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Last Updated: Thursday, 11 September, 2003, 16:30 GMT 17:30 UK
Red tape 'harming cancer patients'
By Kristine Krug, in Salford

Increasing amounts of red tape are leading to crucial delays in getting drugs into the clinic, medical charity Cancer Research UK says.

Micro, Eyewire
Researchers are looking at forms not samples
The charity claims regulations governing pharmaceutical research and trials and the use of patients' data and tissue samples have increased forty-fold over the last 40 years.

It believes "pedantic" rules are "strangling" the search for new cures.

"Whereas I could once go from developing a new drug to testing it in patients in a matter of months, it's now routinely taking more than two years," said Professor Malcolm Stevens, from the University of Nottingham.

"That kind of delay is undoubtedly costing lives."

Freezer details

The regulation of clinical trials alone has seen 18 new pieces of national legislation and eight European directives since 1995.

Professor Stevens told the British Association science festival how a new breast cancer drug called Phortress, developed in his Cancer Research UK Experimental Cancer Chemotherapy Research Group, had been awaiting the start of clinical trials for three years.

Gaining approval involved, for example, long descriptions of how exactly the samples from patients in Newcastle were to be transported to Nottingham for testing, including details such as the person who would receive them at the other end and information on the freezer used for storage.

"My staff are being diverted," he complained. "Instead of working in the lab developing the next generations of drugs, they are having to spend a lot of time writing protocols, having them checked, sending them to auditors, having them revised, and so on.

"This is not what we supposed to be doing which is developing innovative therapies."

Legislative curse

The amount of red tape, he said, did not only delay the time it took to get new drugs to the patients, but it seemed also to deter scientists from getting involved in drug trials in the first place.

"Research fellows don't want to engage in clinical trials because of the paperwork involved," he claimed.

About 80 new cancer drugs went into clinical trials in the last 25 years, but Dr Richard Sullivan, Cancer Research UK's head of clinical programmes, expects that under current legislation this number will be slashed in the future.

Similar problems are hampering research on patients' tissue and data.

Before 1995, much of clinical research was governed by the Medicine's Act alone. Today, research on patients' data or their tissue has to comply with 18 pieces of legislation.

Dr Sullivan explained how even Egyptian mummies were now classified as unauthorised human tissue.

Brussels bureaucracy

Cancer Research UK partly blamed over-reaction by the government in the wake of the scandals of Alder Hey and Bristol, where organs had been retained without consent.

But many of the new regulations were also a direct result of directives from the EU, said Dr Sullivan. "Brussels has become a regulatory super-state."

Cancer Research UK asked the government for a more coordinated approach to regulate research, a simplification of the rules and a more effective representation of research interests at the EU level.

Their call was echoed by North West cancer fundraiser Margaret Macartney.

She is currently in remission after treatment for two bowel tumours and uterine cancer. She told the festival there had to be a revision of the regulations.

"There are unnecessary delays," she said. "It's not that people are not doing the work; it's that they are being prevented from doing it.

"The doctors will become discouraged and do something else. No one wants to work in a cul-de-sac."




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