<story><title>Nearly 1 in 3 drugs have a significant safety issue after FDA approval</title><url>http://www.latimes.com/science/sciencenow/la-sci-sn-fda-drugs-safety-20170509-story.html</url></story><parent_chain><item><author>tvural</author><text>Negative press like this probably contributes to the FDA being so conservative. They get none of the benefits when a great new drug is approved, but get scapegoated when they approve something dangerous even to small numbers of people. So they just approve as few drugs and medical devices as they can get away with - it&amp;#x27;s a massive misalignment of incentives.&lt;p&gt;One might think drugs would be more dangerous if the FDA were less conservative, but I suspect the opposite. If it takes you ten years and 2 billion dollars to release a new drug, and then you find out it has some terrible side effect in 0.1% of the population, you don&amp;#x27;t get to fix the problem. You might not withdraw it either, since the drug would still be a net good for society. And if one drug is approved instead of ten, patients are forced to stick to the flawed solution.&lt;p&gt;The far bigger problem than drugs with side effects is a lack of drugs. Around 1&amp;#x2F;3 as many drugs get approved today relative to 1970, and the costs of a drug approval have risen 5 times faster than inflation since then. Medicine has been an anti-technological field for the last few decades - it&amp;#x27;s doing less with more. The most valuable biomedical companies are the ones that have been around since the 1800s - one could imagine what computers would look like today if IBM were still the largest IT company.</text></item></parent_chain><comment><author>Apfel</author><text>For the record, the 2 billion dollars figure is from the notorious tufts centre for the study of drug development, which is heavily pharma-backed.&lt;p&gt;It&amp;#x27;s a very, VERY controversial figure in the pharmacoeconomic literature, but has been accepted as gospel due to continuous repetition in shitty reporting.&lt;p&gt;Fairly good article discussing this: &lt;a href=&quot;https:&amp;#x2F;&amp;#x2F;www.washingtonpost.com&amp;#x2F;news&amp;#x2F;wonk&amp;#x2F;wp&amp;#x2F;2014&amp;#x2F;11&amp;#x2F;18&amp;#x2F;does-it-really-cost-2-6-billion-to-develop-a-new-drug&amp;#x2F;&quot; rel=&quot;nofollow&quot;&gt;https:&amp;#x2F;&amp;#x2F;www.washingtonpost.com&amp;#x2F;news&amp;#x2F;wonk&amp;#x2F;wp&amp;#x2F;2014&amp;#x2F;11&amp;#x2F;18&amp;#x2F;does-...&lt;/a&gt;</text></comment>
<story><title>Nearly 1 in 3 drugs have a significant safety issue after FDA approval</title><url>http://www.latimes.com/science/sciencenow/la-sci-sn-fda-drugs-safety-20170509-story.html</url></story><parent_chain><item><author>tvural</author><text>Negative press like this probably contributes to the FDA being so conservative. They get none of the benefits when a great new drug is approved, but get scapegoated when they approve something dangerous even to small numbers of people. So they just approve as few drugs and medical devices as they can get away with - it&amp;#x27;s a massive misalignment of incentives.&lt;p&gt;One might think drugs would be more dangerous if the FDA were less conservative, but I suspect the opposite. If it takes you ten years and 2 billion dollars to release a new drug, and then you find out it has some terrible side effect in 0.1% of the population, you don&amp;#x27;t get to fix the problem. You might not withdraw it either, since the drug would still be a net good for society. And if one drug is approved instead of ten, patients are forced to stick to the flawed solution.&lt;p&gt;The far bigger problem than drugs with side effects is a lack of drugs. Around 1&amp;#x2F;3 as many drugs get approved today relative to 1970, and the costs of a drug approval have risen 5 times faster than inflation since then. Medicine has been an anti-technological field for the last few decades - it&amp;#x27;s doing less with more. The most valuable biomedical companies are the ones that have been around since the 1800s - one could imagine what computers would look like today if IBM were still the largest IT company.</text></item></parent_chain><comment><author>WalterBright</author><text>Sam Peltzman goes into great detail on this issue in his book &amp;quot;Regulation of Pharmaceutical Innovation.&amp;quot;</text></comment>