TE PUAWAI worse than those on other drugs. Patients on reboxetine were also more likely to have side effects, more likely to dropout of taking the drug, and more likely to withdraw from the 3 trial because of side effects. Ben Goldacre writes:“ I did everything a doctor is supposed to do. I read all the papers, I critically appraised them, I understood them, I discussed them with the patient, and we made a decision together, based on the evidence. In the published data, reboxetine was a safe and effective drug. In reality, it was no better than a sugar pill, and worse, it does more harm than good, As a doctor, I did something which, on the balance of all the evidence, harmed my patient, simply because unflattering data was left unpublished.”
As stated on the AllTrials website( 1), the problem of the missing data also affects some very expensive drugs. Governments around the world spent billions on an antiviral drug called Tamiflu. The UK spent £ 500 million on this one drug in 2009 which was 5 % of the total of the National Health Services’ drugs budget of £ 10 billion. Roche, the manufacturer of Tamiflu, published fewer than half of the clinical trials conducted on it, and continues to withhold important information about these trials from doctors, researchers and the Cochrane Collaboration, the large international non-profit academic collaboration that produces rigorous systematic reviews. The result is that we don’ t know if Tamiflu is any better than paracetamol.
A number of initiatives have been introduced to try to fix this problem, but they have all failed. Since 2008 in the USA the FDA has required the results of all clinical trials to be posted within a year of completion of the trial. However an audit published in 2012 has shown that 80 % of trials failed to comply with this law. Despite this fact, no fines have ever been issued for non-compliance. However, since most currently used drugs came onto the market before 2008, the trial results that are most important for current medical practice would not have been released even if the FDA’ s law was fully enforced.
The AllTrials campaign is calling on governments, regulators and research bodies to implement measures to ensure the publication of the results of all clinical study reports.
It is also calling for all universities, ethics committees and medical bodies to enact a change of culture, recognise that underreporting of trials is misconduct and police their own members to ensure compliance.
The AllTrials website features a petition which states:“ Thousands of clinical trials have not reported their results; some have not even been registered. Information on what was done and what was found in these trials could be lost forever to doctors and researchers, leading to bad treatment decisions, missed opportunities for good medicine, and trials being repeated. All trials past and present should be registered, and the full methods and the results reported. We call on governments, regulators and research bodies to implement measures to achieve this.”
Check out the website and sign the petition.
References 1. http:// www. alltrials. net / 2. Ben Goldacre. Bad Pharma. Fourth Estate. 2012.
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