LONDON, Feb 10 (APM) - Drug regulators must not swap randomised clinical trials for less thorough research in order to shorten the time to market for new medicines, the head of the World Health Organization (WHO) has said.
Speaking at an event at the University of Washington, Margaret Chan said in what appeared to be a reference to U.S. president Donald Trump's election campaign that in a "post truth and post fact world, views that appeal to emotions and personal views are more influential than objective evidence based on science".
"We need to defend science and evidence like never before," said Chan, whose talk on Wednesday is available as a webcast.
Although she did not mention any person or organisation in particular, she said that she was seeing a "disturbing trend" in calls to limit the power of regulatory agencies in order to speed up approval times for new drugs.
Trump said after meeting with U.S. pharma leaders last month that he is looking to appoint a new head of the U.S. Food and Drug Administration (FDA) who will streamline the organisation (APMMA 51589).
The industry has also been critical of the FDA, with Pfizer's chief executive Ian Read saying in December last year that the agency is beset by deep-seated problems fuelled by criticisms which results in a bias against accelerating innovation (APMMA 50894).
Chan is keen for regulators such as the FDA to stay strong when facing industry pressure, saying: "regulatory agencies everywhere must resist the push to replace randomised clinical trials - for a long time the gold standard for approving new drugs. Do not allow them to be replaced with research summaries provided by the pharmaceutical companies."
She added that it was true that making these changes lowers costs to the industry and gets products onto the market sooner, but that it would come at a cost, asking people not to forget the thalidomide 'disaster', when a morning sickness drug taken by pregnant women in the 1950s and 1960s led to thousands of children being born with birth defects.
"Allow me to argue this kind of thinking is extremely dangerous. We must not let anything, including economic arguments or industry pressure, lower our scientific standards or comprise our integrity. This is an absolute duty."
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