Research that gave little Megan a longer life is threatened by new EU rules

Daily Telegraph (13/07/2003)

Doctors warn that a new EU directive controlling medical trials will halt research and lead to the deaths of people who might have been saved. Jenny Booth reports

New treatments for children's cancers will be halted and patients who might have been saved will die as a result of a new directive from the European Commission governing medical research, doctors have warned.

The directive, which will take effect from next April, imposes so much extra bureaucracy on doctors who carry out trials that costs will quadruple, according to Dr Peter Selby, the head of research at Cancer Research UK (CRUK).

It also leaves charities which fund medical experiments exposed to potentially unlimited legal bills if anything goes wrong, meaning that most will abandon them, Dr Selby believes.

The European Directive on Good Clinical Practice in Clinical Trials was drawn up two years ago after drugs manufacturers complained that there was a different regulatory framework in every country in Europe. The directive, which aims to harmonise regimes for testing medicines, takes effect in Britain from next April.

Critics of the directive say that it was drawn up by the commission's enterprise department and was designed solely to fit the needs of business, ignoring the needs of academics running publicly funded clinical trials.

The directive will not affect commercial trials of new drugs, which constitute 20 per cent of medical research. However, charities say that it will have a paralysing effect on the remaining 80 per cent - experimental treatments carried out with charitable or government funding.

CRUK and the Wellcome Trust - two of the biggest funders of medical research in Europe - have warned that they will refuse to sponsor clinical trials if they are forced to take legal liability for every doctor and every hospital involved in experimental work.

Prof Selby described the directive as a "catastrophe" and added that the British Government's own proposals for implementing the directive were so cumbersome that they made the situation worse. The directive will be incorporated into UK law next year by the Medicines for Human Use (Clinical Trials) regulations.

"The draft regulations include a number of bureaucratic requirements that, if not modified, would more or less stop all academic clinical trials in their tracks from April 2004.

"There is a risk that people could die without these trials," said Prof Selby. Among the areas worst hit will be research into children's cancers, an area of medicine ignored by drugs companies because so few children get cancer that it is not commercially viable to develop treatments. Death rates among child cancer sufferers have fallen in the past 25 years from nearly 100 per cent to 25 per cent - a fall which was due to the kind of clinical trials which were now under threat, said Prof Selby.

One beneficiary of such trials was Megan Rose Leach, who was given three months to live when she was diagnosed with a brain tumour at the age of two. However, she lived for a further three years, managing to go to school and make friends, thanks to experimental stem cell transplants and high-dose chemotherapy that she received on a clinical trial. Megan's parents Lisa and John say that they will never be able to thank doctors enough for the extra years of life given to her by the trials. Megan lived to meet her baby brother Owen and learned to dance during her extra years.

"Many more children are cured of cancer these days and if we don't push the boundaries of science with these clinical trials then we can't make more children better," said Mrs Leach. "The statistics on death rates will stay the same and children will die."

Clare Binns's son Joshua was diagnosed last year, at the age of four, with a brain tumour so rare that doctors at the Queen's Medical Centre in Nottingham had no idea what his survival chances were or how best to treat it. Surgeons could not remove all of the tennis ball-sized tumour as it was too close to Joshua's brain stem.

Mrs Binns was offered the choice of allowing Joshua to go on a clinical trial of a new dosage and combination of chemotherapy, or simply taking him home and keeping him comfortable. She chose the clinical trial and Joshua is now in remission and well enough to attend school full-time.

"It was the hardest thing I have ever done, having to hand over my son as a guinea pig to medical science: the one thing so precious you could never put a price on him," said Mrs Binns.

"But at least we had a choice. If there were no clinical trials, all the doctors would be able to say was that there was nothing they could do. It doesn't bear thinking about."

The Medical Research Council set up a working party to assess the impact of the new directive and found that, even in the best-case scenario, research would be damaged.

"Whatever they do, trials will become more costly," said Stephen Evans, professor of pharmaco-epidemiology at the London School of Hygiene and Tropical Medicine, the chairman of the MRC working party.

"In the worst case, the extra costs could consume the entire £20 million MRC clinical trials budget and stop all new clinical trials."

Diane Garnham, the chief executive of the Association of Medical Research Charities, agreed. "The impact could be extremely serious."

A spokesman for the Department of Health said that the Government had agreed to re-examine its draft regulations.

Per Haugaard, a spokesman for the European Commission, said that Brussels was aware of the British doctors' concerns, and was in talks with the Government about how to minimise the impact of the directive on academic research when it was implemented in national law.

"The last thing we want to do is to hamper any of the research that is going on either now or in the future," said Mr Haugaard.

However, doctors said that was not enough. "That is no good, particularly for groups of patients who are dying quickly, such as those with pancreatic cancer," said Dr Richard Sullivan, the medical director of CRUK.

"The view of the Government is that the directive is complete and cannot be altered but we will be pushing hard for substantial amendments within the next two years. We want this changed."