The drug industry's long and ignoble history of secrecy

DRUG GIANTS WARNED - TELL TRUTH ON MEDICINES
The drug industry's long and ignoble history of secrecy

For the full article from the Independent, click here.

Leading article: The nation should kick this expensive drug habit By Jeremy Laurance, Health Editor

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The latest attack was triggered yesterday by an analysis of published and unpublished trials of modern antidepressants, including Prozac and Seroxat, showing they offer no clinically significant improvement over placebos (dummy pills) in most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 Drug companies are required by law to provide all data on a drug, published and unpublished, to the regulatory authorities when applying for a licence.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 Obviously we have access to the published data and we do ask the industry for unpublished data, but it is up to the companies whether to deliver it or not.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

WHY DOESN'T BIG PHARMA PAY FOR DANGEROUS DRUGS? UK ADR COST: £2 BILLION

www.guardian.co.uk/society/2008/apr/03/nhs.drugsandalcohol

The Guardian. 3 April 2008.
Adverse drug reactions cost NHS £2bn.
Sarah Boseley, health editor

The NHS is spending nearly £2bn a year treating patients who have had an adverse reaction to drugs prescribed for them by doctors, according to new figures from the centre-left thinktank Compass.

The amount of money spent on hospital care for those given the wrong medicine or who have reacted badly to a drug could pay for 10,000 new midwives or easily cover the estimated cost of combating MRSA infections, says Compass.

The health minister Dawn Primarolo confirmed to the organisation that 6.5% of hospital admissions are a result of an adverse reaction.

Total admissions in 2006 were 16 million, which means that 1,040,000 patients were there as a result of the drugs they were prescribed.

Compass bases its calculation on an average stay of eight days in hospital at a cost of £228 a day. That puts the annual NHS bill at £1,896,960,000 just for those admitted with ill-effects. It does not include those patients who had a bad reaction to their medicines while they were in hospital. If that cost were added in, the bill would top £2bn.

The new figures, which are substantially higher than any previous estimates, have been compiled as part of an investigation into the pharmaceutical industry, its relationship to public health and regulation. "It is increasingly apparent that the lack of effective regulation is costing the taxpayer, and in some cases is causing unnecessary suffering," said Zoe Gannon, who is leading the Compass investigation.

Scandals such as that over the arthritis painkiller Vioxx, which caused heart attacks, and the antidepressant Seroxat, which was found to increase the risk of suicidal thinking in young people, suggest that industry could do more, she said. "The industry knew about these adverse drug reactions and chose not to accept the responsibility because its ultimate goal is to make a profit," she said.

"From our perspective this £1.9bn figure is not completely reducible - we are going to have to accept some adverse drug reactions - but the sheer size of this figure is enormous. It is all about getting a balance between risk and benefit and we feel that the balance is wrong."

Drug companies have huge profit margins, she said - in excess of 14.3% against a business average of 4.6%. Yet the number of genuinely innovative medicines - as opposed to copies of those already on the market - is decreasing.

"The pharmaceutical industry has the upper hand in terms of research and development investment and is always promising the latest miracle drug but too often failing to deliver," she added.

"Now is the time for a debate about costs and policies about which drugs the healthcare service can afford as people are paying infinitely higher prices - the drugs bill to the NHS now stands at £11bn - for increasingly marginal rewards an higher risk from adverse drug reactions."

Compass's investigation will question whether it is appropriate for the Department of Health to take the lead in relations with the pharmaceutical industry. It will also be calling for a review of progress since the 2005 report of the health select committee. Compass aims to publish its own report in the autumn.