The 20th century has witnessed the great benefits of the development of antibi- otics, which became a reality after World War IL More than 50 years ago I witnessed the miraculous therapeutic power of penicillin, when I was a student at the Tohoku University Medical School’s Department of Bacteriology in Sendai, Japan. The late Dr. Kondo was a graduate student in the department at that time and developed the first crude penicillin preparation in Japan which was applied with dramatic results in two patients. Although there was patient-family consent at that time, ethics committees, randomization. mutagenesis tests, distribution studies, purity-criteria, and phar- macokinetics were not yet in existence. Today, regulatory procedures have com- plicated the whole drug-approval process. For example, any new antibiotics that have been proven effective in laboratory studies against gram-negative bacteria, as might exist in deadly plague bacteria, must still undergo a long and enormously costly regulatory process before they can be introduced to benefit society, and before government insurance can be applied.
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