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posted by Fnord666 on Sunday March 12 2017, @03:05AM   Printer-friendly
from the time-to-market dept.

President Trump will likely nominate Dr. Scott Gottlieb as head of the FDA. Though he is presently a resident fellow at the conservative American Enterprise Institute and a partner at a large venture capital fund, he used to be an FDA deputy commissioner known for advocating dramatic reforms in the process to approve new medical products.

According to his statements as well as comments to people familiar with his thinking on the FDA, Gottlieb intends to shoot for the rapid approval of complex generics, ushering in a wave of less expensive rivals to some of the biggest blockbusters on the market. He's also likely to spur the FDA to follow the course laid out by agency cancer czar Richard Pazdur in speeding new approvals, possibly setting up a special unit aimed at orphan drugs to hasten OKs with smaller, better designed clinical trials. Other potential reforms include the possible quick adoption of new devices that could be used to improve the kind of medtech Apple, Verily and others have been working on.

Gottlieb is viewed very favorably within the pharmaceutical industry as a regulatory reformer but not destroyer. If nominated, he will have been chosen over another high-profile name on the short list: Jim O'Neill.

The close associate of Peter Thiel, O'Neill famously suggested that drugs should be approved based on safety alone, letting consumers sort out what works. That left many fearing that Trump intended to toss out the regulatory framework for new drug approvals, raising fears that his idea of competition would allow de facto placebos to compete for market share.


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  • (Score: 5, Informative) by stormwyrm on Sunday March 12 2017, @03:23AM (19 children)

    by stormwyrm (717) on Sunday March 12 2017, @03:23AM (#477918) Journal

    Here’s what Orac at Respectful Insolence has to say about him [scienceblogs.com]:

    The third candidate (Scott Gottlieb) is the closest thing I’ve ever seen to a bona fide, honest-to-goodness pharma shill, who called the early termination of a multiple sclerosis drug study “an overreaction,” even though three participants had died, defended the off-label marketing of Evista, and, when he was Deputy Commissioner of the FDA, harassed underlings when FDA scientists rejected Pfizer’s osteoporosis drug candidate Oporia, forecast to earn $1 billion a year.

    And in a bit more detail here [scienceblogs.com]:

    I briefly mentioned Scott Gottlieb in my last post about Trump’s plans for the FDA. Now seems a good time to discuss him a bit more, because the possibility of his becoming the next director of the FDA amuses me to no end. Don’t get me wrong. I am also highly alarmed, almost as much as I am by the prospect of Jim O’Neill becoming the director of the FDA. My amusement is more a “laughing to keep from crying” sort of reaction. Here’s why.

    Scott Gottleib (sic) is a bona fide, honest-to-goodness pharma shill. He works for pharma and has for a long time[…]

    After he left the FDA, Dr. Gottlieb went back to private practice but also worked for Eli Lilly on the side to market Evista, even after Eli Lilly had been shown to have marketed it for off-label indications. During his actual tenure at the FDA as deputy commissioner, he had so many financial conflicts of interest with pharma companies that he had to recuse himself from resource planning for a potential bird flu epidemic because of his financial ties to Sanofi-Aventis, as well as work related to Eli Lilly, Proctor & Gamble, and, yes, five—count ‘em, five!—other drug companies. And yes, he did show his pro-pharma bias in ways other than criticizing the halting of a trial in which three people died…

    So the choice is now between a rapacious fox to guard the hen-house (Gottlieb) or someone who doesn’t believe in the hen-house and will demolish it the first chance he gets (O’Neill).

    --
    Numquam ponenda est pluralitas sine necessitate.
    Starting Score:    1  point
    Moderation   +4  
       Informative=4, Total=4
    Extra 'Informative' Modifier   0  
    Karma-Bonus Modifier   +1  

    Total Score:   5  
  • (Score: 2) by c0lo on Sunday March 12 2017, @03:55AM

    by c0lo (156) Subscriber Badge on Sunday March 12 2017, @03:55AM (#477921) Journal

    Just don't get seriously ill.
    If you do... well, you are going to sell your house anyway; so probably it will be better for you to take the money and go Cuba [nytimes.com].

