More than half of ‘new’ drugs are no better than established treatments

By | July 11, 2019

Pointless pills? More than half of ‘new’ drugs are no better than established treatments at reducing the risk of early death, easing symptoms or improving quality of life

  • A study assessed 216 drugs that entered Germany between 2011 and 2017 
  • Only a quarter were judged to have a ‘considerable or major added benefit’ 
  • 58% had insufficient evidence to prove they were better than existing drugs

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 occur the world over, they added.

Analyses have shown only half of these studies are completed on time or within five to six years. 

The results also found the new drugs that do have a benefit often only help small groups of patients.

‘For the overall patient population, the current output of drug development may thus be resulting in even less progress than our assessments suggest,’ the researchers wrote. 

However, Professor Justin Stebbing, research professor of cancer medicine and medical oncology at Imperial College London, argued: ‘We’re moving towards personalised medicine which means treating the right person at the right time with the right drugs. 

‘Each one might be treated differently, but the benefits of treating a small proportion of patients for those might be much higher, without effecting the entire patient population.’

The researchers stress both patients and doctors ‘deserve impartial and complete information on what to expect from a certain treatment’.

However, information gaps on the benefits of a treatment and how it compares to others, make this ‘impossible’.

‘As a consequence, patients’ ability to make informed treatment decisions consonant with their preferences might be compromised,’ the researchers wrote.

‘And any healthcare system hoping to call itself ‘patient centred’ is falling short of its ethical obligations.’ 

The researchers want regulating bodies to be less tolerant of short drug-development trials.

In order to prove a treatment’s efficacy and safety, studies should be long-term, large and randomised controlled, they added.

A randomised-controlled trial has a similar number of patients assigned to different treatment groups.

One group is given the intervention being tested, while the other is given an alternative treatment, a placebo or nothing at all.

The groups are followed to determine how effective the intervention is, with outcomes being measured and compared at set times. 

Dr Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, who was not involved in the study, said: ‘Carrying out the necessarily larger trials prior to marketing is an obvious solution. 

‘But, under the current system would be more expensive and slower. 

‘Increasing the price of drugs and delaying their use in patients would be the result, but it may or may not be a price worth paying.’ 

The researchers also want reimbursement and pricing decisions to ‘avoid incentivising marginal outcomes for patients or outcomes based on highly uncertain evidence, but rather reward the achievement of relevant outcomes’.

Over the long term, they hope health policy makers will be more proactive in drug development.

‘Rather than waiting for drug companies to decide what to develop, they could define the health system’s needs and implement measures to ensure the development of the treatments required,’ the researchers wrote.

‘Combined action at EU and national levels is required to define public health goals and to revise the legal and regulatory framework.

‘[This includes] introducing new drug development models, to meet these goals and focus on what should be the main priority in healthcare: the needs of patients.’

Professor Ken Paterson, honorary senior research fellow at the University of Glasgow, who was not involved in the study, said: ‘It is completely true most new medicines offer little or no clinical benefit over existing treatments. 

‘While having an impact on the disease they are trying to treat, they are often no better than the medicines we already have.’ 

‘Understandably, patients want access to medicines that can help them as soon as possible. 

‘However, pressure to speed up the drug development process means more new medicines are coming to the market with less evidence of added clinical value, because we don’t have the research data. 

‘This has a negative impact on patients and the healthcare system, as clinicians can’t accurately advise individual patients whether the new drug is better than existing treatments for them.’

Dr Richard Torbett, executive director of commercial policy at the Association of the British Pharmaceutical Industry, said: ‘The UK has robust measures in place to ensure medicines and vaccines are both clinically and cost effective before they can be used in the NHS. 

‘A medicine that can’t demonstrate value is unlikely to be recommended for use.

‘Often we find studies making similar claims invariably take a very narrow view of what constitutes “value” that ignores issues that are important to patients.’


Health News | Mail Online