International governments, including Australia, have spent hundreds of millions of dollars on an influenza drug that did not have credible clinical trial results, according to a British doctor and science writer.
When Tamiflu was released in 2006, it generated considerable hype within the scientific community.
“When Tamiflu first became available, it looked like it was great. I mean, I took the view that ‘Hey, this is like a new antibiotic equivalent – we’ve got a bacterial infection, we can kill that with an antibiotic’,” Professor Peter Collignon from ANU medical school told the ABC’s Catalyst program last month.
But Dr Ben Goldacre, co-founder of AllTrials, a global coalition of doctors and public health experts calling for open-science results that are not withheld from doctors, researchers and patients, said the countries that rushed to buy large amounts of Tamiflu may have reconsidered if they had all the relevant clinical trial data on the drug.
“… I can say for definite that we would have been much less likely to buy Tamiflu,” Dr Goldacre told Lateline.
The Australian Federal Government has spent nearly $200 million stockpiling Tamiflu while the UK has spent close to $800 million on the drug, marketed as an insurance policy against a serious flu pandemic.
However, a recent study from the Cochrane Library, a reputable centre for epidemiology and public health data, found Tamiflu and other “neuraminidase inhibitors” like Relenza, shortened symptoms of a seven-day flu, by only half a day.
The study also found “there was no evidence of a reduction in hospitalisations or serious influenza complications (confirmed pneumonia, bronchitis, and sinusitis or ear infection) in either adults or children”.
“But there was an increased risk of nausea and vomiting in adults by around four per cent and in children by five per cent,” it said.
Dr Goldacre co-founded AllTrials in response to the lack of clear and concise data available from clinical trials.
“We know that the results of clinical trials are routinely, but also legally, withheld from doctors, researchers and patients. And this is a problem that’s been going on for decades and decades now,” he said.
Earlier this week the World Health Organisation announced it was strengthening guidelines regarding the disclosure of clinical trials, including deadlines for reporting results.
Researchers must now report clinical trial results to a primary clinical registry within 12 months, and publish them in a peer-reviewed journal within 24 months of the completion of a study.
“The registration of all interventional trials is a scientific and moral responsibility,” the report said.
But it is not just major pharmaceutical companies who are failing to register clinical trial results, Dr Goldacre said.
“I think there’s actually one extra crucial problem which I think is often missed — this isn’t just about drug companies,” he said.
“Academic researchers, people receiving government funding for clinical trials, those academic researchers are often just as bad as drug companies. And in some studies they’re worse than drug companies for failing to make the results of their trials available.
“This is a problem that cuts right across the board whether it’s industry or non-industry. It’s a huge cultural failing in medicine.”