    --
    https://www.youtube.com/watch?v=aoFiw2jMy-0 https://soylentnews.org/~MichaelDavidCrawford
  • (Score: 3, Informative) by Anonymous Coward on Sunday March 12 2017, @03:56AM (3 children)

    by Anonymous Coward on Sunday March 12 2017, @03:56AM (#477922)

    So the choice is now between a rapacious fox to guard the hen-house (Gottlieb) or someone who doesn’t believe in the hen-house and will demolish it the first chance he gets (O’Neill).

    So, the same choices that we got for all the heads of other agencies in the trump administration.

    • (Score: 2) by digitalaudiorock on Sunday March 12 2017, @07:26PM (2 children)

      by digitalaudiorock (688) on Sunday March 12 2017, @07:26PM (#478173) Journal

      So, the same choices that we got for all the heads of other agencies in the trump administration.

      This...+10000. Who else has been waiting for a single pick by Trump that doesn't seem as though a lot of work went into finding the worst possibly candidate? It's getting to where you can only assume that the underlying motive is sabotage, plain and simple. How is anyone still defending this fucking guy?

      • (Score: 2) by Justin Case on Monday March 13 2017, @03:52AM (1 child)

        by Justin Case (4239) on Monday March 13 2017, @03:52AM (#478304) Journal

        I think this is called draining the swamp.

        What makes people more furious than anything else is that he is keeping his promises.

        • (Score: 0) by Anonymous Coward on Monday March 13 2017, @04:27PM

          by Anonymous Coward on Monday March 13 2017, @04:27PM (#478480)

          > I think this is called draining the swamp.

          Indeed. Sane people thought "draining the swamp" meant removing lobbyists working on behalf of the rich.
          What he really meant was removing all the barriers that the lobbyists were hired to war with, so now the people who previously fertilized the swamp are directly in control. Swamp drained!

  • (Score: 1, Disagree) by khallow on Sunday March 12 2017, @05:19AM (13 children)

    by khallow (3766) Subscriber Badge on Sunday March 12 2017, @05:19AM (#477937) Journal

    Here’s what Orac at Respectful Insolence has to say about him:

    The third candidate (Scott Gottlieb) is the closest thing I’ve ever seen to a bona fide, honest-to-goodness pharma shill, who called the early termination of a multiple sclerosis drug study “an overreaction,” even though three participants had died, defended the off-label marketing of Evista, and, when he was Deputy Commissioner of the FDA, harassed underlings when FDA scientists rejected Pfizer’s osteoporosis drug candidate Oporia, forecast to earn $1 billion a year.

    That's a pretty huge point in favor of Gottlieb actually. Slowing medical treatments that the whole of humanity can benefit from just to save a few people in experimental treatment projects has to be one of the greatest evils of regulation ever just by body count. And if he does reduce the cost of bringing drugs to market via regulatory reduction, he will lower the barrier to entry for new pharmaceutical businesses, which will reduce the power of the current Big Pharma cartel. And current cost of drug development in the US is outright insane [tufts.edu] (what small start up can afford that kind of cost?) and needs to be curbed.

    So the choice is now between a rapacious fox to guard the hen-house (Gottlieb) or someone who doesn’t believe in the hen-house and will demolish it the first chance he gets (O’Neill).

    Kind of sad when Trump is the closest thing to a grown up in the house here with the first attempt in a while to curb the cost of approving new drugs. The point of drug regulation (and medical research regulation as a whole) isn't to protect a few people in a risky experimental program from serious injury or death. Nor is it to protect the Big Pharma cartel from competition. Sure, Gottlieb probably won't be a panacea. But we need to remember the big picture. Sure, we'll all die of something eventually, but there's no reason we can't extend our lives a great deal at a reasonable cost. Sane regulatory and competitive business environments should be part of that.

