Swiss drug company Roche is facing renewed critiscism over its failure to release full research data on its drug Tamiflu, widely stockpiled by governments to combat the 2009 swine flu pandemic.
Following an investigation two years ago by Channel 4 News into the safety and effectiveness of the medicine, the company promised to make “full study reports” relating to Tamiflu available for review by independent scientists.
Writing in today’s issue of the science journal Public Library of Science Medicine, researchers from the Cochrane collaboration detail how, after two years of trying, they are yet to receive full details about the drug.
“All the data we’ve seen so far suggests it’s no better than aspirin. It could be, but we don’t have the data to say so,” Professor Chris Del Mar, the lead author of the paper told ABC News Australia.
In a statement, Roche told Channel 4 News: “Almost 80% of Roche’s Tamiflu clinical data has been published as primary publications or made available to the scientific community on the web.
“However, for confidentiality reasons we believe it would not be appropriate to make raw patient data publicly available.”
So is the publication of 80 per cent of the trial data sufficient? In an accompanying article, officials from the European, British, French and Dutch drug regulatory bodies write: “We consider it neither desirable nor realistic to maintain the status quo of limited availability of regulatory trials data.”
The regulators propose working toward revising the current system to allow more public access to drug company data. Though to work they argue it would have to be balanced with measures to protect the privacy of commerically sensitive data from drug firms.
During a routine review of flu drugs in 2009 the Cochrane Collaboration, an international group of public health specialists, found that there was insufficient evidence in the public domain to account for Tamiflu’s effectiveness as a pandemic flu drug.
They particularly criticised a key paper used to justify Tamiflu’s use during pandemics to international regulatory authorities.
As part of a previous Channel 4 News investigation Dr David Reddy, pandemic taskforce leader at Roche, promised that the company would make available “full study reports” from clinical trials carried out while bringing Tamiflu to market.
Roche provided then provided 3,200 pages of data from their clinical trials of Tamiflu, but the Cochrane scientists maintained it was insufficient to justify the drug’s effectiveness.
In today’s PLoS Medicine article the Cochrane scientists reveal they subsequently obtained “tens of thousands” more pages of clinical trial data following a freedom of information request to the European drug regulator.
They argue these pages show there is yet more data relating ot the effectiveness of the drug that was not seen by regulators or other researchers.
In the article the scientists argue that their experience with gaining access to Tamiflu data speaks to a much wider problem when it comes scrutinising the safety and effectiveness of many medicines.
Historically, the authors maintain, drug companies and regulators have treated the results of clinical trials as confidential. In the light of recent public health scandals surrounding approved medicines like pain relief medicine Vioxx and diabetes drug Avandia, they argue this situation has to change.
“It is the public who take and pay for approved drugs, and therefore the public should have access to complete information about those drugs,” the researchers write.
“We should also not lose sight of the fact that clinical trials are experiments conducted on humans that carry an assumption of contributing to medical knowledge. Non-disclosure of complete trial results undermines the philanthropy of human participants,” they argue.
In a statement the UK drug regulator the MHRA said: “We welcome debate on these issues and there is currently a European initiative to provide public access to the results of clinical trials.
“We remain confident that satisfactory solutions can be found to make complete trials data available in a way that will be in the best interest of public health.”
During the 2009 swine flu pandemic courses of Tamiflu were handed out to anyone with symptoms calling the government’s National Pandemic Flu Service. In the first two weeks of the pandemic, 500,000 courses of the drug were prescribed nationwide. The UK government had spent more than £500 million stockpiling antiviral drugs like Tamiflu in preparation for a pandemic.