Tuesday, December 15, 2009

Drug denial hits victims of leukaemia in England

Leukaemia sufferers in England will be denied potentially life-saving drugs freely available in Scotland. The proposal to ban English patients from getting the medication on the NHS has been branded 'stupid and heartless'.

Doctors and campaigners say the Government rationing body's measures will worsen the postcode lottery, with patients north of the border able to get dasatinib and nilotinib that could add years to their lives.

The preliminary guidance from the National Institute for Health and Clinical Excellence affects patients with chronic myeloid leukaemia. Although the drugs cost £30,000 a year, only a maximum of 300 patients a year are likely to need them. They have failed to respond to treatment with another drug, called Glivec, or become resistant to it.

Professor John Goldman, a specialist at Hammersmith Hospital, in West London, said it was 'a stupid and unjustified decision'. Calling for a rethink, Tony Gavin, of Leukaemia CARE, said: 'Nice's decision is very bad news because there is no acceptable alternative.'

Professor Peter Littlejohns, of NICE, said the evidence presented was 'extremely poor' and the costly drugs were not 'an appropriate use of resources'.


Gamma Knife: a life-and-death lottery for British brain tumour patients

Too many British brain tumour patients are denied state-of-the-art treament that could extend their lives by years

Sally-Anne Wright, a sales manager who lives with her husband and two daughters in Redhill, Surrey, knew something was seriously wrong when she woke up one morning in March to find she had lost all feeling on the right side of her face. "I couldn't feel my nose run, taste anything on the right side of my mouth, or even feel the earring in my right ear," she recalls.

Sally-Anne, 48, went straight to her GP, and was referred to a local ear, nose and throat specialist. "I have medical insurance through my work, so I was able to have a private CAT scan," she says. "A week later, I was told that I had a golf-ball-sized tumour in the middle of my brain. It was a benign, slow-growing meningioma and was pressing on the trigeminal nerve, which controls sensation in the face, and this was what had caused the numbness.

"The tumour was deep, and I was told that removing it surgically would damage healthy tissue. Surgery could also cause terrible complications, such as epilepsy and loss of function on my right side. Instead, my neurosurgeon recommended a non-invasive treatment called Gamma Knife."

Sally-Anne had never heard of Gamma Knife, but she did some research on the internet and discovered that it was a state-of-the art procedure, also known as stereotactic radio-surgery, which uses a single dose of highly focused radiation, designed to destroy only the tumour and leave the surrounding healthy tissue undamaged. It can be used to treat brain tumours (often secondaries which have spread from primary breast cancers, for examople), and conditions such as arteriovenous malformation, a problem affecting the blood vessels in the brain.

Sally-Anne decided it was her best option. "My job involves a lot of driving and if I'd undergone surgery, it could have taken a year to recuperate." In October, she was treated at the BMI Thornbury Hospital in Sheffield, which has a 92 per cent success rate in using a Gamma Knife on this type of tumour.

The procedure was carried out by Mr Andras Kemeny, a pioneer of the treatment, and involved a special frame being attached by pins to the skull under local anaesthetic. The Gamma Knife itself is a semicircular, helmet-like structure containing around 200 sources of radioactive cobalt.

An MRI scan performed while the frame is attached serves as a "road map" for immobilising the patient's head in the helmet. Although each beam causes no damage to the tissue en route, when they all meet at the target, the resulting dose destroys the tumour. The one-off treatment lasts about an hour and most patients leave hospital with only minor side-effects such as a headache.

Sally-Anne's operation was a success, and she went home the next day. "I felt a bit tired and headachy and my face was slightly swollen, but within hours I felt perfectly well and I was driving three days later. I have regular checks, but Mr Kemeny says that it's unlikely to cause any more problems. It's great to come through this unscathed."

Sally-Anne is one of the lucky ones. Though Gamma Knife technology is not new (it was developed in 1967 and has been refined and improved ever since), access to this treatment is limited. There are five Gamma Knife centres in the UK: one at the Leeds General Infirmary, two in Sheffield, at the Royal Hallamshire and BMI Thornbury hospitals, and two in London, at the Cromwell and St Bart's. They are used to treat about 1,500 people each year. However, many cancer specialists, including Professor Christer Lindquist at the Cromwell Hopspital in London and Mr Andras Keneny at the Hallamshire and BMI Thornbury hospitals in Sheffield, believe that thousands more patients are being denied treatment, which could save or extend their lives, because of a shortage of knives and stringent NHS criteria determining who gets access to it.

