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According to one study, no evidence of additional benefit in most new drugs



Cologne, Germany – There seems to be a new drug to treat everything and anything at all these days, but are these medications as effective as they claim? A new study concluded that the answer to this question is no. In addition, researchers say that international drug development processes, standards and policies are fundamentally flawed and need to be reformed.

According to the study conducted at the German Institute for Quality and Effectiveness of Health Care, more than half of the new drugs entering the German health system do not present any additional benefits.

Between 2011 and 2017, researchers examined 216 medicines approved by regulatory authorities and introduced on the German market. Most of these evaluated drugs have also been approved by the European Medicines Agency for widespread use throughout the wider Europe.

Alarmingly, only A quarter based on the evidence available. In addition, 16% had an even minor added benefit and 58% of the drugs studied did not show any additional benefit compared to standard patient care.

When drugs were separated by specialty, the results were just as worrying: only 6% of psychiatric drugs had an additional benefit, as did 17% of antidiabetic drugs.

Even in the studied drugs that showed a significant benefit, most of the research could only be applied to subgroups. "For the entire patient population, the current drug development results could therefore lead to even less progress than our assessments suggest," the study says.

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The authors of the study claim that some health actors argue that the information available on a drug at the time of approval is the way things have always been done, and that it is simply price "to provide patients with rapid access to medicines. unprecedented new drugs.

To refute this argument, the researchers re-examined an anti-cancer drug study conducted between 2009 and 2013, which found that most drugs had been approved without much evidence of benefit to patients' quality of life or survival chances. cancerous. After tracking cancer drug success rates, the researchers found minimal additional evidence of the effectiveness of these drugs.

The research team said that the drugs were almost never studied after their initial approval, and even if a drug proved ineffective, the global regulators hardly punished the manufacturers of drugs in violation.

"As a result, the ability of patients to make informed treatment decisions in accordance with their preferences may be compromised, and any health system that hopes to be called" patient-centered "fails to meet its ethical obligations," states Dr. study.

The authors recommend a much stricter drug approval process that requires stronger evidence of long-term studies of large randomized control groups. Even after the approval of a drug, research should continue to fill any gaps in information that may remain.

How these drugs are priced and stimulated should also be reviewed; At the moment, vague and uncertain results are rewarded with monetary gains, while real and tangible results should be the only end result generating profits.

The authors conclude: "A combined action at European and national level is needed to define public health objectives and to revise the legal and regulatory framework, in particular by introducing new drug development models, to achieve these objectives and focus on this. which should be the main priority of health care. : the needs of patients. "

The study is published in the scientific journal The BMJ.

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