Friday, October 23, 2009

British death panel refuses to approve life-extending cancer drug

A drug that can extend the life of women with advanced breast cancer has been turned down for use in the NHS by the cost-effectiveness watchdog. The National Institute for Health and Clinical Excellence (NICE) said it plans to block use of Tykerb (lapatinib) in the Health Service after a second review. The decision comes despite rule changes brought in to let people at the end of their lives have the chance of new and often expensive treatments. It also puts Britain at loggerheads with much of Europe where the drug is given, in combination with a standard chemotherapy drug called capecitabine.

GlaxoSmithKline, Tykerb’s manufacturer, said the latest appraisal would result in 2,000 British women a year being denied access to the treatment. As well as extending life by weeks or months, it has the additional advantage of being taken in pill form.Campaigners have questioned the decision to refuse it. They said the drug met all three conditions: it is used for patients with less than two years’ life expectancy, offers at least three extra months’ life and is licensed for a small number of patients.

Tykerb is the only drug licensed for women with advanced breast cancer for whom Herceptin is no longer working. However NICE said that at £1,600 a month for each patient, plus the added cost of capecitabine, the treatment did not represent a cost-effective use of resources.

Its complicated quality assessment valued the drug at £59,000 per life year — higher than the £30,000 threshold it normally applies, although no specific limit has been stipulated since the rules for end-of-life drugs changed.Nice concluded that the drug “is not recommended for the routine treatment" of women with advanced breast cancer once Herceptin has failed, although they can be given it in clinical trials. The appraisal is now open to consultation.

The treatment came to public attention after Jane Tomlinson, the charity fundraiser, became one of hundreds of British women to benefit from the programme. She died in 2007 at the age of 43.

Mike Tomlinson, her widower, condemned the ban when it was first proposed earlier this year, saying Nice had failed the “acid test” on being more flexible with life-extending drugs to terminally ill patients.

One of Nice’s reservations concerns the amount of extra life that Tyverb offers women. The evidence from trials suggested they lived for an extra 2.4 months on average. Under the new end-of-life rules, a drug should normally give an extra three months survival.

Gillian Leng, Nice’s deputy chief executive, said: “The appraisal committee considered the updated economic evaluation presented by the manufacturer but was not persuaded that the adjusted estimates of overall survival presented were robust. “The committee therefore concluded lapatinib is not a cost-effective use of NHS resources.”


NHS finally decides to treat the elderly as human beings -- in theory, anyway

Ageism in the NHS, which turns elderly patients into second-class citizens, is to be outlawed. Health Secretary Andy Burnham says all patients - whether 20 or beyond 80 - deserve the same care and attention.

Today's announcement follows alarming new evidence that older people are far less likely to receive a proper diagnosis and essential treatment. Many elderly patients miss out on the scans, drugs and even basic health advice routinely given to the young. Some doctors decide it is simply not worth the bother once patients pass a certain age.

But Mr Burnham told the Daily Mail: 'I have decided it will become illegal for any difference to be made on age grounds. That's quite a big undertaking. 'People in the NHS don't set out to make hard and fast rules that lead to older people getting inferior care. 'But it's perhaps judgments that are made and decisions that are made. 'As we live longer we are having to reassess some of our attitudes to ageing. 'We are saying there shouldn't be an age differential. We should have the highest aspirations for everybody.'

Ministers had been heavily criticised for not including the NHS and social care in the general age discrimination law due to come into force in 2012. But Mr Burnham said the Health Service's own age discrimination ban will now apply at the same time.

Earlier this year, a survey found that almost half of all doctors caring for older patients believe the NHS is 'institutionally ageist'. As many as seven out of ten specialists say the elderly are more likely to struggle to get conditions diagnosed than younger patients. Research suggests two-thirds of those with dementia are never diagnosed - at least in part because their symptoms are dismissed as an inevitable consequence of old age.

Those with easily identifiable conditions fare no better. Younger stroke patients are five times more likely to receive an MRI scan to check for bleeding in the brain than older patients. In other cases, the elderly have not received heart treatments, including clot-busting drugs, that are given to the young without question. There is also enormous concern about poorer provision of mental health services for older patients.

And a study of 9,000 older adults last year - half of whom had serious medical conditions - found many were not getting basic care for conditions such as osteoarthritis, incontinence and osteoporosis.

Ministers initially resisted a blanket ban on NHS age discrimination because of concerns over the cost implications and suggestions it could even have the perverse effect of allowing hospitals to stop some treatments targeted at the elderly alone. Mr Burnham said: 'There has been some progress in improving services for older people. 'But there are some cultural issues that we have to address. The costs are manageable. It's also morally the right thing to do. 'It says something about what kind of country we are, how we look after our oldest people.'

Having NHS age discrimination banned by law means those who believe they are victims will be able to mount challenges in the courts.

