New Website Has Been Formed to “Name and Shame” Institutions that Fail to Disclose Buried Drug Trials

Wednesday 21st February 2018

A new website has been created to name pharmaceutical institutions and organisations that fail to disclose the results of drug and medical test, in order to “nudge” them into disclosing legally required data

FDAAA Trials Tracker is named after the Food and Drug Administration Amendment Act 2007 which requires certain categories of clinical trials that involve US citizens to be registered on the government website clinicaltrials.gov. It was set up by Dr Ben Goldacre MBE, a prolific and outspoken doctor and writer best known for the books Bad Science and Bad Pharma, which explored and critiqued the medical industry, both pharmaceutical and alternative.

The Trials Tracker examines which trials have been registered and whether their results have been reported before the deadline.

A long-term theme in his books and the central theme of Bad Pharma is the lack of transparency in clinical trials, which links into accusations that some pharmaceutical companies bury medical and drug test results that show unfavourable results, biasing their findings towards the manufacturer and denying doctor and patient alike the ability to make a reasoned decision regarding medication.

That being said, Dr Goldacre has noted that it is more likely neglect rather than malice that is the cause of a lot of trials lacking proper disclosure, and believes “most institutions” want to comply with their obligations, both ethical and legal. He also notes the best way to drive up standards is accountability.

The way Trials Tracker works is automated; it pulls data from clinicaltrials.gov and flags trials that have missed the 1 year deadline after completion of a trial, as well as calculating the theoretical amount the Food and Drug Administration (FDA) could collect in fines ($10,000 a day), something that Dr Goldacre claims has never been enforced.

There have been a few criticisms of the system, which can be split into two neat central complaints: those that have issues with the technical collection of data and those who have issues with a name-and-shame website completely.

The former includes the FDA which noted that it assesses compliance on a case by case basis, as it argues that it is not always possible to check who is non-compliant based on the record posted on clinicaltrials.gov. Records may be incomplete or require updating that has not been completed on the FDA’s side.

For the latter, it is a matter of the motive of a name and shame campaign, and the issue that to a casual observer it could appear that Trials Tracker is accusing institutions of deliberately withholding results, and that anyone who does appear is committing a crime. This isn’t the case, and Dr Goldacre has stated his belief that the system is proportionate, fair and reasonable. One of the first organisations to respond to the tracker was Imperial College London, who were among the first six named for missing a reporting deadline. They have since reported that they have updated clinicaltrials.gov with the missing results.

It is a simple solution that at a glance highlights an issue in the academic and medical community. The more information disclosed on the effects of medical treatments and medicine on people the more informed doctors and the general public will be, so this initiative can only be a good thing in terms of disclosure.