Newshound
for meningioma and brain tumour news
Drug approval for NHS to speed up

The government is to set out plans to speed approval of drugs used in the NHS in England, Wales and Northern Ireland.

From BBC News Online: The National Institute of Health and Clinical Excellence (NICE) can take up to two years to make a decision but ministers want this cut to six months. Patients will have their legal rights to drugs recommended by NICE laid out in the NHS constitution to tackle the "postcode lottery". And health trusts will no longer be able to refuse drugs on cost alone.

The draft version of the constitution is expected to set out what patients and staff are entitled to from the NHS. This includes "fundamental principles" such as universal access to healthcare and drugs and treatments approved by NICE.
'Postcode lottery'
In Scotland, the equivalent role of NICE in approving drugs is undertaken for the Scottish NHS by the Scottish Medicines Consortium (SMC). The decision-making process is devolved from that in England, Wales and Northern Ireland and the SMC does not always make the same decisions as NICE on which drugs should be made available. The approval process in Scotland has proved to be quicker due to three-month targets for initial decisions by the SMC.

A Department of Health spokesperson said there was a false "perception" that some treatments approved by NICE were not universally available and the constitution would make the legal rights of patients more clear.

Health Secretary Alan Johnson said: "What we have heard from patients is that one of their major concerns is the perceived 'postcode lottery' in access to drugs - that there are too many variations around who gets access to prescribed drugs and that these variations are a lottery depending on where you live. "The draft constitution will address this by making it explicit that patients have the right to NICE-approved drugs if clinically appropriate." (BBC News 29.06.08)

  2. Government warned on DIY cancer treatments

· Rise in availability of unproven drugs online causes increasing concern

A colour enhanced scanning electron micrograph (SEM) of a breast cancer cell

A colour enhanced scanning electron micrograph (SEM) of a breast cancer cell. Photograph: Science photo library

The government was yesterday warned that cancer sufferers are at increased risk from websites selling unproven cures that could wreck the remaining months of their life. The controversy centres on a drug called DCA (dichloroacetate), a chemical being promoted and hyped across the world as a cure for cancer after news of preliminary laboratory tests on rats.

Dr Ian Gibson, chairman of the all-party parliamentary group on cancer, warned that increasing numbers of British people were purchasing such products, and urged the government to do all it could to highlight the problem and block sales from the websites. The proliferation of such sites was "an increasing problem which started in the United States and is growing almost daily here," he said.

DCA is a cheap off-patent chemical which was the subject of various largely unpromising trials for different diseases dating back around 20 years. It came back to prominence after research on early animal laboratory work by two scientists in Canada was published in the Cancer Cell journal in January last year.

The research by Dr Evangelos Michelakis and his colleague Dr Sebastian Bonnet showed regression of several types of cancer tumour, including brain, breast and lung, with no effect on healthy tissue. Their theory is that DCA restores the mitochondrial function, responsible for energy production, in cells damaged by cancers, allowing them to self-destruct and decreasing tumour growth. If they are right, they may have hit on a new approach to cancer treatment.

Subsequently, Jim Tassano, who runs a pest-control business in California, began to manufacture and sell DCA to all-comers on a website. The US authorities have attempted to stop a California-based website selling the drug, but the Guardian was easily able to obtain a tub of the powdered chemical, with a recommendation to try it with caffeine from strong tea and coffee. Tassano says he only wants to help people who have run out of options.

One of the scientists researching DCA's effect on cancerous cells is appalled. "The concern about this drug is that at this stage it is given to people who are very sick. Unsupervised, it could kill you," said Dr Michelakis, a professor at the University of Alberta who carried out tests in animal brain, lung and breast tumours and is now moving into human trials.

Tassano said in an email to the Guardian: "I am reluctant to speak publicly due to FDA [Food and Drug Administration] issues ... They have made it clear that they do not like high profile people. I am in a tough spot running both the information site on DCA and being involved with it economically as well. If the FDA takes action against me, it will be a big setback for DCA and cancer patients. I hope you understand."

The sale of DCA underscores how difficult it is for authorities to stop people purchasing potentially dangerous drugs on the internet. Gibson said he was very concerned that patients were being given false advice and erroneous information about drugs that had not been tested on humans. "I'm calling for these websites to be researched by the Department of Health and closed down instantly.

"We need to start a campaign to get the message out there that these sites are no good. If need be, we should be talking to the cancer institutes and charities in America to see what pressure they can bring to have the sites closed. But it's a very difficult thing to do. People will always turn to sites like these when they are desperate, so we need to make sure they know the facts."

Michelakis is moving as fast as he can into human clinical trials that will start to give some real answers. "The people who decide to sell this are like drug dealers. They are targeting the most vulnerable people you can imagine," he said.

