which the patent is just about to run out.
The drug is first tested on animals. For every 5000 chemical compounds which get past this stage, about fifteen go on to be tested on human volunteers for metabolic studies. Research companies are then hired to test the drug on other volunteers. There are over 100 such companies in the UK alone. and unlike companies carrying out tests on animals. they do not have to be licensed. About 400 new substances are tested on human volunteers every year in the UK.
The bulk oftests are entirely innocuous, but this is not a universal rule. In 1984. Niall Rush took Eproxindine. an experimental heart drug, and died a few minutes later. The same year, Philip Jones died while testing Midazolam. a tranquiliser. For the thousands who volunteer every year and come through with no problems. there will be a handful who suffer relatively serious side effects. In 1988. the British Pharmacological Society discovered that for 7000 volunteers who had taken part in trials on various drugs. 35 had moderately serious side effects. Two required instant surgery.
lfthe drug works and does not produce adverse reactions it then goes forward for trials on patients recruited by doctors. By this stage, the company may have spent millions of pounds on development and testing and naturally will be eager for the drug to get onto the market and start earning its keep. The pressure on doctors to accept drugs for trials can be intense. Some companies offer direct cash inducements for carrying out the trial and there is the carrot of a scientific paper to write up. which can further the doctor‘s career.
There is also pressure to provide the right results, and not all doctors are as honest as you would hope. Last year Dr David Latta in Glasgow was struck off the register by the General Medical Council after being found guilty of serious professional misconduct. He had falsified the results of a trial for the drugs giant Glaxo. This is not an isolated incident. another twenty similar cases are waiting to be considered.
lfthe drug gets over this hurdle — about halfdo — then further tests are carried out on patients. The drug will then have a name and a 50 per cent chance of making it onto the market as a medicine. In theory the route from chemical compound to medicine is circuitous. meticulous and exhaustive. So it should be. as the effects ofat least two previously marketed drugs. Thalidamide and Opren, testify. (Thom Dibdin)
The French physiologist Duchenne produced hundreds ol artilicial expressions by applying electric currents to the lace ol a workhouse inmate.
The List 14 — 27 February I992
It’s not everybody who’s prepared to take strange drugs and give their lifeblood for The List. Aaron Hicklin drew the short straw and offered his body to science at the Inveresk Research Centre.
nveresk Clinical Research Centre in Riccarton is a private medical establishment that fills its coffers (and they must be pretty full) with (literally) blood money, paid by big pharmaceuticals firms for drug tests on human volunteers. There are similar centres across Britain. with a regular traffic of all-too-willing volunteers. and earlier this year I became one ofthem — for a price. of course.
I never carry donor cards. My family. the doctor. even Arthur Daley cannot persuade me otherwise. Not that I care what happens to my body after I die. it‘s just that I don’t want to tempt fate. Yet ifl was to be given a juicy advance on. say. my kidneys. I might be prepared to think it over. Cynical? Perhaps. But why give your body to science when you can sell it?
It is a prospect which is appealing to a
I D! Rascher a Nazi scientist experimented on prisoners to find the best treatment for hypothermia. Prisoners were forcibly immersed in freezing water until they lost consciousness. Different methods of resuscitation were tried. the best being immediate
regularly experimented on human volunteers. infectingthem with different strains and types of flu. This was supposed to provide evaluation of drug tolerance. virulence and infectivity. but provided little information of immediate benefit before its closure
immersion in hot water. in 1991. Wrapping the chilled. unconscious. male lThe value of
Electroconvulsive Therapy (ECU to schizophrenics was investigated in 198] when 70 patients were randomly allocated either to
prisoners up in blankets with pigs and other men was also tried.
I The Common Cold Unit in Salisbury, Wiltshirc.
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growing number of cash-starved students. and I suspect. not a small number of freelance hacks. Instinct tells me. of course. that clinical research on human volunteers must involve some amount of risk. but so
nicotine. however. whereas a few nights in a
anything up to £600. And depending on the drug being tested. the discomfort is negligible. In fact. a properly monitored clinical trial is probably a good deal safer than dinner at your local burgerjoint. It won‘t cause heart disease. it has no link with BSE or Salmonella. and you won't get shot by a passing psychopath.
While to me Inveresk feels like a prison. with its alarmed doors to prevent escape. the '3 old folk on arthritis trials treat it like a paid
, holiday. organising aerobics sessions and i scrabble tournaments to keep themselves
conventional ECI' or to the ECT procedure but without the electrodes being applied to the scalp. All benefited from the convulsions. but those with pseudo IEC‘T were not subject to the same immediate memory loss.
I In orderto provethat Yellow Fever was carried by mosquitos, volunteers slept in three different huts: one with fever victims. one with itemsof victim‘s clothing. and one with mosquitos which had fed on the victim's blood. Sure enough. those in the