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Will there soon be a cure for everything?


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http://news.independent.co.uk/uk/health ... 499590.ece

Breakthrough treatments for conditions from insomnia to cancer and Alzheimer's get closer every day. Jeremy Laurance reports on the pills for tomorrow's ills

Published: 01 May 2007

This is a golden age for cancer drug discovery. More than three decades on from US President Richard Nixon's famous declaration of war against the disease - decades during which progress at times seemed painfully slow - we are finally starting to reap the benefits of the billions of pounds invested in the search for new cures.

Herceptin, the breast cancer drug, is the harbinger of what is to come. It was one of the first "designer" cancer drugs - targeted on a sub-group of women, the 25 per cent with HER-2 positive breast cancer - and halved their risk of recurrence.

A raft of new drugs are awaiting approval or in the final stages of development that could transform cancer care. Professor Karol Sikora of Imperial College, London, says the proportion of patients with cancer who die of the disease could fall from its present level of two thirds to a quarter during the next 20 years.

But as medicine leaps forward, the NHS will struggle to keep up. The drugs in the pipeline will not be cheap. Herceptin costs more than £20,000 a year and patients have gone to court to force Primary Care Trusts to pay for it.

The next generation of cancer drugs may cost even more - up to £100,000 a year. If they can be convincingly shown to extend life or improve its quality, they will generate demand, even if the National Institute for Clinical Excellence (Nice) deems them too expensive for the NHS.

Obesity, smoking, loss of sexual desire and Alzheimer's disease are all targeted by new drugs already licensed, or are about to be, which will find a ready market.

This will create a financial dilemma for the increasingly stretched NHS. If it declines to pay for them - as in some cases it already has - will patients be forced to go without? Or will they be permitted to buy them privately (for those who can afford to) and continue to receive the rest of their care free on the NHS?

The Department of Health says "co-payments" are not permitted. A spokesman said: "You cannot be both an NHS patient and a private patient at the same time. Co-payments would risk creating a two-tier health service and be in direct contravention with the principles and values of the NHS."

Yet the private health insurer Western Provident Association obtained a legal opinion from Nigel Griffin, QC who concluded there was "no bar to a patient buying his own drugs and having them administered as part of a course of NHS treatment." It launched an insurance scheme last week offering NHS patients the right to receive any cancer drug recommended by an oncologist but not yet available on the NHS, in return for a small annual premium. It plans to extend the scheme in the future to include non-cancer drugs unavailable on the NHS.

A court case to test these opposing views cannot be far off.

Cancer

The traditional approach to cancer treatment has been to blast the disease with chemotherapy, drugs so toxic they poison the cancer cells. But chemical warfare causes collateral damage - the drugs poison the healthy cells as well. The task for the cancer specialist has been to adjust the strength of the chemotherapy so it is toxic enough to kill the cancer but not so toxic that it kills the patient.

The new generation of cancer drugs, developed thanks to an understanding of the biology of the disease, are targeted on the molecular structure of the tumour itself. That makes them gentler on the body. They include monoclonal antibodies such as Herceptin and tyrosine kinase inhibitors such as Glivec, for leukaemia, and are more effective and cause fewer side effects.

Tarceva is one of the first drugs in a generation shown to be effective against lung cancer. There are 37,000 new cases of lung cancer a year in Britain and 33,000 deaths. But the drug costs £1,600 a month, or almost £7,000 for a course of treatment. Nice turned it down in March, but promised to review new evidence in nine months' time. It has been approved in Scotland.

Nice also turned down Velcade, the first drug for multiple myeloma, a bone marrow cancer, developed in 10 years, despite acknowledging it extended life and improved its quality in patients. The drug costs £18,000 per patient.

Other drugs in the pipeline include Tykerb for breast cancer and Sutent and Nexavar for kidney cancer, which will also work on a range of more common cancers.

