More than 50% of new drugs are approved with little evidence that they offer added benefits, researchers claim today.
Experts in Germany questioned the effectiveness of the European Medicines Agency – and called for processes for fast-tracking new drugs to be reconsidered.
Published in The BMJ today, the analysis involves some 216 drugs approved for use in Germany since 2011.
The researchers at the Institute for Quality and Efficiency in Health Care say that just 54 had evidence of "considerable or major" added benefit. In 35 cases the benefit was minor – or unquantifiable.
The researchers say that most cancer drugs approved by the EMA between 2009 and 2013 had no evidence of clinically meaningful benefit.
There is also a dearth of post-marketing studies, they say.
They write: "Combined action at EU and national levels is required to define public health goals and to revise the legal and regulatory framework, including introducing new drug development models, to meet these goals and focus on what should be the main priority in healthcare: the needs of patients.”
Clinicians and patients do not have access to impartial and complete information on these treatments, they say.
They write: "Patients’ ability to make informed treatment decisions consonant with their preferences might be compromised, and any healthcare system hoping to call itself patient centred is falling short of its ethical obligations.”
New drugs: where did we go wrong and what can we do better? BMJ 11 July 2019
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