Friday, April 11, 2014

Cochrane condemns antivirals

Cochrane evaluations are not foolproof.  There is always the GIGO problem.  But Cochrane surveys are normally as good as we get

The £653million spent on drugs to stave off a flu pandemic was ‘money thrown down the drain’, a damning report found yesterday.

The drugs – Tamiflu and Relenza – were stockpiled at huge cost by health chiefs in the hope they could stem the effects of a pandemic.

The mass purchase was triggered in 2005 when Government scientists warned that as many as 700,000 Britons could die from deadly bird flu.

After millions of doses were stockpiled, spending on the drugs escalated still further with the outbreak of swine flu (H1N1 virus) in 2009, the first pandemic in 40 years.

The anti-viral medicines were purchased to reduce admissions to hospital and dangerous complications from flu such as pneumonia.

But the drugs work no better than remedies such as paracetamol, according to an analysis by researchers. There are also claims that vital information from clinical trials was withheld from regulators, researchers and doctors.

The report, which analysed data from published and unpublished trials, concludes there is no evidence to show that the drugs reduce hospital admissions or complications.

It also says the two drugs do shorten the symptoms of flu but only by half a day – about the same as some over-the-counter drugs.

The review by Cochrane, an independent, international network of researchers, also found Tamiflu had side effects including a higher risk of psychiatric and kidney symptoms.

The authors of the report, published in the British Medical Journal (BMJ), called for an immediate end to stockpiling of the drugs on the basis of the evidence.

Dr Carl Heneghan, professor of evidence-based medicine at Oxford University, said: ‘The money spent has been thrown down the drain. There is no credible way these drugs could prevent a pandemic.’

The drugs worked no better at relieving symptoms than over-the-counter medicines but had potential to ‘cause great harm’, he said.

A second author, Dr Tom Jefferson, a clinical epidemiologist, said: ‘The evidence doesn’t justify stockpiling – we should stop it.’

The investigators said there had been ‘multi-system failure’ which included the role of regulators, the European Medicines Agency – which approved licensing of the drug in Europe – and the drugs watchdog Nice.

Investigators from Cochrane say the original evidence the drug companies gave to the Government was incomplete. They used a huge amount of data only made available by manufacturers Roche and GlaxoSmithKline after ‘years of struggles’, said BMJ editor-in-chief Dr Fiona Godlee.

The findings, based on 46 trials involving more than 24,000 people, cast doubt on whether the drugs are worthwhile fighting flu and suggest ‘insufficient grounds’ for using Tamiflu as a preventive measure.

Roche said it ‘fundamentally disagreed’ with the findings.

But Professor Wendy Barclay, chair in influenza virology at Imperial College London, said other evidence showed the drugs benefited sick pregnant women and stockpiling had been ‘prudent’.

Roche UK medical director Dr Daniel Thurley said: ‘Roche stands behind the wealth of data for Tamiflu.

The report’s methodology is often unclear and inappropriate, and their conclusions could potentially have serious public health implications.’

The Department of Health said: ‘Tamiflu is licensed around the world for the treatment of seasonal flu and is a licensed product with a proven record of safety, quality and efficacy. We regularly review all published data and will consider the Cochrane review closely.’


Viagra increases the risk of skin cancer: Men who used the drug were 84% more likely to get melanoma, study claims

There could be something in this.  Viagra users are presumably less robust generally but that does not explain that the ill-effects were confined to melanoma

It has boosted loved lives across the world - but new research suggests men who take Viagra may significantly increase their risk of skin cancer.

American researchers found those who took sildenafil, more commonly known as Viagra, were 84 per cent more likely to get melanoma, the most deadly form of the disease.

It is thought the impotence drug may affect the same genetic mechanism that enables skin cancer to become more invasive.

However the researchers add that because the study is preliminary, it is too early to advise men to stop taking the little blue pill.

'Because it’s just one early study, no one is suggesting that men stop taking Viagra to treat erectile dysfunction,' study co-author Dr Abrar Qureshi, professor of dermatology at Brown University, told NBC News.

But he advised those taking Viagra who have a high risk of melanoma should think about speaking with their doctor.

He added that the risk of less dangerous - and more common skin cancers, such as basal cell or squamous cell cancers - was no higher in men who took the drug.

The study, of 26,000 men in the U.S and China, analysed information from the Health Professionals’ Follow-up Study, which collects data about male healthcare workers (including doctors).

Of those included in the study, the average age was 65 and six per cent had taken the erectile dysfunction drug.

The research, published in the journal JAMA Internal Medicine this week, showed that men who took Viagra even once had double the risk of developing melanoma.

Dr Qureshi added that risk factors for skin cancer - such as the amount of sunlight exposure a man had and family history of the disease - had been taken into account.

Other well-known side-effects of Viagra include heartburn, nausea and headaches.  The drug is also unsuitable for men with angina or very high blood pressure


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