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FWIW, Silicon Valley investor Jim O'Neill, who might well be the next head of the FDA, said this in 2014 about that: “We should reform FDA so there is approvin

FWIW, Silicon Valley investor Jim O'Neill, who might well be the next head of the FDA, said this in 2014 about that: “We should reform FDA so there is approving drugs after their sponsors have demonstrated safety -- and let people start using them, at their own risk, but not much risk of safety,” O’Neill said in a speech at an August 2014 conference called Rejuvenation Biotechnology. “Let’s prove efficacy after they’ve been legalized.” http://www.bloomberg.com/politics/articles/2016-12-07/trump-team-is-said-to-consider-thiel-associate-o-neill-for-fda http://www.bloomberg.com/politics/articles/2016-12-07/trump-...

ufmace 10y ago
Now that's something interesting. I found it funny that the article didn't seem to even briefly question whether the drug approval process could be changed to make it simpler to get things like phages to patients. If we're getting lots of political change, this sounds like something that could benefit.
wahern 10y ago
That makes a ton sense, except that one wonders if any manufacturer will ever bother proving efficacy. Worse, they may instead double-down on marketing campaigns. Doctors and other professionals, working scientists or not, are susceptible to marketing like anybody else. So we'd need to see other mechanisms, regulatory or otherwise[1], that would counter that effect. FDA approval is a powerful motivator for 1) companies to find actually effective therapies and 2) as an extremely efficient signaling mechanism to the market regarding efficacy. But it's sub-optimal for many reasons, including erring too heavily on the side of safety. It's just not obvious what would replace it. Don't forget, snake oil thrives in the free market. [1] Medicare reimbursements predicated on FDA efficacy approval? I'm not sure insurance companies can be expected to do the right[2] thing. It might be cheaper to reimburse a snake oil treatment that allows the patient to die than to pay a premium for an effective treatment. And while presumably a good doctor would insist on the effective treatment, at the margins the insurance company could expect to profit from allowing their patients to choose the snake oil. [2] Where "right" means a course of action that maximizes long-term social wealth (i.e. preferring effective treatment and therefore subsidizing research), rather than simply maximizing the short-term utility of patients and profits (i.e. allowing the patients the salve of snake oil, with reimbursements, in lieu of effective treatment).
refurb 10y ago
The problem with that is that insurance companies won't pay for a drug without demonstrable efficacy. A great example is Exondys 51 for DMD. They got FDA approval with very limited data on efficacy. Anthem said they won't pay for it.[1] [1]http://www.fiercepharma.com/pharma/anthem-declines-coverage-sarepta-s-controversial-dmd-med-exondys-51 http://www.fiercepharma.com/pharma/anthem-declines-coverage-...

ufmace 10y ago

Now that's something interesting. I found it funny that the article didn't seem to even briefly question whether the drug approval process could be changed to make it simpler to get things like phages to patients. If we're getting lots of political change, this sounds like something that could benefit.

wahern 10y ago

That makes a ton sense, except that one wonders if any manufacturer will ever bother proving efficacy. Worse, they may instead double-down on marketing campaigns. Doctors and other professionals, working scientists or not, are susceptible to marketing like anybody else. So we'd need to see other mechanisms, regulatory or otherwise[1], that would counter that effect. FDA approval is a powerful motivator for 1) companies to find actually effective therapies and 2) as an extremely efficient signaling mechanism to the market regarding efficacy. But it's sub-optimal for many reasons, including erring too heavily on the side of safety. It's just not obvious what would replace it. Don't forget, snake oil thrives in the free market. [1] Medicare reimbursements predicated on FDA efficacy approval? I'm not sure insurance companies can be expected to do the right[2] thing. It might be cheaper to reimburse a snake oil treatment that allows the patient to die than to pay a premium for an effective treatment. And while presumably a good doctor would insist on the effective treatment, at the margins the insurance company could expect to profit from allowing their patients to choose the snake oil. [2] Where "right" means a course of action that maximizes long-term social wealth (i.e. preferring effective treatment and therefore subsidizing research), rather than simply maximizing the short-term utility of patients and profits (i.e. allowing the patients the salve of snake oil, with reimbursements, in lieu of effective treatment).

refurb 10y ago

The problem with that is that insurance companies won't pay for a drug without demonstrable efficacy. A great example is Exondys 51 for DMD. They got FDA approval with very limited data on efficacy. Anthem said they won't pay for it.[1] [1]http://www.fiercepharma.com/pharma/anthem-declines-coverage-sarepta-s-controversial-dmd-med-exondys-51 http://www.fiercepharma.com/pharma/anthem-declines-coverage-...