New drugs, new tests: Can we trust them?

Abstract

Very few drugs utilized frequently in audiological medicine have undergone rigorous methodological testing to prove their efficacy. The employment of drugs on patients with dizziness, tinnitus, Meniere's disease or sudden sensorineural hearing loss is determined by empirical not scientific premises. Recent progress in genetics, molecular biology and neurobiology raises expectations that a breakthrough will be made before long for the treatment of certain audiological pathologies. While we are keen to see this progress delivered, we need to proceed with caution in the face of the proposed advances. Over the last few years, 'biotech' drugs, which utilize biotechnologies together with recombinant DNA, have had much media and scientific coverage. Controls carried out recently on the drugs (1,2) seem to put things into perspective, demonstrating that only a small proportion can represent true progress compared with conventional products. In a recent article published in the British Medical Journal entitled 'Disappointing Biotech', Joppi et al. (1) assessed the biotechnology medicines approved by the European Medicine Evaluation Agency from its inception in 1995 to 2003 (3). During this period, the agency approved 87 biotechnology products, corresponding to 65 active ingredients. Four were approved for diagnostic purposes. The 61 active substances were classified according to the type of benefit provided compared with existing treatments or placebo, as appropriate. Only 15 (24.5%) pro- ducts signified therapeutic innovation, namely, drugs for diseases without effective treatment, more effec- tive than existing treatment, or active in patients resistant to current treatment. Twenty-two (36%) offered limited non-therapeutic advantages over existing products (10 in terms of safety and 12 in terms of cost benefit), and 24 (39%) were copycat products. Dosage finding studies were carried out for only seven of the 15 innovative substances. Only 11 had their efficacy and safety tested in randomized control studies.