Alan Morrison spoke to Dr Walter Nimmo. the director of lnvercsk Clinical Research about the measures taken to ensure the safety of volunteers.

few years ago. a group of students at Manchester University began to suffer severe mood swings and acute paranoia. Not an infrequent occurrence in the world ofessay deadlines and exam pressure perhaps. but in this case all had recently taken part in a series oftests for a new anti-depressant. Individually they approached the company who ran the study and individually they were told their symptoms had nothing to do with the drug in question. It was only when they discovered that three-quarters of the test group were I showing the same side effects that they went ' to the company collectively and forced an admission that the tests had been carried out 1 l l

without the company knowing exactly what the manufacturer had put in this particular concoction. A long legal wrangle and an out-of—court settlement followed.

It is to be hoped that such irresponsible behaviour by research companies would not happen today. but the testing of drugs on human volunteers is still subject to less strict 3 government control than similar tests on animals. Guidelines exist in the shape of the 1964 Declaration of l lelsinki and various reports and recommendations by the likes of the DI lSS Medicines Committee. the liliC. the Association of British Pharmaceutical Industries and the Medical Research Council. but with no central body to enforce i them. it is left to the individual companies to have the integrity to adhere to them closely.

‘If you don‘t follow the guidelines which have been established to protect the individual volunteers.‘ says Dr Walter Nimmo. director of lnvercsk Clinical

Research. ‘then it isn‘t worth doing the research in the first place.” lnvercsk is one of only a handful of independent Scottish companies using healthy volunteers for drug tests and. as Dr Nimmo explains. stringent measures are taken to ensure the safety of test subjects. Checks are carried out on various levels: by the doctors and nurses directly working on the project. by an independent quality assurance group within the company. by an independent ethics committee and. every two years. another external watchdog organisation and. finally. by the Government who read over all data collected. Before testing any drug. lnvercsk also makes sure it has a certificate ofanalysis from the manufacturer which details the ‘ingredients‘ ofthe test substance and ensures that it is 100 per cent pure.

A 1986 report by the Royal College of Physicians justified research on volunteers by stating 'new drugs intended for use in man ultimately need to be tested in man to discover whether they are effective medicines. because the response to drugs in humans may differ from that in laboratory animals.’ Dr Nimmo agrees: "l‘herc's no law that says you must study on healthy volunteers. and some drugs do go straight to patients. but in the early stages. you may collect your data from volunteers.’ This. he says. enables those carrying out the study to get a more accurate picture of. for example. how a drug is absorbed into the bloodstream. before it is administered to a genuine patient.

Even if most people would acknowledge the need for such studies. many have qualms over the ethics of paying volunteers. What is

Physiology. it is a reliero learn that both knew about the effects ofopium and other pain-killers.

I By the 19th centuryihe tlsc ofcriminals had become unacceptable and in 1856 Claude Bernard laid down the ethical guidelines for experimentation. These were hardly changed in 1964 when the (icneral Assembly of World Medical Associations produced a declaration in Helsinki. Made partly in response to the atrocities carried out during World

War ll. the most important points ot the declaration are that any study should be of benefit to humanity. volunteers should give informed consent and be able to leave the study whenever they want.

I In the 18th century ()uccn Caroline. \sife oi the langlish King(ieorge l\'. had her physicians try out a smallpox y accine on criminals before administering it to her own children. Moreover 'to make a further trial. ()ueen (.‘aroline procured

BThe List 14— 27 February 1992

regarded as 'expenses‘ by one person may well be an essential step in clearing an overdraft for another. and the whole process shifts into an important ethical area when one considers that some volunteers may push themselves further than they might otherwise do just for financial gain. Dr Nimmo explains that those in the industry do collaborate to come tip with a standardised scale ofpay that reflects the number of hours attended rather than any degree of risk. ‘There may also be some payment for inconvenience.‘ he adds. ‘For example. it may be a little bit higher for a drug tested by injections rather than orally. but it wouldn‘t be higher for a new drug being injected compared with an old drug being injected. It's not designed to be an incentive. and if any person was getting involved for purely financial reasons. we‘d be very concerned about that.‘

‘It you don’t follow the guidelines which have been established to protect the individual volunteers, then it isn’tworth doing the research in the first place.’

While it is reassuring to know the lengths that companies like lnvercsk are prepared to go to safeguard their volunteers. the actual extent of human testing in Scotland is difficult to ascertain. Several manufacturers run their own tests -- and the impartiality of their ethics committees could be called into question. There are also several smaller-scale operations. often attached in some way to universities. operating north of the border. It does seem somewhat ironic that an industry ostensibly devoted to the greater health of mankind should be so secretive and competitive.

I During the Second World War. scabies. caused by parasitic mites yy hich burrow their way through human skin causing intense itching. was rife in both the army and civilian populations. Conscientiousobjectors volunteered to allow themselves to be infected for periods of up to Hit) day s. some developing secondary infections. This. one of the first modern experiments using human guinea pigs. provided information about the transmission and cure ofscabies.

halt a dozen of the charity children belonging to the St James Parish .‘

I Ont March 1954 a 17-megatonll-Bomb yy as dropped on Bikini Atoll. As intended. the bomb produced an abnormal j amount of fallout. some of which fell on the neighbouring island of Rangelop. Sadly . the American military neglected to ex acuate the Rangclop islanders. Happily they have

prov ided an excellent information resource on radiation effects.