All Gamma Knife treatment must be approved by a patient's local Primary Care Trust, and the criteria by which PCTs decide who will be approved for funding is set by one of 10 Specialised Commissioning Groups covering different areas of the country. Some take a harder line than others. Patients in Devon are far more likely to be approved than those in parts of Derbyshire and Yorkshire. Some people refused treatment on the NHS, choose to pay for the £17,000-plus cost, often incurring large debts, rather than undergoing surgery.

The only alternative is Whole Brain Radio-Therapy (WBRT), a treatment most often used on large tumours. WBRT involves delivering daily doses of radiation over three weeks. It is far less precise than Gamma Knife and can cause sickness and hair loss. It also damages normal cells along with cancerous ones, and may cause severe side-effects, such as dementia and loss of movement.

Although a single Gamma Knife treatment costs considerably more than the estimated £1,500 for a three-week course of WBRT, most neurosurgeons acknowledge that the enhanced quality of life and savings on nursing care more than compensate for the expense. "Gamma Knife treatments are highly effective," says Prof Lindquist. "It is more like surgery than Whole Brain Radio-Therapy and is very focused on the tumour.

"Some of our breast-cancer patients can live many years if their secondaries elsewhere are well controlled, but if we don't treat the brain tumours the patients often die within months. Our longest surviving patient has kept going for 19 years after treatment for melanoma (skin cancer). Another Gamma Knife patient with breast cancer has survived 10 years, despite being given six months to live in 1999 when 10 brain tumours were discovered. "With the incidence of cancer on the rise, we certainly need more Gamma Knives; probably double the five we have at the moment."

But funding is not the only issue, according to a Specialised Services Commissioner, who asked to remain anonymous. "Cost is not a major factor," he says. "We have nationally agreed criteria governing who should get the treatment. All people who are suitable, and meet the criteria, are routinely funded and receive their treatment. The apparent differences in treatment provision are down to individual Specialised Commissioning Groups. Work has been in progress for some time, co-ordinated at a national level, to consider any new evidence that has emerged since those criteria were introduced, and if necessary the specifications will be revised, probably within the next few months."

Despite this hint at a change of heart, Sally-Anne's surgeon, Mr Kemeny, remains frustrated at the bureaucracy involved in getting the NHS to pay for treatment. "Each PCT comes up with its own set of rules, based on finance, justified by their reading of the medical literature. If you have two brain metastases and live in Derbyshire, you cannot have Gamma Knife on the NHS, even if it is your only option, because all else has been tried, whereas you may have four treated if you are referred from London or the South West. It is a total lottery.

"More Gamma Knives would not help if we are not allowed to treat those patients who are suitable. In spite of a positive assessment by all the doctors involved, one has to fill in endless, different forms for each patient, jumping through hoops, trying to prove "exceptionality" when the treatment is standard around the world," he says. "It is incredibly sad to see a young woman with small children denied the opportunity of living another few years with good quality of life when, without this treatment, the alternative is death."

Eileen O'Grady, 68, from Bolton, felt almost suicidal after suffering from trigeminal neuralgia (severe pain in her face) for nearly a decade. "It was excruciating" she said. "l couldn't chew, walk or even touch my face. Drugs had no effect, and I wasn't suitable for surgery. In July, my neurosurgeon recommended Gamma Knife treatment on the NHS at the Royal Hallamshire Hospital in Sheffield. It took just half an hour and I came home at once. I can't believe the difference: no pain for the first time in years, and I haven't had a tablet since coming out of hospital. Everyone says I look totally different because I've got my life back."

Jane, 42, a housewife from Nottingham, who requested anonymity to protect her children, was diagnosed with breast cancer eight years ago. She had two sons under four years old. She developed a brain tumour in 2005, which was treated with Whole Brain Radio-Therapy and removed surgically, which has left her with memory loss. Another small brain tumour appeared two years later and, in September 2008, Jane was referred for Gamma Knife treatment, and was the first patient to be treated by Mr Andras Kemeny at the BMI Thornbury in Sheffield.

