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Xenotransplantation - Daily Express UK (fwd)



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http://www.lineone.net/express/00/09/21/news/n1820-d.html

21 September, 2000

DAILY EXPRESS (UK)

Terrible despair of animals cut up in name of research
EXCLUSIVE
LUCY JOHNSTON AND JONATHAN CALVERT

THE SHOCKING truth behind Britain's most high-profile animal experimentation
project is revealed today in confidential documents seen by the Daily
Express. The secret papers show horrific animal suffering despite claims to
the contrary. They also reveal researchers have exaggerated the success of
work aimed at adapting pig organs for human transplant.

The project, carried out by Cambridge-based Imutran, involves transplanting
genetically modified pigs' hearts and kidneys into monkeys. Thousands of
pigs, monkeys and baboons have been used.

Over the past five years Imutran - the world leader in xenotransplantation -
claims to have been close to solving the crucial issue of organ rejection
which has so far prevented trials on humans.

But the Daily Express found scientific papers declaring new breakthroughs
did not give the full picture. In one published paper it is claimed no
baboons died from "hyperacute" reaction when two excluded from the published
study did.

A second publication describes a baboon which survived for 39 days with a
pig heart - the company's greatest success to date - as healthy throughout.
But records show that it was suffering in the last days of its life. Its
heart had grown in weight by three times, a significant fact not mentioned
in the published article.

Internally, the company admits to being a long way off targets set by the
American Food and Drug Administration for trials on humans. It wants
"substantial" improvements from its scientists in the next 18 months.

The experiments are being carried out at the Huntingdon Life Science's
animal research laboratories in Cambridgeshire.

Imutran says the animals do not suffer. But the laboratory technicians' own
detailed records of the animals post-transplant lives paint a different
picture. One monkey which had a pig heart attached to the blood vessels in
its neck was seen holding the transplant which was "swollen red" and
"seeping yellow fluid" for most of the last days of its life.

Animals are described as quiet, huddled, shivering, unsteady and in spasm.
Some had swellings, bruising or were seen with blood or puss seeping from
wounds. Others vomited, or suffered from diarrhoea.

Imutran was given a special dispensation by the Home Office to carry out
this work because of potential benefits to humankind. It has a duty to
ensure the animals suffer as little as possible.

BUT documents show that over a quarter of the animals died on the operating
table or within a few days because of "technical failures" in the surgical
procedures. In one experiment, this accounted for 62 per cent of lives. In
another, 13 out of 22 monkeys died within two days of the operation, a fact
not mentioned in their published paper. Imutron maintains all the relevant
data was included in the scientific paper. There have been a number of awful
mistakes. One monkey had to be "sacrificed" when researchers discovered the
pig kidney it was about to be given had been mistakenly frozen. In the
documents, Imutran acknowledges that it has had "severe problems" with the
data. The documents have gone to animal rights group, Sheffield-based
Uncaged Campaigns, which compiled a report - Diaries of Despair - to present
to the Government calling for a halt to xenotransplantation research and an
independent judicial enquiry. The group's director Dan Lyons said: "The
documents show the true extent of the suffering of these primates. This
atrocious suffering must stop."

An Imutran statement yesterday said: "We should like to emphasise that
animal welfare is very important to Imutran. The conduct of our animal
experimentation is closely monitored by the Home Office."

Last night Dr Gill Langley, a member of the Government's Animal Procedures
Committee, expressed concern. "These documents reveal the PR image and the
reality of xenotransplantation research. It seems even the scientific
community isn't being given the full facts."

THE baboon began its life in the scrubland and sparse trees of a Kenyan
savannah. Its final days were spent in a cramped, stainless steel-framed
cell, four thousand miles away in Cambridgeshire.

It had become baboon number X201m - one of the thousands of residents in
Europe's biggest animal research laboratory, the Huntingdon Research Centre,
owned by Huntingdon Life Sciences.

The barbed wire exterior of the sprawling complex is patrolled by security
guards who keep a wary eye on groups of activists who gather outside to
protest against vivisection.

None of this could be seen from the baboon's new home - the top secret Room
099 - where the light is regulated by the flick of a switch every 12 hours
and the air changed every four minutes by extractor fan.

The monotony was broken on the morning of March 23, 1998, with a flurry of
activity. Baboon X201m was carried to the operating table, where it took
five hours to cut away its healthy heart and replace it with the heart of a
pig.

It is called xenotransplantation - a highly controversial experiment which
some believe will one day be the solution to the shortage of organs for
human transplants.

Baboon X201m clung to life for 39 days after the operation, which makes him
the world's longest survivor with a pig's heart.

His owners, Imutran, the Cambridge company which financed the experiment,
hailed it as a huge success and devoted a scientific paper to him. But all
was not quite as it seemed.

Until now, the full details of Imutran's experiments on live primates have
been a closely guarded secret. The company carefully filters the little
information that has been released.

It claims to be on the verge of a breakthrough which will make it possible
for a human being to live with a pig's heart or kidney. And it insists that
the animals in its experiments do not suffer.

Today the Daily Express can expose the reality. A volume of confidential
documents - the largest set of data on animal experiments ever leaked -
suggests that the company has not been frank with the public and the
scientific community.

It also shows that many animals have endured days or weeks of suffering in
vain.

