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Posted On: 09/29/2019 8:14:37 AM
Post# of 155822
Yes grateful
. Delay probably intentional, FDA is fine with making type I errors, type II, not so much. Leronlimab combo delays are a type I error if I have ever seen one.
https://www.clarionledger.com/story/opinion/c...407350002/
In the performance of this task, FDA officials can make two types of errors — statistically known as the type I error and type II error. With respect to the FDA, a type I error is the rejection or delayed approval of a drug that is safe and effective — erring on the side of over-caution — and a type II error is the approval of a drug that has unanticipated dangerous side effects, or erring on the side of under-caution.
“The FDA is prone to overcaution because the fundamental nature of politics demands it. If the agency approves a drug or device that later is found to be unsafe in some way, the public and politicians blame FDA for the error. However, if the agency delays when reviewing applications, the patients who need experimental new treatments are worse off. Some may die waiting for FDA to act, but neither they, nor their families are likely to be aware that a possible treatment exists—or that it was blocked by the FDA. Because no political pressure comes to bear for making the latter type of mistake, FDA’s natural tendency is to avoid making the first type of error.”
Let’s look at some of the history of the FDA’s erring on the side of over-caution. Beta blockers reduce the risk of secondary heart attacks and were widely used in Europe during the mid-1970s. The FDA imposed a moratorium on approvals of beta blockers in the U.S. because of their carcinogenicity in animals. Finally, in 1981, the FDA approved the first such drug, boasting that it might save up to 17,000 lives per year. That means that as many as 100,000 people died from secondary heart attacks waiting for FDA approval. (http://tinyurl.com/ydxpvd54). Those people are in the “invisible graveyard,” a term to describe people who would have lived but died because the cure that could have saved them was bottled up in the FDA’s regulatory process.
. Delay probably intentional, FDA is fine with making type I errors, type II, not so much. Leronlimab combo delays are a type I error if I have ever seen one. https://www.clarionledger.com/story/opinion/c...407350002/
In the performance of this task, FDA officials can make two types of errors — statistically known as the type I error and type II error. With respect to the FDA, a type I error is the rejection or delayed approval of a drug that is safe and effective — erring on the side of over-caution — and a type II error is the approval of a drug that has unanticipated dangerous side effects, or erring on the side of under-caution.
“The FDA is prone to overcaution because the fundamental nature of politics demands it. If the agency approves a drug or device that later is found to be unsafe in some way, the public and politicians blame FDA for the error. However, if the agency delays when reviewing applications, the patients who need experimental new treatments are worse off. Some may die waiting for FDA to act, but neither they, nor their families are likely to be aware that a possible treatment exists—or that it was blocked by the FDA. Because no political pressure comes to bear for making the latter type of mistake, FDA’s natural tendency is to avoid making the first type of error.”
Let’s look at some of the history of the FDA’s erring on the side of over-caution. Beta blockers reduce the risk of secondary heart attacks and were widely used in Europe during the mid-1970s. The FDA imposed a moratorium on approvals of beta blockers in the U.S. because of their carcinogenicity in animals. Finally, in 1981, the FDA approved the first such drug, boasting that it might save up to 17,000 lives per year. That means that as many as 100,000 people died from secondary heart attacks waiting for FDA approval. (http://tinyurl.com/ydxpvd54). Those people are in the “invisible graveyard,” a term to describe people who would have lived but died because the cure that could have saved them was bottled up in the FDA’s regulatory process.
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