World Health Organization Demands Pharmaceutical Companies Stop Withholding Clinical Trials as Study Finds Over Half of Registered Clinical Trials Are Never Published
In the United States, the FDA has the power to fine drug companies $10,000 a day for failing to publish clinical trials, yet most clinical trials still never see the light of day.
Shocking as it may seem, it is currently fairly standard practice for drug companies to withhold clinical trials with negative results, allowing doctors to blindly prescribe drugs that don't work or are even dangerous. In the United States, failing to publish clinical trials is punishable by a fine of $10,000 per day, but shockingly the fine has never actually been issued as Dr. Ben Goldacre explains in his editorial in PloS Medicine. This is particularly unbelievable given that a recent study found that more than half of the clinical trials registered on clinicaltrials.gov within a given time period were never actually published (within the time period allowed by law). An earlier study, which found similar results, also demonstrated that even when the results are published, negative side effects and even serious adverse events are routinely left out of the published version.
Now, the World Health Organization (WHO) has joined in the chorus calling for the registration and publication of all clinical trials, by issuing a definitive statement. The WHO has demanded that all clinical trials are registered in a publicly available, free-to-access database before any trial is initiated and that the main findings of any study are submitted to an open-access, peer-reviewed journal within 12 months of completion, or otherwise be made publicly available within 24 months.
Sadly, the WHO’s demands are not legally binding. The WHO is merely the latest in a very long list of organizations to call for the publication of clinical trials:
Just in case you’re reading this on your mobile, here’s that list in text form. I hope you have your scrolling finger ready:
I think it is fair to say that the consensus is resounding. There is no excuse for the status quo. The surprisingly fascinating tale of how we came to be in this mess and why it matters such a great deal is told expertly by medical doctor and master storyteller Dr. Ben Goldacre, the brainchild of the All Trials campaign, in the book Bad Pharma. Don’t worry, you don’t need to be a doctor, a scientist, or an academic to understand it or find it interesting or useful, but if you do happen to be a doctor, you should certainly read it (if you haven’t already).
For the spark notes, check out Goldacre’s TED talk on the topic:
And/or his more recent and more detailed talk at the International Forum on Quality and Safety in Healthcare:
Goldacre B. (2015). How to Get All Trials Reported: Audit, Better Data, and Individual Accountability, PLOS Medicine, 12 (4) e1001821. DOI: http://dx.doi.org/10.1371/journal.pmed.1001821
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