When it comes to healthcare, it turns out that new does not necessarily mean better. According to the findings of a research, published in scientific journal The BMJ, more than half of the new drugs entering the German healthcare system have not shown any new benefit.
Dr Beate Wieseler and her colleagues at the German health technology assessment agency IQWiG (Institute for Quality and Efficiency in Health Care) say that international drug development processes and policies are responsible for this lapse and must be reformed.
For the study, IQWiG assessed 216 medicines that were launched in Germany between 2011 and 2017. Most of these were approved by the European Medicines Agency (EMA) for use throughout Europe. Their analysis found that only a quarter of the new drugs brought any significant benefits over the existing treatments. The rest had only minor or no benefits, or the impact of the medicine was unknown.
The study found that only 54 (25%) drugs were judged to have a considerable or major added benefit. While in 35 (16%), the added benefit was either minor or could not be quantified. For the other 125 (58%) drugs, the available evidence did not prove an added benefit over the standard care in the approved patient population.
More particularly, the researchers realised that the situation is more shocking in some specialties. For instance, in psychiatry/neurology and diabetes, added benefit was seen in just 6% and 17%, respectively, of assessments. Even in the drugs that did show significant benefit, most of the research could only apply to sub-groups. “For the overall patient population, the current output of drug development may thus be resulting in even less progress than our assessments suggest,” the study reports.
The study’s authors have said that some within the healthcare industry argue that limited information on a drug at the time of its approval is how things have always been done and it is simply the ‘price to be paid’ to provide patients with early access to new drugs.
However, to refute this claim, the researchers revisited a study on cancer drugs that were evaluated by EMA and was conducted between 2009 and 2013. The study had found that most drugs had been approved with little evidence of any benefits to cancer patients’ quality of life or survival chances. After following up on the cancer drugs’ success rates, researchers found that little had changed on the effectiveness of the drug.
The study also reports that drugs almost never undergo post-marketing studies after being initially approved and, even when a drug is found to be ineffective, regulators globally have failed to punish non-compliant manufacturers. “As a consequence, 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,” says the study.
The study reaffirms that healthcare professionals and patients have the right to impartial and complete information on what is to be expected from a certain treatment, including information on the benefit of alternative treatments or no treatment. But this, as the study reports is not possible with the current information gaps.
Therefore, the authors have recommended a much stricter drug approval process that demands stronger evidence from long-term studies conducted on large, randomised control groups. Furthermore, ideally even after a drug is approved, research should continue to fill in any and all information gaps that may remain.
The study also recommends changing the way these drugs are priced and incentivised—vague and unclear results are being rewarded with monetary gain, when actual tangible results should be the only final outcome that produces profit.
In the longer term, health policy-makers need to take a more proactive approach, the authors suggest. “Rather than waiting for drug companies to decide what to develop, they could define the health system’s needs and implement to ensure the development of the treatments required.”
