Saturday, January 24, 2009

British cancer victim confronts drugs chiefs

Nothing can hasten the glacial pace of bureaucracy

Seventy-year old David Basey is planning to spend his life savings on a drug that could give him a few months of extra life - in the hope that the NHS will step in before it is too late. And yesterday, he and his wife confronted the group which makes drugs decisions for the NHS to ask why it has taken so long to make up its mind on four life-extending drugs for advanced kidney cancer. Mr and Mrs Basey, from Gorleston, went to the public question time held by the National Institute of Health and Clinical Excellence (Nice), the independent body which provides national health guidance.

The retired bricklayer and electricity board worker was diagnosed last February and was given one to two years to live. He has had his kidney removed but the cancer has spread to his spine. His only hope is one of the latest cancer drugs, Sutent, which could double his life expectancy and his time with his wife Ann, to whom he has been married less than a year.

But the drug is not recommended for use on the NHS apart from exceptional cases. Nice is reviewing its guidance and met to make a decision last week, but will not publish it until late March. Until then, Mr Basey has decided to spend his life savings on the 3,000 pounds-a-month drugs in the hope that the NHS will pay for them before his money runs out.

Mrs Basey, 60, asked Nice bosses why there had been such a delay - and chief executive Andrew Dillon admitted that they should have started the process much earlier. She asked: "Bearing in mind that the process has already taken years, can you tell me why there is such a delay between the meeting last week and the announcement in March? Do you realise how many kidney cancer patients are dying for the want of these drugs, or are spending their savings in the hope that it will help them? If the drugs are approved, why do PCTs [primary care trusts] then have three months to implement that guidance?"

Mr Dillon said: "We started work on assessing these drugs far too late. The guilty parties there are Nice and the Department of Health." He said that, once work started, committees had to look at all the evidence, hold a consultation, and look at new evidence. Primary care trusts are given three months to help with financial planning, although some are ready to implement it more quickly. He added: "I know it is tedious, and not just tedious, but distressing. I do sympathise with you."

Nice has been looking at Sutent, Nexavar, Torisel and Avastin since 2007. The drugs could help up to 1,700 people in Britain with advanced kidney cancer each year. It is due to publish its guidance, or final appraisal determination (FAD), in late February, followed by a 28-day chance to appeal, so if there is no appeal it will become official in March. But its new guidance on end-of-life treatments, which was published earlier this month, said it can only publish an appraisal consultation document - in which case the wait will last much longer.

Mr Basey said: "Sutent might double my lifespan. We can afford to pay for it until June and I hope by then the guidance will have changed. I hope something in medicine will come along in the time I have got left. That is my only hope."

Ian Small, deputy head of prescribing for NHS Norfolk, said: "NHS Norfolk welcomes definitive answers on the funding of drugs by Nice. This means that NHS Norfolk would pay for a drug, should it be recommended clinically appropriate for a patient by their consultant. "Nice gives guidance to all primary care trusts to say that processes should be in place to be able to prescribe to appropriate patients within a three-month window and NHS Norfolk would work in line with this."

Fellow kidney cancer sufferer Alan Martin, from Lowestoft, has been campaigning for Sutent to be widely available on the NHS. And David Blackett, from Attleborough, is one of the few to receive Sutent on the NHS as an "exceptional case" after battling to receive it.

Also at the meeting, held at the Norfolk and Norwich University Hospital, was Deborah Browne, the chairman of the N&N's drugs and therapeutics committee. She asked why there had to be a gap between the FAD and the guidance becoming official. She said afterwards: "Once the FAD is published, the patients' expectation is that it will be available. The patients are kept in limbo. That is difficult, when there is a whole group of patients that are waiting."


A small victory for openness in Britain

Gordon Brown performed a swift U-turn over government plans to block the publication of MPs expenses yesterday. The Prime Minister told the Commons that the plans to amend Freedom of Information laws to exempt MPs expenses would be abandoned. The House had been due to vote on the measures today, with Labour MPs under a three line whip to vote in favour. But Mr Brown said yesterday that the lack of cross-party support meant a vote would no longer held tomorrow and the issue would be reviewed further.

