It's a year now since Nice was launched in an atmosphere of frenzied expectation, full of hopes on some sides and fears on the other. What was this beast, the national institute for clinical excellence? A stealthy government-driven rationing machine or a humane and kindly uncle that would ensure all patients got the best new drugs by stamping out pernicious postcode prescribing? Nice has so far produced only three judgments - the fast-tracked rejection of the anti-flu drug Relenza and, lately, guidance on hip joints and the removal of wisdom teeth. And since it has promised to look again, with less haste and more evidence, at Relenza in the summer, there is little we can conclude from that episode.
But crunch time is fast approach ing. Nice will shortly confront some of the biggest challenges it is likely ever to have to face when it publishes its verdict on the taxanes - the family of cancer drugs of which so much is expected by patients - and then beta interferon, which is the only drug that has any effect on multiple sclerosis sufferers.
The stakes are high. Patient groups are ready to damn Nice to perdition if they are not allowed the medicines they want on the NHS, while health authorities are consumed with worry about the possible consequences to their budgets. And don't imagine that the government is watching with equanimity.
At the heart of it, preparing to defend Nice to the hilt and deflect flak from the clinicians who must take the decisions, is Andrew Dillon, the chief executive. Some might think his job unenviable. He says it's great.
"There's huge enthusiasm here for what we're doing because it is something really important for the NHS," he says. "There's nobody who works here who doesn't come into it with their eyes open. All of the pressures, all of the influences on the process, are evident.
"The good thing about what we're doing is that we don't pretend the pressure is not there. And we're as clear as we honestly can be, based on our experience so far, as to how we're going to handle it to produce something that does have integrity, that does have value for the NHS."
He believes in transparency and openness. Cynics might say that is the only way to survive as piggy-in-the-middle between powerful vested interests such as the government and the pharmaceutical industry.
But Dillon is convinced that the appraisal committee - the high-powered group of scientists who must make a cost-effectiveness judgment on controversial new medicines and technologies - will not be swayed. They will make their decisions on the evidence, he says repeatedly, and will defuse the critics by being open about the way they came to their verdict.
"The one thing we've got to show is that we're consistent in the way we approach the analysis of the evidence and that we can show an audit trail that takes you from the evidence that we considered through to the decision that goes out," he insists. "We've got to be able to show how it's possible and appropriate to get from the evidence to the decision. And then we have to explain it."
But Nice's remit is not only clinical effectiveness, but cost effectiveness. So will it not be nothing more than a rationing mechanism? What about those hints in the early days from Sir Michael Rawlings, the chair, that Nice would have to live in the real world and cut its cloth according to NHS budgets? Will Nice take into account the amount of money the government is willing to spend on a new drug when it makes its decisions?
Dillon says the views of the Department of Health and of the national assembly for Wales must be taken into account during the consultation process - but only in the same way as the views of any other interested party.
"Half way through the process, we've got a draft of the appraisal and we send that out to patient groups and manufacturers and the department of health," Dillon explains. "So the department has, entirely appropriately, an opportunity to influence - just as everybody else does - the nature of the appraisal that comes out."
He denies that ministers' views might weigh more heavily than others - but the reality is that the department holds the purse strings.
So far, the government has not indicated that it has any spending limits in respect of the first 20 appraisals it has requested of Nice, says Dillon, but he accepts that it may happen.
"I don't know whether the department would, in any particular circumstances, be so specific as to say that there's a fixed amount - a net total increase - for this particular technology, but any of us can envisage circumstances in which they might, because no healthcare system can write a blank cheque," he admits. "They would know in the consultation process what it's likely to cost. The department would then be in a position to make an assumption about the impact that's going to have on their responsibility to make sure that all services are available to patients."
He could see the government asking whether a new drug might be restricted to the group of patients it would most benefit - which is what Frank Dobson unilaterally decided to do with Viagra. Or perhaps the government, he ponders optimistically, might consider making more money available.
The fact is, he acknowledges, that he is thinking on his feet about the way the process will work "because we don't really have any experience of it at all".
The sticky moments have not yet arrived. The crunch decisions have yet to be made. But it becomes clear in conversation that the absolute objectivity, the demonstrable scientific logic of the process that Dillon likes to emphasise are not the end of the story.
"The appraisal committee will be aware of the department's view, which, in an individual case, might be a view on the ability of the health service to afford what seems to be the emerging guidance," he says. "The committee members have got that information in front of them. So that view is one of a whole series of influences on the committee's thinking. The point of having the appraisal committee - this group of 24 people - is to enable the inevitably very human judgment to be made about how particular technology should be applied."
And so we have the human factor. Ministers will not be the only source of pressure. Other forceful influences will be brought to bear on the committee from patients who may be dying or hope for a better quality of life in the short time they have left. A new drug may offer them an extra year - at a huge cost to the NHS. But what price a year of life? It isn't difficult to anticipate the headlines.
"The committee members are human beings like you and me and like the editors of newspapers and have exactly the same thoughts about precisely that issue," Dillon says. "What they can do is combine that very human thinking and very human sensitivity to what it actually means to get this clinical benefit - they can add to that from their very specific skills and experience.
"So they can arrive at a judgment that can be seen to be informed by the evidence of clinical trials, but turned into advice for the institute by people who can themselves make the judgments human beings can make about benefit. And that simply can't be made on the basis of numbers crunched by a machine."
Whether that will wear with the patient groups if their drug is refused Nice's blessing for supply on the NHS is another matter, but Dillon is hopeful.
"By deliberately and genuinely trying to be open and inclusive, I think we've got to the point where patient groups are prepared to give us a go," he says. "They are sufficiently persuaded of the way we are doing things to take part in it. They haven't rejected the whole concept of Nice."
Not yet. But Nice has not yet pronounced on those controversial medicines for cancer, for multiple sclerosis, for Alzheimer's - and there will be many more such in years to come. Nice will surely win respect if it proceeds as Dillon expects - but winning friends is another matter altogether.
