Lack of trust of the medical community has led to a proliferation of confusing and contradictory legislation, strangling efforts to find new treatments for killer diseases, leading figures from Cancer Research UK warn at the BA Festival of Science.
Nervous bureaucrats in Brussels and London have increased the number of regulations on research forty-fold over the last decade, partly in response to high profile medical scandals. But the legislation is harming cancer patients – just the people it is supposedly designed to protect.
Whereas clinical trials used to take just a few months to set up, now they take several years, slowing the process of getting new drugs to patients. Meanwhile, clinical research has been held back by “pedantic” rules classifying everything from microscope slides to Egyptian mummies as retained human tissue.
Between 1968 and 1995, a single piece of legislation, the Medicines Act, governed much of clinical research. Since then the picture has changed dramatically.
Today, scientists carrying out research using patients, their data or tissue samples have to comply with 18 vastly different pieces of legislation, three of them arriving since 1998 as a direct result of European Directives. Since 1995 there have also been 8 European Directives and 18 pieces of National legislation regulating clinical trials in the UK.
On top of these 44 new sets of regulations in less than 10 years, edgy medical organisations have issued numerous professional guidelines, adding to the complexity. The legislation has created a culture of fear and confusion among scientists and doctors, many of whom are now practising ‘defensive research’, designed primarily to avoid the possibility of breaking any of the rules.
Dr Richard Sullivan, Cancer Research UK’s Head of Clinical Programmes, says: “There has been such a proliferation of new rules and regulations that researchers have found it impossible to keep up. Many are now playing it ultra-safe and avoiding sensitive but potentially important areas of research, so nervous are they of being caught out.
“It’s essential that we maintain the bond of trust between doctors and scientists on one hand and members of the public on the other. Increasingly pedantic regulations aren’t the answer here – we need clear, simple guidance that everyone can trust.”
Legislation on clinical trials has focused on studies involving new drugs, bringing extra regulations for starting up and conducting trials and new rules for bringing them to a close. Charities such as Cancer Research UK now have to pay out much larger sums in administration, while it takes more than five times as long to progress new drugs into patient trials.
Cancer Research UK’s Professor Malcolm Stevens, who over his career has brought five different anti-cancer drugs into clinical trials, says: “I find it incredibly frustrating that 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. That kind of delay is undoubtedly costing lives.
“Nobody disputes that safeguards are necessary, but it’s an illusion that the new paperwork is giving greater patient safety.”
Guidelines on the use of human tissue, introduced on an interim basis in 2002 but still in force, have been particularly problematic. The rules define ‘stored tissues’ much more widely than previously, so the term includes blood samples, microscope slides, stained tissue blocks and even historical materials, such as the mummies in Britain’s museums. Use of these tissues in theory requires written consent – often an impossibility where the tissues were collected years earlier.
Dr Sullivan says: “When Egyptian mummies are classified as unauthorised human tissue, you know there’s something wrong with your rule-book. We need the Government to take feeders from all sides and then come up with a single, simple, unified set of regulations that commands the trust both of researchers and the public.”
He concludes: “Scientific endeavour in this country can only be sustainable with a balanced approach to medical progress. If we continue to resort to excessive regulation instead, then we will fail patients by stifling research.”
Note to Editors:
Professor Malcolm Stevens leads the Cancer Research UK Experimental Cancer Chemotherapy Research Group at the University of Nottingham.