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gorskon's profile
David Gorski, MD, PhD
David Gorski, MD, PhD
David Gorski, MD, PhD
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@gorskon

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David Gorski, MD, PhDVerified account

@gorskon

Surgeon/scientist promoting science in medicine and exposing quackery. Editor of Science-Based Medicine. My opinions do NOT represent those of my employers.

Michigan, USA
sciencebasedmedicine.org
Joined October 2009

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    1. David Gorski, MD, PhD‏Verified account @gorskon 25 May 2018

      For one thing, @GoldwaterInst is part of @ALEC_states, a corporate-funded bill mill. If you want to know why state #RightToTry bills are so similar, it's because they all follow a template that was written by the Goldwater Institute. 4/

      1 reply 4 retweets 6 likes
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    2. David Gorski, MD, PhD‏Verified account @gorskon 25 May 2018

      The result is that all state #RightToTry bills contain certain @GoldwaterInst-approved elements, such as any drug that's passed phase I trials, still has an IND, and is still being tested is eligible for RTT. 5/

      1 reply 1 retweet 5 likes
      Show this thread
    3. David Gorski, MD, PhD‏Verified account @gorskon 25 May 2018

      Of course, claiming phase I testing is enough to show that a drug is "safe" enough for #RightToTry, as I've seen @GoldwaterInst flacks do time and time again, is utterly insane, as anyone who's ever had anything to do with clinical trials knows. 6/

      2 replies 4 retweets 8 likes
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    4. David Gorski, MD, PhD‏Verified account @gorskon 25 May 2018

      Most phase I trials involve less than 30 patients and involve dose escalation. The idea is not to show safety, but to show that the drug is not too unsafe to continue further clinical trials. There is a difference. Requiring only phase I evidence for #RightToTry is madness. 7/

      1 reply 5 retweets 11 likes
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    5. David Gorski, MD, PhD‏Verified account @gorskon 25 May 2018

      As for the other @GoldwaterInst-approved elements of #RightToTry, they involve typical libertarian tropes, such as cutting the @US_FDA out of the decision, eliminating liability for companies and doctors, and leaving patients completely on their own if things go south. 8/

      1 reply 4 retweets 6 likes
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    6. David Gorski, MD, PhD‏Verified account @gorskon 25 May 2018

      Given that less than 15% of drugs that pass phase I ever go on to be @US_FDA-approved, then at least 85% of drugs eligible for #RightToTry will be guaranteed not to provide any benefit, and many of them will cause harm—and the patient might pay a lot of money for the privilege.9/

      1 reply 4 retweets 14 likes
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    7. David Gorski, MD, PhD‏Verified account @gorskon 25 May 2018

      At the federal level, the new #RightToTry bill makes it difficult for @US_FDA to consider RTT results in considering whether to approve a drug. Major barriers to doing this are intentionally baked into the bill. An earlier version expressly forbade the use of RTT outcomes. 10/

      1 reply 4 retweets 6 likes
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    8. David Gorski, MD, PhD‏Verified account @gorskon 25 May 2018

      Of course, helping terminally ill patients was never the main intent of #RightToTry, although @GoldwaterInst would like you to think that it was. 11/

      1 reply 5 retweets 10 likes
      Show this thread
    9. David Gorski, MD, PhD‏Verified account @gorskon 25 May 2018

      The real intent behind #RightToTry was always to cut the @US_FDA out of compassionate/expanded use decisions and to weaken the regulatory power of the FDA. @GoldwaterInst genuinely believes that damned near all regulation is bad. 12/

      1 reply 3 retweets 9 likes
      Show this thread
    10. David Gorski, MD, PhD‏Verified account @gorskon 25 May 2018

      Indeed, I've seen Nick Gillespie and Ronald Bailey argue that @US_FDA regulations governing drug approval kill thousands of people by delaying promising new drugs. It's a bullshit argument, of course, as I've explained before. 13/https://sciencebasedmedicine.org/using-the-fear-of-ebola-to-promote-the-placebo-legislation-that-is-right-to-try/ …

      1 reply 3 retweets 7 likes
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      David Gorski, MD, PhD‏Verified account @gorskon 25 May 2018

      #RightToTry is just the first step in @GoldwaterInst's plan to neuter the @US_FDA. Next up will be broadening RTT so it doesn't apply just to terminally ill patients. After that will be eliminating restrictions on companies advertising off-label indications for their drugs. 14/

      10:19 AM - 25 May 2018
      • 3 Retweets
      • 8 Likes
      • prime tuffet CrankyOtter Pamela Millsaps Lori says be kind. Dr. Alison Bateman-House SandyM 💛🐝Josephine Jones💛 Matthew Prorok KB
      1 reply 3 retweets 8 likes
        1. David Gorski, MD, PhD‏Verified account @gorskon 25 May 2018

          The @GoldwaterInst's long game after #RightToTry is to return the @US_FDA to its pre-thalidomide state, where evidence of efficacy is no longer required to approve drugs. 15/15

          1 reply 5 retweets 13 likes
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