"It was amazing," she said. "It took just half an hour and was quite painless. I've had two scans since and there's been no recurrence. I'm now 42 and to still be here eight years after that first diagnosis is fantastic. My sons are now 10 and 12. Each year is a milestone I never thought I'd see. At the time, it broke my heart to see the boys asleep in bed. I was terrified I wouldn't be around for their next birthday. We have medical insurance, but it seems so wrong that, with this amazing facility available, the recommending committees don't let specialists treat more people who would benefit like me."


Australia: Ham-fisted medical bureaucrats again

You sometimes wonder if they are human beings. They are about as subtle as a punch in the head. Paperwork trumps people. And they are not backing down. The only people they don't bother are the crooks

EMINENT doctors - including prominent pro-RAH crusader Jim Katsaros - have been threatened with suspension unless they prove they are qualified. The demand for proof comes as the Health Department belatedly moves to ensure doctors employed in the public system are qualified. The move comes in the wake of the Queensland scandal in which former Bundaberg Hospital surgeon Dr Jayant Patel faces three charges of manslaughter and two of grievous bodily harm, as well as 387 claims for compensation. [All of which happened years ago]

SA Health Minister John Hill declined to answer whether he could guarantee every doctor in the health system was qualified. Public hospital specialists have been sent letters demanding they produce a certified copy of their primary medical degree, certified copy of post-graduate qualifications and a copy of their curriculum vitae. Surgeons with decades of service have baulked at the demand that they dismantle their framed medical degrees, firmly attached to their office walls, to show bureaucrats they are qualified.

Dr Katsaros, the RAH's head of plastic and reconstructive surgery, has written back objecting to the "wasteful and time-consuming" demand, and invited officials to view his degrees in his office where they are "framed and glued to a wall". During the week he was given a curt written warning by RAH general manager Lindsay Gough saying he would be suspended unless he produced the documents within two weeks. [Bluff! He would be in deep do-do if he fired essential medical staff]

Dr Katsaros, who has worked at the RAH since 1968 and is chairman of the Save the RAH committee, said it was "bureaucracy gone mad". "You have bureaucrats sitting in their ivory towers, who never come into hospital wards to see what happens with patients, trying to justify their existence," he said. "We have patients lying in corridors, waiting lists that have blown out, medical staff juggling the workload and these turkeys come up with this blunderbuss approach to belatedly see if the people they have employed are actually doctors. "We work our butts off in the public system because we care about patients and we want to teach the younger generation coming through, and while we are dealing with the reality of health care the bureaucrats want me to dismantle my degrees off my wall to show I really am a doctor."

Director of ear, nose and throat surgery at the RAH, Dr Suren Krishnan - who has been employed at the hospital since 1982 and is a past president of the Australian and New Zealand Head and Neck Society - is similarly livid. "Some patients are waiting 12 months to see me here - I am too busy looking after patients to deal with over-the-top big brother policies of the Health Department," he said. "When someone applies for a job there should be a duty of care to present their Medical Board credentials - surely they can check that by computer or a phone call rather than a bureaucrat demanding we bring in our degrees. "It shows how divorced they are from the coalface of patient care; we're dealing with waiting lists that are out of control and our focus is on patient care. "Then we get this officious letter that has offended quite a number of doctors."

In response to questions from the Sunday Mail , Mr Hill's office provided a statement saying all doctors appointed to specialist positions across SA public hospitals were now required to produce original certificates for their basic and specialist qualifications in the wake of the Patel scandal. "This credentialling reflects national standards, and health systems across Australia are adopting these more rigorous checks," the statement said. "The tighter checks are aimed at protecting the community, and ensuring that doctors are properly credentialled to provide surgery in SA hospitals."

SA Chief Medical Officer Professor Paddy Phillips said the new policy was fundamental to ensuring people working as doctors had relevant qualifications. "It is mandatory for all medical staff employed within SA Health; it is the foundation of safety and quality in our hospitals," he said.


ObamaCare Starts to Show Cracks, Update: Lieberman Tell Reid to his Face: Nyet

The New York Times is reporting:
“In a surprise setback for Democratic leaders, Senator Joseph I. Lieberman, independent of Connecticut, said on Sunday that he would vote against the health care legislation in its current form.”