Tassano and others believe those with terminal cancer should be allowed to take what risks they choose. Most doctors think patients should take calculated risks only within clinical trials, where they can be properly looked after if things go wrong.

Two doctors in Canada have broken ranks. Akhbar Khan, a GP, and his wife Humaira Khan, whose background is in public health, offer DCA at their Toronto clinic. They have been criticised by other doctors and regulatory bodies, but are allowed to use the drug because, although DCA is not approved as a cancer treatment, it is licensed for metabolic diseases.

Most of their patients are from Canada and the US, but some have made the trip from the UK.

"We haven't seen it cure anyone. It has prolonged life and given a better quality of life," said Dr Humaira Khan. "There's also the psychological aspect: the family feels they are doing something."

The couple are adding other unproven drugs to their repertoire as they hear about them. "The patients out there are researching like crazy and finding all sorts of things on the internet. They bring me lots of literature," said Dr Akhbar Khan.

On the basis of a few patients who said they had positive results from DCA and drank a lot of black tea and coffee, Tassano suggested that people try "the caffeine protocol". Yet he now warns on the site that the idea has resulted in death for some patients. "We are seeing very severe responses to the DCA-caffeine protocol in brain cancer patients. We have heard reports of a couple of people who were on high doses of DCA that started drinking caffeine and had very severe reactions: seizures and death followed," he said.

Dr Kat Arney of Cancer Research UK said the scenario around DCA was "probably the worst thing possible". "Cancer patients are taking this drug with no idea if it is safe, or at what dosage. It could make them very ill indeed."

The Department of Health said responsibility for websites selling medicines rested with the Medicines and Healthcare Regulatory Authority (MHRA). The MHRA in a statement said websites operating illegally in the UK had been closed down and said it was making efforts to alert consumers to the dangers of buying any medicines through the web.

Published with kind permission of The Guardian newspaper.This article appeared in the Guardian on Monday April 28 2008 on p1 of the Top stories section. It was last updated at 11:32 on April 28 2008.


3. Late diagnosis is seen as a major reason why the UK has poorer survival rates than some other countries in Europe.

Patients are dying of cancer because GPs are failing to identify their symptoms, the government's top cancer expert has warned. Professor Mike Richards said botched diagnoses were now 'a significant concern'.
The government's recent Cancer Reform Strategy identified late diagnosis as a major reason why the UK has poorer survival rates than some other countries in Europe. Although the cancer death rate is falling, it killed 153,491 Britons in 2005.

'There are 250,000 new patients with cancer every year,' said Prof Richards. 'It's probably only a small proportion who experience a missed or delayed diagnosis. It's a small minority of patients overall. But it's not a negligible figure. We want to reduce this to the smallest possible number.'
There are no official annual statistics on the scale of the problem. But an unpublished joint study by the Health Department and the National Patient Safety Agency, which investigated records involving missed or late diagnoses of cancer patients from January 2004 to November 2006, showed:
· More than 1,900 patients - 55 a month - suffered a missed or late diagnosis, though officials admitted the problem was probably much greater;
· Patients waited for periods between a day and 23 months to have their condition confirmed because of diagnostic errors, often at their GP's surgery;
· Breast, bowel and lung cancer were the likeliest to involve a botched diagnoses;
· Blunders in hospitals added to delays in cancers being identified. These include X-rays, biopsies or blood tests misfiled or misread.

Richards said some GPs felt they could not refer patients for tests as often as they would like in case hospitals became overloaded. 'Many patients are referred the first time they go to their GP. But some will go three, four, or even more times,' he said.
Cancer experts agree it can be hard for GPs to identify correctly the signs of the disease, partly because the symptoms of certain cancers are also those associated with many other illnesses. A typical GP with a list of 1,800 patients will only see eight or nine new cancer patients every year, and there are about 200 different types of cancer.
'Cancer is difficult to identify and GPs sometimes get it wrong,' said Dr Steve Field, a Birmingham GP and the chairman of the Royal College of General Practitioners. Many of the signs of cancer, such as tiredness, weight loss and rectal bleeding, are also associated with many other conditions, making diagnosis difficult, Field said.   (shortened version of report pub. The Observer, Sunday 13 Apr.08)

4. Post-menopausal hormone therapy may raise risk of meningioma

Last Updated: 2008-02-07 13:55:02 -0400 (Reuters Health)
By Karla Gale
NEW YORK (Reuters Health) - Hormone replacement therapy (HRT) appears to be associated with the occurrence of meningioma, investigators at the Mayo Clinic in Jacksonville, Florida, report in the January 10th issue of the Journal of Clinical Oncology.

"I became interested in this subject when our Southwest Oncology Group found that tamoxifen (an estrogen blocker) showed modest evidence of efficacy in delaying meningioma growth in some individuals," Dr. Kurt A. Jaeckle told Reuters Health. Multiple lines of evidence link meningioma with female hormones, the researcher added, including expression of estrogen and progesterone receptors and higher incidence in women and in patients with breast cancer."So there is a logical, albeit unproven, connection," he said.

