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Cancer victim loses court fight over Herceptin

Pa
Wednesday 15 February 2006 06:02 EST

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Andrew Feinberg

White House Correspondent

Breast cancer victim Ann Marie Rogers today lost her legal challenge over her local NHS trust's refusal to fund treatment with the drug Herceptin.

Ms Rogers, 54, a mother of three, likened the decision by Swindon Primary Care Trust (PCT) not to fund the "wonder drug" to "a death sentence".

But, in a judgment with implications for many other early stage breast cancer sufferers, a High Court judge said: "I find that Swindon's policy is not unlawful whether in English domestic law or under the jurisprudence of the European Court of Human Rights".

Mr Justice Bean, sitting in London, said: "Ms Rogers has not shown that SwindonPCT's refusal to fund her treatment with Herceptin is contrary to a direction orguidance from the Secretary of State for Health.

"Many primary care trusts have a policy of funding Herceptin treatment for early stage breast cancer sufferers who are HER-2 positive, but Swindon's is not to provide such funding unless the individual case is exceptional.

"The court's task is not to say which policy is better, but to decide whether Swindon's policy is arbitrary or irrational and thus unlawful."

Ruling Swindon had not acted unlawfully, the judge said: "Accordingly, despite my sympathy with Ms Rogers's plight, I must dismiss the claim for judicial review.Herceptin is said to halve the chances of the aggressive HER-2 form of breast cancer returning.

Ms Rogers, a former restaurant manager of Haydon Wick, Swindon, has borrowed £5,000 for treatments so far, but says she cannot afford to pay for further courses.

The judge granted Ms Rogers permission to appeal and directed that she shouldcontinue receiving Herceptin in line with an earlier High Court order.

He said "funding or provision of Herceptin to Ms Rogers" should continue until March 31, or until the Court of Appeal gave its judgment, or any further court order was made.

Ms Rogers, who was in court, is due have her next treatment tomorrow.

At a two-day hearing last week, her counsel Ian Wise attacked the PCT's policy of offering Herceptin when a cancer was in its early stages only if there were "exceptional" circumstances.

He asked for court orders compelling the PCT to continue funding Ms Rogers' current course of treatment, and to continue providing her with Herceptin - even though the drug is not formally licensed for early stage cancer - if it was medically appropriate to do so.

But Philip Havers QC, appearing for the PCT, told the court: "The fact is this drug has not yet been licensed as a treatment for early stage breast cancer, or appraised by the National Institute for Clinical Excellence (Nice) as to its efficacy and its safety."

The rules for prescribing new drugs in England and Wales stated that, until they had been formally licensed, they should only be funded in exceptional circumstances, and Ms Rogers's case was not in that category.

The PCT's policy was "wholly in line" with the Health Secretary's guidance and it had not acted arbitrarily or irrationally.

Today the High Court agreed with him.

A Department of Health spokesman said: "Our position remains unchanged.

"PCTs need to take into consideration a whole range of factors before making a decision whether to fund Herceptin for a woman with HER2 positive early stage breast cancer.

"Ahead of a decision on licensing, or Nice appraisal, such decisions will continue to be made at a local level on a case by case basis.

"We are taking action to ensure HER2 testing is available to NHS breast cancer patients across the country and Nice is carrying out an appraisal of Herceptin through its new fast track process in parallel with the licensing application.

"This will mean that, once a licensing decision has been taken, Nice will be able to complete their appraisal and issue their guidance as soon as possible."

Joanne Rule, chief executive of charity CancerBACUP, said: "This ruling has huge implications for cancer care.

"We believe the public will see this as postcode prescribing rather than local-decision making.

"The people who call our helpline want to know that decisions about their treatment depend on clinical need and not on where they live, how much money they have, or how 'exceptional' they are in comparison to someone else.

"The UK spends less on cancer treatments than other countries. In order to fund new treatments like this in future, we need proper planning as new treatments develop and a second national Cancer Plan with money attached to rebuild consensus about the future of cancer care in the UK."

Ms Rogers's solicitor Yogi Amin, of Irwin Mitchell, said she was not going tospeak but she was determined to fight on.

He said: "Ann Marie Rogers is devastated at the outcome of this judicial review but is determined to take her fight for this drug to the Court of Appeal.

"She is angry that the court did not reverse the decision of her Primary Care Trust (PCT) to refuse her Herceptin, despite her consultant's recommendation.

"The judge said that what the Secretary of State for Health issues to Primary Care Trusts did not amount to a direction that they must not refuse this drug.

"Whilst Ann Marie accepts the pressures the Secretary of State is under, in terms of the licensing of life-saving drugs, she also feels that the hopes of hundreds of breast cancer sufferers up and down the country have been built up by previous statements from the Secretary of State.

"The court commented that unless the Secretary of State issues a direction, her views can be dismissed by the trust.

"Ann Marie has an aggressive form of breast cancer and has been let down by her health authority. Access to life-saving cancer treatment depends on where you live in England and Wales.

"The court heard that Professor Mike Richards, the national cancer director at the Department of Health, has urged this PCT to treat all women who fit the criteria for the HERA trial as 'exceptional'.

"A clear direction of the availability of Herceptin for early stage breast cancer sufferers is now needed.

"Ann Marie would like to thank the media and public for all the personal messages of support which have been a great comfort to her. She urges them to continue in their support for the right to equal access for all life-saving medicine."

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