Anyone for pesticide?

Students, the homeless and the hard-up are among those signing up as guinea-pigs to test new chemicals.

THIS WEEK'S finding by a group of British scientists that 43 per cent of patients used in clinical drug trials are not given adequate information about the medicines should come as no surprise to many of the hundreds of human guinea-pigs who volunteer to swallow new chemical products.

The offer of hundreds of pounds for gulping down a cup of doctored orange juice or taking a little pill now and then is simply too inviting to turn down for many immigrants, unemployed people and students. For instance, a recent advertisement in the Big Issue, the homeless people's paper, invited readers to "Earn pounds 100 per day" by "taking part in Medical trials all approved by Ethical Review Boards".

However, such assurances may not mean much. A 10-year audit of clinical drug trials carried out by a group of scientists from the company Good Clinical Research Practices found that the procedures to decide the safety and effectiveness of medicines were flawed to the point of endangering the health of volunteers and patients who take part. In one-third of their sample of 226 trials the scientists reported "significant under-reporting" of side-effects; in 55 per cent there was insufficient proof of the drugs being kept at the appropriate temperature; while 43 per cent of patients were not given clear instructions about using the medicines. Writing an editorial for the journal Clinical Research Focus, one of the project leaders, Dr Wendy Bohaychuk, commented on their consistent finding of lax standards. "I would never go into a clinical study myself and I would certainly try to discourage anyone in my family from doing so," she said.

Over the last two years there has been a stampede by international drug and chemical companies to use English and Scottish laboratories for their testing. It has been suggested that companies are particularly attracted to conditions here. American food-safety legislation passed in 1996 aims to protect children from harmful pesticides. To get their chemicals licensed by the American Food and Drugs Administration, chemical manufacturers needed to pass through extra safety hoops, and this has had the unintended spin-off of prompting them to use large numbers of human guinea-pigs, particularly British ones.

At least five American and European drugs companies are known to have used laboratories in England and Scotland over to the last two years, to test substances including a chemical used in a flea collar and a substance used to kill lice and fruit-eating insects.

While the companies say the tests present no danger to the volunteers, this is by no means universally accepted. There is a suspicion that Britain is chosen because the British tend to be a lot less litigious than Americans.

Paul Tyler MP, the Liberal Democrat chief whip who heads the 90-strong All Party Organophosphate Group of MPs, adds that Britain is regarded by some foreign companies as a "softer touch" because of its lax control system. "They're getting away with tests here they wouldn't try at home. Many of these human guinea-pigs are simply not being given sufficient information about the chemicals concerned," he says.

Drugs companies such as Bayer, however, insist there is no ulterior motive. "We chose Inveresk because they have an excellent international reputation," says Michael George, a Bayer spokesman.

Paul Tyler is particularly concerned about the flimsy ethical controls on private laboratories and the corporations that use them. Companies are required to conduct an audit of their tests but have no legal obligation to disclose the results.

The certificate handed over to the Medicines Control Agency merely states that an audit has been carried out. "In effect they are their own policeman. There is no outside monitoring. Instead they are monitored by the companies themselves who set up their own ethical review boards," says Tyler.

Government representatives do not dispute the essence of this concern. "This is contract research and is therefore covered by the international protocols of the Declaration of Helsinki and the guidelines of the Royal College of Physicians," says Denise Horn, a Department of Agriculture representative, when asked about the organophosphate tests. "It is up to the client to satisfy itself that ethical conditions are being complied with and there is no government control on the process." However, the EU is currently considering a draft directive to make inspections of drugs tests mandatory, although this is being strongly opposed by the industry itself.

This is not to say that human drug trials are inevitably ethically or procedurally dubious. Without them there would be no insulin therapy for diabetes, no polio or smallpox vaccines, no breast-saving alternatives to mastectomy, and research on cancer and HIV/Aids would be floundering. However, there are always risks in exposing volunteers to new drugs. In 1985, for instance, two British student volunteers died after participating in drug trials. In one case there was an open verdict at the inquiry of a medical student who died of aplastic anaemia after taking Midazolam, although there is no proof the drug was responsible for his death.

The other involved a student who neglected to disclose that he had been taking medication to suppress his schizophrenia the day before the trial; it was thought his death was a consequence of the combination of his medication and the drug being tested.

So how far could testing go? Past examples include secret radiation tests carried out on pregnant women and on children's bone samples between 1955 and 1970; LSD tests on 4,500 people in British mental hospitals in the 1950s and 1960s; the 1945 and 1970 Australian experiments, involving hundreds of orphan children, to test vaccines for herpes, whooping cough and other diseases; and the US government's administration of radioactive drugs to more than 100 Alaskan Eskimos, as part of a test to find out whether soldiers could survive better in Arctic conditions.

Laboratories such as Inveresk, however, say their tests comply with internationally accepted ethical standards. While not prepared to comment on individual clients and volunteers, Inveresk said in a statement that "trials are conducted under appropriate medical and nursing supervision ... an independent committee advises on the ethical aspects of the trials," and that "all relevant information" is given to the Ethics Review Committee and the participants, of whom "less than 10 per cent are students".

I don't mind becoming a Guinea Pig, but...

WHEN Robert Lonie (right), a 23-year-old Edinburgh student, was offered the chance of earning pounds 460 to act as a human guinea-pig, he couldn't believe his luck. Like many others, he was happy to donate his body in return for enough cash to see him through the term. He says that drug trials are "a regular source of income for many of us students".

Robert was invited to test the chemical azinphosmethyl for the German company Bayer AG at the Inveresk medical research laboratory in Edinburgh. He assumed it was safe. "They assured me it had been approved by an ethics committee," he recalls.

Just to make sure, however, he asked his mother - a science teacher - to check. She told him that in sufficient quantities it was a potentially dangerous organophosphate pesticide.

"To say I was angry would be an understatement. Basically I felt like they had asked me to swallow poison without explaining exactly what it was and the risks involved," he says.

Robert learnt that azinphosmethyl was one of a group of toxic bug busters which can affect a blood enzyme necessary for the functioning of the nervous system.

Bayer, however, says its tests are perfectly safe and carried out in terms of strict international ethical and scientific guidelines. Spokesman Michael George says they had "no reports of anyone suffering from adverse side-effects".

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