Summary: Pill-popping Waccolites stick to their placebo-induced prejudices and are dismissive in the face of new meta-study evidence to the contrary.
The metastudy is at https://medicine.plosjournals.org/pe...l.pmed.0050045
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https://www.independent.co.uk/opinio...it-787825.html
Leading article: The nation should kick this expensive drug habit
Wednesday, 27 February 2008
The title of a recent paper submitted to the Public Library of Science Medicine journal – "Initial severity and antidepressant benefits: a meta-analysis of data submitted to the FDA" – does not sound like the sort of document likely to inspire a revolution. But a revolution is precisely what this paper by researchers from the University of Hull promises to effect in the world of clinical depression.
Since they emerged two decades ago as a new, safe, chemical remedy for depression and anxiety, Selective Serotonin Reuptake Inhibitors (SSRIs) have been a staggering commercial success story. These drugs are now taken by some 40 million depression sufferers worldwide. Their names – Prozac and Seroxat – have become emblems of 21st century popular culture.
But the so-called "Prozac Nation" is now under unprecedented threat. The Hull study, which analyses 47 separate clinical trials, concludes that SSRIs provide little clinical benefit for most people with mild and moderate depression and actively help only a small group of the most severely depressed.
The manufacturers of Prozac and Seroxat are questioning the study's conclusions. But the drug companies have a strong commercial incentive in protecting a market that generates considerable revenue. And their history of keeping secret the results of their own drug trials into the effectiveness of SSRIs does not support their position. The Hull researchers had to use the US freedom of information laws to gain access to this unpublished data.
The implications of this study should be clear to policymakers here in Britain, where some 30m prescriptions for antidepressants are being written every year: we need to prescribe vastly fewer of these drugs. Thankfully, the NHS has already been moving in this direction in recent years. The National Institute for Health and Clinical Excellence guidelines state that "talking therapies", rather than drugs, should be offered by GPs as a first response to cases of depression. And Alan Johnson, the Health Secretary, has announced that 3,600 therapists are to be trained during the next three years in England to this end.
This is the right road. Cognitive behavioural therapy has been shown to deliver genuine clinical benefits to depression sufferers. No overall cost savings should be expected from this treatment shift. Fewer Seroxat prescriptions will bring down the NHS drugs bill, but it will cost considerably more to train therapists. Yet, we will end up with a more efficient NHS in the end.
The other major implication of this report is that we need more transparency from the pharmaceutical industry over its drug trials to prevent a similar situation occurring again. Can they be prevailed upon to be more open? The record is not encouraging. Up until now the drug companies have only been willing to publish research that shows their products in a good light.
Is legislation necessary? This is a problematic area. Badly-drafted legislation could jeopardise research. It is not in our interests for drug companies to be prevented from developing and profiting from new products. There is also a question over when exactly to demand the disclosure of trial results from a public safety perspective. A single successful trial for a drug could lead to a spike in demand. But later trials might highlight dangerous side effects. Decisions over disclosure would have to be taken sensitively and on a case by case basis.
Yet some form of compulsion clearly needs to be brought to bear on the drug companies. The overwhelming lesson of the Prozac years is that secrecy is no good for our health.
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https://www.independent.co.uk/life-s...es-787907.html
Drug giants warned: Tell the truth on medicines
After antidepressant treatments are discredited, fears grow that other products may be ineffective
By Jeremy Laurance, Health Editor
Wednesday, 27 February 2008
The pharmaceutical industry came under assault from senior figures in medical research yesterday over its practice of withholding information to protect profits, exposing patients to drugs which could be useless or harmful.
Experts criticised the stranglehold exerted by multinational companies over clinical trials, which has led to biased results, under-reporting of negative findings and selective publication driven by the market, which was worth £10.1bn in the UK in 2006, amounting to 11 per cent of total NHS costs.
The latest attack was triggered yesterday by an analysis of published and unpublished trials of modern antidepressants, including Prozac and Seroxat, showing they offer no clinically significant improvement over placebos (dummy pills) in most patients. But doctors said patients on the drugs should not stop taking them without consulting their GPs.
It was the first time researchers – from the UK, Canada and the US – had successfully used freedom of information legislation to obtain all the data presented to regulators when the companies applied to license their drugs. In some cases it had not been made public for 20 years. Over the past two decades the drugs, known as selective serotonin re-uptake inhibitors (SSRIs), have been among the biggest selling of all time, earning billions of pounds for their makers. Yesterday's finding suggests that the money may have been misspent. Drug companies are required by law to provide all data on a drug, published and unpublished, to the regulatory authorities when applying for a licence. But this requirement does not apply to the National Institute for Health and Clinical Excellence (Nice), which assesses cost effectiveness and recommends which drugs should be used by the NHS.
Peter Littlejohns, the clinical and public health director of Nice, said: "The regulatory authorities have access to everything. Obviously we have access to the published data and we do ask the industry for unpublished data, but it is up to the companies whether to deliver it or not. We have no power to demand it. The issue is that it relies on the good will of the industry."
Professor Mike Clarke, the director of the UK Cochrane Centre, an international collaboration between researchers in 100 countries which has published more than 3,000 systematic reviews of published trials to establish best medical practice, said lack of co-operation from the drug industry was damaging medical care.
