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FDA Shouldn’t Keep Safe Drugs off the Market

Summary:
Enter Covid-19, the disease caused by the new coronavirus, SARS-CoV-2. There are no proven therapies to treat an infection of that virus. One of the most promising candidates is Gilead Sciences ’ remdesivir, which has shown some potential in treating other coronaviruses, such as SARS and MERS. Due to its use in treating Ebola infections, remdesivir is known to be generally safe. With the FDA’s two-hurdle requirement in place, however, remdesivir must be proven effective in clinical trials before it can be sold for widespread use in Covid-19. These clinical trials take time, and they still won’t answer many of the questions doctors have about the drug’s use against Covid-19 now. What’s the right dose to get remdesivir into the lungs? How early should it be given?

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FDA Shouldn’t Keep Safe Drugs off the Market

Enter Covid-19, the disease caused by the new coronavirus, SARS-CoV-2. There are no proven therapies to treat an infection of that virus. One of the most promising candidates is Gilead Sciences ’ remdesivir, which has shown some potential in treating other coronaviruses, such as SARS and MERS. Due to its use in treating Ebola infections, remdesivir is known to be generally safe.

With the FDA’s two-hurdle requirement in place, however, remdesivir must be proven effective in clinical trials before it can be sold for widespread use in Covid-19. These clinical trials take time, and they still won’t answer many of the questions doctors have about the drug’s use against Covid-19 now. What’s the right dose to get remdesivir into the lungs? How early should it be given? If it is given to sick patients already on ventilators in hospitals, will it help? All these things will depend on the individual patient.

This is from Charles L. Hooper and David R. Henderson, “FDA Shouldn’t Keep Safe Drugs Off the Market,” Wall Street Journal, March 25 (March 26 print edition.)

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David Henderson
David Henderson is a British economist. He was the Head of the Economics and Statistics Department at the OECD in 1984–1992. Before that he worked as an academic economist in Britain, first at Oxford (Fellow of Lincoln College) and later at University College London (Professor of Economics, 1975–1983); as a British civil servant (first as an Economic Advisor in HM Treasury, and later as Chief Economist in the Ministry of Aviation); and as a staff member of the World Bank (1969–1975). In 1985 he gave the BBC Reith Lectures, which were published in the book Innocence and Design: The Influence of Economic Ideas on Policy (Blackwell, 1986).

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