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There are 2 comments on FDA Watchdog Speaks Out on Dangerous Drugs and Docs

  1. While I think that organization such as have an important place in our culture and institutions, it worries me deeply to see this type of position; especially facing the FDA, which is already so prone to Type 1 error. The cost of developing new drugs has become exorbitant, and only a very selected few companies have the dimes to pay for them.
    Making it harder for drugs to be developed only further selects these companies, since they can afford the research. This creates a perverse incentive to have the entire pharmaceutical world controlled by an oligarchy of companies.
    I find this very problematic, given the death rate of 100% of citizens, and a life expectancy still under 100. We’d rather lose 100,000 people to a disease that was never cured, than lose 10,000 killed by a drug that saved 90,000. We don’t perceive the disease as being a killer since we never had it otherwise. But if a drug that treats it, kills some of the patients with something other than the disease, we perceive the drug as an abominable killer. It’s a normal instinct, and is a symptom of loss aversion. Whether this is socially desirable, or optimal, to become the policy for drug development is a whole different story.
    I would love to see a US where universities become the major drug developers, and where releasing innovating, status-quo shattering treatments is the norm. Until then, we’ll continue this ‘progress’ towards a health care system that becomes ever more risk averse, and fails to provide what it was set up to do.

  2. How about when things work the other way around? What happens when a non-invasive diagnostic test that has no side effects and shows tremendous efficacy is held back from the domestic market by the FDA three times? It has EU approval, and the EU approval was based on the US test. Your reply and recommendation for action is greatly appreciated.

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