Researchers from the London
School of Economics and Political Science (LSE) and the United States say that
many US patients with serious illnesses are being treated by drugs which have
questionable data.
The findings,
published in The Milbank Quarterly, relate to
drugs given "accelerated approval" by the Food and Drug
Administration (FDA) without any strong clinical evaluation.
The study assessed 37 new
drugs given accelerated approval by the FDA between 2000 and 2013.
Drugs eligible for
accelerated approval are assessed as "reasonably likely" to provide
clinical benefits but the bar for their market entry is far lower than those
receiving regular approval, according to Dr Huseyin Naci, an LSE health policy
researcher.
Dr Naci said: "FDA's
accelerated approval pathway allows potentially promising drugs to receive
marketing authorisation on the basis of surrogate measures that are easy to
obtain, rather than clinically meaningful outcomes. The evidence ultimately
accrued on these drugs has major flaws and is inadequate to address the
information needs of patients and doctors."
The study is the first in
the world to systematically evaluate more than 7000 clinical studies conducted
on drugs receiving accelerated approval by the FDA.
Dr Naci said the
shortcomings were as a result of the FDA introducing more flexibility to its
evidence standards over the past three decades.
The key findings reported
by Dr Naci and his colleagues from the University of Pennsylvania and Stanford
University included:
§ Randomised
trials - the gold standard of evaluating clinical effectiveness - constituted
only a small minority of existing evidence;
§ One-third
of randomised trials were in therapeutic areas outside of FDA approval and less
than half evaluated the therapeutic benefit of these drugs, but used them
instead as common backbone treatments;
§ Drugs
receiving accelerated approval were often tested concurrently in different
therapeutic areas;
§ For
most drugs no substantial time lag was apparent between the average start date
of trials evaluating their effectiveness and their use as background therapy.
Article: Timing and Characteristics of Cumulative Evidence Available on
Novel Therapeutic Agents Receiving Food and Drug Administration Accelerated Approval,
Dr Huseyin Naci et al., The Milbank Quarterly,
doi: 10.1111/1468-0009.12261, published 6 June 2017.
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