Following up on the article in the Mail today about Pharmageddon – a book that details the way companies hide inconvenient data to the detriment of patients – I was struck by how the Tamiflu saga was a perfect example of what the author Professor David Healy was talking about.
It also raises the issue of whether companies that can be shown to have distorted evidence for safety or effectiveness should be taken to court in the UK as they are in the States.
The saga started in 2009 at the height of the swine flu panic when an investigation by the BMJ, plus the respected Cochrane Collaboration and Channel 4 raised serious doubts about whether Tamiflu – a front-line defence against the virus that had been bought in vast quantities by the government – was actually any use at all.
The company – Roche – claimed that it could cut your chances of catching the bug, reduce it’s effect if you did and stop vulnerable people such as the elderly and asthma patients from getting dangerous associated infections like pneumonia. However when the Cochrane researchers asked for the evidence to support these claims the company was unable to provide it.
Without that evidence the case for the benefits of Tamiflu collapsed. However the company said they would make it available soon. But this January three years down the line the researchers went public in a hard hitting article saying that they had been “unable to obtain the full set of clinical study reports despite five requests.”
Several points stand out:
Leaving aside a disagreement between the Cochrane researchers and Merck – the company say they did provide data, the researchers say it was far from complete – what’s astonishing to many people is the even if they provided nothing, Merck is entirely within their rights. A recent BMJ article described how researchers often fail to to report relevant trial data, warning that it “biases research, wastes health care resources and may harm patients.”
Even though drug companies are required to provide the full results of their trials to the American Food and Drug Administration( FDA) and to the European regulator, it is regarded a commercial secret.
So the CEO of Merck can declare publically that the drug cuts the risk of developing flu by 60%, encouraging governments to buy it and doctors prescribe it, but he’s under no obligation to provide the evidence for that statement to any independent researchers.
In fact, based on the evidence that they had seen, the FDA did come out with a very unimpressed rresponse to the drug but other agencies ignored their analysis and encouraged everyone to take it.
This raises the question of the rights of those people – 4000 in all – who took part in the trials of Tamiflu. Drug trials rely on a certain selflessness on the part of patients who enrol in them. They aren’t paid, they may not be getting the treatment and they may suffer nasty side effects. You might think that would give them some rights.
Something else that stood out was that of the ten trials that the company had run, only one very positive one had been published This is an all too common feature in drug disasters. Hidden trials featured in scandals surrounding SSRIs Vioxx and Avandia.