Two thousand quid for a couple of weeks doing nothing sounds tempting if you are healthy, young and hard up. Such offers have got many thousands of young people, often students, queuing to be guinea-pigs for trials of new drugs with potentially lethal side-effects. As the Northwick Park disaster showed in March, the tests can go seriously wrong.
You would expect patient safety guidelines, and a European directive does exist. But now an expert watchdog has announced that it is to disband, claiming it has been used as a fig leaf for the Government’s failure to provide volunteers with independent advice or support. Nor does the Government monitor for post-trial problems, or even know how many people enter trials or what incentives they are offered.
The watchdog Ceres (consumers for ethics in research) launched itself as “the voice of the guinea-pig” in 1989. For the past three years this group of academics and health service experts has lobbied for funding to run helplines for drug-test volunteers. It says the service could satisfy a requirement in the European Union’s Clinical Trials Directive that volunteers be given access to an “independent point of advice”. But it is to disband on December 31, claiming that the Government’s clinical ethics committee has been advising drug-trial researchers that simply showing volunteers a leaflet from Ceres will satisfy the EU requirement. Ceres says this has been done “without our permission or recognition that we did not have the capacity to take this on without funding”.
The Ceres decision was precipitated by the Northwick Park disaster, when six young men, paid £2,000 each to take the immune-stimulating drug TGN1412, were taken to intensive care, with two fighting for their lives.
Naomi Pfeffer, the Ceres chairwoman, says: “We believe that the Northwick Park drug test run by Parexel ticked the box on ‘independent advice’ by showing the volunteers a two-page Ceres leaflet on their legal rights.” Parexel did not answer my queries to confirm or deny this. Pfeffer adds: “This often happens in phase-one trials. But how can we be an independent point of contact? We have no helpline. And no one has agreed the sort of information we would give. We have been used to maintain the myth that there is independent advice for volunteers.”
Phase-one trials are potentially the most dangerous; they are the first time a new drug is used on human beings to discover if it is toxic. The drug has to pass two further test phases, using increasing numbers of volunteers to assess its therapeutic potential, before it can be considered for licensing. Pfeffer, a professor of health studies at London Metropolitan University, says: “We get contacted by people who say they have experienced serious adverse effects from clinical trials. We have no idea how often it happens because there is little transparency. In fact, it’s opaque. Protocols for trials are held in secret by research ethics committees under the cloak of commercial confidentiality.”
Pfeffer says that the drug companies’ organisation, the Association of British Pharmaceutical Industries (ABPI), offered funds to run a helpline. “But we could not do it only with drug- company money because we would not be seen as independent. Three years ago the Department of Health gave us seed money and allowed us to use its offices. But amid all the reorganisations in the NHS, things changed and the interest evaporated.” The department argues that it has no duty under the EU clinical-trial directive to provide a “contact point for patients”. But it adds that it “is sorry to hear of Ceres’ disbandment and hopes that others will continue to provide information for research participants that accurately draws attention to the level of risk in clinical trials”.
Do volunteers need more information? The Commons Health Select Committee believes so. It warned last year, for example, that: “Volunteers may be exposed to new drugs for six months before long-term animal studies are completed to determine whether the drugs cause cancer. The responses we received from the Medicines and Healthcare products Regulatory Agency (MHRA) and industry did not indicate that patients are made aware of this upon entry into trials.”
That is not the only point where information seems sorely lacking. Even simple questions get lost between government organisations, most notably the MHRA, which covers drug safety, and the National Patient Safety Agency (NPSA), which monitors adverse incidents involving NHS patients and hosts the Central Office for Research Ethics Committees.
Who counts how many volunteers go into trials each year? The MHRA told me it was the NPSA. But then the NPSA told me that it was the MHRA. After they talked to each other, they agreed that neither did. The NPSA suggested that I ask the drug companies for a guesstimate. Richard Ley, of the ABPI, says: “My best wet-finger-in-air guess is that there are maybe 300 phase-one trials a year, with about six to eight people on each, so that’s maybe 2,500 people a year.”
What about payments to volunteers: are they monitored or capped? Money is not supposed to be a lure, but it is a huge motive for cash-strapped people. In the wake of Northwick Park, trial-recruitment companies reported a surge in applications from youngsters who had not realised that trials could be so lucrative. Ley says there is no official limit, though it should be commensurate with the time and inconvenience involved. “About £2,000 is perfectly normal. There are guidelines, and you aren’t supposed to go overboard. People in phase-one trials tend to be students because it helps to pay off their loans.”
Both Ley and the NPSA thought that the MHRA policed payment guidelines. But the MHRA said that it is the NPSA. And no one independently oversees monitoring of whether drug-trial volunteers suffer long-term effects.
Away from commercially run drug trials, the NHS takes the subject of payments extremely seriously. Sue Eckstein, the director of programme development at King’s College London’s centre of medical law and ethics, says: “Ethics committees reviewing NHS research proposals spend a great deal of time debating what constitutes a financial inducement rather than an incentive. The most money I’ve seen paid to a participant is £50, which the committee considered reasonable for 12 hours fasting, being observed and having blood taken.”
Damien Gough, the director of the website, EnterTrials.co.uk, earns commission for finding suitable volunteers for drug tests. He thinks the current regulatory set-up is a muddle. “There are big grey areas and no clear rules,” he says. “There are definitely problems of accountability with the Government. When I launched my company last May, I went around the various bodies seeking advice on my responsibilities. The assistance and feedback I got was very limited.”
Gough now has 14,000 volunteers on his books, recruited via adverts on internet job boards and magazines such as the TNT, which is aimed at young travellers. He says that giving volunteers proper advice: “I have contacted Ceres and suggested that I take over an element of their work after they disband, by putting their information and legal advice for volunteers on my website. It’s a really important service.”
Pay it safe
Where to go for further information and advice on being a drug-trial guinea-pig:
Drug-trial volunteers’ websites: www.entertrials.co.uk; www.drugtrial.co.uk
