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The Public Accounts Committee has today called on the Government to ensure that full methods and results from clinical trials of all treatments currently used in the UK are available to doctors and researchers. This echoes the call of the AllTrials campaigni for all clinical trials to be registered and results reported. The AllTrials petition calling on governments, regulators and research bodies to implement measures to achieve this has been signed by over 60,000 people. The campaign been joined by more than 400 organisations from medicine, science, consumer rights and industry including over 200 patient groups and the pharmaceutical company GSKii.
The Committee recommends that the Department for Health and the MHRA ensure that clinical trials, past and future, are registered on an appropriate register and that the full methods and results are available for independent scrutiny. Making sure information from past trials is available to researchers is a focus of the AllTrials campaign. Most of the medicines we use today were tested in clinical trials over the last few decades but because around half of these trials have not reported results information on what was found about our medicines is missing and could be lost forever.
MPs on the Committee have said they were "surprised and concerned" to discover that information on methods and results of clinical trials is routinely withheld from doctors and researchers and advises that "[T]he ability of doctors, researchers and patients to make informed decisions about treatments is being undermined."
The Committee also reports that the Department of Health did not have all the information about Tamiflu before they made the decision to stockpile it.
Dr Ben Goldacre, author of Bad Pharma and co-founder of AllTrials: "Today's report is a complete vindication of AllTrials' call for all the results, of all the trials, on all the uses of all currently prescribed treatments. None of the proposed new legislation or codes of conduct come anywhere close to this simple, vital ask. Industry has claimed it is on the verge of delivering transparency for over two decades. While obfuscating and delaying, ever more results have been withheld. Some in industry now claim that results from even a decade ago may be lost and inaccessible. This is both implausible and unacceptable.
"We need urgent action from government, regulators, the GMC, and all professional bodies to ensure that the full methods and results of all trials on all currently used treatments are made available to doctors, researchers, and patients. We cannot make informed decisions about which treatment is best when vitally important information is routinely and legally kept secret. Future generations will look back at this absurd situation in the same way that we look back on mediaeval bloodletting.
"Stephen Whitehead CEO of ABPI said in February that they "would not respond" to the AllTrials petitioniii. It is increasingly clear that researchers, policy makers and patients will not tolerate the current situation."
Tracey Brown, Director, Sense About Science, cofounding organisation of AllTrials: "Today's report adds to the clamour of voices calling for more information from clinical trials to be available. Since the launch of the AllTrials campaign a year ago a number of companies have made commitments to make old data available to researchers. European legislation which would mean that all clinical trials done in Europe will have to be registered and results reported is close to being passed. Now is the time for all companies and academic trialists to commit to registering and reporting results from trials. There is no excuse for not publishing results but a huge public benefit to having a complete picture of what was found in trials conducted on treatments currently available to patients."
Richard Stephens, patient and deeply disappointed clinical trial participant: "Patients have a right to know that the medicines and treatments they are being given are the best available. That means that all the information about how the drugs or procedures were developed and tested must be made available so that doctors and patients can make informed decisions. How can we have informed choice if somebody is keeping back the information we need to make the choice?
"Patients like me participate in clinical trials because we expect the information to be of use to other patients in the future. It is downright immoral to keep running trials and recruiting sick people to them if you aren't going to make all the results known. And that's especially true if we are being asked to enter trials for new drugs against old drugs, and we now find that the evidence for the old drugs has been hidden - if indeed it exists at all.
"For goodness' sake; in our schools we teach our children the basic rules of scientific experiments and of making judgements about evidence. If our 14-year olds can grasp this why can't multi-national drug company CEOs? Or do they just prefer telling half-truths and marketing slogans rather than the whole truth and nothing but the truth?"
Professor Carl Heneghan, Director, Centre for Evidence-based Medicine, Oxford, and chief investigator on a grant funded by the National Institute of Health Research Health Technology Assessment Program to review the evidence for Tamiflu (oseltamvir) and Relenza (Zanamivir): "Today's report is a hard hitting statement that goes right to the heart of the problem. The Committee's recommendations will require substantial input to achieve but if fully implemented it will be one of the major breakthroughs in the development and evaluation of medicines. The committee should be praised for their bravery in promoting transparency, grasping the key facts and promoting evidence-based medicine."
