NOTe doctors, pharmacists, statisticians, researchers, scientists, involved in the care and clinical trials evaluating new drugs for people with cancer, are concerned about the emergence of a discourse questioning the scientific knowledge on which based on the medical assessment.
In particular, it appears that the most effective method for assessing the efficacy of therapeutic innovations, the randomized trial, is gradually being discarded to facilitate ever earlier access to new treatments. This dynamic has various disadvantages: it involves medical risks, can generate excessive hopes for sick people, as well as for health professionals, and constitutes, as we will see, a scientific setback.
The evaluation of the effectiveness of care in medicine is recent. Randomized trials, consisting of randomly assigning treatments to groups of comparable patients in order to avoid bias, were set up after the Second World War, then generalized to evaluate a new treatment. As early as 1970, the American Food and Drug Administration thus required, for their authorization, the results of such trials, marking the beginning of “scientific”, “evidence-based” medicine (EBM for “evidence-based medicine”). Introduced in the 1990s, it defines the levels of uncertainty associated with the various studies. Unlike randomized trials, expert opinions and results of patients receiving a new treatment carry a significant risk of erroneous conclusions.
In response to the AIDS crisis, rapid authorization procedures for new drugs were implemented in the United States, then in Europe in the early 1990s, for potentially fatal diseases without an effective therapeutic solution. New drugs are thus accepted by authorization agencies without a randomized trial, particularly in oncology. The benefit of these treatments, evaluated in the short term, is therefore uncertain, or even not found in the long termwhile their price is high.
Accelerated procedures
The implementation of accelerated procedures is part of a criticism of EBM, discarding randomized trials in favor of “personalized”, “precision” or “individualized” medicine offering each person a treatment adapted to the characteristics of his tumor. It responds to the request of certain oncologists for rapid access to new therapies based solely on a mechanism of action, without their effectiveness having been established. Patients too, whose involvement in the evaluation of drugs has increased since AIDS, participate in these demands. Finally, stories of often tragic individual experiences in the media are exploited.
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