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Tuesday, 22.08.2017

Thomas A. Ban: Psychopharmacology. Baltimore: Williams and Wilkins; 1969

Leon S. Morra’s Extracts 5
Part One, Chapter One: General Principles
C. Legal and Ethical Considerations          

 

This section is divided into two parts: 1. General Aspects, and 2. Special Aspects.

            Part 1. “Human experiments have been instrumental in the development of medical skill. For many centuries they were not controlled by legislation but were bound essentially by the code of approval-dependence of the scientific fraternity… In the middle of the 19th century (Claude) Bernard asserted that ‘physicians conduct therapeutic experiments daily.’ He felt that ‘it is the duty and the right of the physician to perform an experiment on man whenever it can save his life, cure him or gain him some personal benefit.’ He did not think in terms of legal jurisdiction but spoke of ‘the principle of medical and surgical morality’, which ‘consists of never performing an experiment on man which might be harmful to him to any extent, even though the results  might be highly advantageous to science’, i.e., to the health of others."

            “…the first systematic presentation on the legal aspects of human experiments was documented in the Nuremberg Code (1947)."

            “The Rules of the Nuremberg Code were adopted in the United States by the American Medical Association. They emphasized particularly three of the ten articles, i.e., voluntary participation, animal experiments and proper medical protection."

“The most recent guiding principles on human experimentation were incorporated in the Declaration of Helsinki (1964).”

Part 2. “Not too long ago, and even now in certain parts of the world, the protection of the public from the toxic effects of drugs was entirely a moral-ethical problem between the patient and his physician. But with the change from the use of the physician's own preparations and small pharmacy to the establishment of the big pharmaceutical houses, there was a gradual shift toward the view that this protection should be provided by legal jurisdiction."

            “In the United States, Congress made its first attempt to exert some control on drugs by passing the first Pure Food and Drug Act in 1906. An amendment in 1912 gave the government the authority to prosecute any false therapeutic claims if fraudulent intent was involved… The Federal Food and Cosmetic Act, finally enacted in 1938, made provisions which required that the manufacturer not only test the safety of his drug but also report on this safety to the FDA before marketing the product… In 1951 the Humphrey-Durham Amendment was enacted, which distinguished for the first time between drugs which required a medical prescription and those which could be sold without a prescription."

“The United Sates FDA has recently amended its regulation with a statement of policy formulated by Goddard (1966) regarding consent for use of investigational new drugs in humans.” 

 

León S. Morra   

March 09, 2017