Drug Development In Europe Early Days

Clinical pharmacology, the science of drug actions in humans, started its development in the 19th century. Test animals were increasingly used in pharmacology research. In France, Francois Magendie (1783-1855) played a prominent role. He is known to many for his description of the foramen of Magendie in the brain but could be thought of also as one of the most important founders of modern pharmacology. Czech Jan Evangelista Purkinje (1787-1869), whose name is linked to large nerve cells in the brain (Purkinje cells) and to conducting tissue in the heart (Purkinje fibers), was one of the first to study drugs in healthy subjects, an unusual step, to avoid interference by illnesses when studying drug characteristics [4]. In 1805, German pharmacist Friedrich Serturner isolated the pure active ingredient in opium. He named this chemical morphine, after Morpheus, the Greek god of dreams. Serturner's discovery was the first isolation of an active ingredient. For many years he experimented on himself and others to explore the effects of the alkaloid.

In the 17th century, a controlled study design was described. Jan Baptista van Hellemont (1578-1644), a physician in Brussels, had proposed to his opponents to settle a dispute about wound treatments. Several hundred patients were to participate in an experiment, with vitriol or bloodletting treatments assigned by lottery to each individual patient. Results were to be judged by "the number of funerals" on each side. It is only in the 20th century that the randomized controlled study design became generally accepted. The double blind randomized study conducted in the late 1940s by the British Medical Research Council confirming the effect of streptomycin on tuberculosis was to become a classical example. With the emergence of the chemical industry in the second half of the 19th century, drug manufacturing by chemical synthesis became possible and a number of pharmaceutical companies emerged.

Several drugs to treat serious diseases were discovered. Due to insufficient pharmacological knowledge those drugs were probably too easily introduced. The American government realized an important role to play. Legislation in 1938 and later in 1962 required manufacturers to show respectively safety and efficacy of drugs. The American example was followed in Europe with some delay. In the Netherlands the first such legislation was introduced in 1958. But it was only after the thalidomide tragedy in the 1960s that an official agency to evaluate drugs started to operate efficiently in this country. Similarly, in the United Kingdom it was not until the Medicines Act was introduced in 1972 that evidence of efficacy as well as safety was required as a condition for granting a product license.

The legal obligation to demonstrate safety and efficacy before market introduction stimulated the development of clinical pharmacology as a new scientific discipline. The development of clinical pharmacology is a logical consequence of the pharmaceutical revolution in the beginning of the 20th century and the increasing contribution that drug treatments have made to medical practice in the second half of the century [4, 5].

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