Mr Burnham said some NHS services should be exempt from the ban, where there is clear evidence that they need to be targeted at particular age groups. These are likely to include vaccination programmes, screening and IVF treatment. And doctors will still be able to deny treatment on clinical grounds - for instance, if they decide an elderly patient is too frail to safely have surgery.

'The NHS does often provide services on an age basis - a good example being the swine flu vaccine,' he said. 'We do often have recommended age groups and priorities. 'There's flexibility that's needed here so the NHS can target particular groups.


British Boy, 10, dies of meningitis after being wrongly diagnosed with a migraine... despite mother insisting he had killer disease

Careless government doctors looked at only one symptom in complete isolation from the overall condition of the boy. They should be shot

A boy of 10 died from meningitis after doctors wrongly diagnosed a migraine and told his mother to give him calpol, an inquest was told yesterday. William Cressey saw five doctors in three days before finally suffering 'catastrophic' brain damage. His mother, Cheryl, 48, repeatedly told doctors that she suspected meningitis but each time was ignored, she said.

Just hours before he died the schoolboy begged one of those doctors: 'Please help me. I'm going to die.' By then his face was so swollen that he could barely see and he was drifting in and out of consciousness.

Wiping tears from her face Mrs Cressey, a former statistician, told the hearing: 'They wouldn't accept that he had a serious illness. 'They just wouldn't consider meningitis as a possibility. They told me he had a migraine, but he was far too ill for that. 'The deterioration in his health was so sudden and the change so marked that I knew it had to be something very serious. 'I wanted them to investigate and eliminate it as a precaution...but they were adamant that it wasn't meningitis and that was the end of it. 'He was dying and they told me to take him home and stop off at the shops on the way for some calpol.'

The schoolboy fell ill at home in Darlington, County Durham, on Friday, February 25, 2005, the inquest was told. He was complaining of a headache, was feeling sick and had a high temperature. On the Sunday his condition deteriorated and he suddenly 'screamed' out in pain. He put his hands to his head and to the back of his neck and turned 'scarlet red', his mother said.

Miss Cressey, who is divorced from William's father, rang the out of hours GP service and was told to get him to the nearest hospital as soon as possible. She immediately drove to Darlington's Memorial Hospital and was quickly taken into a cubicle within its Accident and Emergncy unit. 'By the time we got there swelling had developed on his face, he was shaking and burning up,' she told the hearing. 'He was sweating, yet his hands and feet were cold. He started complaining of pain in his stomach and legs. 'I told the doctor that I was concerned it was meningitis. I had never seen William become so poorly so quickly.

'The doctor pulled William's pyjama legs up to check for a rash. He told me it wasn't meningitis and that he had a migraine. 'They wouldn't acknowledge that meningitis was a possibility. They dismissed it right from the beginning. 'I asked for blood tests to be carried out and antibiotics to be given to him as a precaution but it was just dismissed. 'The doctor told me to take him home and let him sleep off the migraine.'

Miss Cressey refused to leave and insisted that he be admitted to the children's ward at the hospital. That night his condition worsened. His temperature rose to 38.7C and he began vomiting violently. William was examined by a second doctor who looked at his shins and stomach and said there was no sign of a rash. Miss Cressey again asked for blood tests but was refused. 'She said he had a migraine and that was it,' she told Newcastle Coroners Court.

'The swelling had spread right across his face and his eyes were so swollen that he could hardly blink. 'I kept going back and asking somebody to come and look at him. The nurses wouldn't come. They rolled their eyes at me and turned their backs on me. 'They just didn't want to know.' He was seen by a third doctor on Monday morning but later that day they decided to discharge him.

'I had no choice,' added Miss Cressey, who was refused a second opinion. 'They had decided that he was alright and he was going home and whatever I said they wouldn't change their view. 'I thought (they) were going to help him. I kept going back and asking for somebody to come and look at him. 'I wish I had taken him somewhere else.'

William was discharged but minutes after returning home collapsed. Mrs Cressey returned to the hospital immediately and William was examined by two further doctors. But a few hours later, in the early hours of Tuesday March 1, he suffered a massive seizure which rendered him brain dead.

'I see it every day and every night of my life,' said Miss Cressey. 'I know what they did. They left him until it was too late.' He was transferred to Newcastle General Hospital where further tests confirmed that he was suffering from a rare form of meningitis and would not survive. His heartbroken mother turned off his life support machine.


The folly of work-based health insurance

Wife’s cancer prompts man to enlist in the army to get coverage. In Australia, your employer knows nothing about your health insurance. ALL health insurance is directly between the person and the insurer and is much more affordable than in the USA -- in part because you are more cost-conscious when you are paying for something yourself. And Australian private medicine is as good as any

Chelsea Caudle began signing her text messages this summer with a countdown. At 14 years old, she knew no better way to express what was coming. Day Zero was to be Oct. 7, the day Dad left for Army basic training in Fort Jackson, S.C. He was moving 950 miles from their home in Watertown, 950 miles from Mom.

