MPs raise concerns over 'withholding' of clinical trial results
Clinical trial results are being routinely withheld from clinicians, which is undermining their ability to make informed decisions about how to treat patients, a powerful committee has warned.
MPs have raised “extreme concern” that manufacturers appear to only publish around 50% of completed trial results and warned that the practice has “ramifications for the whole of medicine”.
Research suggests that trials giving a favourable verdict are about twice as likely to be published as trials giving unfavourable results, the Public Accounts Committee (PAC) said.
Experts have failed to agree on how well the anti-viral drug oseltamivir (Tamiflu) works, but discussions have been “hampered” because important information has been held back, it added.
Figures released last year showed the Department of Health spent £424m on stockpiling oseltamivir but had to write off £74m of its stockpile as a result of poor record-keeping by the NHS.
A review carried out by the Cochrane Collaboration into 20 existing studies into the drug found it ”did not reduce influenza-related lower respiratory tract complications” but did induce nausea.
It is now receiving full clinical study reports from manufacturer Roche, which are being used to complete a further review of the effectiveness of oseltamivir.
The results of that should be used by government, the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) to review the drug’s use, MPs said.
They also called on ministers to take action so full trial results are available to doctors and researchers for all treatments currently being prescribed and carry out regular audits of how much information on how much information is being made available.
PAC member Richard Bacon said full results from clinical trials were being “routinely and legally withheld” from clinicians by the manufacturers of medicines, which was undermining the ability of prescribers to make “informed decisions about treatments”.
“This is of extreme concern to this committee,” he warned. “The Department of Health and MHRA must make sure, both prospectively and retrospectively, that clinical trials are registered and the full methods and results of all trials are available for independent wider scrutiny.”
Specifically commenting on oseltamivir, Mr Bacon said a “lack of consensus” remained over how well the antiviral medicine “actually works”.
“The lack of transparency of clinical trial information on this drug to the wider research community is preventing proper discussion of this issue among professionals. We are disturbed by claims that regulators do not have access to all the available information,” he said.
“The case for stockpiling antiviral medicines at the current level is based on judgment rather than on evidence of their effectiveness during an influenza pandemic,” he added.
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