Scientists' success in Cambridgeshire could have saved thousands of lives. But they failed, animals suffered and the truth was covered up, reports Mark Townsend.
Sunday April 20, 2003
Amid the rolling fields of Cambridgeshire stands a sprawling complex, protected by barbed wire and an army of security guards. Beyond the wire is a maze of laboratories where scientists work to find cures for the suffering of mankind.
This is Europe's largest animal research centre, the mysterious Government-sanctioned Huntingdon Life Sciences (HLS) laboratory. Exact details of the experiments on animals have remained fiercely guarded secrets. Until now.
Today The Observer can expose the previously hidden world of vivisection. A huge volume of confidential documents - the largest-ever set of data concerning animal experiments in the UK - has finally been released following the defeat earlier this month of an injunction imposed by drug companies 30 months ago. These documents chart the race to supply an unlimited supply of animal organs in a bid to save the lives of thousands of Britons.
The quest for a successful programme of xenotransplantation - in which genetically modified animal organs are used within humans - remains the scientific equivalent of the holy grail. The rewards for success will be huge: analysts predict that a market worth £6 billion a year awaits the first firm which can prevent the rejection of such organs when used in humans.
Little wonder that scientists, giant drug companies and Government Ministers have been committed to pouring millions of pounds into the HLS programme. So has it been worth it?
To the dismay of animal rights activists, the documents reveal how primates were used in the search for a solution to the chronic global shortage of human organs for transplant. Baboons were transported from the African savannahs to die in steel cages the size of toilet cubicles. The documents show that a quarter of the primates died from 'technical failures'.
Researchers describe how monkeys and baboons died in fits of vomiting and diarrhoea. Symptoms included violent spasms, bloody discharges, grinding teeth and uncontrollable, manic eye movements. Other animals retreated within themselves, lying still in their cages until put of their misery.
Baboon W201m died of a stroke after two days of suffering from limb spasms and paralysis. Baboon W205m was 'sacrificed' after 21 days. A genetically modified pig's heart had been welded to the vital arteries within its neck. Researchers noted the heart was swelling way beyond its natural size. Strange yellow fluid was seen seeping from the organ.
Others never even made it to HLS, suffering painful deaths en route. Faxes from global wildlife dealers reveal how at least 50 baboons were taken from the African plains for the experiments. In one shipment the creatures spent 34 hours in cramped transport crates - 10 hours longer than approved by the Home Office, which chose not to take any action.
In another shipment, three monkeys were found dead with blood oozing from their nostrils at a Paris airport. The animals had not been able to turn and lie down naturally.
The Government's involvement in the xenotransplantation programme - the most high-profile animal experimentation ever conducted in Britain - is made clear in the documents, along with its failure to adequately regulate a project that the Home Office believed would deliver major benefits to society.
Many of the 1,274 pages of documents reveal a litany of failings that will serve to ignite further controversy over HLS, which last week won a ground-breaking injunction preventing animal protesters getting close to employees' homes. Fundamental questions over the value of vivisection itself will also be asked.
The papers reveal attempts to bury the true extent of animal suffering from experiments conducted at the HLS laboratories between 1994 and 2000. Serious incidents of unlicensed animals suffering were not adequately investigated and regulations were not enforced properly.
Breaches of the law even went unpunished in some cases, with the Home Office limiting itself to letters of 'admonishment'. One previously confidential paper reveals how the Home Office worked with Imutran - the former British subsidiary of multi-million drug giant Novartis, which was in control of the programme - to underestimate the suffering caused by the most severe experiments.
An Imutran report states: 'The Home Office will attempt to get the kidney transplants classified as "moderate", ensuring that it is easier for Imutran to receive a licence and ignoring the "severe" nature of these programmes.'
