by Maryanne Demasi, The Pulse:
History shows that hiding clinical trial data can be deadly.
Vioxx is a well-known example of how the US drug regulator withheld important information about the harms of the drug for over three years, before it was withdrawn from the market and tens of thousands of people died as a consequence.
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Numerous initiatives have been launched over the past two decades to improve access to trial data after it became evident that what was reported in peer-reviewed journals was often cherry-picked and misleading.
Eminent scientists have succeeded in gaining access to trial data from the European and Canadian drug regulators, but a recent analysis published in the Journal of Law, Medicine, & Ethics, found that the US FDA still lags behind others when it comes to data transparency.
Europe ahead of the pack
Drug regulators have traditionally been the guardians of a treasure trove of trial data which they kept hidden from the public. But, over a decade ago, the efforts of Danish professor Peter Gøtzsche turned that on its head.
Gøtzsche and his PhD student were studying the effects of an anti-obesity drug and requested the trial data held by the European Medicines Agency (EMA).
“We already had good evidence that the efficacy and harms of drugs were incompletely reported in the medical journals, so by asking for the regulatory data for the anti-obesity pills, we were convinced it would get us closer to the truth”, said Gøtzsche.
At first, EMA denied their request, saying that it needed to protect commercially confidential information, but Gøtzsche was undeterred. He made a formal complaint to the European Ombudsman.
After an arduous 3-year process, the Ombudsman accused EMA of “maladministration” for refusing to share its data – it was a serious and embarrassing charge, so EMA had no choice but to capitulate.
In 2013, EMA announced that it would provide public access to regulatory data – which included study reports, protocols and the raw anonymised patient data in statistical programmes enabling anyone to independently scrutinise the data for all new drugs that it approved.
It was a bitter-sweet moment for Gøtzsche.
“I was satisfied with the outcome, but I also felt a bit betrayed. When EMA praised itself for being transparent, it conveniently omitted telling the public that it was basically forced to make the decision because of my efforts and that of the Ombudsman,” said Gøtzsche.
“I’ve been around a while to know that this is exactly how the drug industry operates. They cover up their failures while praising themselves for what others force them to do,” he added.
Millions of pages containing trial data have since been released. Interestingly though, this remarkable feat has gone largely unrecognised and the response from the research community has been rather tepid.
