An influential British medical journal today scorned claims that Herceptin was "a cure" for breast cancer and attacked the hype - in Government and the media - surrounding the treatment.

The Lancet said that insufficient evidence exists to be sure that the drug is either safe or effective and warned that the Government's off-the-cuff decision to bypass normal regulatory procedures was flawed.

The journal stepped into the row over patient access to Herceptin as a health authority "revisited" its decision not to provide the drug for a mother of four following the dramatic intervention of Patricia Hewitt, the Health Secretary, yesterday.

Elaine Barber, 41, said she was "over the moon" today that her local primary care trust had changed its mind and agreed to give her the £21,000 treatment, avoiding a High Court challenge.

North Stoke PCT had previously argued that the drug's efficacy was unproven and, on that basis, it was too expensive to fund its use.

That view is repeated in The Lancet which today argues that the case for giving Herceptin to women with early Her2-type breast cancer is still not reliably proven.

In an editorial published online today, the journal attacked the "hype" that forces premature decisions to be made about treatments.

It criticised an editorial in the New England Journal of Medicine last month which described Herceptin as "maybe even a cure". The article prompted Ms Hewitt to announce that the drug should be made available on the NHS on demand even though it has not completed approval trials.

The Lancet said: "The best that can be said about Herceptin’s efficacy and safety for the treatment of early breast cancer is that the available evidence is insufficient to make reliable judgments.

"It is profoundly misleading to suggest, even rhetorically, that the published data may be indicative of a cure for breast cancer."

The availability of new treatments in England and Wales is largely determined by the National Institute for Health and Clinical Excellence (Nice), which vets medicines.

In March 2002, Nice recommended Herceptin for women with advanced breast cancer who had the HER2 gene mutation linked to the disease.

The process leading to the decision was criticised as taking too long. Nice insisted that its primary concern was providing reliable advice backed by sufficient evidence.

This year an even more intense debate blew up around promising early results from a study of women with early breast cancer given Herceptin. The findings, initially presented at the annual meeting of the American Society of Clinical Oncology, sparked a wave of demands for the drug.

Some countries, such as France, bypassed their normal approval procedure to make Herceptin available.

The journal stressed that regulatory agencies and bodies such as Nice play a pivotal role in translating research evidence into clinical guidance.

It added: "It is vital that their decisions are made carefully after considering the totality of available evidence. They must be free from political, special interest, or media influence, no matter how well meaning.

"The debate about the availability of Herceptin to women with early breast cancer demands cooler heads than have so far prevailed, in politics, in public, and even in medical journals."

North Stoke PCT had previously argued that there was not enough evidence supporting the long-term efficacy of the drug to justify its expense. In a carefully-worded statement it said that Mike Ridley, the chief executive, had met Ms Barber today and agreed to uphold her appeal.

It said: "The introduction of any new expensive treatment inevitably provokes a review of the PCT’s investment priorities, especially as we work to recover from our financial deficit.

"There is no contingency budget in this financial year for the prescribing of adjuvant Herceptin. It is estimated that the additional cost pressures for the City of Stoke on Trent will be £700,000 in the year 2006/7."

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