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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 13 Mar 2018

      David Gorski, MD, PhD Retweeted James C.Coyne

      Unfortunately, it's also been incredibly effective propaganda. Terminally ill patients have been weaponized against critics by #RightToTry advocates in the the same way that cancer quack Stanislaw #Burzynski weaponized terminally ill cancer patients. 1/https://twitter.com/CoyneoftheRealm/status/973529598377058304 …

      David Gorski, MD, PhD added,

      James C.Coyne @CoyneoftheRealm
      Not a lifesaver: Terming the issue of access to #unproven, often expensive medications as the "right to try" is as biasing as calling opposition to the women having access to abortion as the "right to life". https://theconversation.com/giving-patients-the-right-to-try-experimental-drugs-is-a-political-maneuver-not-a-lifesaver-91382?utm_medium=email&utm_campaign=Latest%20from%20The%20Conversation%20for%20March%2013%202018%20-%2096798347&utm_content=Latest%20from%20The%20Conversation%20for%20March%2013%202018%20-%2096798347+Version+A+CID_74c6681737bad36808e5b61c1fc215b4&utm_source=campaign_monitor_us&utm_term=Giving%20patients%20the%20right%20to%20try%20experimental%20drugs%20is%20a%20political%20maneuver%20not%20a%20lifesaver …
      2 replies 17 retweets 12 likes
      Show this thread
    2. David Gorski, MD, PhD‏Verified account @gorskon 13 Mar 2018

      As #Burzynski used terminally ill patients to lobby Congress and regulators to protect him from the @US_FDA, beginning in the 1990s and continuing until now, the libertarian anti-regulation advocates of #RightToTry use terminally ill patients as their weapons and shields. 2/

      1 reply 2 retweets 2 likes
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    3. David Gorski, MD, PhD‏Verified account @gorskon 13 Mar 2018

      Basically, if you criticize #RightToTry, its supporters, such as @GoldwaterInst, will immediately portray you as an evil Snidely Whiplash-like villain, twirling his mustache and cackling as terminally ill patients suffer and die. 3/

      1 reply 2 retweets 2 likes
      Show this thread
    4. David Gorski, MD, PhD‏Verified account @gorskon 13 Mar 2018

      Never mind that you're pointing out that #RightToTry is incredibly unlikely to help any patients, hasn't demonstrably significantly helped anyone thus far, and is anti-patient in that it strips away many protections patients have. 4/

      1 reply 1 retweet 2 likes
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    5. David Gorski, MD, PhD‏Verified account @gorskon 13 Mar 2018

      For instance, patients using #RightToTry have to pay for everything themselves. In most state statutes, the language can be interpreted as saying that if the patient suffers a complication from a RTT drug insurance companies don't have to pay. 5/

      1 reply 1 retweet 2 likes
      Show this thread
    6. David Gorski, MD, PhD‏Verified account @gorskon 13 Mar 2018

      Under state #RightToTry, patients have close to no recourse in the courts if the company, investigator, or physician (who are immunized against lawsuits) screw up. The federal RTT bill is only marginally better on this score. 6/

      1 reply 3 retweets 2 likes
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    7. David Gorski, MD, PhD‏Verified account @gorskon 13 Mar 2018

      Under #RightToTry, there is no oversight by the @US_FDA or institutional review boards to protect patients trying experimental drugs. 7/

      1 reply 1 retweet 2 likes
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    8. David Gorski, MD, PhD‏Verified account @gorskon 13 Mar 2018

      Under #RightToTry, the only requirements for a drug to be made available for RTT is that they have passed phase I clinical trials, are still in clinical trials, and are still in development. Yet RTT advocates proclaim this as "safe." 8/

      1 reply 1 retweet 2 likes
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    9. David Gorski, MD, PhD‏Verified account @gorskon 13 Mar 2018

      Anyone who has anything to do with clinical trials knows that, contrary to the claims of #RightToTry advocates, merely passing phase I testing doesn't mean a drug is safe. Far from it! Most phase I trials only have less than 30 patients, for one thing. 9/

      1 reply 1 retweet 3 likes
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    10. David Gorski, MD, PhD‏Verified account @gorskon 13 Mar 2018

      The purposes of phase I trials are to find the maximal tolerated dose, identify the worst toxicities that limit the dose, and determine if a drug is promising enough (i.e., not too dangerous) to continue to phase II trials to test efficacy and safety. 10/

      1 reply 1 retweet 4 likes
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      David Gorski, MD, PhD‏Verified account @gorskon 13 Mar 2018

      The federal #RightToTry has another pernicious provision. Older versions explicitly stated that @US_FDA could not use clinical outcomes of patients using a drug under RTT in deciding whether to approve a drug. The new version says that it can, but must justify in writing. 11/

      6:10 AM - 13 Mar 2018
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      • Teesside SitP ✍🏻Ginger, a Australian Woman. Not quiet, usually Liz "The Mask Goes Over Your Nose AND Mouth" Ditz
      1 reply 1 retweet 2 likes
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        2. David Gorski, MD, PhD‏Verified account @gorskon 13 Mar 2018

          Requiring the @US_FDA to justify in writing using #RightToTry clinical outcomes in its drug approval decisions is somewhat better than the old version, which banned it, but the intent is clearly to DISCOURAGE the FDA from doing so. Only a high ranking official can do it. 12/

          1 reply 1 retweet 2 likes
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        3. David Gorski, MD, PhD‏Verified account @gorskon 13 Mar 2018

          Then there's cost. There's no provision in #RightToTry to help patients access the drugs Insurance companies don't have to pay; there is no fund to assist patients. Basically, they are on their own. Fine if you're rich. Otherwise, not so fine. 13/