Dr Fiona Godlee, Editor in Chief BMJ: "Congratulations to the Public Accounts Committee for fully comprehending how absurd and damaging the current situation is and for making these important recommendations. If the Department of Health does what the committee asks - ensures access to the full methods and results for all trials on all treatments in current use - this will be a huge contribution to improved public health and patient care. It should also give people more confidence to take part in clinical trials knowing that they are contributing to the public good rather than to individual companies' commercial gain. The challenge now will be to bring these recommendations to life. All eyes will be on the Department of Health and the MHRA to step up to this crucial responsibility."
Sir Iain Chalmers: "The forceful conclusions of the Public Accounts Committee builds on evidence of scientific misconduct that has accumulated over decades. It is a sad comment that British medical academia has largely acquiesced in this state of affairs. How can the public be expected to trust a research community that has been so widely complicit in behaviour which is so obviously against the interests of patients, prescribers and the public more generally?"
Dr David Tovey, Editor in Chief, The Cochrane Library: "This landmark report of the Public Accounts Committee is extremely welcome news, and a hard-won milestone on the journey to global trial data transparency. The report makes a compelling case for ensuring that healthcare decisions are based on a complete picture of the evidence available, and also reflects the harms and costs of forming policy from incomplete and misleading data."
The PAC's report was prompted by its investigation into the Department of Health's spending of £424 million to stockpile Tamiflu despite a lack of consensus on how well Tamiflu works and disagreement about whether regulators and NICE received all the information on Tamiflu during the licensing process.
The Cochrane Collaboration - who gained full access to all documents held by European regulators - discovered that many large trials on Tamiflu have not reported results and that for many more trials only partial information was available. Cochrane is now receiving full clinical study reports from Roche. This new information is being assessed by the twelve international researchers who make up the Cochrane Collaboration neuraminidase team, funded by the National Institute of Health Research. They are close to submitting the updated evidence for peer review. The findings will for the first time provide what the PAC calls for, 'independent scrutiny of a medicine's effectiveness.' Today's report calls on the Department for Health and regulators to consider whether it is necessary to revisit previous judgments about the efficacy of Tamiflu once this assessment is available.
Dr Ben Goldacre, author and co-founder of AllTrials: "It is not enough that trial results are seen in secret, behind closed doors, by regulators alone: especially when, as with Tamiflu, regulators around the world disagree about the benefits of a treatment. It is also not clear that even regulators see everything. It is particularly concerning to see that the MHRA seems to have told the Committee that regulators had all the information on all trials on Tamiflu. The evidence to the Committee from the Cochrane Collaboration shows that was not the case. We are only able to see this apparent discrepancy because the evidence for Tamiflu has now been subject to half a decade of intensive investigative work by several groups around the globe. This is extremely concerning, and the problem for other treatments may be even greater."
Dr David Tovey, Editor in Chief, The Cochrane Library "Cochrane researchers have dedicated years to demonstrating the deficiencies of published Tamiflu evidence and the current systems of regulation, and we hope that this report will act as an international benchmark, encouraging access to all trials for all treatments.
Today's report is a victory for all those committed to improving awareness and accountability for reporting of clinical trials results; the AllTrials campaign, the indefatigable research team and its supporters, including the UK National Institute for Health Research, which has provided essential funding for Cochrane's drive to uncover the full Tamiflu story, and finally, but most importantly patients."
Commenting on the publication of the Public Accounts Committee report entitled "Access to clinical trial information and the stockpiling of Tamiflu" Bina Rawal Research, Medical and Innovation Director at the ABPI said:
"The ABPI is a strong advocate for transparency in clinical trial data and the role it plays in improving patient care. It is misleading to suggest that the pharmaceutical industry routinely withholds clinical trial data from doctors and researchers.
"In late 2013, an ABPI commissioned study was published in a peer reviewed journal. This study highlighted a positive trend of increasing levels of disclosure for industry-sponsored clinical trials, with almost nine out of ten of all industry sponsored clinical trials disclosed by 31 January 2013a.
