About half of the “innovative” drugs that appear in European pharmacies today turned out to be no better than the old drugs that they replace on sale. The conclusion was made by German researchers from the Institute for Quality and Efficiency in Health Care.

In recent years, scientists and politicians are becoming increasingly concerned about the rapid rise in drug prices and an increase in healthcare spending. Each year, new versions of popular drugs, presumably more effective, appear on the pharmacy shelves, with their prices staying the same or becoming higher. According to many critics of the modern pharmaceutical industry, their development helps large market players to retain the rights to licensed production of drugs which patents are to expire.

Patients Pay More Money for the Same Medicines

A similar situation has arisen around insulin, which doesn’t have a cheap generic version yet, since its manufacturers are constantly creating new, supposedly improved versions of this hormone. Subsequently, prices for some brands of insulin have grown six-fold over the past fifteen years. Some other drugs, such as medicines for HIV patients, have risen in price by several orders as well.

A study published in September 2019 revealed that the efficacy of new (and expensive) cancer drugs approved between 2014 and 2016 has not been proven properly. Among 32 new cancer drugs (oncology list), only 9 had at least one study conducted without serious flaws in the method. While many forms of cancer are difficult to treat, there is social pressure to make new drugs appear faster on the market, since it gives hope to affected cancer patients, while additional research can be done later. Unfortunately, the statistic is disappointing: only 20% of cancer drugs actually had positive effect on life expectancy.

Conclusions based on short-term or flawed clinical studies can give a distorted picture of drug benefits and create a serious risk for patients. Panobinostat, a drug used for multiple myeloma treatment, did not help patients live longer, but was found to cause infections and bleeding. The new promising diabetes drugs canagliflozin and dapagliflozin, which were recently approved in Europe, have been shown to cause Fournier gangrene. The absence of long-term clinical studies poses a risk that unrevealed side effects will outweigh drug’s benefits.

The researchers have also checked the situation with other brands of “innovative” drugs, which are now entering the markets and pharmacies in Germany. In total, over the past eight years, two hundred drugs have appeared that have been tested by European regulatory authorities and recognized as completely safe for the health of patients. The results were upsetting: only a quarter of the new drugs were significantly more effective than their predecessors. Another 16% were slightly better than old drugs, and the remaining 58% were no better.

Moreover, most of the new drugs were based on the same working mechanism despite the fact they were produced by competing companies at different times. This suggests that the industry spends a lot of money on meaningless clinical trials and at the same time does not engage in real scientific work. Due to such trends, progress in many areas of medicine, as the researchers note, has basically stopped. For example, in psychiatry and diabetes treatment, only 6% and 17% of new drugs were more effective than their predecessors.

This situation has arisen essentially because of the regulatory agencies being focused on safety rather than effectiveness, scientists say. Companies producing anti-cancer drugs, in particular, have used this circumstance to introduce many drugs with unproven benefit. The research suggests that national and international health agencies should radically revise the rules governing the work of pharmaceutical companies, so that they would become more focused on innovation and drug efficacy, rather than just making profit. Health officials should take a more proactive stance, suggests the report. They should not wait until pharmaceutical companies decide to develop a particular medicine, but assign tasks and apply measures that will help develop the drugs that are needed to treat patients right now.

All of the above, however, doesn’t mean that no revolutionary methods of treatment were discovered in the recent years. Top medical advances of the last decade include human genome discoveries, stem cell research, heart disease treatment, targeted cancer therapies, robotic surgery, and drug therapies extending HIV patients survival. New promising drugs of 2019 include PRI-002 for the treatment of Alzheimer’s disease, esketamine for fighting against treatment-resistant depression, sotagliflozin with strong efficacy and safety results for managing type 1 diabetes, golodirsen as a gene therapy for Duchenne Muscular Dystrophy (DMD), and some other drugs in various categories.

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