Lothian lab in 'cruelty' probe

Published on Wednesday 27 April 2005 11:53

ROWS of dogs restrained by harnesses with masks clamped over their noses, forcing them to inhale potentially harmful fumes.

A monkey clamped down so that its head cannot move, allowing gases to be pumped into its lungs.

The disturbing scenes will upset animal lovers and raise serious questions about whether scientists at a Lothians laboratory caused unnecessary suffering in the name of medical research.

The images form part of a dossier compiled by animal rights group Animal Defenders International (ADI), which has put practices at Inveresk Research under the spotlight.

The Home Office is studying an ADI report alleging animal cruelty at the laboratory in Elphinstone, East Lothian, where Inveresk carries out tests for some of the world’s biggest drugs manufacturers.

The report was compiled from internal documents and photographs, some dating back five years, leaked to ADI.

Among the allegations contained in the report is that several beagles had a toxic drug mistakenly pumped into their lungs, causing an agonising death. In another experiment, rabbits were said to have breast implants inserted into the muscles on their backs.

And it is alleged that ten rats were killed after being forced to breathe paint for more than 30 minutes in what was described as a "non-lethal limit test".

ADI said it was also keen to find out why the documents show drugs were being tested on animals at the same time as human trials were under way. It wants the Home Office to investigate whether Inveresk has breached its animal testing licence conditions.

American company Charles River Laboratories, which merged with Inveresk Research last year, said it was aware of the dossier. But it insisted it was committed to humane animal research and stated the company "adhere strictly to codes established by the world’s leading regulatory authorities".

Inveresk Research carries out experiments for companies including AstraZeneca and GlaxoSmithKline, and it is estimated it tests up to 25,000 animals a year.

ADI chief executive Jan Creamer said: "This report reveals the true horror of regulatory testing on animals. UK and EU regulations require that animals should only be used when necessary, and that if possible non-animal methods be sought.

"And yet we appear to see at Inveresk experiments on animals when human clinical trials are being undertaken, blunders during experimental procedures which cause animals severe suffering, animals being choked to death with paint for unnecessary tests."

The tests at Inveresk detailed in the report stretch back to 1998, when the experimental psoriasis drug VX-497 was being tested for an American drugs company.

During the testing, 48 beagles had the drug pumped into their stomachs, but two animals died after the drug was mistakenly pumped into their lungs, according to the report.

Dogs in several of the studies are said to have picked up injuries from fighting, which ADI claimed was linked to the cramped conditions the animals are kept in.

The documents also detail testing of an anti-depressant drug from GlaxoSmithKline in 2000, after the drug was already being taken by humans in a clinical trial. Despite this, it is claimed more than 40 dogs were killed after undergoing weeks of tests, with many given dosages considered by the scientists involved to be too high.

The experimental drug, NS2389, was also administered to 210 rats over a one-week study. The animals suffered symptoms including abnormal colouring of their ears and tail, black staining around eyes, broken teeth, hair loss, abnormal vocalisation, irregular breathing and salivation.

Development of the anti-depressant was stopped less than a year later.

A separate test, for Hempel’s Marine Paints, of Denmark, was said to involve ten rats, which were immobilised in tubes and made to breathe liquid paint. After three hours, half of the animals were dead and the survivors, at the point of death, were killed.

The report also carried details of experimental asthma drugs being injected into monkeys, even though the drug would be inhaled by humans.

And it highlights experiments commissioned by a US company to see whether breast implant materials cause irritation.

In an experiment described by Inveresk in the leaked documents as likely to cause "moderate" suffering, breast implants were inserted into the muscles on the backs of three rabbits. After 28 days of examination, during which time it is thought the animals would have suffered "significant pain and discomfort" the rabbits were killed for a post-mortem examination.

ADI campaigns manager Tim Phillips said: "These shocking documents are internal reports taken from Inveresk.

"We will not let this matter drop and will be pressing MPs to ensure there is a full Home Office inquiry and that all the findings are made public."