          1 reply 1 retweet 2 likes
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        4. David Gorski, MD, PhD‏Verified account @gorskon 13 Mar 2018

          To be fair, the federal #RightToTry bill being considered today does require institutional review board oversight, but, given that it cuts the @US_FDA out of the process, that doesn't really mean much, and there are lax IRBs that can be bought. 14/

          1 reply 1 retweet 2 likes
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        5. David Gorski, MD, PhD‏Verified account @gorskon 13 Mar 2018

          To be fair, the federal #RightToTry bill also requires that doctors and investigators report adverse events to the company, which then must report them to the @US_FDA. However, I am skeptical how well that would work outside the context of clinical trials. 15/

          1 reply 1 retweet 3 likes
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        6. David Gorski, MD, PhD‏Verified account @gorskon 13 Mar 2018

          So, to summarize, #RightToTry: 1. Is incredibly unlikely to help patients 2. Strips away important legal protections from patients 3. Strips away important regulatory protections from patients 4. Is unlikely to significantly expand access to experimental therapeutics 16/

          1 reply 4 retweets 5 likes
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        7. David Gorski, MD, PhD‏Verified account @gorskon 13 Mar 2018

          So if #RightToTry is so useless, why do it? There's no good medical or policy reason to pass RTT, except for one: As a first step in deregulation, as a first step in weakening the FDA. 17/

          1 reply 2 retweets 2 likes
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        8. David Gorski, MD, PhD‏Verified account @gorskon 13 Mar 2018

          David Gorski, MD, PhD Retweeted Americans for Prosperity

          Given the source of #RightToTry (@GoldwaterInst), and the fact that the Koch brothers recently threw their support behind RTT through @AFPhq, it is reasonable to conclude that the purpose is to weaken @US_FDA. 18/https://twitter.com/AFPhq/status/973320042292174851 …

          David Gorski, MD, PhD added,

          Americans for ProsperityVerified account @AFPhq
          Tomorrow, the House is set to vote on a piece of legislation that would give hope to millions of terminally-ill patients. RT and sign if you support giving these patients the #RightToTry. http://bit.ly/2p8L8BT 
          1 reply 3 retweets 1 like
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        9. David Gorski, MD, PhD‏Verified account @gorskon 13 Mar 2018

          Indeed, I've long suspected that the true reason for #RightToTry is to be a first step in drastically curtailing the power of the @US_FDA to approve and regulate drugs and devices. 19/

          1 reply 1 retweet 3 likes
          Show this thread
        10. David Gorski, MD, PhD‏Verified account @gorskon 13 Mar 2018

          Think about it. First, you cut @US_FDA out of regulating drugs for an incredibly sympathetic group of patients, the terminally ill, in the name of helping them. 20/

          1 reply 1 retweet 2 likes
          Show this thread
        11. David Gorski, MD, PhD‏Verified account @gorskon 13 Mar 2018

          Once the precedent is set, you ask the question: Why limit #RightToTry to just the terminally ill? What about those who have life-threatening illnesses who have a significant chance of dying? They already did this with Ebola. https://respectfulinsolence.com/2014/10/28/ebola-right-to-try-laws-and-placebo-legislation/ … 21/

          1 reply 2 retweets 2 likes
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        12. David Gorski, MD, PhD‏Verified account @gorskon 13 Mar 2018

          Then, they'll ask, what about patients with severe, not immediately life-threatening diseases that dramatically impact quality of life? Why no #RightToTry for them? 22/

          1 reply 2 retweets 2 likes
          Show this thread
        13. David Gorski, MD, PhD‏Verified account @gorskon 13 Mar 2018

          Finally, they'll ask: Why not everyone? In fact, others have already in essence done that through something called Free To Choose Medicine. 23/https://respectfulinsolence.com/2017/08/30/right-to-try-medicine-the-free-market-fundamentalist-assault-on-the-fda-continues/ …

          1 reply 2 retweets 3 likes
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        14. David Gorski, MD, PhD‏Verified account @gorskon 13 Mar 2018

          Indeed, @GoldwaterInst has already broadened its assault on the @US_FDA's power to regulate drugs beyond #RightToTry with its initiative to prevent the FDA from stopping companies from promoting off-label uses of their drugs to doctors. 24/

          1 reply 2 retweets 1 like
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        15. David Gorski, MD, PhD‏Verified account @gorskon 13 Mar 2018

          So, #RightToTry is not about helping terminally ill patients. It's about returning @US_FDA to a vestigial pre-Kefauver-Harris Amendment status, in which the FDA only had to require that companies show safety, not efficacy, before licensing a drug or device. 25/

          2 replies 4 retweets 2 likes
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        16. David Gorski, MD, PhD‏Verified account @gorskon 13 Mar 2018

          Unfortunately, #RightToTry has been an incredibly effective propaganda technique. 38 states have passed RTT, largely because opponents have been successfully cowed into silence by their desire not to be tarred as hating on terminally ill patients. 26/

          1 reply 3 retweets 2 likes
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        17. David Gorski, MD, PhD‏Verified account @gorskon 13 Mar 2018

          While it's true that @ASCO has finally woken up, it's too little too late. Medical societies have been shamefully silent until now. The time to oppose #RightToTry was four years ago, before it became a juggernaut that will now likely pass. https://respectfulinsolence.com/2018/03/12/cruel-sham-right-to-try-will-be-up-for-a-vote-house-tuesday/ … 27/27

          0 replies 3 retweets 2 likes
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        18. End of conversation

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