"However we recognise that there is still work to be done and we are continuing on a journey to achieving greater clinical trial transparency. The ABPI has made available a new clinical trial disclosure toolkit to assist companies and will continue to engage with key stakeholders on this issue. "
Roche welcomes today's report from the Public Accounts Committee on access to clinical trial information and the stockpiling of Tamiflu® (oseltamivir).
As acknowledged in the report, pandemic influenza is the number one risk on the Government's national risk registry1, recognizing the public health need to ensure adequate plans are in place in order to best manage an influenza pandemic.
Tamiflu is a licensed medicine in over 80 countries2, is NICE approved3, recommended in WHO4 guidelines for the treatment of influenza and one which we are pleased to be able to provide for the benefit of public health.
As the National Audit Office reported in May 2013, regulators are confident that they are provided with all required and requested information5. We stand by the integrity and robustness of the data that supports the efficacy and safety of Tamiflu, and continue to strongly believe that medicines regulators should remain the gatekeeper for medicines assessment and approval.
We support the call for greater transparency in access to clinical trial results. This is why we expanded our policy last year to provide enhanced access to data from our clinical trials. We now release all Clinical Study Reports, Periodic Safety Reports and Summary Reports of clinical data for all licensed, terminated or discontinued medicines via regulatory authorities, and will provide this information on request if it cannot be obtained via regulators themselves.
In line with this policy, the Cochrane Collaboration has now received all 77 completed Roche-sponsored studies in relation to Tamiflu.
We also committed to enabling access to anonymised individual patient level data for third party researchers, and yesterday (2nd January 2014) were pleased to announce that access can now be requested via a shared website. Overall, our Data Sharing Policy goes beyond the European (EFPIA) and American (PhRMA) industry guidelines which came into effect yesterday (2nd January 2014).
For additional information on the Roche data sharing policy, see http://www.roche-trials.com/dataSharingPolicy.action.
i) The AllTrials campaign for all clinical trials to be registered and the results reported was launched on 9th January 2013 by BMJ, the Oxford Centre for Evidence-based Medicine, Bad Science, Sense About Science, the James Lind Initiative, the Cochrane Collaboration and PLOS. It is being led in the US by Dartmouth’s Geisel School of Medicine. The AllTrials.net petition has been signed by over 60,000 individuals and supported by more than 400 organisations from medicine, science, consumer rights and industry including more than 200 patient groups. AllTrials.net
ii) In February 2013 GSK became the first pharmaceutical company to join the campaign and committed to making public Clinical Study Reports for all their approved medicines dating back to the formation of the company in 2000. GSK said they owe it to the thousands of patients who took part in clinical trials to do this. Their full statement can be found here: http://www.alltrials.net/supporters/gsk-statement/
a) The research shows that over three quarters (76%) of all industry-sponsored clinical trials for new medicines recently approved by the European Medicines Agency (EMA) had some results disclosed within a year of completion or of regulatory approval. Rates of disclosure have continued to rise and almost nine in ten (89%) of these trials had disclosed results by 31 January 2013. The research covers new medicines approved between 2009 - 2011, which includes trials conducted over the preceding 10 or more years - i.e. during the entire development program.
1) Committee of Public Accounts, Access to clinical trial information and the stockpiling of Tamiflu. Thirty-fifth Report of Session 2013–14, 3 January 2013
2) Roche data on file.
3) NICE TA168, Amantadine, oseltamivir and zanamivir for the treatment of influenza publications.nice.org.uk - amantadine-oseltamivir-and-zanamivir-for-the-treatment-of-influenza-ta168 (last accessed January 2014.)
4) WHO. WHO Guidelines for pharmacological management of pandemic influenza A(H1N1) 2009 and other influenza viruses. Available at: who.int - h1n1_guidelines_pharmaceutical_mngt.pdf (last accessed June 2013).
5) National Audit Office, Memorandum for the Committee of Public Accounts, HC125 session 2013-2014, Access to clinical trial information and the stockpiling of Tamilfu (last accessed December 2013)
Sense About Science
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