3 ms·

I don't think your view of the situation is any less biased. The problem is that there is very little incentive to ever reject a drug. Shorting is the only ca

I don't think your view of the situation is any less biased. The problem is that there is very little incentive to ever reject a drug. Shorting is the only case I can think of and even that assumes the drug in question is important enough to actually move share price. Remember the FDA is primarily concerned with a drug not harming people, the extent to which it's actually beneficial is of secondary interest at best: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/default.htm http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugs...

cowsandmilk 11y ago
> Remember the FDA is primarily concerned with a drug not harming people, the extent to which it's actually beneficial is of secondary interest at best Uh... no. Just from that page, it states the FDA ensures "that drugs and devices are safe and effective for their intended uses". If safety was the only concern: 1) Why does the FDA approve indications? 2) Why has there been prosecution (possibly violating the first amendment) for promotion of off-label uses? 3) Why does the FDA have a "breakthrough" designation that fast tracks approvals solely based on their effectiveness? 4) Why do Pharma companies frequently run new trials using different end points in an effort to get a drug approved when the original end points they used showed no effect? Why have there been cases when the FDA didn't approve a drug because they declared the end point used in the clinical trials was meaningless for the indication? I think it is fairly clear that a shitload of time and resources at the FDA are spent deciding whether drugs are effective and if the data from the pharmaceutical company shows effectiveness. Edit: I should also add the whole DESI review[1] in the 1960's shows your statement is complete nonsense. Drugs that the FDA previously approved for safety before 1962 were re-analyzed to classify their efficacy. So, the FDA reanalyzed thousands of drugs they had already determined were safe to look at whether they were effective. [1] https://en.wikipedia.org/wiki/Drug_Efficacy_Study_Implementation https://en.wikipedia.org/wiki/Drug_Efficacy_Study_Implementa...
- anthony_d 11y ago
  From the entire page you found the one case where the word "effective" is used and it's used after the word "safe". Here's what the page says about new drug applications: The IND application must contain information in three broad areas: * Animal Pharmacology and Toxicology Studies - It must be reasonably safe. * Manufacturing Information - The company can make consistent batches of the drug. * Clinical Protocols and Investigator Information - Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose subjects to unnecessary risks. The 3 requirements around the new drug application are all safety based. Later on they look at efficacy, but it's later in the process. Efficacy doesn't mean it has to be very effective just somewhat. Read the references for your Wiki page, the FDA is concerned with removing harmful drugs.

cowsandmilk 11y ago

> Remember the FDA is primarily concerned with a drug not harming people, the extent to which it's actually beneficial is of secondary interest at best Uh... no. Just from that page, it states the FDA ensures "that drugs and devices are safe and effective for their intended uses". If safety was the only concern: 1) Why does the FDA approve indications? 2) Why has there been prosecution (possibly violating the first amendment) for promotion of off-label uses? 3) Why does the FDA have a "breakthrough" designation that fast tracks approvals solely based on their effectiveness? 4) Why do Pharma companies frequently run new trials using different end points in an effort to get a drug approved when the original end points they used showed no effect? Why have there been cases when the FDA didn't approve a drug because they declared the end point used in the clinical trials was meaningless for the indication? I think it is fairly clear that a shitload of time and resources at the FDA are spent deciding whether drugs are effective and if the data from the pharmaceutical company shows effectiveness. Edit: I should also add the whole DESI review[1] in the 1960's shows your statement is complete nonsense. Drugs that the FDA previously approved for safety before 1962 were re-analyzed to classify their efficacy. So, the FDA reanalyzed thousands of drugs they had already determined were safe to look at whether they were effective. [1] https://en.wikipedia.org/wiki/Drug_Efficacy_Study_Implementation https://en.wikipedia.org/wiki/Drug_Efficacy_Study_Implementa...

anthony_d 11y ago
From the entire page you found the one case where the word "effective" is used and it's used after the word "safe". Here's what the page says about new drug applications: The IND application must contain information in three broad areas: * Animal Pharmacology and Toxicology Studies - It must be reasonably safe. * Manufacturing Information - The company can make consistent batches of the drug. * Clinical Protocols and Investigator Information - Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose subjects to unnecessary risks. The 3 requirements around the new drug application are all safety based. Later on they look at efficacy, but it's later in the process. Efficacy doesn't mean it has to be very effective just somewhat. Read the references for your Wiki page, the FDA is concerned with removing harmful drugs.