Drug Money
I remember the great flu epidemic of 2009 very well because I came down with the 'lurgy' myself although I opted for the old-fashioned remedy of staying warm and washing down regular doses of paracetamol and suchlike with plenty of fluids.
At the time, politicians at Holyrood and Westminster were all over the airwaves reassuring the nation that Tamiflu was being bought up in sufficient quantities to meet the scale of the threat, which turned out to be a catastrophic waste of public money.
But only now is the truth coming out , as Jenni Russell explains in this excellent piece from The Sunday Times.
The drug companies’ recommended dose: take daily until totally baffled
By Jenni Russell - The Sunday Times
The dominant theme of last week’s news was the outrage of the press and the public over the Maria Miller affair. There was fury that public money had been wrongly claimed; and whether that sum was estimated to be £5,000 or £45,000, writers, callers and tweeters were united in condemning the misallocation of the nation’s limited resources.
It’s curious, then, that there has been less interest in Thursday’s revelations about public money being wasted on a stupendous scale. Over the past five years the government has spent almost half a billion pounds on buying, storing and prescribing the anti-influenza drug Tamiflu. It believed the manufacturer when it claimed that the drug would be a vital first line of defence in the swine flu pandemic that spread around the world in 2009.
Forty million doses were bought by Britain and almost a quarter of a million people were prescribed it. Now independent researchers have discovered that the drug is almost useless, can cause severe side effects and has been linked to suicides among children in Japan. Our government, along with many others around the world, had no idea.
In 2009 Tamiflu was presented by its manufacturer Roche as the answer to the possibility of a worldwide flu pandemic along the lines of the 1918 virus, which killed millions and was fatal to at least 1 in 10 of those who fell ill. The emergence of the swine flu virus H1N1 created fears that this might be the variant that devastated the globe. In Britain the predictions were that 75,000 people might die and that at any one time a fifth of the population could be too sick to work.
Scientists needed time to develop a vaccine and the authorities needed something that would mitigate the virus’s worst effects. Tamiflu promised to slow the spread of swine flu and to ease its impact by making complications less likely. The chief executive of Roche said in 2009 that the drug would reduce hospital admissions by 60%, cut serious complications such as pneumonia by two-thirds and halve the incidence of other respiratory tract infections. The published research supported him. The World Health Organisation recommended that governments buy Tamiflu: £11bn was spent on stockpiling it.
Because so much was being invested in the drug, the British and Australian governments asked the world’s leading data reviewer, the Cochrane Collaboration, to examine the evidence. The Cochrane Collaboration is a not-for-profit association of 14,000 academics who provide rigorously sourced, independent analysis of scientific results. They post their reviews, evidence and working methods online so that anyone can understand and comment on them. In 2008 they had concluded that Tamiflu was effective. When they looked again they realised the evidence was dangerously incomplete.
The Cochrane researchers had based their positive recommendation on a 2003 summary of 10 clinical trials into the drug. But all the authors of that paper, bar one, had worked for Roche and only two of the trials had ever been published in full. The other eight had appeared only in summarised form. That wasn’t enough information for anyone else to evaluate the results. The Cochrane team wanted to see the original data. Roche didn’t want to release it and legally the company had absolutely no obligation to do so. It stalled and stalled and stalled.
It took five years of pressure for Roche to give way. At one point it agreed to hand over the information but demanded that the research itself be kept confidential; the Cochrane group refused. Then it promised to release the full studies but didn’t. Finally, last year, it capitulated. The full data showed that Roche had cherry-picked its published results. Tamiflu did not stop flu spreading, did not cut hospital admissions, did not cut deaths and did not lessen serious complications such as pneumonia. It did cut the experience of flu-like symptoms by half a day, but this alone could never have justified its cost.
Even worse, it caused significant side effects. Eight Japanese children committed suicide after taking it. One Cochrane scientist, Dr Tom Jefferson, said: “This stuff is toxic. It increased the risk of psychiatric events, headaches and renal events in 1 in 150 people. People reported nausea, vomiting and constriction of the airways.” Dr Carl Heneghan, professor of evidence-based medicine at Oxford, concluded that Tamiflu was no more effective for flu symptoms than over-the-counter medication and yet it had potentially serious complications. He would not prescribe it to his patients. Roche protests that these conclusions are wrong but has not offered any evidence to contradict them.
The most alarming fact about this scandal is that we had no right to discover the truth. Roche has broken no laws. Drug companies have never been required to make their discoveries public. We are not permitted to know the real effects of the thousands of drugs we take.
This is intolerable in an age where we demand accountability from the powerful. How has a status quo that permits pharmaceutical companies to make billions from our ignorance been allowed to persist for so long? The Tamiflu case just might be the catalyst that finally brings change. Last week the British Medical Journal warned that the “multisystem failure” and the inadequate biased trials uncovered by the Cochrane authors showed that the entire system of drug evaluation and regulation was deeply flawed. “Why did no one else demand this level of scrutiny before spending such huge sums of money on one drug?” it thundered.
“And why do we have a system of drug evaluation and regulation that is incapable of providing patients, clinicians and policy makers with timely, reliable and independent information?”
There is now a growing movement demanding that the rules of the drug development game be changed. In January the Commons public accounts committee pointed out that half of all clinical trials are never published and that positive findings are twice as likely to be reported as negative ones. It wants the National Institute for Health and Clinical Excellence to be granted the authority to demand trial data. Glaxo Smith Kline and Roche are promising greater openness. This month the European Union announced that from 2016 all new trials will have to be registered and all results reported openly.