    • (Score: 0) by Anonymous Coward on Sunday March 12 2017, @09:27AM (11 children)

      by Anonymous Coward on Sunday March 12 2017, @09:27AM (#477984)
      Someone who has a hankering for a return to the days of the FDA before 1938 looks like. Enjoy your elixir sulfanilamide.
      • (Score: 1) by khallow on Sunday March 12 2017, @01:45PM (10 children)

        by khallow (3766) Subscriber Badge on Sunday March 12 2017, @01:45PM (#478038) Journal

        Someone who has a hankering for a return to the days of the FDA before 1938 looks like.

        Just like rolling back some of the insane regulation on minimum wage laws and short work weeks is a roll-back to the days of sweat shops? This is a typical conservative argument. Change is a bad thing, even when the system is obviously broken.

        • (Score: 3, Informative) by c0lo on Sunday March 12 2017, @01:59PM (9 children)

          by c0lo (156) Subscriber Badge on Sunday March 12 2017, @01:59PM (#478042) Journal

          FYI - the relevant Elixir sulfanilamide [wikipedia.org]

          Elixir sulfanilamide was an improperly prepared sulfanilamide medicine that caused mass poisoning in the United States in 1937. It caused the deaths of more than 100 people. The public outcry caused by this incident and other similar disasters led to the passing of the 1938 Federal Food, Drug, and Cosmetic Act.
          ...
          In 1937, S. E. Massengill Company, a pharmaceutical manufacturer, created a preparation of sulfanilamide using diethylene glycol (DEG) as a solvent, and called the preparation "Elixir Sulfanilamide".[3] DEG is poisonous to humans and other mammals, but Harold Watkins, the company's chief pharmacist and chemist, was not aware of this... Animal testing was not required by law, and Massengill performed none; there were no regulations requiring premarket safety testing of new drugs.
          ...
          The owner of the company, when pressed to admit some measure of culpability, infamously answered, "We have been supplying a legitimate professional demand and not once could have foreseen the unlooked-for results. I do not feel that there was any responsibility on our part."[6] Watkins, the chemist, committed suicide while awaiting trial.
          ...
          Congress responded to public outrage by passing the 1938 Food, Drug, and Cosmetic Act, which required companies to perform animal safety tests on their proposed new drugs and submit the data to the FDA before being allowed to market their products. The Massengill Company paid a minimum fine under provisions of the 1906 Pure Food and Drugs Act, which prohibited labeling the preparation an "elixir" if it had no alcohol in it.

          If that's a pretty huge point in favor of Gottlieb actually (who called the early termination of a multiple sclerosis drug study “an overreaction,” even though three participants had died), I think I understand a scared-shitless reaction whenever Gottlieb is mentioned.

          --
          https://www.youtube.com/watch?v=aoFiw2jMy-0 https://soylentnews.org/~MichaelDavidCrawford
          • (Score: 1) by khallow on Sunday March 12 2017, @02:50PM (8 children)

            by khallow (3766) Subscriber Badge on Sunday March 12 2017, @02:50PM (#478054) Journal
            Your insinuation is an exercise of the false dilemma fallacy. Just because someone wants to roll-back some regulation, doesn't mean that they wish to roll it back to complete absence of regulation.
            • (Score: 2) by c0lo on Sunday March 12 2017, @04:28PM (7 children)

              by c0lo (156) Subscriber Badge on Sunday March 12 2017, @04:28PM (#478087) Journal

              So, Gottlieb says "stopping some trial after 3 deaths is an overreaction" and you ask me to trust him he'll rollback only some regulation which, presumably, are unnecessary, right?

              Just what regulation do you think can be safely rolled-back?

