In theory, NHS doctors have the right to prescribe any drug which is proven to be effective. The reality is very different. Health Editor Barry Nelson examines the issues behind this week's row about the breast cancer drug Herceptin.

ON the face of it, this week's concession by the Government over the breast cancer drug Herceptin looks like good news for patients. Faced with uncomfortable headlines about the plight of Somerset breast cancer patient Barbara Clark - who has been running a one-woman campaign to improve access to this costly drug - the Government decided to do something. But the announcement by Health Secretary Patricia Hewitt that women are to be tested to see if they might benefit from the drug doesn't address the issue of funding and still means that around 2,000 women with an aggressive form of cancer are likely to wait until next summer before they get the drug.

What doesn't help is the knowledge that the same drug is already widely used across Europe, and that waiting until next year could prove fatal for some patients.

The situation also illustrates why the regulatory mechanism set up by the Government to ensure new drugs are properly vetted by experts before being prescribed on the NHS has been criticised for being too slow and inflexible. Without approval by the National Institute for Health and Clinical Excellence (NICE), a panel of expert drug assessors, doctors in England have an uphill task in persuading their hospital or primary care trust to stump up.

Currently there are more than 60 new drugs for a variety of conditions under appraisal by NICE. A quarter of this total is for the treatment of various forms of cancer. It takes an average of 18 months to complete the process, often much longer before patients can get newly approved drugs on the NHS.

Ms Clark grabbed the media's attention in June this year when she revealed that she was putting her home in Bridgwater up for sale to pay for Herceptin privately, at a cost of around £40,000. The problem with Herceptin in England is that it is currently only licensed to be used with advanced forms of aggressive breast cancer, after other forms of treatment have been tried and have failed. Campaigners and breast cancer charities point out that there is ample evidence that the best use of Herceptin is to give it to women in the early stages of breast cancer.

In May this year, the makers of Herceptin, Roche, published interim results of a massive trial involving more than 5,000 patients in 39 countries. The impressive results, which have led to Herceptin being described as a 'wonderdrug', showed that for early stage cancer patients who met the criteria for treatment, Herceptin reduced the risk of cancer coming back after surgery and chemotherapy in nearly half the women who took the drug.

Yesterday, a spokeswoman for Roche explained that the company now has to make a full application to the European Medicines Agency (EMEA) for the existing Herceptin licence to be extended to include women with early stage breast cancer. Because this is a huge undertaking, the company says it expects to be ready to make this application in early 2006.

However, since the interim results were published five months ago, doctors in Canada, France, Germany, Holland, Slovenia, Spain and the US have all been able to prescribe Herceptin to early stage breast cancer patients because these countries have in place a system which allows for the cost of drugs to be reimbursed by the state when it can be demonstrated that giving unlicensed drugs can provide 'exceptional benefit' to patients.

Despite protestations from the Department of Health, it appears that a similar scheme does not exist in England. Most doctors are simply not prepared to take on the local NHS bosses to try to get funding.

Until her local primary care trust in Somerset caved in under mounting pressure and agreed to pay for Barbara Clark's treatment this week, very few NHS bodies had agreed to pay for Herceptin in early breast cancer.

This is despite a recent statement by the Health Secretary making it clear the doctors were entitled to prescribe unlicensed drugs, providing that they are able to persuade their local primary care trusts to fund them.

The pressure on the Government increased two weeks ago when 50 women from a new group, Women Fighting for Herceptin, marched to Downing Street to hand in a petition of 34,000 signatures demanding earlier access to the drug.

There were tears of disappointment in Whitehall when the women were told that they would have to wait for the drug to be licensed specifically for the treatment of early breast cancer before it was made more widely available.

While this week's announcement will mean that newly diagnosed patients with breast cancer will now be tested, it does not mean that anyone will get the drug any faster.

Barry Ogleby, 66, from Thirsk, North Yorkshire, can't believe that women are still being refused Herceptin on the NHS five years after he and his late partner, Eileen Quigley, fought their own battle to get the drug.

Eileen was diagnosed with an aggressive form of breast cancer in 1999 and conventional treatment failed to prevent her illness progressing.

The couple heard about Herceptin from a friend and tried, without success, to persuade Eileen's consultant to prescribe it on the NHS.

In desperation they agreed to pay for a test to see whether Eileen would benefit from the drug. Eventually, after much delay and armed with positive test results, she was put on Herceptin.

"At first she did really well and there were no side-effects and no hair loss," recalls Mr Ogleby. But the cancer had already spread to other parts of her body and in August 2001, Eileen died.

Mr Ogleby is still bitter about her death

and feels strongly that any woman who might benefit from Herceptin should get it without delay.

He is not impressed by the Government's partial concession.

"It is inadequate. It is just the Government trying to give the appearance of doing something. They are dragging their heels. Other countries are using it as a first-line treatment, why not England?" he says.

Four other promising new cancer drugs are among those in the queue to be assessed by NICE. One of them, Rituximab, a treatment developed for non-Hodgkin's lymphoma, got its licence a year ago but the NICE appraisal process is not expected to conclude until September 2007.

Anastrozole, another drug designed for use in early breast cancer, has been licensed since October 2002 but the NICE verdict is not due until November next year.

For its part, NICE recently announced plans to speed up appraisal of new medications for the NHS. Under new proposals, the fast-tracking of appraisals could halve the time normally taken. There is also a plan to give priority to drugs which could increase patient life expectancy.

Professor Alan Ashworth, director of the Breakthrough Breast Cancer Research Centre summed up the frustrations felt by scientists working in the sphere of cancer drug development when he spoke to The Northern Echo earlier this week.

Prof Ashworth has been working with scientists at Newcastle University who announced they are on the trail of an entirely new type of cancer drug which is already very promising.

"We are spending hundreds of millions of pounds on research to develop new cancer drugs and then we won't pay for them. The whole business is crazy," he said.