New cancer drugs held up by the NHS for nine years as rationing body accused of letting down patients
Patients are waiting up to nine years for cancer and Alzheimer’s drugs to be available on the health service because approval takes so long.
The delays mean that even new drugs given the all-clear in extensive trials remain stuck in the queue for years.
A major study found that on average it takes five years from a treatment’s launch by a manufacturer to approval by the rationing body, NICE.
But the process often lasts far longer, and on occasions NICE will not even start its assessment until a drug has been on the market for more than a year.
One of the problems is that NICE – the National Institute for Health and Clinical Excellence – has a wide-ranging remit which includes drawing up NHS guidance on tackling obesity, alcohol abuse and other public health issues.
But last night doctors and charities said it was unfair that patients were being denied potentially life-saving drugs just because the rationing body is bogged down in other tasks.
They said the delays are affecting patients’ quality of life and could make the difference between someone being able to live independently or needing full-time care.
Although patients can get drugs that have not yet been approved by NICE by paying privately or applying to the Cancer Drugs Fund, doctors are often reluctant to prescribe them.
The report by the Office for Health Economics, obtained by GP Newspaper, looked at all the drugs approved by NICE since 2000, covering a total of nearly 300 treatments including those for cancer, Alzheimer’s disease, and heart problems.
When making its decisions, NICE classifies drugs into two groups. Those which would be used on their own undergo ‘single’ appraisals, while those which are taken with another drug are subject to ‘multiple’ appraisals. These take several years longer.
In 2010, the most recent year for which figures are available, the average delay for the 11 drugs which were approved after multiple appraisals was 10.2 years. They included treatments for arthritis, hepatitis C and Crohn’s disease, a debilitating bowel disorder.
The average delay for multiple drugs given the green light in 2005 was 8.7 years. They included treatments for bowel cancer (irinotecan and oxaliplatin) and cancer of the womb (topotecan and pacilitaxel).
In 2006 NICE approved three Alzheimer’s drugs, Aricept, Reminyl and Exelon, although only for patients in the ‘moderate’ stages of the disease.
These treatments would have been classified as multiple appraisals, and that year the average time these assessments had taken was 7.8 years.
Last night Andrew Chidgey of the Alzheimer’s Society said: ‘People with all types of dementia desperately need effective treatments to live a better quality of life and stay independent for longer.
‘Five years is a long time to wait. Whenever a new drug is available, NICE guidance should be issued as quickly as possible.’
Heather Walker of Cancer Research UK said patients needed effective drugs ‘swiftly’ and added: ‘There needs to be a balance between giving NICE enough time to make the right decisions and ensuring that drugs get to patients as soon as possible.’
Dr Anita Sharma, a senior GP in Manchester, said: ‘Being too busy to appraise a drug is not acceptable.’
NICE’s role includes drawing up public health guidelines such as how NHS trusts should tackle obesity. It also sets ‘quality standards’ which state how patients with a range of illnesses should best be treated.
Earlier this year the watchdog took on yet another role and began drawing up guidelines on social care. It will shortly be issuing advice on how NHS staff should care for the elderly with dementia and vulnerable children.
A spokesman from NICE said: ‘We don’t recognise most of the conclusions reached by the Office for Health Economics report which was published in January this year. ‘The report includes in its average figures some drugs that received their licences many years before NICE was established in 1999. ‘NICE has since been asked to appraise such drugs, but their inclusion in this report has skewed the average length of time elapsed from marketing authorisation to published NICE guidance quite considerably.’
Retired paramedic’s £1m payout after bungling surgeons removed wrong part of his brain in operation he didn’t need
A retired paramedic who was left partially blind and needing round-the-clock care after a blunder by surgeons has been awarded more than £1million.
John Tunney, 63, was left severely disabled medical staff mistakenly removed the wrong part of his brain during an operation he didn’t need. Surgeons removed healthy tissue during the operation instead of the tumour which caused a massive brain haemorrhage.
Blood test results – which were not checked before the biopsy – revealed the tumour was benign and could have been treated with tablets.
Mr Tunney, who worked as a paramedic with West Midlands Ambulance Service for 23 years, has been awarded the seven-figure sum from University Hospitals Coventry and Warwickshire NHS Trust after they admitted liability for the blunder. He was awarded a long service award in 2005 and even went back to work part-time two days a week after he retired the same year.
Mr Tunney, from Sutton Coldfield, West Midlands, had a series of tests in 2008 after he suffered suspected thyroid problems.
Doctors at Good Hope Hospital in Sutton Coldfield performed an MRI scan which revealed abnormalities around his pituitary gland and he was referred to a specialist at Walsgrave Hospital in Coventry.
Mr Tunney, had a blood test to determine his hormone levels but doctors failed to check the results.
Mr Tunney, underwent a biopsy on his pituitary gland on April 29, 2008, but suffered brain damage after the surgeon removed normal tissue instead of the tumour.
Mr Tunney’s wife Pamela, 65, said: ‘Our lives have both been completely devastated by a completely avoidable brain injury. ‘It’s something that we have to deal with every single day of our lives. ‘He gets very frustrated at times that he cannot do the things he once took for granted.
‘I remember how we were initially so thankful that this underlying condition had been spotted early.
‘Before the surgery he was a very easy-going, active person who was always on the go. ‘To see the change in him and to know that it was all entirely avoidable is extremely upsetting.
She said the mistakes was ‘not something that the hospital can just take back.’ ‘I pray that they don’t make this sort of error again and no other family has to experience seeing their husband suffer the pain and loss that John has.
‘John was forever praising the work of doctors, so it was only natural for him to put his complete trust in the surgeon after they told him that he needed urgent brain surgery.
‘It is appalling to think the surgeon managed to botch the procedure completely and then to find that the biopsy wasn’t even necessary makes me incredibly angry.’
The family have recently relocated to South Wales along with some friends who help Pamela with John’s constant care.
University Hospitals Coventry and Warwickshire NHS Trust admitted liability and today apologised to the family.
Meghana Pandit, chief medical officer from Walsgrave Hospital said: ‘I would like to apologise on behalf of UHCW again to Mr Tunney and his family for the complications he suffered as a result of his treatment with us four years ago.
‘While we acknowledge that the financial settlement he has now received can never compensate for his suffering, I do hope that our sincere assurances that organisational learning from his management mean that patients with similar conditions will experience high quality and safe care will be reassuring to him.’
Timothy Deeming, a medical law expert with Irwin Mitchell Solicitors in Birmingham, who represented John, said: ‘The fact that the surgeon managed to remove perfectly healthy tissue rather than a sample of the tumour tissue is, in itself, an appalling error. ‘To then find that the procedure was totally unnecessary because clinicians had failed to review a blood test, really does add insult to injury.
‘The failings of the surgeon involved are so serious that the family is calling on the GMC to investigate his actions.’