              ---

              In constructing your answer, on top of "elixir sulfanilamide", consider:
              - homeopathy - pure non-toxic water. You don't die because of it, you die because the original illness is not addressed. In the same category, snake-oil from various snakes pushed by noisy markedroids, swamping out the signal of a good cure;
              - Thalidomide [wikipedia.org] - non-toxic on short time span, on medium-long term causes malformed children with 40-50% chances of survival. After studies of efficacy/safety, it still have (FDA-)approved uses [wikipedia.org].

              --
              https://www.youtube.com/watch?v=aoFiw2jMy-0 https://soylentnews.org/~MichaelDavidCrawford
              • (Score: 1) by khallow on Sunday March 12 2017, @04:50PM (6 children)

                by khallow (3766) Subscriber Badge on Sunday March 12 2017, @04:50PM (#478096) Journal

                So, Gottlieb says "stopping some trial after 3 deaths is an overreaction" and you ask me to trust him he'll rollback only some regulation which, presumably, are unnecessary, right?

                Just what regulation do you think can be safely rolled-back?

                First of all, why should the trial have been halted? Gottlieb made an important point [time.com] at the time that the deaths could have been due to MS complications rather than the drug:

                "Just seems like an overreaction to place a clinical hold" on the trial, he wrote. An FDA scientist rejected his analysis and replied that the complication "seems very clearly a drug-related event."

                Even if the latter was true, that still means that the medication could be adjusted to attempt to reduce such drug-related events.

                Second, a significant part of the problem is that pre-clinical trials (testing before testing on humans occurs) are notoriously ineffective at weeding out drugs that have problems in clinical (human) trials. We need some serious innovation in coming with with better pre-clinical trials. FDA is a solid roadblock to that.

                • (Score: 2) by c0lo on Sunday March 12 2017, @05:00PM (5 children)

                  by c0lo (156) Subscriber Badge on Sunday March 12 2017, @05:00PM (#478101) Journal

                  We need some serious innovation in coming with with better pre-clinical trials. FDA is a solid roadblock to that.

                  Exactly how FDA roadblocks pre-clinical trials?

                  --
                  https://www.youtube.com/watch?v=aoFiw2jMy-0 https://soylentnews.org/~MichaelDavidCrawford
                  • (Score: 1) by khallow on Sunday March 12 2017, @06:24PM (4 children)

                    by khallow (3766) Subscriber Badge on Sunday March 12 2017, @06:24PM (#478129) Journal

                    Exactly how FDA roadblocks pre-clinical trials?

                    Let me first demonstrate that this is a huge problem [sciencemag.org] (speaking of :

                    So how is everyone doing in the clinic? Sheesh, you had to ask. The overall Likelihood of Approval” (LOA) from Phase I is 9.6 per cent. So no, if you were hoping for an upturn in the more recent numbers, it doesn’t seem to be there. Somewhere around ten per cent success has been the estimate for some time now [sciencemag.org], and here it is again [sciencemag.org]. The worst therapeutic area is oncology, with a 5.6% LOA. That reflects some of its traditional features: lower barrier to entry, which brings in a lot of marginal ideas, difficult diseases to target once you’re in the clinic, and a corresponding willingness to try some fairly out-there stuff.

                    These numbers shouldn’t be too surprising to folks in the industry itself. What I’ve found while writing this blog, though, is that people who don’t know drug discovery tend to be very surprised indeed. It bears repeating: ninety per cent of all drugs that go into the clinic fail. And ninety-five per cent of all cancer drugs. That’s the central problem of the whole industry, right there. If you can make those numbers look better, hundreds of millions of grateful patients (and untold billions of dollars in revenue) are waiting for you.

                    The point here is that approval of pharmaceuticals, medical technologies, and other treatments is a sort of inverted pyramid system where expense increases substantially with each step forward. When you get to the point of FDA rejection (one of the very last steps before marketing), it tends to be a huge financial disaster at present. It should be a huge warning sign to us that we're seeing a 90% failure rate (which gets worse as one goes into certain areas like cancer treatments with particularly bad animal models) from human testing (with apparently still a 40% failure rate going into the last and by far most expensive phase of testing before FDA consideration). So right here, the formal testing regime currently approved by the FDA has a huge, rear-loaded failure mechanism and introduces considerable delay in the system.

