Herceptin drug case
Herceptin is the first humanised antibody for the treatment of HER2 positive metastatic breast cancer.
Today in the High Court, lawyers fighting for the rights of Ms Ann Marie Rogers of Haydon Wick, Swindon (53) to receive the breast cancer drug Herceptin will be in the High Court, in London. The full judicial review hearing will be the very first time a person's right to receive the drug has reached the courts. All previous legal actions by women including Barbara Clarke, who recently announced that she was in remission following her course of Herceptin, and Elaine Barber have resulted in the PCT reversing their position before full judicial proceedings have taken place.
Ms Ann Marie Rogers launched her legal challenge against her local primary care trust, Swindon NHS Primary Care Trust (PCT) in November 2005 after being denied the Herceptin cancer drug despite her clinician diagnosing it. If successful this ruling will have a massive effect on the provision of drugs by the NHS. Where the PCT has simply backed down on individual cases, and deal with people on a case by case basis, this ruling will establish a precedent to ensure that those people who are prescribed a drug by a clinician can be assured that the law is on their side if the PCT then denies them the drug.
Ms Rogers is using the law firm Irwin Mitchell, who have successfully challenged a number of PCT's, to change their decision on providing Herceptin on behalf of their clients including Elaine Barber. Ms Rogers argues that the PCT's refusal to provide Herceptin is unfair and in breach of her Human Rights.
Herceptin is a breast cancer drug that, according to evidence (1), halves the chances of the aggressive HER-2 form of the disease. Despite her clinician recommending she receive the drug treatment, Ann Marie was denied the drug on grounds of an alleged lack of evidence of the drug treatment's success and lack of exceptional circumstances. However what is 'exceptional' has yet to be defined.
The PCT's decision could be in direct conflict with the guidance given by Patricia Hewitt the Secretary of State for Health who recently gave a speech on breast cancer awareness in which she said that "PCTs should not refuse to fund Herceptin solely on the grounds of its cost" and has told drugs watchdog, the National Institute of Clinical Excellence (NICE) to fast-track treatment guidelines.
Yet despite this, and the work of campaign group Women Fighting For Herceptin, hundreds of early stage breast cancer patients who have the support of their clinicians are nonetheless being denied this vital drug by their PCTs who fund the drugs, and told that it will have to await broad licensing which is not planned until at least later this year which will be too late for many cancer sufferers including Ann Marie.
Whilst cost is not being given as the sole reason for refusal of the cancer drug, it is an obvious contributing factor.
Ms Rogers's solicitor, Yogi Amin of National law firm Irwin Mitchell, commented: "Health authorities must provide fair access to lifesaving health care, and this should be provided to all NHS patients wherever they live.
The Herceptin drug is already licensed and widely used for late-stage breast cancer. Since the Elaine Barber case, many PCTs have agreed to fund Herceptin. Some PCTs however are still seeking to go against a clinician's advice to the patient and deny treatment. This court case will challenge that decision, and the resulting unfairness created by a postcode lottery of NHS health care provision"
Ms Rogers has already taken a loan to pay for the first 2 treatments she needed and she won the right in a pre-trial hearing on 21st December 2005 to have the drug paid for in the interim between that initial judgement and next week's landmark case.
Ms Rogers said "I was otherwise a very healthy person and was deeply shocked when I was diagnosed with breast cancer. I feel that if my cancer returns I will be handed a death sentence. I have now endured the gruelling chemotherapy and radiotherapy and I am angry with my PCT refusing to fund the health treatment I need. I did not want to fight to get this treatment which my clinician prescribed for me, but I will continue to do so, as it is vital in preventing the cancer recurring and allow me to get my life back."
The Secretary of State has stated that she has done all that she can. However there is concern that PCT's are misinterpreting her comments as allowing them to use an 'exceptionality policy' to refuse the life saving breast cancer drug. This approach raises further concerns that an inequitable postcode lottery for the prescription of life saving treatment exists.
A recent report (2) released by the House of Commons Committee of Public Accounts in January 2006 identified that even cases of cancer for which the drug is licensed and approved by NICE the chances of survival are dictated by a postcode lottery in drug treatment. The report states "the use of the drug Herceptin for mestatic breast cancer in the 6 month period 12 to 18 months following NICE approval in early 2002 ranged across cancer networks from 90% to under 10% of eligible women".
Mr Amin concluded: "Time is running out for early-stage breast cancer patients, who need the drug now. They shouldn't have to be concentrating their efforts in fighting against their Primary Care Trusts' decisions, especially when a clinician has assessed the drug as being vital to the patient. I'm in no doubt that cost is a major factor in the refusal of the drug."
Mr Amin continued "As such the distribution of Herceptin for all breast cancer sufferers, no matter what stage, needs to be addressed immediately. Swindon NHS PCT has said that Ms Rogers is not an exceptional case. All breast cancer suffers assessed as requiring this treatment by their clinician are fighting against potentially life threatening cancer returning. If these are not exceptional cases I do not know what are."
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