"When we ask for details of a trial the company might tell us nothing. We have even less power than Nice. Researchers trying to make sense of trials for decision-makers need to have access to this data. If we have only got access to half of the data, when we see evidence that a drug works we don't know whether to believe it or not.
"It makes us doubtful – that's the big worry. The companies are in the business of making profits – but they are also in the business of providing safe, effective health care."
Legislation to compel the drug industry to publish its results was included in Labour's manifesto at the 2005 election and last month the Commons Health Select Committee demanded that Nice be given unfettered access to all clinical trial results.
Yesterday, the Government said it had been told that compelling the industry to publish trial data would not be allowed and it was instead pursuing a voluntary approach, developing a "searchable register" of all trials that have taken place in the UK and pressing the EU to make its own confidential register public.
A spokesman for the Department of Health said: "The Government has consistently supported open access to information about research when the findings could affect decisions about treatment or health outcomes. We planned to support the principle of mandatory registration of clinical trials in the UK, but legal advice stated this would be illegal under EU law." A World Health Organisation working group is examining how to improve reporting of clinical trials and is expected to announce a consultation shortly.
The pharmaceutical industry was unrepentant about its strategy yesterday. Richard Tiner, the head of medicines at the Association of the British Pharmaceutical Industries, said: "The regulatory authorities have access to all the data – absolutely everything. Nice is not a regulatory authority – it is making decisions on whether medicines should be available on the NHS... There is no reason why the companies would restrict access – it depends what they are asked for. The industry is very much more transparent than it was 10 years ago."
GlaxoSmithKline, maker of Seroxat, said yesterday it "fully endorsed public disclosure of all clinical trial results" and had published all data relating to Seroxat on its website "regardless of study outcome".
The antidepressant debate
Paul Bough, 41: 'You name it, I've tried it: none of them worked'
"The findings of this latest report don't surprise me in the slightest. In fact, they confirm what I already knew.
"I've been a depressive for most of my life, and all of my adult life. After the umpteenth failed suicide attempt seven years ago my doctor said I should try taking antidepressant drugs. You name it, I've tried it. Diazepam, Citalopram, Prozac, Seroxat, Atenolol [a beta-blocker], Efexor: none worked. They turned me into a zombie, totally incapable of motivation or movement and forced to vegetate on a sofa.
"I'd say to anyone on these drugs, you're better off going cold turkey. Talk to people, have therapy, be sociable: but don't rely on these little happy pills. Having tried the lot, I'm coming off – and staying off."
Sylvia Genge, 59: 'Without these drugs I would lose hope altogether'
"The findings go against several decades of experience. I have suffered three major traumas in my life – my father leaving home when I was 11, my husband having an affair, and now an unpleasant divorce – and I'm convinced these drugs helped me survive them. I've been close to suicide myself, but now, in my 60th year, I'm feeling positive and able to survive all the terrifying experiences each day throws at me. I take 20mg of Fluoxetine each day, and it makes me feel I can cope. I simply don't buy the idea that it's just a placebo – but then I suppose the point is even if it were I wouldn't care. These drugs are my crutch and my comfort; without them I would lose hope altogether. I'm staying on."
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https://www.independent.co.uk/life-s...cy-787908.html
The drug industry's long and ignoble history of secrecy
By Jeremy Laurance, Health Editor
Wednesday, 27 February 2008
Discovering, testing and bringing a new drug to market can take more than a decade and cost as much as £500m. Over the past 30 years, as the costs have mounted, so have the pressures to protect new chemical agents which could become potential blockbusters.
Secrecy became the pharmaceutical industry's watchword as it sought to control publication of trials and even manipulate results. Cancer drugs introduced in the 1990s claimed to offer major benefits which later turned out to be more apparent than real. Evidence published in The Journal of the American Medical Association showed that 38 per cent of independent studies of the drugs reached unfavourable conclusions about them, compared with just 5 per cent of studies funded by the pharmaceutical industry.
In 2004, UK researchers commissioned by Nice to develop guidelines for prescribing antidepressant drugs to children tried to obtain unpublished trials from the drug companies. They were refused. They then contacted the individual researchers who had worked on the trials. Only then did a picture emerge of increased risk of attempted suicide, and a lack of efficacy. Nice concluded by banning the drugs for under-18s with the exception of Prozac.
Yesterday's report suggesting that modern antidepressants offer no significant clinical benefit over placebo has been dismissed by the drug industry as "just one study" which should not be allowed to undermine the wealth of research showing that the selective serotonin reuptake inhibitor (SSRI) antidepressants are effective.
But that is to miss the point. The Hull University researchers have demonstrated how partial access to research can give a distorted view of a drug. The non-disclosure of data on the SSRIs has raised doubts about the trustworthiness of all research on antidepressants.
We should be relieved that the licensing authorities have an absolute right to see all trial data, positive and negative, before approving a drug. But, bizarrely, Nice, with the responsibility for deciding which drugs should be used by the NHS, only gets what the drug companies agree to give it. The Health Select Committee has called for action to remedy this omission. Ministers must respond.