And on the issue of abortion, the New York Times was equally shocked by Senator Nelson:
“On a separate issue, Mr. Reid tried over the weekend to concoct a compromise on abortion that would induce Senator Ben Nelson, Democrat of Nebraska, to vote for the bill. Mr. Nelson opposes abortion. Any provision that satisfies him risks alienating supporters of abortion rights.”

Meanwhile, this just in from the Huffington Post, Senator Lieberman told Senator Reid to his face this morning that he will vote against the Reid vapor deal:
“Senator Joseph Lieberman (I-Conn.) informed Senate Majority Leader Harry Reid (D-Nev.) in a face-to-face meeting on Sunday that he will vote against a health care bill that includes a public option or a provision that would expand Medicare, a Democrat Senate aide tells the Huffington Post.

The two Senators had a discussion in Reid’s office shortly after Lieberman appeared on CBS’s Face the Nation Sunday morning. The Connecticut Independent discussed with Reid some of his concerns about the legislation, elaborating on issues he had raised during the show. According to the source, who was briefed on the exchange, Lieberman punctuated the discussion by telling the majority leader directly that he would vote against the bill if the Medicare buy-in and public option provisions remained in it.”

Here is what Senator Lieberman and Senator Nelson said on Face the Nation, via the Weekly Standard:

“On Face The Nation, Sens. Joe Lieberman and Ben Nelson made it pretty clear they weren’t inclined to support the Reid “compromise” featuring a Medicare buy-in. Nelson said he thought such a buy-in is a bad idea, and Lieberman noted that on “the so-called Medicare buy-in — the opposition to it has been growing as the week has gone on. Though I don’t know exactly what’s in it, from what I hear I certainly would have a hard time voting for it because it has some of the same infirmities that the public option did.”
From Robert Costa, in the Corner:
“All of the king’s horses and all of the king’s men may not be able to put 60 together again,” says [Senator] Alexander, in reference to the (barely) 60 votes Reid got last month to bring his bill to the floor. “With two weeks until Christmas, Democrats find themselves in the awkward position of trying to pass a 2,000-page bill — a bill which most of them admit they don’t know much about.”

“Alexander cites the new report from the chief actuary for the Centers for Medicare and Medicaid Services (CMS) as a potential death blow to Reid’s cause. The CMS, a division of the Department of Health and Human Services, says that if Reid’s bill became law, America would spend $234 billion more on health care over the next decade.

“Add the CMS report to the Mayo Clinic’s devastating letter against the expansion of Medicare, as well as the opposition of the American Medical Association and hospitals to Reid’s Medicare idea, and it’s clear that the more people find out about this, the less they like it,” says Alexander. “I’m not ready to make a prediction (on whether it will fail), but things aren’t looking good for the majority leader.”

Given Senator Bill Nelson’s (D-Fla) statement on FOX News that the Reid Vapor Deal is a “non-starter,” and the fact that Senator Snowe has said she does not support it, and Senator Lieberman never has supported it, and the only public statements he has made have been to cast doubt about the idea’s viability; and that Senator Nelson has now publicly stated that he cannot vote to end the filibuster if the abortion restrictions he supports are not in the bill — it appears that the ObamaCare implosion is imminent.

ObamaCare is a political failure. Its political failure will lead to its legislative failure. It is just a matter of when.


A Hundred Billion Here, A Hundred Billion There...

The New York Times reported today that the Democrats “hit a rough patch Friday in their push for sweeping health care legislation” when “a top Medicare official” declared that their proposal would raise, not lower, health care costs.

The Medicare official ... said that total national health spending would increase slightly as a result of the Senate bill, put together by the majority leader, Harry Reid, Democrat of Nevada. President Obama has repeatedly said that one of his top goals is to slow the growth of health costs.

Richard S. Foster, the chief actuary of the federal Centers for Medicare and Medicaid Services, said Friday that under Mr. Reid’s bill national health spending from 2010 to 2019 would total $35.5 trillion. That is $234 billion, or 0.7 percent, more than the amount projected under current law, he added.

So, in the Times’s telling $234 billion is only a slight increase. How much additional spending, I wonder, is required for the Times to regard an increase as un-slight.


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