By Jeremy Laurance
February 27, 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The latest attack was triggered yesterday by an analysis of published and unpublished trials of modern antidepressants, including Prozac and Seroxat, showing they offer no clinically significant improvement over placebos (dummy pills) in most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 Drug companies are required by law to provide all data on a drug, published and unpublished, to the regulatory authorities when applying for a licence.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 Obviously we have access to the published data and we do ask the industry for unpublished data, but it is up to the companies whether to deliver it or not.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".