Mr Phillips added that if no action was forthcoming from the Home Office the group may seek a private legal action against Inveresk Research. A Home Office spokesman said: "I can confirm we have received this report and we are studying it to see what action, if any, should be taken.

"The use of animals in scientific procedures is regulated by the Animals (Scientific Procedures) Act 1986 which is widely viewed as the most rigorous piece of legislation of its type in the world.

"It offers a high level of protection against mistreatment, while realising the need to use animals for testing in medical research, the development of new drugs and scientific testing.

"If a company was found to be in breach of its licence that would be an offence under the Animals Act."

Scottish SPCA superintendent Mike Flynn, who has in the past inspected the Inveresk laboratories, called for companies to be more open to the public.

"The Home Office are incredibly strict and it should be said that if you over-legislate then these companies will simply move abroad, where there are no regulations.

"There has been a general decrease in the number of animals being tested on and companies are making an effort to stop using monkeys, though this can lead to more dogs or mice being used.

"What we want to do is make companies reveal their test results publicly, so the same tests do not have to be performed again and again in different countries.

"If these companies were more open to the public it would allow people to see the good practice that goes on and the importance of animal testing, as well as reducing the amount of testing needed."

THE FACTS

INVERESK Research started up 16 years ago as a tiny science venture on the outskirts of the East Lothian village of Elphinstone.

It has since grown to become part of one of the biggest firms in Scotland and is undoubtedly one of the country’s biggest scientific successes of recent years.

Today, the company employs 900 people in Scotland. As well as its main plant, near Tranent, it has research facilities in Riccarton, Morningside, and Glasgow.

Their main source of work is taking untested drugs from the world’s leading pharmaceutical companies and testing them, both on human volunteers and animals.

Before any company can put a new drug on the market, it is required by law to go through three stages of trials, the first of which is pre-clinical testing.

This is the main business of Inveresk. Pre-clinical trials test whether the drug is toxic in humans, and can be tested on patients who are already in a terminal condition.

Primates, rats and mice are also commonly used.

Their work also involves developing and distributing treatments for human diseases including cancer.

Last year, Inveresk Research merged with American company Charles River Laboratories, one of the world's biggest breeders and sellers of laboratory mice and rats, in a deal worth 816 million.

INVERESK EXPERIMENTS CARRIED OUT FIVE YEARS AGO, SAYS COMPANY

A SPOKESMAN for Charles River Laboratories stressed that the experiments outlined in ADI’s report happened five years ago.

And he highlighted the important benefits animal testing can bring about.

He said: "Charles River Laboratories is aware of the publication of photographs and documents related to work carried out approximately five years ago at our recently acquired Inveresk facility.

"Charles River Laboratories is firmly committed to the welfare and humane care of research animals and to the advancement of drugs, devices and therapies that save lives and enhance the quality of life for people and animals. The company is a world leader in the humane care of animals and adheres strictly to codes established by the world's leading regulatory authorities. The company has also implemented additional standards including a local ethics committee in place at each site.

"Since its founding nearly 60 years ago, Charles River has built a culture of caring and established itself as a worldwide leader in the humane care of research animals.

"We continue to raise awareness and provide training to all employees on the importance of humane care of research animals and to emphasise how our heightened standards of care positively influence medical research.

"Toxicology, the science involving the study of adverse effects of drugs, chemicals and other agents on living organisms, is critical to the drug development process and is mandated by law. "According to the Foundation for Biomedical Research, the use of animals in toxicology studies is essential because of the similarities between their genetic and physiological systems and human systems.

"To date, in vitro alternatives to animal research do not exist which would eliminate the need for the toxicology studies required to ensure the safety and efficacy of drugs and other products which are of benefit to both people and animals. Non-animal research such as computer models, in vitro research, clinical observation and epidemiology are used whenever appropriate, but fall well short of what is required and can only serve as adjuncts to basic animal research.

"From preventing polio to finding cures for cancer, animal research has played a vital role in virtually every major medical advance in both human and animal health. Charles River Laboratories is proud of the role we play in helping save lives and improving the quality of life for people and animals."