History
Benoxaprofen was discovered by a team of Lilly chemists at its British laboratory. This laboratory was assigned to explore new anti-arthritic compounds in 1966. Lilly applied for patents on benoxaprofen seven years later and also filed for permission from the FDA to start testing the drug on humans. It had to undergo the three-step clinical testing procedure required by the Federal Government.
Lilly began Phase I of the progress by testing a handful of healthy human volunteers. These tests had to prove that the drug posed no clear and immediate safety hazards. In Phase II a larger number of human subjects, including some with minor illnesses, was tested. The drug’s effectiveness and safety was the major target of these tests. Phase III was the largest test and began in 1976. More than 2,000 arthritis patients were administered the drug by more than 100 doctors. The doctors reported the results to the Lilly Company.
When the company formally requested to begin marketing the drug in January 1980 with the FDA, the document consisted of more than 100,000 pages of test results and patients’ records. Benoxaprofen was first marketed abroad: in 1980 the drug was released for marketing in the UK. It came on the market in May 1982 in the USA.
When benoxaprofen was on the market as Oraflex in the USA the first sign of trouble came for the Lilly Company. The British Medical Journal reported in May 1982 that physicians in the UK believed that the drug was responsible for at least 12 deaths, mainly caused by kidney and liver failure. A petition was filed to have Oraflex removed from the market.
On the fourth of August 1982 the British government temporarily suspended sales of the drug in UK ‘on grounds of safety’. The British Committee on the Safety of Medicines declared, in a telegram to the FDA, that it had received reports of more than 3,500 adverse side-effects among patients who had used Oraflex. There were also 61 deaths, most of which were of elderly people. Almost simultaneously, the FDA said it had reports of 11 deaths in the USA among Oraflex users, most of which were caused by kidney and liver damage.
The Eli Lilly Company suspended sales of benoxaprofen that afternoon.
Read more about this topic: Benoxaprofen
Famous quotes containing the word history:
“Culture, the acquainting ourselves with the best that has been known and said in the world, and thus with the history of the human spirit.”
—Matthew Arnold (1822–1888)
“History does nothing; it does not possess immense riches, it does not fight battles. It is men, real, living, who do all this.... It is not “history” which uses men as a means of achieving—as if it were an individual person—its own ends. History is nothing but the activity of men in pursuit of their ends.”
—Karl Marx (1818–1883)
“Look through the whole history of countries professing the Romish religion, and you will uniformly find the leaven of this besetting and accursed principle of action—that the end will sanction any means.”
—Samuel Taylor Coleridge (1772–1834)