Letter to the FDA (Dr. Janet Woodcock)

Discussion in 'Awareness & Fundraising' started by FGG, Feb 8, 2020.

    1. AUTHOR
      AUTHOR
      FGG
      No Mood

      FGG Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      I agree that both are probably needed. Personal letters and a broader separate petition.

      I don't think we need to wait until after phase 2 if we stress "if these drugs are effective." That's also one reason i don't like mentioning specific drugs and instead offering to open a dialogue with her. It can come off as premature if we start naming drugs at various very different study points. It is literally her job to be aware of all of these drugs. I just want her to be aware of the suffering.

      I have sent a draft to a friend who has a friend who used to work for the FDA. I will be consulting with this friend to see what the best approach might be.
       
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    2. Ben S
      Curious

      Ben S Member

      Location:
      Connecticut
      Tinnitus Since:
      11/2015
      Also, my problem is mostly hearing loss. My clarity has taken quite the hit. So hopefully the restoration of HFs and UHFs essentially solves it. My fingers are crossed...
       
    3. AUTHOR
      AUTHOR
      FGG
      No Mood

      FGG Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      Unfortunately, even if it works spectacularly for tinnitus, Frequency's trial isn't seeking a label for tinnitus. This means if it doesn't show any improvement in hearing, it can't be released without a new trial specifically for tinnitus. An experimental endpoint as i understand it is just valuable for off label use if it gets approved for the indication they are seeking (which is for hearing).

      As such, it would still need to be shown effective for hearing loss. This is part of my push for surrogate end points if needed (e.g.. Word scores having more weight than audiograms if greater improvements shown).

      Edit: this is why names dropping Hough's drug might be confusing since the trial, at this point, is for CI recipients.
       
    4. AUTHOR
      AUTHOR
      FGG
      No Mood

      FGG Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      I feel like maybe I need to explain this better and where the confusion might lie.

      Frequency, Otonomy and Hough's drugs are not being primarily tested for tinnitus (well OTO-313 is, not OTO-413 but it's not regenerative and based on a user here's report I'm not super optimistic about that one).

      Nether is Pipeline but, like Hough, they suspect it will be a good treatment. Frequency clearly thinks it will benefit tinnitus too based on their Q and A and the fact that suddenly they added tinnitus to their experimental arm.

      None of these drugs are in an FDA trial for tinnitus, though. This means that it would be used off label, if effective. I very strongly suspect they will be very useful for tinnitus.

      This is the point I think might have been lost, though:

      We can't write to Dr. Woodcock and plead for her to approve a drug for an indication the drug is not in trials for. She has zero authority to change the entire FDA approval process for one drug. She can't decide that the tinnitus results of these drugs determine breakthrough status if the drug is not being tested for tinnitus unless it also is a breakthrough in terms of hearing. The reason she can't do that is because the IND was granted based on pre-clinical work for hearing, not tinnitus, and the endpoints and trial design were approved for it. Frequency knows this that's why they are just measuring one measure of tinnitus: TFI.

      An example of what I mean: Rogaine started out as a blood pressure drug. If during clinical trials it didn't work for hypertension but grew hair (which they found out during trials it worked extremely well for), they couldn't then approve it for hair loss. BUT if it did work for blood pressure (which it did), they could approve it for hypertension and then people could use it off label for hair loss.

      So asking the FDA to grant breakthrough status for tinnitus for drugs that are not being specifically tested primarily for tinnitus isn't the right approach imo. Instead, talking about how hearing loss and tinnitus are linked and then emphasizing that drugs that are shown to improve hearing can help us, too, is where i am going with this. Because no matter how much compassion she has for us, she can't re-write the rules but we can get her to understand many if not the vast majority of tinnitus sufferers could benefit from the same urgency she gives to hearing loss drugs.

      Does this make sense?
       
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    5. mrbrightside614

      mrbrightside614 Member Podcast Patron Benefactor Advocate

      Location:
      NE Ohio, USA
      Tinnitus Since:
      July 2019
      Cause of Tinnitus:
      Acoustic trauma
      You're right. I totally forgot about that. Fuck. Guess we just pray to god it has better efficacy on hearing than I suspect it will.
       
    6. Lucifer

      Lucifer Member Podcast Patron Benefactor Hall of Fame

      Location:
      Clown World
      Tinnitus Since:
      -
      Cause of Tinnitus:
      -
      @FGG

      You are right. It will be her job to know about these drugs. Keep us up to date.
       
    7. ajc

      ajc Member

      Tinnitus Since:
      11/2002; spike 2009; worse 2017-18
      Cause of Tinnitus:
      Loud music - noise damage
      @mrbrightside614

      This is Janet Woodcock's email address:

      Janet.Woodcock@fda.hhs.gov

      I took this from a letter template The National Alliance of Advocates for Buprenorphine Treatment used when they tried to lobby her.

      Email confirmed working.
       
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    8. mrbrightside614

      mrbrightside614 Member Podcast Patron Benefactor Advocate

      Location:
      NE Ohio, USA
      Tinnitus Since:
      July 2019
      Cause of Tinnitus:
      Acoustic trauma
      Much love AJC. Plea to humanity incoming, whatever, I’ll sell my dignity for a new ear.
       
