Thursday, October 25, 2012

Drug firms are 'risking lives by hiding bad trials and side effects of their medicines'

This is a routine claim but where is the evidence for it?  Some studies are legitimately not reported if defects are found in their methodology.  As a peer reviewer I have myself caused studies not to be reported by pointing out methodological defects in them

Drug companies are deliberately withholding the results of adverse clinical trials - putting patients at risk, an MP warned yesterday.

Dr Sarah Wollaston, a Tory backbencher, said pharmaceutical companies were burying bad news about the effectiveness and side effects of their medicines.

She is backing a campaign for a change in the law to force drugs firms to publish the details of all trials - good or bad.

The family doctor said such a move would save the NHS millions, because at the moment taxpayers fund medicines which may not be as effective as they claim.

Yesterday Dr Wollaston told MPs: ‘Missing data from clinical trials distorts the evidence and prevents patients and their doctors from making informed decisions about treatment.’

Norman Lamb, the care minister, agreed to meet campaigners to see what more could be done to promote transparency.

Earlier, Dr Wollaston told BBC Radio 4’s Today programme that the previous government had spent £500million stockpiling Tamiflu despite companies ‘holding back’ full clinical study reports about the drug’s effectiveness.

‘You have to ask yourself why is that being held back,’ she said. ‘This is hugely important. And it’s not just about wasting money. This very much matters.’

She called for all historic data to be published, adding it was ‘vitally important’ for patient safety.  ‘This really is a current issue,’ she said. ‘It affects patient safety and it’s wasting millions. If we could see a release of all the historic data...I think we would have a completely different evidence base for medicine. I think it’s vitally important for patient safety.’

Her campaign is supported by senior figures at the Royal College of GPs, the British Medical Journal, the Lancet and the Cochrane Library, which holds the largest collection of reports on clinical trials.

Other drugs for which campaigners say full information has not been made available include weight loss drugs orlistat and rimonabant.

Critics of the system estimate that around half of all clinical trials are never published in academic journals - and that trials with positive results are twice as likely to be published.

Yesterday in the Commons, Lib Dem care minister Norman Lamb told Dr Wollaston: ‘The Government support transparency in publishing results of clinical trials, and they recognise that more can, and should, be done.

‘Greater transparency can only serve to further public confidence in the safety of medicines. I am happy for my noble Friend Lord Howe or me to meet her and experts to discuss this important issue further.’

Stephen Whitehead, chief executive of the Association of the British Pharmaceutical Industry, denied drugs firms were not being transparent.

‘As the representative body for pharmaceutical companies in the UK, we take the issue that we are not transparent in our undertaking of clinical trials and causing patient harm very seriously,’ he said.

‘There has been much discussion of clinical trial data transparency over recent weeks, but we stand firm in our position that, as one of the most heavily regulated enterprises in the world, we do not seek to mislead or misinform.

‘Regulation of the industry is rigorous. In the UK, if a medicine is to gain a licence, then the complete clinical trial dataset relating to quality, efficacy and safety must be submitted to the regulatory authorities for approval.

‘We realise that there is still work to be done as we continually move toward greater transparency.’


Take a walk if you want to beat dementia

This is just the usual correlational rubbish -- and based on self-report questionnaires at that.  To state the obvious, it is maybe people who were healthier to begin with who did more exercise

Forget the crossword – going for a walk may be better insurance against developing dementia, say researchers. A study has found physical exercise, rather than mind-stretching activities, offers the best protection against excessive shrinking of the brain in later life.

Previous studies have found regular exercise can cut the risk of developing dementia by a third, while others suggest keeping mentally active with crosswords, playing cards and computer work.

Study author Alan Gow, from the University of Edinburgh, said the research provided objective evidence that exercise is critical for brain health.

He added: ‘People in their seventies who participated in more physical exercise, including walking several times a week, had less brain shrinkage and other signs of ageing in the brain than those who were less physically active.  'On the other hand, our study showed no real benefit to participating in mentally and socially stimulating activities on brain size, as seen on MRI scans, over the three-year time frame.’

Altogether, 638 Scottish people born in 1936 who had been involved in a long-term study of ageing took part in the research.

They were asked to fill in questionnaires aged 70 and were given MRI scans at 73.  They gave details about their exercise habits, ranging from moving only in connection with household chores to keeping fit with heavy exercise or playing competitive sports several times per week.  They also recorded any socially and mentally stimulating activities they did.

The study, published in the journal Neurology, found that after three years those doing more exercise had less brain shrinkage than those who exercised minimally.  They also had larger volumes of grey matter in the brain, showing that fewer brain cells had died.

Professor James Goodwin, head of research at Age UK, which supported the study, said: ‘This research reemphasises that it really is never too late to benefit from exercise, so whether it’s a brisk walk to the shops, gardening or competing in a fun run it is crucial that, those of us who can, get active as we grow older.’

Dr Simon Ridley, head of research at Alzheimer’s Research UK, said: ‘While we can’t say that exercise is the causal factor in this study, we do know that exercise in middle age can lower the risk of dementia later in life.’


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