Get stuck in

Health Secretary, Patricia Hewitt has stirred up something of a hornets' nest after telling the NHS to prepare to use a new unlicensed treatment for early-stage breast cancer - a move that has also fuelled further criticism of the National Institute for Health and Clinical Excellence (NICE).

Hewitt's unprecedented decision to wade into the debate about the use of Herceptin, a drug made by Roche for use in late-stage breast cancer, has resulted in the NHS testing all women with early-stage breast cancer to establish if they can be treated with Herceptin before it is licensed for use.

Hewitt also said that she wanted the drug to be approved as quickly as possible and the treatment “to be available within weeks of the licence being given”.

Recent results from a phase III trial in early-stage HER2-positive breast cancer patients revealed that adding Herceptin to chemotherapy reduces the risk of cancer returning by 51 per cent.

While the drug delivers outstanding efficacy and safety, detractors believe that Hewitt's decision to promote the use of Herceptin in the NHS comes in the wake of sustained media coverage of one woman's fight to secure treatment with the drug and pressure from cancer groups.

A Primary Care Trust in Somerset agreed to provide the drug to Barbara Clark, a former nurse, after she threatened to take the trust to the European Court of Human Rights.

While Hewitt's move to promote widespread use of the drug has been welcomed by cancer groups, it has been lambasted by medical specialists and health economists who have accused her of undermining NICE and applying unacceptable pressure on regulators.

Joe Collier, professor of medicines policy at St George's Hospital in Tooting, said that the Health Secretary was setting a “dangerous precedent” by putting pressure on regulators to approve a treatment that would cost the NHS around £44,000 for a two-year course.

“Ministers should not be seen, or appear to be, pressurising either the licensing authority or NICE,” he told the FT.

Professor of health economics at York University, Alan Maynard, accused Hewitt of undermining NICE, which has an important role in assessing the cost-effectiveness of new drugs. He said that ministers have to decide whether they are going to stick to the principle of cost-effectiveness or simply give way to pressure and approve medicines, cost-effective or not, above NICE's head.

The Department of Health has said that it is not pre-empting a review by NICE, but is simply making it possible for early adoption of Herceptin, which it claims with save 1,000 lives a year at a cost of £100m to the NHS - similar to the cost of the national breast screening programme.

Critical issue

A study by the Karolinska Institute in Sweden added fuel to the UK cancer care debate when results revealed that Britain was near the bottom of a league table of 19 European countries for rapid uptake of new cancer drugs.

The UK, along with the Czech Republic, Hungary, Norway and Poland, fell below average. According to the study, the time taken by NICE to evaluate new drugs is a major contributing factor in the slow uptake. It also criticises the EU's centralised licensing procedure.

Since it began work in 1999, NICE has faced an almost constant stream of criticism from one quarter or another. One leading health economist once accused the body of being “the marketing arm of the pharmaceutical industry” for allowing too many expensive drugs through. In contrast, the pharma industry has accused NICE of stifling innovation because doctors in both primary and secondary care are reluctant to prescribe new drugs without NICE recommendations.

Yet, the most common complaint from both industry and patients is that NICE is too narrow in focus and takes too long to make its recommendations. Professor Mike Rawlins, chairman of NICE, has acknowledged the latter point and health ministers are now in possession of proposals from the institute to allow it to assess significant new drugs more quickly and in parallel with the licensing process.

Under the proposals, NICE is looking to give recommendations on new drugs in six months, not 18 months.