DATE : 2014-04-10
Half a billion pounds of taxpayers’ money was wasted on a flu drug that is no better than paracetamol after the swine flu outbreak, according to researchers.
Tamiflu does not prevent complications or stop people passing on the flu virus and could not prevent a pandemic, Cochrane Collaboration researchers concluded after a five-year battle to see the full results of all trials of the drug.
Regulators said that they had seen the same data and come to different conclusions, while Roche, which makes Tamiflu, reacted furiously, saying that the researchers had failed to understand the data and had made “basic mistakes”.
Other scientists said that it was too soon to conclude that the antiviral drug did not work, pointing to evidence suggesting that it saved lives during the 2009 swine flu pandemic, and claiming that the researchers were “editorialising”.
The government has spent £473 million stockpiling Tamiflu, plus £136 million on a related drug, Relenza. It is committed to spending a further £50 million to top up supplies. The US spent $1.3 billion (£776 million).
Only a handful of studies have been made public and researchers at Cochrane spent five years fighting to see 170,000 pages of data on dozens of further studies held by Roche and GSK, the makers of Relenza.
After the companies relented last year, the independent scientists say that there is no good evidence to back up two key claims that Tamiflu is considered an “essential medicine” by the World Health Organisation because of research suggesting that it could prevent hospital visits with conditions such as pneumonia and delay transmission of the virus. Conclusions about pneumonia, for example, were largely based on patients’ assessments rather than medical diagnoses, they write in a study in the Cochrane Library journal.
Tamiflu can shorten flu symptoms by about half a day to 6.3 days, similar to the relief given by over the counter medication, researchers said. Yet there was a worryingly high number of kidney problems and mood disorders among people taking the drug.
“There’s no credible way this drug could prevent a pandemic,” said Carl Heneghan, professor of evidence-based medicine at the University of Oxford, one of the Cochrane researchers. Money had been “thrown down the drain”, he said.
Fiona Godlee, editor of the British Medical Journal, said that Cochrane had endured “a lengthy, cat-and-mouse, Alice in Wonderland attempt to get the data”. Their findings “should lead to some serious soul-searching among policymakers” about how drugs were recommended for routine use on the basis of incomplete data.
“There was a political imperative to have something to offer [during the 2009 pandemic] but in clinical public health terms this isn’t value for money,” she said. “When you think what half a billion could be spent on in the NHS we have to be pretty scathing about this.”
Professor Peter Openshaw, of Imperial College London, said that it would be “dangerous” to ditch the pandemic stockpile. “Since data from the 2009 pandemic clearly shows that antivirals do save lives, it seems very sensible to have an adequate supply of these medicines,” he said.
Professor Kevin McConway, of the Open University, said that the review was convincing, but added that it sometimes seemed as if the researchers were “editorialising in a way that is not completely justified by the data and analyses presented”, perhaps because of their campaign on access to trial data.
Barry Clinch, principal Tamiflu scientist at Roche, said that the company stood by its data which had been made available to regulators who were more experienced at handling it and should retain their role of interpreting it for the public.
“We share all the data we have with regulatory agencies, and that is reflected on the label to patients,” he said. “Information is one thing, knowledge is another. What people want is knowledge and understanding, not to be drowned in figures that mean nothing or have been partially understood.”
The Department of Health said: “Tamiflu is licensed around the world for the treatment of seasonal flu and is a licensed product with a proven record of safety, quality and efficacy. We regularly review all published data and will consider the Cochrane review closely.”
SOURCE The Times