Sunday, March 20, 2011

Avandia under fire again

This is just part of a war on drug companies. Anything successful or popular is hated. I covered this issue in detail a year ago, where I noted what the research available then showed:

"In other words, a survey of the strongest data available showed that taking Avandia increased your risk of having a heart attack from 1.05% to 1.46%, an increase in risk of less than one half of one percent -- which is vanishingly trivial compared to the risks we take in most things we do. Given the large sample size, however, the result is statistically significant, if not significant in any other sense. If we were to reject such small risks as that we would have NO drugs on the market because all drugs have some adverse side-effects.

But here's the real kicker. Read the last clause in the abstract above. What it means in plain English is this: Although Avandia takers had a minutely greater risk of having heart attacks, the "extra" heart attacks DID NOT KILL THEM. Avandia takers were no more likely to die from a heart attack than anybody else!"

The effects noted in the report below would appear to be equally inconsequential

A study of 810,000 people, published today online in the British Medical Journal, found that those taking Avandia were 23 per cent more likely to suffer congestive heart failure and 14 per cent more likely to die while on it, compared to a similar medication. In addition, they were 16 per cent more likely to have a heart attack.

Last September the European Medicines Agency (EMA) suspended the licence for the drug, after 10 years on the market, saying the evidence of its harmful effects had tipped the balance against it being prescribed.

Today's study is further evidence supporting that decision. It analysed the results of 16 separate studies in 810,000 patients, of which 429,000 were on Avandia (also known by its generic name rosiglitazone) and 381,000 were on Actos (also known as pioglitazone). Most were over 60. The drugs both belong to a class that help control blood sugar levels in patients with Type 2 diabetes.

It found that Avandia could have led to an extra 431 deaths per 100,000 people on Avandia, an extra 170 heart attacks and an extra 649 cases of heart failure.

Dr Yoon Kong Loke, a lecturer in pharmacology at the University of East Anglia, who led the study, warned that although the drug had been withdrawn in the UK patients could still be affected by it. He said: "We don't know yet if stopping taking the drug at once gets rid of the increased risk of heart disease or if the effect lasts over a long period of time. "It is possible that symptoms may develop years afterwards. These are studies that need to be carried out in the future because Avandia has not been around all that long."

Manufactured by GlaxoSmithKline, Avandia was once one of the best-selling drugs in the world, with annual sales peaking at £3 billion in 2006. It is still available on a restricted basis in the US.

A GSK spokesman said that the meta-analysis contained disimilar studies that should not have been combined, a view taken by the Food and Drugs Administration (FDA) in the US last July. She continued: "It is important to note that there are no head-to-head clinical studies with cardiovascular outcomes results between the two medicines.

"GSK believes that definitive conclusions about differences in cardiovascular data of the two medicines are hard to make in the absence of long-term trials directly comparing both medicines.

"GSK stands behind the safety and efficacy of Avandia when used appropriately. Since 2007, results from six randomized clinical trials with data related to the cardiovascular safety of Avandia have been reported. "Taken together, these trials showed that Avandia does not increase the overall risk of heart attack, stroke or death."


Why a steak for pregnant mothers could stop babies crying

In Britain and Australia, black yeast extracts (Marmite; Vegemite) are a popular sandwich spread and are known for their high B12 content. Do British and Australian mothers have babies who are eight times less likely to fret than mothers elsewhere? I think it would have been noticed by now if that were so

Mothers-to-be who boost their intake of a vitamin found in steak during the first three months of pregnancy are up to eight times more likely to have babies who cry less, researchers suggest.

The B12 vitamin occurs naturally in red meat, fish and dairy products and is already known to help the development of the brain and nervous system in unborn children. It also helps prevent dementia, heart disease and even fertility problems later in life.

Mothers-to-be who boost their intake of vitamin B12, found in steak, during the first three months of pregnancy are up to eight times more likely to have babies who cry less, researchers suggest

Now the latest findings by researchers suggest pregnant women who consume only low levels of B12 may have babies whose nervous systems have not fully developed. They say it means a hormone in the brain which lulls babies to sleep may not be released properly, causing infants to cry for longer periods of the day.

The study, published in the journal Early Human Development, involved nearly 3,000 pregnant women. Each had a blood test during their first pre-natal appointment at three months, which measured the amount of B12 in their blood. Once their babies were born, they recorded how often they cried, and for how long.

The researchers found that those women whose test results showed they had the least B12 were up to eight times more likely to give birth to a child who cried for prolonged periods than those who had the most. On average, five per cent of mothers lacking B12 had a distressed baby while just over one per cent of women with the most B12 reported their baby cried excessively.

The researchers, from the Public Health Service in the Netherlands, concluded: 'This study provides first evidence for an early nutritional origin in infant crying behaviour. 'The results suggest infants born to women with a low B12 status during pregnancy are at a higher risk for excessive crying behaviour in their first months of life.'

The researchers suggest that a lack of B12 may affect how much of a supportive tissue known as myelin, which surrounds and protects the nerve cells, is produced in the brain. Less myelin could cause irritability, they suggest. They also say B12 could affect sleep cycles because low levels prevent the release of the body's sleep hormone, melatonin.

Janet Fyle, of the Royal College of Midwives, said: 'This is an interesting relationship and one which needs to be looked at further.'

But nutritionist Yvonne Bishop-Weston warned: 'Meat comes with saturated fats which can hinder the body's use of essential fats needed for the baby's brain and nervous system development.'


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