                    It appears that final stages of human testing are for the foreseeable future unavoidable [sciencemag.org], due to human biology being ridiculously hard and conflicts of interest often being less than ideal, meaning we will have considerable regulation, delay, and expense even under the best of circumstances. But what we have is this lengthy, expensive, risky, remarkably unreliable process for doing anything to improve peoples' lives and health. That needs to change. The FDA has shown little interest in doing so.

                    • (Score: 2) by c0lo on Sunday March 12 2017, @10:56PM (3 children)

                      by c0lo (156) Subscriber Badge on Sunday March 12 2017, @10:56PM (#478238) Journal

                      Ok, I got the numbers. What I don't get is: what you see as "FDA roadblocks pre-clinical trials" which need to be removed?
                      The only way that I see the higher chances of a new drug to be proven effective and safe with reduced costs is to have the drugs failing the process as soon as possible thus removing extra cost in advanced steps.
                      Do you see some other way here?

                      --
                      https://www.youtube.com/watch?v=aoFiw2jMy-0 https://soylentnews.org/~MichaelDavidCrawford
                      • (Score: 1) by khallow on Monday March 13 2017, @06:42AM (2 children)

                        by khallow (3766) Subscriber Badge on Monday March 13 2017, @06:42AM (#478322) Journal
                        Reading around, I think there's two effects. First, a certain amount of hoop jumping before a drug is allowed to be exposed to humans. Second, I think FDA would be reluctant to embrace particularly aggressive testing such as using human-like clones (eg, cloned human organ clusters or human bodies born without brains). And there's always the risk adverse nature of the FDA job. Nobody gets fired for playing it safe.
                        • (Score: 2) by c0lo on Monday March 13 2017, @07:26AM (1 child)

                          by c0lo (156) Subscriber Badge on Monday March 13 2017, @07:26AM (#478332) Journal

                          First, a certain amount of hoop jumping before a drug is allowed to be exposed to humans.

                          Those hoops, added or removed?
                          If removed: how this is going to drive down the costs if the drug turns out to be toxic? Given that human testing is much expensive than testing on model animals, I believe its their interest of doing the best the pharmas can in pre-clinical trials, when the costs are lower.

                          If added: how's this removing roadblocks from pre-clinical trials?

                          using human-like clones (eg, cloned human organ clusters or human bodies born without brains).

                          I'll let aside we are barely at the level of cloning organs (from stem cells), much less at the level of cloning humans without brains.
                          What stops them from using any line of immortal cells [wikipedia.org]? At least the toxicity can be (partially) evaluated on a cell closer to human than any model animal.

                          --
                          https://www.youtube.com/watch?v=aoFiw2jMy-0 https://soylentnews.org/~MichaelDavidCrawford
                          • (Score: 1) by khallow on Monday March 13 2017, @02:59PM

                            by khallow (3766) Subscriber Badge on Monday March 13 2017, @02:59PM (#478422) Journal

                            If removed: how this is going to drive down the costs if the drug turns out to be toxic?

                            It allows the drug company to solve that problem as they see fit before it gets to human testing.

                            What stops them from using any line of immortal cells?

                            As I recall, for a time, certain lines were banned from federal funding by the Bush administration. And the higher level Department of Health and Human Resources was for a time the means by which a ban on the funding of anything derived from human fetuses was enforced. There is a history of interference here.

    • (Score: 2) by sjames on Sunday March 12 2017, @03:30PM

      by sjames (2882) on Sunday March 12 2017, @03:30PM (#478063) Journal

      The part you're missing is that the drug in testing was killing the research subjects, and would have continued doing that on a much larger scale if it was approved for marketing.

      The trial wasn't halted just to save a few research subjects, it was halted because it had become clear that the new drug was unacceptable. That is, it failed.