The truth of what has been happening at HLS can now be revealed because of a historic legal victory. The verdict represents an extraordinary triumph for a Sheffield-based animal rights group, Uncaged Campaigns, which defeated the injunction imposed by Imutran and Novartis to suppress the release of the documents. The group successfully argued that the issue was one of overwhelming public interest on a highly sensitive area of policy.
Dan Lyons has spent the past two-and-a-half years battling against some of Britain's most powerful lawyers, including those who represented Hollywood couple Catherine Zeta Jones and Michael Douglas against Hello! magazine.
Lyons said: 'This is a tragic scandal of historic proportions. Ultimately, the appalling failure of government in its most fundamental duty - to enforce the law - is unmasked. By trying to cover up their failings, the Government has gambled that their shameful behaviour would remain hidden. They have lost.'
For the scientists involved, the failure of the project to overcome the human body's natural rejection of foreign organs such as hearts and kidneys is the real tragedy. Last year 6,482 people in Britain alone were waiting for transplants. Of these, 414 died while waiting for organs to become available.
Novartis yesterday defended its role at HLS by arguing that developing new cures for humans invariably meant experimenting on live animals.
The documents refer to the transplanting of genetically modified pigs' hearts and kidneys into monkeys. Throughout the Nineties, Imutran claimed it was on the cusp of solving the crucial issue of organ rejection, which has prevented trials on humans. In 1995 it told the world it would be ready to start transplanting pig hearts into humans within a year. Yet the documents clearly show that the company's xenotransplantation programme has come nowhere near to fulfilling its promises.
Imutran finally left the HLS site in 2000 - and then won an injunction to prevent details of the failed xenotransplantation project coming to light.
An internal inquiry recorded that Imutran and the Home Office admitted that the crates breached size and ventilation regulations. Elsewhere, government officials reassured Imutran on several occasions that a crucial meeting to discuss new licence applications would be a 'rubber-stamping' exercise.
Other striking findings reveal that the Government approved Imutran's xenotransplanation experiments with the intention of using sick babies as the first trial patients for animal heart transplants.
Some of the research was personally authorised by Ministers, who have rejected calls for an independent judicial inquiry.
In total, the documents reveal at least 520 errors and omissions in the Imutran research. These include organ weights not being recorded, a quadruple overdose, conflicting pathology reports and re-use of animals. One primate was killed when a swab was left inside it.
Rather than admit defeat, however, Imutran - now defunct - made a number of inaccurate claims regarding the success of experiments, effectively exaggerating the results of its tests to increase the likelihood of new licences being granted.
A Novartis spokesman admitted that Imutran had reported 'several significant' mistakes to the Home Office but said the company was committed to ensuring similar mistakes would never be repeated. And the company remains convinced that its quest to solve the world's organ shortage will one day be realised.
Three centuries searching for the Holy Grail
The strange history of animal-to-human transplants, known as xenotransplantation, goes back to 1682, when the bone from a dog was used to repair the skull of an injured Russian aristocrat. It worked. Heart transplant pioneer Christian Barnard did experimental work on baboons' hearts in South Africa in the Sixties.
In 1963, surgeon Thomas Starzl grafted baboon kidneys into six patients. They survived between 19 and 98 days.
The advent of cyclosporin, an immunosuppressant drug, gave researchers a greater chance of success. In 1977 a 25-year-old woman was given a baboon heart in South Africa. This worked for six hours. In 1984, a newborn baby received a baboon heart in California. She lived 20 days.
Nine years later, baboon bone marrow and a kidney transplant was carried out in Pittsburgh, US. The patient died after 26 days. In 1997, Dolly the Sheep was cloned in Scotland, raising the prospect of cloned animals providing organs for people.
Scientists realised the risk that viruses from an animal could be transmitted to people. The Government announced it was regulating xenotransplantation.
The prospect of the biotech companies earning millions from xenotransplantation began to diminish. Companies such as PPL Therapeutics reported losses.
In 2002, science turned to stem cell research. These cells can be engineered to grow new organs with the right genetic make-up, instead of needing animal organs.