Blindness

Two new drugs, licensed within the past six months, hold out huge promise for the treatment of macular degeneration, the commonest cause of blindness, which affects one in three people before the age of 75. The faster progressing "wet" form - caused by the overgrowth of capillaries at the back of the eye, which start to leak, obscuring the macula in the centre of the retina - affects 27,000 new people a year. Macugen, given by injection directly into the eye, halts the loss of vision in up to half of patients, and Lucentis has been shown to reverse it, improving vision in a third of affected patients and halting the deterioration in most of the rest. Lucentis was hailed as "miraculous" by scientists writing in the New England Journal of Medicine last year, but it costs 100 times as much as the cancer drug, Avastin, from which it is derived and which works just as well, according to eye specialists who have used it. Macugen costs £500 per injection and Lucentis costs £1,000. Avastin, in the tiny quantity needed for injection into the eye, might cost as little as £10. Nice is due to report on Macugen and Lucentis in October but it cannot assess Avastin, as the drug is not licensed to treat blindness.

Alzheimer's disease

The degenerative condition affects 400,000 people in Britain, slowly stripping them of their memory, their cognitive ability and their dignity. Three drugs are claimed to slow its progress, for which there is otherwise no treatment. They were initially approved by Nice, but in a reassessment last year, it ruled that the drugs were not cost effective in the early and late stages of the disease and should only be prescribed on the NHS to those in the moderate stage. The decision provoked outrage among patients groups and the drug manufacturers, who have mounted a legal challenge to get it reversed. The Daily Mail has backed the campaign, claiming the drugs Aricept, Exelon and Reminyl cost "only" £2.50 a day.

The problem with the drugs, says Nice, is that they are of limited effectiveness and only work in some people. Although cheap for each individual patient, they work out expensive for each one that benefits. On that basis, Nice says they cost more than the £30,000 per quality adjusted life year (a measure of health gain). Even when the beneficial impact on carers is taken into account, it doesn't change the calculation. Nice claims that the money would bring greater benefits to patients with dementia if it were spent by health authorities on hiring carers.

Obesity

More than one in five adults is obese and for an increasing number, the only way to lose weight is to pop a pill. Almost one million prescriptions for obesity drugs, such as Reductil (sibutramine) and Xenical (orlistat), are being written by doctors every year. They are likely to increase when Rimonabant (also known as Acomplia), a revolutionary new drug, is considered by Nice later this year. Available on prescription to patients with a body mass index over 30, it costs £55.20 for a month's supply and has been shown to cut 10 per cent of body weight in a year. The drug works by blocking cannabis receptors in the brain and was discovered after researchers decided to investigate why cannabis smokers developed the "munchies". It has also been shown to be effective in helping people give up smoking, giving it a potential role in curbing two of the world's dominant cravings - for food and nicotine.

sex

Men have Viagra - but what about women? For almost a decade there has been no female equivalent, but Intrinsa (right), a testosterone patch billed as the first medically approved treatment for women suffering from low sexual desire, was launched in Britain a month ago. The treatment ran into problems over side effects in the US and has been denied a licence there. Initially, the drug will be restricted to younger women whose ovaries have been removed, for cancer or another reason, and have had an early menopause. Rival drugs still under development include Bremelanotide - a nasal spray said to work on both men and women which creates a stirring in the loins in just 15 minutes. Flibanserin, tested as an antidepressant, was also found to boost sexual desire in women. If either drug reaches the market in a couple of years, purveyors of rhinoceros horn and Spanish fly could be out of a job.

Insomnia

There is an epidemic of sleeplessness in the Western world, driven by the trend to the 24-hour society. Demand for sleeping tablets has soared, creating a market worth more than £2bn a year. At least eight new treatments are in development, says Global Insight. First in the queue is Silenor (chemical name doxepin) made by California-based Somaxon Pharmaceuticals, which is expected to be licensed in the US within months. It will be followed by Gaboxadol (Merck & Co), Eplivanserin (Sanofi-Aventis) and Mirtazepine (Akzo Nobel). These drugs are targeted on sleep receptors in the brain that could help patients get to sleep faster and stay asleep longer than existing treatments. The manufacturers hope to avoid having their products labelled as controlled drugs -

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