European Union, Government, Health, Medical, Research, Science

New European Laws could force drug companies to publish contentious research…

Drug companies have only ever  released small amounts of their research data from clinical trials, with critics claiming that negative results are only half as likely to be published.

Drug companies have only ever released small amounts of their research data from clinical trials, with critics claiming that negative results are only half as likely to be published.

SHARING RESULTS OF CLINICAL TRIALS

Under new European laws, pharmaceutical companies could be forced to publish secret research into how drugs are created. This could potentially lead to drug companies having to disclose information about dangerous and unknown side-effects of many drugs.

The rules would mean that some of the world’s most powerful pharmaceutical companies would have to share the results of clinical trials which could then be analysed by independent scientists.

Analysts say that the move will also reveal if patients have been fooled by the use of placebos or drugs that have not been scientifically proven to work.

Drug companies have only ever released small amounts of their research data from clinical trials, with critics claiming that spurious and negative results are only half as likely to be published.

The disclosure rules being drawn up by the European Medicines Agency, an EU body, have been met with stiff resistance from pharmaceutical companies. They claim that some of their information might be misinterpreted, which might spark significant health scare’ around the use of particular drugs.

In just the last three years, 26 drug companies have racked up financial fines amounting to more than £7 billion for acting dishonestly.

GlaxoSmithKline (GSK), Britain’s largest pharmaceutical company, announced earlier this year that it would support a move for such laws by publishing the results and data of all its clinical trials.

The move and announcement by GSK followed fierce criticism of the company after it was given a £1.9 billion fine in the United States last year, in part for withholding safety data about Avandria, its best-selling and highly profitable diabetes drug.

A leaked e-mail message from the head of a leading pharmaceutical industry body to company executives revealed that ‘patient groups’ would be used in an attempt to block legislative amendments to the clinical trials directive.

The e-mail, first seen by the Guardian, a London based broadsheet newspaper, was sent by the director-general of the European Federation of Pharmaceutical Industries and Associations, Richard Bergström, to the directors and legal departments at companies including Pfizer and GlaxoSmithKline.

In his message, Mr Bergström says that patient groups will be ‘mobilised’ to express concerns about…

… the risk to public health by non-scientific re-use of data.

Campaigners have hit back and have said that the groups – which are often funded by the companies themselves – are a ‘front for the pharmaceutical industry’.

Health Action International, a campaign group, said it was ironic that such a transparency initiative being promoted by the pharmaceutical industry was now ready to use patient organisations to fight their corner. The health lobby group says that patient groups in the pay of the pharmaceutical industry will now go into battle for them, and has suggested there is a clear ‘hidden agenda’. In a statement the group said:

… Patient groups get traction because they are assumed to represent the voice of the suffering. But industry uses them to say we’re not going to get innovative medicines if the industry is deterred from investing by having to be transparent about their clinical trials.

 

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Health, Medical, Research, Science

Resveratrol in health supplements ‘undo effects of exercise’…

RED WINE HEALTH PILLS

Experts have warned that health supplements containing the ‘miracle ingredient’ from red wine could undo the positive effects of exercise.

A daily dose of the antioxidant resveratrol cancelled out many of the benefits of a two-month-long exercise programme, a study has found.

When examining the effects of exercise alone, the results were as expected – blood pressure, the levels of ‘bad’ cholesterol and other harmful blood fats were lowered.

But if combined with a course of supplements, most of the positive effects vanished.

Resveratrol has become increasingly popular as study after study has credited the compound with health-boosting properties, from extending life and battling obesity to warding off heart disease.

Most research to date, however, is carried out on mice or rats, rather than in the human body. This latest study is proving that tests in rodents are not being replicated in humans.

Resveratrol, which is found in the grape skins that give red wine its colour, is supposed to boost health by mopping up dangerous oxygen molecules known as free radicals that attack cells and tissues and are blamed for health issues ranging from ageing to cancer.

The Danish scientists behind the latest study say these free radicals may be needed for the body to recover after exercise. Without them, many of the benefits of exercise – such as lowering blood pressure and increasing oxygen uptake – may disappear.

In the study, 27 men in their mid-sixties were asked to perform eight weeks of high-intensity exercise training – with half the group given 250mg of resveratrol a day and the other group receiving a placebo.

While scientists expect to get the same result from women and younger men, researchers have said that wine lovers need not worry about the effect of the odd glass of red wine on their exercise routine. The amount of resveratrol in the supplements studied was far higher than can be obtained from drinking wine alone. It could, though, easily be obtained from supplements.

It is thought that high doses of vitamin C might have a similar effect.

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Biotechnology, Health, Medical, Research, Science

Cell transplant gives hope for treating blindness…

A MAJOR ADVANCE

Scientists in Britain have made a major leap forward in efforts to treat blindness.

They have grown part of an eye in the laboratory and have extracted the light-sensitive cells which are the key to vision.

These cells were injected into mice, where they seemed to grow normally and formed the crucial connections between the eye and brain.

Such developments could pave the way for a treatment which could eventually give millions back their sight. It is hoped the first human patients could be treated in as little as five years. Transplanting just a small number of cells could have a big impact on quality of life.

Those who could benefit include men and women with age-related macular degeneration – the most common cause of blindness in the elderly. This condition affects more than 600,000 Britons and the number is expected to triple in the next 25 years as the elderly population swells.

There are few treatments for the condition – and no cure.

The research and experimentation is being carried out at University College London in which scientists are trying to replace damaged cells in the retina, the light sensitive ‘film’ at the back of the eye.

Last year, researchers used healthy cells from young mice to restore vision in adult animals. The results were said to be ‘dramatic’, with the treated animals able to quickly find their way out of a miniature swimming pool in dim light, while untreated ones swam around in circles.

Stem Cell Therapy for Blindness

The project’s lead-scientist, Professor Robin Ali, said the results amount to a ‘major advance’. His team took embryonic stem cells – ‘master cells’ capable of turning into other cell types and widely touted as a repair kit for the body – and used a cocktail of nutrients to coax them into turning into a retina.

They then raided the laboratory-grown retina for rods (key cells which pick up light and send it to the brain for conversion into images). The rods were then transplanted into the eyes of mice.

A retina has been grown in a dish before but Professor Ali’s team are the first to transplant cells from one successfully.

The journal Nature Biotechnology was the first to report the findings and has said that the lab-grown cells integrated into the existing eye was successful in forming the nerve connections needed to send information to the brain.

Professor Ali said:

… We are getting closer and closer to carrying out a trial.

However, the need to be highly confident that the treatment is safe and effective means that widespread use is at least 10-15 years away.

The Medical Research Council, which funded the team’s work, said in a statement:

… This study is an important milestone on the road to developing a widely available cell therapy for blindness.

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