The documents have shocked a senior government adviser on animal experiments
and led to calls for the work to be stopped. Even baboon X201m was not the
success he was made out to be. His short life with a pig's heart was
announced to the world in a dry academic paper for the Journal of Heart and
Lung Transplantation.

It suggested that the baboon had led a perfectly normal life following its
operation, stating: "Throughout the first 38 post-transplant days the baboon
was active and energetic, moving freely about his enclosure."

But that is not the picture revealed in detailed scientific records of the
baboon's last days, seen by the Daily Express.

Two weeks after his operation experts noted he was: "Quiet and huddled,
reluctant to move, some abdominal breathing seen, slightly unsteady."

His condition rallied but in the last 10 days of his life he was often only
"occasionally active". None of this is recorded in the company's published
data. Neither is the fact that his pig heart had astonishingly grown to
three times its weight by the time he was eventually "sacrificed".

Indeed the five other animals in the experiment lasted, on average, just 10
days - which again is not mentioned in the paper.

YESTERDAY, the company defended its description of the monkey in the paper.
"We have video recordings made late in the animal's post-operative course at
25 days and 35. This footage shows an active and energetic animal, climbing
in its enclosure."

Over the past five years Imutran has used the services of Hunting-don Life
Sciences to perform more than 400 transplants on primates.

The experiments are aimed at overcoming the problems of rejection caused by
the body's natural immune reaction to foreign organs such as hearts and
kidneys.

Imutran became world leaders in the research when they developed
"transgenic" organs which have been genetically altered to reduce the
chances of rejection.

They have been testing ways of keeping the transplanted animals alive using
a variety of drugs to suppress the immune system.

The rewards for success could be huge. Optimistic City forecasts are that
the industry could be worth 6billion by the year 2010. In particular, it
will open a huge market for the immuno-suppressant drugs produced by
Imutran's parent company, the Swiss drug giant, Novartis.

Ever since the mid-nineties the company has been declaring boldly that it is
within a year of extending the tests to humans. Yet documents seen by the
Daily Express suggest that it has given a highly selective account of its
achievements.

A paper published in the journal of Transplant Proceedings last year claimed
the company had made a key breakthrough in eradicating the problem of
"hyperacute" rejection - in which the monkey's immune system reacts
instantly against the donated pig heart.

It said that a study of nine baboons who had a pig heart sewn onto their
arteries showed that no "transgenic heart underwent hyperacute rejection".
But secret data shows the experiment was actually carried out on 22 baboons.
The company picked nine out of the ten baboons who had lived longest,
probably because they were on different drug regimes. Two of those excluded
from the published paper died after suffering a "hyperacute" rejection to
the organ.

The reality that emerges is that the company is still a long way off making
xenotransplantation work in humans.

The company's raw data from the two major experiments carried out at
Huntingdon shows that, on average, a baboon survives only seven days after
having its heart replaced by that of a pig.

AND it is clear the longest survivors were kept alive with massive doses of
drugs. They have had more success transplanting kidneys into monkeys, but
new problems have been discovered, such as cancer and internal bleeding,
possibly caused by the drugs.

The crisis came to a head at a recent meeting between Imutran and senior
managers in Novartis. An 18-month deadline was set for the research to show
"substantial" increases in survival rates.

The lack of progress will increase pressure on the company to justify its
experiments. By law, vivisection is only licenced if the benefit to mankind
outweighs the harm to animals.

Until now, little has been known about the treatment of the monkeys inside
Huntingdon LIfe Sciences. Publicly, Imutran insists they "don't suffer". But
its own documents show for the first time the true horrifying extent of the
ordeal endured by the monkeys.

They are transported halfway across the globe in tiny cages. In one shipment
three animals died - probably from suffocation - in a 35-hour trip from the
Philippines. All the animals used for xenotransplantation experiments at HLS
die or are killed. It can be a long exit - a research goal is to keep the
animals alive as long as possible after transplant.

Clinical conditions are recorded by scientists. Animals are described as
quiet, huddled, shivering, unsteady, in spasm, vomiting and suffering from
diarrhoea. Some have blood or puss seeping from wounds.

A baboon with a pig's heart transplanted onto its neck had swelling around
the transplant and "yellow fluid around wound".

SOME animals are found dead in their cages and others are "sacrificed" when
their condition goes past the point of no return. Many deaths are wasteful.
In one experiment, 33 out of 61 monkeys died within 24 hours of a transplant
due to "technical failures". The company's correspondence shows an average
of one in five animals lost this way.

Imutran says its work is monitored by the Home Office and regards animal
welfare as "very important". There is much evidence of shoddy work inside
the centre. The documents show animals have been wrongly re-used in
experiments, medicines have been left unlabelled and uncapped, and on
hundreds of occasions scientists have failed to take readings and
measurements from animals following operations.

Worse still, there are mistakes which lead to painful deaths. A monkey
perished because a swab had been left inside his wound during the operation,
causing his spleen to go septic. Another had to be "sacrificed" when
researchers discovered the pig kidney it was to be given had been frozen by
mistake.

A female monkey had to be euthanased the day after she was given a dose of a
drug four times higher than recommended.

The records note that she was shaking and grinding her teeth. Imutran later
wrote to the laboratory, saying the mistake was "unacceptable".

 Express Newspapers, 2000