New cancer treatments that could save tens of thousands of lives will be blocked by regulations that are to be imposed by Brussels in a few months.
The prospect has so alarmed Britain's leading medical researchers that they have written to the Department of Health to warn that the new rules - aimed at controlling clinical trials - will have a disastrous effect in the UK.
'We are facing a catastrophe,' said Professor Peter Selby of Cancer Research UK, speaking at a meeting in Bournemouth yesterday. 'Unless something is done to change the way this EU directive is implemented in Britain, virtually all trials of new treatment regimes carried out by researchers in hospitals and universities will have to be halted.'
The Medicines for Human Use (Clinical Trials) Regulations, to be imposed on the UK on 1 May next year, have caused particular anger because Britain has been making extraordinary improvements in its cancer recovery rates. Survival from children's cancers has jumped from around 20 per cent to more than 70 per cent in the past 40 years. Survival rates for breast cancer have improved by 36 per cent in the past five years.
'We have been carrying out more and more clinical trials in which we tweak different treatment regimes - a couple of drugs combined with a particular type of chemotherapy, for example - to find the one best suited to a particular cancer,' said Dr Richard Sullivan, head of Cancer Research UK's clinical programmes. 'It has been one of the country's major health successes, yet it is the very thing that is now threatened by these new regulations.'
The clinical trials directive will require that only one group can act as the sponsor of a trial, thus preventing different research institutions from launching large co-operative trials. At present, sponsorship, and therefore responsibility, is shared between all the different laboratories and clinics, with more than a dozen being involved in many cases.
'No single institution will be able to take responsibility. The financial implications if something goes wrong and lawyers get involved are simply too high for a hospital or university to contemplate today,' said Sullivan. 'The effect will be very simple: clinical trials of new treatments for cancer and other conditions will cease. It is a horrific, but nevertheless real, prospect.'
The creation of new drugs by pharmaceutical corporations will not be affected, as these companies have the financial clout to deal with possible legal problems. But clinical scientists, whose research on patients often determines the best way to combine these drugs with other treatments, will have their efforts blocked.
An example of the growing effectiveness of UK clinical trials is provided by the case of Pauline Nesham, who was 56 when she was diagnosed with a rare form of lung cancer in 1995. She was given only 18 months to live, but nearly eight years later she is alive and well because she took part in a clinical trial. On the trial - led by Selby but involving many different groups - she was treated with a combination of high doses of chemotherapy and a stem cell transplant. 'If I hadn't taken part in the trial I wouldn't be here now,' Nesham said.
The EU directive has so alarmed British medical researchers that all the major medical research funding groups have written to the Department of Health to demand action to save the clinical trial programme.