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    9. AUTHOR
      AUTHOR
      FGG
      No Mood

      FGG Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      Well, report back. I will probably wait on sending mine until I get the former FDA employee to read it and give me advice so I am sure she will get yours first in that case.
       
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    10. AUTHOR
      AUTHOR
      FGG
      No Mood

      FGG Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      It works well for hearing based on what we know.

      One of the things I mentioned putting in my letter is stressing surrogate endpoints. This means word scores can have as much weight as an audiogram. This is all in the "hearing" realm (and needs to be) because that's the indication that the drug is being tested for.
       
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    11. Lucifer

      Lucifer Member Podcast Patron Benefactor Hall of Fame

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      That’s a good idea. Thank you for doing this.
       
    12. Barbara777

      Barbara777 Member Benefactor

      Location:
      USA
      Tinnitus Since:
      2/2015
      I think we should all be sending letters to Janet Woodcock. If only one or two sends a letter, she won't even notice. But if hundreds of us send personal letters, she might pay attention.
       
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    13. Lucifer

      Lucifer Member Podcast Patron Benefactor Hall of Fame

      Location:
      Clown World
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      I will definitely send a letter if it makes a difference. But will it matter if I’m not based in the US?
       
    14. Barbara777

      Barbara777 Member Benefactor

      Location:
      USA
      Tinnitus Since:
      2/2015
      I don't think country makes a difference. You don't need to say which country you come from in your letter.
       
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    15. Lucifer

      Lucifer Member Podcast Patron Benefactor Hall of Fame

      Location:
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      What should I put in for the subject title in the email?
       
    16. all to gain
      No Mood

      all to gain Member Podcast Patron Benefactor

      Tinnitus Since:
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      If one letter is compelling enough, that's all it needs. It all depends on how she looks at things.
       
    17. Barbara777

      Barbara777 Member Benefactor

      Location:
      USA
      Tinnitus Since:
      2/2015
      Do you understand the number of emails she receives? FGG's letter is more likely to end up being unread than anything. More letters, more chance of her reading one of them. Actually for all we know she has a secretary previewing her emails...
      Something that catches her attention... "Janet, what can you do? I'm losing my mind."
      But the subject title needs to come from your heart, decide for yourself.
       
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    18. all to gain
      No Mood

      all to gain Member Podcast Patron Benefactor

      Tinnitus Since:
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      She will almost certainly have a secretary, or two, checking her emails.
       
    19. HootOwl

      HootOwl Member Podcast Patron Benefactor Advocate

      Location:
      California
      Tinnitus Since:
      2009
      Cause of Tinnitus:
      Explanation in About You
      I am simply going to put this out there. I think that we should allow FGG to send her letter first and see if Janet responds. I think it’s the least we can do given the amount of time and effort FGG has put into its drafting, and that it was her idea to begin with.

      It’s very compelling and well thought out and I seriously implore anyone who is thinking of sending an email to please hold off for at least a few weeks until we see if Dr. Woodcock responds. This could be our one chance to open a dialogue. We can always add or send more letters later but we can’t take them back.
       
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    20. AUTHOR
      AUTHOR
      FGG
      No Mood

      FGG Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      I truly don't care the least about the time and effort but I do wonder if a flood of letters asking to approve a drug with Breakthrough Therapy status *for* tinnitus that not in clinical trials for tinnitus will do much good. Because what can she do?

      It would be equivalent of begging the FDA to have approved Trobalt faster so tinnitus users can use it off label. It is not how it works. On the other hand, Dr. Woodcock is insanely smart and can likely connect the dots at least. But asking for an action she can't legally do obviously won't work.

      It is going to take a bit but I now plan to re-write my letter and send it through the former FDA friend that my friend has and again give my personal story and stress the surrogate hearing end points (something she can and should do to help us get the drug faster approval).

      Let us know what y'all hear with this approach. It may take me a lot longer with the avenue I am now trying, anyway.
       
    21. AUTHOR
      AUTHOR
      FGG
      No Mood

      FGG Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      Her constituents are the American people, though. And her regulations follow US guidelines, law and regulations. It certainly won't *hurt* to send a letter but I encourage everyone to read about the FDA approval process first. It's quite different than Europe.
       
    22. mrbrightside614

      mrbrightside614 Member Podcast Patron Benefactor Advocate

      Location:
      NE Ohio, USA
      Tinnitus Since:
      July 2019
      Cause of Tinnitus:
      Acoustic trauma
      I still want @FGG on the lead with this.

      I want to attach as many signatures as we can.

      If it goes unread then maybe we send it out en masse.

      I’m not sending anything first.
       
    23. AUTHOR
      AUTHOR
      FGG
      No Mood

      FGG Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      If anyone wants to send one first I strongly recommend not trying to plead for her to give Breakthrough Therapy status for the reason that people with tinnitus are suffering. Instead, argue for how hearing loss and tinnitus are linked and see if we can get her to use a *hearing* surrogate to approve a drug that will help more than just hearing patients in the process. So it gives her a reason to help *within the framework of what is possible in the FDA*.

