Glossing Over the Truth: Hidden Clinical Trial Data
Tuesday 28 August
By Kirstine McDermid, Research Support Advisor at the University of Leeds
Selective reporting of data of clinical trials in publications is well documented. Some trials are not published at all; others are published incompletely, including studies that only divulge results showing drugs in a favourable light. Large quantities of drug research is commissioned or undertaken by the very same pharmaceutical companies that manufacture them; and these companies can go to great lengths to stop clinical trial data from being made openly available in an attempt to protect their image and maximise sales.
Take for instance a drug company called AbbVie, who in 2013, took out an injunction to prevent the European Medicines Agency from releasing clinical study reports on Humira, a drug used widely to treat rheumatoid arthritis. This world best-selling drug had no available detailed patient data, and there were reported links to cancer.
Releasing clinical trial data from the outset could have quickly helped researchers understand and rectify a number of reported adverse effects of the drug, including the development of various types of cancer reported by some patients taking Humira. Clearly, any drugs with links to cancer, no matter how tenuous the connection, need to have all clinical trial data available to ensure patient safety is put before profits. Patients need to be fully aware of any risks involved before being prescribed a new drug and medicine can only get better through absolute scrutiny.
When clinical trial data is not made openly available, researchers are unable to connect all the dots and thread together evidence-based conclusions to ascertain whether or not one particular drug is more effective, safe or cost effective than another drug or treatment. When clinical trials are locked down offline it impedes progress.
Let’s consider the drug Tamiflu, for example. A number of randomized controlled trials, systematic reviews and meta-analysis presented a favourable efficacy and safety of Tamiflu back in the nineteen-nineties. Just so happened that the research was carried out by Roche, the same company who made the drug. Roche did not make their clinical trial data open.
Tamiflu purported to effectively treat influenza, and WHO, the Centers for Disease and Control and Prevention and the European Medicines Agency made recommendations to stockpile the drug, validating the drug for treating influenza.
In the UK alone, nearly half a billion pounds was spent on stockpiling Tamiflu to prepare us for future flu pandemics. By 2009, 96 countries possessed enough Tamiflu to treat 350 million people, costing in excess of 15 billion pounds.
In 2006, a study undertaken by the Cochrane Collaboration concluded that Tamiflu was ineffective in preventing serious cases and complications of flu.
In order for the Cochrane review to eliminate bias of the previous published trials published by the Roche pharmaceutical company, the Cochrane review team attempted to track down clinical trial reports through freedom of information requests, reviews and information from regulators and other sources. The drug manufacturer provided incomplete reports for some trials, and the review led to conclusions of numerous reporting biases and flaws in the trial design. Previous claims of the effectiveness of the drug were unfounded.
Had the policy makers from WHO, the Centers for Disease and Control and Preventation and the European Medicines Agency been granted access to unpublished clinical trial information, a light would have been shone on the drug’s fundamental inadequacies, saving over 15 billion pounds worldwide.
But let’s put money aside for now. Yes, money wasted by governments on ineffective drugs is abominable, but what is worse is the level of risk to patient safety which is heightened when clinical trial data is glossed over in papers and raw unpublished clinical trial data is left untapped and hidden. The very same clinical trial information that is needed to help researchers, policy makers and clinicians make informed evidence-based decisions to improve the lives of patients.
Researchers, policy makers, clinicians and the patients themselves can engage with the fuller picture of applied medical research by using altmetrics to track unpublished clinical trials.
The Altmetric Explorer for Institutions can be searched by drug, condition, specific trial name, number or pharmaceutical company name to retrieve trials registered by clinicaltrials.gov. The Altmetric data shows any corresponding trial coverage in news, blog posts, Facebook entries, journal articles, Wikipedia entries or policies. It can be a useful research tool for critically appraising unpublished clinical trials as well as tracking supplementary information that is helpful for clinicians, researchers, patients and policy makers to gain access to more evidence to get a better, more complete picture to aid them in decisions to improve health.
Keen to discuss the themes raised in this blog further? Book your place today to join us at the Altmetrics Conference in London!