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Since early civilizations, people have been concerned about the quality, safety, and integrity of foods and medicines. Curiosity about these matters began thousands of years ago.

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In the Bible's Old Testament, the first chapter of the Book of Daniel describes a clinical trial. After conquering Israel, Nebuchadnezzar, the king of Babylon, ordered that several Jewish youths be brought to his palace to serve for 3 years. The children would be fed and taught just like the king's own children. Among the youths was Daniel, who did not wish to defy Jewish law by eating the king's meat or drinking his wine. Daniel asked that the Jewish youth be allowed to eat peas and beans (“pulse”) and to drink water instead of wine. Melzar, the eunuch assigned to watch over the youth, was hesitant, fearing Nebuchadnezzr's wrath should Daniel and the other youth become ill. Daniel suggested a 10-day experiment of feeding the Jewish youth pulse and water, while the king's servants continued the rich meats and wine as prescribed by the king.

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The result: Daniel 1:15–1:16, King James Version:

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And at the end of ten days their countenances appeared fairer and fatter in flesh than all the children which did eat the portion of the king's meat.

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Thus Melzar took away the portion of their meat, and the wine that they should drink; and gave them pulse.

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The first known English food law was enacted in 1202, when King John of England proclaimed the Assize of Bread, a law prohibiting the adulteration of bread with ingredients such as ground peas or beans (1). One of the earliest food and drug laws in the United States was enacted in 1785, when the Commonwealth of Massachusetts passed the first general food adulteration law regulating food quality, quantity, and branding.

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Since these early times, many events, often accompanied by tragic outcomes, have raised additional concerns related to food and drug safety.

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As we progressed toward more modern times, clinical trials began using specific experimental designs and collected information in numbers rather than in statements such as “looked healthier and better nourished.”

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One of the earliest examples of an experimental design can be traced to 1767 and William Watson, who was the physician for the Hospital for the Maintenance and Education of Exposed and Deserted Children in London, England. At that time, the leading cause of death among children in London was smallpox, and the governors of the hospital ordered that all children who were not already immune to smallpox be inoculated. Although inoculation was already an accepted practice, Watson was curious about the benefit of routinely using mercury as a concomitant treatment with the inoculum.

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In October 1767, Watson performed his first experiment, giving 31 children the same inoculum and then dividing them into three similar groups:

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