He was leaving, even though Mom was sick with ovarian cancer. Even though he had been at her side through two long, miserable rounds of chemotherapy. Even though she now faced the likelihood of a third.

In fact, Dad was leaving because Mom was sick. In March, he was laid off from his job as a raw materials coordinator for a plastics company called PolyOne, where he'd worked for 20 years. His severance package had provided several months' salary, but by August the paychecks were winding down. Soon the cost of his family health coverage was going to triple, then a few months after that, nearly triple again. They needed coverage so Mom could fight her cancer. Dad's solution: a four-year hitch in the Army.

Mom and Dad are Michelle and Bill Caudle, high school sweethearts now 40 and 39, respectively. They have three children: Chelsea, the youngest; Alysha, a 21-year-old working at a nearby Holiday Inn; and Little Bill, an 18-year-old ex-high school wrestler.

The Caudles are not fond of politics. Michelle and Bill have paid little attention to the shouting this summer over health care reform. They have not gone to any of the town hall meetings. They are well aware that politicians and interest groups would like to trumpet their story or dismiss it to score points in the debate - and they would just as soon avoid all of that.

"We're not activists," Michelle said. But this year the national story of lost jobs became their story. And the saga of families losing health insurance was about to become theirs, too. Except that Bill wouldn't let it.

True, he had been interested in the Army for years. And he could always request an emergency leave to come home if Michelle's condition grew dire (Army regulations allow this if a family member's death is imminent).

But for weeks before enlisting, Bill had sought other options. He revised his résumé. He answered "help wanted" ads, then watched the companies cut workers instead of hiring them. He interviewed for one job that would have paid $13 an hour - less than half of what he was making at PolyOne. He didn't get the job. Finally, on May 13, his 39th birthday, he signed the Army papers.

Two weeks later, Michelle Caudle sat in the office of her doctor, Peter Johnson, at Aurora Women's Pavilion in West Allis. Johnson has been an oncologist for 13 years, and despite the immeasurable sorrow that comes with treating cancer, he loves the work for the hope in it. He has shared the joy of patients who've lived to see birthdays, anniversaries, and the graduations and weddings of their children.

On this particular day, Michelle's latest tests had come back. Just six months earlier she'd celebrated the end of her second chemotherapy treatment. Now, the tests revealed tiny "spots," or changes on her abdomen, neck and lungs. Not a good sign. The measure upon which cancer hopes rise and fall, the CA125 number - Please, let it stay low - was climbing.

"I could lie to you but I'm not going to," Johnson told Michelle. Although he could not say for certain the cancer was back, this early sign pointed to that possibility. The doctor compared her cancer to a chronic disease that would never be completely vanquished from the body. Michelle broke down. For three years she'd been nurturing her hope in the face of uncertainty. "I'm not going to beat this," she said.

More here

Bridge for sale, going cheap: Dem bill with public option said to REDUCE deficit

A preliminary estimate from the Congressional Budget Office projects that the House Democrats' health care plan that includes a public option would cost $871 billion over 10 years, according to two Democratic sources. CBO also found that the Democrats' bill reduces the deficit in the first 10 years.

This new CBO estimate, which aides caution is not final, is significantly less than the $1.1 trillion price tag of the original House bill that passed out of three committees this summer. More importantly, it comes under the $900 billion cap set by President Obama in his joint address to Congress last month.

CBO analyzed what House Speaker Nancy Pelosi calls a "more robust" public option -- one that ties reimbursement rates for doctors to current Medicare rates, plus a 5 percent increase.

At a meeting with House Democrats on Tuesday night, Pelosi did not release CBO's preliminary numbers, but told members that CBO told leaders the House bill would cost well below $900 billion. Aides say final CBO numbers could be released on Wednesday.

Senior Democratic aides told CNN that House Democratic leaders are likely to put this version of the public option favored by liberal Democrats in the final bill they are drafting. While no final decision has been made, on Tuesday night Speaker Pelosi made the case to House Democrats that this approach saves the most money and would put the House in a better negotiating position when it comes time to negotiate a final health care bill with the Senate.

Pelosi instructed House Democratic Whip Jim Clyburn, D-South Carolina, to begin canvassing all House Democrats on Wednesday to determine whether this bill had enough votes to pass in the House. According to several sources in the meeting, Pelosi acknowledged she did not currently have the 218 votes needed to pass this version on the House floor, but believed she was close to having around 200 votes.

Moderate, "blue dog" Democrats in the House largely oppose the robust public option and instead argue for a government run insurance option that could negotiate reimbursement rates directly with doctors and hospitals. CBO's analysis of that approach was not available according to Democratic sources, but aides say the preliminary analysis shows it does not save as much as the approach pushed by Pelosi.


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