We need the truth about new drugs, but can we swallow it?

Pharmaceutical firms must be more open about testing, says Julia Neuberger, and consider greater use of animals

Six relatively young men have been left seriously ill, two apparently fighting for their lives, as a result of having participated in a phase-one study of a new drug which a German company, TeGenero, had hoped to bring to market as a treatment for rheumatism. The headlines have been shrieking "Elephant Man", and asking questions about why these drugs were being tested on British people rather than on Germans. But some real questions remain.

First, despite the wish to blame, this was probably - for the most part - a terrible accident. Despite the possibility that the drugs had been tampered with, despite the possibility of human error in the dose, these young men were probably given a fairly small first-use-in-humans dose of a drug which scientists had hoped would prove to be a huge money-maker, as well as transforming the lives of people with rheumatism. Why then was there one real breach of best practice?

At Northwick Park Hospital the young men were all given the drug simultaneously; best practice when a drug is first used on humans (phase one) is to give it to one or two people first, wait a while, and then continue. This is not yet part - though it should be - of the regulations governing such studies, which have evolved in Western countries over many years.

The process began when Henry Beecher, professor of anaesthesia at Harvard, published Ethics and Clinical Research in 1966, drawing attention to 22 reports of unethical research in which patients had been put at considerable risk. Britain was quick to follow. In 1967, Dr Maurice Pappworth, a British researcher, published his influential Human Guinea Pigs, highlighting the dilemmas facing researchers and the general public. Both men were critical of their colleagues, and thought that patients, and healthy volunteers, needed greater protection.

From this, regulation grew apace. In Ireland, a young healthy volunteer died in 1987, which led to the creation of the Control of Clinical Trials and Drugs Act 1990. Similar concerns were expressed to those we are hearing now. But some would argue that the legislation also led to further problems in research in Ireland, particularly on children, since it laid down strict conditions for consent, which children cannot give. Though not so strictly enforced elsewhere, there are real ethical concerns throughout Europe about research on children, which is why 50 per cent of all drugs used on children and 90 per cent of drugs used on babies have never been subject to proper clinical studies for their paediatric use.

The European Commission wants to stimulate the development of specific medicines for children and lay down rules for testing and approval of them. Those studies are urgently needed. But when a committee of the House of Lords looked at this, we were left with some concerns, especially around the information that is made available about the trials that do take place.

We recommended in a report published last month that the Clinical Trials Database should contain full details of all paediatric trials as a vital safeguard not only for those involved in clinical trials, but also for the medical profession and children in Europe generally. A government response is awaited, but commercial confidentiality cannot supersede patient safety.

Though apparently far away from what has happened at Northwick Park, there are some real parallels. These studies are needed by us all. Clearly, there are various other public and commercial interests at play. TeGenero has a major interest in a successful outcome. So too does Parexel, the research company. The NHS probably gains in terms of money paid to the hospital for running the research centre on site. The research subjects gain because they get paid for their participation. And occurrences such as this are so rare that people enrolling for these studies do not think hard about it. The truth is that we all gain. First-use-in-humans studies are essential if we are to develop new drugs. We need to have healthy volunteers trying these products, to ensure that drugs already tested on animals are not toxic to human beings.

More complex still is the extent of the payment. In the UK, the participants were paid about £2,000 for their time, which seems high. It has long been known as a quick way to make a few pounds within student circles. With rising student debt, these clinical studies pay off the bills faster than bar work. But do we want our healthy volunteers to be seduced into it by the money? Or would we prefer them to be like blood donors, doing it for society's benefit? And, if it were unpaid, would anyone volunteer at all? Do we want this testing to be as altruistic as later phase-three studies, where many patients are routinely entered into randomised controlled trials without any payment to find out the optimum treatment for their condition?

