On any given day, Professor Nick Wright and his team at Cancer Research UK's histopathology lab in London study scores of tissue samples: flesh and blood subjected to molecular analysis to try to unlock the mechanics of various forms of the disease. Pathology underpins diagnostic medicine in the UK. It is painstaking, time-consuming, crucial work.
In 2001, research pathologists at the lab showed for the first time that cells in bone marrow were capable of turning into kidney cells, a breakthrough that opened up the possibility of new ways to treat kidney damage.
But Wright is worried that the work of his unit, and possibly the practice of medicine itself, is under threat from the human tissue bill, the legislation drawn up by the government after the organ retention scandals at Bristol Royal Infirmary and Alder Hey hospital in Liverpool.
The scientific and medical communities have been voicing their fears since the bill was first sketched out, reinforced by the Royal Society earlier this week. While they support the aim of the legislation, to increase public confidence in the collection and use of human tissue and organs, they fear its broad brush approach could criminalise doctors, paralyse research and hamper training.
The chief concern centres on the fact that the bill, soon to come to the Lords, makes no distinction between tissue samples taken during surgery and routine diagnostic tests and the removal of organs after death, effectively banning the use of any human tissue for research or training without explicit prior consent. The sanctions are unlimited fines or a prison sentence of up to three years.
This week, there are signs that the government has finally listened to the increasingly panicked calls from doctors and scientists, possibly agreeing to reclassify tissue samples taken from living patients as having presumed consent for use in research and training. Health minister Rosie Winterton would only say that ministers understood that research was vital and have been talking to the medical and scientific community about their concerns. "We are looking at ways of addressing them in the bill but maintaining the balance between the rights of individuals to be consulted and the need for vital medical research," she says.
"We use human tissue all the time," says Wright, who is also warden of Bart's and the London School of Medicine and Dentistry. "Let's say we wanted to collect two to three hundred small tumours of the colon and we only got 40% consent. It would take us much longer to get the required tissue for that research. Also, we teach juniors on the material that we have ... In the future the law will say teaching will be permitted without consent only if it is incidental to diagnosis.
"The main concern in a nutshell is that they have lumped all tissue together. There is no doubt that the law on retained organs needed to be tightened because there was a lot of confusion. What they have done now is to put surgically acquired tissue and remnant samples into the same bill."
Professor Mark Pepys, director of the centre for amyloidosis and acute phase proteins at the Royal Free and University College medical school, goes further. "It isn't only research, it is also clinical practice," he says. "Research impacts on knowledge and the future benefit to the patient. The potential for disaster if this bill goes through in anything like its present form is inevitable."
Pepys also argues that the bill as it stands could make the UK a research backwater as scientists and pharmaceutical firms look elsewhere for a less restrictive environment.
There are also deep misgivings about the bill's creation of a human tissue authority with the power to determine standards without parliamentary oversight, and the apparent downplaying of the role of local research ethics committees. The NHS processes almost 150m tissue specimens from living patients each year. Doctors say it would be impossible to take and record consent for such numbers. They point to Southampton where a new surgical consent form was introduced last year, incorporating consent for teaching and research use. Over 10,000 surgical and biopsy specimens were audited. Only 40% of them had consent forms attached and of those only 23% indicated a preference. If the bill was law, that would mean that 67% of the samples taken in Southampton could not be used for teaching and research.
Doctors also argue that most patients are happy to have tissue that is taken from them through surgery or diagnostic tests used for research and teaching. One study in the British Medical Journal found that 99% of 3,000 patients gave consent for their tissue to be used for research.
Despite the hopes that the government has heeded the concerns, the scientific and medical communities are keeping up the pressure. Earlier this week, Lord May of Oxford, president of the Royal Society, and a former government science adviser, accused ministers of using a sledgehammer to try and crack a nut. Wright prefers the "pig's breakfast" analogy: "I just don't think it has been thought through".