To investigate the relationship between a diagnosis of meningioma and HRT use, Dr. Jaeckle's team reviewed records for the 355,318 women ages 26 to 86 years treated at their clinic between 1993 and 2003. Of these, 18,037 were current or past users of HRT. They identified 1390 patients with a history of either symptomatic meningioma or clinically silent meningioma incidentally discovered on brain MRI. Overall, the prevalence of meningioma was 865 per 100,000 in HRT users and 366 per 100,000 in nonusers (adjusted odds ratio 2.2, p < .0001). The association appeared to be stronger among younger women, with an odds ratio of 4.1 for those aged 26 to 55 years.

For now, this issue is just one of many that the physician should consider in weighing the potential benefits and risks of HRT, Dr. Jaeckle advised. That said, important questions remain to be answered. "If a woman has an 'atypical' malignant or recurrent meningioma and is on HRT, should the HRT be stopped (or not started)? Do any of the benign meningiomas convert to more fast growing tumors if a patient is on HRT?"

Dr. Jaeckle and his associates are actively pursuing answers. "We are planning laboratory studies (eg, gene microarray analysis) to try to identify genetic profiles that predispose women to develop these tumors -- and ideally, whether particular gene patterns would identify women in whom oral contraceptives and HRT should be avoided -- presuming there is a cause-and-effect relationship." Until there is direct evidence of a link between HRT and a more malignant profile, he concluded, "I want to reassure women that in the absence of this information there is no call for alarm."


5.

Brain Tumour Gene Link Found

22 Feb 2008   

Cancer Research UK funded scientists have discovered a mutation in a DNA repair gene which may increase the risk of developing meningioma, a rare type of brain tumour, according to new research published in the latest edition of the Journal of the National Cancer Institute.

The researchers, based at The Institute of Cancer Research, explored 136 DNA repair genes before they homed in on a mutation in the gene BRIP1 - a gene also associated with increased breast cancer risk. This mutation may account for 16 per cent of meningiomas. More than 7,500 people are diagnosed with malignant or benign brain tumours in the UK each year. Meninigiomas account for over 30 per cent of these, yet little is known about the cause of the disease which tends to affect older people, and women. The vast majority of meningiomas are benign. They grow slowly in the tissues of the brain or spinal cord and as a result do not respond well to chemotherapy and cannot always be safely removed by surgery.

The new study examined genetic differences in the brains of 1,268 people from four European countries. Data from 631 patients with meningiomas was compared with 637 healthy individuals. Previous US research had analysed a small sample of just 200 people, making this is the largest study of gene involvement in meningioma risk.

Lead researcher, Professor Richard Houlston, based at The Institute of Cancer Research, said: "Using a large sample, we have identified a new region associated with meningioma risk. However, further investigation into the functions of BRIP1, could shed more light on the relationship between the gene and brain tumour growth. Currently, the only sure way to diagnose many brain tumours is by biopsy. Research like ours, which examines gene changes may offer the hope of non-invasive ways to diagnose the disease and new tailored treatments for brain cancer patients."

Dr Lesley Walker, Cancer Research UK's director of cancer information, said: "Although meningioma is a rare condition, we welcome any insight that helps us to understand it further. This study has shown some very interesting results. However, further studies are needed to explain how additional changes in the BRIP1 gene may also contribute to the growth of these tumours."

Notes
- Ninety percent of meningiomas are benign, 6% are atypical, and 2% are malignant. The word benign is misleading in this case as, when benign tumours grow and constrict the brain, they can cause disability and even be life threatening.
- Cancer Research UK is also funding a series of genome-wide studies in other cancers because it hopes to identify people who are at increased risk of developing the disease and eventually prevent it from occurring. The first results from the breast and bowel cancer studies have already been announced.

- The tendency of cancers to affect family groups cannot be wholly explained by rare, high-risk, inherited mutations. A substantial proportion of such cancers are thought to be attributable to the combined effects of multiple, common gene variants, known as polymorphisms, each of which is associated with a small increase in cancer risk. The search for these polymorphisms is being facilitated by the availability of the human genome sequence and the development of high-throughput single nucleotide polymorphism (SNP) array technology, as used in this study.

About The Institute of Cancer Research

- The Institute of Cancer Research is Europe's leading cancer research centre with expert scientists working on cutting edge research. It was founded in 1909 to carry out research into the causes of cancer and to develop new strategies for its prevention, diagnosis, treatment and care. Website at: www.icr.ac.uk.  - The Institute is a charity that relies on voluntary income. The Institute is one of the world's most cost-effective major cancer research organisations with over 90p in every £ directly supporting research.

Cancer Research UK