More than half of 'new' drugs are no better than established treatments

More than half of 'new' drugs are no better than established treatments, research suggests.

A study assessed the more than 200 medications that entered the German market between 2011 and 2017, many of which were approved for use across Europe.

Only a quarter of these were judged to have a 'considerable or major added benefit' over the drugs that are already available.

These benefits may relate to a lower risk of early death, reduced symptoms or an improvement in quality of life.

For 125 (58 per cent) of the treatments, there was insufficient evidence to prove the drugs were any better than already-available equivalents, the study found.

More than half of 'new' drugs are no better than established treatments, according to researchers who found only around a quarter were a noticeable improvement  (stock image)

More than half of 'new' drugs are no better than established treatments, according to researchers who found only around a quarter were a noticeable improvement  (stock image)

The research was carried out by the technology assessment agency IQWiG in Germany and led by Dr Beate Wieseler, head of the department of drug assessment.

All drugs must be authorised before they can be made in the EU.

The European Medicines Agency (EMA) assesses a treatment by looking at information collected from laboratory tests and clinical trials.

If the benefits of a medication are deemed to be greater than its risks, the EMA recommends it to the European Commission for marketing across the EU and the European Economic Area, which includes the EU27 and Iceland and Norway.

The Food and Drug Administration (FDA), which regulates drugs in the US, has a similar system. 

The approval and development of a drug may be sped up if it is thought to benefit patients, the researchers wrote in The BMJ.

But research dating back to the 1970s suggests only a limited number of these accelerated treatments are any better than existing options.

To better understand the extent of this, the IQWiG looked at the 216 drugs that entered the German market between 2011 and 2017.

By law, the IQWiG must investigate the added benefits of new drugs over standard care by looking at 'evidence contained in the dossier within three months after market entry'.

Almost all of the 216 drugs were approved by the EMA for use throughout Europe.

Yet only 54 (25 per cent) were judged to have a major added benefit.

And 35 (16 per cent) had a benefit that was either minor or could not be quantified. 

This was particularly bad in the fields of psychiatry and neurology, where only one of the 18 (six per cent) newly-launched drugs were found to have an added benefit.

Diabetes also failed to measure up, with just four of the 24 (17 per cent) new treatments being better than what we already have.

HOW ARE DRUGS APPROVED IN THE EU? 

All drugs must be authorised before they can be made available to EU citizens.

The European Medicines Agency (EMA) assesses a treatment by looking at information collected from laboratory tests and clinical trials.

If the benefits of a medication are deemed to be greater than its risks, the EMA recommends it to the European Commission for marketing across the EU and the European Economic Area, which includes Iceland and Norway.

The Food and Drug Administration, which regulates drugs in the US, has a similar system. 

The researchers explain that in order to access innovative drugs, limited information may have to be 'good enough' at the time of approval.

However, when they specifically looked at cancer drugs that were approved between 2009 and 2013, they found all were given the green light despite no evidence of a 'clinically meaningful benefit on patient outcomes'.

And several years later, little had changed, the researchers claimed. 

Post-marketing studies, which monitor the safety of a drug after it has been released, are rarely carried out and do not

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