4 ms·

You could also summarize "trials, data, and more trials" not as regulatory requirements, but actually making sure your treatment works before we put it into hum

• jessriedel 11y ago
  Nothing's ever 100%. You need to balance your degree of confidence against the patients who are dying while you accumulate data, and be prepared for the fact that sometimes you're going to get it wrong. Right now, the FDA faces little penalty for letting people die, but huge penalties if they approve a drug or device that goes bad.
  • fnordfnordfnord 11y ago
    >but huge penalties if they approve a drug or device that goes bad. What penalty does the FDA face?
    • AnimalMuppet 11y ago
      Congress (who controls their budget).
      • Fomite 11y ago
        Congress gives them plenty of slack for being slow to approve things.
        • AnimalMuppet 11y ago
          Yes. And very little if they approve something too fast that causes problems.
          • Fomite 11y ago
            Except that there are counter-examples to this. The FDA's careful for a reason. For example, take the first Rotavirus vaccine (Rotashield), which was associated with intussusception (it's no longer clear it even caused it). It was pulled from the market, but Congress definitely got involved, an newer, unrelated rotavirus vaccines have very, very active post-market intussusception surveillance studies associated with them.
      • fnordfnordfnord 11y ago
        "Congress" isn't a penalty. Budget reductions are a constant threat, and I'd consider that threat more a function of the politics of the majority leader than of whether or not the FDA had to issue a recall or got some bad press.
    • jessriedel 11y ago
      Restrictions on budgets, transfer of some authorities to other agencies, firing of the leadership, embarrassment and loss of status (and so reduced future job prospects) of the leadership. One recent example: http://nationalpainreport.com/activists-want-fda-commissioner-fired-for-opioid-approvals-8824940.html http://nationalpainreport.com/activists-want-fda-commissione...
      • fnordfnordfnord 11y ago
        This is FUD and politics. It sounds like a defense of analysis paralysis as a survival tactic; as if the only goal is to never get fired, even if it means that nothing ever gets accomplished.
• ubernostrum 11y ago
  Also, the origin of the FDA was a time when people could advertise and sell "medicines" which failed to treat or cure anything, and routinely lie about the ingredients and their medicinal properties (or lack thereof), a problem which the free market was conspicuously failing to solve. So now, anyone can sell medicine, but if they want to claim it's effective for some disease or condition they have to actually back up the claim.
  • seehafer 11y ago
    One could argue that much of government regulation came about because of massive information asymmetry. In the age of the Internet it is much harder to peddle snake oil cures (though not impossible, certainly, look at anti-vaxxers) than it was in the early 20th century.
    • Fomite 11y ago
      "Much harder" turns out to still be trivially easy - supplements, the anti-vaxx folks, every weight loss pill ever...