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The FDA is very risk adverse. If they fail to block a dangerous drug and it kills people then they are blamed - if they block a new drug that might save million
by danieltillett 10y ago
The FDA is very risk adverse. If they fail to block a dangerous drug and it kills people then they are blamed - if they block a new drug that might save millions of people then nobody says anything. The result is an ever increasing series of barriers to get a new drug to market in the name of preventing a bad drug getting through.
The solution is to hold the FDA (and other regulatory agencies) responsible for all deaths - those that occur from allowing a bad drug to market and those that result from delaying or blocking a good drug. Tort reform would also help as a large amount of the problem is caused by drug companies killing drugs in development themselves because of a fear of getting sued later if anything goes wrong. We also need to be a little more pragmatic as consumers and accept that drugs are risky and will have unexpected outcomes.
- JoeAltmaier 10y agoWeighing false negatives the same as false positives, disregards the overwhelming predominance of false positives in drug research. Practically speaking, if there were no resistance to releasing new drugs/cures then every quack out there would flood the market. The above suggestion begs to be answered with "Chesterton's Fence". The FDA is acting to solve a real problem.
- danieltillett 10y agoAccounting for deaths caused by inaction is not the same as weighing false negative the same as false positives. I am not suggesting no regulation, I am suggesting that a death caused by inaction (or extreme caution) is the same a death caused by an action such as mistakenly approving a dangerous drug. Both outcomes should both be considered when making a decision. Chesterton’s Fence is not appropriate here as we know the reason the FDA fence exists and what problem it is trying to solve. The issue is the FDA is solving the wrong problem (stopping bad drugs getting to market) not trying to minimise human death and suffering.
- JoeAltmaier 10y agoStopping bad drugs == reducing human death and suffering. Death thru inaction includes taking worthless drugs that have no proven value. Which would happen pervasively if no fence were erected between proposing a drug and selling it.
- Turing_Machine 10y agoThe OP said nothing about removing the fence. He advocated holding the FDA responsible for deaths resulting from failure to approve a good drug as well as deaths resulting from approving a bad one. Those are two entirely different things.
- JoeAltmaier 10y agoWhich would be foolishness, as it ignores the incredible suffering and death caused by quackery in fake medicines. Unless that is included in the calculation, then tragedy is inevitable. Loading the dice against the FDA by blaming them for pre-existing suffering could only result in hasty approval. This sounds exactly like 'removing the fence' to me - gutting the FDA to make folks feel like they're reforming something.
- Turing_Machine 10y agoYou're still arguing against something the OP isn't actually advocating. I see nothing suggesting that "quackery" or "fake medicines" should be approved.
- JoeAltmaier 10y agoThe whole process is to avoid approving medicines that don't work. Shortcutting the process may allow through medicines that don't work. Each time that happens, people die. Its that simple. E.g. My cousin died from a drug that was approved too quickly. He could have used something else and lived.
- 10y ago