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On a related topic, http://www.fdareview.org http://www.fdareview.org argues that much of the FDA is more harmful than useful; in particular the efficacy requir
by ikeboy 11y ago
On a related topic, http://www.fdareview.org http://www.fdareview.org argues that much of the FDA is more harmful than useful; in particular the efficacy requirement. Does anyone know good counterarguments?
- danieltillett 11y agoThere aren’t any. The FDA and it’s related regulatory authorities around the world are responsible for killing more people than any other organisation that has ever existed (conservatively in the hundreds of millions). You might wonder how this could be. Basically the cost of getting a drug approved is such that large sections of the human population (poor people especially) have diseases for which we have no treatment or no cheap treatment. We need to get the cost of drug development down to the level that pharmaceutical companies can make a profit developing and selling medicines to poor people or people with what are considered rare diseases.
- ikeboy 11y agoWhy hasn't anything been done since those studies came out? Is there just not awareness?
- danieltillett 11y agoIt is a very interesting question. The reason is what is known as regulatory capture. This is normally thought of as the regulators being captured by the industry they are trying to regulate, but it is really more a symbiotic relationship between both sides. Through regulation the large pharmaceutical companies can keep out the competition from any small pharmaceutical companies, while the regulators gain a nice job and importance. The only losers here are the public since we miss out on cheap effective drugs because the regulations make them too expensive to produce for most diseases and people.
- pinaceae 11y agorefuting your BS would take far longer than you vomiting this utter, utter nonsense into HN. just please never take any drug approved by the FDA ever.
- danieltillett 11y agoGlad to see reason is alive and well on HN. Don’t both trying to provide an argument, just hurl personal abuse. Since I live in Australia I don’t ever take any drug that is approved by the FDA (this is the job of the TGA). Even if I did live in the USA, I fail to see me advocating for less regulation of the drug approval process somehow prevents me using a drug that has been approved in the past. I am advocating for more drugs, not less.
- deleted 11y ago[deleted]
- dang 11y ago> refuting your BS would take far longer than you vomiting this utter, utter nonsense into HN This comment violates the HN guidelines badly. We ban accounts that do this repeatedly. Please post civilly and substantively from now on, or not at all.
- ccw9302 11y agoWithout FDA, consumers would be flooded with misleading drug ads and waste lots of money on ineffective drugs. US is really lucky to have FDA.
- danieltillett 11y agoAs if the USA does not have this already! Actually you would see far fewer ads since you would remove the ability and need for advertising. The reason drugs are advertised now is because the drug companies have so few new drugs to sell (no drug off-patent is ever advertised). They need to maximise the returns from the few drugs they have to sell. If hundred of new drugs came out each year then mass marketing would not work since the market for each drug would be too small. Yes there would be more “ineffective” drugs, but if you and your doctor had the choice of dozens of drugs for your disease which one would you choose - the one for which had no evidence that it worked, or the one where the drug company has scientific evidence? Even if they did not need to do trials for the approval process, pharmaceutical companies would still do them to convince doctors and patients.
- ikeboy 11y agoThis doesn't address the point at all. That site isn't recommending getting rid of the FDA as far as I see, just changing certain parts. Also, they have an analysis of the advertising aspect. In other words, Dr. Pepine thought that the FDA restrictions preventing the advertising and promotion of aspirin for heart attack patients were responsible for the deaths of tens of thousands of people.