BOOM IN DRUG TESTS ON HUMANS

BRITAIN is rapidly becoming a world leader in the testing of new drugs on
healthy people, a practice that is banned or limited in the US and other
developed countries.

Students, the unemployed and other volunteers are being paid up to UKP1,000
a time to act as human guinea-pigs. Organisers of clinical trials have
launched a television advertising campaign to recruit volunteers in one
area, and nationally up to 8,000 people a year are now being used by
contract companies to test a wide range of drugs before they are used on
sick patients.

Ironically, testing on healthy humans is possible in Britain because there
are no legal restrictions, while testing on sick patients is governed by
legislation. But there is increasing concern about testing on healthy
volunteers. Last week it was disclosed that students had been paid UKP600
by foreign chemical companies to take highly toxic pesticides normally
tested on rats.

The testing of pharmaceuticals on healthy volunteers is expanding so
rapidly that there are growing calls for it to be regulated as in the US,
where approval by the Food and Drug Administration (FDA) is needed.

Yesterday, Rhodri Morgan MP, chairman of the Commons select committee on
public administration and a former Labour health spokesman, said: "It seems
ironic that in this country the giving of drugs to sick people is
regulated, but there is no regulation when the same drugs are given to
healthy people.

"This sector of the pharmaceutical industry appears to be alarmingly
under-regulated. We surely should have formal regulation over the use of
these powerful drugs."

It is thought that there are some 40 independent contract organisations in
the UK testing drugs for major international pharmaceutical companies, and
about half belong to the Association of Independent Clinical Research
Contractors (AICRC).

The biggest five companies, which are based in South Wales, Leeds, London
and Inverness, have large residential units with up to 58 beds where
volunteers stay for the duration of the trials and where the effects of the
drugs are monitored.

Simbec Research, in South Wales, has been advertising for volunteers on
ITV. It pays about UKP200 for a 48-hour stay, and up to UKP1,000 for 14
days. "We test the whole spectrum of drugs, except the very, very potent
compounds like anti-cancer agents which have a high side-effects profile.
Obviously it is not ethical to give drugs to healthy subjects that may
cause them serious health problems," said Jeffrey Maddock, its managing
director and AICRC honorary secretary.

"The volunteers are given full medicals to make sure they fulfil our entry
requirements. They are told about the drug and written informed consent is
obtained. They are effectively hospitalised for the duration of the study,
for their own safety and in order that we get full compliance with the
protocol. There may, for example, be dietary restrictions.

"The compound is then introduced to the subject either orally or
intravenously and there is then close medical and nursing supervision. We
monitor them with various tests and blood samples to see how the drug is
handled in the body.

"The length of stay varies. If we are doing multiple-dose studies they can
take up to 14 days. Payment is geared to the time commitment.

"We get people using their holidays and weekends to come here. We have a
panel of 4,000 volunteers, and we do have a lot of students and some
unemployed people. We are recruiting all day every day."

The only approval needed to conduct the tests is obtained from hospital or
health authority ethics committees, and this comparatively easy procedure
is thought to be a prime reason why Britain is a world leader in such
testing. One estimate is that the industry is expanding at the rate of 20
per cent a year and accounts for up to 35 per cent of world testing.

"The work with healthy subjects is not regulated here," says Mr Maddock.
"That is one of the reasons why the association has set its own standards
and inspection programme. One reason why Britain has more testing
facilities is that the regulatory environment has been attractive. Once you
introduce drugs into patients you have to have approval from the Department
of Health through what are called clinical trial exemption certificates."

The industry admits that there are adverse reactions among the health
volunteers, but say that these only affect a tiny proportion of those
involved. Tests on healthy volunteers are needed to provide a baseline for
the action of a particular drug before it is used on patients.

Mr Maddock argues: "As far as we are concerned we are developing the drugs
of the future and we are doing a worthwhile job. We are working to high
standards, we have a good safety record, and we don't have any reason to be
ashamed of our activities."

A Department of Health spokesman said there were no plans by the Government
to bring in regulations, but that the issue was being debated by the EU.

Last week it was reported that students had been paid by research
laboratories to take an organo-phosphate poison. About 50 people were given
orange juice with doses of a pesticide to assess reaction.

One man reported sweating for four hours, another was light-headed and
others reported headaches. In similar tests, volunteers reported nausea and
nosebleeds.

Checked-by: Mike Gogulski