      If you aren't familiar with end point surrogates, I can give an example: to get a cancer drug approved faster you can look at median survival time even if other measures are not as rigorous (e.g.. Tumor size or biomarkers).

      I don't think I can be the lead on a communal effort as I am realizing I am not very good at communicating my objectives!

      So if y'all want to work in a joint effort, I am going to see if I can approach this through a different channel (that's all I am going to say for now). I'm leaving this thread for you guys to work on that effort together. Keep us posted!
       
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    24. mrbrightside614

      mrbrightside614 Member Podcast Patron Benefactor Advocate

      Location:
      NE Ohio, USA
      Tinnitus Since:
      July 2019
      Cause of Tinnitus:
      Acoustic trauma
      No, I totally get it. Please stay on track. Go with your gut, don’t let our fingerprints muddy your words.
       
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    25. Jack V

      Jack V Member Benefactor

      Tinnitus Since:
      1/2020
      GREAT letter. Thanks for doing this!

      Two thoughts.

      1) You could casually mention one or two drugs you're particularly excited about without making too big a deal out of it. For example, inserting FX-322 into your text:

      "I know from reading op-ed pieces that you are personally very committed to FDA reform to make it work better for suffering patients. I ask that you consider us with debilitating hearing symptoms in these decisions, too. For the first time in history, regenerative medicine may help us. I'm particularly excited about the prospects of FX-322, and I'm sure you're familiar with many others as well. No matter which part of the cochlea is addressed: Outer hair cells, inner hair cells, cochlear synapse etc. I ask that, if any of these medications show efficacy in an important end point and are shown to be safe, I implore you and the FDA to help us get our lives back sooner.

      Thank you so much for the work that you do. I know you fight for so many suffering people,..."


      2) I would remove "Hi. Thank you for your time" from the opening and simply start with "I am a former veterinarian..."

      Anyway, awesome letter!!!

      Jack
       
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    26. hans799
      Mellow

      hans799 Member Benefactor Hall of Fame

      Location:
      Hungary
      Tinnitus Since:
      Born with it
      Cause of Tinnitus:
      Worsened Dec 2016 by headphones
      Superbly written @FGG, thank you for doing this.

      With all the recent activity here (the podcasts, the Lenire interviews, the attendance at and reporting back from conferences, this letter, etc), I feel that Tinnitus Talk/Tinnitus Hub is what the useless ATA/BTA should have been all along. Finally, a real advocate.
       
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    27. Hazel
      Dreaming

      Hazel Director Staff Podcast Patron Benefactor Hall of Fame Advocate

      Location:
      the Netherlands
      Tinnitus Since:
      10/2017
      Cause of Tinnitus:
      one-sided hearing loss (of unknown origin)
      Thank you! That's very kind and great to hear! It does feel like we're getting a lot done these days for just a small club of volunteers. Active members like yourself are what keep us going!

      In this case though, we cannot take any credit, the letter to Dr. Woodcock was fully @FGG's own initiative. But we're always happy to facilitate any personal initiatives and draw attention to it.

      We do by the way have some US political lobbying efforts coming up that are driven by Tinnitus Hub. It has to do with the NIDCD's strategic plan and an opportunity to give feedback there. You'll hear more about it very soon. @TuxedoCat, @mrbrightside614, @lcj, @Watasha and @HootOwl are working hard to prepare a coordinated effort here.
       
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    28. lcj

      lcj Member Podcast Patron Benefactor Advocate

      Tinnitus Since:
      2001
      Cause of Tinnitus:
      medication
      I think you said the reverse of what you meant to say. In oncology, median survival time/overall survival is the most critical endpoint that the FDA considers - other analysis are usually surrogate endpoints for survival. Sometimes survival can be expressed in a compound primary endpoint like progression free survival. Other endpoints like time to metastasis, time to radiographic progression, etc are usually secondary endpoints and endpoints like time to chronic opiate use may be secondary or tertiary endpoints, while biomarkers would usually only be considered as exploratory analysis (not qualifying under any of the endpoint analysis).

      The reason surrogate endpoints are commonly used in oncology along with survival time is that for many populations and disease indications, people may not die fast enough in order for the study to collect enough data within a reasonable amount of time. But the FDA strongly prefers that the survival endpoint be co-primary, and it's very difficult to get approval with using surrogate endpoints alone.

      You make an interesting point though regarding if there was a treatment for tinnitus/hearing loss what the measurable endpoints would be and which may be primary or surrogate.
       
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    29. AUTHOR
      AUTHOR
      FGG
      No Mood

      FGG Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      01/2019
      Cause of Tinnitus:
      Multi-factorial
      This is exactly why I need my friend's former FDA friend to read my letter first. I know the general concepts but if I want to use examples in other fields (I think it might be stronger to do that), I want to make sure they are the right ones that are applicable.
       
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    30. Lucifer

      Lucifer Member Podcast Patron Benefactor Hall of Fame

      Location:
      Clown World
      Tinnitus Since:
      -
      Cause of Tinnitus:
      -
      @FGG

      Did you end up sending the letter in the end?
       
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