The UK’s Public Accounts Committee has called on the Government to make sure that AllTrials’s aims – that all clinical trials, past, present and future, are registered and full methods and results available for independent scrutiny – happen. The Committee of MPs said they were surprised and concerned to discover that information on medicines is routinely withheld from doctors and researchers and warned that “[t]he ability of doctors, researchers and patients to make informed decisions about treatments is being undermined.”
The Committee particularly urges the Government to make sure that information from old clinical trials is made available. We know that the future is going to be different – legislation is about to be agreed in Brussels to ensure all clinical trials in Europe are registered and report results, the European medicines body is going to pro-actively make information it holds available, and, as the Department of Health pointed out to the BBC “All clinical trials conducted in the UK must now be registered on a public database”. This is all fantastic and shows the impact public pressure can have. But the Committee are right to stress the need for “old” data. The majority of medicines we use every day came on the market a decade or more ago, therefore they were tested in clinical trials over the last few decades. Since around half of these trials have not reported results, information on what was found out about our medicines is missing and could be lost forever. This is the information regulators and researchers should be able to scrutinise to make sure they are making the best decisions about medicines and don’t miss the opportunity to do better. And as cancer patient Richard Stephens told the Daily Mail that it is “downright immoral” and a betrayal of patients’ trust that they are asked to take part in clinical trials but findings generated by their participation may never be seen by doctors.
The Public Accounts Committee is the Committee of MPs that scrutinises Government expenditure. It was prompted to look at access to clinical trial information as the Department of Health spent £424 million stockpiling anti-viral drug Tamiflu to be used in a flu pandemic. The Committee points out today that this was in spite of there being no consensus on how effective Tamiflu was or even whether the medicines licensing bodies MHRA and NICE had been allowed to look at all the available evidence of its effectiveness. An investigation by Cochrane Collaboration and the BMJ found that from the 123 trials of the drug, regulators had seen 15. Dr David Tovey, Editor-in-Chief of the Cochrane Library wrote the story of the investigation for Huffington Post UK.
Read comments from AllTrials campaign members on today’s report here.
BBC, Lack of drug data of ‘extreme concern’
BBC Radio 4, Drug companies ‘routinely’ twist research
Channel 4 News, Are drug companies transparent enough about their products?
The Guardian, Drug companies accused of holding back complete information on clinical trials
The Independent, Drug companies ‘routinely withhold results of medical trials’ from doctors, researchers and patients
The Telegraph, When drug companies don’t publish results, real people die
The Times, Secrecy by drug giants could put patients at risk, MPs say
The Daily Mail, Our £400m stockpile of flu medicine that might not even work
BMJ, MPs call for full results of all past clinical trials to be made public
PLOS, Follow the money; or, why it took an accounts committee to decide why access to clinical trial data matters
Nature, Lack of transparency casts doubt on Tamiflu efficacy, says UK politians