transmitting xenozoonoses
are intrinsic to the technology itself. The "risk" assessment as the
NHMRC describes it, is hopeful, but incorrect, as there will be zoonosis
as the result of xenotransplantation. We have inevitability here, not
risk. The true risk is, therefore, the gamble we take of how long it
will be before we get what level of pandemic, and how many we get in what
period of time.
2.
There has not been a satisfactory effort to inform
the public of the science and economics involved with this technology.
It is anti-democratic to subject the public to these risks before
they are adequately informed and can give democratic informed consent.
3.
Despite assurances to the contrary in the Sydney
public meeting, the NHMRC is acting as an advocate of xenotechnology,
and has both put a spin on information, consistently minimising problems
and risks,
and limited information availability to the public.
4.
Immunosuppression of organ recipients and genetically
engineered donor animals with human genes are currently employed in
xenotransplantation. These techniques are said to be necessary to make
xenotransplantation work – however they also increase the inevitability
of transmission of new animal diseases, such as P.E.R.V. into the
human population.
5.
Xenotechnology is a transitional technology with a permanent
legacy. With transitional status, this means that the results of
it are even more likely to be a problem because the monitoring, quarantining,
rules, which stretch resources in the first place, have
a low likelihood of being maintained when they are no longer in the
forefront of any attention paid to them. With xenotechnoloby will have
increased risk of poor monitoring, but an inheritance, forever, of a genetic legacy from PERVs and other pathogens
that we cannot filter out of the other species.
6.
A xenotranplantation trial is not a trial. Biologically
and pathogenically, it is the real thing.
7.
Other solutions have not been adequately discussed. Op-out organ donation will immediately
increase the human organ pool, and for a permanent solution, allotechnology,
particularly, stem cells is the obvious path. It does not have the rejection
nor zoonosis problems, and will clearly be the solution in the future.
8.
The bulk of projected xenotransplant recipients would
not be in their dire state of organ failure, were attention paid to healthy
living and preventive health care. This shift in emphasis is vitally needed
when weighing needs and priorities, and in creating public health worldwide.
9.
Xenotransplanation is not for the common good. It is proposed to solve a health care
issue of well-off (typically, ageing) customers of private corporations
(in which pigs legally defined as "goods") to the detriment of the
entire human population that will be put at risk.
10.
The assurance of safety is based on systems that
are not described as such, yet we have only to look to the recent B.S.E.
Inquiry for an example a new human disease originating in animals due
to innovative animal care, as well as an example of the catastrophic
failure of a well-meaning regulatory system.
11.
The burden of monitoring and liability falls on
a health care system already in funding crisis, both in Australia and
nations in the forefront of xenotechnology.
12.
Xenotechnology is not for the public (or posterity's)
good, even in our own country.
13.
As a world health issue, the cost of xenotranplantation
means the poor can only gain disease.
14.
Sovereign liability in the instance of a pandemic is an incalculable,
but of relatively piddling concern, when compared to the global political
instability.
CONCLUSIONS
Xenotransplantation
> is not safe
>
is not efficacious
> is not for the public good
> places an intolerable burden
on public health systems that are already overstressed
> does not pass any risk assessment
>
is not known enough by the public, its democratic representatives, nor
discussed in the media, for the recommenders to say it passes any ethical
criteria
There are better systems (such as organ donor
opt-out) and better technologies (such as stem cell) using entirely
our own species, that we should develop, not to mention preventive health.
We, therefore, should not give thumbs-up to
the proposals, but stop the xenotechnology that already exists, recognising that xenotechnology
is an efficacious way to cause new plagues
of new zoonoses as well as leaving a legacy in our genetic makeup that
we cannot remove. Nature's warning "the public consequence
could be catastrophic"
should be taken seriously.
Xenotechnology exposes our species, as well
as other species, to new pandemics, is definitely not progress, given who
stands to gain and lose, nor is it medicine for the public good.
As the NHMRC Guidelines say,
"As for other areas of medical research, an
overriding consideration for xenotransplantation research is that it should
serve the common good."
In dry economic terms: to save a life at the
cost of our species is not cost effective.
And in wet compassionate terms: xenotechnology
puts the short-term wants of a few against the rights of humanity itself.
RECOMMENDATIONS:
1.
An immediate
stop to Australian xenotechnology as it exists (including stem cell and
other research using mice and other species as cultures for human cells),
as it is clear no other species is a safe proposition in a technology that
functions by tearing away species barriers in many ways, let alone heightens
susceptibility by immunosuppressing.
2.
Australian
cooperation and fostering of an international moratorium on xenotechnology,
at least until there is broad international public understanding of the
important aspects of this science: both in the health and international
risk/benefit.
ADDENDUM: Appropriate tools for meaningful public
consultation
from Xenotransplantation
by Fritz H. Bach and Adrian
J. Ivinson, HMS Beagle:BioMedNet (an online magazine
from Elsevier Science), Issue 119, February 1, 2002 (Also in Trends in Biology)
Policies
surrounding xenotransplantation, and many other emerging high-technology
interventions, must balance opportunity and risk. Whereas traditional
stakeholders, such as the researcher community, government agencies,
and the commercial sector, readily contribute to the debates that influence
policies, the voice of the public is seldom heard. Not only does this
raise ethical concerns, but also it might ultimately prove to be shortsighted.
Before any country settles unilaterally on comprehensive policies governing
the practice of xenotransplantation, well-informed public opinion needs
to be taken into account.
References:
-pgs 114,115, "The Emergence of Zoonotic
Diseases: Understanding the Impact on Animal and Human Health - Workshop
Summary (2002)"National Academy Press, Washington DC
-"Smart
Investors Ignore Genomics, Look to New Products: If you didn't own biotech
stocks before the sector got red-hot, you're probably kicking yourself
and wondering: Is there still money to be made?", April 3, 2000, BioSpace.com, http://www.biospace.com/articles/bio_smart.cfm