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NICE but nasty
 
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NICE restricts revolutionary anti-cancer drugs

The National Institute for Clinical Excellence (NICE) has recommended denying patients with killer cancer gastrointestinal stromal tumours (GISTs) treatment with Glivec, if they do not respond to the revolutionary drug within just 12 weeks. In addition, patients with some tumours that are responding to Glivec and others that are not will be among those denied further treatment with the drug.

NICE is also proposing to take Glivec away from patients who have some tumour sites that are responding to treatment and some tumour sites that are not. 

These restrictions conflict with clinical evidence, expert medical opinion and will ultimately deny patients diagnosed with GISTs the potentially life-saving benefits of Glivec.

GIST Support UK and Sarcoma UK together challenge the initial recommendations: "As a collaborative voice for GIST patients in the UK , we find NICE's proposed decision to take away Glivec from patients with a life threatening cancer before it is possible to determine whether or not they are benefiting from the treatment shocking and unethical."

NICE recommends that Glivec is stopped if a response to treatment is not seen on a CT scan within 12 weeks but it can take up to nine months to see a radiological response to the drug on a CT scan. In addition,    CT scans do not detect metabolic changes within tumours, which occur as quickly as 24 hours after taking a single dose of Glivec. For those patients shown to be responding to Glivec in some tumour sites but not in others, withdrawing treatment not only denies them access to the only treatment available but also may cause their tumours to flare up, making their condition worse. In addition, NICE has disregarded the expert opinion of specialists who have asked for the discretion to increase the dose of Glivec, if their patients do not respond to the standard 400mg dose.

Speaking on behalf of GIST Support UK , which represents GIST sufferers in the UK , GIST patient Dave Cook said: "While being pleased by the committee's recommendation to approve Glivec, I am extremely concerned and disappointed that the approval comes with such potentially deadly restrictions. This will cause distress and anxiety to patients and their families living with GISTs whose access to Glivec can be a matter of life or death."

The proposed advice from NICE contradicts the situation in Scotland , where the Scottish Medicines Consortium (SMC) advised the NHS that Glivec can and should be used for treating GISTs without restrictions nearly two years ago (August 2002).

Roger Wilson, founder of Sarcoma UK said: "I find it disgraceful that many people suffering from GIST in England and Wales could die needlessly knowing that Glivec might still work for them, whilst their Scottish neighbours are being given the best possible chance of survival and living their lives to the full." He added: "NICE has ignored the opinion of leading medical experts within the oncology field and trivialised the positive patient experiences of people whose lives have been transformed by Glivec."

If these recommendations are upheld and clinicians abide by NICE guidance, then many patients who could benefit from Glivec, will be denied access to the drug, leaving them with no other possible treatment option.

Whilst the recommendations are not final, they are a preliminary indicator of the final opinion from NICE, the final appraisal document (FAD), which is due in July. If this decision is upheld, restrictions to Glivec treatment will affect the chances of survival for many

GIST patients in England and Wales .

All sufferers of GIST and their families have until 5.00 pm on 15 June to email their protests against this unethical decision by NICE by accessing the NICE website at www.nice.org.uk.

For further information on GISTs, visit www.gistsupportuk.com

 

About Glivec

On 24 May 2002 , Glivec received a licence in the UK to treat patients with Kit (CD 117)-positive unresectable (inoperable) and/or metastatic malignant gastrointestinal stromal tumours (GISTs), a rare form of gastrointestinal cancer. On 9 August 2002 , the SMC recommended that Glivec be made available to GIST patients through reimbursement by NHS Scotland.

About GISTs

GISTs are the most common malignant form of sarcoma that arise in the gastrointestinal tract, predominantly affecting people between 30 - 60m years of age. The UK incidence is approximately 15 cases per million or around 900 cases diagnosed each year. Historically, GISTs have been very difficult to treat due to their high levels of resistance to treatment with traditional chemotherapy and radiation therapy.

The UK incidence of metastatic or unresectable disease is 250 cases. For these patients GISTs had represented an incurable malignancy, with a median survival of approximately one year. In cases where surgery was possible, it resulted essentially in palliation of the disease.

  (26/5/04)

 

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