Only a small number of new drugs made available in recent years in Germany provides a benefit over existing drugs, New Scientist reports.
Researchers from the Institute for Quality and Efficiency in Health Care in Germany analyzed 216 drugs that entered the market there between 2011 and 2017, as they report in the BMJ. Of these, 152 were new molecular entities and 64 were drugs with a new indication, and nearly all were approved by the European Medicines Agency for use throughout Europe.
The researchers found that a quarter of those drugs had a "considerable or major added benefit" while 16 percent had a minor benefit or could not be analyzed. But 58 percent of the drugs did not provide an added benefit over the standard of care, they report.
Based on their findings, the researchers argue short drug development programs should be less acceptable and that regulators should insist on evidence from large, long-term phase III randomized controlled trials to show efficacy and safety.
"Unless we address this, we are afraid the problem will become larger and larger," first author Beate Wieseler from IQWiG tells New Scientist.