This is good news but it doesn’t go far enough. It won’t give us the hidden facts about the drugs we are currently taking. We need the right to see the inconvenient facts. Governments must act on this because they can no longer pretend that the science can be trusted to police itself. Last week the public was incensed by the idea that MPs should be left to mark their own homework. It is even more important that we don’t allow drug companies to mark theirs.
It’s curious, then, that there has been less interest in Thursday’s revelations about public money being wasted on a stupendous scale. Over the past five years the government has spent almost half a billion pounds on buying, storing and prescribing the anti-influenza drug Tamiflu. It believed the manufacturer when it claimed that the drug would be a vital first line of defence in the swine flu pandemic that spread around the world in 2009.
Forty million doses were bought by Britain and almost a quarter of a million people were prescribed it. Now independent researchers have discovered that the drug is almost useless, can cause severe side effects and has been linked to suicides among children in Japan. Our government, along with many others around the world, had no idea.
In 2009 Tamiflu was presented by its manufacturer Roche as the answer to the possibility of a worldwide flu pandemic along the lines of the 1918 virus, which killed millions and was fatal to at least 1 in 10 of those who fell ill. The emergence of the swine flu virus H1N1 created fears that this might be the variant that devastated the globe. In Britain the predictions were that 75,000 people might die and that at any one time a fifth of the population could be too sick to work.
Scientists needed time to develop a vaccine and the authorities needed something that would mitigate the virus’s worst effects. Tamiflu promised to slow the spread of swine flu and to ease its impact by making complications less likely. The chief executive of Roche said in 2009 that the drug would reduce hospital admissions by 60%, cut serious complications such as pneumonia by two-thirds and halve the incidence of other respiratory tract infections. The published research supported him. The World Health Organisation recommended that governments buy Tamiflu: £11bn was spent on stockpiling it.
Because so much was being invested in the drug, the British and Australian governments asked the world’s leading data reviewer, the Cochrane Collaboration, to examine the evidence. The Cochrane Collaboration is a not-for-profit association of 14,000 academics who provide rigorously sourced, independent analysis of scientific results. They post their reviews, evidence and working methods online so that anyone can understand and comment on them. In 2008 they had concluded that Tamiflu was effective. When they looked again they realised the evidence was dangerously incomplete.
The Cochrane researchers had based their positive recommendation on a 2003 summary of 10 clinical trials into the drug. But all the authors of that paper, bar one, had worked for Roche and only two of the trials had ever been published in full. The other eight had appeared only in summarised form. That wasn’t enough information for anyone else to evaluate the results. The Cochrane team wanted to see the original data. Roche didn’t want to release it and legally the company had absolutely no obligation to do so. It stalled and stalled and stalled.
It took five years of pressure for Roche to give way. At one point it agreed to hand over the information but demanded that the research itself be kept confidential; the Cochrane group refused. Then it promised to release the full studies but didn’t. Finally, last year, it capitulated. The full data showed that Roche had cherry-picked its published results. Tamiflu did not stop flu spreading, did not cut hospital admissions, did not cut deaths and did not lessen serious complications such as pneumonia. It did cut the experience of flu-like symptoms by half a day, but this alone could never have justified its cost.
Even worse, it caused significant side effects. Eight Japanese children committed suicide after taking it. One Cochrane scientist, Dr Tom Jefferson, said: “This stuff is toxic. It increased the risk of psychiatric events, headaches and renal events in 1 in 150 people. People reported nausea, vomiting and constriction of the airways.” Dr Carl Heneghan, professor of evidence-based medicine at Oxford, concluded that Tamiflu was no more effective for flu symptoms than over-the-counter medication and yet it had potentially serious complications. He would not prescribe it to his patients. Roche protests that these conclusions are wrong but has not offered any evidence to contradict them.
The most alarming fact about this scandal is that we had no right to discover the truth. Roche has broken no laws. Drug companies have never been required to make their discoveries public. We are not permitted to know the real effects of the thousands of drugs we take.
This is intolerable in an age where we demand accountability from the powerful. How has a status quo that permits pharmaceutical companies to make billions from our ignorance been allowed to persist for so long? The Tamiflu case just might be the catalyst that finally brings change. Last week the British Medical Journal warned that the “multisystem failure” and the inadequate biased trials uncovered by the Cochrane authors showed that the entire system of drug evaluation and regulation was deeply flawed. “Why did no one else demand this level of scrutiny before spending such huge sums of money on one drug?” it thundered.
“And why do we have a system of drug evaluation and regulation that is incapable of providing patients, clinicians and policy makers with timely, reliable and independent information?”
There is now a growing movement demanding that the rules of the drug development game be changed. In January the Commons public accounts committee pointed out that half of all clinical trials are never published and that positive findings are twice as likely to be reported as negative ones. It wants the National Institute for Health and Clinical Excellence to be granted the authority to demand trial data. Glaxo Smith Kline and Roche are promising greater openness. This month the European Union announced that from 2016 all new trials will have to be registered and all results reported openly.
This is good news but it doesn’t go far enough. It won’t give us the hidden facts about the drugs we are currently taking. We need the right to see the inconvenient facts. Governments must act on this because they can no longer pretend that the science can be trusted to police itself. Last week the public was incensed by the idea that MPs should be left to mark their own homework. It is even more important that we don’t allow drug companies to mark theirs.