Still more perplexing is the urgency in this. We seem to believe that there is a quick fix for every human complaint. Scientists in the United States are arguing that medical advances are moving so quickly that middle-aged people will extend their projected lifespan by one year per year for the next two decades or so. Death denying, ever hopeful, we want these products brought to market in time for us, so that we can be for ever young, free of the long-term conditions that blighted our parents' and grandparents' later years. So we choose to believe the white-coated scientists when they say they are on the point of finding a cure for one of the big killers.

Meanwhile, we are hopeless at analysing risk. While accepting scientific progress, we fail to recognise that there will always be risk in any new product or programme. Increasingly risk averse, we won't say - as we should - about these poor young men that they knowingly undertook the risk. Whether they really understood it is a different question. Instead of accepting that there is risk in these activities, we look for people to blame. If there is blame there, it must be freely admitted. But first use in human beings contains an inherent risk, and healthy volunteers undertake it - on behalf of us all - and that is precisely why the testing is done.

Once that is established, we will need to ask further questions. If there is always a risk, can it be mitigated in any way? Should we be doing more studies than we now do on animals, particularly primates? Many people think that morally wrong. What if, however, it were clear that more work on primates would reduce the scale of the risk for healthy human volunteers? Added to that, should we be charier of developing new drugs? Do we really need them, or is it just our inability to come to terms with our own mortality that makes the pressure so great to get the drugs out there?

Is science, developing ever more complex drugs, running ahead of our capacity to understand? Or is it that we, as a population, are disgracefully badly educated scientifically? This is not the time for scientists and doctors to be reassuring us that it is quite safe to enter clinical trials. But at the same time we, as a society, have to come to terms with the risks involved in the advances we want, the degree to which we can accept those risks, and how we wish to carry out the studies we undoubtedly need. Nor will these only be on new products; medicines for children, or for women, formerly tested only on men, or for people with particular genetic predispositions all need clinical studies.

If the public does not think these issues through properly, and seeks only to blame those who designed this particular study, we will really be in a mess. We will want the cures but refuse to countenance the means of getting them checked and monitored. Instead, we should examine the extent to which the public can trust all the parties involved. Do we trust TeGenero, whose chief scientific officer has apparently been very open with the media, yet which has never brought a product to market before? Do we trust the research company Parexel, still recruiting healthy volunteers for other trials? Do we trust the Research Ethics Committee that agreed this study could take place? And do we trust the motives of the NHS in allowing such a contract research institution to exist on NHS premises - for gain?

Trust is key here, and much will hinge on the next few weeks. The Medicines and Healthcare Products Regulatory Agency, in charge of the inquiry, will need to be robust and independent of sectional interests. The public's trust in pharmaceutical companies is at a low ebb. One reason for this is the Vioxx affair, in which a company failed to publish some negative results of studies. This meant that people didn't know there was some risk attached to the use of the drug. That was not the only example: people were also concerned about the use of SSRIs (selective serotonin reuptake inhibitors used as antidepressants) in children, because unpublished data showed that all but one of them were unsafe. As a result of all this, the pharmaceutical companies have promised to publish the results of trials, both positive and negative.

What needs to be done now is to clarify whether proper procedures were followed, to admit the mistakes that were made, and to make it clear that the public's fears are being addressed. The precautionary principle will need to be brought into play - what we can do to prevent such things from happening again, while acknowledging that we cannot eliminate risk. But most important of all, as my colleague at Harvard, the distinguished risk expert David Ropeik of the Harvard School of Public Health, puts it so well, is to be clear that "hiding behind the facts with a 'This sort of thing happens' attitude will not be good enough".

Open analysis, transparent, critical, possibly reassuring, is what we need, facing the public's concerns, rather than trying to dampen them down. They must tell us the truth. If necessary, apologise. Reassure us with actions, as well as words. With that will come our trust, and also our willingness, to provide data for everyone's benefit.

Julia Neuberger, a former chief executive of the King's Fund, is Bloomberg Professor of Philanthropy and Public Policy at Harvard Divinity School for this semester, and a Liberal Democrat member of the House of Lords