Speaking at Prime Minister's Questions, he blamed the Tories for withdrawing their support from the controversial move and leaving the Government isolated, a charge that David Cameron, the Conservative leader, denied. "We thought we had agreement on the Freedom of Information Act as part of this wider package," he said. "Recently that support that we believed we had from the main opposition party was withdrawn. "So on this particular matter, I believe all-party support is important and we will continue to consult on that matter." Mr Brown made the announcement in response to a question from Douglas Carswell, the Tory MP, who asked why he was whipping the MPs to pass the matter.

The Conservatives denied, however, that there had been any "trickery", with the Shadow Leader of the House Alan Duncan saying that the party had rejected the moves on principle. "What was wrong with this is that Parliament made the law, the law included Parliament in it and now we're looking backwards and saying 'Oops, we don't like it'," he said. Mr Cameron later issued a statement welcoming the Government's "embarrassing U-turn". "To exempt MPs from the FOI Act would be completely wrong. They should be treated the same as everybody else," he said. "The public demand and deserve greater transparency from their politicians and this would have been a step in the wrong direction. "This is about the simple principle that MPs are given taxpayers' money to help them represent voters. Taxpayers struggling to get by in this recession surely have a right to know how their money is going to be spent."

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There were Greenies in the 19th century too

And they were just as elitist

Environmentalism is the social movement of the "landed interest" - an interest parallel to that of neither business nor labour. "Environmentalism" is readily identifiable in early 19th century Britain. This essay draws from the best-known writings of the era's three most influential intellectuals for a portrait of an anti-democratic, anti-liberal social movement based in the aristocracy but claiming to represent the masses; a movement permeated with the ideas of over-population theorist T. Malthus; a movement benefitting from restricting land supply and suffering from advancing agricultural technology; that fought a cultural civil war using literary Romanticism and monkish asceticism; that was militantly protectionist regarding agriculture; that constrained industrial progress and spread fear of catastrophe.

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$2-a-day anti-obesity pill is going on sale in Britain without prescription

A one pound-a-day pill that can help a woman rapidly drop a dress size could be sold over the counter within months. The drug, called alli, prevents the body from absorbing fat in food and helped slimmers lose an average of 10lb over six months in trials. It has been given the seal of approval by Europe's medicines watchdog and is expected to be available in pharmacies before the summer. Manufacturer GlaxoSmithKline last night described the licensing of the drug, the first of its kind to be available without prescription, as 'a significant milestone'.

In trials, slimmers who took a tablet with every meal typically lost 50 per cent more weight than those who relied on willpower. The 10lb average weight loss after six months is the equivalent of a dress size. But some dieters lost more than five stone.

However the pills do have side-effects. The undigested fat which can't be absorbed passes through the body rather than being stored, making slimmers prone to wind and diarrhoea. Alli can also interfere with the absorption of some vitamins and slimmers are advised to supplement their diet with a daily multi-vitamin pill. The drug, a half-strength version of the prescription-only diet pill Xenical, will be available to those with a body mass index of 28 and over. A BMI of 25 to 29.9 signals that someone is overweight, while those over 30 are classified as obese.

Sales of the drug, which is likely to be displayed behind chemists' counters, totalled œ400million in the U.S. in its first year. Its price is yet to be fixed, but in the U.S., where it has been on sale for over a year, it costs around œ1 a day. Glaxo has stressed that the pill, taken three times a day, is designed to enhance rather than replace the benefits of diet and exercise.

Dr David Haslam, chairman of the National Obesity Forum, said: 'Consumers are spending millions of pounds each year on fad diets, unproven "miracle pills" and potentially unsafe weight loss supplements. 'Medically proven licensed products give consumers the option of something which can genuinely support meaningful weight loss.'

Some, however, have questioned how well the drug will work away from trial conditions. Gareth Williams, editor of the book Obesity: Science to Practice, suggests that a healthier lifestyle would be just as effective. He said: 'Don't eat between meals, leave out food that's obviously full of fat or sugar and get half an hour's walking exercise a day. That's all you need to do.'


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