Roche is withholding key clinical data which may question the safety and effectiveness of its anti-influenza drug Tamiflu (oseltamivir), a BMJ investigation claims.
The Journal is still waiting to receive full access to key clinical data about how well the drug works, two years after Roche promised to release it.
The investigation, published to coincide with a similar report from the Cochrane Collaboration, also questions the use of ghost writers in clinical trials and the different approaches taken by health regulators.
Tamiflu has become the main flu treatment in the UK and has been listed in the World Health Organization’s Essential Medicines.
A request by legitimate investigators from the Journal was made in 2009 to receive access, to which Roche agreed. However, despite repeated requests, the pharma company has yet to provide the data.
Roche, when questioned by investigators, admitted that some of the published papers surrounding Tamiflu had been ghost written. Concerns were also raised about the different approaches taken by regulators considering this data and the conflicting messages it created about the treatment’s effectiveness.
The BMJ found that the FDA chose not to review the largest clinical trial when considering the drug for approval and the US Centers for Disease Control and Prevention refer to trials which had been ghost written.
Meanwhile, the EMA only released a proportion of the clinical study reports to the Cochrane Collaboration after admitting it did not request the remainder of the information from Roche – despite being legally entitled to do so. It now says it will publish full reports for all products submitted for approval in the future; a move backed by the Journal.
“We hope very much that the EMA will indeed take this important step in making the full study reports available,” said Dr Fiona Godlee, BMJ Editor-in-Chief. “But we are still a long way away from having a full trial history for all drugs in clinical use. Public safety and the proper use of public money demands that we should stop at nothing less than this. In a globalised world, regulators should cooperate and pool their limited resources. Otherwise we will continue to waste money and risk people’s health on drugs that don’t work.”
Cochrane researchers aimed to test Roche’s claim that Tamiflu prevented complications and reduced the number of people who required hospitalisation with influenza. However, their investigation was hampered by a lack of supplied data by the pharma giant. It did obtain data from the EMA, but found inconsistencies with published reports and the possibility that the side-effects of the drug had been under-reported.
Questions were raised about the clinical effectiveness of the treatment. The Cochrane group, after evaluating the trial data it did obtain, claims Tamiflu appears to affect antibody production in patients – something Roche refutes. When asked by the BMJ, the manufacturer refused to explain precisely how Tamiflu works.
“Until more is known about the mode of action of neuraminidase inhibitors, health professionals, patients and other decision makers need to reflect on the findings of this review before making any decision about the use of the drug,” say the group.
The Collaboration also claims that Tamiflu’s ability to prevent the spread of influenza has not been demonstrated in trials – a statement which questions the move by governments around the globe to stockpile the drug in addition to the vaccine that has been developed since Tamiflu’s release.